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Designs for Quantitative Nursing Research: Quick-Access Chart

Descriptive Study Designs


Typical descriptive study designs, p. 216
Comparative descriptive designs, p. 217
Time-dimensional designs:
Longitudinal designs, p. 219
Cross-sectional designs, p. 220
Trend designs, p. 221
Event-partitioning designs, p. 222
Case study designs, p. 223
Correlational Study Designs
Descriptive correlational designs, p. 225
Predictive designs, p. 226
Model-testing designs, p. 227
Quasi-experimental Study Designs
Nonequivalent comparison group designs:
One-group posttest-only design, p. 234
Posttest-only design with comparison group, p. 234
One-group pretest-posttest design, p. 234
Pretest and posttest design with a comparison group, p. 237
Pretest and posttest design with two comparison treatments, p. 237
Pretest and posttest design with two comparison treatments and a standard or routine care group, p. 237
Pretest and posttest design with a removed treatment, p. 238
Pretest and posttest design with a reversed treatment, p. 240
Interrupted time-series designs:
Simple interrupted time-series designs, p. 242
Interrupted time-series design with a no-treatment comparison group, p. 242
Interrupted time-series design with multiple treatment replications, p. 243
Experimental Study Designs
Classic experimental design, p. 245
Experimental posttest-only comparison group design, p. 246
Randomized blocking design, p. 246
Factorial design, p. 247
Nested design, p. 248
Crossover or counterbalanced design, p. 249
Clinical trials, p. 250
Randomized controlled trials, p. 251
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SEVENTH
EDITION

THE

PRACTICE OF
NURSING RESEARCH
Appraisal, Synthesis, and Generation of Evidence
Susan K. Grove, PhD, RN, ANP-BC, GNP-BC
Professor
College of Nursing
The University of Texas at Arlington
Arlington, Texas;
Adult Nurse Practitioner
Family Practice
Grand Prairie, Texas

Nancy Burns, PhD, RN, FCN, FAAN


Professor Emeritus
College of Nursing
The University of Texas at Arlington
Arlington, Texas;
Faith Community Nurse
St. Matthew Cumberland Presbyterian Church
Burleson, Texas

Jennifer Gray, PhD, RN


George W. and Hazel M. Jay Professor
College of Nursing
Associate Dean and Chair
Department of MSN Administration, Education, and PhD Programs
The University of Texas at Arlington
Arlington, Texas
3251 Riverport Lane
St. Louis, Missouri 63043

THE PRACTICE OF NURSING RESEARCH: APPRAISAL, SYNTHESIS, 978-1-455-70736-2


AND GENERATION OF EVIDENCE, SEVENTH EDITION
Copyright © 2013, 2009, 2005, 2001, 1997, 1993, 1987 by Saunders, an imprint of Elsevier Inc.

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(other than as may be noted herein).

Notices

Knowledge and best practice in this field are constantly changing. As new research and experience
broaden our understanding, changes in research methods, professional practices, or medical treatment may
become necessary.
Practitioners and researchers must always rely on their own experience and knowledge in evaluating
and using any information, methods, compounds, or experiments described herein. In using such
information or methods they should be mindful of their own safety and the safety of others, including
parties for whom they have a professional responsibility.
With respect to any drug or pharmaceutical products identified, readers are advised to check the most
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To the fullest extent of the law, neither the Publisher nor the authors, contributors, or editors, assume
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Library of Congress Cataloging-in-Publication Data

Grove, Susan K.
  The practice of nursing research : appraisal, synthesis, and generation of evidence / Susan K. Grove,
Nancy Burns, Jennifer Gray.—7th ed.
   p. ; cm.
  Nancy Burns is first named author on previous edition.
  Includes bibliographical references and index.
  ISBN 978-1-4557-0736-2 (pbk.)
  I.  Burns, Nancy, Ph.D.  II.  Gray, Jennifer, 1955-  III.  Title.
  [DNLM: 1.  Nursing Research—methods.  2.  Evidence-Based Nursing.  WY 20.5]
  610.73072—dc23
    2012019862

Executive Content Strategist: Lee Henderson


Associate Content Development Specialist: Julia Curcio
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Production Manager: Hemamalini Rajendrababu
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Last digit is the print number:  9  8  7  6  5  4  3  2


To our readers and researchers, nationally and internationally, who will
provide the science to develop an evidence-based practice for nursing.

To our family members for their constant input, support, and love,
especially our husbands
Jay Suggs,
Jerry Burns,
and
Randy Gray

Susan, Nancy, and Jennifer


Contributors

Daisha J. Cipher, PhD Christine Miaskowski, RN, PhD, FAAN


Clinical Associate Professor Professor & Associate Dean
College of Nursing Physiological Nursing
University of Texas at Arlington University of California
Arlington, Texas San Francisco, California
Chapters 22, 23, 24 & 25 Chapter 29

Kathryn M. Daniel, PhD, RN Rosemary C. Polomano, PhD, RN, FAAN


Assistant Professor Associate Professor of Pain Practice
College of Nursing Department of Biobehavioral Health Sciences
University of Texas Arlington University of Pennsylvania School of Nursing
Arlington, Texas Philadelphia, Pennsylvania
Clinical Educator Faculty
Diane Doran, RN, PhD, FCAHS Department of Nursing
Professor Hospital of the University of Pennsylvania
Scientific Director, Nursing Health Services Philadelphia, Pennsylvania
Research Unit (University of Toronto site) Associate Professor of Anesthesiology and Critical
Lawrence S. Bloomberg Faculty of Nursing Care
University of Toronto Department of Anesthesiology and Critical Care
Toronto, Ontario University of Pennsylvania School of Medicine
Canada Philadelphia, Pennsylvania
Chapter 13 Chapter 14

Kathryn Aldrich Lee, RN, PhD


Professor and Associate Dean for Research
James and Marjorie Endowed Chair in Nursing
Family Health Care Nursing
University of California
San Francisco
San Francisco, California
Chapters 20 & 27

Judy L. LeFlore PhD, RN, NNP-BC, CPNP-PC &


AC, ANEF
Director
Pediatric, Acute Care Pediatric, Neonatal Nurse
Practitioner Programs
Nursing
University of Texas at Arlington
Arlington, Texas
Nurse Practitioner
Advanced Practice Services
Children’s Medical Center, Dallas
Dallas, Texas
Chapters 10 & 11

vi
Reviewers

Lisa D. Brodersen ED, RN Ida Slusher, RN, DSN, CNE


Allen College Professor & Nursing Education Coordinator
Waterloo, Iowa Department of Baccalaureate & Graduate Nursing
Eastern Kentucky University
Sara L. Clutter, PhD, RN Richmond, Kentucky
Associate Professor of Nursing
Waynesburg University Jeanne M. Sorrell, PhD, RN, FAAN
Waynesburg, Pennsylvania Cleveland Clinic
Cleveland, Ohio
Josephine DeVito, PhD, RN
Associate Professor Molly J. Walker, PhD, RN. CNS, CNE
College of Nursing Associate Professor, Angelo State University
Seton Hall University San Angelo, Texas
South Orange, New Jersey
Angela F. Wood RN, NNP-BC, PhD
Jacalyn P. Dougherty, PhD, RN Carson-Newman College
Aurora, Colorado Jefferson City, Tennesse

Betsy Frank, RN, PhD Fatma A. Youssef, RN, MPH, DNSc


College of Nursing, Health, and Human Services Professor of Nursing, Marymount University
Indiana State University Arlington, VA
Terre Haute, Indiana
Mary Beth Zeni, MSN, ScD, RN
Sharon Kitchie, RN, PhD, CNS-BC Senior Nurse Researcher, Cleveland Clinic
Patient Education and Interpreter Services Specialist Cleveland, Ohio
Upstate University Hospital
Syracuse, New York

Madelaine Lawrence, PhD, RN


Queens University of Charlotte
Charlotte, NC

vii
Preface

R
esearch is a major force in the nursing profes- • A balanced coverage of qualitative and quantitative
sion that is used to change practice, education, research methodologies.
and health policy. Our aim in developing the • Electronic references and websites that direct the
seventh edition of The Practice of Nursing Research: student to an extensive array of information that is
Appraisal, Synthesis, and Generation of Evidence is to important for conducting studies and using research
increase excitement about research and to facilitate the findings in practice.
development of evidence-based practice for nursing. • Rich and frequent illustration of major points and
It is critically important that all nurses, especially those concepts from the most current nursing research
in advanced-practice roles (nurse practitioners, clini- literature from a variety of clinical practices areas.
cal nurse specialists, nurse anesthetists, and nurse mid- • A strong conceptual framework that links nursing
wives) and those assuming roles as administrators and research with EBP, theory, knowledge, and
educators, have a strong understanding of the research philosophy.
methods conducted to generate evidence-based knowl- Our text provides a comprehensive introduction to
edge for nursing practice. Graduate and undergraduate nursing research for graduate and practicing nurses.
nursing students and practicing nurses need to be For use at the master’s and doctoral level, the text
actively involved in critically appraising and synthe- provides not only substantive content related to
sizing research evidence for the delivery of quality, research but also practical applications based on the
cost-effective care. This text provides detailed content authors’ experiences in conducting various types of
and guidelines for implementing critical appraisal and nursing research, familiarity with the research litera-
synthesis processes. The text also contains extensive ture, and experience in teaching nursing research at
coverage of the research methods—quantitative, qual- various educational levels.
itative, outcomes, and intervention—commonly con- The seventh edition of this text is now organized
ducted in nursing. Doctoral students might use this text into 5 units and 29 chapters. Unit One introduces the
to facilitate their conduct of quality studies essential reader to the world of nursing research. The content
for generating nursing knowledge. and presentation of this unit have been designed to
The depth and breadth of content presented in this introduce EBP, quantitative research, and qualitative
edition reflect the increase in research activities and research.
the growth in research knowledge since the previous Unit Two provides an in-depth presentation of the
edition. Nursing research is introduced at the bacca- research process for both quantitative and qualitative
laureate level and becomes an integral part of graduate research. As with previous editions, this text provides
education (master’s and doctoral) and clinical practice. extensive coverage of the many types of quantitative
We hope that this new edition might raise the number and qualitative research.
of nurses at all levels involved in research activities Unit Three addresses the implications of research
to improve the outcomes for nursing practice. for the discipline and profession of nursing. Content
The seventh edition is written and organized to is provided to direct the student in conducting critical
facilitate ease in reading, understanding, and imple- appraisals of both quantitative and qualitative research.
menting the research process. The major strengths of A detailed discussion of types of research synthesis
this text are as follows: and strategies for promoting EBP is provided.
• State-of-the-art coverage of EBP—a topic of vital Unit Four gives students and practicing nurses the
and growing importance in a healthcare arena content they need for implementing studies. This unit
focused on quality, cost-effective patient care. includes chapters focused on data collection, statisti-
• A clear, concise writing style that is consistent cal analysis, interpretation of research outcomes, and
among the chapters to facilitate student learning. dissemination of research finding.
• Comprehensive coverage of quantitative, qualita- Unit Five addresses proposal development and
tive, outcomes, and intervention research methods. seeking support for research. Readers are given

viii
Preface ix

direction for developing quantitative and qualitative and Accountability Act (HIPAA), (2) U.S. Depart-
research proposals and seeking funding for their ment of Health and Human Services (DHHS) regu-
research. lations for protection of human subjects in research,
The changes in the seventh edition of this text and (3) U.S. Food and Drug Administration (FDA)
reflect the advances in nursing research and also incor- regulations for protection of research subjects. This
porate comments from outside reviewers, colleagues, chapter also details the escalating problem of
and students. Our desire to promote the continuing research misconduct in all healthcare disciplines
development of the profession of nursing was the and the actions that have been taken to manage this
incentive for investing the time and energy required problem.
to develop this new edition. • Chapter 10, “Understanding Quantitative Research
Designs,” provides new content on mixed-methods
designs that include both quantitative and qual­
New Content itative research methods. Four common mixed-
The seventh edition provides current comprehensive method research strategies conducted in nursing
coverage of nursing research and is focused on the are discussed: sequential explanatory strategy,
learning needs and styles of today’s nursing students sequential exploratory strategy, sequential transfor-
and practicing nurses. Several exciting new areas of mative strategy, and concurrent triangulation strat-
content based on the changes and expansion in the egy. These strategies are presented using models,
field of nursing research are included in this edition. narrative descriptions, and examples.
Some of the major changes from the previous edition • Chapter 11, “Selecting a Quantitative Research
are as follows: Design,” describes many currently used designs
• Chapter 1, “Discovering the World of Nursing that are not covered in other leading texts but that
Research,” is a strong introduction to evidence- are important to the generation of nursing knowl-
based practice (EBP) that is linked to nursing edge. It contains a detailed discussion of random-
research using a revised framework model for this ized controlled trials (RCTs) along with the
edition of the text. Consolidated Standards for Reporting Trials
• Chapter 2, “Evolution of Research in Building Evi- (CONSORT, 2010) guidelines.
dence-Based Nursing Practice,” has a new title • Chapter 12, “Qualitative Research Methodology,”
and is focused on building an EBP for nursing. is completely reorganized to address each step of
This chapter introduces the most current processes the research process from writing the problem
for synthesizing research knowledge, which are statement to interpreting the findings for qualitative
systematic reviews, meta-analyses, meta-syntheses, studies. The data collection methods of observing,
and mixed-method systematic reviews. The chapter interviewing, and conducting focus groups are
includes a table that presents the purposes of these described in depth. In addition, examples of using
syntheses, the types of research they include (the photovoice, videos, and electronic communication
“sampling frame”), and the analysis for achieving are given. Methods specific to each philosophical
the different types of syntheses. A model of the approach are also discussed.
continuum of the levels of research evidence, from • Chapter 13, “Outcomes Research,” a unique feature
strongest to weakest evidence, is provided. of our text, was significantly rewritten to promote
• Chapter 4, “Introduction to Qualitative Research,” understanding of the history, significance, and
describes the philosophical perspectives that guide impact of outcomes research on nursing and health
the following five approaches to qualitative re- care, for both students and nurses in clinical prac-
search: (1) phenomenology, (2) grounded theory, tice. New content is included on nurse-sensitive
(3) ethnography, (4) exploratory-descriptive quali- patient outcomes, advanced-practice nursing out-
tative research, and (5) historical research. Excerpts comes, and databases used in conducting outcomes
from qualitative studies are provided to emphasize research. In addition, the methodologies for con-
the contributions researchers using each approach ducting outcomes research have been updated and
have made to nursing science. expanded. This chapter was revised by a leading
• Chapter 6, “Review of Relevant Literature,” pro- authority in the conduct of outcomes research,
vides current, comprehensive strategies for search- Dr. Diane Doran.
ing the literature to identify relevant sources. • Chapter 14, “Intervention-Based Research,” was
• Chapter 9, “Ethics in Research,” features updated extensively rewritten to focus on the conduct of
coverage of (1) the Health Insurance Portability intervention-based research. It offers students and
x Preface

practicing nurses detailed, current content and systematic reviews. Guidelines are also provided
guidelines for critically appraising and conducting to direct students in evaluating these research syn-
intervention studies. The chapter was revised by theses, which are appearing more frequently in the
Dr. Rosemary Polomano, an authority in the nursing and healthcare literature. Current informa-
conduct of intervention research. tion is given on the activities of Evidence-Based
• Chapter 15, “Sampling,” contains extensive cover- Practice Centers and the new initiative for funding
age of current sampling methods and the processes translation research through the National Institutes
for determining sample size for quantitative and of Health to increase the implementation of evi-
qualitative studies. This chapter includes formulas dence-based interventions in practice.
for calculating the acceptance and refusal rates for • Chapter 20, “Collecting and Managing Data,” now
potential study participants and the retention and covers practical aspects of developing a data collec-
attrition rates for subjects participating in a study. tion plan, including formatting instruments, creat-
Additional current content is provided to assist ing a data flow chart, and training data collectors. In
researchers in determining sample size for quanti- addition, common problems that occur during data
tative and qualitative research and for recruiting collection are described, with possible solutions.
and retaining subjects for their studies. • Major revisions have been made in the chapters
• Chapter 16, “Measurement Concepts,” features focused on statistical concepts and analysis tech-
detailed information for examining the reliability niques (Chapters 21 through 25). The content is
and validity of measurement methods and the pre- presented in a clear, concise manner and supported
cision and accuracy of physiological measures used with examples of analyses conducted on actual
in nursing studies. Students are provided a back- clinical data. Dr. Daisha Cipher, a noted statistician
ground for understanding sensitivity, specificity, and healthcare researcher, assisted with the revi-
and likelihood ratios used to determine the quality sion of these chapters.
of diagnostic tests. • Chapter 27, “Disseminating Research Findings,”
• Chapter 17, “Measurement Methods Used in features expanded and updated content on com-
Developing Evidence for Practice,” provides more municating study findings through oral and poster
detail on the use of physiological measurement presentations and publications.
methods in research. A growing number of nursing • Chapter 29, “Seeking Funding for Research,” pro-
studies are focused on the measurement of the vides current strategies to assist students and prac-
outcomes from interventions using physiological ticing nurses in obtaining funding for their studies.
measurement methods, and this chapter equips
the reader to understand and participate in these
studies. Student Ancillaries
• Chapter 18, “Critical Appraisal of Nursing Studies,” An Evolve Resources website, which is available at
has a more refined process for critically appraising http://evolve.elsevier.com/Grove/practice/, features a
quantitative studies that consists of the following wealth of assets, including the following:
steps: (1) identifying the steps of the research • Interactive Review Questions
process, (2) determining the study strengths and • Data Sets and Data Set Activities
weaknesses, and (3) evaluating the credibility and • Sample Research Proposals
meaning of a study for nursing knowledge and prac- An electronic Study Guide accompanies this
tice. The process of critically appraising qualitative edition of The Practice of Nursing Research. This
studies was revised to evaluate studies using the study guide is keyed chapter-by-chapter to the text. It
standards of philosophical congruence, method- includes the following:
ological coherence, intuitive comprehension, and • Relevant Terms activities that help students under-
intellectual contribution. stand and apply the language of nursing research
• Chapter 19, “Evidence Synthesis with Strategies • Key Ideas exercises that reinforce essential
for Promoting Evidence-Based Practice,” has concepts
undergone extensive revision to achieve a com- • Making Connections activities that give students
pletely new focus on how to conduct research practice in the higher-level skills of comprehension
syntheses and use the best research evidence and content synthesis
in practice. The chapter now contains extensive • Crossword Puzzles that serve not only as a clever
details for conducting systematic reviews, meta- learning activity but also as a welcome “fun” activ-
analyses, meta-syntheses, and mixed-method ity for busy adult learners
Preface xi

• Exercises in Critical Appraisal that provide expe­


riences for students and practicing nurses to cri­ Instructor Ancillaries
tically evaluate both quantitative and qualitative The Instructor Resources are available on Evolve, at
studies http://evolve.elsevier.com/Grove/practice/. Instructors
• Going Beyond activities that provide suggestions also have access to the online student resources. The
for further study Instructor Resources are an Instructor’s Manual, an
• An Answer Key is provided at the end of each expanded Test Bank including 600 questions, Power-
chapter that offers immediate feedback to reinforce Point Presentations totaling more than 700 slides, and
learning an Image Collection consisting of most images from
• A Published Studies appendix is provided for the the text.
critical appraisal exercises in the study guide, and
other current studies are included on the Evolve
website for faculty to use in providing learning
experiences for their students.
Acknowledgments

W
riting the seventh edition of this textbook College of Nursing at The University of Texas at
has allowed us the opportunity to examine Arlington, for their support during the long and some-
and revise the content of the previous times arduous experiences that are inevitable in devel-
edition based on input from a number of scholarly oping a book of this magnitude. We would also like
colleagues, the literature, and our graduate and under- to thank Dr. Julie Barroso for her suggestions regard-
graduate students. A textbook such as this requires ing the qualitative research content in this text. We
synthesizing the ideas of many people and resources. particularly value the questions raised by our students
For the first time, expert contributors have revised key regarding the content of this text, which allow us a
chapters of this textbook. These experts have added unique view of our learners’ perceptions.
invaluable content in critical areas of outcomes We would also like to recognize the excellent
research, intervention research, design, data collec- reviews of the colleagues who helped us make impor-
tion, and statistics. We thank these scholars for sharing tant revisions in this text. These reviewers are located
their expertise. in large and small universities across the United States
We have also attempted to extract from the nursing and provided a broad range of research expertise.
and healthcare literature the essence of knowledge Finally, we thank the people at Elsevier, who have
related to the conduct of nursing research. Thus we been extremely helpful to us in producing a scholarly,
would like to thank those scholars who shared their attractive, appealing text. We extend a special thank
knowledge with the rest of us in nursing and who have you to the people most instrumental in the develop-
made this knowledge accessible for inclusion in this ment and production of this book: Lee Henderson,
textbook. The ideas from the literature were synthe- Executive Content Strategist; and Julia Curcio, Asso-
sized and discussed with our colleagues and students ciate Content Development Specialist. We also want
to determine the revisions needed for the seventh to thank others involved with the production and mar-
edition. keting of this book—Antony Prince, Project Manager;
We would also like to express our appreciation to Karen Pauls, Designer; and Pat Crowe, Marketing
Dean Elizabeth Poster and faculty members of the Manager.
Susan K. Grove, Nancy Burns,
PhD, RN, ANP-BC, GNP-BC PhD, RN, FAAN

Jennifer Gray,
PhD, RN

xii
Contents

Unit One Example of Problem and Purpose Development, 83


Feasibility of a Study, 84
Introduction to Nursing Example Research Topics, Problems, and Purposes
Research, 1 for Different Types of Research, 87
  1 Discovering the World of Nursing
Research, 1   6 Review of Relevant Literature, 97
Definition of Nursing Research, 1 What Is “The Literature”?, 97
Framework Linking Nursing Research to the World of What Is a Literature Review?, 97
Nursing, 2 Purposes of Reviewing the Literature, 98
Significance of Research in Building an Evidence- Practical Considerations, 100
Based Practice for Nursing, 11 Stages of a Literature Review, 102
Processing the Literature, 108
Writing the Review of Literature, 110
  2 Evolution of Research in Building Evidence-
Example of a Literature Review, 112
Based Nursing Practice, 17
Historical Development of Research in Nursing, 17
  7 Frameworks, 116
Methodologies for Developing Research Evidence in
Nursing, 23 Definition of Terms, 116
Classification of Research Methodologies Presented Understanding Concepts, 117
in this Text, 25 Examining Relational Statements, 120
Introduction to Best Research Evidence for Practice, 28 Grand Theories, 125
Application of Middle-Range Theories, 125
Appraising Theories and Research Frameworks, 127
  3 Introduction to Quantitative Research, 34 Developing a Research Framework for Study, 130
Concepts Relevant to Quantitative Research, 34
Steps of the Quantitative Research Process, 38
  8 Objectives, Questions, Hypotheses,
Selecting a Research Design, 43
Types of Quantitative Research, 49 and Study Variables, 138
Formulating Research Objectives or Aims, 138
Formulating Research Questions, 140
  4 Introduction to Qualitative Research, 57
Formulating Hypotheses, 142
Perspective of the Qualitative Researcher, 57 Selecting Objectives, Questions, or Hypotheses for
Approaches to Qualitative Research, 59 Quantitative or Qualitative Research, 150
Identifying and Defining Study Variables, 150
Unit Two Operationalizing Variables or Concepts for a
Study, 155
The Research Process, 73
  5 Research Problem and Purpose, 73   9 Ethics in Research, 159
What Is a Research Problem and Purpose?, 73 Historical Events Affecting the Development of
Sources of Research Problems, 75 Ethical Codes and Regulations, 159
Formulating a Research Problem and Purpose, 81
xiii
xiv Contents

Protection of Human Rights, 163 Federal Government Involvement in Outcomes


Balancing Benefits and Risks for a Study, 175 Research, 300
Obtaining Informed Consent, 176 Outcomes Research and Nursing Practice, 302
Institutional Review, 183 Methodologies for Outcomes Studies, 306
Research Misconduct, 187 Disseminating Outcomes Research Findings, 318
Animals as Research Subjects, 190
14 Intervention-Based Research, 323
10 Understanding Quantitative Research Intervention-Based Research Conducted by
Design, 195 Nurses, 323
Concepts Important to Design, 195 Nursing Interventions, 324
Study Validity, 197 Programs of Nursing Intervention Research, 326
Elements of a Good Design, 202 Terminology for Intervention-Based Research, 329
Questions to Direct Design Development and Types of Research Designs, 335
Implementation in a Study, 207 Planning Intervention Research, 338
Mixed Methods, 208 Design and Testing of Interventions, 339
Process of Testing the Intervention, 342
Data Collection, 345
11 Selecting a Quantitative Research Threats to Study Validity, 345
Design, 214 Critical Appraisal of Intervention-Based
Descriptive Study Designs, 215 Research, 345
Surveys, 224
Correlational Study Designs, 224
15 Sampling, 351
Defining Therapeutic Nursing Interventions, 228
Quasi-experimental Study Designs, 231 Sampling Theory, 351
Experimental Study Designs, 244 Probability (Random) Sampling Methods, 357
Studies That Do Not Use Traditional Research Nonprobability (Nonrandom) Sampling Methods
Designs, 254 Commonly Applied in Quantitative Research, 362
Algorithms for Selecting Research Designs, 256 Nonprobability Sampling Methods Commonly
Applied in Qualitative Research, 364
Sample Size in Quantitative Research, 367
12 Qualitative Research Methodology, 264 Sample Size in Qualitative Research, 371
Clinical Context and Research Problems, 264 Research Settings, 373
Literature Review for Qualitative Studies, 265 Recruiting and Retaining Research
Theoretical Frameworks, 265 Participants, 374
Purposes, 266
Research Objectives or Questions, 266
16 Measurement Concepts, 382
Obtaining Research Participants, 267
Data Collection Methods, 268 Directness of Measurement, 382
Electronically Mediated Data, 276 Measurement Error, 383
Transcribing Recorded Data, 278 Levels of Measurement, 385
Data Management, 279 Reference Testing of Measurement, 388
Data Analysis, 279 Reliability, 389
Methods Specific to Qualitative Approaches, 284 Validity, 393
Accuracy, Precision, and Error of Physiological
Measures, 402
13 Outcomes Research, 294 Sensitivity, Specificity, and Likelihood Ratios, 406
Theoretical Basis of Outcomes Research, 294
Evaluating Structure, 298
Contents xv

17 Measurement Methods Used in Developing


Evidence-Based Practice, 411
Unit Four
Analyzing Data, Determining
Physiological Measurement, 411
Observational Measurement, 421
Outcomes, and Disseminating
Interviews, 422 Research, 507
Questionnaires, 425 20 Collecting and Managing Data, 507
Scales, 429
Data Collection Modes, 507
Q-Sort Methodology, 434
Factors Influencing Data Collection, 515
Delphi Technique, 435
Data Collection and Coding Plan, 517
Diaries, 437
Pilot Study, 523
Measurement Using Existing Databases, 439
Collecting Data, 523
Selection of an Existing Instrument, 440
Serendipity, 530
Constructing Scales, 442
Having Access to Support Systems, 530
Translating a Scale to Another Language, 445
Managing Data, 531

Unit Three 21 Introduction to Statistical Analysis, 534


Putting It All Together
Concepts of Statistical Theory, 534
for Evidence-Based Health Practical Aspects of Data Analysis, 542
Care, 451 Choosing Appropriate Statistical Procedures for a
Study, 546
18 Critical Appraisal of Nursing
Studies, 451
Evolution of Critical Appraisal of Research in
22 Using Statistics to Describe Variables, 550
Nursing, 451 Using Statistics to Summarize Data, 550
Nurses’ Expertise in Critical Appraisal of Using Statistics to Explore Deviations in the
Research, 454 Data, 554
Critical Appraisal Process for Quantitative
Research, 454 23 Using Statistics to Examine
Critical Appraisal Process for Qualitative
Relationships, 560
Studies, 462
Scatter Diagrams, 560
Bivariate Correlational Analysis, 560
19 Evidence Synthesis and Strategies Bland and Altman Plots, 565
for Evidence-Based Practice, 468 Factor Analysis and Principal Components
Benefits and Barriers Related to Evidence-Based Analysis, 566
Nursing Practice, 468
Guidelines for Synthesizing Research Evidence, 471 24 Using Statistics to Predict, 570
Models to Promote Evidence-Based Practice in
Simple Linear Regression, 570
Nursing, 493
Calculation, 571
Implementing Evidence-Based Guidelines in
Multiple Regression, 573
Practice, 496
Odds Ratio, 575
Evidence-Based Practice Centers, 502
Logistic Regression, 576
Introduction to Translational Research, 503
Cox Proportional Hazards Regression, 577
xvi Contents

25 Using Statistics to Determine Seeking Approval for a Study, 644


Differences, 580 Example of a Quantitative Research
Proposal, 647
Choosing Parametric versus Nonparametric Statistics
to Determine Differences, 580
t-tests, 580 29 Seeking Funding for Research, 663
One-Way Analysis of Variance, 584 Building a Program of Research, 663
Chi-Square Test of Independence, 587 Getting Started, 665
Identifying Funding Sources, 667
26 Interpreting Research Outcomes, 590 Submitting a Proposal for a Federal Grant, 670
Grant Management, 671
Examining Evidence, 590
Planning Your Next Grant, 672
Determining Findings, 595
Forming Conclusions, 596
Identifying Limitations, 598 Appendices
Generalizing the Findings, 598 Appendix A. Z Values Table, 674
Considering Implications, 599 Appendix B. Critical Values for Student’s t
Recommending Further Research, 599 Distribution, 677
Appendix C. Critical Values of r for Pearson Product
27 Disseminating Research Findings, 602 Moment Correlation Coefficient, 679
Appendix D. Critical Values of F for α = 0.05 and
Content of a Research Report, 602
α = 0.01, 680
Audiences for Communication of Research
Appendix E. Critical Values of the χ2 Distribution, 683
Findings, 619
Appendix F. Statistical Power Tables
Presenting Research Findings, 621
(Δ = Effect Size), 684
Publishing Research Findings, 627

Glossary, 686
Unit Five
Proposing and Seeking Funding
for Research, 635 Index, 714

28 Writing Research Proposals, 635


Writing a Research Proposal, 635
Content of a Research Proposal, 636
UNIT ONE
Introduction to Nursing Research
1
CHAPTER

Discovering the World


of Nursing Research
  http://evolve.elsevier.com/Grove/practice/

W
elcome to the world of nursing research. You research is the diligent, systematic inquiry or investi-
might think it is strange to consider research gation to validate and refine existing knowledge and
a “world,” but research is truly a new way of generate new knowledge. The concepts systematic and
experiencing reality. Entering a new world requires diligent are critical to the meaning of research because
learning a unique language, incorporating new rules, they imply planning, organization, and persistence.
and using new experiences to learn how to interact Many disciplines conduct research, so what distin-
effectively within that world. As you become a part of guishes nursing research from research in other disci-
this new world, your perceptions and methods of rea- plines? In some ways, there are no differences, because
soning will be modified and expanded. Understanding the knowledge and skills required to conduct research
the world of nursing research is critical to providing are similar from one discipline to another. However,
evidence-based care to your patients. Since the 1990s, when one looks at other dimensions of research within
there has been a growing emphasis for nurses— a discipline, it is clear that research in nursing must
especially advanced practice nurses (nurse practi­ be unique to address the questions relevant to the
tioners, clinical nurse specialists, nurse anesthetists, profession. Nurse researchers need to implement the
and nurse midwives), administrators, educators, and most effective research to develop a unique body of
nurse researchers—to promote an evidence-based knowledge for nursing.
practice in nursing (Brown, 2009; Craig & Smyth, The American Nurses Association (ANA, 2012)
2012; Melnyk & Fineout-Overholt, 2011). Evidence- developed the following definition of nursing that
based practice in nursing requires a strong body of identifies the unique body of knowledge needed by the
research knowledge that nurses must synthesize and profession: “Nursing is the protection, promotion, and
use to promote quality care for their patients, families, optimization of health and abilities, prevention of
and communities. We developed this text to facilitate illness and injury, alleviation of suffering through the
your understanding of nursing research and its con­ diagnosis and treatment of human response, and advo-
tribution to the implementation of evidenced-based cacy in the care of individuals, families, communities,
nursing practice. and populations.” On the basis of this definition,
This chapter broadly explains the world of research. nursing research is needed to generate knowledge
A definition of nursing research is provided followed about human responses and the best interventions to
by the framework for this textbook that connects promote health, prevent illness, and manage illness
nursing research to the world of nursing. The chapter (ANA, 2010b).
concludes with a discussion of the significance of Many nurses hold the view that nursing research
research in developing an evidence-based practice for should focus on acquiring knowledge that can be
nursing. directly implemented in clinical practice, which is
sometimes referred to as applied research or practical
research (Brown, 2009; Mackay, 2009). However,
Definition of Nursing Research another view is that nursing research should include
The root meaning of the word research is “search studies of nursing education, nursing administration,
again” or “examine carefully.” More specifically, health services, and nurses’ characteristics and roles

1
2 UNIT ONE  Introduction to Nursing Research

as well as clinical situations. Riley, Beal, Levi, and Abstract


McCausland (2002) support this second view and
believe nursing scholarship should include education,
practice, and service. Research is needed to identify Philosophy
teaching-learning strategies to promote nurses’ man-
agement of practice. Thus, nurse researchers are
involved in building a science for nursing education Knowledge
so the teaching-learning strategies used are evidence-
based (National League for Nursing [NLN], 2009).
Nurse administrators are involved in research to
enhance nursing leadership and the delivery of quality, Science
cost-effective patient care. Studies of health services
and nursing roles are important to promote quality Theory Research
outcomes in the nursing profession and the healthcare Abstract
system (Doran, 2011). Thought
Processes
Thus, the knowledge generated through nursing
research provides the scientific foundation essential
for all areas of nursing. In this text, nursing research
is defined as a scientific process that validates and Empirical
refines existing knowledge and generates new knowl- World
edge that directly and indirectly influences the deliv- (Evidence-
based nursing
ery of evidence-based nursing.
practice)
Concrete
Framework Linking
Figure 1-1  Framework linking nursing research to the world of
Nursing Research to nursing.
the World of Nursing
To best explore nursing research, we have developed events that we observe and experience in reality. Thus,
a framework to help establish connections between the focus of concrete thinking is immediate events that
research and the various elements of nursing. The are limited by time and space. Most nurses believe
framework presented in the following pages links they are concrete thinkers because they focus on the
nursing research to the world of nursing and is used specific actions in nursing practice. Abstract think-
as an organizing model for this textbook. In the ing is oriented toward the development of an idea
framework model (see Figure 1-1), nursing research without application to, or association with, a particular
is not an entity disconnected from the rest of nursing instance. Abstract thinkers tend to look for meaning,
but rather is influenced by and influences all other patterns, relationships, and philosophical implica-
nursing elements. The concepts in this model are pic- tions. This type of thinking is independent of time and
tured on a continuum from concrete to abstract. The space. Currently, graduate nursing education fosters
discussion introduces this continuum and progresses abstract thinking, because it is an essential skill for
from the concrete concept of the empirical world of developing theory and creating an idea for study.
nursing practice to the most abstract concept of Nurses assuming advanced roles and registered nurses
nursing philosophy. The use of two-way arrows in the (RNs) need to use both abstract and concrete thinking.
model indicates the dynamic interaction among the For example, a nurse practitioner must explore the
concepts. best research evidence about a practice problem
(abstract thinking) before using his or her clinical
Concrete-Abstract Continuum expertise to diagnose and manage an individual
As previously mentioned, Figure 1-1 presents the patient’s health problem (concrete thinking). RNs also
components of nursing on a concrete-abstract contin- use abstract and concrete thinking to develop and
uum. This continuum demonstrates that nursing refine protocols and policies based on current research
thought flows both from concrete to abstract thinking to direct patient care.
and from abstract to concrete. Concrete thinking is Nursing research requires skills in both concrete
oriented toward and limited by tangible things or by and abstract thinking. Abstract thought is required to
CHAPTER 1  Discovering the World of Nursing Research 3

identify researchable problems, design studies, and instruments have been developed to record sensory
interpret findings. Concrete thought is necessary in experiences more accurately. For example, does the
both planning and implementing the detailed steps of patient just feel hot or actually have a fever? Ther-
data collection and analysis. This back-and-forth flow mometers were developed to test this sensory percep-
between abstract and concrete thought may be one tion accurately. Through research, the most accurate
reason why nursing research seems complex and and precise measurement devices have been devel-
challenging. oped to assess the temperature of patients on the
basis of age and health status (Waltz, Strickland, &
Empirical World Lenz, 2010). Thus, research is a way to test reality
The empirical world is what we experience through and generate the best evidence to guide nursing
our senses and is the concrete portion of our existence. practice.
It is what we often call reality, and “doing” kinds of Nurses use a variety of research methods to
activities are part of this world. There is a sense of test their reality and generate nursing knowledge,
certainty about the empirical or real world; it seems including quantitative research, qualitative research,
understandable, predictable, controllable. Concrete outcomes research, and intervention research. Quan-
thinking focuses on the empirical world; words associ- titative research, the most frequently conducted
ated with this thinking include “practical,” “down-to- method, is a formal, objective, systematic meth­
earth,” “solid,” and “factual.” Concrete thinkers want odology to describe variables, test relationships, and
facts. They want to be able to apply whatever they examine cause-and-effect interactions (Kerlinger &
know to the current situation. Lee, 2000; Shadish, Cook, & Campbell, 2002). Since
The practice of nursing takes place in the empirical the 1980s, nurses have been conducting qualitative
world, as demonstrated in Figure 1-1. The scope of research to generate essential theories and knowledge
nursing practice varies for the RN and the advanced for nursing. Qualitative research is a rigorous, inter-
practice nurse (APN). RNs provide care to and coor- active, holistic, subjective research approach used to
dinate care for patients, families, and communities describe life experiences and give them meaning
in a variety of settings. They initiate interventions (Marshall & Rossman, 2011; Munhall, 2012). Both
as well as carry out treatments authorized by other quantitative and qualitative research methods are
healthcare providers (ANA, 2010a). APNs, such important to the development of nursing knowledge
as nurse practitioners, nurse anesthetists, nurse mid- (Fawcett & Garity, 2009; Munhall, 2012; Shadish et
wives, and clinical nurse specialists, have an expanded al., 2002). Some researchers effectively combine these
practice. Their knowledge, skills, and expertise pro­ two methods in implementing mixed method research
mote role autonomy and overlap with medical prac- to address selected nursing research problems (Cre-
tice. APNs usually concentrate their clinical practice swell, 2009).
in a specialty area, such as acute care, pediatrics, ger- Medicine, healthcare agencies, and now nursing
ontology, adult or family primary care, psychiatric- are focusing on the outcomes of patient care. Out-
mental health, women’s health, maternal child, or comes research is an important scientific methodol-
anesthesia (ANA, 2010b). You can access the most ogy that has evolved to examine the end results of
current nursing scope and standards for practice from patient care and the outcomes for healthcare providers,
the ANA (2010a). Within the empirical world of such as RNs, APNs, and physicians, and for healthcare
nursing, the goal is to provide evidence-based practice agencies (Doran, 2011). Nurses are also engaged in
to improve the health outcomes of individuals, fami- intervention research, a methodology for investigat-
lies, and communities (see Figure 1-1). The aspects ing the effectiveness of nursing interventions in
of evidence-based practice and the significance of achieving the desired outcomes in natural settings
research in developing evidence-based practice are (Forbes, 2009). These different types of research are
covered later in this chapter. all essential to the development of nursing science,
theory, and knowledge (see Figure 1-1). Nurses have
Reality Testing Using Research varying roles related to research that include conduct-
People tend to validate or test the reality of their ing research, critically appraising research, and using
existence through their senses. In everyday activities, research evidence in practice.
they constantly check out the messages received from
their senses. For example, they might ask, “Am I Roles of Nurses in Research
really seeing what I think I am seeing?” Sometimes Generating a scientific knowledge base with imple-
their senses can play tricks on them. This is why mentation in practice requires the participation of all
4 UNIT ONE  Introduction to Nursing Research

TABLE 1-1  Nurses’ Participation in Research at Various Levels of Education


Educational Preparation Research Functions
BSN Read and critically appraise studies. Use best research evidence in practice with
guidance. Assist with problem identification and data collection.
MSN Critically appraise and synthesize studies to develop and revise protocols, algorithms,
and policies for practice. Implement best research evidence in practice.
Collaborate in research projects and provide clinical expertise for research.
DNP Participate in evidence-based guideline development. Develop, implement, evaluate,
and revise as needed protocols, policies, and evidence-based guidelines in practice.
Conduct clinical studies, usually in collaboration with other nurse researchers.
PhD Major role in conducting independent research and contributing to the empirical
knowledge generated in a selected area of study. Obtain initial funding for
research. Coordinate research teams of BSN, MSN, and DNP nurses.
Post-doctorate Assume a full researcher role with a funded program of research. Lead and/or
participate in nursing and interdisciplinary research teams. Identified as experts in
their areas of research. Mentor PhD-prepared researchers.

nurses in a variety of research activities. Some nurses The doctorate in nursing can be practice focused
are developers of research and conduct studies to gen- (doctorate of nursing practice [DNP]) or research
erate and refine the knowledge needed for nursing focused (doctorate of philosophy [PhD]). Nurses with
practice. Others are consumers of research and use DNPs are educated to have the highest level of clinical
research evidence to improve their nursing practice. expertise, with the ability to translate scientific knowl-
The American Association of Colleges of Nursing edge for use in practice. These doctorally prepared
(AACN, 2006) and ANA (2010a, 2010b) have pub- nurses have advanced research and leadership knowl-
lished statements about the roles of nurses in research. edge to develop, implement, evaluate, and revise
No matter their education or position, all nurses have evidence-based guidelines, protocols, algorithms, and
roles in research and some ideas about those roles are policies for practice (Clinton & Sperhac, 2006). In
presented in Table 1-1. The research role a nurse addition, DNP-prepared nurses have the expertise to
assumes usually expands with his or her advanced conduct and/or collaborate with clinical studies.
education, expertise, and career path. Nurses with a PhD-prepared nurses assume a major role in the
Bachelor of Science in Nursing (BSN) degree have conduct of research and the generation of nursing
knowledge of the research process and skills in reading knowledge in a selected area of interest (Brar, Boschma,
and critically appraising studies. They assist with the & McCuaig, 2010). These nurse scientists often coor-
implementation of evidence-based guidelines, proto- dinate research teams that include DNP-, MSN-, and
cols, algorithms, and policies in practice. In addition, BSN-prepared nurses to facilitate the conduct of
these nurses might provide valuable assistance in high-quality studies in a variety of healthcare agencies.
identifying research problems and collecting data for Postdoctorate nurses usually assume full-time re-
studies. searcher roles and have funded programs of research.
Nurses with a Master of Science in Nursing (MSN) They lead interdisciplinary teams of researchers and
have undergone the educational preparation to criti- sometimes conduct studies in multiple settings. These
cally appraise and synthesize findings from studies to scientists often are identified as experts in selected
revise or develop protocols, algorithms, or policies for areas of research and provide mentoring of new PhD-
use in practice. They also have the ability to identify prepared researchers (AACN, 2006) (see Table 1-1).
and critically appraise the quality of evidence-based
guidelines developed by national organizations. APNs Abstract Thought Processes
and nurse administrators have the ability to lead Abstract thought processes influence every element
healthcare teams in making essential changes in of the nursing world. In a sense, they link all the ele-
nursing practice and in the healthcare system on the ments together. Without skills in abstract thought, we
basis of current research evidence. Some MSN- are trapped in a flat existence; we can experience the
prepared nurses conduct studies but usually do so in empirical world, we cannot explain or understand it
collaboration with other nurse scientists (AACN, (Abbott, 1952). Through abstract thinking, however,
2006; ANA 2010a). we can test our theories (which explain the nursing
CHAPTER 1  Discovering the World of Nursing Research 5

world) and then include them in the body of scientific the level of evidence for possible use of the ideas in
knowledge (Smith & Liehr, 2008). Abstract thinking practice. If the findings are inadequate, perhaps other
also allows scientific findings to be developed into nurses would be interested in studying this situation
theories (Munhall, 2012). Abstract thought enables with you.
both science and theories to be blended into a cohesive
body of knowledge, guided by a philosophical frame- Intuition
work, and applied in clinical practice (see Figure 1-1). Intuition is an insight into or understanding of a situ-
Thus, abstract thought processes are essential for syn- ation or event as a whole that usually cannot be logi-
thesizing research evidence and knowing when and cally explained (Smith, 2009). Because intuition is a
how to use this knowledge in practice. type of knowing that seems to come unbidden, it may
Three major abstract thought processes— also be described as a “gut feeling” or a “hunch.”
introspection, intuition, and reasoning—are important Because intuition cannot be explained with ease sci-
in nursing (Silva, 1977). These thought processes are entifically, many people are uncomfortable with it.
used in critically appraising and applying best research Some even say that it does not exist. Sometimes,
evidence in practice, planning and implementing therefore, the feeling or sense is suppressed, ignored,
research, and developing and evaluating theory. or dismissed as silly. However, intuition is not the lack
of knowing; rather, it is a result of deep knowledge—
Introspection tacit knowing or personal knowledge (Benner, 1984;
Introspection is the process of turning your attention Polanyi, 1962, 1966). The knowledge is incorporated
inward toward your own thoughts. It occurs at two so deeply within that it is difficult to bring it con-
levels. At the more superficial level, you are aware of sciously to the surface and express it in a logical
the thoughts you are experiencing. You have a greater manner. One of the most commonly cited examples of
awareness of the flow and interplay of feelings and nurses’ intuition is their recognition of a patient’s
ideas that occur in constantly changing patterns. These physically deteriorating condition. Odell, Victor, and
thoughts or ideas can rapidly fade from view and Oliver (2009) conducted a review of the research lit-
disappear if you do not quickly write them down. erature and described nurses’ use of intuition in clini-
When you allow introspection to occur in more depth, cal practice. They noted that nurses have an intuition
you examine your thoughts more critically and in or a knowing that something is not right with their
detail. Patterns or links between thoughts and ideas patients by recognizing changes in behavior and phys-
emerge, and you may recognize fallacies or weak- ical signs. Through clinical experience and the use of
nesses in your thinking. You may question what intuition, nurses are able to recognize patterns of devi-
brought you to this point and find yourself really ations from the normal clinical course and to know
enjoying the experience. when to take action.
Imagine the following clinical situation. You have Intuition is generally considered unscientific and
just left John Brown’s home. John has a colostomy unacceptable for use in research. In some instances,
and has been receiving home health care for several that consideration is valid. For example, a hunch about
weeks. Although John is caring for his colostomy, he significant differences between one set of scores and
is still reluctant to leave home for any length of time. another set of scores is not particularly useful as an
You are irritated and frustrated with this situation. You analysis technique. However, even though intuition is
begin to review your nursing actions and to recall often unexplainable, it has some important scientific
other patients who reacted in similar ways. What were uses. Researchers do not always need to be able to
the patterns of their behavior? explain something in order to use it. A burst of intu-
You have an idea: Perhaps the patient’s behavior is ition may identify a problem for study, indicate impor-
linked to the level of family support. You feel unsure tant variables to measure, or link two ideas together
about your ability to help the patient and family deal in interpreting the findings. The trick is to recognize
with this situation effectively. You recall other nurses the feeling, value it, and hang on to the idea long
describing similar reactions in their patients, and you enough to consider it. Some researchers keep a journal
wonder how many patients with colostomies have this to capture elusive thoughts and hunches as they think
problem. Your thoughts jump to reviewing the charts about their phenomenon of interest. These intuitive
of other patients with colostomies and reading rele- hunches often become important later as they conduct
vant ideas discussed in the literature. Some research their studies.
has been conducted on this topic recently, and you Imagine the following situation. You have been
could critically appraise these findings to determine working in an oncology center for the past 3 years.
6 UNIT ONE  Introduction to Nursing Research

You and two other nurses working in the center have nursing process to identify diagnoses and to imple-
been meeting with the acute care nurse practitioner to ment nursing interventions to resolve these problems.
plan a study to determine which factors are important Problematic reasoning is also evident when one identi-
for promoting positive patient outcomes in the center. fies a research problem and successfully develops a
The group has met several times with a nursing profes- methodology to examine it.
sor at the university, who is collaborating with the
group to develop the study. At present, the group is Operational Reasoning
concerned with identifying the outcomes that need to Operational reasoning involves the identification
be measured and how to measure them. of and discrimination among many alternatives and
You have had a busy morning. Mr. Green, a patient, viewpoints. It focuses on the process (debating alter-
stops by to chat on his way out of the clinic. You listen, natives) rather than on the resolution (Barnum,
but not attentively at first. You then become more 1998). Nurses use operational reasoning to develop
acutely aware of what he is saying and begin to have realis­tic, measurable health goals with patients and
a feeling about one variable that should be studied. families. Nurse practitioners use operational reason-
Although he didn’t specifically mention fear of break- ing to debate which pharmacological and nonphar-
ing the news about having cancer to his children, you macological treatments to use in managing patient
sense that he is anxious about conveying bad news to illnesses. In research, operationalizing a treatment
his loved ones. You cannot really explain the origin of for implementation and debating which measurement
this feeling, something in the flow of Mr. Green’s methods or data analysis techniques to use in a study
words has stimulated a burst of intuition. You suspect require operational thought (Kerlinger & Lee, 2000;
other patients diagnosed with cancer face similar fear Waltz et al., 2010).
and hesitation about informing their family members
of bad news, that they have cancer or that their cancer Dialectic Reasoning
has spread. You believe the variable “fear of breaking Dialectic reasoning involves looking at situations in
bad news to loved ones” needs to be studied. You feel a holistic way. A dialectic thinker believes that the
both excited and uncertain. What will the other nurses whole is greater than the sum of the parts and that the
think? If the variable has not been studied, is it really whole organizes the parts (Barnum, 1998). For
significant? Somehow, you feel that it is important to example, a nurse using dialectic reasoning would view
consider. a patient as a person with strengths and weaknesses
who is experiencing an illness, and not just as the
Reasoning “stroke in room 219.” Dialectic reasoning also involves
Reasoning is the processing and organizing of ideas examining factors that are opposites and making sense
in order to reach conclusions. Through reasoning, of them by merging them into a single unit or idea that
people are able to make sense of their thoughts and is greater than either alone. For example, analyzing
experiences. This type of thinking is often evident in studies with conflicting findings and summarizing
the verbal presentation of a logical argument in which these findings to determine the current knowledge
each part is linked together to reach a logical conclu- base for a research problem require dialectic reason-
sion. Patterns of reasoning are used to develop theo- ing. Analysis of data collected in qualitative research
ries and to plan and implement research. Barnum requires dialectic reasoning to gain an understanding
(1998) identified four patterns of reasoning as being of the phenomenon being investigated (Munhall,
essential to nursing: (1) problematic, (2) operational, 2012).
(3) dialectic, and (4) logistic. An individual uses all
four types of reasoning, but frequently one type of Logistic Reasoning
reasoning is more dominant than the others. Reason- Logic is a science that involves valid ways of relating
ing is also classified by the discipline of logic into ideas to promote understanding. The aim of logic is to
inductive and deductive modes (Chinn & Kramer, determine truth or to explain and predict phenomena.
2008). The science of logic deals with thought processes, such
as concrete and abstract thinking, and methods of rea-
Problematic Reasoning soning, such as logistic, inductive, and deductive.
Problematic reasoning involves (1) identifying a Logistic reasoning is used to break the whole into
problem and the factors influencing it, (2) selecting parts that can be carefully examined, as can the rela-
solutions to the problem, and (3) resolving the problem. tionships among the parts. In some ways, logistic rea-
For example, nurses use problematic reasoning in the soning is the opposite of dialectic reasoning. A logistic
CHAPTER 1  Discovering the World of Nursing Research 7

reasoner assumes that the whole is the sum of the In this example, deductive reasoning is used to move
parts and that the parts organize the whole. For from the two general premises about human beings
example, a patient states that she is cold. You logically experiencing loss and adolescents being human beings
examine the following parts of the situation and their to the specific conclusion, “All adolescents experience
relationships: (1) room temperature, (2) patient’s tem- loss.” However, the conclusions generated from deduc-
perature, (3) patient’s clothing, and (4) patient’s activ- tive reasoning are valid only if they are based on valid
ity. The room temperature is 65° F, the patient’s premises. Consider the following example:
temperature is 98.6° F, and the patient is wearing PREMISES:
lightweight pajamas and drinking ice water. You con- All health professionals are caring.
clude that the patient is cold because of external envi- All nurses are health professionals.
ronmental factors (room temperature, lightweight CONCLUSION:
pajamas, and drinking ice water). Logistic reasoning All nurses are caring.
is used frequently in quantitative, outcomes, and The premise that all health professionals are caring
intervention research to develop a study design, plan is not necessarily valid or an accurate reflection of
and implement data collection, and conduct statistical reality. Research is a means to test and confirm or
analyses. refute a premise so that valid premises can be used as
Inductive and Deductive Reasoning a basis for reasoning in nursing practice.
The science of logic also includes inductive and
deductive reasoning. People use these modes of rea- Science
soning constantly, although the choice of types of rea- Science is a coherent body of knowledge composed
soning may not always be conscious (Kaplan, 1964). of research findings and tested theories for a specific
Inductive reasoning moves from the specific to the discipline (see Figure 1-1). Science is both a product
general, whereby particular instances are observed (end point) and a process (mechanism to reach an end
and then combined into a larger whole or general point) (Silva & Rothbart, 1984). An example from the
statement (Chinn & Kramer, 2008). An example of discipline of physics is Newton’s law of gravity, which
inductive reasoning follows: was developed through extensive research. The knowl-
A headache is an altered level of health that is edge of gravity (product) is a part of the science of
stressful. physics that evolved through formulating and testing
A fractured bone is an altered level of health that theoretical ideas (process). The ultimate goal of
is stressful. science is to explain the empirical world and thus to
A terminal illness is an altered level of health that have greater control over it. To accomplish this goal,
is stressful. scientists must discover new knowledge, expand
Therefore, all altered levels of health are existing knowledge, and reaffirm previously held
stressful. knowledge in a discipline (Greene, 1979). Health pro-
In this example, inductive reasoning is used to fessionals integrate this evidence-based knowledge to
move from the specific instances of altered levels of control the delivery of care and thereby improve
health that are stressful to the general belief that all patient outcomes (evidence-based practice).
altered levels of health are stressful. By testing many The science of a field determines the accepted
different altered levels of health through research to process for obtaining knowledge within that field.
determine whether they are stressful, one can confirm Research is an important process for obtaining scien-
the general statement that all types of altered health tific knowledge in nursing. Some sciences rigidly limit
are stressful. the types of research that can be used to obtain knowl-
Deductive reasoning moves from the general to edge. A valued method for developing a science is the
the specific or from a general premise to a particular traditional research process, or quantitative research.
situation or conclusion. A premise or hypothesis is a According to this process, the information gained
statement of the proposed relationship between two or from one study is not sufficient for its inclusion in the
more variables. An example of deductive reasoning body of science. A study must be replicated several
follows: times and must yield similar results each time before
PREMISES: that information can be considered to be sound empiri-
All human beings experience loss. cal evidence (Fahs, Morgan, & Kalman, 2003).
All adolescents are human beings. Consider the research on the relationships between
CONCLUSION: smoking, lung damage, and cancer. Numerous studies
All adolescents experience loss. conducted on animals and humans over the past
8 UNIT ONE  Introduction to Nursing Research

decades indicate causative relationships between theory of stress continues to be important in under-
smoking and lung damage and between smoking and standing the affects of health changes on patients and
lung cancer. Everyone who smokes experiences lung families. Extensive research has been conducted to
damage; and although not everyone who smokes gets detail the types, number, and severity of stressors
lung cancer, smokers are at a much higher risk for experienced in life and the effective interventions for
cancer. Extensive, quality research has been con- managing these stressful situations.
ducted to generate empirical evidence about the health A theory is developed from a combination of per-
hazards of smoking, and this evidence guides the sonal experiences, research findings, and abstract
actions of nurses in practice. We provide smoking thought processes. The theorist may use findings from
cessation education, emotional support, and drugs research as a starting point and then organize the find-
like nicotine patches and Chantix (Varenicline) to ings to best explain the empirical world. This is the
assist individuals to stop smoking. On the basis of this process Selye used to develop his theory of stress.
scientific evidence about the hazards of smoking, Alternatively, the theorist may use abstract thought
society has moved toward providing many smoke- processes, personal knowledge, and intuition to
free environments. develop a theory of a phenomenon. This theory then
Findings from studies are systematically related to requires testing through research to determine whether
one another in a way that seems to best explain the it is an accurate reflection of reality. Thus, research
empirical world. Abstract thought processes are used has a major role in theory development, testing, and
to make these linkages. The linkages are called laws refinement. Some forms of qualitative research focus
or principles, depending on the certainty of the facts on developing new theories or extending existing
and relationships within the linkage. Laws express the theories. Quantitative, outcomes, and intervention
most certain relationships and provide the best research methods of research are often implemented to test the
evidence for use in practice. The certainty depends on accuracy of theory. The study findings either support
the amount of research conducted to test a relationship or fail to support the theory, providing a basis for
and, to some extent, on the skills in abstract thought refining the theory (Chinn & Kramer, 2008; Fawcett
processes to link the research findings to form mean- & Garity, 2009).
ingful evidence. The truths or explanations of the
empirical world reflected by these laws and principles Knowledge
are never absolutely certain and may be disproved by Knowledge is a complex, multifaceted concept. For
further research. example, you may say that you know your friend John,
Nursing is in the beginning stages of developing a know that the earth rotates around the sun, know how
science for the profession, and additional original and to give an injection, and know pharmacology. These
replication studies are needed to develop the knowl- are examples of knowing—being familiar with a
edge necessary for practice (Fahs et al., 2003; Melnyk person, comprehending facts, acquiring a psychomo-
& Fineout-Overholt, 2011). As discussed earlier, tor skill, and mastering a subject. There are differences
nursing science is being developed with the use of a in types of knowing, yet there are also similarities.
variety of research methodologies, including quantita- Knowing presupposes order or imposes order on
tive, qualitative, outcomes, and intervention. The thoughts and ideas (Engelhardt, 1980). People have a
focus of this textbook is to increase your understand- desire to know what to expect. There is a need for
ing of these different types of research used in the certainty in the world, and individuals seek it by trying
development and testing of nursing theory. to decrease uncertainty through knowledge. Think of
the questions you ask a person who has presented
Theory some bit of knowledge: “Is it true?” “Are you sure?”
A theory is a creative and rigorous structuring of ideas “How do you know?” Thus, the knowledge that we
used to describe, explain, predict, or control a particu- acquire is expected to be an accurate reflection of
lar phenomenon or segment of the empirical world reality.
(Chinn & Kramer, 2008; Smith & Liehr, 2008). A
theory consists of a set of concepts that are defined Ways of Acquiring Nursing Knowledge
and interrelated to present a systematic view of a phe- We acquire knowledge in a variety of ways and expect
nomenon. A classic example is the theory of stress it to be an accurate reflection of the real world (White,
developed by Selye (1976) to explain the physical and 1982). Nurses have historically acquired knowledge
emotional affects of illness on peoples’ lives. This through (1) traditions, (2) authority, (3) borrowing,
CHAPTER 1  Discovering the World of Nursing Research 9

(4) trial and error, (5) personal experience, (6) role- Borrowing
modeling and mentorship, (7) intuition, (8) reasoning, As some nursing leaders have noted, knowledge in
and (9) research. Intuition, reasoning, and research nursing practice is partly made up of information that
were discussed earlier in this chapter; the other ways has been borrowed from disciplines such as medicine,
of acquiring knowledge are briefly described in this psychology, physiology, and education (McMurrey,
section. 1982; Walker & Avant, 2011). Borrowing in nursing
involves the appropriation and use of knowledge from
Traditions other fields or disciplines to guide nursing practice.
Traditions consist of “truths” or beliefs that are based Nursing practice has borrowed knowledge in two
on customs and past trends. Nursing traditions from ways. For years, some nurses have taken information
the past have been transferred to the present by written from other disciplines and applied it directly to
and verbal communication and role-modeling and nursing practice. This information was not integrated
continue to influence the present practice of nursing. within the unique focus of nursing. For example,
For example, some of the policies and procedures in some nurses have used the medical model to guide
hospitals and other healthcare facilities contain tradi- their nursing practice, thus focusing on the diagnosis
tional ideas. In addition, some nursing interventions and treatment of physiological diseases with limited
are transmitted verbally from one nurse to another attention to the patient’s holistic nature. This type of
over the years or by the observation of experienced borrowing continues today as nurses use technologi-
nurses. For example, the idea of providing a patient cal advances to focus on the detection and treatment
with a clean, safe, well-ventilated environment origi- of disease, to the exclusion of health promotion and
nated with Florence Nightingale (1859). illness prevention.
However, traditions can also narrow and limit the Another way of borrowing, which is more useful
knowledge sought for nursing practice. For example, in nursing, is the integration of information from other
tradition has established the time and pattern for pro- disciplines within the focus of nursing. Because disci-
viding baths, evaluating vital signs, and allowing plines share knowledge, it is sometimes difficult to
patient visitation on many hospital units. The nurses know where the boundaries exist between nursing’s
on these units quickly inform new staff members knowledge base and the knowledge bases of other
about the accepted or traditional behaviors for the unit. disciplines. Boundaries blur as the knowledge bases
Traditions are difficult to change because people with of disciplines evolve (McMurrey, 1982). For example,
power and authority have accepted and supported information about self-esteem as a characteristic of the
them for a long time. Many traditions have not been human personality is associated with psychology, but
tested for accuracy or efficiency and require research this knowledge also directs the nurse in assessing the
for continued use in practice. psychological needs of patients and families. However,
borrowed knowledge has not been adequate to answer
Authority many questions generated in nursing practice.
An authority is a person with expertise and power
who is able to influence opinion and behavior. A Trial and Error
person is thought of as an authority because she or he Trial and error is an approach with unknown out-
knows more in a given area than others do. Knowl- comes that is used in a situation of uncertainty when
edge acquired from authority is illustrated when one other sources of knowledge are unavailable. The
person credits another person as the source of informa- nursing profession evolved through a great deal of trial
tion. Nurses who publish articles and books or develop and error before knowledge of effective practices was
theories are frequently considered authorities. Stu- codified in textbooks and journals. The trial-and-error
dents usually view their instructors as authorities, and way of acquiring knowledge can be time-consuming,
clinical nursing experts are considered authorities because multiple interventions might be implemented
within their clinical settings. However, persons viewed before one is found to be effective. There is also a risk
as authorities in one field are not necessarily authori- of implementing nursing actions that are detrimental
ties in other fields. An expert is an authority only when to a patient’s health. Because each patient responds
addressing his or her area of expertise. Like tradition, uniquely to a situation, however, uncertainty in nursing
the knowledge acquired from authorities sometimes practice continues. Because of the uniqueness of
has not been validated through research and is not patient response and the resulting uncertainty, nurses
considered the best evidence for practice. must use trial and error in providing care. The
10 UNIT ONE  Introduction to Nursing Research

trial-and-error approach to developing knowledge practice. The clinical expertise of the nurse is a critical
would be more efficient if nurses documented the component of evidence-based practice. It is the expert
patient and situational characteristics that provided the nurse who has the greatest skill and ability to imple-
context for the patient’s unique response. ment the best research evidence in practice to meet the
unique values and needs of patients and families.
Personal Experience
Personal experience is the knowledge that comes Role-Modeling and Mentorship
from being personally involved in an event, situation, Role-modeling is learning by imitating the behaviors
or circumstance. In nursing, personal experience of an exemplar. An exemplar or role model knows the
enables one to gain skills and expertise by providing appropriate and rewarded roles for a profession, and
care to patients and families in clinical settings. The these roles reflect the attitudes and include the stan-
nurse not only learns but is able to cluster ideas into dards and norms of behavior for that profession (ANA,
a meaningful whole. For example, students may be 2010a). In nursing, role-modeling enables the novice
told how to give an injection in a classroom setting, nurse to learn from interacting with expert nurses or
but they do not know how to give an injection until following their examples. Examples of role models are
they observe other nurses giving injections to patients admired teachers, expert practitioners, researchers,
and actually give several injections themselves. and illustrious individuals who inspire students, prac-
The amount of personal experience you have will ticing nurses, educators, and researchers through their
affect the complexity of your knowledge base as a examples.
nurse. Benner (1984) described five levels of experi- An intense form of role-modeling is mentorship.
ence in the development of clinical knowledge and In a mentorship, the expert nurse, or mentor, serves
expertise that are important today. These levels of as a teacher, sponsor, guide, exemplar, and counselor
experience are (1) novice, (2) advanced beginner, for the novice nurse (or mentee). Both the mentor and
(3) competent, (4) proficient, and (5) expert. Novice the mentee or protégé invest time and effort, which
nurses have no personal experience in the work that often result in a close, personal mentor-mentee rela-
they are to perform, but they have preconceived tionship. This relationship promotes a mutual exchange
notions and expectations about clinical practice that of ideas and aspirations relative to the mentee’s career
are challenged, refined, confirmed, or contradicted by plans. The mentee assumes the values, attitudes, and
personal experience in a clinical setting. The advanced behaviors of the mentor while gaining intuitive knowl-
beginner has just enough experience to recognize and edge and personal experience. Mentorship is essential
intervene in recurrent situations. For example, the for building research competence in nursing (Byrne &
advanced beginner nurse is able to recognize and inter- Keefe, 2002).
vene to meet patients’ needs for pain management. To summarize, in nursing, a body of knowledge
Competent nurses frequently have been on the job must be acquired (learned), incorporated, and assimi-
for 2 or 3 years, and their personal experiences enable lated by each member of the profession and collec-
them to generate and achieve long-range goals and tively by the profession as a whole. This body of
plans (Benner, 1984). Through experience, the com- knowledge guides the thinking and behavior of the
petent nurse is able to use personal knowledge to take profession and of individual practitioners. It also
conscious, deliberate actions that are efficient and directs further development and influences how
organized. From a more complex knowledge base, the science and theory are interpreted within the discipline
proficient nurse views the patient as a whole and as a (see Figure 1-1). This knowledge base is necessary in
member of a family and community. The proficient order for health professionals, consumers, and society
nurse recognizes that each patient and family have to recognize nursing as a science.
specific values and needs that lead them to respond
differently to illness and health. Philosophy
The expert nurse has had extensive experience and Philosophy provides a broad, global explanation of
is able to identify accurately and intervene skillfully the world. It is the most abstract and most all-
in a situation (Benner, 1984). Personal experience encompassing concept in the model (see Figure 1-1).
increases an expert nurse’s ability to grasp a situation Philosophy gives unity and meaning to the world of
intuitively with accuracy and speed. Lyneham, Parkin- nursing and provides a framework within which think-
son, and Denholm (2009) studied Benner’s fifth stage ing, knowing, and doing occur (Kikuchi & Simmons,
of practice development and noted the links of intu- 1994). Nursing’s philosophical position influences its
ition, science, knowledge, and theory to expert clinical knowledge base. How nurses use science and theories
CHAPTER 1  Discovering the World of Nursing Research 11

to explain the empirical world depends on their phi- them seek health from within those worldviews, an
losophy. Ideas about truth and reality, as well as approach that is a critical component of evidence-
beliefs, values, and attitudes, are part of philosophy. based practice.
Philosophy asks questions such as, “Is there an abso-
lute truth, or is truth relative?” and “Is there one
reality, or is reality different for each individual?”
Everyone’s world is modified by her or his philoso- Significance of Research in
phy, as a pair of eyeglasses would modify vision. Building an Evidence-Based
Perceptions are influenced first by philosophy and
then by knowledge. For example, if what you see is Practice for Nursing
not within your ideas of truth or reality, if it does not The ultimate goal of nursing is to provide evidence-
fit your belief system, you may not see it. Your mind based care that promotes quality outcomes for patients,
may reject it altogether or may modify it to fit your families, healthcare providers, and the healthcare
philosophy (Scheffler, 1967). For example, you might system (Craig & Smyth, 2012; Melnyk & Fineout-
believe that education is not effective in promoting Overholt, 2011). Evidence-based practice (EBP)
smoking cessation, so you do not provide your patients evolves from the integration of the best research evi-
this education. As you start to discover the world of dence with clinical expertise and patient needs and
nursing research, it is important for you to keep an values (Sackett, Straus, Richardson, Rosenberg, &
open mind to the value of research and your future Haynes, 2000). Figure 1-2 demonstrates the major
role in the development or use of research evidence in contribution of the best research evidence to the deliv-
practice. ery of EBP. Best research evidence is the empirical
Philosophical positions commonly held within the knowledge generated from the synthesis of quality
nursing profession include the view that human beings study findings to address a practice problem. A discus-
are holistic, rational, and responsible. Nurses believe sion of the levels of best research evidence and the
that people desire health, and health is considered to sources for this evidence is presented in Chapter 2. A
be better than illness. Quality of life is as important as team of expert researchers, healthcare professionals,
quantity of life. Good nursing care facilitates improved policy makers, and consumers often synthesizes the
patterns of health and quality of life (ANA, 2010a, best research evidence for developing standardized
2010b). In nursing, truth is relative, and reality tends guidelines for clinical practice. For example, research
to vary with perception (Kikuchi, Simmons, & Romyn, related to the chronic health problem of hypertension
1996; Silva, 1977). For example, because nurses (HTN) has been conducted, critically appraised, and
believe that reality varies with perception and that synthesized by experts to develop a practice guideline
truth is relative, they would not try to impose their for implementation by APNs, such as nurse practi­
views of truth and reality on patients. Rather, they tioners, and physicians to ensure that patients with
would accept patients’ views of the world and help HTN receive quality, cost-effective care (Chobanian

Clinical
Expertise

Best
Research Evidence-Based
Practice Figure 1-2  Model of evidence-based practice.
Evidence

Patient
Needs and
Values
12 UNIT ONE  Introduction to Nursing Research

Nurse
Practitioner
(Clinical expert)
JNC 7
Figure 1-3  Evidence-based practice for elderly Women with Normal
Hypertension
African-American women with hypertension Blood Pressure of
Guideline
(HTN). JNC, Joint National Committee on Less Than 120/80
(Best research
Prevention, Detection, Evaluation, and Treatment (Evidence-Based Practice)
evidence) Female, elderly,
of High Blood Pressure.
African-American
with HTN
(Patient needs
and values)

et al., 2003). The most current guidelines for the diag- Figure 1-3 provides an example of the delivery of
nosis and management of HTN, “The Seventh Report evidence-based care to women with HTN. In this
of the Joint National Committee on Prevention, Detec- example, the best research evidence on HTN is the
tion, Evaluation, and Treatment of High Blood Pres- JNC 7 National Standardized Guideline (Chobanian et
sure: The JNC 7 Report,” were published in 2003 al., 2003). An expert nurse practitioner translates this
(Chobanian et al., 2003) and are available online at guideline to meet the needs (chronic illness manage-
www.nhlbi.nih.gov/guidelines/hypertension. The JNC ment) and values of elderly African-American women
8 Report is currently under development, with pro- with HTN. In this case, the outcome of EBP is women
jected publication of the revised HTN guidelines with a normal blood pressure, less than 120 mm Hg
in 2012 or 2013 (see http://www.nhlbi.nih.gov/guide systolic/80 mm Hg diastolic (see Figure 1-3). A
lines/hypertension/jnc8). Many national standardized detailed discussion of how to locate, critically appraise,
guidelines are available through the Agency for and use national standardized guidelines in practice is
Healthcare Research and Quality (AHRQ) and profes- presented in Chapter 19.
sional organizations, which are discussed in more In nursing, the research evidence must focus on the
detail in Chapters 2 and 19. description, explanation, prediction, and control of
Clinical expertise is the knowledge and skills of phenomena important to practice. The following sec-
the healthcare professional providing care. A nurse’s tions address the types of knowledge that need to be
clinical expertise is determined by his or her years of generated in these four areas as nursing moves toward
practice, current knowledge of the research and clini- EBP.
cal literature, and educational preparation. The stron-
ger the nurse’s clinical expertise, the better his or her Description
clinical judgment is in the delivery of quality care Description involves identifying and understanding
(Craig & Smyth, 2012; Eizenberg, 2010). The patient’s the nature of nursing phenomena and, sometimes, the
need(s) might focus on health promotion, illness pre- relationships among them (Chinn & Kramer, 2008;
vention, acute or chronic illness management, or reha- Munhall, 2012). Through research, nurses are able to
bilitation (see Figure 1-2). In addition, patients bring (1) explore and describe what exists in nursing prac-
values or unique preferences, expectations, concerns, tice, (2) discover new information, (3) promote under-
and cultural beliefs to the clinical encounter. With standing of situations, and (4) classify information for
EBP, patients and their families are encouraged to take use in the discipline. Some examples of clinically
an active role in managing their health care. In important research evidence developed from research
summary, expert clinicians use the best research evi- focused on description include the following:
dence available to deliver quality, cost-effective care • Identification of the responses of individuals to a
to a patients and families with specific health needs variety of health conditions
and values to achieve EBP (Brown, 2009; Craig & • Description of the health promotion and illness pre-
Smyth, 2012; Sackett et al., 2000). vention strategies used by various populations
CHAPTER 1  Discovering the World of Nursing Research 13

• Determination of the incidence of a disease locally, for a sample of inpatient adults in acute care units. The
nationally, and internationally researchers found that the nurse characteristics and
• Identification of the cluster of symptoms for a par- staffing variables were significantly correlated with
ticular disease MRSA infections and reported patient falls. Thus, the
• Description of the effects and side effects of nursing characteristics and staffing were potential pre-
selected pharmacological agents in a variety of dictors of MRSA infections and patient falls. This
populations study illustrates how explanatory research can identify
For example, Imes, Daugherty, Pyper, and Sullivan relationships among nursing phenomena that are the
(2011, p. 208) conducted “a qualitative study to basis for future research focused on prediction and
describe the experience of living with heart failure control.
(HF) from the perspective of the partner.” These
researchers synthesized their findings as follows: “The Prediction
severity of the patient’s disease limited the partner’s Through prediction, one can estimate the probability
lifestyle, resulting in social isolation and difficulties in of a specific outcome in a given situation (Chinn &
planning for the future for both the patient and the Kramer, 2008). However, predicting an outcome does
partner. The partners were unprepared to manage the not necessarily enable one to modify or control the
disease burden at home without consistent information outcome. It is through prediction that the risk of illness
and assistance by healthcare providers. Moreover, is identified and linked to possible screening methods
end-of-life planning was neither encouraged by health- that will identify the illness. Knowledge generated
care providers nor embraced by patients or partners” from research focused on prediction is critical for EBP
(Imes et al., 2011, p. 208). and includes the following:
The findings from this study provide insights into • Prediction of the risk for a disease in different
the experience of HF by a loved one and their experi- populations
ences with healthcare providers. This type of research, • Prediction of the accuracy and precision of a
focused on description, is essential groundwork for screening instrument, such as mammogram, to
studies that will help to explain, predict, and control detect a disease
nursing phenomena. • Prediction of the prognosis once an illness is identi-
fied in a variety of populations
Explanation • Prediction of the impact of nursing actions on
Explanation clarifies the relationships among phe- selected outcomes
nomena and clarifies why certain events occur. • Prediction of behaviors that promote health and
Research focused on explanation provides the follow- prevent illness
ing types of evidence essential for practice: • Prediction of the health care required based on a
• Determination of the assessment data (both subjec- patient’s need and values
tive data from the health history and objective data For example, Scheetz and Kolassa (2007, p. 399)
from physical examination) needed to address a examined “crash scene variables to predict the need
patient’s health need for trauma center care in older persons.” The research-
• Link of assessment data to determine a diagnosis ers analyzed 26 crash scene variables and developed
(both nursing and medical) triage decision rules for managing persons with severe
• Link of causative risk factors or etiologies to and moderate injuries. Further research is needed to
illness, morbidity, and mortality determine whether the triage decision rules improve
• Determine the relationships among health risks, the health outcomes of the elderly following trauma.
health status, and healthcare costs Predictive studies isolate independent variables that
For example, Manojlovich, Sidani, Covell, and require additional research to ensure that their manip-
Antonakos (2011) conducted an outcomes study to ulation or control results in successful outcomes for
examine the links between a “nurse dose” (nurse char- patients, healthcare professionals, and healthcare
acteristics and staffing) and adverse patient outcomes. agencies.
The nurse characteristics examined were education,
experience, and skill mix. The staffing variables Control
included full-time employees, RN:patient ratio, and If one can predict the outcome of a situation, the next
RN hours per patient day. The adverse outcomes step is to control or manipulate the situation to produce
examined were methicillin-resistant Staphylococcus the desired outcome. Dickoff, James, and Wiedenbach
aureus (MRSA) infections and reported patient falls (1968) described control as the ability to write a
14 UNIT ONE  Introduction to Nursing Research

prescription to produce the desired results. Using the adventure that holds much promise for the future prac-
best research evidence, nurses could prescribe specific tice of nursing.
interventions to meet the needs of patients. Nurses
need this type of research evidence to provide EBP
(see Figure 1-2). Research in the following areas is KEY POINTS
important for generating EBP in nursing:
• Testing interventions to improve the health status • This chapter introduces you to the world of nursing
of individuals, families, and communities research.
• Testing interventions to improve healthcare • Nursing research is defined as a scientific process
delivery that validates and refines existing knowledge and
• Determining the quality and cost-effectiveness of generates new knowledge that directly and indi-
interventions rectly influences the delivery of evidence-based
• Implementing an evidence-based intervention to nursing practice (EBP).
determine whether it is effective in managing a • This chapter presents a framework that links nursing
patient’s health need (health promotion, illness pre- research to the world of nursing and organizes the
vention, acute and chronic illness management, and content presented in this textbook (see Figure 1-1).
rehabilitation) and producing quality outcomes The concepts in this framework range from concrete
Yoo, Kim, Hur, and Kim (2011) conducted a study to abstract and include concrete and abstract think-
that examined the effect of a prescribed animation ing, the empirical world (evidence-based nursing
distraction intervention on the pain response of pre- practice), research, abstract thought processes,
school children during venipuncture. The intervention science, theory, knowledge, and philosophy.
or independent variable was a 3-minute animation • The empirical world is what we experience through
video that could be downloaded from the Internet and our senses and is the concrete portion of our exis-
shown to the child using a laptop computer. The pain tence where nursing practice occurs.
response was measured by the following dependent • Research is a way to test reality, and nurses use a
variables: “self-reported pain response, behavioral variety of research methods to test their reality and
pain response, blood cortisol, and blood glucose” (Yoo generate nursing knowledge, such as quantitative,
et al., 2011, p. 94). The researchers found a significant qualitative, outcomes, and intervention.
difference between the experimental and control • All nurses have a role in research—some are
groups for all four dependent variables of pain developers of research and conduct studies to gen-
response. Thus, the animation distraction intervention erate and refine the knowledge needed for nursing
was determined to be an effective method of managing practice, and others are consumers of research and
children’s pain during venipuncture. The researchers use research evidence to improve their nursing
concluded that this intervention required minimal practice.
effort and time and might be a convenient and cost- • Three major abstract thought processes—
effective intervention to be used in clinical settings to introspection, intuition, and reasoning—are impor-
reduce children’s pain. tant in nursing.
Many more studies need to be conducted to gener- • A theory is a creative and rigorous structuring of
ate the research evidence in the areas of prediction and ideas used to describe, explain, predict, or control
control (Brown, 2009; Craig & Smyth, 2012; Melnyk a particular phenomenon or segment of the empiri-
& Fineout-Overholt, 2011). This need for additional cal world.
nursing research provides you with many opportuni- • Reliance on tradition, authority, trial and error, and
ties to be involved in the world of nursing research. personal experience is no longer an adequate basis
This chapter introduced you to the world of nursing for sound nursing practice.
research and the significance of research in developing • The goal of nurses and other healthcare profession-
an EBP for nursing. The following chapters will als is to deliver evidence-based health care to
expand your understanding of different research meth- patients and their families.
odologies so you can critically appraise studies, syn- • EBP evolves from the integration of best research
thesize research findings, and use the best research evidence with clinical expertise and patient needs
evidence available in clinical practice. This text also and values (see Figure 1-2).
gives you a background for conducting research in • The best research evidence is the empirical knowl-
collaboration with expert nurse researchers. We think edge generated from the synthesis of quality studies
you will find that nursing research is an exciting to address a practice problem.
CHAPTER 1  Discovering the World of Nursing Research 15

• The clinical expertise of a nurse is determined by Creswell, J. W. (2009). Research design: Qualitative, quantitative,
his or her years of clinical experience, current and mixed methods approaches (3rd ed.). Los Angeles, CA: Sage.
knowledge of the research and clinical literature, Dickoff, J., James, P., & Wiedenbach, E. (1968). Theory in a prac-
tice discipline: Practice oriented theory (Part I). Nursing Research,
and educational preparation.
17(5), 415–435.
• The patient brings values—such as unique prefer- Doran, D. M. (2011). Nursing-sensitive outcomes: State of the
ences, expectations, concerns, and cultural beliefs, science. Sudbury, MA: Jones & Bartlett.
and health needs—to the clinical encounter, which Eizenberg, M. M. (2010). Implementation of evidence-based
are important to consider in providing evidence- nursing practice: Nurses’ personal and professional factors?
based care. Journal of Advanced Nursing, 67(1), 33–42.
• The knowledge generated through research is Engelhardt, H. T., Jr. (1980). Knowing and valuing: Looking for
essential for describing, explaining, predicting, and common roots. In H. T. Engelhardt & D. Callahan (Eds.), Knowing
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Fahs, P. S., Morgan, L. L., & Kalman, M. (2003). A call for replica-
findings can have a powerful, positive impact on
tion. Journal of Nursing Scholarship, 35(1), 67–71.
patient outcomes and the healthcare system. Fawcett, J., & Garity, J. (2009). Evaluating research for evidence-
based nursing practice. Philadelphia, PA: F. A. Davis.
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Green, L. A., Izzo, J. L., et al. (2003). The seventh report of the Melnyk, B. M., & Fineout-Overholt, E. (2011). Evidence-based
Joint National Committee on prevention, detection, evaluation, practice in nursing & healthcare: A guide to best practice (2nd
and treatment of high blood pressure: The JNC 7 report. Journal ed.). Philadelphia, PA: Lippincott Williams & Wilkins.
of the American Medical Association, 289(19), 2560–2572. Munhall, P. L. (2012). Nursing research: A qualitative perspective
Clinton, P., & Sperhac, A. M. (2006). National agenda for advanced (5th ed.). Sudbury, MA: Jones & Bartlett Learning.
practice nursing: The practice doctorate. Journal of Professional National League for Nursing (NLN, 2009). Building a science of
Nursing, 22(1), 7–14. nursing education: Foundation for evidence-based teaching and
Craig, J. V., & Smyth, R. L. (2012). The evidence-based practice learning. New York, NY: Author.
manual for nurses (3rd ed.). Edinburgh, Scotland: Churchill Nightingale, F. (1859). Notes on nursing: What it is, and what it is
Livingstone. not. Philadelphia, PA: Lippincott.
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Odell, M., Victor, C., & Oliver, D. (2009). Nurses’ role in detecting Silva, M.C. (1977). Philosophy, science, theory: Interrelationships
deterioration in ward patients: Systematic literature review. and implications for nursing research. Image-Journal of Nursing
Journal of Advanced Nursing, 65(10), 1992–2006. Scholarship, 9(3), 59–63.
Polanyi, M. (1962). Personal knowledge. Chicago, IL: University Silva, M. C., & Rothbart, D. (1984). An analysis of changing trends
of Chicago Press. in philosophies of science on nursing theory development and
Polanyi, M. (1966). The tacit dimension. New York, NY: testing. Advances in Nursing Science, 6(2), 1–13.
Doubleday. Smith, A. (2009). Exploring the legitimacy of intuition as a form of
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sioning nursing scholarship. Journal of Nursing Scholarship, Smith, M. J., & Liehr, P. R. (2008). Middle range theory for nursing
34(4), 383–389. (2nd ed.). New York, NY: Springer Publishing Company.
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tice & teach EBM (2nd ed.). London, England: Churchill Waltz, C. F., Strickland, O. L., & Lenz, E. R. (2010). Measurement
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Research in Nursing & Health, 30(4), 399–412. & Littlefield.
Scheffler, I. (1967). Science and subjectivity. Indianapolis, IN: Yoo, H., Kim, S., Hur, H., & Kim, H. (2011). The effects of an
Bobbs-Merrill. animation distraction intervention on pain response of preschool
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tal and quasi-experimental designs for generalized causal infer-
ence. Chicago, IL: Rand McNally.
  http://evolve.elsevier.com/Grove/practice/

2  
CHAPTER

Evolution of Research in Building


Evidence-Based Nursing Practice

I
nitially, nursing research evolved slowly, from research more than 150 years ago (Nightingale, 1859).
Florence Nightingale’s investigations of patient Following Nightingale’s work (1840-1910), nursing
mortality in the nineteenth century to the studies research received minimal attention until the mid-
of nursing education in the 1930s and 1940s. Nurses 1900s. In the 1960s, nurses gradually recognized the
and nursing roles were the focus of research in the value of research, but few had the educational back-
1950s and 1960s. However, in the late 1970s and ground to conduct studies until the 1970s. However,
1980s, many researchers designed studies aimed at in the 1980s and 1990s, research became a major force
improving nursing practice. This emphasis continued in developing a scientific knowledge base for nursing
in the 1990s with research focused on testing the practice. Today, nurses obtain federal, corporate, and
effectiveness of nursing interventions and examining foundational funding for their research, conduct
patient outcomes. The goal in this millennium is the complex studies in multiple settings, and generate
development of an evidence-based practice for sound research evidence for practice. Table 2-1 identi-
nursing, with the current best research evidence being fies key historical events that have influenced the
used to deliver quality health care. development of nursing research and the movement
Evidence-based practice (EBP) is the conscien- toward EBP. These events are discussed in the follow-
tious integration of best research evidence with ing section.
clinical expertise and patient values and needs in
the delivery of quality, cost-effective health care.
Chapter 1 presents a model depicting the elements Florence Nightingale
of EBP and provides an example (see Figures 1-2 and Nightingale has been described as a reformer, reac-
1-3). You probably have many questions about tionary, and researcher who influenced nursing spe-
EBP because it is an evolving concept in nursing and cifically and health care in general. Nightingale’s
health care. What does “best research evidence” book, Notes on Nursing (1859), described her initial
mean? How is research evidence developed? Are there research activities, which focused on the importance
levels of quality in the types of research evidence? of a healthy environment in promoting the patient’s
This chapter will increase your understanding of how physical and mental well-being. She identified the
nursing research has evolved over the past 150 years need to gather data on the environment, such as ven-
and of the current movement of the profession toward tilation, cleanliness, temperature, purity of water, and
EBP. The chapter describes the historical events rel- diet, to determine their influence on the patient’s
evant to nursing research in building an EBP, identifies health (Herbert, 1981).
the methodologies used in nursing to develop research Nightingale is also noted for her data collection and
evidence, and concludes with a discussion of the best statistical analyses during the Crimean War. She gath-
research evidence needed to build an EBP. ered data on soldier morbidity and mortality rates and
the factors influencing them and presented her results
in tables and pie charts, a sophisticated type of data
Historical Development presentation for the period (Cohen, 1984; Palmer,
1977). Nightingale was the first woman elected to the
of Research in Nursing Royal Statistical Society (Oakley, 2010), and her
Some people think that research is relatively new to research was highlighted in the periodical Scientific
nursing, but Florence Nightingale initiated nursing American in 1984 (Cohen, 1984).

17
18 UNIT ONE  Introduction to Nursing Research

TABLE 2-1  Historical Events Influencing Research in Nursing


Year Event
1850 Florence Nightingale is recognized as the first nurse researcher.
1900 American Journal of Nursing is published.
1923 Teachers College at Columbia University offers the first educational doctoral program for nurses.
1929 First Master’s in Nursing Degree is offered at Yale University.
1932 Association of Collegiate Schools of Nursing is organized to promote conduct of research.
1950 American Nurses Association (ANA) publishes study of nursing functions and activities.
1952 First research journal in nursing, Nursing Research, is published.
1953 Institute of Research and Service in Nursing Education is established.
1955 American Nurses Foundation is established to fund nursing research.
1957 Southern Regional Educational Board (SREB), Western Interstate Commission on Higher Education (WICHE),
Midwestern Nursing Research Society (MNRS), and New England Board of Higher Education (NEBHE) are
developed to support and disseminate nursing research.
1963 International Journal of Nursing Studies is published.
1965 ANA sponsors the first nursing research conferences.
1967 Sigma Theta Tau International Honor Society of Nursing publishes Image, emphasizing nursing scholarship; now
entitled Journal of Nursing Scholarship.
1970 ANA Commission on Nursing Research is established.
1972 Cochrane published Effectiveness and Efficiency, introducing concepts relevant to evidence-based practice (EBP).
ANA Council of Nurse Researchers is established.
1973 First Nursing Diagnosis Conference is held, which evolved into North American Nursing Diagnosis Association
(NANDA).
1976 Stetler/Marram Model for Application of Research Findings to Practice is published.
1978 Research in Nursing & Health and Advances in Nursing Science are published.
1979 Western Journal of Nursing Research is published.
1980s-1990s Sackett and colleagues developed methodologies to determine “best evidence” for practice.
1982-1983 Conduct and Utilization of Research in Nursing (CURN) Project is published.
1983 Annual Review of Nursing Research is published.
1985 National Center for Nursing Research (NCNR) is established to support and fund nursing research.
1987 Scholarly Inquiry for Nursing Practice is published.
1988 Applied Nursing Research and Nursing Science Quarterly are published.
1989 Agency for Health Care Policy and Research (AHCPR) is established and publishes EBP guidelines.
1990 Nursing Diagnosis, official journal of NANDA, is published; now entitled International Journal of Nursing
Terminologies and Classifications.
ANA established the American Nurses Credentialing Center (ANCC), which implemented the Magnet Hospital
Designation Program for Excellence in Nursing Services.
1992 Healthy People 2000 is published by the U.S. Department of Health and Human Services (DHHS).
Clinical Nursing Research is published.
1993 NCNR is renamed the National Institute of Nursing Research (NINR) to expand funding for nursing research.
Journal of Nursing Measurement is published.
Cochrane Collaboration is initiated providing systematic reviews and EBP guidelines (http://www.cochrane.org/).
1994 Qualitative Health Research is published.
1999 AHCPR is renamed Agency for Healthcare Research and Quality (AHRQ).
2000 Healthy People 2010 is published by DHHS.
Biological Research for Nursing is published.
2001 Stetler publishes her model Steps of Research Utilization to Facilitate Evidence-Based Practice.
2002 Joint Commission revises accreditation policies for hospitals supporting evidence-based health care.
NANDA becomes international—NANDA-I.
2004 Worldviews on Evidence-Based Nursing is published.
2011 NINR identifies mission and funding priorities (http://www.ninr.nih.gov/).
Healthy People 2020 is published; available at DHHS website http://www.healthypeople.gov/2020/
topicsobjectives2020/default.aspx.
2012 AHRQ identifies mission and funding priorities (http://www.ahrq.gov/).
American Nurses Association (ANA) Research Agenda is published.
CHAPTER 2  Evolution of Research in Building Evidence-Based Nursing Practice 19

Nightingale’s research enabled her to instigate ANA to develop statements on functions, standards,
attitudinal, organizational, and social changes. She and qualifications for professional nurses. Also during
changed the attitudes of the military and society this time, clinical research began expanding as spe-
toward the care of the sick. The military began to view cialty groups, such as community health, psychiatric,
the sick as having the right to adequate food, suitable medical-surgical, pediatric, and obstetrical nurses,
quarters, and appropriate medical treatment, a change developed standards of care. The research conducted
that greatly reduced the mortality rate (Cook, 1913). by ANA and the specialty groups provided the basis
Nightingale improved the organization of army admin- for the nursing practice standards that currently guide
istration, hospital management, and hospital construc- professional nursing practice (Gortner & Nahm,
tion. Because of Nightingale’s research evidence and 1977).
influence, society began to accept responsibility for Educational studies were conducted in the 1950s
testing public water, improving sanitation, preventing and 1960s to determine the most effective educational
starvation, and decreasing morbidity and mortality preparation for the registered nurse. A nurse educator,
rates (Palmer, 1977). Mildred Montag, developed and evaluated the 2-year
nursing preparation (associate degree) in junior col-
Early 1900s leges. Student characteristics, such as admission and
From 1900 to 1950, research activities in nursing retention patterns and the elements that promoted
were limited, but a few studies advanced nursing edu- success in nursing education and practice, were studied
cation. These studies included the Nutting Report, for both associate and baccalaureate degree–prepared
1912; Goldmark Report, 1923; and Burgess Report, nurses (Downs & Fleming, 1979).
1926 (Abdellah, 1972; Johnson, 1977). On the basis In 1953, an Institute for Research and Service in
of recommendations of the Goldmark Report, more Nursing Education was established at Teachers Col­
schools of nursing were established in university set- lege, Columbia University, which provided research-
tings. The baccalaureate degree in nursing provided a learning experiences for doctoral students (Werley,
basis for graduate nursing education, with the first 1977). The American Nurse’s Foundation, chartered
master of nursing degree offered by Yale University in 1955, was responsible for receiving and administer-
in 1929. Teachers College at Columbia University ing research funds, conducting research programs,
offered the first doctoral program for nurses in 1923 consulting with nursing students, and engaging in
and granted a degree in education (Ed.D.) to prepare research. In 1956, a Committee on Research and
teachers for the profession. The Association of Col- Studies was established to guide ANA research
legiate Schools of Nursing, organized in 1932, pro- (See, 1977).
moted the conduct of research to improve education A Department of Nursing Research was established
and practice. This organization also sponsored the in the Walter Reed Army Institute of Research in 1957.
publication of the first research journal in nursing, This was the first nursing unit in a research institution
Nursing Research, in 1952 (Fitzpatrick, 1978). that emphasized clinical nursing research (Werley,
A research trend that started in the 1940s and con- 1977). Also in 1957, the Southern Regional Educa-
tinued in the 1950s focused on the organization and tional Board (SREB), the Western Interstate Commis-
delivery of nursing services. Studies were conducted sion on Higher Education (WICHE), Midwest Nursing
on the numbers and kinds of nursing personnel, staff- Research Society (MNRS), and the New England
ing patterns, patient classification systems, patient and Board of Higher Education (NEBHE) were devel-
nurse satisfaction, and unit arrangement. Types of care oped. These organizations are actively involved in
such as comprehensive care, home care, and progres- promoting research and disseminating the findings
sive patient care were evaluated. These evaluations of today. ANA sponsored the first of a series of research
care laid the foundation for the development of self- conferences in 1965, and the conference sponsors
study manuals, which are similar to the quality assur- required that the studies presented be relevant to
ance manuals of today (Gortner & Nahm, 1977). nursing and conducted by a nurse researcher (See,
1977). During the 1960s, a growing number of clinical
Nursing Research in the 1950s and 1960s studies focused on quality care and the development
In 1950, the American Nurses Association (ANA) ini- of criteria to measure patient outcomes. Intensive care
tiated a 5-year study on nursing functions and activi- units were being developed, promoting the investiga-
ties. The findings were reported in Twenty Thousand tion of nursing interventions, staffing patterns, and
Nurses Tell Their Story, and this study enabled the cost-effectiveness of care (Gortner & Nahm, 1977).
20 UNIT ONE  Introduction to Nursing Research

Nursing Research in the 1970s related to their theories. The number of doctoral pro-
In the 1970s, the nursing process became the focus of grams in nursing and the number of nurses prepared
many studies, with the investigations of assessment at the doctoral level greatly expanded in the 1970s
techniques, nursing diagnoses classification, goal- (Jacox, 1980). Some of the nurses with doctoral
setting methods, and specific nursing interventions. degrees increased the conduct and complexity of
The first Nursing Diagnosis Conference, held in 1973, nursing research; however, many doctorally prepared
evolved into the North American Nursing Diagnosis nurses did not become actively involved in research.
Association (NANDA). In 2002, NANDA became In 1970, the ANA Commission on Nursing Research
international and is now known as NANDA-I. was established; in turn, this commission established
NANDA-I supports research activities focused on the Council of Nurse Researchers in 1972 to advance
identifying appropriate diagnoses for nursing and gen- research activities, provide an exchange of ideas, and
erating an effective diagnostic process. NANDA’s recognize excellence in research. The commission
journal, Nursing Diagnosis, was published in 1990 also prepared position papers on subjects’ rights in
and was later renamed International Journal of research and on federal guidelines concerning research
Nursing Terminology and Classifications. Details on and human subjects, and it sponsored research pro-
NANDA-I can be found on their website at http:// grams nationally and internationally (See, 1977).
www.nanda.org/. Federal funds for nursing research increased sig-
The educational studies of the 1970s evaluated nificantly, with a total of slightly more than $39 million
teaching methods and student learning experiences. awarded for research in nursing from 1955 to 1976.
The National League for Nursing (NLN), founded in Even though federal funding for nursing studies rose,
1893, has had a major role in the conduct of research the funding was not comparable to the $493 million
to shape nursing education. Currently, NLN provides in federal research funds received by those doing
programs, grants, and resources to advance nursing medical research in 1974 alone (de Tornyay, 1977).
education research in “pursuit of quality nursing edu- Sigma Theta Tau, the International Honor Society
cation for all types of nursing education programs” for Nursing, sponsored national and international
(NLN, 2011; http://www.nln.org/aboutnln/index. research conferences, and the chapters of this organi-
htm/). A number of studies were conducted to differ- zation sponsored many local conferences to promote
entiate the practices of nurses with baccalaureate and the dissemination of research findings. Image was a
associate degrees. These studies, which primarily journal initially published in 1967 by Sigma Theta Tau
measured abilities to perform technical skills, were now titled Journal of Nursing Scholarship, the journal
ineffective in clearly differentiating between the two publishes many nursing studies and articles about
levels of education. research methodology. A major goal of Sigma Theta
Primary nursing care, which involves the delivery Tau is to advance scholarship in nursing by promoting
of patient care predominantly by registered nurses the conduct, communication, and use of research evi-
(RNs), was the trend for the 1970s. Studies were con- dence in nursing. The addition of two new research
ducted to examine the implementation and outcomes journals in the 1970s, Research in Nursing & Health
of primary nursing care delivery models. The number in 1978 and Western Journal of Nursing Research in
of nurse practitioners (NPs) and clinical nurse special- 1979, also increased the communication of nursing
ists (CNSs) with master’s degrees increased rapidly research findings. However, the findings of many
during the 1970s. Limited research has been con- studies conducted and published in the 1970s were not
ducted on the CNS role; however, the NP and nurse being used in practice, so Stetler and Marram (1976)
midwifery roles have been researched extensively to developed a model to promote the communication and
determine their positive impact on productivity, use of research findings in practice.
quality, and cost of health care. In addition, those clini- Professor Archie Cochrane originated the concepts
cians with master’s degrees acquired the background of evidence-based practice with a book he published
to conduct research and to use research evidence in in 1972 titled Effectiveness and Efficiency: Random
practice. Reflections on Health Services. Cochrane advocated
In the 1970s, nursing scholars began developing the provision of health care based on research to
models, conceptual frameworks, and theories to guide improve the quality of care and patient outcomes. To
nursing practice. The works of these nursing theorists facilitate the use of research evidence in practice, the
also directed future nursing research. In 1978, a new Cochrane Center was established in 1992, and the
journal, Advances in Nursing Science, began publish- Cochrane Collaboration in 1993. The Cochrane Col-
ing the works of nursing theorists and the research laboration and Library house numerous resources to
CHAPTER 2  Evolution of Research in Building Evidence-Based Nursing Practice 21

promote EBP, such as systematic reviews of research into specific nursing actions (innovations) that were
and evidence-based guidelines for practice (discussed administered to patients. The implementation of the
later in this chapter) (see the Cochrane Collaboration innovation was to be followed by clinical evaluation
at www.cochrane.org/). of the new practice to ascertain whether it produced
the predicted result (Horsley et al., 1983). The clinical
Nursing Research in the 1980s and 1990s protocols developed during the project were published
The conduct of clinical nursing research was the focus to encourage nurses in other healthcare agencies to use
in the 1980s and 1990s. A variety of clinical journals these research-based intervention protocols in their
(Achieves of Psychiatric Nursing; Cancer Nursing; practice (CURN Project, 1981-1982).
Cardiovascular Nursing; Dimensions of Critical Care To ensure that the studies were incorporated into
Nursing; Heart & Lung; Journal of Neurosurgical nursing practice, the findings needed to be synthesized
Nursing; Journal of Obstetric, Gynecologic, and Neo- for different topics. In 1983, the first volume of the
natal Nursing; Journal of Pediatric Nursing; Oncol- Annual Review of Nursing Research was published
ogy Nursing Forum; and Rehabilitation Nursing) (Werley & Fitzpatrick, 1983). This annual publication
published a growing number of studies. One new contains experts’ reviews of research in selected areas
research journal was started in 1987, Scholarly Inquiry of nursing practice, nursing care delivery, nursing edu-
for Nursing Practice, and two in 1988, Applied Nurs­ cation, and the profession of nursing. The Annual
ing Research and Nursing Science Quarterly. Review of Nursing Research continues to be published
Even though the body of empirical knowledge gen- each year to (1) expand the synthesis and dissemina-
erated through clinical research grew rapidly in the tion of research findings, (2) promote the use of
1970s and 1980s, little of this knowledge was used research findings in practice, and (3) identify direc-
in practice. Two major projects were launched to tions for future research.
promote the use of research-based nursing interven- Many nurses obtained master’s and doctoral
tions in practice: the Western Interstate Commission degrees during the 1980s and 1990s, and postdoctoral
for Higher Education (WICHE) Regional Nursing education was encouraged for nurse researchers. The
Research Development Project and the Conduct and ANA (1989) stated that nurses at all levels of educa-
Utilization of Research in Nursing (CURN) Project. tion have a role in research, which extends from
In these projects, nurse researchers, with the assis- reading research to conducting complex, funded pro-
tance of federal funding, designed and implemented grams of research (see Chapter 1). Another priority of
strategies for using research findings in practice. The the 1980s and 1990s was to obtain greater funding for
WICHE Project participants selected research-based nursing research. Most of the federal funds in the
interventions for use in practice and then functioned 1980s were designated for studies involving the diag-
as change agents to implement the selected interven- nosis and cure of diseases. Therefore, nursing received
tion in a clinical agency. Because of the limited amount a small percentage of the federal research and devel-
of research that had been conducted, the project staff opment (R&D) funds (approximately 2% to 3%) com-
and participants had difficulty identifying adequate pared with medicine (approximately 90%), even
clinical studies with findings ready for use in practice though nursing personnel greatly outnumbered medi­
(Krueger, Nelson, & Wolanin, 1978). cal personnel (Larson, 1984). However, in 1985, the
The CURN Project was a 5-year venture (1975- ANA achieved a major political victory for nursing
1980) directed by Horsley, Crane, Crabtree, and Wood research with the creation of the National Center for
(1983) to increase the utilization of research findings Nursing Research (NCNR) within the National Insti-
by (1) disseminating findings, (2) facilitating organi- tutes of Health (NIH). This center was created after
zational modifications necessary for implementation, years of work and two presidential vetoes (Bauknecht,
and (3) encouraging collaborative research that was 1986). The purpose of the National Center was to
directly transferable to clinical practice. Research uti- support the conduct of basic and clinical nursing
lization was seen as a process to be implemented by research and the dissemination of findings. With its
an organization rather than by an individual nurse. The creation, nursing research had visibility at the federal
Project team identified the activities of research utili- level for the first time. In 1993, during the tenure of
zation to involve identification and synthesis of mul- its first director, Dr. Ada Sue Hinshaw, the NCNR
tiple studies in a common conceptual area (research became the National Institute of Nursing Research
base) as well as transformation of the knowledge (NINR). This change in title enhanced the recognition
derived from a research base into a solution or clinical of nursing as a research discipline and expanded the
protocol. The clinical protocol was then transformed funding for nursing research.
22 UNIT ONE  Introduction to Nursing Research

Outcomes research emerged as an important meth- findings into the best research evidence, using this
odology for documenting the effectiveness of health- research evidence to guide practice, and examining the
care services in the 1980s and 1990s. This type of outcomes of EBP (Brown, 2009; Craig & Smyth, 2012;
research evolved from the quality assessment and Doran, 2011; Melnyk & Fineout-Overholt, 2011). The
quality assurance functions that originated with the focus on EBP has become stronger over the last decade.
professional standards review organizations (PSROs) In 2002, the Joint Commission on Accreditation of
in 1972. During the 1980s, William Roper, the director Healthcare Organizations (JCAHO) revised the accred­
of the Health Care Finance Administration (HCFA), itation policies for hospitals to support the implemen-
promoted outcomes research for determining the tation of evidence-based health care. To facilitate the
quality and cost-effectiveness of patient care (Johnson, movement of nursing toward EBP in clinical agencies,
1993). Stetler (2001) developed her Research Utilization to
In 1989, the Agency for Health Care Policy and Facilitate EBP Model (see Chapter 19 for a description
Research (AHCPR) was established to facilitate the of this model). The focus on EBP in nursing was sup-
conduct of outcomes research (Rettig, 1991). This ported with the initiation of the Worldviews on
Agency also had an active role in communicating Evidence-Based Nursing journal in 2004.
research findings to healthcare practitioners and was The focus of healthcare research and funding has
responsible for publishing the first evidence-based expanded from the treatment of illness to include
national clinical practice guidelines in 1989. Several health promotion and illness prevention. Healthy
of these guidelines, including the latest research find- People 2000 and Healthy People 2010, documents
ings with directives for practice, were published in the published by the U.S. Department of Health and
1990s. The Healthcare Research and Quality Act of Human Services (U.S. DHHS 1992, 2000), have
1999 reauthorized the AHCPR, changing its name to increased the visibility of health promotion goals and
the Agency for Healthcare Research and Quality research. Health People 2020 (U.S. DHHS, 2012)
(AHRQ, 2012). This significant change positioned the information is now available at the department’s
AHRQ as a scientific partner with the public and website, http://www.healthypeople.gov/2020/. Some
private sectors to improve the quality and safety of of the new topics covered by Healthy People 2020
patient care by promoting the use of the best research include: adolescent health; blood disorders and blood
evidence available in practice. safety; dementias; early and middle childhood; genom-
Building on the process of research utilization, ics; global health; healthcare-associated infections;
physicians, nurses, and other healthcare professions lesbian, gay, bisexual, and transgender health; older
focused on the development of EBP during the 1990s. adults; preparedness; sleep health; and social determi-
A research group led by Dr. David Sackett at McMas- nants of health. In the next decade, nurse researchers
ter University in Canada developed explicit research will have a major role in the development of interven-
methodologies to determine the “best evidence” for tions to promote health and prevent illness in individu-
practice. The term evidence based was first used by als, families, and communities.
David Eddy in 1990, with the focus on providing EBP The AHRQ has been designated the lead agency
for medicine (Craig & Smyth, 2012; Sackett, Straus, supporting research designed to improve the quality
Richardson, Rosenberg, & Haynes, 2000). of health care, reduce its cost, improve patient safety,
In 1990, the ANA leaders established the American decrease medical errors, and broaden access to essen-
Nursing Credentialing Center (ANCC) and approved tial services. The AHRQ sponsors and conducts
a recognition program for hospitals called the Magnet research that provides evidence-based information on
Hospital Designation Program for Excellence in healthcare outcomes, quality, cost, use, and access.
Nursing Services (ANCC, 2012). This program has This research information promotes effective health-
evolved over the last 20 years but has remained true care decision making by patients, clinicians, health
to its commitment to promote research conducted by system executives, and policy makers. The three future
nurses in clinical settings and to support implementa- goals of the AHRQ are focused on the following:
tion of care based on the best current research
evidence. Safety and quality: Reduce the risk of harm by
promoting delivery of the best possible health
Nursing Research in the 21st Century care.
The vision for nursing research in the 21st century Effectiveness: Improve healthcare outcomes
includes conducting quality studies through the use of by encouraging the use of evidence to make
a variety of methodologies, synthesizing the study informed healthcare decisions.
CHAPTER 2  Evolution of Research in Building Evidence-Based Nursing Practice 23

Efficiency: Transform research into practice to professional support, nurses can conduct studies
facilitate wider access to effective healthcare using a variety of research methodologies to generate
services and reduce unnecessary costs. (AHRQ, the essential knowledge needed to promote EBP and
2012) quality health outcomes for all.

AHRQ identifies funding priorities and research


findings on their website at http://www.ahrq.gov/. Methodologies for Developing
Currently, the AHRQ and NINR work collaboratively
to promote funding for nursing studies. These agen- Research Evidence in Nursing
cies often jointly call for proposals for studies of high Scientific method incorporates all procedures that sci-
priority to both agencies. entists have used, currently use, or may use in the
NINR is one of the most influential organizations future to pursue knowledge (Kaplan, 1964). This
committed to providing funding, support, and educa- broad definition dispels the belief that there is one way
tion to advance research in nursing. The current to conduct research and embraces the use of both
mission, goals, research priorities, and strategies of quantitative and qualitative research methodologies in
NINR are as follows: developing research evidence for practice.
Since the 1930s, many researchers have narrowly
The mission of the NINR is to promote and defined scientific method to include only quantitative
improve the health of individuals, families, com- research. This research method is based in the philoso-
munities, and populations. NINR supports and phy of logical empiricism or positivism (Norbeck,
conducts clinical and basic research and 1987; Scheffler, 1967). Therefore, scientific knowl-
research training on health and illness across edge is generated through an application of logical
the lifespan. The research focus encompasses principles and reasoning whereby the researcher
health promotion and disease prevention, quality adopts a distant and noninteractive posture with the
of life, health disparities, and end-of-life. NINR research subject to prevent bias (Silva & Rothbart,
seeks to extend nursing science by integrating 1984). Thus, quantitative research is best defined as
the biological and behavioral sciences, employ- a formal, objective, systematic process implemented
ing new technologies to research questions, to obtain numerical data for understanding aspects of
improving research methods, and developing the the world. This research method is used to describe
scientists of the future. (NINR, 2011; http:// variables, examine relationships among variables, and
www.ninr.nih.gov/AboutNINR/NINRMissionand determine cause-and-effect interactions between vari-
StrategicPlan/) ables (Kerlinger & Lee, 2000; Shadish, Cook, &
Campbell, 2002). Currently, the predominantly used
The NINR has supported the development of nurse method of scientific investigation in nursing is quan-
scientists in genetics and genomics and sponsored the titative research.
Summer Genetics Institute to expand nurses’ contribu- Qualitative research is a systematic, interactive,
tions to genetic research. The funding priorities, subjective, holistic approach used to describe life
funding process, and current research findings are experiences and give them meaning (Marshall &
available on the NINR website at http://www.ninr Rossman, 2011; Munhall, 2012). Qualitative research
.nih.gov/. is not a new idea in the social and behavioral sciences
The mission of ANA is to ensure the advancement (Baumrind, 1980; Glaser & Strauss, 1967). This type
of nurses in their profession to improve health for of research is conducted to explore, describe, and
all. Central to this mission is the promotion of quality promote understanding of human experiences, events,
outcomes that require the use of research to provide and cultures over time.
EBP. ANA’s (2012) research agenda can be viewed
online. To accomplish this agenda, we need to ensure Comparison of Quantitative Research
an effective research enterprise in nursing by (1) and Qualitative Research
creating a research culture; (2) providing quality edu- The quantitative and qualitative types of research
cational (baccalaureate, master’s, doctoral, and post- complement each other because they generate differ-
doctoral) programs to prepare a workforce of nurse ent kinds of knowledge that are useful in nursing prac-
scientists; (3) developing a sound research infrastruc- tice. The problem and purpose to be studied determine
ture; and (4) obtaining sufficient funding for essential the type of research to be conducted, and the research-
research (ANA, 2012; AACN, 1999, 2012). With this er’s knowledge of both types of research promotes
24 UNIT ONE  Introduction to Nursing Research

TABLE 2-2  Characteristics of Quantitative and Qualitative Research Methods


Characteristic Quantitative Research Qualitative Research
Philosophical origin Logical positivism, post positivism Naturalistic, interpretive, humanistic
Focus Concise, objective, reductionistic Broad, subjective, holistic
Reasoning Logistic, deductive Dialectic, inductive
Basis of knowing Cause-and-effect relationships Meaning, discovery, understanding
Theoretical focus Tests theory Develops theory and frameworks
Researcher involvement Control Shared interpretation
Methods of measurement Structured interviews, questionnaires, Unstructured interviews, observations, focus groups
observations, scales, physiological measures
Data Numbers Words
Analysis Statistical analysis Text-based analysis
Findings Acceptance or rejection of theoretical propositions Uniqueness, dynamic, understanding of phenomena,
Generalization new theory, models, and/or frameworks

accurate selection of the methodology for the problem postpositivism, “truth can be discovered only imper-
identified (Creswell, 2009). Quantitative and qualita- fectly and in a probabilistic sense, in contrast to the
tive research methodologies have some similarities, positivist ideal of establishing cause-and-effect expla-
because both require researcher expertise, involve nations of immutable facts” (Ford-Gilboe, Campbell,
rigor in implementation, and result in the generation & Berman, 1995, p. 16). The postpositivist approach
of scientific knowledge for nursing practice. Some of also rejects the idea that the researcher is completely
the differences between the two methodologies are objective about what is to be discovered but continues
presented in Table 2-2. Some researchers include both to emphasize the need to control environmental influ-
quantitative and qualitative research methodologies in ences (Newman, 1992; Shadish et al., 2002).
their studies, an approach referred to as mixed methods Qualitative research is an interpretive method­
research (see Chapter 10). ological approach that values more of a subjective
science than quantitative research. Qualitative research
Philosophical Origins of Quantitative evolved from the behavioral and social sciences as a
and Qualitative Research Methods method of understanding the unique, dynamic, holistic
The quantitative approach to scientific inquiry emerged nature of human beings. The philosophical base of
from a branch of philosophy called logical positivism, qualitative research is interpretive, humanistic, and
which operates on strict rules of logic, truth, laws, naturalistic and is concerned with helping those
axioms, and predictions. Quantitative researchers hold involved to understand the meaning of their social
the position that truth is absolute and that there is a interactions. Qualitative researchers believe that truth
single reality that one could define by careful measure- is both complex and dynamic and can be found only
ment. To find truth as a quantitative researcher, you by studying persons as they interact with and within
need to be completely objective, meaning that your their sociohistorical settings (Marshall & Rossman,
values, feelings, and personal perceptions cannot enter 2011; Munhall, 2012).
into the measurement of reality. Quantitative research-
ers believe that all human behavior is objective, pur- Focuses of Quantitative and
poseful, and measurable. The researcher needs only Qualitative Research Methods
to find or develop the “right” instrument or tool to The focus or perspective for quantitative research is
measure the behavior. usually concise and reductionistic. Reductionism
Today, however, many nurse researchers base their involves breaking the whole into parts so that the parts
quantitative studies on more of a postpositivist phi- can be examined. Quantitative researchers remain
losophy (Clark, 1998). This philosophy evolved from detached from the study and try not to influence it with
positivism but focuses on the discovery of reality that their values (objectivity). Researcher involvement in
is characterized by patterns and trends that can be used the study is thought to bias or sway the study toward
to describe, explain, and predict phenomena. With the perceptions and values of the researcher, and
CHAPTER 2  Evolution of Research in Building Evidence-Based Nursing Practice 25

biasing a study is considered poor scientific technique cardiovascular disease, and exercise level, because
(Creswell, 2009; Kerlinger & Lee, 2000; Shadish et these extraneous variables might affect the serum lipid
al., 2002). levels. The intent of this control is to more precisely
The focus of qualitative research is usually broad, examine the effects of nutritional education on serum
and the intent is to give meaning to the whole (holis- lipid levels.
tic). The qualitative researcher has an active part in Quantitative research also requires the use of (1)
the study and acknowledges that personal values and structured interviews, questionnaires, or observations,
perceptions may influence the findings. Thus, this (2) scales, and (3) physiological measures that gener-
research approach is subjective, because the approach ate numerical data. Statistical analyses are conducted
assumes that subjectivity is essential for understand- to reduce and organize data, describe variables,
ing human experiences (Marshall & Rossman, 2011; examine relationships, and determine differences
Munhall, 2012). among groups. Control, precise measurement methods,
and statistical analyses are used to ensure that the
Uniqueness of Conducting Quantitative research findings accurately reflect reality so that the
Research and Qualitative Research study findings can be generalized. Generalization
Quantitative research describes and examines rela- involves the application of trends or general tenden-
tionships and determines causality among variables. cies (which are identified by studying a sample) to the
Thus, this method is useful for testing a theory by population from which the research sample was
testing the validity of the relationships that compose drawn. Researchers must be cautious in making gen-
the theory (Creswell, 2009). Quantitative research eralizations, because a sound generalization requires
incorporates logistic, deductive reasoning as the the support of many studies with a variety of samples
researcher examines particulars to make generaliza- (Shadish et al., 2002).
tions about the universe. Qualitative researchers use observations, inter-
Qualitative research generates knowledge about views, and focus groups to gather data. The interac-
meaning through discovery. Inductive reasoning and tions are guided but not controlled in the way that
dialectic reasoning are predominant in these studies. quantitative data collection is controlled. For example,
For example, the qualitative researcher studies the the researcher may ask subjects to share their experi-
whole person’s response to pain by examining prem- ences of powerlessness in the healthcare system. Qual-
ises about human pain and determining the meaning itative researchers would begin interpreting the
that pain has for a particular person. Because qualita- subjective data during data collection, recognizing
tive research is concerned with meaning and under- that their interpretation is influenced by their own
standing, researchers using qualitative approaches perceptions and beliefs (Munhall, 2012).
may identify relationships among the variables, and Qualitative data take the form of words and are
these relational statements may be used to develop and analyzed according to the qualitative approach that is
extend theories. being used. The intent of the analysis is to organize
Quantitative research requires control (see Table the data into a meaningful, individualized interpreta-
2-2). The investigator uses control to identify and limit tion, framework, or theory that describes the phenom-
the problem to be researched and attempts to limit the enon studied. The findings from a qualitative study are
effects of extraneous or other variables that are not the unique to that study, and it is not the researcher’s
focus of the study. For example, as a quantitative intent to generalize the findings to a larger population.
researcher, you might study the effects of nutritional Qualitative researchers are encouraged to question
education on serum lipid levels (total serum cho­ generalizations and to interpret meaning based on
lesterol, low-density lipoprotein [LDL] cholesterol, individual study participants’ perceptions and realities
high-density lipoprotein [HDL] cholesterol, and tri- (Munhall, 2012).
glycerides). You would control the educational
program by manipulating the type of education pro-
vided, the teaching methods, the length of the program, Classification of Research
the setting for the program, and the instructor. The Methodologies Presented
nutritional program might be consistently imple-
mented with the use of DVDs shown to subjects in a in this Text
structured setting. You could also control other extra- Research methods used frequently in nursing can be
neous variables, such as participant’s age, history of classified in different ways, so a classification system
26 UNIT ONE  Introduction to Nursing Research

Box 2-1 Classification of Research quasi-experimental, and experimental studies (Cres­


well, 2009).
Methods for this Textbook
Types of quantitative research Correlational Research
Descriptive research Correlational research involves the systematic
Correlational research investigation of relationships between or among two
Quasi-experimental research or more variables that have been identified in theories,
Experimental research observed in practice, or both. If the relationships exist,
Types of qualitative research the researcher determines the type (positive or nega-
Phenomenological research tive) and the degree or strength of the relationships.
Grounded theory research The primary intent of correlational studies is to explain
Ethnographic research the nature of relationships, not to determine cause and
Exploratory-descriptive qualitative research effect. However, correlational studies are the means
Historical research for generating hypotheses to guide quasi-experimental
Outcomes research and experimental studies that focus on examining
Intervention research cause-and-effect interactions.

Quasi-Experimental Research
The purposes of quasi-experimental studies are (1)
to identify causal relationships, (2) to examine the
was developed for this textbook and is presented in significance of causal relationships, (3) to clarify why
Box 2-1. This textbook includes quantitative, qualita- certain events happened, or (4) a combination of these
tive, outcomes, and intervention methods of research. objectives (Shadish et al., 2002). These studies test the
The quantitative research methods are classified into effectiveness of nursing interventions that can then be
four categories: (1) descriptive, (2) correlational, (3) implemented to improve patient and family outcomes
quasi-experimental, and (4) experimental. Types of in nursing practice.
quantitative research are used to test theories and gen- Quasi-experimental studies are less powerful than
erate and refine knowledge for nursing practice. Quan- experimental studies because they involve a lower
titative research methods are introduced in this section level of control in at least one of three areas: (1)
and described in more detail in Chapter 3. manipulation of the treatment or independent variable,
The qualitative research methods included in this (2) manipulation of the setting, and (3) selection of
textbook are (1) phenomenological research, (2) subjects. When studying human behavior, especially
grounded theory research, (3) ethnographic research, in clinical areas, researchers are commonly unable to
(4) exploratory-descriptive qualitative research, and manipulate or control certain variables. Also, subjects
(5) historical research. These approaches, all method- are usually not randomly selected but are selected on
ologies for discovering knowledge, are introduced in the basis of convenience. Thus, as a nurse researcher
this section and described in depth in Chapters 4 and you will probably conduct more quasi-experimental
12. Unit Two of this textbook focuses on understand- than experimental studies.
ing the research process and includes discussions of
both quantitative and qualitative research. Experimental Research
Experimental research is an objective, systematic,
Quantitative Research Methods controlled investigation conducted for the purpose of
predicting and controlling phenomena. This type of
Descriptive Research research examines causality (Shadish et al., 2002).
Descriptive research provides an accurate portrayal Experimental research is considered the most power-
or account of characteristics of a particular individual, ful quantitative method because of the rigorous control
situation, or group (Kerlinger & Lee, 2000). Descrip- of variables. Experimental studies have three main
tive studies offer researchers a way to (1) discover characteristics: (1) a controlled manipulation of at
new meaning, (2) describe what exists, (3) determine least one treatment variable (independent variable),
the frequency with which something occurs, and (4) (2) administration of the treatment to some of the
categorize information. Descriptive studies are usually subjects in the study (experimental group) and not to
conducted when little is known about a phenomenon others (control group), and (3) random selection of
and provide the basis for the conduct of correlational, subjects or random assignment of subjects to groups,
CHAPTER 2  Evolution of Research in Building Evidence-Based Nursing Practice 27

or both. Experimental studies usually are conducted in ethnographic research, different cultures are described,
highly controlled settings, such as laboratories or compared, and contrasted to add to our understanding
research units in clinical agencies. A randomized con- of the impact of culture on human behavior and health
trolled trial (RCT) is a type of experimental research (Wolf, 2012).
that produces the strongest research evidence for
practice. Exploratory-Descriptive Qualitative Research
Exploratory-descriptive qualitative research is
Qualitative Research Methods conducted to address an issue or problem in need of a
solution and/or understanding. Qualitative nurse
Phenomenological Research researchers explore an issue or problem area using
Phenomenological research is a humanistic study of varied qualitative techniques with the intent of describ-
phenomena. The aim of phenomenology is to explore ing the topic of interest and promoting understanding.
an experience as it is lived by the study participants Although the studies result in descriptions and could
and interpreted by the researcher. During the study, the be labeled as descriptive qualitative studies, most of
researcher’s experiences, reflections, and interpreta- the researchers are in the exploratory stage of studying
tions influence the data collected from the study par- the area of interest. This type of qualitative research
ticipants (Munhall, 2012). Thus, the participants’ lived usually lacks a clearly identified qualitative methodol-
experiences are expressed through the researcher’s ogy, such as phenomenology, grounded theory, or eth-
interpretations that are obtained from immersion in the nography. In this text, studies that the researchers
study data and the underlying philosophy of the phe- identified as being qualitative without indicating a
nomenological study. Phenomenological research is specific approach like phenomenology or grounded
an effective methodology for discovering the meaning theory will be labeled as being exploratory-descriptive
of a complex experience as it is lived by a person, such qualitative studies.
as the lived experience of chronic illness.
Historical Research
Grounded Theory Research Historical research is a narrative description or
Grounded theory research is an inductive research analysis of events that occurred in the remote or
method initially described by Glaser and Strauss recent past. Data are obtained from records, artifacts,
(1967). This research approach is useful for discover- or verbal reports. Through historical research,
ing what problems exist in a social setting and the nursing has a way of understanding the discipline
processes people use to handle them. Grounded theory and interpreting its contributions to health care and
is particularly useful when little is known about the society. Initial historical research focused on nursing
area to be studied or when what is known does not leaders, such as Nightingale, and her contributions to
provide a satisfactory explanation. Grounded theory nursing research and practice. In addition, the mis-
methodology emphasizes interaction, observation, and takes of the past can be examined to help nurses
development of relationships among concepts. understand and respond to present situations affect-
Throughout the study, the researcher explores, pro- ing nurses and nursing practice. Thus, historical
poses, formulates, and validates relationships among research has the potential to provide a foundation for
the concepts until a theory evolves. The theory devel- and to direct the future movements of the profession
oped is “grounded,” in or has its roots in, the data from (Lundy, 2012).
which it was derived (Wuest, 2012).
Outcomes Research
Ethnographic Research The spiraling cost of health care has generated many
Ethnographic research was developed by anthro- questions about the quality and effectiveness of health-
pologists to investigate cultures through in-depth care services and the patient outcomes. Consumers
study of the members of the cultures. This type of want to know what services they are buying and
research attempts to tell the story of people’s daily whether these services will improve their health.
lives while describing the culture in which they live. Healthcare policy makers want to know whether the
The ethnographic research process is the systematic care is cost-effective and high quality. These concerns
collection, description, and analysis of data to develop have promoted the development of outcomes
a description of cultural behavior. The researcher (eth- research, which examines the results of care and mea-
nographer) actually lives in or becomes a part of the sures the changes in health status of patients (AHRQ,
cultural setting to gather the data. Through the use of 2012; Doran, 2011). Key ideas related to outcomes
28 UNIT ONE  Introduction to Nursing Research

research are addressed throughout the text, and findings is a complex, highly structured process that
Chapter 13 contains a detailed discussion of this is conducted most effectively by at least two research-
methodology. ers or even a team of expert researchers and healthcare
providers. There are various types of research synthe-
Intervention Research ses, and the type of synthesis conducted varies accord-
Intervention research investigates the effectiveness ing to the quality and types of research evidence
of a nursing intervention in achieving the desired available.
outcome or outcomes in a natural setting. “Interven- The quality of the research evidence available in an
tions are defined as treatments, therapies, procedures, area depends on the number and strength of the studies.
or actions implemented by health professionals to and Replicating or repeating of studies with similar meth-
with clients, in a particular situation, to move the odology adds to the quality of the research evidence.
clients’ condition toward desired health outcomes that The strengths and weaknesses of the studies are deter-
are beneficial to the clients” (Sidani & Braden, 1998, mined by critically appraising the validity or credibil-
p. 8). An intervention can be a specific treatment ity of the study outcomes (see Chapter 18). The types
implemented to manage a well-defined patient problem of research commonly conducted in nursing were
or a program. A program intervention, such as a identified earlier in this chapter as quantitative, quali-
cardiac rehabilitation program, consists of multiple tative, outcomes, and intervention (see Box 2-1). The
nursing actions that are implemented as a package to research synthesis process used to summarize knowl-
improve the health conditions of the participants edge varies for quantitative and qualitative research
(Brown, 2002; Forbes, 2009). The goal of intervention methods. In building the best research evidence for
research is to generate sound scientific knowledge for practice, the quantitative experimental study, such as
actions or interventions that nurses can use to provide an RCT, has been identified as producing the strongest
evidence-based nursing care. The details of interven- research evidence for practice (Craig & Smyth, 2012;
tion research are presented in Chapter 14. In summary, Institute of Medicine, 2001; Melnyk & Fineout-
nurse researchers conduct a variety of research meth- Overholt, 2011; Sackett et al., 2000).
odologies (quantitative, qualitative, outcomes, and Research evidence in nursing and health care is
intervention research) to develop the best research synthesized by using the following processes: (1) sys-
evidence for practice. tematic review, (2) meta-analysis, (3) meta-synthesis,
and (4) mixed methods systematic review. Depending
on the quantity and strength of the research findings
Introduction to Best Research available, nurses and healthcare professionals use one
or more of these four synthesis processes to determine
Evidence for Practice the current best research evidence in an area. Table 2-3
EBP involves the use of best research evidence to identifies the processes used in research synthesis, the
support clinical decisions in practice. As a nurse, you purpose of each synthesis process, the types of research
make numerous clinical decisions each day that affect included in the synthesis (sampling frame), and the
the health outcomes of your patients and their fami- analysis techniques used to achieve the synthesis of
lies. By using the best research evidence available, research evidence (Craig & Smyth, 2012; Sandelowski
you can make quality clinical decisions that will & Barroso, 2007; Whittemore, 2005).
improve the health outcomes for patients, families, A systematic review is a structured, comprehen-
and communities. This section introduces you to the sive synthesis of the research literature to determine
concept of best research evidence for practice by pro- the best research evidence available to address a
viding (1) a definition of the term best research evi- healthcare question. A systematic review involves
dence, (2) a model of the levels of research evidence identifying, locating, appraising, and synthesizing
available, and (3) a link of the best research evidence quality research evidence for expert clinicians to use
to evidence-based guidelines for practice. to promote an EBP (Craig & Smyth, 2012; Higgins &
Green, 2008). Teams of expert researchers, clinicians,
Definition of Best Research Evidence and sometimes students conduct these reviews to
Best research evidence is a summary of the highest- determine the current best knowledge for use in
quality, current empirical knowledge in a specific area practice. Systematic reviews are also used in the
of health care that is developed from a synthesis of development of national and international standard-
quality studies (quantitative, qualitative, outcomes, ized guidelines for managing health problems such as
and intervention) in that area. The synthesis of study depression, hypertension, and type 2 diabetes. The
CHAPTER 2  Evolution of Research in Building Evidence-Based Nursing Practice 29

TABLE 2-3  Processes Used to Synthesize Research Evidence


Analysis for
Synthesis Types of Research Included in the Achieving
Process Purpose of Synthesis Synthesis (Sampling Frame) Synthesis
Systematic Use of specific, systematic methods to identify, Usually includes quantitative studies with Narrative and
review select, critically appraise, and synthesize similar methodology, such as statistical
research evidence to address a particular randomized controlled trials (RCTs), and
problem in practice (Craig & Smyth, 2012; can also include meta-analyses focused
Higgins & Green, 2008). on an area of the practice problem.
Meta-analysis Synthesis or pooling of the results from several Includes quantitative studies with similar Statistical
previous studies using statistical analysis to methodology, such as quasi-experimental
determine the effect of an intervention or the and experimental studies focused on the
strength of relationships (Higgins & Green, effect of an intervention or correlational
2008). studies focused on relationships.
Meta-synthesis Systematic compiling and integration of Uses original qualitative studies and Narrative
qualitative studies to expand understanding summaries of qualitative studies to
and develop a unique interpretation of the produce the synthesis.
studies’ findings in a selected area (Barnett-
Page & Thomas, 2009; Finfgeld-Connett,
2010; Sandelowski & Barroso, 2007).
Mixed methods Synthesis of the findings from independent Synthesis of a variety of quantitative, Narrative
systematic studies conducted with a variety of methods qualitative, and mixed methods studies.
review (both quantitative and qualitative) to
determine the current knowledge in an area
(Higgins & Green, 2008).

processes for critically appraising and conducting sys- (Sandelowski & Barroso, 2007). The process for con-
tematic reviews are detailed in Chapter 19. ducting a synthesis of qualitative research is still in
A meta-analysis is conducted to statistically pool the developmental phase, and a variety of synthesis
the results from previous studies into a single quantita- methods have appeared in the literature (Barnett-Page
tive analysis that provides one of the highest levels of & Thomas, 2009; Finfgeld-Connett, 2010; Higgins &
evidence about an intervention’s effectiveness (Andrel, Green, 2008). In this text, the concept meta-synthesis
Keith, & Leiby, 2009; Craig & Smyth, 2012; Higgins is used to describe the process for synthesizing quali-
& Green, 2008). The studies synthesized are usually tative research. Meta-synthesis is defined as the sys-
quasi-experimental or experimental types of studies. tematic compiling and integration of qualitative study
In addition, a meta-analysis can be performed on cor- results to expand understanding and develop a unique
relational studies to determine the type (positive or interpretation of study findings in a selected area. The
negative) or strength of relationships among selected focus is on interpretation rather than the combining of
variables (see Table 2-3). Because meta-analyses study results as with quantitative research synthesis
involve statistical analysis to combine study findings, (see Table 2-3). The process for conducting a meta-
it is possible to be objective rather than subjective in synthesis is presented in Chapter 19.
synthesizing research evidence. Some of the strongest Over the past 10 to 15 years, nurse researchers
evidence for using an intervention in practice is gener- have conducted mixed methods studies (previously
ated from a meta-analysis of multiple, controlled referred to as triangulation studies) that include
quasi-experimental and experimental studies. Thus, both quantitative and qualitative research methods
many systematic reviews conducted to generate (Creswell, 2009). In addition, determining the current
evidence-based guidelines include meta-analyses. The research evidence in an area might require synthesiz-
process for conducting a meta-analysis is presented in ing both quantitative and qualitative studies. Higgins
Chapter 19. and Green (2008) refer to this synthesis of quantita-
Qualitative research synthesis is the process and tive, qualitative, and mixed methods studies as a
product of systematically reviewing and formally mixed methods systematic review (see Table 2-3).
integrating the findings from qualitative studies Mixed methods systematic reviews might include a
30 UNIT ONE  Introduction to Nursing Research

variety of study designs, such as qualitative research studies conducted in the area. Quantitative studies,
and quasi-experimental, correlational, and/or descrip- especially experimental studies like RCTSs, are
tive studies (Higgins & Green, 2008). Some research- thought to provide the strongest research evidence. In
ers have conducted syntheses of quantitative and/or addition, the replication of studies with similar meth-
qualitative studies and called them “integrative odology increases the strength of the research
reviews of research.” In this text, the synthesis of a evidence generated. The levels of the research evi-
variety of quantitative and qualitative study findings dence can be visualized as a continuum with the
is referred to as mixed methods systematic reviews. highest quality of research evidence at one end and
The value of these reviews depends on the standards weakest research evidence at the other (see Figure 2-1)
used to the conduct them. The process for conducting (Craig & Smyth, 2012; Higgins & Green, 2008;
a mixed method systematic review is discussed in Melnyk & Fineout-Overholt, 2011). The systematic
Chapter 19. research reviews and meta-analyses of high-quality
experimental studies provide the strongest or best
Levels of Research Evidence research evidence for use by expert clinicians in prac-
The strength or validity of the best research evidence tice. Meta-analyses and integrative reviews of quasi-
in an area depends on the quality and quantity of the experimental and experimental studies also provide

Strongest or Best Research Evidence

Systematic Review of experimental studies (well-designed randomized


controlled trials [RCTs]) and meta-analyses

Meta-analyses of experimental (RCT) and quasi-experimental studies

Integrative Reviews of experimental (RCT) and quasi-experimental

Single Experimental study (RCT)

Single Quasi-experimental study

Meta-analysis of correlational studies

Integrative Reviews of correlational and descriptive studies

Mixed methods systematic review of quantitatives, qualitatives, and mixed methods studies

Qualitative Research Meta-synthesis

Single Correlational study

Single Qualitative or Descriptive study

Opinions of respected authorities based upon clinical evidence, reports


of expert committees

Weakest Research Evidence

Figure 2-1  Levels of research evidence.


CHAPTER 2  Evolution of Research in Building Evidence-Based Nursing Practice 31

strong research evidence for managing practice prob- An extremely important source for evidence-based
lems. Correlational, descriptive, and qualitative studies guidelines in the United States is the National Guide-
direct further research and provide some useful find- line Clearinghouse (NGC), which was initiated in
ings for practice (see Figure 2-1). The weakest evi- 1998 by the AHRQ. The Clearinghouse started with
dence comes from expert opinions, which can include 200 guidelines and has expanded to contain more than
expert clinicians’ opinions or the opinions expressed 1500 EBP guidelines (see http://www.guideline.gov/).
in committee reports. When making a decision in your Another excellent source of systematic reviews and
clinical practice, be sure to base your decision on the EBP guidelines is the Cochrane Collaboration and
best research evidence available. Library in the United Kingdom, which can be accessed
The levels of research evidence identified in Figure at http://www.cochrane.org/. The Joanna Briggs Insti-
2-1 help nurses determine the quality and validity of tute has also been a leader in developing evidence-
the evidence that is available for them to use in prac- based guidelines for nursing practice (http://www
tice. Advance practice nurses must seek out the best .joannabriggs.edu.au/). In addition, professional nur­
research knowledge available in an area to ensure that sing organizations, such as the Oncology Nursing
they manage patients’ acute and chronic illnesses with Society (http://www.ons.org/) and the National Asso-
quality care (Craig & Smyth, 2012; Higgins & Green, ciation of Neonatal Nurses (http://www.nann.org/),
2008; Melnyk & Fineout-Overholt, 2011). This best have developed EBP guidelines for their specialties.
research evidence generated from systematic reviews, These websites will introduce you to some of guide-
meta-analyses, and mixed methods systematic reviews lines that exist nationally and internationally. Chapter
is used most often to develop standardized or evidence- 19 will help you to critically appraise the quality of an
based guidelines for practice. EBP guideline and implement that guideline in your
practice.
Introduction to Evidence-Based
Practice Guidelines
Evidence-based practice guidelines are rigorous, KEY POINTS
explicit clinical guidelines that are based on the best
research evidence available in that area. These guide- • Florence Nightingale initiated nursing research
lines are usually developed by a team or panel of more than 150 years ago; this start was followed
expert researchers; expert clinicians (physicians, by decades of limited research. During the 1950s
nurses, pharmacists, and other health professionals); and 1960s, research became a higher priority, with
and sometimes consumers, policy makers, and econo- the development of graduate programs in nursing
mists. The expert panel seeks consensus on the content that increased the number of nurses with doctorates
of the guideline to provide clinicians with the best and master’s degrees. In the 1970s and 1980s, the
information for making clinical decisions in practice. major focus was on the conduct of clinical research
There has been a dramatic growth in the production to improve nursing practice.
of EBP guidelines to assist healthcare providers in • Outcomes research emerged as an important meth-
building an EBP and in improving healthcare out- odology for documenting the effectiveness of
comes for patients, families, providers, and healthcare healthcare service in the 1980s and 1990s. In 1989,
agencies. the Agency for Health Care Policy and Research
Every year, new guidelines are developed, and (later renamed the Agency for Healthcare Research
some of the existing guidelines are revised on the basis and Quality [AHRQ]) was established to facilitate
of new research evidence. These guidelines have the conduct of outcomes research.
become the gold standard (or standard of excellence) • The vision for nursing in the 21st century is the
for patient care, and nurses and other healthcare pro- development of a scientific knowledge base that
viders are encouraged to incorporate these standard- enables nurses to implement an EBP.
ized guidelines into their practice. Expert national and • Nursing research incorporates quantitative, qualita-
international government agencies, professional orga- tive, outcomes, and intervention research method-
nizations, and centers of excellence have made many ologies.
of these evidence-based guidelines available online. • Quantitative research is classified into four types
When selecting a guideline for practice, be sure that a for this textbook: descriptive, correlational, quasi-
credible agency or organization developed the guide- experimental, and experimental.
line and that the reference list reflects the synthesis of • Qualitative research is classified into five types
extensive research evidence. for this textbook: phenomenological research,
32 UNIT ONE  Introduction to Nursing Research

grounded theory research, ethnographic research, American Nurses Credentialing Center (ANCC, 2012). Magnet
exploratory-descriptive qualitative research, and Program Overview. Retrieved from http://www.nurse
historical research. credentialing.org/Magnet/ProgramOverview.aspx.
Andrel, J. A., Keith, S. W., & Leiby, B. E. (2009). Meta-analysis:
• Outcomes research focuses on determining the end
A brief introduction. Clinical & Translational Science, 2(5),
results of care or a measure of the change in health 374–378.
status of the patient and family. Barnett-Page, E., & Thomas, J. (2009). Methods for the synthesis
• Intervention research involves the investigation of qualitative research: A critical review. BMC Medical Research
of the effectiveness of a nursing intervention in Methodology, 9, 59. DOI: 10.1186/147–2288–9-59.
achieving the desired outcomes in a natural setting. Bauknecht, V. L. (1986). Congress overrides veto, nursing gets
• Best research evidence is a summary of the highest- center for research. American Nurse, 18(1), 24.
quality, current empirical knowledge in a specific Baumrind, D. (1980). New directions in socialization research.
area of health care that is developed from a synthe- American Psychologist, 35(7), 639–652.
sis of high-quality studies (quantitative, qualitative, Brown, S. J. (2002). Focus on research methods. Nursing interven-
tion studies: A descriptive analysis of issues important to clini-
outcomes, and intervention) in that area.
cians. Research in Nursing & Health, 25(4), 317–327.
• Research evidence in nursing and health care Brown, S. J. (2009). Evidence-based nursing: The research-practice
is synthesized using the following processes: (1) connection. Sudbury, MA: Jones and Bartlett Publishers.
systematic review, (2) meta-analysis, (3) meta- Clark, A. M. (1998). The qualitative-quantitative debate: Moving
synthesis, and (4) mixed methods systematic from positivism and confrontation to post-positivism and recon-
review. ciliation. Journal of Advanced Nursing, 27I(6), 1242–1249.
• The levels of the research evidence can be thought Cohen, B. (1984). Florence Nightingale. Scientific American,
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available in that area. Livingstone.
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Doran, D. M. (2011). Nursing-sensitive outcomes: State of the
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  http://evolve.elsevier.com/Grove/practice/

3  
CHAPTER

Introduction to Quantitative Research

W
hat do you think of when you hear the research process, and (3) providing examples of dif-
word research? Frequently, the word exper- ferent types of quantitative studies.
iment comes to mind. One might equate
experiments with randomizing subjects into groups,
collecting data, and conducting statistical analyses. Concepts Relevant to
Many people believe that an experiment is conducted
to answer a clinical question, such as “Is one pain Quantitative Research
medicine more effective than another?” These ideas Some concepts relevant to quantitative research are
are associated with the classic experimental design basic research, applied research, rigor, and control.
originated by Sir Ronald Fisher (1935). Fisher is These concepts are defined here, and the major points
noted for adding structure and control to the steps of are reinforced with examples from quantitative
the quantitative research process to decrease the studies.
potential for error and improve the accuracy of study
findings. Basic Research
Four types of quantitative research are included in Basic, or pure, research is a scientific investigation
this text: descriptive, correlational, quasi-experimental, that involves the pursuit of “knowledge for knowl-
and experimental. Fisher’s experimentation provided edge’s sake,” or for the pleasure of learning and
the groundwork for what is now known as experi­ finding truth (Nagel, 1961). The purpose of basic
mental research. Throughout the years, other quantita- research is to generate and refine theory and build
tive approaches have been developed. Campbell and constructs; thus, the findings are frequently not directly
Stanley (1963) are noted for developing quasi- useful in practice. However, because the findings are
experimental designs for conducting quantitative more theoretical in nature, they can be generalized to
research. Karl Pearson (Kerlinger & Lee, 2000) devel- various settings (Wysocki, 1983).
oped statistical approaches for examining relation- Basic research also examines pathological and
ships among variables, which increased the conduct physiological responses as well as underlying mecha-
of correlational research. The fields of sociology, edu- nisms of actions of an intervention or outcome
cation, and psychology are noted for their develop- (Fawcett & Garity, 2009). Often basic research is con-
ment and expansion of strategies for conducting ducted in a laboratory with animals or human tissues.
descriptive research. The steps of the research process For example, cachexia in cancer patients clinically
used in these different types of quantitative study are manifests as anorexia, weight loss, and wasting of
the same, but the philosophy and strategies for imple- skeletal muscles that decrease patients’ functioning
menting these steps vary with the approach. and quality of life. Cachexia is a very complex process
Many quantitative research approaches and designs that has been studied for many years, but the knowl-
are essential to develop the body of knowledge needed edge of the specific causes and progression of this
for evidence-based practice. Thus, quantitative re- condition is still evolving. Thus, additional basic
search is a major focus throughout this textbook. This research is needed to examine the pathology of cancer
chapter provides an overview of quantitative research cachexia with skeletal muscle wasting. For example,
by (1) discussing concepts relevant to quantitative re- Byerley et al. (2010) conducted a basic study to
search, (2) identifying the steps of the quantitative examine the causes of body fat loss early in the

34
CHAPTER 3  Introduction to Quantitative Research 35

development of cancer cachexia in male rats. Their generalizable than those from basic research. Applied
study findings are summarized in the following research is also used to test theory and validate
excerpt: its usefulness in clinical practice. Often, the new
knowledge discovered through basic research is exam-
ined for usefulness in practice by applied research,
“We provide evidence that a factor other than the making these approaches complementary (Bond &
previously identified lipid mobilizing factor, zinc Heitkemper, 1987; NHGRI, 2012).
alpha-2 glycoprotein, promotes lipolysis in the … Artinian et al. (2007) conducted an applied study
sarcoma-bearing cachexia model.… We compared to determine the effectiveness of a nurse-managed
tumor-bearing ad lib fed (TB) animals to nontumor- telemonitoring (TM) program on the blood pressure
bearing ad lib fed (NTB) animals.… Prior to cachexia, (BP) of urban African Americans. The TM program
the TB animals lost more than 10 ± 0.7% of their (1) provided BP equipment for patients to monitor
body fat before losing protein mass and decreasing their BPs at home, (2) improved access to care by
their food intake. Fat loss occurred because adipo- sending patients’ BP readings via telephone to health-
cyte size, not number, was reduced.… Yet circulating care agencies, and (3) increased monitoring of the
levels of norepinephrine, epinephrine, and TNF-α patients’ BPs by a care provider with immediate
[tissue necrosing factor-alpha], and zinc alpha-2 gly- feedback to the patients. The treatment group received
coprotein were not increased prior to the loss of fat the nurse-managed TM intervention or treatment, and
mass. We provide evidence for a serum factor(s), the comparison group received usual care (UC). The
other than zinc alpha-2 glycoprotein, that stimulates TM intervention group had a significant reduction
release of glycerol from 3T3-L 1 adipocytes and pro- in systolic BP in comparison with the UC group,
motes the loss of stored adipose lipid prior to the loss and diastolic BP was greatly reduced but was not
of lean body mass in this model.” (Byerley et al., statistically significant from that of the UC group at
2010, p. 484) 12 months. Thus, the TM intervention did have a posi-
tive impact on the BPs of African Americans, and
additional research is needed to determine whether the
Byerley and colleagues’ (2010) study demonstrates intervention has a long-term effect on BPs and
the importance of genetic research in understanding improves hypertension control in this population. The
disease pathology. It provides the basis for further findings from this applied study do have implications
research to isolate and characterize the lipolytic for practice, because this nurse-managed TM interven-
protein causing loss of body fat in animals with cancer. tion significantly affected BP in a population with a
This basic research in animals provides the basis for high incidence of hypertension. On the basis of Artin-
human research in this area. A major force in genetic ian and colleagues’ (2007; 2004; Artinian, Washing-
research is the National Human Genome Research ton, & Templin, 2001) research and the research of
Institute (NHGRI) (2012), which plans and conducts others documenting the importance of home BP moni-
a broad program of laboratory research to improve our toring, a scientific statement from the American Heart
understanding of the human genetic makeup, genetics Association, American Society of Hypertension, and
of diseases, and potential gene therapy. This basic Preventive Cardiovascular Nurses Association recom-
research provides a basis for conducting applied “clin- mended the use of and reimbursement for home BP
ical research to translate genomic and genetic research monitoring (Pickering et al., 2008). Artinian was a
into a greater understanding of human genetic disease, member of the group making this recommendation
and to develop better methods for the detection, pre- about home BP monitoring. For more information
vention, and treatment of heritable and genetic disor- about the home BP monitoring recommendation,
ders” (NHGRI, 2012). you can view an article on the American Heart Asso-
ciation (2011) website, at http://my.americanheart
Applied Research .org/professional/General/Call-to-Action-on-Use-and-
Applied, or practical, research is a scientific inves- Reimbursement-for-Home-Blood-Pressure-Monito
tigation conducted to generate knowledge that will ring_UCM_423866_Article.jsp.
directly influence or improve clinical practice. The Many nurse researchers have conducted applied
purpose of applied research is to solve problems, to studies to produce findings that directly affect clinical
make decisions, or to predict or control outcomes in practice. Usually, applied studies focus on developing
real-life practice situations. Because applied research and testing the effectiveness of nursing interventions
focuses on specific problems, the findings are less in the treatment of patient and family health problems.
36 UNIT ONE  Introduction to Nursing Research

In addition, most previous federal funding for nursing formulation of explicit treatment protocols. The most
has been granted for applied research. However, the explicit use of precision, however, is evident in the
National Institute of Nursing Research (NINR, 2012) measurement of the study variables (Borglin &
recognizes the importance of basic research to nursing Richards, 2010). Measurement involves objectively
and has made it a funding priority. Basic research is experiencing the real world through the senses: sight,
needed to expand our understanding of several patho- hearing, touch, taste, and smell. The researcher con-
physiological variables, such as impaired oxygenation tinually searches for new and more precise ways to
and perfusion, fluid and electrolyte imbalance, altered measure elements and events of the world (Waltz,
neurological function, impaired immune system, Strickland, & Lenz, 2010).
nutritional disorders, and sleep disturbance. NHGRI
(2012) priorities include the identification of the genes Control in Quantitative Research
responsible for numerous human genetic diseases and Control occurs when the researcher imposes “rules”
the generation of animal models essential for the study to decrease the possibility of error and thus increase
of human inherited disorders. Because the future of the probability that the study’s findings are an accurate
any profession rests on its research base, both basic reflection of reality. The rules used to achieve control
and applied studies are needed to develop knowledge are referred to as design. Through control, the
for evidence-based practice (EBP) in nursing (Brown, researcher can reduce the influence or confounding
2009; Melnyk & Fineout-Overholt, 2011). effect of extraneous variables on the study variables.
For example, in a study focused on the effect of relax-
Rigor in Quantitative Research ation therapy on the perception of incisional pain, the
Rigor is the striving for excellence in research and extraneous variables, such as type of surgical incision
involves discipline, scrupulous adherence to detail, and the timing, amount, and type of pain medication
and strict accuracy. A rigorous quantitative researcher administered after surgery, would have to be con-
constantly strives for more precise measurement trolled to prevent them from influencing the patient’s
methods, structured treatments, representative sam­ perception of pain.
ples, and tightly controlled study designs (Borglin & Controlling extraneous variables enables the
Richards, 2010; Shadish, Cook, & Campbell, 2002). researcher to identify relationships among the study
Characteristics valued in these researchers include variables accurately and examine the effects of one
critical examination of reasoning and attention to variable on another. Researchers can control extrane-
precision. ous variables with sampling criteria by selecting a
Logistic reasoning and deductive reasoning are certain type of subject, such as only those individuals
essential to the development of quantitative research. who are having abdominal surgery or those with a
The research process consists of specific steps that are certain medical diagnosis. Using a random sampling
developed with meticulous detail and logically linked method also improves the control of extraneous vari-
together. These steps are critically examined and reex- ables and reduces the potential for bias in the study
amined for errors and weaknesses in areas such as sample. The setting can also be structured to control
design, intervention development and implementa- extraneous variables such as temperature, noise, and
tion, measurement, sampling, statistical analysis, and interactions with other people. The data collection
generalization. Reducing these errors and weaknesses process can be sequenced to control extraneous vari-
is essential to ensure that the research findings are an ables such as fatigue and discomfort (Borglin &
accurate reflection of reality and can be generalized. Richards, 2010).
Generalizing research findings involves applying the Quantitative research requires varying degrees of
findings from a particular study sample to a large control, ranging from minimal control to highly con-
population of similar individuals (Borglin & Richards, trolled, depending on the type of study (Table 3-1).
2010). For example, the findings from the study by Descriptive studies are usually conducted with
Artinian et al. (2007) could be generalized from the minimal control of the study design, because subjects
African American study participants with hyperten- are examined as they exist in their natural setting, such
sion to the larger population of African Americans as home, work, or school. However, the researcher
with hypertension. still hopes to achieve the most precise measurement
Another aspect of rigor is precision, which encom- of the research variables as possible. Experimental
passes accuracy, detail, and order. Precision is evident studies are highly controlled and often conducted on
in the concise statement of the research purpose, the animals in laboratory settings to determine the under-
detailed development of the study design, and the lying mechanisms for and effectiveness of a treatment.
CHAPTER 3  Introduction to Quantitative Research 37

TABLE 3-1  Control in Quantitative Research manipulates or modifies in some way. A growing
number of quasi-experimental studies are being con-
Level of Control in ducted to test the effectiveness of nursing interven-
Development of the tions, and these studies are often conducted in partially
Type of Research Research Design controlled settings. For example, hospitals, clinics, or
Descriptive research Minimal or partial control rehabilitation centers might be manipulated in selected
Correlational research Minimal or partial control ways to control for extraneous variables, such as type
Quasi-experimental research Moderate to high control
of care, medications, and family interactions. Highly
Experimental research High control
controlled settings are artificially constructed envi-
ronments that are developed for the sole purpose of
conducting research. Laboratories, experimental
Some common areas in which control might be centers, and research units are highly controlled set-
enhanced in quantitative research are (1) selection of tings often used for the conduct of experimental
subjects (sampling), (2) reduction of subject or partici- research. Chapter 15 discusses the process for select-
pant attrition, (3) selection of the research setting, (4) ing a setting for the conduct of quantitative research.
development and implementation of the intervention,
(5) measurement of study variables, and (6) subjects’ Development and Implementation of Study
knowledge of the study (Borglin & Richards, 2010; Interventions or Treatments
Forbes, 2009; Shadish et al., 2002). Nurses are being Quasi-experimental and experimental studies examine
encouraged to develop more powerful, controlled, rig- the effect of an independent variable or intervention
orous quantitative studies (NINR, 2012). on a dependent variable or outcome. More interven-
tion studies are being conducted in nursing to establish
Sampling and Attrition an EBP. Controlling the development and implemen-
Sampling is a process of selecting subjects, events, tation of a study intervention increases the validity of
behaviors, or elements for participation in a study. In the study design and the credibility of the findings. A
performing quantitative research, you will use a study intervention needs to be (1) clearly and precisely
variety of random and nonrandom sampling methods developed, (2) consistently implemented, and (3)
to obtain study samples. Random sampling methods examined for effectiveness through quality measure-
usually provide a sample that is representative of a ment of the dependent variables (Forbes, 2009;
population, because each member of the population Morrison et al., 2009; Santacroce, Maccarelli, & Grey,
has a probability greater than zero of being selected 2004). The detailed development of a quality interven-
for a study. Thus, random or probability sampling tion and the consistent implementation of this inter-
methods require greater researcher control and rigor vention are known as intervention fidelity. Chapter
than nonrandom or nonprobability sampling methods. 14 provides detailed directions for the development
Sample sizes in quantitative studies are usually deter- and implementation of a study intervention. Artinian
mined with a power analysis to ensure adequate et al. (2007) provided the following detailed descrip-
numbers of study participants throughout the study. tion of the implementation of the nurse-managed TM
Researchers are rigorous in reducing attrition, or loss (telemonitoring) intervention to improve the BPs of
of study subjects needed to describe variables, examine African Americans:
relationships, and determine the effect of interventions
(Aberson, 2010; Thompson, 2002). Chapter 15 pro-
vides a detailed discussion of the sampling process “Participants in the TM group received UC [usual
and determining sample size for quantitative studies. care] plus nurse-managed TM. Specially trained reg-
istered nurses delivered the intervention. During a
Research Settings prescheduled appointment, the intervention nurse
There are three common settings for conducting delivered the BP monitor and TM link device (device
research: natural, partially controlled, and highly con- that links BP monitor to the telephone) to the par-
trolled. Natural settings are uncontrolled, real-life ticipant’s home. At the time of the home visit, an
settings where studies are conducted (Fawcett & intervention nurse taught participants how to self-
Garity, 2009; Kerlinger & Lee, 2000). Descriptive monitor BP in accordance with The Seventh Report
and correlational types of quantitative research are of the Joint National Committee on Prevention,
often conducted in natural settings. A partially con- Detection, Evaluation, and Treatment of High Blood
trolled setting is an environment that the researcher
38 UNIT ONE  Introduction to Nursing Research

Subjects’ Knowledge of a Study


Pressure (JNC-VII) guidelines (Chobanian et al., Subjects’ knowledge of a study could influence their
2003), set up the home TM system, demonstrated behavior and possibly alter the research outcomes.
the system, had participants practice using the BP This possibility threatens the validity or accuracy of
monitor, and answered questions. Given the memory the study design. An example of this type of threat to
in the BP monitor and that all BPs recorded by the design validity is the Hawthorne effect, which was
monitor were telephonically sent to care providers identified during the classic experiments at the Haw-
and the principal investigator, participants received thorne plant of the Western Electric Company during
verbal and written reminders that the BP monitor was the late 1920s and early 1930s. The employees at this
exclusively for their use.… LifeLink Monitoring, Inc. plant exhibited a particular psychological response
(Bearsville, NY) provided TM services for this when they became research participants: They changed
study.… Telemonitoring participants were also asked their behavior simply because they were subjects in a
to telephonically send their BP readings to the inter- study, not because of the research treatment. In these
vention nurse and their care providers.… Once the studies, the researcher manipulated the working con-
intervention nurses received the BP reports, they ditions (altered the lighting, decreased work hours,
telephoned each participant to provide feedback in changed payment, and increased rest periods) to
relation to the target goals and to provide telecounsel- examine the effects on worker productivity (Homans,
ing about lifestyle modification and medication adher- 1965). The subjects in both the treatment group (whose
ence in accordance with JNC-VII guidelines (Chobanian work conditions were changed) and the control group
et al., 2003).” (Artinian et al., 2007, p. 315) (whose work conditions were not changed) increased
their productivity. The subjects seemed to change
their behaviors (increase their productivity) solely in
Measurement of Study Variables response to being part of a study. In the study by
When you are conducting a quantitative study, you Artinian et al. (2007, p. 321), both the treatment and
will attempt to use the most precise instruments avail- the comparison groups experienced decreases in their
able to measure the study variables. Using a variety BPs, and the researchers indicated “the Hawthorne
of quality measurement methods promotes an accurate effect may have been a factor, with participants paying
and comprehensive understanding of the study vari- more attention to their BP and hypertension self-care
ables. In addition, researchers want to rigorously behaviors because they were aware of their participa-
control the process for measuring study variables to tion in the study.”
improve the design validity and quality of the study There are several ways to strengthen a study,
findings (Waltz et al., 2010). Measurement concepts, decreasing the threats to design validity and selecting
process, and strategies are the foci of Chapters 16 the strongest design for the proposed study. Chapter
and 17. 10 addresses design validity, and Chapter 11 focuses
Nursing studies often include the measurement of on the process for selecting an appropriate study
biophysical variables, which require precise, accurate design. Your understanding of rigor and control
physiological measures (Ryan-Wenger, 2010). For provide the basis for the implementation of the steps
example, Artinian et al. (2007) described their precise of the quantitative research process, which are pre-
measurement of the dependent physiological variable, cisely executed in descriptive, correlational, quasi-
BP, with an accurate, nationally standardized device experimental, and experimental research.
as follows:

“The outcome measure of the BP was measured with Steps of the Quantitative
electronic BP monitor (Omron HEM-737 Intellisense,
Omron Healthcare, Inc., Vernon Hills, IL) that has Research Process
been validated in accordance with the criteria of the The quantitative research process consists of concep-
British Hypertension Society and the Association of tualizing a research project, planning and implement-
the Advancement of Medical Instrumentations (Dabl ing that project, and communicating the findings.
Educational Trust, 2005).” (Artinian et al., 2007, Figure 3-1 identifies the steps of the quantitative
p. 316) research process and shows the logical flow of this
process as each step progressively builds on the
CHAPTER 3  Introduction to Quantitative Research 39

FORMULATING A RESEARCH PROBLEM also contains a feedback arrow, indicating that the
AND PURPOSE research process is cyclical, for each study provides a
basis for generating further research in the develop-
ment of knowledge for EBP.
REVIEW OF RELEVANT LITERATURE
In this chapter, you are briefly introduced to the
steps of the quantitative research process that are pre-
DEVELOPING A FRAMEWORK sented in detail in Unit Two, The Research Process,
and Unit Four, Collecting and Analyzing Data to
Determine Research Outcomes for Dissemination.
Making Assumptions Explicit
The descriptive correlational study conducted by Gill
and Loh (2010), on the relationships of perceived
FORMULATING RESEARCH OBJECTIVES, stress, optimism, and health-promoting behaviors in
QUESTIONS, OR HYPOTHESES new primiparous mothers, is presented as an example
for introducing the steps of the quantitative research
process. Quotations from this study appear throughout
DEFINING STUDY VARIABLES
this section, in shaded boxes, to clarify the steps of the
quantitative research process. The bracketed words are
SELECTING A RESEARCH DESIGN inserted in the quotations to clarify the key concepts
and steps of the quantitative research process.
DEFINING THE POPULATION AND SAMPLE Formulating a Research Problem
and Purpose
SELECTING METHODS OF MEASUREMENT A research problem is an area of concern or phenom-
enon of interest in which there is a gap in the knowl-
edge base needed for nursing practice. The problem
DEVELOPING A PLAN FOR DATA COLLECTION
AND ANALYSIS identifies an area of concern or phenomenon of inter-
est for a particular population and often indicates the
concepts to be studied. The major sources for nursing
IMPLEMENTING THE RESEARCH PLAN research problems include (1) nursing practice, (2)
literature review, (3) research priorities for funding
Pilot Study agencies and professional organizations, (4) researcher
and peer interactions, and (5) theory testing. The
GENERATING research problem usually indicates significance to
Data Collection FURTHER nursing, background knowledge in the area, and
RESEARCH
problem statement of what is not known (Fawcett &
Data Analysis Garity, 2009). As a researcher, you will use deductive
reasoning to generate a research problem from a
research topic or a broad problem area of personal
Interpreting Research Outcomes interest that is relevant to nursing.
The research purpose is generated from the
COMMUNICATING RESEARCH FINDINGS problem and identifies the specific focus or aim
of the study. The focus of the study might be to
Figure 3-1  Steps of the quantitative research process. identify, describe, explain, or predict a solution to a
situation. The purpose often indicates the type of
study to be conducted (descriptive, correlational,
quasi-experimental, or experimental) and usually
previous steps. This research process is also flexible includes the variables, population, and setting for
and fluid, with a flow back and forth among the steps the study. Chapter 5 provides a background for for-
as researchers strive to clarify the steps and strengthen mulating a research problem and purpose. Gill and
the proposed study. This back-and-forth flow among Loh (2010) identified the following problem and
the steps is indicated in the figure by the two-way purpose for their study of new primiparous mothers
arrows connecting the steps of the process. Figure 3-1 as follows:
40 UNIT ONE  Introduction to Nursing Research

refers to those sources that are pertinent or highly


Problem important in providing the in-depth knowledge needed
“The transition to motherhood is considered to be
to study a selected problem and purpose. This back-
one of the most stressful and disruptive life transitions
ground enables researchers to build on the works of
(Chen, Kuo, Chou, & Chen, 2007; Warren, 2005).…
others. The concepts and interrelationships of the con-
Additional competing priorities may include learning
cepts in the problem usually guide the selection of
the maternal role, experiencing physical changes, and
relevant theories and studies presented in the review
learning how to care for their own needs.… These
of literature. Theories are presented to clarify the defi-
different roles and priorities may be perceived by the
nitions of concepts and to develop and refine the study
new mother as highly stressful, particularly as many
framework.
of these stressors occur simultaneously (Warren,
By reviewing relevant studies, researchers are able
2005).… Specifically, perceived stress can occur
to clarify (1) which problems have been investigated,
when the demands of a particular situation are
(2) which require further investigation or replication,
assessed by the individual as greater than their coping
and (3) which have not been investigated. In addition,
attributes [problem significance].…
the literature review can direct researchers in design-
“Past research has found that perceived stress
ing the study and interpreting the outcomes. Chapter
may lead a new mother to neglect personal health-
6 provides details for conducting a review of relevant
promoting behaviors in her effort to balance the com-
literature. Gill and Loh’s (2010) literature review
peting priorities of being a first-time mother (Chen
covered the concepts of perceived stress, optimism,
et al., 2007; Walker, 1989).… Optimism and perceived
and health practice. They also described theoretical
stress have an inverse relationship (Brissette, Scheier,
models relevant to these concepts. The following
& Carver, 2002).… Optimistic people cope better
excerpt from the study identifies the headings and key
with stressful situations and thereby report fewer
ideas covered by the review of relevant literature:
physical health symptoms [problem background].…
“Perceived stress has been associated with fewer “Perceived Stress and Health Practices
health-promoting behaviors in new primiparous
mothers, but less is known about the mechanisms In a longitudinal study from midpregnancy to 12
responsible for such effects” [problem statement]. months postpartum, American primiparous mothers
(Gill & Loh, 2010, pp. 348–349) were found to decline gradually in healthy behaviors
after birth, with exercise and stress management
Purpose behaviors performed least by these women (Patteson
“This investigation was conducted to examine the & Killien, 2001).… There are also significant health
potential role of optimism as a partial mediator of the benefits in practicing health-promoting behaviors. For
relationship between perceived stress and health- example, exercise has been shown to have a dual
promoting behaviors in new primiparous mothers.” effect of promoting weight loss and reducing reported
(Gill & Loh, 2010, p. 350) stress in new mothers (Groth & David, 2008).…
Theoretical Models
The transactional model for understanding stress
The research problem is significant and is based on emphasizes that the environmental event (e.g., new
pervious research. The problem statement indicates motherhood) and the cognitive faculties of the indi-
what is not known and provides a basis for the study vidual are constantly in transaction through the
purpose. The research purpose clearly indicates that process of appraisal (Lazarus & Folkman, 1984).…
the focus of this study is to describe and examine According to the transactional model of stress and
relationships among the variables optimism, perceived coping, individuals adopt different coping mechanisms
stress, and health-promoting behavior in new first- to deal with the perceived stress they encounter.…
time mothers. There are widespread observations that people
with optimism generally tend to use less avoidant and
Review of Relevant Literature more goal-directed coping mechanisms.… In this
A review of relevant literature is conducted to gener- study, optimism (i.e., dispositional optimism) refers to
ate an understanding of what is known about a particu- a personality variable where individuals believe that
lar situation, phenomenon, or problem and to identify good outcomes rather than bad will occur in one’s life
the knowledge gaps that exist. Relevant literature
CHAPTER 3  Introduction to Quantitative Research 41

has been developed in nursing or in another discipline,


(Scheier & Carver, 1992). Optimists tend to have an such as psychology, physiology, or sociology (Smith
internal locus of control and believe that events result & Liehr, 2008). The framework may also be devel-
primarily from their own behaviors and actions.… oped inductively from clinical observations.
The terms related to frameworks are concept, rela-
Perceived Stress and Optimism
tional statement, theory, and framework model or
Another study assessing constructive thinking during map. A concept is a term to which abstract meaning
pregnancy found that optimism helped in the adjust- is attached. A relational statement or proposition
ment to stressful situations during this time and declares that a relationship of some kind exists between
reduced the level of stress experienced (Park, Moore, or among two or more concepts. A theory consists of
Turner, & Adler, 1997). An optimistic disposition can an integrated set of defined concepts and propositions
therefore be seen to reduce perceived stress and that present a view of a phenomenon and can be used
encourage more positive appraisals of situations.… to describe, explain, predict, or control the phenome-
non. The propositions or relationship statements of the
Optimism and Health Practices
theory, not the theory itself, are tested through research.
Optimism was found also to diminish the impact of A study framework can be expressed as a model or
depression in pregnant women and up to 3 weeks a diagram of the relationships that provide the basis
postpartum (Carver & Gaines, 1987).… for a study and/or can be presented in narrative format.
The steps for developing a framework are described
Optimism as a Mediator
in Chapter 7. The framework for Gill and Loh’s (2010)
Substantial research exists where optimism has study is presented in Figure 3-2 and is described in the
served as a mediator of a stress relationship.… In a following quote. The framework model identifies
study with pregnant women, optimism was found to the relationships that are examined in this study, and
confer positive benefits through constructive thinking the description of the framework identifies the propo-
in decreasing perceived stress, anxiety, and substance sition that was tested by this study.
abuse.… Despite these findings, previous studies
have not investigated how optimism might mediate
the relationships between perceived stress and “It was speculated that maternal perceived stress
health-promoting behaviors in new mothers. This is would inversely affect a new primiparous mother’s
important because health-promoting behaviors have health-promoting behaviors. However, this relation-
the potential to help new mothers cope with the daily ship would be mediated partially by a new mother’s
stress of parenthood and define maternal identity sense of optimism. In other words, on the basis of
(Walker, 1989).” (Gill & Loh, 2010, pp. 348–350) work by Scheier and Carver (1992) the protective
role of optimism would enable a new mother to
self-regulate her perception of stress positively and
help her to engage in health-promoting behaviors to
Gill and Loh (2010) clearly cover relevant studies
maintain her sense of well-being and control [see
related to the concepts of stress, health practices, and
Figure 3-2].
optimism in pregnant women and new mothers. They
It is important to note that partial mediation (as
also cover relevant theories that describe the relation-
opposed to full mediation) was proposed because
ships among key concepts. The literature review sum-
optimism was hypothesized to be only one of a
marizes what is known in the areas of stress, health
number of possible variables that contribute to the
practices, and optimism in new mothers and clearly
associate between maternal perceived stress and
indicates what is not known. The study purpose
health-promoting behaviors” [proposition]. (Gill &
focuses on what is not known, which is how optimism
Loh, 2010, p. 350)
mediates the relationship between perceived stress and
health-promoting behaviors.
Making Assumptions Explicit
Developing a Framework Assumptions are statements that are taken for granted
A framework is the abstract, logical structure of or are considered true, even though they have not been
meaning that will guide the development of a study scientifically tested. Assumptions are often embedded
and enable the researcher to link the findings to the (unrecognized) in thinking and behavior, and uncover-
body of nursing knowledge. In quantitative research, ing them requires introspection. Sources of assump-
the framework is often a testable midrange theory that tions include universally accepted truths (e.g., all
42 UNIT ONE  Introduction to Nursing Research

Outcomes
Optimism Reduced
*LOT-R psychological
and
physiological
health risks

Increased
Perceived Health-
positive well-
Stress Promoting
being
*PSS-10 Behaviors
*HPLPII
Increased
maternal identity

Figure 3-2  Theoretical model outlining the relationships between predictor variables and proposed outcomes.
*Instruments used to measure study variables: HPLPII, Health-Promoting Lifestyle Profile II; LOT-R, Life Orientation Test–Revised; PSS-10, Perceived
Stress Scale. (From Gill, R. M., & Loh, J. M. (2010). The role of optimism in health-promoting behaviors in new primiparous mothers. Nursing Research,
59(5), 350.)

humans are rational beings), theories, previous objectives or questions. Some correlational studies
research, and nursing practice (Myers, 1982). include a purpose and specific questions or hypothe-
In studies, assumptions are embedded in the philo- ses. Quasi-experimental and experimental studies
sophical base of the framework, study design, and often use hypotheses to direct the development and
interpretation of findings. Theories and instruments implementation of the studies and the interpretation of
are developed on the basis of assumptions that the findings. Chapter 8 examines the development of
researcher may or may not recognize. These assump- research objectives, questions, and hypotheses. Gill
tions influence the development and implementation and Loh (2010) predicted relationships among the
of the research process. Because researchers’ assump- study variables that were examined with a predictive
tions influence the logic of the study, their recognition correlational design (Kerlinger & Lee, 2000; see
leads to more rigorous study development. Figure 11-9). With this type of design, researchers
Researchers often do not identify assumptions that often formulate hypotheses to predict the outcomes for
provide a basis for their study in their research report; their study as was done by Gill and Loh:
but if assumptions are included, they are usually part
of the framework discussion. Gill and Loh (2010) did
not clearly identify the assumptions for their study, but “Four hypotheses were proposed for the current
the following assumptions seem to provide a basis for study.
it: (1) stress needs to be managed to promote health, 1. Perceived stress will be related negatively to
(2) people’s psychological perspectives influence their health-promoting behaviors in new primiparous
actions, and (3) health is a priority for most people. mothers.
2. Perceived stress will be related negatively to
Formulating Research Objectives, Questions, optimism in new primiparous mothers.
or Hypotheses 3. Optimism will be related positively to health-
Research objectives, questions, and hypotheses bridge promoting behaviors in new primiparous
the gap between the more abstractly stated research mothers.
problem and purpose and the study design and plan 4. Optimism will mediate the relationship between
for data collection and analysis. Objectives, questions, perceived stress and health-promoting behaviors
and hypotheses are narrower in focus than the research partially in new primiparous mothers.” (Gill &
purpose and often (1) specify only one or two research Loh, 2010, p. 350)
variables, (2) identify the relationship between the
variables, and (3) indicate the population to be studied.
Some quantitative studies do not include objec- Defining Study Variables
tives, questions, or hypotheses; the development of The research purpose and the objectives, questions, or
such a study is directed by the research purpose. Many hypotheses identify the variables that are examined in
descriptive studies include only a research purpose, a study. Study variables are concepts of various
and other descriptive studies include a purpose and levels of abstraction that are measured, manipulated,
CHAPTER 3  Introduction to Quantitative Research 43

or controlled in a study. The more concrete concepts,


such as temperature, weight, and blood pressure, are Operational Definition
referred to as “variables.” The more abstract concepts, The Health-Promoting Life-Style Profile II (HPLPII)
such as creativity, empathy, and social support, are (Walker & Hill-Polerecky, 1996) was used to measure
sometimes referred to as “research concepts.” the new primiparous mothers’ health-promoting
The variables or concepts in a study are operation- behaviors.
alized when they are conceptually and operationally
defined. A conceptual definition provides a variable Optimism
or concept with theoretical meaning (Fawcett & Conceptual Definition
Garity, 2009) and either is derived from a theorist’s
definition of the concept or is developed through “In this study, optimism (i.e., dispositional optimism)
concept analysis. An operational definition indicates refers to a personality variable where individuals
how a variable will be measured or manipulated in a believe that good outcomes rather than bad will
study. The knowledge you gain from studying the occur in one’s life (Scheier & Carver, 1992).” (Gill &
variable will increase your understanding of the Loh, 2010, p. 349)
concept that the variable represents (see Chapter 8). Operational Definition
Gill and Loh (2010) provided conceptual and oper-
ational definitions of the study variables identified in “The revised Life Orientation Test (Scheier et al.,
their purpose and hypotheses: perceived stress, health- 1994) was used to measure optimism exhibited by
promoting behaviors, and optimism. The conceptual the mothers in this study.” (Gill & Loh, 2010, p. 351)
definitions for these variables are provided in the
review of literature and are reflective of the framework
that includes Lazarus and Folkman’s (1984) transac- Selecting a Research Design
tional model and the role of optimism by Scheier and A research design is a blueprint for maximizing
Carver (1992). The operational definitions indicate control over factors that could interfere with a study’s
how the variables were measured and are linked to the desired outcome. The type of design directs the selec-
study variables in the framework model (see Figure tion of a population, sampling process, methods of
3-2) and detailed in the measures section of the study measurement, and a plan for data collection and analy-
methodology. sis. The choice of research design depends on the
researcher’s expertise, the problem being examined,
the purpose for the study, and the desire to generalize
the findings.
Perceived Stress Designs have been developed to meet unique
Conceptual Definition research needs as they emerge; thus, a variety of
descriptive, correlational, quasi-experimental, and
“Perceived stress may be defined as the degree to experimental designs have been generated over time.
which individuals appraise events in their life as over- In descriptive and correlational studies, no treatment
whelming and insurmountable. Specifically, perceived is administered, so the study design centers on describ-
stress can occur when the demands of a particular ing variables, examining relationships, and improving
situation are assessed by the individual as greater than the precision of measurement (Waltz et al., 2010).
their coping attributes.” (Gill & Loh, 2010, p. 348) Quasi-experimental and experimental study designs
Operational Definition usually involve treatment and control groups and
focus on achieving high levels of control as well as
Perceived stress was measured by the Perceived precision in measurement (Cook & Campbell, 1979;
Stress Scale (PSS-10) (Cohen & Williamson, 1988). Kerlinger & Lee, 2000; Shadish et al, 2002). Chapter
Health-Promoting Behavior 10 covers the purpose of a design and the threats to
design validity. Chapter 11 presents models and
Conceptual Definition descriptions of several types of descriptive, correla-
“Health-promoting behaviors are defined as a pattern tional, quasi-experimental, and experimental designs.
of actions and cognitions that aim to augment the Gill and Loh (2010) conducted a descriptive cor-
level of wellness, self-actualization, and fulfillment of relational study that involved a cross-sectional, pre-
an individual.” (Gill & Loh, 2010, p. 348) dictive correlational design. Cross-sectional design is
used to examine groups of subjects in various stages
44 UNIT ONE  Introduction to Nursing Research

of development, trends, patterns, and changes simul- studies use both probability (random) and nonproba-
taneously with the intent to describe changes in the bility (nonrandom) sampling methods, and sample
phenomenon across stages. The researchers provide size is usually determined by conduction of a power
very little detail of the cross-sectional aspect of this analysis. The following quote identifies the sample
study design but do mention examining primiparous size, population, sample criteria, and sample charac-
mothers with babies varying in age from 2 to 12 teristics for the study conducted by Gill and Loh
months. The predictive correlational design is clearly (2010). The study would have been strengthened by
addressed in the study. Relationships among study identification of the sampling method, which appears
variables perceived stress, optimism, and health- to be a nonprobability sample of convenience, whereby
promoting behaviors are examined. The predictor or subjects are selected because they happen to be in a
independent variables, perceived stress and optimism, given place at a given time.
are used to predict the criterion or dependent variable,
health-promotion behavior.
“Participants
Defining the Population and Sample Participants were 174 new primiparous mothers
The population is all the elements (individuals, [sample size; population] recruited from online baby
objects, or substances) that meet certain criteria forums [setting]. Tabachnick and Fidell’s (2007) rule
for inclusion in a given universe (Kaplan, 1964; of thumb was applied to calculate the power required
Thompson, 2002). For example, suppose you wanted for this study. With two predictors, 106 participants
to conduct a study to describe patients’ responses to were required, and the study was therefore ade-
nurse practitioners as their primary care providers. quately powered [power analysis]. Only primiparous
You could define the population in different ways: It mothers with babies up to and including 12 months
could include all patients being seen for the first time of age were eligible to complete the study [sample
in (1) a single clinic, (2) all clinics in a specific network criteria]. Demographic information for the partici-
in one city, or (3) all clinics in that network nation- pants is displayed in a table” [see Table 3-2] [sample
wide. Your definition of the population would depend characteristics]. (Gill & Loh, 2010, p. 350)
on the sample criteria and the similarity of subjects in
these various settings. The researcher needs to deter-
mine which population is accessible and can be best Selecting Methods of Measurement
represented by the study sample. Measurement is the process of assigning “numbers to
A sample is a subset of the population that is objects (or events or situations) in accord with some
selected for a particular study, and sampling defines rule” (Kaplan, 1964, p. 177). A component of mea-
the process for selecting a group of people, events, surement is instrumentation, which is defined as the
behaviors, or other elements with which to conduct a application of specific rules to the development of a
study. As mentioned earlier in this chapter, nursing measurement device or instrument. An instrument is

TABLE 3-2  Means, Standard Deviations, Potential Range, Obtained Range, and Cronbach’s Alpha of
the Scores for Main Study Variables
Measure n M SD Potential Range Obtained Range Cronbach’s Alpha
1.  Perceived stress 174 13.62 6.83 0-40 0-29 .75
2.  Optimism 174 17.74 4.51 0-24 0-24 .89
3.  Health-promoting behavior 174 2.74 0.58 1-4 1.54-3.92 .97
4.  Income* 174 4.44 0.89 1-5 1-5 —
5.  Age 174 31.5 4.44 18-40+ 18-42 —
6.  Months since birth 174 6.17 3.28 0-12 –.20-12 —

*1 = <$20,000; 2 = $20,001-35,000; 3 = $35,001-50,000; 4 = $50,001-75,000; 5 = >$75,000. Income reported in Australian dollars.


n = Sample size for calculations.
M = Mean.
SD = standard deviation.
Cronbach’s alpha (α) = reliability of the measurement methods for this study.
From Gill, R. M., & Loh, J. M. (2010). The role of optimism in health-promoting behaviors in new primiparous mothers. Nursing Research, 59(5), 348–355.
The table is on page 352.
CHAPTER 3  Introduction to Quantitative Research 45

selected to measure a specific variable in a study. Data


generated with an instrument are at the nominal, Optimism The revised Life Orientation Test
ordinal, interval, or ratio level of measurement. The [LOT-R] (Scheier et al., 1994) was used to measure
level of measurement, with nominal being the lowest optimism exhibited by the mothers in this study. Par-
form of measurement and ratio being the highest, ticipants were asked to rate their agreement with the
determines the type of statistical analyses that you can statements on a 5-point Likert scale (0 = strongly
perform on the data (Grove, 2007). disagree to 4 = strongly agree). A sample item was, ‘In
Selection of an instrument requires extensive uncertain times, I usually expect the best.’ In a study
examination of its reliability and validity. Reliability with 2,055 undergraduate students, the revised Life
assesses how consistently the measurement technique Orientation Test reported internal consistency was
measures a concept. The validity of an instrument is .78 for the six items used and adequate construct
the extent to which it actually reflects the abstract validity (Scheier et al., 1994). Internal consistency in
concept being examined (Waltz et al., 2010). Chapter the current study was .89 for the six items.” (Gill &
16 introduces the concepts of measurement and Loh, 2010, p. 351)
explains the different types of reliability and validity
for instruments and precision and accuracy for physi-
ological measures (Ryan-Wenger, 2010). Chapter 17 The three Likert scales used in this study seemed
provides a background for selecting measurement to have strong reliability from previous research
methods for a study. Gill and Loh (2010) provided the (Cronbach’s alpha = 0.78 to 0.94) and were reliable in
following description of the three Likert scales that this study (Cronbach’s alpha = 0.75 to 0.97). However,
were used to measure their study variables: the researchers provide very limited specific informa-
tion about the validity of the scales, especially the
PSS-10 and LOT-R.
“Measures
Perceived Stress The Perceived Stress Scale (PSS-10; Developing a Plan for Data Collection
Cohen & Williamson, 1988) was used to measure and Analysis
stress in the mothers. This scale contains 10 items Data collection is the precise, systematic gathering of
that measure perceived stress experienced within the information relevant to the research purpose or the
last month. Participants were asked to indicate on a specific objectives, questions, or hypotheses of a
5-point Likert-type scale (0 = never to 4 = very often) study. The data collected in quantitative studies are
their response to each item. A sample questions was, usually numerical. Planning data collection will enable
‘In the last month, how often have you found that you you to anticipate problems that are likely to occur and
could not cope with all the things that you had to do?’ to explore possible solutions. Usually, detailed proce-
High scores on the scale indicated higher levels of dures for implementing a treatment and collecting
perceived stress. Internal reliability of the PSS-10 for data are developed, with a schedule that identifies
this study was found to be .78, and adequate con- the initiation and termination of the process (see
struct validity was reported (Cohen & Williams, Chapter 20).
1988). Cronbach’s alpha (α) for perceived stress in Planning data analysis is the final step before the
the current study was .75. study is implemented. The analysis plan is based on
Health-Promoting Behaviors The Health- (1) the research objectives, questions, or hypotheses,
Promoting Lifestyle Profile II [HPLPII] (Walker & (2) the data to be collected, (3) research design,
Hill-Polerecky, 1996) was used to measure new (4) researchers’ expertise, and (5) availability of com-
primiparous mothers’ health-promoting behaviors. puter resources. Several statistical analysis techniques
Participants were asked to indicate on a 4-point scale are available to describe the sample, examine rela­
(1 = never to 4 = routinely) the frequency with which tionships, or determine significant differences within
they engaged in the behavior indicated. Sample items studies. Most researchers consult a statistician for
include ‘I discuss my health concerns with health pro- assistance in developing an analysis plan.
fessionals’ and ‘I follow a planned exercise program.’
In the original study, internal consistency was found Implementing the Research Plan
to be .94 for the global scale, and construct validity Implementing the research plan involves intervention
was .68 (Walker & Hill-Polerecky, 1996). Cronbach’s implementation, data collection, data analysis, inter-
alpha in the current study was .97. pretation of research findings, and, sometimes, a
pilot study.
46 UNIT ONE  Introduction to Nursing Research

Pilot Study asked to sign a consent form, which describes the


A pilot study is commonly defined as a smaller study, promises the subjects confidentiality, and indi-
version of a proposed study that is conducted to refine cates that they can stop participation at any time (see
the methodology. It is developed much like the pro- Chapter 9).
posed study, using similar subjects, the same setting, During data collection, the study variables are mea-
the same treatment, and the same data collection and sured through a variety of techniques, such as observa-
analysis techniques. However, you could use a pilot tion, interview, questionnaires, scales, and physiological
study to develop various steps in the research process. measurement methods. In a growing number of
For example, you could conduct a pilot study to studies, nurses measure physiological variables with
develop and refine an intervention, a measurement high-technology equipment. The data are collected
method, a data collection tool, or the data collection and recorded systematically for each subject and are
process. Thus, a pilot study could be used to develop organized to facilitate computer entry or are directly
a research plan rather than to test an already developed recorded in the computer (Ryan-Wenger, 2010). The
plan. procedure for data collection is usually identified in
Some of the reasons for conducting pilot studies the Methods section of a study report. Gill and Loh
are as follows (Arain, Campbell, Cooper, & Lancaster, (2010) provided the following description of their data
2010; Feeley et al., 2009; Hertzog, 2008; Prescott & collection process. This section would have been
Soeken, 1989): strengthened by a more detailed discussion of the
• To determine whether the proposed study is feasi- online survey format and the process for collection
ble (e.g., are the subjects available, does the and management of data.
researcher have the time and money to do the
study?).
• To develop or refine a research treatment or inter- “Procedure
vention (see Chapter 14). New primiparous mothers were asked to complete
• To develop a protocol for the implementation of an an online anonymous survey that could be accessed
intervention. from a link available from an online baby forum Web
• To identify problems with a study design. page. This survey took approximately 20 minutes to
• To determine whether the sample is representative complete. Implied consent was given by the partici-
of the population or whether the sampling tech- pant on the completion and submission of the online
nique is effective. questionnaire; this was stated explicitly in the intro-
• To examine the reliability and validity of the ductory sheet on the first page of the online survey.
research instruments. Ethics approval was granted for this study and all
• To develop or refine data collection instruments. requirements pertaining to this approval were met.”
• To refine the data collection and analysis plan. (Gill & Loh, 2010, pp. 350–351)
• To give the researcher experience with the
subjects, setting, methodology, and methods of
measurement. Data Analysis
• To try out data analysis techniques. Data analysis reduces, organizes, and gives meaning
Hayward et al. (2007) believed that conducting a to the data. The analysis of data from quantitative
pilot study improved the strength of their study design research involves the use of (1) descriptive analysis
and directed their development of a quality proposal techniques (see Chapter 22) to describe demographic
for a large multisite clinical trial that received external variables and study variables; (2) statistical techniques
grant support. Thus, conducting pilot studies has the to test proposed relationships among variables (see
potential to improve the development, funding, and Chapter 23); (3) analysis techniques to make predic-
implementation of future studies. tions (see Chapter 24); and (4) analysis techniques to
examine group differences, such as the difference
Data Collection between the experimental or intervention group and
In quantitative research, data collection involves the control group (see Chapter 25). Computers are
obtaining numerical data to address the research used to perform most statistical analyses, so Chapter
objectives, questions, or hypotheses. To collect data, 21 provides a discussion of the computer software
you must obtain consent or permission from the setting programs used for conducting data analysis.
or agency where the study is to be conducted and from The choice of analysis techniques implemented is
potential subjects. Frequently, study participants are determined primarily by the research objectives,
CHAPTER 3  Introduction to Quantitative Research 47

questions, or hypotheses; the research design; and the The Results Section in the Gill and Loh (2010)
level of measurement achieved by the research instru- article was clearly organized by the study hypotheses.
ments. Gill and Loh (2010) used frequencies and per- All four of the hypotheses were supported, indicating
centages to analyze the demographic variables of support for the study framework. These analyses are
marital status, nationality, employment, education, somewhat complicated at this point in the text, but we
and income. The age and months since the baby’s birth encourage you to examine each of the tables for key
were described with the use of means and standard ideas. Table 3-3 presents a correlation matrix of the
deviations (see Table 3-2). Perceived stress, optimism, results obtained from Pearson correlation analysis of
and health-promoting behavior variables were (1) the study variables (perceived stress, optimism, and
described with means, standard deviations, and ranges, health-promoting behaviors) and the demographic
(2) examined for relationships with Pearson product- variables (income, age, and months since birth) (see
moment correlation, and (3) examined for prediction Chapter 23). These results were examined for signifi-
with regression analysis. cance using the t-test (t value), and the significant

“Analysis Approach analysis in Table 3-4]. Hypothesis 1 was therefore sup-


ported because perceived stress was related inversely
The means [M], standard deviations [SD], ranges, and
to health-promoting behaviors.
Cronbach’s α of the study … variables are presented in
Hypothesis 2 was supported because perceived
Table 3-2. Correlations between the main study vari-
stress was related inversely to optimism, β = −.55,
ables are depicted in Table 3-3. All correlations were in
t(167) = −8.56, and uniquely accounted for 27% of the
the predicted direction. [Perceived stress was signifi-
variance in optimism, F(6,167) = 17.50, p < .001.
cantly negatively correlated with optimism, −.60* and
In the third analysis, optimism positively influenced
health-promoting behaviors, −.67*. Optimism and
health-promoting behaviors, after controlling for the
health-promoting behaviors were significantly positively
effects of perceived stress on health-promoting behav-
correlated, .70*. The * indicates the results were signifi-
iors, β = .46, t(166) = 7.36, and uniquely accounted
cant at p < .01]. On average, participants had missing
for 13% of the variance in optimism, F(7,166) = 36.38,
data on 22.8% of the variables. The missing data in the
p < .001.… Hypothesis 3 therefore was supported
sample were assessed to be missing at random.…
because optimism was related positively to health-
Fifteen cases were deleted for having excessive …
promoting behaviors after controlling for perceived
missing, data on greater than 50% of the variables.” (Gill
stress.
& Loh, 2010, p. 351)
In the fourth analysis, perceived stress was related to
“Results health-promoting behaviors after controlling for the
effects of optimism, β = −.35, t(166) = −5.77, and
… Results indicated that perceived stress was signifi-
explained an additional 8% of the variance in health-
cantly negatively related to health-promoting behaviors,
promoting behaviors, optimism, F(7,166) = 36.83, p <
β = −.60, t(167) = −10.27, and uniquely accounted for
.001 [see Table 3-4]… Hence Hypothesis 4 was sup-
33% of the variance [change] in health-promoting
ported.” (Gill & Loh, 2010, p. 352)
behaviors, F(6,167) = 25.74, p < .001 [see regression

TABLE 3-3  Correlations among the Main Study Variables (N = 174)


Variable 1 2 3 4 5
1.  Perceived stress —
2.  Optimism –.60* —
3.  Health-promoting behavior –.67 .70* —
4.  Income –.30* .26* .38* —
5.  Age –.21* –.34* .27* .45* —
6.  Months since birth –.08 –.03 .02 — —

Asterisk (*) indicates a significant correlation.


From Gill, R. M., & Loh, J. M. (2010). The role of optimism in health-promoting behaviors in new primiparous mothers. Nursing Research, 59(5), 348–355.
Table is on page 352.
48 UNIT ONE  Introduction to Nursing Research

TABLE 3-4  Standard Multiple Regression Testing the Direct Effects of Perceived Stress and Optimism
on Health-Promoting Behaviors: Test of Mediation (N = 174)
Analysis and Predictor Variable β SE R2 F Criterion Variable
Analysis 1*: –.60 0.42 .48 25.74§ HPB
Perceived stress
Analysis 2†: –.55 3.44 .39 17.50* Optimism
Perceived stress
Analysis 3: .46
Optimism
Analysis 4‡: –.35 0.37 .61 36.83* HPB
Perceived stress

HPB, health-promoting behavior.


*Effect of predictor variable on criterion at df = 6,167.

Effect of predictor variable on mediator at df = 6,167.

Effects of predictor variable and mediator on criterion variable at df = 7,166.
§
P < .01 level.
N = Sample size for regression analysis calculation.
df = Degrees of freedoms for regression analysis.
β = Beta coefficients for regression analysis.
SE = Standard error.
R2 = Square of Regression statistic R to determining percent of variance explained by predictor variables.
F = Statistic for Analysis of Variance to determine significance of predictor variables.
From Gill, R. M., & Loh, J. M. (2010). The role of optimism in health-promoting behaviors in new primiparous mothers. Nursing Research, 59(5), 353.

correlations have an asterisk (*). Table 3-4 presents definitions of the variables might decrease the opera-
the regression analysis results, predicting the effects tionalization or measurement of the study variables.
of perceived stress and optimism on health-promoting Methodological limitations result from factors such
behaviors in new first-time mothers. The significance as nonrepresentative samples, weak designs, a single
of the regression analysis results was demonstrated setting, limited control over treatment (intervention),
with F-values (see Chapter 24). The amount of missing instruments with limited reliability and validity, limited
data for the study variables was a concern, and it is control over data collection, and improper use of sta-
unclear how this lack might have influenced the study tistical analyses. These study limitations can limit the
results. credibility of the findings and conclusions and restrict
the population to which the findings can be general-
Interpreting Research Outcomes ized. The study conclusions provide a basis for iden-
The results obtained from data analysis require inter- tifying nursing implications and suggesting further
pretation to be meaningful. Interpretation of research studies (see Chapter 26). In the excerpts that follow,
outcomes involves (1) examining the results from data Gill and Loh (2010) discuss their study findings, limi-
analysis, (2) exploring the significance of the findings, tations, conclusions, suggestions for further research,
(3) identifying study limitations, (4) forming conclu- and implications for practice for their study. Because
sions, (5) generalizing the findings, (6) considering the of the study limitations, the researchers limit the gen-
implications for nursing, and (7) suggesting further eralization of the findings and provide direction for
studies. The study results from data analyses are trans- further research. The discussion section would have
lated and interpreted to become findings, and these been strengthened by a clarification of the implications
findings are synthesized to form conclusions. Study of the study findings for practice.
conclusions are influenced by the limitations of the
study. Limitations are restrictions or problems in a
study that may decrease the generalizability of the “Discussion
findings. Study limitations often include a combina- … Finally, results indicated that optimism partially
tion of theoretical and methodological weaknesses. mediated the relationship between perceived stress
Theoretical weaknesses in a study might include a and health-promoting behaviors, suggesting a protec-
poorly developed study framework and unclear con- tive role of dispositional optimism in the sample of
ceptual definitions of variables. The limited conceptual
CHAPTER 3  Introduction to Quantitative Research 49

report is disseminated through presentations and pub-


new primiparous mothers. This finding is consistent lication (see Chapter 27). The Gill and Loh (2010)
with previous research, in which optimism has served study was published in one of the most prestigious
as a mediator of a stress relationship … and pro- nursing journals, Nursing Research.
moted positive psychological and behavioral health
outcomes in mothers.… Caution must be observed
when interpreting the results of this study. Given the Types of Quantitative Research
cross-sectional data, a causal relationship cannot be This textbook deals with four types of quantitative
confirmed between perceived stress and optimism research: (1) descriptive, (2) correlational, (3) quasi-
in new mothers [findings]. In addition, the sample experimental, and (4) experimental. The level of exist-
group predominantly consists of high-income, well- ing knowledge for the research problem influences the
educated, and computer-literate women who may type of research planned. When little knowledge is
not be representative of most new primiparous available, descriptive studies are often conducted. As
mothers. Expanding on this sample group may be an the knowledge level increases, correlational, quasi-
area for future research. Additional limitations include experimental, and experimental studies are imple-
using retrospective reporting and self-reporting mented. This section builds on the content in Chapter
scales, which can lead to response bias. A further 2 and identifies the purpose of each quantitative
limitation is the use of the PSS-10, which measures research approach. The chapter concludes with the
perceptions of stress that have occurred during the steps of the research process from a published quasi-
last month. Stress relating to the mothers’ daily lives experimental study.
may be perceived differently, depending on how long
ago they gave birth and subsequently how old their Descriptive Research
child is [limitations].… Therefore, although assessing The purpose of descriptive research is to explore and
the perceived stress of the new mother is interesting, describe phenomena in real-life situations. This
it may be more useful for future research to use a approach is used to generate new knowledge about
measure specifically designed to capture stress concepts or topics about which limited or no research
response at different milestones of the baby’s has been conducted. Through descriptive research,
development.… concepts are described and relationships are identified
The results indicated that optimism only partially that provide a basis for further quantitative research
mediated the relationship between perceived stress and theory testing. The study by Gill and Loh (2010)
and health-promoting behaviors in new primiparous presented earlier in this chapter has a descriptive com-
mothers.… Social support received from family or ponent, which included description of the study vari-
new mother groups also may influence positive well- ables optimism, perceived stress, and health-promoting
being in new mothers. Further research is therefore behaviors of new first-time mothers. The descriptive
recommended to explore some of these issues. results of this study can be clearly identified in
In summary, optimism serves as a partial mediator Table 3-2.
for new primiparous mothers to self-regulate their
perceptions of stress positively and thereby to facili- Correlational Research
tate their involvement in health-promoting behaviors. Correlational research examines linear relationships
Health-promoting actions have many positive benefits between or among two or more variables and deter-
for new mothers [conclusion], including building iden- mines the type (positive or negative) and degree
tity as a mother, enhancing positive well-being, and (strength) of the relationship. The strength of a rela-
minimizing the risk of future illness outcomes through tionship varies from −1 (perfect negative correlation)
exercise” [implications for practice]. (Gill & Loh, 2010, to +1 (perfect positive correlation), with 0 indicating
p. 354) no relationship. The positive relationship indicates
that the variables vary together—that is, the two vari-
ables either increase or decrease together. The nega-
tive or inverse relationship indicates that the variables
vary in opposite directions; thus, as one variable
Communicating Research Findings increases, the other decreases (see the results pre-
Research is not considered complete until the findings sented earlier from Gill & Loh, 2010 study). The
have been communicated. Communicating research descriptive correlational study conducted by Gill and
findings involves developing and disseminating a Loh (2010), presented earlier in this chapter, provides
research report to appropriate audiences; the research an example of the steps of the quantitative research
50 UNIT ONE  Introduction to Nursing Research

process for correlational research with a predictive selected independent and dependent variables. Quasi-
correlational design. The results of the relationships experimental studies in nursing are conducted to
among the study variables are clearly presented in determine the effects of nursing interventions or treat-
Table 3-3. Regression analysis results in Table 3-4 ments (independent variables) on patient outcomes
indicated that perceived stress and optimism signifi- (dependent variables) (Cook & Campbell, 1979;
cantly predicted health-promoting behaviors of pri- Shadish et al., 2002). Artinian et al. (2007) conducted
miparous mothers in this study. a quasi-experimental study to determine the effects of
nurse-managed telemonitoring (TM) on the BPs of
Quasi-Experimental Research African Americans. The steps for this study are
The purpose of quasi-experimental research is described here and illustrated with excerpts from the
to examine cause-and-effect relationships among example study.

Steps of the Research Process in a Quasi- at 3, 6, and 12 months postbaseline.” (Artinian et al.,
Experimental Study 2007, p. 313)
Research Problem Review of Literature
“Nearly one in three, or approximately 65 million adults The literature review for this study included relevant,
in the United States have hypertension, defined as (a) current studies that the researchers summarized to
having systolic blood pressure (SBP) of 140 mm Hg or identify what is known and not known about the
higher or diastolic blood pressure (DBP) of at least impact of TM on BP. The sources were current and
90 mm Hg or higher, (b) taking antihypertensive medi- ranged in publication dates from 1998 to 2005, with
cation, or (c) being told at least twice by a physician or the majority of the studies published in the last 5 years.
other health professional about having high blood pres- The study was accepted for publication on May 31,
sure (BP) (American Heart Association [AHA], 2004; 2007, and published in the September/October 2007
AHA Statistics Committee & Stroke Statistics Subcom- issue of Nursing Research. Artinian et al. (2007, p. 314)
mittee [AHASC], 2006; Fields et al., 2004).… Estimated summarized the current knowledge about the effect of
direct and indirect costs associated with hypertension TM on BP by stating, “Although promising, the effects
total $63.5 billion (AHA, 2004).… The crisis of high BP of TM on BP have been tested in small, sometimes
(HBP) is particularly apparent among African Ameri- nonrandomized, samples, with one study suggesting
cans; their prevalence of HBP is among the highest that patients may not always adhere to measuring their
in the world.… Unless healthcare professionals can BP at home. The influence of TM on BP control war-
improve care for individuals with hypertension, approxi- rants further study.”
mately two thirds of the population will continue to
have uncontrolled BP and face other major health risks Framework
(Chobanian et al., 2003) [problem significance].… Self- Artinian et al. (2007) developed a model that identified
monitoring of BP has been shown to lead to improved the theoretical basis for their study. The model pre-
BP control.… The efficacy of BP TM has been tested sented in Figure 3-3 indicates that “nurse-managed TM
using a randomized controlled design, but the sample is an innovative strategy that may offer hope to hyper-
was small (Artinian et al., 2001) [problem background].… tensive African Americans who have difficulty accessing
The influence of TM on BP control warrants further care for frequent BP checks.… In other words, TM may
study” [problem statement]. (Artinian et al., 2007, pp. lead to a reduction in opportunity costs or barriers for
312–314) obtaining follow-up care by minimizing the contextual
risk factors that interfere with frequent healthcare
Research Purpose
visits.… Combined with information about how to
“The purpose of this randomized controlled trial with control hypertension, TM may both help individuals gain
urban African Americans was to compare usual care conscious control over their HBP and contribute
(UC) only with BP telemonitoring (TM) plus UC to to feelings of confidence for carrying out hypertension
determine which leads to greater reduction in BP from self-care actions.… Home TM appeared to contribute
baseline over 12 months of follow-up, with assessments to individuals’ increased personal control and
CHAPTER 3  Introduction to Quantitative Research 51

Transmission of Blood
Blood Pressure (BP) Self Pressure Readings Over
Monitoring Existing Telephone Lines
• Moves hypertension from state of Using a Toll Free Number
silence to salience. • Facilitates access to healthcare
• May help individual: for hypertension without the
• connect symptoms of high need for clinic or office visits.
BP to actual BP level;
• Reduces opportunity costs
• see effects of lapses from
or barriers for obtaining
medical regimen on BP;
hypertension follow-up care.
• see effects of stress or
Blood Pressure • Minimizes contextual risk
worry on BP level; Telemonitoring
• gain conscious control factors that interfere with
over their high BP; frequent healthcare visits.
• gain feelings of confidence • Provides a greater number
that they are capable of of BP readings than can be
carrying out hypertension provided by infrequent clinic
self-care actions; visits; healthcare providers
• gain sense of increased have more data upon which
personal control, self-efficacy or to base treatment decisions
self-responsibility for managing to achieve better BP
their BP. control.

Figure 3-3  Theoretical basis for the effects of telemonitoring on blood pressure (BP). (From Artinian, N. T., Flack, J. M., Nordstrom, C. K., Hockman,
E. M., Washington, O. G. M., Jen, K. C., et al. [2007]. Effects of nurse-managed telemonitoring on blood pressure at 12-month follow-up among urban
African Americans. Nursing Research, 56[5], 313.)

self-responsibility for managing their BP, which ulti- Variables


mately led to improved BP control (Artinian et al., 2004;
The independent variable was the TM Program and the
Artinian et al., 2001).” (Artinian et al., 2007, pp.
dependent variables were SBP and DBP. Only the TM
313–314)
Program, SBP, and DBP conceptual and operational defi-
The framework for this study was based on tentative
nitions are presented as examples. The conceptual defi-
theory that was developed from the findings of previous
nitions are derived from the study framework and/or
research by Artinian et al. (2004; 2001) and other inves-
are included as part of the literature review. In this
tigators. This framework map (see Figure 3-3) and
study, the operational definitions for the dependent vari-
description provide a basis for interpreting the study
ables are found in the methods section under “Outcome
findings and giving them meaning. The framework mainly
Measurement,” and the independent variable is opera-
provides a basis for the TM intervention and would be
tionalized under an “Intervention” heading.
strengthened by including concepts to represent the
outcomes or more of a discussion of the SBP and DBP.
Independent Variable: TM Program
Hypothesis Testing Conceptual Definition: TM program is an innovative
strategy that may offer hope to hypertensive African
“H1: Individuals who participate in UC plus nurse-
Americans to reduce their opportunity costs and barri-
managed TM will have a greater reduction in BP from
ers for obtaining follow-up care for BP management
baseline at 3-, 6-, and 12-month follow-up than would
(Artinian et al., 2007).
individuals who receive UC only.” (Artinian et al., 2007,
Operational Definition: TM “refers to individuals self-
p. 317)
monitoring their BP at home, then transmitting the BP
52 UNIT ONE  Introduction to Nursing Research

readings over existing telephone lines using a toll-free not to differences in the group participants. The partici-
number” (Artinian et al., 2007, p. 313). The BP readings pants were randomly assigned to the treatment or com-
were reviewed by the care providers, with immediate parison groups by a computer with the data collectors
feedback provided to the patients about their treatment blinded to, or kept unaware of, the group assignment.
plan.
Sample
Dependent Variables: SBP and DBP “African Americans with hypertension [population] were
Conceptual Definition: SBP and DBP are an indication of recruited through free BP screenings offered at com-
the patient’s blood pressure control and ultimately the munity centers, thrift stores, drug stores, and grocery
management of his or her hypertension. stores located on the east side of Detroit [natural
Operational Definition: The outcome of SBP and DBP settings].…
were measured with the electronic BP monitor (Omron Inclusion criteria were ≥18 years of age; SBP ≥
HEM-737 Intellisense, Omron Health Care, Inc.) 140 mm Hg or DBP ≥ 90 mm Hg, unless self-identified
(Artinian et al., 2007). as a diabetic or with a history of chronic kidney disease,
then SBP ≥ 130 mm Hg or DBP ≥ 80 mm Hg; access to
Design
a land-based telephone in own residence (owned or
“A randomized, two-group, experimental, longitudinal rented) [natural setting]; oriented to person, time, and
design was used. The treatment group received nurse- place; English speaking; and intent to remain in Detroit
managed TM and the control group received enhanced for the next year. Exclusion criteria were arm circumfer-
UC. Data were collected at baseline and 3-, 6-, and ence > 17.5 in.; history of dementia, mental illness,
12-month follow-ups. Follow-up periods were chosen terminal cancer, advanced liver disease, or hemodialysis;
to allow some comparisons of findings from this study and self-reported illicit drug use or alcohol abuse as
with those from other TM studies that have been measured by the CAGE (Cut, Annoyed, Guilty, Eye-
reported in the literature.… opener) questions.” (Artinian et al., 2007, p. 315)
Because imbalances in the number of participants The population and the recruitment process are
assigned to each group could occur with simple random- clearly described. The sample criteria for including and
ization, block stratified randomization for antihyperten- excluding subjects from the study were detailed and
sive medication use was performed to ensure an equal provided a means of identifying patients with hyperten-
number of participants taking antihypertensive medica- sion. The sample size was 387 (194 in the TM group
tions in each group. It was important to avoid an imbal- and 193 in the UC group), and there was a 13% attri-
ance in the number of participants taking antihypertensive tion, or loss of subjects, over the 12-month study, which
medications in one of the groups because an imbalance are both study strengths. The original sample was a
could confound the effects of the TM intervention. nonrandom sample of convenience, and the subjects
Sequentially numbered computer-generated random- were recruited through free BP screenings offered at a
ization assignments were determined prior to the start variety of locations. The nonrandom sampling intro-
of data collection, but participants were not notified of duces a potential for sampling bias, because not all
the group assignment until after baseline data were col- potential subjects had an equal chance to participate in
lected. To keep data collectors blinded to group assign- the study. . The subjects participating in free BP screen-
ment, the study’s project manager informed the ings might differ in some way from those who do not
participants of their group assignment by mail or tele- seek screening. These study elements are more charac-
phone within a week of their baseline interview. Data teristic of a quasi-experimental study, but the study does
collectors were trained not to ask participants about have an experimental type of design (Kerlinger & Lee,
group assignment and to ask participants not to 2000; Shadish et al., 2002).
reveal their assignment to them.” (Artinian et al., 2007,
Procedures
pp. 314–315)
This study has a strong design with groups stratified Artinian et al. (2007) detailed the nurse-managed TM
according to hypertension medication use. The stratifi- intervention that was presented earlier in this chapter
cation ensured that the TM group was similar to the and provided in entirety on pages 315-316 in the
UC group regarding the number of participants taking research article. The outcome measure of BP was mea-
hypertension medications. Thus, differences found sured with the electronic Omron BP monitor “after a
between the groups would be due to the treatment and 5-minute rest period; at least two BPs were measured,
CHAPTER 3  Introduction to Quantitative Research 53

and the average of all was used for analyses. Participants 12-month follow-up. Although the TM intervention
wore unrestrictive clothing and sat next to the inter- group had a greater reduction in the DBP (6.3 mm Hg)
viewer’s table, their feet on the floor; their back sup- compared with the UC group (4.1 mm Hg), the differ-
ported; and their arm abducted, slightly flexed, and ences were not statistically significant (t = −1.56, p =
supported at heart level by the smooth, firm surface of 0.12)” (Artinian et al., 2007, pp. 317–318). The study
a table” (Artinian et al., 2007, pp. 316–317). results were clearly presented in tables and figures.
“Most of the data were collected during 2-hour struc-
Discussion
tured face-to-face interviews and brief physical exams,
which were conducted by trained interviewers in a “The nurse-managed TM group experienced both clini-
private room at one of the project-affiliated neighbor- cally and statistically significant reductions in SBP
hood community centers. Mailed postcards provided (13.0 mm Hg) and clinically significant reductions in
interview appointment reminders 1 week before the DBP (6.3 mm Hg) over a 12-month monitoring period
scheduled interview; telephone call reminders were [study conclusions].… The BP reductions achieved here
made the evening before the interview.… Participants are important results, which, if maintained over time,
were compensated $25.00 after the completion of each could improve care and outcomes significantly for urban
interview” (Artinian et al., 2007, p. 316). The study was African Americans with hypertension.… This may mean
approved by the Wayne State University Human Inves- that an individual could avoid starting a drug regimen or
tigation Committee, and all participants signed consent may achieve BP control using a one-drug regimen rather
forms indicating their willingness to participate in than a two-drug regimen and thus be at risk for fewer
this study. medication side effects [implications of the findings for
nursing practice].… Future research needs to determine
Results
if this intervention effect maintained over time leads to
“The hypothesis was supported partially by the data. reducing the number of complications associated with
Overall, the TM intervention group had a greater reduc- uncontrolled BP and if it leads to reducing the number
tion in SBP (13.0 mm Hg) than the UC group did of drugs necessary to achieve BP control.” (Artinian
(7.5 mm Hg; t = −2.09, p = 0.04) from baseline to the et al., 2007, pp. 320–321)

Experimental Research quasi-experimental, and experimental—to develop


The purpose of experimental research is to examine nursing knowledge.
cause-and-effect relationships between independent • Some of the concepts relevant to quantitative
and dependent variables under highly controlled con- research are (1) basic research, (2) applied research,
ditions (Shadish et al., 2002). Researchers exert high (3) rigor, and (4) control.
control over the planning and implementation of • Basic, or pure, research is a scientific investigation
experimental studies, including experimental designs, that involves the pursuit of “knowledge for knowl-
random samples, highly structured interventions, and edge’s sake” or for the pleasure of learning and
quality measurement methods. Often these studies are finding truth.
conducted in highly controlled settings, such as labo- • Applied, or practical, research is a scientific inves-
ratories or research units, with humans or animals. The tigation conducted to generate knowledge that will
study by Byerley et al. (2010) introduced earlier in directly influence or improve clinical practice.
this chapter is an experimental study to examine the • Rigor involves discipline, scrupulous adherence to
causes of cancer-related cachexia using male rats that detail, and strict accuracy.
was conducted in a laboratory setting. To improve • Control involves the imposing of “rules” by the
your understanding of the steps of the research process, researcher to decrease the possibility of error and
read this study and identify the steps of quantitative thus increase the probability that the study’s find-
research process outlined in this chapter. ings are an accurate reflection of reality.
• The quantitative research process involves concep-
tualizing a research project, planning and imple-
KEY POINTS menting that project, and communicating the
findings.
• Nurses use a broad range of quantitative ap- • The steps of the quantitative research process are
proaches—including descriptive, correlational, as follows:
54 UNIT ONE  Introduction to Nursing Research

1. Formulating a research problem and purpose 13. Communicating findings includes the develop-
identifies an area of concern and the specific ment and dissemination of a research report to
focus or aim of the study. appropriate audiences through presentations
2. Reviewing relevant literature allows the and publication.
researcher to build a picture of what is known • This chapter introduces four types of quantita-
about a particular situation or phenomenon and tive research: descriptive, correlational, quasi-
identify the knowledge gaps that exist. experimental, and experimental. Examples from
3. Developing a framework guides the develop- published studies are used to illustrate the steps
ment of the study and enables the researcher of the quantitative research process for these
to link the findings to the body of knowledge different types of quantitative research.
in nursing.
4. Formulating research objectives, questions,
or hypotheses allows the researcher to bridge REFERENCES
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and reimbursement for home blood pressure monitoring. Retrieved
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from http://my.americanheart.org/professional/General/Call-to-
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6. Selecting a research design directs the selec- Monitoring_UCM_423866_Article.jsp/.
tion of a population, sampling procedure, American Health Association Statistics Committee and Stoke Sta-
implementation of the intervention, methods tistics Subcommittee. (2006). Heart disease and stroke statistics—
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7. Defining the population and sample deter- (2010). What is a pilot or feasibility study? A review of current
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8. Implementation of the study intervention ogy, 10(1), 67.
Artinian, N. T., Flack, J. M., Nordstrom, C. K., Hockman, E. M.,
involves the detailed development of the steps
Washington, O. G. M., Jen, K. C., et al. (2007). Effects of nurse-
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tent implementation of the intervention during among urban African Americans. Nursing Research, 56(5),
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blood pressure control in urban African Americans: A pilot study.
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11. Implementing the research plan involves inter­ Borglin, G. & Richards, D. A. (2010). Bias in experimental nursing
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  http://evolve.elsevier.com/Grove/practice/

4  
CHAPTER

Introduction to Qualitative Research

Q ualitative research is a scholarly approach to


describe life experiences from the perspective
of the persons involved. It is a way to give
significance to the subjective human experience as
by nurse researchers. Although each qualitative
approach is unique, there are many commonalities.
These commonalities constitute the perspective of the
qualitative researcher.
well as gain insights to guide nursing practice (ZuZelo,
2012). These insights are gained not through measur-
ing concepts or establishing causality but through Perspective of the
improving our comprehension of a phenomenon
of interest. Within a naturalistic holistic framework, Qualitative Researcher
qualitative research allows us to explore the depth, All scientists approach problems from a philosophical
richness, and complexity inherent in the lives of stance or perspective. The philosophical perspective
human beings. The insights from this process can of the researcher guides the questions asked and the
foster an understanding of patient needs and prob- methods selected for conducting a specific study. Both
lems, guide emerging theories, and build nursing quantitative and qualitative researchers have philo-
knowledge (Munhall, 2012). Although qualitative sophical perspectives. Quantitative studies are based
research is somewhat flexible, qualitative researchers primarily on the philosophy of logical positivism that
use rigorous and systematic processes that require values logic, empirical data, and tightly controlled
conceptualization, imaginative reasoning, and elegant methods (see Chapter 3) (Kerlinger & Lee, 2000;
expression. Shadish, Cook, & Campbell, 2002). Qualitative studies
To critically appraise studies in publications, use are based on a wide range of philosophies, such as
the findings in practice, and develop the skills needed phenomenology, symbolic interactionism, construc-
to conduct qualitative research, you must comprehend tivism, and hermeneutics, each of which espouses
qualitative research methodologies. Nurse researchers slightly different approaches to gaining new knowl-
conducting qualitative studies are contributing impor- edge (Liamputtong & Ezzy, 2005).
tant information to our body of knowledge unobtain-
able by quantitative means. The terminology used in Philosophy Describes a View of Science
qualitative research and the methods of reasoning are Qualitative researchers ascribe to a view of science
different from those of quantitative research and are that values the uniqueness of the individual and
reflections of the philosophical orientations of the dif- the holistic approach to understanding human experi-
ferent types of qualitative research. Each qualitative ences. The philosophical perspective of the researcher
approach flows from a specific philosophical orienta- is consistent with research questions that seek the
tion that directs the methodology and interpretation of participant’s perspective of a phenomenon or experi-
data. This chapter presents a general overview of the ence. Figure 4-1 demonstrates this idea, as the arrow
following qualitative approaches: phenomenological on the left of the figure (“Philosophy”) shapes and fits
research, grounded theory research, ethnographic with the next arrow (“View of Science”). Because of
research, exploratory-descriptive qualitative research, their philosophical perspectives, quantitative research-
and historical research. Many other approaches to ers hold views of science that value tightly controlled
qualitative research have been developed, but these studies and generalizable numerical findings. In con-
are the approaches and methods most frequently used trast, the philosophical perspectives of qualitative

57
58 UNIT ONE  Introduction to Nursing Research

Approach
View of Criteria of
Philosophy and
Science Rigor
Methods

Figure 4-1  Valid science is based on congruence from philosophy to rigor.

researchers influence their views of science. As a from the perspective of the participants. Although the
result, qualitative researchers value rigorous, but flex- researcher does not always clearly state the philo-
ible designs to identify study findings. Through the sophical stance on which the study is based, a knowl-
study findings, we are able to increase our under­ edgeable reader can recognize the philosophy through
standing of an experience using a discovery process the description of the problem, formulation of the
that allows a complex picture to emerge (Forman, research questions, and selection of the methods to
Creswell, Damschroder, Kowalski, & Krein, 2008). address the research questions. A well-designed quali-
The primary thinking process used in quantitative tative study is congruent at each stage with the under-
studies is deduction; in contrast, qualitative research- lying philosophical perspective as identified by the
ers tend to be inductive thinkers (Forman et al., 2008). researcher.
Deductive thinking begins with a theory or abstract Qualitative researchers use open-ended methods to
principle that guides the selection of methods to gather gather descriptions of health-related experiences from
data to support or refute the theory or principle. participants (Fawcett & Garity, 2009). These open-
Forman et al. (2008) call this a “top-down” approach. ended methods include interviews, focus groups,
Inductive thinking involves perceptually putting observation, and document review (Speziale & Car-
insights and pieces of information together and iden- penter, 2007). When oral methods are used, the
tifying abstract themes or working from the bottom researcher will usually capture the interaction by an
up. From this inductive process, meanings emerge. audio or video recording so that a transcript of the
Because the perception of each qualitative researcher communication can be prepared for analysis. These
is unique, the meanings identified within the data may methods are discussed in detail in Chapter 12.
vary from researcher to researcher. However, others
should be able to retrace the analysis and thinking Philosophy Guides Criteria of Rigor
processes that resulted in the researcher’s conclusions. Scientific rigor is valued because it is associated with
In order to do this, readers must be aware of the under- the worth of the research outcomes. The rigor of quali-
lying philosophical perspective of the study being tative studies is appraised differently from the rigor of
reviewed. quantitative studies because of the differences in the
underlying philosophical perspectives. Quantitative
Philosophy Guides Methods studies are considered rigorous when the procedures
Each type of qualitative research is consistent with a for the study are prescribed prior to data collection,
particular philosophical perspective (see Figure 4-1). the sample is large enough to represent the population,
The philosophy shapes the view of science that in turn and researchers tightly control the collection and anal-
shapes the approaches and methods selected for the ysis of the data. A quantitative researcher expects that
study, just as the arrows in Figure 4-1 fit together like another researcher could replicate or repeat the study
the pieces of a puzzle. The philosophical perspective with a similar sample and receive similar results. This
includes an epistemology, a view of knowing and is desirable because quantitative researchers define
knowledge (Munhall, 2012). As a result, the philoso- rigor to include objectivity and generalizability. Rigor-
phy directs the research questions and the collection ous qualitative researchers, however, are characterized
and interpretation of the data. Creswell (2009) empha- by openness and dem­onstrate methodological congru-
sizes this point by stating that the assumptions of the ence, scrupulous adherence to a philosophical perspec-
specific philosophical approach cannot be separated tive, thoroughness in collecting data, consideration
from the methods. For example, researchers who hold of all the data in the analysis process, and self-
to a phenomenological philosophy of science will ask understanding. The researcher’s self-understanding is
research questions about the “lived experiences” of important because qualitative research is an interactive
persons. They will analyze the data in such a way as process shaped by the researcher’s personal history,
to develop a rich, deep description of an experience biography, gender, social class, race, and ethnicity as
CHAPTER 4  Introduction to Qualitative Research 59

well as by those of the study participants (Creswell, (p. 1954). The study results revealed the complexity
2009; Marshall & Rossman, 2011). Self-understanding of allowing children to manage their asthma, as they
allows the researcher to have insight into his or her grow older:
potential biases related to the phenomenon of interest
and prevent these biases from interfering with the
voices of the participants being heard. These charac- “For many of the children in our study, their ability to
teristics of qualitative researchers are essential to take responsibility for their condition was often
produce a valid study. Critical appraisal of the rigor of dependent on what they were both allowed and
qualitative studies is discussed in more detail in encouraged to do by their parents/carers. Clearly
Chapter 18. then, we must understand this as a negotiated process
To reinforce the key points of Figure 4-1 that phi- and to appreciate its full complexity, we must also
losophy shapes one’s view of science, the methods, look at how parents approached the sharing of
and criteria of rigor, a study of families with asthmatic responsibility regarding their children’s asthma.”
children are presented as an example. (Meah et al., 2009, p. 1955)
Meah, Callery, Milnes, and Rogers (2009) explored
how parents and preadolescent children shared the
responsibility for asthma management. The research- The researchers concluded that their findings were
ers had noted a gap in knowledge about the transfer consistent with the theoretical framework of responsi-
of responsibility from parents to children. The purpose bility that they introduced at the beginning of the study
of the study was to “examine meaning of responsibil- report. The implementation of the study and its find-
ity in children’s lives and how parents and children ings were also consistent with the philosophical per-
negotiate these responsibilities over time” (Meah spectives that the researchers explicitly identified. The
et al., 2009, p. 1953). An exploratory-descriptive qual- approach and methods allowed for children and
itative study was conducted because quantitative parents to share their thoughts and feelings in a non-
studies had produced diverse results that did not threatening setting. The data analysis involved strate-
provide adequate understanding of the transfer of gies that allowed the perspectives of the participants
responsibility. The study included a framework of to be described. The researchers could have strength-
responsibility, and the researchers designed the study ened the report by providing details about how rigor
to be consistent with feminist philosophy and socio- was ensured. Additional information about the rigor
logical perspectives: of the methods would increase the validity of the
findings.
This example confirms that philosophy shapes
“Interpretation of the data drew upon both feminist one’s view of science, which in turn shapes the
epistemology and sociological understandings of chil- methods used in a study and the criteria by which the
dren, health, and the body which relocate subjective rigor of the study will be evaluated (see Figure 4-1).
experience at the heart of scientific inquiry.” (Meah Because qualitative studies emerge from several phi-
et al., 2009, p. 1954) losophies, an understanding of different approaches to
qualitative research is needed as a foundation for
appraising the rigor of research and making appropri-
Consistent with sociological perspectives, the ate application of the findings.
familial unit was the focus, instead of only the child
or only the parents. The researchers’ methods included
conducting “open-ended, conversational-style inter- Approaches to
views” with 18 children and their parents (Meah
et al., 2009, p. 1954). The researchers also inter- Qualitative Research
viewed the parents separately. The recordings of the Five approaches to qualitative research commonly
interviews were transcribed and “descriptive codes conducted and published in the nursing literature are:
were developed from the transcripts” (p. 1954). The phenomenological research, grounded theory research,
researchers briefly described how they displayed ethnographic research, exploratory-descriptive quali-
excerpts from the transcripts on charts that “enabled tative research, and historical research (see Table 4-1).
comparison of the children’s and adults’ perceptions Although the five approaches have the commonalities
while simultaneously facilitating comparison within already discussed, these approaches are different, in
children’s accounts and those of their parents” great part because researchers in different disciplines
60 UNIT ONE  Introduction to Nursing Research

TABLE 4-1  Philosophical Orientations lived-in phenomenological terms, to capture the “lived
Supporting Qualitative Approaches
experience” of study participants (Fawcett & Garity,
2009; Munhall, 2012). The philosophical positions
to Nursing Research
taken by phenomenological researchers are very dif-
Philosophical and ferent from those common in the culture and research
Theoretical Orientations Qualitative Approach traditions of the nursing field, which value large
Phenomenology Phenomenological research samples and generalizable findings.
Symbolic interaction theory Grounded theory research
Naturalism and ethical Ethnographic research Philosophical Orientation
principles Phenomenologists view the person as integral with the
Interpretive and naturalistic Exploratory-descriptive
environment. The world is shaped by the self and
perspectives; pragmatism qualitative research
Historicism, pragmatism Historical research
shapes the self. At this point, however, phenomenolo-
gists diverge in their beliefs according to adherence to
a particular phenomenological philosopher. The key
philosophers used by nurse researchers adhering to
phenomenology are Husserl and Heidegger.
developed them. For example, the social and psycho- Philosopher Edmund Husserl (1859-1938) is con-
logical scientists developed the approaches known as sidered the father of modern phenomenology (Phillips-
phenomenological research and grounded theory Pula, Strunk, & Pickler, 2011). Husserl wrote Logical
research (Giorgi, 2010; Reed, 2010). Anthropologists Investigations (1901/1970), in which he developed his
developed ethnography with its focus on culture ideas about phenomena in an effort to resolve the
(Morse & Richards, 2002). Exploratory-descriptive conflict in thought between human sciences (primarily
qualitative research has emerged from the disciplines psychology) and the basic sciences (such as physics).
of nursing and medicine and has a pragmatic focus on Phenomena make up the world of experience. These
using the knowledge gained to benefit patients and experiences cannot be explained by examining causal
families and improve health outcomes. Historians relations but need to be studied as the very things they
developed methods to analyze source documents, arti- are. A phenomenon occurs only when there is a person
facts, and interviews of witnesses to summarize the who experiences it. Thus, the experience must be
knowledge gained by studying the past (Lewenson & described, not studied using statistics or the research-
Herrmann, 2008). Nurse researchers adapted these er’s preconceived ideas. To describe the experience,
methods to understand changes within nursing and the researcher must be open to the participant’s world-
health care. The common purpose among the methods, view, set aside personal perspectives, and allow mean-
however, is to examine the meaning of human experi- ings to emerge. Husserlian phenomenologists believe
ences from the perspective of the “knower,” the person that although self and world are mutually shaping, it
(or persons) to whom the experiences belong (Bassett, is possible to separate oneself from one’s beliefs or set
2004). aside one’s beliefs to see the world firsthand in a naive
Although the data are gathered with openness to way (Dowling, 2007). Setting aside one’s beliefs
the individual experiences of study participants, this during qualitative research is called “bracketing.”
fact does not mean that the interpretation is value-free. Researchers who follow the philosophy proposed
Each approach is based on a philosophical orientation by Heidegger do not agree, taking the position
that influences the study design from the wording of that bracketing is not possible. Martin Heidegger
the research question through the interpretation of the (1889-1976) was a student of Husserl but expanded
data (see Figure 4-1). Thus, you as a consumer of the goal of phenomenology from description of lived
qualitative research must be aware of the guiding prin- experience to the interpretation of lived experiences
ciples of the philosophical perspective of a study and (Earle, 2010). Heidegger’s seminal work was Being
use these principles to critically appraise a qualitative and Time (1927/1962). Heideggerian phenomenolo-
study. The discussion of each approach will cover its gists believe that the person is a self within a body, or
philosophical perspective or orientation, methodol- is embodied (Munhall, 2012). Munhall describes
ogy, and contribution to nursing knowledge. embodiment as “the unity of body and mind” that
eliminates the “the idea of a subjective and objective
Phenomenological Research world” (p. 127). She goes on to say, “the world is
Phenomenology is both a philosophy and a research knowable only through the subjectivity of being in the
method. The purpose of phenomenological research world” (p. 127). For example, the interaction between
is to describe experiences (or phenomena) as they are the sensory input that your body sends to your brain
CHAPTER 4  Introduction to Qualitative Research 61

and your brain’s thinking processes determines your reality. Reality is considered subjective, and as a
perceptions of the world in which you exist. A result, unique to the individual. The researcher’s expe-
depressed person may not notice the color of sunset riences in collecting data and analyzing the data during
or the joy in a child’s laughter. Another person may a study are also unique. The researcher must invest
not be able to see the sunset because of blindness but considerable time exploring the various philosophical
may find special meaning in the nuances of the child’s stances within phenomenology to select one compat-
laughter. In each situation, the person’s being in the ible with his or her perspective and the research ques-
world is shaped by the unity of body and mind. tion being asked. More detail on the conduct of
Heideggerian phenomenologists posit that the phenomenological research is provided in Chapter 12.
person is situated in specific context and time that
shapes his or her experiences, paradoxically freeing Phenomenology’s Contribution to Nursing Science
and constraining the person’s ability to establish Phenomenology is the philosophical base for three
meanings through language, culture, history, purposes, nursing theories and studies that have explored these
and values (Munhall, 2012). For example, a 50-year- theories. These theories include the theory of human-
old man diagnosed with aggressive cancer in the istic nursing (Paterson & Zderad, 1976), the theory of
United States would experience the diagnosis differ- human becoming (Parse, 1981, 1992), and the theory
ently from a 20-year-old woman in rural Ethiopia of caring (Watson, 1999). Paterson and Zderad empha-
receiving the same diagnosis. The body, the world, sized in their theory of humanistic nursing that phe-
and the concerns, unique to each person, are the nomenology shapes the nurse and the patient as they
context within which that person can be understood. share experiences in the context of health care. The
Heideggerians believe that the person experiences theory is applicable to research because the researcher
being within the framework of time, also called being- meets the participant with openness and respect for
in-time. The contexts of the man and the woman with uniqueness.
cancer would have different meanings, depending on On the basis of the values of Paterson and Zderad’s
whether they lived during the 1960s or the 2010s. The (1976) theory, Lesniak (2010) conducted a study with
availability of treatment, financial resources, and adolescent females who deliberately injure themselves
gender roles are only a few of the factors that would by cutting. She interviewed six young women who
shape the cancer experience for these individuals. described their experiences, including what they
Each of them has only situated freedom, not total would like emergency nurses to know about self-
freedom. The man has the freedom to choose physi- cutting. From their interviews, the researchers identi-
cians from among those who will accept his insurance. fied “an element of loneliness,” “an overall meaning
The woman may have the freedom only to choose of angst and desperation,” and “a recovery process
whether she will use a traditional healer or not seek after the cutting is over” (Lesniak, 2010, p. 146).
treatment at all. Until a disruption such as an expected Emergency nurses adhering to Paterson and Zderad’s
diagnosis of cancer occurs, the person may not have caring values who are alert to signs of self-cutting will
considered the limits on meaning imposed by the assess the adolescent and identify strategies to “protect
context and the time. the adolescent from future self-injury” (p. 146).
Other philosophers have built on Husserl and Hei- Lesniak noted that the sample was limited to white,
degger’s perspectives and refined phenomenological middle-class adolescents and could not be generalized
methods. Merleau-Ponty (1908-1961) was among the to adolescents of other races/ethnicities or income
French philosophers who further developed the Hei- levels.
deggerian concepts of being-in-time and embodiment In 1981, Parse described her theory of man-living-
(Munhall, 2012). He wrote The Phenomenology of health as evolving from the foundation of existential
Perception (1945/2002). Colaizzi (1973), Giorgi phenomenology. As she conducted studies congruent
(1985), and van Manen (1990) proposed research with the theory, she refined her ideas into the human
guidelines for phenomenological research focused on becoming theory (Parse, 1992). According to her
procedural interpretations of the phenomenological theory, human beings co-create reality with the envi-
method (Speziale & Carpenter, 2007). The novice ronment and structure meaning through images,
nurse researcher interested in phenomenology should words, and actions. Parse proposes research methods
expand his or her knowledge in this area through consistent with phenomenology, the philosophical
immersion in the original writings of these philoso- foundation for her theory (Parse, 2001, 2011). Using
phers (Munhall, 2012). Parse’s research methods, Chen (2010) conducted a
All phenomenologists agree that there is not a study of the lived experience of moving forward
single reality; each individual has his or her own among persons who had experienced a spinal cord
62 UNIT ONE  Introduction to Nursing Research

injury. Chen collected data from 15 persons through mechanisms when a patient dies” (p.160). The
“dialogical engagement, in which the true presence of researchers’ methodology included interviewing eight
the researcher was with the participant” (p. 1134). nurses and analyzing the narratives of the interviews
From the stories of the participants and the recordings according to Colaizzi’s guidelines, a specific approach
of the research interactions, Chen extracted three core to phenomenological data analysis (Dowling, 2007).
concepts that she reframed within Parse’s theory: The researchers found clusters of data around two
“confronting difficulties,” “going on and finding self- phases in the experience—“the death experience” and
value and confidence,” and “co-creating successes “the death thereafter.” In describing the death experi-
amid opportunities and restrictions” (pp. 1137-1138). ence, one nurse commented “I hate it when the patient
The use of Parse’s theory during the interpretation of dies suddenly—everything seems just so disorganized.
the data was consistent with her research approach but … It makes me feel awful when that happens.… I like
somewhat of a departure from remaining open to the to feel that I have done everything that I can” (p. 162).
meanings that emerge from qualitative data. Another nurse talking about the death thereafter said,
Watson’s (1999) theory of caring is also congruent “You do have to keep a distance in a way, because
with phenomenology. She describes values of nurses death happens so often on our unit. You’d be an emo-
that produce caring actions and an intersubjective tional wreck if you let it bother you or affect you all
experience shared by the nurse and patient. She pro- the time” (Shorter & Stayt, 2010, p. 164).
poses 10 carative factors that provide a structure for The death experience was described with the
caring as the core of nursing. Transpersonal caring phrases “expectedness, control and good care,” “strik-
relationships and the carative factors “potentiate thera- ing a chord,” and “meaningful engagement” (Shorter
peutic healing processes and relationships: they affect & Stayt, 2010, pp. 162-163). The phrases “formal
the one caring and the one-being-cared-for” (Watson, support,” “informal support,” “normalization of
1997). Byers and France (2008) conducted a phenom- death,” and “emotional dissociation” (pp. 163-164)
enological study using Watson’s theory with nurses described the death thereafter. Shorter and Stayt con-
who care for patients with dementia hospitalized on cluded that the grief and coping strategies of nurses
medical-surgical units. From their interviews with are complex and may vary by type of care setting.
nine nurses, they extracted a “synthesis of unity,” a Shorter and Stayt (2010) clearly identified the phil-
sentence that captured the experience, which they osophical perspective and methods of their study,
stated as “They stay with you: they come home with although they did not cite primary sources for either
you every day” (p. 47). High nurse-patient ratios and Heidegger or Colaizzi. Consistent with the Heideg-
the needs of dementia patients challenged the nurses gerian perspective, they collected and analyzed data
and resulted in stress. Because of their commitment to simultaneously. They used Colaizzi’s framework to
caring, the nurses were frustrated by giving what they cluster common meanings and identify themes from
perceived to be care that did not meet their personal the transcripts of the interviews they had conducted.
standards. Byers and France conclude by noting that Shorter and Stayt explicitly noted adherence to the
“the essence of caring is revealed as it is manifested Heidegerrian tenets when they discussed the rigor of
in the RN caring for the patients with dementia yet it the study to include “co-construction of knowledge
is also the RN who needs to be cared for” (p. 48). An between researcher and participant” (p. 161). The
appraisal can be made of this study similar to that of researchers proposed that additional studies are needed
the Chen (2010) study. The use of a theory within to explore whether the coping strategies of nurses
a phenomenological approach has the potential to affect the quality of care they provide.
interfere with the emergence of the participants’
perspectives. Grounded Theory Research
Shorter and Stayt (2010) conducted a phenomeno- Grounded theory research is an inductive research
logical study of the experiences of grief and coping technique developed by Glaser and Strauss (1967)
mechanisms of nurses in an adult intensive care unit. through their study of the experience of dying. The
The philosophical perspective, the methodology, and method’s name means that the findings are grounded
the contributions to nursing knowledge of this study in the concrete world as experienced by the partici-
are presented as an example of a phenomenological pants and are interpreted at a more abstract theoretical
study. Shorter and Stayt designed their study to be level. The desired outcome of grounded theory studies
consistent with the Heideggerian phenomenological is a middle range or substantive theory (Fawcett &
perspective (Johnson, 2000) and to “explore critical Garity, 2009; Marshall & Rossman, 2011; Munhall,
care nurses’ experiences of grief and their coping 2012).
CHAPTER 4  Introduction to Qualitative Research 63

Philosophical Orientation experiences of low-income, uninsured African Ameri-


Grounded theory is congruent with symbolic interac- can men diagnosed with prostate cancer. These
tion theory, which holds many views in common with researchers noted that African American men were
phenomenology. George Herbert Mead (1863-1931), disproportionately affected by prostate cancer and
a social psychologist, developed the principles of often were faced with a “death sentence” due to an
interaction theory that were posthumously published unwelcomed and unexpected diagnosis of cancer. The
(Mead, 1934). His principles were shaped and refined methodology of the study was secondary analysis of
by other social psychologists and became known as transcripts from a larger study (Maliski, Rivera,
symbolic interaction theory (Crossley, 2010). Sym- Connor, Lopez, & Litwin, 2008). The sample for the
bolic interaction theory explores how perceptions of original study included 60 Latina and 35 African
interactions with others shape one’s view of self and American men who had undergone treatment for pros-
subsequent interactions. One’s view of self influences tate cancer. When the transcripts were analyzed for the
subsequent interactions and creates meaning. People original study, the researchers noted that spiritual con-
create reality by attaching meanings to situations. cepts emerged in the interviews with some of the
Meaning is expressed in terms of symbols, such as African American men. Thus, Maliski et al. (2010, p.
words, religious objects, and clothing. These symbolic 471) analyzed the transcripts from in-depth interviews
meanings are the basis for actions and interactions. with 18 African American men from the original
Symbolic meanings are different for each indi- study, “focusing on the role of faith in coping with
vidual. We cannot completely know the symbolic their prostate cancer diagnosis, treatment, and adverse
meanings of another individual. In social life, groups effects.” The researchers did not specify the philo-
share meanings. They communicate these shared sophical perspective upon which the study was devel-
meanings to others through socialization processes. oped; however, they did indicate that they used
Group life is based on consensus and shared mean- grounded theory analytic strategies to analyze the
ings. Interaction among people may lead to redefini- data.
tion of experiences, new meanings, and possibly a Listen to the voice of one participant as he used his
redefinition of self. Because of its theoretical impor- faith to conquer his fear. “As long as my heart and
tance, the interactions among the person and other spirit are good, I can keep going. Good things can
individuals in social contexts are the focus of observa- happen in the future, and I was put on Earth for a
tion in grounded theory research. reason so I’m not afraid of death” (Maliski et al.,
2010, p. 474).
Grounded Theory’s Contribution to Nursing Science As you can see, grounded theory research examines
Grounded theory researchers have contributed to our experiences and processes with a breadth and depth
understanding of the patient experience across a wide not usually possible with quantitative research. The
range of settings. Giske and Artinian (2008) helped us reader can intuitively verify these findings through her
understand how gastroenterology patients undergoing or his own experiences. Through the rigorous conduct
diagnostic testing were balancing between hope and of grounded theory research, these investigators were
despair. Balancing was the primary theoretical code in able to conclude that faith was a spiritual coping strat-
the resulting theory of preparative waiting. On similar egy for those men of limited resources (Maliski et al.,
themes of waiting and balance, Trimm and Sanford 2010). The contribution to nursing science is that a
(2010) described the family experience of waiting clear, cohesive description of the phenomenon allows
during surgery as maintaining balance during the wait. greater understanding. Although a theory was not
In cardiac care settings, researchers have described the developed, the improved understanding can guide
inner strength of women following placement of a nursing interventions that meet the needs of patients
coronary artery stent (Mendes, Roux, & Ridosh, 2010) in ways that they value.
and the “dialogue around maintaining and renegotiat-
ing normality” following a coronary artery bypass Ethnographic Research
graft procedure (Banner, 2010, p. 3123). Noiseux and Ethnographic research provides a framework for
Ricard (2008) conducted a grounded theory study to studying cultures. The word ethnography is derived by
develop a theory describing the experience of recov- combining the Greek roots ethno (folk or people) and
ery from schizophrenia from the perspectives of graphy (picture or portrait). Ethnographies are the
patients, their families, and healthcare professionals. written reports of a culture from the perspective of
Maliski, Connor, Williams, and Litwin (2010) con- insiders. These reports were initially the products of
ducted a grounded theory study to understand the anthropologists who studied primitive, foreign, or
64 UNIT ONE  Introduction to Nursing Research

remote cultures. Now, however, a number of other TABLE 4-2  Four Types of Ethnography
disciplines, including social psychology, sociology,
political science, education, and nursing, promote cul- Other
tural research (Wolf, 2012). Type Labels Purpose
Ethnography does not require travel to another Classic Traditional Describe a foreign culture
country or region; however, it requires spending con- through immersion in the
culture for an extended
siderable time in the setting observing and gathering
period
data. A specific group or subculture is identified for Systematic Institutional Describe the social
study, such as women giving birth at home in Haiti or organizational structure
male nurses working in acute care settings. Ethnogra- influencing a specific
phy can be used to describe and analyze aspects of the group of people
ways of life of a particular culture, even your own. Interpretative Interpret the values and
McGibbon, Peter, and Gallop (2010) conducted an attitudes shaping the
ethnographic study with pediatric intensive care nurses behaviors of members of a
focusing on the social organization and the institu- specific group, in order to
tional context that contributed to the stress of the promote understanding of
the context of culture
nurses. They identified “six main forms of nurses’
Critical Disrupted Examine the life of a group
stress, including emotional distress; constancy of pres- in the context of an
ence; burden of responsibility; negotiating hierarchi- alternative theory or
cal power; engaging in bodily caring; and being philosophy, such as
mothers, daughters, aunts, and sisters” (p. 1357). feminism or constructivism
An appreciation of other cultures often begins with
an examination of your own culture and identification
of ethnocentric values that may influence your care of explore “the meanings of social actions within cul-
people of other cultures. The formal study of one’s tures” (Wolf, 2012, p. 285).
own culture or social context, autoethnography, Four schools of thought within ethnography have
involves critical reflection on your own life experi- emerged from different philosophical perspectives:
ences as shaped by your culture (Wolf, 2012). For classic, systematic, interpretive, and critical ethnogra-
example, Brooks (2011) conducted an autoethnogra- phy (Speziale & Carpenter, 2007). Classic ethnogra-
phy of the mental illness of obsessive-compulsive dis- phy seeks to provide a comprehensive holistic
order from her unique viewpoints as “an academic description of a culture (Wolf, 2012). For example,
observer and an individual sufferer” (p. 251). Brooks, researchers who conduct classic ethnographic studies
not a nurse, shared her autoethnography in part so live for extended periods outside of their own country
nurses and other healthcare professionals could under- in the environment of their study and write a factual
stand the ability of some obsessive-compulsive disor- description of the culture (see Table 4-2). In contrast,
der sufferers to appear as though nothing is wrong. In systematic ethnography explores and describes the
her words, by “performing ‘appropriately’ and putting structures of the culture with an increased focus on
on my socially acceptable ‘face,’ ” she “suppressed the groups, patterns of social interaction, organizations,
personal and tragic reality of my illness” (p. 259). Her and institutions. The study by McGibbon et al. (2010,
description of her experience reflected the perfor- p. 1356), described earlier, is an example of a system-
mances required by her roles within the cultures of atic ethnography as evidenced by exploring “nurses’
academia and mental health treatment. everyday work with institutional structures that shape
practice.”
Philosophical Orientation Interpretive ethnography has as its goal under-
Anthropologists seek to understand people: their ways standing the values and thinking that result in behav-
of living, believing, acquiring information, transform- iors and symbols of the people being studied.
ing knowledge, and socializing the next generation. Alexander (2003) identified his study of the black
Studying a culture begins with the philosophical barbershop as an interpretive ethnography. Through
values of respecting, appreciating, and seeking to pre- observation, repeated interaction, and recall of child-
serve the values and ways of life of the culture (Wolf, hood experiences, Alexander clarified the values of
2012). The philosophical bases of ethnography are socializing young black men and creating community
naturalism and respect for others. The purpose of within a physical space. Critical ethnography has a
anthropological research is to describe a culture and political purpose of relieving oppression and
CHAPTER 4  Introduction to Qualitative Research 65

empowering a group of people to take action on their without any attempt to control or alter the context. The
own behalf. Wolf (2012) calls this type of ethnography researcher can be open to explore the insider perspec-
“disrupted” or “disruptive,” and identifies its philo- tive on health and well-being. The primary ethnonurs-
sophical foundation to be critical social theory ing data collection method is participant-observation
(Boutain, 1999; Fontana, 2004). Gardezi and col- (Douglas et al., 2010). Participant-observation is
leagues (2009) conducted a critical ethnography of defined as being present and interacting with partici-
interprofessional communication in the operating pants in routine activities. At the same time, the
suite and analyzed data from 700 surgical procedures researcher is paying attention to what is happening
performed from 2005 through 2007. An unanticipated from the perspective of an outsider.
finding was the importance of silence, especially those Schumacher (2010) conducted an ethnonursing
silences that emerged during the analysis of episodes study in a rural village in the Dominican Republic. She
of ineffective communication. Consistent with critical used Leininger’s Observation-Participation-Reflection
ethnography, the researchers noted that policies and (OPR) Enabler (1997) to guide 28 days of data collec-
procedures are needed that encourage team members tion related to the different aspects of the Sunrise
to speak up to protect the patients, but they also Model, such as technological, cultural, and religious
acknowledged the complex interaction of silence and factors. In addition to observing patterns of behavior
speech in the operating room. related to health, she interviewed 29 people to learn
more about the meaning of the observations. These
Ethnography’s Contribution to Nursing Science people are called informants. The raw data were orga-
Madeline Leininger (1970) brought ethnography into nized into 12 categories consistent with the model.
nursing science by writing the first book linking From the categories, recurring patterns emerged that
nursing with anthropology. Leininger was first a nurse eventually led to three themes presented in the follow-
and then earned her doctoral degree in anthropology. ing quotations from the study:
In the 1950s, she began developing a framework for
culture care that became the Sunrise Model (Clarke,
McFarland, Andrews, & Leininger, 2009). The Sunrise One informant said, “Family is everything. It is the
Model identifies factors that affect health and illness, most important and central thing in this culture.…
such as religion, income, kinship, education, values, Life is lived for the family.… Family is the basis of our
and beliefs. Chapter 7 contains more information society …” (Schumacher, 2010, p. 98). This quotation
about the Theory of Culture Care developed by was used as an exemplar of the first theme that family
Leininger, so this section focuses on the qualitative presence is necessary for cultural care of the com-
method that she developed to be consistent with munity members. The second theme was caring as
ethnonursing. giving respect to the person and paying attention.
Ethnonursing research values the unique per- “Respect and attention are central to the meaning of
spective of groups of people within their cultural care for rural Dominicans” (p. 98). Schumacher noted
context that is influenced at the macro-level by that the people “both value and use generic (folk)
geographical location, political system, and social care practices as well as professional care practices”
structures (see Table 4-1). Multiple levels of factors (p. 99). This third theme was supported by interview
affect the culture and, consequently, the care expres- data about using home remedies and faith healers and
sions of the people. A Vietnamese family who is the seeking treatment by a healthcare professional.
only family in a small rural community in Georgia
may have different care practices from those who live
in New York City in a predominantly Vietnamese Congruent with Leininger’s theory and ethnonurs-
community. Leininger developed “enablers,” sets of ing method, Schumacher (2010, p. 99) discussed
questions to guide the researcher’s study of the culture the findings using the theory’s action modes
(Leininger, 1997; 2002). The enablers provide a flex- of “culture care preservation/maintenance, culture
ible framework for the researcher to use to collect and care accommodation/negotiation, and culture care
analyze the qualitative data. For example, one of the repatterning/restructuring.” The methods were imple-
enablers is “Leininger’s Observation-Participation- mented with rigor and produced quality findings.
Reflection Enabler” (Leininger, 1997, p. 45), which Although this study was conducted in the Dominican
reminds the researcher to use these three processes Republic, the insights into these health values could
during a study. The method is naturalistic, meaning promote culturally appropriate care for immigrants
that the research is conducted in a natural setting from that country in the United States.
66 UNIT ONE  Introduction to Nursing Research

Exploratory-Descriptive Qualitative Research person living the experience—is the source of infor-
Qualitative nurse researchers have conducted studies mation. Closely aligned with the perceived view is a
with the purpose of exploring and describing a topic general approach to science that Liamputtong and
of interest but, at times, have not identified a specific Ezzy (2005) call the “interpretive orientation.” The
qualitative methodology. Other researchers have iden- interpretive orientation acknowledges that meaning is
tified their studies as grounded theory but have not created and maintained in context. Other qualitative
identified theoretical elements and relationships in experts call the general qualitative approach “natural-
their findings. Some have identified their studies as istic inquiry.” Naturalistic inquiry encompasses
phenomenology but have not provided a thick descrip- studies designed to study people and situations in their
tion of a lived experience in their findings. Qualitative natural states (Sandelowski, 2000). Another broad
descriptive research is a legitimate method of research philosophical orientation often inferred by exploratory-
that may be the appropriate “label” for studies that descriptive qualitative researchers is pragmatism.
have no clearly specified method or in which the Pragmatism supports studies designed to gather data
method was specified but that ended with “a compre- for transformation into information needed to solve a
hensive summary of an event in the everyday terms of problem or offer a new strategy. “It [pragmatism] indi-
these events” (Sandelowski, 2000, p. 336). Labeling a cates that there is a goal, that what works is defined
study as a specific type (grounded theory, phenome- in practice and thus must be put into practice”
nology, or ethnographic) implies fixed categories of (McCready, 2010, p. 192). Pragmatism was the philo-
research with distinct boundaries, but the boundaries sophical orientation of the study conducted by Rohr
between methods are more appropriately viewed as et al. (2010).
permeable (Sandelowski, 2010). Although the studies
result in descriptions and could be labeled as descrip- Exploratory-Descriptive Qualitative Research’s
tive qualitative studies, most of the researchers are in Contribution to Nursing Science
the exploratory stage of studying the subject of inter- An exploratory-descriptive qualitative researcher often
est. To decrease any confusion between quantitative indicates that a study is needed with a specific popula-
descriptive studies and the discussion of this qualita- tion to understand the needs of, desired outcomes of,
tive approach, we decided to call this approach or views on appropriate interventions held by the
exploratory-descriptive qualitative research. In this members of the group. The goal is to create a program
book, studies that the researchers identified as being or an intervention to benefit the population. Exploratory-
qualitative without indicating a specific approach like descriptive qualitative researchers identify a specific
phenomenology or grounded theory will be labeled as lack of knowledge that can be addressed only through
being exploratory-descriptive qualitative research. seeking the viewpoints of the people most affected.
Exploratory-descriptive qualitative studies are con- After citing numerous quantitative studies on the topic,
ducted to address an issue or problem in need of a Swanlund (2010) wrote about the need for this
solution. For example, Rohr, Adams, and Young approach in her study of medication adherence of the
(2010) recognized that nurses used inconsistent older cardiovascular patient:
approaches to prevent and relieve oral discomfort of
terminally ill patients. These researchers used inter-
views in their exploratory-descriptive qualitative “Additionally, the research questions for these studies
study to gain the perspective of the patient receiving were derived from the healthcare provider’s per-
palliative care so that standards for oral care could be spective. These studies have left many questions
established for this unique population. They concluded unanswered regarding the reasons for nonadherence
that oral care must begin with structured assessment from the perspective of the older adult. Information
of patients’ mouths every day and include recognition is needed that will help community-dwelling older
of the impact that oral discomfort has on the emotions adults be successful with their medication manage-
and social life of patients receiving palliative care. ment.” (Swanlund, 2010, p. 23)

Philosophical Orientation
The philosophical orientation that supports Researchers who value the perspectives of
exploratory-descriptive qualitative studies undergirds participants may begin a program of research with
most methods of qualitative inquiry. In contrast to the qualitative methods to: (1) begin development of
received view of reality that is the foundation for inter­ventions, (2) evaluate the appropriateness of an
quantitative methods, qualitative researchers ascribe intervention following implementation, or (3) develop
to a perceived view of reality. The perceiver—the participants’ definitions of concepts that researchers
CHAPTER 4  Introduction to Qualitative Research 67

would like to measure. For example, qualitative data From the transcribed interviews of 14 patients and
were collected during a federally funded study of 12 family members, Caress et al. (2010) identified
stress management interventions with healthy adults three themes. The first theme, “Health promotion:
and persons living with HIV infection (Tuck & What’s that?” emerged from the limited spontaneous
Thinganjana, 2007). The researchers sought to under- information about health promoting behaviors pro-
stand the participants’ perspectives on spirituality as a vided by the participants. The behaviors that were
first step in developing an operational definition for mentioned were more preventive in nature, rather
measurement of spirituality. Qualitative data have than health promoting. The second theme, “Commu-
also been collected through interviews or focus groups nity resources for health promotion” (Caress et al., p.
to evaluate the cultural appropriateness of and partici- 569), was derived from participant statements that
pants’ satisfaction with an intervention at the conclu- indicated limited knowledge of community resources,
sion of a study. For example, Vincent (2009) conducted with the exception of pulmonary rehabilitation. The
a focus group with Mexican-Americans with diabetes theme “It wasn’t just the smoking: Patients’ and
who had been the recipients of a tailored intervention family members’ views on the causation of COPD”
for health behavior change. She found that the inter- (p. 569) encompassed several participants’ statements
vention group participants were satisfied with the about the role tobacco played in the development of
intervention. the disease. The researchers concluded the study’s
Health promotion within chronic obstructive pul- report by proposing a new approach to promoting
monary disease (COPD) was the focus of a qualitative health among the patients with COPD and their
study conducted by Caress, Luker, and Chalmers families:
(2010). The philosophical orientation, methodology,
and results of the study are discussed as an example
of the exploratory-descriptive qualitative approach. “Our data suggest that a more wide-ranging approach,
Caress et al. described their study as an “exploratory, encompassing aspects of health promotion, might
descriptive design … using semistructured interviews be welcomed by many patients and their family
with patients and family caregivers” (p. 565). They did carers.… The findings from this study highlight gaps
not specify the philosophical orientation; however, in patients’ and carers’ understanding of the potential
they noted that all interviews took place in the partici- role of health promotion in COPD and areas of inter-
pants’ homes, an approach consistent with a natural- vention for health professionals.” (Caress et al., 2010,
istic orientation. In addition, the aim of the study, pp. 571-772)
provided in the following quotations and summary,
was consistent with a pragmatic philosophical
perspective: This study is a typical example of exploratory-
descriptive qualitative research, in that the researchers
reported the data without transforming the data into
more abstract concepts or constructs. The study would
“The aim of this study was to generate in-depth have been strengthened by a clear discussion of the
insights into patients’ and family members’ under- philosophical perspective of the study, which seems to
standing of the causation, progression, and preven- be a mixture of naturalistic and pragmatic perspec-
tion of COPD and the role of health promotion with tives. The research report clearly identified the
this population” (Caress et al., 2010, p. 565). The exploratory-descriptive qualitative methodology used
interviews were digitally recorded and transcribed. to conduct this study. The researchers took extensive
Data analysis included measures to “ensure the con- steps to ensure rigor in the data collection and analysis
gruence of the analysis amongst the investigators” phase and the development of study findings. An
such as “independent review and coding, discussion unexpected finding was that patients reported anxiety
of the emerging themes, identification of the key and fear more frequently than depression. Prior to this
themes, re-examination of the full data set to ensure study, researchers had focused their attention almost
the ‘fit’ of the codes to the data, and finally discussion exclusively on depression. On the basis of these find-
of any discrepancies with a goal of achieving consen- ings, the researchers would return to the literature to
sus” (Caress et al., 2010, p. 566). Additional measures examine studies on anxiety and fear. They may have
that they used to enhance the rigor of the study and identified a gap in knowledge that warrants additional
to protect the ethical rights of the participants were research. In addition to addressing anxiety and fear of
described in detail in this study. patients with COPD, health professionals can use
these findings as the justification for the development
68 UNIT ONE  Introduction to Nursing Research

of a health promotion program for such patients and knowledge can increase our understanding of the
their family members. present and future. The philosophy of history is a
search for wisdom. The historian examines what has
Historical Research been, what is, and what ought to be. Influenced by the
Historical research examines events of the past. His- values of the profession and the philosophy of prag-
torians describe events in the context of time, social matism, historical nurse researchers often apply the
structures, concurrent events, and key individuals. lessons of the past to current events. Wagner and
These descriptions can increase understanding and Whaite (2010, p. 233) end the report of their study of
raise awareness of the forces shaping current events. the writings of Florence Nightingale with these sen-
Historical nursing research can do the same for tences: “These research findings and others encourage
the profession and its role in society (Lewenson & nurses to examine and reflect on how caring relation-
Herrmann, 2008). Nurse researchers using historical ships impact their practice … helping students to
methods have examined the events and people that understand how caring relationships in nursing can
shaped health in different settings and countries as occur in all practice settings.”
well as nursing as a profession. For example, Wood
(2009) examined the role of the surgical nurse in Aus- Historical Research’s Contribution
tralia, Britain, and New Zealand in the era before to Nursing Science
antibiotics. Her data sources were nursing articles and Historical research, although viewed as a legitimate
textbooks published between 1895 and 1935. She source of knowledge, has received less attention by
noted that the surgical nurse’s role was described in funding agencies and nurse researchers in the past 10
relation to the surgeon rather than the patient. The years because of a shift toward studies that produce
surgical nurse’s role was described as supporter, evidence to improve patient outcomes. The American
scrubber, sentry, saboteur, and sloven. The last two Association for the History of Nursing is an organiza-
descriptors were applied in cases of patient sepsis fol- tion with a focus on historical methodologies. The
lowing a surgery. The relationship between the surgeon association’s journal, Nursing History Review, serves
and the nurses went beyond simple subservience to as vehicle for continued knowledge development
include admiration for each other’s skills and a con- in this area. In this journal, Irwin (2011, p. 79) pub-
scientious approach to protecting the patient. lished “a study of U.S. nurses who worked across
Wagner and Whaite (2010, p. 230) examined continents.”
selected writings of Florence Nightingale using The philosophical orientation and methodology of
content analysis and identified five themes related to the study received minimal attention, but the researcher
caring: “attend to, attention to, nurture, competent, noted the role documents played in the study. “The
and genuine.” Other historical researchers examined archives, sources, and figures that are central to the
recent events; for example, D’Antonio (2004) studied field provide a ready means to trace the spread of U.S.
the push for higher education of nurses as affected by global influence in the early twentieth century” (Irwin,
women’s opportunities as members of racial/ethnic 2011, p. 80). Irwin could have strengthened the report
groups. These studies demonstrate the importance of by providing more detail on methods used to ensure
historical research in describing the past to provide rigor. Like most historical researchers, Irwin focused
direction for the future in nursing education and prac- the report on the product and provided little informa-
tice (Lewenson & Herrmann, 2008). tion on the processes she used.
Irwin (2011) described four nurses who provided
Philosophical Orientation overseas service through the American Red Cross
History is a very old science that dates back to the during World War I and in the immediate post-war
beginnings of humankind, when people and groups of era. The nurses cared for military personnel but were
people asked, “Where have we come from?” Others very involved also in relief efforts for citizens, refu-
asked, “Who are we?” and “Where are we going?” gees, and families. They participated in efforts to
These questions have been asked throughout time. improve hygiene, care for those with tuberculosis,
Although the questions do not change, the answers and open training schools for nurses. Irwin’s contri-
have changed because of the influence of social, cul- bution to nursing knowledge was to increase nurses’
tural, and personal forces. History provides the context awareness of their potential influence. Building on
of experience (Lewenson & Herrman, 2008). this history of nurse reformers, nurses today can
A primary assumption of historical philosophy is conceive of roles that extend beyond political
that we can learn from the past and that this borders.
CHAPTER 4  Introduction to Qualitative Research 69

KEY POINTS Boutain, D. M. (1999). Critical nursing scholarship: Exploring criti-


cal social theory with African American studies. Advances in
• Qualitative research is a scholarly approach used to Nursing Science, 21(4), 37–47.
Brooks, C. F. (2011). Social performance and secret ritual: Battling
describe life experiences from the perspective of
against obsessive-compulsive disorder. Qualitative Health
the persons involved. Research, 21(2), 249–261.
• The philosophical foundation of qualitative re- Byers, D. C., & France, N. E. M. (2008). The lived experience
search describes a view of science and guides both of registered nurses providing care to patients with dementia in
the selection of methods and the criteria of rigor. the acute care setting: A phenomenological study. International
• Quantitative research is guided by the philosophy Journal of Caring, 12(4), 44–49.
of logical positivism. In contrast, qualitative re- Caress, A., Luker, K., & Chalmers, K. (2010). Promoting health of
search is guided by a wider range of philosophies. persons with chronic obstructive pulmonary disease: Patients’ and
• Qualitative researchers use open-ended methods to carers’ views. Journal of Clinical Nursing, 19(19), 564–573.
gather data, such as interviews, focus groups, Chen, H. (2010). The lived experience of moving forward for clients
with spinal cord injury: A Parse research method study. Journal
observation, and examination of documents.
of Advanced Nursing, 66(5), 1132–1141.
• The goal of phenomenological research is to Clark, P. N., McFarland, M. R., Andrews, M. M., & Leininger, J.
describe experiences as they are lived. Phenome- (2009). Caring: Some reflections on the impact of the culture care
nology is the philosophy guiding these studies, a theory by McFarland & Andrews and a conversation with Lein­
philosophy that began with the writings of Husserl. inger. Nursing Science Quarterly, 22(3), 233–239.
• The goal of grounded theory research is to produce Colaizzi, P. F. (1973). Reflection and research in psychology: A
findings grounded in the concrete world as experi- phenomenological study of learning. Dubuque, IA: Kendall Hunt.
enced by the participants that can be interpreted at Creswell, J. W. (2009). Research design: Qualitative, quantitative,
a more abstract level of a theory. Symbolic inter- and mixed methods approaches (3rd ed.). Los Angeles, CA: Sage.
actionism is the underlying philosophical and theo- Crossley, N. (2010). Networks and complexity: Directions for inter-
actionist research? Symbolic Interaction, 33(3), 341–363.
retical perspective.
D’Antonio, P. (2004). Women, nursing, and baccalaureate education
• Ethnographic research is the investigation of cul- in 20th century America. Journal of Nursing Scholarship, 36(4),
tures through an in-depth study of the members of 379–384.
the culture. Nurse anthropologist Leininger devel- Douglas, M. K., Kemppainen, J. K., McFarland, M. R., Papadopou-
oped the ethnonursing research method. los, I., Ray, M. A., Roper, J. M., Scollan-Koliopoulos, M., Shapira,
• Exploratory-descriptive qualitative research elicits J., & Tsai, H-M. (2010). Chapter 10: Research methodologies for
the perceptions of participants to provide insights investigating cultural phenomena and evaluating interventions.
for understanding patients and groups, influencing Journal of Transcultural Nursing, 21(Suppl. 1), 3737–4055.
practice, and developing appropriate programs for Dowling, M. (2007). From Husserl to van Manen: A review of dif-
specific groups of people. The philosophy of prag- ferent phenomenological approaches. International Journal of
Nursing Studies, 44(1), 131–142.
matism and the naturalistic and interpretive orien-
Earle, V. (2010). Phenomenology as research method or substantive
tations guide exploratory-descriptive qualitative metaphysics? An overview of phenomenology’s uses in nursing.
studies. Nursing Philosophy, 11(4), 286–296.
• Historical research is designed to analyze the inter- Fawcett, J., & Garity, J. (2009). Evaluating research for evidence-
action of people, events, and social context that based nursing practice. Philadelphia, PA: F. A. Davis.
occurred in the remote or recent past. The method- Fontana, J. S. (2004). A methodology for critical science in nursing.
ologies of historical research include interviewing Advances in Nursing Science, 27(2), 93–101.
people with knowledge of past events and examin- Forman, J., Creswell, J. W., Damschroder, L., Kowalski, C. P.,
ing documents describing the events. Krein, S. L. (2008). Qualitative research methods: Key features
and insights gained from use in infection prevention research.
American Journal of Infection Control, 36(10), 764–771.
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UNIT TWO
The Research Process
5  
CHAPTER

Research Problem and Purpose


  http://evolve.elsevier.com/Grove/practice/

W
e are constantly asking questions to better practice. Research is conducted to generate knowledge
understand ourselves and the world around that addresses the practice concern, with the ultimate
us. This human ability to wonder and ask goal of providing evidence-based health care. A research
creative questions about behaviors, experiences, and problem can be identified by asking questions such as
situations in the world provides a basis for identifying the following: What is wrong or is of concern in this
research topics and problems. Identifying a problem clinical situation? What knowledge is needed to improve
is the initial step, and one of the most significant, in this situation? Will a particular intervention work in this
conducting quantitative, qualitative, outcomes, and clinical situation? What is known about this interven-
intervention research. The research purpose evolves tion’s effectiveness? Would another intervention be
from the problem and directs the subsequent steps of more effective in producing the desired outcomes?
the research process. By questioning and reviewing the literature,
Research topics are concepts, phenomena of inter- researchers begin to recognize a specific area of
est, or broad problem areas that researchers can focus concern and the knowledge gap that surrounds it. The
on to enhance evidence-based nursing. Research knowledge gap, or what is not known about this clini-
topics contain numerous potential research problems, cal problem, determines the complexity and number
and each problem provides the basis for developing of studies needed to generate essential knowledge
many purposes. Thus, the identification of a relevant for nursing practice (Craig & Smyth, 2012; Creswell,
research topic and a challenging, significant problem 2009). In addition to the area of concern, the research
can facilitate the development of numerous study problem identifies a population and sometimes a
purposes to direct a lifetime program of research. setting for the study.
However, the abundance of research topics and poten- A research problem includes significance, back-
tial problems frequently is not apparent to nurses ground, and a problem statement. The significance of
struggling to identify their first study problem. a problem indicates the importance of the problem to
This chapter differentiates a research problem from a patients and families, nursing, healthcare system, and
purpose, identifies sources for research problems, and pro- society. The background for a research problem
vides a background for formulating a problem and pur­ briefly identifies what we know about the problem
pose for study. The criteria for determining the feasibility area. The problem statement identifies the specific
of a proposed study problem and purpose are described. gap in the knowledge needed for practice. A research
The chapter concludes with examples of research topics, problem from the study by Grady, Entin, Entin, and
problems, and purposes from current quantitative, quali­ Brunye (2011) is presented as an example. This study
tative, outcomes, and intervention studies. was conducted to examine the effectiveness of educa-
tional messages or information on the knowledge,
What Is a Research Problem attitudes, and behaviors of people with diabetes.
and Purpose? “Diabetes prevalence has reached epidemic propor-
A research problem is an area of concern where there tions in this country. The health and economic
is a gap in the knowledge base needed for nursing

73
74 UNIT TWO  The Research Process

identified the significance of the problem, which is


consequences for Americans with this disease are extensive and relevant to patients, families, nursing,
overwhelming and expected to grow as our popula- healthcare system, and society. The problem back-
tion continues to age. Approximately 23.6 million ground focuses on key research conducted to exam­ine
people in the United States have diabetes and, despite the effectiveness of health education on the manage-
the disease being underreported as a cause of death, ment of diabetes. The last sentence in this example is
diabetes was listed as the seventh leading cause of the problem statement, which identifies the gap in the
death in the United States in 2006 (Centers for knowledge needed for practice. In this study, there is
Disease Control and Prevention, 2008a). The direct limited research on how to present diabetic education
medical costs of diabetes care and complications of to maximize its effectiveness on attitudinal and behav-
$116 billion, together with indirect costs of $58 billion ioral change in people with this chronic illness.
related to disability and reduced productivity, resulted The research problem in this example includes
in an estimated economic cost of diabetes totaling concepts or research topics such as diabetes preva-
$174 billion in 2007 (American Diabetes Association, lence, economic consequences, complications of dia-
2009).… Complications contribute to a risk of death betes, consequences of diabetic neuropathy, health
among individuals with diabetes that is about 2 times management education, self-management, and atti­
higher than that of individuals without diabetes tudinal and behavioral changes. Health management
(Centers for Disease Control and Prevention, 2008a). education is an abstract concept, and a variety
Amputations and foot ulcerations are the most of nursing actions or interventions could be imple-
common consequences of diabetic neuropathy and mented to determine their effectiveness in promoting
the major causes of morbidity and disability in people long-term attitudinal and behavioral changes in
with diabetes. Approximately 2% to 3% of individu- persons with diabetes. Thus, each problem may gen-
als with diabetes develop one or more foot ulcers erate many research purposes. The knowledge gap
each year, and an estimated 15% will develop a foot regarding how to present information to foster posi-
ulcer during their lifetime (Singh, Armstrong, & Lipsky, tive attitudinal and behavioral changes in persons
2005) [problem significance].… with diabetes provides clear direction for formulating
As the cornerstone of diabetes treatment and an the research purpose.
integral part of a self-management regime, education The research purpose is a clear, concise statement
of patients with diabetes takes place in both inpatient of the specific focus or aim of the study that is gener-
and outpatient venues.… Patient education takes time ated on the basis of the research problem. The purpose
in the continuum of care that an already overworked usually indicates the type of study (quantitative, quali-
staff is challenged to provide.… The research cited in tative, outcomes, or intervention) to be conducted and
the reviews of Boren et al. (2006) and Jackson et al. often includes the variables, population, and setting
(2006) provides evidence that delivery of healthcare for the study. The goals of quantitative research
information can be accomplished effectively without include identifying and describing variables, examin-
involving diabetes educators or nurses and offers ing relationships among variables, and determining
support for the use of information-technology-based the effectiveness of interventions in managing clinical
education as an alternative way to provide informa- problems (Creswell, 2009; Shadish, Cook, & Camp-
tion and guidance to persons with diabetes [problem bell, 2002). The goals of qualitative research include
background]. However, regardless of whe­ther the exploring a phenomenon, such as depression as it is
information is presented in person or via technology, experienced by pregnant women; developing theories
a relevant and still-open question is how to present to describe and manage clinical situations; examining
the information so as to foster positive attitudinal and the health practices of certain cultures; describing
behavioral change and maximize the long-term effec- health-related issues, events, and situations; and deter-
tiveness of health management education [problem mining the historical evolution of the profession
statement].” (Grady et al., 2011, pp. 22-23) (Marshall & Rossman, 2011; Munhall, 2012). The
focus of outcomes research is to identify, describe,
In this example, the research problem identifies an and improve the outcomes or end results of patient
area of concern (incidence, costs, and complications care (Doran, 2011). Intervention research focuses on
of diabetes) for a particular population (persons investigating the effectiveness of nursing interven-
with diabetes) in selected settings (inpatient and out- tions in achieving the desired outcomes in natural
patient venues). Grady and colleagues (2011) clearly settings (Forbes, 2009). Regardless of the type of
CHAPTER 5  Research Problem and Purpose 75

research, every study needs a clearly expressed pur­ Clinical Practice


pose statement to guide it. Grady et al. (2011) clearly The practice of nursing must be based on knowledge
identified their study purpose following their research or evidence generated through research. Thus, clinical
problem statement of the gap in the knowledge base. practice is an extremely important source for research
Thus, the purpose of their study was to “examine the problems. Problems can evolve from clinical observa-
impact of information framing in an educational tions. For example, while watching the behavior of a
program about proper foot care and its importance for patient and family in crisis, you may wonder how you
preventing diabetic complications on long-term as a nurse might intervene to improve the family’s
changes in foot care knowledge, attitudes, and behav- coping skills. A review of patient records, treatment
ior” (Grady et al., 2011, p. 23). plans, and procedure manuals might reveal concerns
This research purpose indicates that these inves- or raise questions about practice that could be the basis
tigators conducted a quantitative quasi-experimental for research problems. For example, you may wonder:
study to determine the effectiveness of an indepen- What nursing intervention will open the lines of
dent variable or intervention (information framing communication with a patient who has had a stroke?
educational program about diabetic foot care and What is the impact of home visits on the level of func-
prevention of complications) on the dependent or tion, readjustment to the home environment, and
outcome variables (foot care knowledge, attitudes, rehospitalization pattern of a child with a severe
and behaviors). The researchers also identified two chronic illness? What is the most effective treatment
hypotheses to direct their study, which included the for acute and chronic pain? What is the best pharma-
four variables identified (see Chapter 8 for a discus- cological agent or agents for treating hypertension
sion of hypotheses). The study findings indicated in elderly, diabetic patients—angiotensin-converting
that the gain-framed messages focused on the ben- enzyme (ACE) inhibitor, angiotensin II receptor
efits of taking action were significantly more effec- blocker (ARB), diuretic, beta blocker, calcium channel
tive in promoting positive behavioral changes in blocker, or alpha antagonist, or a combination of these
people with diabetes than the loss-framed messages drugs? What are the most effective pharmacological
focused on the costs of not taking action. A gain- and nonpharmacological treatments for a patient with
framed message might be stated as follows: “Achiev- a serious and persistent mental illness? What are the
ing normal blood sugar increases your feelings of needs of stroke survivors from their perspective?
health and well being and promotes control of your What are the cultural factors that promote better birth
illness.” A loss-framed message might be worded outcomes in Hispanic women? These clinical ques-
as follows: “Poorly controlled blood sugars can lead tions could direct you in identifying a significant
to complications of neuropathy, foot lesions, and research problem and purpose.
amputation.” Grady et al. (2011) also found that Extensive patient data, such as diagnoses, treat-
changes in knowledge affected changes in attitudes ments, and outcomes, are now computerized. Analyz-
and that attitudes were direct predictors of long-term ing this information might generate research problems
behavior management of diabetes. The findings from that are significant to a clinic, community, or national
this study and other research provide evidence of healthcare system. For example, you may ask: Why
the effectiveness of information messages in sus­ has adolescent obesity increased so rapidly in the past
taining health promoting behavior by people with 10 years, and what treatments will be effective in
diabetes. managing this problem? What pharmacological and
nonpharmacological treatments have been most effec-
tive in treating common acute illnesses such as otitis
Sources of Research Problems media, sinusitis, and bronchitis in your practice or
Research problems are developed from many sources, nationwide? What are the outcomes (patient health
but you need to be curious, astute, and imaginative to status and costs) for treating such chronic illnesses as
identify problems from the sources. The sources for type 2 diabetes, hypertension, and dyslipidemia in
research problems included in this text are (1) clinical your practice? Review of agency patient data often
practice, (2) researcher and peer interactions, (3) lit- reveals patterns and trends in a clinical setting and
erature review, (4) theories, and (5) research priorities helps nurses and students to identify patient care
identified by funding agencies and specialty groups. problems.
Researchers often use more than one source to identify Because health care is constantly changing in
and refine their research problem. response to consumer needs and trends in society, the
76 UNIT TWO  The Research Process

focus of current research varies according to these for nurses to discuss their ideas and brainstorm to
needs and trends. For example, research evidence is identify potential research problems.
needed to improve practice outcomes for infants and The Internet has greatly extended the ability of
new mothers, the elderly and residents in nursing researchers and clinicians around the world to share
homes, and persons from vulnerable and culturally ideas and propose potential problems for research.
diverse populations. Healthcare agencies would Most colleges or schools of nursing have websites that
benefit from studies of varied healthcare delivery identify faculty research interests and provide mecha-
models. Society would benefit from interventions rec- nisms for contacting individuals who are conducting
ognized to promote health and prevent illness. In research in your area of interest. Thus, interactions
summary, clinically focused research is essential if with others are essential to broaden your perspective
nurses are to develop the knowledge needed for and knowledge base and to support you in identifying
evidence-based practice (EBP) (Brown, 2009; Melnyk significant research problems and purposes.
& Fineout-Overholt, 2011).
Literature Review
Researcher and Peer Interactions Reviewing research journals, such as Advances in
Interactions with researchers and peers offer valuable Nursing Science, Applied Nursing Research, Clinical
opportunities for generating research problems. Expe- Nursing Research, Evidence-Based Nursing, Interna-
rienced researchers serve as mentors and help novice tional Journal of Psychiatric Nursing Research,
researchers to identify research topics and formulate Journal of Nursing Scholarship, Journal of Advanced
problems. Nursing educators assist students in select- Nursing, Journal of Research in Nursing, Nursing
ing research problems for theses and dissertations. Research, Nursing Science Quarterly, Research in
When possible, students conduct studies in the same Nursing & Health, Scholarly Inquiry for Nursing
area of research as the faculty. Faculty members can Practice: An International Journal, Southern Online
share their expertise regarding their research program, Journal of Nursing Research, and Western Journal of
and the combined work of the faculty and students can Nursing Research, as well as theses and dissertations
build a knowledge base for a specific area of practice. will acquaint novice researchers with studies con-
This type of relationship could also be developed ducted in an area of interest. The nursing specialty
between an expert researcher and a nurse clinician. journals, such as American Journal of Maternal Child
Because nursing research is critical for designation as Nursing, Archives of Psychiatric Nursing, Dimensions
a Magnet facility by the American Nurses Credential- of Critical Care, Heart & Lung, Infant Behavior and
ing Center© (ANCC, 2012), hospitals and healthcare Development, Journal of Pediatric Nursing, and
systems employ nurse researchers for the purpose of Oncology Nursing Forum, also place a high priority
guiding studies conducted by staff nurses. Building an on publishing research findings. Reviewing research
EBP for nursing requires collaboration between nurse articles enables you to identify an area of interest and
researchers and clinicians as well as with researchers determine what is known and not known in this area.
from other health-related disciplines. Interdisciplinary The gaps in the knowledge base provide direction for
research teams have the expertise to increase the future research. (See Chapter 6 for the process of
quality and quantity of studies conducted. Being a part reviewing the literature.)
of a research team is an excellent way to expand your At the completion of a research project, an inves-
understanding of the research process. tigator often makes recommendations for further
Beveridge (1950) identified several reasons for dis- study. These recommendations provide opportunities
cussing research ideas with others. Ideas are clarified for others to build on a researcher’s work and
and new ideas are generated when two or more people strengthen the knowledge in a selected area. For
pool their thoughts. Interactions with others enable example, the Grady et al. (2011, p. 27) study, intro-
researchers to uncover errors in reasoning or informa- duced earlier in this chapter, provided recommenda-
tion. These interactions are also a source of support in tions for further research to examine “the longer term
discouraging or difficult times. In addition, another eventualities of gain- and loss-framed messages on
person can provide a refreshing or unique viewpoint, preventative behaviors.” They also recommended
which helps avoid conditioned thinking, or following examining how long the gain-framed message might
an established habit of thought. A workplace that last and when it would be “necessary to provide
encourages interaction can stimulate nurses to identify another message presentation to bolster effective self-
research problems. Nursing conferences and profes- care behavior” (p. 27). These researchers also encour-
sional meetings also provide excellent opportunities aged others to validate their findings through
CHAPTER 5  Research Problem and Purpose 77

replication studies that varied the content and delivery findings, the designs and methods of both studies
format of educational messages provided persons with should be examined for limitations and weaknesses,
diabetes. and further research must be conducted. Conflicting
findings might also generate additional theoretical
Replication of Studies insights and provide new directions for research.
Reviewing the literature is a way to identify a study For a concurrent (or internal) replication, the
to replicate. Replication involves reproducing or researcher collects data for the original study and the
repeating a study to determine whether similar find- replication study simultaneously thereby checking
ings will be obtained (Fahs, Morgan, & Kalman, the reliability of the original study findings. The con-
2003). Replication is essential for knowledge develop- firmation, through replication of the original study
ment because it (1) establishes the credibility of findings, is part of the original study’s design. For
the findings, (2) extends the generalizability of the example, your research team might collect data simul-
findings over a range of instances and contexts, (3) taneously at two different hospitals to compare and
reduces the number of type I and type II errors, contrast the findings. Consistency in the findings
(4) corrects the limitations in studies’ methodologies, increases the credibility of the study and the likelihood
(5) supports theory development, and (6) lessens the that others will be able to generalize the findings.
acceptance of erroneous results. Some researchers Some expert researchers obtain funding to conduct
replicate studies because they agree with the findings multiple concurrent replications, in which a number
and wonder whether the findings will hold up in dif- of individuals conduct repetitions of a single study, but
ferent settings with different subjects over time. Others with different samples in different settings. Clinical
want to challenge the findings or interpretations of trials that examine the effectiveness of the pharmaco-
prior investigators. Some researchers develop research logical management of chronic illnesses, such as dia-
programs focused on expanding the knowledge needed betes, hypertension, and dyslipidemia, are examples
for practice in an area. This program of research often of concurrent replication studies. As each study is
includes replication studies that strengthen the evi- completed, the findings are compiled in a report that
dence for practice. specifies the series of replications that were conducted
Four different types of replications are important in to generate these findings. Some outcome studies
generating sound scientific knowledge for nursing: (1) involve concurrent replication to determine whether
exact, (2) approximate, (3) concurrent, and (4) system- the outcomes vary for different healthcare providers
atic extension (Haller & Reynolds, 1986). An exact and healthcare settings across the United States (Brink
(or identical) replication involves duplicating the & Wood, 1979; Brown, 2009; Doran, 2011).
initial researcher’s study to confirm the original find- A systematic (or constructive) replication is done
ings. All conditions of the original study must be under distinctly new conditions. The researchers con-
maintained; thus, “there must be the same observer, ducting the replication do not follow the design or
the same subjects, the same procedure, the same mea- methods of the original researchers; rather, the second
sures, the same locale, and the same time” (Haller & investigative team identifies a similar problem but for-
Reynolds, 1986, p. 250). Exact replications might be mulates new methods to verify the first researchers’
thought of as ideal to confirm original study findings, findings (Haller & Reynolds, 1986). The aim of this
but these are frequently not attainable. In addition, one type of replication is to extend the findings of the
would not want to replicate the errors in an original original study and test the limits of the generalizability
study, such as small sample size, weak design, or poor- of such findings. Intervention research might use this
quality measurement methods. type of replication to examine the effectiveness of
When conducting an approximate (or operational) various interventions devised to address a practice
replication, the subsequent researcher repeats the problem.
original study under similar conditions, following the Nurse researchers need to actively replicate studies
methods as closely as possible. The intent is to deter- to develop strong research evidence for practice.
mine whether the findings from the original study hold However, the number of nursing studies replicated
up despite minor changes in the research conditions. continues to be limited. The replications of studies
If the findings generated through replication are con- might be limited because (1) some view replication as
sistent with the findings of the original study, then the less scholarly or less important than original research,
knowledge is considered more credible and has a (2) the discipline of nursing lacks adequate resources
greater probability of accurately reflecting the real and funding for conducting replication studies, and (3)
world. If the replication fails to support the original editors of journals publish fewer replication studies
78 UNIT TWO  The Research Process

than original studies (Fahs et al., 2003). However, the adults—Health Promotion Model (Pender, 1996) and
lack of replication studies severely limits the genera- Transtheoretical Model (Prochaska, Norcross, Fowler,
tion of sound research findings needed for EBP in Follick, & Abrams, 1992)—but have not been tested
nursing. Thus, replicating a study should be respected regarding low-fat diet with middle school-aged chil-
as a legitimate scholarly activity for both expert and dren” (Frenn et al., 2003, p. 36). They developed a
novice researchers. Funding from both private and model of the study framework (see Figure 5-1) and
federal sources is needed to support the conduct of described the concepts and propositions from the
replication studies, with a commitment from journal model that guided the development of different aspects
editors to publish these studies. of their study.
Replication provides an excellent learning oppor-
tunity for the novice researcher to conduct a signifi-
cant study, validate findings from previous research, “A combined Health Promotion/Transtheoretical
and generate new research evidence about different Model guided the intervention designed for this study
populations and settings. Students studying for a mas- [see Figure 5-1]. The first individual characteristic
ter’s of science in nursing degree could be encouraged examined in this study was temptation (low self-
to replicate studies for their theses, possibly to repli- efficacy), defined as the inability to overcome barriers
cate faculty studies. Expert researchers, with programs in sustaining a low-fat diet … and an intervention
of research, implement replication studies to generate helping adolescents develop behavioral control may
sound evidence for use in practice. When publishing enhance self-efficacy and improve health habits.
a replication study, researchers need to designate the The second characteristic common to both the
type of replication conducted and the contribution the Health Promotion and Transtheoretical Models was
study made to the existing body of knowledge. benefits/barriers. In a study of fifth- through seventh-
grade children, Baranowski and Simons-Morton
Theory (1990) found the most common barriers to reducing
Theories are an important source for generating saturated fat in the diet were (a) giving up preferred
research problems because they set forth ideas about foods, (b) meals outside the home that contained fat,
events and situations in the real world that require (c) not knowing what foods were low in fat, and (d)
testing (Chinn & Kramer, 2008). In examining a not wanting to take the time to read labels.
theory, you may note that it includes a number of The last individual characteristic used in this study
propositions and that each proposition is a statement was access to low-fat foods. This concept from the
of the relationship of two or more concepts. A research Health Promotion Model is important in a middle
problem and purpose could be formulated to explore school-aged population, as they are, to some extent,
or describe a concept or to test a proposition from a dependent on others for the types of food available.”
theory. Middle range theories are the ones most com- (Frenn et al., 2003, pp. 37-38)
monly used as frameworks for quantitative studies and
are tested as part of the research process (Smith &
Liehr, 2008). In qualitative research, the purpose of Frenn et al. (2003) used the Pender (1996) Health
the study might be to generate a theory or framework Promotion Model and the Transtheoretical Model
to describe a unique event or situation (Marshall & (Prochaska et al., 1992), which are middle range theo-
Rossman, 2011; Munhall, 2012). ries, to develop the following research questions to
Some researchers combine ideas from different guide their study:
theories to develop maps or models for testing through
research. The map serves as the framework for the
study and includes key concepts and relationships “(a) Do demographic variables, access to low-fat
from the theories that the researchers want to study. foods, perceived self-efficacy, benefits/barriers, and
Frenn, Malin, and Bansal (2003, p. 38) conducted a stages of change predict percentage of fat reported
quasi-experimental study to examine the effectiveness in the diet by middle school-aged children? (b) Does
of a “4-session Health Promotion/Transtheoretical the application of a Health Promotion/Transtheoretical
Model-guided intervention in reducing percentage of Model intervention in 4 classroom sessions signifi-
fat in the diet and increasing physical activity among cantly improve adoption of a diet lower in fat and
low- to middle-income culturally diverse middle duration of physical activity as compared with a
school students.” The intervention was based on the control group of students not engaged with the
“components of two behaviorally based research program?” (Frenn et al., 2003, p. 39)
models that have been well tested among
CHAPTER 5  Research Problem and Purpose 79

Individual State of Change Interventions Outcome


Characteristics Transition

Self-reevaluation
Age
Consciousness raising
Pre-contemplation
regarding benefits and
Race to contemplation
access to low-fat
alternatives
Gender

Income Building efficacy and skill


Preparation in preparation of low-fat snacks Decreased
Temptation to action Environmental percentage of
(low efficacy) Reevaluation to create fat in diet
options and access
Benefits/barriers
(pros/cons) Self-reevaluation as
model for peers
Access to Action to Self-liberation
low-fat foods maintenance Reinforcement
Management
Helping relationships
Counterconditioning

Figure 5-1  The health promotion stage of change model: A synthesis of health promotion and transtheoretical models guiding low-fat diet
intervention for students in an urban middle school.

The findings from a study either support or do not (Lewandowski & Kositsky, 1983) and revised these
support the relationships identified in the model. The priorities on the basis of patients’ needs and the
study by Frenn et al. (2003) added support to the changes in health care. The current AACN (2011)
Health Promotion/Transtheoretical Model with their research priorities are identified on this organization’s
findings that the classroom intervention decreased website as (1) effective and appropriate use of technol-
dietary fat and increased physical activity for middle ogy to achieve optimal patient assessment, manage-
school–age adolescents. Further research is needed to ment, or outcomes, (2) creation of a healing, humane
determine whether classroom interventions over time environment, (3) processes and systems that foster the
reduce body mass index, body weight, and the per- optimal contribution of critical care nurses, (4) effec-
centage of body fat of overweight and obese adoles- tive approaches to symptom management, and (5)
cents. As a graduate student, you could use this model prevention and management of complications. AACN
as a framework and test some of the relationships in (2011) has also identified future research needs under
your clinical setting. the following topics: medication management, hemo-
dynamic monitoring, creating healing environments,
Research Priorities palliative care and end-of-life issues, mechanical ven-
Since 1975, expert researchers, specialty groups, pro- tilation, monitoring of neuroscience patients, and non-
fessional organizations, and funding agencies have invasive monitoring. If your specialty is critical care,
identified nursing research priorities. The research pri- this list of research needs might help you identify a
orities for clinical practice were initially identified in priority problem and purpose for study.
a study by Lindeman (1975). Those original research The American Organization of Nurse Executives
priorities included nursing interventions related to (AONE, 2012) provides a discussion of their educa-
stress, care of the aged, pain management, and patient tion and research priorities online at http://www
education. Developing evidence-based nursing inter- .aone.org/education/index.shtml/. For 2011-2012,
ventions in these areas continues to be a priority. AONE identified more than 25 research priorities in
Many professional nursing organizations use web- four strategic areas: (1) design of future patient care
sites to communicate their current research priorities. delivery systems, (2) healthful practice environments,
For example, the American Association of Critical- (3) leadership, and (4) the positioning of nurse leaders
Care Nurses (AACN) determined initial research as valued healthcare executives and managers. To
priorities for this specialty in the early 1980s promote the design of future patient care delivery
80 UNIT TWO  The Research Process

systems, AONE encourages research focused on new important information for nurses seeking funding
technology, patient safety, and the work environment from the NINR. Details about the NINR mission,
that allows strategies for improvement crucial to the strategic plan, and areas of funding are available
success of the delivery system. In the area of healthful on its website at http://www.ninr.nih.gov/AboutNINR/
practice environments, AONE encourages research NINRMissionandStrategicPlan/.
focused on practice environments that attract and Another federal agency that is funding healthcare
retain nurses and that promote professional growth research is the Agency for Healthcare Research and
and continuous learning, including mentoring of staff Quality (AHRQ). The purpose of the AHRQ is to
nurses and nursing leaders. In the area of leadership, enhance the quality, appropriateness, and effective-
AONE encourages research focused on evidence- ness of healthcare services, and access to such ser-
based leadership capacity, measurement of patient vices, by establishing a broad base of scientific
care quality outcomes, and technology to complement research and promoting improvements in clinical
patient care. To promote the positioning of nurse practice and in the organization, financing, and
leaders as valued healthcare executives and managers, delivery of healthcare services. Some of the current
AONE encourages research focused on patient safety AHRQ funding priorities are research focused on
and quality, disaster preparedness, and workforce prevention; health information technology; patient
shortages. AONE recognizes the importance of sup- safety; long-term care; pharmaceutical outcomes;
porting education and research initiatives to create a system capacity and emergency preparedness; and
healthy work environment, a quality healthcare the cost, organization, and socioeconomics of health
system, and strong nurse executives. You can search care. For a complete list of funding opportunities and
online for the research priorities of other nursing orga- grant announcements, see the AHRQ website at http://
nizations to help you identify priority problems for www.ahrq.gov/.
study. The World Health Organization (WHO) is encour-
A significant funding agency for nursing research aging the identification of priorities for a common
is the National Institute of Nursing Research (NINR). nursing research agenda among countries. A quality
A major initiative of the NINR is the development healthcare delivery system and improved patient and
of a national nursing research agenda that involves family health have become global goals. By 2020, the
identifying nursing research priorities, outlining a world’s population is expected to increase by 94%,
plan for implementing priority studies, and obtaining with the elderly population growing by almost 240%.
resources to support these priority projects. The NINR Seven of every 10 deaths are expected to be caused
has an annual budget of more than $90 million, with by noncommunicable diseases, such as chronic condi-
approximately 74% of the budget used for extramural tions (heart disease, cancer, and depression) and inju-
research project grants, 7% for predoctoral and post- ries (unintentional and intentional). The priority areas
doctoral training, 6% for research management and for research identified by WHO are to (1) improve the
support, 5% for the centers program in specialized health of the world’s most marginalized populations,
areas, 5% for other research including career develop- (2) study new diseases that threaten public health
ment, 2% for the intramural program, and 1% for around the world, (3) conduct comparative analyses
contracts and other expenses (see NINR at http:// of supply and demand of the health workforce of dif-
www.ninr.nih.gov/). ferent countries, (4) analyze the feasibility, effective-
The NINR (2011) developed four strategies for ness, and quality of education and practice of nurses,
building the science of nursing: “(1) integrating bio- (5) conduct research on healthcare delivery modes,
logical and behavior science for better health; (2) and (6) examine the outcomes for healthcare agencies,
adopting, adapting, and generating new technologies providers, and patients around the world (WHO,
for better health care; (3) improving methods for 2012). A discussion of WHO’s mission, objectives,
future scientific discoveries; and (4) developing scien- and research policies can be found online at http://
tists for today and tomorrow.” The areas of research www.who.int/rpc/en.
emphasis include: (1) promoting health and prevent- The Healthy People 2020 website identifies and
ing disease, (2) improving quality of life, (3) eliminat- prioritizes health topics and objectives for all age
ing health disparities, and (4) setting directions for groups over the next decade (U.S. Department of
end-of-life research (NINR, 2011). Specific research Health and Human Services, 2012). These health
priorities were identified for each of these four areas topics and objectives direct future research in the areas
of research emphasis and were included in the NINR of health promotion, illness prevention, illness
Strategic Plan. These research priorities provide management, and rehabilitation and can be accessed
CHAPTER 5  Research Problem and Purpose 81

Observation of real world situations


(Nursing practice)

Identify research topics

Nonresearchable questions Generate questions

RESEARCH PROBLEM
Review of literature Input from others
Clarification and refinement

RESEARCH PURPOSE

Objectives, questions, or hypotheses

Figure 5-2  Formulating a research problem and purpose.

online at http://www.healthypeople.gov/2020/topics research problem. From the problem, the researcher


objectives2020/default.aspx/. develops a specific focus or research purpose for
In summary, funding organizations, professional study. The flow of these steps is presented in Figure
organizations, and governmental healthcare organiza- 5-2 and described in the following sections.
tions, both national and international, are sources
for identifying priority research problems and offer Examining a Real-World Situation and
opportunities for obtaining funding for future research. Identifying Research Topics
A nursing situation often includes a variety of research
topics or concepts that identify broad problem areas
Formulating a Research Problem requiring investigation. Nurses frequently investigate
patient- and family-related topics, such as stress, pain,
and Purpose coping patterns, the teaching and learning process,
Potential nursing research problems often emerge self-care deficits, health promotion, rehabilitation,
from real-world situations, such as those in nursing prevention of illness, disease management, and social
practice. A situation is a significant combination of support. Other relevant research topics focus on the
circumstances that occur at a given time. Inexperi- healthcare system and providers, such as cost-effective
enced researchers tend to want to study the entire situ- care; advanced practice nurse roles (nurse practitioner,
ation, but it is far too complex for a single study. clinical nurse specialist, midwife, and nurse anesthe-
Multiple problems exist in a single situation, and each tist); managed care; and redesign of the healthcare
can be developed into a study. A researcher’s percep- system. Outcomes research focuses on topics of health
tion of what problems exist in a situation depends on status, quality of life, cost-effectiveness, and quality
that individual’s clinical expertise, theoretical base, of care. A specific outcome study might focus on a
intuition, interests, and goals. Some researchers spend particular condition, such as terminal cancer, and
years developing different problem statements and examine outcomes, such as nutrition, hygiene, skin
new studies from the same clinical situation. integrity, and pain control with a variety of treatments
The exact thought processes used to extract prob- (Doran, 2011).
lems from a situation have not been clearly identified
because of the abstractness and complexity of the rea- Generating Questions and Reviewing
soning involved. However, in formulating their study the Literature
problems, researchers often implement the following Situations encountered in nursing stimulate a constant
steps: (1) examine a real-world situation, (2) identify flow of questions. The questions fit into three catego-
research topics, (3) generate questions, (4) review rel- ries: (1) questions answered by existing knowledge,
evant literature, and (5) ultimately clarify and refine a (2) questions answered with problem solving, and (3)
82 UNIT TWO  The Research Process

research-generating questions. The first two types of activities, and significantly contribute to a discipline’s
questions are nonresearchable and do not facilitate the body of knowledge.
formulation of research problems that will generate
knowledge for practice. Some of the questions raised Clarifying and Refining a Research Problem
have a satisfactory answer within the nursing profes- Fantasy and creativity are part of formulating a
sion’s existing body of knowledge, and these answers research problem, so you need to imagine prospective
are available in the literature and online, from EBP studies related to the situation. You also need to
guidelines, or from experts in nursing or other disci- imagine the difficulties likely to occur with each study,
plines. For example, suppose you have questions but avoid being too critical of potential research prob-
about performing some basic nursing skills, such as a lems at this time. Which studies seem the most work-
protocol for taking a temperature or giving injections; able? Which ones appeal intuitively? Which problem
you can find answers to questions such as these in the is the most significant to nursing? Which study is of
research literature and procedure manuals (see Figure personal interest? Which problem has the greatest
5-2). However, suppose your questions focus on potential to provide a foundation for further research
investigating new techniques to improve existing in the field (Fawcett & Garity, 2009)?
skills, patient responses to techniques, or ways to The problems investigated need to have profes-
educate patients and families to perform techniques. sional significance and potential or actual significance
Your efforts to answer these types of questions could for society. A research problem is significant when it
add to knowledge needed for EBP. has the potential to generate or refine knowledge to
Some of the questions raised can be answered using build an EBP for nursing (Craig & Smyth, 2012;
problem-solving or evaluation projects. The problem- Melnyk & Fineout-Overholt, 2011). Nurse researchers
solving process addresses a particular problem situa- believe that significant research problems need to
tion, and the goal of the research process is the focus on real-world concerns, to be methodologically
generation of knowledge to be generalized to other sound, to build knowledge for nursing, to develop and/
similar situations. Many evaluation projects are con- or test theory, and to focus on current or timely con-
ducted with minimal application of the rigor and cerns (Alligood, 2010; Chinn & Kramer, 2008; Craig
control required with research. These projects do not & Smyth, 2012; Smith & Liehr, 2008). The problems
fit the criteria of research, and the findings are relevant that are considered significant vary with time and the
for a particular situation. For example, quality assur- needs of society. The priorities identified earlier indi-
ance is an evaluation of the patient care implemented cate some of the current, significant nursing research
by a specific healthcare agency; the results of this topics and problems.
evaluation project are usually relevant mainly to the Personal interest in a problem influences the quality
agency conducting the review. of the problem formulated and the study conducted. A
The type of question that can initiate the research problem of personal interest is one that an individual
process is one that requires further knowledge to has pondered for a long time or one that is especially
answer it. Some of the questions that come to mind important in the individual’s nursing practice or per-
about situations include the following: Is there a need sonal life. For example, if you know someone who has
to explore or describe concepts, to know how they are had a mastectomy, you may be particularly interested
related, or to be able to predict or control some event in studying the emotional impact of a mastectomy or
within the situation? What is known and what is not strategies for caring for mastectomy patients. This per-
known about the concepts? What are the most urgent sonal interest in the topic can become the driving force
factors or outcomes to know? Is there a need to gener- needed to conduct a quality study.
ate or test theory in an area important to practice? Is Answering these questions regarding significance
the patient’s perspective in this situation needed to and personal interest can often assist you in narrowing
develop an intervention? Which intervention is most the number of problems. Without narrowing potential
effective in achieving quality patient outcomes? problems to only one idea, try some of the ideas out
Research experts have found that asking the right on colleagues (see Figure 5-2). Let them play the
question is frequently more valuable than finding the devil’s advocate and explore the strengths and weak-
solution to a problem. The solution identified in a nesses of each idea. Then begin some preliminary
single study might not withstand the test of time or reading in the area of interest. Examine literature
might be useful in only a few situations. However, one related to the situation, the variables within the situa-
well-formulated question can generate numerous tion, measurement of the variables, previous studies
research problems, direct a lifetime of research related to the situation, and supportive theories. The
CHAPTER 5  Research Problem and Purpose 83

literature review often enables you to refine the include the following: What are the physical and psy-
problem and clearly identify the gap in the knowledge chological symptoms demonstrated by someone who
base. Once you have identified the problem, you must has experienced childhood sexual abuse? How would
frame it or ground it in past research, practice, and one assess the occurrence, frequency, and impact of
theory. The discussion of the problem must culminate rape or incest on a woman? What influences do age,
in a problem statement that identifies the gap in the duration, and nature of abuse have on a woman’s
knowledge base that your proposed study will address. current behavior and psychological adjustment? How
Thus, the refined problem has documented signifi- frequently is childhood sexual abuse a problem in the
cance to nursing practice, is based on past research mentally disturbed adult female? How does a health-
and theory, and identifies a gap in nursing knowledge care provider assess, diagnose, and manage the emo-
that directs the development of the research purpose. tional problems of adult survivors of child sexual
abuse? These are the types of questions that Zinzow,
Research Purpose Seth, Jackson, Niehaus, and Fitzgerald (2010) might
The purpose is generated from the problem, identifies have raised as they developed the following problem
the focus, aim, or goal of the study, and directs the and purpose for their study titled “Abuse and Parental
development of the study. In the research process, the Characteristics, Attributions of Blame, and Psycho-
purpose is usually stated after the problem, because logical Adjustments in Adult Survivors of Child
the problem identifies the gap in knowledge in a Sexual Abuse”:
selected area and the purpose clarifies the knowledge
to be generated by the study. The research purpose
must be stated objectively, that is, in a way that does
not reflect particular biases or values of the researcher. Research Problem
Investigators who do not recognize their values might “A history of childhood sexual abuse (CSA) has been
include their biases in the research. This situation can consistently related to adult psychological symptom-
lead them to generate the answers they want or atology in women, including anxiety, depression,
believe to be true and might add inaccurate informa- posttraumatic stress, interpersonal difficulties, sexual
tion to a discipline’s body of knowledge (Kaplan, dysfunction, and somatization.… However, wide
1964). Therefore, on the basis of your research variability among the presence and severity of nega-
purpose, you can develop specific research objec- tive outcomes has been observed. Factors that have
tives, questions, or hypotheses to direct your study been found to account for some of this variation in
(see Chapter 8). adult adjustment include abuse characteristics (e.g.,
severity, number of incidents) (…Steel, Sanna,
Hammond, Whipple, & Cross, 2004) and family char-
Example of Problem and acteristics such as parenting style and parental psy-
chopathology.… Furthermore, an emerging body of
Purpose Development research has demonstrated a link between cognitive
You might have observed the women receiving treat- mechanisms, such as attributions for abuse, and psy-
ment at a mental health clinic and noted that many chological outcomes in abuse survivors (see review
were withdrawn, depressed, and unable to discuss by Valle & Silovsky, 2002).… However, little is known
certain events in their lives. Their progress in therapy about the influence of abuse and parental character-
was usually slow, and they seemed to have similar istics on attributional content. Moreover, the relative
physical and psychological symptoms. Often, after contribution of self-blame, family blame, and perpe-
developing a rapport with a therapist, they would trator blame to the sequelae of CSA is poorly under-
reveal that they were victims of sexual abuse as a stood.” (Zinzow et al., 2010, p. 80)
child. This situation could lead you to identify research
topics and generate searching questions. Research Research Purpose
topics of interest include childhood sexual abuse, “The purpose of this study was to examine the influ-
history and nature of abuse, parental characteristics, ence of abuse and parental characteristics on attribu-
adult survivors of child sexual abuse, physical and tional content and determine the relative contribution
psychological symptoms in adulthood, assessment and of different attributions of blame in predicting psycho-
diagnosis of child sexual abuse history, therapeutic logical symptoms among adult survivors of childhood
interventions to manage abuse history and symptoms, sexual abuse.” (Zinzow et al., 2010, p. 79)
and psychological adjustment. Possible questions
84 UNIT TWO  The Research Process

The research problem identified by Zinzow et al. developed?), (4) methods for collecting data, and (5)
(2010) included significance because CSA was linked the data analysis process. Another factor that can
to several psychological problems in adult women increase the time needed for a study is obtaining insti-
who suffered abuse. The key findings from previous tutional review board (IRB) approval, especially if
research focused on the nature and duration of abuse, more than one clinical agency is used for data collec-
parental characteristics, and attributions of blame. tion in a study. Also, researchers often overlook the
However, the findings were varied regarding the psy- time commitment necessary to write the research
chological adjustment and outcomes of women who report for presentation and publication. You must
were adult survivors of CSA. The contributions of approximate the time needed to complete each step of
self-blame, family blame, and perpetrator blame to the research process and determine whether the study
adult survivors’ adjustment and symptoms are poorly is feasible.
understood. These gaps in the knowledge base pro- Most researchers propose a designated time or set
vided a basis for the study purpose. The study purpose a specific deadline for their project. For example, an
clearly identifies the focus or aim of the study. Zinzow agency might set a 2-year deadline for studying the
et al. (2010) studied 83 female undergraduates with turnover rate of staff. The researcher must determine
a history of CSA. They found that abuse charac­ whether the identified purpose can be accomplished
teristics such as severity and number of incidents by the designated deadline; if not, the purpose could
were significantly related to attributions. Family- and be narrowed or the deadline extended. Researchers
perpetrator-blame accounted for significant variability are often cautious about extending deadlines because
in psychological symptoms and adjustments of the a project could continue for many years. The indi-
women in the sample, which were greater than the vidual interested in conducting qualitative research
contributions of abuse characteristics, family environ- frequently must make an extensive time commitment
ment, and self-blame. The findings from this study of 2 years or longer to allow for quality collection
included implications for treatment of women who and analysis of data (Marshall & Rossman, 2011).
were adult survivors of CSA and directions for further Time is as important as money, and the cost of a
research. study can be greatly affected by the time required to
conduct it.

Feasibility of a Study Money Commitment


As the research problem and purpose increase in The problem and purpose selected are influenced by
clarity and conciseness, the researcher has greater the amount of money available to the researchers.
direction in determining the feasibility of a study. The Sources for nursing research funding include: (1) gov-
feasibility of a study is determined by examining the ernment funding from such offices as the NINR and
time and money commitment; the researcher’s exper- AHRQ; (2) professional organizations such as AACN,
tise; availability of subjects, facility, and equipment; AONE, and the Oncology Nursing Society; and (3)
cooperation of others; and the study’s ethical consid- local clinical agencies, corporations, and universities
erations (Creswell, 2009; Fawcett & Garity, 2009; (see Chapter 29). Potential sources for funding should
Munhall, 2012; Rogers, 1987). be considered at the time the problem and purpose are
identified. For example, Grady et al. (2011), who
Time Commitment studied the effects of educational messages on health-
Conducting research frequently takes longer than related knowledge, attitudes, and behavior of persons
anticipated, making it difficult for any researcher, with diabetes, was partially funded by an Office of
especially a novice, to estimate the time that will be Naval Research Award. Federal and private sources of
involved. In estimating the time commitment, the funding greatly strengthen the feasibility of conduct-
researcher examines the purpose of the study; the ing a research project.
more complex the purpose, the greater the time com- The cost of a research project can range from a few
mitment. You can approximate the time needed to dollars for a student’s small study to hundreds of thou-
complete a study by assessing the following factors: sands of dollars for complex projects, such as multisite
(1) type and number of subjects needed, (2) number clinical trials and major qualitative studies. In estimat-
and complexity of the variables to be studied, (3) ing the cost of a research project, the following ques-
methods for measuring the variables (Are instruments tions need to be considered, in addition to other areas
available to measure the variables or must they be of expense based on the study being conducted:
CHAPTER 5  Research Problem and Purpose 85

Literature: What will the review of the literature— (2011), these investigators had research and clinical
including computer searches, copying articles, expertise in nursing, public health, psychology, and
and purchasing books—cost? biostatistics. The researchers are all doctorally pre-
Subjects: How many subjects or study participants pared, and Grady is a seasoned faculty member for the
will need to be recruited for the study, and will University of Pittsburgh. Eileen and Elliot Entin are
the subjects have to be paid for their participa- both senior research psychologists with Aptima, Inc.;
tion in the project? Grady et al. (2011) paid their and Brunye is a cognitive psychologist for the U.S.
approximately 155 study participants $25 at Army. The credentials and employment sites for the
each of the three data collection periods. This investigators are identified under the title of the study
resulted in an $11,625 expense that would article. These researchers all appear to have strong
require funding to accomplish. backgrounds for conducting research in the discipline
Equipment: What will the equipment for the study of nursing, psychology, and health care. You can
cost? Can the equipment be borrowed, rented, obtain more information about the authors by search-
bought, or obtained through donation? Is the ing their names online. The researchers also acknowl-
equipment available, or will it need to be built? edged the support of the following in conducting their
What type of maintenance will be required for study: registered nurses, Conemaugh Diabetes Insti-
the equipment during the study? What will the tute, Flipside Media, Inc., and Telehealth Department,
measurement instruments cost? Mount Aloysius College.
Personnel: Will assistants or consultants, or both,
be hired to collect, computerize, and analyze the Availability of Subjects or Participants
data and assist with the data interpretation? Will In selecting a research purpose, you must consider the
clerical help be needed to type and distribute the type and number of study participants needed. Finding
report and prepare a manuscript for publication? a sample might be difficult if the study involves inves-
Computer time: Will computer time be required to tigating a unique or rare population, such as quadriple-
analyze the data? If so, what will be the cost? gic individuals who live alone and are currently
Transportation: What will be the transportation attending college. The more specific the population
costs for conducting the study and presenting selected for study, the more difficult it is to find sub-
the findings? jects. In addition, the Health Insurance Portability and
Supplies: Will any supplies—such as envelopes, Accountability Act (HIPAA) prevents clinical agencies
postage, pens, paper, and photocopies—be from sharing lists of potential subjects with a researcher
needed? Will a cell phone be needed to contact without specific stipulations (see Chapter 9). Potential
the researcher about potential subjects? Will a subjects who are stigmatized, such as persons with
survey or reminder postcard by mailed to par- HIV/AIDS, may be more difficult to access.
ticipants? Will long-distance phone calls or The money and time available to the researcher will
overnight mailing be needed? affect the subjects selected. With limited time and
money, the researcher might want to investigate sub-
Researcher Expertise jects who are accessible and do not require payment
A research problem and purpose must be selected on for participation. Even if you identify a population
the basis of the ability of the investigator(s). Initially, with a large number of potential subjects, those indi-
you might work with another researcher (mentor) to viduals may be unwilling to participate in the study
learn the process and then investigate a familiar because of the topic selected. For example, nurses
problem that fits your knowledge base or experience. could be asked to share their experiences with alcohol
Selecting a difficult, complex problem and purpose and drug use, but many might fear that sharing this
can only frustrate and confuse the novice researcher. information would jeopardize their jobs and licenses.
However, all researchers need to identify problems Researchers need to be prepared to pursue the attain-
and purposes that are challenging and collaborate with ment of study participants at whatever depth is neces-
other researchers as necessary to build their research sary. Having a representative sample of reasonable
background. size is critical for generating quality research findings
When a team of researchers conducts a study, the (Aberson, 2010). Grady et al. (2011) selected a setting
team members often have a variety of research and where they could obtain the sample size that they
clinical experiences that add to the quality of the study needed for their study, as identified in the following
conducted. In the study conducted by Grady et al. quotation:
86 UNIT TWO  The Research Process

The researchers did not indicate how they obtained


“The study was conducted at the diabetes outpatient the equipment for their study, making it difficult to
facility of an acute care hospital in west central Penn- determine the expenses related to the study. They did
sylvania. After receiving institutional review board identify the software that was used for data collection
approval from the participating facility, participants and analysis but not the expenses related to using this
were obtained through advertisements in local news- software. You could contact the principal investiga-
papers recruiting people older than 18 years, who tor, Grady, and obtain more details related to equip-
have had diabetes for 5 years or more, and who have ment costs and computer expenses for data collection
no known foot problems.… The final sample was and analysis. The contact information for Grady and
composed of 64 men and 91 women.” (Grady et al., E. B. Entin is provided on the first page of the study
2011, p. 24) article.

Cooperation of Others
Availability of Facilities and Equipment A study might appear feasible, but without the coop-
Researchers need to determine whether their studies eration of others, it is not. Some studies are conducted
will require special facilities to implement. Will a in laboratory settings and require the minimal coop-
special room be needed for an educational program, eration of others. However, most nursing studies
interview, or observations? If the study is conducted involve human subjects and are conducted in hospi-
at a hospital, clinic, or college of nursing, will the tals, clinics, schools, offices, or homes. Having the
agency provide the facilities that are needed? Setting cooperation of people in the research setting, the sub-
up a highly specialized laboratory for the conduct of jects, and the research assistants involved in data col-
a study would be expensive and would probably lection is essential. People are frequently willing to
require external funding. Most nursing studies are cooperate with a study if they view the problem and
done in natural settings such as a hospital room or unit, purpose as significant or if they are personally inter-
a clinic, or a patient’s home. Grady et al. (2011) con- ested. Grady et al. (2011) acknowledged the support
ducted all their research activities in the diabetes out- of nurses and other professional organizations and
patient facility (partially controlled setting). corporations that assisted with the study. The research-
Nursing studies frequently require a limited amount ers seemed to have strong agency support and the
of equipment, such as a tape or video recorder for support of relevant businesses. Having the coopera-
interviews or a physiological instrument, such as a tion of others can improve the subject participation
scale or thermometer. Often you can borrow equip- and promote the successful completion of the study
ment from the facility where the study is conducted, or (see Chapter 20 for details on the data collection
you can rent it. Some companies are willing to donate process).
equipment if the study focuses on determining the
effectiveness of the equipment and the findings are Ethical Considerations
shared with the company. If specialized facilities or The purpose selected for investigation must be
equipment are required for a study, you must be aware ethical, which means that the participants’ rights and
of the options available before actively pursuing the the rights of others in the setting are protected. If
study. Grady et al. (2011) delivered their educational your purpose appears to infringe on the rights of the
messages (either gain-framed or loss-framed) to each participants, you should reexamine that purpose; the
subject individually in the diabetes outpatient facility: investigation may have to be revised or abandoned.
There are usually some risks in every study, but the
value of the knowledge generated should outweigh
“Videos were watched from digital video disk (DVD) the risks. Grady et al. (2011, p. 24) received insti­
on a 19-inch television monitor. The inventories were tutional review board approval from the diabetes
presented one at a time on a personal computer, via outpatient facility in Pennsylvania where the study
ScoreMD Web-based assessment software. Partici- was conducted, and “all eligible adults wishing to
pants controlled the pacing of the questions in the participate in the study provided informed consent.”
inventories; responses were automatically coded and By taking these steps, the researchers attempted
stored in a database.… Participants were paid $25 to implement an ethical study that protected the
at each of the three data collection periods.” (Grady rights of the adults with diabetes who participated
et al., 2011, p. 25) (see Chapter 9 for details on ethical conduct in
research).
CHAPTER 5  Research Problem and Purpose 87

Nyamathi and colleagues found that a program that


Example Research Topics, used nurse case management and tracking was essen-
Problems, and Purposes for tial in supporting the adherence and completion of
6-month hepatitis A and B vaccine series. This was
Different Types of Research especially important for white homeless persons, who
were the least likely to complete their vaccine series
Quantitative Research without an intervention tailored to address their unique
Quantitative and qualitative research approaches needs.
enable nurses to investigate a variety of research prob- Experimental studies are conducted in highly con-
lems and purposes. Examples of research topics, prob- trolled settings and under highly controlled conditions
lems, and purposes for some of the different types of to determine the effect of one or more independent
quantitative studies are presented in Table 5-1. The variables on one or more dependent variables (Shadish
research purpose usually reflects the type of study et al., 2002). Sharma, Ryals, Gajewski, and Wright
that is to be conducted. The purposes of descriptive (2010) conducted an experimental study to determine
research are to identify patterns of variables, to the effects of an aerobic exercise program on the pain-
describe and define variables, to identify initial links like behavior and neurotrophin-3 (NT-3) in mice with
among variables, and to compare and contrast groups chronic widespread pain (see Table 5-1). These
on selected variables (Kerlinger & Lee, 2000). For researchers found that moderate-intensity aerobic
example, Trotter, Gallagher, and Donoghue (2011) exercise had the effect of deep tissue mechanical
conducted their study to describe the patterns of anxiety hyperalgesia on chronic pain in mice. This finding
and concerns of patients undergoing percutaneous provides a possible molecular basis for aerobic exer-
coronary interventions (PCIs). The research topics, cise training in reducing muscular pain.
problems, and purposes for this study are presented in
Table 5-1. Trotter et al. (2011) found that symptoms Qualitative Research
of anxiety were common before and after PCIs. They The problems formulated for qualitative research iden-
recommended that patients who had chest pain or were tify an area of concern that requires investigation. The
undergoing a first PCI should be targeted for an inter- purpose of a qualitative study indicates the focus of
vention to reduce anxiety during the recovery period the study and whether it is a subjective concept, an
and after discharge. event, a phenomenon, experience, situation, or a facet
The purpose of correlational research is to examine of a culture or society (Marshall & Rossman, 2011;
the type (positive or negative) and strength of the Munhall, 2012). Examples of research topics, prob-
relationships among study variables. In their correla- lems, and purposes from some different types of quali-
tional study, Houck, Kendall, Miller, Morrell, and tative studies are presented in Table 5-2 and in Chapter
Wiebe (2011) examined the relationship between 12. Phenomenological research seeks an understand-
behavior problems and self-concept in adolescents ing of human experience from the researcher’s per-
and children with attention deficit hyperactivity disor- spective, such as children’s experiences of living with
der (ADHD) (see Table 5-1). Houck et al. (2011, asthma conducted by Trollvik, Nordbach, Silen, and
p. 239) found that it is important “to assess self- Ringsberg (2011). The research topics, problem, and
concept in children and adolescents with ADHD, purpose for this study are presented in Table 5-2. The
especially those who are older and have comorbid findings from the study by Trollvik et al. (2011,
conditions.” These individuals with ADHD who have p. 295) “described two themes with five subthemes:
low self-concept require diagnosis and treatment as fear of exacerbation (body sensations, frightening
part of their care. experiences, and loss of control) and fear of being
Quasi-experimental studies are conducted to deter- ostracized (experiences of being excluded and dilemma
mine the effect of an intervention or independent vari- of keeping the asthma secret or being open about it).”
able on designated dependent or outcome variables In grounded theory research, the problem identifies
(Shadish et al., 2002). For example, Nyamathi et al. the area of concern and the purpose indicates the focus
(2009) conducted a quasi-experimental study to of the theory to be developed from the research
examine the effects of a nurse-managed program (Munhall, 2012). For example, El-Mallakh (2007)
(intervention) on the vaccine completion rates for investigated the poverty and self-care among individu-
hepatitis A and B vaccine series (outcomes) in a popu- als with schizophrenia and diabetes mellitus. On the
lation of homeless adults. The research topics, basis of findings from this grounded theory study,
problem, and purpose are identified in Table 5-1. Text continued on p. 92
88

TABLE 5-1  Quantitative Research: Topics, Problems, and Purposes


Type of
UNIT TWO  The Research Process

Research Research Topic Research Problem and Purpose


Descriptive Anxiety, concerns, Title of study: “Care of patients with coronary heart disease: Anxiety in patients undergoing percutaneous coronary
research percutaneous interventions” (Trotter, Gallagher, & Donoghue, 2011, p. 185).
coronary Problem: “Coronary artery disease (CAD) is a leading cause of mortality, morbidity, and loss of quality of life globally. One
intervention, of the most common treatments for CAD is percutaneous transluminal coronary angioplasty/stent placement, collectively
coronary heart labeled percutaneous coronary intervention (PCI).… Although PCIs are common and relatively low risk, many patients
disease undergoing these treatments experience clinically relevant anxiety, with an estimated prevalence rate of 24% to 72%.…
Although anxiety levels decrease after a PCI, clinically relevant anxiety may still be common, with one study noting that
21% of patients remained anxious 6 to 8 weeks after the procedure (Astin, Jones, & Thompson, 2005).… Few studies have
investigated anxiety levels and patients’ expressed concerns in the very early recovery period within 24 hours after the
procedure or the early recovery period in the week after discharge” (Trotter et al., 2011, p. 186).
Purpose: The purpose of this study was “to determine the patterns of anxiety and concerns experienced by patients under
going PCI…” (Trotter et al., 2011, 185).
Correlational Self-concept, attention Title of study: “Self-concept in children and adolescents with attention deficit hyperactivity disorder” (Houck, Kendall, Miller,
research deficit hyperactivity Morrell, & Wiebe, 2011, p. 239).
disorder, behavior Problem: “Attention deficit hyperactivity disorder (ADHD) is the most common mental health disorder of childhood, affecting
problems approximately 3%-8.7% of children and adolescents in the United States (National Institutes of Mental Health, 2008).
ADHD is a chronic and stigmatizing neurological disorder with deficits in the neurotransmitter systems that affect executive
functioning.… People with ADHD have impairments in adaptive functioning, which is often manifested in difficult
behaviors, such as aggression, poor rule-regulated behavior, inability to delay gratification, behavioral disinhibition, learning
difficulties, poor impulse control and low motivation.… Findings from previous studies on the relationships between ADHD
and self-concept are mixed, with some studies indicating that self-concept scores are higher in children with ADHD than in
those without ADHD (Treuting & Hinshaw, 2001).… Understanding more specifically how self-concept and behavioral
problems are related, given the behavioral disruption that accompanies ADHD, is important to support a child’s social and
emotional development” (Houck et al., 2011, pp. 239-240).
Purpose: “The purpose of this study was to examine the relationship between behavioral problems and self-concept in children
and adolescents with ADHD” (Houck et al., 2011, p. 241).
Type of
Research Research Topic Research Problem and Purpose

Quasi- Nurse-case-managed Title of study: “Effects of a nurse-managed program on hepatitis A and B vaccine completion among homeless adults”
experimental intervention, hepatitis (Nyamathi et al., 2009, p. 13).
research A and B vaccine Problem: “Hepatitis B virus (HBV) infection poses a serious threat to public health in the United States. Recent estimates
completion rate, place the true prevalence of chronic HBV in the United States at approximately 1.6 cases per 100,000 persons (Centers for
socio-demographic Disease Control and Preventions [CDC], 2008b). It is estimated that there were 51,000 new cases of HBV infection in
factors, risk 2005, a financial burden reaching $1 billion annually (Cohen et al., 2007).… Homeless populations are at particularly high
behaviors, homeless risk of HBV infection due to high rates of unprotected sexual behavior and sharing of needles and other IDU [injection drug
user] paraphernalia. Previous studies have reported that HBV infection rates among homeless populations range from 17%
to 31% (i.e., from 17,000 to 31,000 per 100,000…) compared with 2.1 per 100,000 in the general United States
population.… Vaccination is the most effective way to prevent HBV infection (CDC, 2006).… Improving vaccination
adherence rates among homeless persons is an important step toward reducing the high prevalence of HBV infection in this
population.… Thus, little is known about adherence to HBV vaccination among community samples of urban homeless
persons or about the effect of stronger interventions to incorporate additional strategies, such as nurse case management and
targeted HBV education along with client tracking” (Nyamathi et al., 2009, pp. 13-14.)
Purpose: The purpose of this study was to determine the “effectiveness of a nurse-case-managed intervention compared with
that of two standard programs on completion of the combined hepatitis A virus (HAV) and HBV vaccine series among
homeless adults and to assess socio-demographic factors and risk behaviors related to the vaccine completion” (Nyamathi
et al., 2009, p. 13).
Experimental Chronic widespread Title of study: “Aerobic exercise alters analgesia and neurotrophin-3 [NT-3] synthesis in an animal model of chronic
research pain, aerobic widespread pain” (Sharma, Ryals, Gajewski, & Wright, 2010, p. 714).
exercise, analgesia, Problem: “Chronic widespread pain is complex and poorly understood and affects about 12% of the adult population in
neurotrophin-3 developed countries (Rohrbeck, Jordan, & Croft, 2007).… Management of chronic pain syndromes poses challenges for
synthesis, pain healthcare practitioners, and pharmacological interventions offer limited efficacy.… Exercise training has been long
management, animal suggested to reduce pain and improve functional outcomes (Whiteside, Hansen, & Chaudhuri, 2004).… Surprisingly, the
model current literature is mainly limited to human studies where the molecular basis for exercise training cannot be easily
determined. Relatively few animal studies have addressed the effects and mechanisms of exercise on sensory modulation of
chronic pain” (Sharma et al., 2010, p. 715).
Purpose: “The purpose of the present study was to examine the effects of moderate-intensity aerobic exercise on pain-like
behavior and NT-3 in an animal model of widespread pain” (Sharma et al., 2010, p. 714).
CHAPTER 5  Research Problem and Purpose
89
90

TABLE 5-2  Qualitative Research: Topics, Problems, and Purposes


Type of
Research Research Topic Research Problem and Purpose
Phenomenological Lived experience of Title of study: “Children’s experiences of living with asthma: Fear of exacerbations and being ostracized” (Trollvik,
research children, asthma, Nordbach, Silen, & Ringsberg, 2011, p. 295).
health promotion, Problem: “Asthma is the most common childhood disease and long-term medical condition affecting children (Masoli,
child health, chronic Fabian, Holt, Beasley, & Global Initiative for Asthma [GINA] Program, 2004). The prevalence of asthma is increasing,
illness, fears of and atopic diseases are considered to be a worldwide health problem and an agent of morbidity in children.… Studies
exacerbations, fears show that children with asthma have more emotional/behavioral problems than healthy children.… It has also been found
of being ostracized that asthma control in children is poor and that healthcare professionals (HCPs) and children focus on different aspects of
having asthma (Price et al., 2002).… Few studies have considered very young children’s, 7-10 years old, perspectives;
this study might contribute to new insights into their lifeworld experiences” (Trollvik et al., 2011, pp. 295-296).
UNIT TWO  The Research Process

Purpose: “The aim of this study was to explore and describe children’s everyday experiences of living with asthma to tailor
an Asthma Education Program based on their perspectives.… In this study, a phenomenological and hermaneutical
approach was used to gain an understanding of the children’s lifeworld” (Trollvik et al., 2011, p. 296).
Grounded theory Self-care, poverty, Title of study: “Doing my best: Poverty and self-care among individuals with schizophrenia and diabetes mellitus”
research schizophrenia, (El-Mallakh, 2007, p. 49).
diabetes mellitus Problem: “Mental health clinicians and researchers increasingly recognize that individuals with schizophrenia have a high
risk of developing diabetes mellitus (DM) (Bushe & Holt, 2004).… Whereas rates of diabetes in the general populations
range from 2% to 6%, prevalence rates of diabetes among individuals with schizophrenia range from 15% to 18%, and up
to 30% have impaired glucose tolerance (Bushe & Holt, 2004; Schizophrenia and Diabetes Expert Consensus Group,
2004).… The recent mental health literature has focused on the screening, diagnosis, and treatment of diabetes in this
population, including discussions of the risks and benefits of atypical antipsychotic use.… However, few researchers have
investigated the influence of social and demographic characteristics on diabetic self-care among individuals with
schizophrenia and diabetes” (El-Mallakh, 2007, pp. 49-50).
Purpose: “A grounded theory study was conducted to examine several aspects of diabetic self-care in individuals with
schizophrenia and DM” (El-Mallakh, 2007, p. 50).
Ethnography Critical illness, Title of study: “Family presence and surveillance during weaning from prolonged mechanical ventilation” (Happ et al., 2007,
research mechanical p. 47).
ventilation, weaning, Problem: “During critical illness, mechanical ventilation imposes physical and communication barriers between family
family presence members and their critically ill loved ones.… Most studies of family members in the intensive care unit (ICU) have
focused on families’ needs for information, access to the patient, and participation in decisions to withdraw or withhold
life-sustaining treatment.… Although numerous studies have been conducted of patient experiences with short- and
long-term mechanical ventilation (LTMV), research has not focused on family interactions with patients during weaning
from mechanical ventilation. Moreover, the importance of family members’ bedside presence and clinicians’ interpretation
of family behaviors at the bedside have not been critically examined” (Happ et al., 2007, pp. 47-48).
Purpose: “With the use of data from an ethnographic study of the care and communication processes during weaning from
LTMV, we sought to describe how family members interact with the patients and respond to the ventilator and associated
ICU bedside equipment during LTMV weaning” (Happ et al., 2007, p. 48).
Type of
Research Research Topic Research Problem and Purpose

Exploratory- Intimate partner Title of study: “Supporting mothering: Service providers’ perspectives of mothers and young children affected by intimate
descriptive violence, abuse of partner violence” (Letourneau et al., 2011, p. 192).
qualitative spouse, supporting Problem: “Estimates of the percent of women with exposure to intimate partner violence (IPV) over their lifetimes by
research mothering, husbands, partners, or boyfriends range between 8% and 66%.… The high concentration of preschool-age children in
parent-child households where women experience IPV… is a major concern.… Indeed, preschool-age children exposed to IPV may
relationships, family share many of the adjustment difficulties experienced by victims of direct physical and psychological abuse (Litrownik,
health, providers’ Newton, Hunter, English, & Everson, 2003). The degree to which children from birth to 36 months of age are affected by
perspective, social IPV, however, is not well understood. Even less is known of effective services and supports that target mothers and their
support young children exposed to IPV” (Letourneau et al., 2011, p. 193).
Purpose: “We conducted a qualitative descriptive study of service providers’ understandings of the impact of IPV on
mothers, young children (birth to 36 months), and mother-infant/child relationships, and of the support needs of these
mothers and young children” (Letourneau et al., 2011, p. 192).
Historical History, Cold War, Title of study: “Planning for mass disaster in the 1950s: Harriet H. Werley and nursing research” (Leifer & Glass, 2008, p.
research mass disaster 237).
preparation, nursing Problem: “Americans were continually aware of the potential for nuclear disaster during the Cold War era.… Because the
research, 1950s, fear of nuclear war was ever present, military and civil defense programs were developed to help Americans prepare for
Harriet H. Werley, disaster.… Military and civilian healthcare personnel were mobilized to prepare for any mass casualties caused by a
Army Nurse Corps nuclear attack.
“In the 21st century, world events remind nurses of the need to be prepared to respond to disaster. Since the events of
September 11, 2001; the Southeast Asian tsunami in 2004; and the Gulf Coast hurricanes in 2005, there has been an
increased emphasis on preparedness and response planning for man-made or natural disasters.… During the turbulent
Cold War era, Harriet H. Werley, an Army Nurse Corps (ANC) major, was a pioneer in mass disaster education and
nursing research. She served as the first nursing consultant in the newly formed Department of Atomic Casualties Studies
(DACS) from 1955-1958.… When working with military officials in Washington, DC, including the ANC, the Office of
the Surgeon General, the Army Institute of Research, and the Walter Reed Army Hospital, Werley shared her vision of an
evolving role for nurses that included increased opportunities for leadership, research, and expanded practice.… Primary
and secondary sources regarding Werley’s work in the DACS and the field of disaster nursing were examined to obtain
data for this historical study” (Leifer & Glass, 2008, pp. 237-238).
Purpose: The purpose of this historical study “was to analyze nurses’ involvement in research and mass disaster preparations
during the Cold War era and to describe the role of Harriet H. Werley and the Army Nurse Corps” (Leifer & Glass, 2008,
p. 237).
CHAPTER 5  Research Problem and Purpose
91
92 UNIT TWO  The Research Process

El-Mallakh (2007, p. 49) developed a “model, Evolv- their needs for support (see Table 5-2). These research-
ing Self-Care, that describes the process by which ers found that mothers experiencing such violence and
respondents developed health beliefs about self-care their children require more support than is currently
of dual illnesses. One subcategory of the model, available. In addition, the service providers had diffi-
‘Doing My Best,’ was further analyzed to examine the culty in identifying interventions to promote and
social context of respondents’ diabetic self-care.” protect these mothers and their children.
In ethnographic research, the problem and purpose The problem and purpose in historical research
identify the culture and the specific attributes of the focus on a specific individual, a characteristic of
culture to be examined, described, analyzed, and inter- society, an event, or a situation in the past and iden-
preted. Happ et al. (2007) conducted an ethnographic tify the period in the past that will be examined. For
study of family presence and surveillance during example, Leifer and Glass (2008) conducted a his-
weaning of their family member from a ventilator (see torical study of nurses’ involvement in mass disaster
Table 5-2). These researchers concluded that “this preparations and research during the Cold War era in
study provided a potentially useful conceptual frame- the 1950s (see Table 5-2). These researchers focused
work of family behaviors with long-term critically ill on the career of Harriet Werley and how her plan-
patients that could enhance the dialogue about family- ning for mass disaster during the 1950s increased
centered care and guide future research on family her emphasis on research and interdisciplinary
presence in the intensive care unit” (Happ et al., 2007, collaboration. Werley’s vision provides insights for
p. 47). today’s nurses, who are once again faced with the
Exploratory-descriptive qualitative research is challenges and demands of disaster management
being conducted by several qualitative researchers to preparation.
describe unique issues, health problems, or situations
that lack clear description or definition. This type of Outcomes Research
research often provides the basis for future qualitative Outcomes research is conducted to examine the end
and quantitative research (Creswell, 2009). Letour- results of care (Doran, 2011). Table 5-3 summarizes
neau et al. (2011) conducted an exploratory-descriptive the topics, problem, and purpose from an outcomes
qualitative study of service provider’s understandings study by Bae, Mark, and Fried (2010). These research-
of the impact of intimate partner violence (IPV) on the ers examined the impact of nursing unit turnover rates
mothers and their young children and to determine on patient outcomes in hospitals. They found that

TABLE 5-3  Outcomes Research: Topics, Problem, and Purpose


Type of
Research Research Topic Research Problem and Purpose
Outcomes Nurse turnover, Title of study: “Impact of nursing unit turnover on patient outcomes in hospitals” (Bae,
research workgroup Mark, & Fried, 2010, p. 40)
processes, patient Problem: “The adverse impact of nursing turnover on quality of patient care is a long-
outcomes, quality of standing assumption, yet there is little understanding of the turnover-quality relationship
care, patient safety, or its underlying mechanisms. When turnover occurs, the remaining staff must adjust to
patient satisfaction newcomers, and turnover may affect the interaction and integration among staff members
who remain.… Most empirical research on nursing turnover has focused on a direct
relationship between turnover and patient outcomes; the underlying mechanisms of the
turnover-outcomes relationship have not been explored (Alexander, Bloom, & Nuchols,
1994).… In order to understand the mechanisms by which nursing turnover is related to
patient outcomes, it is necessary to explore the impact of nursing turnover on nursing
units, which is the proximal context for individuals and a bounded interactive context
created by nurses’ attributes, interactions, and responses (Kozlowski, Steve, & Bell,
2003)” (Bae et al., 2010, pp. 40-41).
Purpose: “The aim of this study was to examine how nursing unit turnover affects key
workgroup processes and how these processes mediate the impact of nursing turnover on
patient outcomes” (Bae et al., 2010, p. 40).
CHAPTER 5  Research Problem and Purpose 93

TABLE 5-4  Intervention Research: Topics, Problem, and Purpose


Type of
Research Research Topic Research Problem and Purpose
Intervention Stress management, social Title of study: “Effects of stress management on PNI-based outcomes in persons
research support, nursing with HIV disease” (McCain et al., 2003, p. 102).
interventions, HIV/AIDS, Problem: “Although it remains potentially fatal, infection with the human
psychoneuroimmunology immunodeficiency virus (HIV) has become eminently more treatable as a chronic
(PNI), quality of life, illness with the advent of highly active antiretroviral therapies.… Insights as to
coping, psychosocial the relationship of psychological and physiological health in HIV and other
functioning, immune status, disease are emanating from research in psychoneuroimmunology (PNI).… A
somatic health, viral load growing body of research with persons who have HIV disease, as well as those
who have other chronic and potentially fatal illnesses such as cancer, indicates
that not only can a variety of biobehavioral strategies for stress management
mitigate psychological distress and improve coping skills, they also can enhance
immune function through neuroendocrine–immune system modulation.… More
recent work has continued to support the use of CBSM [cognitive-behavioral
stress management] as an effective strategy in the management of distress
associated with HIV disease.… Little comparative research has been done to
determine the relative effect of these two types of interventions on either
psychological or physiological status” (McCain et al., 2003, pp. 102-105).
Purpose: “This study was undertaken to compare the effects of CBSM groups,
social support groups (SSG), and a wait-listed control group on the outcomes of
psychosocial functioning (perceived stress, coping patterns, social support,
uncertainty, psychological distress), quality of life, neuroendocrine mediation
(salivary cortisol, DHEA levels), and somatic health (disease progression,
HIV-specific health status, viral load, and immune status)” (McCain et al., 2003,
p. 105).

nursing unit turnover had a significant adverse affect variables, which are commonly used to determine the
on the workgroup processes on the unit where turn- health status of patients with HIV. The CBSM inter-
over took place. The negative effects on workgroup vention was found to be the most effective in produc-
processes adversely impact continuity and quality of ing positive physical and psychological outcomes for
patient care and patient outcomes. patients with HIV infection.

Intervention Research
Intervention research determines the interventions that KEY POINTS
are most effective in managing clinical problems.
Some interventions might focus on risk reduction, pre- • A research problem is an area of concern where
vention, treatment, or resolution of health-related there is a gap in the knowledge base needed for
problems or symptoms; management of a problem or nursing practice and includes significance, back-
symptom; or prevention of complications associated ground, and problem statement.
with a practice problem. In intervention research, the • The major sources for nursing research problems
interventions might have more than one purpose include nursing practice; researcher and peer
and multiple outcomes. For example, McCain et al. interactions; literature review; theories; and re-
(2003) examined the effectiveness of two complex search priorities identified by individuals, specialty
interventions, cognitive-behavioral stress manage- groups, professional organizations, and funding
ment (CBSM) and social support, on the multiple out- agencies.
comes of patients with HIV infection. Table 5-4 lists • Replication is essential for the development of
the topics, problem, and purpose from the study by evidence-based knowledge for practice and con-
McCain et al. (2003). The outcomes measured in this sists of four types: exact, approximate, concurrent,
study were many physiological and psychological and systematic.
94 UNIT TWO  The Research Process

• The research purpose is a concise, clear statement Beveridge, W. I. B. (1950). The art of scientific investigation. New
of the specific focus or aim of the study and York, NY: Vintage.
usually indicates the type of study (quantitative, Boren, S. A., Gunlock, T. L., Santosh, K., & Kramer, T. C. (2006).
Computer-aided diabetes education: A synthesis of randomized
qualitative, outcomes, or intervention research) to
controlled trials. American Medical Informatics Association
be conducted. Annual Symposium Proceedings (pp. 51–55).
• The researcher examines the real-world situation, Brink, P. J., & Wood, M. J. (1979). Multiple concurrent replications.
identifies research topics, generates questions, Western Journal of Nursing Research, 1(1), 117–118.
and ultimately clarifies and refines a research Brown, S. J. (2009). Evidence-based nursing: The research-practice
problem. connection. Sudbury, MA: Jones and Bartlett Publishers.
• From the problem, a specific aim or research Bushe, C., & Holt, R. (2004). Prevalence of diabetes and impaired
purpose is developed that provides a clear focus for glucose tolerance in patients with schizophrenia. British Journal
the study. of Psychiatry, 184(Suppl 47), S67–S71.
• On the basis of the research purpose, specific Centers for Disease Control and Prevention. (2006). A comprehen-
sive immunization strategy to eliminate transmission of hepatitis
research objectives, questions, or hypotheses are
B virus infection in the United States. Morbidity and Mortality
developed to direct the study. Weekly Report, 55(RR-16), 1–25.
• The feasibility of the research problem and purpose Centers for Disease Control and Prevention. (2008a). National dia-
are determined by examination of the time and betes fact sheet: General information and national estimates on
money commitments; researchers’ expertise; avail- diabetes in the United States, 2007. Atlanta, GA: U.S. Department
ability of subjects, facility, and equipment; coopera- of Health and Human Services, Author.
tion of others; and the study’s ethical considerations. Centers for Disease Control and Prevention. (2008b). Surveillance
• Quantitative, qualitative, outcomes, and interven- for acute viral hepatitis—United States, 2006. Morbidity and
tion studies enable nurses to investigate a variety Mortality Weekly Report, 57(SS02), 1–24.
of research problems and purposes. Chinn, P. L., & Kramer, M. K. (2008). Integrated theory and knowl-
edge development (7th ed.). St. Louis, MO: Mosby.
Cohen, C. A., London, W. T., Evans, A. A., Block, J., Conti, M. C.,
& Block, T. (2007). Underestimation of chronic hepatitis B in
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  http://evolve.elsevier.com/Grove/practice/

6  
CHAPTER

Review of Relevant Literature

Y
ou have been asked to present a lecture about consists of newspapers, monographs, encyclopedias,
home health care for undergraduate nursing conference papers, scientific journals, textbooks,
students. Maybe you are concerned about the other books, theses, dissertations, and clinical jour-
families of the patients in your critical care unit and nals. Websites and reports developed by government
want to devise a program to address their unique needs. agencies and professional organizations are also
Maybe you are a graduate nursing student and your included. For example, to support the significance of
teacher said your paper needed to include a review of diabetes mellitus as a topic for a research study, you
the literature. Maybe you are in a Magnet hospital and could find statistics about the prevalence and cost of
the nurses on your unit are developing a proposal for the disease from the Centers for Disease Control and
a study. In each situation, you need to understand how Prevention (CDC) and the World Health Organization
to review the literature and to present the information (WHO). Not every source that you find, however,
you find in a logical, synthesized manner. By building will be valid and legitimate for scholarly use. The
on previous knowledge, nurse researchers can add to website of a company that sells insulin may not be an
the evidence upon which we base our practice. appropriate source for diabetes statistics. Online
The rate of new knowledge being generated each encyclopedias to which anyone can contribute, such
year continues to grow. Early studies in the 1960s as Wikipedia, are not considered scholarly sources.
indicated that knowledge doubled every 13 to 15 years These websites might point you toward professional
(Larsen & von Ins, 2010). The vast amount of infor- sources but should not be cited in a professional or
mation available within seconds implies that knowl- academic paper. You should use primary, peer-
edge is doubling much more rapidly in the digital age. reviewed, professional literature. New knowledge
Bachrach (2001) noted that each new discipline develops when researchers and scholars produce
launches new journals to develop its disciplinary manuscripts for journals and books that are reviewed
knowledge. Computerized bibliographical databases by peers to determine whether the manuscripts should
have made the process of searching for relevant empir- be published.
ical or theoretical literature easier in some ways, but
you are faced with the dilemma of selecting the most
relevant sources from a much larger number of arti- What Is a Literature Review?
cles. The task of reading, critically appraising, analyz- The literature review is an organized written presen-
ing, and synthesizing has expanded and can consume tation of what you find when you review the literature.
any time gained by more efficient searching. This The literature review is “central to scholarly work and
chapter provides basic skills and knowledge to iden- disciplined inquiry” (Holbrook, Bourke, Fairbairn, &
tify evidence for changing nursing practice, develop- Lovat, 2007, p. 337); it summarizes what has been
ing a research proposal, preparing a lecture, or writing published on a topic by scholars and presents relevant
a manuscript. research findings. Developing the ability to write
coherently about what you have found in the literature
requires time and guidance. The review should be
What Is “The Literature”? organized into sections that present themes, identify
“The literature” consists of all written sources rele- trends, or examine variables. The purpose is not to
vant to the topic you have selected. The literature list all the material published but, rather, to synthesize

97
98 UNIT TWO  The Research Process

and evaluate it on the basis of the phenomenon of all studies that provide evidence of a particular inter-
interest. vention, to critically appraise the quality of each study,
The focus of the review depends on the reason you and to synthesize all of the studies providing evidence
are reviewing the literature. This overview describes of the effectiveness of a particular intervention. It is
common purposes for conducting literature reviews; also important to locate and include previous evidence-
however, the goal of this chapter is to provide specific based papers that have examined the evidence of a
guidance and practical suggestions related to review- particular intervention, because the conclusions of the
ing research relevant to a proposed study. The three authors of such papers are highly relevant. Literature
major stages of literature reviews are discussed: (1) syntheses related to promoting evidence-based nursing
searching the literature, (2) processing the literature, practice are described in Chapter 19.
and (3) writing the literature review.
Developing a Qualitative Research Proposal
In qualitative research, the purpose and timing of the
Purposes of Reviewing literature review depend on the type of study to be
conducted (see Chapter 12). Some phenomenologists
the Literature believe that the literature should not be reviewed until
after the data have been collected and analyzed, so that
Writing a Course Paper the literature does not interfere with the researcher’s
For most course papers, your instructor will expect ability to suspend what is known and to approach the
you to review published sources on the topic of your topic with openness (Munhall, 2012). In the develop-
paper. Reviews of the literature for a course assign- ment of a grounded theory study, a minimal review of
ment will vary depending on the level of educational relevant studies provides the beginning point of the
program, the purpose of the assignment, and the inquiry, but this review is only a means of making the
expectations of the instructor. The literature review for researcher aware of what studies have been conducted.
a graduate course is expected to have greater depth, This information, however, is not used to direct the
scope, and breadth than a review for an undergraduate collection of data or interpretation of the findings in a
course (Hart, 2009). A paper in a nurse practitioner grounded theory study. During the data analysis stage,
course might require that you review pharmacology a core variable is identified and the researcher theoreti-
and pathology reference books in addition to journal cally samples the literature for extant theories that may
articles. In a nursing education course, you may review assist in explaining and extending the emerging theory
neurological development, cognitive science, and (Munhall, 2012). In historical research, the initial
general education publications to write a paper on review of the literature helps the researcher define the
a teaching strategy. For a doctor of nursing practice study questions and make decisions about relevant
course on clinical information systems, your review sources. The data collection is actually an intense
might need to extend into computer science and hos- review of published and unpublished documents that
pital management literature. For a theory course in a the researcher has found.
doctor of philosophy in nursing program, your review The purposes of reviewing the literature for ethno-
may need to include all the publications of a specific graphic studies and for exploratory descriptive quali-
theorist or all the studies based on the theory. For each tative research are more similar to that for quantitative
of these papers, your professor may specify the research. The researcher develops a general under-
publication years and the type of literature to be standing of the concepts to be examined in relation to
included. Also, you must note the acceptable length of the selected culture or topic. The literature review also
the written review of the literature to be submitted. provides a background for conducting the study and
Reviews of the literature for course assignments tend interpreting the findings. Chapter 12 describes in more
to focus on what is known, the strength of the evi- detail the role of the literature review in qualitative
dence, the implications of the knowledge, and what is research.
not known for the purpose of developing new studies.
Developing a Quantitative Study
Examining the Strength of the Evidence The review of literature in quantitative research directs
Evidence-based practice guidelines are developed the development and implementation of a study. The
through the synthesis of the literature on the clinical focus of the major literature review at the beginning
problem. The purpose of the literature review designed of the research process is to identify a gap in what is
to examine the strength of the evidence is to identify known. The study is designed to add knowledge in the
CHAPTER 6  Review of Relevant Literature 99

TABLE 6-1  The Role of the Literature Review in Developing a Quantitative Research Proposal
Phase of the
Research Process How Literature Is Used and Its Role
Research topic Broad searches using keywords to understand the extent of what is known and what is not known; what
concepts are related to the topic
Statement of the From your synthesis of the literature, the specific gap in knowledge that this study will address
research purpose
Background and Searches of books and articles to provide an overview of the topic
significance Identification of the size, cost, and consequences of the research problem
Research framework Find and read relevant theories
Facilitate development of the framework
Develop conceptual definitions of concepts
Purpose of the study On the basis of your knowledge of the literature, state the purpose of the study
Research objectives, On the basis of the knowledge gained from and examples found in the literature, write the objectives or
questions, or questions of the study
hypotheses If sufficient literature allows a prediction, state the hypotheses of the study
Review of the literature Find sources as evidence for logical argument for why this study and methodology are needed
Summarize current empirical knowledge that is related to the topic
Methodology Compare research designs of reviewed studies to select the most appropriate design for the proposed study
Identify possible instruments or measures of variables
Provide operational definitions of concepts
Describe performance of measures in previous studies
Develop sampling strategies based on what you have learned from the studies in the literature
Findings Refer to statistical textbooks to explain the results of the data analysis
Discussion Compare your findings with those of studies you have previously reviewed
Return to the literature to find new references to interpret unexpected findings
Identify limitations of the study
Refer to theory sources to relate the findings to the research framework
Conclusions On basis of your knowledge of the literature and your study’s findings, draw conclusions
Discuss implications for nursing clinical practice, administration, and education
Propose future studies

area of the identified gap. For example, an intervention Table 6-1 describes the role of the literature
to prevent hospital-acquired infections related to intra- throughout the development and implementation of
venous infusions has been shown to reduce the inci- the study. The types of sources needed and how you
dence of these infections among postoperative patients will search the literature will vary throughout the
who have no history of diabetes mellitus. After a thor- study. The introduction section uses relevant sources
ough review of the literature, the researcher identifies to summarize the background and significance of the
a specific gap in knowledge. What is not known is research problem. The review of the literature section
whether this intervention will be equally effective for includes both theoretical and empirical sources that
postoperative patients who have diabetes. After the document the current knowledge of the problem. The
data have been analyzed and the findings described, researcher develops the framework section from the
the researcher will return to the literature in the gen- theoretical literature and sometimes from empirical
eralization phase of the research report to integrate literature. If little theoretical literature is found, the
knowledge from the literature with new knowledge researcher may need to develop a tentative theory to
obtained from the study. The purposes of the literature guide the study from the findings of previous research
review are similar for the different types of studies (see Chapter 7 for more information).
quantitative studies (descriptive, correlational, quasi- The methods section describes the design, sample,
experimental, and experimental). measurement methods, treatment, and data collection
100 UNIT TWO  The Research Process

process of the planned study and is based on previous serials with predictable publication dates, such as jour-
research. Thus, previous studies may be cited in the nals, which are published over time and are numbered
methods section. In the results section, sources are sequentially for the years published. This sequential
included to document the different types of statistical numbering is seen in the year, volume, issue, and page
analyses conducted and the computer software to numbering of a journal. Monographs, such as books,
conduct these analyses. The discussion section of the hard-copy conference proceedings, and pamphlets, are
research report begins with what the results mean in usually written once and may be updated with a new
light of the results of previous studies. Conclusions edition as needed. Conference proceedings can help
are drawn that are a synthesis of the cited findings you identify major researchers in your research area
from previous research and those from the present who have presented findings that may not yet be pub-
study. lished. Periodicals and monographs are available in a
variety of media, such as print, online, CD-ROM, and
downloadable formats. Textbooks are monographs
Practical Considerations written to be used in formal education programs.
Entire volumes of books available in a digital or
What Types of Literature Can I Expect electronic format are called eBooks (Tensen, 2010).
to Find? You may be familiar with digital books in the mass
Two broad types of literature are cited in the review publication literature that are available to download to
of literature for research: theoretical and empirical. read on a special reading device, such as a Kindle or
Theoretical literature consists of concept analyses, Nook. eBooks are also available for scholarly volumes
models, theories, and conceptual frameworks that and articles that can be downloaded to a reading
support a selected research problem and purpose. device, cell phone, laptop, or other computer. Books
Empirical literature comprises knowledge derived that in the past would have been difficult to obtain
from research. The empirical literature reviewed through interlibrary loan are now available 24 hours a
depends on the study problem and the type of research day, 7 days a week as eBooks.
conducted. Research problems that have been fre- To develop the significance and background section
quently studied or are currently being investigated of a proposal, you may also need to search for govern-
have more extensive empirical literature than new or ment reports for the United States (U.S.) and other
unique problems. If searching the empirical literature, countries, if appropriate for your study. A researcher
you need to identify seminal and landmark studies. developing a proposal on task shifting in HIV care
Seminal studies are the first studies that prompted the settings in low-resource countries would search the
initiation of the field of research. Nurse researchers Ministry of Health websites for those countries to find
studying hearing loss in infants would need to review official guidelines for this type of practice. Research-
the seminal work of Fred H. Bess, an early researcher ers developing a proposal in Wisconsin on the smoking
on this topic who advocated for effective screening cessation in adolescents would consult the Healthy
tools (Gravel, 2009). Critical care nurses comparing People 2020 website for the national goals related
correction formulas for QT intervals on electrocardio- to this topic (http://www.healthypeople.gov/2020/
grams would want to refer to Bazet’s correction default.aspx/). They may also explore health-related
formula. The development of the formula can be agencies in Wisconsin to determine information spe-
traced to his seminal paper, published in 1920, on cific to their state.
time-relations in electrocardiograms (Roguin, 2011). Position papers are disseminated by professional
Landmark studies are the studies that led to an organizations and government agencies to promote a
important development or a turning point in the field particular viewpoint on a debatable issue. Position
of research. For example, researchers conducting papers, along with descriptions of clinical situations,
studies related to glycemic control must be knowl- may be included in the discussion of the background
edgeable of the implications of the Diabetes Control and significance of the research problem. A researcher
and Complications Trial, a longitudinal study whose developing a proposal on race-related differences in
findings changed diabetic care beginning in the mid- HIV treatment outcomes would want to review the
1990s (Everett, Bowes, & Kerr, 2010). Association of Nurses in AIDS Care position paper,
Literature is disseminated in several different “Health Disparities,” which the organization’s board
formats. Serials are published over time or may be approved in 2009.
in multiple volumes but do not necessarily have pre- Master’s theses and doctoral dissertations are valu-
dictable publication dates. Periodicals are subsets of able literature as well but may not be published. A
CHAPTER 6  Review of Relevant Literature 101

thesis is a research project completed as part of the estimate the time required on the basis of the number
requirements for a master’s degree. A dissertation of sources required and the reviewer’s familiarity with
is an extensive, usually original research project the library’s databases. The reviewer knows he or she
that is completed as the final requirement for a doc- needs at least 30 sources and that finding these sources
toral degree. Theses and dissertations can be found may require 10 hours of searching. The reviewer esti-
by searching special databases that are available for mates that it will take another 20 hours to read and
these publications, such as ProQuest Dissertations synthesize the sources. The reviewer estimates that the
and Theses (http://www.proquest.com/en-US/default review will require 30 hours. The reviewer should
.shtml/). then multiply that number by four, making the esti-
The published literature contains primary and sec- mated time required for the review 120 hours. This
ondary sources. A primary source is written by the longer estimate is often more realistic. As searching
person who originated, or is responsible for generat- skills are refined, the need to use this expanded esti-
ing, the ideas published. A research publication pub- mate reduces. Often, the literature review is limited by
lished by the person or people who conducted the the time that the reviewer can commit to the assign-
research is a primary source. A theoretical book or ment. The conclusion related to the time issue is to
paper written by the theorist who developed the start as early as possible and stay focused on the
theory or conceptual content is a primary source. A purpose of the review.
secondary source summarizes or quotes content
from primary sources. Thus, authors of secondary How Many Sources Do I Need to Review?
sources paraphrase the works of researchers and the- Students repeatedly ask, “How many articles should I
orists. The problem with a secondary source is that have? How far back in years should I look to find
its author has interpreted the works of someone else, relevant information?” The answer to both those ques-
and this interpretation is influenced by that author’s tions is an emphatic “It depends.” Course faculty for
perception and bias. Authors have sometimes spread masters courses commonly require that you obtain
errors and misinterpretations by using secondary full-text articles of all studies relevant to the variables
sources rather than primary sources. You should use in the proposed study that were published in the previ-
mostly primary sources to write literature reviews. ous 10 years. The instructors often indicate, however,
Secondary sources are used only if primary sources that the length of time may vary depending on the
cannot be located or if a secondary source contains topic and the presence of classic studies. Doctoral
creative ideas or a unique organization of informa- students are expected to conduct a more extensive
tion not found in a primary source. Citation is the review for course papers. If you are writing a research
act of quoting or paraphrasing a source, using it as an proposal for a thesis or dissertation, the literature
example, or presenting it as support for a position required will be extensive. You need to locate the key
taken. papers in the field of interest. After doing some initial
searches, discuss what you find with your instructor,
How Long Will the Review thesis chair, or dissertation chair, who will be able to
of the Literature Take? help you determine a reasonable publication period for
The time required to review the literature is influenced you to use in your review.
by the problem studied, sources available, and goals
of the reviewer. The literature review for a topic that Am I Expected to Read Every Word
is focused and somewhat narrow may require less time of the Available Sources?
than one for a topic that is broad. The difficulty you The answer is “No.” If researchers attempted to read
experience identifying and locating sources and the every word of every source that is somewhat related
number of sources to be located also influence the time to a selected problem, they would be well read but
involved, as does the intensity of effort. Only through would probably never complete their searches or
experience does one become knowledgeable about the move on to developing study proposals. Some indi-
time needed for a literature review. viduals, even after a thorough literature review, con-
The novice reviewer requires more time to find the tinue to believe that they do not know enough about
relevant literature than an experienced searcher, and their area of interest, so they persist in their review;
the novice frequently underestimates the time needed however, this activity ultimately becomes an excuse
for the review. An experienced librarian who works for not progressing with their work. The opposite of
closely with nursing graduate students on a variety of this situation is the individual who wants to move
course assignments recommends that the reviewer rapidly through the review of literature to reach the
102 UNIT TWO  The Research Process

conclusion or get to the part of the work that is more synthesis of your sources, you identify that the studies
enjoyable or important. you are citing were conducted only in Europe. You
With the availability of full-text online articles, the might go back and search the literature again using the
researcher can easily get “lost in the literature” and United States or another search term to ascertain that
forget the focus of the review. Becoming a skilled no studies have been done in that country. As you are
reviewer of the literature involves finding a balance writing your literature review, you may identify a
and learning to identify the most pertinent and relevant problem with the logic of your presentation. To resolve
sources. On the other hand, you cannot critically it, you may return to the processing stage to clarify the
appraise and synthesize what you have not read. Avoid presentation.
being distracted by nonrelevant information provided
by the author. Learn to read with a purpose and involve Searching the Literature
multiple senses in your reading. Try reading aloud a Before writing a literature review, you must first
section that you have difficulty understanding. Are perform literature searches to identify sources relevant
you having difficulty following an author’s presenta- to your topic of interest. The literature review will help
tion? Try writing an outline. Draw a diagram of key you narrow your topic and develop a feasible study
points. Audio record your thoughts on the content of (Hart, 2009). Whether you are a student, practicing
an article. Listen to soothing music if you are tense or nurse, or nurse researcher, your goal is to develop a
anxious. Listen to music with an upbeat tempo if you search strategy designed to retrieve as much of the
are tired and having trouble staying awake. Try reading relevant literature as possible given the time and finan-
in a quiet place outside or standing up with the copy cial constraints of your project.
of the article or your laptop on a counter or high table. Libraries have become gateways to information or
Involving multiple senses while reading may help you information resource centers, rather than storehouses
stay awake and focused. of knowledge (Hart, 2009). High-quality libraries
provide access to a large number of electronic data-
bases that supply a broad scope of the literature avail-
Stages of a Literature Review able internationally, enabling library users not only to
The stages of a literature review reflect a systems identify relevant sources quickly but also to read full-
model. Systems have input, throughput, and output. text versions of most of these sources immediately.
The input consists of the sources that you find through When your library does not have the hard copy of a
searching the literature. The throughput is the pro- book or electronic access to a specific journal, the
cesses you use to read, critically appraise, analyze, and librarian can usually provide the book or an electronic
synthesize the literature you find. The written litera- copy of the article through interlibrary loan. All librar-
ture review is the output of these processes (see Figure ies, public, private, college, and university, have inter-
6-1). The quality of the input and throughput will library loan capabilities. You may especially need to
determine the quality of the output. As a result, each use interlibrary loan when sources relevant to your
stage of the literature review is critical to producing a topic were published prior to the advent of electronic
high-quality literature review. Although these stages databases.
are presented here as sequential, you may go back to Consider consulting with an information profes-
a previous stage. For example, during the analysis and sional, such as a subject specialist librarian, to develop
a literature search approach (Booth, Colomb, & Wil-
liams, 2008; Tensen, 2010). Often these consultations
can be performed via email or a web-based meeting,
so that communication occurs at the convenience of
both the researcher and the information professional.
INPUT
THROUGHPUT
OUTPUT Many university libraries provide this consultation
Searching Writing the service whether or not the library user is affiliated with
Processing the
the Literature
Literature
Literature
Review
the university.

Develop a Search Plan


Before you begin searching the literature, you must
consider exactly what information you are seeking.
Expending time and effort in the early stage of a
Figure 6-1  Systems model of the review of the literature. review to develop a search strategy is likely to save
CHAPTER 6  Review of Relevant Literature 103

TABLE 6-2  Plan and Record for Searching the Literature


Search Strategy Number and Type Estimate of
Database Searched Date of Search and Limiters of Articles Found Relevant Articles
Cumulative Index to Nursing and
Allied Health Literature (CINAHL)
MEDLINE
Academic Search Premier
Cochrane Library

time and effort later (Hart, 2009). A written plan helps may have received paper copies of a monthly journal
you to avoid duplication of effort, to return to a previ- in the mail until 2006. The hard copies of the issues
ously searched area with a different set of search terms were bound to create annual volumes of the journal.
or a different range of publication years. Your initial Since 2006, the library has subscribed to the elec-
search should be based on the widest possible inter- tronic journal or a journal database that provides
pretation of your topic. This strategy enables you to access to specific issues.
envision the extent of the relevant literature. As you Bibliographical databases provided by the same
see the results of the initial searches and begin reading vendor, such as those databases affiliated with EBSCO
the material, you will refine your topic, and then you Publishing, allow you to search multiple databases
can narrow the focus of your searches. simultaneously to save time. Usually the search engine
As you search, add your selected search terms to will automatically delete duplicates of the same study.
your written search plan. As you search, add other You can also change the order in which the results of
terms that you discover from the references you locate. the search are shown. For example, with the EBSCO
For each search, record (1) the name of the database, Publishing databases, you can sort the citations by
(2) the date, (3) search terms and searching strategy, relevance, date descending (most current first), or date
(4) the number and types of articles found, and (5) an ascending (oldest to more recent).
estimate of the proportion of the citations you retrieved Older sources of reference indexes are useful for
that were relevant articles. Table 6-2 is an example of sources published prior to the electronic databases.
search history that you can use to record what and how Card catalogs, abstract reviews, and indexes were the
you have searched the literature. Save the results of only ways to search for nursing references until 1955,
each search on your computer or external device. when the Cumulative Index to Nursing and Allied
Some databases allow you to create an account and Health Literature (CINAHL) began being published.
save your search history online (i.e., the record of what Because the printed editions had red covers, you still
and how you searched). may hear more experienced scholars fondly refer to
“the Red Books.” The print version of CINAHL is still
Select Databases to Search available in libraries, and you may find it useful when
A database is computer data that have been collected searching for citations published before 1982 or when
and arranged to be searchable and automatically bibliographic databases are not available (Tensen,
retrievable (Tensen, 2010). A bibliographical data- 2010). In medicine, the Index Medicus (IM) was first
base is an “an electronic version of a bibliographic published in 1879 and is the oldest health-related
index” (p. 57) or compilation of citations. The data- index. The Index Medicus includes some citations of
base may consist of citations relevant to a specific nursing publications, with the number of nursing jour-
discipline or may be a broad collection of citations nals cited growing. CINAHL contains, however, a
from a variety of disciplines. Databases of periodical more extensive listing of nursing publications and
citations include the authors, title, journal, keywords, uses more nursing terminology as subject headings.
and usually an abstract of the article. Library data- With the greater focus on interdisciplinary research,
bases contain titles and authors of hard copy books nurse researchers must also be consumers of the litera-
and documents, government reports, and reference ture in the National Library of Medicine (MEDLINE),
books. Library databases also include a searchable list other government agencies, and professional organi-
of the journals to which the library has a paper or zations. Table 6-3 provides descriptions of commonly
electronic subscription. For example, your library used bibliographical databases.
104 UNIT TWO  The Research Process

TABLE 6-3  Bibliographical Databases


Name of Database Description of the Database by the Publisher*
Cumulative Index of Nursing and “Comprehensive source of full text for nursing & allied health journals, providing full
Allied Health Literature (CINAHL) text for more than 770 journals”
MEDLINE “Information on medicine, nursing, dentistry, veterinary medicine, the health care system,
pre-clinical sciences, and much more”
Created and provided by the National Library of Medicine
Uses Medical Subject Headings (MeSH terms) for indexing and searching of “citations
from over 4,800 current biomedical journals”
PubMed Free access to Medline that provides links to full-text articles when available
PsychARTICLES 15,000 “full-text, peer-reviewed scholarly and scientific articles in psychology”
Limited to journals published by the American Psychological Association (APA) and
affiliated organizations
PsychINFO “Scholarly journal articles, book chapters, books, and dissertations, is the largest resource
devoted to peer-reviewed literature in behavioral science and mental health”
Supported by APA
Covers over 3 million records
Academic Search Complete “Comprehensive scholarly, multi-disciplinary full-text database, with more than 8,500
full-text periodicals, including more than 7,300 peer-reviewed journals”
Health Source Nursing/ Academic “Provides nearly 550 scholarly full text journals focusing on many medical disciplines”
Edition Also includes 1,300 patient education sheets for generic drugs
Psychological and Behavioral “Comprehensive database covering information concerning topics in emotional and
Sciences Collection behavioral characteristics, psychiatry & psychology, mental processes, anthropology,
and observational & experimental methods”
400 journals indexed

*Direct quotations from EBSCO Publishing descriptions of the databases, available at http://www.ebscohost.com/academic/.

Search Strategies A simple way to begin identifying a database’s


standardized subject terms is to search using one of
Keywords your keywords and display full records of a few rel-
Keywords are the everyday words and phrases used evant citations. The records are the descriptions of the
for the major concepts or variables that must be articles, not the articles themselves. The subject terms
included in your computer search (Tensen, 2010). To linked to that article are listed on the full record.
determine keywords, identify the concepts relevant to Examine the terminology used to describe these arti-
your study. Ascertain the populations that are of par- cles, and use the terms in additional refined searches.
ticular interest in your area of study or the specific Frequently, word-processing programs, dictionaries,
interventions, measurement methods, or outcomes and encyclopedias are helpful in identifying synony-
that are relevant. These databases have a thesaurus mous terms and subheadings. A combination of both
that the researcher, as well as anyone who reads an keywords and formal subjects most often retrieves
article, can use as keyword search terms. By logging better search results.
on to the database, you can access the thesaurus to The format and spelling of search terms can yield
select relevant terms. The formal subject terms different results. Truncating words can allow you to
included in the thesaurus may encompass a number of locate more citations related to that term. For example,
the terms that you have identified and allow you to authors might have used intervene, intervenes, inter-
expand your search to obtain more references or to vened, intervening, intervention, or intervenor. To
focus your search to be more specific to your interest. capture all of these terms, you can use a truncated term
This expansion or focus occurs because someone who in your search, such as interven, interven*, or inter-
has already read the articles has grouped and linked ven$. The form or symbol used to truncate a search
all citations with similar concepts together. term depends on the rule of the search engine being
CHAPTER 6  Review of Relevant Literature 105

used. Avoid shortening a search word to fewer than


Coping OR Social Support
four letters. Otherwise, you will get far too many 5855 citations
unwanted citations. Also, pay attention to variant
spellings. You may need to search, for example, by Coping Social Support
orthopedic or orthopaedic (British spelling). Consider 3578 citations Coping 2688 citations
AND
irregular plurals, such as woman and women. Social
Support
Authors 409
If an author is cited frequently, you can perform a citations
search using the author’s name. In this case, you
should identify the name as an author term, not a
keyword term. Recognize that some databases list Figure 6-2  Example of search using social support and coping with
authors only under first and middle initials, whereas different Boolean operators.
others use full first names. Identifying and using cita-
tions to seminal studies in various citation indexes or of searches using coping and social support as key-
full-text databases can lead you to other, more current words alone and with Boolean operators.
works that have also cited the seminal studies as refer- Locational operators (field labels) identify terms
ences. Web of Knowledge, a database developed from in specific areas or fields of a record. These fields
the Science Citation Index and the Social Science may be parts of the simple citation, such as the article
Citation Index, focuses on the relationships among title, author, and journal name, or they may be from
these citations. These indexes may require that your additional fields provided by the database, such as
library subscribe to their services, however, Web of subject headings, abstracts, cited references, publica-
Knowledge does have a Facebook page (http:// tion type notes, instruments used, and even the entire
www.facebook.com/pages/Web-of-Knowledge/11968 article. In some databases, these specific fields can be
7984715358/). Several other databases, depending on selected by means of a drop-down menu in the data-
the vendor, may also have a function to search the base input area. In other databases, specific coding
references of articles. can be used to do the same thing. Do not assume that
the entire article is being searched when you are
Complex Searches using the default search; the default is usually looking
A complex search of the literature combines two or for your terms in the title, abstract, and/or subject
more concepts or synonyms in one search. There are fields. You may choose to search for a concept only
several ways to arrange terms in a database search within the abstract of articles, on the basis of the
phrase or phrases. The three most common ways are logic that this strategy is less restrictive than search-
by using (1) Boolean operators, (2) locational opera- ing for the concept only in article titles but more
tors (field labels), and (3) positional operators. Opera- restrictive than searching for the concept in all the
tors permit you to group ideas, select places to search text of the article.
in a database record, and show relationships within a Positional operators are used to look for requested
database record, sentence, or paragraph. Examine the terms within certain distances of one another. Avail-
Help screen of a database carefully to determine ability and phrasing of positional operators are highly
whether the operators you want to use are available dependent on the database search software. Common
and how they are used. positional operators are NEAR, WITH, and ADJ; they
The Boolean operators are the three words AND, also are often required to be capitalized and may have
OR, and NOT. Often they must be capitalized. The numbers associated with them. A positional operator
Boolean operators AND and NOT are used with your is most useful in records with a large amount of infor-
identified concepts. Use AND when you want to mation, such as those with full-text articles attached,
search for the presence of two or more terms in the and is often used with locational operators, either in
same citation. Use NOT when you want to search for an implied way or explicitly. For example, ADJ is an
one idea but not another in the same citation. NOT is abbreviation for adjacent; it specifies that one term
rarely used because it is too easy to lose good cita- must be adjacent to another in the order entered.
tions. The Boolean operator OR is most useful with “ADJ2” commands that there must be no more than
synonymous terms or concepts. Use OR when you two intervening words between the search terms in the
want to search for the presence of any of a group of order entered. NEAR does not define the specific order
terms in the same search. Figure 6-2 shows the results of the terms; the command “term1 NEAR1 term2”
106 UNIT TWO  The Research Process

TABLE 6-4  Selected Internet-Only Nursing Journals


Journal URL
Online Journal of Issues in Nursing http://nursingworld.org/MainMenuCategories/ANAMarketplace/
ANAPeriodicals/OJIN.aspx/
Internet Journal of Advanced Nursing Practice http://www.ispub.com/journal/the_internet_journal_of_advanced_nursing_
practice.html/
Australian Electronic Journal of Nursing Education http://www.scu.edu.au/schools/nhcp/aejne/
CONNECT: The World of Critical Care Nursing http://en.connectpublishing.org/
Open Nursing Journal http://www.benthamscience.com/open/tonursj/
International Journal of Nursing http://www.ijnonline.com/index.php/ijn/index/

requires that the first term occur first and within two databases, and you can access full-text articles from
words of the second term. WITH often indicates that an electronic journal through the database. However,
the terms must be within the same sentence, para- many electronic journals are not yet in the biblio-
graph, or region (such as subject headings) of the graphical databases or may not be in the database you
record. are using. Ingenta Connect (www.ingenta.com) is a
commercial website that allows you to search more
Limiting Your Search than 13,000 publications from many disciplines. Pub-
You can use several strategies to limit your search if, lications available through Ingenta include those that
after performing Boolean searches, you continue to are free to download and those that require the reader
get too many hits. The limits you can impose vary with to buy the article.
the database. In CINAHL, for example, you may limit Metasearch engines, such as Google, allow you to
your search to English-language articles. You can also search the Internet. Google Scholar is a specialized
limit the years of your search. For example, you might tool that allows you to focus your search on research
choose to limit the search to articles published in the and theoretical publications. With the exception of
past 10 years. Searches can be limited to find only articles in online-only journals, scholarly sources are
papers that are research, are reviews, are published in published first in traditional formats. Thus, what you
consumer health journals, include abstracts, or are find online will be older references. Especially early
available in full text. You may also narrow your search in your search, these older articles may point you to
by adding your population or intervention to the search seminal and landmark studies or help you identify
strategy. subject terms for new searches. Government reports
and publications by professional organizations may
Searching the Internet also be found by searching the Internet. Prior to using
A number of nursing journals are published only in a reference from the Internet, you must evaluate the
electronic form. Table 6-4 contains selected online reliability of the information and the potential for bias
nursing journals with their URLs. Because of the high on the part of the author. There is no screening process
costs of publishing and distributing a printed journal, for information placed on the World Wide Web. Thus,
a publishing company risks losing money unless there you find a considerable amount of misinformation as
is a large market for the journal. Most of the electronic well as some “gems” you might not find elsewhere. It
journals are targeted to relatively small specialty audi- is important to check the source of any information
ences. These journals may have more current informa- you obtain from the Web so that you can judge its
tion on your topic than you will find in traditional validity.
journals, because articles submitted by authors to
online journals are reviewed and published within 3 Locate Relevant Literature
to 4 months. Articles submitted to printed journals are Within each database, conduct your search of relevant
usually under review for an extended time and, if literature using the strategies described in this chapter.
accepted, may not be seen in print for over a year. Most databases provide abstracts of the articles in
Faculty members at some universities have estab- which the term is cited, allowing you to get some
lished online journals in a particular specialty area. In sense of their content so you may judge whether the
some cases, you may have to subscribe to the online information is useful in relation to your selected topic.
journal to gain access to the articles. Some electronic If you find the information to be an important refer-
journals are listed in available bibliographical ence, save it to a file on your computer or in an online
CHAPTER 6  Review of Relevant Literature 107

folder maintained by your employer or university, and/ line is on the left margin and subsequent lines are
or move it to a reference management program (next indented. If you do not know how to format a paragraph
section). At this point in the process, do not try to this way, search the Help tool in your word-processing
examine all of the citations listed. program to find the correct command to use. When you
It is rarely, if ever, possible to identify every rele- retrieve an electronic source in portable document
vant source in the literature. The most extensive format (pdf), you cite the source the same as if you had
retrievals of literature are funded literature review made a copy of the print version of the article. When
projects focused on defining evidence-based practice you retrieve an electronic source in html format, you
or developing clinical practice guidelines (see Chapter will not have page numbers for the citation. The
19). In these projects, a literature review coordinator updated APA standard is to provide the URL for the
manages the literature review process. The project home page of the journal from which the reader could
employs several full-time, experienced, professional navigate and find the source (APA, 2010). Providing
librarians as literature searchers. When these extensive the URL that you used to retrieve the article is not
literature reviews are completed, the results are pub- helpful because it is unique to the path you used to find
lished so that you may have access to them and to the the article and reflects your search engines and biblio-
citations from the review, either on the Internet or in graphical databases. The following are examples for
journal articles. citing different types of articles:
Citation for the print copy or electronic pdf copy of
Systematically Record References an article:
The bibliographical information on a source should be Everett, J., Bowes, A., & Kerr, D. (2010). Barriers to
recorded in a systematic manner, according to the achieving glycaemic control in CSII. Journal of
format that you will use in the reference list. The Diabetes Nursing, 14(5), 176-181. doi:10.1177/
purpose for carefully citing sources is that readers can 1043659609357635.
retrieve the reference for themselves, confirm your Online full-text version of an article for which pdf was
interpretation of the findings, and gather additional not available:
information on the topic. Many journals and academic Scott, A. J., & Wilson, R. F. (2011). Social determi-
institutions use the format developed by the American nants of health among African Americans in a rural
Psychological Association (APA) (2010). Computer- community in the Deep South: An ecological study.
ized lists of sources usually contain complete citations Rural and Remote Health, 11, 1634 (Online).
for references and should be saved electronically so Retrieved from http://www.rrh.org.au/
you can access complete reference citations. The 6th
edition of the APA’s Publication Manual (2010) pro- Use Reference Management Software
vides revised guidelines for citing electronic sources Reference management software can make tracking
and direct quotations from electronic sources. Citing the references you have obtained through your searches
direct quotations from electronic sources has posed considerably easier. You can use such software to
unique challenges. The APA standard for direct quota- conduct searches and to store the information on all
tions from a print source is to cite the page of the search fields for each reference obtained in a search,
source on which the quotation appears. The reference including the abstract. Within the software, you can
lists in this text are presented in APA format, with the store articles in folders with other similar articles. For
exceptions that we have not included digital object example, you may have a folder for theory sources,
identifiers (DOIs) and have slightly modified the cita- another for methodological sources, and a third for
tion of multiple authors. relevant research topics. When you export search
DOIs have become the standard for the International results from the bibliographic database to your refer-
Standards Organization (http://www.doi.org/) but have ence management software, all of the needed citation
not yet received universal support. The use of DOIs information and the abstract are readily available to
seems to be gaining in credibility because the DOI you electronically when you write the literature
“provides a means of persistent identification for man- review. As you read the articles, you can also insert
aging information on digital networks” (APA, 2010, comments into the reference file about each one.
p. 188). CrossRef is an example of a registration agency Reference management software has been devel-
for DOIs that enables citations to be linked across oped to interface directly with the most commonly
databases and disciplines (http://www.crossref.org/). used word processing software to organize the refer-
Each citation on the reference list is formatted as a ence information using whatever citation style you
paragraph with a hanging indent, meaning that the first stipulate. You may be familiar with APA format but
108 UNIT TWO  The Research Process

want to submit a manuscript to a journal that uses essential to the development of a high-quality litera-
another bibliographical style. Within these reference ture review.
management programs, you can generate the reference
list or bibliography in the format specific to the journal. Reading
You can insert citations into your paper with just a Skimming a source is quickly reviewing a source to
keystroke or two. The four most commonly used soft- gain a broad overview of its content. You would prob-
ware packages, along with websites that contain infor- ably read the title, the author’s name, and an abstract
mation about them, are as follows: or introduction for the source. Then you would read
EndNote (http://www.endnote.com/) has an inclusive the major headings and sometimes one or two sen-
format that is compatible with Windows and Mac tences under each heading. Finally, you would review
computers. the conclusion or summary. Skimming enables you to
RefWorks (www.refworks.com/) operates from the make a preliminary judgment about the value of a
Web and can be accessed free by some universities’ source and to determine whether it is a primary or
affiliates depending on the license. secondary source. Secondary sources are reviewed
Reference Manager (http://www.refman.com/) oper- and used to locate cited primary sources, but they are
ates on your personal computer or you can use it seldom cited in a research proposal or report.
to make your databases accessible to others in a Comprehending a source requires that you read
Web environment. all of it carefully. Focus on understanding major con-
Bookends (http://www.sonnysoftware.com/) is refer- cepts and the logical flow of ideas within the source.
ence manager for Mac users that allows users to Highlight the content you consider important or make
search bibliographical databases and download notes in the margins. Notes might be recorded on
citations and full-text articles. Searches can also be photocopies or electronic files of articles, indicating
downloaded from iPhone, iTouch, and iPad. where the information will be used in developing a
research proposal. The kind of information you high-
Saved Searches and Alerts light or note in the margins of a source depends on the
If you are working on a research project in which the type of study or source. The information highlighted
literature review may take months or are engaged in a on theoretical sources might include relevant con-
field of study that will interest you for years, you cepts, definitions of those concepts, and relationships
might want to repeat the same search regularly. Many among them. The notes recorded in the margins of
databases permit you to create an account where you empirical literature might include relevant informa-
can save your search strategy so you can redo the same tion about the researcher, such as whether the author
search with just a few clicks and without having to is a major researcher of a selected problem and com-
enter the entire strategy again. You might want to have parisons with other studies this individual has con-
just the new updates of a search strategy sent to you ducted. For a research article, the research problem,
automatically by email without having to redo the purpose, framework, major variables, study design,
entire search, even though this redo now entails just a sample size, data collection, analysis techniques, and
few clicks. These Saved Search and Alert features may findings are usually highlighted. You may wish to
be available in your favorite databases. However, record quotations (including page numbers) that might
review your saved and alert strategies with some regu- be used in a review of literature section. The decision
larity to ensure you are obtaining what you really to use or paraphrase these quotes can be made later.
desire. Many journals also permit a table of contents You might also record creative ideas about content
to be sent to you automatically when new issues come that develop while you are reading a source. At this
out. Examine the database or journal home page help point, you will identify relevant categories for sorting
screens to determine how to create and use these and organizing sources. These categories will ulti-
features. mately guide you in writing the review of literature
section, and some may even be major headings in this
review.
Processing the Literature
Reading and critically appraising sources promote Appraising and Analyzing Sources
understanding of the current knowledge of a research Through analysis, you can determine the value of a
problem. It involves skimming, comprehending, ana- source for a particular study. Analysis must take place
lyzing, and synthesizing content from sources. Skills in two stages. The first stage involves the critical
in reading and critically appraising sources are appraisal of individual studies. The process of
CHAPTER 6  Review of Relevant Literature 109

TABLE 6-5  Literature Summary Table


Author and Year Purpose Framework Sample Measurement Treatment Results Findings

appraising individual studies, including the steps, is and arrange them into some type of format that
detailed in Chapter 18. During the critical appraisal, requires you to become familiar with key concepts
relevant content is clearly identified in the articles and (Hart, 2009). The map may connect studies with
sources are sorted into a sophisticated system of similar methodologies or key ideas.
categories. The second stage of analysis involves making com-
Conducting an analysis of sources to be used in a parisons among studies. This analysis allows you to
research proposal requires some knowledge of the critically appraise the existing body of knowledge in
subject to be critiqued, some knowledge of the research relation to the research problem. You will be able to
process, and the ability to exercise judgment in evalu- determine (1) theoretical formulations that have been
ation (Pinch, 1995, 2011). However, the critical used to explain how the variables in the problem influ-
appraisal of individual studies is only the first step in ence one another, (2) what methodologies have been
developing an adequate review of the literature. Any used to study the problem, (3) the methodological
written literature review that simply appraises indi- flaws in previous studies, (4) what is known about the
vidual studies paragraph by paragraph is inadequate. problem, and (5) what the most critical gaps in the
A literature review that is a series of paragraphs, in knowledge base are. The information gathered by
which each paragraph is a description of a single study using the table format shown in Table 6-5 or displayed
with no link to other studies being reviewed, does in a conceptual map can be useful in making these
not provide evidence of adequate analysis of the comparisons. Various studies addressing a research
literature. problem have approached the examination of the
Analysis requires manipulation of what you are problem from different perspectives. They may have
finding, literally making it your own (Garrard, 2011). organized the study from different theoretical perspec-
Pinch (1995) was the first nurse to publish a strategy tives, asked different questions related to the problem,
to synthesize research findings using a literature selected different variables, or used different designs.
summary table. We modified this table by adding two Pay special attention to conflicting findings as they
columns that are useful in sorting information from may provide clues for gaps in knowledge that repre-
studies into categories for analysis (see Table 6-5). In sent researchable problems.
2001, Pinch published a modified table to use in trans-
lating research findings into clinical innovations. Hart Sorting Your Sources
(2009) provides examples of table formats that may Relevant sources (theoretical and empirical) are orga-
be helpful at different points during the review. The nized for inclusion in the different chapters of the
reference management software may allow you to research proposal. The sources to be included in the
generate these tables from information you record review of literature chapter are organized to reflect
about each study. the current knowledge about the research problem.
Another way to manipulate the information you Those sources that provide background and signifi-
have retrieved and transform it into knowledge is cance for the study are included in the introduction
mapping (Hart, 2009). Nurse educators teach concep- chapter. Certain theoretical sources establish the
tual mapping to their students to encourage students framework for the study. Other relevant sources
to make connections among facts and principles that become the basis for defining research variables and
they are learning (Vacek, 2009). The same strategy identifying assumptions and limitations. Content
applied to a literature review is to classify the sources from methodologically strong studies is used to direct
110 UNIT TWO  The Research Process

Claim Reason 1 Reason 2 Reason 3 Conclusion

Evidence 1 Evidence 2 Evidence 3

Figure 6-3  Building the logical argument. (Adapted from W. C. Booth, G. G. Colomb, & J. M. Williams [2008]. The craft of research [3rd ed.]. Chicago,
IL: University of Chicago Press.)

the development of the research design, guide the intervention. The following outline could be devel-
selection of measurement methods, influence data col- oped for this argument.
lection and analysis, and provide a basis for interpreta- Claim 1: Interventions to promote medication adher-
tion of finding. (Refer back to Table 6-1 to review ence must incorporate the hypertensive patient’s
contributions of the literature to each part of the perspective.
research process.) Reason 1: Provider-focused interventions have not
resulted in long-term improvement in medica-
Synthesizing Sources tion adherence.
Synthesis of sources involves clarifying the meaning Evidence 1: Description of studies of provider-
obtained from the sources as a whole in the review of focused interventions and their outcomes
the literature section of your proposal. “Integration is Reason 2: Patients who do not adhere to an exter-
making connections between ideas, theories, and nally imposed medication regimen (the target
experience” (Hart, 2009, p. 8).Through synthesis and population) may be less likely to use an inter-
integration, one can cluster and connect ideas from vention that is externally imposed.
several sources to develop a personal overall view of Evidence 2: Description of studies in which patients
the topic. Garrard (2011) describes this personal level failed to return for appointments during a trial
of knowledge as ownership, as “being so familiar with of an electronic device to promote adherence
what has been written by previous researchers that you Reason 3: Medication adherence requires behavior
know clearly how this area of research has progressed change that must be incorporated into the
over time and across ideas” (p. 7). Synthesis is the key patient’s life.
to the next step of the review process, which is devel- Evidence 3: Theoretical principles of behavior
oping the logical argument that supports the research change that recommend individualization of
problem you intend to address. Booth et al. (2008) interventions to meet unique patient needs
details the process of constructing the argument as Conclusion 1: Using a participatory approach to
beginning with stating a claim and the supporting develop individual strategies for promoting med-
reasons. The reviewer must also include adequate ication adherence is an important first step to
information so that the reader agrees that the reasons improving patient outcomes.
are relevant to the claim. For each reason, the reviewer
provides evidence to support the reasons. Thinking at
this level and depth prepares you for outlining the
written review. Figure 6-3 provides a visual represen- Writing the Review of Literature
tation of an argument that can be developed through
a written review. The writer/reviewer supports each Writing Suggestions
claim with evidence so that the reader can accept the Clarity and cohesion are characteristics of scholarly
conclusion the reviewer has made. For example, the writing. If you have followed the steps for reviewing
reviewer has synthesized several sources related to the literature in this chapter, you want to demonstrate
medication adherence and is presenting the argument your synthesis and ownership of the literature by
for developing patient-focused medication adherence clearly presenting your argument. Rather than using
CHAPTER 6  Review of Relevant Literature 111

direct quotes from an author, you should paraphrase in this section what you will and will not cover. If
his or her ideas. Paraphrasing involves expressing the you are taking a particular position or developing a
ideas clearly and in your own words. The meanings of logical argument for a particular perspective on the
these sources are then connected to the proposed basis of the literature, make this position clear in the
study. Last, the reviewer combines, or clusters, the introduction.
meanings obtained from all sources to determine the
current knowledge of the research problem (Pinch, Discussion of Theoretical Literature
1995, 2001). Reviews that lack clarity and cohesion The theoretical literature section contains concept
reflect deficits in synthesis more than deficits in written analyses, models, theories, and conceptual frame-
abilities. works that support the research purpose. Concepts,
Start each paragraph with a theme sentence that definitions of concepts, relationships among concepts,
describes the main idea of the paragraph or makes a and assumptions are presented and analyzed to build
claim. Present the relevant studies as evidence of the a theoretical knowledge base for the study. This
main idea or claim and end the paragraph with a con- section of the literature review is sometimes used to
cluding sentence that transitions to the next claim. present the framework for the study and may include
Each paragraph can be compared to a train with an a conceptual map that synthesizes the theoretical lit-
engine (theme sentence), linked cargo cars (sentences erature (see Chapter 7 for more detail on developing
with evidence), and a caboose (summary sentence frameworks).
linking to next paragraph).
Discussion of Empirical Literature
Organization of Written Reviews The presentation of empirical literature should be
The readability and flow of a literature review are organized by concepts or organizing topics. In the
determined by its structure (Cronin, Ryan, & Cough- past, the researcher was expected to present the
lan, 2008). A review of the literature can be organized purpose, sample size, design, and specific findings for
as series of claims with supporting reasons and claims each study reviewed with a scholarly but brief critique
(Booth et al., 2009) or it can be organized according of the study’s strengths and weaknesses, This approach
to the research framework. Theories supporting the is expected less commonly now. Use the synthesis and
research framework may be presented in the first key ideas related to each concept that you developed
section. This then allows the writer/reviewer to use the in the previous stage of the review to organize this
framework as an outline for the section on empirical section. In addition to the synthesis, you want to incor-
literature. In the section on empirical literature, sub- porate the strengths and weaknesses of the overall
heading can identify each concept. Then in these sub- body of knowledge rather than a detailed presentation
sections, studies most relevant to that concept can be and critical appraisal of each study. The findings from
discussed. The availability of studies will directly the studies should logically build on each other so that
affect the length of the literature review. In newer the reader can see how the body of knowledge in the
areas of research, you may not have as many sources research area evolved.
per concept. Evidence from multiple studies is combined to
The purpose of the written literature review is to reveal the current state of knowledge in relation to a
establish a context for your study. The literature review particular concept or study focus (topic area). Con-
for a study may have four major sections: (1) the flicting findings and areas of uncertainty are explored.
introduction, (2) a discussion of theoretical literature, Similarities and differences in the studies should be
(3) a discussion of empirical literature, and (4) a identified. Gaps and areas needing more research are
summary. The introduction and summary are standard discussed. A summary of findings in the topic area is
sections, but you will want to organize the discussion presented, along with inferences, generalizations, and
of sources in a way that makes sense for the topic. You conclusions you have drawn from your review of the
may organize the discussion by themes, your logical literature. A conclusion is a statement about the state
argument, or your research framework. of knowledge in relation to the topic area. This should
include a discussion of the strength of evidence avail-
Introduction able for each conclusion.
The introduction to the literature review indicates the The reviewer who becomes committed to a particu-
focus or purpose of the study, identifies the purpose lar viewpoint on the research topic must maintain the
of the literature review, and presents the organiza- ethical standard of intellectual honesty. The content
tional structure of the review. You should make clear from reviewed sources should be presented honestly,
112 UNIT TWO  The Research Process

not distorted to support the selected problem. Research- TABLE 6-6  Characteristics of High-Quality
ers frequently read a study and wish that the author Literature Reviews
had studied a slightly different problem or that the
study had been designed or conducted differently. Criteria Guiding Questions
However, the reviewers must recognize their own Coverage Did the writer provide evidence of having
opinions and must be objective in presenting reviewed sufficient literature on the
information. topic?
Does the review indicate that the writer is
The defects of a study need to be addressed, but it
sufficiently well informed about the topic
is not necessary to be highly critical of another and has identified relevant studies?
researcher’s work. The criticisms must focus on the Understanding Does the written review indicate that the
content that is in some way relevant to the proposed writer has understood and synthesized
study and to be stated as possible or plausible explana- what is being studied?
tions, so that the criticisms are more neutral and schol- Have similarities and differences of what
arly than negative and blaming. was found been described?
Coherence Does the writer make a logical argument
Summary related to the significance of the topic
The summary consists of a concise presentation of the and the gap to be addressed by the
proposed study?
current knowledge base for the research problem.
Accuracy Does the writer’s attention to detail give the
Other literature reviews conducted in relation to your reader confidence in the conclusions of
field of research should be discussed. The gaps in the the review?
knowledge base are identified, with a discussion of
how the proposed study will contribute to the develop-
ment of knowledge in the defined field of research.
The summary concludes with a statement of how your
study will contribute to the body of knowledge in this Box 6-1 Checking to Avoid Common
field of research. Reference Citation Errors
Does every direct quotation have a citation
Refining the Written Review that includes the author’s name, year, and
You complete the first draft of your review of the lit- page number?
erature and breathe a sigh of relief before moving onto Are authors’ names spelled the same way in
the next portion of the research proposal. Before the text and in the reference list?
moving on, you need to read, review, and refine your Are the years on citations in the text the same
review. Set the review aside for 24 hours and then read as the years for the reference on the
it aloud. You may identify awkward sentences in this reference list?
way that you might overlook when reading the review Are the citations on the reference list
silently. Ask a fellow student or trusted colleague to complete so that the reference can be
read the review and provide constructive feedback. retrieved?
Use the criteria and guiding questions in Table 6-6 to Does every source cited in the text have a
evaluate your literature review. corresponding citation on the reference list?
Is every reference on the reference list cited in
Checking References the text?
Sources that will be cited in a paper or recorded in a
reference list should be cross-checked two or three
times to prevent errors. Questions that will identify
common errors are displayed in Box 6-1. To prevent reduces some errors but does not eliminate all of
these errors, check all the citations within the text of them. Use your knowledge and skills to enhance your
your literature review and each citation in your refer- technology use; relying on technology alone will not
ence list. Typing or keyboarding errors may result in create a quality manuscript.
inaccurate information. You may omit some informa-
tion, planning to complete the reference later, and then
forget to do so. Downloading citations from a database Example of a Literature Review
directly into a reference management system and An excerpt from the literature review of the research
using the system’s manuscript formatting functions report of a quasi-experimental study is provided here
CHAPTER 6  Review of Relevant Literature 113

“When comfort is enhanced, patients are better able to their mind represents more than well-being; it also rep-
be successful in their health-seeking behaviors (HSBs). resents well-thinking. On the contrary, feeling sadness
Scholtfeldt (1975) included internal behaviors and exter- is associated not only with sickliness but also with an
nal behaviors in her definition of HSBs, and both of these inefficient way of thinking, concentrated around a
behaviors are incorporated into Comfort Theory. limited number of ideas of loss (Damásio, 2004).
Therefore, it was hypothesized that increased comfort “In GI, positive mental images and positive affective
would lead to a reduction in anxiety, stress, and experiences can counteract the depression rumination
depression. spiral (Folkman & Moskowitz, 2000). This process
works as an adaptive alternative to decompensation,
Guided Imagery (GI) raising the mood, and relieving depressive symptoms.
“In the context of this study, GI is defined as the use of Therefore, GI contributes to antirumination strategies
the imagination to bring about positive mind/body that, as Nolen-Hoeksema (1991, 2000) states, are debil-
responses (Rossman, 2000). It is a cognitive process that itating. Positive mental images have a relaxing effect and,
evokes and uses many senses: sight, sound, smell, taste, consequently, a psychophysiologic and cognitive effect
and touch and also the senses of movement. All of these (Singer, 2006). When depressed individuals have access
senses together produce regenerative changes in the to positive mental images and to a state of body relax-
mind and body (Achterberg, 1985). GI is a program of ation, they are able to reorient their thoughts away from
instructions meant to help people acquire a state of unpleasant stimuli. Thus, positive thoughts contribute to
psychological and physiological ease through muscular an improvement in feelings about oneself and the world.
relaxation and positive mental images, relieving the “Results from the empirical literature indicated that
discomforts provoked by symptoms associated with GI was effective in improving mood states in individuals
mood disorders (Apóstolo, 2007). Increasing adaptive with a variety of illnesses. Sloman (2002) conducted a
responses in depressive individuals requires replacing community-based nursing study in 56 people with
the negative processes of thinking with a more positive advanced cancer. Progressive muscle relaxation and GI
cognitive style (Achterberg, 1985; Rossman, 2000). GI training revealed significant decreases in depression.
is a complementary nursing intervention that can be Campbell-Gillies (2004) used a program including posi-
implemented in addition to other therapeutic approaches tive mental images and music with 45 women with
to mood disorders. Studies show that focusing the imag- breast cancer. Her findings revealed that GI decreased
ination in a positive way can result in a state of ease, depression and anxiety over a six-cycle period of che-
encouragement, and mood regulation, all of which allow motherapy. McKinney, Antoni, Kumar, Times, and
the patient to reestablish a state of physical and mental McCabe (1997) used GI combined with music with 28
health (Rossman, 2000). healthy adults and reported significant decreases in
depression, fatigue, and total mood disorders between
Guided Imagery and Depression pretest and posttest sessions. Identical outcomes were
“Currently, it is thought that good body functioning is revealed in the study of Watanabe et al. (2006), with a
accompanied by positive thoughts, whereas pathological sample of 148 healthy adults, using relaxation and posi-
body functioning is accompanied by negative and repeti- tive mental images. After two sessions, positive mood
tive thoughts (Damásio, 2004). In the brain, a thought, increased, and negative mood decreased. Finally, in an
idea, or mental image work as “emotionally competent experimental design, Kolcaba and Fox (1999) assessed
stimuli.” These stimuli, whether prescribed by biologic the effects of GI for increasing comfort over time in
evolution or learned have the capacity to produce patients with breast cancer going through radiation
certain patterns of homeostasis. The state of sadness is therapy. However, no experimental studies have been
accompanied by a reduced number of positive mental conducted for patients in a psychiatric context to
images and by more excessive attention to those images. increase their comfort.” (Apostolo & Kolcaba, 2009, pp.
When persons have the experience of positive thoughts, 404-405)
114 UNIT TWO  The Research Process

as an example of a review of the literature. Apóstolo • Processing the literature requires the researcher to
and Kolcaba (2009) conducted a study to determine read the sources to be able to critically appraise,
the effect of guided imagery on comfort, depression, analyze, and synthesize the information that has
anxiety, and stress among 60 hospitalized mental been retrieved.
health patients. The researchers began the review with • A thorough, organized literature review facilitates
a presentation of Kolcaba’s comfort theory, and then the development of a research proposal.
linked that theory to guided imagery and depression. • The well-written literature review presents a logical
The guided imagery treatment group showed sta- argument for why the research question should
tistically significant improvement in their depression, be studied and in the specific way that is being
anxiety, stress, and sense of comfort. Their results proposed.
were compared with those in a matched control group.
Apóstolo and Kolcaba (2009) indicated that GI was
an effective intervention, supporting their findings REFERENCES
with links back to their review of the literature. The Achterberg, J. (1985). Imagery in healing: Shamanism and modern
strengths of the study were the use of matched controls medicine. Boston: Shambhala.
that supported internal validity and the implementa- American Psychological Association (2010). Publication manual of
the American Psychological Association (6th ed.). Washington,
tion of the study in three clinical facilities that sup-
DC: Author.
ported the external validity of the study. Apóstolo, J. L. A. (2007). O imaginário conduzido no conforto de
doentes em contexto psiquiátrico. Doctoral Dissertation. Porto,
PT: Porto University.
KEY POINTS Apóstolo, J. L. A., & Kolcaba, K. (2009). The effects of guided
imagery on comfort, depression, anxiety, and stress of psychiatric
• Reviewing the existing literature related to your inpatients with depressive disorders. Archives of Psychiatric
study is a critical step in the research process. Nursing, 23(6), 403–411.
• A literature review is a written logical presentation Association of Nurses in AIDS Care (2009). Position statement:
of knowledge gained from reading and analyzing Health disparities. Retrieved from http://www.proquest.com/
en-US/default.shtml/.
selected articles, books, conference proceedings,
Bachrach, S. (2001). Scientific journals of the future. In R. S. Berry
and other sources. & A. S. Moffat (Eds.), The transition from paper: Where are we
• Information from the literature guides the develop- going and how will we get there? Cambridge, MA: American
ment and implementation of quantitative studies Academy of Arts & Sciences. Online report. Retrieved from
and is incorporated throughout the research http://www.amacad.org/publications/trans.aspx/.
proposal. Booth, W. C., Colomb, G. G., & Williams, J. M. (2008). The craft
• With use of a systems approach, the three major of research (3rd ed.). Chicago, IL: University of Chicago Press.
stages of a literature review are searching the litera- Campbell-Gillies, L. (2004). Guided imagery as treatment for
ture (input), processing the literature (throughput), anxiety and depression in breast cancer patients: A pilot study
and writing the literature review (output). [Online]. A dissertation submitted in partial fulfillment of the
requirements for the degree of M.A. Psychology. Rand Afrikaans
• The literature consists of all written sources rele-
University. Retrieved from http://etd.rau.ac.za/theses/available/
vant to the topic you have selected. etd-10062004-095533/restricted/GIreviseddissert2003130304.
• Two types of literature are predominantly used in pdf/.
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empirical. ture review: A step-by-step approach. British Journal of Nursing,
• Theoretical literature consists of concept analyses, 17(1), 38–43.
models, theories, and conceptual frameworks that Damásio, A. R. (2004). Ao encontro de Espinosa. As Emoções e a
support a selected research problem and purpose. neurologia do sentir (6th ed.). Mem Martins: Publicações
• Empirical literature comprises relevant studies Europa-América.
in journals and books as well as unpublished Everett, J., Bowes, A., & Kerr, D. (2010). Barriers to achieving
glycaemic control in CSII. Journal of Diabetes Nursing, 14(5),
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• Searching the literature begins with a written plan other side of coping. American Psychologist, 55(6), 647–654.
for the review that is maintained as a search history Garrard, J. (2011). Health sciences literature review made easy: The
during the first stage of the literature review. matrix method (3rd ed.). Sudbury, MA: Jones & Bartlett.
• Searching the literature requires use of bibliograph- Gravel, J. (2009). Bess and hearing screening: Portending the chal-
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Hart, C. (2009). Doing a literature review: Releasing the social Roguin, A. (2011). Henry Cuthbert Bazett (1885-1950)—The man
science imagination. Los Angeles, CA: Sage. behind the QT interval correction formula. Pace, 34(3),
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  http://evolve.elsevier.com/Grove/practice/

7
CHAPTER

Frameworks

A
framework is an abstract, logical structure of theoretical ideas and their application. This section is
meaning that guides the development of the an introduction to key theoretical terms: concept, rela-
study and enables you to link the findings to tional statement, conceptual model, theory, middle-
the body of knowledge in nursing. Frameworks are range theory, and study framework. In response to the
used in quantitative research and sometimes in qualita- ongoing debate and varying opinions about the differ-
tive research. In quantitative studies, the framework ences between a conceptual model and a theory or a
may be a testable theoretical structure or may be devel- conceptual model and a philosophy (Meleis, 2012),
oped inductively from published research or clinical working definitions of these concepts are presented to
observations. In most qualitative studies, the researcher facilitate the application of theoretical principles to
will not identify a theoretical framework. With a research.
grounded theory study, the researcher is attempting to
develop a theory as an outcome of the study. Concept
Every quantitative study has a theoretical frame- A concept is a term that abstractly describes and
work, although some researchers do not identify or names an object, a phenomenon, or an idea, thus pro-
describe the theoretical framework in the report of the viding it with a separate identity or meaning. As a
study. For example, researchers may use anatomy and label for a phenomenon or composite of behavior and
physiology knowledge to guide a study without iden- thoughts, a concept is a concise way to represent the
tifying a framework. Ideally, the framework of a quan- experience or state (Meleis, 2012). An example of a
titative study is carefully structured, clearly presented, concept is the term anxiety. The concept brings to
and well integrated with the methodology. When you mind a feeling of uneasiness in the stomach, a rapid
critically appraise studies, you need to identify and pulse rate, and troubling thoughts about future nega-
evaluate the extent to which the framework guided the tive outcomes. Consider the concept of hope. What
study methodology. Your ability to understand the feelings, expectations, and actions are expressed by
study findings will depend on your ability to under- this label?
stand the logic within the framework and will deter- Concepts can vary in their level of abstraction. At
mine how you will use the findings. In addition, when high levels of abstraction, concepts may have general
you develop a quantitative study, you will need to meanings and are sometimes referred to as constructs.
describe the study’s theoretical framework. To help For example, a construct associated with the concept
you build the knowledge and skills needed to critically of anxiety might be “emotional responses.” Con-
appraise studies and describe or develop a framework structs, because they are abstract, can subsume mul-
for your own studies, this chapter begins by defining tiple concepts. For example, in addition to anxiety,
relevant terms. The chapter also describes processes emotional responses could include, grief, frustration,
used to examine and appraise the components of theo- peace, hope, and confidence.
ries and presents approaches to identifying or develop-
ing a framework to guide a study. Relational Statements
A relational statement declares that a relationship of
some kind exists between or among two or more con-
Definition of Terms cepts (Walker & Avant, 2011). Relational statements
The first step in understanding theories and frame- provide the skeleton of a framework. Clear relational
works is to become familiar with the terms related to statements are essential for constructing an integrated

116
CHAPTER 7  Frameworks 117

framework for guiding study design. The relationships theories have been validated to this extent, physiologi-
expressed in your framework will direct the develop- cal theories have this level of evidence and can provide
ment of your study’s objectives, questions, or hypoth- a strong basis for nursing studies.
eses. The types of relationships described by the
statements will determine the study design and the Middle-Range Theories
statistical analyses needed to address the study objec- Middle-range theories present a partial view of
tives, questions, or hypotheses. Mature theories, such nursing reality. Proposed by Merton (1968), a sociolo-
as physiological theories, have measurable concepts gist, middle-range theories are less abstract and
and clear relational statements that can be tested address more specific phenomena than grand theories
through research. do (Peterson, 2009). They directly apply to practice
and focus on explanation and implementation. Middle-
Conceptual Models range theories may emerge from grand theories or may
A conceptual model, also known as a grand theory, be developed inductively from research findings.
is a set of highly abstract, related constructs. A con- Grounded theory studies are a scientific source of
ceptual model broadly explains phenomena of inter- middle-range theory. Some middle-range theories
est, expresses assumptions, and reflects a philosophical have been developed by combining nursing theories
stance. Nurse scholars have expended time and effort with theories from other disciplines. Some middle-
to debate the distinctions between the definitions of range theories have been developed from clinical
theory, conceptual model, conceptual framework, and practice guidelines. Whatever their source, middle-
theoretical framework (Chinn & Kramer, 2011; range theories are sometimes called substantive theo-
Meleis, 2012). For example, Watson’s theory of caring ries, because they are more concrete than grand
has been identified as a theory (Meleis, 2012), a phi- theories.
losophy (Alligood, 2010), and a conceptual model
(Fitzpatrick & Whall, 2005). In this textbook, we are Research Frameworks
using the terms conceptual model, conceptual frame- One strategy for expressing the theoretical structure
work and grand nursing theory interchangeably guiding a study is to present a map or diagram of
because our purpose is not to classify theoretical the concepts and relational statements. Although
thinking. The purpose of this chapter is to provide the some writers call these diagrams conceptual maps
information needed to use concepts, relational state- (Artinian, 1982; Fawcett, 1999; Newman, 1979,
ments, and theories or theoretical structures to develop 1986), we are calling them research frameworks to
studies and interpret their findings. indicate the purpose for which they were developed.
A research framework summarizes and integrates
Theory what we know about a phenomenon more succinctly
A theory consists of an integrated set of defined and clearly than a literary explanation and allows us
concepts, existence statements, and relational state- to grasp the bigger picture of a phenomenon. A
ments that can be used to describe, explain, predict, research framework should be supported by refer-
or control the phenomenon being discussed. Exis- ences from the literature. These frameworks vary in
tence statements within a theory declare that a given complexity and accuracy, depending on the available
concept exists or that a given relationship occurs. body of knowledge related to the phenomena they
For example, an existence statement might claim are describing. Mapping can also identify gaps in the
that a condition referred to as stress exists and that logic of the theory being used as a framework and
there is a relationship between stress and health. As reveals inconsistencies, incompleteness, and errors.
discussed earlier, relational statements clarify the Now that this basic knowledge of the roles of con-
relationship that exists between or among concepts. cepts, relationships, and theories in research has
It is the statements of a theory that are tested been supplied, the next sections provide a discussion
through research, not the theory itself. Thus, identi- of the analysis and application of each of these
fying statements within the theory is critical to the components.
research endeavor and forms the basis of the study’s
framework.
Scientific theories are those for which repeated Understanding Concepts
studies have validated the relationships among the Concepts are often described as the building blocks
concepts. These theories are sometimes called laws for of theory. Abstract concepts are descriptive but may
this reason. Although few nursing and psychosocial not be as applicable to clinical practice or research
118 UNIT TWO  The Research Process

because of their abstractness. To make a concept Concept Synthesis


more concrete, you can identify how the concept can In nursing, many phenomena have not yet been identi-
be measured or observed. These measurable terms fied as discrete entities. Recognizing, naming, and
are referred to as variables. A variable is more spe- describing these phenomena are often critical steps to
cific than a concept and implies that the term is understanding the process and outcomes of nursing
clearly defined and measurable. The word “variable” practice. In your clinical practice, you may notice pat-
implies that the numerical values associated with the terns of behavior or find patterns in empirical data.
term vary from one instance to another. A variable You may name a concept that emerges during data
related to anxiety might be “palmar sweating,” which analysis in a qualitative study. The process of describ-
the researcher can measure by assigning a numerical ing and naming a previously unrecognized concept is
value to the amount of sweat on the subject’s palm. concept synthesis. Nursing studies often involve pre-
The links among constructs, concepts, and variables viously unrecognized and unnamed phenomena that
are displayed in Figure 7-1. On the left of the figure must be named and carefully defined. Lee and Coakley
is the construct-to-variable continuum. The other two (2011) conducted a concept synthesis of geropalliative
sets of shapes are examples of a construct, concept, care. Conceptual and philosophical works had exam-
and variable. Notice that a concept may have multi- ined gerontology and palliative care separately but the
ple ways of being measured. For example, anxiety combined term lacked conceptual clarity. This lack of
could be measured by palmar sweating, the State- clarity was viewed as hindering progress in this inter-
Trait Anxiety Scale, or a checklist of behaviors such disciplinary area of study. Lee and Coakley (2011)
as pacing, wringing one’s hands, and expressing concluded that geropalliative care is “both a philo-
worries. sophical stance and structured interdisciplinary model
Defining concepts allows us to be consistent in the of care delivery that guides care to patients and fami-
way we use a term in practice, apply it to a theory, lies during the last 5 years of life, irrespective of
and measure it in a study. A conceptual definition disease” (p. 247). They describe the critical attributes
differs from the denotative (or dictionary) definition of geropalliative care as “high risk for ineffective
of a word. A conceptual definition (connotative pain management,” “geriatric syndromes,” “chronic,
meaning) is more comprehensive than a denotative comorbid conditions,” “risk for ineffective communi-
definition because it includes associated meanings the cation,” and “beneficial in the absence of disease” (p.
word may have. For example, a connotative definition 247). The context of the concept includes end-of-life
may associate the term “fireplace” with images of trajectories that are unpredictable, “shrinking social
hospitality and warm comfort, whereas the dictionary networks, insurance limitations,” and “multiple set-
definition would be a rock or brick structure in a tings” (p. 247). Concept synthesis can be an important
house designed for burning wood. A conceptual defi- element in the development of nursing theory (Walker
nition can be established through concept synthesis, & Avant, 2011).
concept derivation, or concept analysis (Walker &
Avant, 2011). Concept Derivation
Concept derivation may occur when the researcher or
theorist finds no concept in nursing to explain a phe-
nomenon (Walker & Avant, 2011). Concepts identified
Emotional Emotional or defined in theories of other disciplines may provide
Construct
Responses Responses insight. In concept derivation, one concept is trans-
posed from one of field of knowledge to another. If a
conceptual definition is found in another discipline, it
Concept Anxiety Grief must be examined to evaluate its fit with the new field
in which it will be used. The conceptual definition may
need to be modified so that it is meaningful within
nursing and consistent with nursing thought (Walker
Variable Palmar Score on & Avant, 2011). For example, the concept of weather-
Sweating Grief Scale ing, from physical material science, means the altera-
Construct-Concept-Variable Continuum tion of a material exposed over time to sun, wind, and
precipitation. Health researchers, including nurses,
Figure 7-1  Links among constructs, concepts, and variables. define weathering as the alteration of fundamental
CHAPTER 7  Frameworks 119

components of the human organism when exposed TABLE 7-1  Methods of Concept Analysis
over time to stress, unsupportive environments, and
limited resources (Holzman et al., 2009). Concept Type of Concept
derivation is a creative process that can be fostered by Analysis
thinking deeply and having a willingness to learn (Author[s], Date) Unique Characteristics
about processes and theories in other disciplines. Principle-based Analysis guided by linguistic,
(Hupcey & epistemological, pragmatic, and
Concept Analysis Penrod, 2005)
Ordinary use (Wilson,
logical principles
Foci of analysis are exemplars
Concept analysis is a strategy that identifies a set of 1963) (cases) that are used to identify
characteristics essential to the connotative meaning of criteria, antecedents, and
a concept. The procedure will require you to explore consequences
the various ways the term is used and to identify a set Evolutionary method Contextual analysis of how the
of characteristics that clarify the range of objects or (Rodgers, 2000 ) concept has developed over time
ideas to which that concept may be applied (Walker in different settings
& Avant, 2011). These essential characteristics, called Hybrid (Schwartz- Contextual analysis and data
defining attributes or criteria, provide a means to dis- Barcott & Kim, collection in the field leading to
tinguish the concept from similar concepts. Several 2000) conclusions about how concept
has developed over time in
approaches to concept analysis have been described in
different settings
the nursing and healthcare literature. Because the Linguistic, pragmatic Analysis of explicit and implicit
approaches have varying philosophical foundations approach (Walker concept definitions in the
and products, nurse theorists and researchers must & Avant, 2011) literature to identify criteria,
select the concept analysis approach that best suits antecedents, and consequences
their purposes in a specific situation. For example, a for pragmatic purposes in practice
researcher attempting to measure the phenomenon of and research
barriers may choose Walker and Avant’s (2011) Simultaneous (Haase, Examines closely related concepts to
approach because of its product of a theoretical defini- Britt, Coward, distinguish their unique meanings
tion. Deepened understanding of the theoretical defini- Leidy, & Penn, as well as areas of overlap
1992)
tions allows the researcher to critically appraise the
construct validity of instruments or methods being
considered to measure the concept in a study. An
emerging nurse theorist may choose Rodger’s evolu-
tionary approach to understand the contextual influ-
ences on and changes in the meaning of the concept TABLE 7-2  Concept Analyses Using
over time. Several writers have compared the different Different Methods
types of concept analysis (Cronin, Ryan, & Coughlan,
Method of
2010; Duncan, Cloutier, & Bailey, 2007; Hupcey &
Concept Analyzed Concept Analysis
Penrod, 2005; Risjord, 2009; Weaver & Mitcham,
2008). Several concept analysis strategies used in Advanced nursing Principle-Based
practice (Ruel & (Hupcey &
nursing and health care are listed in Table 7-1. In addi-
Motyka, 2009) Penrod, 2005)
tion, a number of concept analyses have been pub- Dance in mental health Hybrid (Schwartz-
lished in the nursing literature, such as those listed in nursing (Ravelin, Barcott & Kim,
Table 7-2. The following section provides an example Kylma, & Korhonen, 2000)
of how one group of researchers developed a concep- 2006)
tual definition for the concept frailty through an analy- Clinical reasoning Evolutionary method
sis of published definitions. (Simmons, 2010) (Rodgers, 2000)
Acculturation in Filipino Linguistic, Pragmatic
Importance of a Conceptual Definition: immigrants (Serafica, (Walker & Avant,
An Example 2011) 2011)
Ethical demand in Simultaneous
With the growth in the proportion of the population
nursing (Mårtenson, (Haase, Britt,
that are over age 65 years, there is increased urgency Fägerskiöld, Runeson, Coward, Leidy, &
in preventing frailty among older people who live in & Berterö, 2009) Penn, 1992)
the community (Gobbens, Luijkx, Wijnen-Sponselee,
120 UNIT TWO  The Research Process

& Schols, 2010). An extensive literature review was Literary Form


done to identify conceptual and operational definitions Social support and spirituality influence coping.
of frailty. From their review of 18 conceptual defini-
tions, Gobbens et al. concluded that “frailty is a Diagram Form
Social Support
dynamic state affecting an individual who experiences
losses in one or more domains of human functioning Coping
(physical, psychological, social) that are caused by the Spirituality
influence of a range of variables and which increases
the risk of adverse outcomes” (p. 85). Key
The definition allows researchers to distinguish SS-Measurement of Social Support
frailty from disability and comorbidity. The refine- Mathematical Form SP-Measurement of Spirituality
SS(x) + SP(y) + K = C C-Measurement of Coping
ment of the conceptual definition has limited value x –Strength of relationship between
without a practical way to measure it (Gobbens et al., social support and coping
2010). Having found no operational definition that y –Strength of relationship between
spirituality and coping
was a logical fit with the conceptual definition pro-
posed, the researchers identified their next step to be Figure 7-2  Literary, diagrammatic, and mathematical forms of a simple
developing an operational definition of frailty consis- statement.
tent with the conceptual definition.

Literary Form
Examining Relational
When social support and spirituality exceed perceived stress,
Statements effective coping occurs.
Understanding relational statements is essential for
ensuring consistency between the research frame- Diagram Form Social Support
work, study design, and statistical analyses. Relational
(–)
statements in a research framework can be described Perceived Stress Coping
by their characteristics.
Spirituality
Characteristics of Relational Statements
Relational statements describe the direction, shape, Key
strength, symmetry, sequencing, probability of occur- Mathematical Form SS-Measurement of Social Support
SP-Measurement of Spirituality
rence, necessity, and sufficiency of a relationship (SS)(SP)/PS = C
PS-Measurement of Perceived Stress
(Walker & Avant, 2011). One statement may have C-Measurement of Coping
several of these characteristics; each characteristic is C = or > 1.0 indicates effective coping
not exclusive of the others. Statements may be
expressed as words in a sentence (literary form), as Figure 7-3  Literary, diagrammatic, and mathematical forms of a
complex statement.
shapes and arrows (diagram form), or as equations
(mathematical form). In nursing, the literary and dia-
grammatic forms of statements are used most fre-
quently. Figure 7-2 displays the three forms of simple when the product of spiritual perspective and social
statements of relationships among spiritual perspec- support is greater than perceived stress, coping will be
tive, social support, and coping. Notice in the diagram greater. When the product is less than perceived stress,
in Figure 7-2 that dotted arrows are used to indicate a coping is diminished.
relationship about which little is known. The mathe-
matical form indicates the same relationships. Figure Direction
7-3 provides literary, diagrammatic, and mathematical The direction of a relationship may be positive,
forms of a more complex statement among the previ- negative, or unknown (Fawcett, 1999). A positive
ous concepts with the addition of perceived stress. linear relationship implies that as one concept
Notice the change in the arrow between perceived changes (the value or amount of the concept increases
stress and coping. The arrow is darker and heavier or decreases), the second concept will also change in
until spiritual perspective and social support modify the same direction. For example, the literary state-
the relationship. The mathematical form proposes that ment, “As stress increases (A), the risk of illness (B)
CHAPTER 7  Frameworks 121

increases,” expresses a positive relationship. This details on diagramming relational statements are pre-
positive relational statement could also be expressed sented in Chapter 8.
as “As stress decreases (A), the risk of illness (B)
decreases.” Shape
A negative linear relationship implies that as one Most relationships are assumed to be linear, and sta-
concept changes, the other concept changes in the tistical tests are conducted to identify linear relation-
opposite direction. For example, the statement “As ships. In a linear relationship, the relationship
relaxation (A) increases, blood pressure (B) decreases” between the two concepts remains consistent regard-
expresses a negative linear relationship. The negative less of the values of each of the concepts. For example,
relationship could also be expressed as “As relaxation if the value of A increases by 1 point each time the
decreases (A), blood pressure (B) increases.” value of B increases by 1 point, then the values con-
The nature of the relationship between two con- tinue to increase at the same rate whether the value is
cepts may be unknown because it has not been studied 2 or 200. The relationship can be illustrated by a
or because study findings have been conflicting. For straight line, as shown in Figure 7-5.
example, consider two studies that included the con- Relationships can also be curvilinear or form some
cepts of coping and social support. Tkatch et al. (2011) other shape. In a curvilinear relationship, the rela-
found that the number of people in the social networks tionship between two concepts varies according to
of African American patients in cardiac rehabilitation the relative values of the concepts. The relationship
(N = 115) and their health-related social support had between anxiety and learning is a good example of a
weak, but statistically significant relationships with curvilinear relationship. Very high or very low levels
their coping efficacy. In contrast, Jackson et al. (2009) of anxiety are associated with low levels of learning,
found nonsignificant relationships among social whereas moderate levels of anxiety are associated
support and coping in a longitudinal study of 88 with high levels of learning (Bierman, Comijs,
parents who had a child with a brain tumor. From the Rijmen, Jonker, & Beekman, 2008). This type of
findings, we can conclude that although there is evi- relationship is illustrated by a curved line, as shown
dence that a relationship exists between these two in Figure 7-6.
concepts, the studies examining that relationship have
conflicting findings. Conflicting findings may result Strength
from differences in the researchers’ definitions and The strength of a relationship is the amount of varia-
measurements of the two concepts in various studies. tion explained by the relationship. Some of the varia-
Another reason for conflicting findings may be that an tion in a concept, but not all, is associated with
unidentified confounding variable exists that changes variation in another concept (Fawcett, 1999). In dis-
the relationship between coping and social support. cussing the strength of a relationship, researchers
Whatever the reason, conflicting findings about a rela- sometimes use the term effect size. The effect size
tionship between concepts could be indicated by a explains how much “effect” variation in one concept
question mark. Figure 7-4 has diagrams representing has on variation in a second concept.
the directional characteristics of relationships. More

High
+
A B
Positive relationship
Concept A


A B
Negative relationship

? Low High
A B
Unknown relationship Concept B

Figure 7-4  Directions of relational statements. Figure 7-5  Linear relationship.


122 UNIT TWO  The Research Process

High A B
Asymmetrical relationship
Learning

A B
or
A B
A B
Symmetrical relationship
Low High
Figure 7-8  Relational statement symmetry.
Anxiety

Figure 7-6  Curvilinear relationship.


is to detect relationships between the variables being
studied. This idea will be explored further in the chap-
–1 0 +1 ters on sampling, measurement, and data analysis
Strong Strong (Chapters 15, 16, and 23, respectively).
No
Negative Positive
Relationship
Relationship Relationship Symmetry
Relationships may be symmetrical or asymmetrical. In
Figure 7-7  Relational statement strength. an asymmetrical relationship, if A occurs (or
changes), then B will occur (or change); but there may
be no indication that if B occurs (or changes), A will
Researchers usually determine the strength of the occur (or change). An asymmetrical relationship is not
relationship between concepts by correlational analy- reversible (Fawcett, 1999). You can think of this rela-
sis. The mathematical result of the analysis is a cor- tionship as a one-way street, with influence going only
relation coefficient such as the following: in one direction. Bradford and Petrie (2008) found an
asymmetrical relationship between internalized ideal
r = 0.35 of a thin body and body dissatisfaction in their study
The statistic r is the coefficient obtained by perform- of disordered eating among 236 first-year, female
ing the statistical procedure known as Pearson’s college students. The internalized thin body ideal
product-moment correlation (see Chapter 23). A value affected body dissatisfaction, but the reverse was not
of 0 indicates no strength, whereas a value of +1 or true (see Figure 7-8).
−1 indicates the greatest strength (see Figure 7-7). A symmetrical relationship is complex and con-
When the correlation is large, a greater portion of tains two statements, such as if A changes, B will
the variation can be explained by the relationship; in change and if B changes, A will change (Fawcett,
others, only a moderate or a small portion of the varia- 1999). You may think of the relationship between
tion can be explained by the relationship. For example, these concepts as a two-way street with influence
Tkatch et al. (2011) found a relationship of r = 0.22 going in both directions. These relationships may also
(p < 0.05) between health-related social support and be called reciprocal or reversible. An example is the
coping efficacy. The strength of the relationship meant symmetrical relationship between quality of life and
that a small portion of the variance in coping was perceived health among patients after heart surgery
explained by variations in health-related social support (Mathisen et al., 2007). The researchers found that
(see Chapter 23 for additional information). quality of life influenced perceived health and that
The + or − does not have an impact on the strength perceived health influenced quality of life, indicating
of the relationship. For example, r = −0.35 is as strong a symmetrical relationship between the concepts. A
as r = +0.35. A weak relationship is usually considered second example comes from the study by Bradford
one with an r value of 0.1 to 0.3; a moderate relation- and Petrie (2008). They found a symmetrical (recipro-
ship is one with an r value of 0.31 to 0.5; and a strong cal) relationship between depression and disordered
relationship is one with an r value greater than 0.5. eating in their study with adolescent females (see
The greater the strength of a relationship, the easier it Figure 7-8).
CHAPTER 7  Frameworks 123

A If A, then probably B

Probability statements are tested statistically to deter-


mine the extent of probability that B will occur in the
B event of A. For example, one could state that there is
Concurrent relationship
greater than a 50% probability that a patient who has
an indwelling catheter for 1 week will experience a
urinary bladder infection. This probability could be
A B expressed mathematically as follows:
Sequential relationship
p > 0.50
Passage of Time The p is a symbol for probability. The > is a symbol
for “greater than.” This mathematical statement asserts
Figure 7-9  Relational statement sequencing.
that there is more than a 50% probability that the
relationship will occur.
Sequencing
The amount of time that elapses between one concept Necessity
and another is stated as the sequential nature of a In a necessary relationship, one concept must occur
relationship. If the two concepts occur simultaneously, for the second concept to occur (Fawcett, 1999). For
the relationship is concurrent (Fawcett, 1999). When example, one could propose that if sufficient fluids are
there is a change in one concept, there is change in the administered (A), and only if sufficient fluids are
other at the same time. If one concept changes and the administered, the unconscious patient will remain
second concept changes later, the relationship is hydrated (B). This relationship is expressed as follows:
sequential. Another example from Bradford and Pet-
If A, and only if A, then B
rie’s study (2008) was a hypothesized concurrent rela-
tionship between internalizing the thin body ideal and In a substitutable relationship, a similar concept
dissatisfaction with one’s body. Their findings pro- can be substituted for the first concept and the second
vided mixed support for the relationship. They also concept will still occur. For example, a substitutable
hypothesized that depression would predict later path- relationship might propose that if tube feedings are
ological eating. This sequential relationship was sup- administered (A1), or if hyperalimentation is admin-
ported by their findings. These relationships are istered (A2), the unconscious patient can remain
diagrammed in Figure 7-9. hydrated (B). This relationship is expressed as follows:

Probability of Occurrence If A1, or if A 2, then B


A relationship can be deterministic or probabilistic
depending on the degree of certainty that it will occur. Sufficiency
Deterministic (or causal) relationships are state- A sufficient relationship states that when the first
ments of what always occurs in a particular situation. concept occurs, the second concept will occur, regard-
For example, among Thai patients with heart failure, less of the presence or absence of other factors
nurse researchers found that symptom status, social (Fawcett, 1999). A statement could propose that if a
support, general health perception, and functional patient is immobilized in bed longer than a week, he
status had causal relationships with health-related or she will lose bone calcium, regardless of anything
quality of life (Phuangphaka, Veena, Chanokporn, & else. This relationship is expressed as follows:
Sloan, 2008). Scientific laws are another example of
If A, then B, regardless of anything else
deterministic relationships (Fawcett, 1999). A causal
relationship is expressed as follows: A contingent relationship will occur only if a third
concept is present. For example, a statement might
If A, then always B
claim that if a person experiences a stressor (A), the
A probability statement expresses the probability person will manage the stress (B), but only if she or
that something will happen in a given situation he uses effective coping strategies (C). The third
(Fawcett, 1999). This relationship is expressed as concept, in this case effective coping strategies, is
follows: referred to as an intervening (or mediating) variable.
124 UNIT TWO  The Research Process

TABLE 7-3  Characteristics of Relationships Abstract General Proposition Abstract

Type of
Relationship Descriptive Statement
Positive linear As A increases, B increases.
As A decreases, B decreases. Specific Proposition
Negative linear As A increases, B decreases.
As A decreases, B increases.
Unknown linear As A changes, B may change.
Curvilinear At a specific level, as A changes, B
changes to a similar degree.
At another specific level, as A changes, B
Less Abstract Hypothesis Less Abstract
changes to a greater or lesser extent.
Asymmetrical As A changes, B changes.
Figure 7-10  Abstract to concrete—general proposition to hypothesis.
As B changes, A does not change.
Symmetrical As A changes, B changes.
As B changes, A changes. Statements at varying levels of abstraction that
Concurrent When A changes, B changes at the same
express relationships between or among the same con-
time.
Sequential After A changes, B changes.
ceptual ideas can be arranged in hierarchical form,
Causal If A occurs, B always occurs. from general to specific. This arrangement allows you
Probabilistic If A occurs, then probably B. to see (or evaluate) the logical links among the various
Necessary If A occurs, and only if A occurs, B levels of abstraction. Statement sets link the relation-
occurs. ships expressed in the framework with the hypotheses,
Sufficient If A occurs, and only if A, B occurs. research questions, or objectives that guide the meth-
Substitutable If A1 or A2 occurs, B occurs. odology of the study. The following excerpts provide
Contingent If A occurs, then B occurs, but only if C an example of the more abstract theoretical proposi-
occurs. tion that provided the basis for the hypothesis that was
tested in a study by Xu, Floyd, Westmaas, and Aron
(2010). These researchers asked 66 former and 74
Intervening variables can affect the occurrence, current smokers to select self-expanding activities,
strength, or direction of a relationship. A contingent such as a new romantic relationship or a new job, that
relationship can be expressed as follows: occurred in the time immediately preceding attempts
to stop smoking.
If A, then B, but only if C
Proposition
Being able to describe relationships among the con-
cepts is an important first step in identifying, evaluat- “Because both self-expansion and nicotine appear to
ing, and developing research frameworks. Table 7-3 trigger feelings of reward that originate from the
provides a summary of the characteristics of relational same parts of the brain, it is conceivable that the
statements. Remember that a single statement may reward from self-expanding experiences could (at
have multiple descriptive characteristics. least partly) supplant or act as a substitute for the
reward elicited by nicotine or other addictive drugs.”
Statement Hierarchy (Xu et al., 2010, p. 296)
Statements about the same two conceptual ideas can
Hypothesis
be made at various levels of abstractness. The state-
ments found in conceptual models and grand theories “We hypothesized that smokers would report greater
(general propositions) are at a high level of abstrac- success abstaining from smoking if they had engaged
tion. Statements found in middle-range theories in self-expanding activities prior to their quit attempt.”
(specific propositions) are at a moderate level of (Xu et al., 2010, p. 296)
abstraction. Hypotheses, which are a form of state- Xu and colleagues reported that, “former smokers
ment, are at a low level of abstraction and are specific. reported a mean of 4.60 self-expanding events (SD =
As statements become less abstract, they become 4.1) in the 2-month period prior to their successful
narrower in scope (Fawcett, 1999), as shown in quit attempt” (p. 298).
Figure 7-10.
CHAPTER 7  Frameworks 125

energy fields interacting with the environmental


Grand Theories energy fields.
Most disciplines have several conceptual models, each In addition to concepts specific to the theory, nurse
with a distinctive vocabulary. Table 7-4 lists some of theorists include the metaparadigm or domain con-
the conceptual models or grand theories in nursing. cepts of nursing: person, health, environment, and
These philosophical theories of nursing vary in their nursing (Chinn & Kramer, 2011). For example, Roy,
level of abstraction and the breadth of phenomena they Orem, and Rogers all include the construct health in
explain. Each provides an overall picture, or gestalt, their models but define it in different ways (see Table
of the phenomena they explain. It is not their purpose 7-5). The definitions inherent in grand nursing theories
to provide detail or to be specific. guide nursing practice by providing the characteristics
Nurses have developed a number of conceptual of the person and environment that nurses should
models or grand nursing theories. For example, Roy’s assess. For example, Orem’s theory of self-care
(1988) model describes adaptation as the primary phe- describes factors to be assessed as universal self-care
nomenon of interest to nursing. This model identifies requisites, developmental self-care requisites, and
the constructs she considers essential to adaptation health deviation requisites. A nurse whose assessment
and how these constructs interact to produce is guided by Roy’s theory would gather assessments
adaptation (Roy & Andrews, 2008). Orem (2001) con- related to the adaptive modes of physiological, self-
sidered self-care to be the phenomenon central to concept, role function, and interdependence. Theories
nursing. Her model explains how nurses facilitate the also guide nursing practice by defining the specific
self-care of clients. Rogers (1970, 1990) regarded goal of practice (characteristics of health) and describ-
human beings as the central phenomenon of interest ing the nursing interventions (descriptions of nursing)
to nursing. In her model, human beings are viewed as to achieve the outcomes. Most are not directly testable
through research and thus cannot be used alone as the
framework for a study (Fawcett, 1999; Walker &
Avant, 2011). Application of grand nursing theories to
TABLE 7-4  Selected Grand Nursing Theories research is discussed later in this chapter.
(in Alphabetical Order by  
Author Name)
Descriptive Label Application of
Author (Year) of the Theory
Henderson, Virginia (1964) Nursing as Promoting Patient
Middle-Range Theories
Independence with 14 Middle-range theories are useful in both research and
Activities of Daily Living practice. Middle-range theories are less abstract than
Johnson, Dorothy (1974) Behavioral Systems grand theories and closer to the day-to-day substance
King, Imogene (1981) Interacting Systems Theory of clinical practice, a characteristic that explains why
of Nursing (includes they can be called substantive theories. As a result,
middle-range theory of middle-range theories guide the practitioner to under-
Goal Attainment) standing the client’s behavior, enabling interventions
Leininger, Madeline (1997) Transcultural Nursing Care, that are more effective. Because of their usefulness in
Sunrise Model of Care
practice, some writers refer to middle-range theories
Orem, Dorothea (2001) Self-Care Deficit Theory of
Nursing
as practice theories. Middle-range theories are used
Neuman, Betty (Neuman & Systems Model of Nursing more commonly than grand theories as frameworks
Fawcett, 2002) for research. Researchers need to carefully consider
Newman, Margaret (1986) Health as Expanding which middle-range theory to use as a study frame-
Consciousness work and which aspects of this theory will be tested
Nightingale, Florence (1859) Environmental Health by their study. Tables 7-6 and 7-7 identify some of the
Parse, Rosemarie (1992) Human Becoming Theory middle-range theories more frequently used as frame-
Peplau, Hildegard (1988, Interpersonal Relations works in the past 10 years of nursing research.
1991) Theory Middle-range theories have been developed from
Rogers, Martha E (1970) Unitary Human Beings
clinical insights, elements of existing theories not pre-
Roy, Calista (1988) Adaptation Model
Watson, Jean (1979) Philosophy and Science of
viously related, outcomes of qualitative studies, or
Caring conceptual models. Kolcaba (2009) noted that, although
comfort had been the goal of nursing interventions for
126 UNIT TWO  The Research Process

TABLE 7-5  Comparison of the Domain Concepts—Person, Health, Environment, and Nursing—within
Three Grand Theories
Domain Rogers: Unitary Orem: Self-Care Deficit Theory
Concept Human Beings Roy: Adaptation Model of Nursing
Person Irreducible, indivisible Biopsychosocial beings who adapt Human beings with eight universal needs,
energy fields; open to their environment two developmental needs, and the
systems that are integral potential for six health deviation
with the environment self-care needs; ability to provide
self-care is affected by the
conditioning factors of age, gender,
health, and the availability of resources
Health Symphonic interaction of Return to or maintenance of Extent to which person can meet own
the human and adaptation, through activation of universal, development, and health-
environment the regulator and cognator deviation self-care requisites
systems and of the physiological,
self-concept, role function, and
interdependence adaptive modes
Environment Irreducible, indivisible Source of focal and contextual Source of resources and other factors that
energy fields; open stimuli that may require can affect person’s ability to meet
systems that are integral responses by the person to self-care needs
with the persons maintain adaption
Nursing Promote symphonic Promote the person’s adaptation by Design and implement systems of care to
interaction in the modifying focal and contextual decrease or remove the gap between
human-environmental stimuli and facilitating use of self-care capacity and self-care needs;
energy field the adaptive modes may provide wholly compensatory
(physiological, self-concept, role care, partially compensatory care, or
function, interdependence) supportive-educative care

Compiled from Banfield (2011); Denyes, Orem, & Bekel SozWiss (2001); and Rogers (1990).

many years, the concept had never been defined pre- participation in decision making. The nurse assesses
cisely. Her theory of comfort began with a concept the extent to which each of the characteristics are
analysis of comfort during her graduate nursing educa- present in a specific patient and family. Based on the
tion (Kolcaba & Kolcaba, 1991). As she continued her assessment, the nurse will use specific practice com-
doctoral studies, over the space of a year or more, she petencies. The practice competencies in the model are
developed a taxonomy of comfort that provides the clinical judgment, clinical inquiry, caring practices,
basis for describing types of comfort (Kolcaba, 1991) response to diversity, advocacy/moral agency, facilita-
and an operational definition (Kolcaba, 1992). Through tion of learning, collaboration, and systems thinking.
continued scholarly inquiry, Kolcaba’s middle-range When synergy exists among the eight patient charac-
theory of comfort was developed (Kolcaba, 1994), as teristics and eight nursing practice competencies,
were several instruments to measure different types of optimal patient outcomes are more likely to be found.
comfort (http://www.thecomfortline.com/). Extensive work has been done applying the Synergy
A more recent middle-range theory, the Synergy Model in practice, nursing education, and professional
Model for Patient Care, was developed by members development (Curley, 2007).
and leaders of the American Association of Critical A specific type of middle-range theory is interven-
Care Nurses to identify the unique contributions of tion theory. Intervention theories seek to explain the
nurses to patient and family outcomes (Hardin, 2009). dynamics of a patient problem and exactly how a
The basic premise of the model is that “patient char- specific nursing intervention is expected to change
acteristics drive nurse competencies” (Curley, 2007, patient outcomes. Currently, these new theories are
p. 2). The patient characteristics include stability, tentative, but some will likely become substantive in
complexity, vulnerability, predictability, resiliency, the future. Intervention theories are discussed in detail
resource availability, participation in care, and in Chapter 14.
CHAPTER 7  Frameworks 127

TABLE 7-6  Selected Middle-Range Nursing Theories Developed 2001 through 2011
Name of Theory Theorist Source
Coping of relatives of patients Johansson, I., Hildingh, C., Fridlund, B., & Ahlstrom, G. (2006). Theoretical model of coping
in intensive care units among relatives of patients in intensive care units: A simultaneous concept analysis. Journal of
Advanced Nursing, 56(5), 463-471.
Flight nursing expertise Reimer, A. P., & Moore, S. M. (2011). Flight nursing expertise: Toward a theory of flight nursing.
Journal of Advanced Nursing, 66(5), 1183-1192.
Humor in clinical nurse McCreaddie, M., & Wiggins, S. (2009). Reconciling the good patient persona with problematic and
specialist–patient non-problematic humour: A grounded theory. International Journal of Nursing Studies, 46(8),
interactions 1079-1091.
Music, mood, and movement Murrock, C. J., & Higgins, P. A. (2009). The theory of music, mood, and movement to improve
to improve health outcomes health outcomes. Journal of Advanced Nursing, 65(10), 2249-2257.
Nursing intellectual capital Covell, C. L. (2008). The middle-range theory of nursing intellectual capital. Journal of Advanced
Nursing, 63(1), 94-103.
Nursing presence McMahon, M., & Christopher, K. (2010). Toward a middle-range theory of nursing presence.
Nursing Forum, 46(2), 71-82.
Professional resilience and Hodges, H. F., Troyan, P. J., & Keely, A. C. (2010). Career persistence in baccalaureate-prepared
career persistence acute care nurses. Journal of Nursing Scholarship, 42(1), 83-91.
Quality oncology nursing Radwin, L., Cabral, H., & Wilkes, G. (2009). Relationships between patient-centered cancer nursing
practice interventions and desired health outcomes in the context of the health care system. Research in
Nursing & Health, 32(1), 4-17.
Self-care management for Dorsey, C. J., & Murdaugh, C. L. (2003). Theory of self management for vulnerable populations.
vulnerable populations Journal of Theory Construction and Testing, 7(2), 43-49.
Story theory Smith, M. J., & Liehr, P. (2005). Story theory: Advancing nursing scholarship. Holistic Nursing
Practice, 19(6), 272-276.
Facilitated sense-making with Davidson, J. E. (2010). Facilitated sensemaking: A strategy and new middle-range theory to support
families of patients in families of intensive care unit patients. Critical Care Nurse, 30(6), 28-39.
intensive care
Adaptation to chronic pain Dunn, K. (2004). Toward a middle range theory of adaptation to chronic pain. Nursing Science
Quarterly, 17(1), 78-84.
Caregiver stress Tsai, P. (2003). A middle-range theory of caregiver stress. Nursing Science Quarterly, 16(2),
137-145.
Spiritual empathy Chism, L., & Magnan, M. (2009). The relationship of nursing students’ spiritual care perspectives to
their expressions of spiritual empathy. Nursing Science Quarterly, 48(11), 597-605.

Appraising Theories and Client Health Behavior (IMCHB; Cox, 2003) as the
theoretical framework for their study. This team of
Research Frameworks nurse researchers conducted a descriptive correla-
Nurses examine and evaluate theories to determine tional study of patient satisfaction with the care pro-
their maturity, applicability for practice, and useful- vided by nurse practitioners (NPs) in primary care.
ness for research. The evaluation of theories is com- The study participants (N = 100) were African Ameri-
plicated by the availability of at least seven sets of can routinely seen by NPs in three urban clinics.
possible evaluative criteria (Fawcett, 2005). In keeping Benkert et al. (2009) did not provide a diagram of the
with the purpose of this book, we focus our discussion framework but carefully defined each of the frame-
on critically appraising research frameworks in pub- work’s concepts and described the pencil-and-paper
lished studies. instruments used to measure them.
Other researchers, such as Dailey (2009), do not
Critical Appraisal of a Research Framework identify the frameworks in their studies. In Dailey’s
During the process of critically appraising a study, (2009) study of social stressors and strengths of low-
the first task related to the research framework is to income African American mothers and infant birth
describe it. This task is easier when the researchers weight, the framework can be inferred from the litera-
explicitly identified the framework. For example, ture review and the study variables. Consider the fol-
Benkert, Hollie, Nordstrom, Wickson, and Bins- lowing excerpts from the literature review of the
Emerick (2009) identified the Interactional Model of research report to identify the relational statements:
128 UNIT TWO  The Research Process

TABLE 7-7  Selected Middle-Range Nursing Theories Cited 2001 through 2011 but Developed Earlier
Name of Theory (Theorist[s], Year) Recent Citation
Caring (Swanson, 1991) Andershed, B., & Ollson, K. (2008). Review of literature related to Kristen Swanson’s
middle-range theory of caring. Scandinavian Journal of Caring Sciences, 23(3),
598-610.
Prescriptive pain management theory Good, M., Anderson, G., Ahn, S., & Cong, X. (2005). Relaxation and music reduced
(Good & Moore, 1996) pain following intestinal surgery. Research in Nursing & Health, 28(3), 240-251.
Theory of chronic sorrow (Eakes, Burke, Gordon, J. (2009). An evidence-based approach for supporting parents experiencing
& Hainsworth, 1998) chronic sorrow. Pediatric Nursing, 35(2), 115-119.
Theory of comfort (Kolcaba, 1994) Kolcaba, K., & DiMarco, M. (2005). Comfort theory and its application to pediatric
nursing. Pediatric Nursing, 31(3), 187-194.
Uncertainty in illness theory (Mishel, Lin, L., Yeh, C., & Mishel, M. (2010). Evaluation of a conceptual model based on
1988) Mishel’s theories of uncertainty in illness in a sample of Taiwanese parents of
children with cancer: A cross-sectional questionnaire survey. International Journal of
Nursing Studies, 47(12), 1510-1524.
Self-transcendence theory (Reed, 1991) Reed, P. G., & Rousseau, E. (2007). Spiritual inquiry and well-being in life-limiting
illness. Journal of Religion, Spirituality, and Aging, 19(4), 81-98.
Theory of unpleasant symptoms (Lenz, Brant, J., Beck, S., & Miaskowski, C. (2010). Building dynamic models and theory to
Pugh, Milligan, Gift, & Suppe, 1997) advance the science of symptom management research. Journal of Advanced Nursing,
66(1), 228-240.
Need-driven, dementia-compromised Kovach, C. R., Noonan, P. E., Schlidt, A. M., & Wells, T. (2005). A model of
behavior (Algase et al., 1996). consequences of need-driven, dementia-comprised behavior. Journal of Nursing
Scholarship, 37(2), 134-140.
Experiencing transitions (Meleis, Sawyer, Reedy, S., & Blum, K. (2010). Applying middle-range nursing theory to bariatric surgery
Im, Messiasis, & Schumacher, 2000) patients: Experiencing transitions. Bariatric Nursing and Surgical Patient Care, 5(1),
35-43.

Describing the research framework may be easier


• The link between stressful life circumstances and if you draw a diagram of the concepts and relation-
birth outcomes….” (p. 340). ships among them. In the Dailey (2009) study, the
• “Several studies have identified associations study purpose contained four constructs. The purpose
between maternal experiences of racial was to explore “the extent to which social stressors,
discrimination and low-birth-weight deliveries….” personal resources, and known perinatal risk factors
(pp. 340-341). predict infant birth weight in a sample of urban low-
• “Maternal stress associated with trauma exposure income African American women” (Dailey, 2009, p.
has been linked to … health outcomes” (p. 341). 341). These constructs were the basis for a concep-
• “[J]ust as important to learn how women at risk tual map of the research framework. Figure 7-11
adapt to the negative influences…. [E]ffects of presents our diagrams of the constructs, concepts, and
maternal stress on health outcomes should be relationships among the concepts. In the figure, the
balanced by efforts to study personal resources first diagram shows that the constructs of social
that may be influential to maternal health” stressors, personal resources, and perinatal risk
(p. 341). factors influence birth outcomes. The constructs were
• “Supportive networks contribute to the well derived from the concepts discussed in the article.
being of African American women during The second diagram identifies the concepts that
pregnancy” (p. 341). Dailey (2009) used that were related to each con-
• “Levels of spirituality affect perinatal health” struct. For example, the construct of social stressors
(p. 341). was examined by measuring discrimination, trauma,
• “Numerous researchers have studied and socioeconomic states. Although not identified
socioeconomic status (SES), common medical as such, the conceptual and operational definitions
conditions during pregnancy, and health practices of the concepts were easily identified in the article.
in relation to birth weight outcomes” (p. 341). Table 7-8 displays the definitions of three concepts
as examples.
CHAPTER 7  Frameworks 129

TABLE 7-8  Conceptual and Operational Definitions of Selected Concepts from Dailey’s (2009) Study
Concept Conceptual Definition Operational Definition
Trauma Trauma is experiencing, either as a witness or Trauma History Questionnaire guided the assessment of
participant, an event that involves actual or life trauma with a resulting score of 0-23, with higher
threatened serious injury to or death of self or scores indicative of more types of trauma.
others (Dailey, 2009).
Spirituality Spirituality is defined as making meaning that Spirituality was measured using the Spiritual Perspective
empowers the self, supports coping, and Scale (Reed, 1987). The operational definition is the
promotes equanimity (Dailey, 2009). summed score on the SPS, ranging from 10 to 60.
Discrimination Discrimination is being excluded, exploited, or Discrimination was measured using the Everyday
treated with prejudice and having one’s rights Discrimination Scale. The operational definition is the
and freedoms restricted. summed score on the scale, ranging from 9-54.

Research Framework with Constructs 2. Do the concepts reflect the constructs identified in
the framework? Some frameworks may not iden-
Social Developed from Dailey (2009) tify constructs and may have only concepts.
Stressors
3. Do the variables reflect the concepts identified in
Personal Birth the framework?
Resources Outcomes 4. Are the conceptual definitions validated by refer-
ences to the literature?
Perinatal Risk 5. Are the propositions (relational statements) logical
Factors
and defensible?
Research Framework with Concepts The next step in critically appraising a study frame-
work is to evaluate the extent to which the framework
Discrimination guided the methodology by asking the following
Trauma question:
Socioeconomic Status
1. Do the operational definitions reflect the concep-
Spirituality Infant Birth tual definitions?
Social Support Weight 2. Do the hypotheses, questions, or objectives reflect
Substance Use the constructs and/or concepts in the propositions
Lack of Prenatal Care of the framework?
Medical Conditions 3. Is the design appropriate to test the propositions of
the framework?
Figure 7-11  Derived research framework for Dailey’s (2009) study of When a framework guides the methodology of a
stressors and strengths that predict infant birth weight. study, the answer to these questions will be “yes.”
Some researchers may describe a theory or theories
to provide context for the study but may not use the
framework to guide the methodology. Bond et al.
From your description of the framework, you are (2011) conducted a study of how nurse researchers
ready to examine the logical structure of the frame- use theory by reviewing research reports in seven
work. Meleis’s (2012) criteria for critically appraising leading journals over 5 years. In 837 of the 2184
theories include assessing the clarity and consistency research reports (38%), the researchers included a
of the logical structure. When the following questions theoretical framework, either a nursing theory or a
about clarity and consistency can be answered “yes,” theory from another discipline. Of these 837 reports,
the framework has a strong logical structure: 93% contained evidence that the theory had been inte-
1. Are the definitions of constructs consistent with the grated into the study methodology. Bond et al. have
theorist’s definitions? This question is asked only documented that, when identified, the study frame-
if the researchers link their framework to a parent work most likely will be used to guide the methodol-
theory. (The parent theory is the theory from ogy. The more prevalent problem is that nursing
which the researchers have selected the constructs researchers often do not identify the theories guiding
for their study.) their studies.
130 UNIT TWO  The Research Process

The final step in critically appraising a study frame- construction and are discussed after the presentation
work is to decide the extent to which the researcher of the approaches.
connected the findings to the framework by asking the
following questions: Identifying and Adapting an Existing Theory
1. Did the researcher interpret the findings in terms of Take another look at the research reports you have
the framework? read related to your topic. Which theories have others
2. Are the findings for each hypothesis, question, or used when studying this area? In your exploration,
objective consistent with the relationships pro- include studies on your topic of interest that have been
posed by the framework? done with populations other than your own. For
Even in studies clearly guided by a research frame- example, researchers have used several health behav-
work, the findings may not be discussed in terms of ior and psychological theories to guide studies related
what they mean in relation to the framework. Find- to medication adherence. Kalichman et al. (2011)
ings that are consistent with the framework are evi- tested an adherence intervention based on the conflict
dence of the framework’s validity, and this point theory of decision making with persons with HIV/
should be noted in the discussion. When the findings AIDS. For her randomized controlled trial (RCT) of a
are not consistent with the research framework, nursing intervention to promote medication adherence
researchers should discuss the possible reasons for in cardiac patients, Gould (2011, p.119) used self-
this disconnect. One reason may be a lack of construct regulation theory based on the “Common Sense Model
validity (see Chapter 16). The instruments used may of illness perception for self regulation of care” devel-
not have measured the constructs/concepts of the oped by Leventhal, Diefenbach, and Leventhal (1992).
study framework adequately and accurately. Other Schaffer and Tian (2004) used the protection motiva-
possible reasons are that the framework was based on tion theory (Prentice-Dunn & Rogers, 1986) to
assumptions that were not true for the population examine adherence to preventive medication use of
being studied and that the framework does not repre- persons with asthma. Existing theories can provide
sent the reality of the phenomena being studied in this insights into how the topic has been studied and the
specific sample. range of perspectives available on a given research
topic.
Review theory textbooks and middle-range theory
Developing a Research publications to examine the applicability of other
nursing theories that might provide insight to your
Framework for Study research problem (Tomey & Alligood, 2006). For
Developing a framework is one of the most important example, Orem’s (2001) theory of self-care could be
steps in the research process but, perhaps, also one of used as a framework for a study of the effect of acuity-
the most difficult. A research report in a journal often based staffing assignments on hospital length of stay
contains only a brief presentation of the study frame- for patients after a coronary artery bypass graft surgery.
work because of page limitations. As a result, you may The acuity-based staff assignments could be supported
gain little insight into the careful, thoughtful, pro- by Orem’s nursing systems—wholly compensatory
longed work required to develop a research frame- care, partially compensatory care, and supportive-
work. Part of developing as a researcher is your educative care. Examples of theories for specific
commitment and motivation to learn the skills needed topics are provided in Table 7-9. Prior to making a
to perform this thoughtful work. final decision about a theory, you should read primary
You have identified a research problem and are sources written by the theorists to ensure that your
thinking about the proposed study’s methodology. The topic is a conceptual and pragmatic fit with the con-
guideline you are using for developing the proposal cepts, definitions of concepts, assumptions, and prop-
indicates that you need a research framework for a ositions of the theory.
study. Where do you start? This section presents three
basic approaches to beginning the process of con- Synthesis from Research Findings
structing a study framework: (1) identifying an exist- Developing a theory or a framework from research
ing theory from nursing or another discipline, (2) findings is the most accepted strategy of theory devel-
synthesizing a framework from research findings, and opment (Meleis, 2012). The research-to-theory strat-
(3) proposing a framework from clinical practice. The egy, an inductive approach, begins by identifying
final steps of constructing a research framework are relevant studies. For example, to develop a framework
the same no matter the approach used to start the for a study of coping with HIV infection, Gray and
CHAPTER 7  Frameworks 131

TABLE 7-9  Potential Theories for Different Research Topics


Research Topic Theory (Theorist[s], Year)
Light and noise as influences on patient recovery in acute Environmental theory (Nightingale, 1859, 1946, 1979)
care settings
Peer support group for adolescents to decrease their use of Roy’s adaptation model (Roy & Andrews, 2008)
illegal substances
Sleep quality and dementia progression in long-term care Cognitive brain reserve (Stern, 2009)
facilities
Medication adherence of men on antihypertensive Information motivation behavioral skills model (Fisher, Williams,
medications Fisher, & Mallory, 1999)
Screening for diabetes mellitus among women with a history Cardiometabolic Model (Ruhl, 2009)
of gestational diabetes
Task shifting in low-resource settings Theory of self-regulating teams (Millwood, Banks, & Riga, 2010)
Fear of HIV infection and sexual behavior of young gay men Theory of planned behavior (Ajzen, 1991)
New graduate nurses’ clinical competency and use of NLN-Jeffries simulation framework (Jeffries et al., 2007)
high-fidelity simulation in baccalaureate nursing education
Children’s postoperative pain and parental anxiety Philosophical approach: Externalist perceptual view of pain (Pesut &
McDonald, 2007)
Nurse retention and environmental factors in rural hospitals Theory of structural empowerment (Kanter, 1977)

Cason (2002) conducted an integrated review of 30 Research Framework from Clinical Practice
studies. Studies were included if the subjects were
persons living with HIV infection, and the variables
included coping and/or psychosocial factors related to Concepts Bonding Thriving
coping. The researchers extracted study characteristics
and documented them in a literature summary table
(see Chapter 6). They carefully reviewed the findings
Number of Mother’s
of each study for relationships among concepts. The Variables
Visits
Infant Weight Gain
researchers became immersed in the published find-
ings by diagramming the relationships on a large piece
of paper and creating tables of each relational state- Figure 7-12  Research framework from clinical experience.
ment with the studies supporting the statement.
Through this process, they identified concepts and ideas could be diagrammed as the lower set of rela-
relational statements for inclusion in the proposed tionships shown in Figure 7-12.
study’s framework. The relationship she identified consisted of two
concrete ideas: number of mother visits and weight
Proposing a Framework from Practice Experiences gain. From the perspective of research, these ideas are
As members of a practice discipline, nurses may variables. Instead of starting with a framework and
develop research frameworks from their clinical expe- linking the concepts of the framework to possible
riences. Nurses in practice may make generalizations study variables, she was starting with variables and
about patients’ responses as they repeatedly provide needed to identify the concepts that the variables rep-
care to different types of patients. Nurses who reflect resented. She reviewed the literature and looked for
on practice may, over time, realize underlying prin- explanations for why visits by the mother were impor-
ciples of human behavior that guide their choices of tant and what happened when a mother visited the
interventions. Meleis (2012) notes that a nurse may baby. As she reflected on what she read, she realized
have nagging questions about why certain situations that maybe the visits promoted bonding or attachment.
persist or how to improve patient or organizational The researcher continued to reflect on her experiences
outcomes that lead to tentative theories. For example, and remembered that when babies failed to gain
a novice researcher who worked in a newborn inten- weight or lost weight, they were sometimes labeled as
sive care unit was convinced from her clinical experi- “failing to thrive.” Wording that more positively, she
ences that a mother’s frequent visits to the hospital decided the concept related to weight gain was thriv-
were related to her infant’s weight gain. The nurse’s ing. On the basis of her clinical experiences and her
132 UNIT TWO  The Research Process

thinking processes, the researcher began to learn more may have already been identified. If you synthesized
about theories of bonding and used what she learned research findings, you have evidence that supports
to develop a framework for a study related to bonding relationships between or among some or all of the
and thriving of newborns in the neonatal intensive care concepts. This evidence supports the validity of each
(see Figure 7-12). relational statement. This support must include a dis-
Research frameworks rarely develop from only one cussion of previous quantitative or qualitative studies
source of knowledge. Nurse researchers often combine (or both) that have examined the proposed relationship
existing theories, research findings, and insights from and published observations from the clinical practice
their clinical experiences into a framework for a study. perspective.
For example, to study adherence to blood pressure Extracting relational statements from the literary
medications among older Chinese immigrants, Li, text of an existing theory, published research, or clini-
Wallhagen, and Froelicher (2010) derived their model cal literature can be a daunting task. The following
from Becker’s Health Belief Model (1974), findings procedure describes how to do so: Select the portion
from preliminary studies, hypertension literature, and of the theory, research report, or clinical literature that
clinical experience. Whatever your approach to begin- discusses the relationships among the concepts rele-
ning the process, once you have possible concepts and vant to your study. Write single sentences that connect
relationships, you are ready to move through the one concept to another. Change the sentence to a
remainder of the process to develop a framework that diagram of the relationship, similar to those presented
is explicitly expressed in the final research report. A earlier in this chapter (see Figures 7-3 and 7-4). Con-
study framework developed in this way is considered tinue this process until all the relationships in the text
tentative theory until research findings provide evi- have been expressed as diagrams. Burns and Grove
dence to support the relationships as diagrammed. (2011) illustrate this process in greater detail in
Tentative theories are those that are developed from Chapter 7 of their book.
other theories, research findings, and clinical practice If statements relating the concepts of interest are
and that, as of yet, do not have new evidence to support not available in the literature, statement synthesis is
their relational statements. necessary. Develop statements that propose specific
relationships among the concepts you are studying.
Defining Relevant Concepts You may gain the knowledge for your statement syn-
Concepts are selected for a framework on the basis of thesis through clinical observation and integrative lit-
their relevance to the phenomenon you are studying. erature review (Walker & Avant, 2004).
The concepts included in the research framework
should reflect the problem statement and the literature Developing Hierarchical Statement Sets
review of the proposal. Each concept included in a A hierarchical statement set is composed of a spe-
framework must be defined conceptually. Conceptual cific proposition (relational statement) and a hypoth-
definitions may be found in existing theoretical works esis or research question. The specific proposition may
and quoted in the proposal with sources cited. Con- be preceded by a more general proposition when an
ceptual definitions may also be found in published existing theory was the source of the framework. The
concept analyses, previous studies using the concept, proposition is listed first, with the hypothesis or
or the literature associated with an instrument devel- research question immediately following. In some
oped to measure the concept. Although the instrument cases, more than one hypothesis or research question
itself is an operational definition of the concept, the may be developed for a single proposition. This state-
writer will often provide a conceptual definition on ment set indicates the link between the framework and
which the instrument development was based. (See the methodology.
Chapter 8 for more extensive discussion of conceptual
and operational definitions for study variables.) When Constructing a Conceptual Map
acceptable conceptual definitions are not available, A conceptual map is a visual representation of a
you should perform concept synthesis or concept anal- research framework. With the concepts defined and
ysis to develop them. the relational statements diagrammed, you are ready
to visually represent the framework for your study.
Developing Relational Statements The framework may be limited to only the concepts
The next step in framework development is to link all that you are studying or may be inclusive of other
of the concepts through relational statements. If you related concepts that are not going to be studied or
began with an existing theory, theoretical propositions measured. When the framework includes concepts that
CHAPTER 7  Frameworks 133

are not included in the specific study being proposed, may need to reexamine the statements identified. Are
you must clearly identify the portion of the framework there some missing links? Are some of the links inac-
being used. curately expressed?
From a practical standpoint, first arrange the rela- As the map takes shape and begins to seem right,
tional statements you have diagrammed from left to show it to trusted colleagues. Can they follow your
right with outcomes located at the far right. Concepts logic? Do they agree with your links? Can they iden-
that are elements of a more abstract construct can be tify missing elements? Can you explain the map to
placed in a frame or box. Sets of closely interrelated them? Seek out individuals who have experienced the
concepts can be linked by enclosing them in a frame phenomenon you are mapping. Does the process
or circle. Second, using arrows, link the concepts in a depicted seem valid to them? Find someone more
way that is consistent with the statement diagrams you experienced than you in conceptual mapping to
previously developed. Every concept should be linked examine your map closely and critically.
to at least one other concept. Third, examine the Shanks (2010) conducted a pilot study of the
framework diagram for completeness by asking your- quality of life of 15 patients with coronary artery
self the following questions: disease who were receiving external counterpulsation
1. Are all of the concepts in the study also included (ECP). In the literature review section of the article,
on the map? Shanks states, “According to Rector, Anand, and Cohn
2. Are all the concepts on the map defined? (2006), the effect of heart failure pathology on quality
3. Does the map clearly portray the phenomenon? of life (QOL) is mediated by symptoms such as angina
4. Does the map accurately reflect all the statements? and decreased exercise tolerance” (p. 1). The model
5. Is there a statement for each of the links portrayed in the study by Rector et al. is shown in Figure 7-13.
by the map? Shanks (2010) used some of these concepts and pre-
6. Is the sequence of links in the map accurate? sented them in a more linear fashion in her simple
Developing a well-constructed conceptual map conceptual framework (see Figure 7-14). She clearly
requires repeated tries, but persistence pays off. You identified the concepts of cardiac pathology,

Functional Figure 7-13  Conceptual model of the effects


Limitations of heart failure on quality of life whereby
symptoms depend on pathology and mediate
Heart the effects on quality of life. (From Rector,
Quality of
Failure Symptoms T. S., Anand, I. S., & Cohn, J. H. (2006).
Life
Pathology Relationships between clinical assessments
and patients’ perceptions of the effects of
Psychological heart failure on their quality of life. Journal of
Distress Cardiac Failure, 12(2), 88.

ECP

Cardiac Functional Quality of


Pathology Limitations Life

Cardiac SAQ 6-minute SF-36 MLHF


Output walk test Questionnaire

Figure 7-14  The construct-concept-variable continuum. ECP, External counterpulsation; MLHF, Minnesota Living with Heart Failure; SAQ, Seattle
Angina Questionnaire; SF-36 = Short Form 36 Health Survey. (From Shanks, L. C. [2010]. A pilot study to examine relationships among external
counterpulsation, cardiac output, functional capacity, and quality of life [Online exclusive]. Applied Nursing Research, 2010 Dec 28. DOI: 10.1016/
j.apnr.2010.09.002.)
134 UNIT TWO  The Research Process

functional limitations, and quality of life. Her diagram funded or while your data are being collected, use the
also includes the measurements for each concept, thus time to expand the written description of the frame-
providing clear logical links to the study’s methods. work and the evidence supporting its relationships
She described her conceptual framework as follows: into a manuscript for publication (see Chapter 27).
When disseminated, your research framework has the
potential to make a valuable contribution to nursing
“[Figure 7-14] presents a conceptual model based on knowledge.
the model developed by Rector et al. (2006). This
model focuses on the degree to which cardiac pathol-
ogy influences functional limitations and QOL. One KEY POINTS
or two measures were obtained for each of the three
concepts in this model.” (Shanks, 2010, p. 2) • A concept is a term that abstractly describes and
names an object or a phenomenon, thus providing
it with a separate identity or meaning.
Her research questions reflected the conceptual • A relational statement declares that a relationship
model: of some kind exists between two or more
concepts.
• A conceptual model or grand theory broadly
“1.  What are the relationships among cardiac explains phenomena of interest, expresses assump-
pathology, functional limitations, and QOL at tions, and reflects a philosophical stance.
Week 1 (entry into ECP) and Week 7 (end of • A theory is a set of concepts and relational
ECP)? statements explaining the relationships among
2. Is there an improvement in cardiac output at the them.
end of the 7-week ECP program? • Scientific theories have significant evidence and
3. Is there an improvement in functional limitations their relationships may be considered laws.
at the end of the 7-week ECP program? • Substantive theories are less abstract, can easily be
4. Is there an improvement in perceived QOL at applied in practice, and may be called middle-range
the end of the 7-week ECP program?” (Shanks, theories.
2010, p. 2). • Middle-range theories may be developed from
qualitative data, clinical experiences, clinical prac-
tice guidelines, or more abstract theories.
The participants in the study ranged in age from 50 • Tentative theories are developed from research
to 75 years. Most were white, married men. More than findings and clinical experiences and have not yet
50% were retired and had annual incomes less than been validated.
$50,000. Shanks (2010) found no significant correla- • A framework is the abstract, logical structure of
tions in response to research question 1. She also did meaning that guides the development of the study
not find evidence to support improvements in func- and enables the researcher to link the findings to
tional status or QOL, with one exception. There was the body of knowledge used in nursing.
a statistically significant improvement in the 6-minute • Relational statements are the core of the frame-
walk test (research question 3). On the QOL measure, work; it is these statements that are examined
the improvement in the 6-minute walk was further through research.
supported by similar findings related to “physical role, • Every study has either an implicit or explicit theo-
physical function, and bodily pain” (p. 4). Although retical framework.
the small sample precluded generalizing the findings • The steps of critically appraising a research frame-
to other groups, the findings indicate a need for repli- work are (1) describing the concepts and relational
cation with larger samples. statements, (2) examining its logical structure, (3)
The product of the creative and critical thinking evaluating the extent to which the framework
that you have expended in the development of your guided the methodology, and (4) determining the
research framework may provide a structure for one extent to which the researcher connected the find-
study or become the basis for a program of research. ings to the framework.
Continue to consider the framework as you collect • The logical adequacy of a research framework is
and analyze data and interpret the findings. While the extent to which the relational statements are
you wait to hear whether your proposal has been clear and used consistently.
CHAPTER 7  Frameworks 135

• The framework should be well integrated with the competing hypotheses. Journal of Counseling Psychology, 55(2),
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Curley, M. (2007). Synergy: The unique relationship between nurses
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  http://evolve.elsevier.com/Grove/practice/

8
CHAPTER

Objectives, Questions, Hypotheses,


and Study Variables

R
esearchers formulate objectives, questions, and identify relationships or associations among vari-
hypotheses to bridge the gap between the more ables, determine differences between groups or
abstractly stated research purpose and the compare groups on selected variables, and predict a
detailed plan for data collection and analysis. Objec- dependent variable on the basis of selected indepen-
tives, questions, and hypotheses delineate the study dent variables.
variables, the relationships among the variables, and, A combination of the following formats might
often, the population to be studied. be used in developing objectives to guide a study.
Study variables are concepts at various levels of The focus of each objective is identified in the
abstraction that are measured, manipulated, or con- parentheses at the end of each statement. The objec-
trolled in a study. Concrete concepts, such as tempera- tives are placed in order from the least complex
ture, weight, and blood pressure, are referred to as to the most complex in generating research evi-
variables in a study; abstract concepts, such as creativ- dence. Thus, the objectives or aims of studies
ity, empathy, and social support, are sometimes might be to:
referred to as research concepts. Research variables 1. Identify the elements or characteristics of variable
and concepts are conceptually defined, on the basis of X in a selected population (identification).
the study framework, and are operationally defined to 2. Describe variable X in a selected population
direct their measurement, manipulation, or control in (description).
a study. 3. Determine the difference between groups 1 and 2
In this chapter, you will explore when objectives, or to compare groups 1 and 2 on variable X in a
questions, or hypotheses might be developed to direct selected population (difference).
the conduct of a study. You will also learn how to 4. Examine the relationship between variables X and
formulate research objectives, questions, and hypoth- Y in a selected population (relational).
eses, especially how to test different types of hypoth- 5. Determine whether certain independent variables
eses through research. This chapter concludes with a are predictive of a dependent variable in a selected
discussion of different types of variables and direction population (prediction).
for conceptually and operationally defining variables
for a study. Formulating Objectives or Aims
in Quantitative Studies
The objectives or aims in quantitative studies are
Formulating Research Objectives developed on the basis of the research problem and
purpose to clarify the study goals, variables, and popu-
or Aims lation. The following excerpts, from a descriptive
Research objectives or aims are clear, concise, study of the symptom management strategies used by
declarative statements expressed in the present tense elderly patients after coronary artery bypass surgery
that usually are presented following the study (CABS), demonstrate the logical flow from research
purpose to specify the study focus. For clarity, an problem (including the problem significance, back-
objective usually focuses on one or two variables ground, and statement) and purpose to research aims
(or concepts) and indicates whether the variables are (Schulz, Zimmerman, Pozehl, Barnason, & Nieveen,
to be identified or described. Objectives can also 2011).

138
CHAPTER 8  Objectives, Questions, Hypotheses, and Study Variables 139

evidence-based guidelines developed by the American


Research Problem Heart Association. Schulz et al. (2011, p. 65) found,
“A major component of nursing care after coronary
“Three weeks after surgery, the most frequently used
artery bypass surgery (CABS) is focused on educating
strategies were rest to manage shortness of breath
patients to recognize and manage postoperative sym­
(53%) and fatigue (53%), medications for incision
ptoms [problem significance]. The symptoms com­
pain (24%), and repositioning for swelling (35%) and
monly experienced have been well documented in
sleep disturbance (18%). Overall, fewer patients expe-
the literature and include sleep disturbances (Tranmer
riencing sleep disturbances (39%), incision pain
& Parry, 2004; Zimmerman, Barnason, Nieveen, &
(39%), swelling (46%), and appetite problems (17%)
Schmaderer, 2004), fatigue (Tranmer & Parry, 2004;
reported using a strategy to manage their symptoms.”
Zimmerman et al., 2004), swelling (Tranmer & Parry,
Thus, the researchers stressed the importance of
2004; Zimmerman et al., 2004), shortness of breath
nurses’ education of patients about symptom identifi-
(SOB), appetite problems, and chest and leg incision
cation and effective management strategies to improve
pain (Zimmerman et al., 2004) [problem background].
recovery following CABS.
Although much has been done to document postop­ Formulating Objectives or
erative symptoms, very little has been done to
describe the strategies that patients use to manage
Aims in Qualitative Studies
these symptoms [problem statement].” (Schulz et al.,
Many qualitative studies are guided by the study
2011, pp. 65-66)
purpose and do not include research objectives or
questions. However, some qualitative researchers do
Research Purpose develop objectives to guide selected studies. The
“The purpose of this study was to describe the
objectives in qualitative studies usually have a broader
symptom management strategies used by older adults
focus and include more abstract and complex vari-
after CABS.” (Schulz et al., p. 66)
ables or concepts than those in quantitative studies
(Munhall, 2012). An ethnographic study by Happ,
Research Aims Swigart, Tate, Hoffman, and Arnold (2007) included
“The specific aims of this study were to examine data
objectives to direct their investigation of patients’
3 and 6 weeks after CABS to (a) identify categories
involvement in health-related decisions during pro-
of symptom management strategies from patient’s
longed critical illness, as shown by the following
self-report data; (b) describe symptom management
excerpts.
strategies used for frequently reported symptoms
including SOB, fatigue, incision pain, sleep distur­ Research Problem
bance, swelling, and appetite problems; and (c) deter­
mine if patients used appropriate strategies to manage “Clinicians increasingly recognize the need to involve
symptoms by comparing reported symptom manage­ patients in decision making before, and, if possible,
ment strategies to current evidence.” (Schulz et al., during prolonged critical illness, but have little guid­
2011, p. 66) ance as to how and when to do this most effectively
[problem significance].… Prior reports of studies con­
taining the number of patients able to communicate
In this example, the problem provides a basis for treatment preferences or to participate in decisions
the purpose, and the aims evolve from the purpose to during an acute or critical illness vary from none to
clearly focus the conduct of the study. The first aim as high as 48% [problem background].… Moreover,
was focused on identification of the categories of few reports of studies of treatment decision making
symptom management strategies (variable) used by indicate the criteria used to make decisional capacity
older adults (population) 3 and 6 weeks after CABS assessments.… Consequently, empirical knowledge
(hospital and home settings). The study participants of practice in this important area of patient care is
were recruited from four Midwestern hospitals, but the limited [problem statement].” (Happ et al., 2007, pp.
majority of data collection took place in the partici- 361-362)
pants’ homes. The second aim was focused on descrip-
tion of the older adults’ symptom management Research Purpose
strategies (variable) used. The third objective was The purpose of this study was to “describe patterns
focused on comparison of or differences in patients’ of communication of patients involved in health-
reported symptom management strategies and current
140 UNIT TWO  The Research Process

2. How is variable X described by a selected popula-


related decision making during prolonged mechani­ tion (description)?
cal ventilation (PMV)” (Happ et al., 2007, p. 362). 3. Is there a difference between groups 1 and 2 regard-
ing variable X (difference)?
Research Objectives
4. What is the relationship between variables X and Y
The objectives of this study were to “describe: (a) in a selected population (relational)?
characteristics of patients who were involved in 5. Are independent variables W, X, and Y predictive
health-related decisions; (b) types of health-related of dependent variable Z (prediction)?
decisions made with patient involvement; (c) how
patient involvement occurred; and (d) the extent of Formulating Questions in Quantitative Studies
patient involvement with health-related decisions Delaney, Apostolidis, Lachapelle, and Fortinsky (2011,
during PMV” (Happ et al., 2007, p. 361). p. 285) conducted a comparative descriptive study to
examine “home care nurses’ knowledge of evidence-
In this ethnographic study, the problem statement based education topics for management of heart
indicated that inadequate research had been conducted failure.” The following excerpts from this study dem-
on patient involvement in health-related decisions onstrate the flow from research problem and purpose
during critical illness, which provided a basis for the to research questions.
study purpose. All four objectives focused on detailed
descriptions of the study variables: (1) characteristics
of patients undergoing PMV, (2) health-related deci-
sion making of these patients, (3) how patient involve- Research Problem
ment in decision making occurred, and (4) extent of “Heart failure (HF), a chronic and disabling syndrome
patient decision making. The findings from this study affecting adults of all ages and particularly older adults,
indicated that families, advanced practice nurses, and is a major public health problem. An estimated 5.7
physicians were engaging critically ill patients in deci- million Americans are currently affected by HF, and
sion making whenever possible. However, most of the this figure is expected to double over the next 25
time the patients could not make independent deci- years, primarily because of the aging of the population
sions but were able to share decision making with their and decreased mortality from other cardiovascular
families and clinicians. These findings emphasize how conditions (Hodges, 2009).… HF is characterized by
important it is for families and clinicians to include poor posthospital discharge outcomes [problem sig-
critically ill patients in health-related decisions at nificance].… Home care agencies are currently being
whatever level possible (Happ et al., 2007). challenged by Centers for Medicare and Medicaid
Services (CMS) to improve outcomes in HF manage­
ment.… Home care nurses play key roles in the deliv­
Formulating Research Questions ery of education to patients and their families [problem
A research question is a concise, interrogative state- background]. However, home care nurses face unique
ment that is worded in the present tense and includes challenges compared with nurses at other sites
one or more variables (or concepts). The research of care in providing comprehensive education on
questions focus on the following: (1) the identification managing HF. These challenges include a lack of
and/or description of the variable(s), (2) a determina- access to detailed patient information (Bowles, Pham,
tion of differences between two or more groups O’Connor, & Horowitz, 2010), a focus on generalist
regarding selected variables, (3) an examination of rather than specialist practice, and few opportunities
relationships among variables (relational), and (4) the for continuing education in specialized knowledge
use of independent variables to predict a dependent such as managing HF [problem statement].” (Delaney
variable. et al., 2011, p. 286)
You might use the following formats in developing
research questions for a study (the focus for each ques- Research Purpose
tion is shown in parentheses). The levels of evidence The purpose of this study was to examine “home care
to be generated by the following research questions nurses’ knowledge of evidence-based HF education
progress from simple (identification) to complex related to the disease process, its management, and
(prediction). patients’ self-management” (Delaney et al., 2011,
1. What are the elements or characteristics of variable p. 286).
X in a selected population (identification)?
CHAPTER 8  Objectives, Questions, Hypotheses, and Study Variables 141

Research Questions older adults.… Homeless young adults are highly vul­
nerable to negative health consequences because of
Research questions included the following:
the realities of street life [problem significance].…
“(1) What is the level of knowledge of home care
Homeless young persons are at risk for sexual and
nurses regarding evidence-based education
physical abuse.… Other negative health conse­
topics for patients with HF?…
quences experienced by homeless young adults
(2) Were differences evident in nurses’ knowledge
include sexually transmitted infections, poorly con­
based on education and work experience?…
trolled chronic mental illness, and lack of immuniza­
(3) What are home care nurses’ self-reported
tion for conditions, such as hepatitis A and hepatitis
knowledge needs related to the care of patients
B (Hudson, Nyamathi, & Sweat, 2008).… Homeless
with HF?” (Delaney et al., 2011, p. 287)
persons are more likely to be admitted to the hospital
and have increased durations of hospitalization than
Question 1 focused on description of the home care those of nonhomeless persons due to negative health
nurses’ (population) knowledge about HF (variable). consequences associated with street living.… Nearly
Question 2 focused on determining differences in the half of all homeless young persons have no regular
nurses’ knowledge on the basis of educational level source of health care (Sneller et al., 2008) [problem
and years of work experience (demographic vari- background].… The perceptions of how homeless
ables). Question 3 focused on description of the persons view the health care system have not been
nurses’ self-reported knowledge needs (variable) in well studied.… There is a growing assertion that
managing patients with HF. Delaney et al. (2011) improvements should be made with respect to the
found that home care nurses were limited in their provision of quality care for the homeless young
evidence-based knowledge for managing HF. There adults living in the United States.… One way to
were no significance differences in the nurses’ knowl- achieve high-quality programs designed to improve
edge and their educational level and years of experi- health care for homeless adults is to solicit these
ence. The researchers concluded that the home care adults’ input in program development [problem state-
nurses needed educational programs focused on HF ment].” (Hudson et al., 2010, pp. 212-213)
patient management to improve the quality of patient
Research Purpose
education they could provide.
“The purpose of this article was to gain a further
Formulating Questions in Qualitative Studies understanding of the perceptions of homeless youth
The questions in qualitative studies are often limited in regarding their healthcare-seeking behaviors”
number, have a broad focus, and include concepts that (Hudson et al., 2010, p. 213).
are more complex and abstract than those in quantita-
Research Questions
tive studies. Marshall and Rossman (2011) noted that
the questions in qualitative research either might be This study included the following research questions:
theoretical ones, which can be studied with different “1.  What are homeless young adults’ perspectives on
populations or in a variety of sites, or could be focused facilitators and barriers to receiving health care?
on a particular population or setting. Hudson et al. 2.  How can existing homeless youth and young-
(2010) conducted an exploratory-descriptive qualita- adult-centered healthcare programs be
tive study to examine the health-seeking challenges improved?” (Hudson et al., 2010, 213)
perceived by homeless young adults. The problem,
purpose, and research questions used to direct this
study are presented in the following excerpts. The first study question focused on developing a
description of the homeless young adults’ (popula-
tion) perspectives on facilitators and barriers to receiv-
Research Problem ing health care (research concepts). The second
“Adolescent homelessness is a distressing social question focused on identifying and describing how
problem. Approximately 1.5 to 2 million homeless young-adult-centered healthcare programs can be
adolescent persons live on the streets in the United improved (research concept). The study’s “identified
States (Bucher, 2008); homelessness among young themes were failing access to care based on perceived
persons is more common than homelessness among structural barriers (limited clinic sites, limited hours
of operation, priority health conditions, and long wait
142 UNIT TWO  The Research Process

times) and social barriers (perception of discrimina- testing, because certain patients might not be receiving
tion by uncaring professionals, law enforcement, and adequate pain management.
society in general…)” (Hudson et al., 2010, p. 212). You could conduct a literature review to identify a
The researchers also gained insights into the program- theory that supports this relationship. For example,
matic and agency resources that are needed to promote Fagerhaugh and Strauss (1977) developed a theory of
health-seeking behaviors by homeless young adults. pain management and identified the following rela-
tionship or proposition: As expressions of pain
increase, pain management increases. The researchers
Formulating Hypotheses developed this proposition through the use of grounded
A hypothesis is the formal statement of the expected theory research. Additional testing is necessary to
relationship or relationships between two or more determine its usefulness in describing how patients
variables in a selected population. The hypothesis express pain and how that pain is managed in a variety
translates the problem and purpose into a clear expla- of practice situations. On the basis of theory and clini-
nation or prediction of the expected results or out- cal observation, the following hypothesis might be
comes of the study (Shadish, Cook, & Campbell, formulated: The more frequently a hospitalized patient
2002). This section describes the purpose, sources, verbalizes perceptions of pain, the greater the admin-
and types of hypotheses that are commonly developed istration of analgesic medications by healthcare
by researchers. In addition, the process for developing providers.
and testing hypotheses in nursing studies is described. Some hypotheses are initially generated from rela-
tionships expressed in a theory, when the intent of the
Purpose of Hypotheses researcher is to test a theory. Usually, middle-range
The purpose of a hypothesis is similar to that of theories are tested in research, and a proposition or
research objectives and questions. A hypothesis (1) relationship from the theory provides the basis for the
specifies the variables you will manipulate or measure, generation of one or more study hypotheses (Fawcett
(2) identifies the population you will examine, (3) & Garity, 2009; Smith & Liehr, 2008). For example,
indicates the type of research, and (4) directs the Rungruangsiripan, Sitthimongkol, Maneesriwongul,
conduct of your study. Hypotheses direct the conduct Talley, and Vorapongsathorn (2011) tested the rela-
of a study by influencing the study design, sampling tionships in the Common-Sense Model of Illness Rep-
technique, data collection and analysis methods, and resentation (Diefenbach & Leventhal, 1996) to
interpretation of findings. Hypotheses differ from examine the factors affecting medication adherence in
objectives and questions by predicting the outcomes individuals with schizophrenia. Figure 8-1 contains
of a study. Study hypotheses are used to organize the the framework model for this study based on the
results section of a study, and the results indicate Common-Sense Model of Illness Representation,
support or nonsupport of each hypothesis. Hypothesis which has three stages: sources of information, illness
testing allows us to generate knowledge by testing representation, and coping. “Sources of information
theoretical statements or relationships that were iden- included social support variable, therapeutic alliance
tified in previous research, proposed by theorists, or variable, and experience of medication side effects
observed in practice (Chinn & Kramer, 2008; Fawcett variable. Coping consisted of intention to change
& Garity, 2009). adherence behavior and adherence behavior” (Run-
guangsiripan et al., 2011, p. 272). This model shows
Sources of Hypotheses the direct and indirect relationships among the con-
Research hypotheses can be generated by observing cepts that provide a basis for the study hypotheses. A
phenomena or problems in nursing practice, analyzing direct relationship is when one concept links to another
theory, and reviewing the research literature. Many concept without an intervening concept. For example,
hypotheses originate from real-life experiences. Clini- the concept of social support is linked directly to
cians and researchers observe events in practice and illness representation. In an indirect relationship, one
identify relationships among these events (theorizing), concept is linked to another concept through an inter-
which are the bases for formulating hypotheses. For vening third concept. For example, the concept experi-
example, you may notice that the hospitalized patient ence with medication side effects is indirectly linked
who complains the most about pain receives the most to the concept intention to change adherence behavior
pain medicine and other pain management strategies. through the concept of illness representation (see
The relationship identified is a prediction about events Figure 8-1). The Rungruangsiripan et al. (2011) study
in clinical practice that has potential for empirical set the following hypotheses:
CHAPTER 8  Objectives, Questions, Hypotheses, and Study Variables 143

Social Support

+ Illness
Therapeutic Representation
Alliance

+
+
+
– Intention to Change
Adherence Behavior

Experience of Medication
– –
Side Effects

Adherence Behavior

Figure 8-1  Hypothesized medication adherence model. (From Rungruangsiripan, M., Sitthimongkol, Y., Maneesriwongul, W., Talley, S., &
Vorapongsathorn, T. [2011]. Mediating role of illness representation among social support, therapeutic alliance, experience of medication side effects,
and medication adherence in persons with schizophrenia. Archives of Psychiatric Nursing, 25[4], 273.)

These hypotheses were formulated to test the prop-


“(a)  Social support and therapeutic alliance would ositions or relationships from the Common-Sense
have a positive direct effect on illness Model of Illness Representation (see Figure 8-1). The
representation and adherence behavior in researchers found that “therapeutic alliance and the
individuals with schizophrenia; experience of medication side-effects enhanced illness
(b)  Experience of medication side effects would representation, which in turn led to an intention to
have a negative direct effect on illness change adherence behavior. Social support did not
representation and adherence behavior in alter illness representation or adherence behavior”
individuals with schizophrenia; (Rungruangsiripan et al., 2011, p. 269). Illness repre-
(c)  Intention to change adherence behavior would sentation is the patients’ perception of their schizo-
have a negative direct effect on adherence phrenia and their ability to cope with the illness.
behavior; Patients with a clear perception of their schizophrenia
(d)  Social support, therapeutic alliance, and have strong intentions to change their adherence
experience of medication side effects would behaviors. Thus, mental health nurses need to promote
have an indirect effect on intention to change the patients’ understanding of their schizophrenia
adherence behavior and adherence behavior illness to enhance their adherence to their
through illness representation; and medications.
(e)  Illness representation would have a positive Reviewing the research literature and synthesizing
direct effect on intention to change adherence findings from different studies can also be used to
behavior and adherence behavior as well as an generate hypotheses. For example, Ross, Sawatphanit,
indirect effect on adherence behavior via Mizuno, and Takeo (2011) synthesized the findings
intention to change adherence behavior.” from studies to identify the factors that predict depres-
(Rungruangsiripan et al., 2011, p. 272) sive symptoms in postpartum women who are HIV-
positive. They developed a conceptual framework for
144 UNIT TWO  The Research Process

Types of Hypotheses
Self-esteem Hypotheses identify different types of relationships
and include different numbers of variables. Studies
– might have one, three, or more hypotheses, depending
on the complexity and scope of the study. The type of
Emotional hypothesis developed is based on the problem and
Support –
purpose of a study. The following four categories are
Depressive used to describe types of hypotheses: (1) associative
Symptoms versus causal, (2) simple versus complex, (3) direc-
+ tional versus nondirectional, and (4) null versus
Physical research.
Symptoms

Associative versus Causal Hypotheses
The relationships in hypotheses are identified as asso-
ciative or causal. An associative relationship identi-
Infant fies variables that occur or exist together in practice,
Health Status and as one variable changes so does the other. For
example, research indicates there is an associative
Figure 8-2  Conceptual framework of the study. (From Ross, R., relationship between anxiety and depression, and as a
Sawatphanit, W., Mizuno, M., & Takeo, K. [2011]. Depressive symptoms person’s depression changes so does the anxiety level.
among HIV-positive postpartum women in Thailand. Archives of Thus, associative hypotheses are developed to
Psychiatric Nursing, 25[1], 37.) examine relationships among variables in a study. The
formats used for expressing associative hypotheses
follow:
1. Variable X is related to or associated with variable
their study that is presented in Figure 8-2. The Y in a selected population. (Predicts a relationship
researchers “hypothesized that depressive symptoms between two variables but does not indicate the
are negatively related to self-esteem, emotional type of relationship.)
support, and infant health status but positively associ- 2. An increase in variable X is related to an increase
ated with physical symptoms” (Ross et al., 2011, in variable Y, or variable X is positively related to
p. 37). variable Y in a selected population. (Predicts a posi-
Ross et al. (2011) found that self-esteem and infant tive relationship.)
health status were significant predictors of postpartum 3. A decrease in variable X is related to a decrease in
women’s depressive symptoms but physical symp- variable Y in a selected population. (Predicts a posi-
toms and emotional support were not. The study tive relationship.)
results indicated that 74.1% of the HIV-positive post- 4. An increase in variable X is related to a decrease
partum women had symptoms of depression, and the in variable Y, or variable X is negatively related to
researchers encouraged nurses to examine the self- variable Y in a selected population. (Predicts a
esteem and infant health status of such women to negative or inverse relationship.)
increase identification of episodes of depression. The 5. Variables X and Y are predictive of variable Z in a
researchers also recommended further research to study. (The independent variables X and Y are used
identify additional factors that might be predictive of to predict the dependent variable Z in a predictive
depression in HIV-positive postpartum women. Thus, correlational study.)
two relationships, those of self-esteem and infant Associative hypotheses identify relationships among
health status to depressive symptoms, were supported variables in a study but do not indicate that one variable
in the framework model (see Figure 8-2). However, causes an effect on another variable. Researchers state
the other relationships, those of emotional support and associative hypotheses when the focus of their study is
physical symptoms to depressive symptoms, were not to examine relationships and not to determine cause
supported in this study. Additional research is needed and effect. For example, Reishtein (2005) conducted
to increase understanding of the factors that might be a predictive correlational study to examine the relation-
predictive of depression in postpartum women who ships between symptoms and functional performance in
are HIV-positive. patients with chronic obstructed pulmonary disease
CHAPTER 8  Objectives, Questions, Hypotheses, and Study Variables 145

(COPD). Reishtein developed the following associative The results from Reishtein’s (2005) study partially
hypotheses to guide the study: supported hypothesis 1, in that dyspnea had positive,
significant relationships with fatigue (r = 0.43, p <
0.001) and sleep difficulty (r = 0.39, p < 0.001), but
“1.  Positive relationships exist among dyspnea, fatigue and sleep difficulty were positively but not
fatigue, and sleep difficulty in people with significantly related (r = 0.19). Hypothesis 2 was also
COPD; partially supported in that dyspnea (r = −0.54, p <
2.  Dyspnea, fatigue, and sleep difficulty are related 0.001) and fatigue (r = −0.24, p < 0.01) were signifi-
to functional performance; and cantly, negatively related to functional performance,
3.  Dyspnea, fatigue, and sleep difficulty, taken but sleep difficulty (r = −0.17) was not. Thus, in
together, will explain more of the variance in hypothesis 3, dyspnea was the most predictive of func-
functional performance in people with COPD tional performance, with fatigue and sleep difficulty
than any of these symptoms alone.” (Reishtein, providing limited prediction. Thus, managing dyspnea
2005, p. 40) may be the best way to improve the symptoms and
functional performance in patients with COPD. Addi-
tional research may distinguish other symptoms that
Hypothesis 1 predicts positive relationships or might predict functional performance in COPD
associations among the variables of dyspnea, fatigue, patients and thereby help them and healthcare provid-
and sleep difficulty for patients with COPD. A positive ers in managing this chronic disease.
relationship means that the variables change together; Causal relationships identify a cause-and-effect
thus, they will all increase together in value or all interaction between two or more variables, which are
decrease together. These relationships are depicted in referred to as independent and dependent variables.
the following diagram: The independent variable (intervention, treatment,
or experimental variable) is manipulated or varied
by the researcher to have an effect on the dependent
+
Dyspnea Fatigue variable. The dependent variable (outcome or
response variable) is measured to examine the effect
+ + created by the independent variable. A format for
stating a causal hypothesis is as follows: Subjects
Sleep Difficulty
experiencing the independent variable X demonstrate
greater change in dependent variable Y than do the
Hypothesis 2 predicts relationships between three subjects in the control or comparison group. For
variables—dyspnea, fatigue, and sleep difficulty—and example, cancer patients receiving a relaxation music
the variable functional performance, but it does not intervention have less perceived pain than those
identify the type of relationship. These relationships receiving usual care.
are shown in the following diagram: Scott, Hofmeister, Rogness, and Rogers’s (2010)
review of the literature indicated that nurses working
Dyspnea 12-hour shifts had difficulties staying awake on duty,
reduced time for sleep, and significantly higher risk
Fatigue for errors. Thus, these researchers conducted a quasi-
Functional performance
experimental study to determine the effect of a fatigue
countermeasures program for nurses (FCMPN) on
Sleep difficulty nurses’ alertness and number of near and actual patient
errors. A causal hypothesis was tested in the conduct
Hypothesis 3 uses the independent variables of this study. The researchers hypothesized that imple-
dyspnea, fatigue, and sleep difficulty to predict the menting the FCMPN had the potential for improving
dependent or outcome variable functional perfor- sleep quality and sleep duration and decreasing
mance in COPD patients. The predictive relationship daytime sleepiness, drowsiness episodes, risk for auto
is shown in the following diagram: accidents, and actual and near reported work errors
(Scott et al., 2010).
Dyspnea + Fatigue + Sleep Difficulty → The independent variable or study intervention was
Functional Performance the FCMPN that was implemented to determine its
146 UNIT TWO  The Research Process

impact on the dependent or outcome variables sleep supported for the outcome daytime sleepiness. The
quality, sleep duration, daytime sleepiness, drowsiness interpretation of the results might have been facilitated
episodes, auto accident risk, and work errors. The by the statement of additional hypotheses with fewer
study population was hospital staff nurses, and the dependent variables in each hypothesis. A diagram of
settings were medical-surgical units in three major this hypothesis follows, with causal arrows (→) indi-
acute care Michigan hospitals. Scott et al. (2010) cating the cause-and-effect relationship between the
found that the FCMPN significantly improved the hos- independent variable (IV) and dependent variables
pital nurses’ sleep duration, sleep quality, alertness (DVs). Causal arrows indicate the effect of IV on the
(fewer episodes of drowsiness), and accident and error DV (see Chapter 7 for discussion of types of relation-
risk. However, there was not significant improvement ships). After each dependent variable is indicated
in daytime sleepiness. Thus, the hypothesis was sup- whether this part of the hypothesis was supported or
ported for five of the six dependent variables and not not supported.

Independent Variable Dependent or Outcome Variables

Sleep quality (supported)


+
+ Sleep duration (supported)
Fatigue Countermeasures
Program for Nurse –
(FCMPN) Daytime sleepiness (not supported)

Drowsiness episodes (supported)

Risk of auto accidents (supported)

Actual and near reported work errors (supported)

Simple versus Complex Hypotheses The results of this 8-year study indicated that an ele-
A simple hypothesis predicts the relationship (asso- vated plasma homocysteine concentration was posi-
ciative or causal) between two variables. One format tively and strongly related to risk of CHF in both men
for stating a simple associative hypothesis is as and women who did not have a prior history of MI.
follows: Variable X is related to variable Y. A simple The hypothesis was supported in this study, indicating
causal hypothesis identifies the relationship between that nurse practitioners and clinical nurse specialists
one independent variable and one dependent variable, need to examine plasma homocysteine levels in indi-
for example, independent variable X causes a change viduals with a family history of CHF and treat those
in dependent variable Y. Vasan et al. (2003) studied levels as needed.
the relationship of elevated plasma homocysteine A complex hypothesis predicts the relationship
levels with the risk for congestive heart failure (CHF) (associative or causal) among three or more variables.
in adults without prior myocardial infarction (MI). A A complex associative hypothesis predicts the rela-
simple, associative hypothesis was developed to direct tionships among three or more variables, such as the
this study: “We hypothesized that elevated plasma relationships among the variables X, Y, and Z. Complex
homocysteine levels are associated with an increased causal hypotheses also include three or more variables
risk for CHF” (Vasan et al., 2003, p. 1251). The fol- but predict the effects of one independent variable on
lowing diagram demonstrates the positive relationship two (or more) dependent variables or predict the
that was identified between the two study variables of effects of two or more independent variables on one
plasma homocysteine level and risk for CHF: or more dependent variables. For example, Scott et al.

+
↑ Plasma homocysteine level ↑ Risk for CHF
CHAPTER 8  Objectives, Questions, Hypotheses, and Study Variables 147

(2010) tested a complex causal hypothesis in their associations among variables), complex (includes five
examination of the effects of the nurse fatigue inter- variables), and directional (identifies positive and
vention program (FCMPN) on the sleep duration, negative associations among variables).
sleep quality, daytime sleepiness, drowsiness episodes, A causal hypothesis predicts the effect of an inde-
risk of auto accident, and actual and near reported pendent variable on a dependent variable, specifying
work errors. The figure presented earlier demonstrat- the direction of the relationship. Thus, all causal
ing this causal hypothesis includes one independent hypotheses are directional. Efe and Özer (2007) exam-
variable, FCMPN, and six dependent or outcome vari- ined the pain-relieving effect of breast-feeding during
ables. This intervention offers potential benefits for immunization injections in healthy neonates and used
managing nurses’ fatigue but requires additional a causal hypothesis to direct their study. “The hypoth-
investigation to determine its effectiveness in manag- esis tested was that breast-feeding would decrease the
ing daytime sleepiness. Often, in practice situations, length of crying time, prevent an increase in heart rate,
multiple variables cause an event, or an intervention and prevent a decrease in oxygen saturation during
results in multiple outcomes. Therefore, complex vaccination as compared with the control condition
rather than simple associative or causal hypotheses are (i.e., no breast-feeding)” (Efe & Özer, 2007, p. 11).
often more representative of nursing practice. This causal hypothesis predicted the effect of an inter-
vention or independent variable, breast-feeding,
Nondirectional versus Directional Hypotheses during immunization injections on the dependent or
A nondirectional hypothesis states that a relationship outcome variables length of crying time, heart rate,
exists but does not predict the nature of the relation- and oxygen saturation. Thus, this is a complex (four
ship. If the direction of the relationship being studied variables), directional (decrease crying time and
is not clear in clinical practice or the theoretical or prevent increased heart rate and decreased oxygen
empirical literature, the researcher has no clear indica- saturation), causal hypothesis. The breast-feeding sig-
tion of the nature of the relationship and states a non- nificantly decreased crying time but did not signifi-
directional hypothesis (Fawcett & Garity, 2009). For cantly affect the neonates’ heart rate or oxygen
example, Reishtein’s (2005, p. 4) second hypothesis saturation values. Because breast-feeding did decrease
(introduced earlier in this chapter) is nondirectional: neonate crying time during immunizations, nurses
“Dyspnea, fatigue, and sleep difficulty are related to might encourage mothers to implement this safe, easy,
functional performance.” This hypothesis indicates effective intervention in practice.
that dyspnea, fatigue, and sleep difficulty are related
to functional performance, but it does not indicate the Null versus Research Hypotheses
direction or nature (positive or negative) of the rela- The null hypothesis (H0), also referred to as a statisti-
tionship. This hypothesis is nondirectional, complex cal hypothesis, is used for statistical testing and inter-
(four variables), and associative (indicating that a rela- pretation of these results. Even if the null hypothesis
tionship exists). is not stated, it is implied, because it is the converse
A directional hypothesis states the nature or direc- of the research hypothesis (Kerlinger & Lee, 2000;
tion of the relationship between two or more variables. Shadish et al., 2002). A null hypothesis can be simple
These hypotheses are developed from theoretical or complex and associative or causal. An associative
statements, findings of previous studies, and clinical null hypothesis states that there is no relationship
experience. As the knowledge on which a study is between the variables studied. A causal null hypoth-
based increases, the researcher is able to predict the esis might be stated in one of the following formats:
direction of a relationship between the variables being 1. The independent variable has no effect on the
studied. Terms such as less, more, increase, decrease, dependent variable.
positive, negative, greater, and smaller indicate the 2. The experimental group, who received the inde-
directions of relationships in hypotheses. Directional pendent variable, is no different from the control
hypotheses can be associative or causal and simple or or comparison group for the dependent variable.
complex. In a study introduced earlier, Ross et al. Youngkin and Lester (2010, p. 5) conducted a study
(2011) “hypothesized that depressive symptoms are to “(a) determine if nonpregnant, childbearing-age
negatively related to self-esteem, emotional support, women could accurately self-screen to predict BV
and infant health status but positively associated [bacterial vaginosis] using a researcher-developed
with physical symptoms” based on their framework home self-test system comprised of three integrated
model [see Figure 8-2] (Ross et al., 2011, p. 37). This components—education, application of self-test
hypothesis is associative (examines relationships or method, and scoring of self-test findings using a
148 UNIT TWO  The Research Process

unique scoring system—and (b) determine if the hypothesis when she or he believes there is no rela-
women would seek early professional diagnosis and tionship between two or more variables and when
treatment.” These researchers developed two hypoth- there is inadequate theoretical or empirical informa-
eses to direct their study: tion to state a research hypothesis. Otherwise it is best
to state a research hypothesis that clearly predicts the
outcome of a study. As previously discussed, Young-
“The researchers expected to find a significant posi­ kin and Lester (2010) stated both a research hypoth-
tive correlation between the self-screening scores esis and a null hypothesis based on previous research
from the women and the follow-up evaluation scores and clinical expertise. They expected both hypotheses
from the nurse researchers using the self-test system. to be supported by their study results, and they were.
It was further expected that there would be no sig­
nificant differences between the women’s scores on Developing Hypotheses
the criteria using the scoring method and the related Developing hypotheses requires inductive and deduc-
researchers’ scores.” (Youngkin & Lester, 2010, p. 5) tive thinking. Most people have a predominant way of
thinking and will use that thinking pattern in develop-
The first hypothesis is associative (identifies a rela- ing hypotheses. Inductive thinkers have a tendency to
tionship between women’s scores and researchers’ focus on the relationships they observe in clinical prac-
scores on the self-test system), simple (includes two tice, and they synthesize these observations to formu-
variables), and directional (examines positive correla- late a general statement about the relationships. For
tion or relationship). The second hypothesis is a null example, inductive thinkers might note that elderly
hypothesis that states there is no difference between patients who are not instructed in the importance of
the women’s and the researchers’ scores on the basis early postoperative ambulation are slow to get out of
of the scoring method. Null hypothesis is nondirec- bed. Deductive thinkers examine more abstract state-
tional since it states that no relationship exists between ments from theories or previous research and then
variables or that no difference exists between groups. formulate a hypothesis for study (Smith & Liehr, 2008).
Research hypotheses are supported or not supported Deductive thinkers might translate a statement or prop-
and null hypotheses are accepted or rejected on the osition, such as “People who receive education about
basis of statistical results. Youngkin and Lester (2010) self-care are more capable in caring for themselves,”
stated a simple null hypothesis about no difference from Orem’s (2001) theory into a hypothesis.
between the women’s and researchers’ scores on the The inductive thinker must link the relational state-
basis of previous research and their clinical expertise. ment or hypothesis that was developed from clinical
The researchers found that the women accurately observations with a theoretical framework. Making
tested themselves for BV using the self-test system this connection with the framework requires deductive
and appropriately sought definitive professional diag- thinking and improves the usefulness of the study
nosis and treatment. Thus, the research hypothesis was findings. The deductive thinker must use inductive
supported and the null hypothesis was accepted on the thinking to determine whether the proposition from a
basis of study results. theory accurately predicts the relationship of events in
A research hypothesis is the alternative hypothesis clinical practice. Without this real-world experience,
(H1 or Ha) to the null. The research hypothesis states the selection of subjects and the identification of ways
that there is a relationship between two or more vari- to measure the variables would be unclear. An example
ables, and it can be simple or complex, nondirectional hypothesis is, “Elderly patients receiving an activity
or directional, and associative or causal. The predic- educational program before surgery ambulate earlier
tion in a research hypothesis might be based on theo- and have a shorter hospital stay after surgery than
retical statements, previous research findings, and/or elderly patients receiving standard care.”
clinical experience. All the previous examples of In formulating a hypothesis, you as a researcher
hypotheses presented in this chapter are research will have several decisions to make. These decisions
hypotheses except for the one null hypothesis formu- are directed by the problem studied and by your own
lated by Youngkin and Lester (2010). expertise and preference. You must decide whether the
Researchers have different beliefs about when to problem is best investigated with the use of simple or
state a research hypothesis versus a null hypothesis. complex hypotheses. Complex hypotheses frequently
Some researchers state the null hypothesis because it require complex methodology, and the outcomes may
is more easily interpreted on the basis of the results of be difficult to interpret. Some beginning researchers
statistical analyses. A researcher will also use the null prefer the clarity of simple hypotheses.
CHAPTER 8  Objectives, Questions, Hypotheses, and Study Variables 149

The research problem and purpose determine and measured the heart rate and oxygen saturation
whether you will study an associative or a causal rela- with a pulse oximeter (Nellcor N180).
tionship. Testing a hypothesis that states a causal rela- Hypotheses are evaluated with statistical analyses.
tionship requires expertise in implementing a treatment If the hypothesis states an associative relationship,
and controlling extraneous variables. Another decision correlational analyses are usually conducted on the
you must make involves the formulation of a research data. Spearman’s rank order correlation coefficient is
or a null hypothesis. You must make this decision often used to analyze ordinal level data, and Pearson’s
according to what you believe is the most accurate product-moment correlation coefficient is used for
prediction of the relationship between the study interval and ratio level data (see Chapter 23). These
variables. correlational analyses determine the existence, type,
A hypothesis that is clearly and concisely stated and degree of the relationship between the variables
gives the greatest direction for conducting a study. For studied.
clarity, hypotheses are expressed as declarative state- A hypothesis that states a causal relationship is
ments written in the present tense. Thus, hypotheses analyzed through the use of statistics that examine
are best developed without the phrase “There will/will differences, such as the Mann-Whitney U test, the t
not be a relationship…,” because the future tense test, and analysis of variance (ANOVA) (see Chapter
refers to the sample being studied. Hypotheses are 25). It is the null hypothesis (stated or implied) that is
statements of relationships about populations, not tested through statistical analysis. The intent is to
about study samples. According to mathematical determine whether the independent variable had a sig-
theory regarding generalization, one cannot generalize nificant effect on the dependent variable. The level of
to the future (Kerlinger & Lee, 2000). significance, alpha (α) = 0.05, 0.01, 0.001, is set after
Hypotheses are clearer without the phrase “There the generation of causal hypotheses and before the
is no significant difference…,” because the level of conduct of the study. To learn more about selecting
significance is only a statistical technique applied to statistical tests and a level of significance for testing
sample data. In addition, hypotheses should not iden- hypotheses, see Chapter 21.
tify methodological points, such as techniques of The results obtained from testing a hypothesis are
sampling, measurement, and data analysis (Kerlinger described with the use of certain terminology. Research
& Lee, 2000). Therefore, a statement such as “mea- findings do not prove hypotheses true or false; instead,
sured by,” “in a random sample of,” or “using hypotheses are statements of relationships or differ-
ANOVA (analysis of variance)” are not appropriate. ences in populations. Even after a series of studies, the
Such a phrase limits the hypothesis to measurement word proven is not used in scientific language because
methods, sampling methods, or data analysis tech- of the tentative nature of science. Research hypotheses
niques in a single study. A well-formulated hypothe- are described as being supported or not supported in
sis clearly identifies the relationship between the a study. When a null hypothesis is tested, it is either
variables and the study population. There is no set rejected or accepted. Accepting the null hypothesis
number for how many hypotheses are needed to indicates that no relationship or effect was found
direct a study, but the number formulated usually among the variables. Rejecting the null hypothesis
reflects the researcher’s expertise and the complexity indicates the possibility that a relationship or differ-
of the problem and purpose being studied. However, ence exists. A study might partially support a complex
most studies contain one to three hypotheses, and the hypothesis. Efe and Özer’s (2007, p. 11) hypothesis
relationships identified in these hypotheses set the stated that “breast-feeding decreases the length of
limits for a study (Fawcett & Garity, 2009; Shadish crying time, prevents an increase in heart rate, and
et al., 2002). prevents a decrease in oxygen saturation during vac-
cination as compared with the control condition (i.e.,
Testing Hypotheses no breast-feeding).” Their study supported the
A hypothesis’s value is ultimately derived from decreased crying time part of the hypothesis, but it did
whether or not it can be tested in the real world. A not support the part of the hypothesis that focused on
testable hypothesis contains variables that can be the prevention of increased heart rate and decreased
measured or manipulated in practice. For example, oxygen saturation. However, the study did provide
Efe and Özer (2007) manipulated the breast-feeding valuable evidence about the effectiveness of breast-
intervention in their study using set protocol so that feeding in reducing the pain of immunization injec-
the treatment was consistently manipulated for each tions in infants. In addition, this study provides
study situation. They measured crying time in seconds direction for future research.
150 UNIT TWO  The Research Process

Selecting Objectives, Questions, TABLE 8-1  Selecting Objectives, Questions,


or Hypotheses for Different Types  
or Hypotheses for Quantitative of Research
or Qualitative Research Objectives, Questions, or
Selecting objectives, questions, or hypotheses for a Hypotheses Commonly
study is often based on (1) the number and quality of Type of Research Developed
relevant studies conducted on a selected problem Qualitative research Objectives, questions, or none
(existing knowledge base), (2) the framework of the Quantitative research:
study, (3) the expertise and preference of the researcher,   Descriptive studies Objectives, questions, or none
and (4) the type of study to be conducted (quantitative   Correlational studies Objectives, questions,
hypotheses, or none
or qualitative). Commonly, if minimal or no research
  Quasi-experimental studies Usually hypotheses
has been conducted on a problem, investigators state   Experimental studies Hypotheses
objectives or questions because they do not have the Outcomes research Hypotheses or questions
knowledge necessary to formulate hypotheses. The Intervention research Hypotheses
framework for a study indicates whether the intent is
to develop or to test theory. Objectives and questions
are usually stated to guide theory development, and
the focus of a hypothesis is to test theory. characteristics of variables, to examine relationships
Researcher expertise and preference can also influ- among variables, or both. Thus, objectives or ques-
ence the selection of objectives, questions, or hypoth- tions are formulated to direct qualitative and selected
eses to direct a study. The number of nursing studies quantitative (descriptive and correlational) studies
containing hypotheses continues to grow, and there (see Table 8-1). However, some experienced research-
appears to be a trend away from descriptive quantita- ers can clearly focus and develop a study without
tive studies toward studies focused on examining rela- using objectives or questions. In these studies, the
tionships between variables and testing hypotheses. research purpose directs the research process.
The greater use of hypotheses to direct quantitative, In some qualitative research, the investigator uses
outcomes, and intervention research indicates growth only a problem and purpose to direct the study. The
of knowledge in selected problem areas and the specification of objectives or questions might limit the
increasing sophistication of nurse researchers (Doran, scope of the study and the methods of data collection
2011; Forbes, 2009). However, it is important that and analysis (Munhall, 2012). Discovery is important
researchers state hypotheses to direct their studies in qualitative research, and hypotheses are neither nec-
explicitly versus implicitly or through implication. An essary nor desirable in qualitative studies.
explicit statement of hypotheses is important to Researchers often develop hypotheses when the
provide clear direction for the conduct of a study, the relationships or results of a study can be anticipated
interpretation of the findings, and the use of the find- or predicted. Hypotheses are typically used in quanti-
ings in practice (Brown, 2009; Craig & Smyth, 2012; tative research to direct predictive correlational, quasi-
Fawcett & Garity, 2009). experimental, and experimental studies and are also
The objectives, questions, or hypotheses desig- important to guide outcomes and intervention studies
nated for study frequently indicate a pattern that the (Doran, 2011; Forbes, 2009; Shadish et al., 2002).
researcher uses in conducting investigations. Prob-
lems can be investigated in a variety of ways. Some
researchers start at the core of a problem and work Identifying and Defining
their way outward. Other investigators study a problem
from the outside edge and work to the core (Kaplan, Study Variables
1964). Each study must logically build on the other, The research purpose and objectives, questions, and
as the researcher establishes a pattern for studying a hypotheses identify the variables or concepts to
problem area that will affect the quality and quantity be examined in a study. Variables are qualities, prop-
of the knowledge generated in that area. erties, or characteristics of persons, things, or situa-
Researchers select objectives, questions, or hypoth- tions that change or vary in a study. Variables are
eses according to the type of study they plan to characterized by degrees, amounts, and differences
conduct. Objectives and questions are typically stated within a study. Variables are also concepts of various
when the intent of the study is to identify or describe levels of abstraction that are concisely defined so that
CHAPTER 8  Objectives, Questions, Hypotheses, and Study Variables 151

they can be measured or manipulated within a study identified but not measured; others are measured with
(Waltz, Strickland, & Lenz, 2010). refined measurement devices. The different types of
The concepts examined in research can be concrete variables presented in this section include the follow-
and directly measurable in practice, such as heart rate, ing: independent, dependent, research, extraneous,
hemoglobin value, and tidal volume of the lung. These demographic, moderator, and mediator.
concrete concepts are usually referred to as variables
in a study. Other concepts, such as anxiety, coping, Independent and Dependent Variables
and pain, are more abstract and are indirectly observ- The relationship between independent and dependent
able in the real world. Thus, the properties of these variables is the basis for formulating hypotheses
concepts are inferred from a combination of measure- for predictive correlational, quasi-experimental, and
ments. For example, one can infer the properties of experimental studies. As introduced earlier in this
anxiety by combining information obtained from (1) chapter, an independent variable is an intervention
observing the signs and symptoms of anxiety (fre- or treatment manipulated by the researcher to create
quent movements, sweating, rapid eye movement, an effect on the dependent variable. A dependent
lack of eye contact, and verbalization of anxiety), (2) variable is the outcome the researcher wants to predict
examining completed questionnaires or scales (state or explain. Changes measured in the dependent vari-
and trait anxiety scales), and (3) measuring physiolog- able are presumed to be caused by the independent
ical responses (galvanic skin response). The concept variable (Kerlinger & Lee, 2000; Shadish et al., 2002).
of anxiety might be represented by the variable Recall the quasi-experimental study by Scott et al.
“reported anxiety” or “perceived level of anxiety” (2011) introduced earlier in this chapter that included
(Waltz et al., 2010). independent and dependent variables. These variables
In many qualitative studies and in some quantita- were identified in the study’s complex, causal, direc-
tive studies (descriptive and correlational), the focus tional research hypothesis that focused on the effect
is abstract concepts, such as grieving, caring, and pro- of the FCMPN on sleep duration, sleep quality, day­
moting health (Creswell, 2009; Munhall, 2012). time sleepiness, drowsiness episodes, risk of auto
Researchers identify the elements of the study as con- accident, and actual and near reported work errors.
cepts, not variables. In the ethnographic study previ- The independent variable that was manipulated in this
ously described, Happ et al. (2007) investigated the study was the FCMPN, and the effect of this program
concept of health-related decision making by critically was determined by measuring the dependent variables
ill patients during prolonged mechanical ventilation. sleep duration, sleep quality, daytime sleepiness,
The concept health-related decision making was drowsiness episodes, risk of auto accident, and actual
defined as “choices about initiating, continuing, or and near errors (see the previous figure showing these
discontinuing treatment, diagnostics, or therapeutic variables).
care activities” (p. 363). Qualitative studies are often
conducted to clarify the definitions of concepts so Research Variables or Concepts
these definitions are usually presented in the results Qualitative studies and some quantitative (descriptive
section of the study. In the results of this study, health- and correlational) studies involve the investigation of
related decision making was described as including research variables or concepts. Research variables or
the following: “choices about mechanical ventilation concepts are the qualities, properties, or characteris-
and other therapies, such as invasive diagnostic pro- tics identified in the research purpose and objectives
cedures and placement of central lines and nutritional or questions that are measured in a study. They are
access devices that may or may not require written used when the intent of the study is to measure vari-
informed consent, and about discharge placement. ables as they exist in a natural setting without the
Financial or legal decisions, such as appointment of a implementation of a treatment. Thus, no independent
power of attorney or signing financial documents to variables are manipulated, and no cause-and-effect
enable insurance payment for health care, were con- relationships are examined.
sidered health-related in the context of prolonged criti- Qualitative studies often focus on abstract con-
cal illness” (Happ et al., 2007, p. 363). cepts. For example, Hudson et al. (2010) conducted
an exploratory-descriptive qualitative study to describe
Types of Variables the concept of “health-seeking challenges” among
Variables have been classified into a variety of types homeless youth. This study, also introduced earlier
to explain their use in research. Some variables are in the chapter, focused on gaining an understanding
manipulated; others are controlled. Some variables are of the perceptions of homeless youth regarding
152 UNIT TWO  The Research Process

their healthcare-seeking behaviors. The study results BV that reduced the potential for measurement error
described the concept of “health-seeking challenges” (see Figure 8-3) (Waltz et al., 2010). The design of
with a discussion of the young adults’ perspectives on the study ensured the blinding of researchers to the
the facilitators and barriers to receiving health care. participants’ scores on their home self-test for BV
before they determined their own score. The follow-
Extraneous Variables ing study excerpts identify the controls the research-
Extraneous variables exist in all studies and can ers used in their study to decrease the effect of
affect the selection of study participants, implementa- extraneous variables and increase the likelihood that
tion of the study intervention, measurement of study the findings are an accurate reflection of reality and
variables, and implementation of study procedures. not due to error:
Extraneous variables are of primary concern in quan-
titative and intervention studies, because they can
Sample Criteria
obscure one’s understanding of the relational or causal
dynamics within the studies. Extraneous variables are “Study eligibility was female participants who were
classified as (1) recognized or unrecognized and (2) (a) volunteers, (b) aged 18 to 45 years, (c) not preg­
controlled or uncontrolled. nant, and (d) able to read and understand English. A
The extraneous variables that are not recognized prior history of vaginitis or vaginosis was not required
until the study is in process or that are recognized for eligibility. Participants came from three clinical
before the study is initiated but cannot be controlled sites: a university college of nursing community well­
are referred to as confounding variables. Sometimes ness center, a private family practice, and a university
these variables can be measured during the study and student health service site.” (Youngkin & Lester,
controlled statistically during analysis. In other cases, 2010, p. 5)
it is not possible to measure a confounding variable,
Intervention
and the variable thus hinders the interpretation of
findings. Such extraneous variables must be identified “The researchers provided the educational compo­
as limitations or areas of study weakness in the nent about BV, the BV home self-test system and safe
discussion section of a research report. As control and correct use of the system, interpretation of self-
decreases in quasi-experimental and experimental test results and scoring findings, and how to follow
studies, the potential influence of confounding vari- up for provider evaluation after self-testing. Visual
ables increases. and verbal instruction methods were employed.…
Researchers attempt to recognize and control as The BV self-test kit was provided free, and all com­
many extraneous variables as possible in quasi- ponents were reviewed with the specific regimen for
experimental and experimental studies, and specific use. Researchers selected the kit contents with con­
designs have been developed to control the influence sideration for cost, future use, and ease of use. Ten
of such variables (see Chapter 11). Youngkin and applications of self-testing materials and scoring
Lester (2010) conducted a quasi-experimental study sheets were provided in the kit along with educa­
to determine the effectiveness of a home self-test tional materials, a copy of the signed consent form,
system in screening for bacterial vaginosis (BV). The laminated instructions for kit use, and a listing of con­
research and null hypotheses developed to direct this tents. Directions for follow-up with the researcher
study were introduced earlier, in the discussion of the clinicians were on the outside of each kit.” (Youngkin
null hypothesis. These researchers controlled some of & Lester, 2010, p. 5)
the extraneous variables in their study by selecting
Measurement with BV Scoring Sheet
inclusion and exclusion sample criteria to ensure that
study participants were similar or homogeneous. The “The women were taught how to safely obtain a
home self-test system for BV was implemented using vaginal specimen using directions outlined on a card
a detailed protocol to ensure that all participants in the kit and to test and score the specimen using
received consistent, complete implementation of the the criteria of (a) discharge color and consistency, (b)
intervention (Fawcett & Garity, 2009). The interven- pH level, and (c) amine odor. The tests and scoring
tion was implemented on the basis of the Centers for were specific to these three of the four criteria that
Disease Control (CDC) 2002 guidelines, which are CDC guidelines (2002) advised for providers to use
the same as the Centers for Disease Control and Pre- for clinical diagnosis. Figure 8-3 provides an example
vention 2006 guidelines. The researchers used a struc- of the scoring sheet. The specifics of the scoring
tured scoring process for determining the incidence of
CHAPTER 8  Objectives, Questions, Hypotheses, and Study Variables 153

BACTERIAL VAGINOSIS SELF-DIAGNOSIS


SCORING SHEET

Please mark the correct item by putting in the points in the blank space beside the item. For instance, if the
color of the strip of paper with your discharge is the number 4.5 or a smaller number, please put a “1” in
the first column, but if it is a color indicating a higher number, put a 2 in the second column. If the color of
the discharge is milky or creamy white or gray, put a 2 in the second colomn. If it is any other color, put a 1
in the first column. If there is no fishy odor, put a 1 in the first column. If there is a fishy odor, put a 2 in the
second column.

Remember: don’t worry about what you think you have; just put the number that “fits” the characteristic
the best in either Column 1 or 2. You should have only one number for the characteristic.

Add the numbers in the two columns up, then, add these two numbers together for the final score. For
example, if the total for Column 1 is a 2 and the total for Column 2 is 2, then the total score is 4.

Characterisitic Column 1 (non BV) Column 2 (BV)


Put a 1 in the column Put a 2 in the column
beside the correct finding beside the correct finding
Color of paper from
dispenser after it is wet
from vaginal discharge 4.5 or under 5 or higher

Color of discharge on
cotton of applicator yellow, green, white or gray
clumpy white, smooth or
brown, red creamy or frothy

Fishy smell when


discharge is mixed
with the KOH drop No fishy smell Fishy smell

Scores Column 1 Column 2

Add the scores from Column 1 and 2 together. The Total Score is

If your score is 4, 5, or 6, please make an appointment to see the clinician listed on the front of your
BV Self-Diagnosis Kit.

Figure 8-3  Scoring sheet for BV [bacterial vaginosis] home self-test. (From Youngkin, E. Q., & Lester, P. B. [2010]. Promoting self-care and secondary
prevention in women’s health: A study to test the accuracy of a home self-test system for bacterial vaginosis. Applied Nursing Research, 23[1], 6.)

Environmental variables are types of extraneous


method developed by the researchers and the form variables that make up the setting in which the study
for recording the self-test findings were taught as the is conducted. Examples are climate, home, healthcare
last component of the BV home self-test system.… system, community setting, and governmental organi-
Thus, higher total scores would be associated with a zations. If a researcher is studying humans in an
greater chance of BV if the woman was accurately uncontrolled or natural setting, it is impossible and
testing herself. The provider’s scoring would either sometimes undesirable to control most of the environ-
support or not support the self-test scoring.… The mental variables. In qualitative and some quantitative
women brought their scored results sheets with (descriptive and correlational) studies, researchers
them; the researchers did not review these results make little or no attempt to control environmental
until after the professional examination was com­ variables. Their intent is to study subjects in their
pleted and the findings had been scored on separate natural environment without controlling or altering it.
scoring form.” (Youngkin & Lester, 2010, pp. 5-6) The environmental variables in quasi-experimental
and experimental research can be controlled through
154 UNIT TWO  The Research Process

the use of a study protocol and a laboratory setting or TABLE 8-2  Demographic Summary
a specially constructed research unit in a hospital. of Study Participants
Demographic Variables Initial Intervention
Demographic variables are attributes of the subjects Respondents Respondents
that are measured during the study and used to describe Attribute (n = 62) (n = 47)
the sample. Some common demographic variables Age (years) 37.74 ± 11.70 38.98 ± 12.21
examined in nursing research are age, gender, ethnicity, Time as a 9.82 ± 10.95 10.95 ± 11.87
educational level, income, job classification, length of registered
nurse (years)
hospital stay, and medical diagnosis. Researchers select
Shift length (hours):
demographic variables according to the focus of their   8 9 7
study, the demographic variables included in previous   12 52 40
studies, and clinical experience. However, age, gender, Shift pattern:
and ethnicity are essential demographic variables to   Days 25 17
examine in all types of research. These demographics   Evenings 4 2
describe the sample and determine the population for   Nights 29 25
generalization of the findings. More research is needed   Rotating 0 0
to improve health care for elderly, women, children, Relationship/marital status:
and minorities, and funding agencies often give priority   Single 15 12
  Spouse or 47 35
to studies that focus on these individuals.
significant
To obtain data on demographic variables, research- other
ers ask subjects to complete a demographic or infor- Additional 4 (6.5%) 3 (6.4%)
mation sheet. When the study is completed, the employment
demographic information is analyzed to provide a
picture of the sample, which is called the sample Note: Frequencies may not match sample size due to missing data.
characteristics. Sample characteristics are presented Adapted from Scott, L. D., Hofmeister, N., Rogness, N., & Rogers, A. E.
(2010). An interventional approach for patient and nurse safety: A fatigue
in a table and/or discussed in the narrative of the countermeasures feasibility study. Nursing Research, 59(4), 252.
research report. As previously discussed, Scott et al.
(2010) implemented the FCMPN intervention to
improve staff nurses’ sleep duration, sleep quality,
daytime sleepiness, drowsiness episodes, risk for auto The demographic variables in this study were eth-
accident, and actual and near work errors. These nicity, gender, age, time as a registered nurse in years,
researchers summarized their sample characteristics in shift length in hours, shift pattern, relationship/marital
a table (see Table 8-2) and discussed them in the nar- status, and additional employment (see description of
rative of their article, as follows: sample and Table 8-2). The participants from three
different sites were compared and found to have no
differences in demographic variables at the start of the
“Most participants were White (96.8%) and women study. These demographic variables seem appropriate
(96.8%), with an average age of 37.74 years (range = to describe the sample of staff nurses for this study. It
22-63 years, SD = 11.70 years). Fifty-two (83.9%) of was important to ensure that the participants from the
the nurses reported being employed in 12-hour day three different settings were similar at the start of
shifts positions. Although all three work shifts were the study so significant differences in the dependent
represented, the nurses worked predominantly variables might be assumed to be caused by the
12-hour day shifts (e.g., 7 : 00 a.m.-7:30 p.m.; n = 25) FCMPN intervention and not due to demographical
or night shift (e.g., 7:00 p.m.-7:30 a.m.; n = 29). Only differences.
4 nurses (6.5%) reported working evening shifts. The
average length of experience as hospital staff nurses Moderator and Mediator Variables
was 9.82 years (range = 1-43 years, SD = 11.83 years). Moderator and mediator variables are examined in
Although the nurses were employed in full-time posi­ intervention effectiveness research to improve our
tions, 4 nurses (6.5%) reported working a second understanding of the effect of the intervention on
job. No significant differences were noted between practice-related outcomes. A moderator variable
participants across the three sites before data aggre­ occurs with the intervention (independent variable)
gation.” (Scott et al., 2010, p. 252) and alters the causal relationship between the inter-
vention and the outcomes. Moderator variables include
CHAPTER 8  Objectives, Questions, Hypotheses, and Study Variables 155

TABLE 8-3  Conceptual and Study Variables, Instruments, and Scores or Measurement
Possible Scores and
Concepts Variables Instruments Measurement
Sleep loss (deprivation or Sleep duration Logbook (self-report sleep Total sleep duration
disruption) times)
Sleep quality Pittsburgh Sleep Quality Index Global score = 0-21
Cognitive-behavioral Daytime sleepiness Epworth Sleepiness Scale Summative score = 0-24
outcomes
Vigilance (inability to remain Drowsiness and unplanned Frequencies
alert) sleep episodes at work and
while driving
Short-term memory Logbook (accident or error Frequencies
data)
Problem solving and coping Logbook (error description) Frequencies

From Scott, L. D., Hofmeister, N., Rogness, N., & Rogers, A. E. (2010). An interventional approach for patient and nurse safety: A fatigue countermeasures
feasibility study. Nursing Research, 59(4), 253.

characteristics of the subjects and of the person imple- duration, sleep quality, daytime sleepiness, episodes
menting the intervention. Mediator variables bring of drowsiness, risk of auto accident, and actual and
about the effects of the intervention after it has near work errors. These researchers linked their frame-
occurred and thus influence the outcomes of the study. work concepts, variables, instruments of measure-
The theoretical model that provides the framework for ment, and possible scores and measurement in Table
the study usually identifies the relevant moderator and 8-3. Conceptual and operational definitions of the
mediator variables to be examined in the study. The independent variable and three dependent variables in
design is developed to examine not only the indepen- this study are as follows:
dent (intervention) and dependent (outcomes) vari-
ables but also the moderator and mediator variables
(see Chapter 14 for a detailed discussion of interven-
tion research). Independent Variable: Fatigue
Countermeasures Program for
Nurses (FCMPN)
Operationalizing Variables Conceptual definition: The FCMPN evolved from the
model of impaired sleep by Lee and colleagues (2004).
or Concepts for a Study The FCMPN was thought to have the potential to
decrease sleep loss and improve sleep quality and
Conceptual and Operational Definitions of their associated cognitive-behavioral responses (Scott
Variables in Quantitative Studies et al., 2010).
Operationalizing a variable or concept in quantita- Operational definition: “Comprehensive program to
tive studies involves developing conceptual and oper- manage fatigue in work settings usually includes the
ational definitions. A conceptual definition provides following six elements: (a) education and training, (b)
the theoretical meaning of a concept or variable and compliance with hours of service regulations, (c)
is derived from a theorist’s definition of that concept appropriate scheduling practices, (d) countermea­
or is developed through concept analysis. The study sures that can be instituted in the work setting, (e)
framework, which includes concepts and their defini- design, and (f) research.… The FCMPN used in this
tions, provides a basis for conceptually defining the study is modeled after the National Aeronautics and
variables. The Scott et al. (2010) study described pre- Space Administration Ames Research Center’s
viously in the sections on causal hypotheses, indepen- Fatigue Countermeasures Program . . . with additional
dent and dependent variables, and demographic content obtained from the Sleep, Alertness, and
variables is presented here as an example of how Fatigue Education in Residency Program (American
to operationalize study variables. These researchers Academy of Sleep Medicine, 2006).” (Scott et al.,
implemented the FCMPN intervention with staff 2010, pp. 252-253)
nurses to improve the following outcomes: sleep
156 UNIT TWO  The Research Process

defined until the results of the study are determined


Dependent Variables (Marshall & Ross, 2011; Munhall, 2012). Thus, some
Sleep Duration
concepts may not be clearly conceptually defined until
late in the conduct of the study. For example, Hudson
Conceptual definition: Sleep duration is an indication et al. (2010) developed the following description of
of the sleep loss (deprivation and/or disruption) and the health-seeking challenges among homeless youth
fatigue that is experienced by an employee (see Table during their discussion of study results:
8-3 for the link of the model concepts to this study
variable).
Operational definition: Sleep duration was measured Conceptual Definition of Health-Seeking
by self-report in a Logbook that involved the partici­ Challenges among Homeless Youth
pants completing 15 items about their sleep patterns “Participants were quite verbal in expressing their
(Scott et al., 2010). perspectives and experiences in order that positive
Daytime Sleepiness changes could be made. The major themes expressed
related to the issues they experienced in accessing
Conceptual definition: Daytime sleepiness is a cogni­ health care, followed by barriers that were experi­
tive-behavior outcome resulting from employees enced, as well as a pervasive sense of stigma and
who experience sleep loss or poor quality sleep. discrimination, which was quite telling.…
Operational definition: Daytime sleepiness was mea­
sured with the Epworth Sleepiness Scale with a sum­ Failing Access to Health Care
mative score equal to 0 through 24. “Homeless young adults revealed that accessing
Episodes of Drowsiness health care was challenging due to scarcity of service
sites and generally long waiting times for services, yet
Conceptual definition: Vigilance is a cognitive-behavioral homeless young adults experienced a number of
outcome that focuses on the ability and inability to health problems ranging from chronic conditions such
remain alert at work without drowsiness. as migraine headaches to more serious conditions of
Operational definition: Vigilance was measured by asthma and meningitis. Mental health issues were
the drowsiness and unplanned sleep episodes at work reported most commonly.…
and while driving. These were part of the self-report
items in the participants’ Logbook. Needing More Help
“Homeless young persons experienced a number of
The variables in quasi-experimental and experi- unmet needs.… Despite their hardships, young adults
mental quantitative research, outcomes research, and craved for support from family, friends, and homeless
intervention research are narrow and specific in focus peers.…
and are capable of being quantified (converted to
numbers) or manipulated through the use of specified Perceiving Stigma
steps. In addition, the variables are objectively defined “The youth were most frustrated by the discrimina­
to reduce researcher bias. tion they experienced from passersby and law
enforcement. Rather than provide resources for
Conceptual Definitions in Qualitative Studies homeless youth, youth frequently were confronted
The concepts in qualitative studies are usually more with unforgettable comments that were full of
abstract and broadly defined than the variables in quan- judgment.…
titative, outcomes, and intervention studies. Many
researchers believe that the concepts in qualitative Making it Work
studies do not have operational definitions because “Regardless of the challenges experienced, homeless
sensitizing or experiencing the real situation rather than young adults were able to deal with life in the only
operationalizing the concepts is most important. Oper- ways they knew how and were grateful for the help
ational definitions are not appropriate because they are and support of others. For several homeless young
thought to limit the investigation so that a phenome- adults, they were grateful for the information they
non, such as pain, or a characteristic of a culture, such received from the more experienced homeless young
as health practices, is not completely experienced or persons in terms of when services were available and
understood. In qualitative research, often the phenom- where to go.” (Hudson et al., 2010, pp. 215-216)
enon being studied is not clearly identified and/or
CHAPTER 8  Objectives, Questions, Hypotheses, and Study Variables 157

KEY POINTS conceptual definition provides the theoretical


meaning of a concept or variable and is derived
• Research objectives, questions, and hypotheses are from a theorist’s definition of the concept or is
formulated to bridge the gap between the more developed through concept analysis.
abstractly stated research problem and purpose and • An operational definition is derived from a set of
the detailed design and plan for data collection and procedures or progressive acts that a researcher
analysis. performs either to manipulate an independent
• Research objectives are clear, concise, declarative variable or to measure the existence or degree of
statements that are expressed in the present tense existence of the dependent variable or research
to provide specific focus to the conduct of a variable.
study. • Concepts in qualitative research are usually con-
• A research question is a concise, interrogative ceptually defined when the results or findings of the
statement that is worded in the present tense and study are presented.
consists of one or more variables (or concepts).
• A hypothesis is the formal statement of the expected
relationships between two or more variables in a REFERENCES
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• The types of variables discussed in this chapter are edge development (7th ed.). St. Louis: Mosby.
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istics and is used to describe the sample. ment. Menlo Park, CA: Addison-Wesley.
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Hudson, A. L., Nyamathi, A., Greengold, B., Slagle, A., Koniak- An interventional approach for patient and nurse safety: A fatigue
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Munhall, P. L. (2012). Nursing research: A qualitative perspective congestive heart failure in adults without prior myocardial infarc-
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  http://evolve.elsevier.com/Grove/practice/

9  
CHAPTER

Ethics in Research

N
ursing research requires not only expertise and phenomenon of the ethical conduct in research defies
diligence but also honesty and integrity. Con- precise delineation, the historical events, ethical codes,
ducting research ethically starts with the iden- and regulations presented in this chapter provide guid-
tification of the study topic and continues through the ance for nurse researchers. The chapter also discusses
publication of the study. Over the years, ethical codes the actions essential for conducting research ethically:
and regulations have been developed to provide guide- (1) protecting the rights of human subjects; (2) balanc-
lines for (1) selecting a study purpose, design, and ing benefits and risks in a study; (3) obtaining informed
subjects; (2) collecting and analyzing data; (3) inter- consent from study participants; and (4) submitting a
preting study results; and (4) presenting and publish- research proposal for institutional review. A discus-
ing a study. One of the more recent regulations, the sion of current ethical issues related to research mis-
Health Insurance Portability and Accountability Act conduct and animals used in research concludes the
(HIPAA), was enacted in 2003 to protect the privacy chapter.
of an individual’s health information. HIPAA has had
an important impact on researchers and institutional
review boards (IRBs) in universities and healthcare Historical Events Affecting the
agencies. This chapter provides an overview of this Development of Ethical Codes
act and the other United States and international regu-
lations that have been developed to promote the ethical and Regulations
conduct of research. The ethical conduct of research has been a focus since
An ethical problem that has received increasing the 1940s because of the mistreatment of human sub-
attention since the 1980s is research misconduct. Mis- jects in selected studies. Four experimental projects
conduct has occurred during the conduct, reporting, have been highly publicized for their unethical treat-
and publication of studies, and the Office of Research ment of subjects: (1) Nazi medical experiments; (2)
Integrity (ORI, 2012) was developed to manage this the Tuskegee syphilis study; (3) the Willowbrook
problem. Many disciplines, including nursing, have study; and (4) the Jewish Chronic Disease Hospital
experienced episodes of research misconduct that study. Although these were biomedical studies and the
have affected the quality of research evidence gener- primary investigators were physicians, there is evi-
ated and disseminated. dence that nurses were aware of the research, identi-
Ethical research is essential to generate a sound fied potential subjects, delivered treatments to the
evidence-based practice for nursing, but what does the subjects, and served as data collectors in these proj-
ethical conduct of research involve? This question has ects. The four projects demonstrate the importance of
been debated for many years by researchers, politi- ethical conduct for anyone reviewing, participating in,
cians, philosophers, lawyers, and even research sub- and conducting nursing or biomedical research. These
jects. The debate continues, probably because of the four projects and other incidences of unethical treat-
complexity of human rights issues; the focus of ment of subjects and research misconduct in the devel-
research in new, challenging arenas of technology and opment, implementation, and reporting of research
genetics; the complex ethical codes and regulations have influenced the formulation of ethical codes and
governing research; and the various interpretations of regulations that direct research today. In addition, the
these codes and regulations. Even though the concern for patient privacy with the electronic storage

159
160 UNIT TWO  The Research Process

and exchange of health information has resulted in protection of subjects from physical and mental suf-
HIPAA privacy regulations (Olsen, 2003). fering, injury, disability, and death during studies; and
(4) the balance of benefits and risks in a study. Box
Nazi Medical Experiments 9-1 reproduces the Nuremberg Code, which was for-
From 1933 to 1945, the Third Reich in Europe imple- mulated mainly to direct the conduct of biomedical
mented atrocious, unethical activities (Steinfels & research worldwide; however, the rules it contains are
Levine, 1976). The programs of the Nazi regime con- essential to research in other sciences, such as nursing,
sisted of sterilization, euthanasia, and numerous psychology, and sociology.
medical experiments to produce a population of
racially pure Germans, or Aryans, who the Nazis Declaration of Helsinki
maintained were destined to rule the world. The Nazis The Nuremberg Code provided the basis for the devel-
encouraged population growth among the Aryans opment of the Declaration of Helsinki in 1964 by the
(“good Nazis”) and sterilized people they regarded as World Medical Association (WMA) General Assem-
racial enemies, such as the Jews. They also practiced bly. Over the years, the Declaration of Helsinki has
what they called “euthanasia,” which involved killing been amended as needed with the final amendment in
various groups of people whom they considered 2008 (WMA General Assembly). This document dif-
racially impure, such as the insane, deformed, and ferentiates therapeutic research from nontherapeutic
senile. In addition, researchers conducted numerous research. Therapeutic research gives the patient
medical experiments on prisoners of war as well as on an opportunity to receive an experimental treatment
racially “valueless” persons who had been confined to that might have beneficial results. Nontherapeutic
concentration camps. research is conducted to generate knowledge for a
The medical experiments involved exposing sub- discipline, and the results from the study might benefit
jects to high altitudes, freezing temperatures, malaria, future patients but will probably not benefit those
poisons, spotted fever (typhus), and untested drugs and acting as research subjects.
operations, usually without any anesthesia (Steinfels The Declaration of Helsinki includes ethical prin-
& Levine, 1976). These medical experiments were ciples for medical research involving human subjects,
conducted to generate knowledge about human beings, such as the following: (1) well-being of the individual
but the goal often was to destroy certain groups of research subject must take precedence over all other
people. Extensive examination of the records from interests; (2) a strong, independent justification must
some of these studies showed that they were poorly be documented prior to exposing healthy volunteers
designed and conducted. Thus, they generated little if to risk of harm just to gain new scientific information;
any useful scientific knowledge. (3) investigators must protect the life, health, privacy,
The Nazi experiments violated numerous rights of and dignity of research subjects; and (4) extreme care
the research participants. Researchers selected sub- must be taken in making use of placebo-controlled
jects on the basis of their race, demonstrating an unfair trials, which should be used only in the absence of
selection process. The subjects also had no opportu- existing proven therapy (WMA General Assembly,
nity to refuse participation; they were prisoners who 2008). Clinical trials must focus on improving diag-
were coerced or forced to participate. The study par- nostic, therapeutic, and prophylactic procedures for
ticipants were frequently killed during the experi- patients with selected diseases without exposing sub-
ments or sustained permanent physical, mental, and jects to any additional risk of serious or irreversible
social damage (Levine, 1986; Steinfels & Levine, harm. Most institutions worldwide in which clinical
1976). The mistreatment of human subjects in these research is conducted have adopted the Declaration of
Nazi studies led to the development of the Nuremberg Helsinki. However, neither this document nor the
Code in 1949. Nuremberg Code has prevented some investigators
from conducting unethical research (Beecher, 1966;
Nuremberg Code ORI, 2012).
The people involved in the Nazi experiments were
brought to trial before the Nuremberg Tribunals, Tuskegee Syphilis Study
which publicized their unethical activities. These In 1932, the U.S. Public Health Service (U.S. PHS)
unethical studies resulted in the Nuremberg Code initiated a study of syphilis in black men in the small,
(1949), which was developed with guidelines for (1) rural town of Tuskegee, Alabama (Brandt, 1978;
subjects’ voluntary consent to participate in research; Rothman, 1982). The study, which continued for 40
(2) the right of subjects to withdraw from studies; (3) years, was conducted to determine the natural course
CHAPTER 9  Ethics in Research 161

Box 9-1 The Nuremberg Code


1. The voluntary consent of the human subject 7. Proper preparations should be made and
is absolutely essential. adequate facilities provided to protect the
2. The experiment should be such as to yield experimental subject against even remote
fruitful results for the good of society, possibilities of injury, disability, or death.
unprocurable by other methods or means of 8. The experiment should be conducted only by
study, and not random and unnecessary in scientifically qualified persons. The highest
nature. degree of skill and care should be required
3. The experiment should be so designed and through all stages of the experiment of
based on the results of animal those who conduct or engage in the
experimentation and knowledge of the experiment.
natural history of the disease or other 9. During the course of the experiment the
problem under study that the anticipated human subject should be at liberty to bring
results will justify the performance of the the experiment to an end if he has reached
experiment. the physical or mental state where
4. The experiment should be so conducted as continuation of the experiment seems to him
to avoid all unnecessary physical and mental to be impossible.
suffering and injury. 10. During the course of the experiment the
5. No experiment should be conducted where scientist in charge must be prepared to
there is a prior reason to believe that death terminate the experiment at any stage, if he
or disabling injury will occur, except, has probable cause to believe, in the exercise
perhaps, in those experiments where the of the good faith, superior skill, and careful
experimental physicians also serve as judgment required of him, that a
subjects. continuation of the experiment is likely to
6. The degree of risk to be taken should never result in injury, disability, or death to the
exceed that determined by the humanitarian experimental subject.
importance of the problem to be solved by
the experiment.
From Nuremberg Code. (1949). Trials of War Criminals before the Nuremberg Military Tribunals under Control
Council Law No. 10, Vol. 2, pp. 181–182. Washington, D.C.: U.S. Government Printing Office, 1949. Retrieved from
http://ohsr.od.nih.gov/guidelines/nuremberg.html/.

of syphilis in the adult black male. The research sub- appearing in 1936, and additional papers were pub-
jects were organized into two groups: one group con- lished every 4 to 6 years. In 1969, the U.S. Centers
sisted of 400 men who had untreated syphilis, and the for Disease Control (CDC) reviewed the study and
other was a control group of 200 men without syphilis. decided that it should continue. In 1972, a story
Many of the subjects who consented to participate in describing the study published in the Washington Star
the study were not informed about the purpose and sparked public outrage. Only then did the U.S. Depart-
procedures of the research. Some individuals were ment of Health, Education, and Welfare (DHEW) stop
unaware that they were subjects in a study. the study. An investigation of the Tuskegee syphilis
By 1936, study results indicated that the men with study found it to be ethically unjustified.
syphilis experienced more health complications than
the control group. Ten years later, the death rate of the Willowbrook Study
group with syphilis was twice as high as that of the From the mid-1950s to the early 1970s, Dr. Saul
control group. The subjects were examined periodi- Krugman at Willowbrook, an institution for the men-
cally but were not treated for syphilis, even after peni- tally retarded, conducted research on hepatitis
cillin was determined to be an effective treatment for (Rothman, 1982). The subjects, all children, were
the disease in the 1940s (Brandt, 1978). Published deliberately infected with the hepatitis virus. During
reports of the Tuskegee syphilis study first started the 20-year study, Willowbrook closed its doors to
162 UNIT TWO  The Research Process

new inmates because of overcrowded conditions. to protect human subjects. Clinical researchers were
However, the research ward continued to admit new presented with strict regulations for research involving
inmates. To gain their child’s admission to the institu- humans, with additional regulations to protect persons
tion, parents were forced to give permission for the having limited capacities to consent, such as the ill,
child to be a subject in the study. mentally impaired, and dying (Levine, 1986). All
From the late 1950s to early 1970s, Krugman’s research involving human subjects had to undergo full
research team published several articles describing the institutional review, even nursing studies that involved
study protocol and findings. Beecher (1966) cited minimal or no risks to study participants. Institutional
the Willowbrook study as an example of unethical review improved the protection of subjects’ rights;
research. The investigators defended injecting the however, reviewing all studies, without regard for the
children with the virus by citing their own belief that degree of risk involved, overwhelmed the review
most of the children would have acquired the infection process and greatly prolonged the time required for
after admission to the institution. The investigators study approval. The government recognized the need
also stressed the benefits that the subjects received, for additional strategies to manage the problems
which were a cleaner environment, better supervision, related to the DHEW regulations.
and a higher nurse-patient ratio on the research ward
(Rothman, 1982). Despite the controversy, this unethi-
cal study continued until the early 1970s. National Commission for the Protection of
Human Subjects of Biomedical and
Jewish Chronic Disease Hospital Study Behavioral Research
Another highly publicized example of unethical Because of the problems related to the DHEW regula-
research was a study conducted at the Jewish Chronic tions, the National Commission for the Protection of
Disease Hospital in the 1960s. Its purpose was to Human Subjects of Biomedical and Behavioral
determine the patients’ rejection responses to live Research (1978) was formed. The goals of the com-
cancer cells. Twenty-two patients were injected with mission were (1) to identify the basic ethical principles
a suspension containing live cancer cells that had been that should underlie the conduct of biomedical and
generated from human cancer tissue (Levine, 1986). behavioral research involving human subjects and (2)
An extensive investigation of this study revealed to develop guidelines based on these principles. The
that the patients were not informed that they were commission developed The Belmont Report (available
taking part in research or that the injections they online at http://www.fda.gov/). This report identified
received were live cancer cells. In addition, the Jewish three ethical principles as relevant to research involv-
Chronic Disease Hospital’s institutional review board ing human subjects: the principles of respect for
never reviewed the study; even the physicians caring persons, beneficence, and justice. The principle of
for the patients were unaware that the study was respect for persons holds that persons have the right
being conducted. The physician directing the research to self-determination and the freedom to participate or
was an employee of the Sloan-Kettering Institute for not participate in research. The principle of benefi-
Cancer Research, and there was no indication that cence requires the researcher to do good and “above
this institution had reviewed the research project all, do no harm.” The principle of justice holds that
(Hershey & Miller, 1976). The study was considered human subjects should be treated fairly. Currently,
unethical and was terminated, with the researcher these ethical principles must be followed when
being in violation of the Nuremberg Code (1949) and researchers in the United States and internationally
the Declaration of Helsinki (WMA General Assem- conduct studies. The commission developed ethical
bly, 1964). This research had the potential to cause research guidelines based on these three principles,
the study participants serious or irreversible harm and made recommendations to the U.S. Department of
possibly death and reinforced the importance of con- Health and Human Services (U.S. DHHS), and was
scientious institutional review and ethical researcher dissolved in 1978.
conduct. In response to the commission’s recommendations,
the U.S. DHHS developed federal regulations in 1981
U.S. Department of Health, Education, and to protect human research subjects, which have been
Welfare Regulations revised as needed over the last 30 years. The most
The continued conduct of harmful, unethical research current U.S. DHHS (2009) regulations are part of the
made additional controls necessary. In 1973, the Code of Federal Regulations (CFR), Title 45, Part 46,
DHEW published its first set of regulations intended Protection of Human Subjects (available online at
CHAPTER 9  Ethics in Research 163

http://www.hhs.gov/ohrp/policy/ohrpregulations confidentiality of information obtained through


.pdf/). These regulations are interpreted by the Office research. However, with the advent of electronic
for Human Research Protection (OHRP), an agency access and transfer, the public was concerned about
within U.S. DHHS (2012), whose functions include: the potential abuses of the health information of indi-
(1) providing guidance and clarification of regula- viduals in all circumstances, including research proj-
tions; (2) developing educational programs and mate- ects. Thus HIPAA was implemented in 2003 to protect
rials; (3) maintaining regulatory oversight of research; an individual’s health information. The U.S. DHHS
and (4) providing advice on ethical and regulatory developed regulations titled the Standards for Privacy
issues related to biomedical and social-behavior of Individually Identifiable Health Information, and
research. compliance with these regulations is known as the
The U.S. DHHS (2009) regulations provide direc- Privacy Rule (U.S. DHHS, 2003). The HIPAA Privacy
tion for (1) the protection of human subjects in Rule established the category of protected health
research, with additional protection for pregnant information (PHI), which allows covered entities,
women, human fetuses, neonates, children, and pris- such as health plans, healthcare clearinghouses, and
oners; (2) the documentation of informed consent; and healthcare providers that transmit health information,
(3) the implementation of the institutional review to use or disclose PHI to others only in certain situa-
board process. These regulations apply to all research tions. These situations are discussed later in this
involving human subjects in the following areas: (1) chapter.
studies conducted, supported, or otherwise subject to The HIPAA Privacy Rule affects not only the health-
regulations by any federal department or agency; (2) care environment but also the research conducted in
research conducted in educational and healthcare set- this environment (U.S. DHHS, 2010). An individual
tings; (3) research involving the use of biophysical must provide his or her signed permission, or authori-
measures, educational tests, survey procedures, scales, zation, before his or her PHI can be used or disclosed
interview procedures, or observation; and (4) research for research purposes. To determine how the HIPAA
involving the collection or study of existing data, Privacy Rule might impact the informed consent
documents, records, pathological specimens, or diag- and IRB processes for your study, go to the website
nostic specimens. at http://privacyruleandresearch.nih.gov/, which was
Essentially all the biomedical and behavioral developed to address researchers’ questions.
studies conducted in the United States are governed Table 9-1 was developed to clarify the overall
by the U.S. DHHS (2009) Protection of Human Sub- objectives and applicability of the HIPAA Privacy
jects Regulations or the U.S. Food and Drug Admin- Rule, U.S. DHHS Protection of Human Subjects Reg-
istration (U.S. FDA). The FDA, within the U.S. ulations, and U.S. FDA Protection of Human Subjects
DHHS, manages the CFR Title 21, Food and Drugs, Regulations (U.S. DHHS, 2007a). Any study you
Part 50, Protection of Human Subjects (U.S. FDA, propose with human subjects must comply with these
2010a), and Part 56, Institutional Review Boards regulations. Thus, this chapter covers these regula-
(IRBs) (U.S. FDA, 2010b). These regulations apply to tions in the sections on protecting human rights,
studies of drugs for humans, medical devices for obtaining informed consent, and institutional review
human use, biological products for human use, human of research.
dietary supplements, and electronic products. The role
of the FDA was expanded by the Food and Drug
Administration Amendments Act (FDAAA) of 2007 Protection of Human Rights
to include increased responsibility for the manage- Human rights are claims and demands that have been
ment of new drugs and medical devices. Physicians justified in the eyes of an individual or by the consen-
and nurses conducting clinical trials to generate new sus of a group of individuals. Having rights is neces-
drugs and refine existing drug treatments must comply sary for the self-respect, dignity, and health of an
with these FDA regulations. In summary, these regula- individual (Fry, Veatch, & Taylor, 2011). The Ameri-
tions focus on the protection of human subjects’ rights, can Nurses Association (ANA, 2001) Code of Ethics
informed consent (U.S, FDA, 2010a), and IRBs (U.S. for Nurses and the American Psychological Associa-
FDA, 2010b), with content that is consistent with the tion (APA, 2010) Principles of Psychologists and
U.S. DHHS (2009) regulations. Code of Conduct provide guidelines for protecting the
The U.S. DHHS and FDA regulations provide rights of human subjects in biological and behavioral
guidelines to protect subjects in federally and pri- research. Researchers and reviewers of research
vately funded research by ensuring privacy and have an ethical responsibility to protect the rights of
164 UNIT TWO  The Research Process

TABLE 9-1  Clarification of the Focus of Federal Regulations and Impact on Research
U.S. DHHS Protection of U.S. FDA Protection of Human
Area of Human Subjects Regulations Subjects Regulations Title 21
Distinction HIPAA Privacy Rule Title 45 CFR Part 46 CFR Parts 50 and 56
Overall objective Establishes a federal floor of To protect the rights and welfare To protect the rights, safety, and
privacy protections for most of human subjects involved in welfare of subjects involved in
individually identifiable health research conducted or clinical investigations regulated by
information by establishing supported by U.S. DHHS. the FDA. Not specifically a privacy
conditions for its use and Not specifically a privacy regulation.
disclosure by certain healthcare regulation.
providers, health plans, and
healthcare clearinghouses.
Applicability Applies to HIPAA-defined Applies to human subject Applies to research involving
covered entities, regardless of research conducted or products regulated by the FDA.
the source of funding. supported by U.S. DHHS and Federal support is not necessary for
research with private funding. FDA regulations to be applicable.
When research subject to FDA
jurisdiction is federally funded,
both the U.S. DHHS Protection of
Human Subjects Regulations and
FDA Protection of Human Subjects
Regulations apply.

CFR, Code of Federal Regulations; DHHS, U.S. Department of Health and Human Services; U.S. FDA, U.S. Food and Drug Administration; HIPAA, Health
Insurance Portability and Accountability Act.
From U.S. Department of Health and Human Services. (2007a). How do other privacy protections interact with the privacy rule? Retrieved from http://
privacyruleandresearch.nih.gov/pr_05.asp/.

human research participants. The human rights that Preventing Violation of Research Subjects’ Right to
require protection in research are (1) the right to self- Self-Determination
determination;, (2) the right to privacy; (3) the right A subject’s right to self-determination can be violated
to anonymity and confidentiality; (4) the right to fair through the use of (1) coercion; (2) covert data collec-
treatment or justice; and (5) the right to protection tion; and (3) deception. Coercion occurs when one
from discomfort and harm (ANA, 2001; APA, 2010; person intentionally presents another with an overt
Fry et al., 2011). threat of harm or the lure of excessive reward to obtain
his or her compliance. Some subjects are coerced to
Right to Self-Determination participate in research because they fear that they will
The right to self-determination is based on the ethical suffer harm or discomfort if they do not participate. For
principle of respect for persons. This principle holds example, some patients believe that their medical or
that because humans are capable of self-determination, nursing care will be negatively affected if they do not
or controlling their own destinies, they should be agree to be research subjects. Sometimes students feel
treated as autonomous agents who have the freedom forced to participate in research to protect their grades
to conduct their lives as they choose without external or prevent negative relationships with the faculty con-
controls. As a researcher, you treat prospective sub- ducting the research. Other subjects are coerced to
jects as autonomous agents by informing them about participate in studies because they believe that they
a proposed study and allowing them to voluntarily cannot refuse the excessive rewards offered, such as
choose to participate or not. In addition, subjects have large sums of money, specialized health care, special
the right to withdraw from a study at any time without privileges, and jobs. Most nursing studies do not offer
a penalty (Fry et al., 2011). Conducting research ethi- excessive rewards to subjects for participating. Some-
cally requires that research subjects’ right to self- times nursing studies have included a small financial
determination not be violated and that persons with reward of $10 to $30 or support for transportation to
diminished autonomy have additional protection increase participation, but this would not be considered
during the conduct of studies (U.S. DHHS, 2009). coercive (Fawcett & Garity, 2009; Fry et al., 2011).
CHAPTER 9  Ethics in Research 165

An individual’s right to self-determination can also Protecting Persons with Diminished Autonomy
be violated if he or she becomes a research subject Some persons have diminished autonomy or are vul-
without realizing it. Some researchers have exposed nerable and less advantaged because of legal or mental
persons to experimental treatments without their incompetence, terminal illness, or confinement to an
knowledge, a prime example being the Jewish Chronic institution (Fry et al., 2011). These persons require
Disease Hospital study. Most of the patients and their additional protection of their right to self-determination,
physicians were unaware of the study. The subjects because they have a decreased ability, or an inability,
were informed that they were receiving an injection to give informed consent. In addition, these persons
of cells, but the word cancer was omitted (Beecher, are vulnerable to coercion and deception. The U.S.
1966). With covert data collection, subjects are DHHS (2009) has identified certain vulnerable groups
unaware that research data are being collected because of individuals, including pregnant women, human
the investigator develops a description of the study fetuses, neonates, children, mentally incompetent
indicating that it is normal activity or part of health persons, and prisoners, who require additional protec-
care (Reynolds, 1979). This type of data collection has tion in the conduct of research. Researchers need to
more commonly been used by psychologists to justify their use of subjects with diminished autonomy
describe human behavior in a variety of situations, but in a study, and the need for justification increases as
it has also been used by nursing and other disciplines the subjects’ risk and vulnerability increase. However,
(APA, 2010). Qualitative researchers have debated in many situations, the knowledge needed to provide
this issue, and some believe that certain group and evidence-based care to these vulnerable populations
individual behaviors are unobservable within the can be gained only by studying them.
normal ethical range of research activities, such as the
actions of cults or the aggressive or violent behaviors Legally and Mentally Incompetent Subjects
of individuals. Thus, these types of behaviors require Neonates and children (minors), the mentally impaired,
study with covert data collection processes. However, and unconscious patients are legally or mentally
covert data collection is considered unethical when incompetent to give informed consent. These indi-
research deals with sensitive aspects of an individual’s viduals lack the ability to comprehend information
behavior, such as illegal conduct, sexual behavior, and about a study and to make decisions regarding partici-
drug use (U.S. DHHS, 2009). With the HIPAA Privacy pation in or withdrawal from the study. Their vulner-
Rule (U.S. DHHS, 2003), the use of any type of covert ability ranges from minimal to absolute. The use of
data collection would be questionable and illegal if persons with diminished autonomy as research sub-
PHI data were being used or disclosed. jects is more acceptable if (1) the research is therapeu-
The use of deception in research can also violate tic, so that the subjects have the potential to benefit
a subject’s right to self-determination. Deception is the directly from the experimental process; (2) the
actual misinforming of subjects for research purposes researcher is willing to use both vulnerable and non-
(Kelman, 1967). A classic example of deception is the vulnerable individuals as subjects; (3) preclinical and
Milgram (1963) study, in which the subjects thought clinical studies have been conducted and provide data
they were administering electric shocks to another for assessing potential risks to subjects; and (4) the
person. The subjects were unaware that the person was risk is minimized and the consent process is strictly
really a professional actor who pretended to feel the followed to secure the rights of the prospective sub-
shocks. Some subjects experienced severe mental jects (U.S. DHHS, 2009).
tension, almost to the point of collapse, because of Neonates
their participation in this study. The use of deception A neonate is defined as a newborn and is identified
still occurs in some healthcare, social, and psychologi- as either viable or nonviable on delivery. Viable neo-
cal investigations, but it is a controversial research nates are able to survive after delivery, if given the
activity. If deception is to be used in a study, research- benefit of available medical therapy, and can indepen-
ers must determine that there is no other way to gain dently maintain a heartbeat and respiration. A nonvi-
the essential research data needed and that the subjects able neonate is a newborn who after delivery, although
will not be harmed. In addition, the subjects must be living, is not able to survive (U.S. DHHS, 2009). Neo-
informed of the deception once the study is completed, nates are extremely vulnerable and require extra pro-
provided full disclosure of the study activities that tection to determine their involvement in research.
were conducted, (APA, 2010; Fry, 2011; U.S. DHHS, However, research may involve viable neonates, neo-
2009) and given the opportunity to withdraw their data nates of uncertain viability, and nonviable neonates if
from the study. the following five conditions are met:
166 UNIT TWO  The Research Process

1. The study is scientifically appropriate and the pre- meaningful assent to participate as a subject in studies
clinical and clinical studies have been conducted (Thompson, 1987). With advancing age and maturity,
and provided data for assessing the potential risks a child should have a stronger role in the consent
to the neonates. process.
2. The study provides important biomedical knowl- To obtain informed consent, federal regulations
edge that cannot be obtained by other means and require both the assent of the children (when capable)
will not add risk to the neonate. and the permission of their parents or guardians (U.S.
3. The research has the potential to enhance the prob- DHHS, 2009). Assent means a child’s affirmative
ability of survival of the neonate. agreement to participate in research. Permission to
4. Both parents are fully informed about the research participate in a study means the agreement of parents
during the consent process. or guardian to the participation of their child or ward
5. The research team will have no part in determining in research (U.S. DHHS, 2009). If a child does not
the viability of the neonate. assent to participate in the study, he or she should not
In addition, for the nonviable neonate, the vital be included as a subject even if parental permission is
functions of the neonate should not be artificially obtained.
maintained because of the research, and the research Using children as research subjects is also influ-
should not terminate the heartbeat or respiration of the enced by the therapeutic nature of the research and the
neonate (U.S. DHHS, 2009). risks versus the benefits. Thompson (1987) developed
Children a guide for obtaining informed consent that is based
The unique vulnerability of children makes the on the child’s level of competence, the therapeutic
decision to use them as research subjects particularly nature of the research, and the risks versus the benefits
important. To safeguard their interests and protect (Table 9-2). Children who are experiencing a devel-
them from harm, special ethical and regulatory con- opmental delay, cognitive deficit, emotional disorder,
siderations have been put in place for research involv- or physical illness must be considered individually
ing children (U.S. DHHS, 2009). However, the laws (Broome, 1999; Broome & Stieglitz, 1992).
defining the minor status of a child are statutory and A child 7 years or older with normal cognitive
vary from state to state. Often a child’s competency to development can provide assent or dissent to partici-
consent is governed by age, with incompetence being pation in a study, and the process for obtaining
nonrefutable up to age 7 years (Broome, 1999; Fry et the assent should be included in the research proposal.
al., 2011). Thus, a child younger than 7 years is not In the assenting process, the child must be given
believed to be mature enough to assent or consent to developmentally appropriate information on the study
research. Developmentally by age 7, a child is capable purpose, expectations, and benefit-risk ratio (discussed
of concrete operations of thought and can give later). DVDs, written materials, demonstrations,

TABLE 9-2  Guide to Obtaining Informed Consent Based on the Relationship between a Child’s Level
of Competence, the Therapeutic Nature of the Research, and Risk versus Benefit
Nontherapeutic Research Therapeutic Research
MMR-LB MR-LB MR-HB MMR-HB
Child, Incompetent (generally, 0-6 yr)
Parents’ consent Necessary Necessary Sufficient* Sufficient
Child’s assent Optional† Optional† Optional
Child, Relatively Competent (7 yr and older)
Parents’ consent Necessary Necessary Sufficient‡ Recommended
Child’s assent Necessary Necessary Sufficient§ Sufficient

*A parent’s refusal can be superseded by the principle that a parent has no power to forbid the saving of a child’s life.

Children making “deliberate objection” would be precluded from participation by most researchers.

In cases not involving the privacy rights of a “mature minor.”
§
In cases involving the privacy rights of a “mature minor.”
HB, high benefit; LB, low benefit; MMR, more than minimal risk; MR, minimal risk.
From Thompson, P. J. (1987). Protection of the rights of children as subjects for research. Journal of Pediatric Nursing, 2(6), 397.
CHAPTER 9  Ethics in Research 167

diagrams, role-modeling, and peer discussions are


possible methods for communicating study informa- The children were oriented to the A-CASI format
tion. The child also needs an opportunity to sign an and were directed to select either the English- or
assent form and to have a copy of this form. An Spanish-language version to complete. For children
example assent form is presented in Box 9-2. During who had difficulty with reading, audio support was
the study, the researcher must give the child the oppor- engaged on the laptop computer and the children
tunity to ask questions and to withdraw from the study listened with an earpiece as the items were read to
if he or she desires (Broome, 1999). Assent becomes them in their preferred language.… As each child
more complex if the child is bilingual, because the completed the questionnaire, the research assistants
researchers must determine the most appropriate lan- saved the data record to a secure Web site.” (Rew et
guage to use for the consent process for the child and al., 2010, pp. 158, 160)
the parents. Holaday, Gonzales, and Mills (2007) offer
a list of seven questions in their article to assist
researchers in determining the language for commu- Rew et al. (2010) provided a detailed description
nication during a study. of the protection of the children and their parents’
Rew, Horner, and Fouladi (2010) conducted a study rights. The study was described in a language of
of school-aged children’s health behaviors to deter- choice with an offer to answer questions. The parents
mine whether they were precursors of adolescents’ agreed to their children’s participation in the study
health-risk behaviors. The sample included Hispanic through signed permissions. The children gave written
and non-Hispanic children and their parents. The assent to participating in the study. Other ethical
ethical aspects of the study are described in the fol- aspects of the study were the IRB approvals from the
lowing quotation: university and school administrators and the storage
of study data in a secure location. All of these activi-
ties promoted the ethical conduct of this study accord-
ing to the U.S. DHHS (2009) regulations. The
“The study took place in a rural setting in central researchers found that girls have more health-focused
Texas, a state with a rapidly expanding population of behaviors than boys, health behaviors decreased from
Hispanics, primarily of Mexican descent. The non­ grades 4 to 6, and the school environment was impor-
probability sample was composed of 1,934 children tant for promoting health behaviors.
in Grades 4 (n = 781), 5 (n = 621), and 6 (n = 532) Pregnant Women
who were enrolled in three rural school districts in Pregnant women require additional protection in
central Texas and one of their parents…. research because of their fetuses. Federal regulations
After study approval was obtained from the uni­ define pregnancy as encompassing the period of time
versity’s institutional review board [IRB] and each of from implantation until delivery. “A woman is assumed
the school administrators, a packet was mailed to to be pregnant if she exhibits any of the pertinent
parents of all the children in Grades 4 through 6 in presumptive signs of pregnancy, such as missed
three rural school districts. The packets included a menses, until the results of a pregnancy test are nega-
cover letter from the child’s school, an explanatory tive or until delivery” (U.S. DHHS, 2009, 45 CFR
letter from the researchers, and consent forms. All Section 46.202). Research conducted with pregnant
materials were written in English and Spanish, with women should have the potential to directly benefit
forward and backward translations by independent the woman or the fetus. If your investigation is thought
speakers, and were reviewed by bilingual members to provide a direct benefit only to the fetus, you must
of the community for translation clarity and accuracy obtain the consent of the pregnant woman and father.
before mailing. Informational meetings were held at In addition, studies with pregnant women should
the schools after parent-teacher meetings. At those include no inducements to terminate the pregnancy
school meetings, the study was explained to the chil­ (U.S. DHHS, 2009).
dren, questions were answered, and signed permis­ Adults with Diminished Capacity
sions were obtained from parents. Data were later Certain adults have a diminished capacity for, or
collected during school hours using audio (optional) are incapable of, giving informed consent because of
computer-assisted self-interviewing (A-CASI) tech­ mental illness (Beebe & Smith, 2010), cognitive
nology using laptop computers after the children who impairment, or a comatose state (Simpson, 2010).
agreed to participate provided written assent.… Persons are said to be incompetent if a qualified clini-
cian judges them to have attributes that designate them
168 UNIT TWO  The Research Process

Box 9-2 Sample Assent Form for as incompetent (U.S. DHHS, 2009). Incompetence
can be temporary (e.g., inebriation), permanent (e.g.,
Children Ages 6 To 12 Years:
advanced senile dementia), or subjective or transitory
Pain Interventions for (e.g., behavior or symptoms of psychosis).
Children with Cancer If an individual is judged incompetent and inca-
Oral Explanation pable of consent, you must seek approval from the
I am a nurse who would like to know whether prospective subject and his or her legally authorized
relaxation, special ways of breathing, and representative. A legally authorized representative
using your mind to think pleasant things help means an individual or other body authorized under
children like you to feel less afraid and feel law to consent on behalf of a prospective subject to
less hurt when the doctor has to do a bone his or her participation in research. However, indi-
marrow aspiration or spinal tap. Today, and viduals can be judged incompetent and can still assent
the next five times you and your mom and/or to participate in certain minimal-risk research if they
dad come to the clinic, I would like for you have the ability to understand what they are being
to answer some questions about the things asked to do, to make reasonably free choices, and to
in the clinic that scare you. I would also like communicate their choices clearly and unambiguously
you to tell me about how much pain you (U.S. DHHS, 2009).
felt during the bone marrow or spinal tap. A number of people in intensive care units and
In addition, I would like to videotape (take nursing homes are experiencing some level of cogni-
pictures of) you and your mom and/or dad tive impairment. These individuals must be assessed
during the tests. The second time you visit the for their capacity to give consent to participate in
clinic I would like to meet with you and teach research. The assessment needs to include the follow-
you special ways to relax, breathe, and use ing elements: understanding of the study information,
your mind to imagine pleasant things. You can developing a belief about the information, reasoning
use the special imagining and breathing ability, and understanding of a choice. Simpson (2010)
during your visits to the clinic. I would ask you reviewed the literature and found that the MacArthur
and your mom and/or dad to practice the Competency Assessment Tool for Clinical Research
things I teach you at home between your visits (MacCAT-CR) is one of the strongest instruments
to the clinic. At any time you could change available for assessing an individual’s capacity to give
your mind and not be in the study anymore. informed consent. Using this instrument or others dis-
cussed by Simpson (2010), researchers can make a
To Child more sound decision about a subject’s ability to
1. I want to learn special ways to relax, consent to research or about whether the legal guard-
breathe, and imagine. ian must be contacted for permission.
2. I want to answer questions about things Some individuals have become permanently
children may be afraid of when they come incompetent from the advanced stages of senile
to the clinic. dementia of the Alzheimer type (SDAT), and their
3. I want to tell you how much pain I feel legal guardians must give permission for their partici-
during the tests I have. pation in research. Often families or guardians of these
4. I will let you videotape me while the doctor patients are reluctant to give consent for their partici-
does the tests (bone marrow and spinal pation in research. However, nursing research is
taps). needed to establish evidence-based interventions for
If the child says YES, have him/her put an comforting and caring for these individuals. Levine
“X” here: _______________________ (1986) identified two approaches that families, guard-
If the child says NO, have him/her put an ians, researchers, or IRBs might use when making
“X” here: ________________________ decisions on behalf of these incompetent individuals:
Date: ______________________ (1) best interest standard and (2) substituted judgment
Child’s signature: ________________________ standard. The best interest standard involves doing
what is best for the individual on the basis of balanc-
From Broome, M. E. (1999). Consent (assent) for
ing risks and benefits. The substituted judgment
research with pediatric patients. Seminars in
Oncology Nursing, 15(2), 101.
standard is concerned with determining the course of
action that incompetent individuals would take if they
were capable of making a choice (Beattie, 2009).
CHAPTER 9  Ethics in Research 169

Jones, Munro, Grap, Kitten, and Edmond (2010) Subjects Confined to Institutions
conducted a quasi-experimental study to determine the Hospitalized patients have diminished autonomy
effect of toothbrushing on bacteremia risk in mechani- because they are ill and are confined in settings that
cally ventilated adults. These researchers described are controlled by healthcare personnel (Levine, 1986).
their process for obtaining consent from their study Some hospitalized patients feel obliged to be research
participants in the following study excerpt: subjects because they want to assist a particular prac-
titioner (nurse or physician) with his or her research.
Others feel coerced to participate because they fear
“The study was reviewed and approved by the uni­ that their care will be adversely affected if they refuse.
versity’s institutional review board. All subjects who Some of these hospitalized patients are survivors of
met inclusion criteria were assessed for ability to trauma (such as auto accidents, gunshot wounds, or
provide informed consent through gesturing or physical and sexual abuse) who are very vulnerable
writing. If subjects had medications that impaired cog­ and often have decreased decision-making capacities
nition or were unable to provide informed consent (McClain, Laughon, Steeves, & Parker, 2007). When
due to their illness, the legally authorized representa­ conducting research with these types of patients, you
tive provided informed consent.” (Jones et al., 2010, must pay careful attention to the informed consent
p. S58) process and make every effort to protect these subjects
from feelings of coercion and harm (U.S. DHHS,
2009).
Jones et al. (2010) developed a process for deter- In the past, prisoners have experienced diminished
mining the cognitive competence of their potential autonomy in research projects because of their con-
research participants and obtained appropriate consent finement. They might feel coerced to participate in
on the basis of their assessments. The competent sub- research because they fear harm if they refuse or
jects were given the right to self-determination regard- because they desire the benefits of early release,
ing study participation. The researchers found that the special treatment, or monetary gain. Prisoners have
toothbrushing intervention did not cause transient bac- been used for drug studies in which there were no
teremia in this population of ventilated patients. health-related benefits and there was possible harm for
Terminally Ill Subjects the prisoners. Current regulations regarding research
When conducting research on terminally ill sub- involving prisoners require that “the risks involved in
jects, you should determine (1) who will benefit from the research are commensurate with risks that would
the research and (2) whether it is ethical to conduct be accepted by nonprisoner volunteers and procedures
research on individuals who might not benefit from for the selection of subjects within the prison are fair
the study (U.S. DHHS, 2009). Participating in research to all prisoners and immune from arbitrary interven-
could have greater risks and minimal or no benefits tion by prison authorities or prisoners” (U.S. DHHS,
for these subjects. In addition, the dying subject’s con- 2009, Section 46.305).
dition could affect the study results and lead you to Protecting the rights of subjects with diminished
misinterpret the results. However, Hinds, Burghen, autonomy in research is regulated internationally by
and Pritchard (2007) stressed the importance of con- the Council for International Organizations of Medical
ducting end-of-life studies in pediatric oncology to Sciences (CIOMS). CIOMS (2010) developed inter-
generate evidence that will improve the care for ter- national ethical guidelines for biomedical research
minally ill children and adolescents. involving human subjects, and the guidelines require
Some terminally ill individuals are willing subjects protection of vulnerable individuals, groups, commu-
because they believe that participating in research is a nities, and populations during research. Researchers
way to contribute to society before they die. Others must evaluate each prospective subject’s capacity for
want to take part in research because they believe that self-determination and must protect subjects with
the experimental process will benefit them. For diminished autonomy during the research process
example, individuals with AIDS might want to partici- (ANA, 2001, APA, 2010; U.S. DHHS, 2009).
pate in AIDS research to gain access to experimental
drugs and hospitalized care. Researchers studying Right to Privacy
populations with serious or terminal illnesses are Privacy is an individual’s right to determine the time,
faced with ethical dilemmas as they consider the rights extent, and general circumstances under which per-
of the subjects and their responsibilities in conducting sonal information will be shared with or withheld from
quality research (Fry et al., 2011; U.S. DHHS, 2009). others. This information consists of one’s attitudes,
170 UNIT TWO  The Research Process

beliefs, behaviors, opinions, and records. The Privacy (De-identifying PHI is defined in the following
Act of 1974 provided the initial protection of an indi- section.)
vidual’s privacy. Because of this act, data collection • The data are part of a limited data set, and a
methods were to be scrutinized to protect subjects’ data use agreement with the researcher(s) is in
privacy, and data cannot be gathered from subjects place.
without their knowledge. Individuals also have the • The individual who is a potential subject for a study
right to access their records and to prevent access by authorizes the researcher to use and disclose his or
others (U.S. DHHS, 2009). The intent of this act was her PHI.
to prevent the invasion of privacy that occurs when • A waiver or alteration of the authorization require-
private information is shared without an individual’s ment is obtained from an IRB or a privacy board
knowledge or against his or her will. Invading an (U.S. DHHS, 2007b) (see http://privacyruleand
individual’s privacy might cause loss of dignity, research.nih.gov/pr_08.asp/).
friendships, or employment or create feelings of The first two items are discussed in this section of
anxiety, guilt, embarrassment, or shame. the chapter. The authorization process is discussed in
The HIPAA Privacy Rule expanded the protection the section on obtaining informed consent, and the
of an individual’s privacy, specifically his or her pro- waiver or alteration of authorization requirement is
tected individually identifiable health information, and covered in the section on institutional review of
described the ways in which covered entities can use research.
or disclose this information. “Individually identifi-
able health information (IIHI) is information that is De-identifying Protected Health Information under
a subset of health information, including demographic the Privacy Rule
information collected from an individual, and: (1) is Covered entities, such as healthcare providers and
created or received by healthcare provider, health agencies, can allow researchers access to health infor-
plan, or healthcare clearinghouse; and (2) [is] related mation if the information has been de-identified.
to past, present, or future physical or mental health or De-identifying health data involves removing the 18
condition of an individual, the provision of health care elements that could be used to identify an individual
to an individual, or the past, present, or future payment or his or her relatives, employer, or household
for the provision of health care to an individual, and members. The 18 identifying elements are listed in
that identifies the individual; or with respect to which Box 9-3.
there is a reasonable basis to believe that the informa- An individual’s health information can also be
tion can be used to identify the individual” (U.S. de-identified through the use of statistical methods.
DHHS, 2003, 45 CFR, Section 160.103). However, the covered entity and you as the researcher
According to the HIPAA Privacy Rule, the IIHI is must ensure that the individual subject cannot be iden-
protected health information (PHI) that is transmitted tified or that there is a very small risk that the subject
by electronic media, maintained in electronic media, could be identified from the information used. The
or transmitted or maintained in any other form or statistical method used for de-identification of the
medium. Thus, the HIPAA privacy regulations affect health data must be documented, and you must certify
nursing research in the following ways: (1) accessing that the 18 elements for identification have been
data from a covered entity, such as reviewing a removed or revised to ensure the individual is not
patient’s medical record in clinics or hospitals; (2) identified. You must retain this certification informa-
developing health information, such as the data devel- tion for 6 years.
oped when an intervention is implemented in a study
to improve a subject’s health; and (3) disclosing data Limited Data Set and Data Use Agreement
from a study to a colleague in another institution, such Covered entities (healthcare provider, health plan, and
as sharing data from a study to facilitate development healthcare clearinghouse) may use and disclose a
of an instrument or scale (Olsen, 2003). limited data set to a researcher for a study without an
The U.S. DHHS developed the following guide- individual subject’s authorization or an IRB waiver.
lines to help researchers, healthcare organizations, and However, a limited data set is considered PHI, and the
healthcare providers determine when they can use and covered entity and the researcher must have a data use
disclose IIHI. IIHI can be used or disclosed to a agreement. The data use agreement limits how the
researcher in the following situations: data set may be used and how it will be protected. The
• The protected health information has been HIPAA Privacy Rule requires the data use agreement
“de-identified” under the HIPAA Privacy Rule. to do the following (U.S. DHHS, 2003):
CHAPTER 9  Ethics in Research 171

1. Specifies the permitted uses and disclosures of the Box 9-3 18 Elements that Could Be
limited data set.
Used to Identify an Individual
2. Identifies the researcher who is permitted to use or
receive the limited data set. to Relatives, Employer, or
3. Stipulates that the recipient (researcher) will: Household Members
a. Not use or disclose the information other than 1. Names.
permitted by the agreement. 2. All geographical subdivisions smaller than
b. Use appropriate safeguards to prevent the use or a state, including street address, city,
disclosure of the information, except as provided county, precinct, zip code, and their
for in the agreement. equivalent geographical codes, depending
c. Hold any other person (co-researchers, stat­ on size of population according to the
isticians, or data collectors) to the standards, current publicly available data from the
restrictions, and conditions stated in the data Bureau of the Census, as follows:
use agreement with respect to the health a. If the geographical unit formed by
information. combining all zip codes with the same
d. Not identify the information or contact the three initial digits contains more than
individuals whose data are in the limited 20000 people, the initial three digits of
data set. the zip code may be retained.
Riegel et al. (2011) conducted a secondary analysis b. For all such geographical units
of data from the Heart Failure (HF) Quality of Life containing 20000 or fewer people, the
Registry database. The purpose of the study was to initial three digits of the zip code are
establish whether confidence and activity status deter- changed to 000.
mined the HF patients’ self-care performance. The 3. All elements of dates (except year) for
researchers found three levels of self-care perfor- dates directly related to an individual,
mance: (1) novice in self-care with limited confidence including birth date, admission date,
and few activity restrictions; (2) inconsistent in self- discharge date, date of death; and all ages
care abilities; and (3) expert with confidence in self- over 89 and all elements of dates (including
care abilities. The researchers ensured the PHI of the year) indicative of such age, except that
individuals in the database was ethically managed, as such ages and elements may be aggregated
described in the following excerpt: into a single category of age 90 or older.
4. Telephone numbers.
5. Facsimile numbers.
“By prior consensus of investigators in the HF Quality 6. Electronic mail (email) addresses.
of Life Registry, study samples are enrolled using com­ 7. Social security numbers.
parable inclusion and exclusion criteria, as well as the 8. Medical record numbers.
same variables and measures whenever possible. All 9. Health plan beneficiary numbers.
data are stored at one site, where one of the inves­ 10. Account numbers.
tigators has volunteered to integrate newly acquired 11. Certificate/license numbers.
data. The only identifiers in the data set are site (e.g., 12. Vehicle identifiers and serial numbers,
Cleveland Clinic) and the specific study name, as including license plate numbers.
more than one study is common at each site. No 13. Device identifiers and serial numbers.
protected health information [PHI] is included in the 14. Web universal resource locators (URLs).
database. All requests to use the full database are 15. Internet protocol (IP) address numbers.
viewed and approved by the lead investigators. For 16. Biometric identifiers, including fingerprints
this analysis, five samples enrolled at three different and voiceprints.
sites in the United States between 2003 and 2008 17. Full-face photographic images and any
were used.” (Riegel et al., 2011, p. 133) comparable images.
18. Any other unique identifying number,
characteristic, or code, unless otherwise
Right to Autonomy and Confidentiality permitted by the Privacy Rule for
On the basis of the right to privacy, the research Re-identification (see http://privacyruleand
subject has the right to anonymity and the right research.nih.gov/pr_08.asp/) (U.S. DHHS,
to assume that the data collected will be 2007b).
172 UNIT TWO  The Research Process

kept confidential. Anonymity exists if the subject’s access to information about the patients in the hospital
identity cannot be linked, even by the researcher, with and will request to see the data the researchers have
his or her individual responses (APA, 2010; Fry et al., collected. Sometimes, family members or close friends
2011). For studies that use de-identified health infor- would like to see the data collected on specific sub-
mation or data from a limited data set, the subjects are jects. Sharing research data in these circumstances is
anonymous to the researchers. The researchers are a breach of confidentiality. When requesting permis-
unable to contact these subjects for additional infor- sion to conduct a study, you should tell healthcare
mation without special approval, as described in the professionals, family members, and others in the
study by Riegel et al. (2011). setting that you will not share the raw data. However,
In most studies, researchers desire to know the you may elect to share the research report, including
identity of their subjects and promise that their identity a summary of the data and findings from the study,
will be kept confidential. Confidentiality is the with healthcare providers, family members, and other
researcher’s management of private information interested parties.
shared by a subject that must not be shared with others
without the authorization of the subject. Confidential- Maintaining Confidentiality
ity is grounded in the following premises: (1) indi- Researchers have a responsibility to protect the ano-
viduals can share personal information to the extent nymity of subjects and to maintain the confidentiality
they wish and are entitled to have secrets; (2) one can of data collected during a study. You can protect ano-
choose with whom to share personal information; (3) nymity by giving each subject a code number. Keep a
people who accept information in confidence have an master list of the subjects’ names and their code
obligation to maintain confidentiality; and (4) profes- numbers in a locked place; for example, subject Mary
sionals, such as researchers, have a duty to maintain Jones might be assigned the code number “001.” All
confidentiality that goes beyond ordinary loyalty of the instruments and forms that Mary completes and
(Levine, 1986; U.S. DHHS, 2009). the data you collect about her during the study will be
identified with the “001” code number, not her name.
Breach of Confidentiality The master list of subjects’ names and code numbers
A breach of confidentiality can occur when a is best kept separate from the data collected to protect
researcher, by accident or direct action, allows an subjects’ anonymity. You should not staple signed
unauthorized person to gain access to the study raw consent forms and authorization documents to instru-
data. Confidentiality can also be breached in the ments or other data collection tools, as this would
reporting or publication of a study when a subject’s make it easy for unauthorized persons to readily iden-
identity is accidentally revealed, violating the sub- tify the subjects and their responses. Consent forms
ject’s right to anonymity (Munhall, 2012a). Breaches are often stored with the master list of subjects’ names
of confidentiality can harm subjects psychologically and code numbers. When entering the data collected
and socially as well as destroy the trust they had in into the computer, use the code numbers for identifica-
the researchers. Breaches of confidentiality can be tion and ensure that the data are stored in a secure
especially harmful to a research participant if they place on a flash drive, in the computer, or on a website.
involve (1) religious preferences; (2) sexual prac- In the study by Rew et al. (2010) that was introduced
tices; (3) employment; (4) racial prejudices; (5) drug earlier in this chapter, the school-aged children par-
use; (6) child abuse; or (7) personal attributes, such ticipating in the study of their health behaviors com-
as intelligence, honesty, and courage. For example, a pleted a questionnaire on the computer and their data
university researcher conducted a study of nurses’ were saved by the research assistants to a secure
stressful life events and work-related burnout in an website. These actions ensured that each subject’s data
acute care hospital. One of the two male participants were kept confidential during and after completion of
in the study was a nurse who is being treated for an the study.
anxiety disorder. Reporting that one of the male Another way to protect your subjects’ anonymity is
nurses in the study was being treated for an anxiety to have subjects or study participants generate their
disorder would violate his confidentiality and poten- own identification codes (Damrosch, 1986). With this
tially cause harm. Nurse administrators might be less approach, each subject generates an individual code
likely to promote a nurse who is receiving mental from personal information, such as the first letter of a
health treatment. mother’s name, the first letter of a father’s name, the
Some nurse researchers have encountered health- number of brothers, the number of sisters, and middle
care professionals who believe that they should have initial. Thus, the code would be composed of three
CHAPTER 9  Ethics in Research 173

letters and two numbers, such as “BD21M.” This code Confidentiality of subjects’ information can also be
would be used on each form that the subject com- ensured during the data analysis process in quantita-
pletes. Using a subject-generated code is especially tive research. The data collected should undergo group
helpful when the researcher needs to link the subject’s analysis so that an individual cannot be identified by
data over time. Because of the specific components of his or her responses. If the subjects are divided into
the ID number, the subject does not have to remember groups for data analysis and there is only one subject
the code number from one data collection point until in a group, combine that subject’s data with that of
the next. Even you as the researcher would not know another group or delete the data. In writing the research
the subject’s identity, only the subject’s code. If a report, you should describe the findings in such a way
qualitative study is being conducted in which exten- that an individual or a group of individuals cannot be
sive, often sensitive data are collected on just a few identified from their responses.
study participants, researchers might want to use this
type of coding system. Qualitative researchers also use Right to Fair Treatment
the approach of allowing participants to provide The right to fair treatment is based on the ethical
pseudonyms by which they want to be known during principle of justice. This principle holds that each
the study. person should be treated fairly and should receive
Maintaining confidentiality of participants’ data in what he or she is due or owed. In research, the selec-
qualitative studies often requires more effort than in tion of subjects and their treatment during the course
quantitative research. The nature of qualitative of a study should be fair.
research requires that the “investigator must be close
enough to understand the depth of the question under Fair Selection of Subjects
study, and must present enough direct quotes and In the past, injustices in subject selection have resulted
detailed description to answer the question” (Ramos, from social, cultural, racial, and sexual biases in
1989, p. 60). The small number of participants used society. For many years, research was conducted on
in a qualitative study and the depth of detail gathered categories of individuals who were thought to be espe-
on each participant requires planning to ensure confi- cially suitable as research subjects, such as the poor,
dentiality. Ford and Reutter (1990) have recommended charity patients, prisoners, slaves, peasants, dying
that to maintain confidentiality, the researcher should persons, and others who were considered undesirable
(1) use pseudonyms instead of the participants’ names (Reynolds, 1979). Researchers often treated these sub-
and (2) distort certain details in the participants’ stories jects carelessly and had little regard for the harm and
while leaving the contents unchanged. Researchers discomfort they experienced. The Nazi medical exper-
must respect participants’ privacy as they decide how iments, Tuskegee syphilis study, and Willowbrook
much detail and editing of private information are study all exemplify unfair subject selection and
necessary to publish a study (Munhall, 2012a; Orb, treatment.
Eisenhauer, & Wynaden, 2001). The selection of a population and the specific sub-
Researchers should also take precautions during jects to study should be fair, and the risks and benefits
data collection and analysis to maintain confidentiality of a study should be fairly distributed on the basis of
in qualitative studies. The interviews conducted with the subject’s efforts, needs, and rights. Subjects should
participants are frequently recorded and later tran- be selected for reasons directly related to the problem
scribed, so the participants’ names should not be men- being studied and not for “their easy availability, their
tioned during the recording. They have the right to compromised position, or their manipulability”
know whether anyone other than you will be transcrib- (National Commission for the Protection of Human
ing information from the interviews. In addition, par- Subjects of Biomedical and Behavioral Research,
ticipants should be informed on an ongoing basis that 1978, p. 10).
they have the right to withhold information. By allow- Another concern with subject selection is that some
ing other researchers to critically appraise the rigor researchers select certain people as subjects because
and credibility of a qualitative study, an audit trail is they like them and want them to receive the specific
produced. Allowing others to examine the data to benefits of a study. Other researchers have been
confirm the study findings may create a dilemma swayed by power or money to make certain individu-
regarding the confidentiality of participants’ data, so als subjects so that they can receive potentially benefi-
you must inform them if other researchers will be cial treatments. Random selection of subjects can
examining their data to ensure the credibility of the eliminate some of the researcher bias that might influ-
study findings (Munhall, 2012a; Orb et al., 2001). ence subject selection.
174 UNIT TWO  The Research Process

A current concern in the conduct of research is and try to bring about the greatest possible balance of
finding an adequate number of appropriate subjects to benefits in comparison with harm. Discomfort and
take part in certain studies. As a solution to this harm can be physiological, emotional, social, and eco-
problem in the past, some biomedical researchers have nomic in nature. Reynolds (1979) identified the fol-
offered physicians finder’s fees for identifying research lowing five categories of studies, which are based on
subjects. For example, investigators studying patients levels of discomfort and harm: (1) no anticipated
with lung cancer would give a physician a fee for effects; (2) temporary discomfort; (3) unusual levels
every patient with lung cancer the physician referred of temporary discomfort; (4) risk of permanent
to them. However, the HIPAA Privacy Rule requires damage; and (5) certainty of permanent damage. Each
that individuals give their authorization before PHI level is defined in the following discussion.
can be shared with others. Thus, healthcare providers
cannot recommend individuals for studies without No Anticipated Effects
their permission. Researchers can obtain a partial In some studies, the subjects expect neither positive
waiver from the IRB or privacy board so that they can nor negative effects. For example, studies that involve
obtain PHI necessary to recruit potential subjects reviewing patients’ records, students’ files, pathology
(U.S. DHHS, 2003). This makes it more difficult for reports, or other documents have no anticipated effects
researchers to find subjects for their studies; however, on the subjects. In these types of studies, the researcher
researchers are encouraged to work closely with their does not interact directly with the research subjects.
IRBs and the personnel in the settings of their studies Even in these situations, however, there is a potential
to enlarge their sample sizes. risk of invading a subject’s privacy. The HIPAA
Privacy Rule requires that the agency providing the
Fair Treatment of Subjects health information de-identify the 18 essential ele-
Researchers and subjects should have a specific agree- ments (see Box 9-3), which could be used to identify
ment about what a subject’s participation involves and an individual, to promote subjects’ privacy during
what the role of the researcher will be (APA, 2010). a study.
While conducting a study, you should treat the sub-
jects fairly and respect that agreement. If the data Temporary Discomfort
collection requires appointments with the subjects, be Studies that cause temporary discomfort are described
on time for each appointment and terminate the data as minimal-risk studies, in which the discomfort
collection process at the agreed-on time. You should encountered is similar to what the subject would expe-
not change the activities or procedures that a subject rience in his or her daily life and ceases with the ter-
is to perform unless you obtain the subject’s consent. mination of the study. Many nursing studies require
The benefits promised the subjects should be pro- the subjects to complete questionnaires or participate
vided. For example, if you promise a subject a copy in interviews, which usually involve minimal risk. The
of the study findings, you should deliver on your physical discomforts might be fatigue, headache, or
promise when the study is completed. In addition, muscle tension. The emotional and social risks might
subjects who participate in studies should receive entail the anxiety or embarrassment associated with
equal benefits, regardless of age, race, and socioeco- responding to certain questions. The economic risks
nomic status. When possible, the sample should be might consist of the time spent participating in the
representative of the study population and should study or travel costs to the study site. Participation
include subjects of various ages, ethnic backgrounds, in many nursing studies is considered a mere incon-
and socioeconomic status. Treating subjects fairly venience for the subject, with no foreseeable risks
often facilitates the data collection process and of harm.
decreases the chances of subjects’ withdrawal from a Most clinical nursing studies examining the impact
study (Fry et al., 2011; Orb et al., 2001). of a treatment involve minimal risk. For example, your
study might involve examining the effects of exercise
Right to Protection from Discomfort on the blood glucose levels of type 2 diabetics. During
and Harm the study, you ask the subjects to test their blood
The right to protection from discomfort and harm glucose level one extra time per day. There is discom-
is based on the ethical principle of beneficence, which fort when the blood is drawn and a risk of physical
holds that one should do good and, above all, do no changes that might occur with exercise. The subjects
harm. Therefore, researchers should conduct their might also experience anxiety and fear in association
studies to protect subjects from discomfort and harm with the additional blood testing, and the testing is an
CHAPTER 9  Ethics in Research 175

added expense. The diabetic subjects in this study


would experience similar discomforts in their daily Balancing Benefits and Risks for
lives, and the discomforts would cease with the termi-
nation of the study. a Study
Researchers and reviewers of research must examine
Unusual Levels of Temporary Discomfort the balance of benefits and risks in a study. To deter-
In studies that involve unusual levels of temporary mine this balance or benefit-risk ratio, you must (1)
discomfort, the subjects commonly experience dis- predict the outcome of your study; (2) assess the actual
comfort both during the study and after its termina- and potential benefits and risks on the basis of this
tion. For example, subjects might experience a deep outcome; and then (3) maximize the benefits and mini-
vein thrombosis (DVT), prolonged muscle weakness, mize the risks (see Figure 9-1). The outcome of a
joint pain, and dizziness after participating in a study study is predicted on the basis of previous research,
that required them to be confined to bed for 7 days to clinical experience, and theory.
determine the effects of immobility. Studies that
require subjects to experience failure, extreme fear, or Assessment of Benefits
threats to their identity or to act in unnatural ways The probability and magnitude of a study’s potential
involve unusual levels of temporary discomfort. In benefits must be assessed. A research benefit is
some qualitative studies, participants are asked ques- defined as something of health-related, psychosocial,
tions that reopen old emotional wounds or involve or other value to a subject, or something that will
reliving traumatic events (Ford & Reutter, 1990; contribute to the acquisition of knowledge for
Munhall, 2012a). For example, asking participants to evidence-based practice. Money and other compensa-
describe their rape experience could precipitate feel- tions for participation in research are not benefits but,
ings of extreme fear, anger, and sadness. In these types rather, are remuneration for research-related inconve-
of studies, you should be vigilant about assessing the niences (U.S. DHHS, 2009). In most proposals, the
participants’ discomfort and refer them for appropriate
professional intervention as necessary.
Developing a Study Benefit-Risk Ratio
Risk of Permanent Damage
In some studies, subjects have the potential to suffer
Predict the outcomes of the study
permanent damage; this potential is more common in
biomedical research than in nursing research. For
example, medical studies of new drugs and surgical
procedures have the potential to cause subjects perma-
nent physical damage. However, nurses have investi- Assess Assess
benefits risks
gated topics that have the potential to damage subjects
permanently, both emotionally and socially. Studies
examining sensitive information, such as sexual behav-
ior, child abuse, or drug use, can be risky for subjects.
These types of studies have the potential to cause per- Benefit-risk ratio
manent damage to a subject’s personality or reputation. Maximize benefits
There are also potential economic risks, such as and minimize risks
reduced job performance or loss of employment.

Certainty of Permanent Damage


In some research, such as the Nazi medical experi- Benefits are greater Risks
ments and the Tuskegee syphilis study, the subjects than or equal outweigh
to risks benefits
experience permanent damage. Conducting research
that will permanently damage subjects is highly ques-
tionable, regardless of the benefits gained. Frequently,
the benefits are for other people but not for the sub- Approve Reject
jects. Studies causing permanent damage to subjects study study
violate the fifth principle of the Nuremberg Code
(1949) (see Box 9-1). Figure 9-1  Balancing benefits and risks for a study.
176 UNIT TWO  The Research Process

research benefits are described for the individual sub- effect of an exercise and diet program on the partici-
jects, subjects’ families, and society. pants’ serum lipid values (serum cholesterol, low-
The type of research conducted, whether therapeu- density lipoprotein [LDL], and high-density lipoprotein
tic or nontherapeutic, affects the potential benefits for [HDL]) and cardiovascular (CV) risk level. The ben-
the subjects. In therapeutic nursing research, the indi- efits to the participants are instruction about exercise
vidual subject has the potential to benefit from the and diet and information about their serum lipid values
procedures, such as skin care, range of motion, touch, and CV risk level at the start of the program and 1
and other nursing interventions, that are implemented year later. The potential benefits are improved serum
in the study. The benefits might include improvement lipid values, lowered CV risk level, and better exercise
in the subject’s physical condition, which could facili- and dietary habits. The risks consist of the discomfort
tate emotional and social benefits. In addition, the of having blood specimens drawn twice for serum
knowledge generated from the research might expand lipid measurements and the time spent participating in
the subjects’ and their families’ understanding of the study (Bruce & Grove, 1994). These discomforts
health. The conduct of nontherapeutic nursing research are temporary, are no more than what the subject
does not benefit the subject directly but is important would experience in his or her daily life, and would
to generate and refine nursing knowledge for practice. cease with the termination of the study. The subjects’
By participating in research, subjects have the poten- time participating in the study can be minimized
tial to increase their understanding of the research through organization and precise scheduling of
process and an opportunity to know the findings from research activities. When you examine the ratio of
a particular study (Fry et al., 2011). benefits to risks, you find that (1) the benefits are
greater in number and importance than the risks and
Assessment of Risks (2) the risks are temporary and can be minimized.
You must assess the type, severity, and number of risks Thus, you could justify conducting this study, and it
that subjects might experience by participating in your would probably receive approval from the IRB.
study. The risks involved depend on the purpose of the The obligation to balance the benefits and risks
study and the procedures used to conduct it. Research of studies is the responsibility of the researcher,
risks can be physical, emotional, social, and economic health professionals, and society. The researcher must
in nature and can range from no risk or mere incon- balance the benefits and risks of a particular study and
venience to the risk of permanent damage (Reynolds, protect the subjects from harm during it. Health pro-
1979). Studies can have actual (known) risks and fessionals participating on IRBs must evaluate the
potential risks for subjects. In a study of the effects of benefit-risk ratio of studies to ensure the conduct of
prolonged bed rest, for example, an actual risk would ethical research in their agencies. Society must be
be muscle weakness and the potential risk would be a concerned with the benefits and risks of the entire
DVT. Some studies have actual or potential risks for enterprise of research and with the protection of all
the subjects’ families and society. You must determine human research subjects from harm.
the likelihood of the risks and take precautions to
protect the rights of subjects when implementing your
study. Obtaining Informed Consent
Obtaining informed consent from human subjects is
Benefit-Risk Ratio essential for the conduct of ethical research in the
The benefit-risk ratio is determined on the basis of the United States (U.S. FDA, 2010a; U.S. DHHS, 2009)
maximized benefits and the minimized risks. The and internationally (CIOMS, 2010). Informing is the
researcher attempts to maximize the benefits and mini- transmission of essential ideas and content from the
mize the risks by making changes in the study purpose investigator to the prospective subject. Consent is the
or procedures or both. If the risks entailed by your prospective subject’s agreement to participate in a
study cannot be eliminated or further minimized, you study as a subject, which the subject reaches after
need to justify their existence. If the risks outweigh assimilating essential information. The phenomenon
the benefits, you probably need to revise the study or of informed consent was formally defined in the first
develop a new one. If the benefits equal or outweigh principle of the Nuremberg Code as follows: “The
the risks, you can usually justify conducting the study, voluntary consent of the human subject is absolutely
and an IRB will probably approve it (see Figure 9-1). essential.… This means that the person involved
Say, for example, that you want to balance the should have legal capacity to give consent; should be
benefits and risks of a study that would examine the so situated as to be able to exercise free power of
CHAPTER 9  Ethics in Research 177

choice, without the intervention of any element of will be implemented, how many times, and in what
force, fraud, deceit, duress, over-reaching or other setting.
ulterior form of constraint or coercion; and should Research participants also need to know the funding
have sufficient knowledge and comprehension of the source(s) of a study and whether the study is spon-
elements of the subject matter involved as to enable sored by specific individuals, organizations, or com-
him to make an understanding and enlightened deci- panies. For example, researchers studying the effects
sion” (Levine, 1986, p. 425). Prospective subjects, to of a specific drug must identify any sponsorship by a
the degree that they are capable, should have the pharmaceutical company. If the study is being con-
opportunity to choose whether or not to participate in ducted as part of an academic requirement, researchers
research. With careful accommodations, the subjects should also share that information (Fry et al., 2011).
may include persons with cognitive impairment
(Simpson, 2010), psychiatric diagnosis (Beebe & Description of Risks and Discomforts
Smith, 2010), or dementia (Beattie, 2009). Prospective subjects need to be informed about any
This definition of informed consent provided a foreseeable risks or discomforts (physical, emotional,
basis for the discussion of consent in all subsequent social, or economic) that might result from the study
codes and regulations and has general acceptance in (U.S. FDA, 2010b; U.S. DHHS, 2009). They also
the research community. As the definition indicates, need to know how the risks of the study were mini-
informed consent consists of four elements: (1) disclo- mized and the benefits were maximized. If the study
sure of essential information; (2) comprehension; involves greater than minimal risk, it is a good idea to
(3) competence; and (4) voluntarism. This section encourage the prospective subjects to consult another
describes the elements of informed consent and the person regarding their participation. A trusted advisor,
methods of documenting consent. such as a friend, family member, or another nurse,
could serve as a consultant.
Information Essential for Consent
Informed consent requires the researcher to disclose Description of Benefits
specific information to each prospective subject. The You should also describe any benefits to the subject or
following information has been identified as essential to others that may be expected from the research. The
content for informed consent in research by federal study might benefit the current subjects or might gen-
regulations (U.S. FDA, 2010a; U.S. DHHS (2009). erate knowledge that will provide evidence-based care
to patients and families in the future (U.S. FDA,
Introduction of Research Activities 2010a; U.S. DHHS, 2009).
The introduction of the research must indicate that a
study is being conducted and provide key information Disclosure of Alternatives
about the study. Each prospective subject is provided Study participants must receive a disclosure of alter-
a statement that he or she is being asked to participate natives related to their participating in a study. They
in research and a description of the purpose and the must be informed about appropriate, alternative pro-
expected duration of participation in the study. In cedures or courses of treatment, if any, that might be
clinical nursing research, the patient, serving as a advantageous to them (U.S. DHHS, 2009). For
subject, must know which nursing activities are example, nurse researchers examining the effect of a
research activities and which are routine nursing inter- distraction intervention on the chronic pain of patients
ventions. If at any point the prospective subject dis- with osteoarthritis would need to make potential
agrees with the researchers’ goals or the intent of the subjects aware of the other alternatives for pain
study, he or she can decline participation or withdraw management.
from the study.
Prospective subjects also need to receive a com- Assurance of Anonymity and Confidentiality
plete description of the procedures to be followed and Prospective subjects must be assured that the confi-
identification of any procedures in the study that are dentiality of their records and PHI will be maintained
experimental (U.S. FDA, 2010a; U.S. DHHS, 2009). during and following their study participation (U.S.
Thus, researchers need to describe the research vari- FDA, 2010a; U.S. DHHS, 2003, 2009). Thus, subjects
ables and the procedures or mechanisms that will be need to know that their responses and the information
used to observe, examine, manipulate, or measure obtained from their records during a study will be kept
these variables. In addition, they must inform pro- confidential and their identities will remain anony-
spective subjects about when the study procedures mous in presentations, reports, and publications of the
178 UNIT TWO  The Research Process

study. Depending on the study design, some partici- under which they might be withdrawn from the study,
pants’ identities will be anonymous to the researchers and make a general statement about the circum-
to decrease the potential for bias. stances that could lead to the termination of the entire
project.
Compensation for Participation in Research
For research involving more than minimal risks, pro- Consent to Incomplete Disclosure
spective subjects must be given an explanation as to In some studies, subjects are not completely informed
whether any compensation or medical treatments or of the study purpose because that knowledge would
both are available if injury occurs. If medical treat- alter the subjects’ actions. However, prospective sub-
ments are available, you need to describe the type and jects must know that certain information is being with-
extent of the treatments. Female prospective subjects held deliberately. You must ensure that there are no
need to know whether the study treatment or proce- undisclosed risks to the subjects that are more than
dure may involve potential risks to them or their minimal and that their questions are truthfully
fetuses if they are or may become pregnant during the answered regarding the study. Subjects who are
study (U.S. FDA, 2010a; U.S. DHHS, 2009). Potential exposed to nondisclosure of information must know
subjects also need to know whether they will receive when and how they will be debriefed about the study.
a small financial payment ($10 to $30) to compensate Subjects are debriefed by informing them of the
them for their time and effort related to participating actual purpose of the study and the results that were
in the study. obtained. At this point, subjects have the option to
have their data withdrawn from the study. If the sub-
Offer to Answer Questions jects experience adverse effects related to the study,
You need to offer to answer any questions that the you need to make every attempt to reconcile the
prospective subjects may have during the consent effects (APA, 2010; U.S. DHHS, 2009).
process. Study participants also need an explanation
of whom to contact for answers to questions about the Comprehension of Consent Information
research during the conduct of the study and of whom Informed consent implies not only the imparting of
to contact in the event of a research-related problem information by the researcher but also the comprehen-
or injury as well as how to do so (U.S. FDA, 2010a; sion of that information by the subject. Studies exam-
U.S. DHHS, 2009). ining subjects’ levels of comprehension of consent
information have found their comprehension to be
Noncoercive Disclaimer limited (Erlen, 2010). The potential subjects’ compre-
A noncoercive disclaimer is a statement that partici- hension of the consent depended on the complexity of
pation is voluntary and refusal to participate will the study, the amount of information communicated,
involve no penalty or loss of benefits to which the and the process for communicating the information.
subject is entitled (U.S. FDA, 2010a; U.S. DHHS, The amount of information to be taught depends on
2009). This statement can facilitate a relationship the subjects’ knowledge of research and the specific
between you and your prospective subjects, especially research project proposed. Federal regulations require
if the relationship has a potential for coercion. that the information given to subjects or their repre-
sentatives must be in a language they can understand
Option to Withdraw (U.S. FDA, 2010a; U.S. DHHS, 2009). Thus, the
Subjects may discontinue participation in or may consent information must be written and verbalized in
withdraw from a study at any time without penalty or lay terminology, not professional jargon, and must be
loss of benefits. However, researchers do have the presented without the use of biased terms that might
right to ask subjects whether they think that they will coerce a subject into participating in a study. Meade
be able to complete the study, to decrease the number (1999) identified the following tips for promoting the
of subjects withdrawing early. There may be circum- comprehension of a consent document by potential
stances under which the subject’s participation may research subjects:
be terminated by the researcher without regard to the • Introduce the purpose of the study early in the
subject’s consent (U.S. DHHS, 2009). For example, consent form.
if a particular treatment becomes potentially danger- • Outline the study treatment with specificity and
ous to a subject, you have an obligation to discon- conciseness.
tinue the subject’s participation in the study. Thus, • Convey the elements of informed consent in an
describe for prospective subjects the circumstances organized fashion.
CHAPTER 9  Ethics in Research 179

• Define technical terms, and be consistent in the use • Estimate the reading level of the document with the
of terminology. use of a computerized readability formula, and
• Use clear terminology, and avoid professional revise it to achieve no higher than an eighth grade
jargon. reading level.
• Develop the document using headings, uppercase Meade (1999) used these tips to simplify a para-
and lowercase letters, and spacing to make it easy graph from an example consent form, as shown in Box
to read. 9-4. Once you have developed the consent document,
• Use headings for major elements in the consent pilot-test it with patients who are comparable to the
form, such as “Purpose,” “Benefits,” and “Risks.” proposed subjects for the study. These patients can
• Use a readable font, that is, a minimum of 12- to give feedback on the ease of reading, clarity, and
14-point font for text and a 16- to 18-point font for understandability of the consent document. You can
the headers. then revise the document as needed on the basis of the
• Address the subject directly, using phrases such feedback. These guidelines will help you develop a
as, “You are being asked to take part in this clear, concise consent document that your study sub-
study.…” jects can comprehend.

Box 9-4 Simplification of Consent Document


Origin Consent Document prolonged patient survival and result in a
Example A*: decrease in the number of patients experiencing
Side effects of the marrow infusion are a recurrence.
uncommon and consist primarily of an unusual Revised Simplified Consent Document
taste from the preservative, occasional nausea
Example A*:
and vomiting, and, rarely, fever and chills. In
Side effects of getting stem cells:
addition, your chest may feel tight for a while,
• An unusual or funny taste in your mouth
but that will pass.
• Mild nausea and vomiting
Example B†:
• Fever and chills (rarely)
The standard approach to treating breast cancer
• Tightness in chest (rarely)
is to give several “cycles” (repeated doses at
Example B†:
regularly specified intervals) of a combination of
Why is this study being done?
two or more chemotherapy drugs (drugs that
The purpose of this research study is to find
kill cancer cells). Recent information suggests
out whether adding the drug Taxol (paclitaxel)
that it may be more beneficial to give several
to a commonly used chemotherapy is better
cycles of one drug followed by several cycles of
than the commonly used chemotherapy by itself
another drug. Some researchers think that the
at preventing your cancer from coming back.
second approach may kill more cells that are
The study also will see what side effects there
resistant to chemotherapy. The approach being
are from adding Taxol to the commonly used
tested in this study is to administer four cycles
chemotherapy. Taxol has been found to be
of standard chemotherapy (doxorubicin/
effective in treating patients with advanced
cyclophosphamide) followed by four cycles of
breast cancer. In this study, we want to see
the drug paclitaxel. Researchers hope to show
whether Taxol will help to treat patients with
that cancer cells resistant to the doxorubicin/
early stage breast cancer and whether the side
cyclophosphamide chemotherapy may be
effects seem to be worth the possible benefit.
sensitive to paclitaxel. This may then result in
NCI Model Document Sub-Group: Comprehensive Working Group on Informed Consent, 1998.
*Standard doses versus myeloablative therapy for previously untreated symptomatic multiple myeloma. Phase III.
SWOG 9321.

A randomized trial evaluating the worth of paclitaxel (Taxol) following doxorubicin (Adriamycin)/
cyclophosphamide (Cytoxan) in breast cancer.
From Broome, M. E. (1999). Consent (assent) for research with pediatric patients. Seminars in Oncology Nursing,
15(2), 130.
180 UNIT TWO  The Research Process

Researchers can also take steps to determine the and has shown comprehension of this information
prospective subjects’ level of comprehension by (U.S. FDA, 2010a; U.S. DHHS, 2009). Some research-
having them complete a survey or questionnaire ers, because of their authority, expertise, or power,
examining their understanding of consent information have the potential to coerce subjects into participating
(Cahana & Hurst, 2008). In complex, high-risk studies, in research. Researchers need to ensure that their per-
it is more difficult for subjects to comprehend consent suasion of prospective subjects is not coercive. Thus,
information, so some researchers might require pro- the rewards offered in a study ought to be congruent
spective subjects to pass a test on consent information with the risks taken by the subjects.
before becoming research subjects.
In qualitative research, the participants might com- Documentation of Informed Consent
prehend their participation in a study at the beginning, The documentation of informed consent depends on
but unexpected events or consequences might occur (1) the level of risk involved in the study and (2) the
during the study to obscure that understanding. These discretion of the researcher and those reviewing the
events might precipitate a change in the focus of the study for institutional approval. Most studies require
research and the type of participation by the partici- a written consent form, although in some studies, the
pants. For example, the topics of an interview might consent form may be replaced by oral consent or the
change with an increased need for information from consent form may be used but the subject’s signature
the participants to address these topics. Thus, informed is waived.
consent is an ongoing, evolving process in qualitative
research. The researcher must renegotiate the partici- Written Consent Waived
pants’ consent and determine their comprehension of The requirements for written consent may be waived
that consent as changes occur in the study. By continu- in research that “presents no more than minimal risk
ally informing and determining the comprehension of of harm to subjects and involves no procedures for
participants, you will establish trust with them and which written consent is normally required outside of
promote the conduct of an ethical study (Munhall, the research context” (U.S. DHHS, 2009, 45 CFR
2012a). Section 46.117c). For example, if you were using
questionnaires to collect relatively harmless data, you
Competence to Give Consent would not need to obtain a signed consent form from
Autonomous individuals, who are capable of under- the subjects. The subject’s completion of the question-
standing and weighing the benefits and risks of a pro- naire may serve as consent. The top of the question-
posed study, are competent to give consent. The naire might contain a statement such as “Your
competence of the subject is often determined by the completion of this questionnaire indicates your consent
researcher using an assessment of decisional capacity to participate in this study.”
(Beattie, 2009). Persons with diminished autonomy Written consent is also waived when the only
resulting from legal or mental incompetence, terminal record linking the subject and the research would be
illness, or confinement to an institution might not be the consent document and the principal risk is the
legally competent to consent to participate in research harm that could result from a breach of confidentiality.
(see the earlier discussion of the right to self- The subject needs to be given the option of signing a
determination). However, the researcher makes every consent form or not and the subject’s wishes will
effort to present the consent information at a level govern (U.S. DHHS, 2009). However, the four ele-
prospective subjects can understand, so that they can ments of consent—disclosure, comprehension, com-
assent to the research. In addition, researchers need to petence, and voluntarism—are essential in all studies
clearly present essential information for consent to the whether written consent is waived or required.
legally authorized representative, such as the parents
or guardian, of the prospective subject (U.S. DHHS, Written Consent Documents
2009). Short-Form Written Consent Document
The short-form consent document includes the fol-
Voluntary Consent lowing statement: “The elements of informed consent
Voluntary consent means that the prospective subject required by Section 46.116 [see the section on infor-
has decided to take part in a study of his or her own mation essential for consent] have been presented
volition without coercion or any undue influence. Vol- orally to the subject or the subject’s legally authorized
untary consent is obtained after the prospective subject representative” (U.S. DHHS, 2009, 45 CFR Section
has been given essential information about the study 46.117b). The researcher must develop a written
CHAPTER 9  Ethics in Research 181

summary of what is to be said to the subject in the oral Formal Written Consent Document
presentation, and the summary must be approved by The written consent document or consent form
an IRB. When the oral presentation is made to the includes the elements of informed consent required by
subject or to the subject’s representative, a witness is the U.S. DHHS (2009) and U.S. FDA (2010a) regula-
required. The subject or representative must sign the tions (see the previous section on information essen-
short-form consent document. The witness must sign tial for consent). In addition, a consent form might
both the short-form and a copy of the summary, and include other information required by the institution
the person actually obtaining consent must sign a copy where the study is to be conducted or by the agency
of the summary. Copies of the summary and short funding the study. Most universities provide consent
form are given to the subject and the witness; the form guidelines for researchers to use. A sample
researcher retains the original documents and must consent form is presented in Figure 9-2 with the
keep these documents for 3 years after the end of the common essential consent information. The subject
study. The short-form written consent documents can read the consent form, or the researcher can read
might be used in studies that present minimal or mod- it to the subject; however, it is wise also to explain the
erate risk to the subjects. study to the subject. The subject signs the form, and

Study title: The Needs of Family Members of Critically Ill Adults


Investigator: Linda L. Norris, R.N.

Ms. Norris is a registered nurse studying the emotional and social needs of family members of patients in the
Intensive Care Units (research purpose). Although the study will not benefit you directly, it will provide information that
might enable nurses to identify family members’ needs and to assist family members with those needs (potential
benefits).
The study and its procedures have been approved by the appropriate people and review boards at The University of
Texas at Arlington and X hospital (IRB approval). The study procedures might cause fatigue for you or your family
(potential risks). The procedures include: (1) responding to a questionnaire about the needs of family members of
critically ill patients and (2) completing a demographic data sheet (explanation of procedures). Participation in this
study will take approximately 20 minutes (time commitment). You are free to ask any questions about the study or
about being a subject and you may call Ms. Norris at (999) 999-9999 (work) or (999) 999-9999 (home) if you have
further questions (offer to answer questions).
Your participation in this study is voluntary; you are under no obligation to participate (alternative option and
voluntary consent). You have the right to withdraw at any time and the care of your family member and your
relationship with the healthcare team will not be affected (option to withdraw).
The study data will be coded so they will not be linked to your name. Your identity will not be revealed while the
study is being conducted or when the study is reported or published. All study data will be collected by Ms. Norris,
stored in a secure place, and not shared with any other person without your permission (assurance of anonymity and
confidentiality).

I have read this consent form and voluntarily consent to participate in this study.
(If Appropriate)

Subject’s Signature Date Legal Representative Date

I have explained this study to the above subject and have sought his/her understanding
for informed consent

Investigator’s Signature Date

Figure 9-2  Sample consent form. Words in parentheses and boldface identify common essential consent information and would not appear in an
actual form.
182 UNIT TWO  The Research Process

the investigator or research assistant collecting the


data witnesses it. This type of consent can be used for primary and co-investigators left the room to protect
minimal- to moderate-risk studies. All persons signing the anonymity of the participants. All instruments and
the consent form must receive a copy of it. The materials were blind coded with an alphanumeric
researcher keeps the original consent form for 3 years code to further protect participant anonymity. When
in a secure location, such as a locked file cabinet in a explaining the study, permission to answer only the
locked room. questions they were comfortable with was empha­
Studies that involve subjects with diminished sized. All participants, regardless of consent status,
autonomy require a written consent form. If these pro- then received the psycho-educational intervention.”
spective subjects have some comprehension of the (Kravits et al., 2010, p. 133)
study and agree to participate as subjects, they must
sign the consent form. However, each subject’s legally
authorized representative also must sign the form. The
representative indicates his or her relationship with the Recording of the Consent Process
subject under the signature (see Figure 9-2). A researcher might elect to audio-record or obtain a
The written consent form used in a high-risk study DVD of the consent process. These methods docu-
often contains the signatures of two witnesses, the ment what was said to the prospective subject and
researcher, and an additional person. The additional record the subject’s questions and the investigator’s
person signing as a witness must observe the informed answers. Audio-recording and DVD creation are time-
consent process and must not be otherwise connected consuming and costly, however, and are not appropri-
with the study. The best witnesses are research or ate for studies of minimal or moderate risk. If your
patient advocates who are employed by the institution. study is considered high risk, it might be wise to com-
Sometimes nurses are asked to sign a consent form as pletely document the consent process, because doing
a witness for a biomedical study. They must know the so might protect you and your subjects. Both of you
study purpose and procedures and the subject’s com- would retain a copy of the recording.
prehension of the study before signing the form (Fry
et al., 2011). The role of the witness is more important Authorization for Research Uses
in the consent process if the prospective subject is in and Disclosure
awe of the investigator and does not feel free to ques-
tion the procedures of the study. The HIPAA Privacy Rule provides individuals the
Kravits, McAllister-Black, Grant, and Kirk (2010) right, as research subjects, to authorize covered enti-
conducted a study to examine the effect of a psycho- ties (healthcare provider, health plan, and healthcare
educational intervention on the stress reduction and clearinghouse) to use or disclose their private health
prevention of burnout in registered nurses (RNs). information (PHI) for research purposes. This autho-
These researchers provided a detailed description of rization is regulated by the HIPAA and is separate
their consent process in the following quotation. The from the informed consent that is regulated by the U.S.
researchers found that the intervention was useful in DHHS (2009) and the U.S. FDA (2010a). The autho-
reducing the stress and exhaustion of the RNs but rization focuses on the privacy risks and states how,
recommended additional research on the impact of the why, and with whom the PHI will be shared. The
intervention. authorization form must include the following
information:

Authorization Core Elements (see Privacy Rule,


“Informed Consent 45 CFR Section 164.508[c][1])
The study was reviewed and approved by the Insti­ • “Description of PHI to be used or disclosed (iden-
tutional Review Board. Consent was obtained prior tifying the information in a specific and meaningful
to initiating the intervention. The primary investigator manner).
and/or the co-investigator explained the study includ­ • The name(s) of person(s) authorized to make the
ing risks and benefits to all attendees including com­ requested use or disclosure.
munity healthcare providers. The potential participants • The name(s) of person(s) who may use the PHI or
were assured that participation was strictly voluntary to whom the covered entity may make the requested
and confidential. Consent was obtained by the project disclosure.
director, an RN, and the research assistant after the • Description of each purpose of the requested use
or disclosure. Researchers should note that this
CHAPTER 9  Ethics in Research 183

element must be study specific, not for future these individuals. The members must have sufficient
unspecified research. experience and expertise to review a variety of studies,
• Authorization expiration date. The terms ‘end of including quantitative, outcomes, intervention, and
the research study’ or ‘none’ may be used for qualitative research (Munhall, 2012b). The IRB
research, including for the creation and mainte- members must not have a conflicting interest related
nance of a research database or repository. to a study conducted by an institution. Any member
• Signature of the individual and date. If the autho- having a conflict of interest with a research project
rization is signed by an individual’s personal rep- being reviewed must excuse himself or herself from
resentative, a description of the representative’s the review process, except to provide information
authority to act for the individual must be included.” requested by the IRB. The IRB also must include other
(U.S. DHHS, 2004) members whose primary concern is nonscientific,
The authorization information can be included as such as an ethicist, a lawyer, or a minister. At least one
part of the consent form, but it is probably best to have of the IRB members must be someone who is not
two separate forms (Olsen, 2003). U.S. DHHS (2004) affiliated with the institution (U.S. FDA, 2010b; U.S.
developed a sample authorization form, which is pre- DHHS, 2009). The IRBs in hospitals are often com-
sented in Figure 9-3. posed of physicians, nurses, lawyers, scientists, clergy,
and community laypersons.
In 2009, the U.S. FDA and U.S. DHHS regulations
Institutional Review were revised to require all IRBs to register through a
In institutional review, a committee of the research- system maintained by the DHHS. The registration
er’s peers, examines his or her study for ethical con- information includes contact information for the insti-
cerns. The first federal policy statement on protection tution with the IRB and the official overseeing the
of human subjects by institutional review was issued activities performed by the IRB (such as names,
by the U.S. PHS in 1966. The statement required that addresses, emails, and telephone numbers), the
research involving human subjects must be reviewed number of active protocols involving federally regu-
by a committee of peers or associates to confirm that lated products reviewed during the preceding 12
(1) the rights and welfare of subjects will be protected, months, and a description of the types of products
(2) appropriate methods will be used to secure involved in the protocols reviewed (U.S. FDA, 2010b;
informed consent, and (3) the potential benefits of the U.S. DHHS, 2009). The IRB registration requirement
investigation are greater than the risks (Levine, 1986). was implemented to make it easier for the DHHS to
In 1974, DHEW passed the National Research Act, inspect IRBs and communicate information to them.
which required that all research involving human sub- This rule was made effective in July of 2009 and
jects undergo institutional review. Currently, the U.S. requires each IRB to renew its registration every 3
DHHS (2009, 45 CFR Sections 46.107-46.115) and years.
the U.S. FDA (2010b, 21 CFR Sections 56.101-
56.124) have similar regulations for institutional Levels of Reviews Conducted by Institutional
review of research. These regulations describe the Review Boards
membership, functions, and operations of an institu- Universities and healthcare agencies have IRBs that
tional review board. An institutional review board function in a similar way to review research following
(IRB) is a committee that reviews research to ensure federal regulations (U.S. FDA. 2010b; U.S. DHHS,
that the investigator is conducting the research ethi- 2009). Faculty and students must receive IRB approval
cally. Universities, hospital corporations, and many from their university prior to seeking IRB approval at
managed care centers have IRBs to promote the the agency where the study is to be conducted. The
conduct of ethical research and protect the rights of functions and operations of an IRB involve the review
prospective subjects at these institutions. of research at three different levels: (1) exempt from
Each IRB has at least five members of various review; (2) expedited review; and (3) complete review.
backgrounds (cultural, economic, educational, gender, We want to stress with students and practicing nurses
racial) to promote a complete, scholarly, and fair that the level of the review required for each study is
review of research that is commonly conducted in an decided by the IRB chairperson and/or committee, not
institution. If an institution regularly reviews studies by the researcher.
with vulnerable subjects, such as children, neonates, Studies are usually exempt from review if they
pregnant women, prisoners, and mentally disabled pose no apparent risks for the research subjects. The
persons, the IRB should include one or more members studies that are usually considered exempt from
with knowledge about and experience in working with IRB review by the federal regulations are identified in
184 UNIT TWO  The Research Process

AUTHORIZATION TO USE OR DISCLOSE (RELEASE) HEALTH INFORMATION


THAT IDENTIFIES YOU FOR A RESEARCH STUDY
REQUIRED ELEMENTS:
If you sign this document, you give permission to [name or other identification of specific healthcare provider(s) or
description of classes of persons, e.g., all doctors, all healthcare providers] at [name of covered entity or entities] to use or
disclose (release) your health information that identifies you for the research study described below:
[Provide a description of the research study, such as the title and purpose of the research.]

The health information that we may use or disclose (release) for this research includes
[complete as appropriate]:
[Provide a description of information to be used or disclosed for the research project. This description may include, for
example, all information in a medical record, results of physical examinations, medical history, lab tests, or certain health
information indicating or relating to a particular condition.]
The health information listed above may be used by and/or disclosed (released) to:
[Name or class of persons involved in the research; i.e., researchers and their staff**]

[Name of covered entity] is required by law to protect your health information. By signing
this document, you authorize [name of covered entity] to use and/or disclose (release)
your health information for this research. Those persons who receive your health
information may not be required by Federal privacy laws (such as the Privacy Rule) to
protect it and may share your information with others without your permission, if permitted
by laws governing them.

Please note that [include the appropriate statement]:


• You do not have to sign this Authorization, but if you do not, you may not receive research-related treatment.
(When the research involves treatment and is conducted by the covered entity or when the covered
entity provides health care solely for the purpose of creating protected health information to disclose to
a researcher)

• [Name of covered entity] may not condition (withhold or refuse) treating you on whether you sign this
Authorization.
(When the research does not involve research-related treatment by the covered
entity or when the covered entity is not providing health care solely for the
purpose of creating protected health information to disclose to a researcher)

Please note that [include the appropriate statement]:


• You may change your mind and revoke (take back) this Authorization at any time,
except to the extent that [name of covered entity(ies)] has already acted based on
this Authorization. To revoke this Authorization, you must write to: [name of the
covered entity(ies) and contact information].
(When the research study is conducted by an entity other than the covered
entity)

• You may change your mind and revoke (take back) this Authorization at any time. Even if you revoke this
Authorization, [name or class of persons at the covered entity involved in the research] may still use or disclose
health information they already have obtained about you as necessary to maintain the integrity or reliability of the
current research. To revoke this Authorization, you must write to: [name of the covered entity(ies) and contact
information].
(When the research study is conducted by the covered entity)

Signature of participant or participant’s Date


personal representative

Printed name of participant or participant’s If applicable, a description of the personal


personal representative representative’s authority to sign for the participant

** When a covered entity conducts the research study, the Authorization must list ALL names or other identification, or ALL
classes, of persons who will have access through the covered entity to the protected health information (PHI) for the
research study (e.g., research collaborators, sponsors, and others who will have access to data that includes
PHI). Examples may include, but are not limited to, the following:

• Data coordinating centers that will receive and process PHI;


• Sponsors who want access to PHI or who will actually own the research data; and/or
• Institutional Review Boards or Data Safety and Monitoring Boards.

If the research study is conducted by an entity other than the covered entity, the authorization need only list the name or other
identification of the outside researcher (or class of researchers) and any other entity to whom the covered entity is expected to
make the disclosure.

Figure 9-3  Sample of authorization language for research uses and disclosures of individually identifiable health information by a covered healthcare
provider. Words in parentheses and boldface are explanations for the reader and would not appear in an actual form.
CHAPTER 9  Ethics in Research 185

Box 9-5 Research Qualifying for Exemption from Review


Unless otherwise required by department or without exception that the confidentiality of
agency heads, research activities in which the the personally identifiable information will
only involvement of human subjects will be in be maintained throughout the research and
one or more of the following categories are thereafter.
exempt from review: (4) Research involving the collection or study of
(1) Research conducted in established or existing data, documents, records,
commonly accepted educational settings, pathological specimens, or diagnostic
involving normal educational practices, such specimens if these sources are publicly
as (i) research on regular and special available or if the information is recorded by
education instructional strategies, or (ii) the investigator in such a manner that
research on the effectiveness of or the subjects cannot be identified, directly or
comparison among instructional techniques, through identifiers linked to the subjects.
curricula, or classroom management (5) Research and demonstration projects which
methods. are conducted by or subject to the approval
(2) Research involving the use of educational of Department or Agency heads, and which
tests (cognitive, diagnostic, aptitude, are designed to study, evaluate, or otherwise
achievement), survey procedures, interview examine: (i) Public benefit or service
procedures or observation of public programs; (ii) procedures for obtaining
behavior, unless: (i) information obtained is benefits or services under those programs;
recorded in such a manner that human (iii) possible changes in or alternatives to
subjects can be identified, directly or those programs or procedures; or (iv)
through identifiers linked to the subjects; possible changes in methods or levels of
and (ii) any disclosure of the human payment for benefits or services under those
subjects’ responses outside the research programs.
could reasonably place the subjects at risk of (6) Taste and food quality evaluation and
criminal or civil liability or be damaging to consumer acceptance studies (i) if
the subjects’ financial standing, wholesome foods without additives are
employability, or reputation. consumed or (ii) if a food is consumed that
(3) Research involving the use of educational contains a food ingredient at or below the
tests (cognitive, diagnostic, aptitude, level and for a use found to be safe, or
achievement), survey procedures, interview agricultural chemical or environmental
procedures, or observation of public contaminant at or below the level found to
behavior that is not exempt under be safe, by the Food and Drug
paragraph (b)(2) of this section, if: (i) the Administration or approved by the
human subjects are elected or appointed Environmental Protection Agency or the
public officials or candidates for public Food Safety and Inspection Service of the
office; or (ii) Federal statute(s) require(s) U.S. Department of Agriculture.
From U.S. Department of Health and Human Services (U.S. DHHS, 2009). Protection of human subjects. Code of
Federal Regulations, Title 45, Part 46. Retrieved from http://www.hhs.gov/ohrp/policy/ohrpregulations.pdf/.

Box 9-5. For example, studies by nurses and other risk means “that the risks of harm anticipated in the
health professionals that have no foreseeable risks or proposed research are not greater, considering proba-
are a mere inconvenience for subjects might be identi- bility and magnitude, than those ordinarily encoun-
fied as exempt from review by the chairperson of the tered in daily life or during the performance of routine
IRB committee. Studies incorporating previously col- physical or psychological examinations or tests” (U.S.
lected data from which PHI has been de-identified are DHHS, 2009, 45 CFR Section 46.102). Expedited
usually exempt as well (U.S. DHHS, 2004). review procedures can also be used to review minor
Studies that have some risks, which are viewed as changes in previously approved research. Under expe-
minimal, are expedited in the review process. Minimal dited IRB review procedures, the review may be
186 UNIT TWO  The Research Process

Box 9-6 Research Qualifying for Expedited Institutional Review Board Review
Expedited review (by committee chairpersons or 4. Collection of blood samples by venipuncture,
designated members) is authorized for the in amounts not exceeding 450 mL in an
following research involving no more than 8-week period and no more than two times
minimal risk: per week, from subjects 18 years of age or
1. Collection of hair and nail clippings, in a older and who are in good health and not
nondisfiguring manner; deciduous teeth and pregnant.
permanent teeth if patient care indicates a 5. Collection of both supragingival and
need for extraction. subgingival dental plaque and calculus,
2. Collection of excreta and external secretions provided the procedure is not more invasive
including sweat, uncannulated saliva, than routine prophylactic scaling of the
placenta removed at delivery, and amniotic teeth and the process is accomplished in
fluid at the time of rupture of the accordance with accepted prophylactic
membrane before or during labor. techniques.
3. Recording of data from subjects 18 years of 6. Voice recordings made for research purposes
age or older using noninvasive procedures such as investigations of speech defects.
routinely employed in clinical practice. This 7. Moderate exercise by healthy volunteers.
includes the use of physical sensors that are 8. The study of existing data, documents,
applied either to the surface of the body or records, pathological specimens, or
at a distance and do not involve input of diagnostic specimens.
matter or significant amounts of energy into 9. Research on individual or group behavior or
the subject or an invasion of the subject’s characteristics of individuals, such as studies
privacy. It also includes such procedures as of perception, cognition, game theory, or
weighing, testing sensory acuity, test development, where the investigator
electrocardiography, electroencephalography, does not manipulate subjects’ behavior and
thermography, detection of naturally research will not involve stress to subjects.
occurring radioactivity, diagnostic 10. Research on drugs or devices for which an
echography, and electroretinography. It does investigational new drug exemption or an
not include exposure to electromagnetic investigational device exemption is not
radiation outside the visible range (for required.
example, x-rays, microwaves).
From U.S. Department of Health and Human Services (U.S. DHHS, 2009). Protection of human subjects. Code of
Federal Regulations, Title 45, Part 46. Retrieved from http://www.hhs.gov/ohrp/policy/ohrpregulations.pdf/.

carried out by the IRB chairperson or by one or more subject’s legally authorized representative, (5)
experienced reviewers designated by the chairperson informed consent will be appropriately documented,
from among members of the IRB. In reviewing the (6) the research plan makes adequate provision for
research, the reviewers may exercise all of the authori- monitoring data collection for subjects’ safety, and (7)
ties of the IRB except disapproval of the research. A adequate provisions are made to protect the privacy of
research proposal may be disapproved only after a subjects and to maintain the confidentiality of data.”
complete review by the IRB (U.S. FDA, 2010b; U.S. (U.S. FDA, 2010b, 21 CFR 56.111; U.S. DHHS, 2009,
DHHS, 2009). Box 9-6 identifies research that usually 45 CFR 46.111).
qualifies for expedited review. Every research report must indicate that the study
A study involving greater than minimal risks to had IRB approval and whether the approval was from
research subjects requires a complete IRB review. To a university and/or clinical agency. All the reports
obtain IRB approval, researchers must ensure that “(1) used as examples in this chapter indicated the studies
risks to subjects are minimized, (2) risks to subjects had appropriate IRB approval. For example, Riegel et
are reasonable in relation to anticipated benefits, (3) al. (2011) provided the following description of their
selection of subjects is equitable, (4) informed consent IRB approval. This study involved a secondary data
will be sought from each prospective subject or the analysis using a national database of HF patients to
CHAPTER 9  Ethics in Research 187

determine their levels of self-care performance. These The healthcare provider, health plan, or healthcare
researchers ensured the studies in the database had clearinghouse cannot release the PHI to the researcher
IRB approval and that they obtained IRB approval until the following documentation has been received:
from their university. (1) the identity of the approving IRB; (2) the date the
waiver or alteration was approved; (3) IRB documen-
tation that the criteria for waiver or alteration have
“All studies had been approved by local institutional been met; (4) a brief description of the PHI to which
review boards. In each, eligibility was confirmed by a the researcher has been granted access or use; (5) a
trained nurse research assistant who then explained statement as to whether the waiver was approved
study requirements and obtained written informed under normal or expedited review procedures; and
consent. This secondary analysis was approved by the (6) the signature of the IRB chair or the chair’s
institutional review board of the University of Penn­ designee.
sylvania.” (Riegel et al., 2011, p. 134) The HIPAA Privacy Rule does not change the IRB
membership and functions that are designated under
the U.S. DHHS and U.S. FDA regulations. For clari-
Influence of HIPAA Privacy Rule on fication, the responsibilities of the IRB/privacy board
Institutional Review Boards for HIPAA (U.S. DHHS, 2007b) and the responsibili-
Under the 2003 HIPAA Privacy Rule, an IRB or an ties of the IRB under the U.S. DHHS (2009) and U.S.
institutionally established privacy board can act on FDA (2010a) are outlined in Table 9-3.
requests for a waiver or an alteration of the authoriza-
tion requirement for a research project. If an IRB and
a privacy board both exist in an agency, the approval Research Misconduct
of only one board is required, and it will probably be The goal of research is to generate sound scientific
the IRB for research projects. Researchers can choose knowledge, which is possible only through the honest
to obtain a signed authorization form from potential conduct, reporting, and publication of studies.
subjects or can ask for a waiver or an alteration of the However, since the 1980s, a number of fraudulent
authorization requirement. An altered authorization studies have been conducted and published in presti-
requirement occurs when an IRB approves a request gious scientific journals. An example of research mis-
that some but not all of the required 18 elements be conduct was evident in the publications of Dr. Robert
removed from health information that is to be used in Slutsky, a heart specialist at the University of Califor-
research. The researcher can also request a partial or nia, San Diego, School of Medicine, whose study
complete waiver of the authorization requirement results raised questions of data fabrication (Friedman,
from the IRB. For a partial waiver, discussed earlier, 1990). In 6 years, Slutsky published 161 articles, and
the researcher obtains PHI to contact and recruit at one time, he was completing an article every 10
potential subjects for a study. An IRB can give a days. Eighteen of the articles were found to be fraudu-
researcher a complete waiver of authorization in lent and have retraction notations, and 60 articles were
studies in which the informed consent requirements judged to be questionable.
might also be waived. Thus, a waiver or alteration of Another example of research misconduct is the
the authorization requirement might occur when the work of Stephen Breuning, a psychologist at the Uni-
following criteria have been met: versity of Pittsburgh, who engaged in deceptive and
• The PHI use or disclosure involves no more than misleading practices in reporting his research on
minimal risk to the privacy for research subjects retarded children. He used his fraudulent research to
based on (1) an adequate plan presented to the IRB obtain more than $300,000 in federal grants. In 1988,
to protect the PHI identifiers from improper use of he was criminally charged with research fraud, pleaded
disclosure; (2) an adequate plan exists to destroy guilty, was fined $20,000, and was sentenced to up to
the identifiers at the earliest opportunity; and (3) 10 years in prison (Garfield & Welljams-Dorof, 1990).
written assurance the PHI will not be reused or Research misconduct is also evident in nursing as
disclosed to any other person. identified by a survey of nurse research directors,
• The research could not reasonably be conducted coordinators, and deans of nursing programs by
without the waiver or alteration of the authorization Rankin and Esteves (1997). Of the 88 nurses surveyed,
requirement. 27.2% reported cheating on data collection, 33.2%
• The research cannot be done without access to and identified misinterpretations of findings, 65.8%
use of the PHI. (U.S. DHHS, 2003) reported protocol violations related to the study site
188 UNIT TWO  The Research Process

TABLE 9-3  Comparison of IRB/Privacy Board Responsibilities for HIPAA, U.S. DHHS, and FDA
U.S. DHHS Protection of
Human Subjects U.S. FDA Protection of Human
Area of Regulations Title 45 CFR Subjects Regulations Title 21 CFR
Distinction HIPAA Privacy Rule Part 46 Parts 50 and 56
Permissions for Authorization Informed consent and Informed consent and authorization
research authorization
IRB/privacy board Requires the covered entity to Requires the covered entity to The IRB must ensure that informed
responsibilities obtain authorization for obtain authorization for consent will be sought from, and
research use or disclosure research use or disclosure documented for, each prospective
of PHI unless a regulatory of PHI unless a regulatory subject or the subject’s legally
permission applies. Because permission applies. Because authorized representative in accordance
of this, the IRB or privacy of this, the IRB or privacy with, and to the extent required by,
board would see only board would see only FDA regulations. If specified criteria
requests to waive or alter requests to waive or alter are met, the requirements for either
the authorization the authorization obtaining informed consent or
requirement. In exercising requirement. In exercising documenting informed consent may be
privacy rule authority, the privacy rule authority, the waived. The IRB must review and
IRB or privacy board does IRB or privacy board does approve the authorization form if it is
not review the authorization not review the authorization combined with the informed consent
form. form. document. Privacy boards have no
authority under the FDA Protection of
Human Subjects Regulations.

CFR, Code of Federal Regulations; DHHS, U.S. Department of Health and Human Services; U.S. FDA, U.S. Food and Drug Administration; HIPAA, Health
Insurance Portability and Accountability Act; IRB, institutional review board; PHI, protected health information.
From U.S. Department of Health and Human Services. (2007b). How can covered entities use and disclose protected health information for research and
comply with the Privacy Rule? Retrieved from http://privacyruleandresearch.nih.gov/pr_08.asp/.

and subjects, and 49.7% reported an occasional inci- misconduct. Research misconduct was defined as
dence of plagiarism. Habermann, Broome, Pryor, and “the fabrication, falsification, or plagiarism in pro-
Ziner (2010) studied 266 research coordinators, pre- cessing, performing, or reviewing research, or in
dominately RNs, who indicated they had firsthand reporting research results. It does not include honest
knowledge of scientific misconduct in the past year. error or differences in opinion” (ORI, 2005, 42 CFR
The types and frequencies of research misconduct Section 93.103). Fabrication in research is the
included: 50% protocol violations, 26.6% consent vio- making up of results and the recording or reporting of
lations, 13.9% fabrication, 5.2% financial conflict of them. Falsification of research is manipulating
interest, and 5% falsification. research materials, equipment, or processes or chang-
In response to the increasing incidences of scien- ing or omitting data or results such that the research
tific misconduct, the federal government developed is not accurately represented in the research record.
the Office of Research Integrity (ORI) in 1989 within Fabrication and falsification of research data are two
the U.S. DHHS. The ORI was to supervise the imple- of the most common acts of research misconduct
mentation of the rules and regulations related to managed by the ORI (2012) over the past 5 years.
research misconduct and to manage any investigations Plagiarism is the appropriation of another person’s
of misconduct. The most current regulations imple- ideas, processes, results, or words without giving
mented by the ORI (2005) are CFR 42, Parts 50 and appropriate credit, including those obtained through
93, Policies of General Applicability, which are dis- confidential review of others’ research proposals and
cussed in the following section. manuscripts.
Currently, the ORI promotes the integrity of bio-
Role of the ORI in Promoting the Conduct of medical and behavioral research in approximately
Ethical Research 4000 institutions worldwide (ORI, 2011). The office
The ORI was responsible for defining important terms applies federal policies and regulations to protect the
used in the identification and management of research integrity of the U.S. PHS’s extramural and intramural
CHAPTER 9  Ethics in Research 189

research programs. The extramural program provides ranging from 18 months to 8 years; prohibition from
funding to research institutions, and the intramural U.S. PHS advisory service; and other actions requiring
program provides funding for research conducted supervised research, certification of data, certification
within the federal government. The ORI carries out its of sources, and correction or retraction of articles
responsibilities by: (ORI, 2012).
• Developing policies, procedures, and regulations
related to the detection, investigation, and preven- Role of Journal Editors and Researchers in
tion of research misconduct and the responsible Preventing Scientific Misconduct
conduct of research. Editors of journals also have a major role in monitor-
• Reviewing and monitoring research misconduct ing and preventing research misconduct in the pub-
investigations. lished literature. Friedman (1990, p. 1416) identified
• Recommending research misconduct findings and criteria for classifying a publication as fraudulent,
administrative actions to the assistant secretary for questionable, or valid and indicated that research arti-
health for decision, subject to appeal (ORI, 2012). cles were “fraudulent if there was documentation or
• Assisting the Office of the General Counsel (OGC) testimony from coauthors that the publication did not
to present cases before the U.S. DHHS departmen- reflect what had actually been done.” Articles were
tal appeals board. considered questionable if no coauthor could produce
• Providing technical assistance to institutions that the original data or if no coauthor had personally
respond to allegations of research misconduct. observed or performed each phase of the research or
• Implementing activities and programs to teach participated in the research publication. A research
responsible conduct of research, promote research article was considered valid if one or more coauthors
integrity, prevent research misconduct, and improve had personally participated in each aspect of the
the handling of allegations of research misconduct. research and publication.
• Conducting policy analyses, evaluations, and Preventing the publication of fraudulent research
research to build the knowledge base in research requires the efforts of authors, coauthors, research
misconduct, research integrity, and prevention and coordinators, reviewers of research reports for publi-
to improve the DHHS research integrity policies cation, and editors of professional journals (Hansen &
and procedures. Hansen, 1995; Hawley & Jeffers, 1992; Wager, 2007).
• Administering programs for maintaining institu- Authors who are primary investigators for research
tional assurances, responding to allegations of projects must be responsible in their conduct, report-
retaliation against whistleblowers, approving intra- ing, and publication of research. Coauthors and
mural and extramural policies and procedures, and coworkers should question and, if necessary, chal-
responding to Freedom of Information Act and lenge the integrity of a researcher’s claims. Some-
Privacy Act requests (ORI, 2005). times, well-known scientists’ names have been added
The ORI classifies research misconduct as (1) an to a research publication as coauthors to give it cred-
act that involves a significant departure from the ibility. Individuals should not be listed as coauthors
acceptable practice of the scientific community for unless they were actively involved in the conduct and
maintaining the integrity of the research record; (2) an publication of the research.
act that was committed intentionally; and (3) an alle- Research coordinators in large, funded studies also
gation that can be proved by a preponderance of evi- have a role to promote integrity in research and to
dence. The office has a section on its website titled identify research misconduct activities. These indi-
“Handling Misconduct,” which includes a summary of viduals are often the ones closest to the actual conduct
the allegations and investigations managed by its of the study, during which misconduct often occurs.
office from 1994 to 2012 (ORI, 2012). The most In the Habermann et al. (2010) study introduced
common sites for the investigations were medical earlier, research coordinators were identified as having
schools (68%), hospitals (11%), and research insti- firsthand experiences with both scientific misconduct
tutes (10%). The individuals charged with misconduct and research integrity. Research coordinators often
were primarily males holding a PhD or medical degree learned of the misconduct firsthand, and the principal
(MD) and were mostly associate professors, profes- investigator was usually identified as the responsible
sors, and postdoctoral fellows. When research miscon- party. The five major categories of misconduct identi-
duct was documented, the actions taken against the fied were protocol violations, consent violations, fab-
researchers or agencies might have included debar- rication, falsification, and financial conflict of interest.
ment from receiving federal funding for periods Thus, Habermann et al. recommended that the
190 UNIT TWO  The Research Process

definition of research misconduct might need to be treated humanely. However, some of these animal
expanded beyond fabrication, falsification, and rights groups have tried to frighten the public with
plagiarism. sometimes distorted stories about inhumane treatment
Peer reviewers have a key role in determining the of animals in research. Some of the activist leaders
quality and publishability of a manuscript. They are have made broad comparisons between human life
considered experts in the field, and their role is to and animal life. For example, a major animal rights
examine research for inconsistencies and inaccuracies. group called People for the Ethical Treatment
Editors must monitor the peer review process and of Animals (PETA) has a website that posts videos
must be cautious about publishing manuscripts that and blogs about the unethical treatment of animals
are at all questionable. Editors also need procedures in research (see http://www.peta.org/tv/videos/
for responding to allegations of research misconduct. investigations-animal-experimentation/). Some of
They must decide what actions to take if their journal these activists have now progressed to violence, using
contains an article that has proven to be fraudulent. physical attacks, including real bombs, arson, and van-
Usually, fraudulent publications require retraction dalism. Even more damage is being done to research
notations and are not to be cited by authors in future through lawsuits that have blocked the conduct of
publications (ORI, 2005). research and the development of new research centers.
The publication of fraudulent research is a major Medical schools now spend millions of dollars annu-
concern in medicine and nursing (Habermann et al., ally for security, public education, and other efforts to
2010; Njie & Thomas, 2001; Rankin & Esteves, 1997). defend research.
The smaller pool of funds available for research and The use of animals in research is a complicated
the greater emphasis on research publications could issue that requires careful consideration by investiga-
lead to a higher incidence of fraudulent publications. tors, considering the knowledge that is needed to
However, the ORI (2011; 2012) has made major manage healthcare problems. Two important ques-
advances in addressing research misconduct and the tions must be addressed: Should animals be used as
management of fraudulent publications by: (1) identi- subjects in research, and, if animals are used in
fying the administrative actions for acts of research research, what mechanisms ensure that they are treated
misconduct; (2) developing a process for notifying humanely? In regard to the first question, the type of
funding agencies and journals of acts of research mis- research project developed influences the selection of
conduct; and (3) providing for public disclosure of the subjects. Animals are just one of a variety of types of
incidents of research misconduct. subjects used in research; others are human beings,
Each researcher is responsible for monitoring the plants, and computer data sets. Most researchers use
integrity of his or her research protocols, results, and nonanimal subjects in their studies because they are
publications. In addition, nursing professionals and generally less expensive for the type of study being
journal editors must foster a spirit of intellectual conducted. In studies that are low risk, which most
inquiry, mentor prospective scientists regarding the nursing studies are, human beings are commonly used
norms for good science, and stress quality, not quan- as subjects.
tity, in publications (Wager, 2007; Wocial, 1995). Some studies, however, require the use of animals
to answer the research question. Animals are more
commonly used in laboratory studies that involve
Animals as Research Subjects investigation of high-risk physiological variables.
The use of animals as research subjects is a controver- Approximately 17 to 22 million animals are used in
sial issue of growing interest to nurse researchers. A research each year, and 90% of them are rodents, with
small but increasing number of nurse scientists are the combined percentage of dogs and cats being only
conducting physiological studies that require the use 1% to 2% (Goodwin & Morrison, 2000). Studies using
of animals. Many scientists, especially physicians, animals account for about one eighth of the published
believe that the current animal rights’ movement could studies (Osborne, Payne, & Newman, 2009). Because
threaten the future of health research. The animal animals are deemed valuable subjects for selected
rights groups are active in anti-research campaigns research projects, the second question, concerning
and are often backed by financial resources estimated their humane treatment, must also be answered. At
in the millions of dollars (Pardes, West, & Pincus, least five separate types of regulations exist to protect
1991). The goal of these groups is to raise the con- research animals from mistreatment. The federal gov-
sciousness of researchers and society to ensure that ernment, state governments, independent accreditation
animals are used wisely in the conduct of research and organizations, professional societies, and individual
CHAPTER 9  Ethics in Research 191

institutions work to ensure that research animals are KEY POINTS


used only when necessary and only under humane
conditions. At the federal level, animal research is • The ethical conduct of research starts with the
conducted according to the guidelines of U.S. PHS identification of the study topic and continues
Policy on Humane Care and Use of Laboratory through the publication of the study if quality
Animals, which was adopted in 1986, reprinted essen- research evidence is going to be developed for
tially unchanged in 1996, and is available on the Office practice.
of Laboratory Animal Welfare (OLAW, 2008) website • The debate about ethics and research must continue
(http://grants.nih.gov/grants/olaw/olaw.htm/). probably because of (1) the complexity of human
The Humane Care and Use of Laboratory Animals rights issues; (2) the focus of research in new, chal-
Regulations define animal as any live, vertebrate lenging arenas of technology and genetics; (3) the
animal used or intended for use in research, research complex ethical codes and regulations governing
training, experimentation, or biological testing or for research; and (4) the variety of interpretations of
related purposes. Any institution proposing research these codes and regulations.
involving animals must have a written Animal Welfare • Two historical documents that have had a strong
Assurance statement acceptable to the U.S. PHS that impact on the conduct of research are the Nurem-
documents compliance with the U.S. PHS policy. berg Code and the Declaration of Helsinki. More
Every assurance statement is evaluated by the National recently, the U.S. Department of Health and Human
Institutes of Health’s Office for Protection from Services (U.S. DHHS, 2009) and the U.S. Food and
Research Risks (OPRR) to determine the adequacy of Drug Administration (U.S. FDA, 2010a, 2010b)
the institution’s proposed program for the care and use have promulgated regulations that direct the ethical
of animals in activities conducted or supported by the conduct of research. These regulations include (1)
U.S. PHS (OLAW, 2011). The studies including general requirements for informed consent; (2)
animals require an animal-use protocol that describes documentation of informed consent; (3) institu-
the following elements: (1) research project; (2) ratio- tional review board (IRB) review of research; (4)
nale for animal use and consideration of alternatives; exempt and expedited review procedures for certain
(3) justification for the choice of species and numbers kinds of research; and (5) criteria for IRB approval
of animals; (4) research procedures involving animals; of research.
(5) procedures to minimize pain and distress; (6) • The Council for International Organizations of
animal living conditions and veterinary care; (7) Medical Sciences revises and updates ethical
names and qualifications of personnel who will guidelines for biomedical research conducted
perform work with animals; (8) method of euthanasia; internationally.
and (9) endpoint criteria. OLAW (2011) website • Public Law 104-191, the Health Insurance Portabil-
includes guidelines for the care and use of animals in ity and Accountability Act (HIPAA), was enacted
research (http://grants.nih.gov/grants/olaw/Investiga in 1996 and implemented in 2003 to protect an
torsNeed2Know.pdf/). individual’s health information.
Institutions’ assurance statements about compli- • Conducting research ethically requires protection
ance with the U.S. PHS policy have promoted the of the human rights of subjects. Human rights are
humane care and treatment of animals in research. In claims and demands that have been justified in the
addition, more than 700 institutions conducting health- eyes of an individual or by the consensus of a group
related research have sought accreditation by the of individuals. The human rights that require pro-
American Association for Accreditation of Laboratory tection in research are (1) self-determination; (2)
Animal Care (AAALAC), which was developed to privacy; (3) anonymity and confidentiality; (4) fair
ensure the humane treatment of animals in research treatment; and (5) protection from discomfort and
(OLAW, 2011). In conducting research, each investi- harm.
gator must carefully select the type of subject needed; • The rights of research subjects can be protected by
if animals are used as subjects, they require humane balancing benefits and risks of a study, securing
treatment. Osborne et al. (2009) conducted a study to informed consent, and submitting the research for
determine the journal editorial policies regarding use institutional review.
of animals in research. These researchers found that • To balance the benefits and risks of a study, the
journals need clear polices on the essential informa- type, level, and number of risks are examined,
tion to be included in a research report to reflect the and the potential benefits are identified. If possible,
fair treatment of animals in studies. the risks must be minimized and the benefits
192 UNIT TWO  The Research Process

maximized to achieve the best possible benefit-risk Bruce, S. L. & Grove, S. K. (1994). The effect of a coronary artery
ratio. risk evaluation program on serum lipid values and cardiovascular
• Informed consent involves the transmission of risk levels. Applied Nursing Research, 7(2), 67–74.
Cahana, A. & Hurst, S. A. (2008). Voluntary informed consent
essential information, comprehension of that infor-
in research and clinical care: An update. Pain Practice, 8(6),
mation, competence to give consent, and voluntary 446–451.
consent of the prospective subject. Council for International Organizations of Medical Sciences
• In institutional review, a committee of peers called (CIOMS, 2010). CIOMS: About us. Retrieved from http://www.
an institutional review board (IRB) examines each cioms.ch/about/frame_about.htm/.
study for ethical concerns. The IRB conducts three Damrosch, S. P. (1986). Ensuring anonymity by use of subject-
levels of review: exempt, expedited, and complete. generated identification codes. Research in Nursing & Health,
The process for accessing protected health infor- 9(1), 61–63.
mation according to the HIPAA Privacy Rule is Erlen, J. A. (2010). Informed consent: Revisiting the issues. Ortho-
also detailed. paedic Nursing, 29(4), 276–280.
Fawcett, J. & Garity, J. (2009). Evaluation research for evidence-
• Research misconduct includes fabrication, falsifi-
based practice. Philadelphia, PA: F. A. Davis.
cation, and plagiarism during the conduct, report- Ford, J. S. & Reutter, L. I. (1990). Ethical dilemmas associated
ing, or publication of research. The Office of with small samples. Journal of Advanced Nursing, 15(2),
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tigate and manage incidents of research misconduct Friedman, P. J. (1990). Correcting the literature following fraudu-
to protect the integrity of research in all lent publication. JAMA, 263(10), 1416–1419.
disciplines. Fry, S. T., Veatch, R. M. & Taylor, C. (2011). Case studies in
• Another current ethical concern in research is the nursing ethics (4th ed.). Sudbury, MA: Jones & Bartlett
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research on the scientific literature: The Stephen E. Breuning case.
subjects? and If animals are used in research, what
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The U.S. Public Health Service Policy on Humane Reason, 32(5), 22–28.
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Hansen, B. C. & Hansen, K. D. (1995). Academic and scientific
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  http://evolve.elsevier.com/Grove/practice/

10 CHAPTER

Understanding Quantitative
Research Design

A
research design is the blueprint for conduct- of a good design. You are also provided questions to
ing a study. It maximizes control over factors assist you in selecting and implementing a design in
that could interfere with the validity of the a study. The chapter concludes with a discussion of
study findings. Being able to identify the study design mixed methods, which are relatively recent approaches
and to evaluate design flaws that might threaten the used in nursing that combine quantitative and qualita-
validity of findings is an important part of critically tive research designs.
appraising studies. When you are conducting a study,
the research design guides you in planning and imple-
menting the study in a way to achieve accurate results. Concepts Important to Design
The control achieved through the quantitative study Many terms used in discussing research design have
design increases the probability that your study find- special meanings within this context. An understand-
ings are an accurate reflection of reality. ing of these concepts is essential for recognizing the
The term research design is used in two ways in purpose of a specific design. Some of the major con-
the nursing literature. Some consider research design cepts used in relation to research design are causality,
to be the entire strategy for the study, from identifica- bias, manipulation, control, and validity.
tion of the problem to final plans for data collection.
Others limit design to clearly defined structures within Causality
which the study is implemented. In this text, the first The first assumption you must make in examining
definition refers to the research methodology and the causality is that causes lead to effects. Some of the
second is a definition of the research design. The ideas related to causation emerged from the logical
research design of a study is the end result of a series positivist philosophical tradition. Hume, a positivist,
of decisions you will make concerning how best to proposed that the following three conditions must be
implement your study. The design is closely associ- met to establish causality (1) there must be a strong
ated with the framework of the study. As a blueprint, relationship between the proposed cause and the
the design is not specific to a particular study but effect; (2) the proposed cause must precede the effect
rather is a broad pattern or guide that can be applied in time; and (3) the cause has to be present whenever
to many studies (see Chapter 11 for different types of the effect occurs. Cause, according to Hume, is not
quantitative research designs). Just as the blueprint for directly observable but must be inferred (Kerlinger &
a house must be individualized to the house being Lee, 2000; Shadish, Cook, & Campbell, 2002).
built, so the design must be made specific to a study. A philosophical group known as essentialists pro-
Using the problem statement, framework, research posed that two concepts must be considered in deter-
questions, and clearly defined variables, you can map mining causality: necessary and sufficient. The
out the design to achieve a detailed research plan for proposed cause must be necessary for the effect to
collecting and analyzing data. occur. (The effect cannot occur unless the cause first
This chapter gives you a background for under- occurs.) The proposed cause must also be sufficient
standing the elements of a design and critically (requiring no other factors) for the effect to occur. This
appraising the designs in published quantitative leaves no room for a variable that may sometimes, but
studies. You are introduced to (1) the concepts impor- not always, serves as the cause of an effect. John
tant to design; (2) design validity; and (3) the elements Stuart Mill, another philosopher, added a third idea

195
196 UNIT TWO  The Research Process

related to causation. He suggested that, in addition to identified and explored, the clearer the understanding
the preceding criteria for causation, there must be no of the phenomenon. This greater understanding
alternative explanations for why a change in one vari- improves our ability to predict and control. For
able seems to lead to a change in a second variable example, currently nurses have a limited understand-
(Campbell & Stanley, 1963). ing of patients’ preoperative attitudes, knowledge,
Causes are frequently expressed within the propo- and behaviors and their effects on postoperative atti-
sitions of a theory. Testing the accuracy of these theo- tudes and behaviors. Nurses assume that high preop-
retical statements indicates the usefulness of the theory erative anxiety leads to less healthy postoperative
(Fawcett & Garity, 2009). A theoretical understanding responses and that providing information before
of causation is considered important because it surgery improves healthy responses in the postopera-
improves our ability to predict and, in some cases, to tive period. Many nursing studies have examined this
control events in the real world. The purpose of an particular phenomenon. However, the causal factors
experimental design is to examine cause and effect. involved are complex and have not been clearly delin-
The independent variable in a study is expected to be eated. The research evidence needed to reduce patients’
the cause, and the dependent variable is expected to anxiety and improve their postoperative recovery is
reflect the effect of the independent variable. still evolving.

Multicausality Probability
Multicausality, the recognition that a number of inter- The original criteria for causation required that a
relating variables can be involved in causing a particu- variable should have an identified effect each time
lar effect, is a more recent idea related to causality. the cause occurred. Although this criterion may apply
Because of the complexity of causal relationships, a in the basic sciences, such as chemistry or physics,
theory is unlikely to identify every variable involved it is unlikely to apply in the health sciences or
in causing a particular phenomenon. A study is unlikely social sciences. Because of the complexity of the
to include every component influencing a particular nursing field, nurses deal in probabilities. Probabil-
change or effect. ity addresses relative, rather than absolute, causality.
Cook and Campbell (1979) have suggested three From the perspective of probability, a cause will not
levels of causal assertions that one must consider in produce a specific effect each time that particular
establishing causality. Molar causal laws relate to cause occurs.
large and complex objects. Intermediate mediation Reasoning changes when one thinks in terms of
considers causal factors operating between molar and probabilities. The researcher investigates the probabil-
micro levels. Micromediation examines causal con- ity that an effect will occur under specific circum-
nections at the level of small particles, such as atoms. stances. Rather than seeking to prove that A causes B,
Cook and Campbell (1979) used the example of a researcher would state that if A occurs, there is a
turning on a light switch, which causes the light to 50% probability that B will occur. The reasoning
come on (molar). An electrician would tend to explain behind probability is more in keeping with the com-
the cause of the light coming on in terms of wires and plexity of multicausality. In the example about preop-
electrical current (intermediate mediation). However, erative attitudes and postoperative outcomes, nurses
the physicist would explain the cause of the light could seek to predict the probability of unhealthy post-
coming on in terms of ions, atoms, and subparticles operative patient outcomes when preoperative anxiety
(micromediation). levels are high.
The essentialists’ ideas of necessary and sufficient
do not hold up well when one views a phenomenon Causality and Nursing Philosophy
from the perspective of multiple causation. The light Traditional theories of prediction and control are built
switch may not be necessary to turn on the light if the on theories of causality. The first research designs
insulation has worn off the electrical wires. Addition- were also based on causality theory. Nursing science
ally, even though the switch is turned on, the light will must be built within a philosophical framework of
not come on if the light bulb is burned out. Although multicausality and probability. The strict senses of
this is a concrete example, it is easy to relate it to single causality and of “necessary and sufficient” are
common situations in nursing. not in keeping with the progressively complex, holis-
Few phenomena in nursing can be clearly reduced tic philosophy of nursing. To understand multicausal-
to a single cause and a single effect. However, the ity and increase the probability of being able to predict
greater the proportion of causal factors that can be and control the occurrence of an effect, researchers
CHAPTER 10  Understanding Quantitative Research Design 197

need to comprehend both wholes and parts (Fawcett intervention. The experimental group receives the
& Garity, 2009; Shadish et al., 2002). treatment or intervention during a study and the
Practicing nurses must be aware of the molar, control group does not. For example, in a study on
intermediate mediational, and micromediational preoperative care, preoperative relaxation therapy
aspects of a particular phenomenon. A variety of might be manipulated so that the experimental group
differing approaches, reflecting both qualitative and receives the treatment and the control group does not.
quantitative research, are necessary to develop a In a study on oral care, the frequency of care might be
knowledge base for nursing. Some see explanation manipulated to determine its effect on patient out-
and causality as different and perhaps opposing forms comes (Doran, 2011).
of knowledge. Nevertheless, the nurse must join these In nursing research, when experimental designs are
forms of knowledge, sometimes within the design of used to explore causal relationships, the nurse must be
a single study, to acquire the knowledge needed free to manipulate the variables under study. For
for nursing practice (Creswell, 2009; Marshall & example, in a study of pain management, if the
Rossman, 2011). freedom to manipulate pain control measures is under
the control of someone else, a bias is introduced into
Bias the study. In qualitative, descriptive, and correlational
The term bias means to slant away from the true or studies, the researcher does not attempt to manipulate
expected. A biased opinion has failed to include both variables. Instead, the purpose is to describe a situa-
sides of the question. A biased witness is one who is tion as it exists (Marshall & Rossman, 2011; Munhall,
strongly for or against one side of the situation. A 2012).
biased scale is one that does not provide a valid mea-
surement of a concept. Control
Bias is of great concern in research because of the Control means having the power to direct or manipu-
potential effect on the meaning of the study findings. late factors to achieve a desired outcome. In a study
Any component of the study that deviates or causes a of pain management, one must be able to control inter-
deviation from true measure leads to error and dis- ventions to relieve pain. The idea of control is impor-
torted findings. Many factors related to research can tant in research, particularly in experimental and
be biased: the researcher, the measurement methods, quasi-experimental studies. The more control the
the individual subjects, the sample, the data, and the researcher has over the features of the study, the more
statistics (Grove, 2007; Thompson, 2002; Waltz, credible the study findings. The purpose of research
Strickland, & Lenz, 2010). In critically appraising a designs is to maximize control factors in the study
study, you need to look for possible biases in these (Shadish et al., 2002).
areas. An important concern in designing a study is to
identify possible sources of bias and eliminate or
avoid them. If they cannot be avoided, you need to Study Validity
design your study to control them. Designs, in fact, Study validity, a measure of the truth or accuracy of
are developed to reduce the possibilities of bias a claim, is an important concern throughout the
(Shadish et al., 2002). research process. Study validity is central to building
sound evidence for practice. Questions of validity
Manipulation refer back to the propositions from which the study
Manipulation tends to have a negative connotation and was developed and address their approximate truth or
is associated with one person underhandedly maneu- falsity. Is the theoretical proposition from the study
vering a second person so that he or she behaves or framework an accurate reflection of reality? Was the
thinks in the way the first person desires. Denotatively, study designed to provide a valid test of the proposi-
to manipulate means to move around or to control the tion? Validity is a complex idea that is important to
movement of something, such as manipulating a the researcher and to those who read the study report
syringe to give an injection. The major role of nurses and consider using the findings in their practice. Criti-
is to implement interventions that involve manipula- cal appraisal of research requires that we think through
tion of events related to patients and their environment threats to validity and make judgments about how
to improve their health. Manipulation has a specific seriously these threats affect the integrity of the find-
meaning when used in experimental or quasi- ings. Validity provides a major basis for making deci-
experimental research because it is the manipulation sions about which findings are sufficiently valid to add
or implementation of the study treatment or to the evidence base for practice.
198 UNIT TWO  The Research Process

Shadish et al. (2002) have described four types Violated Assumptions of Statistical Tests
of validity: statistical conclusion validity, internal Most statistical tests have assumptions about the data
validity, construct validity, and external validity. These collected, such as the following: (1) the data are at
types of design validity need to be critically appraised least at the interval level; (2) the sample was randomly
for strengths and possible threats in published studies. obtained; and (3) the distribution of scores was normal.
When conducting a study, you will be confronted with If these assumptions are violated, the statistical analy-
major decisions about the four types of design validity. sis may provide inaccurate results (Corty, 2007;
To make these decisions, you must address a variety Grove, 2007). The assumptions of statistical tests
of questions, such as the following: commonly conducted in nursing studies are provided
1. Is there a relationship between the two variables? in Chapters 23, 24, and 25.
(statistical conclusion validity)
2. Given that there is a relationship, is it possibly Fishing and the Error Rate Problem
causal from the independent variable to the depen- A serious concern in research is incorrectly conclud-
dent variable, or would the same relationship have ing that a relationship or difference exists when it does
been obtained in the absence of any treatment or not (Type I error, rejecting a true null). The risk of
intervention? (internal validity) Type I error increases when the researcher conducts
3. Given that the relationship is probably causal and multiple statistical analyses of relationships or differ-
is reasonably known to be from one variable to ences; this procedure is referred to as fishing. When
another, what are the particular cause-and-effect fishing is used, a given portion of the analyses shows
constructs involved in the relationship? (construct significant relationships or differences simply by
validity) chance. For example, the t-test is commonly used to
4. Given that there is probably a causal relationship make multiple statistical comparisons of mean differ-
from construct A to construct B, can this relation- ences in a single sample (Kerlinger & Lee, 2000). This
ship be generalized across persons, settings, and procedure increases the risk of a Type I error because
times? (external validity) (Cook & Campbell, some of the differences found in the sample occurred
1979; Shadish et al., 2002) by chance and are not actually present in the popula-
tion. Multivariate statistical techniques have been
Statistical Conclusion Validity developed to deal with this error rate problem
The first step in inferring cause is to determine whether (Goodwin, 1984). Fishing and error rate problems are
the independent and dependent variables are related. discussed in Chapter 21.
You can determine this relationship (covariation)
through statistical analysis. Statistical conclusion Reliability of Measures
validity is concerned with whether the conclusions The technique of measuring variables must be reliable
about relationships or differences drawn from statisti- to reveal true differences. A measure is a reliable
cal analysis are an accurate reflection of the real world. measure if it gives the same result each time the same
The second step is to identify differences between situation or factor is measured. If a scale is used to
groups. There are reasons why false conclusions can measure anxiety, it should give the same score (be
be drawn about the presence or absence of a relation- reliable) if repeatedly given to the same person in a
ship or difference. The reasons for the false conclusions short time (unless, of course, repeatedly taking the
are called threats to statistical conclusion validity. same test causes anxiety to increase or decrease) (Waltz
These threats are described in the following section. et al., 2010). Physiological measurement methods that
consistently measure physiological variables are con-
Low Statistical Power sidered precise (Ryan-Wenger, 2010). For example, a
Low statistical power increases the probability of thermometer would be precise if it showed the same
concluding that there is no significant difference temperature reading when tested repeatedly on the
between samples when actually there is a difference same patient within a limited time (see Chapter 16).
(Type II error, failing to reject a false null) (see Chapter
8 for discussion of the null hypothesis). A Type II error Reliability of Intervention Implementation
is most likely to occur when the sample size is small Intervention reliability ensures that the research
or when the power of the statistical test to determine treatment is standardized and applied consistently
differences is low (Aberson, 2010). The concept of each time it is administered in a study. In some studies,
statistical power and strategies to improve it are dis- the consistent implementation of the treatment is
cussed in Chapters 15 and 21. referred to as intervention fidelity. Intervention
CHAPTER 10  Understanding Quantitative Research Design 199

fidelity often includes a protocol to standardize the 2002). Any study can contain threats to internal design
elements of the treatment and a plan for training to validity, and these validity threats can lead to false-
ensure consistent implementation of the treatment pro- positive or false-negative conclusions. The researcher
tocol (Forbes, 2009; Santacroce, Maccarelli, & Grey, must ask, “Is there another reasonable (valid) explana-
2004). If the method of administering a research inter- tion (rival hypothesis) for the finding other than the
vention varies from one person to another, the chance one I have proposed?” Threats to internal validity are
of detecting a true difference decreases. During the described here.
planning and implementation phases, researchers must
ensure that the study intervention is provided in Controlling the Environment
exactly the same way each time it is administered to History effect results when an event that is not related
prevent a threat to statistical conclusion design valid- to the planned study occurs during the time of the
ity. Chapter 14 provides a detailed discussion of types study and creates an effect on the study outcome.
of interventions, intervention development, and inter- History could influence a subject’s response to the
vention fidelity. treatment and alter the measurements obtained on the
dependent variables. For example, if you are studying
Random Irrelevancies in the Experimental Setting the effect of an emotional support intervention on sub-
Environmental extraneous variables in complex field jects’ completion of their cardiac rehabilitation
settings (e.g., a clinical unit) can influence scores on program and several of the nurses quit their jobs in the
the dependent variable. These variables increase the rehabilitation center during your study, this event
difficulty of detecting differences. Consider the activi- could influence the subjects’ rehabilitation program
ties occurring on a nursing unit. The numbers and completion rate in your study.
variety of staff, patients, crises, and work patterns
merge into a complex arena for the implementation of Maturation
a study. Any of the dynamics of the unit can influence In research, maturation is defined as growing older,
manipulation of the independent variable or measure- wiser, stronger, hungrier, more tired, or more experi-
ment of the dependent variable. enced during the study. Such unplanned and unrecog-
nized changes are a threat to the study internal design
Random Heterogeneity of Respondents validity and can influence the findings of the study.
Subjects in a treatment or intervention group can differ
in ways that correlate with the dependent variable, a Testing Effect
situation referred to as random heterogeneity. This Sometimes, the effect being measured (referred to as
difference can influence the outcome of the interven- the testing effect) can be due to the number of times
tion and prevent detection of a true relationship the subject’s responses have been tested. The subject
between the independent variable and the dependent may remember earlier, inaccurate responses and then
variable. For example, subjects may have a variety of modify them, thus altering the outcome of the study.
responses to preoperative interventions to lower The test itself may influence the subject to change
anxiety because of unique characteristics of patients attitudes or may increase the subject’s knowledge.
associated with their differing levels of anxiety.
Instrumentation
Internal Validity Effects can be due to changes in measurement instru-
Internal validity is the extent to which the effects ments (instrumentation) between the pretest and the
detected in the study are a true reflection of reality posttest rather than a result of the treatment. For
rather than the result of extraneous variables. Although example, a weight scale that was accurate when the
internal validity should be a concern in all studies, it study began (pretest) could now show subjects to
is addressed more commonly in relation to studies weigh 2 lbs less than they actually weigh (posttest).
examining causality than in other studies. When Instrumentation is also involved when people serving
examining causality, the researcher must determine as observers or data collectors become more experi-
whether the independent and dependent variables may enced between the pretest and the posttest, thus alter-
have been affected by a third, often unmeasured, vari- ing in some way the data they collect.
able (an extraneous variable). Chapter 8 describes
the different types of extraneous variables. The pos- Selection
sibility of an alternative explanation of cause is some- Selection addresses the process by which subjects are
times referred to as a rival hypothesis (Shadish et al., chosen to take part in a study and how subjects are
200 UNIT TWO  The Research Process

grouped within a study. A selection threat is more Compensatory Equalization of Treatments


likely to occur in studies in which randomization is When the experimental group receives a treatment
not possible (Kerlinger & Lee, 2000; Thompson seen as desirable, such as a new treatment for AIDS,
2002). In some studies, people selected for the study administrative people and other health professionals
may differ in some important way from people not may not tolerate the difference and may insist that the
selected for the study. In other studies, the threat is control group also receive the treatment. The researcher
due to differences in subjects selected for study therefore no longer has a control group and cannot
groups. For example, people assigned to the control document the effectiveness of the treatment through
group could be different in some important way from the study. In health care, both giving treatment and
people assigned to the experimental group. This dif- withholding treatment have ethical implications.
ference in selection could cause the two groups to
react differently to the treatment; in this case, the Resentful Demoralization of Respondents Receiving
treatment would not have caused the differences in Less Desirable Treatments
group responses. If control group subjects believe that they are receiv-
ing less desirable treatment, they may withdraw, give
Subject Attrition up, or become angry. Changes in behavior resulting
The subject attrition threat is due to subjects from this reaction rather than from the treatment can
who drop out of a study before completion. Partici- lead to differences that cannot be attributed to the
pants’ attrition becomes a threat when (1) those who treatment.
drop out of a study are different types of people
from those who remain in the study or (2) there is Construct Validity
a difference between the kinds of people who drop Construct validity examines the fit between the con-
out of the experimental group and the people who ceptual definitions and operational definitions of vari-
drop out of the control or comparison group (see ables. Theoretical constructs or concepts are defined
Chapter 15). within the study framework (conceptual definitions).
These conceptual definitions provide the basis for the
Interactions with Selection operational definitions of the variables. Operational
The aforementioned threats can interact with selection definitions (methods of measurement) must validly
to further complicate the validity of the study. The reflect the theoretical constructs. (Theoretical con-
threats most likely to interact with selection are history structs are discussed in Chapter 7; conceptual and
effect, maturation, and instrumentation. For example, operational definitions of concepts and variables are
if the control group you selected for your study has a discussed in Chapter 8.)
different history from that of the experimental group, Is use of the measure a valid inference about the
responses to the treatment may be due to this differ- construct? By examining construct validity, we can
ence rather than to the treatment. determine whether the instrument actually measures
the theoretical construct it purports to measure. The
Diffusion or Imitation of Treatments process of developing construct validity for an instru-
The control group may gain access to the treatment ment often requires years of scientific work. When
intended for the experimental group (diffusion) or a selecting methods of measurement, the researcher
similar treatment available from another source (imi- must determine the previous development of instru-
tation). For example, suppose your study examined ment construct validity (DeVon et al., 2007; Waltz
the effect of teaching specific information to hyperten- et al., 2010). The threats to construct validity are
sive patients as a treatment and then measured the related both to previous instrument development and
effect of the teaching on blood pressure readings and to the development of measurement techniques as part
adherence to treatment protocols. Suppose that the of the methodology of a particular study. Threats to
experimental group patients shared the teaching infor- construct validity are described here.
mation with the control patients (treatment diffu-
sion). This sharing changed the behavior of the control Inadequate Preoperational Clarification
group. The control group patients’ responses to the of Constructs
outcome measures may show no differences from Measurement of a construct stems logically from a
those of the experimental group even though the concept analysis of the construct, either by the theorist
teaching actually did make a difference (Type II error; who developed the construct or by the researcher. The
fail to reject a false null). conceptual definition should emerge from the concept
CHAPTER 10  Understanding Quantitative Research Design 201

analysis, and the method of measurement (operational if a researcher expects a particular intervention to
definition) should clearly reflect both. A deficiency in relieve pain. The data he or she collects may be
the conceptual or operational definition leads to low biased to reflect this expectation. If another researcher
construct validity. who does not believe the intervention would be
effective had collected the data, results could have
Mono-Operation Bias been different. The extent to which this effect actu-
Mono-operation bias occurs when only one method ally influences studies is not known. Because of
of measurement is used to assess a construct. When their concern about experimenter expectancy, some
only one method of measurement is used, fewer researchers are not involved in the data collection
dimensions of the construct are measured. Construct process. In other studies, data collectors do not know
validity greatly improves if the researcher uses more which subjects are assigned to treatment and control
than one instrument (Waltz et al., 2010). For example, groups.
if anxiety were a dependent variable, more than one Another way to control this threat is to design the
measure of anxiety could be used. It is often possible study so that the various data collectors have different
to apply more than one measurement of the dependent expectations. If the sample size is large enough, the
variable with little increase in time, effort, or cost. researcher could compare data gathered by the differ-
ent data collectors. Failing to determine differences in
Monomethod Bias the data collected by the collectors would give evi-
In monomethod bias, the researcher uses more than dence that the construct is valid.
one measure of a variable, but all the measures use the
same method of recording. Attitude measures, for Confounding Constructs and Levels of Constructs
example, may all be paper and pencil scales. Attitudes When developing the methodology of a study, you
that are personal and private, however, may not be must decide about the intensity of the variable that
detected through the use of paper and pencil tools. will be measured or provided as a treatment. This
Paper and pencil tools may be influenced by feelings intensity influences the level of the construct that
of nonaccountability for responses, acquiescence, or will be reflected in the study. These decisions can
social desirability. For example, construct validity affect validity, because the method of measuring the
would improve if anxiety were measured by a paper variable influences the outcome of the study and
and pencil test, verbal messages of anxiety, the gal- the understanding of the constructs in the study
vanic skin response, and the observer’s recording of framework.
incidence and frequency of behaviors that have been For example, in reviewing your research, you
validly linked with anxiety. might find that variable A does not affect variable B
when, in fact, it does, but either not at the level of A
Hypothesis Guessing within that was manipulated or not at the level of B that was
Experimental Conditions measured. This issue is a particular problem when A
Hypothesis guessing occurs when subjects within a is not linearly related to B or when the effect being
study guess the hypotheses of the researcher. The studied is weak. To control this threat, you will need
validity concern relates to behavioral changes that to include several levels of A in the design and will
may occur in the subjects as a consequence of knowing have to measure many levels of B. For example, in a
the hypothesis. The extent to which this issue modifies study in which A is preoperative teaching and B is
study findings is not currently known. anxiety, (1) the instrument being used to measure
anxiety measures only high levels of anxiety or (2) the
Evaluation Apprehension preoperative teaching is provided for 15 minutes but
Subjects want researchers to see them in a favorable 30 minutes or an hour of teaching is required to cause
light. They want to be seen as competent and psycho- significant changes in anxiety.
logically healthy. Evaluation apprehension occurs In some cases, confounding of variables occurs,
when the subject’s responses in the experiment are due leading to mistaken conclusions. Few measures of a
to this desire rather than the effects of the independent construct are pure measures. Rather, a selected method
variable. of measuring a construct can measure a portion of the
construct as well as other related constructs. Thus,
Experimenter Expectancies (Rosenthal Effect) the measure can lead to confusing results, because
The expectancies of the researcher can bias the the variable measured does not accurately reflect the
data. For example, experimenter expectancy occurs construct.
202 UNIT TWO  The Research Process

Interaction of Different Treatments they consented to participate in the study. Subjects


The interaction of different treatments is a threat to might be volunteers, “do-gooders,” or people with
construct validity if subjects receive more than one nothing better to do. In this case, generalizing the
treatment in a study. For example, your study might findings to all members of a population, such as all
examine the effectiveness of pain relief measures, and nurses, all hospitalized patients, or all persons experi-
subjects might receive medication, massage, distrac- encing diabetes, is not easy to justify.
tion, and relaxation strategies. In this case, each one The study must be planned to limit the investment
of the treatments interacts with the others, and the demands on subjects and thereby improve participa-
effect of any single treatment on pain relief would be tion. The researcher must report the number of persons
impossible to extract. Your study findings could not who were approached and refused to participate in the
be generalized to any situation in which patients did study (refusal rate) so that those who are examining
not receive all four pain treatments. Chapter 14 pro- the study can judge any threats to external validity. As
vides direction in preventing and managing interac- the percentage of those who decline to participate
tions of treatments. increases, external design validity decreases. Suffi-
cient data need to be collected on the subjects to allow
Interaction of Testing and Treatment the researcher to be familiar with the characteristics
In some studies, pretesting the subject is thought to of subjects and, to the extent possible, the character-
modify the effect of the treatment. In this case, the istics of those who decline to participate.
findings can be generalized only to subjects who have
been pretested. Although there is some evidence that Interaction of Setting and Treatment
pretest sensitivity does not have the impact that was Bias exists in types of settings and organizations that
once feared, it must be considered when the validity agree to participate in studies. This bias has been par-
of the study is examined. The Solomon four-group ticularly evident in nursing studies. For example,
design (discussed in Chapter 11) tests this threat to some hospitals welcome nursing studies and encour-
validity. Repeated posttests can also lead to an interac- age employed nurses to conduct studies. Others are
tion of testing and treatment. resistant to the conduct of nursing research. These two
types of hospitals may be different in important ways;
External Validity thus, there might be an interaction of setting and treat-
External validity is concerned with the extent to ment that limits the generalizability of the findings. As
which study findings can be generalized beyond the a researcher, you must consider this factor when
sample used in the study. With the most serious threat, making statements about the population to which your
the findings would be meaningful only for the group findings can be generalized.
being studied. To some extent, the significance of the
study depends on the number of types of people and Interaction of History and Treatment
situations to which the findings can be applied. Some- The circumstances in which a study was conducted
times, the factors influencing external validity are (history) influence the treatment and thus the general-
subtle and may not be reported in research reports; izability of the findings. Logically, one can never gen-
however, the researcher must be responsible for these eralize to the future; however, replicating the study
factors. Generalization is usually narrower for a single during various periods strengthens the usefulness of
study than for multiple replications of a study using findings over time. In critically appraising studies, you
different samples, perhaps from different populations must always consider the period of history during
in different settings. The threats to the ability to gen- which the study was conducted and the effect of
eralize the findings (external validity) in terms of nursing practice and societal events during that period
study design are described here. on the reported findings (see Chapter 14 for more
details on research with interventions).
Interaction of Selection and Treatment
Seeking subjects who are willing to participate in a
study can be difficult, particularly if the study requires Elements of a Good Design
extensive amounts of time or other investments by The purpose of design is to set up a situation that
subjects. If a large number of the persons approached maximizes the possibilities of obtaining accurate
to participate in a study decline to participate, the responses to objectives, questions, or hypotheses.
sample actually selected will be limited in ways that Select a design that is (1) appropriate to the purpose
might not be evident at first glance. For example, the of the study; (2) feasible given realistic constraints;
researcher knows the subjects well and probably why and (3) effective in reducing threats to design validity.
CHAPTER 10  Understanding Quantitative Research Design 203

In most studies, comparisons are the basis of obtaining occurs when sampling criteria have not been ade-
valid answers. A good design provides the subjects, quately defined or when unidentified extraneous vari-
the setting, and the protocol within which those com- ables increase variation in the group.
parisons can be clearly examined. The comparisons The most effective strategy for achieving equiva-
may focus on differences or relationships or both. The lence consists of random sampling followed by
study may require that comparisons be made between random assignment to groups. However, this strategy
or among individuals, groups, or variables. A compari- does not guarantee equivalence. Even when random-
son may also be made of measures taken before a ization has been used, the researcher must examine the
treatment (pretest) and measures taken after a treat- extent of equivalence by measuring and comparing
ment (posttest). After these comparisons have been characteristics for which the groups must be equiva-
made, you can compare the sample values with statis- lent. This comparison is usually reported in the
tical tables reflecting population values. In some cases, description of the sample (Shadish et al., 2002).
the study may involve comparing group values with Contrary to the aforementioned need for equiva-
population values. lence, groups must be as different as possible in rela-
Designs were developed to reduce threats that tion to the research variables. Small differences or
might invalidate the comparisons. However, some relationships are more difficult to distinguish than
designs are more effective in reducing threats than large differences. These differences are often addressed
others. It may be necessary to modify the design to in terms of effect size. Although sample size plays an
reduce a particular threat. Before selecting a design, important role, effect size is maximized by a good
you must identify the design validity threats that are design. Effect size is greatest when variance within
most likely to invalidate your study. groups is small.
Strategies for reducing threats to design validity are
sometimes addressed in terms of control. Selecting a Control and Comparison Groups
design involves decisions related to control of the If the study involves an experimental treatment, the
environment, sample, treatment, and measurement. design usually calls for a comparison. Outcome mea-
Increasing control (to reduce threats to validity) will sures for individuals who receive the experimental
require you to carefully think through every facet of treatment are compared with outcome measures for
your design. An excellent description of one research those who do not receive the experimental treatment.
team’s efforts to develop a good design and control This comparison requires a control group, subjects
threats to validity is offered by McGuire et al. (2000) who do not receive the experimental treatment.
in their study, “Maintaining Study Validity in a Chang- However, in nursing studies, all patients require care
ing Clinical Environment.” and those who do not receive the study intervention
receive standard or usual care. Nurse researchers often
Controlling the Environment refer to the group receiving standard care, but no treat-
The study environment has a major effect on research ment, as the comparison group rather than the control
outcomes. An uncontrolled environment introduces group.
many extraneous variables into the study situation. One threat to validity is the lack of equivalence
Therefore, the study design may include strategies for between the experimental and control groups. This
controlling that environment. In many studies, it is threat is best controlled by random assignment to
important that the environment be consistent for all groups. Another strategy is for the subjects to serve as
subjects. Elements in the environment that may influ- their own controls. With this design strategy, pretest
ence the application of a treatment or the measurement and posttest measures are taken of the subjects in the
of variables must be identified and, when possible, absence of a treatment, as well as before and after
controlled. the treatment. In this case, the timing of measures
must be comparable between control and treatment
Controlling Equivalence of Subjects conditions.
and Groups
When comparisons are made, it is assumed that the Controlling the Treatment
individual units of the comparison are relatively In a well-designed experimental study, the researcher
equivalent except for the variables being measured. has complete control of any treatment provided. The
The researcher does not want to be comparing “apples first step in achieving control is to develop a detailed
and oranges.” To establish equivalence, the researcher description of the treatment, such as an intervention
defines sampling criteria. Deviation from this equiva- protocol, to ensure standardization of the treatment.
lence is a threat to internal design validity. Deviation The next step is to use strategies to ensure consistency
204 UNIT TWO  The Research Process

in implementing the treatment. Consistency may and visual imagery) or various levels of the same treat-
involve elements of the treatment such as equipment, ment (e.g., different doses of a drug or varying lengths
time, intensity, sequencing, and staff skill. This process of relaxation time). Sometimes the application of one
is referred to as intervention fidelity and is discussed treatment can influence the response to later treat-
in more detail in Chapter 14. ments, a phenomenon referred to as a carryover
Variations in the treatment reduce the effect size. It effect. If a carryover effect is known to occur, it is not
is likely that subjects who receive fewer optimal advisable for a researcher to use this design strategy
applications of the treatment will have a smaller for the study. However, even when no carryover effect
response, resulting in more variance in posttest mea- is known, the researcher may take precautions against
sures for the experimental group. To avoid this the possibility that this effect will influence outcomes.
problem, the treatment is administered to each subject In one such precaution, known as counterbalancing,
in exactly the same way. This consideration requires the various treatments are administered in random
the researcher to think carefully through every order rather than being provided consistently in the
element of the treatment to reduce variation wherever same sequence.
possible (Morrison et al., 2009; Santacroce et al.,
2004). For example, if information is being provided Controlling Measurement
as part of the treatment, some researchers record the Measurement methods play a key role in the validity
information, present it to each subject in the same of a study. Instruments such as scales must have docu-
environment, and attempt to decrease variation in the mented validity and reliability, and physiological mea-
subject’s experience before and during the viewing of sures require accuracy and precision (Ryan-Wenger,
the DVD content. Variations include elements such as 2010; Waltz et al., 2010). When measurement is crude
time of day, mood, anxiety, experience of pain, inter- or inconsistent, variance within groups is high, and it
actions with others, and amount of time spent waiting. is more difficult to detect differences or relationships
Yamada, Stevens, Sidani, Watt-Watson, and Silva among groups. Thus, the study does not provide a
(2010) provide a detailed discussion of the process valid test of the hypotheses. However, the consistent
they used to measure intervention implementation implementation of measurements enhances validity.
fidelity in their study. For example, each subject must receive the same
In many nursing studies, the researcher does not instructions about completing a pain scale. Data col-
have complete control of the treatment. It may be lectors must be trained and observed for consistency.
costly to control the treatment carefully; it may be Designs define the timing of measures (e.g., pretest,
difficult to persuade staff to be consistent in the treat- posttest). Sometimes, the design calls for multiple
ment, or the time required to implement a carefully measures over time. The researcher must specify the
controlled treatment may seem prohibitive. In some points in time during which measures will be taken.
cases, the researcher may be studying causal outcomes The research report must include a rationale for the
of an event occurring naturally in the environment. timing of measures.
Regardless of the reason for the researcher’s decision,
internal design validity is reduced when the treatment Controlling Extraneous Variables
is inconsistently applied. The risk of a Type II error is When designing a study, you must identify variables
higher owing to greater variance and a smaller effect not included in the design (extraneous variables) that
size. Thus, studies with uncontrolled treatments need could explain some of the variance that occurs when
larger samples to reduce the risk of a Type II error. the study variables are measured. In a good design,
External validity may improve if the treatment is the effect of these variables on variance is controlled.
studied as it typically occurs clinically. If the study The extraneous variables commonly encountered in
does not reveal a statistically significant difference, nursing studies are age, education, gender, social
then perhaps the typical clinical application of the class, severity of illness, level of health, functional
treatment does not have an important effect on patient status, and attitudes. For a specific study, you must
outcomes. The question then becomes whether a dif- think carefully through the variables that could have
ference might have been found if the treatment had an impact on that study.
been consistently applied. Design strategies used to control extraneous vari-
ables include random sampling, random assignment
Counterbalancing to groups, selecting subjects who are homogeneous
In some studies, each subject receives several different in terms of a particular extraneous variable, selecting
treatments sequentially (e.g., relaxation, distraction, a heterogeneous sample, blocking, stratification,
CHAPTER 10  Understanding Quantitative Research Design 205

TABLE 10-1  Studies Using Control Strategies for Good Design


Design Strategy Example Studies
Control group McCorkle, R., Jeon, S., Ercolano, E., & Schwartz, P. (2011). Healthcare utilization in women after
abdominal surgery for ovarian cancer. Nursing Research, 60(1), 47–57.
Chen, K., Fan, J., Wang, H., Wu, S., Li, C., & Lin, H. (2010). Silver yoga exercises improved physical
fitness of transitional frail elders. Nursing Research, 59(5), 364–370.
Counterbalancing Cacciola, J. S., Alterman, A. I., McLellan, A. T., Lin, Y., & Lynch, K. G. (2007). Initial evidence for the
reliability and validity of a “Lite” version of the Addiction Severity Index. Drug and Alcohol
Dependence, 87(2–3), 297–302.
Ivarsson, B., Larsson, S., Lührs, C., & Sjöberg, T. (2007). Patients’ perceptions of information about risks
at cardiac surgery. Patient Education and Counseling, 67(1–2), 32–38.
Random sampling Laschinger, H. K. S., Finegan, J., & Wilk, P. (2011). Situational and dispositional influences on nurses’
workplace well-being: The role of empowering unit leadership. Nursing Research, 60(2), 124–131.
Simons, S. R., Stark, R. B., & DeMarco, R. F. (2011). A new, four-item instrument to measure workplace
bullying. Research in Nursing & Health, 34(2), 132–140.
Random assignment Jones, D., Duffy, M. E., & Flanagan, J. (2011). Randomized clinical trial testing efficacy of a nurse-
coached intervention in arthroscopy patients. Nursing Research, 60(2), 92–99.
Lee, K. A., & Gay, C. L. (2011). Can modifications to the bedroom environment improve sleep of new
parents? Two randomized controlled trials. Research in Nursing & Health, 34(1), 7–19.
Homogeneity Hodgin, R. F., Chandra, A., & Weaver, C. (2010). Correlates to long-term-care nurse turnover: Survey
results from the State of West Virginia. Hospital Topics, 88(4), 91–97.
Estok, P. J., Sedlak, C. A., Doheny, M. O., & Hall, R. (2007). Structural model for osteoporosis preventing
behavior in postmenopausal women. Nursing Research, 56(3), 148–158.
Heterogeneity Kwok, C. S., Loke, Y. K., Hale, R., Potter, J. F., & Myint, P. K. (2011). Atrial fibrillation and incidence of
dementia: A systematic review and meta-analysis. Neurology, 76(10), 914–922.
Neufeld, A., & Harrison, M. J. (2003). Unfulfilled expectations and negative interactions: Nonsupport in
the relationships of women caregivers. Journal of Advanced Nursing, 41(4), 323–331.
Blocking Rousaud, A., Blanch, J., Hautzinger, M., De Lazzari, E., Peri, J. M., Puig, O., et al. (2007). Improvement of
psychosocial adjustment to HIV-1 infection through a cognitive-behavioral oriented group psychotherapy
program: A pilot study. AIDS Patient Care and STDs, 21(3), 212–222.
Tsay, S. L., Wang, J. C., Lin, K. C., & Chung, U. L. (2005). Effects of acupressure therapy for patients
having prolonged mechanical ventilation support. Journal of Advanced Nursing, 52(2), 142–150.
Stratification Botticello, A. L., Chen, Y., Cao, Y., & Tulsky, D. S. (2011). Do communities matter after rehabilitation?
The effect of socioeconomic and urban stratification on well-being after spinal cord injury. Archives of
Physical Medicine & Rehabilitation, 92(3), 464–471.
Carey, T. A. (2006). Estimating treatment duration for psychotherapy in primary care. Journal of Public
Mental Health, 5(3), 23–28.
Matching Mehta, S., Chen, H., Johnson, M. L., & Aparasu, R. R. (2010). Risk of falls and fractures in older adults
using antipsychotic agents: A propensity-matched retrospective cohort study. Drugs & Aging, 27(10),
815–829.
Trevisanuto, D., Micaglio, M., Pitton, M., Magarotto, M., Piva, D., & Zanardo, V. (2006). Laryngeal mask
airway: Is the management of neonates requiring positive pressure ventilation at birth changing? Journal
of Neonatal Nursing, 12(5), 185–192.
Statistical control Griffin-Blake, C. S., & DeJoy, D. M. (2006). Evaluation of social-cognitive versus stage-matched, self-help
(partialing out) physical activity interventions at the workplace. American Journal of Health Promotion, 20(3), 200–209.
Roberts, J. E., Burchinal, M. R., & Zeisel, S. A. (2002). Otitis media in early childhood in relation to
children’s school-age language and academic skills. Pediatrics, 110(4), 696–706.

matching subjects between groups in relation to Random Sampling


a particular variable, and statistical control. Table Random sampling increases the probability that
10-1 identifies some nursing studies and the various subjects with various levels of an extraneous variable
strategies they have used to control extraneous are included and are randomly dispersed throughout
variables. the groups within the study (Thompson, 2002).
206 UNIT TWO  The Research Process

This strategy is particularly important for controlling be generalized to types of people excluded from the
uni­dentified extraneous variables. Whenever possible, study.
however, extraneous variables must be identified,
measured, and reported in the description of the Heterogeneity
sample. In studies using nonrandom sampling methods, the
researcher may attempt to obtain subjects with a wide
Random Assignment variety of characteristics (or who are heterogeneous)
Random assignment enhances the probability that to reduce the risk of biases. When using the strategy
subjects with various levels of extraneous variables of heterogeneity, you may seek subjects from multiple
are equally dispersed in treatment and control or com- diverse sources. The strategy is designed to increase
parison groups. When subjects are randomly assigned generalizability of the study findings. Characteristics
to groups, these groups are considered independent. of the sample must be described in the research report
Independent groups exist when the selection and to indicate the heterogeneity of the sample.
assignment of subjects to one group, such as the
experimental group, are unrelated to the subjects Blocking
selected and assigned to the control group. Whenever In blocking, the researcher includes subjects with
possible, however, this dispersion must be evaluated various levels of an extraneous variable in the sample
rather than assumed. but controls the numbers of subjects at each level of
the variable and their random assignment to groups
Homogeneity within the study. Designs using blocking are referred
Homogeneity is a more extreme form of equiva- to as randomized block designs (see Chapter 11).
lence in which the researcher limits the subjects to The extraneous variable is then used as an independent
only one level of an extraneous variable to reduce its variable in the data analysis. Therefore, the extraneous
impact on the study findings. To use this strategy, variable must be included in the framework and the
you must have previously identified the extraneous study hypotheses.
variables. You might choose to include subjects with Using this strategy, you might randomly assign
only one level of an extraneous variable in the study. equal numbers of subjects in three age categories
For example, only subjects between the ages of 20 (younger than 18 years, 18 to 60 years of age, and
and 30 years may be included in a study, or only older than 60 years) to each group in the study. You
subjects with a particular level of education. The could use blocking for several extraneous variables.
study may include only breast cancer patients who For example, you could block the study in relation to
have been diagnosed within 1 month, are at a par- both age and ethnic background (African American,
ticular stage of disease, and are receiving a specific Hispanic, Caucasian, and Asian). Table 10-2 summa-
treatment for cancer. The difficulty with this strategy rizes an example of this approach.
is that it limits generalization to the types of subjects During data analysis for the randomized block
included in the study. Findings could not justifiably design, each cell in the analysis is treated as a group.

TABLE 10-2  Example of Blocking Using Age and Ethnic Background


Age Ethnic Group Experimental Control
Younger than 18 years (n = 160) African American n = 40 n = 20 n = 20
Hispanic, nonwhite n = 40 n = 20 n = 20
White, non-Hispanic n = 40 n = 20 n = 20
Asian n = 40 n = 20 n = 20
19 to 60 years of age (n = 160) African American n = 40 n = 20 n = 20
Hispanic, nonwhite n = 40 n = 20 n = 20
White, non-Hispanic n = 40 n = 20 n = 20
Asian n = 40 n = 20 n = 20
Older than 60 years (n = 160) African American n = 40 n = 20 n = 20
Hispanic, nonwhite n = 40 n = 20 n = 20
White, non-Hispanic n = 40 n = 20 n = 20
Asian n = 40 n = 20 n = 20
CHAPTER 10  Understanding Quantitative Research Design 207

Therefore, you must evaluate the cell sample size and as satisfactory as those of the various methods of
the effect size to ensure adequate power to detect dif- design control.
ferences in the study. A minimum of 20 subjects per
group is recommended but the final group size is best
determined by power analysis (Aberson, 2010). Thus, Questions to Direct Design
the example described for Table 10-2 would require a Development and
minimal sample of 480 subjects. Using randomized
block designs usually require very large sample sizes Implementation in a Study
to implement. Developing and implementing a study design requires
the researcher to consider multiple details such as
Stratification those discussed in the sections on design validity and
Stratification involves the distribution of subjects elements of a good design. The more carefully thought
throughout the sample, using sampling techniques out these details are, the stronger the design. Strong
similar to those used in blocking, but the purpose of research designs are essential to generate valid research
the procedure is even distribution throughout the evidence for nursing (Brown, 2009; Melnyk &
sample. The extraneous variable is not included in the Fineout-Overholt, 2011). The elements central to the
data analysis. Distribution of the extraneous variable study design include the presence or absence of a
is included in the description of the sample. treatment, the number of groups in the sample, the
number and timing of measurements, the sampling
Matching method, the time frame for data collection, planned
To ensure that subjects in the control or comparison comparisons, and the control of extraneous variables.
group are equivalent to subjects in the experimental Finding answers to the following questions will help
group, some studies are designed to match subjects in you to develop a study design:
the two groups. Matching is used when a subject in 1. Is the primary purpose of the study to describe
the experimental group is randomly selected and then variables and groups within the study situation, to
a subject similar in relation to important extraneous examine relationships, or to examine causality
variables is randomly selected for the control group. within the study situation? (Kerlinger & Lee,
This matching of subjects on selected characteristics 2000; Shadish et al., 2002)
to be included in both the experimental and control 2. Will a treatment or intervention be implemented
groups results in dependent groups. For example, in the study? (Forbes, 2009)
subjects in the experimental and control groups might 3. If an intervention is implemented, will the re-
be matched for age, gender, severity of illness, or searcher control the intervention? (Forbes, 2009;
number of chronic illnesses. Clearly, the pool of avail- Morrison et al., 2009; Santacroce et al., 2004)
able subjects would have to be large to accomplish this 4. Will the sample be pretested before the
goal. In quasi-experimental studies, matching may be intervention?
performed without randomization (Cook & Campbell, 5. Will the sample be randomly or nonrandomly
1979). selected?
6. What sampling method is used to obtain study
Statistical Control participants? (Thompson, 2002)
In some studies, it is not considered feasible to control 7. Will the sample be studied as a single group or
extraneous variables through the design. However, the divided into groups? (Fawcett & Garity, 2009)
researcher recognizes the possible impact of extrane- 8. How many groups will there be?
ous variables on variance and effect size. Therefore, 9. What will be the size of each group? (Aberson,
measures are obtained for the identified extraneous 2010)
variables. Data analysis strategies that have the capac- 10. Will there be a control group, or will a comparison
ity to remove (partial out) the variance explained by group or standard care group be compared with
the extraneous variable are performed before the anal- the experimental group?
ysis of differences or relationships between or among 11. Will the study participants be randomly assigned
the variables of interest in the study. One statistical to the groups? If the participants are randomly
procedure commonly used for this purpose is analysis assigned, how is this assignment accomplished?
of covariance (Corty, 2007). Although statistical 12. What instruments will be used to measure the
control seems to be a quick and easy solution to variables? (Bialocerkowski, Klupp, & Bragge,
the problem of extraneous variables, its results are not 2010; Waltz et al., 2010)
208 UNIT TWO  The Research Process

13. Are the measurement methods valid and reliable available strategies. To capitalize on the representa-
or precise and accurate? (DeVon et al., 2007) tiveness and generalizability of quantitative research
14. Will the variables be measured more than once? and the in-depth, contextual nature of qualitative
15. Will the data be collected cross-sectionally or research, several methods are combined in a single
over time? research study (Creswell, 2009).
16. Have extraneous variables been identified? The idea of using mixed-methods approaches to
17. Are data being collected on extraneous variables? conduct studies has a long history. More than 50 years
18. What strategies are being used to control for ago, quantitative researchers Campbell and Fiske
extraneous variables? (1959) recommended mixed methods to more accu-
19. What strategies are being used to compare vari- rately measure a psychological trait. The multi-trait–
ables or groups? multi-method matrix was designed to rule out method
20. Will data be collected at a single site or at multiple effects to allow researchers to attribute individual
sites? variation to the personality trait itself (Rocco, Bliss,
21. What strategies are used to ensure consistent col- Gallagher, & Perez-Prado, 2003). This mixed method-
lection of data? (Creswell, 2009; Fawcett & ology was later expanded into what Denzin (1989)
Garity, 2009; Shadish et al., 2002) identified as “triangulation.” Denzin (1989) believed
that combining multiple theories, methods, observers,
and data sources can help researchers overcome the
Mixed Methods intrinsic bias that comes from single-theory, single-
There is controversy among researchers about the methods, and single-observer studies. Triangulation
relative validity of various approaches to research. evolved to include using multiple data collection and
Designing quantitative experimental studies with rig- analysis methods, multiple data sources, multiple ana-
orous controls may provide strong external validity lysts, and multiple theories or perspectives (Patton,
but questionable or limited internal validity. Qualita- 2002). The concept of triangulation has now been
tive studies may have strong internal validity but ques- replaced by the idea of mixed-methods approaches
tionable external validity. A single approach to (Creswell, 2009).
measuring a concept may be inadequate to justify a Because phenomena are complex, combining qual-
claim that it is a valid measure of a theoretical concept. itative and quantitative methods enables researchers to
Testing a single theory may leave the results open to be more likely to capture the essence of the phenom-
the challenge of rival hypotheses from other theories enon. There are selected techniques or strategies
(Creswell, 2009). associated with conducting mixed-methods studies.
As research methodologies continue to evolve, Strategies frequently associated with the mixed-
mixed-methods approaches offer investigators the methods approaches include the following:
ability to utilize the strengths of both qualitative and Sequential procedures are those in which the
quantitative research designs. Mixed-methods research researcher investigates a phenomenon so that find-
is characterized as research that contains elements of ings of one method may elaborate on or elucidate
both qualitative and quantitative approaches (Coward, the findings of another method. This may involve
1990; Creswell, 2009; Duffy, 1987; Marshall & beginning with a qualitative method to explore and
Rossman, 2011; Mitchell, 1986; Morse, 1991; Myers then following up with a quantitative method using
& Haase, 1989; Patton, 2002; Porter, 1989). The phil- a large sample so that results can be generalized to
osophical underpinnings of mixed-methods research a population. Alternatively, the study may begin
and what paradigms best fit these research methods with a quantitative method so that theories or prop-
are still evolving. It is recognized that all researchers ositions can be tested, followed by a qualitative
bring assumptions to their studies, consciously or method using in-depth interviews with study par-
unconsciously, and investigators decide whether they ticipants to expand a theory (Creswell, 2009).
are going to view their study from a post-positivist Concurrent procedures is an approach in which the
(quantitative) or constructivist (qualitative) perspec- researcher merges quantitative and qualitative data
tive, or through an “advocacy lens,” such as feminism in order to present an all-inclusive analysis of the
(Fawcett & Garity, 2009; Munhall, 2012). research problem. Collection of quantitative and
Over the last few years, many researchers have qualitative data is done concurrently during the
departed from the idea that one paradigm or one study. Then the investigator assimilates the results
research strategy is right and have taken the perspec- obtained from both methods in order to interpret
tive that the search for the truth requires the use of all the overall findings. The researcher may nest one
CHAPTER 10  Understanding Quantitative Research Design 209

form of data within another larger data collection strategy; (3) sequential transformative strategy; and
to analyze different questions (Creswell, 2009). (4) concurrent triangulation strategy. Models of these
Transformative procedure is one in which the mixed-methods approaches and examples are pro-
researcher uses a “theoretical lens” in order to vided to expand your understanding of these designs.
encompass a broad perspective within a design that
contains both quantitative and qualitative data. This Sequential Explanatory Strategy
broad perspective is based on a theoretical frame- With the sequential explanatory strategy, the
work and provides methods for data collection and researcher collects and analyzes quantitative data and
anticipated outcomes from the study. This method then collects and analyzes qualitative data. Integration
usually serves a larger purpose to advocate for of the data occurs during the interpretation phase. The
minority or marginalized groups. Data could be purpose of this approach is to assist in explaining and
sequential or concurrent (Creswell, 2009). interpreting quantitative data (see Figure 10-1). It is
In each of these three strategies, both quantitative useful when unexpected quantitative results are
and qualitative data are collected and the researcher revealed. Qualitative examination of the phenomenon
may integrate the data at different stages of the facilitates a fuller understanding and is well suited to
research process. The priority may be given to one explaining and interpreting relationships. There may
type of data over the other (i.e., quantitative over or may not be a theoretical perspective to the study.
qualitative or vice versa), or they can be equal (con- This approach is easy to implement because the steps
current). If the sequential approach is implemented fall in sequential stages; however the two-stage
and qualitative data are collected first, then qualitative approach extends the time involved in data collection
data are the priority, and integration of the two data and is seen as a weakness of the design.
sets occurs during data interpretation and is then expli- This type of methodology was used in a study by
cated in the discussion. If quantitative data are col- Carr (2009), who examined the experience of postop-
lected first, then these data are the priority, and erative pain. Women undergoing surgery completed
qualitative data are used to augment the quantitative questionnaires to measure pain, anxiety, and depres-
data. Data integration is completed during analysis sion (quantitative data). Follow-up telephone inter-
and interpretation and is expressed in the discussion. views explored their pain experiences (qualitative
With the concurrent approach, data are considered data). Using a second series of patients, Carr once
equal and therefore are collected at the same time, or again looked at the frequency and patterns of anxiety
concurrently. Integration of the data occurs during in the immediate preoperative and postoperative
data collection. periods, followed by semi-structured telephone inter-
Creswell (2009) identifies six types of mixed- views. During the interviews, patients identified
methods approaches, expanding the three strategies events/situations occurring during their hospitaliza-
previously introduced. The four approaches usually tion that contributed to their anxiety.
implemented in nursing research are: (1) sequential As indicated by the use of sequential explanatory
explanatory strategy; (2) sequential exploratory strategy, priority was given to the quantitative data.

Quantitative Qualitative

Data Data Data Data


Collection Analysis Collection Analysis Figure 10-1  Sequential explanatory strategy. (Adapted
from Creswell, J. W. [2009]. Research design: Qualitative,
quantitative, and mixed methods approaches [3rd ed.].
Los Angeles, CA: Sage; and Hanson, W. E., Creswell, J. W.,
Interpretation of entire analysis Plano Clark, V. L., Petska, K. S., & Creswell, J. D. [2005].
Mixed methods research designs in counseling
psychology. Journal of Counseling Psychology, 52[2],
Purpose is to use qualitative results to assist in explaining and 224–235.)
interpreting the findings of a primarily quantitative study.
Easy to implement, describe and report.
Weakness is the length of time involved in data collection, with the
two separate phases.
210 UNIT TWO  The Research Process

However, during interpretation, the qualitative data quantitative scale to explore each item. A pilot study
seemed to indicate that lack of knowledge about the was conducted to examine the women’s intolerance to
operative procedure, which is traditionally thought to physical abuse by their husbands, and a third phase of
be a contributor to anxiety, was not as contributory to the study was conducted to establish construct validity
patient anxiety as expected. By interpreting both quan- of the scale (Choi, Phillips, Figueredo, Insel, & Min,
titative and qualitative data in the same study, the 2008).
investigator was able to broaden the understanding
of the pain and anxiety of postoperative patients. Sequential Transformative Strategy
Carr (2009) also noted that some of the events that When the sequential transformative strategy is
led to patients’ anxiety and pain were amenable to employed, qualitative or quantitative data collection
nursing interventions and not solely due to lack of and analysis can come first. The results are integrated
knowledge. during the interpretation phase. But unlike the prior
two approaches, sequential transformative strategy is
Sequential Exploratory Strategy guided by a theory or through the advocacy lens. The
Sequential exploratory strategy is very similar to the purpose of this approach is to employ methods that
sequential explanatory strategy except the collection will best serve the theoretical perspective. The theo-
and analysis of qualitative data precedes the collection retical perspective drives the entire research process
of quantitative data. Integration of the data occurs from the introduction of the problem to the directional
during the interpretation phase, and the quantitative research question, which generates a sensitive
data are used to understand the qualitative data (see approach to data collection and ends with an appeal
Figure 10-2). There may or may not be a theoretical to act (see Figure 10-3). Using this strategy, research-
perspective to the study. The purpose of this approach ers may have the opportunity to speak out about dif-
is to: (1) explore a phenomenon’s distribution within ferent perspectives, serve as an advocate for study
a population; (2) test elements of an emerging theory; participants, or better understand a phenomenon that
or (3) develop and test new measurement instruments. is changing as a result of being studied. The staging
The sequential exploratory strategy is also easy to inherent in the design is a strength, but once again,
implement because of the staged approach, but the this approach extends the length of time required to
length of time required for data collection is consid- collect data. There is little written on this approach, so
ered a weakness. there is little guidance on how to use the “transforma-
An example of sequential exploratory strategy is tive vision” to guide the methods.
the research by Choi and Harwood (2004), who con- The sequential transformative strategy was used by
ducted a qualitative study to explore the themes of Park, Knapp, and Shin (2009) in the conduct of their
Korean women’s response to domestic violence. Five mixed-methods study of social engagement in assisted
themes emerged centered on intolerance to abusive living communities. These researchers used a frame-
husbands and were the basis for the development of a work of social relationships and support among older

Qualitative Quantitative

Data Data Data Data


Figure 10-2  Sequential exploratory strategy. (Adapted Collection Analysis Collection Analysis
from Creswell, J. W. [2009]. Research design: Qualitative,
quantitative, and mixed methods approaches [3rd ed.].
Los Angeles, CA: Sage; and Hanson, W. E., Creswell, J. W., Interpretation of entire analysis
Plano Clark, V. L., Petska, K. S., & Creswell, J. D. [2005].
Mixed methods research designs in counseling
psychology. Journal of Counseling Psychology, 52[2],
Purpose is to use quantitative data and results to assist in the
224–235.) interpretation of qualitative findings.
Primary focus of this model is to explore a phenomenon.
Weakness is the length of time involved in data collection, with the two
separate phases.
CHAPTER 10  Understanding Quantitative Research Design 211

Quantitative Qualitative
Figure 10-3  Sequential transformative strategy. (Adapted
from Creswell, J. W. [2009]. Research design: Qualitative,
Vision Advocate Ideas Theory
quantitative, and mixed methods approaches [3rd ed.].
Los Angeles, CA: Sage; and Hanson, W. E., Creswell, J. W.,
Plano Clark, V. L., Petska, K. S., & Creswell, J. D. [2005].
Mixed methods research designs in counseling
Purpose is to employ methods that will best serve the theoretical psychology. Journal of Counseling Psychology, 52[2],
perspective of the researcher. 224–235.)
Caters to diverse perspectives and helps understand a phenomenon
or process changing as a result of being studied.

adults to guide the research design. Although there Quantitative + Qualitative


was substantial information on female older adults in
assisted living communities, a review of the literature
revealed that little was known about how social Data Data
engagement is experienced by men in later life. Using Collection Collection
a quantitative approach followed by a qualitative
approach, the researchers were able to examine gender
differences in social engagement and psychological Data Data
well-being among residents in assisted living com- Analysis Analysis
munities. In addition, they explored experiences and
challenges concerning social relationships for older
Data Results Compared
men. Their findings suggested that older men are less
likely to be satisfied with their lives in an assisted
living community because they feel that their social Used as a means to offset the weakness inherent with
worlds are limited. The most striking finding was that one method with the strengths of the other method.
assisted living communities are not well designed for Interpretation can either note the convergence of the
men’s emotional or social needs. These researchers findings as a way to strengthen the knowledge claims
gave a “voice” to older men and a call for assisted of the study or explain any lack of convergence that
may result.
living administrators, social workers, and staff to be
aware of the specialized social and emotional needs
of male residents (Park et al., 2009). Figure 10-4  Concurrent triangulation strategy. (Adapted from Creswell,
J. W. [2009]. Research design: Qualitative, quantitative, and mixed
Concurrent Triangulation Strategy methods approaches [3rd ed.]. Los Angeles, CA: Sage; and Hanson, W.
Concurrent triangulation strategy is a more familiar E., Creswell, J. W., Plano Clark, V. L., Petska, K. S., & Creswell, J. D.
[2005]. Mixed methods research designs in counseling psychology.
approach to researchers. This model is selected when
Journal of Counseling Psychology, 52[2], 224–235.)
a researcher wishes to use quantitative and qualitative
methods in an attempt to confirm, cross-validate, or
corroborate findings within a single study. This model
generally uses separate quantitative and qualitative difficulty of comparing the study results and determin-
methods as a mechanism to compensate for the weak- ing the study findings. It is still unclear how to best
nesses intrinsic in one method with the strengths of resolve discrepancies in findings between methods
the other method. Therefore, the quantitative and qual- (Creswell, 2009).
itative data collection processes are conducted concur- An example of the concurrent mixed-methods
rently. This strategy usually integrates the results of or triangulation approach is the study by Manuel et al.
the two methods during the interpretation phase; and (2007). These researchers concurrently conducted
convergence strengthens the knowledge claims or quantitative and qualitative approaches to examine the
explains lack of convergence (see Figure 10-4). Great coping strategies used by young women diagnosed
researcher effort and expertise are needed to study with breast cancer. The modified Ways of Coping–
a phenomenon with two methods. Because of the dif- Cancer Version (WOC-CA) scale was used to
ferent methods, researchers are challenged with the collect quantitative data. After the WOC-CA scale,
212 UNIT TWO  The Research Process

participants were asked two open-ended questions accurate reflection of the real world. Several poten-
(qualitative) because studies have consistently found tial threats to statistical conclusion design validity
that younger women show greater psychological dis- are addressed.
tress in response to breast cancer than older women. • Internal validity is the extent to which the effects
The researchers thought the open-ended responses detected in the study are a true reflection of reality
would be particularly important because they provided rather than the result of extraneous variables, and
the opportunity to explore whether existing scales potential threats to internal validity are discussed.
adequately cover the strategies used by younger • Construct validity examines the fit between the
women to cope with breast cancer. In the discussion conceptual and operational definitions of a vari-
section of their report, the researchers indicated that able, and threats to this type of design validity are
the data did not converge to confirm current knowl- discussed.
edge. The qualitative data provided useful insights • External validity is concerned with the extent to
about coping in the population of younger women. For which study findings can be generalized beyond the
example, although quantitative data revealed that sample used in the study. The potential threats to
“wishful thinking” was commonly used in dealing external design validity are identified.
with the cancer, responses of the younger women to • A good design provides the subjects, the setting,
the open-ended items indicated this strategy was not and the protocol within which these comparisons
used. Qualitative analysis revealed that being physi- can be clearly examined.
cally active, seeking information, resting, and using • Designs are developed to reduce threats to the
medications and complementary and alternative thera- validity of the comparisons. However, some designs
pies were the most effective strategies used by younger are more effective in reducing threats than others.
women. However, these items are not included in • The elements of a good design include control of
either the WOC-CA or other commonly used cancer (1) the environment; (2) equivalence of subjects
coping scales. These findings suggest that researchers and groups; (3) treatment; (4) measurement; and
and healthcare professionals should be aware that fre- (5) extraneous variables.
quently used coping scales may not include significant • In designing the study, the researcher must identify
strategies used by younger women dealing with the extraneous variables that could explain some of the
diagnosis of breast cancer. variance in measurement of the study variables.
• Questions are provided to direct the reader in
developing and implementing a study design.
KEY POINTS • Mixed-methods approaches include the combined
use of quantitative and qualitative research methods.
• Research design is a blueprint for the conduct of a Data are collected either sequentially or concur-
study that maximizes the researcher’s control over rently, and theory may or may not be used in
factors that could interfere with the desired conducting the study. Merging of data occurs at
outcomes. different points of the study depending on how
• Before selecting a design, the researcher must the qualitative and quantitative methods are
understand certain concepts: causality, multicausal- implemented.
oasis-ebl|Rsalles|1475856587

ity, probability, bias, manipulation, and control. • The four mixed-methods approaches usually imple-
• The purpose of design is to set up a situation mented in nursing research are (1) sequential
that maximizes the possibilities of obtaining explanatory strategy; (2) sequential exploratory
valid answers to research questions or testing strategy; (3) sequential transformative strategy; and
hypotheses. (4) concurrent triangulation strategy.
• Study validity is a measure of the truth or accuracy
of the research findings and is an important concern
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  http://evolve.elsevier.com/Grove/practice/

11
CHAPTER

Selecting a Quantitative
Research Design

A
design is the blueprint for conducting a study Ronald A. Fisher (1935) developed the first experi-
that maximizes control over factors that mental designs that were published in a book titled
could interfere with the validity of the find- The Design of Experiments. However, most work
ings. A research design gives you greater control and on design has been conducted since the 1970s, and
thus improves the validity of your study. To select the designs of the last 20 years have become
an appropriate research design, you will need to much more sophisticated and varied. There is no
integrate many elements. Chapter 10 began with universal standard for categorizing designs. Names
questions that will help you select a design or iden- of designs change as various writers discuss them.
tify by name the design of a study you are critically Researchers sometimes merge elements of several
appraising. Identifying the design of a published designs to meet the research needs of a particular
study is not always easy, because many published study. From these developments, new designs some-
studies do not identify the design used. Determining times emerge.
the design may require you to put together bits Originally, only experimental designs were con-
of information from various parts of the research sidered of value. In addition, many believed that
report. the only setting in which an experiment can be
This chapter describes the designs most commonly conducted is a laboratory, where stricter controls
used in nursing research, using the study categories can be maintained than in a field or natural setting.
described in Chapter 3: descriptive, correlational, This approach is appropriate for the natural sciences
quasi-experimental, and experimental. Descriptive but not for the social sciences. From the social sci-
and correlational designs examine variables in natural ences have emerged additional quantitative designs
environments, such as home, and do not include (descriptive, correlational, and quasi-experimental),
researcher-designed treatments or interventions. Quasi- methodological designs, and qualitative designs
experimental and experimental designs examine the (Cook & Campbell, 1979; Creswell, 2009; Fawcett
effects of an intervention by comparing differences & Garity, 2009). The epidemiology, public health,
between groups that have received the intervention and community health fields have presented time-
and those that have not received the intervention. As series designs, health promotion designs, and preven-
you review each design, note the threats to validity tion designs.
that are controlled by the design, keeping in mind that Currently, most nurse researchers are using
uncontrolled threats in the design you choose may designs developed in other disciplines, such as psy-
weaken the validity of your study. Box 11-1 lists the chology, medicine, sociology, epidemiology, and
designs discussed in this chapter. Each of the designs education, that meet the needs of those disciplines.
is briefly described, and a model is provided so you Will these designs be effective in adding to the
can see the different elements of the designs. After the knowledge base required for nursing? These designs
descriptions of the designs, we provide a series of are a useful starting point, but nurse scientists must
decision trees or algorithms that will help you to select go beyond them to develop designs that will more
the appropriate design for your study or to identify the appropriately meet the needs of the nursing commu-
design used in a published study. nity. To go beyond current designs, nurse scientists
Investigators have always developed designs to must have a working knowledge of available designs
meet emerging research needs. In the 1930s, Sir and of the logic on which they are based. Designs

214
CHAPTER 11  Selecting a Quantitative Research Design 215

Box 11-1 Research Designs created to meet nursing needs should be congruent
with nursing philosophy. They must provide a means
Descriptive Study Designs for nurses to examine dimensions of nursing within a
Typical descriptive study designs holistic framework and to review those dimensions
Comparative descriptive designs over time. Designs must be developed that can seek
Time-dimensional designs: answers to important nursing questions rather than
Longitudinal designs answering only questions that can be examined by
Cross-sectional designs existing designs.
Trend designs Innovative design strategies are beginning to
Event-partitioning designs appear within nursing research. One example is the
Case study designs intervention research design described in Chapter
14. Developing designs to study the outcomes of
Correlational Study Designs
nursing actions is also important. The emerging
Descriptive correlational designs field of outcomes research in nursing is described in
Predictive designs Chapter 13. Nurse researchers must see themselves
Model-testing designs as credible scientists before they will dare to develop
Quasi-experimental Study Designs new design strategies to explore little-understood
aspects of nursing. To develop a new design, the
Nonequivalent comparison group designs:
researcher must carefully consider possible threats
One-group posttest-only design
to validity and ways to diminish them. Nurses must
Posttest-only design with comparison group
also be willing to risk the temporary failures that
One-group pretest-posttest design
are always inherent in the development of some-
Pretest and posttest design with a
thing new.
comparison group
Pretest and posttest design with two
comparison treatments Descriptive Study Designs
Pretest and posttest design with two
Descriptive study designs (see Box 11-1) are crafted
comparison treatments and a standard or
to gain more information about characteristics within
routine care group
a particular field of study. Their purpose is to provide
Pretest and posttest design with a removed
a picture of situations as they naturally happen. In
treatment
many aspects of nursing, a phenomenon must be
Pretest and posttest design with a reversed
clearly delineated before prediction or causality can
treatment
be examined. A descriptive design may be used to
Interrupted time-series designs:
develop theory, identify problems with current prac-
Simple interrupted time-series designs
tice, justify current practice, make judgments, or
Interrupted time-series design with a
determine what others in similar situations are doing.
no-treatment comparison group
Variables are not manipulated, and there is no treat-
Interrupted time-series design with multiple
ment or intervention. Dependent and independent
treatment replications
variables are not appropriate for use within a descrip-
Experimental Study Designs tive design, because the design involves no attempt to
Classic experimental design establish causality.
Experimental posttest-only comparison group Descriptive designs vary in levels of complexity.
design Some contain only two variables, whereas others may
Randomized block design have multiple variables. The relationships among vari-
Factorial design ables present an overall picture of the phenomenon
Nested design being examined, but examination of types and degrees
Crossover or counterbalanced design of relationships is not the primary purpose of a descrip-
Clinical trials tive study. Protection against bias (or threat to the
Randomized controlled trials validity) in a descriptive design is achieved through
(1) links between conceptual and operational defini-
tions of variables (Fawcett & Garity, 2009); (2) sample
selection and size (Aberson, 2010; Thompson, 2002);
(3) the use of valid and reliable instruments (Waltz,
216 UNIT TWO  The Research Process

CLARIFICATION MEASUREMENT DESCRIPTION INTERPRETATION

Description
Variable 1 of variable 1

Description
Variable 2 of variable 2
Phenomenon Interpretation
of interest of meaning
Description
Variable 3 of variable 3

Description Development
Variable 4
of variable 4 of hypotheses

Figure 11-1  Typical descriptive study design.

Strickland, & Lenz, 2010) or accurate and precise


biophysical measures (Ryan-Wenger, 2010); and (4) “Aim: This paper is a report of a study of the effects
data collection procedures that achieve some environ- of lateral turning on skin-bed interface pressures in
mental control (Bialocerkowski, Klupp, & Bragge, the sacral, trochanteric and buttock regions, and its
2010; Creswell, 2009; DeVon et al., 2007; Kerlinger effectiveness in unloading at-risk tissue.
& Lee, 2000). Design: This was a descriptive, observational study.
Data were collected from 15 healthy adults from a
Typical Descriptive Study Designs university-affiliated hospital. Mapped 24-inch ×
Figure 11-1 presents the commonly used descriptive 24-inch (2304 half-inch sensors) interface pressure
study design that examines characteristics of a single profiles were obtained in the supine position, fol-
sample. The design identifies a phenomenon of inter- lowed by lateral turning with pillow or wedge support
est and the variables within the phenomenon, develops and subsequent head-of-bed elevation to 30°.”
conceptual and operational definitions of the vari- (Peterson et al., 2010, pp. 1557-1558)
ables, and describes the variables. The description of “Results: Raising the head-of-bed to 30° in the
the variables leads to an interpretation of the theoreti- lateral position statistically significantly increased peak
cal meaning of the findings and provides knowledge interface pressures and total area ≥ 32 mm Hg. Com-
of the variables and the study population that can be paring areas ≥ 32 mm Hg from all positions, 93% of
used for future research in the area. participants had skin areas with interface pressures ≥
Most studies contain descriptive components; 32 mm Hg throughout all positions (60 ± 54 cm2),
however, the methodology of some studies is confined termed ‘triple jeopardy areas’. The triple jeopardy
to the typical descriptive design. This is a critically area increased statistically significantly with wedges as
important design for acquiring knowledge in an area compared to pillows (153 ± 99 cm2 vs. 48 ± 47 cm2,
in which little research has been conducted. Peterson, p < 0.05).
Schwab, van Oostrom, Gravenstein, and Caruso Conclusions: Standard turning by experienced
(2010) implemented a descriptive study design to intensive care unit nurses does not reliably relieve
examine the effects of various patient positions on the elevated skin-bed interface pressures as intended.
development of pressure in common areas such as the These areas of the body remain at risk for skin break-
sacrum and hips. Minimizing skin–support surface down, and help to explain why pressure ulcers occur
interface pressure is important in preventing and con- despite the implementation of standard preventive
trolling pressure ulcers, but the effects of standard measures. Support materials for maintaining lateral
patient repositioning on skin interface pressure has not turned positions can also influence tissue unloading
been clearly described. The study design and key and triple jeopardy areas.” (Peterson et al., 2010,
results are presented in the abstract, which is reprinted p. 1556)
in full:
CHAPTER 11  Selecting a Quantitative Research Design 217

A descriptive research design is appropriate when pressure ulcers; additionally, time, acuity of the
the current practice (that is, routine turning of patients) patient’s condition, and the availability of supportive
does not seem sufficient to alleviate the problem (risk equipment were barriers to the prevention of pressure
for pressure ulcers). To discover why traditional ulcers. The study focused on surveying nurses’ knowl-
nursing interventions have failed to eliminate the pres- edge of, attitudes toward, and perceived barriers to
sure ulcers on three at-risk areas of the body, Peterson opportunities for pressure ulcer prevention using a
et al. (2010) decided to explore the currently used questionnaire. A descriptive design was appropriate
techniques (pillows versus wedges) and objectively for identifying variables that might influence nursing
measure and describe the pressures that participants care of patients at risk for pressure ulcers in ICU
experienced using digital pressure sensors. This study settings.
involved no treatment and had one study group of Some descriptive studies obtain data from retro-
participants who were measured for pressures in the spective chart review. For example, Kline and Edwards
at-risk areas. (2007) conducted a chart review to describe the effec-
Some descriptive studies use questionnaires tiveness of intrapartum intravenous (IV) insulin on
(surveys) to describe an identified area of concern. For antepartum and intrapartum control of the mother’s
example, Strand and Lindgren (2010) used a descrip- diabetes and on the occurrence and severity of hypo-
tive design to study nurses’ knowledge, attitude, and glycemia in the neonate. Researchers measured and
barriers regarding preventing pressure ulcers in described the variables of intrapartum IV insulin, ante-
patients in intensive care units (ICUs). The following partum diabetic control, intrapartum diabetic control,
excerpt from the abstract describes the design of their and hypoglycemia in the neonate.
study: It is not uncommon for researchers using a descrip-
tive design to combine quantitative descriptive
methods and qualitative methods (mixed methods)
Background: “Pressure ulcer incidence varies between (Creswell, 2009). Chapter 10 includes a discussion of
1 and 56% in intensive care and prevention is an different types of mixed-methods approaches. To use
important quest for nursing staff. Critically ill patients this strategy, consult with a researcher experienced in
that develop pressure ulcers suffer from increased using qualitative methods or include this person as a
morbidity and mortality and also require prolonged research partner to appropriately collect, analyze, and
intensive care. interpret qualitative data.
Purpose: The aim of this study was to investigate Meghani and Keane (2007) used quantitative and
registered nurses’ and enrolled nurses’ (1) attitudes, qualitative methods in their study of preference
(2) knowledge, and (3) perceived barriers to oppor- for analgesic treatment in African-American cancer
tunities towards pressure ulcer prevention, in an ICU patients. The investigators used demographic data, the
setting. These are important aspects in the Theory of Brief Pain Inventory, and in-depth semi-structured
Planned Behaviour, a conceptual framework when interviews. Their sample of 35 patients was taken
trying to predict, understand, and change specific from three outpatient oncology clinics. Their study
behaviours. identified the major sources of anxiety described by
Method: The study is descriptive. Questionnaires this sample. The goal of this study was to improve our
were distributed to registered nurses and enrolled understanding of patients’ needs and assist in the
nurses in four ICUs in a Swedish hospital. development of specific interventions that might alle-
Results: The mean score regarding attitude was 34 viate their problems.
± 4. Correct categorization of pressure ulcers was
made by 46.8% of the nursing staff…. Pressure relief Comparative Descriptive Designs
(97.3%) and nutritional support (36.1%) were the The comparative descriptive design (Figure 11-2)
most frequently reported preventive measures. examines and describes differences in variables in two
Reported barriers were lack of time (57.8%) and or more groups that occur naturally in the setting.
severely ill patients (28.9%); opportunities were Descriptive statistics and inferential statistical analy-
knowledge (38%) and access to pressure relieving ses may be used to examine differences between or
equipment (35.5%).” (Strand & Lindgren, 2010, among groups. Commonly, the results obtained from
p. 335) these analyses are not generalized to a population
because the description is for a very specific sample
The results of this descriptive study indicated that and would not necessarily apply to a larger population.
nurses are lacking in comprehensive knowledge of An example of this design is the study by Cramer,
218 UNIT TWO  The Research Process

Group I
(variable[s] Describe
measured)

Comparison
of groups on Interpretation
select variables of meaning

Group II
Development
(variable[s] Describe
of hypotheses
measured)

Figure 11-2  Comparative descriptive design.

Chen, Roberts, and Clute (2007) of the social and Using a comparative descriptive design, Cramer
economic impact of community-based prenatal care. and colleagues (2007) described the variables inci-
The abstract for this study, which is reprinted in full, dence of case management, home visits, screening,
describes the focus, design, and major findings: referral, transportation, and health education, as well
as the outcomes low birth weight, infant mortality,
adequacy of care, trimester of care, and costs of care
“Objective: This article describes the evaluation and in three groups (OHS birth mothers, non-OHS birth
findings of a community-based prenatal care program, mothers, and Douglas County birth mothers) yearly
Omaha Healthy Start (OHS), designed to reduce local for 3 years. The results of the study were comparisons
racial disparities in birth outcome. across the 3 years and among the three groups.
Design: This evaluative study used a comparative
descriptive design, and Targeting Outcomes of Pro- Time-Dimensional Designs
grams was the conceptual framework for evaluation. Time-dimensional designs were developed within
Sample: The evaluation followed 3 groups for 2 years: the discipline of epidemiology, a field that studies the
OHS birth mothers (N = 79; N = 157); non-OHS occurrence and distribution of disease among popula-
participant birth mothers (N = 746; N = 774); and tions. These designs examine trends over time, growth,
Douglas County birth mothers (N = 7,962; N = or sequences and patterns of change. The dimension
7,987). of time, then, becomes an important factor. Within the
Measurement: OHS provided case management, field of epidemiology, the samples in time-dimensional
home visits, screening, referral, transportation, and studies are called cohorts. Originally, cohorts were
health education to participants. Program outcome age categories; however, the concept has been
measures included low birth weight, infant mortality, expanded to apply to groups distinguished by many
adequacy of care, trimester of care, and costs of care. other variables. Other means of classifying popula-
Results: OHS birth outcomes improved during year tions that have relevance in relation to time are time
2, and there was a 31% cost saving in the average of diagnosis, point of entry into a treatment protocol,
hospital expenditure compared with the nonpartici- point of entry into a new lifestyle, and age at which
pant groups. Preliminary evaluative analysis indicates the subject started smoking. An understanding of tem-
that prenatal case management and community out- poral sequencing is an important prerequisite to exam-
reach can improve birth outcomes for minority ining causality between variables. Thus, the results of
women, while producing cost savings. these designs lead to description of trends, processes,
Conclusions: Further prospective study is needed to patterns, and changes over time as well as the develop-
document trends over a longer period of time regard- ment of hypotheses, and are often forerunners of
ing the relationship between community-based case experimental designs (Fawcett & Garity, 2009).
management programs for minority populations, Epidemiological studies that use time-dimensional
birth outcomes, and costs of care.” (Cramer et al., designs determine the risk factors or causal factors of
2007, p. 329) illness states. Cause determined in this manner is
called inferred causality (Kerlinger & Lee, 2000).
CHAPTER 11  Selecting a Quantitative Research Design 219

Time 1 Time 2 Time 3 Time 4 Time..n

measure measure measure measure measure


variables variables variables variables variables
Figure 11-3  Longitudinal design.

Sample 1 Sample 1 Sample 1 Sample 1 Sample 1

These studies also examine trends, patterns, and before the health situation occurred. These patterns
changes over time. The best-known studies in this area then influence the person’s responses to nursing inter-
are those on smoking and cancer. Because of the ventions. Several designs are used to conduct time-
strength of studies that have undergone multiple rep- dimensional studies: longitudinal, cross-sectional,
etitions, the causal link is strong. The strategy is not trend, and event or treatment partitioning. These
as powerful as experimental designs in supporting designs are discussed in the following sections.
causality; however, in this situation, as in many
nursing contexts, one can never ethically conduct a Longitudinal Designs
true experiment. A true experiment requires that there Longitudinal designs examine changes in the same
be an experimental group (who would not smoke) and subjects over time. They are sometimes called panel
a control group (who smoke). The participants must designs (Figure 11-3). Longitudinal designs are expen-
be randomly assigned to one of these groups. There- sive and require a long period of researcher and subject
fore, without being provided a choice, some individu- commitment. The area to be studied, the variables, and
als would be required to smoke and others would be their measurement must be clearly identified before
required to abstain from smoking over a long period. data collection begins. Measurement must be carefully
Epidemiologists use two strategies to examine planned and implemented because the measures will
changes over time: retrospective studies and prospec- be used repeatedly over time. If children are being
tive studies. The norm in epidemiological studies is to studied, the measures must be valid for all the ages
use the word cohorts to refer to groups of subjects in being studied. To use this design, researchers must be
prospective studies, but the term is generally not used familiar with how the construct being measured
in retrospective studies. In retrospective studies, both changes and its patterns and trends over time. In addi-
the proposed cause and the proposed effect have tion, they need to provide a clear rationale for the
already occurred. For example, the subjects could points of time they have selected for measurement.
have a specific type of cancer, and the researcher could There is often a bias in selection of subjects because
be searching for commonalities among subjects that of the requirement for a long-term commitment. Indi-
may have led to the development of that type of viduals participating in a study conducted over long
cancer. In a prospective cohort study, causes may periods might differ in some important ways from the
have occurred, but the proposed effect has not. target population. In addition, attrition or loss of sub-
The Framingham study is the best-known example jects from the study can be high and can decrease the
of a prospective study (U.S. Department of Health and validity of findings.
Human Services, 1968). In this study, researchers The sample size calculated with power analysis
monitored members of a community for 20 years and needs to take into consideration the potential attrition
examined variables such as dietary patterns, exercise, rate when determining the final number of subjects to
weight, and blood lipid levels. As the subjects experi- recruit. As a researcher, you must invest considerable
enced illnesses, such as heart disease, hypertension, energy in developing effective strategies to maintain
and lung disease, their illnesses could be related to the sample (see Chapter 15). The period during which
previously identified variables. subjects will be recruited into the study must be care-
Prospective studies are considered more powerful fully planned, and a timeline depicting data collection
than retrospective studies in inferring causality, points for each subject must be developed to enable
because the researcher can demonstrate that the risk planning for the numbers and availability of data col-
factors occurred before the illness and are positively lectors. If this issue is not carefully thought out, data
related to the illness. Both designs are important for collectors may be confronted with the need to recruit
use in nursing studies, because a person’s responses new subjects while they are attempting to collect data
to health situations are patterns that developed long scheduled for subjects recruited earlier. You must also
220 UNIT TWO  The Research Process

decide whether you will use a single data collector to


obtain all data from a particular subject or whether you Relevance to Clinical Practice: Understanding illness
will use a different data collector at each point to representation in patients with traumatic injury may
ensure that data are collected blindly. help nurses to provide anticipatory guidance and to
Because of the large volumes of data acquired in a design nursing interventions before and after hospital
longitudinal study, you must give careful attention to discharge, ultimately to improve health outcomes of
strategies for managing the data. The repetition of those patients.” (Lee et al., 2010, p. 556)
measures requires that data analysis be carefully
thought through. Analyses commonly used are
repeated measures analyses of variance, multivariate Cross-Sectional Designs
analyses of variance (MANOVA), regression analysis, Cross-sectional designs examine groups of subjects
cluster analysis, and time-series analysis (see Chapters in various stages of development, trends, patterns, and
24 and 25) (Corty, 2007; Munro, 2005). changes simultaneously with the intent to describe
Lee, Chaboyer, and Wallis (2010) conducted a changes in the phenomenon across stages (see Figure
descriptive study using a longitudinal cohort design. 11-4). The assumption is that the stages are part of a
This study was conducted to describe the perceptions
and physical manifestations of injury and illness of
patients with traumatic injury and to examine the Time 1
changes they experienced over time. The following measure
abstract from the study demonstrates the background, variables
longitudinal design, key results, conclusions, and
implications for practice: Sample 1
Immediate Loss

“Background: Traumatic injury has attracted global Time 1


concern because it is the major reason for death and measure
disability in people under 45 years old. One model, variables
the Common Sense Model of Illness Representation
(CSMIR), has the potential to help individuals adjust Sample 2
Loss 6 mo
to changes in health status such as traumatic injury.
Design: Longitudinal study design.
Methods: This study was conducted using data col- Time 1
lected prior to hospital discharge and at three and six measure
months after hospital discharge. One individual ques- variables
tion form and the Chinese Illness Perception Ques-
tionnaire Revised (IPQ-R) (Trauma) were used to Sample 3
Loss 1 yr
collect demographic data, clinical data, and illness
representations.
Results: A total of 114 participants completed Time 1
the survey three times. The overall response rate measure
was 79.7%. Six subscales of the Chinese IPQ-R variables
(Trauma)… identity, emotional representations, con-
sequences, controllability, illness coherence, and Sample 4
causes… changed significantly over time. Two sub- Loss 2 yr
scales, Timeline (acute/chronic) and Timeline Cycli-
cal, did not change significantly. Time 1
Conclusions: Based on these findings, there may be
measure
a window of opportunity to provide appropriate variables
interventions to individuals with traumatic injury at
each time point. The results of this study have impli- Sample 5
cations for nursing practice and further nursing Loss 5 yr
research.
Figure 11-4  Cross-sectional design.
CHAPTER 11  Selecting a Quantitative Research Design 221

process that will progress over time. Selecting subjects


at various points in the process provides important outcomes included satisfaction with care, functional
information about the totality of the process, even status, symptom resolution, and sense of well-being,
though the same subjects are not monitored through which were measured with established instruments.
the entire process. The processes of development The two groups of patients were equivalent in terms
selected for the study might be related to age, position of their demographic profile and severity of condition.
in an educational system, growth pattern, or stages of The results indicated that patients who received
maturation or personal growth (if they could be clearly ACNP care, as compared to those who did not,
enough defined that criteria could be developed for reported higher levels of satisfaction with care and of
inclusion within differentiated groups or disease physical, psychological, and social functioning. These
stages). Subjects are then categorized by group, and findings provide preliminary evidence supporting the
data on the selected variables are collected at a single contribution of ACNPs to high quality care. However,
point in time. the small sample size limits the generalizability of the
For example, suppose you wish to study grief reac- study findings.” (Sidani et al., 2007, p. 1)
tions at various periods after the death of a spouse.
With a cross-sectional design, you could study a group
of individuals whose spouses had died 1 week ago, Trend Designs
another group composed of individuals whose losses Trend designs examine changes in the general popu-
occurred 6 months ago, and other groups whose losses lation in relation to a particular phenomenon (see
occurred 1 year, 2 years, and 5 years ago (see Figure Figure 11-5). The researchers select different samples
11-4). You could study all of these groups during one of subjects from the same population at preset inter-
period of time, but you could describe a pattern of vals of time, and at each selected time, they collect
grief reactions over a 5-year period. The design is not data from that particular sample. Researchers need to
as strong as the longitudinal design, in which the same be able to justify generalizing from the samples to the
participants continue in the study over time, thus elim- population under study. Analysis involves strategies to
inating some variance, but it allows some understand- predict future trends by examining past trends. Harris,
ing of the phenomenon over time when time allowed Gordon-Larsen, Chantala, and Udry (2006, p. 74) used
for the study is limited. a trend design to describe “longitudinal trends in race/
Sidani et al. (2007) conducted a cross-sectional ethnic disparities in 20 leading health indicators from
study titled “Outcomes of Nurse Practitioners in Acute Healthy People 2010 [U.S. Department of Health and
Care: An Exploration.” The following abstract Human Services, 2000] across multiple domains from
describes the design of their study: adolescence to young adulthood.” These researchers
examined the study trends in an ethnically diverse,
national database, and their study design is described
in the following excerpt.
“The purpose of this study was to compare the out-
comes achieved by adult patients who did (n = 78)
and did not (n = 45) receive care by acute care nurse
practitioners (ACNPs), within one week following “Design, Setting, and Participants: Nationally represen-
discharge. A comparative, cross-sectional design was tative data for more than 14,000 adolescents enrolled
used. Consenting patients completed the outcome in wave I (1994-1995) or wave II (1996) of the
measures within one week following discharge. The National Longitudinal Study of Adolescent Health

Time 1 Time 2 Time 3 Time 4 Time..n

measure measure measure measure measure


variables variables variables variables variables PREDICTION

Sample 1 Sample 2 Sample 3 Sample 4 ...n

Figure 11-5  Trend design.


222 UNIT TWO  The Research Process

Time 1
Key event 1
Sample 1

Time 2
Key event 2
Sample 2

Time 3
Key event 3
Sample 3

Time..n
Merger of data for analysis
Key event 4 and interpretation of meaning
Sample..n

Figure 11-6  Cross-sectional study with treatment partitioning.

in some cases to enlarge sample size and to avoid the


(Add Health) were followed up into adulthood (wave effects of history on the validity of findings. Cook and
III; 2001-2002). We fit longitudinal regression models Campbell (1979) referred to these as cohort designs
to assess and contrast the trend in health indicators with treatment partitioning. Figure 11-6 shows a
among racial/ethnic groups of adolescents as they model of the cross-sectional study design with treat-
transition into adulthood…. ment partitioning, and Figure 11-7 provides the model
Results: Diet, inactivity, obesity, health care access, of a longitudinal design with treatment partitioning.
substance use, and reproductive health worsened The term treatment is used loosely here to mean a key
with age. Perceived health, mental health, and expo- event that is thought to lead to change. In a descriptive
sure to violence improved with age. On most health study, the researcher would not cause or manipulate
indicators, white and Asian subjects were at the the key event but rather would clearly define it so that
lowest risk and Native American subjects at the when it occurred naturally, it would be recognized.
highest risk. Although white subjects had more favor- For example, you could use the event-partitioning
able health in adolescence, they experienced the design to study subjects who have completed pro-
greatest declines by young adulthood. No single race/ grams to stop smoking. Smoking behaviors and
ethnic group consistently leads or falters in health incidence of smoking-related diseases might be mea-
across all indicators.” (Harris et al., 2006, p. 74) sured at intervals of 1 year for a 5-year period.
However, the number of subjects available at one time
might be insufficient for you to adequately analyze
findings. Therefore, you could use subjects from
several programs offered at different times. You would
Harris et al. (2006) found the trend design to be an examine the data in terms of the relative time since
effective way to examine health indicators of Ameri- the subjects’ completion of the stop-smoking program,
cans over time. They noted for 15 of 20 indicators that not the absolute length of time. Data would be assumed
the health risk increased and access to health care to be comparable, and a larger sample size would be
decreased from teen to adult years for most Ameri- available for analysis of changes over time.
cans. The health indicators varied over time by gender Sutton’s (2007) dissertation described a study to
and race/ethnicity, causing the health disparities to examine the relationship of preoperative education for
fluctuate over time. the aging adult and anxiety. Most individuals experi-
ence anxiety in anticipation of surgery, and they expect
Event-Partitioning Designs education and support to help alleviate their anxiety
A merger of the cross-sectional or longitudinal and prior to entering the operating room. Because a
trend designs, the event-partitioning design, is used growing number of surgical procedures are being
CHAPTER 11  Selecting a Quantitative Research Design 223

Time 1 Time 2 Time 3 Time 4


Key event 1
Sample 1 Sample 1 Sample 1 Sample 1

Time 1 Time 2 Time 3 Time 4


Key event 2
Sample 2 Sample 2 Sample 2 Sample 2

Time 1 Time 2 Time 3 Time 4


Key event 3
Sample 3 Sample 3 Sample 3 Sample 3

Merger of data
for analysis and
interpretation of
meaning

Figure 11-7  Longitudinal design with treatment partitioning.

conducted on an outpatient basis (day surgery), there Case Study Designs


is limited time for healthcare personnel to provide The case study design involves an intensive explora-
psychological preparation of patients for the periop- tion of a single unit of study, such as a person, family,
erative process. Sutton used an event-partitioning group, community, or institution, or of a small number
design and correlational analysis to examine the rela- of subjects. Although the number of subjects tends to
tionship between education and the state anxiety expe- be small, the number of variables involved is usually
rienced by aging adults in the preoperative setting. large. In fact, it is important to examine all variables
Quantitative data were collected using the Visual that might have an impact on the situation being
Analog Scale (VAS) to measure state anxiety in a pre- studied.
test and post-test format, with treatment consisting of Case studies were commonly used in nursing
a scripted preoperative educational presentation. research in the 1970s. Their use then declined, but
Patients scheduled for general anesthesia for a sur- they are beginning to appear in the literature more
gical procedure in two acute care facilities in southern frequently today. Well-designed case studies are good
West Virginia were asked to participate in this study sources of descriptive information and can be used as
over a 4-week time frame. The sample included 52 evidence for or against theories. Case studies can use
pre-surgical patients, ages 65 to 94 years, who were a mixed-methods approach, incorporating both quan-
asked to participate in the study. Participants were titative and qualitative methods (Creswell, 2009;
asked to score their state anxiety on the VAS prior to Fawcett & Garity, 2009). Sterling and McNally (1992)
the scripted educational presentation to establish a recommended single-subject case studies for examin-
baseline anxiety level. State anxiety is the emotion a ing process-based nursing practice. This strategy
person experiences in a particular situation, versus allows the researcher to investigate daily observations
trait anxiety, which is the innate anxiety of a person. and interventions that are a common aspect of nursing
Upon completion of this presentation, the participants practice.
were given an opportunity to ask questions and receive Case studies also can demonstrate the effectiveness
answers. They were then asked to indicate their state of specific therapeutic techniques. In fact, by reporting
anxiety on the VAS. The study results indicated that a case study, the researcher introduces the technique
75% of the study participants reported a decrease in to other practitioners. The case study design also has
their state anxiety levels following the preoperative potential for revealing important findings that can gen-
educational presentation. This intervention requires erate new hypotheses for testing. Thus, the case study
further testing using a quasi-experimental study design can lead to the design of large sample studies to
but has the potential to reduce state anxiety in indi- examine factors identified through the case study. For
viduals experiencing day surgery (Sutton, 2007). example, Sprague and Chang (2011) used a single
224 UNIT TWO  The Research Process

subject case study design to examine the effect of into a coherent whole is a difficult but critical compo-
acupuncture on the treatment of chronic pain. Their nent of the study (Fawcett & Garity, 2009). General-
study abstract identifies the key elements of their izing study findings in the statistical sense is not
study: appropriate; however, generalizing the findings to
theory is appropriate and important (Crombie &
Davies, 1996; Gray, 1998; Sandelowski, 1996).
“Background: Chronic complex regional pain syn- Not all case studies are research. Many of the arti-
drome (CRPS) is a chronic pain conduction that leads cles referring to case studies are clinical practice arti-
to sympathetic nervous system involvement and cles, in which a clinical situation is reported for the
trophic changes. purpose of illustrating clinical practice, problems in
Objective: This study describes the use of acupunc- clinical practice, or changes that need to be made in
ture in a case study of CRPS. clinical practice. These articles do not use research
Design, Setting, and Patient: This is a single case methods but, rather, describe events out of the patient
report of a 34-year-old patient diagnosed with CRPS. record or the writer’s personal experience.
Intervention: Acupuncture treatment including
acupoints along the Gallbladder, Liver, Spleen, Heart,
and Kidney meridians. Self-treatment plan included a Surveys
laser acupuncture pen device and disposable press The term survey is used in two ways within scientific
needles. thought. It is used in a broad sense to mean any
Main Outcome Measures: Beck Depression Inven- descriptive or correlational study; in this sense, survey
tory (BDI), McGill Pain Questionnaire, and Sheehan tends to mean nonexperimental (Kerlinger & Lee,
Disability Scale (SDS). 2000). In a narrower sense, the term is used to describe
Results: The patient reported a decrease in pain a data collection technique in which the researcher
levels, depression, and an improved quality of life. uses questionnaires (collected by email, by mail, or in
Pretreatment SDS score of 17, a 12 on the BDI, and person) or personal interviews to gather data about an
a 67 on the McGill Pain Questionnaire. Post-treatment identified population.
SDS decreased to 4, her BDI went to 0, and her Surveys, in the narrower definition, are used to
McGill Pain Questionnaire decreased to a 10.” gather data that can be acquired through self-report.
(Sprague & Change, 2011, p. 67) Because of this limitation in data, some researchers
view surveys as rather shallow and as contributing in
Sprague and Chang (2011) noted that this patient a limited way to scientific knowledge. This belief has
had dramatic improvements in depression, disability, led to a bias in the scientific community against survey
and pain scores over the 6 months of the study. Thus, research. In this context, the term survey is used deri-
this case study justifies conducting further clinical sively. However, surveys can be an extremely impor-
studies to determine the effectiveness of acupuncture tant source of data. In this text, we use the term survey
in the management of patients with CRPS. They rec- to designate a data collection technique, not a design.
ommended conducting studies with larger samples Surveys can be used within many designs, including
and randomized controlled treatment designs. descriptive, correlational, and quasi-experimental
How you design a case study depends on the cir- studies.
cumstances of the case but usually includes an element
of time. History and previous behavior patterns are
usually explored in detail. As the case study proceeds, Correlational Study Designs
you may become aware of components important to Correlational study designs examine relationships
the phenomenon being examined that were not origi- among variables. The examination can occur at several
nally built into the study. A case study is likely to have levels of the independent variable. The researcher can
both quantitative and qualitative elements; and if the seek to describe a relationship, predict relationships
study incorporates both of these components, the among variables, or test the relationships proposed by
study design must clearly present this fact (Creswell, a theoretical proposition or a model. In any correla-
2009). Methods used to analyze and interpret qualita- tional study, a representative sample must be selected
tive data need to be carefully planned. Consultation for the study. That sample reflects the full range of
with a qualitative researcher can strengthen the study. values possible on the variables being measured.
Large volumes of data are generally obtained during Thus, large samples are required. In correlational
a case study. Organizing the findings of a case study designs, a large variance in the variable values is
CHAPTER 11  Selecting a Quantitative Research Design 225

necessary to determine the existence of a relationship. correlational study, the relationship examined is
Therefore, correlational designs are unlike experimen- between or among two or more research variables
tal designs, in which variance in variable scores is within an identified situation. Thus, the sample is not
controlled by controlling such design elements as the separated into groups. Analyses examine variable
study setting, sampling criteria, and sampling method values in the entire sample. In a correlational design,
(Kerlinger & Lee, 2000). data from the entire sample are analyzed as a single
In correlational designs, if the range of scores is group (Grove, 2007; Kerlinger & Lee, 2000).
truncated, the obtained correlational value will be arti-
ficially depressed. Truncated means that the lowest Descriptive Correlational Designs
values and the highest values for a variable either are A descriptive correlational design examines the rela-
not measured or are condensed and merged with less tionships that exist in a situation. Using this design
extreme values. For example, if an attitude scale were facilitates the identification of many interrelationships
scored from a low score of 1 to a high score of 50, in a situation in a short time. Although the descriptive
truncated scores might indicate only scores in the design discussed earlier may reveal relationships
range 10 to 40. More extreme scores would be com- among variables, the descriptive correlational design
bined with scores within the designated range. If trun- focuses specifically on relationships among study
cation is performed, the researcher may not find a variables. Descriptive correlational studies may lead
correlation when the variables are actually correlated. to hypotheses for later studies. Figure 11-8 provides a
Neophyte researchers tend to make two serious model of a typical descriptive correlational design
errors with correlational studies. First, they often for examining a relationship between two research
attempt to establish causality by correlation, reasoning variables. This design can be expanded to include
that if two variables are related, one must cause the examination of relationships among several study
other. Second, they confuse studies in which differ- variables.
ences are examined with studies in which relation- A descriptive correlational study may examine
ships are examined. Although the existence of a variables in a situation that has already occurred or is
difference assumes the existence of a relationship, the currently occurring. No attempt is made to control or
design and statistical analysis of studies examining manipulate the situation. As with descriptive studies,
differences are not the same as those of studies exam- variables must be clearly identified and defined. An
ining relationships. If your study examines two or example of a descriptive correlational design is the
more groups in terms of one or more variables, then study by Bailey, Sabbagh, Loiselle, Boileau, and
you are exploring differences between or among McVey (2010, p. 114) titled “Supporting families in
groups as reflected in scores on the identified the ICU: A descriptive correlational study of informa-
variables. If your study examines a single group in tional support, anxiety, and satisfaction with care.”
terms of two or more variables, then you are exploring The researchers conducted this study to describe
relationships between or among variables. In a family members’ perceptions of informational support,

MEASUREMENT

Research
variable Description Interpretation
1 of variable of meaning

Examination
of relationship

Research
Description Development
variable
of variable of hypotheses
2

Figure 11-8  Descriptive correlational design.


226 UNIT TWO  The Research Process

Predicted
Value of Value of
Value of Value of
+ Independent + Independent =
Intercept Dependent
Variable 1 Variable 2
Variable

Figure 11-9  Predictive design.

anxiety, and satisfaction with care and to examine the relationships among these three variables were deter-
relationships among these variables. The design for mined using Pearson’s product moment correlational
this study is described in the following excerpt from coefficient (see Chapter 23).
its abstract:
Predictive Designs
“Methodology/Design: This cross-sectional descriptive Predictive designs are used to predict the value of one
correlational pilot study collected data from a conve- variable on the basis of values obtained from another
nience sample of 29 family members using self-report variable or variables. Prediction is one approach you
questionnaires. can use to examine causal relationships between or
Setting: 22-bed medical-surgical intensive care unit among variables. Because causal phenomena are
of 659-bed University affiliated teaching hospital in being examined, the terms dependent and independent
Montreal, Quebec, Canada. are used to describe the variables. One variable (the
Results: Mean informational support, assessed with one to be predicted) is classified as the dependent
a modified version of the CCFNI [Critical Family variable, and all other variables (those that are predic-
Needs Inventory]…, was 55.41 (SD = 13.28; theoreti- tors) are classified as independent variables.
cal range of 20-80). Mean anxiety, assessed with the The aim of a predictive design is to predict the level
State Anxiety Scale (Spielberger et al., 1983) was of the dependent variable from the independent vari-
45.41 (SD = 15.27; theoretical range 20-80). Mean ables. Figure 11-9 is a model of a predictive design
satisfaction with care… was 83.09 (SD = 15.49; theo- with two independent variables used to predict the
retical range 24-96). A significant positive correlation dependent variable. Independent variables most effec-
was found between informational support and satis- tive in prediction are highly correlated with the depen-
faction with care (r = 0.741, p < 0.001). No significant dent variable but not highly correlated with other
relationships were noted between informational independent variables used in the study. Predictive
support and anxiety or between satisfaction with care designs require you to develop a theory-based math-
and anxiety.” (Bailey et al., 2010, p. 114) ematical hypothesis proposing the independent vari-
ables that are expected to predict the dependent
variable effectively. You can then test the hypothesis
By implementing a descriptive, correlational using regression analysis (see Chapter 24) (Corty,
research design, Bailey et al. (2010) were able to 2007; Munro, 2005). Predictive studies are also used
describe their study variables and determine relation- to establish the predictive validity of measurement
ships among them. The ultimate objective of the scales.
researchers was to further refine a local informational Mancuso (2010) conducted a correlational study
support initiative for families with members in the with a cross-sectional predictive correlational design
intensive care unit. Thus, this research provided the to examine the impact of health literacy and patient
basis for development of an intervention that might be trust on glycemic control in diabetic adults. The inde-
tested in future quasi-experimental or experimental pendent variables of patient trust, health literacy,
studies. knowledge of diabetes, performance of self-care activ-
This study had a descriptive correlational design, ities, and depression were used to predict the depen-
as evidenced by the single study group, the absence dent variable of glycosylated hemoglobin concentration
of treatment, and the use of descriptive and correla- (HbA1c). Regression analysis was conducted to deter-
tional statistical techniques to analyze study data. The mine how effective the independent variables were in
study variables informational support, anxiety, and predicting the dependent variable of HbAlc. The fol-
satisfaction with care were described with means, lowing except from the abstract describes the study
standard deviations, and ranges (see Chapter 22). The design, results, and conclusions:
CHAPTER 11  Selecting a Quantitative Research Design 227

EXOGENOUS ENDOGENOUS
VARIABLES VARIABLES

variable
1
CAUSAL
CORRELATIONS

NONCAUSAL variable variable variable


CORRELATIONS 2 4 5

a b
variable
3

RESIDUAL
VARIABLES

Figure 11-10  Model-testing design.

is required. All the paths expressing relationships


“A quantitative study was conducted that examined between concepts are identified, and a conceptual map
health literacy and patient trust as predictors of gly- is developed (see Figure 11-10). The analysis deter-
cemic control. The related factors of demographic, mines whether or not the data are consistent with the
socioeconomic status, diabetes knowledge, self-care model. For some studies, you might set aside data
activities, and depression were also considered. from half of the subjects and not include them in the
Implementing a cross-sectional, predictive design, a initial path analysis. You might use these data from
convenience sample of 102 patients with diabetes was the second half of the subjects to test the fit of the
recruited from two urban primary care clinics in the paths defined by the initial analysis.
USA. A simultaneous multiple regression was con- Variables are classified into three categories: exog-
ducted. The regression analysis was significant, with enous variables, endogenous variables, and residual
patient trust and depression accounting for 28.5% of variables. Exogenous variables are within the theo-
the variance in HbA1c.” (Mancuso, 2010, p. 94) retical model but are caused by factors outside this
model. Endogenous variables are those whose varia-
Mancuso (2010) reported that patient trust and tion is explained within the theoretical model. Exog-
depression were important factors that significantly enous variables influence the variation of endogenous
predicted HbA1c (R2 = 0.320; R2adj = 0.285; F(5, 96) variables. Residual variables indicate the effect of
= 9.047; p < 0.05). However, knowledge of diabetes, unmeasured variables not included in the model.
health literacy, and self-care activities was not a sig- These variables explain some of the variance found in
nificant predictor of glycemic control. She recom- the data but not the variance within the model (Mason-
mended further research examining depression and Hawkes & Holm, 1989; Norris, 2005a).
patient trust as predictors of glycemic control and In Figure 11-10, the illustration of a model-testing
additional studies to explore other influences on or design, paths are drawn to demonstrate directions of
barriers to glycemic control. Mancuso’s implementa- cause and effect. The arrows (paths) from the exoge-
tion of a predictive correlational design and conduct nous variables 1, 2, and 3 lead to the endogenous
of regression analysis were appropriate to address the variable 4, indicating that variable 4 is theoretically
study purpose and research questions. proposed to be caused by variables 1, 2, and 3. The
arrow (path) from endogenous variable 4 to endoge-
Model-Testing Designs nous variable 5 indicates that variable 4 theoretically
Some studies are designed specifically to test the accu- causes variable 5.
racy of a hypothesized causal model. The model- To measure exogenous and endogenous variables,
testing design requires that all variables relevant to you would collect data from the subjects and analyze
the model be measured. A large, heterogeneous sample the accuracy of the proposed paths. Historically, these
228 UNIT TWO  The Research Process

analysis procedures were performed with a series of


regression analyses. Researchers now conduct statisti- development, opportunity for nurse-to-nurse col-
cal procedures that have been developed specifically laboration, and staffing and support services. Increased
for path analysis using the computer programs LISREL emotional exhaustion led to less reported research
and EQS (Norris, 2005a). Structural equation model- utilization and higher rates of patient and nurse
ing is a commonly used statistical procedure (Norris, adverse events. Nurses working in contexts with
2005b). Path coefficients are calculated that indicate more positive culture, leadership, and evaluation also
the effect that one variable has on another. The amount reported significantly more research utilization, staff
of variance explained by the model, as well as the fit development, and lower rates of patient and staff
between the path coefficients and the theoretical adverse events than did nurses working in less posi-
model, indicates the accuracy of the theory. Variance tive contexts (i.e., those that lacked positive culture,
that is not accounted for in the statistical analysis is leadership, or evaluation).
attributed to residual variables (variables a and b) not Conclusion: The findings highlight the combined
included in the analyses (Mason-Hawkes & Holm, importance of culture, leadership, and evaluation to
1989; Norris, 2005a). increase research utilization and improve patient
An example of this design is the Cummings, safety. The findings may serve to strengthen the
Estabrooks, Midodzi, Wallin, and Hayduk (2007) PARIHS framework and to suggest that, although it is
study testing a model of the influence of organiza- not fully developed, the framework is an appropriate
tional characteristics and context on research utiliza- guide to implement research into practice.”
tion in nursing. The following study abstract identifies (Cummings et al., 2007, S24)
the study purpose, design, results, and conclusions:

Defining Therapeutic
“Background: Despite three decades of empirical
investigation into research utilization and a renewed Nursing Interventions
emphasis on evidence-based medicine and evidence- In quasi-experimental and experimental studies, an
based practice in the past decade, understanding of intervention (or protocol) is developed that is expected
factors influencing research uptake in nursing remains to result in differences in posttest measures of the
limited. There is, however, increased awareness that treatment and control or comparison groups. This
organizational influences are important. intervention may be physiological, psychosocial, edu-
Objectives: To develop and test a theoretical model cational, or a combination of these and should be
of organizational influences that predict research uti- designed to maximize the differences between the
lization by nurses and to assess the influence of groups. Thus, it should be the best intervention pos-
varying degrees of context, based on the Promoting sible in the circumstances of the study and should be
Action on Research Implementation in Health Ser- expected to improve the outcomes of the experimental
vices (PARIHS) framework, on research utilization group (Egan, Snyder, & Burns, 1992; Forbes, 2009;
and other variables. Santacroce, Maccarelli, & Grey, 2004).
Methods: The study sample was drawn from a Over the last 5 years, the nursing literature has
census of registered nurses working in acute care included a growing number of publications focused
hospitals in Alberta, Canada, accessed through their on the methodology for designing interventions
professional licensing body (n = 6,526 nurses; 52.8% for nursing studies (Morrison et al., 2009; Wyatt,
response rate). Three variables that measured Sikorskii, Rahbar, Victorson, & Adams, 2010; Yamada,
PARIHS dimensions of context (culture, leadership, Stevens, Sidani, Watt-Watson, & Silva, 2010). In addi-
and evaluation) were used to sort cases into one of tion, descriptions of nursing interventions in published
four mutually exclusive data sets that reflected less studies have more detail and specificity but still not at
positive to more positive context. Then, a theoretical the level given to describing measurement instruments
model of hospital- and unit-level influences on (Fawcett & Garity, 2009; Waltz et al., 2010). Thus,
research utilization was developed and tested, using nurse researchers provide detailed information about
structural equation modeling, and 300 cases were measurement but often do not provide sufficient detail
randomly selected from each of the four data sets. to allow a nurse to implement a nursing intervention
Results: Hospital characteristics that positively as it was used in a published nursing study. To some
influenced research utilization by nurses were staff extent, this situation may reflect the state of knowl-
edge in the nursing field regarding the provision of
CHAPTER 11  Selecting a Quantitative Research Design 229

nursing interventions in clinical practice. Many clini- range of knowledge, skill, and urgency of the inter-
cal nursing interventions are not well defined; thus, ventions (Bulechek et  al., 2008).
each nurse may use her or his own terminology to The interventions in the NIC have been subjected
describe a particular intervention. In addition, an inter- to multiple studies examining the effects on different
vention tends to be applied differently in each case by populations and the effects of varying degrees of
a single nurse and even less consistently by different intensity. The 5th edition of the Nursing Interventions
nurses. However, the quality of nursing interventions Classification, developed by faculty at the University
has been greatly enhanced with the development of of Iowa, included 542 research-based interventions
the Nursing Interventions Classification by a team of (Bulechek et al., 2008). NIC development continues
nurses at the University of Iowa. through the Center for Nursing Classification & Clini-
cal Effectiveness located at the University of Iowa,
The Nursing Interventions Classification and you can email them with questions (classification-
The Nursing Interventions Classification (NIC) is a center@uIowa.edu/; see Chapter 14 for more details
standardized language used to describe interventions on NIC).
or treatments performed by nurses in research and Currently, studies are being conducted to determine
practice. Each intervention consists of a label, a defini- the outcomes of each intervention and to establish
tion, and a set of activities performed by nurses car- links between the intervention and outcomes at varying
rying out the intervention. The NIC was initiated by points in time after the intervention has been imple-
the University of Iowa in Iowa City, IA, in 1987 (NIC, mented. Outcomes that occur immediately following
2011). The intervention labels developed over the last the intervention are easiest to determine. However, the
20 years were derived from nursing education and most important outcomes may be those that occur after
practice. The research to develop the NIC was initi- a client has been discharged or several weeks or
ated in 1987 and progressed through four phases that months after the intervention. Table 11-1 provides
overlapped in time: “Phase I: Construction of the Clas- some of the most current examples of the research
sification (1987-1992); Phase II: Construction of the related to the NIC and the Nursing Outcomes Classi-
Taxonomy (1990-1995); Phase III: Clinical Testing fication (NOC) being conducted nationally and inter-
and Refinement (1993-1997); and Phase IV: Use and nationally. This information is critical for ensuring the
Maintenance (1996-ongoing)” (Bulechek, Butcher, & quality of care provided by nurses and justifying
Dochterman, 2008, p. 5). The research methods used nursing actions in a cost-conscious market (Doran,
to develop the classification included content analysis, 2011). For a more extensive discussion of the impor-
surveys, focus groups, similarity analysis, and hierar- tance of linking interventions with outcomes mea-
chical clustering. The NIC Taxonomy contained seven sures, see Chapter 13.
domains: Domain 1: Physiological: Basic; Domain 2:
Physiological: Complex; Domain 3: Behavioral; Designing an Intervention for a
Domain 4: Safety; Domain 5: Family; Domain 6: Nursing Study
Health System; and Domain 7: Community. There are The therapeutic nursing intervention implemented in
a total of 30 classes under the seven domains (Bowles a nursing study needs to be carefully designed, clearly
& Naylor, 1996; Bulechek et al., 2008). described, and well linked to the outcomes (dependent
Tripp-Reimer, Woodworth, McCloskey, and Bu- variables) to be measured in the study. Each of these
lechek (1996), in their analysis of the structure of the dimensions must be considered to develop consis-
NIC interventions, identified three dimensions: inten- tency in the intervention. The intervention needs to
sity of care, focus of care, and complexity of care. be provided consistently to all subjects. Thus, a pub-
A high intensity of care is associated with the physi- lished study should document intervention fidelity,
ological illness level of the patient and the emer- which includes the detailed description of the essen-
gency nature of the illness. The dimension of intensity tial elements of the intervention and the consistent
of care includes indicators of (1) intensity (or acuity) implementation of the intervention during the study
and (2) whether the care is typical or novel. The (Forbes, 2009; Morrison et al., 2009; Santacroce
dimension of focus of care addresses (1) the target et al., 2004). In some studies, you may need to develop
of the intervention, ranging from the individual to a step-by-step protocol in order to ensure the detail
the system; (2) whether the care action is direct or and control the consistency of the study intervention.
on behalf of the patient; and (3) the continuum of Educational treatments or educational components of
practice from independent to collaborative actions. treatments might be audio or video recorded for
The dimension of complexity of care encompasses a consistency.
230 UNIT TWO  The Research Process

TABLE 11-1  Work in Nursing Related to the NIC and the Nursing Outcomes Classification (NOC)
Year Source
2011 Lee, E., Park, H., Nam, M., & Whyte, J. (2011). Identification and comparison of interventions performed by Korean
school nurses and U.S. school nurses using the Nursing Interventions Classification (NIC). Journal of School Nursing,
27(2), 93–101.
2011 Scherb, C. A., Head, B. J., Maas, M. L., Swanson, E. A., Moorhead, S., Reed, D., & Kozel, M. (2011). Most frequent
nursing diagnoses, nursing interventions, and nursing-sensitive patient outcomes of hospitalized older adults with heart
failure: Part 1. International Journal of Nursing Terminologies & Classifications, 22(1), 13–22.
2010 de Cordova, P., Lucero, R. J., Hyun, S., Quinlan, P., Price, K., & Stone, P. W. (2010). Using the Nursing Interventions
Classification as a potential measure of nurse workload. Journal of Nursing Care Quality, 25(1), 39–45.
2010 Lunney, M., McGuire, M., Endozo, N., & McIntosh-Waddy, D. (2010). Consensus-validation study identifies relevant
nursing diagnoses, nursing interventions, and health outcomes for people with traumatic brain injuries. Rehabilitation
Nursing, 35(4), 161–166.
2010 Smith, K. J., & Craft-Rosenberg, M. (2010). Using NANDA, NIC, and NOC in an undergraduate nursing practicum.
Nurse Educator, 35(4), 162–166.
2010 Solari-Twadell, P., & Hackbarth, D. P. (2010). Evidence for a new paradigm of the ministry of parish nursing practice
using the nursing intervention classification system. Nursing Outlook, 58(2), 69–75.
2009 Scherb, C. A., & Weydt, A. P. (2009). Work complexity assessment, nursing interventions classification, and nursing
outcomes classification: Making connections. Creative Nursing, 15(1), 16–22.
2009 Schneider, J. S., & Slowik, L. H. (2009). The use of the Nursing Interventions Classification (NIC) with cardiac patients
receiving home health care. International Journal of Nursing Terminologies & Classifications, 20(3), 132–140.
2009 Wong, E. (2009). Novel nursing terminologies for the rapid response system. International Journal of Nursing
Terminologies & Classifications, 20(2), 53–63.
2009 Wong, E., Scott, L. M., Briseno, J. R., Crawford, C. L., & Hsu, J. Y. (2009). Determining critical incident nursing
interventions for the critical care setting: A pilot study. International Journal of Nursing Terminologies &
Classifications, 20(3), 110–121.
2008 Schneider, J. S., Barkauskas, V., & Keenan, G. (2008). Evaluating home health care nursing outcomes with OASIS and
NOC. Journal of Nursing Scholarship, 40(1), 76–82.
2008 Sheerin, F. K. (2008). Diagnoses and interventions pertinent to intellectual disability nursing. International Journal of
Nursing Terminologies & Classifications, 19(4), 140–149.

The first step in designing an intervention should additional information on interventions (http://www
be a thorough review of the clinical and research .nursing.uiowa.edu/excellence/nursing_knowledge/
literature related to the intervention. Because of the clinical_effectiveness/nic.htm/) (NIC, 2011).
scarcity of information in the literature on selected The person or persons designated to implement the
nursing interventions, you may need to rely on your study intervention must be trained for this process.
personal knowledge emerging from expertise in clin- These individuals need to be trained in a precise way
ical practice. The nursing actions that are included in to ensure that they are 90% to 100% consistent and
the intervention must be spelled out sequentially so accurate in their implementation of the study treat-
that other nurses are able to follow the description ment. Often during the study, the implementation of
and provide the intervention in a consistent manner. the treatment is evaluated with a protocol checklist to
The intervention implemented in a study must be ensure consistent implementation throughout the
consistent in areas such as (1) content, (2) intensity, study. If an intervention is complex, you may need to
and (3) length of time. You need to review the employ a pilot study to refine the intervention so that
interventions that are provided in the NIC text to it can be applied consistently (Wyatt et al., 2010;
help you develop an intervention protocol for a Yamada et al., 2010).
study (Bulechek et al., 2008). This text provides Pierce et al. (2011) provided a detailed discussion
details for numerous interventions that have been of the intervention they implemented in their quasi-
implemented in previous studies. You might find an experimental study to raise stroke awareness among
intervention to implement in your study with a dif- people in rural areas. The intervention they imple-
ferent population, or you might use the format to mented was the Facts for Action to Stroke Treatment
develop a detailed new intervention to be imple- (FAST) educational intervention program to improve
mented in your study. Also visit the NIC website for 402 participants’ knowledge about stroke. The FAST
CHAPTER 11  Selecting a Quantitative Research Design 231

intervention was chosen because of its success in


teaching people to identify stroke symptoms. The fol- Quasi-experimental
lowing excerpt from the study describes the interven-
tion content and implementation process: Study Designs
Quasi-experimental and experimental designs examine
causality. The power of the design to accomplish this
“The FAST educational program consisted of a purpose depends on the extent to which the actual
43-slide PowerPoint presentation developed from effects of the experimental treatment (the independent
materials from AHA [American Heart Association], variable) can be detected by measuring the dependent
the ASA [American Stroke Association], a review of variable. Obtaining an understanding of the true
the literature, and the CPSS [Cincinnati Prehospital effects of an experimental treatment or intervention
Stroke Scale]. FAST team members presenting the requires action to control threats to the validity of the
program were registered nurse faculty members or findings. Threats to design validity are controlled
graduate students at the School of Nursing who used through selection of subjects, control of the environ-
a printed script to ensure the programs were equal ment, manipulation of the treatment, and reliable and
in content. The CPSS test highlighted in the presenta- valid measurement of the dependent variables. These
tion takes 1 minute to perform and is appropriate for design validity threats are described in Chapter 10.
teaching to the public. CPSS includes looking for Experimental study designs, with their strict
asymmetry of the face when a person is instructed to control of variance, are the most powerful method of
smile, arm drift when asked to raise both arms with examining causality. For many reasons, both ethical
eyes closed for 10 seconds, and slurred or inappropri- and practical, however, experimental designs cannot
ate speech when asked to repeat a familiar saying. always be used in social science research. Quasi-
The saying used in this program was ‘You can’t teach experimental study designs were developed to
an old dog new tricks.’ To help individuals remember provide alternative means of examining causality
the components of the CPSS, this program made the in situations not conducive to experimental controls.
connection to the acronym FAST by pointing out they Campbell and Stanley first described quasi-
should look at the Face, Arm, Speech, and if there experimental designs as a group in 1963, when only
were abnormalities in any of these areas it was Time experimental designs were considered of any worth.
to call 911 (see FAST components below). Cook and Campbell expanded this description in 1979
F = Face, check for droop or asymmetry and Shadish, Cook, and Campbell (2002) provide the
A = Arm, look for drift or lack of movement most current discussion of quasi-experimental and
S = Speech, use common saying / listen for experimental designs. Quasi-experimental designs
slurred or garbled speech facilitate the search for knowledge and examination of
T = Time to call 911 if any of these signs are causality in situations in which complete control of a
abnormal.” (Pierce et al., 2011, p. 85) study design is not possible. These designs have been
developed to control as many threats to validity as
possible in a situation in which at least one of the three
components of true experimental design (randomiza-
Pierce et al. (2011) selected a strong intervention tion, comparison groups, and controlled manipulation
(FAST Educational Program) that had been used in of the treatment) is lacking.
previous research and implemented it with a relative There are differences of opinion in nursing about
new population of rural adults. The content of the the classification of a particular study as quasi-
intervention was detailed and based on current research experimental or experimental. The experimental
and national organizations’ (AHA and ASA) materials. designs emerged from a logical positivist perspective
The intervention was implemented consistently using with the purpose of determining cause and effect. The
PowerPoint slides and a script. The study would have focus is to determine differences between or among
been strengthened by a description of the training of groups using statistical analyses on the basis of deci-
the faculty and students who implemented the inter- sion theory. The true experimental design (from a
vention. The researchers concluded that the FAST- logical positivist view) requires the use of random
based program was an effective intervention for sampling to obtain subjects, random assignment to
teaching rural adults to recognize stroke symptoms. control and experimental groups, rigorous control of
Chapter 14 provides a detailed discussion of the devel- the treatment, a highly controlled study environment,
opment and implementation of interventions and the and designs that control threats to validity (Shadish
conduct of intervention research. et al., 2002).
232 UNIT TWO  The Research Process

A less rigorous type of experimental design is particular subject will be assigned is biased in favor
referred to as the comparative experimental design. of groups that have smaller sample sizes at the point
Researchers in both nursing and medicine are using it of the assignment of that subject. This strategy is par-
for clinical situations in which the expectation of ticularly useful when assignment is being made to
random sampling is difficult, if not impossible, to more than two groups. The researcher can complete
achieve. These studies use convenience samples with calculations for the sequencing of assignment to
random assignment to groups. For example, random- groups before collecting data, thus freeing the
ized controlled trials (RCT) usually do not use ran- researcher for other activities during this critical
domly obtained samples but tend to be considered period. Hjelm-Karlsson (1991) suggested using cards
experimental in nature. These studies are classified as to make group assignments. The subject numbers and
experimental because they have internal validity if the random group assignments are written on cards. As
two groups (experimental and control) are comparable each subject agrees to participate in the study, the next
on variables important to the study, even though there card is drawn from the stack, indicating that subject’s
are biases in the original sample. However, these number and group assignment. These activities could
designs do not address threats to statistical conclusion also be accomplished with the computer.
validity and threats to external validity by the nonran- Stout, Wirtz, Carbonari, and Del Boca (1994) sug-
dom sample. Threats to external validity have not, in gested a similar strategy they referred to as urn ran-
the past, been considered a serious concern because domization, which they described as follows:
they affect not the claim that the treatment caused a
difference but rather the ability to generalize the find-
ings. The importance of external validity, although “One would begin the study with two urns, each urn
discounted in the past, is taking on greater importance containing a red marble and a blue marble. There is
in the current political and health policy climate. one urn for each level of the stratifying variable; that
Chapter 13, on outcomes research, explores the con- is, in this example there is an urn for severely ill
cerns some researchers and clinicians have about the patients and another urn for the less severe[ly ill]
validity of RCTs. patients. When a subject is ready for randomization,
we determine whether or not he/she is severely ill
Random Assignment to Groups and consult the corresponding urn. From this urn (say,
Random assignment to groups is a procedure used for the severely ill group) we randomly select one
to assign subjects to treatment or control groups ran- marble and note its color. If the marble is red we
domly. Random assignment is most commonly used assign the patient to Treatment A. Then we drop that
in nursing and medicine to assign subjects obtained marble back into the urn and put a blue marble into
through convenience sampling methods to groups for the urn as well. This leaves the ‘severely ill’ urn with
purposes of comparison. Random assignment used one red and two blue marbles. The next time a
without random sampling is purported to decrease the severely ill patient shows up, the probability that he/
risk of bias in the selection of groups. However, Otten- she will be assigned to Group B will be 2/3 rather than
bacher (1992) performed a meta-analysis to examine 2, thus biasing the selection process toward balance.
the effect of random assignment versus nonrandom A similar procedure is followed every time a severely
assignment on outcomes. The results failed to reveal ill subject presents for randomization. After each
significant differences in these two sampling tech- subject is assigned, the marble chosen from the urn
niques. He suggested that previous assumptions about is replaced together with a marble of the opposite
design strategies should be empirically tested. The color. The urn for the less severely ill group is not
term RCT usually means that the study used random affected. If a low-severity patient presents for the
assignment of subjects to groups, not that the sample study, that patient’s probability of assignment to
was obtained through random sampling methods. either treatment is not affected by the assignment of
Traditional approaches to random assignment patients in the other stratum. To some extent, urn
involve using a random numbers table or flipping an randomization can be tailored to maximize balancing
unbiased coin to determine group assignment. or to maximize randomization.” (Stout et al., 1994,
However, these procedures can lead to unequal group p. 72)
sizes and thus a decrease in power. Hjelm-Karlsson
(1991) suggested using what is referred to as a biased Stout and colleagues (1994) also provided strate-
coin design to randomly assign subjects to groups. gies for balancing several variables simultaneously
With this technique, selection of the group to which a during random assignment.
CHAPTER 11  Selecting a Quantitative Research Design 233

Matthews, Cook, and Terada (2010) tested the Each of the quasi-experimental designs described
ability of urn randomization versus simple random in this section involves threats to validity owing to
assignment to groups in producing balanced groups constraints in controlling variance. Some achieve
with small sample sizes. They conducted simulated greater amounts of control than others. When choos-
randomizations 10 times, developing “sample size ing a design for a study, you must select the design
scenarios of 20, 40, 60 (group sizes of 10, 20, and 30, that offers the greatest amount of control possible
respectively), for 30 trials in total. For groups of within your study situation (Shadish et al., 2002).
20-30, urn surpassed simple randomization in the Even the first designs described in this section, which
equal distribution of confounding variables between have low power in terms of establishing causality, can
groups, leading to effects of these variables that were provide useful information from which to design later
both smaller on average and more consistently close studies.
to zero over multiple trials” (Matthews et al., 2010, p.
243). These researchers concluded that the urn method Control and Comparison Groups
was easy to implement and has the advantages of Quasi-experimental and experimental studies include
unpredictability in assignment of participants to an experimental or intervention group that receives the
groups and decreased potential for investigator bias. treatment or intervention and a control that receives
This article includes an illustration of the urn method no treatment. Control groups, traditionally used in
to facilitate your understanding of the process for experimental studies, are selected randomly from the
assigning study participants to groups (see Figure 1 in same population as the experimental group and receive
Matthews et al., 2010, p. 248). no treatment. Use of a control group increases the
Schlairet and Pollock (2010) used random assign- ability of the researcher to detect differences between
ment of participants to groups in their study of under- groups in the real world. Thus, control groups reduce
graduate nursing students’ knowledge obtained with the risk of error. Control groups are rarely used in
traditional versus simulated clinical experiences. The nursing or medical studies because of requirements
following excerpt from the study describes the design related to consent, ethical issues regarding withhold-
with participant group assignment: ing treatment, and the difficulty of acquiring sufficient
potential subjects from which to select a sample
(Shadish et al., 2002).
“This intervention study used a 2x2 crossover design Comparison groups are usually selected through
and equivalence testing to explore the effects of simu- the use of convenience sampling rather than random
lated clinical experiences on undergraduate students’ sampling methods. There are four types of compari-
(n = 74) knowledge acquisition in a fundamentals of son groups: (1) groups that receive no treatment; (2)
nursing course. Following random assignment, stu- groups that receive a placebo treatment; (3) groups
dents participated in laboratory-based simulated clini- that receive the “usual treatment” or standard care; and
cal experiences with high-fidelity human patient (4) groups that receive a second experimental treat-
simulators and traditional clinical experiences and ment or a different treatment dose for comparison with
completed knowledge pretests and posttests.” the first experimental treatment (e.g., clinical trials of
(Schlairet & Pollock, 2010, p. 43) drug effectiveness). As a researcher, you should clarify
the type of comparison group you are using.
These researchers administered the knowledge When a study uses a comparison group that receives
pretest to establish equivalence between the groups. no treatment, demonstrating statistical significance is
After the simulated clinical experience and traditional easier because there is less variation in the treatment
clinical experience, the students were administered a and a greater difference between the two groups.
posttest. Analysis revealed a significant knowledge Placebo treatments provide consistency in the com-
gained associated with both simulated and traditional parison group, provide less difference between groups
clinical experiences, with the groups’ knowledge than in no-treatment comparison groups, and would
scores being statistically significantly equivalent. be unethical in some nursing studies. “Usual treat-
Thus, the researchers concluded that the simulated ment” is the care routinely provided by the healthcare
clinical experience was as effective as the traditional system. However, usual treatment is uneven and thus
clinical experience in this study. The description of the is often not standardized for all patients. Thus, provi-
study design would have been strengthened by a dis- sion of care may vary from one patient to another
cussion of how random assignment of participants to depending on the availability of nursing staff and the
groups was accomplished. intensity of care demands being made on nurses at the
234 UNIT TWO  The Research Process

time the care is provided. Some patients may receive One-Group Posttest-Only Design
little or no care, whereas others may receive consider- The one-group posttest-only design is referred to as
ably more or better care. There will likely be a greater pre-experimental rather than quasi-experimental
amount of difference between patients who received because of its weaknesses and the numerous threats to
little or no care and patients in the experimental group, validity it involves. It is inadequate for making causal
and less difference between patients in the “usual care inferences (see Figure 11-11). Usually in this design,
group” who received considerably more care and the no attempt is made to control the selection of subjects
experimental group. This wide variation reduces the who receive the treatment (the experimental group). It
effect size of the experimental treatment, increases the is difficult to justify generalizing findings beyond
variance, and decreases the possibility of obtaining a those tested. The group is not pretested; therefore,
significant difference between groups. The researcher there is no direct way to measure change. The
should carefully spell out “usual or standard care” and researcher cannot claim that posttest scores were a
the degree of variation in the care in the facility in consequence (effect) of the treatment if scores before
which the study is being conducted. the treatment are unknown. Because there is no com-
parison group, one does not know whether groups not
Nonequivalent Comparison Group Designs receiving the treatment would have similar scores on
A comparison group is one in which the groups are the dependent variable. The one-group posttest-only
not selected by random means. Some groups are design is used more commonly in evaluation than in
more nonequivalent than others, and some quasi- research.
experimental designs involve using groups (compari- Cook and Campbell (1979) suggested situations in
son and treatment or intervention) that have evolved which the one-group posttest-only design can be
naturally rather than being developed randomly. For appropriate and adequate for inferring causality. For
example, the treatment group might include students example, the design could be used to determine that a
registered for an 8:00 am class in a university, and the single factory’s use of vinyl chloride is causing an
comparison group might be students registered for a increase in the rate of neighborhood and employee
7:00 pm class. These groups cannot be considered cancers. The incidence of cancer in the community at
equivalent because the individuals in the comparison large is known. The fact that vinyl chloride causes
group may be different from individuals in the treat- cancer and the types of cancer it causes are also
ment group. Allowing individuals to select the group known. These norms would then take the place of the
they will be in (treatment or comparison) rather than pretest and the comparison group. Thus, to use this
being randomly assigned by the researcher also design intelligently, one must know a great deal about
increases the threat to design validity. For example, the causal factors interacting within the situation
allowing subjects to select either the treatment group (Shadish et al., 2002). This is not the usual situation
that receives an exercise program or the comparison in nursing studies.
group that has no exercise program threatens the valid-
ity of the study. The subjects selecting the treatment Posttest-Only Design with a Comparison Group
of the exercise program are different from those select- Although the posttest-only design with a compari-
ing no exercise program. son group offers an improvement on the previous
The approach to statistical analysis is problematic design because of the addition of a nonequivalent com-
in quasi-experimental designs. Although many parison group, it is still referred to as pre-experimental
researchers use the same approaches to analysis as are (see Figure 11-12). The addition of a comparison
used for experimental studies, the selection bias inher- group can lead to a false confidence in the validity of
ent in nonequivalent comparison groups makes this the findings. Selection threats are a problem with both
practice questionable. Reichardt (1979) recommended groups. The lack of a pretest remains a serious impedi-
using additional statistical analyses to examine the ment to defining change. Differences in posttest scores
data from various perspectives and to compare levels between groups may be caused by the treatment or by
of significance obtained from each analysis. As a differential selection processes (Shadish et al., 2002).
researcher, you must carefully assess the potential
threats to validity in interpreting statistical results, One-Group Pretest-Posttest Design
because statistical analysis cannot control for threats Another pre-experimental design, the one-group
to validity (Munro, 2005; Shadish et al., 2002). The pretest-posttest design, is one of the more commonly
following sections describe examples of nonequiva- used designs. However, it has such serious
lent comparison group designs. weaknesses that findings are often uninterruptable
CHAPTER 11  Selecting a Quantitative Research Design 235

Manipulation of Measurement of
independent variable dependent variable(s)
TREATMENT POSTTEST

Treatment—often ex post facto

Experimental group—those who receive the treatment and the posttest

Pretest—inferred—norms of measures of dependent variable(s) of population


from which experimental group taken

Comparison group—implied—norms of measures of dependent variable(s) of


population from which experimental group taken

Approach to analysis: • comparison of posttest scores with inferred norms


• confident inferences about change

Uncontrolled threats to validity: • no link between treatment and change


• no comparison group
• maturation
• undetected confounding variables
• inability to access threats to validity

Figure 11-11  One-group posttest-only design.

Manipulation of Measurement of
independent variable dependent variable(s)

Experimental group TREATMENT POSTTEST

Nonequivalent comparison group POSTTEST

Treatment—often ex post facto


may not be well defined

Experimental group—those who receive the treatment and the posttest

Pretest—inferred—norms of measures of dependent variable(s) of population


from which experimental group taken

Comparison group—not randomly selected—tend to be those who naturally in


the situation do not receive the
treatment

Approach to analysis: • comparison of posttest scores of experimental and


comparison group
• comparison of posttest scores with norms

Uncontrolled threats to validity: • no link between treatment and change


• no pretest
• selection

Figure 11-12  Posttest-only design with a comparison group.


236 UNIT TWO  The Research Process

Measurement of Manipulation of Measurement of


dependent variable(s) independent variable dependent variable(s)
Experimental POSTTEST
PRETEST TREATMENT
group group

Treatment—greater research control


usually not ex post facto

Experimental group—greater researcher control


expected to serve as comparison group

Comparison group—pretest scores of treatment group expected to serve as control

Approach to analysis: • comparison of pretest and post-test scores

Uncontrolled threats to validity: • history


• statistical regression
• maturation
• testing
• instrumentation

Figure 11-13  One-group pretest-posttest design.

(see Figure 11-13). Pretest scores cannot adequately


serve the same function as a comparison group. Events test n = 40, attrition rate of 31%…. Descriptive sta-
can occur between the pretest and posttest that alter tistical data analysis of overall pre- and post-test
responses to the posttest. These events then serve as incorrect responses showed: pre-test proportion
alternative hypotheses to the proposal that the change of incorrect responses = 0.40; post-test proportion
in posttest scores is due to the treatment. Posttest of incorrect responses = 0.27; Z-test comparing pre-
scores might be altered by (1) maturation processes; and post-tests scores of incorrect responses = 6.55
(2) administration of the pretest; and (3) changes in and one-sided p-value = 2.8E-11 (p < 0.001).” (Lim
instrumentation. Additionally, subjects in many studies et al., 2010, p. 98)
using this design are selected on the basis of high or
low scores on the pretest. Thus, there is an additional
threat that changes in the posttest may be due to Lim et al. (2010) concluded that the pretest identi-
regression toward the mean. Lim, Chiu, Dohrmann, fied knowledge deficits in medication management
and Tan (2010) implemented a one-group pretest- and adverse drug reactions in the elderly and the post-
posttest design to study medication management by test indicated statistically significant improvement in
registered nurses (RNs). The following study excerpt the RNs’ knowledge. The researchers recognized the
describes their design: limitations of their study design by calling it explor-
atory and also identified the fairly high attrition rate,
31%. The use of the same questionnaire as a pretest
“This exploratory study used a non-randomized and posttest could also threaten the study validity
pre- and post-test one group quasi-experimental because the change in the posttest scores might be due
design without comparators. It comprised a 23-item to memory of questionnaire items in addition to the
knowledge-based test questionnaire, one-hour teach- effect of the educational treatment. Based on these
ing session, and a self-directed learning package. The limitations, Lim et al. recommended further studies
volunteer sample was RNs from residential aged with larger samples and stronger design to determine
care facilities, involved in medication management. the impact of the educational treatment on the RNs’
Participants sat a pre-test immediately before the knowledge of medication management. The addition
education, and post-test 4 weeks later (same of a nonequivalent comparison group, as described in
questionnaire)…. Pre-test sample n = 58, post- the next design, can greatly strengthen the validity of
the findings.
CHAPTER 11  Selecting a Quantitative Research Design 237

Measurement of Manipulation of Measurement of


dependent variable(s) independent variable dependent variable(s)

Experimental Pretest Treatment Posttest


group

Nonequivalent Pretest Posttest


comparison group

Treatment—experimental group
comparison group not treated or receives standard or routine care

Comparison group—not randomly selected

Approach to analysis: • Examine difference between comparison and experimental pretest


• Examine difference between pretest and posttest
• Examine difference between comparison and experimental posttest

Uncontrolled threats to validity: • Selection-maturation


• Instrumentation
• Differential statistical regression
• Interaction of selection and history

Figure 11-14  Pretest and posttest design with a comparison group.

Pretest and Posttest Design with a


Comparison Group “Physical inactivity is a major factor in increasing
The pretest and posttest design with a comparison women’s risk for chronic disease, disability, and pre-
group is the most commonly used design in mature mortality. This study compared the effective-
social science research (see Figure 11-14). This quasi- ness of five behavioral counseling (BC) sessions with
experimental design is the first design discussed here a comparison group receiving one BC session based
that is generally interpretable. The uncontrolled threats on the five A’s (ask, advise, assist, arrange, and agree)
to validity are primarily due to the absence of random- to increase moderate-intensity physical activity,
ization and, in some studies, the inability of the muscle strengthening, and stretching activity. The
researcher to manipulate the treatment. Cook and health promotion model provided the framework for
Campbell (1979) offered a detailed discussion of the intervention. A pretest/posttest comparison
the effects of these threats on interpreting study group design was used, with random assignment of
findings. 46 women recruited from an urban Midwestern com-
Variations in this design include the use of (1) munity. A significant group interaction was found only
proxy pretest measures (a different pretest that corre- for cardiorespiratory fitness (p < 0.001). Significant
lates with the posttest); (2) separate pretest and post- time effects were found (p < 0.001) for both groups
test samples; and (3) pretest measures at more than in increasing handgrip, leg strength, and flexibility. BC
one time interval. The first two variations weaken the is a promising intervention to achieve physical activity
design, but the last variation greatly strengthens it. In behavior change with older women.” (Costanzo
some studies, the comparison group consists of et al., 2006, p. 786)
patients cared for before a new treatment was initiated.
Data on this comparison group are obtained through
chart audit or from electronic databases owned by the Pretest and Posttest Design with Two
facility. Obviously there is no opportunity to control Comparison Treatments
the quality of the data obtained through chart audit. The two-treatment design is used when two experi-
Thus, this strategy weakens the design. mental treatments are being compared to determine
Costanzo, Walker, Yates, McCabe, and Berg (2006) which is the more effective. In most cases, this design
used a pretest-posttest comparison group design in is used when one treatment is the currently identified
their study of physical activity counseling for older treatment of choice and the researcher has identified a
women. They described their design as follows: treatment that might lead to even better outcomes
238 UNIT TWO  The Research Process

Measurement of Manipulation of Measurement of


dependent variable(s) independent variable dependent variable(s)

Experimental Pretest T1 Posttest


group 1

Experimental Pretest T2 Posttest


group 2

T1 = Treatment #1
T2 = Treatment #2

Figure 11-15  Pretest and posttest design with two comparison treatments.

(see Figure 11-15). This design is strengthened by the


addition of one or more of the following: a no-treatment increase in growth hormone (GH) (p < 0.05) and a
group, a placebo-treatment group, or a routine or stan- 34% decrease in cortisol (CORT) (p < 0.05) at the
dard care group (see Figure 11-16). post time point, a 31% increase in interleukin-6 (IL-6)
Dudgeon et al. (2010) conducted a quasi-experiment (p < 0.05) at 30 minutes post exercise, a 23% increase
study of HIV-infected men using a pretest and posttest in IL-6 (p < 0.05), and a 13% decrease in soluble
design with two comparison treatment groups and a tumor necrosis factor receptor 2 (sTNFrII) (p < 0.05)
control group (see Figure 11-16). The two treatment at 60 minutes post exercise. The LOW (n = 11) group
groups participated in moderate- and low-intensity had a 3.5% decrease in sTNFrII (p < 0.05) at 30
exercise interventions, and the control group partici- minutes post exercise compared with baseline and
pated in no activity. This study had a strong design, 49% decrease (p < 0.05) in GH at 60-minutes post
and the moderate-intensity exercise was found to be exercise. The CON group (n = 13) had a decrease in
the most effective in improving circulating hormones GH at 30-minutes (62%, p < 0.05) and 60-minute
and cytokines in the HIV-infected men. The research- (61%, p < 0.05) post exercise [group participated in
ers provided a clear discussion of their study design no exercise] compared with baseline. The increase in
that is presented in the following excerpt: GH from baseline to post was greater in the MOD
group (p < 0.05) than the other groups and the
decrease in CORT from pre to post was greater in
the MOD group (p < 0.05) than in the other groups.
“Exercise has the potential to impact disease by alter- These data suggest that individual sessions of both
ing circulating anabolic and catabolic factors. It was low-intensity and moderate-intensity exercise can
the goal of this study to determine if two different alter circulating anabolic and catabolic factors in HIV-
regimes of low-intensity and moderate-intensity infected men. The changes in the MOD group present
exercise affected circulating levels of anabolic and potential mechanisms for the increases in lean tissue
catabolic factors in HIV-infected men. Exercise-naïve, mass seen with resistance exercise training.”
HIV-infected men, medically cleared for study partici- (Dudgeon et al., 2010, p. 560)
pation, were randomized into one of the following
groups: a moderate-intensity group (MOD), who
completed 30 minutes of moderate-intensity aerobic Pretest and Posttest Design with a
training followed by 30 minutes of moderate-intensity Removed Treatment
resistance training; a low-intensity group (LOW), who In some cases, gaining access to a comparison group
completed 60 minutes of treadmill walking; or a is not possible. The removed-treatment design with
control group (CON), who attended the clinic but pretest and posttest creates conditions that approxi-
participated in no activity. Blood and saliva samples mate the conceptual requirements of a control group
were collected at selected time points before, during, receiving no treatment. The design is basically a one-
and after each of the 3 required sessions. Compared group pretest-posttest design. However, after a delay,
with baseline, the MOD group (n = 14) had a 135% a third measure of the dependent variable is taken,
followed by an interval in which the treatment is
CHAPTER 11  Selecting a Quantitative Research Design 239

Measurement of Manipulation of Measurement of


dependent variable(s) independent variable dependent variable(s)

Experimental Pretest T1 Posttest


group 1

Experimental Pretest T2 Posttest


group 2

Comparison Pretest Usual Posttest


group or routine care

T1 = Treatment #1
T2 = Treatment #2

Figure 11-16  Pretest and posttest design with two comparison treatments and a usual or routine care group used as a comparison group.

Sample Experimental Dissipation of Controlled condition


condition treatment effect (treatment withheld)

#1 M(1) T M(2) M(3) M(4)

Equivalent time intervals

M = measurement of dependent variable(s)

T = treatment–manipulation of the independent variable

Approach to analysis: • Comparison of changes in dependent variable


• Scores between measurement points

Uncontrolled threats to validity: • Statistical conclusion validity


• Construct validity of the cause
• Selection

Figure 11-17  Pretest and posttest design with a removed treatment. M(1), pretest; M(2), posttest; M(3), pretest of controlled condition; M(4), posttest
of controlled condition.

removed, followed by a fourth measure of the depen-


dent variable (see Figure 11-17). The periods between “An interrupted time series design with removed
measures must be equivalent. In nursing situations, the treatment was used to answer the following research
researcher must consider the ethics of removing an questions: (1) Is virtual reality an effective distraction
effective treatment. Even if doing so is ethically intervention for reducing chemotherapy related
acceptable, the response of subjects to the removal symptom distress in children? And (2) Does virtual
may make interpreting changes difficult. reality in children have a lasting effect? Hypotheses:
It is difficult in CINAHL (Cumulative Index to (1) There will be differences in measures of symptom
Nursing and Allied Health Literature) and MEDLINE distress in a single group of children with cancer who
to locate examples of studies using removed-treatment receive a virtual reality distraction intervention during
designs because of the search process required. A the second chemotherapy treatment and who receive
search in PsychInfo located one study: Schneider no virtual reality intervention during the first and third
(1998) described a study of the effects of virtual reality chemotherapy treatments. The convenience sample
on symptom distress in children receiving cancer che- consisted of 11 children receiving outpatient
motherapy, as shown in the following excerpt:
240 UNIT TWO  The Research Process

causal variable must be rigorously defined to allow


chemotherapy at a clinical cancer center. Measures of differential predictions of directions of effect. To be
symptom distress were obtained at nine time points maximally interpretable, the following two groups
during three consecutive chemotherapy treatments. must be added: (1) a placebo control group in which
Four indicators were used to measure the dependent the treatment is not expected to affect the dependent
variable of symptom distress. The Symptom Distress variable and (2) a no-treatment control group to
Scale (SDS) (McCorkle & Young, 1978) was consid- provide a baseline. This design is not commonly used
ered a general indicator. Specific indicators of in nursing, so an older study is presented as an
symptom distress included the State-Trait Anxiety example.
Inventory for Children (STAIC C-1) (Spielberger McConnell (1976) used a reversed-treatment
et al., 1978) and single item indicators for nausea and design to test how knowledge of the results affected a
vomiting.” (Schneider, 1998, p. 2126) subject’s attitude toward a motor learning task, as
described in the following excerpt:

Schneider (1998) found that the use of a virtual


reality distraction intervention did decrease symptom The study “tested the hypotheses that a group which
distress in children receiving outpatient chemother- has the greatest number of gains in performance in
apy. However, the study had a very small sample, and successive trial scores of a motor task will develop a
the researcher recommended replication with a larger more positive attitude toward the task, and that a
sample using additional clinical cancer centers. group which has the greatest number of gains in per-
formance in successive trial scores will show the
Pretest and Posttest Design with a greatest change in an already formed attitude. Twelve
Reversed Treatment male and 12 female physical education majors were
The reversed-treatment nonequivalent control randomly divided into 2 groups. Each subject per-
group design with pretest and posttest introduces two formed 20 trials of 15 seconds each on a rotary
independent variables—one expected to produce a pursuit task, read the directions for the completion
positive effect and one expected to produce a negative of the attitude measuring instrument, and then com-
effect (see Figure 11-18). There are two experimental pleted the instrument. This series of activities was
groups, each exposed to one of the treatments. The repeated a 2nd time. The difference in the treatment
design tests differences in response to the two treat- of the 2 groups occurred in the knowledge of results
ments. This design, because of its high construct valid- (KR: i.e., time on target). The 1st group received its
ity of the cause, is more useful for theory testing than KR during the 1st 20 trials to the full second; during
the no-treatment control group design. This means that the 2nd 20 trials, this group received its KR to .01
there are strong theoretical sources proposing that spe- second. The other group received the reverse
cific treatments cause specific effects. The theoretical

Measurement of Manipulation of Measurement of


dependent variable(s) independent variable dependent variable(s)

Experimental Pretest Proposed positive Posttest


group 1 effective treatment

Experimental Pretest Proposed negative Posttest


group 2 effective treatment

Approach to analysis: • Comparison of group 1 and group 2 pretest


• Comparison of group 1 and group 2 posttest
• Comparison of changes between pretest and
posttest between groups

Uncontrolled threats to validity: • Statistical conclusion validity

Figure 11-18  Pretest and posttest design with a reversed treatment.


CHAPTER 11  Selecting a Quantitative Research Design 241

Some threats, however, are particularly problem-


treatment. The difference in treatment caused the atic in time-series designs. Record-keeping proce-
subjects in the group being given KR to .01th of a dures and definitions of constructs used for data
second to achieve more gains in performance than collection tend to change over time. Thus, maintaining
those whose KR was to the full second. Further analy- consistency can be a problem. The treatment can result
ses supported both hypotheses.” (McConnell, 1976, in attrition so that the sample before treatment may be
p. 394) different in important ways from the post-treatment
group. Seasonal variation or other cyclical influences
can be interpreted as treatment effects. Therefore,
Interrupted Time-Series Designs identifying cyclical patterns and controlling for them
The interrupted time-series designs are similar to are critical to the analysis of study findings (Shadish
descriptive time designs except that a treatment is et al., 2002).
applied at some point in the observations. Time-series McCain and McCleary (1979) have suggested
analyses have some advantages over other quasi- using the autoregressive integrated moving average
experimental designs. First, repeated pretest observa- (ARIMA) statistical model to analyze time-series
tions can assess trends in maturation before the data. The ARIMA is a statistical model that has some
treatment. Second, the repeated pretest observations distinct advantages over regression analysis tech-
allow measures of trends in scores before the treat- niques. For adequate statistical analysis, at least 50
ment, decreasing the risk of statistical regression, measurement points are needed; however, Cook and
which would lead to misinterpretation of findings. If Campbell (1979) believe that ARIMA with even small
you keep records of events that could influence sub- numbers of measurement points can provide better
jects in your study, you can determine whether histori- information than that obtained in cross-sectional
cal factors that could modify responses to the treatment studies. The numbers of measurements of the depen-
were in operation between the last pretest and the first dent variables (M) shown in the designs illustrated in
posttest. Figures 11-19 through 11-21 are limited by space.

Measurement of Manipulation of Measurement of


dependent variable(s) independent variable dependent variable(s)

Pretests Treatment Posttests

Experimental
group M(1) M(2) M(3) M(4) T M(5) M(6) M(7) M(8)

Subjects: May remain the same across the study or different individuals may be
selected at each measurement period (as in the descriptive
time-dimensional designs)

Pretest dependent variable measures: In addition to researcher-initiated tools,


measures may be obtained from archival data sources such as patient
records, scores available in student records, or employee records.

Treatment: May be a key event occurring at one specific time that is expected to modify
subject responses to the dependent variable; that is, curriculum change,
administrative change, change in nursing care of a particular type of patient.
The treatment tends to continue after implementation rather than occurring and
then being withdrawn.
Approach to analysis: • Changes in trends of scores before and after treatment

Uncontrolled threats to validity: • History


• Seasonal trends
• Instrumentation
• Selection
• Mono-operation bias
• Cyclical influences interpreted as treatment effects

Figure 11-19  Simple interrupted time-series design. M(1) through M(8), Measurement of dependent variable(s).
242 UNIT TWO  The Research Process

Measurement of Manipulation of Measurement of


dependent variable(s) independent variable dependent variable(s)

GROUPS Pretests Treatment Posttests


Experimental group M(1) M(2) M(3) M(4) T M(5) M(6) M(7) M(8)
Comparison group M(1) M(2) M(3) M(4) M(5) M(6) M(7) M(8)

Subjects: May remain the same across the study or may be part of a group in which
some individuals may change (e.g., class, work group, patient teaching,
or patient care group).

Pretest dependent variable measures: In addition to researcher-initiated tools,


measures may be obtained from archival data sources.

Treatment: May be a key event occurring at one specific time that is expected to modify
experiment subject’s responses to dependent variable measures. Treatment
tends to continue after implementation rather than occurring and then
being withdrawn.

Approach to analysis: • Changes in trends of scores before and after treatment


• Comparison of trends in experimental and comparison groups
• Temporal persistence of treatment effects

Uncontrolled threats to validity: • Selection and history interaction


• As experimental and comparison groups increase in
noncompatibility, threats to validity increase
• Interaction of populations and treatment
• Cyclical influences interpreted as treatment effects

Figure 11-20  Interrupted time-series design with a no-treatment comparison group.

Pretest T Posttest Pretest T Posttest etc.


Single sample
M(1) M(2) T M(3) M(4) T M(5) M(6) T M(7) M(8) T M(9) M(10)

Treatment: • Provided repeatedly


T= • Effects must dissipate rapidly
• Should be scheduled randomly

Approach to analysis: • Powerful for inferring casual effects


• Differences in pretest and posttest scores must be in
opposite directions to be interpretable

Figure 11-21  Interrupted time-series design with multiple treatment replications. M(1) through M(8), Measurement of dependent variable(s).

They are not meant to suggest limiting measures to The treatment, which in some cases is not completely
the numbers shown. under the control of the researcher, must be clearly
defined. There is no control or comparison group in
Simple Interrupted Time-Series Design this design. The use of multiple methods to measure
The simple interrupted time-series design is similar the dependent variable greatly strengthens the design.
to the descriptive time-series study, with the addition Threats that are well controlled by this design are
of a treatment that occurs or is applied (interrupts the maturation and statistical regression. van Doormaal
time series) at a given point in time (see Figure 11-19). et al. (2009) implemented an interrupted time-series
CHAPTER 11  Selecting a Quantitative Research Design 243

design to determine the effect of a Computerized the findings. The comparison group allows the
Physician Order Entry system with basic Clinical researcher to examine the differences in trends between
Decision Support (CPOE/CDSS) on the incidence of groups after the treatment and the persistence of treat-
medication errors (MEs) and preventable adverse drug ment effects over time (see Figure 11-20). Although
events (PADEs). The outcome measurements included the treatment may continue (e.g., a change in nursing
percentage of medication orders with one or more management practices or patient teaching strategies),
MEs and the percentage of patients with one or more the initial response to the change may differ from later
PADEs. The following study excerpt describes the responses.
study design: Zhang, Adams, Ross-Degnan, Zhang, and Soume-
rai (2009, p. 520) implemented an interrupted time-
series design with a comparison group to determine
Design the impact of a prior-authorization policy in Maine on
“The study was set up as an interrupted time series the ordering of second-generation antipsychotic and
that is characterized by a series of measurements anticonvulsant for patients with bipolar disorder, how
over time interrupted by an intervention. In this study often they were discontinued, and pharmacy costs
the intervention was the implementation of a Com- among Medicaid beneficiaries.” The excerpt from the
puterized Physician Order Entry system in combina- study abstract describes the study design, key results,
tion with a basic Clinical Decision Support System and conclusions:
(CPOE/CDSS). Data collection took place during a
5-month pre-implementation period (during which
the hand-written medication order system continued
to be used) and during a 5-month post-implementations “Methods: Using Medicaid and Medicare utilization
period (when the CPOE/CDSS system continued to data for 2001-2004, the authors identified 5,336
be used.) The post-implementation data collection patients with bipolar disorder in Maine (study group)
period started 8 weeks after finishing the implemen- and 1,376 in New Hampshire (comparison group).
tation process in order to make sure that initial prob- With an interrupted time-series and comparison
lems were solved.” (van Doormaal et al., 2009, group design, longitudinal changes were measured in
p. 817) second-generation antipsychotic and anticonvulsant
use; survival analysis was used to examine treatment
discontinuations and rates of switching medications.
These researchers found that 55% of the medica- Results: The prior-authorization policy resulted in
tion orders contained at least one ME prior to the an 8-percentage point reduction in the prevalence of
implementation of the CPOE/CDSS, and 17% post use of nonpreferred second-generation antipsychotic
intervention. Thus, the implementation of the CPOE/ and anticonvulsant medications (those requiring prior
CDSS led to a significant immediate reduction of authorization) but did not increase use of preferred
40.3% in medication orders with one or more errors. agents (no prior authorization) or rates of switching.
Pre-implementation, the mean percentage of admitted The prior-authorization policy reduced total phar-
patients experiencing at least one PADE was 15.5%, macy reimbursements for bipolar disorder by $27 per
as opposed to 7.3% post implementation. However, patient during the eight-month policy period.
when the use of interrupted time-series design is con- However, the hazard rate of treatment discontinua-
sidered, the immediate change was not significant tion (all bipolar drugs) while the policy was in effect
(−0.42%; 95% CI: −15.52%, 14.68%) because of the was 2.28 (95% confidence interval = 1.36-4.33)
observed underlying negative trend and could not be higher than during the pre-policy period, with adjust-
attributed to the introduction of CPOE/CDSS. van ment for trends in the comparison state.
Doormaal et al. (2009, p. 816) concluded that the Conclusion: The small reduction in pharmacy
“CPOE/CDSS reduces the incidence of medication spending for bipolar treatment per patient after the
errors. However, a direct effect on actual patient harm policy was implemented may have resulted from
(PADEs) was not demonstrated.” higher rates of medication discontinuation rather than
switching. The findings indicate that the prior-
Interrupted Time-Series Design with a authorization policy may have increased patient risk
No-Treatment Comparison Group without appreciable cost savings.” (Zhang et al.,
The addition of a comparison group to the interrupted 2009, p. 520)
time-series design greatly strengthens the validity of
244 UNIT TWO  The Research Process

Interrupted Time-Series Design with Multiple factors are eliminated by being controlled. The study
Treatment Replications is designed to prevent any other element from intrud-
The interrupted time-series design with multiple ing into observation of the specific cause and effect
treatment replications is a powerful design for infer- that the researcher wishes to examine.
ring causality (see Figure 11-21). It requires greater The three essential elements of experimental
researcher control than is usually possible in social research are (1) randomization; (2) researcher-
science research outside closed institutional settings, controlled manipulation of the independent variable;
such as laboratories or research units. The studies that and (3) researcher control of the experimental situa-
led researchers to adopt behavior modification tech- tion, including a control or comparison group. Experi-
niques used this design. For significant differences to mental designs exert much effort to control variance.
be interpretable, the pretest and posttest scores must Sample criteria are explicit, the independent variable
be in different directions with the introduction and or intervention is provided in a precisely defined way,
removal of the treatment. Within this design, treat- the dependent variables are carefully operationalized,
ments can be modified by substituting one treatment and the situation in which the study is conducted is
for another or combining two treatments and examin- highly controlled to prevent the interference of unstud-
ing interaction effects (Shadish et al., 2002). ied factors from modifying the dynamics of the process
being studied (Shadish et al., 2002).
Table 11-2 was developed so you might compare
Experimental Study Designs the four major types of designs: descriptive, correla-
Experimental study designs provide the greatest tional, quasi-experimental, and experimental. The
amount of control possible to examine causality more key focus of each type of design is identified with
closely. To examine cause, one must eliminate all an example study. Interventions are implemented
factors influencing the dependent variable other than only in quasi-experimental and experimental study
the cause (independent variable) being studied. Other designs.

TABLE 11-2  Comparison of Four Major Types of Design


Type of
Design Key Focus Sample Purpose Statement Intervention?
Descriptive Describes “what is” The purpose of this study was to (a) “determine practice and No
differences in practices between registered nurses and
respiratory therapists in managing patients receiving mechanical
ventilation” (Kjonegaard, Fields, & King, 2010, p. 168).
Correlational Examines relationships “The purpose of this study was to examine Jordanian mental health No
among study nurses’ experiences of providing mental health care, their
variables work-related stress, and organizational support received
“(Hamdan-Mansour, Al-Gamal, Puskar, Yacoub, & Marini, 2011,
p. 86).
oasis-ebl|Rsalles|1475959166

Quasi- Tests causality with “The aim of the study was to investigate the outcome of nursing Yes
experimental suboptimal control assessment, pain assessment and nurse-initiated intravenous
opioid analgesic compared to standard procedure for patients
seeking emergency care for abdominal pain. Outcome measures
were: (a) pain intensity, (b) frequency of received analgesic, (c)
time to analgesic, (d) transit time, and (e) patients’ perceptions
of the quality of care in pain management” (Muntlin, Carlsson,
Safwenberg, & Gunningberg, 2011, p. 13).
Experimental Tests causality with The purpose of this “experimental study was to examine the effects Yes
optimal control of a moderate-intensity aerobic exercise program on pain-like
behavior and neurotrophin-3 (NT-3) in female mice. The
rationale for conducting this study was that the literature and
clinical practice have supported the use of aerobic exercise in
reducing pain and improving function in people with chronic
pain but the molecular basis for these positive actions are poorly
understood” (Sharma, Ryals, Gajewski, & Wright, 2010, p. 714).
CHAPTER 11  Selecting a Quantitative Research Design 245

Measurement of Manipulation of Measurement of


dependent variable(s) independent variable dependent variable(s)

Randomized Pretest Treatment Posttest


experimental
group
Randomized Pretest Posttest
comparison or
control group
Treatment: Under control of researcher

Approach to analysis: • Comparison of pretest and posttest scores


• Comparison of comparison and experimental groups
• Comparison of pretest/posttest differences between samples

Uncontrolled threats to validity: • Testing


• Instrumentation
• Mortality
• Restricted generalizability as control increases

Figure 11-22  The classic experimental design; pretest-posttest control group design.

Classic Experimental Design levels of the treatments, such as differing frequency,


The original, or classic, experimental design, or intensity, or duration of nursing care interventions.
pretest-posttest control group design, is still the These additions greatly increase the generalizability
most commonly used experimental design (see Figure of the study findings.
11-22). There are two randomized groups, one receiv- Malm, Karlsson, and Fridlund (2007) conducted an
ing the experimental treatment and one receiving no experimental study of the effects of a self-care program
treatment, a placebo treatment, or the routine or stan- on health-related quality of life (HRQoL) for pace-
dard care. By comparing pretest scores and the groups’ maker patients. The abstract describes their study as
demographic characteristics, one can evaluate the follows:
effectiveness of randomization in providing equivalent
groups. The researcher implements the treatment or
independent variable under very controlled conditions. “An experimental, multi-centre, randomized study
The dependent variable is measured twice, before and with a nurse-led intervention was conducted with the
after the manipulation of the independent variable aim of evaluating the effects on HRQoL of a 10-month
(Shadish et  al., 2002). As in all well-designed studies, self-care program for pacemaker patients. In the
the dependent and independent variables are conceptu- present study, there were no significant differences in
ally linked, conceptually defined, and operationalized. HRQoL when comparisons were made between the
Instruments used to measure the dependent variable experimental group and the control group. Results
clearly reflect the conceptual meaning of the variable show two main findings for patients in the self-care
and have good evidence of reliability and validity. program (n = 97; mean age 71 years): a significantly
Often, more than one means of measuring the depen- better HRQoL in terms of experiencing the symp-
dent variable is advisable to avoid mono-operation toms that were the reason for pacemaker implanta-
and mono-method biases (Waltz et  al., 2010). tion, as having decreased or disappeared, and a higher
Most other experimental designs are variations of level of perceived exertion in a 1 1/2-minute stair test
the classic experimental design. Multiple groups (both compared with patients who had standard checkups
experimental and comparison) can be used to great (n = 115; mean age 73 years). It is important to
advantage in the pretest-posttest design and the actively include pacemaker patients in a self-care
posttest-only design. For example, the researcher program while still in the acute phase in the hospital.
could withhold treatment from one comparison group Healthcare professionals should support the patient
and treat another comparison group with a placebo. in a kind and professional manner by providing clear,
Multiple experimental groups could receive varying
246 UNIT TWO  The Research Process

terms of sample characteristics and other relevant


relevant information, and planning a self-care program variables.
based on the nurse’s assessment of the patient’s
needs. To enable patients to manage their life situa- Randomized Blocking Designs
tions, training and continued education for healthcare The randomized blocking design uses the two-group
professionals is necessary so that their efforts are pretest-posttest pattern or the two-group posttest
based on a holistic approach to nursing care and rec- pattern with one addition: a blocking variable. The
ognition of the patient perspective, with emphasis on blocking variable, if uncontrolled, is expected to con-
developing education and counseling for women, found the findings of the study. To prevent this confu-
patients with atrial fibrillation/sick sinus disease, and sion, the subjects are rank ordered in relation to the
patients whose pacemakers have ventricular pacing.” blocking variable.
(Malm et al., 2007, p. 15) For example, if effectiveness of a nursing interven-
tion to relieve post-chemotherapy nausea was the
independent variable in your study, severity of nausea
Experimental Posttest-Only Comparison could confound the findings. Subjects could be ranked
Group Design according to severity of nausea. You would then iden-
In some studies, the dependent variable cannot be tify and randomly assign the two subjects with the
measured before the treatment. For example, before most severe nausea, one to the experimental group and
the beginning of treatment, it is not possible to one to the comparison group. You then would identify
measure, in a meaningful way, a subject’s responses and randomly assign the two subjects next in rank.
to interventions designed to control nausea from che- You would follow this pattern until the entire sample
motherapy or postoperative pain. Additionally, in was randomly assigned as matched pairs. This proce-
some cases, subjects’ responses to the posttest can be dure ensures that the experimental group and the com-
due, in part, to learning from or having a subjective parison group are equal in relation to the potentially
reaction to the pretest (pretest sensitization). If this confounding variable.
issue is a concern in your study, you may eliminate The effect of blocking can also be accomplished
the pretest and use an experimental posttest-only statistically (through the use of analysis of covariance)
design with a comparison group (see Figure 11-23). without categorizing the confounding variable into
However, you then will not be able to use many pow- discrete components. However, for this analysis to be
erful statistical analysis techniques within the study. accurate, one must be careful not to violate the assump-
Additionally, the effectiveness of randomization in tions of the statistical procedure (Shadish et al., 2002;
obtaining equivalent experimental and comparison Spector, 1981).
groups cannot be evaluated in terms of the study vari- Santana-Sosa, Barriopedro, Lopez-Mojares, Perez,
ables. Nevertheless, the groups can be evaluated in and Lucia (2009) implemented a randomized block

Manipulation of Measurement of
independent variable dependent variable

Randomized Treatment Posttest


experimental
group
Randomized Posttest
comparison or control group

Treatment: Under control of researcher

Approach to analysis: • Comparison of comparison and experimental groups

Uncontrolled threats to validity: • Instrumentation


• Mortality
• Restricted generalizability as control increases

Figure 11-23  Experimental posttest-only comparison group design.


CHAPTER 11  Selecting a Quantitative Research Design 247

design in their study of the effect of exercise training the other independent variable are examined (Shadish
on patients with Alzheimer’s disease (AD). The et al., 2002; Spector, 1981).
purpose of this study was to determine the effects of Extensions of the factorial design to more than two
a 12-week training program for patients with AD levels of variables are referred to as M × N factorial
using the Senior Fitness test on their (1) overall func- designs. Within this design, independent variables can
tional capacity and (2) ability to perform activities of have any number of levels within practical limits.
daily living. With use of a randomized block design, Note that a 3 × 3 design involves 9 cells and requires
16 patients (8 control; 8 experimental) were assigned a much larger sample size. A 4 × 4 design would
to a training group (mean age 76 ± 4 years) or a control require 16 cells. A 4 × 4 design would allow relaxation
group (73 ± 4 years). The results showed significant to be provided at four levels of intensity, such as no
improvements after training (p < 0.05) in upper and relaxation, relaxation for 10 minutes twice a day,
lower body muscle strength and flexibility; agility and relaxation for 15 minutes three times a day, and relax-
dynamic balance; and endurance, fitness, gait, and ation for 20 minutes four times a day. Distraction
balance abilities in performing activities of daily would be provided at similar levels.
living (ADLs) independently. No changes were found Factorial designs are not limited to two indepen-
in the control group over the 12-week period. The dent variables; however, interpretation of larger
researchers indicated that exercise training should be numbers becomes more complex and requires greater
included in the nursing care for patients with AD. knowledge of statistical analysis. Factorial designs do
allow the examination of theoretically proposed inter-
Factorial Design relationships between multiple independent variables.
In a factorial design, two or more different character- However, very large samples are required (Shadish
istics, treatments, or events are independently varied et al., 2002).
within a single study. This design is a logical approach Winzer et al. (2010) conducted a clinical trial using
to examining multicausality. The simplest arrange- a factorial design to examine the effects of radiother-
ment is one in which two treatments or factors are apy and tamoxifen on the breast cancer recurrence
involved and, within each factor, two levels are rates of patients after breast-conserving surgery (BCS).
manipulated (for example, the presence or absence of The following excerpt from this study’s abstract
the treatment); this is referred to as a 2 × 2 factorial describes the design and key outcomes of the study.
design. This design is illustrated in Figure 11-24, in
which the two independent variables are relaxation
and distraction as means of relieving pain.
A 2 × 2 factorial design produces a study with four “Between 1991 and 1998, 361 patients… were ran-
cells (A through D). Each cell must contain an approx- domised to radiotherapy (yes/no) and tamoxifen for
imately equivalent number of subjects. Cells B and C 2 years (yes/no) in a 2 x 2-factorial design; the exclu-
allow the researcher to examine each intervention sion of 7 centers (14 patients) left 347 patients for the
separately. Cell D subjects receive no treatment and analysis. First results after a median follow-up of 5.9
serve as a control group. Cell A allows the researcher years were published. Herein we present updated
to examine the interaction between the two indepen- results after a median follow-up of about 10 years.
dent variables. This design can be used, as in the One hundred and eleven events concerning event-
randomized block design, to control for confounding free survivals (EFS) have been observed. Since a
variables. The confounding variable is included as an strong interactive effect between radiotherapy and
independent variable, and interactions between it and tamoxifen has been established, the results are pre-
sented in terms of the treatment effects for all four
treatment groups separately. Mainly due to the pres-
Level of Distraction ence of local recurrences, the event rate was much
Level of higher in the group with BCS only than in the other
Relaxation Distraction No Distraction three groups. No significant difference could be
established between the four treatment groups for
Relaxation A B
distant disease-free survival rates (DDFS). Updated
No Relaxation C D results give further evidence that even in patients with
a favorable prognosis, the avoidance of radiotherapy
and tamoxifen after BCS increases the rate of local
Figure 11-24  Example of factorial design.
248 UNIT TWO  The Research Process

Pain Control Primary Nursing Care


Management
Primary Care No Primary Care
Unit Unit Unit Unit Unit Unit Unit Unit
A B C D E F G H
Unit
A
Unit
Traditional Care
B
PRN Medication Unit
C
Figure 11-25  Nested design.
Unit
D

Unit
E
Unit
New Approach F
“around the clock”
medication Unit
G
Unit
H

considered a subject and would be randomly assigned


recurrences substantially. Rates are about three times to a treatment.
higher in the BCS only group. For the two outcomes, Sawyer, Deatrick, Kuna, and Weaver (2010)
EFS and DDFS, no important difference could be seen explored patients with obstructive sleep apnea and
between the three groups with an additional treat- their perceptions of their disease and treatment with
ment. However, because of the limited sample size continuous positive airway pressure by implementing
with corresponding low power, the strength of evi- a nested design. A picture of this study design is pre-
dence for such a comparison is weak.” (Winzer et al., sented in Figure 11-26. The following study excerpts
2010, p. 95) describe its design and key findings:

Nested Designs Background: “Obstructive sleep apnea (OSA) patients’


In some experimental situations, you may wish to consistent use of continuous positive airway pressure
consider the effect of variables that are found only at (CPAP) therapy is critical to realizing improved func-
some levels of the independent variables being studied. tional outcomes and reducing untoward health risks
Variables found only at certain levels of the indepen- associated with OSA.
dent variable are called nested variables and are best Methods: We conducted a mixed methods, con-
investigated with nested designs (Shadish et al., current, nested study to explore OSA patients’
2002). Possible nested variables are gender, race, beliefs and perceptions of the diagnosis and CPAP
socioeconomic status, and education. A nested vari- treatment that differentiate adherent from nonad-
able may also be the patients who are cared for on herent patients prior to and after the first week of
specific nursing units or at different hospitals; the sta- treatment, when the pattern of CPAP use is estab-
tistical analysis in this case would be conducted as lished [see Figure 11-26]. Guided by social cognitive
though the unit or hospital were the subject rather than theory, themes were derived from 30 interviews
the individual patient. Figure 11-25 illustrates the conducted post-diagnosis and after 1 week of CPAP
nested design. In actual practice, nursing units used in use. Directed content analysis, followed by categori-
this manner would have to be much larger in number zation of participants as adherent/nonadherent from
than those illustrated, because each unit would be
CHAPTER 11  Selecting a Quantitative Research Design 249

Crossover or Counterbalanced Designs


Initial Clinical Evaluation at In some studies, more than one treatment is adminis-
Sleep Center & Recruitment (n = 19) tered to each subject. The treatments are provided
sequentially rather than concurrently. Comparisons
are then made of the effects of the different treatments
on the same subject. For example, two different
Informed Consent &
Enrollment (n = 18) methods known to achieve relaxation might be used
Demographic Survey as the two treatments. One difficulty with this type of
study is that exposure to one treatment may result in
effects (called carryover effects) that persist and
influence responses of the subject to later treatments.
Standardized OSA and Also, subjects can improve as they become more
CPAP Education:
20-minute video & brochure
familiar with the experimental protocol, a situation
called a practice effect. They may become tired or
bored with the study, a development called a fatigue
effect. The direct interaction of one treatment with
Diagnostic Sleep Study (n = 16) another, such as the use of two drugs, can confound
Failure to attend sleep study differences in the two treatments.
excluded
Crossover, or counterbalancing, is a strategy
designed to guard against possible erroneous conclu-
sions resulting from carryover effects. With crossover
Interview 1 or counterbalancing design, subjects are randomly
Postdiagnosis (n = 16) assigned to a specific sequencing of treatment condi-
tions. This approach distributes the carryover effects
equally throughout all the conditions of the study, thus
canceling them out. To prevent an effect related to
CPAP Sleep Study
(n = 16) time, the same amount of time must be allotted to each
treatment, and the crossover point must be related to
time, not to the condition of the subject (Shadish et al.,
2002).
Interview 2 In addition, the design must allow for an adequate
Post-CPAP Treatment (n = 16) interval between treatments to dissipate the effects
CPAP Adherence Data
Collection (n = 15)
of the first treatment; this interval is referred to as a
Refused CPAP treatment excluded washout period. For example, the design would
specify that each treatment would last 6 days and
that on the eighth day, each subject would cross over
Figure 11-26  Nested study design. (From Sawyer, A. M., Deatrick, J. A., to the alternative treatment after a 2-day washout
Kuna, S. T., & Weaver, T. E. [2010]. Differences in perceptions of the period.
diagnosis and treatment of obstructive sleep apnea and continuous The researcher also must be alert to the possibil-
positive airway pressure therapy among adherers and nonadherers. ity that changes may be due to factors such as
Qualitative Health Research, 20[7], 876.) disease progression, the healing process, or the
effects of treatment of the disease rather than the
study treatment. The process of counterbalancing
objectively measured CPAP use, preceded across- can become complicated when more than two treat-
case analysis among 15 participants with severe OSA. ments are involved. Counterbalancing is effective
Beliefs and perceptions that differed between adher- only if the carryover effect is essentially the same
ers and nonadherers included OSA risk perception, from treatment A to treatment B as it is from treat-
symptom recognition, self-efficacy, outcome expec- ment B to treatment A. If one treatment is more
tations, treatment goals, and treatment facilitators/ fatiguing than the other or more likely to modify
barriers. Our findings suggest opportunities for response to the other treatment, counterbalancing
developing and testing tailored interventions to will not be effective. You can use the crossover
promote CPAP use.” (Sawyer et al., 2010, p. 373) design to control variance in your study and thus
allow the sample size to be smaller. The sample size
250 UNIT TWO  The Research Process

required to detect a significant effect is considerably


smaller because the subjects serve as their own con- “Until very recently, the genesis and use of new treat-
trols. Because the data collection period is longer, ments came about by means having little to do with
however, the rate of subject dropout may increase the scientific method. For millennia, the majority of
(Beck, 1989). therapies appear to have evolved by one of three
An example of this design is the Chang, Lin, Lin, methods: accidental discovery of treatments with
and Lin (2007) study of feeding premature infants unmistakable efficacy; the use of hypotheses alone,
using either single-hole or cross-cut nipple units. They without any experimentation; or the utilization of
described their study as follows: experimentation without controls, randomization,
blinding,… or adequate sample sizes. Treatments
originating by one of the latter two routes frequently
persisted for a very long time despite a lack of unbi-
“The purpose of this study was to compare the
ased evidence of their efficacy. Bloodletting, purging,
amount of total milk intake, feeding time, sucking
and the use of homeopathic dosages of drugs are
efficiency, heart rate (HR), respiratory rate (RR), and
examples. Failure of a treatment in any particular case
oxygen saturation (SpO2) of premature infants when
was usually attributed by its practitioners to its
fed with either single-hole or cross-cut nipple units.
misuse, to poor diagnosis, or to complicating factors.”
Twenty stable infants admitted to a level II nursery in
(Wooding, 1994, p. 26)
a tertiary care center with gestational ages averaging
32.2 +/- 3.2 wks were enrolled. Subjects had an
average postmenstrual age of 34.1 +/- 1.6 wks, and
average body weight of 1996 +/- 112 gm. A crossover
Over the years, the methodology for clinical trials
design was used and infants were observed for two
has evolved in medicine, resulting in less bias in sam-
consecutive meals separated by a four-hour interval.
pling, treatment implementation, and data collection
They were bottle fed with equal feeding amounts
(Meinert & Tonascia, 1986; Piantadosi, 1997; Pocock,
using a single-hole and cross-cut nipple administered
1996; Whitehead, 1992; Wooding, 1994). Meinert and
in random order. Results showed that infants fed with
Tonascia (1986) defined a clinical trial as a planned
single-hole nipple units took more milk (57.5 +/-
experiment designed to determine the efficacy of a
8.3 ml vs. 51.6 +/- 9.5 ml, p = 0.011), had a shorter
treatment or independent variable in a study in which
feeding time per meal (11.5 +/- 4.9 min vs. 20.9 +/-
the experimental group receives the treatment and the
5.0 min, p < 0.001), and sucked more efficiently (5.8
control group does not. The experimental group and
+/- 2.5 ml/min vs. 2.7 +/- 1.0 ml/min, p < 0.001) com-
the control group are usually established through
pared to those fed through cross-cut nipples. Infants
random assignment, and the study outcomes or depen-
using cross-cut nipple units had a higher RR (44.4
dent variables are compared for the two groups. In
+/- 4.6 breaths/minutes vs. 40.8 +/- 4.9 breaths/
clinical trials, the patients in both groups are enrolled,
minutes, p = 0.002) and SpO2 (96.1 +/- 1.4% vs. 94.6
treated, and followed over the same time. The outcome
+/- 3.2%, p = 0.044) than those using single-hole
measures are usually clinical events, laboratory tests,
nipples. Oxygen desaturation (SpO2 < 90% and
or mortality.
lasting for longer than 20 sec) and bradycardia were
The phase I, II, III, and IV clinical trial categories
not recorded in either group of infants during feeding.
were developed specifically for testing experimental
Compared to using cross-cut nipple units, premature
drug therapy (Meinert & Tonascia, 1986; Whitehead,
infants using single-hole nipple units take more milk
1992). Phase I, the initial testing of a new drug,
and tend to tolerate feedings better. A single-hole
focuses on determining the best drug dose and identi-
nipple may be a choice for physiologically stable
fying safety effects. Phase II trials seek preliminary
bottle-fed premature infants.” (Chang et al., 2007,
evidence of efficacy and side effects of the drug dose
p. 215)
determined by the phase I trial. Sometimes in Phase
II, the experimental group receiving the drug is com-
pared with a placebo group.
Clinical Trials Phase III trials are comparative definitive studies in
Clinical trials have been used in medicine since 1945. which the new drug’s effects are compared with those
Wooding (1994) described the strategies that were of the drug considered standard therapy. Phase III
used to introduce new medical therapies before that trials are sometimes referred to as “full-scale defini-
time: tive clinical trials,” suggesting that a decision is made
CHAPTER 11  Selecting a Quantitative Research Design 251

on the basis of the findings as to whether the experi- Randomized Controlled Trials
mental drug is more effective than standard treatment. Currently in medicine and nursing, the randomized
In some phase III clinical trials, the sample size is not controlled trial (RCT) design is noted to be the
determined before initiation of data collection. Rather, strongest methodology for testing the effectiveness of
data are analyzed at intervals to test for significant a treatment because of the elements of the design that
differences between groups. If a significant difference limit the potential for bias. Subjects are randomly
is found, data collection may be discontinued. Other- assigned to the treatment and control groups to
wise, the data collection will continue and retesting is reduce selection bias (Shadish et al., 2002). Biases
initiated after accrual of additional subjects (Meinert developing from participant attrition from studies are
& Tonascia, 1986; Whitehead, 1992). Phase IV trials managed with intention-to-treat analyses (Polit, Gil-
occur after regulatory approval of the drug and are lespie, & Griffin, 2011). In addition, blinding or
designed to monitor patients over time to determine withholding of study information from data collec-
drug safety, uncommon side effects, and long-term tors, participants, and their healthcare providers can
consequences in a larger population. Phase IV trials reduce the potential for bias. Thus, RCTs when
might also focus on testing marketing strategies and appropriately conducted are considered the gold stan-
examining cost-effectiveness for the drug (Piantadosi, dard for determining the effectiveness of healthcare
1997; Wooding, 1994). interventions.
Piantadosi (1997) recommended redefining these However, there were serious criticisms of the
stages to be broader and applicable to more types of inconsistencies and biases identified in the clinical
trials. He suggested using the following terminology: trials conducted. Thus, in 1993, a panel of 30 experts—
early development, middle development, comparative clinical trial researchers, medical journal editors, epi-
studies, and late development. In early development demiologists, and methodologists—met in Ottawa,
trials, researchers would develop and test the treat- Canada, to develop a scale to assess the quality of
ment mechanism (thus, they could also be called TM RCTs reports. This group initiated the Standardized
trials). Middle development studies would focus on Reporting of Trials (SORT) statement (CONSORT,
clinical outcomes and treatment “tolerability.” Toler- 2011). This statement included a checklist and flow
ability would have three components: feasibility, diagram that investigators were encouraged to follow
safety, and efficacy; thus, Piantadosi (1997) referred when conducting and reporting RCTs. The initial work
to middle development studies as safety and efficacy of this group was revised in 2001 and became
trials, or SE trials. In this phase, the researcher would the Consolidated Standards for Reporting Trials
estimate the probability that patients would benefit (CONSORT). This guideline was updated with the
from the treatment (or experience side effects from it). CONSORT 2010 Statement published by Schultz,
Performance criteria such as success rate might Altman, and Moher (2010) as representatives of the
be used. CONSORT Group. Figure 11-27 provides a flow
Comparative studies, according to Piantadosi diagram of the progression through the phases of an
(1997), would have defined clinical end points and RCT— enrollment, intervention allocation, follow-up,
would address comparative treatment efficacy (so and data analysis—for two randomized parallel
could be called CTE trials). These studies would groups. This diagram was included in the CONSORT
include a concurrent control group that receive the 2010 Statement to facilitate the conduct of quality
standard treatment and an experimental group that RCTs nationally and internationally (Schulz et al.,
receives the experimental treatment. These studies 2010). The CONSORT 2010 Statement also offers
might also include a placebo group, which receives a a checklist of information that researchers need
faux treatment to determine the psychological response to supply when reporting a RCT; it can be found
to receiving a treatment. Late development studies in Chapter 19, the Schulz et al. (2010) publication,
would be designed to identify uncommon side effects, or online (http://www.consort-statement.org/consort-
interactions with other treatments, and unusual com- statement/) (CONSORT, 2012).
plications. They would be developed as expanded Only in the past 10 years has the term RCT been
safety trials, or ES trials, conducted overtime with used to describe studies conducted in nursing. When
larger samples. Over the years, researchers have implementing these clinical trials in nursing, the meth-
increased the control in the development and imple- odology needs to be redefined to fit the knowledge-
mentation of healthcare clinical trials and these trials building needs of nursing and also conform to the
are usually referred to as randomized controlled trials CONSORT standards. Thus, an RCT conducted in
(RCTs) in the research literature. nursing needs to meet the following expectations:
252 UNIT TWO  The Research Process

Assessed for eligibility (n = )


Enrollment

Excluded (n = )
Not meeting inclusion criteria (n = )
Declined to participate (n = )
Other reasons (n = )

Randomized (n = )
Allocation

Allocated to intervention (n = ) Allocated to intervention (n = )


Received allocated intervention (n = ) Received allocated intervention (n = )
Did not receive allocated intervention (give Did not receive allocated intervention (give
reasons) (n = ) reasons) (n = )
Follow-Up

Lost to follow-up (give reasons) (n = ) Lost to follow-up (give reasons) (n = )


Discontinued intervention (give reasons) (n = ) Discontinued intervention (give reasons) (n = )
Analysis

Analyzed (n = ) Analyzed (n = )
Excluded from analysis (give reasons) (n = ) Excluded from analysis (give reasons) (n = )

Figure 11-27  2010 Statement flow diagram of the progress through the phases of a parallel randomized trial of two groups (that is, enrollment,
intervention allocation, follow-up, and data analysis). (From CONSORT. [2012]. The CONSORT Statement. Retrieved from http://www.consort-
statement.org/consort-statement/; Schulz, K. F., Altman, D. G., Moher, D., for the CONSORT Group [2010]. CONSORT 2010 Statement: Updated
guidelines for reporting parallel group randomised trials. British Medical Journal, 340, c332.)

1. The study is designed to be a definitive test of the 5. The design meets the criteria of an experimental
hypothesis that the intervention causes the defined study (Schulz et al., 2010).
effects or outcomes. 6. Subjects are drawn from a reference population
2. Previous studies have provided evidence that the through the use of clearly defined criteria. Base-
intervention causes the desired outcome. line states are comparable in all groups included
3. The intervention is clearly defined, and a protocol in the study. Selected subjects are then randomly
has been established for its clinical application assigned to treatment and comparison groups—
ensuring intervention fidelity (Santacroce et al., thus, the term randomized clinical trial
2004; Yamada et al., 2010). (CONSORT, 2012; Schulz et al., 2010).
4. The study is conducted in a clinical setting, not in 7. Subjects are accrued individually over time as
a laboratory. they enter the clinical area, are identified as
CHAPTER 11  Selecting a Quantitative Research Design 253

meeting the study criteria, and agree to participate per patient per year of the study are less for multi-
in the study. center studies than for single-center trials. If you plan
8. The study has high internal validity. The design to use this technique in your research, you must con-
is rigorous and involves a high level of control of front several problems. Coordination of a project of
potential sources of bias that will rule out possible this type requires much time and effort. Keeping up
alternative causes of the effect (Shadish et al., with subjects is critical but may be difficult. Commu-
2002). The design may include blinding to accom- nication with and cooperation of staff assisting with
plish this purpose. Blinding means that the the study in the various geographical locations are
patient, those providing care to the patient, and/or essential but sometimes challenging. You may encoun-
the data collectors do not know whether the ter attempts to ignore the protocol and provide tradi-
patient is in the experimental group or the control tional care (Fetter et al., 1989; Gilliss & Kulkin, 1991;
group. The CONSORT 2010 Statement recom- Schulz et al., 2010; Tyzenhouse, 1981). Meinert and
mends that the researchers clearly designate who Tonascia (1986) recommended the development of a
is blinded in the research plan, conduct the study coordinating center for multisite clinical trials that will
as planned, and designate who was blinded in the be responsible for receiving, editing, processing, ana-
final report (Polit et al., 2011; Schulz et al., 2010). lyzing, and storing data generated in the study. Nurse
9. The treatment or independent variable is equal researchers need to follow the CONSORT 2010 State-
and consistently applied to all subjects in the ment recommendations in the conduct of RCTs and in
experimental group (CONSORT, 2012). their reporting (CONSORT, 2012; Schulz et al., 2010).
10. Dependent variables or outcomes are measured Jones, Duffy, and Flanagan (2011) conducted an
consistently with quality measurement methods RCT to test the efficacy of a nurse-coached interven-
(Waltz et al., 2010). tion (NCI) on the outcomes of patients undergoing
11. The proposed study has been externally reviewed ambulatory arthroscopy surgery. The NCI was devel-
by expert researchers who have approved the oped to improve the postoperative experiences of
design. patients and families following ambulatory surgery.
12. The study has received external funding sufficient This study was funded by the National Institute of
to allow a rigorous design with a sample size Nursing Research. The following study excerpt identi-
adequate to provide a definitive test of the fies the study hypothesis, design and major findings:
intervention.
13. The research report covers the items on
the CONSORT 2010 Statement checklist “This study was conducted to test the hypothesis that
(CONSORT, 2012). ambulatory arthroscopic surgery patients who receive
14. If the clinical trial results indicate a significant a nurse-coached telephone intervention will have sig-
effect of the intervention, the evidence is suffi- nificantly less symptom distress and better functional
cient to warrant application of the findings in health status than a comparable group who receive
clinical practice (Melnyk & Fineout-Overholt, usual practice….
2011). The study sample in this randomized clinical trial
15. The intervention is defined in sufficient detail so with repeated measures was 102 participants (52 in
that clinical application can be achieved (Bulechek the intervention group and 50 in the usual practice
et al., 2008; Polit et al., 2011; Schulz et al., 2010). group) drawn from a large academic medical center
Elwood (1998) suggested that clinical trial meth- in the Northeast United States. Symptom distress
odology could be used for prevention intervention was measured using the Symptom Distress Scale, and
studies as well as testing treatments. Murray (1998) functional health was measured using the Medical
proposed methods of randomizing groups rather than Outcomes Study 36-Item Short-Form Health Survey
subjects in prevention studies and explored issues General Health Perceptions and Mental Health sub-
related to community-based trials such as sample scales.” (Jones et al., 2011, p. 92)
mortality.
Clinical trials may be carried out simultaneously in
multiple geographical locations to increase sample Jones et al. (2011) detailed their study intervention
size and resources and to obtain a more representative and the steps taken by the researchers to promote fidel-
sample (Schulz et al., 2010). In this case, the primary ity in the implementation of the NCI. The nurses were
researcher must coordinate activities at all the sites. trained in the delivery of the NCI by the study team
Meinert and Tonascia (1986) indicated that the costs using a video. Each nurse coach was given a packet
254 UNIT TWO  The Research Process

of guidelines for management of the participants’ in the community, and the variables are called indica-
symptoms: tors. A change in an identified indicator is inferred to
be a consequence of the effectiveness of the preven-
tion program (treatment).
“The guidelines addressed common patient problems Specific indicators would depend on the focus of
associated with postoperative recovery after arthros- prevention. For example, nurses in Canada identified
copy with general anesthesia (e.g., nausea, vomiting, oral mucositis as a recurring issue in oncology clinical
pain, immobility). The guidelines contained five areas practice and developed an oral care guide. They used
to evaluate: (a) assessment (self-report), (b) current the University Health Network Nursing Research Uti-
management of symptoms, (c) evaluation by the lization Model and the Neuman Systems Model as
coach of the adequacy of the intervention, (d) addi- conceptual frameworks (Salvador, 2006). The follow-
tional intervention strategies to address the present- ing excerpt describes their study:
ing symptoms, and (e) proposed outcome (self-
report).” Jones et al., 2011, p. 95)
“A flowchart was developed to ensure a coordinated
and continuous provision of oral care. Educational
The sample criteria were detailed to identify the presentations were conducted to familiarize nurses
target population. Once the patients consented to be in and members of the multidisciplinary team of the
the study, they were randomly assigned to the NCI practice changes. The introduction of the oral care
group or the usual care group with use of the sealed- regimen as primary prevention, plus systematic oral
envelope method (Maxwell & Delaney, 2004). The assessment and monitoring had the potential to
researchers found that the NCI delivered by telephone reduce the occurrence and severity of oral mucositis
postoperatively to patients undergoing arthroscopic in patients undergoing autologous stem cell transplan-
surgery significantly reduced their symptom distress tation.” (Salvador, 2006 p. 18)
and improved their physical and mental health.
The steps of this study followed the steps outlined
in the CONSORT flow diagram in Figure 11-27. How might you study the effectiveness of this
More details for conducting RCTs can be found in primary prevention strategy? Because one indicator
Chapter 14. alone would be insufficient to infer effect, multiple
indicators and statistical analyses appropriate for these
indicators must be used. For example, you might
Studies That Do Not Use measure the color of the oral mucosa, moistness in the
mouth, severity of oral mucositis, and amount of pain
Traditional Research Designs expressed by the patient when eating.
In some approaches to research, the research designs
described in this chapter cannot be used. These studies Secondary Analyses
tend to be in highly specialized areas that require Secondary analysis design involves studying data
unique design strategies to accomplish their purposes. previously collected in another study. Data are reex-
Designs for primary prevention and health promotion, amined with the use of different subsets of the data or
secondary analysis, and methodological studies are variables and different statistical analyses from those
described here. previously used. The design involves analyzing data
to validate the reported findings, examine dimensions
Primary Prevention and Health previously unexamined, or redirect the focus of the
Promotion Studies data to allow comparison with data from other studies
To study primary prevention and health promotion as (Gleit & Graham, 1989; Windle, 2010).
a nurse researcher, you must apply a treatment of Secondary analysis studies may use data collected
primary prevention (the cause) and then attempt to by state and national governments. For example,
measure the effect (an event that does not occur if the Chertok, Luo, and Anderson (2011) analyzed over 17
treatment was effective). Primary prevention studies, years of West Virginia’s birth certificate data to answer
then, attempt to measure things that do not happen. a research question about associations between
One cannot select a sample to study, apply a treatment, changes in prenatal smoking habits and subsequent
and then measure an effect. The sample must be the infant birth weights. Cipher, Hooker, and Guerra
community. The design involves examining changes (2006) compared the prescribing trends of nurse
CHAPTER 11  Selecting a Quantitative Research Design 255

practitioners, physician assistants, and physicians


using data in the National Ambulatory Medical Care All of the reasons offered for using secondary
Survey (NAMCS) database. They found that for 70% analysis—answering new questions with existing data,
of the visits, the three clinician types were likely to applying new methods to answer old questions, the
write at least one prescription, and that PAs were more real exigencies of cost and feasibility—serve equally
likely than NPs or physicians to prescribe controlled to justify the continued use of data collected years
substances. ago, by the original investigator of a large project, as
Because data collected for some national databases well as by others…. The issue remains one of sound
may have used oversampling of underrepresented science. The question that must be asked is: Does this
groups, researchers using these databases must care- particular paper make a meaningful and distinct con-
fully examine the inclusion and exclusion sampling tribution to the scientific literature?” (Aaronson,
criteria used by the original research team. Providing 1994, pp. 61-62)
substantive information about the challenges pre-
sented by large database research is beyond the scope
of this book. Researchers interested in using large An example of secondary analysis is Koci and
databases for secondary analysis should consult a ref- Strickland’s (2007) study of the relationship of ado-
erence book on the topic (Kiecolt & Nathan, 1985; lescent physical and sexual abuse with perimenstrual
Trzesniewski, Donnellan, & Lucas, 2011; Vartanian, syndrome (PMS) in adulthood. Data analyzed in this
2011). study were from a longitudinal study of a community
Data accumulated during the research programs of sample of 568 women in a database called Nursing
groups of faculty provide opportunities for secondary Assessment of PMS: Neurometric Indices. A study
data analysis as well. This approach allows the inves- such as this yields an enormous amount of data that
tigators to examine questions related to the data that are not examined in the original study. Koci and
were not originally posed. These data sets may provide Strickland (2007) posed a different research question
opportunities for junior faculty members or graduate that could be examined using the data from the longi-
students to become involved in a research program. tudinal study. They found that “a history of both ado-
This type of secondary data analysis requires thought- lescent physical abuse and sexual abuse was
ful, honest consideration to avoid violation of profes- significantly associated with PMS in adulthood.
sional standards, as Aaronson (1994) recommends: Women with a history of adolescent physical and
sexual abuse had significantly more severe PMS pat-
terns with more dysphoria than women without abuse”
(Koci & Strickland, 2007, p. 75).
“Fundamentally, each paper written from the same
study or the same dataset must make a distinct and Methodological Designs
significant scientific contribution. Presumably this is Methodological designs are used to develop the
not only the major overriding criterion used by validity and reliability of instruments to measure con-
reviewers, but also the author’s intent when writing structs used as variables in research. The process is
the paper. When a particular paper is one of several lengthy and complex. The average researcher time
oasis-ebl|Rsalles|1475959179

from the same study, project, or dataset, the author’s required to develop a research tool to the point of
responsibility to identify the source of the data is that appropriate use in a study is 5 years (Waltz et al.,
much greater. To lead readers to think a report is 2010). Methodological studies include assessment of
from a new study or a different dataset than that used content validity, evaluation of the conceptual structure
in the authors’ previous work is dishonest, particu- of a scale, construct validity, and assessment of
larly if the second paper purports to substantiate find- reliability.
ings of the first one…. Apart from the overriding Simons, Stark, and DeMarco (2011) conducted a
concern about ‘milking the data,’ the most common methodological study to develop a new, four-item
objection to multiple articles from a single study is instrument to measure bullying of nurses in the work-
concern about the age of the data…. Concerns in place. These researchers described their process for
nursing about the number of papers generated from developing a valid and reliable questionnaire for mea-
a single study may reflect the emerging status of sec- suring workplace bullying and provided direction for
ondary analysis as a legitimate approach to nursing further research to support continued development of
research…. this instrument. The key ideas of this study are pre-
sented in the following abstract:
256 UNIT TWO  The Research Process

“Studies on workplace bullying either in the U.S. or to be both valid and reliable in measuring bullying in this
internationally rarely include nurses. We tested the con- sample. Findings support use of a one-dimensional, four-
current validity of the Negative Acts Questionnaire- item questionnaire to measure perceived bullying in
Revised (22 items) with a sample of nurses. Five hundred nursing populations. Using a four-item questionnaire
eleven registered nurses (RNs) responded to a mailed decreases participant and researcher burden and makes
survey. Factor, reliability, and regression analyses tested available an outcome measure for future descriptive and
dimensionality, reliability, and construct and criterion predictive interventional research.” (Simons et al.,
validity. Workplace bullying is best seen as a one- 2011, p. 132)
dimensional construct. A subset of four items was found

KEY POINTS
Algorithms for Selecting
• Researchers have developed designs to meet unique
Research Designs research needs as they emerge.
To select a research design, the investigator must • At present, most nurse researchers are using designs
follow paths of logical reasoning. You need a calculat- developed by other disciplines, which are a useful
ing mind to explore all the possible consequences of starting point, but nurse scientists need to go
using a particular design in a study. In some ways, beyond them to develop designs that will more
selecting a design is like thinking through the moves appropriately meet the needs of the knowledge base
in a chess game. You must carefully think through the in nursing.
consequences of each option. The research design • Descriptive studies are designed to gain more infor-
organizes all the components of the study in a way that mation about variables within a particular field of
is most likely to lead to valid answers to the questions study.
that have been posed. Studies with high-quality • Correlational studies examine relationships
research designs implemented over time have a strong between variables but do not provide information
influence on the research evidence generated for prac- on causality.
tice (Brown, 2009; Fawcett & Garity, 2009; Melnyk • Quasi-experimental and experimental designs
& Fineout-Overholt, 2011). examine causality. The power of the design to
To help you select the most appropriate design for accomplish this purpose depends on the degree to
your study, we encourage you to use the algorithms, which the actual effects of the experimental treat-
or decision trees, provided at the end of this chapter. ment (the independent variable) can be detected by
The first algorithm (see Figure 11-28) will help you measuring the dependent or outcome variable.
identify the type of study you plan to conduct or to • Obtaining an understanding of the true effects of
determine the type of study in a publication. The next an experimental treatment requires action to control
four algorithms (see Figures 11-29 through 11-32) will threats to the validity of the findings.
assist you in identifying designs in published studies • Threats to validity are controlled through selection
and in selecting a specific design for a study you plan of subjects, manipulation of the treatment, and
to conduct. Figure 11-29 is an algorithm of commonly measurement of variables.
conducted descriptive study designs, and Figure 11-30 • Currently in medicine and nursing, the randomized
includes common correlational study designs. Figure controlled trial (RCT) design is noted to be the
11-31 is an algorithm for identifying common quasi- strongest methodology for testing the effectiveness
experimental designs, and Figure 11-32 includes of a treatment because of the elements of the design
experimental designs. Most of the designs identified that limit the potential for bias. The CONSORT
in these figures have been discussed in this chapter. 2010 Statement clarifies the steps for conducting
Selecting a design is not a rigid, rule-guided task. As and reporting an RCT.
a researcher, you have considerable flexibility in • Studying primary prevention and health promotion
choosing a design. The pathways within the algo- involves applying a treatment of primary preven-
rithms are not absolute and are to be used as guides. tion (the cause) and then attempting to measure the
Sometimes researchers combine different types of effect (an event that does not occur if the treatment
designs to address their study purpose and their was effective).
research objectives, questions, or hypotheses. Text continued on p. 261
CHAPTER 11  Selecting a Quantitative Research Design 257

Is there a treatment?

No Yes

Is the primary purpose Is the treatment tightly


examination of relationships? controlled by the researcher?

No Yes No Yes

Descriptive Will the sample be Quasi-experimental Will a randomly


design studied as a study assigned comparison
single group? or control group
be used?

No Yes No Yes

Correlational Is the original


design sample randomly
selected?

No Yes

Experimental
study

Figure 11-28  Type of study.


258 UNIT TWO  The Research Process

Examining sequences across time?

No Yes

One group? Following same subjects


across time?

No Yes
No Yes

Comparative Descriptive
descriptive design Data collected Single unit
design across time? of study?

No Yes No Yes

Cross- Study events Longitudinal Case


sectional partitioned study study
design across time?

No Yes

Trend Repeated
analysis measures of
each subject?

Yes No

Cross-sectional design Longitudinal design


with treatment with treatment
partitioning partitioning

Figure 11-29  Descriptive studies.

Describe relationships Predict relationships Test theoretically


between/among between/among proposed
variables? variables? relationships?

Figure 11-30  Correlational studies.

Descriptive correlational Predictive correlational Model testing


design design design
CHAPTER 11  Selecting a Quantitative Research Design 259

No Comparison group? Yes

Pretest? Pretest?

No Yes No Yes

One-group Repeated Posttest Repeated


posttest only measures? only with measures?
design nonequivalent
group

Comparison
with No Yes No Yes
population
values?
Strategy for Compare Compare Interrupted
comparison? experimental and treatments? time series
comparison conditions with
nonequivalent
No Yes comparison
group

Suggest No Yes No Yes


reevaluating
design
Compare Treatment No Yes
Suggest Compare variables? replications?
reevaluating treatment
design and
comparison Untreated Reversed-treatment
conditions comparison nonequivalent
group with comparison group
One-group No Yes pretest and with pretest
posttest only posttest and posttest
design
Simple Interrupted
interrupted time series
time with
series nonequivalent
dependent
No Yes variables No Yes

Nonequivalent Repeated Interrupted Interrupted


dependent treatment time series time series
variables design with with
design removed repeated
treatment replications

Figure 11-31  Quasi-experimental studies.


260 UNIT TWO  The Research Process

No Comparison group? Yes

Posttest Repeated
only comparison measures?
group design

No Yes

Examine effects Repeated


of confounding measures design
variables?

No Yes

Multiple sites? Blocking?

No Yes No Yes

Pretest/posttest Randomized Comparison of Randomized


comparison or controlled multiple levels block design
control group design trials (RCTs) of treatment

No Yes

Examination of Nested
complex relationships designs
among variables in
relation to treatment

No Yes

Examination Multivariate
of multiple designs
causality?

No Yes

Solomon Factorial
four-group designs
design

Figure 11-32  Experimental studies.


CHAPTER 11  Selecting a Quantitative Research Design 261

• Secondary analysis is the study of data previously Costanzo, C., Walker, S. M., Yates, B. C., McCabe, B., & Berg, K.
collected in another study or for a non-research (2006). Physical activity counseling for older women. Western
purpose. Journal of Nursing Research, 28(7), 786–810.
Cramer, M. E., Chen, L. W., Roberts, S., & Clute, D. (2007). Evalu-
• Methodological studies are designed to develop the
ating the social and economic impact of community-based prena-
validity and reliability of instruments to measure tal care. Public Health Nursing, 24(4), 329–336.
constructs used as variables in research. Creswell, J. W. (2009). Research design: Qualitative, quantitative,
• Algorithms for design identification and selection and mixed methods approaches (3rd ed.). Los Angeles, CA:
are provided in Figures 11-29 to 11-32. Sage.
Crombie, I. K., & Davies, H. T. O. (1996). Research in health care:
Design, conduct and interpretation of health services research.
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  http://evolve.elsevier.com/Grove/practice/

12
CHAPTER

Qualitative Research Methodology

Q
ualitative researchers begin the research may adapt the data collection or analysis strategies
process with reviewing the literature and iden- during the study; however, changes are not impulsive
tifying a research problem. Depending on the and must be supported with clear rationale. These
research problem and type of knowledge that is changes are documented as part of maintaining rigor.
needed, the qualitative researcher develops objectives Maintaining rigor in the context of flexibility can
or questions and determines which philosophical be difficult. Therefore, we suggest that you seek
approach will be used to guide the study (see Chapter primary and additional sources of guidance for under-
4). The early steps of the qualitative research process, standing the philosophical base you plan to use, as
which is similar to the quantitative research process, well as the process of collecting and analyzing qualita-
are explored in Chapters 5 and 6. Other steps in the tive data. A research mentor, especially a researcher
research process are implemented differently in or are with more experience with the methods you are using,
unique to qualitative studies. In this chapter, informa- can be invaluable. By sharing their personal experi-
tion about qualitative methodology will be provided ences with the mentees, research mentors can guide
so that you can understand the process and envision less experienced researchers in application of research
what the experience will be like if you conduct a principles in qualitative studies (Kostovich, Saban, &
qualitative study. Collins, 2010).
Qualitative analysis techniques use words rather This chapter provides examples of qualitative
than numbers as the basis of analysis. In qualitative methods used to gather, analyze, and interpret data.
analysis, reasoning flows from the images, documents, Literature reviews, theoretical frameworks, study
or words provided by the participant toward more purposes, and research questions or objectives are
abstract concepts and themes. This reasoning process, described in the context of qualitative methods,
inductive thinking, guides the organizing, reducing, because these are steps in the research process that are
and clustering of the data. To achieve the goal of implemented somewhat differently in qualitative
describing and understanding participant perspectives, studies. The chapter also includes qualitative sampling
qualitative methods of sampling, data gathering, and and the data collection methods of observation, inter-
analyses allow for more flexibility than the methods views, focus groups, and electronically mediated data.
of the quantitative paradigm. Because data analysis Data analysis strategies are described, and examples
begins as data are gathered, insights from early data are provided. The chapter ends with a presentation of
may suggest additional questions that need to be asked methods specific to different philosophical approaches.
or other modifications to the study methods. For
example, suppose a researcher was conducting a
grounded theory study about personal identity after Clinical Context and
losing a limb during military combat. During the inter-
views, a participant mentions feeling he is an imposter Research Problems
when others treat him as a war hero. Although the Qualitative studies are motivated by the desire to
planned interview questions did not include a question know more about a phenomenon, a social process, or
about feelings related to the reactions of others to a culture from the perspectives of the people who are
military service, the researcher may choose to add such experiencing the phenomenon, involved in the social
a question for subsequent interviews. The researcher process, or living in the culture (Creswell, 2007). The

264
CHAPTER 12  Qualitative Research Methodology 265

motivation may be that nurses realize that patient helped or hindered their ability to manage their car-
teaching is not effective with a specific group. A new diovascular medications.
project may be planned for low-income teenage
mothers, but all those implementing the project are
more than 40 years of age and have above average Literature Review for
incomes. A hurricane ravages a community, and disas-
ter relief efforts are not well received by the commu- Qualitative Studies
nity. Persons with sickle cell anemia are living past Both Lesniak (2010) and Swanlund (2010) conducted
age 60 years, and previous studies are focused on a review of the literature and referred to the conclu-
younger persons who are being diagnosed with the sions of their review, which confirmed a lack of evi-
disease. Any of these situations may indicate the need dence about their topics. However, some qualitative
for understanding the insider’s perspective that could researchers defer the literature review until after data
be addressed by a qualitative study. collection and analysis to avoid biasing their analysis
For example, Lesniak (2010) established the need and interpretation of the data (Walls, Parahoo, &
for her phenomenological study by defining the phe- Fleming, 2010). Most often, qualitative researchers
nomenon of self-injury from the literature, indicating review the literature at the beginning of the process to
the problem of uncaring treatment, and identifying the establish the need for the study and to provide guid-
nurses who could most benefit from the information: ance for the development of data collection methods.
A more thorough review of published research find-
ings and theories may occur during data analysis and
“Self-injury behavior is the nonsuicidal, deliberate interpretation to “place the findings of the study in the
infliction of a wound to oneself in an attempt to seek context of what is already known about the phenom-
expression. Self-injury is more prevalent in the ena” (Speziale & Carpenter, 2007).
adolescent population, and often emergency and
advanced practice nurses are the health professionals
who encounter this phenomenon.… [M]any of these Theoretical Frameworks
adolescents have reported receiving less than caring Most qualitative researchers do not identify specific
treatment in those emergency departments. Emer- theoretical frameworks during the design of their
gency nurses are on the frontline in many emergen- studies, as is expected for quantitative studies. The
cies involving adolescents; therefore, a working concern of most qualitative researchers is that design-
knowledge of self-injury behavior would impact their ing a study in the context of a theory will influence
practice. It would benefit them to be provided infor- the researcher’s thinking and result in findings that are
mation concerning the characteristics of adolescents meaningful in the theoretical context but may not be
who are self-injuring, how the behavior is expressive true to the participants’ perspectives on the topic.
in nature, and the repeating emotional patterns of However, the philosophical bases for the various
those who self-injure (Lesniak, 2008).” (Lesniak, approaches to qualitative studies provide theoretical
2010, pp. 137-138) grounding for qualitative studies without predisposing
the data analysis to a single interpretation.
Theory is an explicit component in some qualita-
Swanlund (2010) provided the rationale for her tive research designs. The expectation of grounded
exploratory descriptive study by describing the theory researchers is that qualitative research is induc-
research findings related to medication management tive in nature and that theory will emerge from the
in older adults. She noted that other researchers had data (Speziale & Carpenter, 2007; Walls et al., 2010).
focused on medication management for a single Parse’s (2001) research methodology begins with
illness, instead of the more realistic situation of taking selecting phenomena to study that are universal human
medications for multiple chronic illnesses. “Addition- experiences, move through analysis using Parse’s
ally, the research questions for these studies were theoretical principles as a guide, and end with evaluat-
derived from the healthcare providers’ perspectives. ing the findings for their contribution to her theory.
These studies have left many questions unanswered Researchers who used Parse’s research methodology
regarding the reasons for nonadherence from the per- usually present their findings using language from
spective of the older adult” (Swanlund, 2010, p. 23). Parse’s theory. Chen (2010) used Parse’s research
On the basis of this reasoning, Swanlund asked 27 method to study the lived experiences of persons
adults older than 74 years to describe situations that with spinal cord injuries. From the stories told by the
266 UNIT TWO  The Research Process

participants, Chen stated the structure of the experi- TABLE 12-1  Selected Examples of Purpose
ence in one sentence: “The lived experience of moving Statements in Qualitative Studies
forward is confronting difficulties, going on and
finding self-value and confidence to affirm oneself Qualitative
while co-creating successes amid opportunities and Approach Purpose Statement
restrictions” (p.1138). Chen further transformed the Phenomenological “[E]xplore patients’ lifeworld and way
structure through conceptual integration into the con- research of managing life with advanced PD
clusion that “moving forward is transforming the [Parkinson’s disease] prior to DBS
[deep brain stimulation] and to
valuing of originating ‘enabling-limiting’ ” (p. 1138).
illuminate what they expect from
Exploratory qualitative study design may benefit life following DBS” (Haahr,
from making explicit the researcher’s theoretical per- Kirkevold, Hall, & Ostergaard,
spective on the research problem. Scott and Wilson 2010, p. 410).
(2011) used the ecology theory for their qualitative Grounded theory “[D]escribe the processes that patients
study of African Americans living in the South in the research in palliative home care use to
United States. The ecology theory was consistent with maintain hope” (Ollson, Ostlund,
their research objective, “identifying potential social Strang, Grassman, & Friedrichsen,
determinants of health among African Americans in a 2010, p. 607).
rural community in the Deep South, from the perspec- Ethnographic “[U]nderstand the culture care value
tives of African American community members” research and beliefs of women during
(p. 3). In Singapore, researchers Cheng, Qin, and Tee addiction and recovery” (Lange,
(2009) interviewed patients with hematological disor- 2007, p. 74).
ders about their experiences in isolation. They noted Exploratory “[D]etermine the situations or variables
that Maslow’s (1987) hierarchy of needs theory and qualitative that influence successful
research cardiovascular medication
Roy’s Adaptation Theory (1976) guided the develop-
management, as perceived by
ment of the interview questions and the data analysis. community-dwelling adults over age
Qualitative researchers who use frameworks during 74” (Swanlund, 2010, p. 23).
study development must maintain intellectual honesty
Historical “[C]harts the international travels of
to prevent the theoretical perspective from obscuring
research four especially mobile nurses… tells
the perspectives of the participants. Your decision these nurses’ stories and analyzes
about whether to identify a theoretical perspective their ideologies of development and
should be consistent with the research approach you progress” (Irwin, 2011, p. 78).
have chosen. If a theoretical perspective has shaped
your views of a research problem, you should acknowl-
edge that influence and indicate explicitly the compo- on life-world of the participants and the grounded
nents of the study guided by the theory. theory study focused on the processes used to maintain
hope. The purposes listed in Table 12-1 are consistent
with the study’s identified philosophical approach.
Purposes
The purpose should clearly identify the goal or aim of
the study that has emerged from the research problem Research Objectives
and literature review. The purpose of qualitative
studies should include the phenomenon of interest, the or Questions
population, and the setting (see Chapter 5). Ask your- Hypotheses are not appropriate for qualitative studies
self, “Can I achieve this purpose with a qualitative because hypotheses specify outcomes of studies and
study?” Study purposes such as testing an intervention variables that are to be manipulated or measured,
and determining the effectiveness of a program are not actions that are not consistent with the philosophical
consistent with qualitative approaches. However, a orientation of qualitative research. Qualitative
qualitative researcher could address the participants’ researchers may identify research objectives or ques-
experiences with the intervention or their perceptions tions to connect the purpose of the study to the plan
about a program. The purpose of qualitative studies for data collection and analysis. Because qualitative
will vary slightly depending on the qualitative research is more open-ended and the focus is on the
approach that is being used. For example, note in participants’ perspectives, qualitative researchers may
Table 12-1 that the phenomenological study focused not specify research objectives or research questions
CHAPTER 12  Qualitative Research Methodology 267

in order to avoid prematurely narrowing the topic. In should be congruent with the theory. Schumacher
their study of the occupational stress of children’s pal- clearly stated appropriately broad questions that
liative care nurses, McCloskey and Taggart (2010) included the study’s sample (rural Dominicans) and
identified two research objectives: desired outcome (plan culturally congruent nursing
care). The following three themes were identified,
each consistent with Leininger’s theory: “(a) family
“Two objectives were set. Firstly, to explore the presence is essential for meaningful care experiences
experiences of occupational stress within nurses and care practices, (b) respect and attention are central
working in three distinct young people’s palliative to the meaning of care, and (c) rural Dominicans both
care services (i.e., hospice care, hospital care and value and use generic (folk) and professional care
community care) and secondly, to examine the con- practices” (Schumacher, 2010, p. 97).
sequences of such stress upon the nurses’ lives.”
(McCloskey & Taggart, 2010, p. 234)
Obtaining Research Participants
These objectives clearly stated and did not limit The goal of sampling for quantitative studies is to
what the researcher might find. These are ideal char- obtain data from a subgroup of a population that is
acteristics of objectives for a qualitative study. McClo- statistically representative of the population with the
skey and Taggart (2010) found four themes that intent of being able to generalize the findings to the
described the experiences of the nurses: work demands, population (see Chapter 15). Qualitative researchers
relationships, maintaining control, and support and seek participants who have experienced the phenom-
roles. The theme of relationships was seen as particu- enon of interest (Speziale & Carpenter, 2007) and are
larly challenging because of emotional demands and thus deemed to be “information-rich cases for in-depth
ethical conflicts. study” (Liamputtong & Ezzy, 2005, p. 46). For ethno-
A research question establishes “the perimeters of graphic studies, the participants may also include key
the project and suggest the methods to be used for data informants who are knowledgeable of the culture being
gathering and analysis” (Corbin & Strauss, 2008, p. studied. The selection of participants is nonrandom and
19). Research questions may be broadly stated or may may not be totally specified before the study begins.
be based on a theoretical framework if the researcher Depending on the research question and the aims
has identified a framework. Schumacher (2010) iden- of the study, the researcher may use more than one
tified Leininger’s (1985) theory of culture care diver- sampling strategy during the study. For example, a
sity and universality as the conceptual guide for her researcher who is studying the experience of reacting
ethnographic study with persons in rural Dominican to a diagnosis of breast cancer may choose to select
Republic. Schumacher identified four comprehensive only women who have not previously been diagnosed
research questions based on the theory. Questions 2 with cancer, have not had a family member die from
and 4 are provided as examples: breast cancer, and have been diagnosed within the last
6 weeks. This approach to sampling is called criterion
sampling. Similar logic can be applied to identify par-
“Research Question 2: In what ways do technological, ticipants for a focus group, when it is desirable to have
religious, philosophical, kinship and social, cultural, participants who can identify with each other’s experi-
political and legal, economic, and educational factors ences. When used for focus groups, this sampling
influence care meanings, beliefs, and practices of method is called homogeneous group sampling (Liam-
Dominicans?… puttong & Ezzy, 2005). Table 12-2 provides defini-
“Research Question 4: In what ways can Leini- tions and references for sampling strategies that are
nger’s care modes of preservation/maintenance, frequently used by qualitative researchers. These sam-
accommodation/negotiation, and repatterning/ pling strategies are not mutually exclusive and may be
restructuring be used to plan nursing care that is labeled differently by various researchers.
culturally congruent for rural Dominicans?” (Schu­ The sample for a rigorous qualitative study is not
macher, 2010, p. 94) as large as the sample for a rigorous quantitative study.
The researcher stops collecting data when enough
Schumacher (2010) developed research questions rich, meaningful data have been obtained to achieve
that were congruent with Leininger’s theory. When a the study aims. For new researchers, this answer to
researcher identifies a conceptual framework or “How big should my sample be?” is totally unsatisfac-
guiding theory for a study, the research questions tory. When applying for human subjects’ approval, the
268 UNIT TWO  The Research Process

TABLE 12-2  Sampling Strategies used by Researcher-Participant Relationships


Qualitative Researchers
One of the important differences between quantitative
research and qualitative research is the nature of rela-
Sampling Definition tionships between the researcher and the individuals
Convenience Inviting participants from a location or group being studied. The nature of these relationships has an
sampling because of ease and efficiency. impact on the data collected and their interpretation.
Snowball Researcher asks participants to refer others In varying degrees, the researcher influences the indi-
sampling who have had similar experiences to viduals being studied and, in turn, is influenced by
participate in the study; also called chain them. The mere presence of the researcher may alter
sampling or network sampling.
behavior in the setting. The researcher desires to
Historical Exhaustive search for all relevant, surviving connect at the human level with the participant (Corbin
sampling primary and secondary sources about an
& Strauss, 2008). Although this involvement is con-
event or phenomenon that occurred in the
past (Lundy, 2012).
sidered a source of bias in quantitative research, quali-
Purposive Recruitment of participants as sources of data
tative researchers consider it to be a natural and
sampling that can provide and expand upon the data necessary element of the research process. Shorter and
needed to achieve the study aims. Stayt (2010, p. 161) noted that “the research findings
Theoretical Recruitment of participants who are are thus a product of a co-constructive process between
sampling* considered to be best sources of data related researcher and participant.”
to the study (Wuest, 2012); additional The researcher’s personality is a key factor in
participants may be recruited to validate or qualitative research, in which skills in empathy and
expand upon emerging concepts; associated intuition are cultivated. You will need to become
with grounded theory approaches. closely involved in the subject’s experience to inter-
Criterion Recruitment of participants who do or do not pret it. Participants need to feel safe and to be able to
sampling* have certain characteristics deemed to affect trust the researcher prior to sharing their deepest
the phenomena being studied (Liamputtong experiences with the researcher. It is necessary for
& Ezzy, 2005). you to be open to the perceptions of the participants
Maximum Recruitment of participants who represent rather than attaching your own meaning to the experi-
variation potentially different experiences related to ence. To do this, you need to be aware of personal
sampling* the domain of interest (Seidman, 2006).
experiences and potential biases related to the phe-
Critical case Recruitment of participants whose experiences
nomenon being studied. It is helpful to document
sampling* with the research topic are expected to be
very different.
these experiences and potential biases before and
during the study in a reflective journal, to be able to
Deviant case Recruitment of participants who may be set them aside or bracket them. For example, a
sampling* outliers or represent extreme cases of the
researcher who plans to interview women undergoing
domain of interest.
irradiation for breast cancer would need to acknowl-
*Considered by some authors to be subtypes of purposive sampling. edge that his/her own mother died from complica-
tions of breast cancer. This awareness and ability to
researcher will be asked the maximum sample size. be involved with the participants and yet be able to
Giving a generous range of 12 to 25 can be a way to analyze the data abstractly with intellectual honesty is
answer this question but will depend on the study called reflexivity. Reflexivity consists of the ability to
design. Researchers who use focus groups often have be aware of your biases and past experiences that
larger samples. The actual number depends on when might influence how you would respond to a partici-
data saturation is achieved. Data saturation is the pant or interpret the data. This ability is critical in
point when new data begins to repeat what has already qualitative studies because data emerge from a rela-
been found. Patterns emerge in the data. The researcher tionship with the participant and are analyzed in the
has the data needed to answer the research question mind of the researcher, rather than through a statisti-
and remain true to the principles of the study design. cal program (Wolf, 2012).
Marshall and Rossman (2011) indicate that a better
term is theoretical sufficiency, because one can never
completely know all there is to know about a topic. Data Collection Methods
Chapter 15 also provides some detailed ideas about Because data collection occurs simultaneously with
sampling methods and sample size in qualitative data analysis in qualitative studies, the process is
studies. complex. Collecting data is not a mechanical process
CHAPTER 12  Qualitative Research Methodology 269

that can be completely planned before it is initiated. periods. If taking notes is a problem, then the researcher
The researcher as a whole person is completely needs to record the observations as soon as possible
involved—perceiving, reacting, interacting, reflecting, afterwards.
attaching meaning, and recording. For a particular Collecting data through unstructured observation
study, the researcher may need to address data collec- may evolve into more structured observations. The
tion issues related to relationships between the researcher may begin with few predetermined ideas
researcher and the participants, reflect on the mean- about what will be observed. As the study progresses,
ings obtained from the data, and organize management the researcher clarifies the situations or areas of focus
and reduction of large volumes of data. Qualitative that are most relevant to the research questions and
researchers are not limited to a single type of data or begins to structure the observation. A researcher
collection method during a study. For example, one observing parent behavior in an ambulatory pediatric
research team used interviews and focus groups in care clinic may initially focus on the interaction of
their study of fall prevention for older people in parents with their children in the waiting area and in
the community (Dickinson, Machen, Horton, Jain, & the room with the provider. During data collection,
Maddex, 2011). Lopez (2009) used data from semi- the researcher begins to notice common nurturing
structured interviews, nonparticipant observation, and behaviors of the parents and, from these observations,
informal conversational interviews to describe the develops a checklist to use while observing. In this
processes used to make decisions about the care of way, the researcher has structured the observations
nursing home residents who become acutely ill. Quali- that might be the focus of future studies. Other
tative data collection may also be combined in a study researchers may enter the setting with a checklist or
with the collection of quantitative data. These mixed- tool for documenting observations and revise the tool
methods studies are described in detail in Chapter 10. as needed. The notes made during and immediately
Observations, interviews, and focus groups are the following the observations are called field notes
most common methods of gathering qualitative data, (Speziale & Carpenter, 2007). Recording observa-
and each is described in detail, followed by an example tions can be as simple as using a pad and writing
from the literature. Electronic means of qualitative utensil in a public place or as sophisticated as pro-
data collection, such as photographs, videos, and ducing an electronic diagram of the locations of
blogs, are briefly described as well. Following the nurses by having them wear positioning devices.
general types of data collection, methods specific to Observations may be supplemented by taking photo-
each qualitative approach are discussed. graphs in the setting or video recording an observa-
tion. After the observation, the diagrams of the
Observations nurses’ positions, the photographs, or the videos may
In many qualitative studies, the researcher observes serve to remind the observer of specific elements of
social behavior and may participate in social interac- the situation. In addition, the researcher may analyze
tions with those being studied. Observation is collect- the video by viewing short segments and making
ing data through listening, smelling, touching, and notes about each. By reflecting on the photographs
seeing, with an emphasis on what is seen. Even when and videos, the researcher may identify details that
other data collection methods are being used, such as were not captured in the actual observation. The field
interviews, you want to stay aware of your surround- notes, notes about the electronic records made during
ings and attend to the nonverbal communication that the observation, and the researcher’s memories of
occurs between the participant and others in the imme- and reflections about being in the setting are the data
diate surroundings (Marshall & Rossman, 2011). that are analyzed.
Unstructured observation involves spontaneously The researcher, by virtue of being in the setting,
observing and recording what one sees. Although becomes a participant to some degree. The balance
unstructured observations give the observer freedom, between participation and observation has been
there is a risk that the observer may lose objectivity described in four ways. The first is complete partici-
or may not remember all of the details of the event. pation. The people in the situation may not be aware
The most complete way to collect observation data is that the participant is a researcher (Speziale &
to video-record the situation being studied, but doing Carpenter, 2007). In public settings, a researcher can
so may alter the behavior of those being observed or ethically observe people and interactions without
may not be possible because of confidentiality con- obtaining permission (Liamputtong & Ezzy, 2005). In
cerns. If video recording is not possible, then the less public settings, the researcher may observe others
researcher may take notes during the observation who learn later that he or she is a researcher. When
270 UNIT TWO  The Research Process

the researcher’s role is unknown to the study partici- collection was observation. Note the emphasis placed
pants, they need to have consented to incomplete dis- on gaining access to the setting.
closure before the study is conducted. After the study,
they must be debriefed regarding the undisclosed
aspects of the study (see Chapter 9). The participants “[T]he focus was on gaining entry to the hospital and
have the option as to whether the data the researcher simultaneously to each unit, establishing the research-
collected about them is included or not in the study. er’s role, developing relationships with the nursing
When the researcher is in the participant as observer staff, becoming familiar with the general routines and
role, participants are aware of the dual roles of the rhythms of practice, as well as beginning to map out
researcher from the beginning of the study. Full the social context of each unit. During this phase, the
engagement in the situation may interfere with the primary method was participant observation. The
researcher’s ability to note important details and researcher (LLC) [one of the authors] was present on
move within the setting to follow an evolving situa- the unit through the course of normal care primarily
tion. In these situations, the role of observer as par- for the purpose of observation, but also interacted
ticipant may be more appropriate. As the term informally with staff in hallway conversations. Data
indicates, the researcher’s observer role takes priority were recorded and analysed on an ongoing basis using
and is the focus of the data collection. Complete field notes that included a daily event log and a series
observation occurs when the researcher remains of observational, theoretical and methodological
passive and has no direct social interaction in the notes.” (Lauzon Clabo, 2008, p. 533)
situation.
When the researcher is observing for the purposes
of data collection, multiple types of information Lauzon Clabo (2008) followed the initial phase of
should be noted. The observer may gather data on the data collection with observations of individual nurses
physical setting, the people in the setting, and their on the day shift. Each of these observations was fol-
activities and interactions. Activities and interactions lowed by an interview with the nurse.
can be described in terms of their frequency, duration,
precipitating factors, and organization. Hall, Pedersen,
and Fairley (2010) observed the activities and interac- “The observations provided an overall sense of how
tions of nurses during their work on medical and surgi- any one nurse went about conducting a pain assess-
cal units in three hospitals. The data from 480 hours ment, while the semi-structured interviews captured
of observations were analyzed to produce a frame- more detail regarding the nurse’s actual thinking,
work to describe interruptions by source, type, cause, especially in regard to the approaches used to assess
the activity that was interrupted, and the outcomes of each client’s pain.” (Lauzon Clabo, 2008, p. 533)
the interruptions. In addition to interviewing nurses in
a burn intensive care unit, Zengerle-Levy (2006)
observed them for 134 hours as they cared for pediat- The final phase of the study was a focus group on
ric patients. Through observation, the researcher was each unit, during which Lauzon Clabo (2008) pre-
able to “uncover common practices that were not sented a rough draft of the findings for that unit. On
articulated” about how they cared for children in the Unit A, the nurses had similar expectations for level
unit in which parents were absent (p.227). Hall et al. and type of pain for specific surgical procedures. They
(2010) used observation as the primary source of data. found caring for patients whose pain did not follow
Zengerle-Levy (2006) used observations to supple- the usual trajectory to be challenging because of the
ment the data collected during the interview. In both need to contact the physician frequently and the desire
cases, the researchers clearly described the purpose of to keep the physician happy. On Unit B, the nurses
the observations and details such as total time spent focused on the patient’s description of his or her pain
and types of activities observed. This information and supplemented it with objective and subjective
indicates that observations were effectively used and data, such as the use of pain medications. Lauzon
the study was rigorous. Clabo (2008) concluded that pain assessment was a
synthesis of the patient’s narrative, evidence from
Example Study Using Observation behaviors and medication usage, and expectations
Lauzon Clabo (2008) studied pain assessment on two based on experience. This study had rigorous method-
postoperative units in a teaching hospital. During the ology as evidenced by the researcher’s going back to
first phase of the study, her primary method of data the nurses as individuals (interviews) and as a group
CHAPTER 12  Qualitative Research Methodology 271

(focus group) to supplement and validate the initial private areas, is convenient for the participant
findings. This rigor gives the reader of the study con- (Speziale & Carpenter, 2007), and considers the
fidence to view the results as credible. The clinical safety of those involved. Accessibility and confiden-
implications are that nurses must allow the patient’s tiality should also be considerations. An exam room
narrative to take precedence over behaviors, medica- may not be a neutral site for a study exploring the
tion usage, and the nurses’ expectations in the assess- patient-provider relationship. During a community-
ment of postoperative pain. based study, the researcher’s appearance may become
associated with a stigmatized topic, such as HIV
Interviews infection, substance use, or domestic violence. A
Interviews are interactions between the participant public place may not protect the participant’s identity
and the qualitative researcher that produce data as and confidentiality. A participant’s home may not be
words. The researcher as an interviewer seeks infor- safe for the researcher to come to at certain times of
mation from a number of individuals, whereas the day. A participant’s home, however, can offer a sense
focus group strategy is designed to obtain the perspec- of comfort and familiarity for the participant and
tive of the normative group, not individual perspec- provide the researcher insight into the participant’s
tives. Interviews may also be conducted in quantitative experience. Gharaibeh and Owels (2009) conducted
studies to assist subjects in the completion of a survey a qualitative study of Jordanian women who stayed
or questionnaire. This assistance may include reading in abusive relationships (N = 28). They allowed par-
the questions to subjects with limited literacy and ticipants to “choose the place of the interview in
documenting their responses to the questions in person order to make them feel comfortable and secure” (p.
or over the phone. The focus of this section is inter- 379). All participants chose to be interviewed in their
viewing in qualitative studies. homes when the husband or other relatives were not
Depending on the research question, the qualitative present.
researcher may conduct multiple interviews with each The format of the interview can be unstructured,
participant or may follow an initial interview with semistructured, or structured. Unstructured inter-
another during which the participant can review the views are informal and conversational and may be
researcher’s description of the first interview. Seidman useful during an ethnographical study or the early
(2006) recommends that the researcher interview each stages of a study. Most qualitative interviews are sem-
participant three times for phenomenological studies. istructured, or organized around a set of open-ended
The first interview is focused on a life history, the questions. Some experts call these topical or guided
second on details of the phenomenon, and the third on interviews (Marshall & Rossman, 2011). The degree
reflection on the experience. Using multiple inter- of guidance may be as minimal as having one initial
views allows the relationship between the researcher abstract question or prompt or as structured as multi-
and the participant to develop. Over time, the partici- ple predefined questions to narrow the interview
pant may learn to trust the researcher more and reveal to specific aspects of the phenomenon being studied.
insights about his or her experiences that contribute to In either case, the researcher remains open to how
the study’s findings. Follow-up interviews may be the participant responds and carefully words follow-
used to share the results of the ongoing data analysis up questions or prompts to allow the emic view,
with participants and ask additional questions for the participant’s perspective, to emerge. Structured
clarification. Multiple interviews may be required to interviews are organized with narrower questions in
study an ongoing process. For a grounded theory a specific order. The questions may be asked without
study of women undergoing coronary artery bypass follow-up questions, and the researcher responses may
graft surgery, Banner (2010a) interviewed the women be scripted in a structured interview (Marshall &
preoperatively and at 6 weeks and 6 months after Rossman, 2011). Having this level of structure may
surgery. decrease the anxiety of less experienced interviewers
In addition to determining how many times each but may result in findings that reflect the etic, or out-
participant will be interviewed, the researcher will sider’s, view.
need to plan the interview location, format, and The words spoken and the nonverbal communica-
method of documenting the interview. Interviews tion during an interview are the data. Some research-
might be conducted in a room in a public library, a ers prefer to audio-record or video-record the interview
fast-food restaurant at an off-peak time, an exam and focus on the interaction and relationship with the
room in a clinic, or the participant’s home. The loca- participant during the interview (Banner, 2010b). A
tion should be selected as a neutral place that has recording of the interview results in a “transportable,
272 UNIT TWO  The Research Process

repeatable resource that allows multiple hearings or Participants may need to be able to catch a bus to get
viewings as well as access to other readers” (Nikander, home, pick up children from child care, or stop to take
2008, p. 229). The participant must be aware that the a dose of medication.
interview is being electronically recorded, but the less
obtrusive the equipment, the more quickly the partici- Establishing a Positive Environment
pant will forget its presence, relax, and speak more for an Interview
freely. Logistically, the researcher needs to plan ahead When preparing for an interview, establish an environ-
to have the power cords or batteries needed for the ment that encourages an open, relaxed conversation.
recording device (Banner, 2010b). Using batteries Be sensitive to the physical surroundings. Sit in com-
may make the device less obtrusive. A sensitive micro- fortable chairs so that neither you nor the participant
phone will allow you to pick up even faint or distorted is facing windows with direct sunlight. Sitting at a
voices, thereby increasing your ability to make an table may be more comfortable and provides a surface
accurate transcription later. If tapes are being used, for the participant to sign the consent form or com-
ensure that the lengths of the tapes are adequate to plete a demographic form. You may want to offer
record the entire interview with few interruptions to water or other beverage as a way to provide time for
change the tape. More likely, the recording will be a social connection prior to beginning the interview.
made on a digital device that can be saved on a com- When dressing for an interview, the researcher needs
puter for transcription. In some situations, recording to consider how the participant is likely to be dressed.
devices may not be appropriate or the participant may Dressing in formal business attire or a nursing uniform
prefer that the interview not be recorded. During the may emphasize the power differences in the relation-
unrecorded interviews, the researcher may take notes ship. Dressing too casually may be viewed as an indi-
and set aside time immediately following the inter- cation that the interaction is not important to the
view to document the interview with as much detail researcher. Power issues may affect the effectiveness
as possible. of the interview.

Learning to Interview Conducting an Effective Interview


Preparing to interview is critical because interviewing As the researcher, you have the power to shape the
is a skill that directly affects the quality of the data interview agenda. Participants have the power to
produced (Marshall & Rossman, 2011). Researchers choose the level of responses they will provide. You
must give themselves the opportunity to develop this might begin the interview with a broad request such
skill before they start interviewing study participants. as “Describe for me your experience with…” or “Tell
A skilled interviewer can elicit higher-quality data me about.…” Ideally, the participant will respond as
than an inexperienced interviewer by allowing for though she or he is telling a story. You respond non-
silence or asking a probing follow-up question without verbally with a nod or eye contact to convey your
alienating the participant. Unskilled interviewers may interest in what is being said. Try to avoid agreeing or
not know how or when to intervene, when to encour- disagreeing with what the participant is saying. Being
age the participant to continue to elaborate, or when nonjudgmental allows the participants to share their
to divert to another subject. The interviewer must experiences more freely. When it seems appropriate,
know how to handle intrusive questions. For practice, encourage your subject to elaborate further on a par-
conduct interviews with colleagues with experience in ticular dimension of the topic. Use of nonthreatening
interviewing (Munhall, 2012). These rehearsals will but thought-provoking questions is often called
help you identify problems before initiating the study probing. Participants may need validation that they
(Banner, 2010b). You may want to conduct one or are providing the needed information. Some partici-
more trial interviews with individuals who meet the pants may give short answers, so you may have to
sampling criteria to allow you to try out the proposed encourage them to elaborate. When the participant
questions. Practice sessions and pilot interviews also stops talking, ask a follow-up question that reflects
allow you to determine a realistic time estimate for the back on what you have heard. Interviewer responses
interviews. Researchers often underestimate the time should be encouraging and supportive without being
needed for an interview. Allow yourself enough time leading. Listening more and talking less is a key prin-
so that you can conduct the interview without feeling ciple of effective interviews (Seidman, 2006). That
rushed. Be sensitive to time-related concerns of the includes tolerating silence. If the participant is not
participants, however, and offer the option of stopping talking but seems to be thinking or considering the
if an interview is going longer than expected. topic, stay quiet. Silence can be a powerful invitation
CHAPTER 12  Qualitative Research Methodology 273

that allows the participant to show deeper emotions health professionals readily available because they
and thoughts. were hospitalized. In other settings, the researcher
needs to prepare to refer the participant if necessary.
Problems during Interviews Emotional expression during an interview may be
Difficulties can occur during interviews. Common expected, depending on the topic. When the partici-
problems include interruptions such as telephone calls pant becomes distressed or overcome with emotion,
or text messages, “stage fright” that often arises when however, you may choose to turn off the recording
the participant realizes he or she is being recorded, device and stop the interview completely or for a few
failure to establish a rapport with your subject, verbose minutes. You may be able to continue if the participant
participants, and those who tend to wander off the is able to become composed. Stay with the individual,
subject. Turn off or silence your cell phone at the offer a tissue, and move closer to the participant. Rec-
beginning of the interview, and ask the participant to ognize topics that are more likely to be distressing,
do the same. If a participant seems paralyzed by the and have a plan developed for emergency assistance
presence of the recording device, move the device out if needed or a list of mental professionals available if
of his or her line of sight if possible. Ask demographic support or a referral is needed. For example, you
questions or factual questions to ease into the inter- might schedule interviews in collaboration with the
view. When the participant moves to a subject that you chaplain or psychiatric mental health nurse practitio-
think is unrelated to the focus of the study, you may ner to ensure that one of them is available for consulta-
want to ask how this new subject is related to previous tion when you will be interviewing family members
comments on the topic of interest. You may be sur- whose spouses are receiving hospice care. Recognize
prised to learn that what you perceived to be unrelated that you, the researcher, may also need emotional and
is associated with the topic in the participant’s per- psychological support. The researcher may be strongly
spective. You may also need to tactfully guide the affected by the stories of the participants. Arrange to
interview back to the topic. Remind participants that have a mentor or trusted friend available to talk with
they can decline answering any question and can end before or after interviews. The researcher may need to
the interview at any time. rest following an interview, because the experience
The physical, mental, and emotional condition of requires heightened focus for an extended period,
the participant may cause difficulties during the inter- which can result in fatigue (Creswell, 2007).
view. The data you obtain are affected by characteris-
tics of the person being interviewed. These include Example Study Using Interviews
age, ethnicity, gender, professional background, edu- Greco, Nail, Kendall, Cartwright, and Messecar
cational level, and relative status of interviewer and (2010), in the report of their grounded theory study on
interviewee as well as impairments in vision or mammography decision making among older women
hearing, speech impediments, fatigue, pain, poor (N = 23), limited the sample to women who were 55
memory, disorientation, emotional state, and language years or older and had at least one relative who had
difficulties. Although institutional review boards tend been diagnosed with breast cancer. They clearly
to view interviews as noninvasive, interviews are an described the rationale for the study, the selection of
invasion of the psyche. For some participants, the participants, and collection of data in the following
experience may be therapeutic. However, an interview excerpt:
is capable of producing risks to the health of the par-
ticipant. Therefore, the interviewer must always avoid
inflicting unnecessary harm upon the participant. “[D]ecision-making studies of women with a breast
Participants with fatigue or pain related to illness or cancer family history have largely focused on younger
treatments should be offered the opportunity to stop, women who have undergone genetic testing for
take a break, or schedule a second interview for breast cancer disposition.… In this study, older
another day. woman are defined as 55 years of age and older since
In a phenomenological study of persons hospital- 65% of the breast cancers occur in this age group.…
ized for depression, Moyle (2002) noted challenges Women who met the study criteria and agreed to
with obtaining rich data due to the flattened emotions participate were interviewed in person at a private
and slowed cognition that may result from severe place of their choosing. Recruitment was discontin-
depression. During the study, some of the participants ued when the analysis provided no new information
underwent electroconvulsive therapy that led to some contributing to the development of the theory. The
memory loss. The participants in Moyle’s study had
274 UNIT TWO  The Research Process

Latino immigrants (Coffman, Shobe, & O’Connell,


researcher conducted open-ended interviews using a 2008) and the excessive drinking of college students
semi-structured interview guide. For the purpose of (Dodd, Glassman, Arthur, Webb, & Miller, 2010) have
describing the participants, demographic data were also been studied by means of focus groups. Using
collected at the end of the interview. Field notes were focus groups, researchers have explored nurses’ expe-
maintained to describe the environmental and emo- riences such as the stress of providing palliative care
tional context of the interviews. Interviews were for children (McCloskey & Taggart, 2010) and the
recorded and transcribed verbatim, with all person- strategies used in critical care units to prevent and
ally identifying information deleted.” (Greco et al., correct medical errors (Henneman et al., 2010). Focus
2010, p. 349-350) groups of nurses have also been the data collection
method for studies of the barriers school nurses
encounter when talking to parents about their chil-
dren’s weight (Steele et al., 2011) and teamwork as
Greco et al. (2010) used a collaborative process to experienced by nurses in the neonatal intensive care
come to consensus during the data collection and units and emergency departments (Simmons & Sher-
analysis process. In addition, some participants were wood, 2010).
interviewed a second time to assist in refining the Instrument development and refinement are fre-
theory. These actions strengthened the data collection quently based on the data collected during focus
and analysis process and improved the credibility of groups. An example of instrument development was
the findings. The researchers produced a theory they the study conducted by Anatchkova and Bjorner
called “guarding against cancer” (p. 351). Study limi- (2010). They conducted focus groups to identify key
tations included an all-white sample and the use of elements of role functioning as a part of health. The
self-report for mammograms. Implications for prac- roles identified were to be used to develop items for
tice are that health professionals recommending that a research instruments measuring quality of life. An
woman obtain a mammogram was a strong motivator. example of instrument refinement was the study con-
Another was that older women may believe they no ducted by Owen-Smith, Sterk, McCarty, Hankeson-
longer need to be screened and so may stop obtaining Dyson, and DiClemente (2010). Their sample consisted
mammograms. of persons diagnosed with AIDS who used comple-
mentary and alternative medicine (CAM) therapies.
Focus Groups During two focus groups, the researchers provided
Focus groups were designed to obtain the partici- the copy of an existing measure of CAM use and
pants’ perceptions in a focused area in a setting that is asked each participant to complete the instrument. Fol-
permissive and nonthreatening. One of the assump- lowing completion of the instrument, the participants
tions underlying the use of focus groups is that interac- were asked to identify the strengths and limitations of
tions among people can help them to express and the instrument. The third and fourth focus groups were
clarify their views in ways that are less likely to occur not given the CAM instrument but were asked to
in a one-on-one interview (Gray, 2009). People in a describe what CAM meant to them. By combining the
focus group who are alike in some characteristic may data from the focus groups, the researchers developed
feel safer or less anxious when talking about difficult a revised CAM instrument. They validated their find-
experiences. Many different communication forms ings by having participants in a fifth focus group com-
occur in focus groups, including teasing, arguing, plete a computer-based version of the revised
joking, anecdotes, and nonverbal clues, such as gestur- instrument and provide feedback. This rigorous process
ing, facial expressions, and other body language. produced a revised instrument that will be appropriate
Focus groups as a means of data collection serve a for use with the persons diagnosed with AIDS.
variety of purposes in nursing research. Focus groups The effective use of focus groups requires careful
have been used to understand the experiences of planning. The location needs to be carefully selected
people who are receiving care or may need care. to ensure privacy, comfort, and safety. Meeting rooms
Researchers have used focus groups to explore the in public facilities such as schools, libraries, or
fatigue of patients following a stroke (Finn & Stube, churches may be appropriate community locations for
2010) and the social support needs of older African focus groups, depending on the research question and
Americans who have survived cancer (Hamilton, the study aims. For focus groups with specific popula-
Moore, Powe, Agarwai, & Martin, 2010). The use of tions, the facility used for support services may have
prescription medications without medical care of a quiet room that is accessible and known to
CHAPTER 12  Qualitative Research Methodology 275

participants. Nurses or other health professionals may cash, phone card, gift card, or bus token incentives.
participate in focus groups in the healthcare facility Cash payments are, of course, the most effective if the
but might be more forthcoming in a location away resources are available through funding. Other incen-
from the facility. For a focus group with Hispanic tives include refreshments at the focus group meeting,
persons who were infected with HIV, a hospital T-shirts, coffee mugs, gift certificates, and coupons.
meeting room was selected. When the research team Over-recruiting may be necessary; a good rule is to
approached the reception desk in a hospital waiting invite two more potential participants than you need
area to ask the location of the room, the staff person for the group.
stated the location of the “AIDS focus group” in a loud Recruiting participants with common social and
voice heard by the waiting visitors (Gray, 2009). In cultural experiences creates more homogeneous
this case, the researchers’ schedule for travel to the groups (Liamputtong & Ezzy, 2005). Selecting par-
out-of-town focus group did not allow for previewing ticipants who are similar to one another in lifestyle or
the location so they did not have the opportunity to experiences, views, and characteristics is believed to
inform the reception staff of the name being used for facilitate open discussion and interaction. These char-
the focus group meeting. If a focus group is planned acteristics might be age, gender, social class, income
for a sensitive topic, indicate on the invitation and any level, ethnicity, culture, lifestyle, or health status. For
materials the name by which the group will be identi- example, for a study of barriers to implementing HIV/
fied. For example, instead of identifying the group as AIDS clinical trials in low-income minority commu-
the “Testicular Cancer Study,” a better name might be nities, focus groups might be organized by race/
the “Men’s Health Study.” ethnicity and gender. In heterogeneous groups, com-
Other logistics include the expected length of munication patterns, roles, relationships, and tradi-
the meeting, recruiting subjects, and recording the tions might interfere with the interactions within the
group interaction. Focus groups typically last from 45 focus group. Be cautious about bringing together par-
minutes to 1 1 2 hours. Liamputtong and Ezzy (2005) ticipants with considerable variation in social stand-
indicate that a group might go as long as 3 hours but ing, education, or authority, because some group
that participants will begin to tire before 2 hours have members may hesitate to participate fully, whereas
passed. Be clear on the recruitment materials about others may discount the input of those with perceived
the expected duration of the focus group. Allow for lower standing.
the time it will take to complete consent and demo- Establish a setting for your focus group that is
graphic forms in determining the length of the data relaxed. There should be space for participants to
collection process. Provide a reasonable estimate of sit comfortably in a circle or U shape and maintain
the time needed, recognizing that whether people eye contact with one another. Ensure that the acous-
attend may be affected by how long the group is tics of the room will allow you to obtain a quality
expected to last. audio-recording of the sessions. As with the one-
Recruiting appropriate participants for each of the on-one interview discussed earlier, place your audio
focus groups is critical, because recruitment is the or video recorders unobtrusively. Use a highly sensi-
most common source of failure. Each focus group tive microphone. Hiring a court reporter to do a
should consist of 4 to 12 participants (Marshall & real-time transcription may have advantages over
Rossman, 2011). If there are fewer participants, the recording the interaction for transcription later (Scott
discussion tends to be inadequate. In most cases, par- et al., 2009). Inaudible voices on the recording or
ticipants are expected to be unknown to one another. overlapping voices can pose challenges to later
However, for a focus group targeting professional transcription.
groups such as clinical nurses or nurse educators, such The facilitator is critical to the success of a focus
anonymity usually is not possible. You may use pur- group. Select a facilitator when possible who reflects
posive sampling to seek out individuals known to have the age, gender, and race/ethnicity of the group. The
the desired expertise (see Chapter 15). In other cases, researcher may be the facilitator of the group or may
you may look for participants through the media, train another person for the role. Training of the facili-
posters, or advertisements. A single contact with an tator should be thorough and allow time for practice
individual who agrees to attend a focus group does not (Gray, 2009). The facilitator, sometime called the
ensure that this person will attend the group session. moderator, needs to deeply understand the aims of
You will need to make repeated phone calls and the focus groups and to communicate these aims to
remind the candidates by mail. You may need to offer the participants before the group session. Instruct par-
compensation for their time and effort in the form of ticipants that all points of view are valid and helpful
276 UNIT TWO  The Research Process

and that speakers should not be asked to defend their


positions. Make clear to the group that the facilitator’s “Patients who had entered onto the ERP between 1
role is to moderate the discussion, not to contribute. September 2008 and 28 February 2009, and lived
In addition to the moderator, you may want to have an locally (i.e., within 1 hour’s drive from the hospital)
observer or assistant moderator who takes notes, espe- were included. Fifty patients who met these criteria
cially of facial expressions or interactions not captured were identified from the ERP database. They were
by the recording (Liamputtong & Ezzy, 2005). Making contacted by post, inviting them to participate and
notes on the dynamics of the group is also useful. Note explaining what the focus groups would involve and
how group members interact with one another. how their participation could help. If willing to par-
Carefully plan the questions that are to be asked ticipate, patients completed a detachable slip at the
during the focus group and, if time permits, pilot-test bottom of the letter stating their availability for one
them. Limit the number of questions to those most of three planned focus group sessions. It was hoped
essential to allow adequate time for discussion. You that 4-6 people would participate in each session.
may elect to give participants some of the questions “A quiet non-clinical room was arranged which had
before the group meeting to enable them to give a circular table allowing participants to maintain eye
careful thought to their responses. Questions should contact with each other. Refreshments were offered,
be posed in such a way that group members can build enabling informal interaction before the focus groups
on the responses of others in the group, raise their own began. The focus groups commenced with an intro-
questions, and question one another. Probes can be duction by the facilitators (CT and JB) explaining the
used to elicit richer details, by means of questions purpose and how the session would run. Written
such as “How would that make a difference?” or consent was obtained using a specifically developed
responses such as “Tell us more about that situation.” participant information sheet. Initial ground rules
Avoid pushing participants toward taking a stand and were generated to ensure everyone’s opinions were
defending it. Once rapport has been established, you respected and heard without interruption, and confi-
may be able to question or challenge ideas and increase dentiality would be maintained.” (Taylor & Burch,
group interaction. 2011, p. 287)
The researcher and/or facilitator may come to the
focus groups with preconceived ideas about the topic.
Early in the session, provide opportunities for partici- The researchers invited 50 participants, but only 10
pants to express their views on the topic of discus- patients and 3 relatives participated in the three focus
sion. Use probes or questions if the discussion groups. One group had two patients; the second had
wanders too far from the focus of the study. A good four patients and two relatives; and the third had four
facilitator will weave questions into the discussion patients and one relative. The low response rate and
naturally. The facilitator’s role is to clarify, para- the small sample may have limited the data that were
phrase, and reflect back what group members have collected. The data reflected those who participated
said. These discussions tend to express group norms, but may not have accurately reflected other patients in
and individual voices of dissent may be stifled. the enhanced recovery protocol program. The research-
However, when a sensitive topic is being discussed, ers could have been clearer about whether the invited
the group may actively facilitate the discussion participants were continuing to receive care from the
because less inhibited members break the ice for hospital. If so, some participants may have hesitated
those who are more reticent. Participants may also to participate, especially if their perceptions of the
provide group support for expressing feelings, opin- program were less than satisfactory. The data from the
ions, or experiences. Late in the session, the facilita- focus groups revealed that environmental details such
tor may encourage group members to go beyond the as hot meals and available washing facilities for family
current discussion or debate and reflect on inconsis- members were as important as the clinical aspects of
tencies among the views of participants and within the care they received.
their own thinking.

Example Study Using Focus Groups Electronically Mediated Data


Taylor and Burch (2011) conducted focus groups to Images created by still and video photography and
evaluate an enhanced recovery protocol (ERP) that Internet communication are newer methods of qualita-
was developed for patients undergoing colorectal tive data collection that are being used by health-
surgery. The following excerpt gives further details: related researchers. Each is described briefly, and an
CHAPTER 12  Qualitative Research Methodology 277

example provided. Prior to using one of these forms harm. These cameras were collected and the photo-
of data, the reader is encouraged to study in greater graphs processed by the local research assistant using
depth the technology used and the ethical issues due research funds. Four months later, the researchers
to potential loss of confidentiality and breach of the returned to Guatemala and each of the photographs
privacy of participants’ protected health information was discussed with the photographers in a second
(see Chapter 9). focus group. The researchers noted the differences in
Anthropologists and historical researchers have the focus group discussions. “Although the first phase
included photographs as data in their studies for many produced specific and concrete ideas and concerns,
years. However, creating photographic images as part such as specific illnesses and environmental problems,
of data collection is emerging as a viable scientific the second phase elicited, for the most part, a ‘peeling
method in different types of qualitative and quantita- back’ of health issues” (p. 649). For example, a picture
tive studies the past few years. The ubiquitous nature of a basin of water and a dipper took on new meaning
of digital photography is likely to speed the accep- when the photographer explained that this represented
tance of the method. When used as research data, the entire daily water supply for the family. One of the
photographs and videos may be made by participants, strengths of this study was the researchers’ procedures
researchers, or a combination of the two. Photovoice that protected the rights of the participants and those
is the idea of “recording and reflecting on the strengths photographed. Another strength was the unique com-
and concerns” of one’s community and is most often bination of data collection methods that produced a
used in participatory research studies (Findholt, rich picture of health in these rural communities. The
Michael, & Davis, 2011, p. 186). Caroline Wang and researchers identified limitations of the study to be that
her colleagues are credited with guiding the first the health ministry nurse was present during the focus
health-related study during which rural Chinese groups and that the photographers were younger
women were given cameras to photograph their lives participants.
and especially their health needs (Wang, Burris, & Photovoice can often generate a deeper understand-
Ping, 1996). Wang called this practice photo novella, ing of stigmatizing conditions. Fleming, Mahoney,
but others since have used the term photovoice. Nurse Carlson, and Engebretson (2009) examined images in
researchers have used photovoice in studies with a photovoice exhibit on mental illness. They identified
rural adolescents to increase awareness of childhood their data as the “renderings of the artist’s observa-
obesity and the need for prevention (Findholt et al., tions and firsthand narrative accounts of persons living
2011) and with siblings in families with children who with mental illness” (p. 18). They selected 15 photo-
have Down syndrome (Rampton et al., 2007). Other graphs with narratives that were available in the
health-related studies conducted by non-nurses have museum exhibit, in the online exhibit, and in the
included studies with older adults who experience printed brochure. This choice allowed the researchers
chronic pain (Baker & Wang, 2006) and with African to encounter the data in different formats and strength-
American men in rural and urban communities to ened the analysis process. The researchers developed
explore their perceptions of social and cultural factors the themes of suffering and stigma. A loss of identity
that affect individual and community health (Ornelas was an overarching theme linking the other two
et al., 2009). themes. The analysis process was rigorous with notes
Photovoice is a creative way to facilitate commu- made on each case that resulted in a three-page inter-
nication across cultures. Cooper and Yarborough pretive statement for each. The thematic analysis was
(2010) first conducted a focus group with 20 tradi- validated through repeated meetings of the researchers
tional birth attendants or comodronas in rural Guate- to debrief and compare within-case studies with the
mala. They defined comodronas as “generally older original data for logic, coherence, and fittingness”
women who have become recognized for their knowl- (p. 19). The researchers provided details about the
edge and experience in caring for pregnant women, analysis process and their conclusions that support
delivering babies, and caring for the neonate and the the quality of the study and the credibility of the
mother post delivery” (p. 646). After the focus group, findings.
six participants were given disposable 35-mm cameras Photovoice may pose unique ethical considerations
and asked to take photographs of positive and negative because people in photographs can be identified and
aspects of health in their communities. The research- may not have consented to participating in the study.
ers asked the comodronas to obtain written consent Researchers who are considering photovoice as a
from any persons in the photographs and not to take research methodology are urged to read primary
any photographs that would put themselves at risk for sources and consult with researchers experienced in
278 UNIT TWO  The Research Process

the methodology. The rights of the research partici- major themes affect the credibility of the findings of
pants must be protected during the conduct and report- Internet-mediated studies. The first is sample bias.
ing of the research. This concern is diminishing as access to the Internet
Internet communication provides a way to collect continues to increase. A researcher could minimize
data from persons separated by distance. Quantitative concerns about sample bias by comparing the demo-
researchers are regularly using World Wide Web– graphic characteristics of the online sample with those
based surveys and instruments to gather data, but of samples in traditional studies on the same topic.
qualitative researchers are also using Web-based Whitehead (2007) identified the second concern to be
communities such as online forums and blogs for ethical issues such as seeking consent, assuring ano-
research purposes. The number of participants avail- nymity of the participants, and protecting the security
able for Internet-based research is extensive but does of the site. The third concern was the reliability and
have the limitation that the sample include only those validity of the data collected because the researcher
who can read and write, are comfortable using a com- cannot verify whether participants meet the inclusion
puter, and have access to the Internet (Marshall & criteria for the study and has no control over distrac-
Rossman, 2011). A nurse leader using Internet com- tions that may occur during data collection. Despite
munication for data collection is Eun-Ok Im. Im has these issues, studies will continue to be conducted
used mixed-methods studies with quantitative and using the Internet and researchers aware of these
qualitative phases. The focus here is on the qualita- issues can develop studies to minimize the concerns.
tive phases. Im, Chee, Lim, Liu, and Kim (2008) Researchers considering this methodology may benefit
used an online forum created for their study to gather from reading the research reports of Im’s teams, which
data about physical activity of middle-aged women. contain how they addressed issues of confidentiality
The month-long online forum was completed by 15 and security.
of the 30 women who started. The researchers posted
17 topics for discussion with three or four introduced
each week. The topics were about physical activity Transcribing Recorded Data
and cultural influences on physical activity. The Transcription of verbal data into written data is almost
participants used pseudonyms when posting to the an assumption in qualitative research. Transcripts
forum to protect anonymity. The text of the discus- present the data in a form that allows the researcher
sions was converted into transcripts for analysis. As to share the data with team members for analysis and
themes were identified, the researchers shared them validation. Data collected during a qualitative study
with participants and asked for feedback. Im’s may be narrative descriptions of observations, tran-
program of research using online forums includes 11 scripts from audio recordings of interviews, entries in
studies. As examples, her team has completed studies the researcher’s diary reflecting on the dynamics of
on ethnic differences in cancer pain (Im et al., 2009), the setting, or notes taken while reading written docu-
ethnic commonalities and differences in the experi- ments. Audio-recorded interviews are generally tran-
ence of menopause (Im, Lee, Chee, Domire, & scribed verbatim with different punctuation marks
Brown, 2010), black women’s experiences with used to indicate laughter, changes in voice tone, or
menopause (Im, Seoung Hee Lee, & Chee, 2010), other nuances. Verbatim transcripts contribute to the
Asian Americans’ perspectives on Internet cancer expense and time required for qualitative research and
support groups (Im, Bokim Lee, & Chee, 2010), and may not always be needed to answer the research
white women’s attitudes toward physical activity (Im, question (Halcomb & Davidson, 2006). For example,
Lee, Chee, Stuifbergen, and the eMAPA Research in qualitative studies used to evaluate a program and
Team, 2011). Im and other colleagues noted in these mixed-methods studies, interviews may be used with
studies that one of the limitations was that the data structured questions that may not require word-for-
represent only those who have Internet access and word transcription.
were comfortable describing personal experiences in Transcription may require 4 to 6 hours for each 1
the online forum. hour of interview or focus group time, depending on
The literature on using Internet communication for the equipment used and the transcriber’s skill. Hiring
collecting data, or Internet-mediated research, is a professional transcriptionist may decrease the time
growing. Whitehead (2007) produced an integrated but may be too expensive, depending on the study’s
review of the literature on issues of quantitative and budget. When hiring a transcriptionist, indicate the
qualitative Internet-mediated research. On the basis of details that you want included and whether you
her review of 46 papers, she concluded that three want the transcript to be verbatim (Davidson, 2009).
CHAPTER 12  Qualitative Research Methodology 279

Transcribing the recordings yourself has the advan- observational memo, transcript, analysis record, or
tage of immediately immersing you in the data. A field note. The study manager may also want to keep
pedal-operated recorder allows you to listen, stop, and records of who is currently working on that file and
start the recording without removing your hands from whether it is being transcribed, analyzed, or reviewed
the computer or word processor keyboard. Even when by a team member.
you hire another person to transcribe the recordings, Some researchers may prefer to make notes, mark
you want to check the transcription by listening to the text, and label (code) sections of data on a hard copy
recording while reviewing the transcript. Voice recog- of a transcript or field note using colored markers,
nition programs may be of some benefit but require pencil, or pen. If hard copies are to be used, ensure
time for the software to “learn” the voice of the inter- that each page is clearly identified with the file name
viewee (Alcock & Iphofen, 2007). For transcription of in the header or footer of the document. You may want
focus group recordings, voice recognition software is to format the document with large right-hand margins
not likely to be effective. Other software may allow to allow more space for coding and notes. It is recom-
conversion of audio recording to digital formats ready mended that you also include line numbers, not for
for analysis within computer analysis software. You each page, but for the entire document continuously.
also may code the actual recording, negating the need Having line numbers allows the researcher to note the
for a word transcription. Hutchinson (2005) developed source of a code by line number within a specific
an innovative method of data analysis that uses audio- document.
editing software to save selected audio bytes from Other researchers prefer to work on electronic files
digital audio recordings. The data are never tran- within a software program, using tools ranging from
scribed but remain in audio form. A database is used as simple as highlight or comment functions in a docu-
to code and manage the linked audio files and generate ment within a word processing file to as complex as
detailed and summary reports. Although the system is analysis of visual images, transcripts, field notes, and
time consuming to set up, it negates the need for memos within one of several specialized computer
expensive and time-intensive transcription of recorded programs. The program does not analyze the data but
data. records the analysis performed in the mind of the
Video recordings are maintained in their original researcher (Banner & Albarran, 2009; Leech &
format. However, the researcher may make notes on Onwuegbuzie, 2011). It can also allow links to be
sequential segments of the recording, creating a type made between codes, facilitate retrieval of similar
of field notes. The researcher may also code the text, or produce diagrams of relationships among
recordings directly. Video recordings can be used for codes.
quantitative studies, but the recordings are coded and Computer-assisted qualitative data analysis soft-
assigned a numerical value. ware (CAQDAS) can maintain a file directory, allow
for annotation of coding decisions, and retrieve sec-
tions of text that the researcher has identified with
Data Management the same code (Banner & Albarran, 2009; Garcia-
Because data are collected simultaneously with data Horta & Guerra-Ramos, 2009; Hoover & Koerber,
analysis, the study manager, who may be the researcher, 2011). Hoover and Koerber (2011) summarize the
needs to have a plan developed for how to organize advantages of CAQDAS to be efficiency, transpar-
and store data. Label electronic files consistently. For ency, and multiplicity. Table 12-3 provides a more
example, the digital files from recordings can be detailed list of the advantages and disadvantages of
labeled with the date and the code number or pseud- using CAQDAS, and Table 12-4 contains descrip-
onym of the participant. Make copies of all original tions and suppliers of a selected group of CAQDAS
files on a second computer or external storage device. programs.
Similarly, scan or copy all handwritten notes, field
notes, or memos and, if possible, store originals in a
waterproof and fireproof storage box. Any electronic Data Analysis
files containing personally identifiable information Qualitative data analysis is “a process of examining
(family member, hospital name, addresses, doctor’s and interpreting data in order to elicit meaning, gain
name) should be encrypted prior to being sent elec- understanding, and develop empirical knowledge”
tronically to a transcriptionist or team member. You (Corbin & Strauss, 2008, p. 1). Qualitative data analy-
may want to keep a Word document or Excel file sis is creative, challenging, time consuming, and, con-
listing all files by date, file name, and type such as sequently, expensive (Jirwe, 2011). Less experienced
280 UNIT TWO  The Research Process

TABLE 12-3  Advantages and Disadvantages TABLE 12-4  Examples of Computer-Assisted


of Computer-Assisted Qualitative Qualitative Data Analysis Software
Data Analysis Software (CAQDAS) (CAQDAS)
Advantages Store and organize data files Software Description and Website
Provide documentation of coding and ATLAS/ti 6.2 Robust CAQDAS functions; large
analysis searchable data storage including
Click and drag to merge codes media files; multiple users
Search for related codes and quotations allowed; facilitates theory building;
efficiently flexible; supports use of PDF files.
Send coded data files to others http://www.atlasti.com/
Link memos to text Ethnograph v6 Originally developed for use by
Generate a list of all codes ethnographers; import and code
Minimize clerical tasks to allow focus data files; sort and sift codes;
on actual analysis retrieve data and files.
Support and integrate the work of http://www.qualisresearch.com/
multiple team members FrameWork Textual analysis tools plus
Decrease paper usage summarization tool and ability to
Disadvantages Cost of software analyze using a matrix format.
Need to allow time and expend energy http://www.framework-
to learn the software and its functions natcen.co.uk/
Potential that technical/functional HyperRESEARCH Code and retrieval functions; theory
aspects will overwhelm thinking building features added on;
about the analysis handles media files; compatible
Potential for computer problems with Macintosh computers.
interfering with the software and http://www.researchware.com/
causing data and analysis to be lost MAXQDA 10 Robust CAQDAS functions, but less
powerful search tool; allows
integration of quantitative and
qualitative analysis; color-based
researchers may feel uncertain about how to proceed filing; supports different types of
text analysis.
because the process feels ambiguous (Speziale &
http://www.maxqda.com/products
Carpenter, 2007). Data analysis in qualitative research NVivo 9 Robust CAQDAS functions including
occurs concurrently with data collection. Analysis of (combined with several types of queries; familiar
an interview’s data may result in the asking of an NUD*IST) format of file organization system;
additional question in subsequent interviews to handles multimedia files; latest
confirm or not confirm an initial interpretation of the version includes compatibility with
data. The process of interpretation occurs in the mind quantitative analysis and
of the reader. Corbin and Strauss (2008) describe bibliographic software.
interpretation as translating the words and actions of http://www.qsrinternational
participants into meanings that readers and consumers .com/#tab_you/
Weft QDA Free software that provides most
can understand. The virtual text grows in size and
commonly used CAQDAS
complexity as the researcher reads and rereads the functions.
transcripts. Throughout the process of analysis, the http://www.pressure.to/qda/
virtual text develops and evolves. Although multiple
valid interpretations may occur if different researchers Synthesized from Davis and Meyer (2009), Hoover and Koerber (2011),
examine the text, all findings must remain trustworthy Speziale and Carpenter (2007), and websites of suppliers and professional
organizations.
to the data. This trustworthiness applies to the unspo-
ken meanings emerging from the totality of the data,
not just the written words of the text. The first step in and experiences, listening to audio recordings and
data analysis is to be familiar with the data. viewing videotapes until you have become immersed
in the data. Being immersed means that you are fully
Immersion in the Data invested in the data and are spending extensive
Becoming familiar with the data involves reading and amounts of time reading and thinking about the data.
rereading notes and transcripts, recalling observations Recordings contain more than words; they contain
CHAPTER 12  Qualitative Research Methodology 281

feeling, emphasis, and nonverbal communications. overlap. As data analysis proceeds, the codes may be
These aspects are at least as important to the com- merged and relabeled at a higher level of abstraction.
munication as the words are. As you listen to record- In a study of medication adherence, the initial codes
ings, look at photographs, or read transcripts, you might be “paying attention to time,” “counting and
relive the experiences described and become very recounting,” and “remembering to get prescription.”
familiar with the phrases that different participants These codes might be grouped later into the more
used or the images that were especially poignant. In abstract code “attending to logistics.” The first level
phenomenology, this immersion in the data has been of coding is descriptive and uses participant phrases
referred to as dwelling with the data (Munhall, 2012). as the label for the code. The label for the merged
Byers and France (2008) designed a phenomenologi- codes is interpretive and might be called a theme if
cal study using van Manen’s (1984) approach to phe- repeatedly identified in the data.
nomenology. They examined the experiences of Trimm and Sanford (2010) studied the experiences
registered nurses who cared for dementia patients in of people waiting while a family member undergoes
acute care settings. Byers and France described dwell- surgery. Their grounded theory study resulted in a
ing with the data in the following excerpt: middle-range theory that they called “maintaining
balance during the wait” (p. 441). Their analysis
yielded 56 open codes that they transformed into six
“Staying true to phenomenology as philosophy and axial codes. Further analysis resulted in four domains
method, data collection and analysis occurred simul- that comprise the theory: “focusing on the patient,
taneously and the researchers maintained a stance of passing the time, interplay of thoughts and feelings,
sensitive attunement and openness to the possibilities and giving and/or receiving support” (p. 440). Table
of meaning to reach self-reflection, bracketing, and 12-5 contains excerpts from quotations of participants
phenomenological reduction. Following each inter- with their corresponding codes for one of the substan-
view, the researchers transcribed the interview and tive domains, focusing on the patient. Trimm and
dwelt with the data, continually writing and rewriting, Sanford (2010) provided extensive detail about their
and reading and re-reading the transcript, eventually analysis and validated their findings with some of the
formulating judgments about the recurring patterns participants. These actions indicate that the study was
and emerging themes of the parts within the whole rigorously implemented and lend credibility to the
staying true to van Manen’s phenomenology.” (Byers findings.
& France, 2008, p. 45) The type and level of coding vary somewhat
according to the qualitative approach being used.
Table 12-6 displays types of codes described in the
Coding social science literature. The terms can be confusing,
Because of the volumes of data acquired in a qualita- because different writers have given different names
tive study, initial efforts at analysis focus on reducing to similar codes.
the volume of data so that the researcher can more
effectively examine them. The reduction of the data Content Analysis
occurs as you attach meaning to elements in your data Content analysis is designed to classify the words in
and document that meaning with a word, symbol, or a text into categories. The researcher is looking for
phrase known as a code. Coding is a means of naming repeated ideas or patterns of thought. In exploratory-
and labeling. A code is a symbol or abbreviation used descriptive qualitative studies, researchers may ana­
to label words or phrases in the data. Through coding, lyze the content of the text using concepts from a
the researcher explores the phenomenon of the study. guiding theory, if one was selected during planning for
Therefore, it is important that the codes be consistent the study. During historical studies, the researcher
with the philosophical base of the study. Organization analyzes documents and photographs to describe their
of data, selection of specific elements of the data for content related to the focus of the study.
categories, and naming of these categories all reflect Garwick, Seppelt, and Riesgraf (2010) used a par-
the philosophical basis of the study. Later in the study, ticipatory qualitative study design to explore the chal-
coding may progress to the development of a taxon- lenges of managing asthma of children in urban Head
omy or a theoretical framework. For example, you Start programs at multiple sites. They conducted focus
might develop a taxonomy of types of pain, types of groups with teachers and managers of Head Start
patients, or types of patient education. Initial catego- Centers and transcribed the data, as described in the
ries should be as broad as possible with minimal following excerpt:
282 UNIT TWO  The Research Process

TABLE 12-5  Example of Participants’ Quotations and Codes for the Substantive Domain of Focusing
on the Patient
Participants’ Quotations Code
From the wife of a patient having back surgery on why they spent the night before surgery in a hotel: Driving/admitting
“Because we live a long way . . . we had kind of a rough night … because I know he’s nervous.” (p. 443) the patient
“I just wanted to go back there [holding area] and reassure him that I loved him and boost him up a little Reassure/comfort
bit. I definitely wanted to see him before surgery, ’cause it could have been the last time.” (p. 443) the patient
“I was better when I got here last night, just to see dad and that he was really okay … just wondering if he Getting
was okay. Like if he really [italics added] was okay, if he really could talk well and didn’t have any information
physical disabilities or so and he was fine.” (p. 443) first hand
“I love you. I’ll see you in a few minutes.” (p. 444) ‘See you soon’
“I never say goodbye, because it feels so final.” (p. 444)
“We’ll be right here in the waiting room.” (p. 444)
Description of family behavior, not a participant quotation: “When the family entered the waiting area, they Entering the
would look at the room’s arrangement and select a place to sit. Once seated, the conversations and waiting room
actions focused on how the patient looked, when they would hear information, and what activity should
be done first.” (p. 445)
“I was thinking about [spouse’s name] and I know exactly what they are doing in that surgery, because he’s Thinking about
had it done before. So I pictured the saw. I pictured the hammer. I mean I have a wild imagination, so I the surgical
was just crying and thinking of all those things. I can picture the surgery happening and the position that procedure
he’s in and it just made me feel so emotional and that’s why I was crying.” (p. 445)
“This time the surgery will either result in her being able to continue her life or she’s going to have to Worried about
remain an invalid … we’re banking on everything on this move. There’s the potential that she would be the outcome
permanently paralyzed from below the waist. Everything hinges on this operation, because none of her
plans can go forwards unless this works.” (p. 446)

From Trimm, D. R., & Sanford, J. T. (2010). The process of family waiting during surgery. Journal of Family Nursing, 16(4), 435–461.

challenging interactions with parents of children with


“Descriptive content analytic techniques (Neuendorf, asthma and the complexity of the treatment plans that
2002) were used to identify and categorize asthma must be implemented with no additional staff and
management issues and action plan strategies. First, limited equipment.
the [principal investigator] PI and research associate
(RA) read and reread each focus group transcript in Narrative Analysis
its entirety to understand the context of the focus Narrative inquiry is a qualitative approach that uses
group discussions. Next, each independently read the stories as its data (Duffy, 2012). Through a series of
responses in the verbatim transcripts on a line-by-line life experiences, people create their identities in the
basis to identify types of asthma management issues historical and social context in which they live. As a
within and across the focus groups. Then they met to philosophical approach to qualitative research, narra-
confirm, through a consensus process, common tive inquiry was not included in this textbook (see
themes that participants emphasized in all three of Duffy, 2012, for additional information on the method).
the teacher focus groups. After the RA systematically Data analysis, however, may yield stories, and
organized the findings by theme and ID number, the researchers using other philosophical approaches may
PI validated the categorization of findings. Exemplars tell a participant’s story in their analysis and presenta-
of each of the common themes or challenges are tion of findings. In addition to being organized chron-
included in the findings.” (Garwick et al., 2010, ologically, you might analyze a story as one would a
p. 331) published book during a literature course, looking for
characters, setting, plot, conflict, and resolution. His-
torical researchers may compare participants’ stories
The credibility of the findings was increased to present a broader picture of an event. Lesniak
through checking the accuracy of the transcription, (2010), in her phenomenological study of adolescents
assessing consistency between two data coders, and who injure themselves (mentioned earlier in this
validating the findings with participants. The Head chapter), did not indicate that she used narrative analy-
Start teachers and managers noted helpful and sis. She presented, however, rich descriptions of the
CHAPTER 12  Qualitative Research Methodology 283

TABLE 12-6  Types of Coding for Qualitative Data Analysis*


Type Description
Axial coding Finding and labeling connections between concepts; assigning codes to categories; also may be called Level II
coding in grounded theory studies
Descriptive coding Classifying elements of data using terms that are close to the participant’s words, usually early in the analysis
Explanatory coding Connecting coded data to an emerging theory; describing coded data as patterns, themes, and links
Interpretive coding Labeling coded data into more abstract terms that represent merged codes
In-vivo coding “Concepts using actual words of research participants rather than being named by analyst” (Corbin & Strauss,
2008, p. 65)
Open coding “Breaking data apart and delineating concepts to stand for blocks of raw data” (Corbin & Strauss, 2008, p.
195); also called Level I coding in grounded theory studies
Process coding Incorporating previously assigned codes into an overall basic social process that is the core of the
phenomenon of interest; used in grounded theory studies (Speziale & Carpenter, 2007)
Selecting coding “Building a ‘story’ that connects the categories” (Creswell, 2007). The researcher may generate propositions
or statements that bridge the categories.
Substantive coding Includes in-vivo coding (using words of participants) and implicit coding, in which the unspoken codes are
constructed by researchers

*These terms are not mutually exclusive, because different writers have used different labels for similar analytical processes.

lived experiences of the adolescents as stories. She Lesniak (2010) gave the readers insight into the lives
then extracted themes from the stories. This is an of the participants by presenting the descriptions as
excerpt of one of the stories: stories. When one goal of a study is to influence policy
makers or promote behavior change, stories can be a
powerful tool to generate support for the advocated
“Emma had just turned 17 years old when she agreed message. Table 12-7 provides definitions of additional
to be interviewed.… Emma cut as a means to gain a types of qualitative data analysis.
sense of control over her life. She could not control
her parents’ divorce or the loneliness she experi- Memoing
enced during her childhood. She had no friends and The researcher develops a memo to record insights or
her parents began dating other people, which further ideas related to notes, transcripts, or codes. Memos
isolated Emma. Cutting was there for her and did not move the researcher toward theorizing and are con-
abandon her. It was a dependable variable in her life. ceptual rather than factual. They may link pieces of
Emma felt she did not fit in with other girls at school, data together or use a specific piece of data as an
becoming a target of their jokes and cruelty. After the example of a conceptual idea. The memo may be
first time she cut, Emma felt immediate relief from written to someone else involved in the study or may
her pent-up emotions, and she was able to sleep. She be just a note to yourself. The important thing is to
stated that before she cut, she would feel numb inside value your ideas and document them quickly. Initially
and after she cut, the emotional pain became tangible you might feel that the idea is so clear in your mind
through the physical pain of cutting. Cutting made that you can write or record it later. However, you may
Emma not want to die; instead, she cut to feel alive. soon forget the thought and be unable to retrieve it.
The wound became a tangible and visible external As you become immersed in the data, these ideas will
representation of the pain she felt internally. It also occur at odd times, such as when you are sleeping,
gave her a location upon which to focus as the scars walking, or driving (Schiellerup, 2008). Whenever an
became a reminder of everything she had gone idea emerges, even if it is vague and not well thought
through; it was the story of her life. She stated that out, develop the habit of writing it down immediately
cutting was her expression, but on her skin. It became, or recording it on a hand-held device such as a cell
in other words, her voice.” (Lesniak, 2010, p. 143) phone.

Findings and Conclusions


Stories may produce an emotional link between the Qualitative findings reflect the study’s philosophical
research consumer and the participant beyond that roots and the data that were collected. Unlike in quan-
achieved through discussion of codes and themes. titative research, conclusions are formed throughout
284 UNIT TWO  The Research Process

TABLE 12-7  Types of Qualitative Data Analysis


Data Analysis Description
Chronological analysis Identifying and organizing major elements in a time-ordered description as events and epiphanies
Componential analysis Identifying units of meaning that are cultural attributes; process allows ethnographer to identify gaps
in observations and selectively collect additional data
Constant comparison Analyzing new data for similarities to and differences from existing data
Direct interpretation Identifying a single instance of the phenomenon or topic and drawing out its meaning without
comparing to other instances
Domain analysis Focusing on specific aspects of a social situation such as people involved; used in ethnography
Narrative analysis Looking for the story in the data; identifying the characters, setting, plot, conflict, and resolution as an
exemplar of the phenomenon being studied
Taxonomic analysis Identifying categories with a domain (see domain analysis); used in ethnography
Thematic analysis Finding within the data three to six overriding abstract ideas that summarize the phenomenon of
interest
Theoretical comparison Thinking about the properties and characteristics of categories; linking to existing theories and models
Three-dimensional analysis Thinking about and identifying continuity, interactions, and situations within a story

Synthesized from Corbin and Strauss (2008) and Creswell (2007).

the data analysis process in qualitative research. Con- theory. Exploratory-descriptive qualitative studies are
clusions are intertwined with the findings in a qualita- reported by addressing each research question and
tive study. For a phenomenological study, the findings providing the pertinent findings. The report of a his-
are presented as an exhaustive description (Speziale torical study may have limited information about the
& Carpenter, 2007). The findings of a focused ethno- methods; rather, the report is the story of the events or
graphic study would include a description of the series of events that were studied.
culture that achieved the study objectives or answered
the research questions. In grounded theory studies, the
researcher’s aim is to produce a text or graphic descrip- Methods Specific to
tion of social processes. As the description is refined,
a theoretical structure or framework emerges that Qualitative Approaches
might be considered a tentative theory (Fawcett &
Garity, 2009; Marshall & Rossman, 2011; Munhall, Phenomenological Research Methods
2012). Phenomenological researchers have several choices
about methods that are related to their specific philo-
Reporting Results sophical views on phenomenology. In Chapter 4, dif-
In any qualitative study, the first section of a research ferences in Husserl’s and Heidegger’s views on
report should be a detailed description of the partici- phenomenology were discussed. Researchers sub-
pants. The ethnography report will also include details scribing to Husserl’s views would use bracketing,
about the setting and the environment in which the which is consciously identifying, documenting, and
data were gathered. The results of the data analysis choosing to set aside one’s own views on the phenom-
may be displayed in the form of a table with the enon (Dowling, 2007). Heidegger’s view was that
themes in the first column of a table and exemplar researchers could not separate their own perspectives
quotations in the second column. Using tables in this from that of the participants’ during the collection,
way increases the transparency of the analysis and analysis, and interpretation of the data. In phenome-
interpretation. Other writers incorporate supporting or nology, additional philosophical approaches to the
disconfirming evidence from the literature within the analysis and interpretation of data are available, such
results section of the report. How the results are pre- as those advocated by van Kaam (1966), Giorgi
sented depends on the philosophical approach upon (1970), Colaizzi (1978), and van Manen (1984).
which the study was developed. As previously men- Munhall (2012) calls these men “second-generation
tioned, phenomenologists provide a thick, rich, and phenomenologists” (p. 126). Prior to selecting an
exhaustive description of the phenomenon that was approach, you are encouraged to read the primary
studied. Ground theorists present their tentative sources listed in the references. Shorter and Stayt
CHAPTER 12  Qualitative Research Methodology 285

(2010) conducted a phenomenology study according data analysis (Cooney, 2010). In Table 12-5, substan-
to Heidegger’s philosophy. They emphasized the tive and theoretical codes are attributed to Glaser, and
importance of co-creating the data, as follows: open, axial, and selective are attributed to Strauss
(Cooney, 2010). Researchers considering grounded
theory methodology will want to read the primary
“A key tenet of Heideggerian phenomenology is sources on the different methods and choose the one
co-construction of knowledge between researcher that is most compatible with the researchers’ beliefs.
and participant, which assumes that both contribute During grounded theory studies, data analysis for-
to understanding the topic. Adequate participant con- mally begins with the first interview or focus group.
tribution to the construction of knowledge was The researchers review the transcript and code each
ensured in the present study by providing each par- line, constantly comparing the meaning of one line
ticipant with an annotated version of their interview with the meanings in the lines that preceded it. Con-
transcription, detailing subject themes that had been cepts as abstract representations of processes or enti-
identified. They were offered the opportunity to ties are named. As the data analysis continues,
clarify meaning and comment on identified themes.” relationships between concepts are hypothesized and
(Shorter & Stayt, 2010, p. 161) then tested for validity (Wuest, 2012). Researchers are
looking for a core category that explains the underly-
ing social process in the experience. Existing theory
Shorter and Stayt (2010) concluded with the fol- and literature are reviewed for contributions to the
lowing paragraph: researcher’s understanding of the core category.
Banner (2010a) conducted a grounded theory study
of women (N = 30) undergoing coronary-artery bypass
“Confronting death and dying is unavoidable in critical graft (CABG) surgery. She explicitly described the
care settings. End-of-life care is therefore an impor- methodological principles guiding the study, as
tant aspect of critical care nursing. This study has follows:
revealed a complex web of predisposing factors and
occurrences that can shape both the nature of care
for the dying and critical care nurses’ subsequent grief “Key principles of the grounded theory methodology
experiences.” (Shorter & Stayt, 2010, p. 165) are the following: (1) recursive data collection and
analysis to the explore merging data, (2) construction
of codes and categories, (3) theoretical sampling
This study was congruent with the Heideggerian techniques to achieve conceptual density, (4) constant
philosophy as evidenced by the validation of the anal- comparison, (5) generation of substantive theory as
ysis with the participants. From their findings, the opposed to pure analytical description, (6) use of
researchers indicated several areas needing additional theoretical memos to track emerging data and theory
study, such as the informal support structures that and (7) deferred literature review until after analysis
allow critical care nurses to deal with patient deaths. is complete to encourage analytical sensitivity
The inferred clinical implications are that nurses (Charmaz 2006).” (Banner, 2010a, p. 3125)
involved in end-of-life care in acute care settings
experience patients’ deaths in complex ways and use
multiple ways to deal with the grief. Nurses and man- Using Strauss and Corbin’s (1998) approach to data
agers in critical care units need to be aware of the analysis, Banner (2010a) found six categories in the
diversity of grief responses and coping methods. pre-operative experiences of women scheduled for
CABG surgery: “help seeking, diagnosis and referral,
Grounded Theory Methodology conceptualizing surgery, living with coronary heart
Philosophical discussions of grounded theory method- disease, and waiting for surgery” (p. 3123). Banner
ology center on the nuances of the different approaches reported quotations that exemplified each category and
(Cooney, 2010). Sociologists Glaser and Strauss then compared the categories with the findings of other
(1967) worked together during their early years, but studies. The underlying social process was described
eventually their philosophies resulted in at least two as “the public-private dialogue around maintaining
variations of grounded theory. The original works pro- and renegotiating normality” (Banner, 2010a, p.
vided little detail on data analysis methods, so Corbin 3123). Banner did not develop a graphic representa-
and Strauss (2008) described a structured method of tion of the relationships among the categories and with
286 UNIT TWO  The Research Process

the overall social process, but provided a description researcher needs to blend into the culture but remain
of the theoretical structure. The theoretical structure in an outsider role. A researcher who over-identifies
could be further refined by Banner or other investiga- with the culture being studied and becomes an insider
tors on this topic. The clinical implications are that is said to be going native. In going native, the
nurses who read the study report may be sensitized researcher becomes a part of the culture and loses all
to the significant life disruption and challenges faced objectivity—and with it the ability to observe clearly.
by women through CABG surgery into recovery. Negotiating relationships and roles is a critical skill
Because several of the participants did not see them- for ethnographers, who must possess self-awareness
selves as being at risk for coronary artery disease, and social acumen.
they may have delayed seeking care. Nurses must
teach women how the symptoms of coronary artery Gatekeepers and Informants
disease may be different in women and that the women Gatekeepers are people who can provide access to the
need to seek care when they experience symptoms. culture, facilitate the collection of data, and increase
the legitimacy of the researcher (Wolf, 2012). A gate-
Ethnographical Methodology keeper may be a formal leader, such as a mayor,
Ethnography is unique among the qualitative village leader, or nurse manager, or an informal leader,
approaches because of its cultural focus. Thus, eth- such as the head of the women’s club, the village
nography requires field work, which is spending time midwife, or the nurse who is considered the unit’s
in the selected culture to learn by being present, clinical expert. The support of people who are accepted
observing, and asking questions. Wolf (2012) defines in the culture is key to gaining the access needed to
field work as a “disciplined mode of inquiry that understand the culture. In addition to gatekeepers, you
engages the ethnographer firsthand in data collection may seek out other individuals who are willing to
over extended periods of time” (p. 302). Field work interpret the culture for you. These other individuals
allows the researcher to participate in a wide range of may be informants, insiders in the community who
activities. The observations of the researcher typically can provide their perspective on what the researcher
focus on objects, communication patterns, and behav- has observed (Wolf, 2012). Not only will the infor-
iors to understand how values are socially constructed mants answer questions, but they may also help you
and transmitted (Wolf, 2012). The researcher looks to formulate the questions because they understand the
below the surface to identify the shared meaning and culture better than you do.
values expressed through everyday actions, language,
and rituals (Creswell, 2007). Meanings and values Gathering and Analyzing Data
may reveal power differences, gender issues, opti- During field work, the researcher will make extensive
mism, or views of diversity. notes about what is observed and thoughts on possible
One difficulty in planning an ethnographic study is interpretations. The researcher may seek input on the
knowing how much time is needed and actually possible interpretations with an informant or a person
what will be observed. Enough time in the field is being interviewed. Data analysis is coding field notes
needed to achieve some degree of cultural immersion and interviews for common ideas to allow patterns to
(Speziale & Carpenter, 2007). The length of an ethno- emerge. Data may also be subjected to content analy-
graphic study is usually limited by the resources— sis. The notes themselves may be superficial. However,
money and time—that the researcher has allotted for during the process of analysis, you will clarify, extend,
the project. When one is studying a different culture, and interpret those notes. Abstract thought processes
the time might extend to months or even a year. When such as intuition and reasoning are involved in analy-
studying the culture of a nursing unit or waiting area, sis. The data are then formed into categories and rela-
the researcher will not live on the unit, but would tionships developed between categories. From these
identify a tentative plan for observing on the unit at categories and relationships, the ethnographer
different times during the day and night and on differ- describes patterns of behavior and supports the pat-
ent days of the week. The researcher may want to terns with specific examples.
observe unit meetings, change-of-shift reports, or The analysis process in ethnography provides
other unit rituals, such as holiday meals. Initial accep- detailed descriptions of cultures. The descriptions
tance into a culture may lead to resistance later if the may be presented as cultural themes or a cultural
researcher’s presence extends beyond the communi- inventory (Speziale & Carpenter, 2007). These
ty’s expectations or the ethnographer is perceived as descriptions may be applied to existing theories of
prying or violating the community’s privacy. The cultures. In some cases, the findings may lead to the
CHAPTER 12  Qualitative Research Methodology 287

development of hypotheses, theories, or both. The McGibbon et al. (2010) found six forms of nurses’
results may be useful to nurses when members of the stress, “including emotional distress; constancy of
community that was studied interact with the health presence; burden of responsibility; negotiating hierar-
system. The results may be tested by whether another chical power; engaging in bodily caring; and being
ethnographer, using the findings of the first ethno- mothers, daughters, aunts, and sisters” (p. 1357).
graphical study, can accurately anticipate human
behavior in the studied culture.
“Prolongation of life and active caring for those
McGibbon, Peter, and Gallop (2010) conducted an
declared dead were socially organized and textually
institutional ethnography of nurses’ stress, a specific
mediated processes that obscured nurses’ emotional
type of ethnography, as the following excerpt explains:
suffering through their scientific and rational charac-
ter.… Nurses were uniquely situated temporally and
spatially in the PICU. Their presence for 12 hours for
“Institutional ethnography is a framework that
almost any given shift and for consecutive shifts meant
describes how people’s activities are socially orga-
that their temporal connection with patients was
nized in a particular way as they go about the routine
markedly different than that of any of the other clini-
activities of their daily lives.… Institutional ethnogra-
cians.” (McGibbon et al., 2010, p. 1359)
phy provides a specific method to link nurses’ every-
day work with institutional structures that shape
practice. Although ethnographic practice in general The study was rigorous, as evidenced by the use of
provides a framework for rich description of the con- multiple sources of data and thorough analysis by the
texts of everyday life, the aim of institutional ethnog- team. The researchers conclude that nurses’ stress was
raphy is not thick description; rather, the aim is to increased and perpetrated by the organizational struc-
expose the articulation of the activities of everyday tures that de-emphasized the centrality of nurses to the
life with institutional power relations.” (McGibbon et work of hospitals. The study’s findings substantiated
al., 2010, p. 1356) the complexity of nurses’ stress in the workplace and
the need for nurses to develop effective stress manage-
ment strategies.
The researchers collected and analyzed data from
numerous sources, as described here: Exploratory-Descriptive Qualitative
Methodology
Researchers often design exploratory-descriptive qual-
“Data collection included tape-recorded interviews at itative studies to address a specific research question.
a time and place that was convenient for the nurses, For example, Mahoney and Ladd (2010) conducted
participant observation in the pediatric ICU (PICU) focus groups at a national meeting of gerontological
for a 3-month period, focus groups with participating nurse practitioners (GNPs) to fill a specific gap in the
nurses, field notes that incorporated a researcher literature, the lack of knowledge about the influence
journal, and the examination of selected nonconfiden- of pharmaceutical marketing on GNP prescribing prac-
tial texts related to the nurses’ everyday work.… tices. The 15 GNPs who participated were not asked
The focus of data analysis was explicating the forms to describe all aspects of their practice: “This study
of stress in nurses’ everyday PICU work and their was undertaken to explore NP participants’ prescrip-
social organization. Data analysis initially consisted of tive decision-making issues related to older adult
coding for the forms of stress in nurses’ work, par- patients with specific inquiry about the influence of
ticularly given the absence of much of nurses’ experi- pharmaceutical marketing” (Mahoney & Ladd, p. 18).
ences in current formulations of nurses’ stress.… Kaddoura (2010) designed a study with a slightly
The purpose of attending to thematic codes in the broader focus, as described in this excerpt:
data was not necessarily to arrive at any unifying
description of the nurses’ experiences across indi-
vidual accounts; rather, thematic coding helped to “This study explored new graduate nurses’ percep-
identify aspects of the nurses’ experiences related to tions of factors that helped to develop their critical
the research questions and the social relations thinking skills throughout their critical care orienta-
inherent in their work.” (McGibbon et al., 2010, tion program. The study attempted to answer the
pp. 1356, 1357) following research question: How do new graduate
288 UNIT TWO  The Research Process

interested in the life stories, they did not use narrative


nurses characterize the role of the ECCO [Essential data analysis. They selected interview questions that
of Critical Care Orientation] program in influencing reflected the different components of Belsky’s model
the critical thinking of new critical care nurses edu- and then used the components as a structure for content
cated by this program?” (Kaddoura, 2010, p. 426) analysis of the transcripts, as described in the follow-
ing excerpt:

Data analysis for exploratory-descriptive qualita-


tive studies is often content analysis, with or without “The life story method is used to understand the
a guiding theoretical framework. Kaddoura (2010) did subjective experience of individuals within a given
not identify a guiding theory and described her data group (here, vulnerable fathers). Being told by the
analysis in this way. person who experienced it, the life story’s purpose
is not only to get factual information but also to
understand the meaning given to events. This enables
“Data were analyzed by the qualitative content analy- the researcher to compare different life stories and
sis approach to identify key points that described discover common themes that emerge within the
graduate nurses’ perceptions of how their critical identified group. Thus, data collection was essentially
thinking skills were developed throughout the critical intended to encourage fathers to tell us about their
care orientation program. Four key codes or themes lives. The participants’ life stories were examined
emerged as the participants verbalized their percep- from a variety of angles that correspond with those
tions and experiences with the ECCO program. The identified in our conceptual framework.” (Devault,
major themes were related to knowledge and its 2008, p. 231)
application in the development of new graduates’
critical thinking skills as well as the graduates’
perceptions of the merits and concerns related to the The researchers presented their conclusions in the
ECCO program presentation. These primary themes context of the conceptual framework, as follows:
included gathering knowledge, application of knowl-
edge, benefits of the ECCO program, and concerns
about the ECCO program in relation to the new “Returning to our conceptual framework, our study
graduate nurses’ critical thinking skills.” (Kaddoura, suggests that the mother of origin plays an important
2010, p. 426) role in the individual history of vulnerable fathers.…
In regards to the co-parental relationship, we found
that a positive co-parental relationship is manifested
Kaddoura’s (2010) study provided helpful informa- by frequent contacts, shared activities, and mutual
tion to use in evaluating the orientation program. support.… The influence of work on fatherhood was
Nurse educators designing orientation programs for less clear. In fact, we found that it is the other way
new graduates may find the study’s results applicable around: becoming a father seems to have an influence
to their work. Other than this group, the study has on work. Most fathers try to overcome their profes-
limited applicability. Kaddoura does provide an sional instability in order to meet the family needs.
exploratory design that would be helpful in evaluating Finally, we found that fatherhood had a very impor-
programs, especially when combined with quantita- tant meaning to vulnerable fathers and that it pushes
tive data in a mixed design study. them to better themselves and become more respon-
Exploratory-descriptive qualitative studies may be sible. Involvement can take different forms but we
designed using a theoretical framework. In their quali- found that the most involved fathers were active in
tative study with low-income young fathers (N =17), every aspect of their child’s life; they formed a stron-
Devault et al. (2008) examined the participants’ life ger commitment to the father role and status, and
stories in the context of the Belsky (1984) model of were more centered on their children than on them-
parental behavior. From Belsky’s model, Devault et selves.” (Devault et al., 2008, p. 242)
al. (2008) developed a conceptual framework in which
the concepts of individual history, coparental history,
and professional history influenced fathering. Father- Devault et al. (2008) are not nurses but they con-
ing influenced meaning and involvement in parenting. ducted a study of interest to nurses working with fami-
Although the researchers indicated that they were lies, especially child-bearing families. The researchers
CHAPTER 12  Qualitative Research Methodology 289

clearly described their analysis process and recog- reveals that many of her materials are housed
nized the limitations of their study. Their methods lend in Boston University’s Howard Gotlieb Archival
credibility to their results. Research Center. Accessing these documents would
include obtaining permission to review the docu-
Historical Research Methodology ments, traveling to Boston, and making notes about or
The methodology of historical research consists of images of the documents.
(1) identifying a question or study topic; (2) identify- Secondary sources are those written about the
ing, inventorying, and evaluating sources; and (3) time or the people involved, but not by the person of
writing the historical narrative. Whether motivated interest. Secondary sources are also examined because
by curiosity, personal factors, or professional reasons, they may validate or corroborate primary sources or
the researcher’s interest in a specific topic needs to present additional information or opinions (Lundy,
be explainable to others (Lundy, 2012). One way to 2012; Speziale & Carpenter, 2007). In fact, validation
do this is for the researcher to develop a clear, and corroboration are important for determining
concise statement of the topic. The topic may be nar- whether sources are genuine and authentic. External
rowed to be manageable with available resources. criticism determines the “genuineness of primary
Although the historical researcher may be interested sources” (Lundy, 2012, p. 265). The researcher needs
in the effect of World War II on nursing science, the to know where, when, why, and by whom a document
researcher may need to narrow the study to one or a was written, which may involve verifying the hand-
few nurse theorists who were nurses during the war writing or determining the age of the paper on which
or the nurse scientists educated at one university. The it was written. Internal criticism involves establish-
statement of the topic may evolve into a title for the ing the authenticity of the document. The researcher
study, which includes the period being addressed. may ask whether the document’s content is consistent
Prior to determining the years to be studied, you with what was known at the time the document was
must have knowledge of the broader social, political, written. Are dates, locations, and other details consis-
and economic factors that would have an impact on tent across sources? The researcher remains open to
the topic. Using this knowledge, you can identify the the views presented in the documents or other sources
questions you will examine during the research but remains somewhat skeptical until sources are
process. verified.

Sources Historical Data Analysis


Sources in a historical study may be documents such Data gathering and analysis occur simultaneously as
as books, letters, newspaper clippings, professional the researcher samples documents, seeking descrip-
journals, and diaries. Sources may also be people who tions, conflicting records, or contextual details. As
were alive during the time being studied or who heard with other qualitative approaches, historical research-
stories from older relatives. Review the literature that ers become immersed in the data. Content analysis
is available on the topic you have selected, and start a yields data that the researcher will use to develop a
bibliography or inventory of materials you want to description of the topic. The connections made among
review. Library searches identify published materials documents, opinions, and stories constitute the inter-
and may have some archives, unpublished materials pretation of the data that are essential to an unfolding,
purchased or donated for their historical value (Spe- deep understanding of the topic. Figuring out when to
ziale & Carpenter, 2007). Pay attention to the organi- stop examining sources may be one of the major
zations and institutions with which the person was challenges faced by historical researchers. Like phe-
affiliated. These organizations and affiliations provide nomenological researchers, who stop interviewing
clues to the location of primary sources (Lundy, participants when redundancy in the data is confirmed,
2012). Primary sources are “firsthand accounts of historical researchers decide to stop gathering data
the person’s experience, an institution, or an event and when new data are no longer being found. The
may lack critical analysis” (Speziale & Carpenter, researcher may return to data gathering if gaps or
2007, p. 263). For example, historical researchers questions emerge as the findings are being written.
interested in Martha Rogers and the effect of World
War II on her theory would note that Rogers was the Writing the Historical Narrative
Dean of New York University, increasing the likeli- The historical researcher keeps extensive records of
hood that the university has documents written by her. the source of each fact, event, and story that is
In the case of Rogers, however, an Internet search extracted. The extracted data may be organized as a
290 UNIT TWO  The Research Process

chronology or attached to an outline. The chronology Irwin (2011) intertwines the career of each nurse
or outline will become the skeleton of the narrative with the concurrent events of that era. She concludes
that will be written. The historical narrative may take as follows, with support for a fresh view of the United
the form of a case study, a rich narrative, or a biogra- States’ role in international health:
phy. The links made by the historical researcher from
the past to the present give historical research its sig-
nificance to nursing (Lundy, 2012). “Taking the histories of U.S. nurses into account and
Irwin (2011) conducted a historical study but gave highlighting their centrality to the study of U.S. inter-
few details of the methods, a situation that is common national history invites a reconsideration of the history
with this qualitative research approach. Historical of U.S. foreign relations in new and vital ways. These
researchers focus on the final product, which may be nurses—Besom, Bridge, D’Olier, Fitzgerald, and
a book, a documentary, or an essay. Early in her essay many others—are our U.S. international history, for
of findings, Irwin indicates her purpose in conducting they were the actual, physical embodiments of the
the study: United States in the world. Their letters, writings, and
biographies are an invaluable archive for scholars
interested in examining the on-the-ground workings
“The archives, sources, and figures that are central to of U.S. influence and soft power.” (Irwin, 2011, p. 96)
the field [nursing] provide a ready means to trace the
spread of U.S. global influence in the early twentieth This is a rigorous study with extensive archive and
century. The discipline should not be relegated to the literature support. The study could have been strength-
peripheries of U.S. international history, therefore, ened, however, if Irwin had provided more informa-
but must be made central in any historical consider- tion about how she integrated the facts from various
ation of the United States in the world.… To demon- documents into a coherent whole.
strate how the history of nursing can inform the study
of both U.S. international history and the broader
history of medicine, this essay traces the careers of KEY POINTS
four nurses during World War I and the following
decade.” (Irwin, 2011, p. 80) • Qualitative methods are more flexible than quanti-
tative methods to ensure that the participant’s voice
is heard.
The four nurses who Irwin highlighted were • Qualitative data collection and data analysis occur
selected because of their service with the American simultaneously.
Red Cross, as described in this excerpt: • Researchers and participants in qualitative studies
co-create the data that will be analyzed.
• Qualitative methods of data collection are observa-
“Pansy V. Besom, Helen L. Bridge, Kathleen D’Olier, tion, interviews, focus groups, images, and elec-
and Alice L. Fitzgerald were among nearly 20,000 tronically mediated communication.
nurses from the United States who volunteered for • Recordings and notes are transcribed into data files
overseas service with the American Red Cross (ARC) prior to analysis.
in World War I and the 1920s. These women gradu- • Qualitative researchers select coding and analysis
ated from U.S. hospital training schools during the strategies consistent with the philosophical
first decade of the twentieth century and went to approach of their studies.
work as nurses in U.S. urban centers.” (Irwin, 2011, • Phenomenological methods may include bracket-
p. 80) ing and interviewing to elicit rich descriptions of
lived experiences.
• Methods specific to grounded theory studies are
A review of Irwin’s reference list makes it clear coding, describing concepts, and identifying links
that she used personal letters, press releases, and between the concepts for the purpose of developing
organizational documents from the National Archives, a theory.
College Park, Maryland. Each citation includes the • Ethnographic methods are characterized by exten-
box number and the file from which data were sive field work that includes observations and inter-
extracted. In addition, Irwin listed more than 100 views for the purpose of describing aspects of the
books as references. culture being studied.
CHAPTER 12  Qualitative Research Methodology 291

• Exploratory qualitative studies may use a theoreti- Cooper, C. M. & Yarborough, S. P. (2010). Tell me-show me: Using
cal perspective on the research topic as the basis combined focus group and photovoice methods to gain under-
for data analysis. standing of health issues in rural Guatemala. Qualitative Health
Research, 20(5), 644–653.
• Historical researchers extract the meaning from
Corbin, J. & Strauss, A. (2008). Basics of qualitative research:
primary and secondary source documents to Techniques and procedures for developing grounded theory (3rd
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of nuances of the research situation and one’s own Davidson, C. (2009). Transcription: Imperative for qualitative
biases. research. International Journal of Qualitative Methods, 8(1),
36–52.
Devault, A., Milcent, M.-P., Ouellet, F., Laurin, I., Jauron, M., &
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  http://evolve.elsevier.com/Grove/practice/

13
CHAPTER

Outcomes Research

O
utcomes research, now an established field in outcomes research. A broad base of literature from
of health research, focuses on the end results a variety of disciplines was used to develop the content
of patient care. Numerous studies have been for this chapter, in keeping with the multidisciplinary
conducted by nursing and medicine over the last three perspective of outcomes research.
decades in the United States (Aiken, Clarke, Sloane,
Lake, & Cheney, 2008; Bakker et al., 2011; Stone
et al., 2007), Canada (Tourangeau, 2003; Tourangeau Theoretical Basis of
et al., 2007), and internationally (Van den Heede et al.,
2009) that explore the relationships among nursing Outcomes Research
interventions and patient outcomes. Nursing-related The theory on which outcomes research is based
interventions and variables that have been studied emerged from evaluation research (Structure-
include skill mix and configuration of nursing person- Process-Outcomes Framework). The theorist Avedis
nel; staffing levels; assignment patterns (primary, Donabedian (1976, 1978, 1980, 1982, 2005) proposed
functional, or team); shift patterns; levels of nursing a theory of quality health care and the process of
education, experience, and expertise; ratios of full- evaluating it. Quality is the overriding construct of the
time to part-time nurses; level and type of nursing theory; however, Donabedian never defined this
leadership available centrally and on units; cohesion concept himself (Mark, 1995). He noted that quality
and communication among the nursing staff and of care is a “remarkably difficult notion to define and
between nurses and physicians; the implementation of is a reflection of the values and goals current in the
clinical care maps for patients with selected diagnoses; medical care system and in the larger society of which
and the interrelationships of these factors. it is a part” (Donabedian, 2005, p. 692). The World
The momentum propelling outcomes research Health Organization (2009, p. 13) defined quality of
comes primarily from policy makers, insurers, and the care as the “degree to which health services for indi-
public. There is a growing demand for data from viduals and populations increase the likelihood of
providers that justify interventions and costs and for desired health outcomes and are consistent with
systems of care that demonstrate improved patient current professional knowledge.”
outcomes. By linking the care people receive to the The cube shown in Figure 13-1 explains the ele-
outcomes they experience, outcomes research has ments of quality health care. The three dimensions of
become the key to developing better ways to monitor the cube are health, subjects of care, and providers of
and improve the quality of care. There has been a care. The concept health has many aspects; three
major shift in published nursing studies as the number are shown on the cube: physical-physiological func-
of studies using traditional quantitative or qualitative tion, psychological function, and social function.
methods is dwarfed by the number of outcomes Donabedian (1987, p. 4) proposed that “the manner in
studies. which we conceive of health and of our responsibility
This chapter describes the theoretical basis of out- for it, makes a fundamental difference to the concept
comes research, provides a brief history of the emerg- of quality and, as a result, to the methods that we use
ing endeavors to examine outcomes, explains the to assess and assure the quality of care.”
importance of outcomes research designed to examine The concept subjects of care has two primary
nursing practice, and highlights methodologies used aspects: patient and person. A patient is defined as

294
CHAPTER 13  Outcomes Research 295

Plan, institution, system

Organized team

Several practitioners*

Individual practitioner

Physical-psychological function

Psychological function

Social function

Individual

Individual
Aggregate:
case load

Aggregate:
target
population,
community
Patient Person

*Of the same profession or of different professions

Figure 13-1  Level and scope of concern as factors in the definition of quality.

someone who has already gained access to some care, requires social consensus that “the scope of profes-
and a person as someone who may or may not have sional competence and responsibility embraces these
gained access to care. Each of these concepts is further areas of function” (Donabedian, 1987, p. 5). Donabe-
categorized by the concepts individual and aggregate. dian indicated, however, that providers of care may
Within patient, the aggregate is a caseload; within make efforts to persuade subjects of care to expand
person, the aggregate is a target population or a their definition of the dimensions of health.
community. The essence of Donabedian’s framework is the
The concept providers of care shows levels of physical-physiological function of the individual
aggregation and organization of providers. The first patient being cared for by the individual practitioner.
level is the individual practitioner. At this level, con- Examining quality at this level is relatively simple. As
sideration is given to the individual provider rather one moves outward to include more of the cubical
than others who might be involved in the subject’s structure, the notions of quality and its assessment
care, whether individual or aggregate. As the levels become increasingly difficult (see Figure 13-1). When
progress, providers of care include several practitio- more than one practitioner is involved, both individual
ners, who might be of the same profession or different and joint contributions to quality must be evaluated.
professions and “who may be providing care con­ Concepts such as coordination and teamwork must be
currently, as individuals, or jointly, as a team” conceptually and operationally defined. When a person
(Donabedian, 1987, p. 5). At higher levels of aggrega- is the subject of care, an important attribute is access.
tion, the provider of care is institutions, programs, or When an aggregate is the subject of care, an important
the healthcare system as a whole. attribute is resource allocation. Access and resource
Donabedian theorized that the dimensions of health allocation are interrelated, because they each define
are defined by the subjects of care, not by the provid- who gets care, the kind of care received, and how
ers of care, and are based on “what consumers expect, much care is received.
want, or are willing to accept” (Donabedian, 1987, p. As more elements of the cube are included, con-
5). Thus, practitioners cannot unilaterally enlarge the flicts among competing objectives emerge. The chief
definition of health to include other aspects; this action conflict is between the practitioner’s responsibilities
296 UNIT TWO  The Research Process

to the individual and to the aggregate. The practitioner temporary, and others are permanent. Thus, an appro-
is expected to have an exclusive commitment to each priate time frame for determining the selected out-
patient, yet the aggregate demands a commitment to comes must be established.
the well-being of society, a situation that may lead to A final obstacle to outcomes evaluation is deter-
ethical dilemmas for the practitioner. Spending more mining attribution. This requires assigning the place
time with an individual patient decreases access for and degree of responsibility for the outcomes observed.
other patients. Society’s demand to reduce costs for an Many factors other than health care may influence
overall financing program may require raising costs to outcomes, and precautions must be taken to hold all
the individual. From an examination of the cube, logic significant factors other than health care constant or
would suggest that one could build up quality begin- account for their effect if valid conclusions can be
ning with the primordial, or elemental, cell and drawn from outcomes research. A particular outcome
increase by increments with the assumption that each is often influenced by a multiplicity of factors. Patient
increment would contribute positively to a greater factors, such as compliance, predisposition to disease,
total quality (see Figure 13-1). However, the conflicts age, propensity to use resources, high-risk behaviors
among competing objectives may preclude this pos- (e.g., smoking, poor dietary habits, and drug abuse),
sibility and lead instead to moral dilemmas. and lifestyle, must be taken into account. Environmen-
Donabedian (1987) identified three objects to eval- tal factors such as air quality, public policies related
uate when appraising quality: structure, process, and to smoking, and occupational hazards must be
outcome. A complete quality assessment program included. The responsibility for outcomes may be dis-
requires the simultaneous use of all three constructs tributed among providers, patients, employers, insur-
and an examination of the relationships among the ers, the community, and the government.
three. However, researchers have had little success in There is as yet little scientific basis for judging the
accomplishing this theoretical goal. Studies designed precise relationship between each of these factors and
to examine all three constructs would require suffi- the selected outcome. Many of the influencing factors
ciently large samples of various structures, each with may be outside the jurisdiction or influence of the
the various processes being compared and large healthcare system or of the providers within it. One
samples of subjects who have experienced the out- solution to this problem of identifying relevant out-
comes of those processes. The funding and the coop- comes is to define a set of proximate outcomes spe-
eration necessary to accomplish this goal have not yet cific to the condition for which care is being provided.
been realized; however, examples of nursing research Critical pathways and care maps may help the
in which two or more aspects have been evaluated are researcher to define at least proximate outcomes.
provided in this chapter. However, proximate outcomes do not provide the
level of evidence that examining the desired outcomes
Evaluating Outcomes does. In addition, researchers must be ever vigilant not
The goal of outcomes research is the evaluation of to confound causality and correlation, because an
outcomes as defined by Donabedian. However, this association or relationships between or among factors
goal is not as simple as it might immediately appear. cannot imply that certain factors caused particular
Donabedian’s theory requires that identified outcomes outcomes.
be clearly linked with the process that caused the
outcome. Researchers need to define the process and Evaluating Process
justify the causal links with the selected outcomes. Clinical management has been, for most health profes-
The identification of desirable outcomes of care sionals, an art rather than a science. Understanding the
requires dialogue between the subjects of care and the process sufficiently to study it must begin with much
providers of care. Although the providers of care may careful reflection, dialogue, and observation. There are
delineate what is achievable, the subjects of care must multiple components of clinical management, many of
clarify what is desirable. The outcomes must also be which have not yet been clearly defined or tested.
relevant to the goals of the health professionals, the Three components of process that are of particular
healthcare system of which the professionals are a interest to Donabedian are standards of care, practice
part, and society. styles, and costs of care.
Outcomes are time dependent. Some outcomes
may not be apparent for a long period after the process Standards of Care
that is purported to cause them, whereas others may A standard of care is a norm on which quality of care
be apparent immediately. Some outcomes are is judged. Clinical guidelines, critical paths, and
CHAPTER 13  Outcomes Research 297

care maps define standards of care for particular situ- outcomes are explained by differences in system of
ations. According to Donabedian (1987), a practi­ care, clinician specialty, and clinicians’ technical and
tioner has legitimate responsibility to apply available interpersonal styles (Tarlov et al., 1989).
knowledge when managing a dysfunction or disease Practice pattern is a concept closely related to
state. This management consists of (1) identifying or practice style. Although practice style represents
diagnosing the dysfunction; (2) deciding whether or variation in how care is provided, practice pattern rep-
not to intervene; (3) choosing intervention objectives; resents variation in what care is provided. Small area
(4) selecting methods and techniques to achieve the analysis is an example of research that attempts to
objectives; and (5) skillfully executing the selected describe variation in practice patterns. Researchers of
techniques or interventions. variations in practice patterns have found that such
Donabedian (1987) recommended the development variation is not totally explained by patients’ clinical
of criteria to be used as a basis for judging the quality conditions. For example, previous researchers have
of care. These criteria may take the form of clinical found that prescribing practices differ by region of the
guidelines or care maps based on prior validation that country and are influenced in part by drug company
the care contributed to the desired outcomes. The clini- resources and marketing practices. The research meth-
cal guidelines published by the Agency for Healthcare odology involved in small area analysis is described
Research and Quality (AHRQ, 2011) establish norms later in this chapter, under the term geographical
or standards against which the validity of clinical man- analysis.
agement can be judged. These norms are now estab- Evidence-based practice (EBP) is another dimen-
lished through clinical practice guidelines available sion of the process of care that is considered a critical
through the National Guideline Clearinghouse within aspect of professional practice (Stetler & Caramanica,
the AHRQ (see http://www.guideline.gov/). However, 2007). The ultimate goals of EBP are improved patient
the core of the problem, from Donabedian’s perspec- health status and quality of care (Graham, Bick,
tive, is clinical judgment. Analysis of the process of Tetroe, Strause, & Harrison, 2011). Thus, the impact
making diagnoses and therapeutic decisions is critical of EBP should be assessed through measurement of
to the evaluation of the quality of care. The emergence patient outcomes. Graham et al. (2011) suggest that
of decision trees and algorithms is a response to when planning evaluation of EBP, evaluators should
Donabedian’s concerns and provides a means of evalu- begin by defining a clear question to guide their evalu-
ating the adequacy of clinical judgments. ation. They use the PICO question as a framework for
structuring their evaluation question (Straus, Tetroe,
Practice Styles Graham, Zwarenstein, & Bhattacharyya, 2009). P
The style of practitioners’ practice is another dimen- refers to the population of interest, which could be the
sion of the process of care that influences quality; public or a specific patient population. I refers to the
however, it is problematic to judge what constitutes implementation of a knowledge translation (KT) inter-
“goodness” in style and to justify the decisions regard- vention. C refers to a comparison or control group who
ing it. Donabedian (1987) identified the following did not receive the intervention, and O refers to the
problem-solving styles: (1) routine approaches to care outcome of interest. For instance, the outcome could
versus flexibility; (2) parsimony versus redundancy; be improvement in health status. Very few empirical
oasis-ebl|Rsalles|1475959208

(3) variations in degree of tolerance of uncertainty; (4) studies have assessed the impact of evidence-based
propensity to take risks; and (5) preference for Type I nursing practice on patient outcomes. Davies, Edwards,
errors versus Type II errors. There are also diverse Ploeg, and Virani (2008) found implementation of best
styles of interpersonal relationships. Westert and practice guidelines in nursing resulted in improved
Groenewegen (1999, p. 174) suggest that “differences outcomes in diverse settings, but there was consider-
in practice styles are a result of differences in oppor- able variability in the indicators evaluated, suggesting
tunities, incentives, and influences.” They suggest that the need for more research in this area. Chapter 19
“there is an (often implicit) idea of what should be provides more details on the synthesis of research
done and how, and this shared (local) standard influ- evidence and the implementation of EBP in nursing.
ences the choices made by individual practitioners.”
This alternative originates in the borders between eco- Costs of Care
nomics and sociology and it can be characterized as A third dimension of the examination of the process
the social production function approach. The Medical of care is cost. There are cost consequences to
Outcomes Study, described later in this chapter, was maintaining a specified level of quality of care. Pro-
designed to determine whether variations in patient viding more and better care is likely to raise costs but
298 UNIT TWO  The Research Process

is also likely to produce savings. Economic benefits A related issue is who bears the costs of care. Some
(savings) result from preventing illness, preventing measures purported to reduce costs have instead
complications, maintaining a higher quality of life, simply shifted costs to another party. For example, a
and prolonging productive life. The Institute for hospital might reduce its costs by discharging a par-
Healthcare Improvement has identified the following ticular type of patient early, but total costs could
simple framework for identifying the return on invest- increase if the necessary community-based health care
ment for quality initiatives (Sadler, Joseph, Keller, & raised costs above those incurred by keeping the
Rostenberg, 2009): patient hospitalized longer or if complications resulted
Step 1: Identify your improvement goal. in rehospitalization. In this case, the third-party pro-
Step 2: Estimate improvement costs. vider could experience higher costs. In many cases,
Step 3: Calculate revenue improvement through cost the costs are shifted from the healthcare system to the
avoidance. family as out-of-pocket costs or costs that are not
Step 4: Calculate the return on investment. covered by healthcare reimbursement systems. Studies
Schifalacqua, Mamula, and Mason (2011) used this examining changes in costs of care should consider
framework in their development of a cost of care cal- total costs, which include out-of-pocket costs. Table
culator for evaluating an EBP program. The goal was 13-1 provides a few examples of studies that examine
to compare the costs of care before and after imple- the direct and indirect costs of care.
mentation of an EBP program. The cost of care analy-
sis focused on potential cost savings realized through
the prevention of serious adverse events, such as Evaluating Structure
healthcare-associated infections, pressure ulcers, and Structures of care are the elements of organization
falls. Many challenges were revealed in identifying and administration, as well as provider and patient
costs that were comparable among healthcare facilities characteristics, that guide the processes of care. The
participating in the implementation of the EBP first step in evaluating structure is to identify and
program for preventing serious adverse events. Base- describe the elements of the structure. Various admin-
line costs associated with each adverse event were istration and management theories could be used to
estimated on the basis of U.S. published studies and identify the elements of the structure. These elements
refined using organizational event data. might be leadership, tolerance of innovativeness,

TABLE 13-1  Studies Examining Costs of Care


Year Source
2011 Madsen, L. B., Christiansen, T., Kirkegaard, P., & Pedersen, E. B. (2011). Economic evaluation of home blood
pressure telemonitoring: A randomized controlled trial. Blood Pressure, 20(2), 117–125.
2010 Spekle, E. M., Heinrich, J., Hoozemans, M. J., Blatter, B. M., van der Beek, A. J., van Dieen et al. (2010). The
cost-effectiveness of the RSI QuickScan program for computer workers: Results of an economic evaluation
alongside a randomized controlled trial. BMC Musculoskeletal Disorders, 11, 259–271.
2010 Van Oostrom, S. H., Heymans, M. W., de Vet, H. C., van Tulder, M. W., van Mechelen, W., & Anema, J. R.
(2010). Economic evaluation of a workplace intervention for sick-listed employees with distress. Occupational
& Environmental Medicine, 67(9), 603–610.
2009 Marchetti, A., & Rossiter, R. (2009). Managing acute acetaminophen poisoning with oral versus intravenous
N-acetylcysteine: A provider-perspective cost analysis. Journal of Medical Economics, 12(4), 384–391.
2007 Griffiths, P. D., Edwards, M. H., Forbes, A., Harris, R. L., & Ritchie, G. (2007). Effectiveness of intermediate
care in nursing-led inpatient units. Cochrane Database of Systematic Reviews, (2), CD002214.
2006 Phibbs, C. S., Holty, J. C., Goldstein, M. K., Garber, A. M., Wang, Y., Feussner, J.R., et al. (2006). The effect of
geriatrics evaluation and management on nursing home use and health care costs: Results from a randomized
trial. Medical Care, 44(1), 91–95.
2005 Harris, R., Richardson, G., Griffiths, P., Hallett, N., & Wilson-Barnett, J. (2005). Economic evaluation of a
nursing-led inpatient unit: The impact of findings on management decisions of service utility and sustainability.
Journal of Nursing Management, 13(5), 428–438.
2004 Altimier, L. B., Eichel, M., Warner, B., Tedeschi, L., & Brown, B. (2004). Developmental care: Changing the
NICU physically and behaviorally to promote patient outcomes and contain costs. Neonatal Intensive Care,
17(2), 35–39.
CHAPTER 13  Outcomes Research 299

TABLE 13-2  Studies Investigating the Relationship between Structural Variables and Outcomes
Year Source
2011 McHugh, M. D., Shang, J., Sloane, D. M., & Aiken, L. H. (2011). Risk factors for hospital-acquired ‘poor glycemic
control’: A case control study. International Journal for Quality in Health Care, 23(1), 44–51.
2011 Trinkoff, A. M., Johantgen, M., Storr, C. L., Gurses, A. P., Liang, Y., & Han, K. (2011). Nurses’ work schedule
characteristics, nurse staffing, and patient mortality. Nursing Research, 60(1), 1–8.
2010 Flynn, L., Liang, Y., Dickson, G. L., & Aiken, L. H. (2010). Effects of nursing practice environments on quality
outcomes in nursing homes. Journal of the American Geriatrics Society, 58(12), 2401–2406.
2010 Fries, C. R., Earle, C. C., & Silber, J. H. (2010). Hospital characteristics, clinical severity, and outcomes for surgical
oncology patients. Surgery, 147(5), 602–609.
2010 Cummings, G. G., Midodzi, W. K., Wong, C. A., & Estabrooks, C. A. (2010). The contribution of hospital nursing
leadership styles to 30-day patient mortality. Nursing Research, 59(5), 331–339.
2009 Silber, J. H., Rosenbaum, P. R., Romano, P. S., Rosen, A. K., Wang, Y., Teng, Y., et al. (2009). Hospital teaching
intensity, patient race, and surgical outcomes. Archives of Surgery, 144(2), 113–120.
2008 Kutney-Lee, A., & Aiken, L. H. (2008). Effect of nurse staffing and education on the outcomes of surgical patients with
comorbid serious mental illness. Psychiatric Services, 59(12), 1466–1469.
2007 Castle, N. G., & Engberg, J. (2007). The influence of staffing characteristics on quality of care in nursing homes. Health
Services Research, 42(5), 1822–1847.
2007 Goldman, L. E., Vittinghoff, E., & Dudley, R. A. (2007). Quality of care in hospitals with a high percent of Medicaid
patients. Medical Care, 45(6), 579–583.
2007 Standing, M. (2007). Clinical decision-making skills on the developmental journal from student to registered nurse: A
longitudinal inquiry. Journal of Advanced Nursing, 60(3), 257–269.
2006 Mor, V. (2006). Defining and measuring quality outcomes in long term care. Journal of the American Medical Directors
Association, 7(8), 532–538.
2006 Rubin, F. H., Williams, J. T., Lescisin, D. A., Mook, W. J., Hassan, S., & Innouye, S. K. (2006). Replicating the Hospital
Elder Life Program in a community hospital and demonstrating effectiveness using quality improvement methodology.
Journal of the American Geriatrics Society, 54(6), 969–974.
2005 Donaldson, N., Brown, D. S., Aydin, C. E., Bolton, M. L., & Rutledge, D. N. (2005). Leveraging nurse-related
dashboard benchmarks to expedite performance improvement and document excellence. Journal of Nursing
Administration, 35(4), 163–172.
2005 Kleinpell, R., & Gawlinski, A. (2005). Assessing outcomes in advanced practice nursing practice: The use of quality
indicators and evidence-based practice. AACN Clinical Issues, 16(1), 43–57.
2005 Wilson, I. B., Landon, B. E., Hirschhorn, L. R., McInnes, K., Ding, L., Marsden, P. V., et al. (2005). Quality of HIV care
provided by nurse practitioners, physician assistants, and physicians. Annals of Internal Medicine, 143(10), 729–736.

organizational hierarchy, decision-making processes, sample of another structure providing the same pro-
oasis-ebl|Rsalles|1476144234

distribution of power, financial management, and cesses and examining the same outcomes. For example,
administrative decision-making processes. Nurse in your research you might want to compare various
researchers investigating the influence of structural structures providing primary health care, such as the
variables on quality of care and outcomes have studied private physician office, the health maintenance orga-
factors such as nurse staffing, nursing education, nization (HMO), the rural health clinic, the community-
nursing work environment, hospital characteristics, oriented primary care clinic, and the nurse-managed
and organization of care delivery (Table 13-2). center. You might examine surgical care provided
The second step is to evaluate the impact of various within the structures of a private outpatient surgical
structure elements on the process of care and on out- clinic, a private hospital, a county hospital, and a teach-
comes. This evaluation requires comparing different ing hospital associated with a health science center.
structures that provide the same processes of care. In Within each of these examples, the focus of your study
evaluating structures, the unit of measure is the struc- would be the impact of structure on processes and
ture. The evaluation requires access to a sufficiently outcomes of care. Table 13-2 lists some current out-
large sample of “like” structures with similar processes comes studies that examined the impact of structure
and outcomes, which can then be compared with a of care and process of care on patient outcomes.
300 UNIT TWO  The Research Process

The federal government requires nursing homes, Quality (AHRQ). The AHRQ is designated as a sci-
home healthcare agencies, and hospitals to collect and entific research agency. The term policy was removed
report specifically measured quality variables to the from the agency name to avoid the perception that
government. The mandate was established because of the agency determined federal healthcare policies
considerable variation in the quality of care in these and regulations. The word quality was added to the
structures. Various government agencies analyze the agency’s name, establishing the AHRQ as the lead
quality of these structures so that they can adequately federal agency on quality of care research, with a
oversee the quality of care provided to the American new responsibility to coordinate all federal quality
public. These data are made available to the general improvement efforts and health services research.
public so that individuals can make their own deter- The new legislation eliminated the requirement that
mination of the quality of care provided by various the AHRQ develop clinical practice guidelines.
nursing homes, home healthcare agencies, or hospi- However, the AHRQ (2011) still supports these
tals. Researchers can also access these data for studies efforts through EBP centers and the dissemination of
of the quality of various structures. To access these evidence-based guidelines through its National
data on the Internet, you can search using the phrases Guideline Clearinghouse (see Chapter 19 for a more
nursing home compare, home health compare, and detailed discussion of EBP guidelines).
hospital compare. In addition to being able to select a The AHRQ, as a part of the U.S. Department of
specific hospital, nursing home, or home healthcare Health and Human Services (DHHS), supports
agency, you can access considerable general informa- research designed to improve the outcomes and quality
tion about quality related to these structures of health of health care, reduce its costs, address patient safety
care. You can also do a search for Magnet hospitals and medical errors, and broaden access to effective
on the American Nurses Credentialing Center website services. The AHRQ website (at http://www.ahrq.gov/)
(http://www.nursecredentialing.org/Magnet/Finda is a valuable source of information about outcomes
MagnetFacility.aspx/) to check the status of a particu- research, funding opportunities, and results of recently
lar hospital regarding its recognition for excellence in completed research, including nursing research. In
nursing care. 2010, AHRQ awarded $25 million in funding to
support efforts by states and health systems to imple-
ment and evaluate patient safety approaches and
Federal Government medical liability reform models. In addition, AHRQ
Involvement in invested $17 million to expand projects to help prevent
healthcare-associated infections (HAIs), the most
Outcomes Research common complication of hospital care. The AHRQ
initiated several major research efforts to examine
Agency for Healthcare Research and Quality medical outcomes and improve quality of care. One
Nurses participated in the initial federal involvement of the latest, which is described in the next section, is
in studying the quality of health care. In 1959, two their comparative effectiveness research.
National Institutes of Health (NIH) study sections,
the Hospital and Medical Facilities Study Section and American Recovery and Reinvestment Act
the Nursing Study Section, met to discuss concerns Funding from the American Recovery and Reinvest-
about the adequacy and appropriateness of medical ment Act (Recovery Act), signed into law in February
care, patient care, and hospital and medical facilities. 2009, allowed AHRQ to expand its work in support
As a result of their dialogue, a Health Services of comparative effectiveness research, including
Research Study Section was initiated. This study enhancing the Effective Health Care Program. A total
section eventually became the Agency for Health Ser- of $473 million was designated for funding patient-
vices Research (AHSR), and subsequently the Agency centered outcomes research (AHRQ, 2010). This
for Health Care Policy and Research (AHCPR). With AHRQ program provides patients, clinicians, and
a growing budget and strong political support, propo- others with evidence-based information to make
nents of the AHCPR were becoming a powerful informed decisions about health care, through activi-
force. They insisted on a change in health care ties such as comparative effectiveness reviews con-
because of the demand for healthcare reform that ducted through AHRQ’s Evidence-based Practice
existed throughout the government and among the Center (EPC) (see Chapter 19). The AHRQ has a
public. A reauthorization act changed the name of the broad research portfolio that touches on nearly every
AHCPR to the Agency for Healthcare Research and aspect of health care, including:
CHAPTER 13  Outcomes Research 301

• Clinical practice
• Outcomes and effectiveness of care “The Medical Outcomes Study was designed to (1)
• Evidence-based practice determine whether variations in patient outcomes
• Primary care and care for priority populations are explained by differences in system of care, clini-
• Healthcare quality cian specialty, and clinicians’ technical and interper-
• Patient safety/medical errors sonal styles and (2) develop more practical tools for
• Organization and delivery of care and use of health- the routine monitoring of patient outcomes in medical
care resources practice. Outcomes included clinical end points; phys-
• Healthcare costs and financing ical, social, and role functioning in everyday living;
• Health information technology patients’ perceptions of their general health and well-
• Knowledge transfer being; and satisfaction with treatment. Populations of
The United States is not the only country demanding clinicians (n = 523) were randomly sampled from dif-
improvements in quality of care and reductions in ferent healthcare settings in Boston, MA; Chicago, IL;
healthcare costs. Many countries are experiencing and Los Angeles, CA. In the cross-sectional study,
similar concerns and addressing them in relation to adult patients (n = 22,462) evaluated their health
their particular government structures. Thus, the move- status and treatment. A sample of these patients (n =
ment into outcomes research and the approaches 2349) with diabetes, hypertension, coronary heart
described in this chapter are a worldwide phenomenon. disease, and/or depression were selected for the lon-
gitudinal study. Their hospitalizations and other treat-
Medical Outcomes Study ments were monitored and they periodically reported
The Medical Outcomes Study (MOS) was the first outcomes of care. At the beginning and end of the
large-scale study in the United States to examine longitudinal study, Medical Outcomes Study staff per-
factors influencing patient outcomes. The study was formed physical examinations and laboratory tests.
designed to identify elements of physician care associ- Results [were] reported serially, primarily in the
ated with favorable patient outcomes. Figure 13-2 [Journal of the American Medical Association].” (Tarlov
shows the conceptual framework for the MOS. The et al., 1989, p. 925)
following describes the MOS:

STRUCTURE OF CARE PROCESS OF CARE OUTCOMES


System characteristics Technical style Clinical end points
• Organization • Visits • Symptoms and signs
• Specialty mix • Medications • Laboratory values
• Financial incentives • Referrals • Death
• Workload • Test ordering
• Access/convenience • Hospitalizations
• Expenditures Functional status
• Continuity of care • Physical
Provider characteristics • Coordination • Mental
• Age • Social
• Gender • Role
• Specialty training Interpersonal style
• Economic incentives • Interpersonal manner Figure 13-2  Conceptual framework of the
• Patient participation General well-being
• Beliefs/attitudes • Health perceptions Medical Outcomes Study.
• Preferences • Counseling
• Communication level • Energy/fatigue
• Job satisfaction • Pain
• Life satisfaction
Patient characteristics
• Age Satisfaction with care
• Gender • Access
• Diagnosis/condition • Convenience
• Severity • Financial coverage
• Comorbid conditions • Quality
• Health habits • General
• Beliefs/attitudes
• Preferences
302 UNIT TWO  The Research Process

MOS failed to control for the effects of nursing Over time other countries developed similar data
interventions, staffing patterns, and nursing practice sets. In Canada, “Standards for Management Informa-
delivery models on medical outcomes. Coordination tion Systems” (MIS) were developed in the 1980s.
of care, counseling, and referral activities, which are Upon the establishment of the Canadian Institute for
more commonly performed by nurses than physicians, Health Information (CIHI) in 1994, the MIS became
were inappropriately considered in the MOS to be a set of national standards used to collect and report
components of medical practice. Kelly, Huber, financial and statistical data from health service orga-
Johnson, McCloskey, and Maas (1994) suggested nizations’ daily operations (Canadian Institute for
modifications to the MOS framework that would rep- Health Information, 2012). Simultaneously, CIHI
resent the collaboration among physicians, nurses, and implemented a national Discharge Abstract Database
allied health practitioners and the influence of their (DAD), which has become a key resource. However,
interactions on patient outcomes. These researchers as was the case with the Medical Outcomes Study
also suggested adding the domain of societal out- discussed earlier, these data sets did not include infor-
comes to include such outcome variables as cost. They mation about nursing care delivered to patients in the
noted that “the MOS outcomes framework incorpo- hospital (Kleib et al., 2011). Without this information,
rated areas in which nursing science contributed to the contribution of nursing care to patient, organiza-
health and medical care effectiveness. It also includes tional, and system outcomes was rendered invisible.
structure, process, and outcome variables in which This major gap in information was addressed by the
nursing practice overlaps with that of other health development of nursing minimum data sets in the
professionals” (p. 213). Kelly et al. (1994) further Unites States, Canada, and other countries around
observed that “client outcome categories of the MOS the world.
framework that go beyond the scope of physician
treatment and intervention alone include functional
status, general well-being, and satisfaction with care” Outcomes Research and
(p. 213). A review of the state of the science on
nursing-sensitive outcomes published in 2011 con- Nursing Practice
firmed the relevance of these outcomes to nursing Outcome studies provide rich opportunities to build a
practice and suggested several more, including self- stronger scientific underpinning for nursing practice.
care; therapeutic self-care, defined as patients’ ability Nurse researchers have been actively involved in the
to manage their disease and its treatment; symptom effort to examine the outcomes of patient care. Ideally,
control; psychosocial functioning; healthcare utiliza- we would like to understand the outcomes of nursing
tion; and mortality (Doran, 2011). practice within a one-to-one nurse/patient relation-
ship. However, in most cases, more than one nurse
cares for a patient. Therefore, the nursing effect is
Origins of Outcomes/ shared. In addition, nurse managers and nurse admin-
Performance Monitoring istrators have control over the nursing staff and the
Florence Nightingale has been credited as being the environment of nursing practice, and this control
first nurse to collect data in order to identify nursing’s affects the autonomy of the nurse to implement prac-
contribution to quality care and to conduct research tice. Therefore, outcomes research must first focus on
into patient outcomes (Magnello, 2010; Montalvo, how nursing care is organized rather than what nurses
2007). However, efforts to systematically collect data do. Then, perhaps, we can begin to determine how
to assess outcomes in more modern times did not gain what nurses do influences patient outcomes (Lake,
widespread attention in the United States until the late 2006). We know that nurses do have an effect on
1970s. At that time, concerns about quality of care patient outcomes. Kramer, Maguire, and Schmalen-
prompted the development of the “Universal Minimum berg (2006) indicated that a growing body of evi-
Health Data Set,” which was followed shortly there- dence supports a relationship between empowered
after by the Uniform Hospital Discharge Data Set shared leadership/governance structure and the imple-
(Kleib, Sales, Doran, Mallette, & White, 2011). These mentation of nursing practice. The importance of
data sets facilitated consistency in data collection autonomy in clinical nursing practice is being recog-
among healthcare organizations by prescribing the nized as critically important to positive patient out-
data elements to be gathered. The aggregated data comes. It is important to identify autonomy-enabling
were then used to perform the assessment of quality structures in the organizational structures of nursing
of care in hospitals and provide information on patients practice. One such structure revealed in a number of
discharged from hospitals. nursing studies is the Magnet hospital designation,
CHAPTER 13  Outcomes Research 303

which represents excellence in nursing in the agency problems that had to be resolved before the project
with this designation. could go forward. Researchers learned that not only
must the indicators be measured consistently but data
Nursing-Sensitive Patient Outcomes collection must also be standardized. As studies con-
A nursing-sensitive patient outcome (NSPO) is tinued, indicators were amplified and continue to be
“sensitive” because it is influenced by nursing care tested.
decisions and actions. It may not be caused by nursing The ANA proposed that all hospitals collect and
but is associated with nursing. In various situations, report on the nursing-sensitive quality indicators. To
“nursing” might be the individual nurse, nurses as a encourage researchers to collect these indicators, the
working group, the approach to nursing practice, the ANA accredited organizations and the federal gov-
nursing unit, or the institution that determines numbers ernment helped by sharing the data with key groups.
of nurses, salaries, educational levels of nurses, assign- The ANA also encouraged state nurses’ associations
ments of nurses, workload of nurses, management of to lobby state legislatures to include the nursing-
nurses, and policies related to nurses and nursing prac- sensitive quality indicators in regulations or state law.
tice. It might even include the architecture of the In 1998, the ANA provided funding to develop a
nursing unit. In whatever form, nursing actions have national database to house data collected using
a role in the outcome, even though acts of other pro- nursing-sensitive quality indicators. This became the
fessionals, organizational acts, and patient character- National Database of Nursing Quality Indicators
istics and behaviors often are involved in the outcome. (NDNQI). Currently, NDNQI has more than 1500
What patient outcomes can you think of that might be participating organizations. Participation in NDNQI
nursing-sensitive? meets requirements for the Magnet Recognition
Nursing-sensitive outcomes have become an issue Program®, and 20% of database members participate
because of national concerns related to the quality of for that reason. The remaining 80% of the members
care. The demand for professional accountability participate voluntarily to support their evaluation and
regarding patient outcomes dictates that nurses be able improvement of nursing care quality and outcomes
to identify and document outcomes influenced by (Montalvo, 2007).
nursing care. Efforts to study nursing-sensitive out- Detailed guidelines for data collection, including
comes were initiated by the American Nurses Associa- definitions and decision guides, are provided by
tion (ANA). In 1994, the ANA, in collaboration with NDNQI (2010). Healthcare organizations submit data
the American Academy of Nursing Expert Panel on electronically via the internet. Statistical methods such
Quality Health Care, launched a plan to identify indi- as hierarchical mixed models are used to examine the
cators of quality nursing practice and to collect and correlation between the nursing workforce character-
analyze data using these indicators throughout the istics and outcomes (Montalvo, 2007). Quarterly and
United States (Mitchell, Ferketich, & Jennings, 1998). annual reports of structure, process, and outcome indi-
The goal was to identify and/or develop nursing- cators are available 6 weeks after the close of each
sensitive quality measures. Donabedian’s theory was reporting period. The database is housed at the
used as the framework for the project. Together, these Midwest Research Institute (MRI), Kansas City, Mis-
indicators were referred to as the ANA Nursing Care souri, and is managed by MRI in partnership with the
Report Card, which could facilitate benchmarking, University of Kansas School of Nursing (Alexander,
or setting a desired standard that would allow com- 2007). The NDNQI nursing sensitive indicators are as
parisons of hospitals in terms of their nursing care follows:
quality. 1. Patient falls/injury falls
No one knew empirically what indicators were sen- 2. Pressure ulcers (hospital acquired, unit acquired)
sitive to nursing care provided to patients or what the 3. Physical/sexual assault
relationships were between nursing inputs and patient 4. Pain assessment/intervention/reassessment cycle
outcomes. Every hospital had a different way of mea- 5. Peripheral intravenous (IV) infiltration
suring the indicators that the ANA had selected. Per- 6. Physical restraints
suading them to change to a standardized measure of 7. Registered Nurse (RN) survey: Job satisfaction;
the indicators for consistency among hospitals was a Practice Environment Scale
major endeavor (Jennings, Loan, DePaul, Brosch, & 8. Healthcare associated infections:
Hildreth, 2001; Rowell, 2001). Multiple pilot studies (a) Catheter-associated urinary tract infections
were conducted as nurse researchers and cooperating (UTI)
hospitals put in place the mechanisms required for (b) Central line–associated bloodstream infection
data collection. These pilot studies identified multiple (c) Ventilator-associated pneumonia
304 UNIT TWO  The Research Process

9. Staff mix (RN; Licensed Practical Nurse [LPN]/ 1. Hours per patient-day (RN, LPN, UAP)
Licensed Vocational Nurse [LVN]/Unlicensed 2. Skill mix
Assistive Personnel [UAP]) 3. Nurse/patient ratios
10. Nursing care hours provided per patient day 4. Percentage of contracted staff utilization (hours)
11. Nurse turnover (total, adapted National Quality 5. Staff voluntary turnover rate
Forum voluntary, Magnet controllable) 6. Workload intensity (admissions, discharges,
12. RN education/certification transfers)
13. RN survey: 7. Sitter hours as percentage of total care hours
(a) Practice Environment Scales 8. RN characteristics (education, certification, years
(b) Job Satisfaction Scales (option) of experience)
(c) Job Satisfaction Scales–Short Form (option) Process indicators:
Other organizations currently involved in efforts to 1. Risk assessment for pressure ulcers (Braden
study nursing-sensitive outcomes include the National Scale)
Quality Forum (NQF), Collaborative Alliance for 2. Time since last risk assessment
Nursing Outcomes California Database, Veterans 3. Risk score (pressure ulcers)
Affairs Nursing Outcomes Database, the Center for 4. Risk status (pressure ulcers, falls)
Medicare and Medicaid Services’ (CMS) Hospital 5. Prevention protocols in place (pressure ulcers,
Quality Initiative, the American Hospital Association, falls)
the Federation of American Hospitals, The Joint Com- 6. Medication administration accuracy: observed
mission, and the AHRQ. A description of the Collab- prevalence of 6 key safe practices
orative Alliance for Nursing Outcomes California 7. Peripherally inserted central catheter (PICC):
Database project follows. line insertion practices (who inserted, where,
presence of a dedicated team)
The Collaborative Alliance for Nursing Outcomes 8. Restraint use: type and clinical justification
California Database Project Outcome measures:
California Nursing Outcomes Coalition (CalNOC) 1. Community-acquired pressure ulcer prevalence
was a statewide nursing quality report card pilot 2. Hospital-acquired pressure ulcer prevalence
project launched in 1996. CalNOC was a joint venture stages 1-4
of the ANA/California and the Association of Califor- 3. Patient fall rate per 1000 patient-days and con-
nia Nurse Leaders that was funded by ANA. Member- sequences (injury fall rate)
ship is voluntary and is composed of approximately 4. Restraint prevalence
300 hospitals from the United States, with pilot work 5. Central line–associated bloodstream infections
in Sweden, England, and Australia. As its membership (CABSIs) in PICC lines
grew nationally, CalNOC was renamed the Collabora- 6. Medication administration error rates
tive Alliance for Nursing Outcomes (CALNOC, For further information on these outcome initia-
2010). It is a not-for-profit corporation, and member tives, you can review Doran, Mildon, and Clarke’s
hospitals pay a size-based annual data management (2011) knowledge synthesis of the state of science on
fee to participate and access CALNOC industry Web- nursing outcomes measurement and international
based benchmarking reporting system. nursing report card initiatives. The knowledge synthe-
Hospital-generated unit-level acute nurse staffing sis was a review of nursing-sensitive outcome and
and workforce characteristics and processes of care report card initiatives in the United States, Canada, the
data as well as key endorsed nursing-sensitive out- United Kingdom, and Belgium.
comes measures are submitted electronically via the
Web. In addition, the CALNOC database includes National Quality Forum
unique measures such as its Medication Administra- The National Quality Forum was created in 1999 as a
tion Accuracy metric, which helps in tracking medica- national standard-setting organization for healthcare
tion errors. CALNOC data are stratified by unit type performance measures (NQF, 2011). The NQF portfo-
and hospital characteristics, and reports can be aggre- lio of voluntary consensus standards includes perfor-
gated to division, hospital, and system/group/geo- mance measures, serious reportable events, and
graphical levels. The following list of nursing-sensitive preferred practices (i.e., safe practices). A complete
indicators has been extracted from Nurse Minimum list of measures included in the NQF portfolio can
Data Sets and CALNOC: be found online (www.qualityforum.org/Measures_
Structure indicators: List.aspx/). Approximately one third of the measures
CHAPTER 13  Outcomes Research 305

in NQF’s portfolio are measures of patient outcomes. RNs educationally prepared at the master’s or doctoral
Examples are mortality, readmissions, health function- level. These practitioners have expertise in a particular
ing, depression, and experience of care (NQF, 2011). area of clinical practice and provide direct patient care.
The NQF includes in their performance measure- The ANA recognizes four types of APNs: certified
ment portfolio several nursing-sensitive measures. registered nurse anesthetists (CRNAs), certified nurse
Those that were submitted by the ANA under the midwives (CNMs), clinical nurse specialists (CNSs),
NDNQI include the following: and nurse practitioners (NPs). Studying APNs requires
• Nursing staff skill mix determining what happens during the process of APN
• Nursing hours per patient-day care. This care involves a set of activities within,
• Catheter-associated urinary tract infection (UTI) among, and between practitioners and patients and
rate includes both technical and interpersonal elements.
• Central line–associated bloodstream infection rate This process of care is complex and somewhat mysteri-
• Fall/injury rates ous. However, clearly describing what occurs during
• Hospital/unit-acquired pressure ulcer rates this process of care is essential to developing a com-
• Nurse turnover rate prehensive understanding of how APNs affect out-
• RN practice environment scale comes.Although researchers have provided descriptions
• Ventilator-associated pneumonia rate of APN care, considerable detailed work must still be
These indicators are the first nationally standard- done to more thoroughly describe the activities and
ized performance measures of nursing-sensitive out- interactions that occur between APNs and patients
comes in acute care hospitals, and they are designed during the process of care (Cunningham, 2004).
to assess healthcare quality, patient safety, and a pro- The next step is to establish the relationship
fessional and safe work environment. Although most between APN interventions and outcomes. The out-
measures currently used focus on the failure to meet comes must be clearly defined and measurable or
the expected standards, the NQF believes that quality observable. Outcomes may require risk adjustments
is as much about influencing positive outcomes as for factors that may confound the results, such as
about avoiding negative outcomes. Thus, the NQF is comorbidity, stage of illness, severity of illness, and
interested in developing measures that reflect the posi- demographic characteristics. Failure to use rigor in
tive effects of nursing care. Priority areas for indica- measurement will limit your ability to interpret study
tors include assessment, patient education, and care findings meaningfully. It is important for variables to
coordination (Naylor, 2007). be measured using the same measurement methods
across studies so that results are more readily com-
Oncology Nursing Society pared. Understanding which outcomes are sensitive to
The Oncology Nursing Society (ONS) is a profes- APN interventions is critical to building knowledge in
sional organization of more than 35,000 RNs and this area. We need a classification of outcomes of APN
other healthcare providers dedicated to excellence in practice. Ingersoll, McIntosh, and Williams (2000)
patient care, education, research, and administration generated a beginning list of 27 relevant outcome indi-
in oncology nursing (ONS, 2012). The ONS has cators of APN practice. The nine highest outcomes are
taken a leadership role among specialty nursing orga- as follows:
nizations in developing an EBP resource area on its • Satisfaction with care delivered
website (http://www.ons.org/ClinicalResources/). The • Symptom resolution or reduction
site provides nurses with a guide to identify, critically • Perception of being well cared for
appraise, and use evidence to solve clinical problems. • Compliance with or adherence to treatment plan
The ONS website also assists nurses—especially • Knowledge of patients and families
advanced practice nurses—who are helping others • Trust of care provider
develop EBP protocols. The outcomes resource area • Collaboration among care providers
helps nurses to achieve desired outcomes for people • Frequency and type of procedures ordered
with cancer by providing outcome measures, resource • Quality of life
cards, and evidence tables. Doran, Sidani, and DiPietro (2010) conducted a
systematic review of the empirical evidence on out-
Advanced Practice Nursing comes of CNS practice. CNSs are licensed registered
Outcomes Research professional nurses with graduate preparation demon-
Studies of outcomes of advanced practice nurses strated in an earned master’s or doctorate degree
(APNs) are now appearing in the literature. APNs are (National Association of Clinical Nurse Specialists
306 UNIT TWO  The Research Process

[NACNS], 2004). CNS-sensitive outcomes are those not considered desirable and is seldom used. Hetero-
that can be theoretically linked to the activities of geneous, rather than homogeneous, samples are
CNSs and observed in the three domains of CNS obtained. Rather than using sampling criteria—which
practice: patient and patient care, nurse and nursing restrict subjects included in the study to decrease pos-
practice, and organization and system (NACNS, sible biases and also reduce the variance and increase
2004). Examples of CNS-sensitive outcomes are the possibility of identifying a statistically significant
disease-specific patient outcomes, physical and psy- difference—outcomes researchers seek large hetero-
chosocial patient outcomes, nurse outcomes (job sat- geneous samples that reflect, as much as possible, all
isfaction), and system outcomes (costs of care) (Doran patients who would be receiving care in the real world.
et al., 2010). For example, samples need to include patients with
various comorbidities and patients with varying levels
of health status. In addition, persons should be identi-
Methodologies for fied who do not receive treatment for their condition.
Devising ways to evaluate the representativeness of
Outcomes Studies such samples is problematic. As noted in Chapter 15
Outcomes research methodologies have been devel- of this text, for a sample to be representative it must
oped to link the care people receive to the results they be as much like the target population as possible,
experience, thereby providing better ways to monitor particularly in relation to the variables being studied.
and improve the quality of care (Clancy & Eisenberg. Because the target population in outcomes research is
1998). This section describes some of the current often heterogeneous, there are a large number of vari-
methodologies used in conducting outcomes research, ables for which sample representativeness needs to be
including sampling methods, research strategies or determined. Another challenge in outcomes research
designs, measurement processes, and statistical is developing strategies to locate untreated individuals
approaches. These descriptions are not sufficient to and include them in follow-up studies. To address
guide you in using the approaches described; rather some of these challenges, outcomes researchers have
they provide a broad overview of the variety of meth- used large databases as sample sources in observa-
odologies being used. This knowledge will help you tional research designs.
understand and critically appraise the methodologies
used in published outcomes studies. For additional Large Databases as Sample Sources
information, you can refer to the citations in each One source of samples for outcomes studies is large
section. Outcomes studies cross a variety of disci- databases. Two broad categories of databases emerge
plines; thus, the emerging methodologies are being from patient care encounters: clinical databases and
enriched by a cross-pollination of ideas, some of administrative databases, as illustrated by Figure 13-3
which are new to nursing research. (Waltz, Strickland, & Lenz, 2010). Clinical databases
are created by providers such as hospitals, HMOs, and
Samples and Sampling healthcare professionals. The clinical data are gener-
The preferred methods of obtaining samples are ated either as a result of routine documentation of care
different in outcomes studies; random sampling is or in relation to a research protocol. Some databases

Patient care
encounter

Figure 13-3  Types of databases emanating from Clinical data Administrative data
patient care encounters.

Large clinical databases Large administrative databases


Computerized medical records Insurance claims databases
Disease or organ-specific databases Tumor or disease registries
Vital statistics databases
CHAPTER 13  Outcomes Research 307

are data registries that have been developed to gather disease, geographical variations in medical care utili-
data related to a particular disease, such as heart zation, characteristics of medical care, outcomes of
disease or cancer (Lee & Goldman, 1989). With a care, and complementarity with clinical trials. Wray
clinical database, you can link observations made by et al. (1995) cautioned, however, that analyses should
many practitioners over long periods. Links can be be restricted to outcomes specific to a particular sub-
made between the process of care and outcomes group of patients rather than to one adverse outcome
(Mitchell et al., 1994; Moses, 1995). of all disease states. Examples of large database indi-
Administrative databases are created by insur- cators used to assess the quality of care are provided
ance companies, government agencies, and others not in Table 13-3.
directly involved in providing patient care. Adminis- Large databases are used in outcomes studies to
trative databases have standardized sets of data for examine patient care outcomes. The outcomes that can
enormous numbers of patients and providers (Deyo be examined are limited to those recorded in the data-
et al., 1994; McDonald & Hui, 1991). An example is base and thus tend to be general. Existing databases
the Medicare database managed by the Centers for can be used for analyses such as (1) assessing nursing
Medicare & Medicaid Services. These databases can care delivery models; (2) varying nursing practices; or
be used to determine the incidence or prevalence of (3) evaluating patients’ risk of hospital-acquired

TABLE 13-3  Examples of Large Database Indicators Used to Monitor Nursing Structural, Process, and
Outcome Indicators
Type of Indicator Indicator Source
Structural Nursing (e.g., RN, LPN, UAP) National Database Nursing Quality Indicators (NDNQI, 2010)
hours per patient day Collaborative Alliance for Nursing Outcomes (CALNOC, 2010)
National Quality Forum (NQF, 2011)
Staff mix (RN, LPN, LVN, UAP) NDNQI (2010)
CALNOC (2010)
NQF (2011)
Nurse turnover NDNQI (2010)
CALNOC (2010)
NQF (2011)
RN Practice Environment NDNQI (2010)
NQF (2011)
Process Risk assessment for pressure ulcers CALNOC (2010)
Physical restraints NDNQI (2010)
CALNOC (2010)
Prevention protocols in place CALNOC (2010)
B-NMDS (Belgian nursing minimum data set) (Van den Heede, et al.,
2009; Sermeus, Delesie, Van den Heede, Diya, & Lesaffre, 2008)
Medication administration accuracy CALNOC
Outcome Patient falls/injury falls NDNQI (2010)
CALNOC (2010)
NQF (2011)
Catheter-associated urinary tract NDNQI (2010)
infection rate NQF (2011)
Hospital-acquired pressure ulcer NDNQI (2010)
CALNOC (2010)
NQF (2011)
Central line–associated blood- NDNQI (2010)
stream infection rate CALNOC (2010)
NQF (2011)

LPN, licensed practical nurse; LVN, licensed vocational nurse; RN, registered nurse; UAP, unlicensed assistive personnel.
308 UNIT TWO  The Research Process

infection, hospital-acquired pressure ulcer, or falls. To researchers and clinical experts in the field, who are
examine these questions, nurses must develop the sta- asked to carefully examine the material and then par-
tistical and methodological skills needed for working ticipate in a consensus conference. The consensus
with large databases. Large databases contain patient conference yields clinical guidelines, which are pub-
and institutional information from huge numbers of lished and widely distributed to clinicians. The clinical
patients. They exist in computer-readable form, require guidelines are also used as practice norms to study
special statistical methods and computer techniques, process and outcomes in that field. Gaps in the knowl-
and can be used by researchers who were not involved edge base are identified and research priorities deter-
in the creation of the database. mined by the consensus group.
Initiatives such as CALNOC (2010), NDNQI Preliminary steps in this process might include con-
(2010; Montalvo, 2007), and the Veterans Affairs ducting extensive integrative reviews and seeking
Nursing Outcome Database (Alexander, 2007) are consensus from a multidisciplinary research team and
making nursing data more accessible for large data- locally available clinicians. A review could be accom-
base research. The following nursing classification plished by establishing a website and conducting dia-
schemes have been used in national databases: logue with experts via the internet. The review could
• The North American Nursing Diagnosis Associa- be published in Sigma Theta Tau’s online journal,
tion (NANDA) Classification Knowledge Synthesis in Nursing, and then dialogue
• The Omaha System: Applications for Community related to the review could be conducted over the
Health Nursing Classification internet. The Delphi method has also been used to seek
• The Home Health Care Classification consensus (Tork, Dassen, & Lohrmann, 2008).
• The Nursing Interventions Classification (NIC) Described as a group process to obtain judgments
• The Nursing Outcomes Classification (NOC) from a panel of experts, the Delphi method involves
a series of questionnaires or rounds until a predeter-
Research Strategies for Outcomes Studies mined level of group consensus is reached (see Chapter
Outcomes research programs usually consist of studies 17). The experts are questioned individually, and a
with a mix of strategies carried out sequentially. summary of the individual judgments is distributed to
Although these strategies could be referred to as panel members, with subsequent questionnaires to
designs, for some the term design as used in Chapters influence the panel members through group feedback
10 and 11 is inconsistent with the strategies used in (Keeney, Hasson, & McKenna, 2011).
outcomes studies. Research strategies for outcomes
studies have emerged from a variety of disciplines, Practice Pattern Profiling
and innovative new strategies continue to appear in Practice pattern profiling is an epidemiological tech-
the literature. Strategies for outcomes studies tend to nique that focuses on patterns of care rather than indi-
employ fewer controls than traditional research vidual occurrences of care. Researchers use large
designs and cannot be as easily categorized. The database analysis to identify a provider’s pattern of
research strategies described in this section are only a practice and compare it with that of similar providers
sampling from the outcomes research literature and or with an accepted standard of practice. The tech-
include consensus knowledge building, practice nique has been used to determine overutilization and
pattern profiling, prospective cohort studies, retro- underutilization of services, to examine costs associ-
spective cohort studies, population-based studies, geo- ated with a particular provider’s care, to uncover prob-
graphical analyses, economic studies, and ethical lems related to efficiency and quality of care, and to
studies. assess provider performance. The provider being pro-
filed could be an individual practitioner, a group of
Consensus Knowledge Building practitioners, or a healthcare organization such as a
Consensus knowledge building is usually performed hospital or an HMO. The provider’s pattern is
by a multidisciplinary group representing a variety of expressed as a rate aggregated over time for a defined
constituencies. Initially, the group conducts an exten- population of patients under the provider’s care. For
sive international search of the literature on the topic example, using data on the universe of deliveries in
of concern, including unpublished studies, studies in Florida and New York over a 15-year period, Epstein
progress, dissertations, and theses. Several separate and Nicholson (2009) examined why treatment styles
reviews may be performed, focusing on specific ques- differ among obstetricians at a point in time and why
tions about the outcomes of care, diagnosis, preven- styles change over time. They found that variation in
tion, or prognosis. The results are dispersed to cesarean section rates among physicians within a
CHAPTER 13  Outcomes Research 309

market is about twice as large as variation between at-risk group will experience the event. The entire
markets. group is followed over time to determine the point at
Profiling can be used when the data contain hierar- which the event occurs, the variables associated with
chical groupings: Patients could be grouped by nurse, the event, and the outcomes for those who experienced
nurses by unit, and units by larger organizations. The the event in comparison with those who did not.
analysis uses regression equations to examine the rela- The Harvard Nurses’ Health Study is an example
tionship of an outcome to the characteristics of the of a prospective cohort study. This study recruited
various groupings. To be effective, the analysis must 100,000 nurses to determine the long-term conse-
include data on the different sources of variability that quences of the use of birth control pills. Every 2 years
might contribute to a given outcome. or more often, nurses complete a questionnaire about
The structure of the analysis reflects the structure their health and health behaviors. The study has now
of the data. For example, patient characteristics could been in progress for more than 20 years. Multiple
be data on disease severity, comorbidity, emergent or studies reported in the literature have used the large
developing status, behavioral characteristics, socio- data set yielded by the study. The following summary
economic status, and demographics. Nurse character- describes a prospective cohort study on smoking and
istics might consist of level of education, specialty risk of psoriasis in women, using the Nurses’ Health
status, years of practice, age, gender, and certifica- Study II, a second study using a younger population
tions. Unit characteristics could comprise number of than the Harvard study (Setty, Curhan, & Choi, 2007).
beds, nursing management style used on the unit, ratio These researchers were able to obtain an extremely
of patients to nurses, and the proportion of staff who large heterogeneous sample for their study by using
are RNs (Doran et al., 2006). Profiles are designed to data from the Nurses’ Health Study.
generate some type of action, such as to inform the
provider that his or her rates of patient improvement
are high or too low in comparison with the norm. By Background: Psoriasis is a common, chronic, inflam-
examining aggregate patterns of practice, profiling can matory skin disorder. Smoking may increase the risk
be used to compare the care provided by different of psoriasis.
organizations or received by different populations of Methods: Over a 14-year time period from 1991 to
patients. Critical pathways or care maps can then be 2005, the relation between smoking status, duration,
used to determine the proportion of patients who intensity, cessation, exposure to second-hand smoke,
diverged from the pathway for a particular nurse, and incident of psoriasis was prospectively examined
group of nurses, or group of nursing units. Profiling in 78,532 women from the Nurses Health Study II.
can be used to improve quality, assess provider per- The primary outcome was incident, self-reported,
formance, and review utilization patterns. physician-diagnosed psoriasis.
Profiling does not address methods of improving Results: Eight hundred eighty-seven incident cases
outcomes, although this process can identify problem of psoriasis were documented. The multivariate rela-
areas. It can be used to determine how performance tive risk (RR) of psoriasis was 1.78 (95% confidence
should be changed to improve outcomes and who interval [CI], 1.46 to 2.16) for current smokers and
should make those changes. Profiling can also identify 1.37 (95% CI, 1.17 to 1.59) for past smokers in
outliers, allowing more detailed examination of these comparison with persons who had never smoked.
individuals and their practice. To date, most of the The multivariate RR of psoriasis was 1.60 (95% CI,
profiling research has been about medical practice. 1.31 to 1.97) for those who had smoked 11 to 20
The development of nursing-sensitive structure, pack-years and 2.05 (95% CI, 1.66 to 2.53) for those
process, and outcome indicators that are assessed and who had smoked 21 or more pack-years in compari-
benchmarked over time, as is being done with NDNQI son with nonsmokers. The multivariate RR of psoria-
(Montalvo, 2007; NDNQI, 2010) will enable profiling sis was 1.61 (95% CI, 1.30 to 2.00) for those who
of nursing practice. quit smoking less than 10 years ago, 1.31 (95% CI,
1.05 to 1.64) for those who had quit 10 to 19 years
Prospective Cohort Studies ago, and 1.15 (95% CI, 0.88 to 1.51) for those who
A prospective cohort study is an epidemiological had quit 20 or more years ago in comparison with
study in which the researcher identifies a group of persons who had never smoked. An increased risk of
people who are at risk for experiencing a particular psoriasis was associated with prenatal and childhood
event. Sample sizes for these studies often must be exposure to passive smoke.
very large, particularly if only a small portion of the
310 UNIT TWO  The Research Process

recall can result in the recall’s appearing to be differ-


Conclusions: The prospective analysis suggests that ent from what actually occurred. Herrmann (1995, p.
current and past smoking, and cumulative measures AS90) also identified four bases of recall:
of smoking, were associated with the incidence of Direct recall: The subject “accesses the memory
psoriasis. After 20 years of smoking cessation, the risk without having to think or search memory,” result-
of the incident psoriasis among ex-smokers decreases ing in correct information.
nearly to that of persons who have never smoked. Indirect recall: The subject “accesses the memory
(Setty et al., 2007, p. 953) after thinking or searching memory,” resulting in
correct information.
Limited recall: “Access to the memory does not occur
Retrospective Cohort Studies but information that suggests the contents of the
A retrospective cohort study is an epidemiological memory is accessed,” resulting in an educated
study in which the researcher identifies a group of guess.
people who have experienced a particular event. This No recall: “Neither the memory nor information rel-
is a common research technique used in the field of evant to the memory may be accessed, resulting in
epidemiology to study occupational exposure to a wild guess.”
chemicals. Events of interest to nursing that could be The following abstract developed by Rozen, Ugoni,
studied in this manner include a procedure, an episode and Sheehan (2011), on their study of vaginal birth
of care, a nursing intervention, and a diagnosis. Nurses after cesarean section, is presented as an example of
might use a retrospective cohort study to follow a a retrospective cohort study:
cohort of women who had received a mastectomy for
breast cancer or of patients in whom a urinary bladder “Background: Previous studies assessing the safety of
catheter was placed during and after surgery. The vaginal birth after caesarean section (VBAC) have
cohort is evaluated after the event to determine the compared VBAC to elective repeat caesarean section
occurrence of changes in health status, usually the (ERCS), despite the fact that the risks posed by each
development of a particular disease or death. Nurses are considerably different. Explaining the complica-
might be interested in the pattern of recovery after an tions of VBAC in a way that is meaningful to women
event or, in the case of catheterization, the incidence can be challenging, and thus a comparison to a similar
of bladder infections in the months after surgery. group of women who have also not undergone
On the basis of the study findings, epidemiologists previous vaginal delivery may be a more relevant
calculate the relative risk of the identified change in comparison.
health for the group. For example, if death were the Research Question: When counseling women
occurrence of interest, the expected number of deaths undergoing planned VBAC, should a comparison of
would be determined. The observed number of deaths outcomes be made to women undergoing ERCS, or
divided by the expected number of deaths and multi- is a comparison to other nulliparous women undergo-
plied by 100 yields a standardized mortality ratio ing vaginal birth a more valid comparison in terms of
(SMR), which is regarded as a measure of the relative risk outcomes?
risk of the studied group to die of a particular condi- Participants and Methods: A retrospective cohort
oasis-ebl|Rsalles|1476144236

tion. In nursing studies, patients might be followed study was undertaken comprising a consecutive
over time after discharge from a healthcare facility to cohort of 21,389 women who delivered, stratified by
determine complication rates and the SMR (Swaen & Robson’s criteria into Robson groups 1-5. Those in
Meijers, 1988). Robson groups 6-10 were not included. Demographic
In retrospective studies, researchers commonly ask data and maternal/neonatal outcomes were reviewed,
patients to recall information relevant to their previous with main outcome measures comprising uterine
health status. This information is often used to deter- rupture, post-partum hemorrhage (PPH), 3rd/4th
mine the amount of change occurring before and after degree tears, and neonatal morbidity.
an intervention. Recall can easily be distorted, thereby Results: There was no increase in PPH, vaginal
misleading researchers in determining outcomes. tears, or neonatal complications in the VBAC group
Thus, recall should be used with caution. Herrmann when compared to Robson groups 1 and 2 (nullipa-
(1995) identified three sources of distortion in recall: rous women in spontaneous or induced labour,
(1) the question posed to the subject may be conceived respectively). Uterine rupture rates were low in all
or expressed incorrectly; (2) the recall process may be groups, with no correlation identified.
in error; and (3) the research design used to measure
CHAPTER 13  Outcomes Research 311

Discussion: The maternal and neonatal morbidity measures were birth weight, preterm delivery,
associated with VBAC is comparable to primiparous small-for-gestational-age, and large-for gestational-
women undergoing a vaginal birth. age babies. Multivariate linear and logistic regression
Conclusion: In demonstrating the low relative mor- analyses were used to analyze study data.
bidity in this comparison, these outcomes may aid in Results: In this study, mothers aged 30-34.9 years
counseling women faced with the choice of VBAC had no differences in risk of preterm delivery. Mothers
versus ERCS.” (Rozen et al., 2011, p. 3) <20 years had the highest risk of delivering small-
for-gestational-age babies (OR 1.6, 95% CI: 1.1-2.5);
however, after adjustment for sociodemographic and
Population-Based Studies lifestyle-related determinants this increased risk was
Population-based studies are also important in out- not present. Mothers >40 years had the highest risk
comes research. Conditions must be studied in the of delivering large-for-gestational-age babies (OR 1.3,
context of the patient’s community rather than of the 95% CI: 0.8-2.4); however no associations of
medical system. With this method, all cases of a condi- maternal age with the risks of delivering large-
tion occurring in the defined population are included, for-gestational-age babies could be explained by
rather than only patients treated at a particular health- sociodemographic and lifestyle-related determinants.
care facility, because the latter could introduce a selec- Conclusions: Younger mothers have an increased
tion bias. The researcher might make efforts to include risk of small-for-gestational age babies, whereas older
individuals with the condition who had not received mothers have an increased risk of large-for-
treatment. gestational-age babies when compared with mothers
Community-based norms of tests and survey instru- aged 30-34.9 years. Sociodemographic and lifestyle-
ments obtained in this manner provide a clearer picture related determinants cannot entirely explain these
of the range of values than the limited spectrum of differences.” (Bakker et al., 2011, p. 500)
patients seen in specialty clinics. Estimates of instru-
ment sensitivity and specificity are more accurate.
This method enables researchers to understand the
natural history of a condition or of the long-term risks Geographical Analyses
and benefits of a particular intervention (Guess et al., Geographical analyses examine variations in health
1995). Bakker et al. (2011) conducted a study examin- status, health services, patterns of care, or patterns of
ing the differences in birth outcomes related to mater- use by geographical area and are sometimes referred
nal age. The following is an abstract of their study: to as small area analyses. Variations may be associ-
ated with sociodemographic, economic, medical, cul-
tural, or behavioral characteristics. Locality-specific
“Background: Previous studies have shown that birth factors of a healthcare system, such as capacity, access,
weight and preterm birth are strong predictors of and convenience, may play a role in explaining varia-
neonatal morbidity and mortality. Maternal age might tions. The social setting, environment, living condi-
be a modifiable determinant of weight and gestational tions, and community may also be important factors.
age at birth. In most Western countries the age of The interactions between the characteristics of a
mothers having their first child is increasing due to locality and of its inhabitants are complex. The char-
prolonged education, professional commitment, acteristics of the total community may transcend the
delayed marriage, and other personal reasons. It has characteristics of individuals within the community
been suggested that older maternal age is associated and may influence subgroup behavior. High educa-
with increased risks of pregnancy complications, such tional levels in the community are commonly associ-
as gestational hypertension or diabetes, preterm ated with greater access to information and
delivery, fetal malformations, and fetal death. receptiveness to ideas from outside the community.
Methods: This is a population-based prospective Regression analyses are commonly used to develop
cohort study with 8,568 mothers and their children models using all the risk factors and the characteristics
based in Rotterdam, Netherlands. Maternal age, of the community. Results are often displayed through
sociodemographic, lifestyle-related determinants, the use of maps (Kieffer, Alexander, & Mor, 1992).
and birth outcomes were obtained from question- After the analysis, the researcher must determine
naires and hospital records. The main outcome whether differences in rates are due to chance alone
and whether high rates are too high. From a more
312 UNIT TWO  The Research Process

theoretical perspective, the researcher must then benefit from available resources. If available resources
explain the geographical variation uncovered by the must be shared with other programs or other types of
analysis (Volinn, Diehr, Ciol, & Loeser, 1994). patients, an economic study can determine whether
Geographical information systems (GISs) can changing the distribution of resources will increase
provide an important tool for performing geographical total benefit or welfare.
analyses. A GIS uses relational databases to facilitate Economic evaluation is a “set of formal, quantita-
processing of spatial information. The software tools tive methods used to compare two or more treatments,
in a GIS can be used for mapping, data summaries, programs, or strategies with respect to their resource
and analysis of spatial relationships. GISs have the use and their expected outcomes” (Guyatt, Rennie,
capability of modeling data flows so that the effect of Meade, & Cook, 2008, p. 781). In 1993, the U.S.
proposed changes in interventions applied to individu- Public Health Service established the Panel on Cost-
als or communities on outcomes can be modeled. Effectiveness in Health and Medicine to address the
Dunn, Anderson, and Bierman (2009) conducted a Public Health System’s growing need for evaluating
study of temporal and regional trends in intrauterine techniques that could guide decision-making pro-
device (IUD) insertion. Their study abstract is reprinted cesses in an era of rising cost restrictions (Gold, 1996).
here: The Panel was charged with the development of rec-
ommendations for addressing the (1) poor quality of
many economic analyses; (2) lack of comparability
“Background: In Canada, intrauterine device (IUD) use across cost-effectiveness analyses (CEAs) of different
is low and declined between 1985 and 1995. This interventions or types of illness; and (3) lack of data
study examines temporal and regional trends in IUD on the costs and effects of interventions (Gold, 1996).
insertion in Ontario, Canada, from 1996 to 2006. Cost-effectiveness analysis, rather than cost-benefit
Study Design: Physician billing data was used to analysis, was identified as the appropriate tool for
determine annual age-adjusted IUD insertion rates economic analysis for the purpose of public health
for women aged 15-55 years and proportions inserted uses because of the former’s focus on health rather
by gynecologists and family physicians (FPs). Small than economic outcomes. The recommendations of
area variation statistics were used to analyze variation the Panel are summarized here.
in rates across the province. CEAs compare different ways of accomplishing a
Results: Annual insertion rates followed a U-shaped clinical goal, such as diagnosing a condition, treating
distribution and were lowest in 2001 and highest in an illness, or providing a service. The alternative
2006. From 1996 to 2006, the proportion inserted by approaches are compared in terms of costs and bene-
FPs fell from 38.2% to 31.6% (p<0.001). In 2006, fits. The purpose is to identify the strategy that pro-
women in regions with the highest rates were twice vides the most value for the money. There are always
as likely to have an IUD inserted as those in the tradeoffs between costs and benefits. When making
lowest-rate regions. decisions for patient groups, clinicians need to con-
Conclusions: IUD insertion rate began to increase sider whether the benefits of providing treatment are
in 2001, the year of introduction of levonorgestrel- worth the healthcare costs. It is also important to indi-
releasing intrauterine system. Regional variation in cate whose perspective the analysis will consider, for
rates suggests that access is not equal across the example, that of patients, providers, insurers, or the
province and that strategies to support FPs to insert broader society. The Panel on Cost-Effectiveness in
IUDs may be important to ensure sufficient access.” Health and Medicine assumed a societal perspective.
(Dunn et al., 2009, p. 469) The Panel’s recommendations fell into the following
eight categories (Weinstein, Siegel, Gold, Kamlet, &
Russell, 1996):
Economic Studies 1. The nature and limits of CEA and of the reference
Many of the problems studied in health services case for the analysis.
research address concerns related to the efficient use 2. Components (variables) belonging in the numera-
of scarce resources and, thus, to economics. Health tor and denominator of a cost/effectiveness ratio.
economists are concerned with the costs and benefits 3. Measuring terms in the numerator (i.e., costs).
of alternative treatments or ways of identifying the 4. Valuing the health consequences in the denomi­
most efficient means of care. The economist’s defini- nator.
tion of efficiency is the least expensive method of 5. Estimating effectiveness of the intervention.
achieving a desired end while obtaining the maximum 6. Time preference and discounting.
CHAPTER 13  Outcomes Research 313

7. Handling uncertainty in CEA. conclusions still hold. For the last category, reporting
8. Reporting guidelines. guidelines, the Panel developed a set of recommenda-
With regard to category #1, the Panel chose the tions for reporting CEA that addressed how to report
societal perspective for the reference case they con- the background to the problem, data and methods,
sidered in their analysis, because it does not represent results, and discussion (Siegel, Weinstein, Russell, &
the viewpoint of any specific group and provides a Gold, 1996). Building on these recommendations,
benchmark against which to assess results from other Stone (1998) described the methodology for conduct-
perspectives. “The reference case is defined by a stan- ing and reporting cost-effectiveness analyses in
dard set of methods and assumptions. It includes a set nursing.
of standard results: the reference case results” (Russell, Costs can vary hugely across jurisdictions, because
Gold, Siegel, Daniels, & Weinstein, 1996, p. 1173). hospitals may have different success in negotiating
As to category #2, the “results of CEA are summarized with suppliers for drugs and equipment (Drummond,
in cost-effectiveness ratios that demonstrate the cost Groeree, Moayyedi, & Levine, 2008). Costs also
of achieving a unit of health effect (e.g., cost per year depend on how care is organized. “The same service
of life gained) for diverse types of patients and for may be delivered by a physician or a nurse practitio-
variations of the intervention” (Russell et al., 1996, p. ner, in the outpatient setting or in the hospital, and
1173). Changes in health due to the intervention are with or without administrative costs related to the
captured in the denominator, and changes in resource adjudication of patient eligibility to receive the
use due to the intervention are captured in the numera- service” (Drummond et al., 2008, p. 623). It is time
tor. The societal perspective dictates that all important for nurses to take a more active role in conducting
effects on human health (e.g., social and physical cost-effectiveness research. Nurses are well positioned
function, quality of life, years of life) and on resources to evaluate healthcare practices and have the incentive
must be included in the analysis. Therefore the panel to conduct the studies. However, nursing practice is
recommended that the denominator of the C/E ratio seldom a subject of cost-effectiveness analyses. The
be reserved for the improvement in health associated knowledge gained from this effort could enable nurses
with an intervention (Weinstein et al., 1996). With to refine their practice by substituting interventions
regard to category #3, there were several recommen- that maximize nurses’ time (a cost variable) to the best
dations related to what to include in the numeration of advantage of patient outcomes.
the C/E ratio, which reflects the change in costs or use Fraher, Collins, Bourke, Phelan, and Lynch (2009)
of resources caused by a health intervention. For conducted an economic analysis of employing a total
example, the Panel recommended that costs be mea- parenteral nutrition surveillance nurse for the preven-
sured in constant dollars, an approach that requires tion of catheter-related bloodstream infections. The
adjusting dollars for different years because of infla- following is an abstract of that study.
tion. Valuing the health consequences in the denomi-
nator (category #4) requires a measurement of adjusted
life-years expressed in an interval scale so that the Background: “The cost of catheter-related blood-
ratio of differences between values is meaningful. stream infection (CRBSI) is substantial in terms of
Acceptable data for estimating effectiveness of the morbidity, mortality, and financial resources. Total
intervention, which is category #5, may come from a parenteral nutrition (TPN) is a recognized risk factor
variety of sources such as randomized controlled for CRBSI. In 1997, an intravenous nutrition nurse
trials, observational studies, uncontrolled experi- was promoted to TPN surveillance clinical nurse
ments, or descriptive series (Weinstein et al., 1996). manager (CNM) and quarterly infection audit meet-
As to category #6, on time preference and discounting, ings were introduced to monitor trends in CRBSI.”
the Panel recommended that costs and health out- Methods: “Data were prospectively collected over
comes occurring during different time periods should a 15-year period using specific TPN records in a
be discounted to their present value and that they 535-bed tertiary acute university hospital. A total of
should be discounted at the same rate. The Panel rec- 20,439 CVC-days and 307 CRBSIs were recorded.
ommended a discount rate of 3%. It is important to Mean number of infections before, and after, the
address uncertainty in conclusions of CEA (category introduction of a dedicated TPN surveillance CNM
#7) because CEA conclusions might change with were compared.”
changes in assumptions or values (e.g., discount rate). Results: “Mean CRBSI per 1000 catheter-days ± SD
Uncertainty is addressed by varying the values/ was 20.5 ± 6.34 prior to 1997 and 14.64 ± 7.81 after
assumptions in the analysis and assessing whether the
314 UNIT TWO  The Research Process

1997, representing a mean reduction of 5.84 CRBSIs special importance to Israel, given its high fertility
per 1000 catheter-days (95% CI: –4.92 to 16.60; rates. To this end, this study conducted a survey of
p=0.05). Mean number of CRBSIs per year ± SD was physicians’ attitudes regarding access to fertility care
28.3 ± 4.93 prior to 1997 and 18.5 ± 7.37 after 1997, and treatment. An anonymous questionnaire was dis-
representing a mean decrease of 9.8 infections per tributed among IVF [in vitro fertilization] providers in
year (95% CI: 0.01 to 19.66; p<0.05). The savings all fertility clinics in Israel during 2008-2009. A total
made by preventing 9.8 infections per year were cal- of 46 physicians (> 40%) responded. Although all
culated from data on bed-days obtained from the agree that every person has a right to procreate,
hospital finance office. The cost in hospital days saved 15.25% believe it is important to screen candidates
per annum was c 135,000.” and 55.6% believe they should consider non-medical
Conclusions: “Introduction of the TPN surveillance criteria when providing care. Only 47.8% of physi-
CNM saved the hospital at least c 78,300 per annum cians acknowledge the existence of guidelines in their
and led to a significant decrease in CRBSIs in TPN units, but where they exist, 22.5% state they do not
patients.” (Fraher et al., 2009, p. 129) follow them. Furthermore, between 24.4-63.0% of
physicians are willing to perform controversial proce-
dures if backed by official guidelines. In conclusion,
Ethical Studies existing guidelines are often vague or ignored. Con-
Outcomes studies often lead to policies for allocating trary to the USA, IVF providers in Israel are shaped
scarce resources. Ethicists take the position that moral by the pro-natalist [an attitude or policy that encour-
principles, such as justice, constrain the use of costs ages childbearing] approach highly encouraged by the
and benefits to choose treatments that might maximize state and they act less as trustees and gatekeepers to
the benefit per unit cost. Value commitments are inher- the future child.” (Sperling & Simon, 2010, p. 854)
ent in choices about research methods and about the
selection and interpretation of outcome variables, and
researchers should acknowledge these commitments. Measurement Methods
“The choices researchers make should be documented The selection of appropriate outcome variables is criti-
and the reasons for those choices should be given cal to the success of a study (Bernstein & Hilborne,
explicitly in publications and presentations so that 1993). As in any study, the researcher must evaluate
readers and other users of the information are enabled the evidence of validity and the reliability of the mea-
and expected to bear more responsibility for interpret- surement methods. Outcomes selected for nursing
ing and applying the findings appropriately” (Lynn & studies should be those most consistent with nursing
Virnig, 1995, p. AS292). Veatch (1993) proposed that practice and theory (Harris & Warren, 1995). In some
by analyzing the implications of rationing decisions in studies, rather than selecting the final outcome of care,
terms of the principles of justice and autonomy, we which may not occur for months or years, researchers
would establish more acceptable criteria than we use measures of intermediate end points. Intermedi-
would by using outcomes predictors alone. As an ate end points are events or markers that act as pre-
example, Veatch performed an ethical analysis of the cursors to the final outcome. It is important, however,
use of outcome predictors in decisions related to the to document the validity of the intermediate end point
early withdrawal of life support. Ethical studies need in predicting the outcome (Freedman & Schatzkin,
to play an important role in outcomes programs of 1992). In early outcomes studies, researchers selected
research. outcome measures that they could easily obtain rather
Sperling and Simon (2010) investigated physician than those most desirable for outcomes studies. Later
attitudes and policies regarding access to fertility care outcome studies have selected outcome measures
and assisted reproductive technologies in Israel. The from secondary data sources (e.g., Aiken et al., 2008;
abstract of that study follows: Cummings, Midodzi, Wong, & Estabrooks, 2010).
Secondary analysis is “any reanalysis of data or infor-
“Despite the high profile of fertility care and assisted mation collected by another researcher or organiza-
reproductive technologies, their social and regulatory tion, including analysis of data sets collected from a
contexts remain largely unexplored. Yet, studies variety of sources to create time-series or area-based
reveal a practice of candidate screening on a some- data sets” (Shi, 2008, p. 129). Outcomes researchers
what arbitrary basis. Examining the above issues is of have used secondary data from sources such as hospi-
tal discharge data (Aiken et al., 2008; Cummings
CHAPTER 13  Outcomes Research 315

et al., 2010). Data collected through NDNQI or (2006) and Bettger, Coster, Latham, and Keysor
CALNOC can also be utilized in nursing outcomes (2008).
research. For some outcomes, the changes may be nonlinear
Table 13-4 identifies characteristics important to or may go up and down rather than always increasing.
evaluate in selecting methods of measuring outcomes. Thus, it is as important to uncover patterns of change
In evaluating a particular outcome measure, the as it is to test for statistically significant differences at
researcher should consult the literature for previous various time points. Some changes may occur in rela-
studies that have used that particular method of mea- tion to stages of recovery or improvement. These
surement, including the publication describing devel- changes may occur over weeks, months, or even years.
opment of the method of measurement. This approach A more complete picture of the process of recovery
was used by Doran et al. (2011) when they reviewed can be obtained by examining the process in greater
the state of the science on nursing-sensitive outcomes. detail and over a broader range. With this approach,
For each outcome concept (e.g., functional status, the examiner can develop a recovery curve, which
pain, pressure ulcer, self-care), the empirical literature provides a model of the recovery process that can then
investigating the concept in nursing research was be tested (Boz et al., 2004; Hernandez, Fernandez,
reviewed. The approach to measurement of the Luzon, Cuena, & Montejo, 2007; McCauley, Hannay,
outcome concept was identified, and the reliability, & Swank, 2001).
sensitivity, and validity of the measurement tools were
appraised and summarized in tabular form. Sensitivity Analysis of Improvement
to change is an important measurement property to In addition to reporting the mean improvement
consider in outcomes research because researchers are score for all patients treated, it is important to report
often interested in evaluating how outcomes change what percentage of patients improved. Do all patients
in response to healthcare interventions. As the sensi- improve slightly, or is there a divergence among
tivity of a measure increases, statistical power patients, with some improving greatly and others not
increases, allowing smaller sample sizes to detect sig- improving at all? This divergence may best be illus-
nificant differences. For a full discussion of reliability trated by plotting the data. Researchers studying a
and validity of scales and questionnaires, precision particular treatment or approach to care might develop
and accuracy of physiological measures, and sensitiv- a standard or index of varying degrees of improvement
ity and specificity of diagnostic tools, refer to Chapter that might occur. The index would allow better com-
16 of this text. parisons of the effectiveness of various treatments.
Characteristics of patients who experience varying
Statistical Methods for Outcomes Studies degrees of improvement should be described, and out-
Although outcomes researchers test for the statistical liers should be carefully examined. This step requires
significance of their findings, this evaluation is not that the study design include baseline measures of
considered sufficient to judge the findings as impor- patient status, such as demographic characteristics,
tant. Their focus is the clinical importance of study functional status, and disease severity measures. An
findings (see Chapter 21 for more information on analysis of improvement allows better judgments of
clinical importance). In analyzing data, outcomes the appropriate use of various treatments (Fasting &
researchers have moved away from statistical analyses Gisvold, 2003).
that use the mean to test for group differences. They
place greater importance on analyzing change scores Variance Analysis
and use exploratory methods for examining the data Variance analysis is used to track individual and
to identify outliers. group variance from a specific critical pathway. The
goal is to decrease preventable variance in process,
Analysis of Change thus helping patients and their families achieve optimal
With the focus on outcomes studies has come a outcomes. Some of the variance is due to comorbidi-
renewed interest in methods of analyzing change. ties. You may find that keeping a patient with comor-
Gottman and Rushe (1993) reported that the first book bidities on the desired pathway may require you to
addressing change in research, Problems in Measuring utilize more resources early in the patient’s care. Thus,
Change, edited by Harris (1967), is the basis for most it is important to track both variance and comorbidi-
of the current approaches to analyzing change. ties. Studies examining variations from pathways may
However, some new ideas have emerged regarding the make it easier for healthcare providers to tailor exist-
analysis of change, such as the studies by Tracy et al. ing critical pathways for specific comorbidities.
316 UNIT TWO  The Research Process

TABLE 13-4  Characteristics of Outcomes Assessment Instruments*


Characteristic Considerations in Patient Outcomes Evaluation References
Applicability Consider purpose of instruments Deyo & Carter, 1992
Discriminate between subjects at a point in time Stewart et al., 1989
Predict future outcomes Guyatt, Walter, & Norman, 1987
Evaluate changes within subjects over time Feinstein, Josephy, & Wells, 1986
Screen for problems Deyo, 1984
Provide case-mix adjustment
Assess quality of care
Consider whether norms are established for clinical population of interest
Instrument format is compatible with assessment approach (e.g.,
observer-rated versus self-administered)
Setting in which instrument was developed
Practicality The Instrument: Leidy, 1991
(clinical utility) Includes outcomes important to the patient Nelson, Landgraf, Hays, Wasson,
Is short and easy to administer (low respondent burden) includes & Kirk, 1990
questions that are easy to understand and acceptable to patients and Stewart et al., 1989
interviewers Lohr, 1988
Has scores that reflect condition severity and condition-specific features, Bombardier & Tugwell, 1987
and discriminate those with conditions from those without Feinstein et al., 1986
Is easily scored and has readily understandable scores Kirshner & Guyatt, 1985
Uses a level of measurement that allows a change score to be determined Deyo, 1984
Provides information that is clinically useful
Is performance or capacity based
Includes patient rating of magnitude of effort and support needed for
performance of physical tasks
Comprehensiveness Generic measures are designed to summarize a spectrum of concepts Nelson et al., 1990
applied to different impairments, illnesses, patients, and populations Patrick & Deyo, 1989
Disease-specific measures are designed to assess specific patients with Deyo, 1984
specific conditions or diagnoses
Dimensions of the instrument; a core set of physical, mental, and role
functions-desirable
Reliability Can be influenced by day-to-day variations in patients, differences Nelson et al., 1990
between observers, items in the scale, mode of administration Spitzer, 1987
Is the critical determinant of usefulness of an instrument Guyatt et al., 1987
Is designed for discriminative purpose Deyo, 1984
Validity No consensus of what are scientifically admissible criteria for many Spitzer, 1987
indices Deyo, 1984
No “gold standard” exists for establishing criterion validity for many
indices
Responsiveness Not yet indexed for virtually any evaluative measures Stewart & Archbold, 1992
Coarse scale rating may not detect changes Leidy, 1991
Aggregated scores may obscure changes in subscales Jaeschke, Singer, & Guyatt, 1989
Useful for determining sample size and statistical power Bombardier & Tugwell, 1987
Reliable instruments are likely to be responsive, but reliability not Guyatt et al., 1987
adequate as sole index of consistent results over time Deyo & Centor, 1986
Detail in scaling should be considered Deyo, 1984
As baseline variability of score changes within stable subjects, larger
treatment effects may be needed to demonstrate efficacy
Temporal relationship between intervention and outcome should be
considered

*Examples are illustrative; for complete list of structural, process, and outcome indicators, refer to original sources cited in the table.
Modified from Harris M. R., & Warren, J. J. (1995). Patient outcomes: Assessment issues for the CNS. Clinical Nurse Specialist, 9(2), 82.
CHAPTER 13  Outcomes Research 317

Variance analysis can also be used to identify results from LTA provided useful information about
at-risk patients who might benefit from the services of for whom and in what direction the intervention
a case manager. Variance analysis tracking is expressed resulted in change. In addition, LTA is a useful proce-
through the use of graphics, with the expected pathway dure for nurse researchers because it collapses large
plotted on a graph. The care providers plot deviations arrays of categorical data into meaningful patterns
(negative variance) on the graph, allowing immediate (Roberts & Ward, 2011). For example, Cain, Epler,
comparison with the expected pathway. Deviations Steinley, and Sher (2010) used LTA to examine change
may be related to the patient, system, or provider in patterns of concerns related to eating, weight, and
(Okita et al., 2009; Olive & Solomonides, 2009; shape in young adult women.
Tidwell, 1993).
Multilevel Analysis
Latent Transition Analysis Multilevel analysis is a statistical technique that
Latent transition analysis (LTA) is used in situations is useful when data exist at several different levels,
in which stages or categories of recovery have been for example, if data are nested or if a study has
defined and transitions between stages can be identi- several different units of analysis. It has been used in
fied. To use this analysis method, the researchers epidemiology to study how environmental factors
assign each member of the population to a single cat- (aggregate-level characteristics) and individual attri-
egory or stage for a given point of time. However, butes and behaviors (individual-level characteristics)
stage membership changes over time. The analysis interact to influence individual-level health behaviors
tests stage membership to provide a realistic picture and disease risks. Growing numbers of nursing studies
of development. have used multilevel analysis as a statistical technique
Roberts and Ward (2011) described an example of to study phenomena measured at different units of
latent transition analysis (LTA) for nursing research analysis. One such example is the study by Simon,
by presenting a case example, using secondary analy- Muller, and Hasselhorn (2010), who used multilevel
sis. The secondary analysis involved a psychoeduca- analysis to determine which variables were associated
tional intervention for cancer pain management in with nurses’ intention to leave the profession and
which LTA was used to describe for whom and in what which were associated with their intention to leave the
direction the tailored intervention resulted in change organization. As described in the following excerpt
with respect to attitudinal barriers and pain symptoms. from the abstract, data existed at individual, depart-
The study sample consisted of 791 participants from mental, and hospital levels:
the original study. Participants’ response patterns to
the Barriers Questionnaire II (Ward, Wang, Serlin,
Peterson, & Marray, 2009) were used to determine “A secondary data analysis of the German sample
latent classes for the LTA, as described here: of the European Nurses’ Early Exit-Study was per-
formed, using a generalized linear mixed-model
approach… Data from 2119 Registered Nurses in 71
“The LTA model was specified using a four-step departments of 16 hospitals from 2003 were ana-
process. … Specifically, these steps were (a) defining lyzed. Models for intentions to leave the profession
latent class structure using latent class analysis, (b) explained more variance (R2 = 0.46) than models for
predicting class membership by adding demographic intentions to leave the organization (R2= 0.28). Both
predictors to the latent class model at Time 1, (c) leaving intentions were associated with age, profes-
testing distal pain outcomes across latent classes at sional commitment, and job satisfaction. Intentions to
Time 2, and (d) modeling and testing transition prob- leave the profession were strongly associated with
abilities for change in class membership over time.” variables related to the personal background and the
(Roberts & Ward, 2011, p. 75) work/home interface whereas intentions to leave the
organization were related to organizational leader-
ship and the local context.” (Simon et al., 2010,
Roberts and Ward (2011) found that the older, less p. 616)
educated individuals in the study were more likely to
be in the High Barriers class at Time 1. For those
individuals who transitioned across classes, those who In this example, the multilevel analysis was a
received the intervention were more likely to move in useful technique for differentiating the determinants
a favorable direction (to the Low Barriers class). The of nurses’ intention to leave, demonstrating that
318 UNIT TWO  The Research Process

departmental level variables (e.g., leadership) had news media, requires careful planning (see Chapter
an influence on intention to leave the organization 27, Disseminating Research Findings).
whereas individual level variables (e.g., personal
background) had an influence on intention to leave the
profession. In another nursing study, Tak, Sweeney, KEY POINTS
Alterman, Baron, and Calvert (2010) examined deter-
minants of workplace assaults on nursing assistants in • Outcomes research examines the end results of
U.S. nursing homes. Data from the National Nursing patient care.
Assistant Survey (individual level) were linked to • The scientific approaches used in outcomes studies
facility information (organizational level). The inves- differ in some important ways from those used in
tigators found that mandatory overtime and not having traditional research.
enough time to assist residents with their activities of • Donabedian (1987, 2005) developed the theory on
daily living (i.e., workload) were associated with which outcomes research is based.
experiencing injuries from assault as well as working • Quality is the overriding construct of the theory,
in a facility with Alzheimer care units. although Donabedian never defined this term.
• The three major concepts of the theory are health,
subjects of care, and providers of care.
Disseminating Outcomes • Donabedian identified three objects of evaluation
in appraising quality: structure, process, and out­
Research Findings come.
Once you have completed fieldwork and data analysis • The goal of outcomes research is to evaluate out-
and have documented your findings, you need to comes as defined by Donabedian, whose theory
ensure that your research findings are disseminated. requires that identified outcomes be clearly linked
Often funding agencies have particular requirements with the process that caused the outcome.
about the dissemination of research findings, which • Clinical guideline panels are developed to incorpo-
involves the communication of studies through pre- rate available evidence on health outcomes.
sentations and publications. This means that the first • Outcome studies provide rich opportunities to
step in deciding the format of your reporting is to build a stronger scientific underpinning for nursing
understand the responsibilities that you have to funders practice.
and others. Including plans for the dissemination of • A nursing-sensitive patient outcome is “sensitive”
findings is an essential component of a program of because it is influenced by nursing.
research. Strategies for the dissemination of research • Organizations currently involved in efforts to study
findings need to be carefully planned and need to nursing-sensitive outcomes include the American
include at least the following: Nurses Association, the National Quality Forum,
• Decide on the objectives of dissemination. the Collaborative Alliance for Nursing Outcomes,
• Identify the audience for your material. the Veterans Affairs Nursing Outcomes Database,
• Ascertain whether you will be preparing a written the Center for Medicare and Medicaid Services’
or oral report (usually both). Hospital Quality Initiative, the American Hospital
• Identify other methods for disseminating results. Association, the Federation of American Hospitals,
• Identify timelines for each section of the reporting The Joint Commission, and the Agency of Health-
strategy. care Research and Quality.
The audiences for your research could include (1) • Another area of interest in terms of outcomes
the clinicians, who will apply the knowledge to prac- research is the process of care delivered by
tice; (2) the public, who may make healthcare deci- advanced practice nurses (nurse practitioners, nurse
sions on the basis of the information; (3) healthcare midwives, nurse anesthetists, and clinical nurse
institutions, which must evaluate care in their facilities specialists).
on the basis of the information; (4) health policy • Outcome design strategies tend to have less control
makers, who may set standards on the basis of the than traditional research designs and, except for the
information; and (5) researchers, who may use the clinical trial, seldom use random samples; rather,
information in designing new studies. Disseminating they use large representative samples.
information to these various constituencies through • Statistical approaches used in outcomes studies
presentations at meetings and publications in a variety include new approaches to examining measure-
of journals, as well as releasing the information to the ment reliability, strategies to analyze change, the
CHAPTER 13  Outcomes Research 319

analysis of improvement, variance analysis, latent Cummings, G. G., Midodzi, W. K., Wong, C. A., & Estabrooks,
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Davies, B., Edwards, N., Ploeg, J., & Virani, T. (2008). Insights
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  http://evolve.elsevier.com/Grove/practice/

14 CHAPTER

Intervention-Based Research

I Intervention-Based Research
nvestigations of interventions that address prob-
lems or issues of concern to patients, nurses, and
healthcare organizations are vitally important to Conducted by Nurses
expanding the scientific basis for nursing practice. Thousands of intervention-based studies conducted by
Intervention-based research verifies the efficacy, nurses have contributed to the scientific foundations
effectiveness, and efficiency of interventions needed for nursing practice. Nurse scientists, such as PhD-
for the development of evidence-based nursing prac- prepared nurses, not only have conducted individual
tice. This type of research requires careful decision studies but also have summarized the state of the
making regarding the optimal study design, controlled science in selected areas with meta-analyses and sys-
implementation of the treatment protocol and proce- tematic reviews. This high level of synthesis of
dures, use of quality outcome measure(s), and appro- research findings through meta-analyses and system-
priate analysis of data to ensure the best conditions for atic reviews has enabled the pooling of data from
testing a selected intervention. A rigorously developed multiple studies to formulate statistical and evaluative
and implemented intervention study improves the conclusions about the strength of evidence for inter-
likelihood of detecting statistically significant differ- ventions. Data compiled from intervention-based
ences between the experimental and comparison studies have guided the development and application
groups on specified outcomes. The ability to find a of evidence-based practice approaches to care and, in
statistical difference with an intervention is also based some instances, have contributed to the development
on having enough statistical power from an adequately of national evidence-based guidelines. One of the
sized sample and controlling sources of error and bias most influential meta-analyses that forever changed
that can obscure study findings. Error and bias intro- nursing practice demonstrated that saline was just as
duced into a study create threats to the validity of the effective as heparin flush solution in maintaining the
study and limit the ability of drawing definitive con- patency of peripheral intravenous locks in adults
clusions about the effects of the intervention. (Goode et al., 1991). Investigators pooled data from
This chapter examines approaches to intervention- 15 studies involving a total of 3490 patients to draw
based research and describes various aspects of the this conclusion. This would not have been possible
research process that are unique to the study of inter- without the individual studies conducted to examine
ventions. The focus is on highlighting those distinct the efficacy and effectiveness of a very common
features of intervention-oriented research and explain- nursing intervention.
ing designs and methods to accomplish such research. Summaries of intervention-based research are also
Because the methods employed in testing interven- valuable in determining how strong an intervention
tions can be complex and rigorous, additional guide- might be by gauging its effectiveness among multiple
lines are provided for critically appraising these studies. For example, it is vitally important to under-
studies. The ability to critically appraise intervention- stand what health promotion interventions work best
based research has wide-spread implications for and under what conditions. To address this issue,
examining the scientific merit of studies and translat- Conn, Hafdahl, and Mehr (2011) conducted a meta-
ing findings into practice. This chapter also covers analysis of studies focused on physical activity inter-
essential information for nurses conducting interven- ventions in adults. They found that behavioral
tion studies. approaches were more effective than cognitive ones in

323
324 UNIT TWO  The Research Process

improving adults’ activity outcomes. Face-to-face interventions that are performed with, or on behalf of,
delivery of the intervention, instead of telephone or communities. Sidani and Braden (1998, p. 8) view
mail, and individualized-focused interventions, rather interventions as “treatments, therapies, procedures,
than targeting of communities, were more effective in or actions implemented by health professionals to and
promoting physical activities. Systematic review, with clients, in a particular situation, to move the
meta-analysis, meta-synthesis, and mixed-methods clients’ condition toward desired health outcomes that
systematic review techniques in the evaluation of are beneficial to the clients.” Nursing interventions are
interventions across multiple studies provide much nurse-initiated and based on nursing classifications
stronger evidence for implementing them in practice of interventions unique to clinical problems or
than one isolated investigation (see Chapter 19 for issues addressed by nurses (Bulechek, Butcher, &
conducting these research syntheses). Dochterman, 2008; Forbes, 2009).
This chapter introduces you to approaches to Historically, nursing interventions have tended to
inquiry, ways of interpreting outcomes, and the evalu- be viewed as discrete actions, such as “positioning a
ative aspects of research aimed at testing nursing inter- limb with pillows,” “raising the head of the bed 30
ventions and plans of care. You will learn to examine degrees,” and “assessing a patient’s pain.” Interven-
components of intervention studies and to appreciate tions can be described more broadly as all of the
the scientific approaches that are relevant to the study actions required to address a particular nursing
of interventions. Few investigators do research alone, problem or issue. But there is little agreement regard-
and intervention research is no exception. More often ing the conceptualization of interventions and how
than not, research teams are required to accomplish these discrete actions fit together (McCloskey &
studies using interventions. These research teams are Bulechek, 2000). Frameworks have been proposed in
composed of nurse scientists and sometimes investiga- moving from isolated action-oriented interventions to
tors from other disciplines, such as medicine, phar- more integrative approaches to care. For example,
macy, psychology, and sociology. Interprofessional dance therapy might be used as part of a falls reduc-
and/or interdisciplinary studies include additional tion initiative (Krampe et al., 2010). In addition, care
intellectual perspectives, collective efforts among sci- bundles, which are combinations of interrelated
entists, and additional resources that promote quality nursing actions, might be the basis for comprehensive
research. Whether interventions are unique to nursing approaches to care (Deacon & Fairhurst, 2008; Quigley
or have implications for other disciplines, intervention- et al., 2009). These variations in interventions are dis-
based research involves similar processes consisting cussed in the following section.
of thoughtful planning, theory- or literature-driven
rationales, appropriate designs for testing the interven- Variations in Nursing Interventions
tion, systematic and consistent methods of implement- Nursing intervention research involves quite a few
ing the intervention and collecting data, data analyses variations in how the intervention is conceived, deliv-
using parametric or nonparametric statistics, and dis- ered, and evaluated. An intervention can be: (1) a
semination of results. Examples of these steps in car- treatment, protocol, or clinical tools to improve patient
rying out intervention research are described and care processes and outcomes; (2) an educational
illustrated with examples from published nursing program to provide support for the patient; (3) an
studies. educational program targeting nurses or other health-
care providers (e.g., a continuing education program);
or (4) a leadership practice to change staffing patterns
Nursing Interventions or improve the workplace environment.
The term intervention-based research encompasses Sequencing of interventions is also an important
a broad range of investigations that examines the consideration when one is designing and conducting
effects of any intervention or treatment having rele- intervention-based research. A single intervention can
vance to nursing. Nursing interventions are defined be delivered and studied at one point in time. This
as “deliberative cognitive, physical, or verbal activi- approach is typically reserved for interventions that
ties performed with, or on behalf of, individuals require limited exposure to produce a response, such
and their families [that] are directed toward accom- as a one-time educational intervention of preoperative
plishing particular therapeutic objectives relative to teaching on the study participants’ knowledge. A
individuals’ health and well-being” (Grobe, 1996, p. single intervention might also be delivered over a
50). An expansion of this definition includes nursing series of time points. These interventions include
CHAPTER 14  Intervention-Based Research 325

those that have to be repeated for their maximum compiles nursing diagnoses and classifications
benefits, such as exercise programs, counseling ses- (http://www.nanda.org/Home.aspx/). NANDA-I
sions, pain reduction strategies, and medication adher- publishes the International Journal of Nursing Ter-
ence teaching. The effects of two or more separate minologies and Classifications (IJNTC) quarterly,
interventions might be examined in the context of a which is distributed internationally.
study at just one point in time or delivered over mul- • Home Health Care Classification System (HHCC)
tiple time points. Interventions can be combined and has two taxonomies with 20 Care Components
administered together to determine the collective used as a standardized framework to code, index,
impact that they may have on outcomes. Thus, and classify home health nursing practice (Saba,
researchers can deliver different variations of inter- 2002).
ventions and examine outcomes at one time point or • The Omaha System provides a list of diagnoses and
across time points. an Intervention Scheme designed to describe and
Stage-based interventions are tailored to a spe- communicate multidisciplinary practice intended
cific phase of recovery, response to treatment, or to prevent illness, improve or restore health,
change in behavior. These interventions can be deliv- decrease deterioration, and/or provide comfort
ered to: (1) study participants as they progress into before death. There are 75 targets or objects of
different phases along a continuum or recovery trajec- action (Martin, 2005). Martin and Bowles (2008)
tory over time that require different approaches or (2) address the link between practice and research that
discrete or selected samples in various settings at is predicated on the Omaha System.
various points in recovery or along a continuum, as • The Nursing Intervention Lexicon and Taxonomy
with a cross-sectional design, when the intervention is (NILT) (Grobe, 1996). Grobe (1996, p. 50) sug-
tailored to this stage. Stage-based interventions are gested that “theoretically, a validated taxonomy
used in studies such as testing of smoking cessation that describes and categorizes nursing interventions
techniques when the intervention strategies differ can represent the essence of nursing knowledge
according to whether a person is contemplating quit- about care phenomena and their relationship to one
ting smoking, has just quit smoking, or has remained another and to the overall concept of care.”
free of smoking (Cahill, Lancaster, & Green, 2010). Although taxonomies may contain brief definitions
As a novice researcher, you might want to implement of interventions, they do not provide sufficient detail
a specific intervention and measure a selected outcome to allow one to implement an intervention. The actions
at one point in time. Students are also encouraged to identified in taxonomies may be too discrete for testing
join research teams to examine the effects of and may not be linked to the resolution of a particular
interventions. patient problem. Populations and settings for which
nursing interventions are intended are not elucidated
Nursing Intervention Taxonomies through nursing intervention taxonomies, making
An intervention taxonomy is an organized categori- them somewhat ambiguous for guiding studies (Sidani
zation of the interventions performed by nurses. A & Braden, 1998; Forbes, 2009).
number of classifications of nursing diagnoses and
interventions have been developed, which include the Problems Examined by Intervention Studies
following: Interventions are developed to address problems or
• The Nursing Interventions Classification (NIC), issues in practice. The researcher must make a careful
containing 542 direct and indirect care interven- analysis of the situational or contextual aspects of a
tions, each of which has an assigned numerical problem or issue prior to designing an intervention.
code and that are categorized in seven domains Box 14-1 outlines a list of questions that researchers
including a new community domain (McCloskey often ask to focus their attention on who, what, where,
& Bulechek, 2000; Bulechek et al., 2008). The and how in designing and implementing an interven-
Center for Nursing Classification & Clinical Effec- tion in a study. Upon answering many of these ques-
tiveness is housed at the University of Iowa College tions, researchers gain a better idea of the planning
of Nursing and can be accessed online (http:// process needed before undertaking an intervention-
www.nursing.uiowa.edu/excellence/nursing_ based study. Moreover, plans for a grand-scale study
knowledge/clinical_effectiveness/nic.htm/). may need to be executed in phases, depending on the
• NANDA International (NANDA-I; formerly resources, commitment, support, and feasibility of the
North American Nursing Diagnosis Association) study.
326 UNIT TWO  The Research Process

Box 14-1 Problem Analysis Questions


1. Who? e. What conditions must change to establish
a. For whom is the situation, condition, or or support a resolution of the problem?
circumstance a problem (e.g., patients, f. What is an acceptable and realistic level of
families, nurses, other healthcare change that needs to occur?
professionals)? g. What does each stakeholder have invested
b. Who (if anyone) would benefit from a in the status quo?
change as it is now? 3. Where?
c. Who should share the responsibility for a. Where would the greatest impact for the
“solving” the problem? greatest numbers occur?
d. Who are stakeholders having an invested b. Where would it be easiest to bring about
interest and stake in wanting positive change (technically, financially, and
resolution to the problem? politically)?
e. Who might support change? c. Where are the most resources available?
f. Who might function as champions for d. Where are the individuals who would be
change? most willing to participate in change?
g. Who should be involved in designing the 4. How?
intervention? a. How should the problem be addressed (e.g.,
2. What? small scale or large scale)?
a. What are the negative consequences of the b. How will the complexity of the problem
problem for the affected individuals? require multilevel actions to have the
b. What are the negative consequences of the greatest impact for change?
problem for the community (healthcare c. How should stakeholders be involved and at
providers or the healthcare system or what points in development and execution
agency)? of a study might they be best used?
c. What barriers exist to implementing an d. How long might it take to accomplish the
intervention? goals of the research?
d. What has to occur for the problem to be
considered solved?
Questions adapted from Fawcett, S. B., Suarez-Belcazar, Y., Belcazar, F. E., White, G. W., Paine, A. L., Blanchard, K.
A., et al. (1994). Conducting intervention research: The design and development process. In J. Rothman & E. J.
Thomas (Eds.), Intervention research: Design and development for human service (pp. 25–54). New York, NY:
Haworth Press.

Programs of Nursing Equally important in advancing nursing science are


replication studies, which mimic the design and pro-
Intervention Research cedures of interventions tested in previous research.
It is becoming increasingly clear that the design and Despite the recognized importance of replicating
testing of a nursing intervention require an extensive intervention studies, few have been repeated to vali-
program of research rather than a single well-designed date and verify their results.
study (Forbes, 2009; Sidani & Braden, 1998). As the Intervention research is a methodology that holds
discipline of nursing advances its mission to accumu- great promise as a more effective way of testing inter-
late a strong practice science, it is apparent that a ventions. It shifts the focus from causal connection to
larger portion of nursing studies must focus on design- causal explanation. In causal connection, the focus of
ing and testing interventions. Moreover, intervention a study is to provide evidence that the intervention
research is central to the role of nurses in practice, contributes to the outcome. In causal explanation, in
education, and leadership. Vallerand, Musto, and addition to demonstrating that the intervention causes
Polomano (2011), in an extensive review of nurses’ the outcome, the researcher must provide scientific
roles in pain management, depict intervention-based evidence to explain why the intervention contributes
research as an integral component of advocacy, quality to changes in outcomes and how it does so. Causal
care, and innovation in patient care (see Figure 14-1). explanation is theory based. Thus, research focused on
CHAPTER 14  Intervention-Based Research 327

Phase IV:
Long-term follow-
up and/or
Phase III: replication
Test intervention in
clinical setting
Clinical questions: Phase II: comparing new
patient problems; Efficacy studies to treatment to
clinical observations; establish outcome current best
a new theory (etc) Phase I: effects and optimal treatment (usually
Proof of concept treatment via RCT)
safety conditions
Pre-clinical work estimates of effect
Clinical answers:
change clinical
practice (evidence
implementation
strategies)

Theory Factor Factor Situation Situation


Replication
development isolating relating relating producing

Figure 14-1  Model of the integral components of the role of nurses in pain management.
Note: RCT, randomized controlled trial. Adapted from Vallerand, A. H., Musto, S., & Polomano, R. C. (2011). Nursing’s role in cancer pain management.
Current Pain and Headache Reports, 15(4), 250–562; Vallerand, A. H., Musto, S., & Polomano, R. C. (2011). Nursing’s role in cancer pain management.
Current Pain and Headache Reports, 15(4), 250–562.

causal explanation is guided by theory, and the find- in the design of the study and testing procedures. The
ings are expressed theoretically. Researchers employ theory itself should contain conceptual definitions,
a broad base of methodologies, including qualitative propositions linked to hypotheses, and any empirical
studies, to examine the effectiveness of an interven- generalizations available from previous studies
tion. Qualitative approaches offer substantial value to (Rothman & Thomas, 1994; Sidani & Braden, 1998).
the development, feasibility, and validation of nursing Theoretical constructs serve as frameworks for many
interventions. For example, Van Hecke et al. (2011) nursing intervention studies, for example, risk
used qualitative research in the development and vali- reductions strategies for cardiovascular disease
dation of their nursing intervention for promoting life- (Gholizadeh, Davidson, Salamonson, & Worrall-
style changes in patients with leg ulcers. Carter, 2010), improving quality of life with pressure
ulcers (Gorecki et al., 2010), and goal-directed thera-
Theory-based Interventions pies for rehabilitative care (Scobbie, Wyke, & Dixon,
Knowledge obtained through a synthesis of collected 2009). Kolanowski, Litaker, Buettner, Moeller, and
information can be used to develop a middle-range Costa (2011) derived their activity interventions for
intervention theory. An intervention theory is explan- nursing home residents with dementia from the Need-
atory and combines characteristics of descriptive, Driven Dementia–Compromised Behavior Model for
middle-range theories and prescriptive, practice theo- responding to behavioral symptoms. Their random-
ries. A descriptive theory describes the causal pro- ized double-blind controlled trial involving cogni-
cesses that are occurring. A prescriptive theory tively impaired residents also linked theory-based
specifies what must be done to achieve the desired underpinnings to the behavioral outcome measures for
effects, including (1) the components, intensity, and the study.
duration required; (2) the human and material resources Not all interventions are examined in the context
needed; and (3) the procedures to be followed to of theories and theoretical propositions, but some
produce the desired outcomes. researchers contend that they should, especially when
A theory or model can be used to guide the devel- frameworks can be used to help refine interventions
opment of an intervention as well as provide direction and select outcomes (Li, Melnyk, & McCann, 2004).
328 UNIT TWO  The Research Process

Master’s and doctoral nursing students working in col- Box 14-2 Elements of Intervention
laboration with faculty researchers or project teams
Theory
should recognize the value of theory-driven interven-
tions in providing greater clarity to their studies and Problem or Issue
contributing to the science of intervention theory. Nature of the problem or issue
Deciding on the best theory to guide intervention Manifestations
research requires: (1) a thorough and thoughtful Causative factors
review and synthesis of the literature (see Chapters 6 Level of severity
and 19); (2) scholarly papers that discuss appropriate Variation in different patient populations
theory-based interventions in areas of research inter- Variation in different conditions
est; (3) interactive discussions among faculty, stu-
dents, and other nurses about options for an optimal Critical Inputs
theory to guide interventions; and (4) once a theory Activities to be performed
has been selected, conversations with the project team Procedures to be followed
to determine its application to the study. Amounts of the intervention elements
Theory-based interventions can be developed for (intensity)
broad populations of patients, such as those with Frequency of the intervention
chronic illnesses, and then be more specifically applied Duration of the intervention
to patients with diabetes. For example, Kazer, Bailey, Mediating Processes
and Whittemore (2010) used a theory-based interven-
tion for self-management of the uncertainty associated Stages of change that occur after the
with active surveillance for prostate cancer. These intervention
researchers discussed an uncertainty management Mediating variables that bring about
intervention from a theory-based perspective to formu- treatment effects
late approaches to care for men with prostate cancer. Hypothesized relations among mediating
Research and Theory for Nursing Practice is a specific variables
journal that seeks intervention-based research derived Expected Outcomes
from theoretical frameworks and perspectives. Aspects of health status affected
An intervention theory must include a careful Biopsychosocial (physical, psychological, social,
description of the problem the intervention will and spiritual)
address, the intermediate actions that must be imple- Timing and pattern of changes
mented to address the problem, moderator variables Hypothesized interrelationships among
that might change the impact of the intervention, outcomes
mediator variables that might alter the effect of the
intervention, and expected outcomes of the interven- Extraneous Factors
tion. Box 14-2 lists the elements of an intervention Contextual factors
theory that are applied to research processes. Models Environmental factors
of theories or frameworks help explain the relation- Patient characteristics
ships of concepts, interventions, and outcomes. When
Treatment Delivery System Resources
critically appraising intervention research, students
need to keep in mind that a major threat to construct Setting
study validity arises if a framework or model used to Equipment
guide a study and its intervention has no clear link to Intervener characteristics
the development and implementation of the interven-
tion and the interpretation of study findings. Evidence
as to how the framework has guided the study needs solely on empirical evidence from existing literature
to be threaded throughout the research report (see that provides scientific perspectives for different inter-
Chapter 7 for understanding the inclusion of frame- ventions. A thorough review and synthesis of prior
works in studies). research should let researchers know the basis for an
intervention and justify the study design. Several peer-
Scientific Rationale for Interventions reviewed nursing journals publish studies without
Not all interventions need to be derived from theory theoretical underpinnings or models depicting the
or conceptual frameworks. Interventions can be based relationships of interventions to outcomes. In such
CHAPTER 14  Intervention-Based Research 329

cases, clarity in the scientific basis for the intervention greater return in bowel evacuation but were more
must be presented throughout the research report. uncomfortable than those using a polyethylene glycol
Some interventions might evolve from experiential electrolyte solution (Schmelzer, Schiller, Meyer,
knowledge in clinical practice, nursing education, and Rugari, & Case, 2004). Although the two former inter-
administrative leadership. These interventions might ventions resulted in a more effective response, a higher
not have a strong scientific foundation to support their degree of surface epithelium loss in the bowel was
use. Investigators conducting studies on these types of confirmed on biopsy. These investigators concluded
interventions need to make a case for the importance that the risks and benefits of selecting an enema solu-
of their research. These types of studies can be impor- tion must be balanced with the desire to produce a
tant in formulating study methodologies, establishing better response versus safety concerns, for example,
relevant outcomes for novel interventions, and advanc- the resultant effects on the bowel and the patient.
ing nursing science.
An example of an intervention with minimal scien-
tific rationale is evident in the early work of Schmelzer Terminology for Intervention-
and Wright (1993). These gastroenterology nurses
began a series of studies that examined the procedures Based Research
for administering an enema. At that time, they found Specific research terms and concepts have importance
no research in the nursing or medical literature that to intervention-based research, and it is necessary to
tested the effectiveness of various enema procedures. understand these when critically appraising and con-
Without scientific evidence to justify the use of various ducting this type of research. Master’s and Doctor of
procedures for administering enemas—such as the Nursing Practice (DNP) students need to be able to
amount of solution, temperature of solution, speed of critically appraise individual intervention studies and
administration, content of the solution (soap suds, those synthesized in meta-analyses and systematic
normal saline, or water), positioning of the patient, or reviews. PhD students have the preparation to be prin-
measurement of expected outcomes or possible cipal investigators for various types of studies, includ-
complications—they were faced with relying on the ing intervention-based research. Thus, this section
tradition of practice and clinical experience. Their first discusses relevant terms to increase nurses’ expertise
study involved telephone interviews with nurses in critically appraising and conducting intervention
across the country in an effort to identify patterns in research.
the methods used to administer enemas; however, this
study was unsuccessful in helping Schmelzer and Efficacy versus Effectiveness
Wright (1996) validate any commonly used techniques Fundamental terms that are often mistakenly inter-
to establish guidelines for enema interventions. changed with intervention-based research are efficacy
In their next study, these researchers developed and effectiveness. Both words are used to describe an
their own protocol for enemas and pilot-tested it on effect of a treatment or intervention; however, these
hospitalized patients awaiting liver transplantation. In terms are different and should not be used synony-
their subsequent study with a sample of liver trans- mously. Efficacy refers to the ability to produce a
plant patients, these researchers tested for differences desired, beneficial, or therapeutic effect, and it can be
in the effects of various enema solutions (Schmelzer, determined only in controlled experimental research
Case, Chappell, & Wright, 2000). Schmelzer (1999- trials in which study criteria are stringent. Random-
2001) then conducted a study funded by the National ized controlled trials (RCTs) involving the testing of
Institute for Nursing Research to compare the effects drugs or procedures are most often efficacy studies
of three enema solutions on the bowel mucosa. Healthy designed to demonstrate, under optimal conditions,
subjects were paid $100 for each of three enemas, after the desired outcomes that a drug or procedure pro-
which a small biopsy specimen was collected. These duces (Compher, 2010). Efficacy studies require strict
researchers’ experiences illustrate how the lack of sci- control of as many potentially confounding variables
entific evidence for an intervention requires a series as possible to allow measures of efficacy to be quanti-
of studies before a large-scale study can be launched fied. A treatment that is deemed “efficacious” is one
to answer important research questions. that produces good outcomes when subjected to highly
Eventually, these programs of intervention-based controlled, experimental conditions. Randomized,
research with enemas led to a safety and effectiveness placebo-controlled trials are required in drug develop-
study involving healthy volunteers that showed that ment before the U.S. Federal Drug Administration
enemas using soap suds and tap water produced (U.S. FDA) can approve the new drug.
330 UNIT TWO  The Research Process

TABLE 14-1  Comparison of Characteristics for inherent risks in applying ES parameters across diverse
Efficacy vs. Effectiveness Studies
fields of study because interpretations of ESs can vary.
Cohen (1988) identifies a small ES as 0.2, a medium
Criteria Efficacy Effectiveness ES as 0.5, and a large ES as 0.8. A small ES of 0.20
Purpose Test a question Assess effectiveness for an intervention means a 20% difference can be
Sample size Smallest adequate Large sample size expected between the intervention and comparison
sample size groups. Likewise, a 0.5 ES represents a 50% differ-
Study cohort Homogeneous Heterogeneous
ence attributed to the intervention. Knowledge of the
Population Study population Study population in
in tertiary care initial care setting
ES for any intervention is helpful and often necessary
setting for calculations of the sample size needed to provide
Eligibility Stringent or strict Minimally restrictive sufficient statistical power to detect a treatment differ-
criteria or relaxed ence. The nature of the ES also varies from one statis-
Outcomes Single or minimal Multiple outcomes tical procedure to the next; it could be the difference
outcomes in cure rates, a standardized mean difference, or a
Duration Short study Long study duration correlation coefficient. However, the ES function in
duration conducting a power analysis is the same in all proce-
Adverse event Minimal Comprehensive dures (Aberson, 2010; see Chapter 15 for a more
recording
detailed discussion of ES and power analysis).
Focus of Internal validity External validity
inference
Analysis Completer-only Intent-to-treat Placebo and Sham Interventions
analysis analysis A placebo is an intervention intended to have no
effect. However, a placebo generally looks, tastes,
Adapted from Piantadosi, S. (2005). Clinical trials: A methodologic smells, and/or feels like the test intervention or is
perspective (2nd ed) (p. 323). Hoboken, NJ: John Wiley & Sons; and experienced like the real study intervention. The
Gartlehner, G., Hansen, R. A., Nissman, D., Lohr, K. N., & Carey, T. S.
(2006). Criteria for distinguishing effectiveness from efficacy trials in
purpose of a placebo is to account for how study par-
systematic reviews. Technical Review, Agency for Healthcare Research and ticipants would respond without actually receiving the
Quality. (AHRQ Publication No. 06-0046.) Rockville, MD: U.S. active intervention. Sham interventions are often used
Department of Health and Human Services. with procedures, and are a variation of a “fake” inter-
vention that omits the essential therapeutic element of
the intervention. A “sham” intervention also attempts
Effectiveness of a treatment or intervention indi- to control for the placebo effect. Rates for placebo
cates that it is capable of producing positive results responses do differ depending on the types of inter-
in a usual or routine care condition. This term is gen- ventions and populations studied. For example, the
erally reserved for interventions studied in situations rate for a placebo response with symptom manage-
in which stringent controls on group assignment are ment research can be as high as 90% (Kwekkeboom,
not possible or the study might not include a placebo, 1997). Very complex psychobiological responses
control, or comparison group. With effectiveness occur in the brain, called the real placebo effect, even
studies, the new intervention may be compared with when an intervention is perceived to be inert or of no
the existing standard of care to ascertain whether the known therapeutic value (Benedetti, Carlino, & Pollo,
new treatment is better, worse, or the same as the 2011). It is important to note that designs using placebo
existing intervention. These studies still require con- or sham interventions are typically carefully evaluated
trols in the design and execution of the interventions by institutional review boards (IRBs) to ensure that
but are not nearly as stringent as occurs in RCTs. patients’ rights are not violated.
Effectiveness studies most often use real-world clini- The placebo effect is extremely complex and often
cians and patients available to researchers. Table attributed to multiple variables. These might include
14-1 contrasts the characteristics of efficacy and attention that a participant receives in a study even if
effectiveness. there is no structured intervention or documented
therapeutic value. The influence of the nurse or physi-
Treatment Effect Size cian demeanor, patient factors such as motivations to
The treatment effect size (ES) refers to the magnitude do better, and the patient-provider relationship can
of effect produced by the intervention. Cohen (1988) have a placebo effect. Other factors, such as
and Aberson (2010) provide parameters for qualifying co-interventions that cannot be controlled, expecta-
and quantifying the ES but caution that there are tions of a treatment effect, the context in which an
CHAPTER 14  Intervention-Based Research 331

intervention is delivered, relief associated with receiv- knowledge.” Procedures for blinding or masking in
ing some treatment, and spontaneous improvement of the conduct of clinical trials are of utmost importance
problem during a study, are also likely explanations to the validity of findings and estimates of treatment
for placebo effects. effects. One reason is that participants may respond
A placebo or sham intervention is intended to spe- differently on study outcomes if they have knowledge
cifically blind study participants and/or research per- of their exposure to a treatment condition. Along
sonnel to the treatment conditions in intervention these same lines, investigators and data collectors
trials. Placebos also blind healthcare providers taking can unknowingly or knowingly encourage certain
care of or interacting with study participants, who responses from participants in favor of one treatment
might introduce bias into the study if study conditions over another if they are aware of a patient’s treatment
are known. Placebos are most frequently used with group assignment. Those caring for patients in studies
RCTs involving drug testing. could inadvertently share information about treat-
Sham procedures are often used in research ments that might bias participant performance on
focused on interventions such as healing touch, relax- outcome measures. Some study conditions even stipu-
ation therapy, acupuncture, cognitive and behavioral late that knowledge of group assignment be kept from
therapy, or any treatment that might produce an effect data analysts or statisticians to safeguard against bias
just from the intervener/participant interactions. To in the analysis and interpretation of data.
account for the benefits of paying attention to partici- Blinding or masking occurs at various levels.
pants or doing something to them that might in and of Although this procedure helps to reduce bias in favor
itself lead to a positive response, researchers some- of one intervention over another, only 33% of 199
times use sham techniques to control for the con- published RCTs from 2007 to 2009 published in 16
founding effects of a treatment. For example, Baird, nursing journals reported using blinding procedures
Murawski, and Wu (2010) studied the efficacy of (Polit, Gillespie, & Griffin, 2011). With single-blinded
guided imagery and relaxation on pain reduction, studies, there are two variations. Study participants are
improvements in mobility, and decreased over-the- not aware of their treatment assignment, but investiga-
counter medication use in older adults with osteoar- tors and research staff may have knowledge of who is
thritis. These investigators provided a sham condition in what group. The reverse may be used when partici-
with planned relaxation provided to the comparison pants have knowledge of their treatment group assign-
group to control for any positive influence on out- ment, but this information is not available to the
comes that might be caused by simply engaging investigators and research staff. For example, children
patients in a study. With this type of design, the involved in research comparing the calming effects of
investigators were able to detect the true effects of music alone with those of music with mother’s voice
the experimental condition under investigation, delivered by audiotaped recordings would recognize
guided imagery and relaxation. It is always important the contents of the tape if they were alert. Researchers
that the design of a sham technique be similar in and data collectors may not be told of participant
many respects to the experimental treatment, such as group assignment. Double-blinded studies keep
the circumstances surrounding the encounter with the knowledge of study conditions from study partici-
researcher or intervener, duration of the encounter, pants, investigators, and research staff. When a study
and implementation of procedural steps or sequenc- is triple-blinded, the participants, researchers, and
ing of the mock treatment. those involved in data management are unaware of
group assignment.
Blinding versus Open Label Open-label extension is a term that usually applies
The term blinding refers to preventing disclosure of to RCTs or other clinical trials whereby participants
group assignment while a study is being conducted to in the active treatment group are offered an opportu-
avoid bias or undesirable influence in the ways par- nity to continue treatment and those in the placebo or
ticipants respond and researchers perform. According control group are given the option to transition to the
to the CONSORT (CONsolidated Standards of Report- active treatment at the conclusion of the intervention
ing Trials, 2011) Transparency Reporting of Trials period. This phase of a clinical trial is often used in
statement, the term “blinding” or “masking,” which is drug studies as a continuation phase to obtain safety
gaining greater acceptance as the more appropriate data about the frequency of adverse events or side
designation, “refers to withholding information about effects over an extended period. This aspect of the
the assigned interventions from people involved in study is required by the FDA for approval of new
the trial who may potentially be influenced by this drugs. Participants are closely monitored by research
332 UNIT TWO  The Research Process

coordinators and study personnel, and data are often to which internal validity can be established affects
still collected on the study primary end points to dem- the conclusions’ accuracy drawn from the interven-
onstrate whether treatment effectiveness continues. tion” (Radziewicz et al., p. 194).
Important attention needs to be paid to the side effect Best practices in constructing treatment fidelity cri-
profile of the drug that develops over time. Other treat- teria and executing sound methodological procedures
ment trials may use open-label extensions to accumu- have been summarized for behavioral research (Bellg
late more data about the treatment and its effect on et al., 2004; Borrelli et al., 2005). According to Bellg
study outcomes. et al. (2004), specific goals should direct fidelity
checks. The goals include: (1) ensuring same treatment
Treatment Fidelity dose within conditions; (2) ensuring equivalent dose
Treatment fidelity has to do with the accuracy, con- across conditions; and (3) planning for implementa-
sistency, and thoroughness of how an intervention is tion setbacks. Investigators should make provisions to
delivered according to the specified protocol, treat- accomplish these goals while formulating criteria by
ment program, or intervention model. Strict adherence which fidelity or adherence to treatment protocols can
to treatment specifications must be evaluated on an be assessed. Often a sampling parameter is set prior
ongoing basis during the course of a study. Thus, inter- to initiation of the study that a certain percentage of
vention fidelity is “the adherent and competent deliv- study intervention episodes will be evaluated. Manipu-
ery of an intervention by the interventionist as set forth lation checks are also a critical part of ensuring the
in the research plan” (Santacroce, Maccarelli, & Grey, integrity of study procedures. These types of checks
2004, p. 63), and this fidelity is of utmost importance are valuable in gathering information about circum-
to the inference of the study’s internal validity in stances and study conditions that might interfere with
intervention-based research. Stringent controls for or impede implementation of the study intervention.
implementation of study procedures are critical to the Box 14-3 shows an example of a manipulation check
study’s integrity. Methodological approaches to treat- used by interventionists in a study of activity interven-
ment fidelity include education and training of all tions for nursing home residents with dementia (Kola-
persons implementing the treatment, periodic moni- nowski et al., 2011). This type of checklist is also
toring or surveillance of the implementation of the useful to investigators in determining intervention fre-
treatment or fidelity checks (either conspicuous or quency, dose intensity, and protocol deviations. This
inconspicuous observation), and retraining and reeval- information not only is critical in recording adherence
uation of study research staff if deviations from the to the study intervention but also might be included
prescribed protocol for study procedures are found. in the analyses of data to separate out or account for
Gearing et al. (2011) propose a scientific guide to variations in exposures to the intervention.
treatment fidelity and discuss implications at all phases
of the treatment, including: (1) implementing the Dose-Intensity of the Intervention
design; (2) training the research staff; and (3) monitor- The exposure to an intervention can influence the
ing the delivery and receipt of the intervention. response to it; therefore, the dose-intensity of the
Treatment fidelity is important in the conduct of all intervention must be carefully monitored and tracked.
intervention-based research, but it is especially critical Dose-intensity refers to the amount of the intervention
for complex interventions such as those involving delivered in terms of the (1) components of the inter-
information dissemination, social support, counseling, vention; (2) duration of a single session for the inter-
and other interventions intended to bring about vention; (3) the frequency with which the intervention
changes in health behaviors and psychosocial out- is delivered (e.g., daily, times per week, times per
comes. Radziewicz et al. (2009) reported their experi- month); and (4) cumulative intervention intensity
ences maintaining treatment fidelity in a study testing (number of treatments received and duration). The
a communication support by telephone intervention latter is the product of dose × dose frequency × total
for older adults with advanced cancer and their family intervention duration (Breit-Smith, Justice, McGinty,
caregivers. These researchers contended that fidelity & Kaderavek, 2009). The ability to capture, quantify,
was maximized by the following: ensuring that the and report the exposure to an intervention in the
intervention is congruent with relevant theory, stan- context of a single study enhances the ability to draw
dardizing the training, using stringent criteria for con- conclusions about how effective an intervention might
ducting fidelity checks to determine interventionist be on the basis of the quantity delivered. Reed et al.
competence, monitoring the delivery of the interven- (2007) provide a comprehensive review of ways to
tion, and carefully documenting findings. “The degree measure the dose of nursing interventions and offer
CHAPTER 14  Intervention-Based Research 333

Box 14-3 Example of a Manipulation Check for a Study of an Activity Intervention for
Nursing Home Residents with Dementia
Subject Code: _____________ Facility: _______________________
Date: _____________________ Time: __________________________
Interventionist: _______________

At the completion of each activity session, _____ c.  Interference from staff, other
please evaluate the extent to which the activity residents, visitors, etc.
was implemented by answering the following Explain:
questions: _____ d.  Subject uncooperative.
1. Was today’s activity the one selected for this Explain:
condition? _____ e.  Subject ill.
a. Yes ___ Explain:
b. No ____ _____ f.  Subject engaged in another activity.
Explain: Explain:
2. Were there any extraneous circumstances that _____ g.  Subject not available.
influenced the delivery of the activity? Explain:
_____ a.  Inability to form group activity. _____ h.  Interventionist not available.
Explain: Explain:
_____ b.  Inability of study participant to stay
by himself or herself for independent
activity.
Explain:
Kolanowski, A., Buettner, L., & Moeller, J. (2006). Treatment fidelity plan for an activity intervention designed for
persons with dementia. American Journal of Alzheimer’s Disease and Other Dementias, 21(5), 326–332.

formulas for calculating intervention exposure in that might have occurred with standard treatment. It
terms of metrics for frequency and duration of the is necessary that NNT be estimated in context of those
intervention. deriving a benefit or those who might be harmed by
For repeated measures designs involving interven- the intervention (Day, 2007). Intuitively, it is an easy
tions delivered over time, research staff must maintain concept to grasp because it is expressed in a numeric
accurate records of all intervention sessions for all value. For example, if the NNT is 4 for a benefit from
study participants, including completed sessions (the an intervention, then a prescriber of an intervention
full intervention was delivered), partial sessions (only could expect that 1 out of 4 patients treated with the
a part or parts of the intervention were administered), intervention would derive a positive outcome. The
and missed sessions (the intervention was not admin- NNT is determined by an analysis of the data follow-
istered at the appropriate time point in the study). ing the completion of a study that is adequately
Field notes should be kept to explain reasons for the powered (i.e., the sample size is adequate) to detect
inability to deliver the total intervention. Maintaining treatment differences. The researcher establishes cri-
detailed information regarding dose-intensity is essen- teria for the primary outcome measure for the study
tial for determining the treatment effect. If known, that is indicative of a positive or undesirable response,
varying levels of the exposure to the intervention can and the NNT is expressed in terms of either outcome.
be handled in the statistical analyses to separate out Researchers are often required to calculate the NNT
the magnitude of benefits on the outcome(s) if partici- for clinical trials prior to submitting a manuscript for
pants received full exposure to the intervention or only publication to influential research journals. NNT
partial exposure. values are often pooled and analyzed in meta-analyses
and systematic reviews of studies. Moreover, the NNT
Numbers Needed to Treat is a meaningful parameter for practice because it
Numbers needed to treat (NNT) is a metric that is informs clinicians of the overall effectiveness of the
defined as the number of patients who would need to intervention and of the expected response when pre-
be treated with the new intervention to avoid one event scribing an intervention.
334 UNIT TWO  The Research Process

When one is interpreting NNT, it is important to Research Council, 2010). Two of the more commonly
determine whether the NNT value is for a single used methods are baseline observation carried forward
administration of the intervention, at a single time (BOCF) and last observation carried forward (LOCF).
point, or overall across multiple time points. For BOCF populates the missing data points for an
example, Hatfield, Gusic, Dyer, and Polomano (2008) outcome following the last data collection value
conducted a blinded, placebo-controlled trial of oral obtained with the baseline value obtained for that par-
sucrose administration for pain associated with immu- ticipant. Use of this procedure assumes that the par-
nizations in infants 2 and 4 months of age. With use ticipant would have returned to baseline without
of a repeated measures design, infants receiving 24% further treatment. LOCF, on the other hand, assumes
oral sucrose (n = 38) or sterile water (placebo) (n = that the last value obtained for a particular outcome
45) via a pacifier were assessed for pain at baseline for a participant would continue for the rest of the
and 2, 5, 7 and 9 minutes after a series of vaccine study. A variation on these techniques is termed the
injections. Pain was measured using the University of worst observation carried forward (WOCF), which
Wisconsin Children’s Hospital (UWCH) Pain Scale (0 takes the worst value for the participant no longer in
denoting the absence of any pain response to 5 reflect- the study and carries this value forward for all the
ing the highest degree of the pain response). These missing data collection points for the study outcomes.
investigators assigned a pain score of 2 or less as the Sometimes the preferred method(s) for observation
desirable criterion for a favorable response to the treat- carried forward in drug development studies is stipu-
ment. At 2 minutes the NNT was 4, and at 9 minutes, lated by the FDA drug approval section. For example,
the end of the study, it was 2. This can be interpreted the FDA guidance for studies of pain stipulates that
that at 9 minutes after administration of oral sucrose the more conservative BOCF analysis be used for all
with a sequence of vaccine injections, 1 in 2 infants regulatory submissions for drug approval (National
(50%) received a beneficial response to the therapy; Research Council, 2010). There are no known guide-
whereas earlier, at 2 minutes, the intervention was not lines for nursing research studies using intention-to-
as effective with only 1 in 4 infants (25%) achieving treat designs.
the desired level of response. A review of 71 clinical trials published in high-
impact medical journals in the late 1990s found that
Analysis of Intention-to-Treat 63 (89%) had incomplete data sets owing to missing
Intention-to-treat (ITT) is an analysis based on the data, and for 13 of these trials, outcomes data were
principle that participant data are analyzed according missing for more than 20% of participants (Wood,
to the groups into which they were randomly assigned White, & Thompson, 2004). In 37 trials using repeated
regardless of what happens to them in the study. In measures to obtain outcome measurements over time,
other words, if a participant drops out or changes 46% performed the analysis after excluding those with
therapy after randomization, this individual would be only some follow-up data, 19% of the trials used
retained in the data set and in the group to which he LOCF, and 11% imputed missing data with the worst
or she was randomly assigned in the analysis. If any case value (WOCF). LOCF is less conservative,
participants are not included in the analysis, then the assuming that participants who drop out may have had
equalization of the treatment groups is no longer main- some benefit before dropping out, and has been
tained, possibly introducing bias into the results. favored as an analytical strategy for missing data;
Nurses need to understand the concept of intention to however, in studies of pharmacotherapy for chronic
treat, especially because this analysis strategy is pain, for example, there are circumstances in which
widely used by healthcare researchers. BOCF may be more appropriate and scientifically jus-
There are several ways to account for the missing tified (Dworkin, et al., 2009). The imputation of
data for subjects who leave a study earlier than missing data allows the application of intention-to-
expected. It is important, however, to understand that treat analysis for clinical trials. It is vital that the
all methods of imputing data values create “made-up” method selected as the strategy of handling missing
data. The ideal clinical trial or intervention-based data be determined and specified a priori (before the
study must be designed to minimize participant study is initiated) to maximize the likelihood of
dropout and missed interventions to limit as much obtaining a valid conclusion from the data analysis.
missing data as possible. There are many ways to
impute data. They have a variety of advantages and Responder Analysis
disadvantages, which have been well described in a Responder analysis is an additional technique to iden-
National Academy of Science report (National tify variables associated with a beneficial response
CHAPTER 14  Intervention-Based Research 335

to an intervention or to determine outcomes of poten- both experimental and nonexperimental quantitative


tial importance to the treatment. This technique can be research designs are presented in Chapter 11. A quali-
performed when one is analyzing the effect of the tative research design may be used if a researcher is
intervention or during a secondary analysis of study in the initial phase of developing a model or prototype
data after the primary data have been reported. A for an intervention. This type of research methodology
responder analysis can also be conducted on more than might also be used in later phases, when the interven-
one study using pooled data from investigations with tion is implemented and the experiences encountered
similar designs and outcomes. This type of analysis with the intervention from the perspectives of those
informs researchers and clinicians about the significant who receive or deliver it are of interest (see Chapter
variables contributing to participants’ response or lack 12, which is focused on qualitative research). Mixed-
of response to a particular intervention. Responder methods studies that combine both quantitative and
analyses provide useful information about sample qualitative research methods are of great value when
characteristics and conditions likely to lead to signifi- the interventions are complex or various aspects of the
cant results for researchers conducting similar future interventions must be validated (Brady et al., 2011;
studies. Criterion-based parameters on outcome Creswell & Zhang, 2009). Chapter 10 explains differ-
measures can also be determined to define what is ent types of mixed-method designs.
considered to be a positive or beneficial response to a In the context of interventional research, one way
treatment. of examining research designs is to focus on the types
Clinicians often relish these types of studies to of clinical trials and the design strategies used to test
guide practice in selecting those individuals who interventions. From a generic view, a clinical trial
might benefit most from an intervention and to quan- involves the systematic study of the effects of a treat-
tify levels of responses on specific instruments. ment in human subjects (Day, 2007). There are many
Weaver, Chasens, and Arora (2009) conducted a types of clinical trials, and many levels of scientific
responder analysis with two randomized, double- rigor are applied in studying treatment effects. Duffy
blind, placebo-controlled studies examining the effi- (2006) provides a basic overview for types of clinical
cacy of modafinil, a drug used to treat excessive trial designs and also emphasizes the growing use of
sleepiness in individuals with sleep disorders. The these designs in nursing research. Some of the clinical
response to treatment with modafinil in these two pre- trial designs discussed here are gaining greater accep-
vious studies was measured with the Functional Out- tance for studying nursing interventions. Additionally,
comes of Sleep Questionnaire (FOSQ). The FOSQ nonexperimental approaches can be used to observe
was administered to patients with obstructive sleep and describe outcomes that result from nursing inter-
apnea who were experiencing residual excessive ventions, and these also need to be considered as part
sleepiness with continuous positive airway pressure of intervention research.
(CPAP) use. A secondary data analysis using a covari-
ance model showed that a greater proportion of Experimental and
responders were in the active drug arm, and functional Quasi-experimental Designs
outcomes indicative of a beneficial response were
characterized on the basis of improvements for certain Parallel Group Randomized Controlled Trials
items and domains on the FOSQ. These findings will Parallel group RCTs represent the most common or
help both researchers and clinicians better understand standard type of RCTs. Subjects are randomly assigned
the items and subscales on the FOSQ that are most to receive either one or two or more concurrently
important in capturing improvements with modafinil administered treatments (Piantadosi, 2005). This
in this patient population. design is experimental in nature and offers a high
degree of scientific rigor in determining the efficacy
(if placebo control is used) of a treatment or the effec-
Types of Research Designs tiveness if the comparison group includes another
Experimental or quasi-experimental research designs treatment and/or a control group receiving no treat-
are required if investigators want to test the efficacy ment, just routine care. RCTs can be costly and diffi-
or effectiveness of nursing interventions. The effects cult to conduct because of the complexity of the design
of interventions can also be examined, evaluated, and stringent controls that must be in place to ensure
described, or observed in the context of nonexperimen- the validity of results. An integrative review of pub-
tal designs such as descriptive, correlational, or obser- lished nurse-led RCTs revealed several challenges
vational research designs. Models and descriptions of encountered by nurse researchers. They included: (1)
336 UNIT TWO  The Research Process

difficulties with sufficient patient recruitment; (2) non- Further, interventions that may be highly influenced
adherence to research protocols; and (3) economic and by existing clinical practices, which cannot be con-
organizational barriers to conducting these trials trolled, are challenging to study. Cluster randomized
(Vedelø & Lomborg, 2011). Nonetheless, RCTs are controlled trials or group randomized trials employ a
vitally important to advancing nursing science and randomized sampling method to more efficiently test
evidence-based practice because they yield the stron- interventions using representative groups of samples
gest level of evidence for single studies. When pos- randomized to study conditions rather than individu-
sible, both nurses in clinical practice and students need als. In this design, the unit of analysis is the research
to participate in nurse-led RCTs as co-investigators site, and investigators randomly select research set-
and research assistants. tings from a sampling frame of eligible and willing
sites, which would then be assigned to serve as test
Crossover Randomized Controlled Trials sites receiving either the experimental intervention
A crossover randomized controlled trial exposes each or the control condition. This type of random selec-
subject to both treatment conditions, which can be a tion involving clinical settings can more efficiently
placebo and an active intervention or two active inter- accomplish participant accrual, control for confound-
ventions. This type of design is used to determine how ing variables introduced by site-specific practice
each subject responds to both study conditions, and variations, and ensure more representative groups or
it enables investigators to examine each subject’s clusters. For example, Pellfolk, Gustafson, Bucht,
responses under these study conditions. As such, par- and Karlsson (2010) selected 40 group dwelling units
ticipants serve as their own controls. This design of individuals with dementia to examine the impact
maximizes enrollment because fewer subjects are of a 6-month educational program in restraint reduc-
needed in crossover than in parallel RCTs. This design tion offered to the nursing staff. Because their study
is typically executed using a repeated measures design, involved both nurses and patients, nursing units were
whereby time is the variable under which within- randomized for nursing staff members either to
subject variability is examined. Study conditions need receive a 6-month educational intervention or to
to be delivered in random order so that the influence serve as the controls. Nurses working on these units
of sequence of exposure to the intervention is con- participated in the study, and outcomes from their
trolled and does not result in a confounding variable. patients were collected and analyzed. Knowledge
This approach lessens the likelihood that exposure to and attitudes regarding restraint practices improved
one study condition first would influence the response for the educational intervention group, and this
to the second condition, and vice versa. improvement translated into a reduction in restraint
A washout period (or time) is incorporated into use in comparison with practices by the staff in the
crossover designs, which occurs between exposures control group.
to study conditions. The purpose of this interval is to
provide ample time for any effects of first exposure to Preference Clinical Trials
the active intervention or placebo to dissipate. Conse- With most clinical trials, participants are randomly
quently, each study condition can be examined sepa- assigned to treatment or control conditions. However,
rately with little risk that diffusion of their effects in some situations, patient preference takes prece-
oasis-ebl|Rsalles|1476144266

may contaminate the outcomes. During this washout dence over randomization to maximize enrollment.
period, subjects do not receive any intervention; Understandably, preference for treatment conditions
however, they remain in the study and may also be plays an important role prior to randomization and has
monitored or asked to complete study outcome mea- significant implications for outcomes. A meta-analysis
sures. Overall, crossover designs are thought to offer of clinical trials for musculoskeletal conditions dem-
greater precision in conducting comparisons of treat- onstrated that patients who were randomly assigned to
ments (Matthews, 2000). A major disadvantage is that their preferred treatment had a standardized ES of the
subjects are often required to stay in the study longer treatment that was greater than those who were indif-
and are exposed to two and not just one study ferent to their group assignment (Preference Collab-
condition. orative Review Group, 2009). Although not found to
be statistically significant in this study, a trend emerged
Cluster Randomized Controlled Trials showing that those who received their preferred treat-
Intervention-based research can often be costly, and ment did better on outcome measures than participants
gaining access to representative samples in multiple not assigned to their preferred treatment. Outcomes
study sites can be time consuming and difficult. were similar for participants allocated to their
CHAPTER 14  Intervention-Based Research 337

undesired treatment and those who were indifferent to Open-Label Designs


the treatment arm. Open-label designs refers to the absence of any blind-
One way to handle participant preference or partial- ing or masking procedures for the intervention. For
ity for treatment conditions is through the use of pref- obvious reasons, open-label clinical trials, or other
erence designs that allow an option for patients to intervention-based designs in which the intervention
receive the treatment of their choice (Day, 2007). groups are known, must be used when it is impossible
These types of designs include Wennberg’s design and to blind or mask the intervention. In such cases,
Zelen’s randomized consent design. In the latter, researchers, research participants, and healthcare pro-
patients are randomly assigned to treatment conditions fessionals caring for research participants have knowl-
and informed of the group assignment prior to consent edge of the intervention. Research participants can
to participate. If they decline, patients are offered the still be randomly assigned to groups of intact cohorts
alternative treatment option(s) of their choice. This receiving an intervention as part of routine clinical
procedure is used to prevent the biasing of the results care. Regardless of the design, it is critical for research-
of clinical trial associated with “resentful demoraliza- ers to take measures to ensure that investigator or
tion” (unhappiness with the group assignment) and the participant bias does not interfere with the validity or
Hawthorne effect (responses that result when study credibility of the results. Safeguards to control for bias
participants change their behavior because they are and improve internal validity of the study include: (1)
being observed and are not a true reflection of the clear specifications for the implementation of the
intervention) (Adamson, Cockayne, Puffer, & Torger- study protocol or treatment; (2) education and training
son, 2006). Thus, in preference clinical trials, rather of research assistants or nurses implementing the
than being randomly assigned to subject groups, interventions; (3) establishing interrater reliability for
patients choose among all treatments available. With the implementation of study procedures and interob-
preference clinical trials, researchers blend both server reliability for measurement of the study
experimental and quasi-experimental design strategies outcome(s); and (4) separation of study participants to
in the context of a single study. avoid experimental diffusion of the treatment effect,
which may occur when study participants interact with
Treatment Matching Designs one another. As with all intervention-based research,
Treatment matching or client treatment matching any violations in execution of study procedures or data
(CTM) compares the relative effectiveness of various collection should be immediately communicated to
treatments. Treatment matching designs are used the investigators, however minor these may be.
when the following conditions are met: (1) there is no
clearly superior treatment for all individuals with a Nonexperimental Designs
given problem; (2) a number of treatments with some
proven efficacy have comparable effectiveness for Observational Studies
undifferentiated groups of subjects; and (3) there is The effects of nursing interventions can be studied
evidence of differential outcomes, either within or through observation. Although observation is also
among treatments, for defined subtypes of patients used in experimental research designs, nonexperimen-
(Donovan & Mattson, 1994; Donovan et al., 1994). tal observational designs can be used to assess patient
Unlike sample matching techniques to ensure equal responses and outcomes to the implementation of new
distribution of sample characteristics across treatment or existing nursing practices; new technology or
groups, treatment matching designs align interven- equipment; or specific prevention protocols to reduce,
tions with predetermined criteria that will ensure the for example, occurrences of falls, hospital-acquired
best possible benefit to subjects. Thus far, CTM inter- pressure ulcers, and catheter-associated bloodstream
vention studies have been successful, albeit limited to infections. Observational studies are generally carried
studies involving treatment approaches for substance out in the naturalistic setting in the course of routine
abuse and addiction (Melnick, De Leon, Thomas, & clinical care. Methods for data collection might
Kressel, 2001). Faul et al. (2011) have suggested include surveillance, extraction of clinical data from
that this strategy be used in studies of exercise therapy electronic health information systems or paper health
for patients with cancer in order to consider pre- records, compliance monitoring by observers, and
intervention activity levels as criteria for matching data storage or output from monitoring technology or
patients to the most appropriate type of exercise pro- devices.
grams to improve participants’ functionality and For example, Shever (2011) conducted an observa-
overall quality of life. tional study of the impact of nursing surveillance on
338 UNIT TWO  The Research Process

failure to rescue, a nursing-sensitive indicator related qualitative and quantitative data collection and analy-
to surgical death from preventable complications. sis approaches. Including a team member with market-
Data were extracted from various electronic clinical ing expertise will be beneficial, because the final step
information repositories and a nursing documentation of the project will be to market the intervention. Teams
system based on the Nursing Interventions Classifica- are enhanced by the inclusion of undergraduate, mas-
tion (NIC). A high level of nursing surveillance of ter’s, and doctoral nursing students.
patients was quantified as an average of 12 times per Recruiting colleagues located in other areas of the
day or more. Patients receiving low and high nursing country or the world for the research team can add an
surveillance were evaluated, and when nursing important dimension by permitting multisite interven-
surveillance was high, there was a significant decrease tion studies. To achieve this goal, investigators need
(p = 0.006) in the likelihood of experiencing failure to to: (1) contact researchers with similar interests; (2)
rescue. attend specialty conferences related to the research
area, during which they can speak with researchers
Retrospective Descriptive Studies and possibly extend an invitation to participate in the
Not all interventions occur in prospective studies, so project; (3) invite colleagues to join the project after
retrospective designs are employed to examine the presentations at a professional meeting; (4) develop a
effects of interventions. In a retrospective study of project website that invites other researchers to par-
nursing practice across three community nursing sites, ticipate; and (5) develop or participate in an internet
Schoneman (2002) compiled data on nursing interven- mailing list (Listserv) or a blog related to the topic.
tions using the computerized Omaha Classification The process of developing a team is dynamic rather
System (OCS) to examine “surveillance” as a nursing than static, with changes occurring as development of
intervention. The practice of surveillance was identi- the research program continues.
fied as a significant nursing intervention accounting
for 27.1% of all nursing interventions. Of the 1506 Work of the Project Team
clients studied, those most likely to receive surveil- There is almost always a core group in a project team
lance were more than 40 years of age (p = 0.001) and that carries on most of the work, maintains group
female (p = 0.001). The primary reasons for this inter- activities, and encourages the achievement of tasks.
vention were to promote health and prevent disease. However, other people can contribute in lesser ways
Specifically, subjects with a nursing diagnosis of cir- to benefit the project. For example, you may want to
culation and nutrition deficits seemed to be assessed establish liaison groups from the clinical facilities in
more frequently with surveillance nursing practices. which the intervention will be studied. In some cases,
the addition of other advisory groups can be helpful.
The initial focus of the team is to clarify the
Planning Intervention Research problem or issue of interest. In analyzing identified
problems or issues, the team should answer the ques-
Project Planning tions listed in Box 14-1. Considering these questions
Because an intervention research project often involves may provide new insights that redefine the problem or
a study extended over a long time, sometimes years, issue and may lead to a more effective intervention.
nurse researchers are advised to give careful thought Sidani and Braden (1998) have cautioned the project
to the composition of their research teams. Research- team to be alert to the risk of making a Type III error.
ers need to determine (1) who will be included on the A Type III error is the risk of asking the wrong
project team; (2) what level of expertise is required question—a question that does not address the problem
for team members; (3) how team members will func- of concern. This error is most likely to occur when the
tion together; and (4) the roles team members will researchers do not thoroughly analyze the problem
assume. and, as a result, have a fuzzy or inaccurate understand-
ing of the issue of concern. The solution, then, does
Forming a Project Team not fit the problem. A study conducted on the basis of
Because of the nature of intervention research, you a Type III error provides the right answer to the wrong
may need to gather a multidisciplinary project team to question, leading to the incorrect conclusion that the
facilitate distribution of the work and a broader gen- newly designed intervention will resolve the problem.
eration of ideas. If both quantitative and qualitative Once the problem or issue to be examined is clari-
data will be gathered during the research project, your fied, you must establish your goals and objectives.
team should include members experienced in various Project team tasks include: (1) gathering information;
CHAPTER 14  Intervention-Based Research 339

(2) developing an intervention theory; (3) designing Box 14-4 Topics for Information
the intervention; (4) establishing an observation
Gathering
system;, (5) testing the intervention; (6) collecting and
analyzing data; and (7) disseminating the intervention. Nature of the Problem (Actual or Potential)
Seeking funding for the various studies of the project or Issue
will be an ongoing effort. Manifestations
Causative factors
Gathering Information Level of severity
Once a clinical problem or issue has been identified, Variation in different patient populations
the investigators and members of the research team Variation in different conditions
can begin by conducting an extensive search for
information related to the project. This search is con- Intervention
siderably more focused and encompassing than the How people who have actually experienced
traditional literature review. Box 14-4 lends some the problem or issue have addressed it
organization and clarity to topics that need to be Previous interventions designed to address the
addressed as the basis for developing a plan for inter- problem or issue
vention research. Several sources of information can Unsuccessful interventions
be accessed to gain knowledge of existing nursing Value to target population
interventions, extant research conducted on these Sensitivity to cultural diversity
interventions, and evidence-based practice guidelines Biases or prejudices
that incorporate these interventions and guide their Processes underlying the intervention effects
application to practice (Box 14-5). It is important to Intervention actions
keep in mind that researchers should not “reinvent the Components
wheel.” For many nursing interventions, prescriptive Mode of delivery
procedures are already published in credible scientific Strength of dosage
sources that can be adapted for the purposes of inter- Amount
vention testing. Undergraduate, master’s, and doctoral Frequency
nursing students as well as clinicians working with Duration
the project team can be very helpful in retrieving lit- Mediating Processes
erature and resources and assisting with synthesizing
information. Patient characteristics
Setting characteristics
Intervener characteristics
Design and Testing of Expected Outcomes

Interventions Contextual factors


Environmental factors
Researchers either develop their own procedures for Patient characteristics
implementing an intervention or replicate an interven- Provider factors
tion and its protocol from an existing study. As men- Healthcare system factors
tioned earlier, theory-driven intervention research is
conceived from theoretical or conceptual perspectives
that form the basis of the intervention and its per-
ceived effectiveness or benefit. Theory-based inter-
vention research can begin with a concept analysis of using specific interventions in selected populations
the problem or the intervention intended to address it. and settings.
By dissecting the components of problems and plau- A study by Forbes (2009) provides an excellent
sible solutions, investigators can gain clarity of the model of the four phases of testing clinical interven-
issues at hand. At the other end of the spectrum are tions. The model in Figure 14-2 reflects the testing of
replication studies that involve similar intervention interventions on a continuum from preclinical work to
designs, approaches, and outcomes used by other the final phase of study replication. This model is
investigators. These types of studies are especially particularly useful in guiding students through the
important to validate or refute results from published phases of intervention-based research. Initially, ideas
research. Replication studies add to the strength of for interventions and the need for intervention research
340 UNIT TWO  The Research Process

Box 14-5 Sources of Information begin with problems and questions that arise in prac-
tice. You might be involved in any of these four phases
about Interventions
of intervention research as an investigator, consultant,
Peer-reviewed journal articles on nursing or research assistant (see Figure 14-2).
interventions
Nursing intervention taxonomies Designing the Intervention
Computerized databases containing data on An intervention to be tested must be carefully devel-
nursing interventions oped and well thought out to accomplish the purpose
Nursing textbooks of the study. The study framework should guide the
Previous intervention studies (theses, identification of the research hypotheses and the
dissertations, and other publications) development of the study design and intervention.
Clinical guidelines: http://www.guidelines.gov Investigators may need to consult other researchers
(see Chapter 19 for additional websites) who have designed and tested similar interventions,
Critical pathways the research project team who will carry out the
Intervention protocols research, and clinical experts who might use the inter-
Interviews with patients who have vention in practice. Aranda (2008) recommends taking
experienced the problem and related a similar approach to that used in pharmacological
interventions research, which is illustrated by a progressive path
Interviews with providers who have addressed from phase I to phase IV studies in determining safety,
the problem efficacy, and effectiveness.
Interviews with researchers who have tested During the design period, and guided by the inter-
previous interventions vention theory, the project team specifies the proce-
Probing of personal experiences dural elements of the intervention and develops an
Observations of care provided to patients observation system (Fawcett et al., 1994). The inter-
with the problem vention may be (1) a strategy; (2) a technique; (3) a
program; (4) informational or training materials;
(5) environmental design variables; (6) a motivational
system; or (7) a new or modified policy. The interven-
tion must be specified in sufficient detail to allow
interveners to implement it consistently.

Pain Promoting
assessment self-management

Practice Education
Advocacy
Pain Empowering
Qu

on

management patients
alit

ati
ov
yc

Inn
are

Evidence-based Overcoming
Research
practice barriers to care

Influencing
Intervention- Descriptive
research
based research research
agendas

Figure 14-2  Phases of intervention-based research from theory development to study replication.
CHAPTER 14  Intervention-Based Research 341

Box 14-6 Criteria for Intervention Typically, in an experimental or quasi-experimental


study in which intervention efficacy and effectiveness
Design
are determined, there is a primary end point or outcome
1. The intervention is effective. of greatest interest to investigators and secondary out-
2. The intervention is replicable by typical comes that add value to the impact of the intervention.
interveners. Regardless of whether they are primary or secondary,
3. The intervention is simple to use. outcome measures have to represent the concept or
4. The intervention is practical. concepts within the measurement domain(s) for the
5. The intervention is adaptable to various study and must be sensitive and specific to the desired
contexts and settings. effects brought about by the intervention.
6. The intervention is compatible with patient Outcomes can be obtained using self-reported
preferences and values. questionnaires, survey instruments, or scales admin-
Adapted from Fawcett, S. B., Suarez-Belcazar, Y., istered by the investigators or research personnel.
Belcazar, F. E., White, G. W., Paine, A .L., Blanchard, These outcome measures can be related to experi-
K. A., et al. (1994). Conducting intervention ences categorized as physical, psychological, social,
research: The design and development process. In J. spiritual, or any combination of these types. Physio-
Rothman & E. J. Thomas (Eds.), Intervention logical outcomes can be measured by specialized
research: Design and development for human equipment that records patients’ physical status, such
service (pp. 25–54). New York: Haworth Press. as heart rate, blood pressure, respiratory rate, and
oxygen saturation. Outcomes can also be measured by
criteria-based observational instruments or scales that
capture observed phenomena relevant to the interven-
During the design process, the intervention emerges tion. Box 14-7 lists the steps of the observation
in stages as it is repeatedly tested, redesigned, and process for intervention research. For example, a
retested. Training materials and programs for inter- study of an intervention to reduce hospital-acquired
veners also must be developed and repeatedly tested pressure ulcers would require a grading scale to assess
and revised. Design criteria are established to evaluate the presence and severity of pressure ulcers that can
the implementation of the intervention and outcomes only be determined by a rater. Study outcomes can be
(Box 14-6). In addition to the detailed development of clinical indicators relating to events, sequences of
the intervention, an operational development of the care, and resultant effects of care. Length of hospital-
design guided by the theory should include the follow- ization, transfer to a critical care unit, rates of com-
ing actions: plications, and disposition at discharge as defined by
• Define the target population. the need for home health care, long-term care, or
• List acceptable strategies for selecting a sample. rehabilitative therapy all represent clinical indicators
• Identify subgroups that might show differential of care.
effects of the intervention. The timing and expected pattern of changes must
• Specify essential characteristics of interventionists. also be considered and specified for the frequency and
• Determine study variables. sequencing of collecting outcome measures. Timing is
• Indicate appropriate measures of variables. the point in time after the intervention that a change
• Specify the appropriate time or times to measure is expected to occur. Some changes occur immediately
outcomes. after an intervention, whereas others may not appear
• Indicate what analyses to perform and what rela- for some time. The sequencing of data collection on
tionships to test on the basis of the relationships outcomes should be done at the early and most optimal
among the treatment and the mediating and outcome points in which that intervention may show an effect.
variables specified by the intervention theory However, the selected outcomes measures must be
guiding the study. able to demonstrate these changes at the particular
time points. For example, studies involving interven-
Study Outcomes tions focused on quality of life need to allow ample
Outcomes are determined by the problem and purpose time during and following the intervention to detect
of the intervention and reflect the various effects of improvements in quality of life. Changes in symp-
the intervention. Selecting study endpoints to capture toms, on the other hand, may occur more rapidly with
the outcomes of an intervention must reflect changes an intervention, so more frequent surveillance of these
that occur as a consequence of the intervention. outcomes is often warranted. Interventions that have
342 UNIT TWO  The Research Process

Box 14-7 Steps of the Observation significantly affect the problem, the treatment process,
or the outcomes. Unlike mediator variables, extrane-
Process
ous factors tend not to be well understood and may
1. Determine elements that must be observed not be identified until a study has been initiated. They
on the basis of the intervention theory. are seldom included in explanations of the causal links
2. Develop methods of measuring essential between intervention and outcomes. Thus, they are
elements. extraneous to existing theoretical explanations of
3. Develop criteria for determining whether cause. They are sometimes referred to as confounding
or not the event to be observed has variables. If the researcher recognizes their potential
occurred. effect, extraneous factors may be held constant or
4. Select observers. measured so that they can be statistically controlled
5. Train observers. during analysis. Careful analyses may indicate that
6. Develop scoring instructions to guide some variables defined as extraneous are actually
recording of desired behaviors or moderator or mediator variables. (For additional infor-
outcomes. mation on types of variables refer to Chapter 8.)
7. Develop a schedule of observations to
include the following:
a. What is happening before the
intervention is implemented?
Process of Testing
b. What is happening during the the Intervention
intervention?
c. What changes occur after the Intervention Validation
intervention? For some interventions, before the pilot test, it is
8. Perform preliminary analysis of pre- useful to test prototypes in situations and environ-
intervention data. ments that are similar to those planned for the actual
9. Apply preliminary analysis results to study. Van Meijel, Gamel, van Swieten-Duijfjes, and
further develop the intervention. Grypdonck (2004) contend that too little time is spent
10. Analyze changes in environment and on the development of an intervention, since more
behaviors before, during, and after the time is spent in the actual testing of the intervention.
intervention. Before one proceeds with a formal study, an interven-
11. Refine intervention theory. tion should be examined in the setting in which the
problem occurs or in a situation resembling the natural
setting. This examination helps investigators and
no anticipated or appreciable carry-over effect follow- research staff, as well as nurses caring for study par-
ing implementation do require study outcomes col- ticipants, to experience how an intervention may play
lected at the time or shortly after the intervention. out under actual study conditions. Logistical aspects
Typically, the literature and psychometric properties of the intervention may not be fully developed or
of instruments and scales can be used to guide sched- foreseeable until a “real world” trial can be realized,
ules for collection of outcomes. and the problems addressed. This method of prelimi-
If theory-guided intervention research is used, there nary validation of the intervention is quite helpful for
may be mediating variables, referred to in some studies involving sensitive issues, such as sexual
studies as intermediate outcomes, that have rele- abuse, alcohol abuse, and drug use. Intervention vali-
vance to understanding the intervention. Hypothesized dation is important when there is uncertainty about
interrelationships among the outcomes must be indi- how research staff will perform and/or participants
cated in the theory and must be represented in the will react. It helps researchers determine the feasibility
study through either controlling for these variables in of the intervention and its components as well as how
the design and sampling procedures, or measuring accepting nurses and potential participants might be
them as part of the study in order to manage them in to the intervention.
the analysis and interpretations of results. Another strategy is to conduct intervention
validation under simulated conditions. Conducting
Extraneous Factors simulation exercises in an artificial environment close
Extraneous factors or variables are elements of the to the natural study environment might identify issues
environment or characteristics of the patient that in delivering the intervention that can be corrected
CHAPTER 14  Intervention-Based Research 343

before the study is conducted. Role-playing tech- pilot tests, clinicians and research staff should
niques are often used to deliver the intervention. continually question any concerns or issues that
Members of the project team, staff from the settings arise.
to be used for the project, or nursing students might 6. Verify whether there are problems in gaining
perform the roles. Simulation scenarios are con- access to study participants and how participants
structed following the exact steps prescribed by the are reacting to study conditions and procedures.
intervention protocol. Video recording may be used to 7. Ensure that study participants understand what is
allow investigators to carefully examine any issues or required of the study and can interpret and com-
procedures that require modifications prior to imple- plete outcome measures.
menting the pilot or final study. Observers also make 8. Test the feasibility of the design.
notes during the testing of the intervention to identify 9. Obtain reliability and validity estimates for mea-
missing elements, gain insights, or develop questions surement methods in the target population.
the project team must explore. Some degree of infer- 10. Ascertain whether there are any unanticipated
ence is gleaned from validating an intervention in an effects that may be of concern for participants or
artificial environment and being proactive in refining detrimental to the internal and external validity of
study procedures and measurement outcomes on the the study.
basis of simulated experiences. Importantly, pilot testing allows the generation of
data or point estimates (such as means and standard
Pilot Testing of an Intervention deviations) for the study outcomes. These estimates
For multiple reasons, pilot or field testing of an inter- can be used to calculate sufficient statistical power in
vention is recommended. In some cases, pilot testing terms of study sample size needed to detect a statisti-
is required when a researcher is applying for grant cally significant treatment effect. Pilot data are often
funding, seeking approval from an IRB, or garnering a prerequisite for determining adequate sample sizes
support from an institution to conduct the study. when there are no available studies to calculate the ES
Feeley et al. (2009) underscore the importance of pilot for the intervention. Typically, only 10 to 20 partici-
testing in developing RCTs for the following reasons: pants are needed to obtain estimates of variance in the
(1) to assess the feasibility and acceptability of the primary outcome measure(s) needed to determine
intervention; (2) to determine the feasibility and intervention ES (Hertzog, 2008; see Chapter 15 for
acceptability of the design and procedures; and (3) to calculation of ESs for interventions).
facilitate the determination of treatment ES to use in Pilot studies should be conducted with the target
power analysis calculations of sample size. In general, population and in settings similar to those planned for
pilot studies are very useful to: the proposed study. These studies must also be
1. Determine whether the intervention as a prototype approved by the organization’s IRB in compliance
will work and whether it is feasible. with all regulations and mandates for acceptable
2. Guide the refinement of the intervention and to conduct of research and protection of human subjects.
work out any problems or issues with implement- The manner in which all study procedures are imple-
ing it in clinical or research settings. Pilot studies mented must also be exactly the same as described in
are especially valuable when interventions are the study proposal. Strict adherence to study proce-
delivered in the context of usual or routine clinical dures enables investigators to use pilot data as the
care. Investigators can determine any barriers to starting point for the study if no amendments or
as well as facilitators for the execution of study changes are made. The pilot testing phase can move
procedures, and seek support and resources to right into the larger-scale study if this is a condition
administer the intervention in the manner intended. stipulated in the approved IRB application.
3. Test and refine instructions, manuals, or training Often pilot studies are separate studies, and inves-
programs to ensure that study procedures are tigators may alter protocols on the basis of the experi-
understandable and the preparation of study staff ence of the pilot study. Keeping field notes is
is adequate. particularly useful during pilot studies so relevant
4. Estimate how long it takes to recruit the study issues can be addressed prior to implementing the
population, implement the intervention, and larger-scale study. Pilot data may be published,
collect the desired data. although with controlled trials, findings must be mean-
5. Assess whether the intervention has been ingful to the body of research (Watson, Atkinson, &
described in sufficient detail to allow clinicians Rose, 2007). Thus, pilot studies need to be published
and other researchers to replicate the work. During if they provide estimates of variance in the outcomes,
344 UNIT TWO  The Research Process

help determine the quality of the intervention protocol, Advanced Testing


and/or identify issues relevant to future studies. Advanced testing of the intervention occurs after suf-
However, it is imperative that researchers avoid any ficient evidence is available that the intervention is
inference to hypothesis testing using pilot studies. effective in achieving the desired outcomes. The
Some researchers have cautioned that problems remain model proposed by Forbes (2009) places this type of
in the interpretation of pilot studies’ findings in pub- testing in phases III and IV, during which the interven-
lications (Arain, Campbell, Cooper, & Lancaster, tion is compared with standard of care interventions,
2010).With the limited sample sizes, researchers run followed by replication studies with long-term
the risk of misinterpreting any significant or nonsig- follow-up of the intervention’s effectiveness (see
nificant results. Type II errors are common when the Chapter 11 for discussion of phases I to IV of clinical
sample size is insufficient to provide acceptable sta- trials). Phase III of intervention testing might involve
tistical power to detect differences from interventions. a single, well-designed study that indicates a satisfac-
Pilot samples are nonrepresentative of the target popu- tory ES for an intervention, but often an intervention
lation, and data tend to be nonnormally distributed. requires modification through additional studies. Rep-
Assumptions of normally distributed data are often lication studies ensure that an intervention is refined
violated if parametric statistical tests were used in the to create the desired effect in practice. Sidani and
analyses of pilot data. Nonparametric statistics are Braden (1998) emphasize that the advanced testing
more appropriate for conducting group comparisons phase must include variations in the studies conducted
with pilot data and should be considered. Sometimes to ensure the intervention is ready for delivery in prac-
only descriptive statistics (frequencies, means, stan- tice to a variety of patients.
dard deviations, ranges, scatter plots or diagrams, and
medians) are most appropriate in reporting the results Testing Variations in Effectiveness Based on
from pilot studies. Variations in Patient Characteristics
Graduate students should consider opportunities to Intervention effects that have been determined through
work on pilot studies because they are generally of the use of a sample of only white, middle-class Ameri-
short duration and instructive about the research cans may not have the same effect with other groups.
process. Investigators often try to recruit graduate stu- The intervention should be tested among various
dents for their studies because they have knowledge ethnic groups and vulnerable populations, such as the
of research and can provide useful feedback about the socioeconomically and educationally disadvantaged.
experience as well as flexible daytime schedules to Pilot tests may reveal a need to refine the intervention
accommodate the work. to make it more culturally appropriate and adaptive to
diverse groups. Minority and disadvantaged popula-
Formal Testing of an Intervention tions may respond differently to interventions because
The most desirable formal test of an intervention is a they: (1) have different views of health and preventive
conventional experimental design to determine behaviors; (2) do not fully understand the purpose of
whether the intervention causes the intended effects. the study and their role in participation; (3) are more
The design should be as rigorous as possible. Research- vulnerable to persuasion from researchers and health-
ers need to conduct a power analysis to determine a care professionals; and (4) encounter difficulties in
sample size sufficient to avoid a Type II error (see comprehending patient-reported outcome measures
Chapter 15 for discussion of power analysis). Analy- used in the study. For these reasons, researchers need
ses must be performed to ensure that the treatment and to design studies and select outcomes that are tailored
control groups are comparable on important demo- to diverse patients or screen potential participants for
graphic variables. The measurement methods used in variables that might interfere with study participation.
studies must have documented reliability and validity However, eliminating diversity as a requisite for a
(see Chapter 16). The ES for each outcome needs to study can limit the generalizability of findings and
be examined and reported. The observation system hamper efforts to better understand and reduce health-
established before the initiation of testing must be care disparities.
continued, and patient characteristics, intervener Studies also must be conducted to examine
characteristics, and setting characteristics need to be the effect of an intervention on patients with comor-
measured and described (Sidani & Braden, 1998). bidities or differing levels of illness severity. Other
Researchers also must develop plans for statistical variations in patient characteristics, such as age,
analyses to detect differences between the intervention gender, and diagnosis, must be examined. Character-
and comparison groups (see Chapter 25). istics specific to the intervention may be identified as
CHAPTER 14  Intervention-Based Research 345

important for determining differential effects. When interveners to provide the intervention. Studies need
sufficiently large samples are obtained in initial to be conducted to determine variations in the effec-
studies, these patient characteristics can be examined tiveness of the intervention based on the competencies
in secondary analyses of available data. of interveners.

Testing Variations in Effectiveness Based on Setting Testing Variations in Effectiveness Based on


If the research setting is similar for the testing of an Strength of an Intervention
intervention with similar circumstances, conditions, The strategy of testing the variations of an interven-
and subjects, then the effects of a different setting can tion’s strength is used to determine the amount of
potentially confound the treatment effects. Therefore, treatment needed to achieve the desired outcome in
one component of testing the intervention is to set up practice. To test this issue, the researcher must provide
multisite projects, in which the settings are varied and varying doses of the intervention. Researchers might
the effects of the settings on outcomes are examined vary the intensity of the intervention, the length of
(Sidani & Braden, 1998). time of a single treatment, the frequency of an inter-
vention, and/or the span of time over which the inter-
Testing Variations in Effectiveness Based on vention is continued or repeated.
Variations in Intervener Characteristics
The initial study examining the effectiveness of an
intervention is usually conducted under ideal condi- Data Collection
tions. Ideal conditions involve the selection of highly Data collection in intervention research consists of not
educated interveners judged to be experts in the field only accurate collection and recording of study out-
of practice related to the intervention. However, comes but also accurate documentation of the study
after the intervention is found to be effective, ques- intervention. Researchers need to document the timing
tions arise regarding the use of less well-prepared of the intervention, dose-intensity of the intervention,

Box 14-8 Factors Affecting the Integrity of an Intervention and Study Validity
Lack of Stringent Study Controls Study Intervener and Staff Variables
Poorly defined study intervention Too many individuals delivering the
Lack of attention to detail in planning the intervention(s)
intervention(s) Level of education and research experience of
Lack of or inadequate use of written guidelines study staff
and protocols for the intervention(s) Failure to obtain intraobserver and
Unreported protocol violations or deviations interobserver reliability
from standardized procedures Lack of initial and ongoing preparation and
Inadequate supervision and guidance during competency verification assessments
study from the principal investigator and/or Level of compliance of staff with treatment
research coordinator protocol
Variations in dose intensity of study Competing priorities and responsibilities of
intervention(s) across study participants study staff
Lack of reliable and valid outcome measures Turnover of study staff during the investigation
Level of staff interest and commitment to the
Complexity of Intervention Procedures
intervention
Level of complexity of the intervention(s)
Variation in elements of intervention provided Study Site Variables
Difficulties in implementing intervention Lack of human, professional, and financial
activities resources to support the study
Number of sites involved in implementing the Changes in organizational policies, procedures,
intervention and practices after initiation of study
Adoption of new technology or equipment as
part of the intervention
346 UNIT TWO  The Research Process

Box 14-9 Step by Step Approach to Critically Apprising Intervention-Based Research:


A Focus on the Intervention
Step 1: Background and Review of Literature statistical power to detect statistically
Examine the scientific basis for the study significant differences between or among
intervention: study treatment conditions?
• Is the scientific rationale for the intervention • Do inclusion and exclusion sample criteria
supported by the study literature review? control for sample characteristics that might
• Do authors cite variations in ways the influence the outcomes?
intervention has been studied? • To what extent does the sample allow for
• Has the intervention been tested in different generalizations to similar populations, thereby
study populations? improving the study’s external validity?
• Is the magnitude or effect size of the Step 5: Study Outcomes
intervention provided from previous studies?
Evaluate the study outcomes:
Step 2: Theoretical Framework • Are reliability and validity (psychometric
Establish whether the intervention is theory- properties) of all instruments and outcome
based or conceptually derived and the level to measures reported, and are they acceptable?
which theory drives the intervention: • Do investigators plan to conduct psychometric
• Does the intervention evolve from a theory or testing of instruments or outcomes measures
conceptual framework? if existing ones are applied to different
• How has the intervention been developed populations or if new ones are designed by
using a theory? the investigators for the purpose of the
• Are the relationships of the study framework study?
to the intervention explicit? • Has interrater or intrarater reliability been
• Is the intervention represented in a model of established for data collectors if observational
the study framework? methods are used to obtain outcome
measurements?
Step 3: Design • What limitations are evident for the outcome
Determine the appropriateness of the design to measures, and are these addressed?
test the intervention:
Step 6: Study Procedures
• Is the design appropriate to test study
hypotheses? Evaluate the integrity for the implementation of
• Are confounding variables controlled by the the intervention:
design? • Are the study procedures clearly explained to
• Is an experimental design with a control, the degree that other researchers might be
placebo, or standard care group used to test able to replicate the study?
the efficacy or effectiveness of an • How were study personnel or clinical staff
intervention? prepared to execute study procedures?
• In a study with a quasi-experimental design, is • Were fidelity or manipulation checks
a comparison group used in testing the conducted during training or in the course
intervention? of the study?
• Was information collected on protocol
Step 4: Sample deviations and dose intensity of the
Examine the appropriateness of the sample and intervention?
sampling process:
Step 7: Statistical Analyses
• Is the sample representative of the population
that might benefit most from the Assess the appropriateness of statistical
intervention? methods:
• How are subjects allocated to treatment and, • Are appropriate statistical methods applied
if appropriate, control or comparison groups? given the level of measurement for outcome
• Was a power analysis performed to determine variables?
an adequate sample size to yield sufficient
CHAPTER 14  Intervention-Based Research 347

Box 14-9 Step by Step Approach to Critically Apprising Intervention-Based Research:


A Focus on the Intervention—cont’d
• Have the investigators violated any statistical • Did the intervention show a statistically
assumptions in the selection of analytical significant difference in the study outcomes?
procedures raising statistical conclusion • Were the study results clinically important?
validity issues?

subject responses to the intervention, missed treat- Equally important are controls to reduce bias and error
ments, and any protocol deviations that occur even if that pose threats to study validity. Many of these issues
these are beyond the intervener’s control. Investiga- have been discussed previously. Guidelines for evalu-
tors also must keep track of any unexpected circum- ating components of the intervention are outlined in
stances that occur in the implementation of the study Box 14-9. Important questions are posed to help
intervention or at the time the outcomes are measured. nurses identify aspects of studies specific to the inter-
These types of field notes can be vital to the interpreta- vention and to assist them in critically appraising the
tion of study participants’ responses during data analy- intervention and its implementation in a study.
sis and the development of findings (see Chapter 20
for more details on the data collection process).
KEY POINTS
Threats to Study Validity • Intervention research holds great promise for
Like other types of research, intervention research is designing and testing nursing interventions and
subject to threats to validity. Box 14-8 summarizes advancing nursing science.
aspects of the research design, intervention, and analy- • Nursing interventions are defined as “deliberative
ses that need to be examined for threats to validity. cognitive, physical, or verbal activities performed
Determining threats to internal validity in the execu- with, or on behalf of, individuals and their families
tion of a study is critically important to examining that are directed toward accomplishing particular
study results and interpreting findings. Studies must therapeutic objectives relative to individuals’ health
be evaluated for sources of bias from systematic error and well-being” (Grobe, 1996, p. 50).
that might occur with problems of treatment fidelity • Nursing interventions are nurse-initiated and can
and uncontrolled confounding variables. Researchers be based on nursing classifications of interventions
also need to evaluate the bias and possible threats to unique to clinical problems addressed by nurses.
design validity occurring from random error intro- • Intervention research programs consist of multiple
duced by low statistical power, imprecise instruments, studies conducted over a period of years by a
and inappropriate statistical methods (Gerhard, 2008; project team that may include undergraduate and
Shadish, Cook, & Campbell, 2002; see Chapter 10). graduate nursing students.
• Some teams use a participatory research method
that involves community groups.
Critical Appraisal of • An intervention theory must include: (1) a careful
description of the problem to be addressed; (2) the
Intervention-Based Research intervening actions that must be implemented to
Criteria for critically appraising intervention-based address the problem; (3) moderator variables that
research are very similar to those for the appraisal of might change the impact of the intervention; (4)
any type of study. However, a more thorough and mediator variables that might alter the effect of the
systematic evaluation of the integrity of the interven- intervention; and (5) expected outcomes of the
tion, study procedures for implementing the interven- intervention.
tion, and outcomes for measuring its efficacy or • The intervention theory guides the design and
effectiveness is required. The validity of research find- development of an intervention, which is then
ings involving interventions depends on sound meth- extensively tested, refined, and retested using quan-
odological practices including accuracy, precision, titative, qualitative, and mixed-methods research
and consistency in the delivery of a study intervention. designs.
348 UNIT TWO  The Research Process

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  http://evolve.elsevier.com/Grove/practice/

15 CHAPTER

Sampling

M
any of us have preconceived notions about study. A sampling plan defines the process of making
samples and sampling, which we acquired the sample selections; sample denotes the selected
from television commercials, polls of public group of people or elements included in a study. Sam-
opinion, market researchers, and newspaper reports of pling decisions have a major impact on the meaning
research findings. The advertiser boasts that four of and generalizability of the findings.
five doctors recommend its product; the newscaster Sampling theory was developed to determine math-
announces that John Jones is predicted to win the ematically the most effective way to acquire a sample
senate election by a margin of 3 to 1; the newspaper that would accurately reflect the population under
reports that scientists’ studies have found that taking study. The theoretical, mathematical rationale for
a statin drug, such as atorvastatin (Lipitor), signifi- decisions related to sampling emerged from survey
cantly reduces the risk of coronary artery disease. research, although the techniques were first applied to
All of these examples use sampling techniques. experimental research by agricultural scientists. One
However, some of the outcomes are more valid than of the most important surveys that stimulated improve-
others, partly because of the sampling techniques ments in sampling techniques was the U.S. census.
used. In most instances, television, newspapers, and Researchers have adopted the assumptions of sam-
advertisements do not explain their sampling tech- pling theory identified for the census surveys and
niques. You may hold opinions about the adequacy of incorporated them within the research process
these techniques, but there is not enough information (Thompson, 2002).
to make a judgment. Key concepts of sampling theory are (1) popula-
The sampling component is an important part of the tions, (2) elements, (3) sampling criteria, (4) represen-
research process that needs to be carefully thought out tativeness, (5) sampling errors, (6) randomization,
and clearly described. To achieve these goals, research- (7) sampling frames, and (8) sampling plans. The fol-
ers need to understand the techniques of sampling and lowing sections explain these concepts; later in the
the reasoning behind them. With this knowledge, you chapter, these concepts are used to explain various
can make intelligent judgments about sampling when sampling methods.
you are critically appraising studies or developing a
sampling plan for your own study. This chapter exam- Populations and Elements
ines sampling theory and concepts; sampling plans; The population is a particular group of people, such
probability and nonprobability sampling methods for as people who have had a myocardial infarction, or
quantitative, qualitative, outcomes, and intervention type of element, such as nasogastric tubes, that is
research; sample size; and settings for conducting the focus of the research. The target population is the
studies. The chapter concludes with a discussion of the entire set of individuals or elements who meet the
process for recruiting and retaining subjects or partici- sampling criteria, such as women who have experi-
pants for study samples in various settings. enced a myocardial infarction in the past year. Figure
15-1 shows the relationships among the population,
target population, and accessible populations. An
Sampling Theory accessible population is the portion of the target
Sampling involves selecting a group of people, events, population to which the researchers have reasonable
behaviors, or other elements with which to conduct a access. The accessible population might be elements

351
352 UNIT TWO  The Research Process

Population
biases are similar to biases that may be encountered
in a nonrandom sample (Thompson, 2002).
Target Population
(Determined by sampling In some studies, the entire population is the target
criteria) of the study. These studies are referred to as popula-
Accessible Population tion studies (Barhyte, Redman, & Neill, 1990). Many
(Available to researcher) of these studies use data available in large databases,
Sample such as the census data or other government-maintained
(Selected with sampling databases. Epidemiologists sometimes use entire
method)
populations for their large database studies. In other
Subject, Research studies, the entire population of interest in the study
Participant, is small and well defined. For example, one could
or Informant
conduct a study in which the defined population was
Figure 15-1  Population, sample, and subject selected for a study.
all living recipients of heart and lung transplants.
In some cases, a hypothetical population is defined
for a study. A hypothetical population assumes the
presence of a population that cannot be defined accord-
within a country, state, city, hospital, nursing unit, or ing to sampling theory rules, which require a list of all
clinic, such as the adults with diabetes in a primary members of the population. For example, individuals
care clinic in Fort Worth, Texas. The sample is who successfully lose weight would be a hypothetical
obtained from the accessible population by a particu- population. The number of individuals in the popula-
lar sampling method, such as simple random sam- tion, who they are, how much weight they have lost,
pling. The individual units of the population and how long they have kept the weight off, and how they
sample are called elements. An element can be a achieved the weight loss are unknown. Some popula-
person, event, behavior, or any other single unit of tions are elusive and constantly changing. For example,
study. When elements are persons, they are usually identifying all women in active labor in the United
referred to as subjects or research participants or States, all people grieving the loss of a loved one,
informants (see Figure 15-1). The term used by or all people coming into an emergency department
researchers depends of the philosophical paradigm would be impossible.
that is reflected in the study and the design. The term
subject, and sometimes research participant, is used Sampling or Eligibility Criteria
within the context of the postpositivist paradigm of Sampling criteria, also referred to as eligibility cri-
quantitative research (see Chapter 2). The term study teria, include a list of characteristics essential for
or research participant or informant is used in the membership or eligibility in the target population. The
context of the naturalistic paradigm of qualitative criteria are developed from the research problem, the
research (Fawcett & Garity, 2009; Munhall, 2012). purpose, a review of literature, the conceptual and
In quantitative, intervention, and outcomes research, operational definitions of the study variables, and the
the findings from a study are generalized first to the design. The sampling criteria determine the target
accessible population and then, if appropriate, more population, and the sample is selected from the acces-
abstractly to the target population. sible population within the target population (see
Generalizing means that the findings can be Figure 15-1). When the study is complete, the findings
applied to more than just the sample under study are generalized from the sample to the accessible
because the sample is representative of the target pop- population and then to the target population if the
ulation. Because of the importance of generalizing, study has a representative sample (see the next
there are risks to defining the accessible population section).
too narrowly. For example, a narrow definition of the You might identify broad sampling criteria for a
accessible population reduces the ability to generalize study, such as all adults older than 18 years of age able
from the study sample to the target population and to read and write English. These criteria ensure a large
diminishes the meaningfulness of the findings. Biases target population of heterogeneous or diverse poten-
may be introduced that make generalization to the tial subjects. A heterogeneous sample increases your
broader target population difficult to defend. If the ability to generalize the findings to a larger target
accessible population is defined as individuals in a population. In descriptive or correlational studies, the
white, upper-middle-class setting, one cannot general- sampling criteria may be defined to ensure a hetero-
ize to nonwhite or lower income populations. These geneous population with a broad range of values for
CHAPTER 15  Sampling 353

the variables being studied. However, in quasi- identified inclusion and exclusion sampling or eligibil-
experimental or experimental studies, the primary ity criteria that are presented in the following excerpt.
purpose of sampling criteria is to limit the effect of
extraneous variables on the particular interaction
between the independent and dependent variables. In “Women were included if they were 35-77 years of
these types of studies, the sampling criteria need to be age, had a history of stage 0 (in situ), I, or II breast
specific and designed to make the population as cancer, a BMD [bone mineral density] T-score of −1.0
homogeneous or similar as possible to control for the or less at any of three sites (hip, spine, forearm), were
extraneous variables. Subjects are selected to maxi- at least 6 months post breast-cancer treatment and
mize the effects of the independent variable and mini- 12 months postmenopausal, resided within 100 miles
mize the effects of variation in other extraneous of one of four research sites (Omaha, Lincoln,
variables so that they have a limited impact on the Kearney, and Scottsbluff, NE), and had their physi-
dependent variable scores. cians’ permission to participate [inclusion sampling
Sampling criteria may include characteristics such criteria]. Women were excluded if they (a) had a
as the ability to read, to write responses on the data recurrence of breast cancer; (b) were currently taking
collection instruments or forms, and to comprehend hormone therapy, bisphosphonates, glucocorticoste-
and communicate using the English language. Age roids, or other drugs affecting bone; (c) were cur-
limitations are often specified, such as adults 18 years rently engaging in ST exercises; (d) had a body mass
and older. Subjects may be limited to individuals who index (BMI) of 35 or greater; (e) had serum calcium,
are not participating in any other study. Persons who creatinine, or thyroid stimulating hormone (if on
are able to participate fully in the procedure for obtain- thyroid therapy) outside normal limits; or (f) had
ing informed consent are often selected as subjects. If active gastrointestinal problems or other conditions
potential subjects have diminished autonomy or are that prohibited ST exercises, risedronate, calcium, or
unable to give informed consent, consent must be vitamin D intake [exclusion sampling criteria].” (Twiss
obtained from their legal representatives. Thus, persons et al., 2009, p. 72)
who are legally or mentally incompetent, terminally
ill, or confined to an institution are more difficult to
access as subjects (see Chapter 9). However, sampling Twiss et al. (2009) identified specific inclusion and
criteria should not become so restrictive that the exclusion sampling criteria to designate the subjects
researcher cannot find an adequate number of study in the target population precisely. These sampling cri-
participants. teria probably were narrowly defined by the research-
A study might have inclusion or exclusion sam- ers to promote the selection of a homogeneous sample
pling criteria (or both). Inclusion sampling criteria of postmenopausal BCSs with bone loss. These inclu-
are characteristics that a subject or element must sion and exclusion sampling criteria were appropriate
possess to be part of the target population. Exclusion for the study to reduce the effect of possible extrane-
sampling criteria are characteristics that can cause a ous variables that might have an impact on the treat-
person or element to be excluded from the target popu- ment (ST exercises) and the measurement of the
lation. Researchers need to provide logical reasons for dependent variables (muscle strength, balance, and
their inclusion and exclusion sampling criteria, and falls). Because this is a quasi-experimental study that
certain groups should not be excluded without justifi- examined the impact of the treatment on the dependent
cation. In the past, some groups, such as women, or outcome variables, the increased controls imposed
ethnic minorities, elderly adults, and poor people, by the sampling criteria strengthened the likelihood
were unnecessarily excluded from studies (Larson, that the study outcomes were caused by the treatment
1994). Today, federal funding for research is strongly and not by extraneous variables. Twiss et al. (2009)
linked to including these populations in studies. Exclu- found significant improvement in muscle strength and
sion criteria limit the generalization of the study find- balance for the treatment group but no significant dif-
ings and should be carefully considered before being ference in the number of falls between the treatment
used in a study. and comparison groups.
Twiss et al. (2009) conducted a quasi-experimental
study to examine the effects of strength and weight Sample Representativeness
training (ST) exercises on muscle strength, balance, For a sample to be representative, it must be similar
and falls of breast cancer survivors (BCSs) with to the target population in as many ways as possible.
bone loss (population). This study included clearly It is especially important that the sample be
354 UNIT TWO  The Research Process

representative in relation to the variables you are Sampling error


studying and to other factors that may influence the
study variables. For example, if your study examines
attitudes toward acquired immunodeficiency syn- Population Sample
drome (AIDS), the sample should represent the distri-
bution of attitudes toward AIDS that exists in the
specified population. In addition, a sample must rep-
resent the demographic characteristics, such as age,
gender, ethnicity, income, and education, which often
influence study variables. Population Sample
The accessible population must be representative mean mean
of the target population. If the accessible population
is limited to a particular setting or type of setting, the Figure 15-2  Sampling error.
individuals seeking care at that setting may be differ-
ent from the individuals who would seek care for the with small samples and decreases as the sample size
same problem in other settings or from individuals increases. Sampling error reduces the power of a
who self-manage their problems. Studies conducted in study, or the ability of the statistical analyses con-
private hospitals usually exclude poor patients, and ducted to detect differences between groups or to
other settings could exclude elderly or undereducated describe the relationships among variables (Aberson,
patients. People who do not have access to care are 2010; Cohen, 1988). Sampling error occurs as a result
usually excluded from health-focused studies. Sub- of random variation and systematic variation.
jects and the care they receive in research centers are
different from patients and the care they receive in Random Variation
community clinics, public hospitals, veterans’ hospi- Random variation is the expected difference in
tals, and rural health clinics. Obese individuals who values that occurs when one examines different sub-
choose to enter a program to lose weight may differ jects from the same sample. If the mean is used to
from obese individuals who do not enter a program. describe the sample, the values of individuals in that
All of these factors limit representativeness and limit sample will not all be exactly the same as the sample
our understanding of the phenomena important in mean. Values of individual subjects vary from the
practice. value of the sample mean. The difference is random
Representativeness is usually evaluated by compar- because the value of each subject is likely to vary in
ing the numerical values of the sample (a statistic a different direction. Some values are higher and
such as the mean) with the same values from the target others are lower than the sample mean. The values are
population. A numerical value of a population is called randomly scattered around the mean. As the sample
a parameter. We can estimate the population param- size becomes larger, overall variation in sample values
eter by identifying the values obtained in previous decreases, with more values being close to the sample
studies examining the same variables. The accuracy mean. As the sample size increases, the sample mean
with which the population parameters have been esti- is also more likely to have a value similar to that of
mated within a study is referred to as precision. Preci- the population mean.
sion in estimating parameters requires well-developed
methods of measurement that are used repeatedly in Systematic Variation
several studies. You can define parameters by conduct- Systematic variation, or systematic bias, is a conse-
ing a series of descriptive and correlational studies, quence of selecting subjects whose measurement
each of which examines a different segment of the values are different, or vary, in some specific way from
target population; then perform a meta-analysis to the population. Because the subjects have something
estimate the population parameter (Thompson, 2002). in common, their values tend to be similar to the
values of others in the sample but different in some
Sampling Error way from the values of the population as a whole.
The difference between a sample statistic and a popu- These values do not vary randomly around the popula-
lation parameter is called the sampling error (Figure tion mean. Most of the variation from the mean is in
15-2). A large sampling error means that the sample the same direction; it is systematic. All the values in
is not providing a precise picture of the population; it the sample may tend to be higher or lower than the
is not representative. Sampling error is usually larger mean of the population (Thompson, 2002).
CHAPTER 15  Sampling 355

For example, if all the subjects in a study examin- For example, if 200 potential subjects met the sam-
ing some type of healthcare knowledge have an intel- pling criteria, and 40 refused to participate in the
ligence quotient (IQ) higher than 120, many of their study, the refusal rate would be 20%.
scores will likely be higher than the mean of a popula-
tion that includes individuals with a wide variation in Refusal rate = 40 (number refusing) ÷
IQ, such as IQs that range from 90 to 130. The IQs of 200 (number meeting sampling criteria) =
the subjects have introduced a systematic bias. This 0.2 × 100% = 20%
situation could occur, for example, if all the subjects
were college students, which has been the case in Sometimes researchers provide an acceptance
the development of many measurement methods in rate, or the number and percentage of the subjects
psychology. who agree to participate in a study, rather than a
Because of systematic variance, the sample mean refusal rate. The acceptance rate is calculated by
is different from the population mean. The extent of dividing the number of potential subjects who agree
the difference is the sampling error (see Figure 15-2). to participate in a study by the number of potential
Exclusion criteria tend to increase the systematic bias subjects who meet sampling criteria and multiplying
in the sample and increase the sampling error. An the result by 100%.
extreme example of this problem is the highly restric-
tive sampling criteria used in some experimental Acceptance rate formula = number potential
studies that result in a large sampling error and greatly subjects agreeing to participate ÷ number
diminished representativeness. potential subjects meeting sample criteria
If the method of selecting subjects produces a × 100%
sample with a systematic bias, increasing the sample If you know the refusal rate, you can also subtract
size would not decrease the sampling error. When a the refusal rate from 100% to obtain the acceptance
systematic bias occurs in an experimental study, it can rate. Usually researchers report either the acceptance
lead the researcher to believe that a treatment has rate or the refusal rate but not both. In the example
made a difference when, in actuality, the values would mentioned earlier, 200 potential subjects met the sam-
be different even without the treatment. This situation pling criteria; 160 agreed to participate in the study,
usually occurs because of an interaction of the system- and 40 refused.
atic bias with the treatment.
Acceptance rate = 160 (number accepting) ÷
Refusal and Acceptance Rates in Studies 200 (number meeting sampling criteria) =
Systematic variation or bias is most likely to occur 0.8 × 100% = 80%
when the sampling process is not random. However,
even in a random sample, systematic variation can Acceptance rate = 100% - refusal rate or
occur if potential subjects decline participation. Sys- 100% - 20% = 80%
tematic bias increases as the subjects’ refusal rate
increases. A refusal rate is the number and percent- Sample Attrition and Retention
age of subjects who declined to participate in the Rates in Studies
study. High refusal rates to participate in a study Systematic variation can also occur in studies with
have been linked to individuals with serious physical high sample attrition. Sample attrition is the with-
and emotional illnesses, low socioeconomic status, drawal or loss of subjects from a study. Systematic
and weak social networks (Neumark, Stommel, variation is greatest when a high number of subjects
Given, & Given, 2001). The higher the refusal withdraw from the study before the data have been
rate, the less the sample is representative of the collected or when a large number of subjects withdraw
target population. The refusal rate is calculated by from one group but not the other in the study (Ker-
dividing the number of potential subjects refusing linger & Lee, 2000; Thompson, 2002). In studies
to participate by the number of potential subjects involving a treatment, subjects in the control group
meeting sampling criteria and multiplying the results who do not receive the treatment may be more likely
by 100%. to withdraw from the study. Sample attrition should
be reported in the published study to determine if the
Refusal rate formula = number potential subjects final sample represents the target population. Research-
refusing to participate ÷ number potential ers also need to provide a rationale for subjects with-
subjects meeting sample criteria × 100% drawing from the study and to determine if they are
356 UNIT TWO  The Research Process

different from the subjects who complete the study.


The sample is most like the target population if the women (exercise = 14; comparison = 12) withdrew
attrition rate is low (<10% to 20%) and the subjects from the study before 24 months. Reasons for with-
withdrawing from the study are similar to the subjects drawal included the desire for a different exercise
completing the study. Sample attrition rate is calcu- program (n = 7); insufficient time (n = 6); intolerance
lated by dividing the number of subjects withdrawing to meds (n = 5); cancer recurrence (n = 5); health
from a study by the sample size and multiplying the problems (n = 2); and relocation (n = 1).” (Twiss et al.,
results by 100%. 2009, p. 22)

Sample attrition rate formula = number subjects Twiss et al. (2009) identified that 249 participants
withdrawing ÷ sample size × 100% or subjects met the sampling criteria and 249 were
enrolled in the study indicating that the acceptance
For example, if a study had a sample size of 160, and rate for the study was 100%. The sample retention
40 people withdrew from the study, the attrition rate was 223 women for a retention rate of 90% (223 ÷
would be 25%. 249 × 100% = 89.6% = 90%), and the sample attrition
rate was 26 women for an attrition rate of 10% (100%
Attrition rate = 40 (number withdrawing) ÷ − 90% = 10%). The treatment group retention was
160 (sample size) = 0..25 × 100% = 25% 110 women with a retention rate of 89% (110 ÷ 124
× 100% = 88.7% = 89%). The comparison group
The opposite of the attrition rate is the retention retention was 113 women with a retention rate of
rate, or the number and percentage of subjects com- 90% (113 ÷ 125 = 90.4% = 90%). This study has an
pleting the study. The higher the retention rate, the excellent acceptance rate (100%) and a very strong
more representative the sample is of the target popula- sample retention rate of 90% for a 24-month-long
tion, and the more likely the study results are an accu- study. The retention rates for both groups were very
rate reflection of reality. Often researchers identify strong and comparable (treatment group 89% and
either the attrition rate or the retention rate but not comparison group 90%). Twiss et al. (2009) also pro-
both. It is better to provide a rate in addition to the vided a rationale for the subjects’ attrition, and the
number of subjects withdrawing or completing a reasons were varied and seemed appropriate and
study. In the example just presented with a sample size typical for a study lasting 24 months. The acceptance
of 160, if 40 subjects withdrew from the study, then rate, the sample and group retention rates, and the
120 subjects were retained or completed the study. reasons for subjects’ attrition indicate limited poten-
The retention rate is calculated by dividing the number tial for systematic variation in the study sample. The
of subjects completing the study by the initial sample likelihood is increased that the sample is representa-
size and multiplying by 100%. tive of the target population and the results are an
accurate reflection of reality. The study would have
Sample retention rate formula = number subjects been strengthened if the researchers would have
completing study ÷ sample size × 100% included not only the numbers but also the sample
and group retention rates.
Retention rate = 120 (number retained) ÷
160 (sample size) = 0.75 × 100% = 75% Randomization
From a sampling theory point of view, randomization
The study by Twiss et al. (2009) of the effects of means that each individual in the population should
ST exercises on muscle strength, balance, and falls of have a greater than zero opportunity to be selected for
BCSs with bone loss was introduced earlier in this the sample. The method of achieving this opportunity
chapter with the discussion of sampling criteria; the is referred to as random sampling. In experimental
following excerpt presents the acceptance rate and studies that use a control group, subjects are randomly
sample attrition for this study. selected and randomly assigned to either the control
group or the experimental group. The use of the
“A sample of 249 participants met the screening cri- term control group—the group not receiving the
teria and they were enrolled in the study.… Of the treatment—is usually limited to studies using random
249 women, 223 completed the 24-month testing sampling and random assignment to the treatment and
and were included in the analysis (exercise [treatment control groups. The control group usually receives no
group] = 110; comparison = 113). The remaining 26 care. If nonrandom sampling methods are used for
sample selection, the group not receiving a treatment
CHAPTER 15  Sampling 357

receives usual or standard care and is generally The sampling frame in this study included the
referred to as a comparison group. With a compari- names of the 746 RNs who were asked to participate
son group, there is an increase in the possibility of in the study.
preexisting differences between that group and the
experimental group receiving the treatment. Sampling Plan
Random sampling increases the extent to which A sampling plan describes the strategies that will be
the sample is representative of the target population. used to obtain a sample for a study. The plan is devel-
However, random sampling must take place in an oped to enhance representativeness, reduce systematic
accessible population that is representative of the bias, and decrease the sampling error. Sampling strate-
target population. Exclusion criteria limit true ran- gies have been devised to accomplish these three tasks
domness. Thus, a study that uses random sampling and to optimize sample selection. The sampling plan
techniques may have such restrictive sampling criteria may use probability (random) sampling methods or
that the sample is not truly random. In any case, it is nonprobability (nonrandom) sampling methods.
rarely possible to obtain a purely random sample for A sampling method is the process of selecting a
nursing studies because of informed consent require- group of people, events, behaviors, or other elements
ments. Even if the original sample is random, persons that represent the population being studied. A sam-
who volunteer or consent to participate in a study may pling method is similar to a design; it is not specific
differ in important ways from persons who are unwill- to a study. The sampling plan provides detail about the
ing to participate. All samples with human subjects application of a sampling method in a specific study.
must be volunteer samples, which includes individu- The sampling plan must be described in detail for
als willing to participate in the study, to protect the purposes of critical appraisal, replication, and future
rights of the individuals (Fawcett & Garity, 2009). meta-analyses. The sampling method implemented
Methods of achieving random sampling are described in a study varies with the type of research being
later in the chapter. conducted. Quantitative, outcomes, and intervention
research apply a variety of probability and nonprob-
Sampling Frame ability sampling methods. Qualitative research usually
For each person in the target or accessible population includes nonprobability sampling methods. The sam-
to have an opportunity to be selected for the sample, pling methods to be included in this text are identified
each person in the population must be identified. To in Table 15-1 and are linked to the types of research
accomplish this goal, the researcher must acquire a list that most commonly incorporate them. The following
of every member of the population through the use of sections describe the different types of probability and
the sampling criteria to define membership. This nonprobability sampling methods most commonly
listing of members of the population is referred to as used in quantitative, qualitative, outcomes, and inter-
the sampling frame. The researcher selects subjects vention research in nursing.
from the sampling frame using a sampling plan.
Djukic, Kovner, Budin, and Norman (2010) studied
the effect of nurses’ perceived physical work environ- Probability (Random)
ment on their job satisfaction and described their sam-
pling frame in the following excerpt. Sampling Methods
Probability sampling methods have been developed
to ensure some degree of precision in estimations of
“The study was conducted at a large urban hospital the population parameters. Probability samples reduce
in the U.S. northeast region that is a nongovernment, sampling error. The term probability sampling
not-for-profit, general medical and surgical major method refers to the fact that every member (element)
teaching hospital. About 1,300 staff RNs [population] of the population has a probability higher than zero of
were employed at the hospital at the time of the being selected for the sample. Inferential statistical
study.… A total of 746 RNs who met eligibility criteria analyses are based on the assumption that the sample
were invited to participate in the study [sampling from which data were derived has been obtained ran-
frame of target population]. The eligible RNs were domly. Thus, probability sampling methods are often
those who had a functioning work e-mail account referred to as random sampling methods. These
and who worked fulltime, on inpatient units, provid- samples are more likely to represent the population
ing direct patient care.” (Djukic et al., 2010, than samples obtained with nonprobability sampling
pp. 444-445) methods. All subsets of the population, which may
differ from one another but contribute to the
358 UNIT TWO  The Research Process

TABLE 15-1  Probability and Nonprobability randomly selected from the sampling frame. Accord-
Sampling Methods Commonly
ing to sampling theory, it is impossible to select a
sample randomly from a population that cannot be
Applied in Nursing Research
clearly defined. Four sampling designs have been
Sampling Method Common Applications developed to achieve probability sampling: simple
Probability Sampling Methods random sampling, stratified random sampling, cluster
sampling, and systematic sampling.
Simple random Quantitative, outcomes, and
sampling intervention research
Stratified random Quantitative, outcomes, and Simple Random Sampling
sampling intervention research Simple random sampling is the most basic of the
Cluster sampling Quantitative, outcomes, and probability sampling methods. To achieve simple
intervention research random sampling, elements are selected at random
Systematic sampling Quantitative, outcomes, and from the sampling frame. This goal can be accom-
intervention research plished in various ways, limited only by the imagina-
Nonprobability Sampling Methods tion of the researcher. If the sampling frame is small,
the researcher can write names on slips of paper, place
Convenience Quantitative, qualitative, outcomes,
sampling and intervention research
the names in a container, mix well, and draw out one
Quota sampling Quantitative, outcomes, and at a time until the desired sample size has been reached.
intervention research Another technique is to assign a number to each name
Purpose or purposeful Qualitative and sometimes in the sampling frame. In large population sets,
sampling quantitative research elements may already have assigned numbers. For
Network or snowball Qualitative and sometimes example, numbers are assigned to medical records,
sampling quantitative research organizational memberships, and professional licenses.
Theoretical sampling Qualitative research The researcher can use a computer to select these
numbers randomly to obtain a sample.
There can be some differences in the probability
for the selection of each element, depending on
parameters of the population, have a chance to be whether the name or number of the selected element
represented in the sample. Probability sampling is replaced before the next name or number is selected.
methods are most commonly applied in quantitative, Selection with replacement, the most conservative
outcomes, and intervention research. random sampling approach, provides exactly equal
There is less opportunity for systematic bias if sub- opportunities for each element to be selected (Thomp-
jects are selected randomly, although it is possible for son, 2002). For example, if the researcher draws
a systematic bias to occur by chance. Using random names out of a hat to obtain a sample, each name must
sampling, the researcher cannot decide that person X be replaced before the next name is drawn to ensure
would be a better subject for the study than person Y. equal opportunity for each subject.
In addition, a researcher cannot exclude a subset of Selection without replacement gives each element
people from selection as subjects because he or she different levels of probability for selection. For
does not agree with them, does not like them, or finds example, if the researcher is selecting 10 subjects from
them hard to deal with. Potential subjects cannot be a population of 50, the first name has a 1 in 5 chance
excluded just because they are too sick, not sick (10 draws, 50 names), or a 0.2 probability, of being
enough, coping too well, or not coping adequately. selected. If the first name is not replaced, the remain-
The researcher, who has a vested interest in the study, ing 49 names have a 9 in 49 chance, or a 0.18 probabil-
could (consciously or unconsciously) select subjects ity, of being selected. As further names are drawn, the
whose conditions or behaviors are consistent with the probability of being selected decreases.
study hypothesis. It is tempting to exclude uncoopera- There are many ways to achieve random selection,
tive or assertive individuals. Random sampling leaves such as with the use of a computer, a random numbers
the selection to chance and decreases sampling error table, drawing names out of a hat, or a roulette wheel.
and increases the validity of the study (Thompson, The most common method of random selection is
2002). the computer, which can be programmed to select a
Theoretically, to obtain a probability sample, the sample randomly from the sampling frame with
researcher must develop a sampling frame that includes replacement. However, some researchers still use a
every element in the population. The sample must be table of random numbers to select a random sample.
CHAPTER 15  Sampling 359

TABLE 15-2  Section from a Random


patients.… Because some patients accepted the
Numbers Table
intervention before the operation, but changed their
06 84 10 22 56 72 25 70 69 43 mind after the operation (3 patients in total), not all
07 63 10 34 66 39 54 02 33 85 patients participated in the study.” (Degirmen et al.,
03 19 63 93 72 52 13 30 44 40 2010, p. 154)
77 32 69 58 25 15 55 38 19 62
20 01 94 54 66 88 43 91 34 28

Degirmen et al. (2010) clearly identified their target


population as women needing cesarean operations, and
the 281 women with presenting orders provided the
Table 15-2 shows a section from a random numbers sampling frame for the study. The sample of 75 women
table. To use a table of random numbers, the researcher was randomly selected, but the researchers did not
places a pencil or a finger on the table with the eyes indicate the process for the random selection. The use
closed. The number touched is the starting place. of a computer to select a sample randomly is usually
Moving the pencil or finger up, down, right, or left, the most efficient and unbiased process. The subjects
the researcher uses the numbers in order until the were evenly divided with 25 in each group, but the
desired sample size is obtained. For example, the researchers do not indicate if the assignment to groups
researcher places a pencil on 58 in Table 15-2, which was random or based on the convenience of the sub-
is in the fourth column from the left and fourth row jects or researchers. Application of simple random
down. If five subjects are to be selected from a popula- sampling and the attrition of only three (4%) subjects
tion of 100 and the researcher decides to go across the from the study seem to provide a sample representative
column to the right, the subject numbers chosen are of the target population. However, the study would
58, 25, 15, 55, and 38. Table 15-2 is useful only if the have been strengthened by a discussion of the process
population number is less than 100. However, tables for random sampling and a clarification of how the
are available for larger populations, such as the subjects were assigned to groups. The outcomes of the
random numbers table provided in the online resources study were that foot and hand massage interventions
for this textbook or the Thompson (2002, pp. 14-15) significantly reduced postoperative pain experienced
sampling text. by the women and that foot and hand massage was
Degirmen, Ozerdogan, Sayiner, Kosgeroglu, and significantly more effective than foot massage only.
Ayranci (2010, p. 153) conducted a pretest-posttest
randomized controlled experimental study to deter- Stratified Random Sampling
mine the effect of hand and foot massage and foot Stratified random sampling is used when the
massage only interventions on the postoperative researcher knows some of the variables in the popula-
pain of women who had a cesarean operation. These tion that are critical to achieving representativeness.
researchers obtained their sample using a simple Variables commonly used for stratification are age,
random sampling method that is described in the fol- gender, ethnicity, socioeconomic status, diagnosis,
lowing excerpt from their study. geographical region, type of institution, type of care,
care provider, and site of care. The variable or vari-
ables chosen for stratification need to be correlated
“The study was conducted in obstetric intensive care with the dependent variables being examined in the
units and services of all the public and university hos- study. Subjects within each stratum are expected to be
pitals in the province of Eskisehir, Turkey.… During more similar (homogeneous) in relation to the study
the 4 month study, 281 patients attended for the variables than they are to be similar to subjects in
cesarean operations to the obstetric intensive care other strata or the total sample. In stratified random
units and services of all hospitals concerned [target sampling, the subjects are randomly selected on the
population and settings]. The total 75 study patients basis of their classification into the selected strata.
[sample] out of the 281 were selected by random For example, if in conducting your research you
sampling method from the patients’ presenting orders selected a stratified random sample of 100 adult sub-
[sampling frame] and evenly divided into three groups; jects using age as the variable for stratification, the
a control group, a foot and hand massage group, and sample might include 25 subjects in the age range 18
a foot massage group, each of which included 25 to 39 years, 25 subjects in the age range 40 to 59 years,
25 subjects in the age range 60 to 79 years, and 25
360 UNIT TWO  The Research Process

subjects 80 years or older. Stratification ensures that


all levels of the identified variable, in this example industry lists (www.mmslists.com/main.asp). The list
age, are adequately represented in the sample. With a for PAs was derived from the American Academy of
stratified random sample, you could use a smaller Physicians Assistants (AAPA), and a comprehensive
sample size to achieve the same degree of representa- list of NPs was derived from the medical and nursing
tiveness as a large sample acquired through simple boards of the 50 states and the District of Columbia
random sampling. Sampling error decreases, power [sampling frames for NPs and PAs].… After undeliv-
increases, data collection time is reduced, and the cost erable (1.9%) and other disqualified respondents
of the study is lower if stratification is used (Fawcett (13.2%, i.e., no longer practicing, non-primary-care
& Garity, 2009; Thompson, 2002). practitioner) were removed, the overall adjusted
One question that arises in relation to stratification response rate was 50.6%.” (Ulrich et al., 2006, p.
is whether each stratum should have equivalent 393)
numbers of subjects in the sample (termed dispropor-
tionate sampling) or whether the numbers of subjects
should be selected in proportion to their occurrence in The study sampling frames for the NPs and PAs are
the population (termed proportionate sampling). For representative of all 50 states and the District of
example, if stratification is being achieved by ethnicity Columbia, and the lists for the sampling frames were
and the population is 45% white non-Hispanic, 25% from quality sources. The study has a strong response
Hispanic nonwhite, 25% African American, and 5% rate of 50.6% for a mailed questionnaire, and the
Asian, your research team would have to decide researchers identified why certain respondents were
whether to select equal numbers of each ethnic group disqualified. The final sample was large (1536 sub-
or to calculate a proportion of the sample. Good argu- jects) with strong representation for both NPs (833
ments exist for both approaches. Stratification is not subjects) and PAs (689 subjects). The study sample
as useful if one stratum contains only a small number might have been stronger with a more equal number
of subjects. In the aforementioned situation, if propor- of NP and PA subjects. The 833 NPs and 689 PAs add
tions are used and the sample size is 100, the study to 1522 subjects and it is unclear why the sample size
would include only five Asians, hardly enough to be is identified as 1536 unless there are missing data from
representative. If equal numbers of each group are subjects. However, the sample was a great strength of
used, each group would contain at least 25 subjects; this study and appeared to represent the target popula-
however, the white non-Hispanic group would be tion of NPs and PAs currently practicing in primary
underrepresented. In this case, mathematically weight- care in the United States.
ing the findings from each stratum can equalize the
representation to ensure proportional contributions of Cluster Sampling
each stratum to the total score of the sample. Most Cluster sampling is a probability sampling method
textbooks on sampling describe this procedure (Levy applied when the population is heterogeneous; it is
& Lemsbow, 1980; Thompson, 2002; Yates, 1981). similar to stratified random sampling but takes advan-
Ulrich et al. (2006) used a stratified random sam- tage of the natural clusters or groups of population
pling method to obtain their sample of nurse practitio- units that have similar characteristics (Fawcett &
ners (NPs) and physician assistants (PAs) for the Garity, 2009). Cluster sampling is used in two situa-
purpose of studying the ethical conflict of these health- tions. The first situation is when a simple random
care providers associated with managed care. The fol- sample would be prohibitive in terms of travel time
lowing excerpt from this study describes the sampling and cost. Imagine trying to arrange personal meetings
method used to obtain the final sample of 1536 provid- with 100 people, each in a different part of the United
ers (833 NPs and 689 PAs). States. The second situation is in cases in which the
individual elements making up the population are
unknown, preventing the development of a sampling
“A self-administered questionnaire was mailed to frame. For example, there is no list of all the heart
an initial stratified random sample [sampling method] surgery patients who complete rehabilitation programs
of 3,900 NPs and PAs practicing in the United in the United States. In these cases, it is often possible
States. The sample was selected from the national to obtain lists of institutions or organizations with
lists provided by Medical Marketing Services, an inde- which the elements of interest are associated.
pendently owned organization that manages medical In cluster sampling, the researcher develops a sam-
pling frame that includes a list of all the states, cities,
CHAPTER 15  Sampling 361

institutions, or organizations with which elements of


the identified population would be linked. States, cluster sampling]. In a third step, clusters of dwelling
cities, institutions, or organizations are selected ran- units form the secondary sampling units selected
domly as units from which to obtain elements for the from each substratum [3rd stage cluster sampling].
sample. In some cases, this random selection contin- Finally, within each secondary sampling unit, all African
ues through several stages and is referred to as mul- American and Hispanic households were selected for
tistage cluster sampling. For example, the researcher interviews, whereas other households were sampled
might first randomly select states and next randomly at differing rates within the substrata. Therefore, the
select cities within the sampled states. Hospitals sampling design of the NHIS includes oversampling of
within the randomly selected cities might then be ran- minorities.” (Fouladbakhsh & Stommel, 2010, pp.
domly selected. Within the hospitals, nursing units E8-E9)
might be randomly selected. At this level, either all
the patients on the nursing unit who fit the criteria for
the study might be included, or patients could be ran- These researchers detailed their use of multistage
domly selected. cluster sampling and clearly identified the three stages
Cluster sampling provides a means for obtaining a implemented and the rationale for each stage. The
larger sample at a lower cost. However, it has some study had a large, national sample that seemed repre-
disadvantages. Data from subjects associated with the sentative of all 50 states and the District of Columbia
same institution are likely to be correlated and not with an oversampling of minorities to accomplish the
completely independent. This correlation can cause a purpose of the study. The complex cluster sampling
decrease in precision and an increase in sampling method used in this study provided a representative
error. However, such disadvantages can be offset to sample, which decreases the likelihood of sampling
some extent by the use of a larger sample. error and increases the validity of the study findings.
Fouladbakhsh and Stommel (2010, p. E8) used The findings reported by Fouladbakhsh and Stommel
multistage cluster sampling in their study of the (2010, p. E7) indicated that “CAM practice use was
“complex relationships among gender, physical and more prevalent among female, middle-aged, Cauca-
psychological symptoms, and use of specific CAM sian, and well-educated subjects. Pain, depression, and
[complementary and alternative medicine] health insomnia were strong predictors of practice use, with
practices among individuals living in the United States differences noted by gender and practice type.”
who have been diagnosed with cancer.” These
researchers described their sampling method in the Systematic Sampling
following excerpt from their study. Systematic sampling can be conducted when an
ordered list of all members of the population is avail-
able. The process involves selecting every kth indi-
“The NHIS [National Health Interview Survey] meth- vidual on the list, using a starting point selected
odology employs a multistage probability cluster sam- randomly. If the initial starting point is not random,
pling design [sampling method] that is representative the sample is not a probability sample. To use this
of the NHIS target universe, defined as ‘the civilian design in your research, you must know the number
noninstitutionalized population’ (Botman, Moore, of elements in the population and the size of the
Moriarty, & Parsons, 2000, p. 14; National Center for sample desired. Divide the population size by the
Health Statistics). In the first stage, 339 primary sam- desired sample size, giving k, the size of the gap
pling units were selected from about 1,900 area sam- between elements selected from the list. For example,
pling units representing counties, groups of adjacent if the population size is N = 1200 and the desired
counties, or metropolitan areas covering the 50 states sample size is n = 100, then you could calculate the
and the District of Columbia [1st stage cluster sam- value of k:
pling]. The selection included all of the most populous
primary sampling units in the United States and strati- k = population size ÷ sample size desired
fied probability samples (by state, area poverty level,
and population size) of the less populous ones. In a Example: k = 1200 (population size) ÷
second step, primary sampling units were partitioned 100 (sample size desired) = 12
into substrata (up to 21) based on concentrations of
African American and Hispanic populations [2nd stage Thus, k = 12, which means that every 12th person on
the list would be included in the sample. Some authors
362 UNIT TWO  The Research Process

argue that this procedure does not truly give each Li and Mukamel (2010) used a national database
element an opportunity to be included in the sample; developed with strong probability sampling methods
it provides a random but unequal chance for inclusion (stratified random sampling and systematic sampling).
(Thompson, 2002). The database included a nationally representative
Researchers must be careful to determine that the sample of nursing homes and their residents, which
original list has not been set up with any ordering that decreases the potential for sampling error and supports
could be meaningful in relation to the study. The the validity of the findings. The study design was
process is based on the assumption that the order of limited to an examination of data from white and black
the list is random in relation to the variables being subjects, who were the largest groups represented in
studied. If the order of the list is related to the study, the nursing homes surveyed. The sample size was
systematic bias is introduced. In addition to this risk, extremely large, which increases the potential to gen-
it is difficult to compute sampling error with the use eralize the findings to these two ethnic groups. The
of this design (Floyd, 1993). study would have been strengthened by a more detailed
Li and Mukamel (2010, p. S256) conducted a sec- discussion of the systematic sampling of the nursing
ondary data analysis of National Nursing Home Survey homes and the random sampling of the residents. The
(NNHS) data to identify any “racial disparities in the researchers found that disparities existed in vaccina-
receipt and documentation of influenza and pneumo- tion coverage of white and black nursing home
coccus vaccinations among nursing-home residents.” residents and recommended interventions to improve
The NNHS data were obtained using stratified random coverage.
sampling and systematic sampling for selection of the
nursing homes and random sampling of the residents
for interviews. The researchers described the sampling Nonprobability (Nonrandom)
plan for the NNHS and the participants for their study
in the following study excerpt. Sampling Methods
Commonly Applied in
“We obtained the public-use resident file of the Quantitative Research
Centers for Disease Control and Prevention’s 2004 In nonprobability sampling, not every element of the
NNHS, which includes a nationally representative population has an opportunity to be included in the
sample of nursing homes, their residents, and the sample. Nonprobability sampling methods increase
services the residents received.… The 2004 NNHS the likelihood of obtaining samples that are not repre-
involved a stratified 2-stage probability design. The sentative of their target populations. However, most
first stage was the selection of nursing homes strati- nursing studies use nonprobability sampling, espe-
fied by geographical location (state, county, and zip cially convenience sampling, to select study samples.
code), bed-size category (number of beds), and own- In conducting studies in nursing and other health dis-
ership status (profit vs. nonprofit). Nursing homes ciplines, limited subjects are available, and it is often
were finally selected by systematic sampling, with the impossible to obtain a random sample. Researchers
probability proportional to bed-size category. The often include any subjects willing to participate who
second stage, sampling of current residents, was meet the eligibility criteria.
carried out by interviewers at the time of their visits There are several types of nonprobability (nonran-
to the facilities. Individuals were randomly selected dom) sampling designs. Each addresses a different
from patient rosters, and a sample of up to 12 current research need. The five nonprobability sampling
residents per facility was selected for the final inter- designs described in this textbook are (1) convenience
view. The final NNHS comprised 13,507 residents in sampling, (2) quota sampling, (3) purposive or pur-
1174 nursing homes, with an overall response rate of poseful sampling, (4) network or snowball sampling,
78%.… Our analyses were limited to 11,448 nonHis- and (5) theoretical sampling. These sampling methods
panic Whites and 1384 Blacks, excluding 765 resi- are applied in both quantitative and qualitative
dents (5.7%) of other races/ethnicities.… The final research. However, convenience sampling and quota
sample comprised 10,562 residents for analysis of sampling are applied more often in quantitative, out-
influenza and 12,134 residents for the analysis of comes, and intervention research than in qualitative
pneumococcus vaccinations.” (Li & Mukamel, 2010, studies and are discussed in this section (see Table
p. S256) 15-1). Purposive sampling, network sampling, and
theoretical sampling are more commonly applied in
CHAPTER 15  Sampling 363

qualitative studies than in quantitative studies and are examined through the use of probability sampling.
discussed later in this chapter. Convenience sampling enables researchers to acquire
information in unexplored areas. According to Ker-
Convenience Sampling linger and Lee (2000), a convenience sample is prob-
In convenience sampling, subjects are included in the ably not that bad when it is used with reasonable
study because they happened to be in the right place at knowledge and care in implementing a study. Health-
the right time. Researchers simply enter available sub- care studies are usually conducted with particular
jects into the study until they have reached the desired types of patients experiencing varying numbers of
sample size. Convenience sampling, also called acci- health problems; these patients often are reluctant to
dental sampling, is considered a weak approach to participate in research. Thus, researchers often find it
sampling because it provides little opportunity to very difficult to recruit subjects for their studies and
control for biases. Multiple biases may exist in conve- frequently must use a sample of convenience versus
nience sampling; these biases range from minimal to random sampling to obtain their sample.
serious. Researchers need to identify and describe O’Shea, Wallace, Griffin, and Fitzpatrick (2011,
known biases in their samples. You can identify biases p. 35) used convenience sampling to determine the
by carefully thinking through the sample criteria used “effectiveness of a spiritual educational session on
to determine the target population and taking steps to pediatric nurses’ perspectives concerning the provi-
improve the representativeness of the sample. For sion of pediatric spiritual care.” The following excerpt
example, in a study of home care management of describes their sampling method.
patients with complex healthcare needs, educational
level would be an important extraneous variable. One
solution for controlling this extraneous variable would “The setting for the data collection was a large
be to redefine the sampling criteria to include only university-affiliated children’s hospital located in the
patients with a high school education. Doing so would northeast. Participants represented a convenience
limit the extent of generalization but decrease the bias sample [sampling method] from a potential 355 reg-
created by educational level. Another option would be istered neonatal and pediatric staff nurses employed
to select a population known to include individuals at the hospital [target population]. Forty-one nurses
with a wide variety of educational levels. Data could voluntarily consented to participate. Number of par-
be collected on educational level so that the descrip- ticipants per session varied from approximately two
tion of the sample would include information on edu- to five, depending on the day and time of the session.”
cational level. With this information, one could judge (O’Shea et al., 2011, p. 37)
the extent to which the sample was representative
with respect to educational level (Thompson, 2002). O’Shea et al. (2011) clearly identified their sam-
Decisions related to sample selection must be care- pling method, target population, and sample size. The
fully described to enable others to evaluate the pos- acceptance rate for the study was 41 neonatal and
sibility of biases. In addition, data need be gathered to pediatric nurses, which is only 12% of the 355 nurses
allow a thorough description of the sample that can in the target population. The nurses volunteering to
also be used to evaluate for possible biases. Data on participate in the study might be different in some way
the sample can be used to compare the sample with from the nurses refusing to participate. The small
other samples and to estimate the parameters of popu- sample size (N = 41) and low acceptance rate increase
lations through meta-analyses. the chance for sampling error and decrease the repre-
Many strategies are available for selecting a con- sentativeness of the sample. However, all 41 partici-
venience sample. A classroom of students might be pants completed this quasi-experimental study (0%
used. Patients who attend a clinic on a specific day, attrition rate), which decreases the potential for bias.
subjects who attend a support group, patients currently The sample was homogeneous for registered nurse
admitted to a hospital with a specific diagnosis, and status, employed on pediatric units, and gender (female
every fifth person who enters the emergency depart- n = 40). The sample was heterogeneous for education
ment are examples of types of commonly selected ranging from associate’s degree to master’s in nursing
convenience samples. and for years of experience ranging from less than 2
Convenience samples are inexpensive and acces- years to more than 20 years. In a quasi-experimental
sible, and they usually require less time to acquire than study, a homogeneous sample decreases the extrane-
other types of samples. Convenience samples provide ous variables that might influence the findings. Based
means to conduct studies on topics that could not be on the sampling method (nonprobability convenience
364 UNIT TWO  The Research Process

sample), small sample size, high refusal rate, and dif-


ferences in the education and years of experience of was to allow comparisons of type of drug use with
the nurses, the findings from this study are best gen- minimal confounding by age, gender, or ethnicity.
eralized to the sample and not the accessible or target Additional inclusion criteria included presence of both
populations. The researchers found that the educa- legs, able to walk, and able to speak and understand
tional sessions had a positive effect on the nurses’ English. The analyses reported here are on the 569
perspectives toward providing spiritual care, but addi- participants who completed the revised LDUQ [Legs
tional research is needed to confirm the effect of this in Daily Use Questionnaire], which were edited after
intervention. Additional studies with large conve- examining the test-retest data from 104 participants,
nience samples that have similar results would indicate not included in the 569, who were tested first.”
the effectiveness of this intervention for practice. (Pieper et al., 2010, p. 429)

Quota Sampling
Quota sampling uses a convenience sampling tech- Pieper et al. (2010) clearly identified that the origi-
nique with an added feature, a strategy to ensure the nal sample was one of convenience because it included
inclusion of subject types or strata in a population that people attending 12 methadone treatment clinics who
are likely to be underrepresented in the convenience were willing to participate in the study. The quota
sample, such as women, minority groups, elderly sampling involved stratification of the sample on four
adults, poor people, rich people, and undereducated variables with a clear rationale for the variables
adults. This method may also be used to mimic the selected for stratification. The study was completed by
known characteristics of the target population or to 569 participants, but 104 participants were used for
ensure adequate numbers of subjects in each stratum examining the test-retest reliability of the LDUQ and
for the planned statistical analyses. The technique is not included in the final data collection. The study had
similar to the technique used in stratified random sam- an attrition of 40 participants (attrition rate = 40 ÷ 569
pling, but the initial sample is not random. If neces- × 100% = 7%).
sary, mathematical weighting can be used to adjust The study by Pieper et al. (2010) has several
sample values so that they are consistent with the strengths in the sampling process. The use of quota
proportion of subgroups found in the population. sampling ensured that the study sample was more
Quota sampling offers an improvement over conve- representative of the target population than using con-
nience sampling and tends to decrease potential biases. venience sampling only. In addition, the participants
In most studies in which convenience samples are were obtained from 12 different clinics and the sample
used, quota sampling could be used and should be size was large (N = 713 − 104 [used only for instru-
considered (Thompson, 2002). ment reliability testing] = 569) with a small attrition
Pieper, Templin, Kirsner, and Birk (2010) used rate (7%). The sample appeared to be representative
quota sampling to examine the impact of vascular leg of the target population with limited potential for sam-
disorders, such as chronic venous disorders and pling error. The findings indicated that motivation was
peripheral arterial disease, on the physical activity the strongest predictor of physical activity and that
levels of opioid-addicted adults in a methadone- healthcare professionals need to evaluate the vascular
maintained program. The following excerpt describes health of legs of drug injection users before encourag-
their sampling process. ing exercise.

“The sample (N = 713) was obtained from September


Nonprobability Sampling
2005 to December 2007 from 12 methadone treat- Methods Commonly Applied
ment clinics located in a large urban area [conve-
nience sampling]. The sample was stratified on four in Qualitative Research
variables: age (25-39 years, 40-49 years, 50-65 years); Qualitative research is conducted to gain insights and
gender (male, female); ethnicity (African American, discover meaning about a particular experience, situa-
White); and drug use (nonIDU [injection drug use], tion, cultural element, or historical event. The intent is
arm/upper body injection only, or legs ± upper body an in-depth understanding of a purposefully selected
injection; Pieper, Templin, Kirsner, & Birk, 2009) sample and not the generalization of the findings from
[quota sampling]. The purpose of the stratification a randomly selected sample to a target population, as
in quantitative, outcomes, and intervention research. In
CHAPTER 15  Sampling 365

qualitative research, experiences, events, and incidents understanding of a complex experience or event
are more the focus of sampling than people (Marshall (Munhall, 2012).
& Rossman, 2011; Munhall, 2012; Patton, 2002). The Sternberg and Barry (2011, p. 64) applied purpo-
researcher attempts to select participants or informants sive and snowball sampling methods in conducting
who can provide extensive information about the expe- their phenomenological study of “the experiences of
rience or event being studied. For example, if the goal transnational Latina mothers who immigrated to the
of your study was to describe the phenomenon of United States without legal documentation or their
living with chronic pain, you would purposefully children.” Snowball sampling, discussed in the next
select participants who were articulate and reflective, section, involves current study participants identifying
had a history of chronic pain, and were willing to share additional potential study participants who are similar
their chronic pain experience (Coyne, 1997). to them. Sternberg and Barry describe their sampling
The three common sampling methods applied in methods in the following study excerpt.
qualitative research are purposive or purposeful sam-
pling, network or snowball sampling, and theoretical
sampling (see Table 15-1). These sampling methods “A purposive sample of Latina mothers who immi-
enable the researcher to select the specific participants grated to the United States without their children was
who would provide the most extensive information selected. Interviews were conducted and analyzed
about the phenomenon, event, or situation being until saturation and redundancy was achieved
studied (Marshall & Rossman, 2011). The sample (Munhall, 2007). Eight women in total participated in
selection process can have a profound effect on the the study. Three women visiting a free community
quality of the research and should be described in clinic in southeast Florida were invited to participate
enough depth to promote the interpretation of the find- in the study by the nurse researcher; the other five
ings and the replication of the study (Munhall, 2012; were recruited using snowball sampling. Snowball
Patton, 2002). sampling was chosen over random sampling because
of the difficulty in gaining access to a population with
Purposive Sampling so many undocumented members (Munhall, 2007).
In purposive sampling, sometimes referred to as Further, it enabled the researcher to establish a trust-
purposeful, judgmental, or selective sampling, the ing relationship with the participants and obtain a
researcher consciously selects certain participants, more heterogeneous sample group. To be included in
elements, events, or incidents to include in the study. this study, participants had to be mothers who were
In purposive sampling, qualitative researchers select 18 years of age or older, Spanish or English speaking,
information-rich cases, or cases that can teach them and immigrants to the United States from Latin
a great deal about the central focus or purpose of the America who had left their child or children in their
study (Green & Thorogood, 2004; Patton, 2002). country of origin.” (Sternberg & Barry, 2011, pp.
Efforts might be made to include typical and atypical 65-66)
participants or situations. Researchers also seek criti-
cal cases, or cases that make a point clearly or are
extremely important in understanding the purpose of Sternberg and Barry (2011) clearly identified their
the study (Munhall, 2012). The researcher might select sampling methods that were appropriate for the quali-
participants or informants of various ages, participants tative study they conducted. The initial three partici-
with differing diagnoses or illness severity, or partici- pants were identified through purposive sampling so
pants who received an ineffective treatment versus an that they could achieve a group reflective of their
effective treatment for their illness. sampling criteria. Individuals without legal documen-
This sampling plan has been criticized because it tation are hard to locate, so use of snowball sampling
is difficult to evaluate the precision of the researcher’s was appropriate to identify five additional partici-
judgment. How does one determine that the patient or pants. The eight participants provided an adequate-
element was typical or atypical, good or bad, effective sized sample because the researchers were able to
or ineffective? Researchers need to indicate the char- reach saturation and redundancy of themes during
acteristics that they desire in participants and provide their data analysis. The findings from the study
a rationale for selecting these types of participants to included seven essential themes: “living in extreme
obtain essential data for their study. Purposive sam- poverty, having hope, choosing to walk from poverty,
pling method is used in qualitative research to gain suffering through the trip to and across the U.S.-
insight into a new area of study or to obtain in-depth Mexican border, mothering from afar, valuing family,
366 UNIT TWO  The Research Process

and changing personally” (Sternberg & Barry, 2011, they include information that generates, delimits, and
p. 67). saturates the theoretical codes in the study needed for
theory generation. A code is saturated if it is complete
Network (Snowball) Sampling and the researcher can see how it fits in the theory. The
Network sampling, sometimes referred to as snow- researcher continues to seek sources and gather data
ball or chain sampling, holds promise for locating until the codes are saturated and the theory evolves
samples difficult or impossible to obtain in other ways from the codes and the data. Diversity in the sample
or that had not been previously identified for study. is encouraged so that the theory developed covers a
Network sampling takes advantage of social networks wide range of behavior in varied situations (Marshall
and the fact that friends tend to have characteristics in & Rossman, 2011; Patton, 2002).
common. When you have found a few participants Beaulieu, Kools, Kennedy, and Humphreys (2011,
with the necessary criteria, you can ask for their assis- p. 41) conducted a qualitative study using grounded
tance in getting in touch with others with similar char- theory methods to “explore and better understand the
acteristics. The first few participants are often obtained reasons for the apparent underuse of emergency con-
through convenience or purposive sampling methods, traceptive pills (ECPs) in young people in coupled
and the sample size is expanded using network or relationships.” These researchers applied three sam-
snowball sampling. This sampling method is occa- pling methods: (1) convenience sampling, (2) snow-
sionally used in quantitative studies, but it is more ball sampling, and (3) theoretical sampling. They
commonly used in qualitative studies. In qualitative described their sampling methods in the following
research, network sampling is an effective strategy for study excerpt.
identifying participants who know other potential par-
ticipants who can provide the greatest insight and
“A convenience sample was recruited via public
essential information about an experience or event that
notices and snowball sampling (Fain, 2004). Inclusion
is identified for study (Marshall & Rossman, 2011;
criteria were women 18 to 25 years of age, English
Munhall, 2012; Patton, 2002).
speaking, with basic knowledge of ECPs, and cur-
This strategy is also particularly useful for finding
rently involved in a sexual relationship with a partner
participants in socially devalued populations, such as
who was also willing to participate in the study.…
alcoholics, child abusers, sex offenders, drug addicts,
Analysis began simultaneously with data collection as
and criminals. These individuals are seldom willing to
dictated by the tenets of grounded theory.… The
make themselves known. Other groups, such as
initial analysis of interviews and field notes consisted
widows, grieving siblings, or individuals successful at
of strategies of open coding and memoing (Glaser &
lifestyle changes, can be located using this strategy.
Strauss, 1967).… As new categories emerged, the
These individuals are outside the existing healthcare
original interview guide was revised and additional
system and are difficult to find. Biases are built into
couples were recruited to allow for theoretical sam-
the sampling process because the participants are not
pling, that is, sampling specifically to fill in theoretical
independent of one another. However, the participants
gaps, strengthen categories and their relationships,
selected have the expertise to provide the essential
and verify or challenge emerging conceptualizations
information needed to address the study purpose. The
(Strauss & Corbin, 1998) and forced coding (Charmaz,
study by Sternberg and Barry (2011) presented in the
2006).” (Beaulieu et al., 2011, p. 43)
previous section applied snowball or network sam-
pling to identify additional study participants who had
immigrated to the United States without legal docu- Beaulieu et al. (2011) clearly identified their sam-
mentation. These researchers clearly identified their pling methods that were appropriate for a qualitative
use of snowball sampling and their rationale for using study conducted with grounded theory methodology.
this method in their study. Both convenience and snowball sampling methods
were applied because the researchers wanted an ade-
Theoretical Sampling quate number of couples to participate in their study
Theoretical sampling is usually applied in grounded and discuss their decision making regarding ECPs
theory research to advance the development of a use. Beaulieu et al. also provided a detailed rationale
selected theory throughout the research process for their use of theoretical sampling to develop a
(Munhall, 2012). The researcher gathers data from any theory about decision making of young couples
individual or group that can provide relevant data for related to ECPs use. The sampling methods provided
theory generation. The data are considered relevant if a strong sample of 22 couples, who provided the
CHAPTER 15  Sampling 367

essential information for grounded theory develop- problems if the study failed to detect significant dif-
ment (Glaser & Strauss, 1967; Strauss & Corbin, ferences or relationships, which might be due to an
1998). More details on this study are presented later inadequate sample size. The calculation of the power
in this chapter in the discussion of sample size in analysis varies with the types of statistical analyses
qualitative studies. used to analyze study data. Statistical programs are
available to conduct a power analysis for a study (see
Chapter 21). However, you can get a general idea
Sample Size in about sample size using the power tables in Appendix
F in this textbook.
Quantitative Research The adequacy of sample sizes must be evaluated
One of the questions beginning researchers commonly more carefully in future nursing studies before data
ask is, “What size sample should I use?” Historically, collection. Studies with inadequate sample sizes
the response to this question has been that a sample should not be approved for data collection unless they
should contain at least 30 subjects for each study vari- are preliminary pilot studies conducted before a
able measured. Statisticians consider 30 subjects as planned larger study. If it is impossible for you to
the minimum number for data on a single variable to obtain a larger sample because of time or numbers of
approach a normal distribution. So if a study includes available subjects, you should redesign your study so
4 variables, researchers need at least 120 subjects in that the available sample is adequate for the planned
their final sample. Researchers are encouraged to analyses. If you cannot obtain a sufficient sample size,
determine the possible attrition rate for their study to you should not conduct the study.
ensure an adequate sample size at the completion of Large sample sizes are difficult to obtain in nursing
their study. For example, researchers might anticipate studies, require long data collection periods, and are
a 10-15% attrition rate in their study and need to costly. In developing the methodology for a study,
obtain a sample of 130 to 140 subjects to ensure the you must evaluate the elements of the methodology
final sample size after attrition is 120. The best method that affect the required sample size. Kraemer and
of determining sample size is a power analysis but if Thiemann (1987) identified the following factors that
information is not available to conduct a power analy- must be taken into consideration in determining
sis, this recommendation of 30 subjects per study vari- sample size:
able might be used. 1. The more stringent the significance level (e.g.,
The deciding factor in determining an adequate 0.001 versus 0.05), the greater the necessary sample
sample size for correlational, quasi-experimental, and size. Most nursing studies include a level of sig-
experimental studies is power. Power is the capacity nificance or alpha (α) = 0.05.
of the study to detect differences or relationships that 2. Two-tailed statistical tests require larger sample
actually exist in the population. Expressed another sizes than one-tailed tests. (Tailedness of statistical
way, power is the capacity to reject a null hypothesis tests is explained in Chapters 21 and 25.)
correctly. The minimum acceptable power for a 3. The smaller the effect size, the larger the necessary
study is commonly recommended to be 0.80 (80%) sample size. The effect size is a determination of
(Aberson, 2010; Cohen, 1988; Kraemer & Thiemann, the effectiveness of a treatment on the outcome
1987). If you do not have sufficient power to detect (dependent) variable or the strength of the relation-
differences or relationships that exist in the popula- ship between two variables.
tion, you might question the advisability of conduct- 4. The larger the power required, the larger the neces-
ing the study. You determine the sample size needed sary sample size. Thus, a study requiring a power
to obtain sufficient power by performing a power of 90% requires a much larger sample than a study
analysis. Power analysis includes the standard power with power set at 80%.
(usually 80%), level of significance (usually set at 5. The smaller the sample size, the smaller the
0.05 in nursing studies), effect size (discussed in the power of the study (Aberson, 2010; Cohen, 1988;
next section), and sample size. Kraemer & Thiemann, 1987).
An increasing number of nurse researchers are The factors that must be considered in decisions
using power analysis to determine sample size, but it about sample size (because they affect power) are
is essential that the results of the power analyses be effect size, type of study, number of variables, sensi-
included in the published studies. Not conducting a tivity of the measurement methods, and data analysis
power analysis for a study and omitting the power techniques. These factors are discussed in the follow-
analysis results in a published study are significant ing sections.
368 UNIT TWO  The Research Process

Effect Size Extremely small ESs (e.g., <0.1) may not be clini-
Effect is the presence of a phenomenon. If a phenom- cally important because the relationships between the
enon exists, it is not absent, and the null hypothesis is variables are small or the differences between the treat-
in error. However, effect is best understood when not ment and comparison groups are limited. Knowing the
considered in a dichotomous way—that is, as either ES that would be regarded as clinically important
present or absent. If a phenomenon exists, it exists to allows us to limit the sample to the size needed to
some degree. Effect size (ES) is the extent to which a detect that level of ES (Kraemer & Thiemann, 1987).
phenomenon is present in a population. In this case, A result is clinically important if the effect is large
the term effect is used in a broader sense than the term enough to alter clinical decisions. For example, in
cause and effect. For example, you might examine the comparing glass thermometers with electronic ther-
impact of distraction on the experience of pain during mometers, an effect size of 0.1° F in oral temperature
an injection. To examine this question, you might is probably not important enough to influence selection
obtain a sample of subjects receiving injections and of a particular type of thermometer in clinical practice.
measure the perception of pain in a group of subjects The clinical importance of an ES varies on the basis
who were distracted during injection and a group of of the variables being studied and the population.
subjects who were not distracted. The null hypothesis ESs vary according to the population being studied.
would be: “There is no difference in the level of pain Researchers must determine the ES for the particular
perceived by the treatment group receiving distraction relationship or effect being studied in a selected popu-
than the comparison group receiving no distraction.” lation. The most desirable source of this information
If this were so, you would say that the effect of distrac- is evidence from previous studies (Aberson, 2010;
tion on the perception of pain was zero, and the null Melnyk & Fineout-Overholt, 2011). The correlation
hypothesis would be accepted. In another study, you value (r) is equal to the ES for the relationship between
might be interested in using the Pearson product two variables. For example, if depression is correlated
moment correlation r to examine the relationship with anxiety at r = 0.45, then the ES = r = 0.45, a
between coping and anxiety. Your null hypothesis is medium ES.
that the population r would be zero, or coping is not
related to anxiety (Cohen, 1988). ES formula for relationships = r
In a study, it is easier to detect large differences
between groups than to detect small differences. Example: ES = r = 0.45
Strong relationships between variables in a study are
easier to detect than weak relationships. Thus, smaller In published studies with treatments, means and
samples can detect large ESs; smaller ESs require standard deviations can be used to calculate the ES
larger samples. ESs can be positive or negative because (Grove, 2007). For example, if the mean weight loss
variables are positively and negatively correlated. A for the treatment or intervention group is 5 pounds per
negative ES is calculated if a treatment causes a month with a standard deviation (SD) = 4.5, and the
decrease in the study mean, such as an exercise mean weight loss of the control or comparison group
program that decreases the weight of subjects. Broadly is 1 pound per month with SD = 6.5, you can calculate
speaking, the definitions for ES strengths might be as the ES, which is usually expressed as d.
follows:
Small ES would be <0.3 or <−0.3 ES formula for group differences = d = mean of
Medium ES would be about 0.3 to 0.5 or −0.3 to the treatment group - mean of the control group
−0.5 ÷ standard deviation of control group
Large ES would be >0.5 or >−0.5
These broad ranges are provided because the ES Example: ES = d = 5 − 1 ÷ 6.5 = 4 ÷ 6.5 = 0.615 = 0.62
definitions of small, medium, and large vary based on
the analysis being conducted. For example, the ESs This calculation can be used only as an estimate of
for comparing two means, such as the treatment group ES for the study. If the researcher changes the mea-
mean with the comparison group mean (expressed as surement method used, the design of the study, or the
d), are small = 0.2 or −0.2, medium = 0.5 or −0.5, and population being studied, the ES will be altered. When
large = 0.8 or −0.8. The ESs for relationships (expressed estimating ES based on previous studies, you might
as r) might be defined as small = 0.1 or −0.1, medium note the ESs vary from 0.33 to 0.45; it is best to choose
= 0.3 or −0.3, and large = 0.5 or −0.5 (Aberson, 2010; the lower ES of 0.33 to calculate a sample size for a
Cohen, 1988). study. The best estimate of a population parameter of
CHAPTER 15  Sampling 369

ES is obtained from a meta-analysis in which an esti- symptom distress at 72 hours and 1 week postsurgery
mated population ES is calculated through the use of and significantly better overall physical and mental
statistical values from all studies included in the analy- health at 1 week postsurgery than those who received
sis (Aberson, 2010; Cohen, 1988). usual practice.” The significant results indicate the
If few relevant studies have been conducted in the study had an adequate sample size to determine dif-
area of interest, a small pilot study can be performed, ferences between the intervention or experimental
and data analysis results can be used to calculate the group and usual practice or comparison group. If the
ES. If pilot studies are not feasible, dummy power study findings had been nonsignificant, the research-
table analysis can be used to calculate the smallest ers would have needed to conduct a power analysis
ES with clinical or theoretical value. Yarandi (1991) to determine the power achieved in the study.
described the process of calculating a dummy power
table. If all else fails, ES can be estimated as small, Type of Study
medium, or large. Numerical values would be assigned Descriptive case studies tend to use small samples.
to these estimates and the power analysis performed. Groups are not compared, and problems related to
Cohen (1988) and Aberson (2010) indicated the sampling error and generalization have little relevance
numerical values for small, medium, and large effects for such studies. A small sample size may better serve
on the basis of specific statistical procedures. In new the researcher who is interested in examining a
areas of research, ESs for studies are usually set as situation in depth from various perspectives. Other
small (<0.3) (Aberson, 2010). descriptive studies, particularly studies using survey
Jones, Duffy, and Flanagan (2011) conducted a ran- questionnaires, and correlational studies often require
domized clinical trial to test the efficacy of a nurse- large samples. In these studies, multiple variables may
coached telephone intervention on the distress be examined, and extraneous variables are likely to
symptoms and functional health status of ambulatory affect subject responses to the variables under study.
arthroscopic surgery patients. These researchers con- Statistical comparisons are often made among mul-
ducted a power analysis to identify the sample size for tiple subgroups in the sample, requiring that an ade-
their study, and it is described in the following excerpt. quate sample be available for each subgroup being
analyzed. In addition, subjects are likely to be hetero-
geneous in terms of demographic variables, and mea-
“The inclusion criteria were as follows: adults (18 surement tools are sometimes not adequately refined.
years or older) who were able to read and write Although target populations may have been identified,
English, would undergo ambulatory arthroscopic sampling frames may be unavailable, and parameters
surgery under general anesthesia, had telephone have not usually been well defined by previous studies.
access at home, and were discharged home on the All of these factors decrease the power of the study
day of surgery [target population]. According to and require increases in sample size (Aberson, 2010;
power calculations, a sample size of 102 participants Kraemer & Thiemann, 1987).
would assure a power >.80, given a significance level In the past, quasi-experimental and experimental
[alpha] of .05, three measurement times, a minimum studies often used smaller samples than descriptive
correlation of repeated measure of .30, and a low to and correlational studies. As control in the study
moderate effect size (d = .75).” (Jones et al., 2011, increases, the sample size can decrease and still
p. 94) approximate the population. Instruments in these
studies tend to be refined, improving precision.
However, sample size must be sufficient to achieve an
Jones et al. (2011) clearly identified their target acceptable level of power (0.8) and reduce the risk of
population and the process for determining their a type II error (indicating the study findings are non-
sample size using power analysis. The standard significant, when they are really significant) (Aberson,
power of 0.80 or 80% was used, and alpha was set at 2010; Kraemer & Thiemann, 1987).
0.05, which is common in nursing studies. The focus The study design influences power, but the design
of the study was determining differences between the with the greatest power may not always be the most
treatment and comparison groups, so the ES was valid design to use. The experimental design with
expressed as d = 0.75, which is a moderate ES for the greatest power is the pretest-posttest design with
examining differences between groups (see previous a historical control or comparison group. However,
discussion of ESs). Jones et al. (2011, p. 92) found this design may have questionable validity because
the “intervention participants had significantly less of the historical control group. Can the researcher
370 UNIT TWO  The Research Process

demonstrate that the historical control group is com- the analysis plan (just to be on the safe side) can
parable to the experimental group? The repeated mea- increase the sample size by a factor of 5 to 10 if the
sures design increases power if the trait being assessed selected variables are uncorrelated with the dependent
is relatively stable over time. Designs that use block- variable. In this case, instead of a sample of 50, you
ing or stratification usually require an increase in the may need a sample of 250 to 500 if you plan to use
total sample size. The sample size increases in propor- the variables in the statistical analyses. (Using them
tion to the number of cells included in the data analy- only to describe the sample does not cause a problem
sis. Designs that use matched pairs of subjects have in terms of power.) If the variables are highly corre-
greater power and require a smaller sample (see lated with the dependent variable, however, the effect
Chapter 11 for a discussion of these designs). The size will increase, and the sample size can be reduced.
higher the degree of correlation between subjects on Variables included in the data analysis must be
the variable on which the subjects are matched, the carefully selected. They should be essential to the
greater the power (Kraemer & Thiemann, 1987). research purpose or should have a documented strong
Kraemer and Thiemann (1987) classified studies relationship with the dependent variable (Kraemer
as exploratory or confirmatory. According to their & Thiemann, 1987). Sometimes researchers have
approach, confirmatory studies should be conducted obtained sufficient sample size for the primary analy-
only after a large body of knowledge has been ses but failed to plan for analyses involving subgroups,
gathered through exploratory studies. Confirmatory such as analyzing the data by age categories or by
studies are expected to have large samples and to use ethnic groups, which require a larger sample size. A
random sampling techniques. These expectations are larger sample size is also needed if multiple dependent
lessened for exploratory studies. Exploratory studies variables have been included.
are not intended for generalization to large popula-
tions. They are designed to increase the knowledge of Measurement Sensitivity
the field of study. For example, pilot or preliminary Well-developed instruments measure phenomena with
studies to test a methodology or provide estimates of precision. For example, a thermometer measures body
an ES are often conducted before a larger study. In temperature precisely. Instruments measuring psycho-
other studies, the variables, not the subjects, are the social variables tend to be less precise. However, a
primary area of concern. Several studies may examine scale with strong reliability and validity tends to
the same variables using different populations. In measure more precisely than an instrument that is less
these types of studies, the specific population used well developed. Variance tends to be higher in a less
may be incidental. Data from these studies may be well-developed tool than in one that is well developed.
used to define population parameters. This informa- An instrument with a smaller variance is preferred
tion can be used to conduct confirmatory studies using because the power of a test always decreases when
large, randomly selected samples. within-group variance increases (Kraemer & Thie-
Confirmatory studies, such as studies testing the mann, 1987). If you were measuring anxiety and the
effects of nursing interventions on patient outcomes actual anxiety score for several subjects was 80, the
or studies testing the fit of a theoretical model, require subjects’ scores on a less well-developed scale might
large sample sizes. Clinical trials are being conducted range from 70 to 90, whereas a well-developed scale
in nursing for these purposes. The power of these would tend to show a score closer to the actual score
large, complex studies must be carefully analyzed of 80 for each subject. As variance in instrument
(Leidy & Weissfeld, 1991). For the large sample sizes scores increases, the sample size needed to gain an
to be obtained, subjects are acquired in numerous accurate understanding of the phenomenon under
clinical settings, sometimes in different parts of the study increases.
United States. Kraemer and Thiemann (1987) believed The range of measured values influences power.
that these studies should not be performed until exten- For example, a variable might be measured in 10
sive information is available from exploratory studies. equally spaced values, ranging from 0 to 9. ESs vary
This information should include meta-analysis and the according to how near the value is to the population
definition of a population ES. mean. If the mean value is 5, ESs are much larger in
the extreme values and lower for values near the mean.
Number of Variables If you decided to use only subjects with values of 0
As the number of variables under study grows, the and 9, the ES would be large, and the sample could be
needed sample size may also increase. Adding vari- small. The credibility of the study might be question-
ables such as age, gender, ethnicity, and education to able, however, because the values of most individuals
CHAPTER 15  Sampling 371

would not be 0 or 9 but rather would tend to be in the the categories should be limited to those essential to
middle range of values. If you decided to include the study.
subjects who have values in the range of 3 to 6,
excluding the extreme scores, the ES would be small,
and you would require a much larger sample. The Sample Size in
wider the range of values sampled, the larger the ES
(Kraemer & Thiemann, 1987). If you had a heteroge- Qualitative Research
neous group of study participants, you would expect In quantitative research, the sample size must be large
them to have a wide range of scores on a depression enough to describe variables, identify relationships
scale, which would increase the ES. A strong measure- among variables, or determine differences between
ment method has validity and reliability and measures groups. However, in qualitative research, the focus is
variables at the interval or ratio level. The stronger the on the quality of information obtained from the person,
measurement methods used in a study, the smaller the situation, event, or documents sampled versus the size
sample that is needed to identify significant relation- of the sample (Marshall & Rossman, 2011; Munhall,
ships among variables and differences between groups. 2012; Patton, 2002; Sandelowski, 1995). The sample
size and sampling plan are determined by the purpose
Data Analysis Techniques and philosophical basis of the study. The sample size
Data analysis techniques vary in their ability to detect required is determined by the depth of information
differences in the data. Statisticians refer to this as the needed to gain insight into a phenomenon, explore
power of the statistical analysis. For your data analy- and describe a concept, describe a cultural element,
sis, choose the most powerful statistical test appropri- develop a theory, or describe a historical event. The
ate to the data. Overall, parametric statistical analyses sample size can be too small when the data collected
are more powerful than nonparametric techniques in lack adequate depth or richness. An inadequate sample
detecting differences and should be used if the data size can reduce the quality and credibility of the
meet criteria for parametric analysis. However, in research findings. Many qualitative researchers use
many cases, nonparametric techniques are more purposive or purposeful sampling methods to select
powerful if your data do not meet the assumptions the specific participants, events, or situations that they
of parametric techniques. Parametric techniques vary believe would provide them the rich data needed to
widely in their capacity to distinguish fine differences gain insights and discover new meaning in an area of
and relationships in the data. Parametric and nonpara- study (Sandelowski, 2000).
metric analyses are discussed in Chapter 21. The adequacy of the sample size in a study should
There is also an interaction between the measure- be justified by the researchers. Often the number of
ment sensitivity and the power of the data analysis participants in a qualitative study is adequate when
technique. The power of the analysis technique saturation of information is achieved in the study area
increases as precision in measurement increases. (Fawcett & Garity, 2009). Saturation of data occurs
Larger samples must be used when the power of the when additional sampling provides no new informa-
planned statistical analysis is low. tion, only redundancy of previously collected data.
For some statistical procedures, such as the t-test Important factors that must be considered in determin-
and analysis of variance (ANOVA), having equal ing sample size to achieve saturation of data are (1)
group sizes increases power because the effect size scope of the study, (2) nature of the topic, (3) quality
is maximized. The more unequal the group sizes of the data, and (4) study design (Marshall & Rossman,
are, the smaller the effect size. In unequal groups, 2011; Morse, 2000; Munhall, 2012; Patton, 2002).
the total sample size must be larger (Kraemer &
Thiemann, 1987). Scope of the Study
The chi-square (χ2) test is the weakest of the sta- If the scope of a study is broad, researchers need
tistical tests and requires very large sample sizes to extensive data to address the study purpose, and it
achieve acceptable levels of power. As the number of takes longer to reach data saturation. A study with a
categories (cells in the chi-square analysis) in a study purpose that has a broad scope requires more sampling
grows, the sample size needed increases. Also, if there of participants, events, or documents than a study with
are small numbers in some of the categories, you must a narrow scope (Morse, 2000). A study that has a clear
increase the sample size. Kraemer and Thiemann focus and provides focused data collection usually has
(1987) recommended that the chi-square test be used richer, more credible findings. The depth of a study’s
only when no other options are available. In addition, scope and its clarity of focus influence the number
372 UNIT TWO  The Research Process

of participants needed for the study sample. For with a single study participant. In critically appraising
example, fewer participants would be needed to a qualitative study, determine if the sample size is
describe the phenomenon of chronic pain in adults adequate for the design of the study.
with rheumatoid arthritis than would be needed to Beaulieu et al. (2011) provided a detailed discus-
describe the phenomenon of chronic pain in elderly sion of how they determined their final sample size.
adults. A study of chronic pain experienced by elderly This qualitative study conducted with grounded theory
adults has a much broader focus, with less clarity, than methodology was introduced earlier in the discussion
a study of chronic pain experienced by adults with a of theoretical sampling. The study focused on devel-
specific medical diagnosis of rheumatoid arthritis. oping a theory about decision making of young adult
couples regarding their use of ECPs. The sample was
Nature of the Topic obtained with convenience, snowball, and theoretical
If the topic of your study is clear and the participants sampling and resulted in a sample size of 22 couples.
can easily discuss it, fewer individuals are needed to The following study excerpt provides the researchers’
obtain the essential data. If the topic is difficult to rationale for the final sample size of their study.
define and awkward for people to discuss, you will
probably need a larger number of participants or infor-
mants to saturate the data (Morse, 2000; Patton, 2002). “A convenience sample was recruited via public
For example, a phenomenological study of the experi- notices and snowball sampling.… All interested
ence of an adult living with a history of child sexual young women initiated the first contact with the
abuse is a sensitive, complex topic to investigate. This researcher by e-mail or telephone.… At the first
type of topic would probably require a greater number meeting, which also included partners, study proce-
of participants and increased interview time to collect dures were reviewed with participants, after which
the essential data. written consent and demographic information were
obtained.…
Quality of the Data Analysis began simultaneously with data collection
The quality of information obtained from an interview, as dictated by the tenets of grounded theory.… As
observation, or document review influences the sample these processes progressed, axial coding was per-
size. The higher the quality and richness of the data, formed to identify core categories and their relation-
the fewer the research participants needed to saturate ships. As new categories emerged, the original
data in the area of study. Quality data are best obtained interview guide was revised and additional couples
from articulate, well-informed, and communicative were recruited to allow for theoretical sampling, that
participants. These participants are able to share more is sampling specifically to fill in theoretical gaps,
rich data in a clear and concise manner. In addition, strengthen categories and their relationships, and
participants who have more time to be interviewed verify or challenge emerging conceptualizations
usually provide data with greater depth and breadth. (Strauss & Corbin, 1998) and focused coding
Qualitative studies require that you critically appraise (Charmaz, 2006). Member checking occurred
the quality of the richness of communication elicited throughout the analysis by sharing the preliminary
from the participants, the degree of access provided to findings with subsequent couples to meet the require-
events in a culture, or the number and quality of docu- ments of confirmability of developing conceptualiza-
ments studied. These characteristics directly affect the tions (Denzin & Lincoln, 2000). Saturation—when no
richness of the data collected and influence the sample new categories emerge (Strauss & Corbin, 1998)—
size needed to achieve quality study findings (Fawcett was reached after interviewing 18 couples, but five
& Garity, 2009; Munhall, 2012). more couples were included to ensure comprehen-
sive analysis as well as theoretical verification. As the
Study Design analysis continued through the processes of grounded
Some studies are designed to increase the number theorizing, salient categories consistent with contem-
of interviews with participants. The more interviews porary grounded theory principles (Clarke, 2005)
conducted with a participant, the greater the quality of were constructed to characterize the experience of
the data collected. For example, a study design that young couples regarding ECPs. A theoretical model
includes an interview both before and after an event was developed to describe and explain the process of
would produce more data than a single interview. emergency contraceptive decision making in young
Designs that involve interviewing a family or a group couples.” (Beaulieu et al., 2011, p. 43)
of individuals produce more data than an interview
CHAPTER 15  Sampling 373

The study by Beaulieu et al. (2011) has many muscle strength, balance, and falls of breast cancer
strengths in the area of sampling, including quality survivors (BCSs) with bone loss. These researchers
sampling methods (convenience, snowball, and used both partially controlled and natural settings in
theoretical), strong sample size (N = 22 couples), their studies, which are described in the following
and conscientious participants. The investigators excerpt.
provide extensive details of the theoretical sampling
conducted to ensure saturation was achieved with no
new categories emerging. The saturation occurred “This was a multisite, randomized controlled trial of
after 18 couples, but the researchers interviewed 5 a 24-month multi-component intervention with
more couples to ensure depth and breadth in the data follow-up data collection at 36 months.…
for theoretical verification. Beaulieu et al. (2011)
described how they were able to develop successfully “Setting
a theoretical model of experiences of young couples “Exercise activities were performed in participants’
regarding use of ECPs. The study would have been homes [natural setting] or at investigator-approved
strengthened by knowing how many study participants fitness centers [partially controlled setting], and
were obtained by each of the sampling methods (con- Biodex and balance testing were performed by physi-
venience, snowball, and theoretical). Also the research- cal therapists at hospitals or rehabilitation centers
ers mentioned saturation was obtained with 18 couples [partially controlled settings] at each of the four
but 5 more couples were included or N = 23 but the sites.” (Twiss et al., 2009, p. 22)
sample size identified was N = 22. A rationale is needed
for the attrition of one of the couples from the study.
Twiss et al. (2009) partially controlled the fitness
centers by approving them but did not try to control
Research Settings the specific activities of each center. The researchers
The setting is the location where a study is conducted. also ensured that the measurements were taken in a
There are three common settings for conducting precise and accurate way by an expert (physical thera-
nursing research: natural, partially controlled, and pist) in partially controlled settings of hospitals and
highly controlled. A natural setting, or field setting, rehabilitation centers. The natural and partially con-
is an uncontrolled, real-life situation or environment trolled settings seemed appropriate in this study for
(Kerlinger & Lee, 2000). Conducting a study in a the implementation of the ST intervention and for the
natural setting means that the researcher does not precise and accurate measurement of the outcome
manipulate or change the environment for the study. variables.
Descriptive and correlational quantitative studies and A highly controlled setting is an artificially con-
qualitative studies are often conducted in natural set- structed environment developed for the sole purpose
tings. For example, in the study by Beaulieu et al. of conducting research. Laboratories, research or
(2011) discussed previously, the investigators made no experimental centers, and test units in hospitals or
attempt to manipulate the settings when they con- other healthcare agencies are highly controlled set-
ducted the interviews for their qualitative study. All tings where experimental studies are often conducted.
the data were conducted in natural settings as the This type of setting reduces the influence of extrane-
interviews of the couples took place in various public ous variables, which enables the researcher to examine
settings or in their homes. The intent of the study was accurately the effect of one variable on another. Highly
to develop a theory of the decision making of young controlled settings are commonly used to conduct
adult couples regarding ECP use in a natural experimental research. Sharma, Ryals, Gajewski, and
environment. Wright (2010) conducted an experimental study
A partially controlled setting is an environment to examine the effects of a moderate-intensity
that the researcher manipulates or modifies in some aerobic exercise program on painlike behavior and
way. An increasing number of nursing studies, usually neurotrophin-3 (NT-3) in female mice. The rationale
correlational, quasi-experimental, and experimental for conducting this study was that the literature and
studies, are being conducted in partially controlled clinical practice supported the use of aerobic exercise
settings. In a study that was introduced earlier in the in reducing pain and improving function in people
discussion of sampling criteria, Twiss et al. (2009) with chronic pain, but the molecular basis for these
conducted a quasi-experimental study to determine the positive actions was poorly understood. This study
effects of a strength training (ST) intervention on was conducted in a laboratory using a selected type of
374 UNIT TWO  The Research Process

mouse, and the setting is described in the following setting. Special attention must focus on recruiting sub-
excerpt. jects who tend to be underrepresented in studies, such
as minorities, women, children, and elderly adults
(Fulmer, 2001; Gul & Ali, 2010; Hendrickson, 2007;
“All experiments were approved by the Institutional Hines-Martin, Speck, Stetson, & Looney, 2009). The
Animal Care and Use Committee of the University of sampling plan, initiated at the beginning of data col-
Kansas Medical Center and adhered to the universi- lection, is almost always more difficult than expected.
ty’s animal care guidelines. Forty CF-1 female mice In addition to subject recruitment, retaining acquired
(weight = 25 g) were used to examine the effects of subjects is critical to achieve an acceptable sample
moderately intense exercise on primary (muscular) size and requires researchers to consider the effects of
and secondary (cutaneous) hyperalgesia and NT-3 the data collection strategies on subject attrition.
synthesis. Because women develop wide-spread pain Retaining research participants involves the partici-
syndromes at a greater rate than age-matched men, pants or subjects completing the required behaviors of
hyperalgesia was induced in female mice. The mice a study to its conclusion. The problems with retaining
were exposed to 12-hour light/dark cycle and had participants increase as the data collection period
access to food and water ad libitum.… lengthens. Some researchers never obtain their planned
Initially, the mice were randomly assigned to either sample size because of the problems they encounter
the acidic saline injection (experimental) group or the as they try to recruit and retain subjects. These
normal saline injection (placebo) group. Five days researchers often are forced to complete their study
after inducing hyperalgesia with acidic saline injection with a smaller sample size, which could decrease the
into the right limb, the animals were further assigned power of the study and potentially produce nonsignifi-
to either exercise or no-exercise group.… Two cant results (Aberson, 2010). With an increasing
6-lane, motorized treadmills were used for the exer- number of studies being conducted in health care,
cise training.” (Sharma et al., 2010, pp. 715-716) recruiting and retaining subjects have become more
complex issues for researchers to manage (Gul & Ali,
2010; McGregor, Parker, LeBlanc, & King, 2010).
Sharma et al. (2010) conducted their study in a
highly controlled laboratory setting in terms of the Recruiting Research Participants
housing and feeding of the mice, the light and tem- The effective recruitment of subjects is crucial to the
perature of the environment, implementation of the success of a study. A few studies examining the effec-
treatments, and the measurements of the dependent tiveness of various strategies of participant recruitment
variables. Only with animals could this type of setting and retention have appeared in the literature (David-
control be achieved in conducting this study. This type son, Cronk, Harrar, Catley, & Good, 2010; Hines-
of highly controlled setting removes the effect of Martin et al., 2009; Whitebird, Bliss, Savik, Lowry, &
numerous extraneous variables, so the effects of the Jung, 2010). However, most of the information avail-
independent variables on the dependent variables can able to guide researchers comes from the personal
be clearly determined. However, because this research experiences of skilled researchers, some of whom have
was conducted on animals, the findings cannot be gen- published their ideas (Gul & Ali, 2010; McGregor
eralized to humans, and additional research is needed et al., 2010). Some of the positive and negative factors
to determine the molecular basis of the influence of that influence a subject’s decision to participate in a
aerobic exercise on pain and functioning in humans. study are (1) the attitudes and ethics of the researchers,
(2) the subject’s need for a treatment, (3) the subject’s
interest in the study topic, (4) financial compensation,
Recruiting and Retaining (5) fear of the unknown, (6) time and travel con-
straints, (7) language barriers, and (8) the nature of the
Research Participants informed consent (Gul & Ali, 2010; Hine-Martin et al.,
After a research team makes a decision about the size 2009; Madsen et al., 2002; Papadopoulos & Lees,
of the sample, the next step is to develop a plan for 2002; Sullivan-Bolyai et al., 2007).
recruiting research participants, which involves The researcher’s initial communication with a
identifying, accessing, and communicating with potential subject usually strongly affects the subject’s
potential study participants who are representative of decision about participating in the study. Therefore,
the target population. Recruitment strategies differ, the approach must be pleasant, positive, informative,
depending on the type of study, population, and culturally sensitive, and nonaggressive. The researcher
CHAPTER 15  Sampling 375

needs to explain the importance of the study and studied the recruitment and retention process for inter-
clarify exactly what the subject will be asked to do, vention research conducted with a sample of primarily
how much of the subject’s time will be involved, and low-income African American women. Their complex,
what the duration of the study will be. Research par- multistage recruitment strategies are introduced in the
ticipants are valuable resources, and the researcher following excerpt.
must communicate this value to the potential subject.
High-pressure techniques, such as insisting that the
subject make an instant decision to participate in a “Phase 1 involved the development of a recruitment
study, usually lead to resistance and a higher rate of team, composed of a co-investigator, in addition to
refusals. If the study involves minorities, researchers an African American nurse familiar with the target
must be culturally competent or knowledgeable and population, and two women who were long-standing
skilled in relating to the particular ethnic group being community members.
studied (Hines-Martin et al., 2009; Papadopoulos & Phase 1 activities began with periods of observa-
Lees, 2002). If the researcher is not of the same culture tion in the community setting and discussions with
as the potential subjects, he or she may employ a data community center personnel to improve the investi-
collector who is of the same culture. Hendrickson gators’ understanding of who used the community
(2007) used a video for recruiting Hispanic women for center services and when. It became increasingly
her study, and she provided all the details related to clear that only two of the three communities felt a
the study in the subjects’ own language in the video. connection with or used the community center rou-
This approach greatly improved the subjects’ under- tinely.… Therefore, the recruitment team, with the
standing of the study and their desire to participate. assistance from nursing graduate students, walked
If a potential subject refuses to participate in a every block of the two relevant communities at dif-
study, you must accept the refusal gracefully—in ferent times of the day and different days of the week
terms of body language as well as words. Your actions to better understand when and where community
can influence the decision of other potential subjects women could be found in their daily lives.… Com-
who observe or hear about the encounter. Studies in munity women were informed of new initiatives at
which a high proportion of individuals refuse to par- the center and were provided with recruitment flyers
ticipate have a serious validity problem. The sample including pictures of the research team. The recruit-
is likely to be biased because often only a certain type ment team then undertook usual recruitment activi-
of individual has agreed to participate. You should ties, such as meeting with women’s groups in the
keep records of the numbers of persons who refuse communities and recruitment at community fairs.”
and, if possible, their reasons for refusal. With this (Hines-Martin et al., 2009, pp. 665-666)
information, you can include the refusal rate in the
published research report with the reasons for refusal.
It would also be helpful if you could determine if the If researchers use data collectors in their studies,
potential subjects who refused to participate differed they need to verify the data collectors are following
from the individuals who agreed to participate in the the sampling plan, especially in random samples.
study. This information will help you to determine the When the data collectors encounter difficult subjects
representativeness of your sample (Thompson, 2002). or are unable to make contact easily, they may simply
Recruiting minority subjects for a study can be shift to the next person without informing the principal
particularly problematic. Minority individuals may investigator. This behavior could violate the rules of
be difficult to locate and are often reluctant to partici- random sampling and bias the sample. If data collec-
pate in studies because of feelings of being “used” tors do not understand, or do not believe in, the impor-
while receiving no personal benefit from their involve- tance of randomization, their decisions and actions can
ment or because of their distrust of the medical com- undermine the intent of the sampling plan. Thus, data
munity. Effective strategies for recruiting minorities collectors must be carefully selected and thoroughly
include developing partnerships with target groups, trained. A plan for the supervision and follow-up of
community leaders, and potential participants in the data collectors to increase their accountability should
community; using active face-to-face recruitment in be developed (Thompson, 2002).
nonthreatening settings; and using appropriate lan- If you conduct a survey study, you may never
guage to communicate clearly the purpose, benefits, have personal contact with the subjects. To recruit
and risks of the study (Alvarez, Vasquez, Mayorga, such subjects, you must rely on the use of attention-
Feaster, & Mitrani, 2006). Hines-Martin et al. (2009) getting techniques, persuasively written material, and
376 UNIT TWO  The Research Process

strategies for following up on individuals who do not emailed or mailed, precise plans need to be made for
respond to the initial written or email communication. monitoring the return of each questionnaire. A bar
The strategies need to be appropriate to the potential graph could be developed to record the return of each
subjects; mailed surveys are probably still the best questionnaire as a means of suggesting when the
way to obtain information from elderly adults. Because follow-up mailing or emailing should occur. The
of the serious problems of low response rates in survey cumulative number and percentage of responses would
studies, using strategies to increase the response rate be logged on the graph to reflect the overall data col-
is critical. For instance, we have received a teabag or lection process. The data from emailed questionnaires
packet of instant coffee with a questionnaire, accom- can be immediately analyzed so that researchers
panied by a recommendation in the letter to have a cup can easily keep track of the numbers of participants
of tea or coffee “on” the researcher while we complete responding. When the daily or weekly responses
the questionnaire. Creativity is required in the use of decline, a follow-up email or first-class letter could
such strategies because they tend to lose their effect be sent encouraging individuals to complete the ques-
on groups who receive questionnaires frequently. In tionnaire. Study participants and questionnaires are
some cases, small amounts of money ($1.00 to $5.00) assigned the same code numbers, and nonrespondents
are enclosed with the letter, which may suggest that are identified by checking the list of code numbers of
the recipient buy a soft drink or that the money is a unreturned questionnaires. A third follow-up question-
small offering for completing the questionnaire. This naire with a further modified cover letter could be
strategy imposes some sense of obligation on the emailed or mailed to increase the return rate for the
recipient to complete the questionnaire, but it is not questionnaires.
thought to be coercive. Also, you should plan emailing The factors involved in the decision of whether to
or mailings to avoid holidays or times of the year respond to a questionnaire are not well understood.
when activities are high for potential subjects, possi- One factor is the time required to respond; this includes
bly reducing the return rate. the time needed to orient to the directions and the
Researchers frequently use the Internet to recruit emotional energy necessary to deal with the threats
subjects and to collect survey data. This method makes and anxieties generated by the questions. There is also
it easier for you to contact potential subjects and for a cognitive demand for thinking. Subjects seem to
the subjects to provide the requested data. However, make a judgment about the relevance of the research
an increased number of surveys are being sent by topic and the potential for personal application of find-
the Internet, which can decrease the response rate of ings. Previous experience with questionnaires is also
potential subjects who are frequently surveyed. In a deciding factor.
studies with surveys, the letter emailed to potential Traditionally, subjects for physiological nursing
subjects must be carefully composed. It may be your studies have been sought in the hospital setting.
only chance to persuade the subject to invest the time However, access to these subjects is becoming more
needed to complete the questionnaire. You must sell difficult—in part because of the larger numbers of
the reader on the importance of both your study and nurses and other healthcare professionals now conduct-
his or her response. The tone of your letter will be the ing research. The largest involvement of research sub-
potential subject’s only image of you as a person; yet, jects within a healthcare agency usually occurs with
for many subjects, their response to the perception of medical research and mainly with clinical trials that
you as a person most influences their decision about include large samples (Gul & Ali, 2010). Nurse
completing the questionnaire. Seek examples of letters researchers are recruiting subjects from a variety of
sent by researchers who have had high response rates, clinical settings. Whitebird et al. (2010) identified three
and save letters you received to which you responded successful recruitment methods to use in healthcare
positively. You also might pilot-test your letter on agencies: (1) identifying potential participants using
potential research participants who can give you feed- administrative databases, (2) obtaining referrals of
back about their reactions to the letter’s tone. potential participants through healthcare providers and
The use of follow-up emails, letters, or cards has other sources, and (3) approaching directly a known
been repeatedly shown to raise response rates to potential subject. An initial phase of recruitment may
surveys. The timing is important. If too long a period involve obtaining community and institutional support
has lapsed, the potential subject may have deleted the for the study. Support from other healthcare profession-
questionnaire from his or her email box or discarded als, such as nurses and physicians, and clinical agency
the mailed copy. However, sending the follow-up too staff is usually crucial to the successful recruitment of
soon could be offensive. Before the questionnaires are research participants.
CHAPTER 15  Sampling 377

Recruitment of subjects for clinical trials requires posters in public places, such as supermarkets, drug-
a different set of strategies because the recruitment stores, and public laundries. With permission, you can
may be occurring simultaneously in several sites set up tables in shopping malls with a member of the
(perhaps in different cities). Many of these studies research team present to recruit subjects. Plan for pos-
never achieve their planned sample size. The number sible challenges in recruitment and include multiple
of subjects meeting the sampling criteria who are methods and locations in your application for human
available in the selected clinical sites may not be as subject approval for your study. Otherwise, you would
large as anticipated. Researchers must often screen need to submit a modified protocol to the institutional
twice as many patients as are required for the study to review board when you add a method or site for
obtain a sufficient sample size. Screening logs must recruitment.
be kept during the recruiting period to record data on Davidson et al. (2010) used multiple strategies to
patients who met the criteria but were not entered into recruit and retain college smokers in a cessation clini-
the study. Researchers commonly underestimate the cal trial. Their four-phase recruitment process is pre-
amount of time required to recruit subjects for a clini- sented in the following study excerpt.
cal trial. In addition to defining the number of subjects
and the time set aside for recruitment, it may be
“Participants in this study were members of Greek
helpful to develop short-term or interim recruitment
fraternities and sororities enrolled at a large Midwest-
goals designed to maintain a constant rate of patient
ern university, and data were collected from 2006 to
entry (Gul & Ali, 2010). Hellard, Sinclair, Forbes,
2009.… The clinical trial involved testing a four-
and Fairley (2001) studied methods to improve the
session, MI [motivational interviewing] counseling
recruitment and retention of subjects in clinical trials
intervention on smoking cessation. Participants were
and found that the four most important strategies were
recruited from college fraternity and sorority chap-
to (1) use nonaggressive recruitment methods, (2)
ters regardless of their interest in quitting smoking.
maintain regular contact with the participants, (3)
Recruitment involved four phases. First, out of 41
ensure that the participants are kept well informed of
fraternity and sorority chapters from a large Midwest-
the progress of the study, and (4) provide constant
ern university, the 30 chapters with the larger mem-
encouragement to subjects to continue participation.
berships were invited to participate. Second, within
Sullivan-Bolyai et al. (2007) identified the barriers
these invited chapters, individuals were recruited to
and strategies to improve the recruitment of study
participate in an initial, 5-minute, 8-item screening
participants from clinical settings. Table 15-3 identi-
survey (i.e., Screener).
fies these common barriers to research participant
Third, individual members of these 30 chapters
recruitment and provides possible strategies to manage
who met the inclusion criteria based on the Screener
them.
and who were interested in participating in the study
Studies may also benefit from the endorsement of
were recruited to participate in a more extensive
community leaders, such as city officials; key civic
(30-45 minute) computerized baseline assessment
leaders; and leaders of social, educational, religious, or
approximately 1-4 days following the Screener.…
labor groups. In some cases, these groups may be
Fourthly, eligible individuals who completed the base-
involved in planning the study, leading to a sense of
line assessment were recruited for enrollment in the
community ownership of the project. Community
clinical trial.” (Davidson et al., 2010, pp. 146-147)
groups may also help researchers to recruit subjects for
the study. Subjects who meet the sampling criteria
sometimes are found in the groups assisting with the The recruitment for this smoking cessation clinical
study. Endorsement may involve letters of support and, trial was accomplished by using the Greek chapters.
in some cases, funding. These activities can add legiti- Davidson et al. (2010) developed relationships with
macy to the study and make involvement in the study these Greek organizations by meeting with leaders
more attractive to potential subjects (Alvarez et al., and members and attending special events. To accom-
2006; Davidson et al., 2010; Hines-Martin et al., 2009). plish phases two and three, the researchers met with
Media support can be helpful in recruiting subjects. the participants at convenient times and in accessible
Researchers can place advertisements in local news- locations. The participants were also provided incen-
papers and church and neighborhood bulletins. Radio tives of food (cookies and pizza), small cash gifts,
stations can make public service announcements. and raffles for iPods. These creative strategies
Members of the research team can speak to groups increased the recruitment and retention of the study
relevant to the study population. Your team can place participants.
378 UNIT TWO  The Research Process

TABLE 15-3  Barriers to Recruitment with Actions and Strategies for Engaging Health Care Providers
in the Referral Process
Barriers and Actions Strategies
HIPAA* Ask Clinicians to distribute letters to potential study participants
Create alternative recruitment methods Obtain institutional review board waiver of authorization requirement for the use
or disclosure of personal health information
Work with clinics to secure a consent that meets HIPAA* regulations and allows
the staff to provide names and contact information of patients with specific
conditions that may be of interest to researchers
Recognize and acknowledge the burden that recruitment places on healthcare
providers
Work burden Provide Salary support
Create compensations Provide educational incentives (e.g., purchase laptop, journals, books, pay for
conference attendance in the field under study) for healthcare providers who
do not normally have access to such opportunities as part of their job
Assess administrative or managerial perceptions of healthcare providers’
recruitment-related responsibilities, and if salary support is given, how that
money will be used
Discuss the designated recruitment tasks and responsibilities with the assigned
staff to determine their perceptions and expectations
Financial disincentives Assess the clinic’s financial situation and determine if it is realistic, pragmatic, or
feasible to use that site, especially if its funding depends on patient numbers
Recognize that patient numbers or productivity Help keep participants linked to the clinical site while they are participating in
may be linked to the clinic’s livelihood the study
Provider competition Develop a research proposal that reflects the clinical site’s philosophical and
policy perspectives and priorities
Create a partnership with healthcare Include healthcare providers in the development of a study
providers involved in recruitment so that
they are rewarded and acknowledged for
their participation in the research process
Hire and pay a clinical staff member to be responsible for introducing the study
to potential participants
Link recruitment activities to nursing clinical ladder or organization values
Maintain open communication between the clinical and research teams regarding
the workings of the study
Provider concerns Assess healthcare providers’ perceptions of research
Demystify research process Encourage healthcare providers to participate in developing the research proposal
Develop a team atmosphere and a spirit of Include healthcare providers in developing study-related manuscripts
“we’re all in this together”
Include healthcare providers in research team meetings at a mutually convenient
time
Express appreciation in an ongoing basis for healthcare providers’ involvement
in recruitment process
Share recruitment status information on a monthly basis with healthcare
providers
Share pilot or feasibility data with healthcare providers to support the study
rationale and choice of specific methods
Desire to protect patients Acknowledge responsibility of healthcare providers to protect patients from harm
Work with healthcare providers to acknowledge Address concerns of healthcare providers by emphasizing the pilot data that
and respect patient decision-making abilities supports the protocol
Encourage healthy partnerships between Model respectful partnerships with study participants
patients and healthcare providers

From Sullivan-Bolyai, S., Bova, C., Deatrick, J. A., Knafl, K., Grey, M., Leung, K., et al. (2007). Barriers and strategies for recruiting study participants in
clinical settings. Western Journal of Nursing Research, 29(4), 498–499.
*HIPAA, Health Insurance Portability and Accountability Act.
CHAPTER 15  Sampling 379

Retaining Subjects the recruitment and retention of research participants


A serious problem in many studies is subject retention, for qualitative studies.
and sometimes participant attrition cannot be avoided. Clinical trials can also require extensive time com-
Subjects move, die, or withdraw from a treatment. If mitments from subjects. Gul and Ali (2010) mentioned
you must collect data at several points over time, the importance of overcoming participant barriers to
subject attrition can become a problem. Subjects who continuing in a study, such as time to complete data
move frequently and subjects without phones pose a collection forms, transportation problems, and con-
particular problem. Numerous strategies have been flicts with work and family commitments. There is no
found to be effective in maintaining the sample. It is formula for compensating study participants, but
a good idea to obtain the names, email addresses, and many studies mention small monetary payments, gifts,
phone numbers (cell and home numbers if possible) or free health or child care. It is important that the
of at least two family members or friends when you incentives used to recruit and retain research partici-
enroll the participant in the study. Ask if the partici- pants be documented in the published study. Com-
pant would agree to give you access to unlisted phone munication is one of the most important facets to
numbers in the event of changes in his or her number. retaining study participants. Davidson et al. (2010),
In some studies, subjects are reimbursed for time whose recruitment strategies were introduced earlier,
and expenses related to participation. A bonus payment describe their success with retention in their smoking
may be included for completing a certain phase of the cessation clinical trial in the following excerpt.
study. Gifts can be used in place of money. Sending
greeting cards for birthdays and holidays helps main-
tain contact. Researchers found that money was more “A very high proportion of participants (89%) com-
effective than gifts in retaining subjects in longitudinal pleted at least one session (90% treatment; 87%
studies. However, some people pointed out the moral comparison). The majority (73%) were retained,
issues related to providing monetary payment to sub- completing three or more sessions (75% treatment;
jects. This strategy can compromise the voluntariness 70% comparison), and over half completed the
of participation in a study and particularly has the maximum of four sessions (63% treatment; 61%
potential of exploiting low-income persons. comparison). At the follow-up assessment occurring
Collecting data takes time. The participant’s time 6 months after the baseline assessment, 79% of the
is valuable and should be used frugally. During data participants (n = 357) were retained (80% treatment;
collection, it is easy to begin taking the participant for 78% comparison).” (Davidson et al., 2010, p. 150)
granted. Taking time for social amenities with partici-
pants may also pay off. However, take care that these
interactions do not influence the data being collected. Research participants who have a personal invest-
Beyond that, nurturing subjects participating in the ment in the study are more likely to complete the
study is critical. In some situations, providing refresh- study. This investment occurs through interactions
ments and pleasant surroundings is helpful. During the with and nurturing by the researcher. A combination
data collection phase, you also may need to nurture of the participant’s personal belief in the significance
others who interact with the participants; these may of the study, the perceived altruistic motives of the
be volunteers, family, staff, students, or other profes- researcher in conducting the study, the ethical actions
sionals. It is important to maintain a pleasant climate of the researcher, and the nurturing support provided
for the data collection process, which pays off in the by the researcher during data collection can greatly
quality of data collected and the retention of subjects diminish subject attrition (Hines-Martin et al., 2009;
(Davidson et al., 2010; Gul & Ali, 2010; Hines-Martin Madsen et al., 2002; McGregor et al., 2010). The
et al., 2009; McGregor et al., 2010). recruitment and retention of subjects will continue to
Qualitative studies and longitudinal studies require be significant challenges for researchers, and creative
extensive time commitment from subjects. They are strategies are needed to manage these challenges.
asked to participate in detailed interviews or to com-
plete numerous forms at various intervals during a
study (Marshall & Rossman, 2011; Munhall, 2012; KEY POINTS
Patton, 2002). Sometimes data are collected with
diaries that require daily entries over a set period of • Sampling involves selecting a group of people,
time. These studies face the greatest risk of participant events, behaviors, or other elements with which to
mortality. Chapters 4 and 12 provide more details on conduct a study. Sampling denotes the process of
380 UNIT TWO  The Research Process

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  http://evolve.elsevier.com/Grove/practice/

16
CHAPTER

Measurement Concepts

M
easurement is the process of assigning methods and valid and reliable scales and question-
numbers to objects, events, or situations in naires is essential in measuring study variables and
accord with some rule (Kaplan, 1963). The outcomes in practice (Bannigan & Watson, 2009;
numbers assigned can indicate numerical values or Bialocerkowski, Klupp, & Bragge, 2010; DeVon,
categories for the objects being measured for research et al., 2007).
or practice. Instrumentation, a component of mea- Researchers need to understand the logic within
surement, is the application of specific rules to develop measurement theory so that they can select and use
a measurement device such as a scale or questionnaire. existing instruments or develop new quality measure-
Quality instruments are essential for obtaining trust- ment methods for their studies. Measurement theory,
worthy data when measuring outcomes for research as with most theories, uses terms with meanings that
and practice (Doran, 2011; Melnyk & Fineout- can be best understood within the context of the
Overhold, 2011; Waltz, Strickland, & Lenz, 2010). theory. The following explanation of the logic of mea-
The rules of measurement were developed so that surement theory includes definitions of directness of
the assigning of values or categories might be done measurement, measurement error, levels of measure-
consistently from one subject (or event) to another and ment, and reference of measurement. The reliability
eventually, if the measurement method is found to be and validity of measurement methods, such as scales
meaningful, from one study to another. The rules of and questionnaires, are detailed. The accuracy, preci-
measurement established for research are similar to sion, and error of physiological measures are described.
the rules of measurement implemented in nursing The chapter concludes with a discussion of sensitivity;
practice. For example, when nurses measure the urine specificity; and likelihood ratios examined to deter-
output from patients, they use an accurate measure- mine the quality of diagnostic tests and instruments
ment device, observe the amount of urine in the device used in healthcare research and practice.
or container in a consistent way, and precisely record
the urine output in the medical record. This practice
promotes accuracy and precision and reduces the Directness of Measurement
amount of error in measuring physiological variables Measurement begins by clarifying the object, charac-
such as urine output. teristic, or element to be measured. Only then can one
When measuring a subjective concept such as pain identify or develop strategies or methods to measure
experienced by a child, researchers and nurses in prac- it. In some cases, identification of the measurement
tice need to use an instrument that captures the pain object and measurement strategies can be objective,
the child is experiencing. A commonly used scale to specific, and straightforward, as when we are measur-
measure a child’s pain is the Wong-Baker FACES Pain ing concrete factors, such as a person’s weight or waist
Rating Scale (Hockenberry & Wilson, 2009). By using circumference; this is referred to as direct measure-
this valid and reliable rating scale to measure the ment. Healthcare technology has made direct mea-
child’s pain, any change in the measured value can be sures of objective elements—such as height, weight,
attributed to a change in the child’s pain rather than temperature, time, space, movement, heart rate, and
measurement error. A copy of the Wong-Baker FACES respiration—familiar to us. Technology is also avail-
Pain Rating Scale is provided in Chapter 17. Selecting able to measure many biological and chemical char-
accurate and precise physiological measurement acteristics, such as laboratory values, pulmonary

382
CHAPTER 16  Measurement Concepts 383

functions, and sleep patterns. Nurses are also experi-


enced in gathering direct measures of demographic A-1
variables, such as age, gender, ethnicity, diagnosis,
marital status, income, and education.
However, in nursing, the characteristic we want to
measure often is an abstract idea or concept, such as
pain, stress, depression, anxiety, caring, or coping. If
the element to be measured is abstract, it is best clari-
fied through a conceptual definition (see Chapter 8).
The conceptual definition can be used to select or
develop appropriate means of measuring the concept.
The instrument or measurement strategy used in the
A
study must match the conceptual definition. An
abstract concept is not measured directly; instead,
indicators or attributes of the concept are used to rep-
resent the abstraction. This is referred to as indirect
measurement. For example, the complex concept of
coping might be defined by the frequency or accuracy Figure 16-1  Measurement error when measuring a concept.
of identifying problems, the creativity in selecting
solutions, and the speed or effectiveness in resolving
the problem. A single measurement strategy rarely, if
ever, can completely measure all aspects of an abstract Types of Measurement Errors
concept. Multi-item scales have been developed to Two types of errors are of concern in measurement:
measure abstract concepts, such as the Spielberger random error and systematic error. To understand
State-Trait Anxiety Inventory developed to measure these types of errors, we must first understand the ele-
individuals’ innate anxiety trait and their anxiety in a ments of a score on an instrument or an observation.
specific situation (Spielberger, Gorsuch, & Lushene, According to measurement theory, there are three
1970). components to a measurement score: true score,
observed score, and error score. The true score (T) is
what we would obtain if there was no error in mea-
Measurement Error surement. Because there is always some measurement
There is no perfect measure. Error is inherent in any error, the true score is never known. The observed
measurement strategy. Measurement error is the dif- score (O) is the measure obtained for a subject using
ference between what exists in reality and what is a selected instrument during a study. The error score
measured by an instrument. Measurement error exists (E) is the amount of random error in the measurement
in both direct and indirect measures and can be random process. The theoretical equation of these three mea-
or systematic. Direct measures, which are considered sures is as follows:
to be highly accurate, are subject to error. For example,
Observed score = true score + random error
the weight scale may not be accurate, laboratory
equipment may be precisely calibrated but may change This equation is a means of conceptualizing random
with use, or the tape measure may not be placed in the error and not a basis for calculating it. Because the
same location or held at the same tension for each true score is never known, the random error is never
measurement. known but only estimated. Theoretically, the smaller
There is also error in indirect measures. Efforts to the error score, the more closely the observed score
measure concepts usually result in measuring only reflects the true score. Therefore, using instruments
part of the concept or measures that identify an aspect that reduce error improves the accuracy of measure-
of the concept but also contain other elements that are ment (Waltz et al., 2010).
not part of the concept. Figure 16-1 shows a Venn Several factors can occur during the measurement
diagram of the concept A measured by instrument A-1. process that can increase random error. These factors
In this figure, A-1 does not measure all of concept A. include (1) transient personal factors, such as fatigue,
In addition, some of what A-1 measures is outside the hunger, attention span, health, mood, mental status,
concept of A. Both of these situations are examples of and motivation; (2) situational factors, such as a hot
errors in measurement and are shaded in Figure 16-1. stuffy room, distractions, the presence of significant
384 UNIT TWO  The Research Process

others, rapport with the researcher, and the playfulness +2


or seriousness of the situation; (3) variations in the –2
administration of the measurement procedure, such as
0
interviews in which wording or sequence of questions
is varied, questions are added or deleted, or research- T1 02 01 T2 T3
ers code responses differently; and (4) processing of
data, such as errors in coding, accidentally marking Figure 16-2  Conceptualization of random error.
the wrong column, punching the wrong key when
entering data into the computer, or incorrectly totaling
instrument scores (Devon et al., 2007; Waltz et al.,
2010).
Random error causes individuals’ observed scores
to vary in no particular direction around their true A-1
score. For example, with random error, one subject’s
observed score may be higher than his or her true
score, whereas another subject’s observed score may
be lower than his or her true score. According to mea-
surement theory, the sum of random errors is expected
to be zero, and the random error score (E) is not
expected to correlate with the true score (T). Random
error does not influence the mean to be higher or lower
but rather increases the amount of unexplained vari-
ance around the mean. When this occurs, estimation A
of the true score is less precise.
If you were to measure a variable for three sub-
jects and diagram the random error, it might appear
as shown in Figure 16-2. The difference between the
true score of subject 1 (T1) and the observed score Figure 16-3  Conceptualization of systematic error.
(O1) is two positive measurement intervals. The dif-
ference between the true score (T2) and observed
score (O2) for subject 2 is two negative measurement
intervals. The difference between the true score (T3) (which is 0) yields the observed score, as shown by
and observed score (O3) for subject 3 is zero. The the following equations:
random error for these three subjects is zero (+2 − 2
T ( true score with systematic error ) +
+ 0 = 0). In viewing this example, one must remem-
E ( random error of 0) = O (observed score)
ber that this is only a means of conceptualizing
random error. or
Measurement error that is not random is referred
T+E =O
to as systematic error. A scale that weighs subjects 3
pounds more than their true weights is an example of Some systematic error is incurred in almost any
systematic error. All of the body weights would be measure; however, a close link between the abstract
higher, and, as a result, the mean would be higher theoretical concept and the development of the instru-
than it should be. Systematic error occurs because ment can greatly decrease systematic error. Because
something else is being measured in addition to the of the importance of this factor in a study, researchers
concept. A conceptualization of systematic error is spend considerable time and effort in selecting and
presented in Figure 16-3. Systematic error (repre- developing quality measurement methods to decrease
sented by the shaded area in the figure) is due to the systematic error.
part of A-1 that is outside of A. This part of A-1 mea- Another effective means of diminishing systematic
sures factors other than A and biases scores in a par- error is to use more than one measure of an attribute
ticular direction. or a concept and to compare the measures. To make
Systematic error is considered part of T (true score) this comparison, researchers use various data collec-
and reflects the true measure of A-1, not A. Adding the tion methods, such as scale, interview, and observa-
true score (with systematic error) to the random error tion. Campbell and Fiske (1959) developed a technique
CHAPTER 16  Measurement Concepts 385

A-2

Concept A Concept B

A-1 A-3

Area of relationship
A
Figure 16-5  True relationship of concepts A and B.
A-4

the relationship between concept A and concept B. In


Figure 16-5, the shaded area enclosed in the dark lines
Figure 16-4  Multiple measures of an abstract concept. represents the true relationship between concepts A
and B, such as the relationship between anxiety and
depression. For example, two instruments, A-1 (Spiel-
berger State Anxiety Scale) and B-1 (Center for Epi-
of using more than one method to measure a concept, demiological Studies Depression Scale, Radloff,
referred to as the multimethod-multitrait technique. 1977), are used to examine the relationship between
More recently, the technique has been described as a concepts A and B. The part of the true relationship
version of mixed methodology, as discussed in actually reflected by A-1 and B-1 measurement
Chapter 10. These techniques allow researchers to methods is represented by the colored area in Figure
measure more dimensions of abstract concepts, and 16-6. Because two instruments provide a more accu-
the effect of the systematic error on the composite rate measure of concepts A and B, more of the true
observed score decreases. Figure 16-4 illustrates how relationship between concepts A and B can be
more dimensions of concept A are measured through measured.
the use of four instruments, designated A-1, A-2, A-3, If additional instruments (A-2 and B-2) are used to
and A-4. measure concepts A and B, more of the true relation-
For example, a researcher could decrease system- ship might be reflected. Figure 16-7 demonstrates with
atic error in measures of anxiety by (1) administering different colors the parts of the true relationship
oasis-ebl|Rsalles|1476233285

the Spielberger State-Trait Anxiety Inventory, (2) between concepts A and B that is measured when
recording blood pressure readings, (3) asking the concept A is measured with two instruments (A-1 and
subject about anxious feelings, and (4) observing the A-2) and concept B is measured with two instruments
subject’s behavior. Multimethod measurement strate- (B-1 and B-2).
gies decrease systematic error by combining the values
in some way to give a single observed score of anxiety
for each subject. However, sometimes it may be dif- Levels of Measurement
ficult logically to justify combining scores from The traditional levels of measurement have been used
various measures, and a mixed-methods approach for so long that the categorization system has been
might be the most appropriate to use in the study. considered absolute and inviolate. In 1946, Stevens
Mixed-methods study uses a combination of quantita- organized the rules for assigning numbers to objects
tive and qualitative approaches in their implementa- so that a hierarchy in measurement was established
tion (Creswell, 2009). called the levels of measurement. The levels of mea-
In some studies, researchers use instruments to surement, from lower to higher, are nominal, ordinal,
examine relationships. Consider a hypothesis that tests interval, and ratio.
386 UNIT TWO  The Research Process

Absolute
A-1 Zero
B-1
Equal Equal
Interval Interval
Categories Categories
Ranked Ranked Ranked
Categories Categories Categories
Exhaustive Exhaustive Exhaustive Exhaustive
Categories Categories Categories Categories
A
Exclusive Exclusive Exclusive Exclusive
B
Categories Categories Categories Categories
Nominal Ordinal Interval Ratio

Figure 16-8  Summary of the rules for levels of measurement.

Figure 16-6  Examining a relationship using one measure of each


concept. Nominal Level of Measurement
Nominal level of measurement is the lowest of the
four measurement levels or categories. It is used when
data can be organized into categories of a defined
property but the categories cannot be ordered. For
example, diagnoses of chronic diseases are nominal
A-1 data with categories such as hypertension, type 2 dia-
B-1 betes, and dyslipidemia. One cannot say that one cat-
egory is higher than another or that category A
(hypertension) is closer to category B (diabetes) than
to category C (dyslipidemia). The categories differ in
quality but not quantity. One cannot say that subject
A possesses more of the property being categorized
than does subject B. (Rule: The categories must be
unorderable.) Categories must be established so that
A each datum fits into only one of the categories. (Rule:
B The categories must be exclusive.) All the data must
fit into the established categories. (Rule: The catego-
ries must be exhaustive.)
Figure 16-8 provides a summary for the rules for
the four levels of measurement—nominal, ordinal,
interval, and ratio. Data such as ethnicity, gender,
marital status, religion, and diagnoses are examples of
A-2
nominal data. When data are coded for entry into the
B-2 computer, the categories are assigned numbers. For
example, gender may be classified as 1 = male and
2 = female. The numbers assigned to categories in
nominal measurement are used only as labels and
Figure 16-7  Examining a relationship using two measures of each cannot be used for mathematical calculations.
concept.
Ordinal Level of Measurement
Data that can be measured at the ordinal level can be
assigned to categories of an attribute that can be
ranked. There are rules for how one ranks data. As
CHAPTER 16  Measurement Concepts 387

with nominal-scale data, the categories must be exclu- absolute zero point, one can justifiably say that object
sive and exhaustive. With ordinal level data, the quan- A weighs twice as much as object B, or that container
tity of the attribute possessed can be identified. A holds three times as much as container B. Labora-
However, it cannot be shown that the intervals between tory values are also an example of ratio level of mea-
the ranked categories are equal (see Figure 16-8). surement where the individual with a fasting blood
Ordinal data are considered to have unequal intervals. sugar (FBS) of 180 has an FBS twice that of an indi-
Scales with unequal intervals are sometimes referred vidual with a normal FBS of 90. To help expand
to as ordered metric scales. understanding of levels of measurement (nominal,
Many scales used in nursing research are ordinal ordinal, interval, and ratio) and to apply this knowl-
levels of measure. For example, one could rank inten- edge, Grove (2007) developed a statistical workbook
sity of pain, degrees of coping, levels of mobility, focused on examining the levels of measurement,
ability to provide self-care, or daily amount of exer- sampling methods, and statistical results in published
cise on an ordinal scale. For daily exercise, the scale studies.
could be 0 = no exercise; 1 = moderate exercise, no
sweating; 2 = exercise to the point of sweating; 3 = Importance of Level of Measurement for
strenuous exercise with sweating for at least 30 Statistical Analyses
minutes per day; 4 = strenuous exercise with sweating An important rule of measurement is that one should
for at least 1 hour per day. This type of scale may be use the highest level of measurement possible. For
referred to as a metric ordinal scale. example, you can collect data on age (measured) in a
variety of ways: (1) you can obtain the actual age of
Interval Level of Measurement each subject (ratio level of measurement); (2) you can
In interval level of measurement, distances between ask subjects to indicate their age by selecting from a
intervals of the scale are numerically equal. Such mea- group of categories, such as 20 to 29, 30 to 39, and
surements also follow the previously mentioned rules: so on (ordinal level of measurement); or (3) you can
mutually exclusive categories, exhaustive categories, sort subjects into two categories of younger than 65
and rank ordering. Interval scales are assumed to be a years of age and 65 years of age and older (nominal
continuum of values (see Figure 16-8). The researcher level of measurement). The highest level of measure-
can identify the magnitude of the attribute much more ment in this case is the actual age of each subject,
precisely. However, it is impossible to provide the which is the preferred way to collect these data. If you
absolute amount of the attribute because of the absence need age categories for specific analyses in your
of a zero point on the interval scale. research, the computer can be instructed to create
Fahrenheit and Celsius temperatures are commonly age categories from the initial age data (Waltz et al.,
used as examples of interval scales. A difference 2010).
between a temperature of 70° F and one of 80° F is The level of measurement is associated with the
the same as the difference between a temperature of types of statistical analyses that can be performed on
30° F and one of 40° F. We can measure changes in the data. Mathematical operations are limited in the
temperature precisely. However, it is impossible to say lower levels of measurement. With nominal levels of
that a temperature of 0° C or 0° F means the absence measurement, only summary statistics, such as fre-
oasis-ebl|Rsalles|1476233289

of temperature because these indicate very cold quencies, percentages, and contingency correlation
temperatures. procedures, can be used. However, if a variable such
as age is measured at the ratio level (actual age of the
Ratio Level of Measurement subject), the data can be analyzed with more sophisti-
Ratio level of measurement is the highest form of cated analysis techniques. Variables measured at the
measure and meets all the rules of the lower forms interval or ratio level can be analyzed with the stron-
of measures: mutually exclusive categories, exhaus- gest statistical techniques available, which are more
tive categories, rank ordering, equal spacing between effective in identifying relationships among variables
intervals, and a continuum of values. In addition, ratio or determining differences between groups (Corty,
level measures have absolute zero points (see Figure 2007; Grove, 2007).
16-8). Weight, length, and volume are common exam-
ples of ratio scales. Each has an absolute zero point, Controversy over Measurement Levels
at which a value of zero indicates the absence of There is controversy over the system that is used to
the property being measured: Zero weight means categorize measurement levels, dividing researchers
the absence of weight. In addition, because of the into two factions: fundamentalists and pragmatists.
388 UNIT TWO  The Research Process

Pragmatists regard measurement as occurring on a Therefore, we have included the nonparametric statis-
continuum rather than by discrete categories, whereas tical procedures needed for their analysis in Chapters
fundamentalists adhere rigidly to the original system 22 to 25 on statistics.
of categorization (Nunnally & Bernstein, 1994;
Stevens, 1946).
The primary focus of the controversy relates to the Reference Testing
practice of classifying data into the categories ordinal
and interval. This controversy developed because, of Measurement
according to the fundamentalists, many of the current Referencing involves comparing a subject’s score
statistical analysis techniques can be used only with against a standard. Two types of testing involve
interval and ratio data. Many pragmatists believe that referencing: norm-referenced testing and criterion-
if researchers rigidly adhered to rules developed by referenced testing. Norm-referenced testing ad-
Stevens (1946), few if any measures in the social sci- dresses the question, “How does the average person
ences would meet the criteria to be considered interval- score on this test or instrument?” This testing in-
level data. They also believe that violating Stevens’ volves standardization of scores for an instrument
criteria does not lead to serious consequences for the that is accomplished by data collection over several
outcomes of data analysis. Pragmatists often treat years, with extensive reliability and validity informa-
ordinal data from multi-item scales as interval data, tion available on the instrument. Standardization
using statistical methods (parametric analysis tech- involves collecting data from thousands of subjects
niques) to analyze them, such as Pearson’s product- expected to have a broad range of scores on the
moment correlation coefficient, t-test, and analysis of instrument. From these scores, population parameters
variance (ANOVA), which are traditionally reserved such as the mean and standard deviation (described
for interval or ratio level data (Armstrong, 1981; in Chapter 22) can be developed. Evidence of the
Knapp, 1990). Fundamentalists insist that the analysis reliability and validity of the instrument can also be
of ordinal data be limited to statistical procedures evaluated through the use of the methods described
designed for ordinal data, such as nonparametric pro- later in this chapter. The best-known norm-referenced
cedures. Parametric statistical analysis techniques test is the Minnesota Multiphasic Personality Inven-
were developed to analyze interval and ratio level tory (MMPI), which is used commonly in psychology
data, and nonparametric techniques were developed to and occasionally in nursing research and practice to
analyze nominal and ordinal data (see Chapter 21). diagnosis personality disorders. The Graduate Record
The Likert scale uses scale points such as “strongly Examination (GRE) is another norm-referenced test
disagree,” “disagree,” “uncertain,” “agree,” and commonly used as one of the admission criteria for
“strongly agree.” Numerical values (e.g., 1, 2, 3, 4, graduate study.
and 5) are assigned to these categories. Fundamental- Criterion-referenced testing asks the question,
ists claim that equal intervals do not exist between “What is desirable in the perfect subject?” It involves
these categories. It is impossible to prove that there is comparing a subject’s score with a criterion of
the same magnitude of feeling between “uncertain” achievement that includes the definition of target
and “agree” as there is between “agree” and “strongly behaviors. When the subject has mastered these
agree.” Therefore, they hold this is ordinal level data, behaviors, he or she is considered proficient in
and parametric analyses cannot be used. Pragmatists the behavior (DeVon et al., 2007; Sax, 1997). The
believe that with many measures taken at the ordinal criterion might be a level of knowledge or desirable
level, such as scaling procedures, an underlying inter- patient outcomes. Criterion measures have been used
val continuum is present that justifies the use of para- for years to evaluate outcomes in healthcare agencies
metric statistics (Knapp, 1990; Nunnally & Bernstein, and to determine clinical expertise of students. For
1994). example, a clinical evaluation form would include the
Our position agrees more with the pragmatists critical behaviors the nurse practitioner (NP) student
than with the fundamentalists. Many nurse research- is expected to master in a pediatric course to be clini-
ers analyze data from Likert scales and other rating cally competent to care for pediatric patients at the
scales as though the data were interval level (Waltz end of the course. Criterion-reference testing is also
et al., 2010). However, some of the data in nursing used in nursing research. Criterion-referenced testing
research are obtained through the use of crude mea- might be used to measure the clinical expertise of a
surement methods that can be classified only into the nurse or the self-care of a cardiac patient after cardiac
lower levels of measurement (ordinal or nominal). rehabilitation.
CHAPTER 16  Measurement Concepts 389

comparability of a measurement method (Bartlett &


Reliability Frost, 2008). The strongest measure of reliability is
The reliability of an instrument denotes the consis- obtained from heterogeneous samples versus homoge-
tency of the measures obtained of an attribute, item, neous samples. Heterogeneous samples have more
or situation in a study or clinical practice. The greater between-participant variability, and this is a stronger
the reliability or consistency of the measures of a evaluation of reliability than homogeneous samples
particular instrument, the less random error in the with little between-participant variation. When criti-
measurement method (Bannigan & Watson, 2009; cally appraising the reliability of an instrument in a
Bialocerkowski et al., 2010; DeVon et al., 2007). If study, you need to examine the sample for heterogene-
the same measurement scale is administered to the ity by determining the variability of the scores among
same individuals at two different occasions, the mea- study participants (Bartlett & Frost, 2008; Bialocer-
surement is reliable if the individuals’ responses to the kowski et al., 2010).
items remain the same (assuming that nothing has All measurement techniques contain some random
occurred to change their responses). For example, if error, and the errors might be due to the measurement
you use a scale to measure the anxiety levels of 10 method used, the study participants, or the researchers
individuals at two points in time 30 minutes apart, you gathering the data. Reliability exists in degrees and is
would expect the individuals’ anxiety levels to be rela- usually expressed as a form of correlation coefficient,
tively unchanged from one measurement to the next with 1.00 indicating perfect reliability and 0.00 indi-
if the scale is reliable. If two data collectors observe cating no reliability (Bialocerkowski et al., 2010). For
the same event and record their observations on a example, reliability coefficients of 0.80 or higher are
carefully designed data collection instrument, the considered strong values for an established psychoso-
measurement would be reliable if the recordings from cial scale such as the State-Trait Anxiety Inventory by
the two data collectors are comparable. The equiva- Spielberger et al. (1970). With test-retest, the closer
lence of their results would indicate the reliability of that reliability coefficient is to 1.00, the more stable
the measurement technique. If responses vary each the measurement method. The reliability coefficient
time a measure is performed, there is a chance that the varies based on the type of reliability being examined.
instrument is unreliable, meaning that it yields data The three most common types of reliability discussed
with a large random error. in healthcare studies are (1) stability reliability, (2)
Reliability plays an important role in the selection equivalence reliability, and (3) internal consistency
of measurement methods for use in a study. Research- (Bannigan & Watson, 2009; Bialocerkowski et al.,
ers need instruments that are reliable and provide 2010; DeVon et al., 2007; Waltz et al., 2010).
values with only a small amount of error. Reliable
instruments enhance the power of a study to detect Stability Reliability
significant differences or relationships actually occur- Stability reliability is concerned with the consistency
ring in the population under study. It is important to of repeated measures of the same attribute with the
examine the reliability of an instrument from previous use of the same scale or instrument over time. It is
research before using it in a study. Estimates of instru- usually referred to as test-retest reliability. This
ment reliability are specific to the population and measure of reliability is generally used with physical
sample being studied. High reported reliability values measures, technological measures, and paper-and-
on an established instrument do not guarantee that its pencil scales. The technique requires an assumption
reliability would be satisfactory in another sample that the factor to be measured remains the same at the
from a different population (Waltz et al., 2010). two testing times and that any change in the value or
Researchers need to perform reliability testing on each score is a consequence of random error.
instrument used in their study before performing other The optimal time period between test-retest mea-
statistical analyses. The reliability values must be surements depends on the variability of the variable
included in the published report of a study to docu- being measured, complexity of the measurement
ment that the instruments used were reliable for the process, and characteristics of the participants (Bialo-
study sample (Bialocerkowski et al., 2010; DeVon cerkowski et al., 2010). Physical measures and equip-
et al., 2007). ment can be tested and then immediately retested, or
Reliability testing examines the amount of mea- the equipment can be used for a time and then retested
surement error in the instrument being used in a study. to determine the necessary frequency of recalibration.
Reliability is concerned with the dependability, con- For example, in measuring blood pressure (BP),
sistency, stability, precision, reproducibility, and researchers often take two to three BP readings 5
390 UNIT TWO  The Research Process

minutes apart and average the readings to obtain a Stability of a measurement method is important and
reliable or precise measure of BP. Researchers can needs to be examined as part of instrument develop-
follow the standards for recalibration of equipment or ment and discussed when the instrument is used in a
be more conservative. The standard requirements study. When describing test-retest results, researchers
might be to recalibrate the BP equipment every 6 need to discuss the process and the time period
months, but researchers might choose to recalibrate between administering an instrument and the rationale
the equipment every month or even every week if for this time frame. If a scale was administered twice
multiple BP readings are being taken each day for a 30 minutes apart or there was 1 month between test
study. The test-retest of a measurement method might and retesting, the consistency of the subjects’ scores
have a longer period of time if the variable being need to be discussed in terms of the timing for retest-
measured changes slowly. For example, the diagnosis ing (Bannigan & Watson, 2009; Bialocerkowski et al.,
of osteoporosis is made by bone mineral density 2010; DeVon et al., 2007).
(BMD) study of the hip, spine, and wrist. The BMD
score is determined with a dual-energy x-ray absorp- Equivalence Reliability
tiometry (DEXA) scan. Because the BMD does not Equivalence reliability compares two versions of the
change rapidly in people even with treatment, test- same paper-and-pencil instrument or two observers
retest over a 1- to 2-month time period could be used measuring the same event. Comparison of two observ-
to show reliable or consistent DEXA scan scores for ers is referred to as interrater reliability. Comparison
patients. of two paper-and-pencil instruments is referred to as
With paper-and-pencil educational tests, a period alternate-forms reliability or parallel-forms reli-
of 2 to 4 weeks is recommended between the two ability. Alternative forms of instruments are of more
testing times, but the time period for retesting does concern in the development of normative knowledge
depend on what is measured and the instrument used testing. However, when repeated measures are part of
(Sax, 1997). After the same participants have been the design, alternative forms of measurement, although
retested with the same instrument, the investigators not commonly used, would improve the design. Dem-
perform a correlational analysis on the scores from the onstrating that one is actually testing the same content
two measurement times. This correlation is called the in both tests is extremely complex, and the procedure
coefficient of stability, and the closer the coefficient is rarely used in clinical research (Bialocerkowski
is to 1.00, the more stable the instrument (Waltz et al., et al., 2010).
2010). For some scales, test-retest reliability has not The procedure for developing parallel forms
been as effective as originally anticipated. The proce- involves using the same objectives and procedures to
dure presents numerous problems. Subjects may develop two like instruments. These two instruments
remember their responses from the first testing time, when completed by the same group of study partici-
leading to overestimation of the reliability. Subjects pants on the same occasion or two different occasions
may be changed by the first testing and may respond should have approximately equal means and standard
to the second test differently, leading to underestima- deviations. In addition, these two instruments should
tion of the reliability (Bialocerkowski et al., 2010). correlate equally with another variable. For example,
Test-retest reliability requires the assumption that if two instruments were developed to measure pain,
the factor being measured has not changed between the scores from these two scales should correlate
the measurement points. Many of the phenomena equally with perceived anxiety score. If both forms of
studied in nursing, such as hope, coping, pain, and the instrument are administered during the same occa-
anxiety, do change over short intervals. Thus, the sion, a reliability coefficient can be calculated to deter-
assumption that if the instrument is reliable, values mine equivalence. A coefficient of 0.80 or higher
will not change between the two measurement periods indicates equivalence (Waltz et al., 2010).
may not be justifiable. If the factor being measured Determining interrater reliability is a concern
does change, the test is not a measure of reliability. If when studies include observational measurement,
the measures stay the same even though the factor which is common in qualitative research. Interrater
being measured has changed, the instrument may lack reliability values need to be reported in any study in
reliability. If researchers are going to examine the reli- which observational data are collected or judgments
ability of an instrument with test-retest, they need to are made by two or more data gatherers. Two tech-
determine the optimum time between administrations niques determine interrater reliability. Both tech-
of the instrument based on the variable being mea- niques require that two or more raters independently
sured and the study participants (Devon et al., 2007). observe and record the same event using the protocol
CHAPTER 16  Measurement Concepts 391

developed for the study or that the same rater ob- without administering the test twice. The instrument
serves and records an event on two occasions. To items were split in odd-even or first-last halves, and a
judge interrater reliability adequately, the raters need correlational procedure was performed between the
to observe at least 10 subjects or events (DeVon et al., two halves. In the past, researchers generally reported
2007; Waltz et al., 2010). A digital recorder can be the Spearman-Brown correlation coefficient in their
used to record the raters to determine their consis- studies (Nunnally & Bernstein, 1994; Sax, 1997). One
tency in recording essential study information. Every of the problems with the procedure was that although
data collector used in the study must be tested for items were usually split into odd-even items, it was
interrater reliability and trained to a consistency in possible to split them in a variety of ways. Each
data collection. approach to splitting the items would yield a different
One procedure for calculating interrater reliability reliability coefficient. The researcher could continue
requires a simple computation involving a comparison to split the items in various ways until a satisfactorily
of the agreements obtained between raters on the high coefficient was obtained.
coding form with the number of possible agreements. More recently, testing the internal consistency of
This calculation is performed through the use of the all the items in the instrument has been seen as a better
following equation: approach to determining reliability. Although the
mathematics of the procedure are complex, the logic
Number of agreements ÷ number of possible
is simple. One way to view it is as though one con-
agreements = interrater reliability
ducted split-half reliabilities in all the ways possible
This formula tends to overestimate reliability, a and then averaged the scores to obtain one reliability
particularly serious problem if the rating requires only score. Internal consistency testing examines the extent
a dichotomous judgment, such as present or absent. In to which all the items in the instrument consistently
this case, there is a 50% probability that the raters will measure a concept. Cronbach’s alpha coefficient is
agree on a particular item through chance alone. If the statistical procedure used for calculating internal
more than two raters are involved, a statistical proce- consistency for interval and ratio level data. This reli-
dure to calculate coefficient alpha (discussed later in ability coefficient is essentially the mean of the inter-
this chapter) may be used. ANOVA may also be used item correlations and can be calculated using most
to test for differences among raters. There is no abso- data analysis programs such as the Statistical Program
lute value below which interrater reliability is unac- for the Social Sciences (SPSS). If the data are dichoto-
ceptable. However, any value less than 0.80 (80%) mous, such as a symptom list that has responses of
should generate serious concern about the reliability present or absent, the Kuder-Richardson formulas (KR
of the data because there is 20% chance of error. The 20 or KR 21) can be used to calculate the internal
more ideal interrater reliability value is 0.90, which consistency of the instrument (DeVon et al., 2007).
means 90% reliability and 10% error. The process for The KR 21 assumes that all the items on a scale or test
determining interrater reliability and the value are equally difficult; the KR 20 is not based on this
achieved need to be included in the research report assumption. Waltz et al. (2010) provided the formulas
(DeVon et al., 2007). for calculating both KR 20 and KR 21.
When raters know they are being watched, their Cronbach’s alpha coefficients can range from 0.00,
accuracy and consistency are considerably better than indicating no internal consistency or reliability, to
when they believe they are not being watched. Inter- 1.00, indicating perfect internal reliability with no
rater reliability declines (sometimes dramatically) measurement error. Alpha coefficients of 1.00 are not
when the raters are assessed covertly (Topf, 1988). obtained in study results because all instruments have
You can develop strategies to monitor and reduce the some measurement error. However, many respected
decline in interrater reliability, but they may entail psychosocial scales used for 15 to 30 years to measure
considerable time and expense. study variables in a variety of populations have strong
0.8 or greater internal reliability coefficients. The
Internal Consistency coefficient of 0.80 (or 80%) indicates the instrument
Tests of instrument internal consistency or homoge- is 80% reliable with 20% random error (DeVon et al.,
neity, used primarily with paper-and-pencil tests or 2007; Fawcett & Garity, 2009; Grove, 2007). Scales
scales, address the correlation of various items within with 20 or more items usually have stronger internal
the instrument. The original approach to determining consistency coefficients than scales with 10 to 15
internal consistency was split-half reliability. This items or less. Often scales that measure complex con-
strategy was a way of obtaining test-retest reliability structs such as quality of life (QOL) have subscales
392 UNIT TWO  The Research Process

that measure different aspects of QOL, such as health,


physical functioning, and spirituality. Some of these themselves on a 4-point scale of 1 (not at all) to 4
complex scales with distinct subscales, such as the (very much so). The median α [alpha] reliability of the
QOL scale, might have lower Cronbach’s alpha coef- inventory was reported to be 0.93 [from previous
ficients since the scale is measuring different aspects studies].… Cronbach’s α scores for the present study
of QOL. The subscales have fewer items than the total ranged from 0.90 to 0.96 for the 3 time periods. Only
scale and usually lower Cronbach’s alpha coefficients the state anxiety score was used in this analysis.
but do need to show internal consistency in measuring “Quality-of-life measure. Quality-of-life was mea-
a concept (Bialocerkowski et al., 2010; Waltz et al., sured using the Ferrans and Powers Quality of Life
2010). Index, Cardiac Version (QLI: CV) (Bliley & Ferrans,
Newer instruments, developed in the last 5 years, 1993). The QLI: CV measures the subject’s percep-
might show moderate internal reliability (0.70 to 0.79) tion of QOL, according to a 72-item scale consisting
when used in measuring variables in a variety of of 2 parts. The first part measures satisfaction with
samples. The subscales of these new instruments various aspects of life and the second part measures
might have internal reliability from 0.60 to 0.69. The the importance of these aspects to a subject. In part
authors of these scales might continue to refine them 1, subjects respond to a 6-point scale, ranging from
based on additional reliability and validity information ‘very important’ (6 points) to ‘very unimportant’ (1
to improve the reliability of the total scale and sub- point). Scores are calculated by weighing the satisfac-
scales. Reliability coefficients less than 0.60 are con- tion responses with the importance responses. They
sidered low and indicate limited instrument reliability reflect how satisfied subjects are with the aspects of
or consistency in measurement with high random life that are important to them. The 4 subscales of
error. Higher levels of reliability or precision (0.90 to QOL scored include health and functioning, social and
0.99) are important for physiological measures that are economic, psychological/spiritual, and family. The reli-
used to determine critical physiological functions such ability of the total scale’s internal consistency was
as arterial pressure and oxygen saturation (Bialocer- supported by α coefficients ranging from 0.90 to 0.95.
kowski et al., 2010; DeVon et al., 2007). Stability and reliability were supported by a test-retest
The quality of the instrument reliability needs to correlation of 0.87 at a 2-week interval, and 0.81 at
be examined in terms of the type of study, measure- a 1-month interval.… Cronbach’s α scores for the
ment method, and population (DeVon et al., 2007; present study ranged from 0.95 to 0.96 for total QLI:
Kerlinger & Lee, 2000). In published studies, research- CV, and for the subscales, Cronbach’s α scores ranged
ers need to identify the reliability coefficients of an from 0.88 to 0.94.” (Dickerson et al., 2010, p. 468)
instrument from previous research and for their par-
ticular study. Because the reliability of an instrument
can vary from one population or sample to another, it Dickerson et al. (2010) used two very reliable
is important that the reliability of the scale and sub- scales to measure their study variables and docu-
scales be determined and reported for the sample in mented this in their article. They measured anxiety
each study (Bialocerkowski, et al., 2010). with the Spielberger STAI, which was developed more
Dickerson, Kennedy, Wu, Underhill, and Othman than 40 years ago (Spielberger et al., 1970), has shown
(2010) conducted a study of QOL and anxiety levels strong internal consistency in previous research
of patients with implantable defibrillators. They pro- (median alpha = 0.93), and was reliable in this study
vided the following discussion of the reliability of the (Cronbach’s alpha = 0.90 to 0.96). In previous studies,
scales they used in their study. the QLI: CV had strong internal consistency for the
total scale (alpha = 0.90-0.95) and stability reliability
with test-retest over 2 weeks and 1 month. In addition
“Anxiety. Anxiety was measured by the Spielberger to the strong stability reliability coefficients, the
State-Trait Anxiety Inventory (STAI), which deter- researchers also provided the time frames for the test-
mines a subject’s current state of anxiety. This instru- retests that were run on the scale. Another strength is
ment differentiates between the temporary condition that the QLI: CV showed strong internal consistency
of ‘state anxiety’ and the longstanding quality of ‘trait for the total scale (alpha = 0.95 to 0.96) and the four
anxiety.’ The STAI is a 40-item instrument that gages subscales (alpha = 0.88 to 0.94) with the population
emotional reactions to the environment (e.g., ‘I am in this study.
tense,’ ‘I feel upset,’ or ‘I am worried’). Subjects rate Other approaches to testing internal consistency are
(1) Cohen’s kappa statistic, which determines the
CHAPTER 16  Measurement Concepts 393

percentage of agreement with the probability of chance the evidence of validity. This important work greatly
being taken out; (2) correlating each item with the extends our understanding of what validity is and how
total score for the instrument; and (3) correlating each to achieve it. According to the American Psychologi-
item with each other item in the instrument. This pro- cal Association’s Committee to Develop Standards
cedure, often used in instrument development, allows (1999), validity addresses the appropriateness, mean-
researchers to identify items that are not highly cor- ingfulness, and usefulness of the specific inferences
related and delete them from the instrument. Factor made from instrument scores. It is the inferences made
analysis may also be used to develop instrument reli- from the scores, not the scores themselves, that are
ability. The number of factors being measured influ- important to validate (Devon et al., 2007; Goodwin &
ences the reliability of the instrument, and total Goodwin, 1991).
instrument scores may be more reliable than the scores Validity, similar to reliability, is not an all-or-
of the subscales. After performing the factor analysis, nothing phenomenon but rather a matter of degree. No
the researcher can delete instrument items with low instrument is completely valid. One determines the
factor weights. After these items have been deleted, degree of validity of a measure rather than whether or
reliability scores on the instrument are higher. For not it has validity. Determining the validity of an
instruments with more than one factor, correlations instrument often requires years of work. Many authors
can be performed between items and factor scores (see equate the validity of the instrument with the rigorous-
Chapter 23 for a discussion of factor analysis). ness of the researcher. The assumption is that because
It is essential that an instrument be both reliable the researcher develops the instrument, the researcher
and valid for measuring a study variable in a popula- also establishes the validity. However, this is an erro-
tion. If the instrument has low reliability values, it neous assumption because validity is not a commodity
cannot be valid because its measurement is inconsis- that researchers can purchase with techniques. Validity
tent and has high measurement error (DeVon et al., is an ideal state—to be pursued, but not to be attained.
2007; Waltz et al., 2010). An instrument that is reliable As the roots of the word imply, validity includes truth,
cannot be assumed to be valid for a particular study strength, and value. Some authors might believe that
or population. You need to determine the validity of validity is a tangible “resource,” which can be acquired
the instrument you are using for your study, which you by applying enough appropriate techniques. However,
can accomplish in a variety of ways. we reject this view and believe measurement validity
is similar to integrity, character, or quality, to be
assessed relative to purposes and circumstances and
Validity built over time by researchers conducting a variety of
The validity of an instrument determines the extent to studies (Brinberg & McGrath, 1985).
which it actually reflects or is able to measure the Figure 16-9 illustrates validity (the shaded area) by
construct being examined. Several types of validity the extent to which the instrument A-1 reflects concept
are discussed in the literature, such as content validity,
predictive validity, criterion validity, and construct
validity. Within each of these types, subtypes have
been identified. These multiple types of validity are
very confusing, especially because the types are not
discrete but are interrelated (Bannigan & Watson,
2009; DeVon et al., 2007; Fawcett & Garity, 2009).
In this text, validity is considered a single broad
measurement evaluation that is referred to as con- A-1 A
struct validity and includes various types, such as
content validity, validity from factor analysis, conver-
gent and divergent validity, validity from contrasting
groups, and validity from prediction of future and
current events (DeVon et al., 2007). All of the previ-
ously identified types of validity are now considered
evidence of construct validity. In 1999, in its Stan- Systemic
error
dards for Educational and Psychological Testing, the Validity
American Psychological Association’s Committee to
Develop Standards published standards used to judge Figure 16-9  Representation of instrument validity.
394 UNIT TWO  The Research Process

A. As measurement of the concept improves, validity Documentation of content validity begins with
improves. The extent to which the instrument A-1 development of the instrument. The first step of instru-
measures items other than the concept is referred to as ment development is to identify what is to be mea-
systematic error (identified as the unshaded area of sured; this is referred to as the universe or domain of
A-1 in Figure 16-9). As systematic error decreases, the construct. You can determine your domain through
validity increases. a concept analysis or an extensive literature search.
Validity varies from one sample to another and Qualitative methods can also be used for this purpose.
from one situation to another; therefore, validity Johnson and Rogers (2006) developed the Medication-
testing affirms the appropriateness of an instrument Taking Questionnaire (MTQ) based on purposeful
for a specific group or purpose rather than the instru- action dimensions to determine the decision-making
ment itself (DeVon et al., 2007; Waltz et al., 2010). process of individuals for adherence to medication
An instrument may be valid in one situation but not treatment for hypertension. They described their initial
valid in another. Instruments used in nursing studies instrument development process as follows.
that were developed for use in other disciplines need
to be examined for validity in terms of nursing knowl-
edge. An instrument developed to measure cognitive
“A total of 20 items (need, n = 8; effectiveness, n = 6;
function in educational studies might not capture the
and safety, n = 6) were initially developed to tap the
cognitive function level of elderly adults measured in
three underlying dimensions of purposeful action
a nursing study. Researchers are encouraged to reex-
based on the statements given by participants in a
amine validity in each of their study situations. The
qualitative study (Johnson, 2002; Johnson, Williams, &
types of validity covered in this section include face
Marshall, 1999). The method for item construction
and content validity, readability of an instrument,
was guided by the principles outlined in DeVellis
validity from factor analysis, validity from structural
(1991) and Streiner and Norman (1995).… The
analysis, validity from contrasting (or known) groups,
MTQ: Purposeful Action items were arranged in
convergent and divergent validity, validity from dis-
a 7-point, Likert-type format describing responses
criminant analysis, validity from prediction of future
based on agreement (7 = always agree, 6 = very fre-
and concurrent events, and successive verification
quently agree, 5 = usually agree, and 4 = occasionally
validity.
agree, 3 = rarely agree, 2 = almost never agree, 1 =
never agree). The 7-response option was used in an
Face and Content Validity attempt to obtain optimal variance while discouraging
In the 1960s and 1970s, the only type of validity that
a ceiling effect (Steiner & Norman, 1995). Higher
most studies addressed was referred to as face valid-
scores for the MTQ: Purposeful Action indicated
ity, which verified basically that the instrument looked
greater intent to take medications based on per-
like it was valid or gave the appearance of measuring
ceived need, effectiveness, and safety.” (Johnson &
the construct it was supposed to measure. Face valid-
Rogers, 2006, p. 339)
ity is a subjective assessment that might be made by
the researchers or potential subjects. Because this is a
subjective judgment with no clear guidelines for
making the judgment, this is considered the weakest Researchers need to describe the procedures used
form of validity (DeVon et al., 2007). However, it is to develop or select items for the instrument that rep-
still an important aspect of the usefulness of the instru- resent the domain of the construct. One helpful strat-
ment because the willingness of subjects to complete egy commonly used is to develop a blueprint or matrix,
the instrument relates to their perception that the such as was used in developing test items for an exam-
instrument measures the construct they agreed to ination that was done by Johnson (2002) in her dis-
provide (Thomas, 1992). Face validity is often consid- sertation focused on development of the MTQ.
ered a step before or an aspect of content validity. However, before developing such items, the blueprint
Content validity examines the extent to which the specifications must be submitted to an expert panel to
measurement method includes all the major elements validate that they are appropriate, accurate, and repre-
relevant to the construct being measured. This evi- sentative. At least five experts are recommended,
dence is obtained from the following three sources: although a minimum of three experts is acceptable if
the literature, representatives of the relevant popula- you cannot locate additional individuals with expertise
tions, and content experts (DeVon et al., 2007; Fawcett in the area. Researchers might seek out individuals
& Garity, 2009; Waltz et al., 2010). with expertise in various fields—for example, one
CHAPTER 16  Measurement Concepts 395

individual with knowledge of instrument develop- succinct.” In addition to evaluating existing items, the
ment, a second with clinical expertise in an appropri- experts were asked to identify important areas not
ate field of practice, and a third with expertise in included in the instrument. The calculation for the
another discipline relevant to the content area. CVI is presented in Table 16-1 using the format devel-
The experts need specific guidelines for judging the oped by Lynn (1986). Complete agreement needs to
appropriateness, accuracy, and representativeness of exist among the expert reviewers to retain an item with
the specifications. Berk (1990) recommended that the seven or fewer reviewers. If few reviewers are used
experts first make independent assessments and then and many of the experts support most of the items on
meet for a group discussion of the specifications. The an instrument, this often results in an inflated CVI and
instrument specifications then can be revised and an inflation in the content validity of the instrument
resubmitted to the experts for a final independent (DeVon et al., 2007).
assessment. Davis (1992) recommended that the As presented earlier, Johnson and Rogers (2006)
researcher provide expert reviewers with theoretical developed the MTQ: Purposeful Action and described
definitions of concepts and a list of which instrument their content validity testing process and outcomes as
items are expected to measure each of the concepts. follows.
The researcher asks the reviewers to judge how well
each of the concepts has been represented in the
instrument.
Researchers need to determine how to measure the “Content validity testing was undertaken to deter-
domain. The item format, item content, and proce- mine clarity and relevance of content. Participants and
dures for generating items must be carefully described. experts were given verbal instructions and a packet
Items are then constructed for each cell in the matrix, consisting of a consent form, written instructions,
or observational methods are designated to gather data clarity instrument, content validity instrument, and
related to a specific cell. Researchers are expected to demographic questionnaire. The clarity instrument
describe the specifications used in constructing items asked participants to rate items as clear or unclear
or selecting observations. Sources of content for items (Imle & Atwood, 1988). Participants were given a
must be documented. Then researchers can assemble, definition of each subscale and asked to rate each
refine, and arrange the items in a suitable order before item’s relevancy using a 4-point scale from 1 (irrele-
submitting them to the content experts for evaluation. vant) to 4 (extremely relevant; Lynn, 1986). Space
Specific instructions for evaluating each item and the was provided to make comments after each rating
total instrument must be given to the experts. procedure. (p. 339)
In developing content validity for an instrument, Items met clarity criterion if 70% of participants
researchers can calculate a content validity ratio rated the item as clear and the content validity crite-
(CVR) for each item on a scale by rating it 0 (not rion if 80% of participants rated the item as 3 or 4
necessary), 1 (useful), or 3 (essential). A method for (Imle & Atwood, 1988; Lynn, 1986). The comments
calculating the CVR was developed by Lawshe (1975) from the clarity and content validity criterion were
and is presented in Table 16-1 (DeVon et al., 2007). used to revise the MTQ: Purposeful Action items and
Minimum CVR scores for including items in an instru- subscales.…
ment can be based on a one-tailed test with a 0.05 level Of the 20 MTQ: Purpose Action items, 19 achieved
of significance. clarity and content validity agreement. The 1 item
The content validity score calculated for the com- that had an unacceptable clarity agreement was even-
plete instrument is called the content validity index tually eliminated from the questionnaire. Profession-
(CVI). The CVI was developed to obtain a numerical als expressed a concern about the lack of specificity
value that reflects the level of content-related validity in the questions, but that was not an issue for the
evidence for a measurement method (Waltz & Bausell, hypertensive participants. For example, one profes-
1981). In calculating CVI, experts rate the content sional indicated that the item, ‘Blood pressure pills
relevance of each item in an instrument using a 4-point keep me from having problems,’ lacked specificity.
rating scale. Lynn (1986, p. 384) recommended stan- Because the purpose of this questionnaire was to
dardizing the options on this scale to read as follows: establish a general screening tool for individuals who
“1 = not relevant; 2 = unable to assess relevance potentially may choose not to take their medications
without item revision or item is in need of such revi- rather than to create a diagnostic tool, the partici-
sion that it would no longer be relevant; 3 = relevant pants’ scores were given priority. Of the 20 items [see
but needs minor alteration; 4 = very relevant and
396 UNIT TWO  The Research Process

TABLE 16-1  Two Methods of Calculating the Content Validity Ratio (CVR) and the Content Validity
Index (CVI)
Lawshe (1975) Lynn (1986)
Rating scale Scale used for rating items Scale used for rating items
0 1 3 1 2 3 4
Not necessary Useful Essential Irrelevant Extremely Relevant
Calculations To calculate CVR (a score for individual CVI for each scale item is the proportion of experts who rate the
scale items) item as a 3 or 4 on a 4-point scale. Example: If 4 of 6 content
experts rated an item as relevant (3 or 4), CVI would be: 4/6
= 0.67
CVR = (ne − N/2)/(N/2) This item would not meet the 0.83 level of endorsement required
to establish content validity using a panel of 6 experts at the
0.05 level of significance. Therefore, it would be dropped
Note: ne = The number of experts who rated CVI for the entire scale is the proportion of the total number of
an item as “essential” items deemed content valid. Example: If 77 of 80 items were
deemed content valid, CVI would be: 77/80 = 0.96
N = the total number of experts. Example: If
8 of 10 experts rated an item as essential,
CVR would be (8 − 5/5) = 0.60
Acceptable Depends on number of reviewers Depends on number of reviewers
range

From DeVon, H. A., Block, M. E., Moyle-Wright, P., Ernst, D. M., Hayden, S. J., Lazzara, D. J., Savoy, S. M., & Kostas-Polston, E. (2007). A psychometric
toolbox for testing validity and reliability. Journal of Nursing Scholarship, 39(2), 158.

Table 16-2 for the 20 items in the original question- professionals who examined the MTQ for clarity and
naire], 12 underwent minor grammatical revisions content relevance (Imle & Atwood, 1988; Lynn,
guided by the comments of both the participants and 1986). Professionals were invited to participate in the
professionals. For example, items were made specific study based on their known experience with antihy-
to blood pressure and the term medication was pertensive treatment and included two family physi-
changed to pills. Several items were reworded, or the cians, a cardiology nurse practitioner, a nurse working
tense of the verb was changed.” (Johnson & Rogers, with a statewide cardiovascular disease program, and
2006, pp. 341-342) a nurse researcher who had published articles on
adherence. All professionals were Anglo American
and were nearly equally divided with regard to
Before sending the instrument to experts for evalu- gender.
ation, researchers need to decide how many experts Participants for the content validity phase who had
must agree on each item and on the total instrument been prescribed antihypertensive medications and
for the content to be considered valid. Items that do lived in a situation in which they managed their own
not achieve minimum agreement by the expert panel medications were recruited through healthy aging
must be either eliminated from the instrument or clinics, worksite wellness programs, hospital outpa-
revised (DeVon et al., 2007; Lynn, 1986). Johnson and tient clinics, and hospital emergency departments in
Rogers (2006) described their panel of reviewers, who the intermountain west. The five hypertensive par-
were health professionals and patients prescribed anti- ticipants were Anglo American, had at least a high
hypertensive medications, for the MTQ in the follow- school education and ranged in age from 48 to 90
ing excerpt. years (M = 62.0 ± 16.4).” (Johnson & Rogers, 2006,
p. 338)

“Content validity testing was conducted in a sample


of five hypertensive patients and five health care Johnson and Rogers (2006) provided excellent
detail about the development of their instrument and
CHAPTER 16  Measurement Concepts 397

TABLE 16-2  Medication-Taking Questionnaire: Purposeful Action—Initial 20 Items Statistics


Item-Total Mann-Whitney
M SD Correlation Adherence p Values*
Perceived Need
My blood pressure pills keep me from having a stroke. 5.8 1.5 0.58 0.08
I need to take my blood pressure pills. 6.4 1.4 0.77 0.01
I take my blood pressure pills for my health. 6.5 1.3 0.75 0.01
Blood pressure pills keep me from having health-related 5.7 1.5 0.63 0.17
problems.
I could have health problems if I do not take my blood 6.1 1.3 0.74 0.13
pressure pills.
It’s not a problem if I miss my blood pressure pills.† 5.1 2.0 0.30 0.02
I would rather treat my blood pressure without pills.† 4.1 2.3 0.37 0.26
I am OK if I do not take my blood pressure pills.† 5.6 1.8 0.64 0.012
Perceived Effectiveness
My blood pressure will come down enough without pills.† 5.4 1.8 0.40 0.10
I will have problems if I don’t take my blood pressure pills. 6.1 1.4 0.63 0.001
My blood pressure pills control my blood pressure. 6.0 1.4 0.66 0.46
Blood pressure pills benefit my health. 6.1 1.4 0.74 0.01
I feel better when I take my blood pressure pills. 5.4 1.8 0.56 0.01
I have problems finding pills that will control my blood 5.7 1.8 0.09 0.059
pressure.†
Perceived as Safe
The side effects from my blood pressure pills are a problem.† 5.2 1.9 0.40 0.10
The side effects from my blood pressure pills are harmful.† 5.6 1.8 0.63 0.27
My blood pressure pills are safe. 5.8 1.4 0.66 0.47
Taking my blood pressure pills is not a problem because they 6.0 1.4 0.74 0.02
benefit my health.
My blood pressure pills cause other health problems.† 5.4 1.8 0.56 0.35
I will become dependent on my blood pressure pills.† 3.9 2.3 −0.5 0.20

From Johnson, M. J., & Rogers, S. (2006). Development of the Purposeful Action Medication-Taking Questionnaire. Western Journal of Nursing Research,
28(3), 344.
*Difference between low (scored 1-3) versus high (scored 7-10) adherence.
†Reverse coded.
M, Mean; SD, standard deviation.

the process for determining content validity. They also evaluated for content-related validity. With the per-
provided extensive information about the expert mission of the author or researcher who developed
review panel for conducting the content validity the instrument, you could revise the instrument to
testing. The strength of the review panel is that it improve its content-related validity (Lynn, 1986). In
included both health professionals and patients taking addition, the panel of experts or reviewers evaluating
medications for hypertension. However, since all the the items of the instrument for content validity might
reviewers were Anglo American, there was no ethnic also examine it for readability and language accept-
diversity in the review process. The MTQ was a Likert ability to possible subjects or data gatherers (Berk,
scale with 7-point response options (described earlier), 1990; DeVon et al., 2007).
so it would be clearer if the researchers had called the
MTQ a Likert scale versus a questionnaire (Waltz Readability of an Instrument
et al., 2010). Readability is an essential element of the validity and
With some modifications, the content validity pro- reliability of an instrument. Assessing the level of
cedure previously described can be used with exist- readability of an instrument is simple and takes
ing instruments, many of which have never been seconds with the use of a computer. There are more
398 UNIT TWO  The Research Process

than 30 readability formulas. These formulas count Inventory (CRI), which is based on the Flesch, Space,
language elements in the document and use this infor- Dale, and Fry reading comprehension scales (Flesch
mation to estimate the degree of difficulty a reader 1984; Silvaroli, 1986). This instrument determines the
may have in comprehending the text. Readability for- level at which an individual can comprehend written
mulas are now a standard part of word-processing material without assistance. Johnson and Rogers
software. Box 16-1 provides instructions for using the (2006) described the readability of their MTQ: Pur-
Fog formula to determine the readability of a measure- poseful Action as follows.
ment method. “Items were worded at approximately a sixth-grade
Although readability has never been formally iden- reading level, evaluated by using the Flesch-Kincaid
tified as a component of content validity, it is essential grade-level assessment program in Microsoft Word
that the items of an instrument be comprehended by (2000) (Rasin, 1997). Items ranged from a 1.0 to 6.2
subjects. Miller and Bodie (1994) suggested that the grade level, with a 3.5 grade level readability score for
researcher should directly assess the reading compre- the overall questionnaire.” (Johnson & Rogers, 2006,
hension level of the study population before using a p. 339)
formula to calculate an instrument’s readability. They
indicated that it is a mistake to assume that someone’s Validity from Factor Analysis
literacy is equivalent to the last grade level the indi- Factor analysis is a valuable approach for determining
vidual completed. Miller and Bodie (1994) recom- evidence of an instrument’s construct validity. This
mended that researchers use the Classroom Reading analysis technique is used to determine the various
dimensions or subcomponents of a phenomenon of
interest. To employ factor analysis, the instrument
must be administered to a large, representative sample
Box 16-1 How to Find the Fog Index of participants at one time. Usually the data are ini-
(Fog Formula) tially analyzed with exploratory factor analysis (EFA)
1. Pick a sample of writing 100 to 125 words
to examine relationships among the various items of
long. Count the average number of words
the instrument. Items that are closely related are clus-
per sentence. In counting, treat
tered into a factor. The researcher needs to preset the
independent clauses as separate sentences.
minimum loading for an item to be included in a
“In school we studied; we learned; we
factor. The minimum loading is usually set at 0.30 but
improved” is three sentences.
might be as high as 0.50 (Waltz et al., 2010). The
2. Count the words of three syllables or more.
factors identified are the subcomponents of the con-
Do not count: (a) capitalized words, (b)
struct the instrument was developed to measure.
combinations of short words such as
Determining and naming the factors identified through
butterfly or manpower, or (c) verbs made
EFA require detailed work on the part of the researcher.
into three syllables by adding “-es” or “-ed”
The researcher can validate the number of factors or
such as trespasses or created. Divide the
subcomponents in the instrument and measurement
count of long words by the number of
equivalence among comparison groups through the
words in the passage to get the percentage.
use of confirmatory factor analysis (CFA). Items that
3. Add the results from no. 1 (average
do not fall into a factor (because they do not correlate
sentence length) and no. 2 (percentage of
with other items) may be deleted (DeVon et al., 2007;
long words). Multiply the sum by 0.4.
Munro, 2005; Stommel, Wang, Given, & Given, 1992;
Ignore the numbers after the decimal point.
Waltz et al., 2010). A more extensive discussion of
4. The result is the years of schooling needed
EFA and CFA is presented in Chapter 23.
to understand the passage tested easily.
Johnson and Rogers (2006) conducted an EFA to
Few readers have more than 17 years of
determine the factor structure for their MTQ: Pur-
schooling, so give any passage higher than
poseful Action scale. The EFA identifies the specific
17 a Fog Index of 17-plus.
factors or subscales for the scale and the items that fit
each of these subscales. The original scale had 20
Adapted from Gunning, R., & Kallan, R. A. (1994). items sorted into three subscales (labeled perceived
How to take the fog out of business writing. need, perceived effectiveness, and perceived as safe)
Chicago, IL: Dartnell. The Fog Index is a service that are identified in Table 16-2. The EFA and the
mark licensed exclusively to RK Communication
results are presented in Table 16-3 and described as
Consultants by D. and M. Mueller.
follows.
“Factor analysis is a grouping technique that allows for The Benefits subscale retained nine items that focused
evaluation of the dimensionality of scales (Munro, 2001; on the actual perceived benefits of treatment, such as
Nunnally & Bernstein, 1994). A principal axis factoring preventing a stroke, controlling blood pressure, prevent-
solution with an oblimen rotation, considered the best ing further health problems, and feeling better when
analysis for achieving a theoretical solution uncontami- taking medications, which indicated a desire to control
nated by unique and random error variability was blood pressure to maintain and promote health and
undertaken.… well-being. The subscale had an eigenvalue of 5.5 and a
The EFA yielded two interpretable factors [see Table total item variance explained by the factor of 46%.…
16-3], which eliminated six additional items because of The Safety subscale (three items) focused on side
factor loadings < 0.40. The first factor merged the need effects of medications. This subscale had an eigenvalue
and effectiveness items along with one item from the of 1.9 and a total item variance explained by the factor
Safe subscale. This factor was renamed treatment ben- of 16%.… Together, the two factor solution had a coef-
efits (benefits). The second factor, renamed medication ficient alpha [Cronbach alpha] of 0.87 and an explained
safety (safety), was reduced to three of the original safe variance of 62%.” (Johnson & Rogers, 2006, pp.
subscales items. 343-346)

TABLE 16-3 Principal Axis Factor Analysis with Oblimen Rotation Pattern (and Structure
in Parentheses) Coefficients for the Medication-Taking Questionnaire:  
Purposeful Action Two-Factor Solution
Factor Loadings
Eigen- % Variance Coefficient
1 2 h2 value Explained Alpha
Treatment benefits 5.5 45.9 0.90
I need to take my blood pressure 0.84 (0.85) (0.34) 0.73
pills.
Taking my blood pressure pills is 0.82 (0.84) (0.35) 0.72
not a problem because they
benefit my health.
I could have problems if I do not 0.81 (0.84) (0.21) 0.70
take my blood pressure pills.
Blood pressure pills keep me from 0.81 (0.79) (0.16) 0.63
having health-related problems.
My blood pressure pills keep me 0.75 (0.75) (0.23) 0.55
from having a stroke.
I feel better when I take my blood 0.74 (0.74) (0.21) 0.55
pressure pills.
My blood pressure pills control my 0.74 (0.74) (0.26) 0.55
blood pressure.
I am OK if I do not take my blood 0.72 (0.71) 0.52
pressure pills.*
My blood pressure will come 0.54 (0.48) 0.30
down enough without pills.*
Medication safety 1.9 15.6 0.80
The side effects from my blood (0.19) 0.87 (0.86) 0.74
pressure pills are harmful.*
The side effects from my blood (0.27) 0.84 (0.86) 0.71
pressure pills are a problem.*
My blood pressure pills cause (0.29) 0.82 (0.83) 0.70
other health problems.*
Total 7.4 61.5 0.88

From Johnson, M. J., & Rogers, S. (2006). Development of the Purposeful Action Medication-Taking Questionnaire. Western Journal of Nursing Research,
28(3), 345.
Note: n = 229.
*Item required reverse coding. Factor loadings in parentheses represent structure coefficients. If patterned or structure coefficient is not listed, the value was
<0.15.
400 UNIT TWO  The Research Process

Johnson and Rogers (2006) provided a clear, young children, and the researcher may choose to
concise rationale for the revisions that they made in develop a new instrument for a study. In examining
their MTQ: Purposeful Action scale. In this study, the the validity of the new instrument, it is important to
revised scale showed internal consistency (Cronbach determine how closely the existing instruments
alpha = 0.87) and construct validity obtained through measure the same construct as the newly developed
content analysis and EFA. Johnson and Rogers (2006, instrument (convergent validity). One can administer
p. 348) also conducted CFA that “supported the all of the instruments (the new one and the existing
hypothesis that benefits and safety [factors or sub- ones) to a sample concurrently and evaluate the results
scales] underlie the cognitive component of medica- using correlational analyses. If the measures are highly
tion taking in hypertensive medications.” positively correlated, the validity of each instrument
is strengthened.
Validity from Structural Analysis Johnson and Rogers (2006) strengthened the valid-
Structural analysis is used to examine the structure of ity of their 12-item MTQ: Purposeful Action scale
relationships among the various items of an instru- and its subscales (benefit and safety) by correlating
ment. This approach provides insights beyond that them with a variety of other instruments (Hamilton
provided by factor analysis. Factor analysis deter- Health Belief Model Hypertension [HBM] Scale with
mines what items group together. Structural analysis the HBM subscales of Susceptibility, Severity, Bene-
determines how each item is related to other items. fits, and Barriers; Lifestyle Busyness Questionnaire
Structural analysis goes a step beyond factor analysis. with Busyness and Routine subscales; and Blood
The exact relationship of each item in a factor is exam- Pressure Feedback Log). The results of these correla-
ined through correlational analyses. tions are presented in Table 16-4. The significant
positive correlations of 0.3 to 0.63 between the exist-
Convergent Validity ing scales (Hamilton HBM Scale with Susceptibility
In some cases, instruments are available to measure a and Benefits subscales and the Blood Pressure Feed-
construct, such as depression. However, for many pos- back Log for adherent group) and the MTQ and the
sible reasons, the existing instruments may be unsat- benefits subscale add to the construct validity of these
isfactory for a particular purpose or a particular instruments. This is an example of examining conver-
population, such as measuring major depression in gent validity for this scale, which was strong for the

TABLE 16-4 Validity Correlation Coefficients for the Medication-Taking Questionnaire: Purposeful
Action and Subscales
MTQ: Purposeful Action MTQ Benefit Subscale MTQ Safe Subscale
Hamilton HBM Scalea 0.30** 0.43** −0.12
HBM: Susceptibility subscale 0.36** 0.41** 0.01
HBM: Severity subscale 0.00 0.12 −0.27**
HBM: Benefits subscale 0.58** 0.63** 0.19
HBM: Barriers subscale −0.49** −0.42** −0.41**
Lifestyle Busyness Questionnaireb 0.08 0.11 −0.02
Busyness subscale 0.10 0.13 0.01
Routine subscale −0.07 −0.06 −0.06
Blood Pressure Feedback Logc
  Adherent 0.53** 0.54** 0.25*
  Nonadherent −0.60** −0.50** −0.53**

From Johnson, M. J., & Rogers, S. (2006). Development of the Purposeful Action Medication-Taking Questionnaire. Western Journal of Nursing Research,
28(3), 347.
HBM, Health Belief Model Hypertension Scale.
a
n = 107.
b
n = 104.
c
n = 102.
*p < 0.05, two-tailed.
**p < 0.01, two-tailed.
CHAPTER 16  Measurement Concepts 401

MTQ and the benefit subscale but not the safety depression, and retired Roman Catholic nuns, as
subscale. described in the following excerpt.

Divergent Validity
Sometimes, instruments can be located that measure a “The community college sample was chosen for its
construct opposite to the construct measured by the heterogeneous mix of students and ease of access.
newly developed instrument (divergent validity). For Depressed clients were included based on the litera-
example, if the newly developed instrument measures ture and the researcher’s clinical experience that
hope, you could search for an instrument that mea- interpersonal relationships and feeling ‘connected’
sures hopelessness or despair. If possible, you could are difficult when one is depressed. It was hypothe-
administer this instrument and the instruments used to sized that the depressed group would score signifi-
test convergent validity at the same time. This approach cantly lower on the SOBI than the student group. The
of combining convergent and divergent validity testing nuns were selected to examine the performance of
of instruments is called multitrait-multimethod the SOBI with a group that, in accordance with the
(MT-MM). theoretical basis of the instrument, should score sig-
The MT-MM approach can be used when research­ nificantly higher than the depressed and student
ers are examining two or more constructs being mea- groups.” (Hagerty & Patusky, 1995, p. 10)
sured by two or more measurement methods (DeVon
et al., 2007). Correlational procedures are conducted The nuns had the highest sense of belonging, the
with the different scales and subscales. If the conver- student groups followed, and the depressed group had
gent measures positively correlate and the divergent the lowest sense of belonging. This test increased the
measures negatively correlate with other measures, validity of the instrument in that the scores of groups
validity for each of the instruments is strengthened. were as anticipated.
Johnson and Rogers (2006) used an MT-MM ap-
proach in examining convergent and divergent valid- Evidence of Validity from
ity related to their MTQ: Purposeful Action. The Discriminant Analysis
convergent validity findings were discussed in the Instruments sometimes have been developed to
previous section. Table 16-4 shows that the MTQ and measure constructs closely related to the construct
the subscales benefits and safety were significantly, measured by a newly developed instrument. For
negatively correlated with HBM Barriers subscale example, an instrument might exist to measure medi-
and the Blood Pressure Feedback Log for nonadher- cation management in patients with diabetes that is
ent hypertensive patients. These scales measure the similar to the MTQ: Purposeful Action developed by
opposite construct from the MTQ and its subscales, Johnson and Rogers (2006) for patients with hyperten-
so these significant negative correlations indicated sion. If such instruments can be located, you can
that the construct validity was strengthened for these strengthen the validity of the MTQ instrument and the
instruments. The correlations with the Lifestyle other medication management instrument by testing
Busyness Questionnaire were too low (−0.07 to 0.13) the extent to which the two instruments can finely
to add to the convergent or divergent validity of the discriminate between these related concepts. Testing
MTQ: Purposeful Action scale and subscales (see of this discrimination involves administering the two
Table 16-4). instruments simultaneously to a sample and perform-
ing a discriminant analysis (see Kerlinger & Lee,
Validity from Contrasting (or Known) Groups 2000, for a discussion of discriminant analysis).
To test the validity of an instrument, identify groups
that are expected (or known) to have contrasting Validity from Prediction of Future Events and
scores on the instrument. Generate hypotheses about Concurrent Events
the expected response of each of these known groups The ability to predict future performance or attitudes
to the construct. Next, select samples from at least on the basis of instrument scores adds to the validity of
two groups that are expected to have opposing an instrument. Nurse researchers often want to deter-
responses to the items in the instrument. Hagerty mine the ability of scales developed to measure selected
and Patusky (1995) developed a measure called the health behaviors to predict the future health status of
Sense of Belonging Instrument (SOBI). They tested individuals. One approach might be to examine
the instrument on the following three groups: com- reported stress levels of selected individuals in highly
munity college students, clients diagnosed with major stressful careers such as nursing and see if stress is
402 UNIT TWO  The Research Process

linked to the nurses’ future incidence of hypertension. assumed to be accurate and precise, an assumption
If study analysis links stress to future hypertension, that is not always correct. The most common physi-
measuring a nurse’s stress could be used to predict his ological measures used in nursing studies are blood
or her future likelihood of becoming hypertensive. For pressure, heart rate, weight, and temperature. These
example, the validity of the Nursing Stress Scale (NSS) measures are often obtained from the patient’s record
could be tested in this manner. French, Lenton, Walters, with no consideration given to their accuracy. It is
and Eyles (2000) did an expanded evaluation of the important to consider the possibility of differences
reliability and validity of the NSS with a random between the obtained value and the true value of phys-
sample of 2280 nurses working in a wide range of iological measures. Thus, researchers using physio-
healthcare settings. They noted that the NSS included logical measures need to provide evidence of the
nine subscales: death and dying, conflict with physi- accuracy and precision of their measures (Ryan-
cians, inadequate preparation, problems with supervi- Wenger, 2010).
sors, workload, problems with peers, uncertainty The evaluation of physiological measures may
concerning treatment, patients and their families, and require a slightly different perspective from that
discrimination. Confirmatory factor analyses sup- applied to behavioral measures, in that standards for
ported the factor structure. Cronbach alpha coefficients most biophysical measures are defined by national and
of eight of the subscales were 0.70 or higher. The NNS international organizations such as the International
showed reliability and validity in measuring stress in Organization of Standardization (IOS) (2011a) and the
nurses and could be used in a study to determine the Clinical Laboratory Standards Institute (CLSI) (2011).
link to hypertension. The accuracy of predictive valid- CLSI develops standards for laboratory and other
ity is determined through regression analysis. healthcare-related biophysical measures. The IOS is
Validity can be tested by examining the ability to the world’s largest developer and publisher of interna-
predict the current value of one measure on the basis tional standards and includes a network of 160 coun-
of the value obtained on the measure of another tries (see IOS website for details at http://www.iso.org/
concept. For example, you might be able to predict the iso/home.htm). The ISO standards were developed to
self-esteem score of an individual who had a high accomplish the following:
score on an instrument to measure coping. A person • Make the development, manufacturing, and supply
who received a high score on coping might be expected of products and services more efficient, safer, and
also to have a high self-esteem score. If these results cleaner
held true in a study in which both measures were • Facilitate trade between countries and make it
obtained concurrently, the two instruments would fairer
have evidence of concurrent validity. • Provide governments with a technical base for
health, safety, and environmental legislation and
Successive Verification of Validity conformity assessment
After the initial development of an instrument, it is • Share technological advances and good manage-
hoped that other researchers would begin using the ment practice
instrument in additional studies. Each of these studies • Disseminate innovations
could add to the validity and reliability information on • Safeguard consumers and users in general of prod-
the instrument. There is a successive verification of ucts and services
the validity of the instrument over time when used in • Make life simpler by providing solutions to
a variety of studies with different populations and set- common problems (ISO, 2011b)
tings. For example, additional researchers are using You can locate the standards for different biophysi-
the MTQ: Purposeful Action in their studies, which cal equipment, products, or services that you might
has the potential to add to the validity of this question- use in a study or in clinical practice. Within IOS, the
naire (Lehane & McCarthy, 2007). Joint Committee for Guides in Metrology (JCGM) has
two major areas of focus: (1) Guide to the Expression
of Uncertainty in Measurement (GUM) and (2) Inter-
Accuracy, Precision, and Error of national Vocabulary of Basic and General Terms in
Metrology (VIM) (JCGM, 2011). VIM is a document
Physiological Measures that standardizes terminology related to biophysical
Accuracy and precision of physiological and biochem- measurements, such as accuracy, precision, error, sen-
ical measures tend not to be reported in published sitivity, specificity, and likelihood ratio that are
studies. These routine physiological measures are described in this section.
CHAPTER 16  Measurement Concepts 403

Accuracy researcher must choose instruments that have selectiv-


Accuracy involves determining the closeness of the ity for the dimension being studied. For example, elec-
agreement between the measured value and the true trocardiographic readings allow one to differentiate
value of the quantity being measured (JCGM, 2011). electrical signals coming from the myocardium from
Accuracy is similar to validity, in which evidence of similar signals coming from skeletal muscles.
content-related validity addresses the extent to which To determine the accuracy of biochemical mea-
the instrument measured the construct or domain sures, review the standards set by CLSI (2011) and
defined in the study. New measurement devices are determine if the laboratory where the measures are
compared with existing standardized methods of mea- going to be obtained is certified. Most laboratories are
suring a biophysical property or concept. For example, certified, so researchers could contact experts in the
measures of oxygen saturation with a pulse oximeter agency on the laboratory procedure and ask them to
were correlated with arterial blood gas measures of describe the process for collection, analysis, and
oxygen saturation to determine the accuracy of the values obtained for specimens. You might also ask
pulse oximeter. Thus, there should be a very strong, these experts to judge the appropriateness of the bio-
positive correlation (≥0.95) between pulse oximeter physical device for the construct being measured in
and blood gas measures of oxygen saturation to the study. Use contrasted groups’ techniques by select-
support the accuracy of the pulse oximeter (CLSI, ing a group of subjects known to have high values on
2011). the biochemical measures and comparing them with a
Accuracy of physiological measures depends on group of subjects known to have low values on the
the (1) quality of the measurement equipment or same measure. In addition, to obtain concurrent valid-
device, (2) detail of the data collection plan, and (3) ity, compare the results of the test with results from
expertise of the data collector (Ryan-Wenger, 2010). the use of a known standard (CLSI, 2011), such as the
The data collector or person conducting the biophysi- example of the comparison of pulse oximeter values
cal measures must do the measurements in a standard- with blood gas values for oxygen saturation.
ized way that is usually directed by a measurement
protocol. For example, BP readings in a study need to Precision
be taken using a protocol: (1) place the subject in a Precision is the degree of consistency or reproduc-
chair and allow 5 minutes of rest; (2) remove restric- ibility of measurements made with physiological
tive clothing from the subject’s arm; (3) measure the instruments or devices. There should be close agree-
subject’s upper arm and select the appropriate cuff ment in the replicated measures of the same variable
size; (4) instruct the subject to place his or her feet flat or object under specified conditions (Ryan-Wenger,
on the floor; (5) support the subject’s arm when taking 2010). Precision is similar to reliability. The precision
the BP reading; and (6) take three BP readings each 5 of most physiological devices or equipment is deter-
minutes apart, average the readings, and enter the mined by the manufacturer and is part of quality
averaged BP reading into a computer. Some measure- control testing done in the agency using the device.
ments, such as arterial pressure, can be obtained by Similar to accuracy, precision depends on the collector
the biomedical device producing the reading and auto- of the biophysical measures and the consistency of the
matically recorded in a computerized database. This measurement equipment or device. The protocol for
type of data collection greatly reduces the potential for collecting the biophysical measures improves preci-
error and increases accuracy and precision. sion and accuracy (see the previous example of pro-
The biomedical device or equipment used to tocol to measure BP).
measure a study variable must be examined for accu- The data collectors need to be trained to ensure
racy. Researchers need to document the extent to consistency, which is documented with intrarater
which the biophysical measure is an accurate mea- (within a single data collector) and interrater (among
surement of a study variable and the level of error data collectors) percentages of agreements. The kappa
expected. Reviewing the ISO (2011b) and CLSI coefficient of agreement is one of the most common
(2011) standards could provide essential accuracy and simplest statistics to determine intrarater and
information and information about the company that interrater accuracy and precision for nominal level
developed the device or equipment. data (Cohen, 1960; Ryan-Wenger, 2010). The equip-
Selectivity, an element of accuracy, is “the ability ment and devices used to measure physiological vari-
to identify correctly the signal under study and to ables need to be maintained according to the standards
distinguish it from other signals” (Gift & Soeken, set by IOS and the manufacturers of the devices. Many
1988, p. 129). Because body systems interact, the devices need to be recalibrated according to set criteria
404 UNIT TWO  The Research Process

to ensure consistency in measurements. Because of subject. In some cases, the machine may not be used
fluctuations in some physiological measures, test- to its full capacity. Machine error may be related to
retest reliability might be inappropriate. calibration or to the stability of the machine. Signals
Two procedures are commonly used to determine transmitted from the machine are also a source of error
the precision of biochemical measures. One is the and can cause misinterpretation (Ryan-Wenger, 2010).
Levy-Jennings chart. For each analysis method, a Sources of error in biochemical measures are bio-
control sample is analyzed daily for 20 to 30 days. The logical, preanalytical, analytical, and postanalytical.
control sample contains a known amount of the sub- Biological variability in biochemical measures is due
stance being tested. The mean, the standard deviation, to factors such as age, gender, and body size. Vari-
and the known value of the sample are used to prepare ability in the same individual is due to factors such as
a graph of the daily test results. Only 1 value of 22 is diurnal rhythms, seasonal cycles, and aging. Preana-
expected to be greater than or less than 2 standard lytical variability is due to errors in collecting and
deviations from the mean. If two or more values are handling of specimens. These errors include sampling
more than 2 standard deviations from the mean, the the wrong patients; using an incorrect container, pre-
method is unreliable in that laboratory. Another servative, or label; lysis of cells; and evaporation.
method of determining the precision of biochemical Preanalytical variability may also be due to patient
measures is the duplicate measurement method. The intake of food or drugs, exercise, or emotional stress.
same technician performs duplicate measures on ran- Analytical variability is associated with the method
domly selected specimens for a specific number of used for analysis and may be due to materials, equip-
days. The results are essentially the same each day if ment, procedures, and personnel used. The major
there is high precision. Results are plotted on a graph, source of postanalytical variability is transcription
and the standard deviation is calculated on the basis error. This source of error can be greatly reduced by
of difference scores. The use of correlation coeffi- entering data into the computer directly (DeKeyser &
cients is not recommended (DeKeyser & Pugh, 1990). Pugh, 1990).
When the scores obtained in a study are at the
Sensitivity interval or ratio level, a commonly used method of
Sensitivity of physiological measures relates to “the evaluating precision and accuracy errors is the Bland-
amount of change of a parameter that can be measured Altman chart (Bland & Altman, 1986). This chart is a
precisely” (Gift & Soeken, 1988, p. 130). If changes scatter plot of the differences between observed scores
are expected to be small, the instrument must be very on the Y-axis and the combined mean of the two
sensitive to detect the changes. Thus, sensitivity is methods on the X-axis. The distribution of the differ-
associated with effect size (see Chapter 15). With ence scores is examined in context of the limits of
some instruments, sensitivity may vary at the ends of agreement that are drawn as a horizontal line across
the spectrum. This is referred to as the frequency the chart or scatter plot (see Chapter 23). The limits
response. The stability of the instrument is also related are set by the researchers and might include 1 or 2
to sensitivity. This feature may be judged in terms of standard deviations from the mean or might be the
the ability of the system to resume a steady state after clinical standards of the maximum amount of error
a disturbance in input. For electrical systems, this that is safe. The data points are examined for level of
feature is referred to as freedom from drift (Gift & agreement (congruence) and for level of bias (system-
Soeken, 1988). atic error). Outliers are readily visible from the chart,
and each outlier case should be examined to identify
Error the cause of such a large discrepancy. Clinical labora-
Sources of error in physiological measures can be tory standards indicate that “more than 3 outliers per
grouped into the following five categories: environ- 100 observations suggest there are major flaws in the
ment, user, subject, machine, and interpretation. The measurement system” (Ryan-Wenger, 2010, p. 381).
environment affects both the machine and the subject. Schell et al. (2011) conducted a study to compare
Environmental factors include temperature, baromet- upper arm and calf automatic noninvasive BPs in chil-
ric pressure, and static electricity. User errors are dren in a pediatric intensive care unit (PICU). The
caused by the person using the instrument and may be researchers documented the accuracy of their BP mon-
associated with variations by the same user, different itoring equipment, training of their data collectors, and
users, changes in supplies, or procedures used to the procedures for taking the BPs in their study. The
operate the equipment. Subject errors occur when the errors in precision and accuracy are documented with
subject alters the machine or the machine alters the Bland-Altman charts for systolic BP, diastolic BP, and
CHAPTER 16  Measurement Concepts 405

mean arterial pressure readings. The chart of the sys-


tolic BP is included as an example in Figure 16-10. larger cuff was selected. Using a paper tape measure,
This study was conducted to determine an alternative arm circumference was obtained at the point halfway
method of obtaining BP when the injuries of the child between the elbow and the shoulder. Calf circumfer-
prevent BP readings using the upper arm. ence was measured at the point midway between the
ankle and the knee. The BP cuffs were applied to the
arm and calf on the same side. Subjects’ extremities
were positioned at the side of their bodies, resting on
“BP Monitor the bed, for all measurements.… Systolic, diastolic,
“BP was obtained using a Spacelabs Ultraview SL and mean BP values for the arm and calf as well as a
monitoring system (Spacelabs Healthcare, Issaquah, simultaneous heart rate were documented. Data col-
WA), which consists of hemodynamic parameter lectors notified the child’s nurse or physician if an
modules that can be inserted into stationary bedside abnormal arm reading was obtained.” (Schell et al.,
and portable monitor housings. All monitoring func- 2011, pp. 6-7)
tions were controlled through the modules. During “To promote best practice, clinicians should base
data collection, each set of arm and calf BP measure- treatment choices on individual patient data, not
ments was obtained simultaneously using two identi- group data. Therefore, Bland-Altman analyses were
cal parameter modules: one inserted into the subject’s used to determine agreement between arm and calf
stationary bedside housing and the other inserted in oscillometric BPs for individual subjects. Perfect
to a portable monitor housing brought to the sub- agreement occurs when all data points lie on the line
ject’s bedside. Modules and housings are inspected of equality of the X-axis. The bias (mean difference
and tested annually by Biomedical Support Services between arm and calf pressures) systolic BP was
to ensure accurate functioning. The accuracy of these 8.0 mm Hg with the limits of agreement −18.9 and
monitors for arm BPs meets or exceeds SP10-1992 34.9 mm Hg. Limits of agreement indicated that 95%
Association for the Advancement of Medical Instru- of the sample falls between these values [see Figure
mentation standards (mean error = ±4.5 mm Hg, SD 16-10]. The limits of agreement for diastolic BP were
= ±7.3 mm Hg) for arm measurements (White et al., −22.7 and 25.0 mm Hg with a bias of 1.1 mm Hg.”
1993). Spacelabs Healthcare did not report data (Schell et al., 2011, p. 9)
regarding accuracy of calf BPs.
“Training of Data Collectors
“Data were collected by five pediatric intensive care Schell et al. (2011) provided evidence of the accu-
nurses who attended a data training session that racy, precision, and error of the BP monitoring equip-
addressed location of arm and calf sites, measure- ment used in their study. They also provided a detailed
ment of limb circumference, and use of the RASS discussion of the procedures for data collection that
[Richmond Agitation Sedation Scale]. The nurses also followed a rigorous protocol to ensure accurate and
attended a BP monitor in-service offered by the precise BP readings were obtained for all ages of chil-
Spacelab representative when the monitors were dren based on their measured arm and calf sizes. The
adopted in the PICU in January 2006.… data collectors were trained in BP monitoring by the
Spacelab representative, which would increase their
“Procedure expertise in the use of the equipment. However, the
“Subjects were placed in a supine position with the study would have been strengthened by a discussion
head of bed elevated 30° as determined by a handheld of the intrarater and interrater percentage of agreement
protractor or the degree indicator incorporated into for the data collectors. The use of the Bland-Altman
the bed frame. Subjects remained in this position for plot to identify the error in precision and accuracy for
at least 5 minutes prior to data collection. Cuff sizes systolic BPs, diastolic BPs, and mean arterial pres-
were selected based on limb circumferences mea- sures added to the credibility of the findings. The
sured to the nearest 0.5 cm. Spacelabs cuff sizes were researchers found that the arm and calf BPs were not
as follows: neonate, 6-11 cm; infant, 8-11 cm; child, interchangeable for many of the children 1 to 8 years
12-19 cm; small adult, 17-26 cm; and adult, 24-32 cm. old. “Clinical BP differences were the greatest in chil-
Per manufacturer’s recommendations, if circumfer- dren between ages 2 and less than 5 years. Calf BPs
ence overlapped two categories of cuff size, the are not recommended for this population. If the calf is
unavoidable due to medical reasons, trending of BP
406 UNIT TWO  The Research Process

from this site should remain consistent during the & Haynes, 2000). When you order a diagnostic test,
child’s stay” (Schell et al., 2011, p. 10). how can you be sure that the results are valid or accu-
rate? This question is best answered by current, quality
research to determine the sensitivity and specificity of
60 the test.
Calf Systolic BP - Arm Systolic BP

40 +1.96 SD Sensitivity and Specificity


34.9 The accuracy of a screening test or a test used to
20 confirm a diagnosis is evaluated in terms of its ability
Mean to assess correctly the presence or absence of a disease
0 8.0 or condition as compared with a gold standard. The
gold standard is the most accurate means of currently
–1.96 SD diagnosing a particular disease and serves as a basis
–20
–18.9 for comparison with newly developed diagnostic or
screening tests (Campo, Shiyko, & Lichtman, 2010).
–40 If the test is positive, what is the probability that the
60 80 100 120 140 160
disease is present? If the test is negative, what is the
AVERAGE of Calf Systolic BP and Arm Systolic BP
probability that the disease is not present? When you
Figure 16-10  Bland-Altman plot of systolic BP. (From Schell, K., talk to the patient about the results of their tests, how
Briening, E., Lebet, R., Pruden, K., Rawheiser, S., & Jackson, B. [2011]. sure are you that they do or do not have the disease?
Comparison of arm and calf automatic noninvasive blood pressures in Sensitivity and specificity are the terms used to
pediatric intensive care patients. Journal of Pediatric Nursing, 26[1], 9.) describe the accuracy of a screening or diagnostic test
(Table 16-5). There are four possible outcomes of a
screening test for a disease: (1) true positive, which
Sensitivity, Specificity, and accurately identifies the presence of a disease; (2) false
positive, which indicates a disease is present when it
Likelihood Ratios is not; (3) true negative, which indicates accurately
An important part of building evidence-based practice that a disease is not present; or (4) false negative,
(EBP) is the development, refinement, and use of which indicates that a disease is not present when it is
quality diagnostic tests and measures in research and (Campo et al., 2010; Grove, 2007). The 2 × 2 contin-
practice. Researchers want to use the most accurate gency table shown in Table 16-5 should help you to
and precise measure or test in their study to promote visualize sensitivity and specificity and these four out-
quality outcomes. If a quality diagnostic test does not comes (Craig & Smyth, 2012; Sackett et al., 2000).
exist, some nurses have participated in the develop- Sensitivity and specificity can be calculated based
ment and refinement of new biophysical tests. Clini- on research findings and clinical practice outcomes to
cians want to know what diagnostic test, such as determine the most accurate diagnostic or screening
laboratory or imaging study, to order to help screen tool to use in identifying the presence or absence of a
for and accurately determine the absence or presence disease for a population of patients. The calculations
of an illness (Sackett, Straus, Richardson, Rosenberg, for sensitivity and specificity are provided as follows:

TABLE 16-5 Results of Sensitivity and Specificity of Screening Tests


Diagnostic Test Result Disease Present Disease Not Present or Absent Total
Positive test a (true positive) b (false positive) a+b
Negative test c (false negative) d (true negative) c+d
Total a+c b+d a+b+c+d

From Grove, S. K. (2007). Statistics for health care research: A practical workbook. Philadelphia, PA: Saunders, p. 335.
a = The number of people who have the disease and the test is positive (true positive).
b = The number of people who do not have the disease and the test is positive (false positive).
c = The number of people who have the disease and the test is negative (false negative).
d = The number of people who do not have the disease and the test is negative (true negative).
CHAPTER 16  Measurement Concepts 407

Sensitivity calculation = probability of disease • Use the acronym SpPin: High specificity (Sp), test
= a/(a + c) is positive (P), rules the disease in (in).
= truee positive rate Sarikaya, Aktas, Ay, Cetin, and Celikmen (2010)
conducted a study to determine the sensitivity and
Specificity calculation = probability of disease specificity of rapid antigen diagnostic testing (RADT)
= d/(b + d) for diagnosing pharyngitis in patients in the emer-
= truee negative rate gency department. Acute pharyngitis is primarily a
viral infection, but in 10% of the cases it is caused by
Sensitivity is the proportion of patients with the bacteria. Most cases of bacterial pharyngitis are caused
disease who have a positive test result or true positive. by group A beta-hemolytic streptococci (GABHS).
The ways the researcher or clinician might refer to the One laboratory method for diagnosing GABHS is
test sensitivity include the following: RADT, which has become more popular than a throat
• Highly sensitive test is very good at identifying the culture because it can be processed rapidly during an
patient with a disease. emergency department and primary care visit.
• If a test is highly sensitive, it has a low percentage
of false negatives.
“We conducted a study to define the sensitivity and
• Low sensitivity test is limited in identifying the
specificity of RADT, using throat culture results as the
patient with a disease.
gold standard, in 100 emergency department patients
• If a test has low sensitivity, it has a high percentage
who presented with symptoms consistent with strep-
of false negatives.
tococal pharyngitis. We found that RADT had a sen-
• If a sensitive test has negative results, the patient
sitivity of 68.2% (15 of 22), a specificity of 89.7% (70
is less likely to have the disease.
of 78), a positive predictive value of 65.2% (15 of 23),
• Use the acronym SnNout: High sensitivity (Sn), test
and a negative predictive value of 90.9% (70 of 77).
is negative (N), rules the disease out (out) (Campo
We conclude that RADT is useful in the emergency
et al., 2010; Grove, 2007).
department when the clinical suspicion is GABHS, but
Specificity of a screening or diagnostic test is the
results should be confirmed with a throat culture in
proportion of patients without the disease who have a
patients whose RADT results are negative.” (Sarikaya
negative test result or true negative. The ways the
et al., 2010, p. 180)
researcher or clinician might refer to the test specific-
ity include the following:
• Highly specific test is very good at identifying The results of the study by Sarikaya et al. (2010)
patients without a disease. were put into Table 16-6 so that you might see how
• If a test is very specific, it has a low percentage of the sensitivity and specificity were calculated in this
false positives. study.
• Low specificity test is limited in identifying patients
without a disease. Sensitivity calculation = probability of disease
• If a test has low specificity, it has a high percentage = a/ (a + c) = true positive rate
of false positives.
• If a specific test has positive results, the patient is Sensitivity = probability of GABHS pharyngitis
more likely to have the disease. = 15/ (15 + 7) = 15 / 22 = 68.18% = 68.2%

TABLE 16-6 Results of Sensitivity and Specificity of Rapid Antigen Diagnostic Testing (RADT)
RADT Result GABHS Disease Present GABHS Disease Absent Total
Positive test a (true positive) = 15 b (false positive) = 8 a + b = 15 + 8 = 23
Negative test c (false negative) = 7 d (true negative) = 70 c + d = 7 + 70 = 77
Total a + c = 15 + 7 = 22 b + d = 8 + 70 = 78 a + b + c + d = 100

GABHS, Group A beta-hemolytic streptococci.


a = The number of people who have GABHS pharyngitis disease and the test is positive (true positive).
b = The number of people who do not have GABHS pharyngitis disease and the test is positive (false positive).
c = The number of people who have GABHS pharyngitis disease and the test is negative (false negative).
d = The number of people who do not have GABHS pharyngitis disease and the test is negative (true negative).
408 UNIT TWO  The Research Process

Specificity calculation = probability of disease to read clinical studies and to determine the most
= d/ ( b + d) = true negative rate accurate diagnostic test to use in research and clinical
practice.
Specificity = probability no GABHS pharyngitis
= 70 / (8 + 70) = 70 / 78 = 89.74% = 89.7%
KEY POINTS
The sensitivity of 68.2% indicates the percentage
of patients with a positive RADT who had GABHS • Measurement is the process of assigning numbers
pharyngitis (true positive rate). The specificity of to objects, events, or situations in accord with some
89.7% indicates the percentage of patients with a rule.
negative RADT who did not have GABHS pharyngitis • Instrumentation is the application of specific rules
(true negative rate). In developing a diagnostic or to develop a measurement device or instrument.
screening test, researchers need to achieve the highest • Measurement theory and the rules within this
sensitivity and specificity possible. In selecting screen- theory have been developed to direct the measure-
ing tests to diagnose illnesses, clinicians need to deter- ment of abstract and concrete concepts.
mine the most sensitive and specific screening test but • There is direct measurement and indirect measure-
also need to examine cost and ease of access to these ment.
tests in making their final decision (Craig & Smyth, • Healthcare technology has made researchers famil-
2012; Grove, 2007; Sackett et al., 2000). iar with direct measures of concrete elements, such
as height, weight, heart rate, temperature, and
Likelihood Ratios blood pressure.
Likelihood ratios (LRs) are additional calculations • Indirect measurement is used with abstract con-
that can help researchers to determine the accuracy of cepts, when the concepts are not measured directly,
diagnostic or screening tests, which are based on the but when the indicators or attributes of the concepts
sensitivity and specificity results. LRs are calculated are used to represent the abstraction. Common
to determine the likelihood that a positive test result abstract concepts measured in nursing include
is a true positive and a negative test result is a true anxiety, stress, coping, quality of life, and pain.
negative. The ratio of the true positive results to false • Measurement error is the difference between what
positive results is known as the positive LR (Campo exists in reality and what is measured by a research
et al., 2010). The positive LR is calculated as follows instrument.
using the data from the study by Sarikaya et al. (2010): • The levels of measurement, from lower to higher,
are nominal, ordinal, interval, and ratio.
Positive LR = sensitivity ÷ 100% - specificity • Reliability refers to how consistently the measure-
ment technique measures the concept of interest
Positive LR for GABHS pharyngitis and includes stability reliability, equivalence reli-
= 68.2% ÷ 100% − 89.7% = 68.2% ÷ 10.3% = 6.62 ability, and internal consistency.
• The validity of an instrument is determined by
The negative LR is the ratio of true negative the extent to which the instrument actually
results to false negative results, and it is calculated reflects the abstract construct being examined and
as follows: includes such types as face and content validity,
validity from factor analysis, validity from struc-
Negative LR = 100% − sensitivity ÷ specificity tural analysis, convergent validity, divergent valid-
ity, validity from contrasting groups, validity from
Negative LR for GABHS pharyngitis discriminant analysis, validity from prediction of
= 100% − 68.2% ÷ 89.7% = 31.8% ÷ 89.7% = 0.35 future and concurrent events, and successive veri-
fication validity.
The very high LRs (or LRs that are >10) rule in the • Evaluation of physiological measures requires a
disease or indicate that the patient has the disease. The different perspective from that of behavioral mea-
very low LRs (or LRs that are <0.1) virtually rule out sures and requires evaluation for accuracy, preci-
the chance that the patient has the disease (Campo sion, and error.
et al., 2010; Craig & Smyth, 2012; Melnyk & Fineout- • The accuracy of screening or diagnostic tests is
Overholt, 2011; Sackett et al., 2000). Understanding determined by calculating the sensitivity, specific-
sensitivity, specificity, and LR increases your ability ity, and likelihood ratios for the test.
CHAPTER 16  Measurement Concepts 409

Dickerson, S. S., Kennedy, M., Wu, Y. B., Underhill, M., & Othman,
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  http://evolve.elsevier.com/Grove/practice/

17 CHAPTER

Measurement Methods Used in


Developing Evidence-Based Practice

N
ursing research examines a wide variety of discussed include Q-sort methodology, the Delphi
phenomena, requiring an extensive array of technique, diaries, and use of existing databases. The
measurement methods. However, nurse re- chapter also describes the process for locating existing
searchers have sometimes found limited instruments instruments, determining their reliability and validity,
available to measure phenomena central to the studies and assessing their readability. Directions are pro-
essential for generating evidence-based practice vided for describing an instrument in a written report.
(EBP). Thus, for the last 30 years, nurse researchers The chapter concludes with a description of the
have made it a priority to develop valid and reliable process of scale construction and issues related to
instruments to measure phenomena of concern to translating an instrument into another language.
nursing. As a result, the number and quality of mea-
surement methods have greatly increased (DeVon
et al., 2007; Waltz, Strickland, & Lenz, 2010). Physiological Measurement
Knowledge of measurement methods is important Much of nursing practice is oriented toward physio-
to all aspects of nursing. To perform a critical logical dimensions of health. Therefore, many of our
appraisal of a study, nurses need knowledge of mea- questions require us to be able to measure these di-
surement theory and an understanding of the state of mensions. Of particular importance are studies linking
the art for developing instruments to examine the physiological, psychological, and social variables.
phenomena under study. For example, when evaluat- The need for physiological research reached national
ing someone else’s research, you might want to know attention in 1993 when the National Institute of
whether the researcher was using an older tool that Nursing Research (NINR) recommended an increase
has been surpassed by more precise and accurate in physiologically-based nursing studies because 85%
physiological measures. It might help you to know of NINR-funded studies involved nonphysiological
that measuring a particular phenomenon has been a variables. According to NINR staff, a review of physi-
problem with which nurse researchers have struggled ological studies funded by the NINR found that “the
for many years. Your understanding of the successes biological measurements used in the funded grants
and struggles in measuring nursing phenomena may often were not state-of-the-science, and the biological
stimulate your creative thinking and lead you to con- theory underlying the measurements often was unde-
tribute your own research to the development of mea- rutilized” (Cowan, Heinrich, Lucas, Sigmon, & Hin­
surement approaches. Some nursing phenomena have shaw, 1993, p. 4). Cowan et al. proposed a 10-year
not been adequately examined because reliable and plan to enhance the education of nurse researchers in
valid instruments are not available to measure them, physiological measurement, expand the number and
which makes it difficult for nurse researchers to gen- quality of physiological studies conducted, and in-
erate the essential evidence needed for practice crease the funding for physiological research. Rudy
(Brown, 2009; Craig & Smyth, 2012; Melnyk & and Grady (2005) noted in their small study of funded
Fineout-Overholt, 2011). researchers (N = 31) that nursing is building a group
This chapter describes the common measurement of nurse scientists who are committing their research
approaches used in nursing research, including physi- careers to studying various biological and pathological
ological measures, observations, interviews, question- phenomena. Over the last 15 years, nurse researchers
naires, and scales. Other methods of measurement have expanded their use and development of precise

411
412 UNIT TWO  The Research Process

and accurate physiological measures. An example is when study participants experience a physiological
the current research taking place in genetics, which phenomenon that cannot be observed or measured
was encouraged by Grady, Director of the NINR, with by others. Nonobservable physiological phenomena
the implementation of the Summer Genetics Institute include pain, nausea, dizziness, indigestion, patterns
(SGI) to expand the conduct of genomic research of hunger or thirst, hot flashes, tinnitus, pruritus,
(NINR, 2012). fatigue, malaise, and dyspnea (DeVon et al., 2007;
The 2011 Strategic Plan for NINR emphasized the Waltz et al., 2010).
conduct of biological research to provide a foundation Bhengu et al. (2011) studied the physiological
for understanding and managing diseases and to test symptoms experienced by individuals infected with
preventive care and self-management strategies. NINR human immunodeficiency virus (HIV) and receiving
(2011) proposed to invest in research to “[i]mprove antiretroviral therapy. These physiological symptoms
quality of life by managing symptoms of chronic were measured using a self-report checklist completed
illness,” which will require expansion in the number of by the HIV-infected patients. The measurement
biologically based studies and the quality of physiolog- method was the revised Sign and Symptom Checklist
ical measurements used in these studies (see the NINR for HIV patients (SSC-HIVrev) developed by Holze-
most current Mission and Strategic Plan document at mer et al. (1999) and revised by Holzemer, Hudson,
http://www.ninr.nih.gov/AboutNINR/NINRMission Kirksey, Hamilton, and Bakken (2001). The SSC-
andStrategicPlan/). The increased number of biological HIVrev instrument is described in the following
researchers and the expanded funding for biological excerpt.
research have increased the quality and quantity of
physiological measures used in nursing studies.
Physiological measures include two categories, “[The SSC-HIVrev has been widely used and] found
biophysical and biochemical. Biophysical measures to be valid and reliable for measuring HIV-related
might include the use of the stethoscope and sphyg- symptoms.… Respondents report the presence and
momanometer to measure blood pressure, and a bio- intensity of the symptoms based on the following:
chemical measure might include the laboratory value ‘Below is a list of potential problems related to HIV
for total cholesterol. Physiological measures can be that you may be experiencing today. If you have the
acquired in a variety of ways from instruments within problems, please rate the degree of intensity of the
the body (in vivo), such as a reading from an arterial problem. If you do not have the problem, do not
line, or from application of an instrument on the outside check a box.’
of a subject (in vitro), such as a blood pressure cuff Items are scored using the following scale: 0 = not
(Stone & Frazier, 2010). The following sections checked, 1 = mild, 2 = moderate, and 3 = severe.
describe how to obtain physiological measures by self- Total symptom score is a count of the number of
report, observation, direct or indirect measurement, symptoms checked as present on the day of complet-
laboratory tests, electronic monitoring, and the creative ing the questionnaire, ranging from 0 to 72. A total
development of new instruments. The measurement of symptom intensity score is a weighting of symptoms
physiological variables across time is also addressed. based on the 1-to-3 scale of mild, moderate, or
This section concludes with a discussion of how to severe. Prior studies indicate that the six factors have
select physiological measures for a particular study. strong reliability estimates and stable factor structure
that supports the construct validity of the 26-item
Obtaining Physiological Measures instrument. Additional evidence supports the concur-
by Self-Report rent validity of the scale as well as its sensitivity to
Self-report has been used effectively to obtain physi- change over time. The final version of the SSC-HIVrev
ological information and may be particularly useful (Parts I and II; Holzemer et al., 2001) used in this
when the subjects are not in closely monitored settings study is a 26-item scale available for use by clinicians
such as hospitals, clinics, or research facilities. Phe- and researchers to measure the patient’s self-report
nomena that have been or could be measured by self- of HIV-related signs and symptoms. In this study,
report include hours of sleep, patterns of daily alpha reliabilities ranged from .77 to .91 (malaise/
activities, eating patterns, dieting patterns, stool fre- fatigue = .91, confusion/distress/pain = .89, fever/
quency and consistency, patterns of joint stiffness, chills = .83, gastrointestinal discomfort = .85, short-
variations in degree of mobility, and exercise patterns. ness of breath = .80, and nausea/vomiting = .77).”
For some variables, self-report may be the only means (Bhengu et al., 2011, pp. 4-5)
of obtaining the information. Such may be the case
CHAPTER 17  Measurement Methods Used in Developing Evidence-Based Practice 413

The self-report SSC-HIVrev scale was refined by criterion validity of the tool and the interrater reli-
Holzemer et al. (1999, 2001) over the years and has ability of the data collectors. The following excerpt
documented reliability and validity. The SSC-HIVrev describes development of the NPAT and its demon-
has demonstrated construct validity through factor strated reliability and validity.
analysis, with six factors being identified, and concur-
rent validity. The scale has strong reliability in previ-
ous studies and in this study for the total scale and the “Content validity examines the extent of the tool’s
six subscales (alpha reliabilities ranging from 0.77 to ability to measure the construct under consideration
0.91). Using self-report measures may enable nurses (in this study, pain). Construction of the scale began
to study research questions that were not previously with an in-depth review of the literature to determine
considered, which could be an important means to commonly accepted signs and behaviors of pain.
build knowledge in areas not yet explored. The insight Three nurse experts, including 2 clinical nurse special-
gained could alter the way nurses manage patient situ- ists and a nurse from the Pain Management Service,
ations that are now considered problematic and reviewed the tool and selected behaviors.
improve patient outcomes (Doran, 2011). However, Criterion-related validity compares the new tool to
self-report is a subjective way to measure physiologi- a ‘gold standard.’… We hypothesized that a significant
cal variables, and studies are strengthened by having correlation would be found between the NPAT score
both subjective and objective measurements of physi- and the patient’s self-report of pain, the ‘gold stan-
ological variables. dard’ for pain assessment.” (Klein et al., 2010, p. 523)
“The internal reliability for the entire scale was .82
Obtaining Physiological Measures (Cronbach’s alpha).… Subscale internal reliability
by Observation scores comprised: emotion, .77; movement, .78;
Researchers sometimes obtain data on physiological verbal, .79; facial, .77; and position, .78.… To deter-
parameters by using observational data collection mine the interrater reliability of the revised NPAT, a
measures. These measures provide criteria for quan- convenience sampling included all patients more than
tifying various levels or states of physiological func- 16 years old and admitted to any of the 4 ICUs during
tioning. In addition to collecting clinical data, this the data collection period. The same teams of nurses
method provides a means to gather data from the were used. Data were collected for 50 patients,
observations of caregivers. This source of data has although data from only 39 patients were useable.
been particularly useful in studies involving criti- The concordance correlation coefficient was .72
cally ill patients in intensive care units (ICUs) and (95% confidence interval), demonstrating strong
patients with Alzheimer’s disease, advanced cancer, interrater reliability.… The criterion validity of the
and severe mental illness. Observation is also an revised NPAT was again tested.… The concordance
effective way to gather data on frail elderly adults, correlation coefficient was .66 (95% confidence
infants, and young children. Studies involving home interval), indicating moderate to strong validity.”
health agencies and hospices often use observation (Klein et al., 2010, pp. 525-526)
tools to record physiological dimensions of patient
status. These data are sometimes stored electroni-
cally and are available to researchers for large data- Klein et al. (2010) found the NPAT had strong
base analysis. Measuring physiological variables internal reliability for both the total scale (Cron-
using observation requires a quality tool for data col- bach’s alpha = 0.82) and the subscales (Cronbach’s
lection and consistent use of this tool by data collec- alpha ranging from 0.77 to 0.79). Because the NPAT
tors. If the observations in a study are being is a new tool, these researchers described the content
conducted using multiple data collectors, it is essen- and criterion validity of the tool and recognized the
tial that the consistency or interrater reliability of the need for additional research to determine the reliabil-
data collectors be determined (see Chapter 16) ity and validity of the tool with different samples.
(Bialocerkowski, Klupp, & Bragge, 2010; DeVon The final copy of this tool is presented later in this
et al., 2007; Waltz et al., 2010). chapter.
Klein, Dumpe, Katz, and Bena (2010) developed a
Nonverbal Pain Assessment Tool (NPAT) to measure Obtaining Physiological Measures Directly
the pain experience by nonverbal adult patients in the or Indirectly
ICU. Testing of the tool occurred in three phases that Physiological variables can be measured either directly
focused on the internal reliability, content validity, and or indirectly. Direct measures are more accurate
414 UNIT TWO  The Research Process

because there is an objective measurement of the study


variable. For example, patients might be asked to Obtaining Physiological Measures from
report any irregular heartbeats during waking hours Laboratory Tests
over a 24-hour period, which is an indirect measure- Laboratory tests are usually very precise and accurate
ment of heart rhythm, and each patient’s heart could and provide direct measures of many physiological
be monitored with a Holter monitor over the same variables. Biochemical measures, such as total choles-
24-hour time frame (direct measure of heart rhythm). terol, triglycerides, hemoglobin, and hematocrit, must
Whenever possible, researchers usually select direct be obtained through invasive procedures. Sometimes
measures of study variables because of the accuracy these invasive procedures are part of routine patient
and precision of these measurement methods. care, and researchers, with institutional review board
However, if a direct measurement method does not (IRB) approval, can obtain the results from the
exist, an indirect measurement method could be used patient’s record. Although nurses are now performing
in the initial investigation of a physiological variable. some biochemical measures in the nursing unit, these
Sometimes researchers use both direct and indirect measures often require laboratory analysis. When
measurement methods to expand the understanding of invasive procedures are not part of routine care but are
a physiological variable. Dubbert, White, Grothe, instead performed specifically for a study, great care
O’Jile, and Kirchner (2006) studied the physical activ- must be taken to protect the subjects and to follow
ity of patients who are severely mentally ill. These guidelines for informed consent and IRB approval.
researchers measured the variable physical activity Neither the patients nor their insurers can be billed for
with indirect and direct measurement methods that are invasive procedures that are not part of routine care;
described in the following excerpt. thus, the researcher must seek external funding or the
institution in which the patient is receiving care must
agree to forego billing for the procedure.
Researchers need to ensure the accuracy and preci-
“Self-Reported Physical Activity sion of laboratory measures and the methods of col-
[Indirect Measurement] lecting specimens for their studies. The laboratory
“The 42-item Community Health Activities Model performing the analyses needs to be certified and in
Program for Seniors (CHAMPS) … was used to compliance with national standards developed by the
assess frequency and duration of a variety of physical Clinical and Laboratory Standards Institute (CLSI,
activities for the previous 4 weeks. The CHAMPS 2011). The data collectors need to be trained to ensure
yields estimates of kilocalorie (kcal) energy expendi- that intrarater reliability and interrater reliability are
ture per unit time and physical activity frequency. In maintained during the data collection process (see
nonclinical samples, CHAMPS scores have test-retest Chapter 16) (Bialocerkowski et al., 2010; Waltz et al.,
reliability intraclass correlations (ICCS) R = 0.76 for 2010). Smith, Annesi, Walsh, Lennon, and Bell (2010)
moderate and R = 0.66 for total estimated kcal expen- examined the effects of a behavioral treatment on vol-
diture over 6 months and validity correlations in the untary physical activity, self-efficacy, and risk factors
R = 0.20 to 0.30 range with performance on a for type 2 diabetes in obese preadolescents 10 to 14
6-minute walk test.… years old. The risk factors for diabetes measured in
this study included lipid values and glucose/insulin
“Objectively Measured Physical Activity ratio that were determined before and after the 12-week
[Direct Measurement] behavioral treatment. The following excerpt describes
“Participants wore RT3 (Stayhealthy, Inc., Monrovia, the blood analyses that were conducted in this study.
CA) accelerometers to obtain objective estimates of
daily physical activity. The RT3 instrument, about the
size of a pager, measures acceleration of movement “Blood Analyses
along three axes, which was averaged into a compos- “Total cholesterol, low-density lipoprotein (LDL)
ite score (i.e., vector movement [VM]), representing cholesterol, and high-density lipoprotein (HDL) cho-
the overall magnitude of activity for each minute. RT3 lesterol are measures of lipids in the blood. Each is
software transformed VM into an estimate of energy expressed as milligram per deciliter. For ages less than
expenditure (i.e., kcal per day and per hour), using 18 years, normal ranges are 125 to 170 mg/dl, less
participant’s height, weight, age, and gender.” than 110 mg/dl, and 38 to 76 mg/dl, respectively.
(Dubbert et al., 2006, p. 206) Generally, lower values on total cholesterol and LDL
CHAPTER 17  Measurement Methods Used in Developing Evidence-Based Practice 415

measure changes in body functions such as electrical


cholesterol and a higher value on HDL cholesterol are energy. Figure 17-1 shows the process of electronic
preferable. Glucose/insulin ratio is a measure of meta- measurement. Many sensors need an external stimulus
bolic functioning and expressed as a ratio of glucose to trigger the measurement process. Transducers
(mg/dl) to insulin (mcIU/ml). The target value is 7.0 convert the electrical signal to numerical data. Electri-
or above (Silfen et al., 2001). Generally, a higher score cal signals often include interference signals as well as
is preferable. Blood was drawn while participants the desired signal, so you may choose to use an ampli-
were in a fasting state and analyzed by Quest Diag- fier to decrease interference and amplify the desired
nostics (Madison, NJ) at no cost to participants’ fami- signal. The electrical signal is digitized (converted to
lies.” (Smith et al., 2010, p. 395) numerical digits or values) and stored in a computer.
In addition, it is immediately displayed on a monitor.
These researchers clearly described the blood anal- The display equipment may be visual or auditory or
yses performed in their study and the normal values both. One type of display equipment is an oscilloscope
for preadolescents. To promote precision and accuracy that displays the data as a waveform; it may provide
in the lipid values and the glucose/insulin ratios information such as time, phase, voltage, or frequency
obtained, the participants were instructed to fast and of the target event or behavior. The final phase is
the blood was analyzed in a certified laboratory (Quest the recording, data processing, and transmission that
Diagnostics). The blood was drawn in a physician’s might be done through computer, camera, graphic
office and transferred to the laboratory for analysis. recorder, or magnetic tape recorder (Stone & Frazier,
The study report would have been strengthened by a 2010). A graphic recorder provides a printed version
discussion of the data collection process in the physi- of the data. Some electronic equipment simultane-
cian’s office to ensure that the blood specimens were ously records multiple physiological measures that are
consistently collected and managed in the delivery to displayed on a monitor. The equipment is often linked
the laboratory. to a computer or might be wireless, which allows the
researcher to review the data. The computer often con-
Obtaining Physiological Measures through tains complex software for detailed analysis of the data
Electronic Monitoring and provides a printed report of the analysis results
The availability of electronic monitoring equipment (Pugh & DeKeyser, 1995; Stone & Frazier, 2010).
has greatly increased the possibilities of physiological The advantages of using electronic monitoring
measurement in nursing studies, particularly in critical equipment are the collection of accurate and precise
care environments. Understanding the processes data, recording of data accurately within a computer-
of electronic monitoring can make the procedure ized system, potential for collection of large amounts
less formidable to individuals critically appraising of data frequently over time, and transmission of data
published studies and individuals considering using electronically for analysis. One disadvantage of using
the method for measurement. certain sensors to measure physiological variables is
To use electronic monitoring, usually sensors are that the presence of a transducer within the body can
placed on or within study participants. The sensors alter the reading. For example, the presence of a flow

Signal
Sensing conditioning
equipment equipment

Transducer Amplifier

Stimulus Subject
Figure 17-1  Process of electronic measurement.
Signal Display
Electrodes
processor equipment

Recording, data processing,


and transmission equipment
416 UNIT TWO  The Research Process

“Developed by Cadi Scientific in Singapore as part of


an integrated wireless system for temperature moni-
toring and location tracking, this system uses a reus-
able skin-contact thermometer or sensor called the
ThermoSENSOR. This thermometer takes the form
of a small disc that can be easily adhered to the
patient’s skin, and each disc is assigned a unique radio
frequency identification (RFID) number [see Figure
17-2]. The thermometer measures body tempera-
ture continuously and transmits a temperature
A reading and the RFID number approximately every
30 seconds to a computer or server through one or
more signal receivers (nodes) installed in the vicinity
of the patient [Figure 17-3].” (Ng et al., 2010, pp.
176-177)
“Before the study, a ThermoSENSOR wireless
temperature monitoring system was installed in the
ward. A wireless signal receiver (node) was installed
in the ceiling of each of the five-bedded rooms.…
These receivers were connected to the hospital’s
local area network (LAN). The system worked in
such a way that temperature readings and RFID
numbers transmitted by a sensor were received by
one or more wireless receivers in the vicinity of the
sensor and transferred through the LAN to a personal
computer.… Web-based application software
designed for use with the wireless system and installed
B on the computer was used to configure the computer
to receive, store, and display the temperature and
Figure 17-2  A, OR wireless thermometer. The disc has an elliptical RFID data. A total of 32 sensors were used for the
cross section, and the sensing element consists of a metal strip located study.
at the center of the skin-contact side. B, ThermoSENSOR. The device The ThermoSENSOR uses a thermistor as the
has been placed over the first piece of hypoallergenic adhesive film sensing element. When in use, the sensor is attached
dressing on the lower abdomen and is about to be secured to the lower to the patient using a two-layer dressing system that
abdomen by a second piece of the same dressing. (From Ng, K., Wong, prevents the sensor from coming in direct contact
S., Lim, S., & Goh, Z. [2010]. Evaluation of the Cadi ThermoSENSOR
with the skin [see Figure 17-2]. The sensor is water
wireless skin-contact thermometer against ear and axillary temperatures
in children. Journal of Pediatric Nursing, 25[3], 177.)
resistant and can be cleaned by immersing it in a
cleaning and disinfectant solution. The manufacturer
provided the following specifications for the sensor:
operating ambient temperature range, 10° C to 50°
transducer in a blood vessel can partially block the C; thermistor accuracy, ± 0.2° C for temperature
vessel and alter blood flow resulting in an inaccurate range of 32.0° C to 42.0° C; data transmission rate,
reflection of the flow (Ryan-Wenger, 2010). every 30 seconds on average; radio frequency,
Ng, Wong, Lim, and Goh (2010) compared the 868.4 MHz; typical transmission range, 10 m
Cadi ThermoSENSOR wireless skin-contact ther- (unblocked); power source, internal 3-V lithium coin-
mometer (Figure 17-2) readings with the ear and axil- cell battery; battery life, 12 months (continuous oper-
lary temperatures in children. The ThermoSENSOR ation); dimensions, diameter of 36 mm, height of
thermometer provides a continuous measurement of 11.6 mm; weight, 10 g without battery; applicable
body temperature and transmits the readings wire- radio equipment standards, ETSI 300 220, ETSI EN
lessly to a central server. The measurement with the 301 489.” (Ng et al., 2010, pp 177-178)
ThermoSENSOR thermometer is described in the fol-
lowing excerpt.
CHAPTER 17  Measurement Methods Used in Developing Evidence-Based Practice 417

Wireless signal receiver


Ward 1

Ethernet hub
Temperature sensor

Central server

Wireless signal receiver


Ward 2

Monitoring and e-mail Monitoring and e-mail


alert via Tablet PC Monitoring SMS alert via alert via desktop computer
connected to LAN via PDA mobile phone connected to LAN

Figure 17-3  Setup of the ThermoSENSOR wireless temperature monitoring system. Each sensor transmits data wirelessly to a signal receiver (node)
that is within the prescribed transmission range. The signal receiver uploads the data to a central server through the local area network (LAN), through
which the data can be accessed from computers and other devices that are connected, wirelessly or by wired means, to the LAN. The server can be
configured to send out e-mail and short message service (SMS) alerts. (From Ng, K., Wong, S., Lim, S., & Goh, Z. [2010]. Evaluation of the Cadi
ThermoSENSOR wireless skin-contact thermometer against ear and axillary temperatures in children. Journal of Pediatric Nursing, 25[3], 177.)

Ng et al. (2010) provided detailed descriptions and and behaves. The DNA is a double-stranded helix and
pictures of both the ThermoSENSOR thermometer serves as the code for the production of the single-
and the wireless setup. The thermometer was consis- stranded messenger ribonucleic acid (RNA) (Stone &
tently applied to the abdomen of each child and was Frazier, 2010).
cleaned in a precise way. The manufacturer specifica- “The project goals were to:
tions of the thermometer documented that it was an • Identify all the approximately 20,000-25,000 genes
accurate device to measure temperature. The wireless in human DNA,
system was described in detail with documentation of • Determine the sequences of the 3 billion chemical
its precision and accuracy in obtaining and transfer- base pairs that make up human DNA,
ring the children’s temperatures to a computer for • Store this information in databases,
recording, display, and analysis of the data. The find- • Improve tools for data analysis,
ings of the study indicated that the ThermoSENSOR • Transfer related technologies to the private
wireless skin-contact thermometer readings were sector, and
comparable to the ear and axillary temperature • Address the ethical, legal, and social issues (ELSI)
readings. that may arise from the project” (Department of
Education Genomic Science, 2011)
Genetic Advancements in Measuring The advancements in genetics have facilitated the
Nucleic Acids development of new technologies that have permitted
The Human Genome Project has greatly expanded the the analysis of normal and abnormal genes for the
understanding of deoxyribonucleic acid (DNA) that detection and diagnosis of genetic diseases. Through
contains the code for controlling human development. the use of molecular cloning, sufficient quantities of
The U.S. Human Genome Project was begun in 1990 DNA and RNA have been produced to permit analysis
by the Department of Energy and the National Insti- in research. The Southern blotting technique is the
tutes of Health and was completed in 2003. The standard way for analyzing the structure of DNA. The
genome is the entire DNA sequence in an organism, Northern blotting technique is used for RNA analysis.
including its genes. The genes carry information for Analyses of both normal and mutant genes are of
making all the proteins required by the organism that interest, and the Western blotting technique is used to
are used to determine how the body looks, functions, examine the mutant proteins in cells obtained from
418 UNIT TWO  The Research Process

patients with diseases. In addition, polymerase chain


reaction can selectively amplify DNA and RNA mol- involves molecular comparison of collections of essen-
ecules for study (Stone & Frazier, 2010). tial genes also referred to as the ‘housekeeping’
It is important that nurses be aware of the advances genes.… Comparison of DNA sequences from iso-
in technologies to measure nucleic acids and use them lates found in blood cultures and oral cultures would
in their programs of research. Nurses are becoming enhance the determination of whether the isolates
more aware of the conduct of genetic research through were identical or different, and differentiate transient
doctoral and postdoctoral programs specialized in this bacteremia from intravenous line or sample contami-
area. In addition, the NINR provides the SGI to expand nation from bacteremia of oral origin. DNA typing
researchers’ expertise in conducting genetic research. would reduce the likelihood that confounding vari-
You can access information on the SGI at the follow- ables in the ICU (e.g., the presence of invasive lines,
ing NINR (2012) website: http://www.ninr.nih.gov/ frequent and invasive procedures, intubation, comor-
Training/TrainingOpportunitiesIntramural/Summer bidities, and immunosuppression) would adversely
GeneticsInstitute/. These educational opportunities affect the analysis.” (Jones et al., 2010, p. S59)
have expanded genetic research in nursing and
increased the number of studies focused on the mea-
surement of nucleic acids by nurses. Through the use of DNA typing, Jones et al. (2010)
Jones, Munro, Grap, Kitten, and Edmond (2010) were able to measure very precisely bacteremia risk
conducted a study to determine the impact of oral care associated with oral care in mechanically ventilated
on the bacteremia risk in mechanically ventilated patients. By comparison of DNA sequences in the
adults. The researchers wanted to determine if tooth blood and oral cultures, other confounding potential
brushing induced transient bacteremia in this group of causes of bacteremia could be eliminated. The
patients. They used DNA typing to identify organisms researchers found that tooth brushing did not induce
for the blood and oral cultures collected before and 1 transient bacteremia in the patient population. This
minute and 30 minutes after tooth brushing. Their research provides a basis for future research focused
measurement of oral microbial organisms is presented on standardizing effective and safe oral care in this
in the following excerpt. population.

Developing New Physiological Measures


“Oral microbial culture. A swab of the oral cavity Some studies require imaginative approaches to mea-
for microbial culture was performed immediately pre- suring phenomena that are traditionally observed in
ceding the first tooth brushing intervention. The oral clinical practice but are not measured. The first step in
cavity was swabbed in the following order using a this process is to recognize that the phenomenon being
single swab: upper and lower buccal and lingual gingival observed by the nurse can be measured. Once that idea
margin (obtaining organisms from the gum line and has emerged, one can begin envisioning various means
tooth surface), and palate. The oral microbial cultures of measuring the phenomenon. As new physiological
were performed using BBL Culture Swab Plus collec- measurements are developed, they must be compared
tion and transport media (Becton, Dickinson and Co, with previous methods to determine the best strategy
Sparks, MD) and were analyzed using standard opera- for measuring each physiological outcome based on the
tions for the clinical microbiology laboratory. Cultures patient’s condition. Gelinas et al. (2010) developed a
were analyzed and quantified for the following poten- new approach for detecting pain in adults by measuring
tially pathogenic organisms: viridians group Strepto- the cerebral regional oxygen saturation (rSO2) using
cocci, Staphylococcus aureus, Pseudomonas aeruginosa, near-infrared spectroscopy (NIRS). The NIRS tech-
Enterococcus spp., Klebsiella pneumoniae, and Candida nique (IN-VOS-4100 system; Somanetics, Troy, MI)
spp. These organisms are most commonly cited as was used to measure pain during the nociceptive pro-
causes of bloodstream infections in mechanically ven- cedures, such as intravenous and arterial line inser-
tilated patients. Positive cultures were frozen and tions, sternal bone incision, and thorax opening, during
stored for comparison with blood culture organisms cardiac surgery. The rSO2 measurements were com-
by DNA typing. We prospectively planned the micro- pared with the scores from the Critical-Care Pain
bial analysis using multi-locus sequence typing to iden- Observation Tool (CPOT) and the faces pain thermom-
tify species at the strain level. Multi-locus sequence eter (FPT) to determine discriminant and criterion
typing is a relatively new and powerful technique that validity. These physiological measures used in this
study are presented in the following excerpt.
CHAPTER 17  Measurement Methods Used in Developing Evidence-Based Practice 419

“Measurement Instruments .001, using the 5-point descriptive pain scale) and
discriminant (t = −5.10, p ≤ .001, comparing patients’
“Near-infrared spectroscopy. Near-infrared spec-
pain intensity at rest and during turning) validity in
troscopy technology is based on the property of near-
cardiac-surgery patients, showing an association with
infrared light to diffuse throughout biological tissue.
a higher pain intensity score during turning.” (Gelinas
At near-infrared wavelengths, hemoglobin and cyto-
et al., 2010, p. 488)
chrome c-oxydase, also known as the enzyme cyto-
chrome aa3, are the main chromophores (i.e.,
substances absorbing light at a given wave-length).
The light source of the oximeter provides two con-
These researchers detailed the use of the NIRS
tinuous wavelengths of near-infrared light (730 and
technique to measure rSO2, and this measurement of
810 nm) in the frontal region.… The ratio of oxygen-
pain was comparable to the CPOT and the FPT. Com-
ated hemoglobin and total hemoglobin is measured,
parison of the rSO2 with the CPOT and FPT added to
and a subtraction of the superficial signal from the
the criterion, convergent, and discriminant validity of
deeper signal is performed by the monitor to obtain
the measurement methods. Gelinas et al. (2010, p.
the regional hemoglobin oxygen saturation (rSO2) in
485) concluded, “Although further research is needed
the frontal cortex, i.e., the main variable in this
in critically ill adult patients undergoing more painful
study.… Brain-activity imaging was associated with
procedures, the NIRS may become a promising tech-
changes in cerebral oxygenation indicators as mea-
nique for assessing pain.”
sured with the NIRS, supporting the validity of this Obtaining Physiological Measures
noninvasive technique. The NIRS system used in the
present study was the INVOS-4100. It continuously
across Time
monitors rSO2, and was used according to the manu-
Many nursing studies using physiological measure-
facturer’s instructions.
ment methods focused on a single point in time. Thus,
“Critical-Care Pain Observation Tool. The
there is insufficient information on normal variations
CPOT was a key pain measure in this study, because
in physiological measures across time and much less
it was used to examine criterion validity of rSO2. This
information on changes in physiological measures
behavioral pain scale includes 4 behaviors (facial
across time in individuals with abnormal physiologi-
expression, body movements, muscle tension, and
cal states. In some cases, physiological states exhibit
vocalization), with a possible total score ranging from
cyclic activity and are associated with circadian
0 to 8. It was developed and validated in different ICU
rhythms and day-night patterns. An important ques-
groups.… The CPOT showed good interrater reli-
tion to ask is “How labile is the measure?” Some
ability (ICC = .80 to .93), discriminant validity (signifi-
measures vary within the individual from time to time,
cantly higher CPOT scores during procedural pain),
even when conditions are similar. Circadian rhythms,
and criterion validity. During procedural pain (turning),
activities, emotions, dietary intake, or posture can also
correlation coefficients of .59 and .71 (p ≤ .05) were
affect physiological measures. Researchers need to
obtained between patients’ self-reports of pain inten-
determine to what extent these factors would affect the
sity and their CPOT scores, whereas correlation
ability to interpret measurement outcomes. When a
coefficients of .49 and .40 (p ≤ .05) were evident
clinician observes variation in a physiological value,
when patients were at rest before and after turning.
it is important to know whether the variation is within
Finally, a sensitivity of 86% and a specificity of 78%
the normal range or signals a change in the patient’s
were obtained for a cutoff score >2 in the presence
condition. Thus, additional studies need to be con-
of pain on the CPOT during nociceptive exposure of
ducted to describe patterns of physiological function
postoperative ICU adults.
over time.
“Faces pain thermometer. The faces pain ther-
In the previously discussed study using NIRS,
mometer (FPT) consists of a thermometer graded
Gelinas et al. (2010) conducted a repeated-measures
from 0 to 10, including 6 faces.… The FPT was
design that involved obtaining measurements from 40
another key pain measure in this study, because it
subjects at two test periods. The first test period
provided a standardized indicator of the patient’s self-
occurred while patients were awake, and the rSO2,
report of pain intensity, which was also used to deter-
CPOT, and FPT measurements were recorded for each
mine the criterion validity of rSO2. This scale
subject. The second test period took place after the
demonstrated good convergent (r = .80 to .86, p ≤
induction of anesthesia, and it was possible to record
only the rSO2. These simultaneous measurements of
420 UNIT TWO  The Research Process

pain using various instruments as well as the repeated used to identify physiological measurement methods
measures of the rSO2 when patients were anesthetized are previous studies that have measured a particular
allowed the examination of reliability and validity of physiological variable. Literature reviews or meta-
the NIRS technique to measure rSO2 as a pain indica- analyses can provide reference lists of relevant
tor over time. studies. Because the measure might have been used
in studies unrelated to the current research topic, it is
Selecting a Physiological Measure usually important to examine the research literature
Researchers designing a physiological study have less broadly.
assistance in selecting methods of measurement than Physiological measures must be linked conceptu-
researchers conducting studies using psychosocial ally with the framework of the study. The logic of
variables. Multiple books and electronic sources are operationalizing the concept in a particular way
available that discuss various methods for measuring must be well thought out and expressed clearly (see
psychosocial variables. In addition, numerous articles Chapter 7). It is often a good idea to use diverse
in nursing journals describe the development of psy- physiological measures of a single concept, which
chosocial variables or discuss various means of mea- reduces the impact of extraneous variables that might
suring a particular psychosocial variable. However, affect measurement. The operationalization of a
literature guiding the selection of physiological vari- physiological variable in a study should clearly indi-
ables is still sparse. You might consider the following cate the physiological measure to be used. The link
factors when selecting a physiological measure for a of the physiological variable to the concept in the
study: framework must be made explicit in the published
1. What physiological variables are relevant to the report of your study.
study? You also need to evaluate the accuracy and preci-
2. Do the variables need to be measured continu- sion of physiological measures. Until more recently,
ously or at a particular point in time? researchers commonly used information from the
3. Are repeated measures needed? equipment manufacturer to describe the accuracy of
4. Do certain characteristics of the population under measurement. This information is useful, but it is
study place limits on the measurement approaches insufficient to evaluate accuracy and precision. The
that can be used? accuracy and precision of physiological measures are
5. How has the variable been measured in previous discussed in Chapter 16 (CLSI, 2011; IOS, 2011;
research? Ryan-Wenger, 2010).
6. Is more than one measurement method available You need to consider problems you might encoun-
to measure the physiological variable being ter when using various approaches to physiological
studied (Stone & Frazier, 2010)? measurement. One factor of concern is the sensitivity
7. Which measurement method is the most accurate of the measure. Will the measure detect differences
and precise for the population you are studying finely enough to avoid a type II error—known as a
(Fawcett & Garity, 2009; Ryan-Wenger, 2010)? false negative—that occurs when the investigator
8. Could the study be designed to include more than claims there is no difference between groups or rela-
one measurement method for the variable being tionships among variables when one really exists (see
studied (DeVon et al., 2007; Fawcett & Garity, Chapter 21)? Physiological measures are usually norm
2009)? referenced. Data obtained from a study participant are
9. Where can the measurement device or devices be compared with a norm as well as with other partici-
obtained to measure the physiological variable pants. You need to determine whether the norm used
being studied? for comparison is relevant for the population you are
10. Can the measurement device be obtained from the studying. Laboratories are certified by ensuring that
manufacturer for use in the study, or must it be the analyses conducted in the laboratory meet a
purchased? national standard (CLSI, 2011). New physiological
11. What are the standards for the measurement measures are compared with the “gold standard” or
device or equipment that has been designated the current best measurement method for a physiologi-
nationally and internationally (International Orga- cal variable. For example, Klein et al. (2010) com-
nization for Standardization [IOS], 2011)? pared their NPAT with the “gold standard” of the
It is more difficult to identify previous research on patients’ self-reports of pain using the CPOT.
physiological measures than it is to find research on Many measurement strategies require the use of
psychosocial measures. The sources most commonly specialized equipment. In many cases, the equipment
CHAPTER 17  Measurement Methods Used in Developing Evidence-Based Practice 421

is available in the patient care area and is part


of routine patient care in that unit. Otherwise, the Observational Measurement
researcher may need to purchase, rent, or borrow the Observational measurement is the use of unstruc-
equipment specifically for the study. You need to be tured and structured inspection to gauge a study vari-
skilled in operating the equipment or obtain the assis- able. This section focuses on structured observational
tance of someone who has these skills. You need to measurement; unstructured observational measure-
ensure that the equipment is operated in an optimal ment is described in Chapter 12. Although data col-
fashion and is used in a consistent manner. Sometimes lection by observation is most common in qualitative
equipment must be recalibrated, or reset, regularly to research, it is used to some extent in all types of
ensure consistent readings. For example, weight studies (Marshall & Rossman, 2011; Munhall, 2012).
scales are recalibrated periodically to ensure that the First, you must decide what you want to observe, and
weight indicated is accurate and precise. According then you need to determine how to ensure that every
to federal guidelines, recalibration must be performed variable is observed in a similar manner in each
as follows: instance. Much attention must be given to training
• In accordance with the manufacturers’ instructions data collectors, especially when the observations are
• In accordance with national and international stan- complex and examined over time (Waltz et al., 2010).
dards (IOS, 2011) You must create opportunities for the observational
• In accordance with criteria set up by the laboratory technique to be pilot-tested and to generate data on
(CLSI, 2011) interrater reliability. Observational measurement tends
• At least every 6 months to be more subjective than other types of measurement
• After major preventive maintenance or replace- and is often seen as less credible. However, in many
ment of a critical part cases, observation is the only possible way to obtain
• When quality control indicates a need for recalibra- important evidence for practice.
tion
Structured Observations
Reporting Physiological Measures The first step in a structured observation is to define
in Studies carefully what specific behaviors or events are to be
When publishing the results of a physiological study, inspected or observed in a study. From that point,
researchers must describe the measurement technique researchers determine how the observations are to be
in considerable detail to allow an adequate critical made, recorded, and coded. In most cases, the research
appraisal of the study, enable others to replicate the team develops an observational checklist or category
study, and promote clinical application of the results. system to direct collecting, organizing, and sorting of
At the present time, only a few physiological replica- the specific behaviors or events being observed. The
tion studies have been reported in the nursing litera- extent to which these categories are exhaustive varies
ture. A detailed description of physiological measures with the study.
in a research report includes the following:
1. Description of the equipment or device used in Category Systems
performing the measurement The observational categories should be mutually
2. Identification of the name of the equipment exclusive. If the categories overlap, the observer will
manufacturer be faced with making judgments regarding which cat-
3. Account of the accuracy and precision of the equip- egory should contain each observed behavior, and data
ment or device based on previous research, the collection and recording may be inconsistent. In some
manufacturers’ specifications, and national and category systems, only the behavior that is of interest
international standards is recorded. Most category systems require the
4. Explanation of the exact procedure followed to observer to make some inference from the observed
measure the physiological variable event to the category. The greater the degree of infer-
5. Overview of the process the device used to record, ence required, the more difficult the category system
retrieve, and store data is to use. Some systems are applicable in a wide
The examples discussed in this section can be used variety of studies, whereas others are specific to the
as models for describing the methods for obtaining study for which they were designed. The number of
and implementing physiological measures to obtain categories used varies considerably with the study. An
accurate and precise measures of physiological vari- optimal number for ease of use and therefore effec-
ables to ensure quality study outcomes. tiveness of observation is 15 to 20 categories.
422 UNIT TWO  The Research Process

Klein et al. (2010) developed the NPAT that was techniques of developing interview questions (Briggs,
introduced earlier in this chapter. The NPAT included 1986; Dillman, Smyth, & Christian, 2009; Dillon,
categories of behaviors that were to be observed to 1990; Foddy, 1993; Fowler, 1990; Gorden, 1987,
determine the pain level for nonverbal adults in the 1998; McLaughlin, 1990; Mishler, 1986). If you plan
ICU (see Figure 17-4). The interrater reliability of the to use this strategy, consult a text on interview meth-
tool in this study was ensured when “Two RNs, trained odology before designing your instrument. Because
in the use and scoring of the NPAT, simultaneously nurses frequently use interview techniques in nursing
observed a patient unable to verbalize his or her pain” assessment, the dynamics of interviewing are familiar;
(Klein et al., 2010, p. 523). however, using this technique for measurement in
Another type of category system used to direct the research requires greater sophistication.
collection of observational data is a checklist. Obser-
vational checklists are techniques used to establish Structured Interviews
whether a behavior occurred. The observer places a Structured interviews are verbal interactions with
tally mark on a data collection form each time he or subjects that allow the researcher to exercise increas-
she witnesses the behavior. Behavior other than that ing amounts of control over the content of the inter-
on the checklist is ignored. In some studies, the view to obtain essential data for a study. The researcher
observer may place multiple tally marks in various designs the questions before data collection begins,
categories while witnessing a particular event. and the order of the questions is specified. In some
However, in other studies, the observer is required cases, the interviewer is allowed to explain the
to select a single category in which to place the meaning of the question further or modify the way in
tally mark. which the question is asked so that the subject can
understand it better. In more structured interviews, the
Rating Scales interviewer is required to ask the question precisely as
Rating scales (discussed in detail later in this chapter) it has been designed. If the subject does not under-
can be used for observation and for self-reporting. A stand the question, the interviewer can repeat it only.
rating scale allows the observer to rate the behavior or The subject may be limited to a range of responses
event on a scale. This method provides more informa- previously developed by the researcher, similar to
tion for analysis than the use of dichotomous data, those in a questionnaire. If the possible responses are
which indicate only that the behavior either occurred lengthy or complex, they may be printed on a card so
or did not occur. The NPAT also included a rating scale that study participants can review them visually before
in which each observational category was scored on a selecting a response.
scale or 0 to 2 or 0 to 3 (see Figure 17-4). The tool
resulted in a total score between 0 and 10, with 0 Designing Interview Questions
indicating no pain and 10 indicating the worst pain The process for developing and sequencing interview
ever experienced by the patient (Klein et al., 2010). questions is similar to the process used to design ques-
tionnaires and is explained in the section on question-
naires. Briefly, questions progress from broad and
Interviews general to narrow and specific. Questions are grouped
Interviews involve verbal communication during by topic, with fairly “safe” topics being addressed first
which the subject provides information to the and sensitive topics reserved until late in the interview
researcher. Although this measurement strategy is process. Other data such as age, educational level,
most common in qualitative and descriptive studies, it income, and other demographic information are
also can be used in other types of studies. The various usually collected last. These data are best obtained
approaches to conducting interviews range from very from other sources, such as patient records, to allow
unstructured interviews in which study participants more time for the primary interview questions. The
control content (see Chapter 12) to interviews in wording of questions in an interview depends on the
which the participants respond to a questionnaire that educational level of the study participants. Different
the researcher has carefully designed (Waltz et al., participants may interpret the wording of certain ques-
2010). Although most interviews are conducted face tions in a variety of ways, and researchers need to
to face, telephone interviews are also commonly used. anticipate this possibility. After the interview protocol
Using the interview method for measurement has been developed, it is wise to seek feedback from
requires careful detailed work with a scientific an expert on interview technique and from a content
approach. Excellent books are available on the expert.
CHAPTER 17  Measurement Methods Used in Developing Evidence-Based Practice 423

Is patient able to make vocalizations or sound cues?


Score under the yes or no column; add scores for total score (range 0-10)

YES NO
SCORE SCORE
EMOTION An affective EMOTION
response to a situation
0 0
Smiling; calm; relaxed or none due to coma state or analgesia
Anxious; irritable; withdrawn; closes eyes;
1 1
does not engage with physical environment

2 Tearful/crying or uncooperative 2

MOVEMENT Change in placement and MOVEMENT


positioning of the body and
extremities when not
engaged in any care activities
0 0
None; sleeping comfortable; no unusual movements;
or none due to coma state or analgesia
Restless or slow, decreased movement;
1 2
reluctant to move; muscle tenseness
Rigidity; increasing motion; stiffening; tossing; turning;
2 3
flapping of arms; stiffening
VERBAL CUES Sound cues or vocalizations other than speech
0 No vocalization
n/a
1 Whimpering; moaning; sighing
2 Screaming; crying out
FACIAL CUES Expressions on face FACIAL CUES
0 Relaxed, calm expression or none due to coma state or analgesia 0
1 Drawn around the mouth and eyes; narrowed eyes 1

2 Wincing; grimacing; clenched teeth; furrowed brows; tightened lips 2


POSITIONING/GUARDING POSITIONING/GUARDING

Body responses that imply a protection of


the body from contact with external touch

0 Relaxed body or none due to coma state or analgesia 0

1 Guarding/tense 2

Jumpy when touched; clutching of siderails;


2 3
withdraws when touched

TOTAL
Choose only one behavior per category

Figure 17-4  Nonverbal Pain Assessment Tool—Final. (From Klein, D. G., Dumpe, M., Katz, E., & Bena, J. [2010]. Pain assessment in the intensive care
unit: Development and psychometric testing of the nonverbal pain assessment tool. Heart & Lung, 39[6], 527.)
424 UNIT TWO  The Research Process

Pilot-Testing the Interview Protocol pick up on a comment the participant made and begin
After the research team has satisfactorily developed asking questions to understand better what the subject
the interview protocol, team members need to pretest meant. Probes should be neutral to avoid biasing
or pilot-test it on subjects similar to the individuals participants’ responses. Probing for additional infor-
who will be included in their study. Pilot-testing mation needs to be done within reasonable guidelines
allows the research team to identify problems in the so that participants do not feel they are being
design of questions, sequencing of questions, or pro- cross-examined.
cedure for recording responses. It also provides an
opportunity to assess the reliability and validity of the Recording Interview Data
interview instrument (Waltz et al., 2010). Data obtained from interviews are recorded, either
during the interview or immediately afterward. The
Training Interviewers recording may be in the form of handwritten notes,
Skilled interviewing requires practice, and interview- video recordings, or audio recordings. If you hand-
ers must be familiar with the content of the interview. record your notes, you must have the skill to identify
They need to anticipate situations that might occur key ideas (or capture essential data) in an interview
during the interview and develop strategies for dealing and concisely record this information. Data must be
with them. One of the most effective methods of recorded without distracting the interviewee. Some
developing a polished approach is role-playing. interviewees have difficulty responding if it is obvious
Playing the role of the subject can give the interviewer that the interviewer is taking notes or recording the
insight into the experience and facilitate an effective conversation. In such a case, the interviewer may need
response to unscripted situations. to record data after completing the interview. If you
The interviewer must establish a permissive atmo- wish to record the interview, you first must obtain IRB
sphere in which the subject is encouraged to respond approval and then obtain the participant’s permission.
to sensitive topics. He or she also needs to develop an Plan to prepare verbatim transcriptions of the record-
unbiased verbal and nonverbal manner. The wording ings before data analysis. In some studies, researchers
of a question, the tone of voice, a raised eyebrow, and use content analysis to capture the meaning within the
a shifting body position all can communicate a posi- data (see Chapter 12).
tive or negative reaction to the subject’s responses—
either of which can alter the data. Advantages and Disadvantages
of Interviews
Preparing for an Interview Interviewing is a flexible technique that can allow
If you are serving as the interviewer and expect the researchers to explore greater depth of meaning than
meeting to be lengthy, you need to make an appoint- they can obtain with other techniques. Use your inter-
ment. Dress nicely for the meeting, but do not over- personal skills to encourage your subject’s coopera-
dress, and be prompt. Choose a site for the interview tion and elicit more information. The response rate to
that is quiet and private and provides a pleasant envi- interviews is higher than the response rate to question-
ronment. Before the appointment, carefully plan the naires; thus interviews can offer a more representative
instructions you will give to the subject. For example, sample. Interviews allow researchers to collect data
you might say, “I am going to ask you a series of from participants who are unable or unlikely to com-
questions about …. Before you answer each question plete questionnaires, such as very ill subjects or sub-
you need to …. Select your answer from the following jects whose reading, writing, and ability to express
…, and then you may elaborate on your response. I themselves are marginal. Interviews are a form of self-
will record your answer and then, if it is not clear, I report, and the researcher must assume that the infor-
may ask you to explain some aspect further.” mation provided is accurate. Interviewing requires
much more time than questionnaires and scales and is
Probing more costly. Because of time and cost, sample size is
Interviewers use probing to obtain more information usually limited. Subject bias is always a threat to
in a specific area of the interview. In some cases, you the validity of the findings, as is inconsistency in
may have to repeat a question. If your subject answers, data collection from one subject to another (Dillman
“I don’t know,” you may have to press for a response. et al., 2009).
In other situations, you may have to explain the ques- Interviewing children requires a special under-
tion further or ask the subject to explain statements standing of the art of asking children questions. The
that he or she has made. At a deeper level, you may interviewer must use words that children tend to use
CHAPTER 17  Measurement Methods Used in Developing Evidence-Based Practice 425

to define situations and events. Interviewers also must


be familiar with the language skills that exist at dif- Questionnaires
ferent stages of development. Children view topics A questionnaire is a printed self-report form designed
differently than adults do. Their perception of time, to elicit information that can be obtained from a sub-
past and present, is also different. Holaday and Turner- ject’s written responses. The information derived
Henson (1989) provided detailed suggestions for through questionnaires is similar to information
developing an interview guide or questionnaire appro- obtained by interview, but the questions tend to have
priate for children. less depth. The subject is unable to elaborate on
Some researchers use a combination of structured responses or ask for questions to be clarified, and the
interview questions and open-ended or unstructured data collector cannot use probe strategies. However,
interview questions to gather the data needed for a questions are presented in a consistent manner, and
study. Harralson (2007, p. 96) used structured and there is less opportunity for bias than in an
unstructured questions to examine the “factors associ- interview.
ated with delay in seeking emergency medical atten- Questionnaires can be designed to determine facts
tion for acute ischemic symptoms in a sample of about the study participants or persons known by the
predominantly African American women.” Harralson participants; facts about events or situations known by
interviewed female patients who presented with symp- the participants; or beliefs, attitudes, opinions, levels
toms of acute myocardial infarction in a large, urban of knowledge, or intentions of the participants. Ques-
teaching hospital in the United States. The following tionnaires can be distributed to large samples directly
excerpt describes the interview process used in this or indirectly through email or mail. The design, devel-
study. opment, and administration of questionnaires have
been addressed in many excellent books that focus on
survey techniques (Berdie, Anderson, & Niebuhr,
1992; Converse & Presser, 1986; Saris & Gallhofer,
“Structured Interview 2007; Thomas, 2004). Two nursing methodology texts
“The study used a structured interview to explore the (Shelley, 1984; Waltz et al., 2010) provide detailed
variables of interest. The 45-minute interview explanations of the procedure for questionnaire
included questions pertaining to sociodemographics, development.
social support, general physical health, medical Although questions on a questionnaire appear easy
comorbidities, perceived and practical barriers to to design, a well-designed item requires considerable
seeking health care, and CHD [coronary heart effort. Similar to interviews, questionnaires can have
disease] symptoms and severity. Open-ended ques- varying degrees of structure. Some questionnaires ask
tions addressed the patients’ experiences from open-ended questions that require written responses.
symptom onset until a decision was made to seek Others ask closed-ended questions with options that
medical attention. Open-ended questions included the researcher has selected. Data from open-ended
questions about patients’ physical and emotional feel- questions are often difficult to interpret, and content
ings during the experience, decision-making pro- analysis may be used to extract meaning. Open-ended
cesses (i.e., who they told and who they sought questionnaire items are not advised if your data are
advice from), and beliefs about what was happening being obtained from large samples.
to them at the onset of the symptoms of AMI [acute Researchers frequently use computers to gather
myocardial infarction]. questionnaire data (Saris, 1991; Thomas, 2004). Com­
The structured interview was developed specifi- puters are sometimes set up at the data collection
cally for this study on the basis of a systematic review site, such as a clinic or hospital; the questionnaire
of the literature that examined concepts and factors is presented on screen; and subjects respond by using
associated with delay in seeking medical treatment. the keyboard or mouse. Data are stored in a computer
In addition, several nurses, cardiologists, and social file and are immediately available for analysis. Data
scientists reviewed the interview. entry errors are greatly reduced. Most researchers
To reduce recall bias in this study, interviews were email subjects and direct them to a website where they
conducted within 5 days of the acute ischemic event. can complete the questionnaire online, allowing the
This recall time frame is similar to time periods used data to be stored and analyzed immediately. Thus,
in other studies reviewed in the background section.” researchers can keep track of the number of subjects
(Harralson, 2007, p. 98) completing their questionnaire and the evolving
results.
426 UNIT TWO  The Research Process

Development of Questionnaires for which several meanings are possible, the term
The first step in either selecting or developing a ques- must be defined (Saris & Gallhofer, 2007; Waltz et al.,
tionnaire is to identify the information desired. For 2010).
this purpose, the research team develops a blueprint Leading questions suggest to the respondent the
or table of specifications. The blueprint identifies the answer the researcher desires. These types of ques-
essential content to be covered by the questionnaire; tions often include value-laden words and indicate the
the content must be at the educational level of the researcher’s bias. For example, a researcher might ask,
potential subjects. It is difficult to stick to the blueprint “Do you believe physicians should be coddled on the
when designing the questionnaire because it is tempt- nursing unit?” or “All hospitals are stressful places to
ing to add “just one more question” that seems to be work, aren’t they?” These examples are extreme, and
a “neat idea” or a question that someone insists “really leading questions are usually constructed more subtly.
should be included.” However, as a questionnaire The degree of formality with which the question is
lengthens, fewer subjects are willing to respond, and expressed and the permissive tone of the questions are,
more questions are left blank. in many cases, important for obtaining a true measure.
The second step is to search the literature for ques- A permissive tone suggests that any of the possible
tionnaires or items in questionnaires that match the responses would be acceptable.
blueprint criteria. Sometimes published studies include Questions implying a preexisting state of affairs
questionnaires, but frequently you must contact the often lead respondents to admit to a previous behavior
authors of a study to request a copy of their question- regardless of how they answer. Examples are “How
naire. Researchers are encouraged to use questions in long has it been since you used drugs?” or, to an ado-
exactly the same form as questionnaires in previous lescent, “Do you use a condom when you have sex?”
studies to determine the validity of the questionnaire Double questions ask for more than one bit of
for new samples. However, questions that are poorly information: “Do you like critical care nursing and
written need to be modified, even if rewriting makes working closely with physicians?” It would be possi-
it more difficult to compare the validity results of the ble for the respondent to like working in critical care
questionnaire directly with questionnaires from previ- settings but dislike working closely with physicians.
ous studies. In this case, the question would be impossible to
In some cases, you may find a questionnaire in the answer accurately. A similar question is, “Was the
literature that matches the questionnaire blueprint that in-service program educational and interesting?”
you have developed for your study. However, you may Questions with double negatives are often difficult
have to add items to or delete items from an existing for study participants to interpret. For example, one
questionnaire to accommodate your blueprint. In some might ask, “Do you believe nurses should not question
situations, items from several questionnaires are com- doctors’ orders? Yes or No.” In this case, the wording
bined to develop an appropriate questionnaire. of this question can be easily misinterpreted and the
An item on a questionnaire has two parts: a ques- word “not” possibly overlooked. This situation can
tion (or stem) and a response set. Each question must lead participants to respond in a way contrary to how
be carefully designed and clearly expressed. Problems they actually think or feel.
include ambiguous or vague language, leading ques- Each item in a questionnaire has a response set that
oasis-ebl|Rsalles|1476233357

tions that influence the response, questions that assume provides the parameters within which the respondent
a preexisting state of affairs, and double questions. can answer. This response set can be open and flexible,
In some cases, respondents interpret terms used in as it is with open-ended questions, or it can be narrow
the question in one way when the researcher intended and directive, as it is with closed-ended questions. For
a different meaning. For example, the researcher example, an open-ended question might have a
might ask how heavy the traffic is in the neighborhood response set of three blank lines. With closed-ended
in which the family lives. The researcher might be questions, the response set includes a specific list of
asking about automobile traffic, but the respondent alternatives from which to select.
interprets the question in relation to drug traffic. The Response sets can be constructed in various ways.
researcher might define neighborhood as a region The cardinal rule is that every possible answer must
composed of a three-block area, whereas the respon- have a response category. If the sample includes
dent considers a neighborhood to be a much larger respondents who might not have an answer, a response
area. Family could be defined as people living in one category of “don’t know” or “uncertain” should be
house or as all close blood relations. If a question included. If the information sought is factual, include
includes a term that is unfamiliar to the respondent or “other” as one of the possible responses. However,
CHAPTER 17  Measurement Methods Used in Developing Evidence-Based Practice 427

recognize that the item “other” is essentially lost data. question should clearly instruct the subject how to
Even if the response is followed by a statement such respond (i.e., choose one, mark all that apply), or
as “Please explain,” it is rarely possible to analyze the instructions should be included at the beginning of the
data meaningfully. If a large number of study partici- questionnaire. The subject must know whether to
pants (>10%) select the alternative “other,” the circle, underline, or fill in a circle as he or she responds
alternatives included in the response set might not to items. Clear instructions are difficult to construct
be appropriate for the population studied (Saris & and usually require several attempts. Cazzell (2011)
Gallhofer, 2007). provided clear directions and an example of how to
The simplest response set is the dichotomous yes/ complete her questionnaire and directed the students
no option. Arranging responses vertically preceded by to report their participation in these risk behaviors
a blank reduces errors. For example, over the past 30 days (see Figure 17-5).
____ Yes After the questionnaire items have been developed,
____ No you need to plan carefully how they will be ordered.
is better than Questions related to a specific topic must be grouped
____ Yes ____ No together. General items are included first with progres-
because in the latter example, the respondent might sion to more specific items. More important items
not be sure whether to indicate yes by placing a might be included first, with subsequent progression
response before or after the “Yes.” to items of lesser importance. Questions of a sensitive
Response sets must be mutually exclusive, which nature or questions that might be threatening should
might not be the case in the following response set appear last on the questionnaire. In some cases, the
because a respondent might legitimately need to select response to one item may influence the response to
two responses: another. If so, the order of such items must be care-
____ Working full-time fully considered. Open-ended questions should be
____ Full-time graduate student presented last because their responses require more
____ Working part-time time than needed for closed-ended questions. The
____ Part-time graduate student general trend is to ask for demographic data about the
Cazzell (2010) developed the Self-Report College subject at the end of the questionnaire.
Student Risk Behavior Questionnaire, an eight-item An introductory page in the computer or a cover
questionnaire with response set of yes and no possible letter for a mailed questionnaire is needed to
answers. This questionnaire was developed and refined explain the purpose of the study and identify the
as part of her dissertation at The University of Texas researchers, the approximate amount of time required
at Arlington. Cazzell’s questionnaire was developed to complete the form, and organizations or institutions
based on the 87 risk behaviors identified in a national supporting the study. Often researchers indicate that
survey conducted by the U.S. Centers for Disease completion of the questionnaire implies informed
Control and Prevention on the Youth Risk Behavior consent. A questionnaire on the computer when com-
Surveillance System (Brener et al., 2004). Cazzell’s pleted can be easily submitted, and the data can be
(2010) Self-Report College Student Risk Behavior analyzed immediately. Returning mailed question-
Questionnaire was developed based on the eight most naires is much more complex. The instructions need
commonly identified adolescent risk behaviors from to include an address to which the questionnaire can
the Centers for Disease Control and Prevention survey. be returned. This address must be at the end of the
Content validity of this eight-item questionnaire was questionnaire and on the cover letter and envelope.
developed by having two addiction experts, a doctor- Respondents often discard both the envelope and the
ally prepared social worker and a pediatric clinical cover letter and do not know where to send the ques-
nurse specialist evaluate the items. The content valid- tionnaire after completing it. It is also wise to provide
ity index calculated for the questionnaire was 0.88, a stamped, addressed envelope for the subject to return
supporting the inclusion of these eight items in the the questionnaire. If possible, the best way to provide
questionnaire. Cazzell (2011) continued her develop- questionnaires to potential subjects is by emailing a
ment and refinement of this questionnaire and web address so participants can easily complete the
expanded question #2 on use of alcohol to target binge questionnaire in their own time, and their responses
drinking (see Figure 17-5). are automatically submitted at the end of the question-
The questionnaire instructions should be pilot- naire. Sending questionnaires by email has many
tested on naive subjects who are willing and able to advantages, but one disadvantage is being able to
express their reactions to the instructions. Each access only individuals with email. Researchers need
428 UNIT TWO  The Research Process

Unique ID:

Self-Report College Student Risk Behavior Measure

Shade Circles Like This -->


Not Like This --> 

Answer YES or NO based on your participation in these behaviors


over the past 30 days.

1. I smoked a cigarette (even a puff). Yes No

2. I drank alcohol (even one drink). Yes No


If you answered YES to Question #2:

a. If you are a female, did you have 4 or Yes No


more drinks on one occasion?
b. If you are a male, did you have 5 or Yes No
more drinks on one occasion?

3. I used an illegal drug (even once). Yes No

4. I had sexual intercourse without a condom. Yes No

5. I rode in a car without wearing my seatbelt Yes No


(even once).

6. I drove a car without wearing my seatbelt Yes No


(even once).

7. I rode in a car with a person driving under Yes No


the influence (even once).

8. I drove a car while under the influence Yes No


(even once).

Figure 17-5  Self-Report College Student Risk Behavior Questionnaire. (From Cazzell, M. [personal communication, March 20, 2011]. Self-report college
student risk behavior questionnaire. The University of Texas at Arlington, Arlington, TX.)

to determine if the population they are studying has


email access (Thomas, 2004). Questionnaire Validity
Your questionnaire must be pilot-tested to deter- One of the greatest risks in developing response sets
mine the clarity of questions, effectiveness of instruc- is leaving out an important alternative or response. For
tions, completeness of response sets, time required to example, if the questionnaire item addressed the job
complete the questionnaire, and success of data col- position of nurses working in a hospital and the sample
lection techniques. As with any pilot test, the subjects included nursing students, a category must be added
and techniques must be as similar as possible to those to represent the student role. When seeking opinions,
planned for the main study. In some cases, the open- there is a risk of obtaining a response from an indi-
ended questions are included in a pilot test to obtain vidual who actually has no opinion on the research
information for the development of closed-ended topic. When an item requests knowledge that the
response sets for the main study. respondent does not possess, the subject’s guessing
CHAPTER 17  Measurement Methods Used in Developing Evidence-Based Practice 429

interferes with obtaining a true measure of the study statistics, such as chi square, Spearman rank-order
variables. correlation, and Mann-Whitney U (see Chapters 22
The response rate to questionnaires is generally through 25). However, in certain cases, ordinal data
lower than that with other forms of self-reporting, from questionnaires are treated as interval data, and
particularly if the questionnaires are mailed out. If the t-tests and analysis of variance are used to test for
response rate is less than 50%, the representativeness differences between responses of various subsets of
of the sample is seriously in question. The response the sample (Grove, 2007). Discriminant analysis may
rate for mailed questionnaires is usually small (25% be used to determine the ability to predict membership
to 35%), so researchers are frequently unable to obtain in various groups from responses to particular
a representative sample, even with randomization. questions.
There seems to be a stronger response rate for ques-
tionnaires that are sent by email, but the response is
still usually less than 50%. Strategies that can increase Scales
the response rate for an emailed or mailed question- Scales, a form of self-report, are a more precise means
naire are discussed in Chapter 20. of measuring phenomena than questionnaires. Most
Study participants commonly fail to respond to scales have been developed to measure psychosocial
all the questions on a questionnaire. This problem, variables. However, self-reports can be obtained on
especially with long questionnaires, can threaten the physiological variables such as pain, nausea, or func-
validity of the instrument. In some cases, study par- tional capacity by using scaling techniques as dis-
ticipants may write in an answer if they do not agree cussed earlier in this chapter. Scaling is based on
with the available choices, or they might write com- mathematical theory, and there is a branch of science
ments in the margin. Generally, these responses cannot whose primary concern is the development of mea-
be included in the analysis; however, you should keep surement scales. From the point of view of scaling
a record of such responses. These responses might be theory, considerable measurement error, both random
used later to refine the questionnaire questions and and systematic error, is expected in a single item.
responses. Therefore, in most scales, the various items on the
Consistency in the way the questionnaire is admin- scale are summed to obtain a single score, and these
istered is important to validity. Variability that could scales are referred to as summated scales. Less
confound the interpretation of the data reported by the random and systematic error exists when using the
study participants is introduced by administering some total score of a scale in conducting data analyses,
questionnaires in a group setting, mailing some ques- although subscale comparisons are usually of interest
tionnaires, and emailing some questionnaires. There and are conducted. Using several items in a scale to
should not be a mix of mailing or emailing to business measure a concept is comparable to using several
addresses and to home addresses. If questionnaires are instruments to measure a concept (see Figure 16-4 in
administered in person, the administration needs to be Chapter 16). The various items in a scale increase the
consistent. Several problems in consistency can occur: dimensions of the concept that are reflected in the
(1) Some subjects may ask to take the form home to instrument. The types of scales commonly used in
complete it and return it later, whereas others will nursing studies include rating scale, Likert scale,
complete it in the presence of the data collector; (2) semantic differential scale, and visual analogue scale
some subjects may complete the form themselves, (VAS).
whereas others may ask a family member to write the
responses that the respondent dictates; and (3) in some Rating Scale
cases, a secretary or colleague may complete the form, A rating scale lists an ordered series of categories of
rather than the individual whose response you are a variable that are assumed to be based on an underly-
seeking. These situations may lead to biases in ing continuum. A numerical value is assigned to each
responses that are unknown to the researcher and can category, and the fineness of the distinctions between
alter the true measure of the variables. categories varies with the scale, making this one of the
crudest forms of scaling technique. The general public
Analysis of Questionnaire Data commonly uses rating scales. In conversations, one
Data from questionnaires are often at the nominal or can hear statements such as “On a scale of 1 to 10, I
ordinal level of measurement, which limit analyses for would rank that ….” Rating scales are easy to develop;
the most part to descriptive statistics, such as frequen- however, one must be careful to avoid end statements
cies and percentages, and nonparametric inferential that are so extreme that no subject would select them.
430 UNIT TWO  The Research Process

0 1 2 3 4 5
No hurt Hurts Hurts Hurts Hurts Hurts
little bit little more even more whole lot worst

Figure 17-6  Wong-Baker FACES Pain Rating Scale. (From Hockenberry, M. J., & Wilson, D. [2009]. Wong’s essentials of pediatric nursing [8th ed., p.
1203]. St. Louis, MO: Mosby.).

Numeric Rating Scale (NRS)


No Moderate Unbearable
Pain Pain Pain

0 1 2 3 4 5 6 7 8 9 10

Figure 17-7  Numeric Rating Scale (NRS).

A rating scale could be used to rate the degree of agree, agree, uncertain, disagree, and strongly dis-
cooperativeness of the patient or the value placed by agree. Evaluation responses ask the respondent for an
the subject on nurse-patient interactions. This type of evaluative rating along a good/bad continuum, such as
scale is often used in observational measurement to positive to negative or excellent to poor. Frequency
guide data collection. The Wong-Baker FACES Pain responses may include statements such as never,
Rating Scale is commonly used to assess the pain rarely, sometimes, frequently, and all the time. The
of children in clinical practice and has been shown terms used are versatile and must be selected for their
to be valid and reliable over the years (Figure 17-6) appropriateness to the stem (Spector, 1992). Some-
(Hockenberry & Wilson, 2009). Pain in adults is times seven options are given, and sometimes only
often assessed with a numeric rating scale such as four options are given.
the one presented in Figure 17-7. Klein et al. (2010) Use of the uncertain or neutral category is contro-
developed the NPAT rating scale, which was intro- versial because it allows the subject to avoid making
duced earlier in this chapter to determine the pain level a clear choice of positive or negative statements.
for nonverbal adults in the ICU (see Figure 17-4). Thus, sometimes only four or six options are offered,
with the uncertain category omitted. This type of
Likert Scale scale is referred to as a forced choice version. Some-
The Likert scale determines the opinion or attitude of times respondents become annoyed at forced choice
a subject and contains a number of declarative state- items and refuse to complete them. Researchers who
ments with a scale after each statement. The Likert use the forced choice version consider an item that is
scale is the most commonly used of the scaling tech- left blank as a response of “uncertain.” However,
niques in nursing and healthcare studies. The original responses of “uncertain” are difficult to interpret, and
version of the scale included five response categories. if a large number of respondents select that option
Each response category was assigned a value, with or leave the question blank, the data may be of little
a value of 1 given to the most negative response and value.
a value of 5 given to the most positive response How the researcher phrases item stems depends on
(Nunnally & Bernstein, 1994). the type of judgment that the respondent is being
Response choices in a Likert scale most commonly asked to make. Agreement items are declarative state-
address agreement, evaluation, or frequency. Agree- ments such as “Nurses should be held accountable for
ment options may include statements such as strongly managing a patient’s pain.” Frequency items can be
CHAPTER 17  Measurement Methods Used in Developing Evidence-Based Practice 431

behaviors, events, or circumstances to which the


respondent can indicate how often they occur. A fre- Psychological Outcome
quency stem might be “You read research articles in “The 20-item Center for Epidemiological Studies
nursing journals.” An evaluation stem could be “The Depression Scale (CES-D) (Radloff, 1977) measured
effectiveness of ‘X’ drug for relief of nausea after depressive symptoms [see Figure 17-8]. Participants
chemotherapy.” Items must be clear, concise, and con- reported the frequency of occurrence of depressive
crete (Spector, 1992). symptoms during the past week ranging from 0
An instrument using a Likert scale usually consists ([Rarely or none of the time or] < a day) to 3 (Most
of 15 to 30 items, each addressing an element of the of the time [5-7 days]). Scores range from 0 to 60
concept being measured. Half the statements should with higher scores reflecting greater depressive
be expressed positively and half should be expressed symptoms. Used extensively in CHD [coronary heart
negatively, termed counterbalancing, to avoid insert- disease] populations (Beckie, Fletcher, Beckstead,
ing response-set bias into the participants’ responses. Schocken, & Evans, 2008; Dunn, Corser, Stommel, &
Response-set bias tends to occur when participants Holmes-Rovner, 2006; Scholz, Knoll, Sniehotta, &
anticipate that either the positive or the negative Schwarzer, 2006; Swardfager et al., 2008), a score of
(agree or disagree) response is consistently provided 16 is typically the cut-off score for an elevated level
either in the right or left hand columns of the scale. of depressive symptoms. Evidence of concurrent
Participants might note a pattern that agreeing with validity, construct validity, and reliability of the CES-D
scale items consistently falls to the right and dis- has also been provided for community samples
agreeing to the left. Thus, they might fail to read all (Radloff, 1977). Cronbach’s alpha in the current study
questions carefully and just mark the right or left at all three time-points was over .90.” (Beckie et al.,
column based on whether they agree or disagree with 2011, p. 6)
scale items. Response-set bias can be avoided by
wording some scale items positively and other items
negatively. Participants would need to mark some
items in the right column (agree) and others in the Beckie et al. (2011) clearly described the CES-D
left column (disagree) of the scale based on their used to measure depression in their study. The scoring
sentiments. of the scale was discussed with a score of 16 indicat-
Scale values of negatively worded items must be ing elevated depressive symptoms in women with
reversed before analysis so that the participants’ agree- coronary heart disease. The reliability of the scale for
ment with certain positively worded items and, accord- this study was strong (r = .90). The discussion of the
ingly, their disagreement with negatively worded scale would have been strengthened by expanding the
items on the same scale have higher scale values or validity and reliability information from previous
scores reflecting their agreement. Usually, the values research. Beckie et al. (2011) found that the gender-
obtained from each item in the instrument are summed tailored cardiac rehabilitation program significantly
to obtain a single score for each subject. Although the reduced the depressive symptoms of the women com-
values of each item are technically ordinal-level data, pared with the traditional cardiac rehabilitation
the summed score is often treated as interval-level program.
data, allowing more sophisticated parametric statisti-
cal analyses (Nunnally & Bernstein, 1994). Semantic Differential Scale
The Center for Epidemiological Studies Depres- The semantic differential scale was developed by
sion Scale (CES-D) is an example of a 4-point Likert Osgood, Suci, and Tannenbaum (1957) to measure
scale that is commonly used to measure depression in attitudes or beliefs. It is now used more broadly to
nursing studies (Figure 17-8). The CES-D was devel- measure variations in views of a concept. A semantic
oped by Radloff in 1977 and has shown to be a reliable differential scale consists of two opposite adjectives
and valid measure of depression. Beckie, Beckstead, with a 7-point scale between them. The subject is to
Schocken, Evans, and Fletcher (2011) implemented a select 1 point on the scale that best describes his or
tailored cardiac rehabilitation program to determine its her view of the concept being examined. The scale is
effect on the depressive symptoms of women with designed to measure the connotative meaning of the
coronary heart disease. In this randomized clinical concept to the subject. Although the adjectives may
trial, the CES-D was used to measure depressive not seem to be particularly related to the concept being
symptoms in the women and is described in the fol- examined, the technique can be used to distinguish
lowing excerpt. varying degrees of positive and negative attitudes
432 UNIT TWO  The Research Process

Center for Epidemiologic Studies Depression Scale


DEPA
THESE QUESTIONS ARE ABOUT HOW YOU HAVE BEEN FEELING LATELY.
AS I READ THE FOLLOWING STATEMENTS, PLEASE TELL ME HOW OFTEN YOU FELT OR
BEHAVED THIS WAY IN THE LAST WEEK. [Hand card ]. FOR EACH STATEMENT, DID YOU FEEL
THIS WAY: [Interviewer: You may help respondent focus on the whichever “style” answer is easier]
0 = Rarely or none of the time (or less than 1 day)?
1 = Some or a little of the time (or 1-2 days)?
2 = Occasionally or a moderate amount of time (or 3-4 days)?
3 = Most or all of the time (or 5-7 days)?

1. I WAS BOTHERED BY THINGS THAT USUALLY DON’T R S O M NR


BOTHER ME. 0 1 2 3 --
2. I DID NOT FEEL LIKE EATING; MY APPETITE WAS POOR. 0 1 2 3 --
3. I FELT THAT I COULD NOT SHAKE OFF THE BLUES EVEN
WITH HELP FROM MY FAMILY AND FRIENDS. 0 1 2 3 --
4. I FELT THAT I WAS JUST AS GOOD AS OTHER PEOPLE. 0 1 2 3 --
5. I HAD TROUBLE KEEPING MY MIND ON WHAT I WAS DOING. 0 1 2 3 --
6. I FELT DEPRESSED. 0 1 2 3 --
7. I FELT THAT EVERYTHING I DID WAS AN EFFORT. 0 1 2 3 --
8. I FELT HOPEFUL ABOUT THE FUTURE. 0 1 2 3 --
9. I THOUGHT MY LIFE HAD BEEN A FAILURE. 0 1 2 3 --
10. I FELT FEARFUL. 0 1 2 3 --
11. MY SLEEP WAS RESTLESS. 0 1 2 3 --
12. I WAS HAPPY. 0 1 2 3 --
13. I TALKED LESS THAN USUAL. 0 1 2 3 --
14. I FELT LONELY. 0 1 2 3 --
15. PEOPLE WERE UNFRIENDLY. 0 1 2 3 --
16. I ENJOYED LIFE. 0 1 2 3 --
17. I HAD CRYING SPELLS. 0 1 2 3 --
18. I FELT SAD. 0 1 2 3 --
19. I FELT PEOPLE DISLIKED ME. 0 1 2 3 --
20. I COULD NOT GET GOING. 0 1 2 3 --

Figure 17-8  Center for Epidemiologic Studies Depression Scale (CES-D). (From Radloff, L. S. [1977]. The CES-D scale: A self-report depression scale
for research in the general population. Applied Psychological Measures, 1, 385–394.)

toward a concept. Figure 17-9 illustrates the form used obtain one score for each subject. Factor analysis is
for this type of scale. used to determine the factor structure, which is
In a semantic differential scale, values from 1 to 7 expected to reflect three factors or dimensions:
are assigned to each of the spaces, with 1 being the (1) evaluation, (2) potency, and (3) activity (Osgood
most negative response and 7 the most positive. Place- et al., 1957). Researchers need to explain theoretically
ment of negative responses to the left or right of the why particular items on the scale cluster together in
scale should be randomly varied to avoid global the factor analysis. Thus, development of the instru-
responses (in which the subject places checks in the ment contributes to theory development. Factor analy-
same column of each scale). Each line is considered sis is also used to evaluate the construct validity of the
one scale, and the values for the scales are summed to instrument. With some of these instruments, three
CHAPTER 17  Measurement Methods Used in Developing Evidence-Based Practice 433

Nursing Research
Logical Illogical

Insignificant Significant

Structured Unstructured

Active Passive

Organized Disorganized Figure 17-9  Example items from a semantic


differential scale to measure nursing research.
Scientific Unscientific

Important to Unimportant to
Practice Practice

Lacking Rigor Rigorous

Detailed Vague

Boring Exciting

factor scores, each representing one of the dimensions, feelings (Wewers & Lowe, 1990). The VAS is referred
are used to describe the subject’s responses and to as magnitude scaling (Gift, 1989). This technique
provide for further analysis (Nunnally & Bernstein, seems to provide interval-level data, and some
1994). researchers argue that it provides ratio-level data
Chase (2011) conducted a quasi-experimental study (Sennott-Miller, Murdaugh, & Hinshaw, 1988). It is
to examine the effect of an intergenerational email particularly useful in scaling stimuli. This scaling
project on the attitudes of college students toward technique has been used to measure pain, mood,
older adults. The college students were paired with anxiety, alertness, craving for cigarettes, quality of
older adults with whom they exchanged emails for 6 sleep, attitudes toward environmental conditions,
weeks. The students’ attitudes toward the older adults functional abilities, and severity of clinical symptoms
were measured with the Aging Semantic Differential (Waltz et al., 2010; Wewers & Lowe, 1990).
(ASD). The ASD includes 32 bipolar adjectives with The stimuli must be defined in a way that the
a 7-point linear scale between them. The college stu- subject clearly understands. Only one major cue
dents indicated their degree of agreement with each should appear for each scale. The scale is a line 100
pair of the adjectives on a scale from 1 to 7. Chase mm in length with right-angle stops at each end. The
found that the emailing intervention significantly line may be horizontal or vertical as shown in Figure
improved the college students’ attitudes toward older 17-10. Bipolar anchors are placed beyond each end
adults in the experimental group versus the students of the line. The anchors should not be placed under-
in the comparison group. neath or above the line before the stop. These end
anchors should include the entire range of sensations
Visual Analogue Scale possible in the phenomenon being measured. Exam-
One of the problems with scaling procedures is the ples include “all” and “none,” “best” and “worst,”
difficulty of obtaining a fine discrimination of values. and “no pain” and “worst pain imaginable” (see
In an effort to resolve this problem, the visual ana- Figure 17-10).
logue scale was developed to measure magnitude, The VAS is frequently used in healthcare research
strength, and intensity of an individual’s sensations or because it is easy to construct, administer, and score.
434 UNIT TWO  The Research Process

Visual Analogue Scale


Figure 17-10  Example of a visual analogue
scale to measure pain. No pain Worst pain
imaginable

A VAS can be administered using a drawn, printed, or


computer-generated 100-mm line (Raven et al., 2008; imaginable at the top of the line (Gagliese, Weizblit,
Waltz et al., 2010). The research participant is asked Ellis, & Chan, 2005). A mark at the bottom (i.e., zero)
to place a mark through the line to indicate the inten- indicated no pain; 100 was the greatest value of pain.
sity of the sensation or stimulus. A ruler is used to Each subject placed a mark on the vertical line to
measure the distance between the left end of the line represent the level of pain or discomfort. A superim-
and the mark placed by the subject. This measure is posed transparency marked in 1-mm increments was
the value of the subject’s sensation. With a computer- used to record the distance of each subject’s mark
generated VAS, research participants can touch the from the bottom of the line. Intrarater reliability for
VAS line on the computer screen to indicate the degree VAS values was set at 2 mm; 90% agreement was
of their sensations, such as pain. The computer can maintained.… A standard dermatome chart was also
determine the value of the sensation for each subject used in data collection.… Dermatomes represent
and store it in a database (Raven et al., 2008). The sensory input from spinal nerves to specific areas of
scale is designed to be used while the subject is seated. the skin.” (Winkelman et al., 2008, pp. 105-106)
Whether use of the scale from the supine position “VAS and dermatome levels were moderately cor-
influences the results by altering perception of the related at each time point with Pearson’s r ranging
length of the line has yet to be determined (Gift, from .331 to .546 (p > .05).… Overall, there was
1989). A VAS can be developed for children by using insufficient agreement on the intensity of pain sensa-
pictorial anchors at each end of the line rather than tion between dermatome level and VAS scores.…
words (Lee & Kieckhefer, 1989). The lack of agreement between dermatome levels
Wewers and Lowe (1990) published an extensive and VAS scores indicates that one value cannot be
evaluation of the reliability and validity of VAS, substituted for another. Specifically, the assessment of
although reliability is difficult to determine. Reliabil- dermatome level provided an equivalent substitute
ity of the VAS is most often determined with the test- for the VAS as a measure of pain in laboring women
retest method, which is effective if the variable being only at 20 minutes following epidural analgesia admin-
measured is fairly stable, such as chronic pain. Because istration.” (Winkelman et al., 2008, pp. 107-108)
most of the variables measured with the VAS are
labile, test-retest consistency is not applicable, and
because a single measure is obtained, internal consis- Winkelman et al. (2008) clearly described the VAS
tency cannot be examined. The VAS is more sensitive used in their study and how the scale was administered
to small changes than numerical and rating scales and and scored. These researchers found that both the VAS
can discriminate between two dimensions of pain. and the dermatome assessment were easy to use during
Validity of the VAS has most commonly been labor and were good measures of pain shortly after
determined by comparing VAS scores with other mea- epidural anesthesia. However, one measure could not
sures of a concept. Winkelman, Norman, Maloni, and be substituted for the other, and the best measure of
Kless (2008) compared VAS scores with dermatome pain in laboring women is currently dermatome
assessment in measuring pain during labor. The fol- assessment. Other studies comparing the VAS with
lowing study excerpt describes the agreement between other instruments measuring the same construct have
these two measures of pain in laboring women who had varying positive and negative results. Additional
received an epidural analgesia. research is needed with the VAS to ensure it is a reli-
able and valid measure of certain patients’ sensations
(Waltz et al., 2010).
“The Visual Analogue Sensation of Pain Scale was
used to measure patient reports of labor pain. The
solid line was vertical in this study, with no pain Q-Sort Methodology
anchoring the bottom of the line and worst pain Q-sort methodology is a technique of comparative
rating that preserves the subjective point of view of
CHAPTER 17  Measurement Methods Used in Developing Evidence-Based Practice 435

the individual (McKeown & Thomas, 1988). Cards


are used to categorize the importance placed on (Akhtar-Danesh et al., 2008).” (Dariel et al., 2010,
various words or phrases in relation to the other p. 60)
words or phrases in the list. Each phrase is placed on “Statements with which participants most agree
a separate card. The number of cards should range are placed on the far right of the grid, whereas those
from 40 to 100 (Tetting, 1988). The subject is with which they most disagree are placed on the far
instructed to sort the cards into a designated number left. Cards are then placed in each subsequent column
of piles, usually 7 to 10 piles ranging from the most based on their views towards the previous cards.
to the least important. However, the subject is limited While participants read the statements, they are
in the number of cards that may be placed in each asked to make comments about their interpretation
pile. If the subject must sort 60 cards, category 1 (of of the statements and their placement on the grid.
greatest importance) may allow only 2 cards; cate- “During the pilot study, participants were asked to
gory 2, 5 cards; category 3, 10 cards; category 4, 26 read the statements using a specific ‘condition of
cards; category 5, 10 cards; category 6, 5 cards; and instruction’ to guide the sort and provide a lens
category 7 (the least important), 2 cards. Placement through which to read each statement. The guiding
of the cards fits the pattern of a normal curve. The statement was ‘Think about the issues which might
subject is usually advised to select first the cards that be influencing your approach to using technology in
he or she wishes to place in the two extreme catego- your teaching practice as you read and sort the state-
ries and then work toward the middle category ments according to how you most agree or most
(which contains the largest number of cards), rear- disagree with how they each impact your use (or
ranging cards until he or she is satisfied with the decision not to use) e-learning.’ Participants then
results. When sorting the cards, subjects might be placed each statement into a quasi-normal distribu-
encouraged to make comments about the statements tion grid with 11 categories ranging from −5 to +5.”
on the cards and provide a rationale for the catego- (Dariel et al., 2010, pp. 67-68)
ries where they placed the cards (Akhtar-Danesh,
Baumann, & Cordingley, 2008; Dariel, Wharrad, &
Windle, 2010).
The Q-sort method can also be used to determine Delphi Technique
the priority of items or the most important items to The Delphi technique measures the judgments of a
include in the development of a scale. In the previ- group of experts for the purpose of making decisions,
ously mentioned example, the behaviors sorted into assessing priorities, or making forecasts (Vernon,
categories 1, 2, and 3 might be organized into a 2009). Using this technique allows a wide variety of
17-item scale. Correlational or factor analysis is used experts to express opinions and provide feedback,
to analyze the data (Dariel et al., 2010; Dennis, 1986; nationally and internationally, without meeting to­
Tetting, 1988). Simpson (1989) suggested using the gether. When the Delphi technique is used, the
Q-sort method for cross-cultural research, with pic- opinions of individuals cannot be altered by the per-
tures rather than words used for nonliterate groups. suasive behavior of a few people at a meeting. Three
Dariel et al. (2010) used the Q-sort methodology to types of Delphi techniques have been identified:
examine faculty views toward the use of technology classic or consensus Delphi, dialectic Delphi, and
in nursing education. They described the Q-sort meth- decision Delphi. In classic Delphi, the focus is on
odology in-depth in their article, and the following reaching consensus. Dialectic Delphi is sometimes
excerpt includes the Q-sort methodology they used in called policy Delphi, and the aim is not consensus
their study. but rather to identify and understand a variety of
viewpoints and resolve disagreements. In decision
Delphi, the panel consists of individuals in decision-
“The Q-sort [methodology] typically consists of a making positions. The purpose is to come to a deci-
number of statements printed on small cards, which sion (Vernon, 2009; Waltz et al., 2010). Mitchell
participants rank according to a ‘condition of instruc- (1998) assessed the validity of the Delphi technique
tion.’ This act of ranking each statement in relation to in nursing education planning and found that 98.1%
others, rather than evaluating them individually, is of the predicted events had either occurred or were
designed to capture the way people think about ideas still expected to occur.
in relation to other ideas rather than in isolation To implement the Delphi technique, researchers
identify a panel of experts, who have a variety of
436 UNIT TWO  The Research Process

Experimenter
(start) Perform
final analysis and
Design initial report findings
questionnaire

Redesign
Consensus
succeeding
reached
questionnaire(s)
Plan and
provide feedback
Pilot test questionnaire
No consensus reached

Finalize questionnaire
Analyze data and
summarize comments

Mail questionnaire
Collect responses

Respond to questionnaires
with numerical data and
comments

Respondent group

Figure 17-11  Delphi technique sequence model. Multiple arrows indicate repeated cycles of review by experts.

perceptions, personalities, interests, and demograph- agreement reached is genuine (Vernon, 2009; Waltz et
ics to reduce biases in the process. Members of the al., 2010). Couper (1984) developed a model of the
panel usually remain anonymous to each other. A Delphi technique, which is presented in Figure 17-11.
questionnaire is developed that addresses the topics of This model might assist you in implementing a Delphi
concern. Although most questions call for closed- technique in a study.
ended responses, the questionnaire usually contains Vernon (2009) identified benefits and limitations of
opportunities for open-ended responses by the expert. the Delphi technique. The benefits include increased
Once they have completed the questionnaires, the access to experts and usually good response rates. The
respondents return them to the researcher, who then Delphi design has simplicity and flexibility in its use;
analyzes and summarizes the results. The statistical it is easily understood and implemented by research-
analyses usually include measures of central tendency ers. Because the participants are anonymous, views
and measures of dispersion. The role of the researcher can be expressed freely without direct persuasion from
is to maintain objectivity. The outcome of the statisti- others.
cal analysis is returned to the panel of experts, along There are also several potential problems that
with a second questionnaire. Respondents with researchers could encounter when using the Delphi
extreme responses to the first round of questions may technique. There has been no documentation that the
be asked to justify their responses. The respondents responses of “experts” are different from responses
return the second round of questionnaires to the one would receive from a random sample of subjects.
researcher for analysis. This procedure is repeated Because the panelists are anonymous, they have no
until the data reflect a consensus among the panel. accountability for their responses. Respondents could
Limiting the process to two or three rounds is not a make hasty, ill-considered judgments because they
good idea if consensus is the goal. In some studies, know that no negative feedback would result. Feed-
true consensus is reached, whereas in others, “major- back on the consensus of the group tends to centralize
ity rules.” Some authors question whether the opinion, and traditional analysis with the use of means
CHAPTER 17  Measurement Methods Used in Developing Evidence-Based Practice 437

and medians may mask the responses of individuals (frequency and time required), symptoms of disease,
who are resistant to the consensus sentiment. Conclu- eating behavior, exercise behavior, sexual activities,
sions could be misleading (Vernon, 2009). the child development process, and care provided by
Some nursing specialty organizations have estab- family members in a home-care situation. Although
lished their research priorities by using Delphi tech- diaries have been used primarily with adults, they are
niques. Lindeman (1975) conducted one of the initial also an effective means of collecting data from school-
studies using the Delphi technique to determine age children.
research priorities in clinical nursing. She used a panel Health diaries have been used to document health
of 433 experts, nurses and nonnurses, with a wide problems, responses to symptoms, and efficacy of
range of interests. The panel was sent four rounds of responses. Diaries may also be used to determine how
a 150-item questionnaire. The report, published in people spend their days; this information could be
Nursing Research, had an important influence on the particularly useful in managing the care needs of indi-
research conducted in nursing for clinical practice. viduals with chronic illnesses. In experimental studies,
Wilkes, Mohan, Luck, and Jackson (2010) used the diaries may be used to determine responses of subjects
Delphi technique to develop a violence assessment to experimental treatments. Diaries can take a variety
tool for a hospital emergency department. The follow- of forms and might include filling in blanks, selecting
ing excerpt from their study describes the methodol- the best response from a list of options, or checking a
ogy they used. column. Figure 17-12 shows a page from a diary for
patients to record their symptoms and how they were
“The aim of this study was to develop a violence
managed. This diary includes blanks to identify the
assessment tool by refining a list of predictive cues
symptoms and an option to check how the symptoms
identified from both a previous study and existing
were managed. This type of diary is used to collect
literature. Using the Delphi technique, a panel of 11
numerical data for a quantitative study. Validity and
expert nurse academics and clinicians developed a
reliability have been examined by comparing the
37-item questionnaire and used three rounds of
results with data obtained through interviews and have
Delphi to refine the violence assessment question-
been found to be acceptable. Participation in studies
naire. The resulting tool comprises 17 cues of poten-
using health diaries has been good, and attrition rates
tial violence that can be easily observed and requires
are reported as low. Some diaries include the collec-
no prior knowledge of the perpetrators’ medical
tion of narrative data and are more common in qualita-
history.” (Wilkes et al., 2010, p. 70)
tive studies (Alaszewski, 2006).
Nicholl (2010) and Burman (1995) provide some
key points to consider when selecting a diary for col-
lecting data in a study:
Diaries 1. Analyze the phenomenon of interest to determine
A diary is a recording of events over time by an indi- if it can be adequately captured using a diary. Also,
vidual to document experiences, feelings, or behavior determine if a diary is the best data collection
patterns. Diaries are also called logs or journals and approach when compared with interviews, ques-
have been used since the 1950s to collect data for tionnaires, and scales.
research from various populations including children, 2. Decide if the diary will be used alone or with other
patients with acute and chronic illness, pregnant measurement methods.
women, and elderly adults (Aroian & Wal, 2007; 3. Determine which format of the diary to use so that
Nicholl, 2010). A diary, which allows recording the most valid information can be obtained to
shortly after an event, is thought to be more accurate address the study purpose without burdening the
than obtaining the information through recall during study participants. Diaries can be paper, online, or
an interview. In addition, the reporting level of inci- phone text-messaging formats. Some researchers
dents is higher, and one tends to capture the partici- are using blogs as a way to collect diary data (Lim,
pant’s immediate perception of situations. Sacks-Davis, Aitken, Hocking, & Hellard, 2010).
The diary technique gives nurse researchers a The format of the questions in diaries can also vary
means to obtain data on topics of particular interest based on the purpose of the study. Diaries with
within nursing that have not been accessible by other closed-ended questions are usually used in quanti-
means. Some potential topics for diary collection tative research, and participants are provided spe-
include expenses related to a healthcare event (par- cific direction on the data to be recorded. Diaries
ticularly out-of-pocket expenses), self-care activities with open-ended questions are more common in
438 UNIT TWO  The Research Process

Did you talk Did you talk Did you take


with a family with a health any pills or
member or professional treatments
friend about about it? for the
the symptom? symptom?

Date What symptom No Yes No Yes No Yes,


did you have?
Specify
Figure 17-12  Sample diary page.

qualitative research with the narrative data requir- events under study. For example, if a person were
ing content analysis (Alaszewski, 2006; Nicholl, keeping a diary of the nursing care that he or she was
2010). providing to patients, the insight that the person gained
4. Pilot-test any new or refined diary with the target from recording the information in the diary might lead
population of interest to identify possible prob- to changes in care. In addition, patients can become
lems, determine if the instructions and terminology more sensitive to items (e.g., symptoms or problems)
are clear, ensure that the data can be recorded with reported in the diary, which could result in overreport-
this approach, and examine the ability of partici- ing. Subjects may also become bored with keeping the
pants to complete diaries. diary and become less thorough in recording items,
5. Determine the period of time that the diary will be which could result in underreporting (Aroian & Wal,
completed to accomplish the purpose of the study, 2007; Nicholl, 2010).
taking into consideration the burden on the partici- Lim et al. (2010) conducted a randomized con-
pants. Typical diary periods are 2 to 8 weeks. trolled trial to determine the best diary format for
6. Provide clear instructions to all participants on the collecting sexual behavior information from adoles-
use of a diary before the study begins to enhance cents. The three formats for the diaries were paper,
the quality of data collected. Participants need to online, and phone text messaging (short message
know how to use the diaries, what types of events service); these were compared for response rate, time-
are to be reported, and how to contact the researcher liness, completeness of data, and acceptability. The
or clinician with questions. following excerpt describes the use of the diaries for
7. Use follow-up procedures, such as phone calls or data collection and the outcomes.
emails, during data collection to enhance comple-
tion rates. Diaries might be emailed, mailed, or
picked up by the researchers. Picking up the diary “Participants were recruited by telephone and ran-
in person promotes a higher completion rate than domized into one of three groups. They completed
mailing. weekly sexual behavior diaries for 3 months by SMS
8. Plan data analysis procedures during diary devel- [short message service], online, or paper (by post).
opment and refine these plans to ensure the most An online survey was conducted at the end of 3
appropriate analyses are used. Diary data are very months to compare retrospective reports with the
dense and rich, and carefully prepared analysis diaries and assess opinions on the diary collection
plans can minimize problems (Burman, 1995; method.… Conclusions were that the SMS is a con-
Nicholl, 2010). venient and timely method of collecting brief
The use of diaries has some disadvantages. In some behavioral data, but online data collection was
cases, keeping the diary may alter the behavior or
CHAPTER 17  Measurement Methods Used in Developing Evidence-Based Practice 439

on answering the research questions or testing the


preferable to most participants and more likely to be study hypotheses. However, with existing databases,
completed. Data collected in retrospective sexual researchers need to ensure that the data they require
behavior questionnaires were found to agree substan- for their study is in the database they are planning to
tially with data collected through weekly self-report use. Sometimes researchers must revise their study
diaries.” (Lim et al., 2010, p. 885) questions and variables based on what data exist in the
database. The level of measurement of the study vari-
ables might limit the analysis techniques that can be
Lim et al. (2010) provided some valuable informa- used. There is also the question of the validity and
tion about the formats for collecting data with diaries. reliability of the data in existing databases; unless
Researchers might want to consider using online or these are specifically reported, researchers using these
phone text messaging to collect diary data from data files need to be cautious in their interpretation of
younger populations. These formats could signifi- findings.
cantly increase the response rate and the completeness
of the data collected. The paper format for collecting Existing Healthcare Data
diary data also provides quality information and might Existing healthcare data consist of two types: second-
be better for populations with limited access to ary and administrative. Data that are collected for a
technology. particular study are considered primary data. Data that
are collected from previous research and stored in a
database are considered secondary data when used by
Measurement Using other researchers to address their study purposes.
Because these data were collected as part of research,
Existing Databases details can be obtained about the data collection and
Nurse researchers are increasing their use of existing storage process. Researchers usually clearly indicate
databases to address the research problems they have in their article in the methodology section when sec-
identified as essential in generating evidence for prac- ondary data analyses were conducted as part of their
tice. The reasons for using these databases in studies research (Johantgen, 2010).
are varied. With the computerization of healthcare Data that are collected for reasons other than
information, more large data sets have been developed research are considered administrative data. Adminis-
internationally, nationally, regionally, at the state level, trative data are collected within clinical agencies;
and within clinical agencies. These databases include obtained by national, state, and local professional
large amounts of information that have relevance in organizations; and collected by federal, state, and
developing research evidence needed for practice local agencies. The processes for collection and
(Brown, 2009; Melnyk & Fineout-Overholt, 2011). storage of administrative data are more complex and
The costs and technology for storage of data have often more unclear than the data collection process
improved over the last 10 years making these large for research (Johantgen, 2010). The data in adminis-
data sets more reliable and accessible. Using existing trative databases are collected by different people
databases makes it possible to conduct complex analy- in different sites using different methods. However,
ses to expand understanding of healthcare outcomes the data elements collected for most administrative
(Doran, 2011). Another reason is that the primary col- databases include demographics, organizational char-
lection of data in a study is limited by the availability acteristics, clinical diagnosis and treatment, and geo-
of participants and the expense of the data collection graphical information. These database elements were
process. By using existing databases, researchers are standardized by the Health Insurance Portability and
able to have larger samples, conduct more longitudinal Accountability Act (HIPAA) of 1996, which improved
studies, experience less costs during the data collec- the quality of the databases. The HIPAA regulations
tion process, and limit the burdens placed on study can be viewed online at http://www.hhs.gov/ocr/
participants (Johantgen, 2010). privacy/ (U.S. Department of Health & Human Ser-
There are also problems with using data from exist- vices, 2011).
ing databases. The data in the database might not When using secondary data and administrative
clearly address the researchers’ study purpose. Most data in a study, researchers need to determine the reli-
researchers identify a study problem and purpose and ability and validity of the data in the database they
then develop a methodology to address these. The data plan to access. They also need to ensure that the data
collected are specific to the study and clearly focused in the data set address the research questions or
440 UNIT TWO  The Research Process

hypotheses of their study Lake, Shang, Klaus, and measurement selected must fit closely the conceptual
Dunton (2010) used an existing database entitled the definition of the variable. Researchers need to conduct
National Database of Nursing Quality Indicators an extensive search of the literature to identify appro-
(NDNQI) for the conduct of their study. The NDNQI priate methods of measurement. In many cases, they
was designed to measure nursing quality and patient find instruments that measure some of the needed ele-
safety. Lake et al. examined the relationships between ments but not all, or the content may be related to but
patient falls, nursing unit staffing, and hospital Magnet somehow different from what is needed for a study.
status. The following excerpt describes the database Instruments found in the literature may have little or
they used. no documentation of their validity and reliability.
Beginning researchers often conclude that no
appropriate method of measurement exists and that
“NDNQI Database Overview they must develop a tool. At the time, this solution
The NDNQI, a unique database that was well-suited seems to be the most simple because the researcher
to our study aims, is part of the American Nurses has a clear idea of what needs to be measured. This
Association’s (ANA) Safety and Quality Initiative. This solution is not recommended unless all else fails. Tool
initiative started in 1994 with information gathering development is a lengthy process and requires sophis-
from an expert panel and focus groups to specify a ticated research. Using a new instrument in a study
set of 10 nurse-sensitive indicators to be used in the without first evaluating its validity and reliability can
database.… The database was pilot tested in 1996 be problematic and lead to questionable findings.
and 1997 and was established in 1998 with 35 hospi- For novice researchers developing their first study,
tals. Use of the NDNQI has grown rapidly.… In 2009, it is essential to identify existing instruments to
1,450 hospitals—one out of every four general hos- measure study variables. Jones (2004) developed a
pitals in the U.S.—participated in it. flow chart that might help you to select an existing
The NDNQI has served as a unit-level benchmark- instrument for your study (Figure 17-13). The major
ing resource, but research from this data repository steps include (1) identifying an instrument from the
has been limited. NDNQI researchers have published literature, (2) determining if the instrument is appro-
two studies on the association between characteris- priate for measuring a study variable, and (3) examin-
tics of nursing workforce and fall rates.… The scope ing the performance of the instrument by evaluating
of work on this topic was extended in the current its reliability and validity. These steps are detailed in
study by: (a) specifying nurse staffing separately for the following sections.
RNs [registered nurses], LPNs [licensed practical
nurses], and NAs [nursing assistants], (b) using the Locating Existing Instruments
entire NDNQI database, (c) selecting the most Locating existing measurement methods has become
detailed level of observation (month), and (d) applying easier in recent years. A computer database, the Health
more extensive patient risk adjustment than had been and Psychological Instruments Online (HAPI), is
evaluated previously.” (Lake et al., 2010, p. 415) available in many libraries and can be used to search
for instruments that measure a particular concept or
for information on a particular instrument. Sometimes
Lake et al. (2010) provide a detailed description of a search on Medline or CINAHL might uncover an
the national database that they used in their study. This instrument that is useful. Many reference books have
database was selected because it was “well-suited” to compiled published measurement tools, some that are
the study’s aims and because the focus of the study specific to instruments used in nursing research. Dis-
was to expand on previous research that had been done sertations often contain measurement tools that have
using this database information. The development of never been published, so a review of Dissertation
the database was very structured, which increases the Abstracts online might be helpful.
reliability and validity of the field data. Another important source of recently developed
measurement tools is word-of-mouth communication
among researchers. Information on tools is often pre-
Selection of an sented at research conferences years before publica-
tion. There are usually networks of researchers
Existing Instrument conducting studies on similar nursing phenomena.
Selecting an instrument to measure the variables in a These researchers are frequently associated with
study is a critical process in research. The method of nursing organizations and keep in touch through
CHAPTER 17  Measurement Methods Used in Developing Evidence-Based Practice 441

Existing Tool New Tool

Identification
Perform literature search Develop new tool

Design
Potentially No Write study protocol
relevant
tool exists?

Implementation
Yes Collect data
Appropriateness
Define criteria

Analysis
Perform univariate
and multivariate Figure 17-13  Flow chart depicting the identification and
Tool No analyses assessment of an existing tool and development of a new
satisfies tool.
criteria?

Yes Tool
Devise allocation rule
Performance
Evaluate reliability and validity

Performance
Evaluate goodness
of fit, reliability, and
Is tool validity
No
valid and
reliable?

Yes

Use existing tool

newsletters, correspondence, telephone, email, com-


puter discussion boards, and web pages. Questioning “(1) [S]earch computerized databases by using the
available nurse investigators can lead to a previously name of the instrument or keywords or phrases;
unknown tool. These researchers can often be reached (2) generalize the search to the specific area of inter-
by telephone, letter, or email and are usually willing est and related topics (research reports are particu-
to share their tools in return for access to the data to larly valuable); (3) search for summary articles
facilitate work on developing validity and reliability describing, comparing, contrasting, and evaluating the
information. The Sigma Theta Tau Directory of Nurse instruments used to measure a given concept;
Researchers provides email address and phone infor- (4) search journals, such as Journal of Nursing Measure-
mation on nurse researchers. In addition, it lists nurse ment, that are devoted specifically to measurement;
researchers by category according to their area of (5) after identifying a publication in which relevant
research. instruments are used, use citation indices to locate
Waltz and colleagues (2010) made the following other publications that used them; (6) examine
suggestions to facilitate locating existing instruments computer-based and print indices, and compendia of
for studies:
442 UNIT TWO  The Research Process

instruments developed by nursing, medicine, and Assessing Readability Levels of Instruments


other disciplines; and (7) examine copies of published The readability level of an instrument is a critical
proceedings and abstracts from relevant scientific factor when selecting an instrument for a study.
meetings.” (Waltz et al., 2010, pp. 393-394) Regardless of how valid and reliable the instrument is,
it cannot be used effectively if study participants do
not understand the items. Calculating readability is
Evaluating Existing Instruments for easy and can be done in a few minutes. Many word
Appropriateness and Performance processing programs and computerized grammar
You may need to examine several instruments to find checkers report the readability level of written mate-
the one most appropriate for your study. When select- rial. The Fog formula described in Chapter 16 pro-
ing an instrument for research, carefully consider how vides a quick and easy way to assess readability. If the
the instrument was developed, what the instrument reading level of an instrument is beyond the reading
measures, and how to administer it. Before you review level of the study population, you need to select
existing instruments, be sure you have conceptually another instrument for use in your study. Changing the
defined your study variable and are clear on what you items on an instrument to reduce the reading level can
desire to measure. You then need to address the fol- alter the validity and reliability of the instrument.
lowing questions to determine the best instrument for
measuring your study variable:
1. Does this instrument measure what you want to Constructing Scales
measure? Scale construction is a complex procedure that should
2. Does the instrument reflect your conceptual defi- not be undertaken lightly. There must be firm evidence
nition of the variable? of the need for developing another instrument to
3. Is the instrument well constructed? measure a particular phenomenon important to nursing
4. Does your population resemble populations previ- practice. However, in many cases, measurement
ously studied with the instrument? (Waltz et al., methods have not been developed for phenomena of
2010) concern to nurse researchers, or measurement tools
5. Is the readability level of the instrument appropri- that have been developed may be poorly constructed
ate for your population? and have insufficient evidence of validity to be accept-
6. How sensitive is the instrument in detecting small able for use in studies. It is possible for the researcher
differences in the phenomenon you want to to carry out instrument development procedures on an
measure (what is the effect size)? existing scale with inadequate evidence of validity
7. What is the process for obtaining, administering, before using it in a study. Neophyte nurse researchers
and scoring the instrument? Are there costs asso- could assist experienced researchers in carrying out
ciated with the instrument? some of the field studies required to complete the
8. What skills are required to administer the instru- development of scale validity and reliability.
ment? Do you need training or a particular cre- The procedures for developing a scale have been
dential to administer the instrument? well defined. The following discussion describes this
9. How are the scores interpreted? theory-based process and the mathematical logic
10. What is the time commitment of the study partici- underlying it. The theories on which scale construc-
pants and researcher for administration of the tion is most frequently based include classic test
instrument? theory (Nunnally & Bernstein, 1994), item response
11. What evidence is available related to the reliabil- theory (Hulin, Drasgow, & Parsons, 1983), multi­
ity and validity of the instrument? Have multiple dimensional scaling (Borg & Groenen, 2010; Kruskal
types of validity been examined (content validity, & Wish, 1990), and unfolding theory (Coombs, 1950).
validity from factor analysis, validity from exam- Most existing instruments used in nursing research
ining measures assessing for convergence and have been developed with classic test theory, which
divergence, or evidence of validity from predic- assumes a normal distribution of scores.
tion of concurrent and future events)? Chapter 16
provided a detailed discussion of reliability and Constructing a Scale by Using Classic
validity (Bartlett & Frost, 2008; Bialocerkowski Test Theory
et al., 2010; DeVon et al., 2007; Fawcett & Garity, In classic test theory, the following process is used to
2009). construct a scale:
CHAPTER 17  Measurement Methods Used in Developing Evidence-Based Practice 443

1. Define the concept. A scale cannot be constructed subjects who represent the target population.
to measure a concept until the nature of the Spector (1992) recommended a sample size of
concept has been delineated. The more clearly the 100 to 200 subjects. However, the sample size
concept is defined, the easier it is to write items needed for the statistical analyses to follow
to measure it (Spector, 1992). Concepts are depends on the number of items in the instrument.
defined through the process of concept analysis, Some experts recommend including 10 subjects
a procedure discussed in Chapter 7. for each item being tested. If the final instrument
2. Design the scale. Items should be constructed to was expected to have 20 items, and 40 items were
reflect the concept as fully as possible. The constructed for the field test, 400 subjects could
process of construction differs depending on be required.
whether the scale is a rating scale, Likert scale, or 6. Conduct item analyses. The purpose of item anal-
semantic differential scale. Items previously ysis is to identify items that form an internally
included in other scales can be used if they have consistent or reliable scale and to eliminate items
been shown empirically to be good indicators of that do not meet this criterion. Internal reliability
the concept (Hulin et al., 1983). A blueprint may implies that all the items are consistently mea­
ensure that all elements of the concept are covered. suring a concept. Before these analyses are
Each item must be stated clearly and concisely conducted, negatively worded items must be
and express only one idea. The reading level of reverse-scored or given a score as though the item
items must be identified and considered in terms was stated positively. For example, the item might
of potential respondents. The number of items read “I do not believe exercise is important to
constructed must be considerably larger than health,” with the responses of 1 = strongly dis-
planned for the completed instrument because agree, 2 = disagree, 3 = uncertain, 4 = agree, and
items are discarded during the item analysis step 5 = strongly agree. If the subject marked a 1 for
of scale construction. Nunnally and Bernstein strongly disagree, this item would be reverse-
(1994) suggested developing an item pool at least scored and given a 5, indicating the subject thinks
twice the size of that desired for the final scale. exercise is very important to health. The analyses
3. Review the items. As items are constructed, it is examine the extent of intercorrelation among the
advisable to ask qualified individuals to review items. The statistical computer programs cur-
them. Crocker and Algina (1986) recommended rently providing the set of statistical procedures
asking for feedback in relation to accuracy, appro- needed to perform item analyses (as a package)
priateness, or relevance to test specifications; are SPSS, SPSS/PC, and SYSTAT. These pack-
technical flaws in item construction; grammar; ages perform item-item correlations and item-
offensiveness or appearance of bias; and level of total correlations. In some cases, the value of the
readability. The items should be revised according item being examined is subtracted from the total
to the critical appraisal. score, and an item-remainder coefficient is calcu-
4. Conduct preliminary item tryouts. While items are lated. This latter coefficient is most useful in
still in draft form, it is helpful to test them on a evaluating items for retention in the scale.
limited number of subjects (15 to 30) who repre- 7. Select items to retain. Depending on the number
sent the target population. The reactions of of items desired in the final scale, items with the
respondents should be observed during testing to highest coefficients are retained. Alternatively, a
note behaviors such as long pauses, answer chang- criterion value for the coefficient (e.g., 0.40) can
ing, or other indications of confusion about spe- be set, and all items greater than this value are
cific items. After testing, a debriefing session retained. The greater the number of items retained,
needs to be held during which respondents are the smaller the item-remainder coefficients can be
invited to comment on items and offer sugges- and still have an internally consistent scale. After
tions for improvement. Descriptive and explor- this selection process, a coefficient alpha is calcu-
atory statistical analyses are performed on data lated for the scale. This value is a direct function
from these tryouts while noting means, response of the number of items and the magnitude of inter-
distributions, items left blank, and outliers. Items correlation. Thus, one can increase the value of
need to be revised based on this analysis and com- a coefficient alpha by increasing the number of
ments from respondents. items or raising the intercorrelations through
5. Perform a field test. All the items in their final inclusion of more highly intercorrelated items.
draft form are administered to a large sample of Values of coefficient alphas range from 0 to 1. The
444 UNIT TWO  The Research Process

alpha value should be at least 0.70 to indicate suf- after the initial development because of the length
ficient internal consistency in a new tool (Nunnally of time required to validate the instrument. Some
& Bernstein, 1994). An iterative process of remov- researchers never publish the results of this work.
ing or replacing items or both, recalculating item- Studies using the scale are published, but the
remainder coefficients, and recalculating the alpha instrument development process may not be
coefficient are repeated until a satisfactory alpha available except by writing to the author. This
coefficient is obtained. Deleting poorly correlated information needs to be added to the body of
items raises the alpha coefficient, but decreasing knowledge, and colleagues should encourage
the number of items lowers it (Spector, 1992). The instrument developers to complete the work and
initial attempt at scale development may not submit it for publication (Lynn, 1989; Norbeck,
achieve a sufficiently high coefficient alpha. In 1985). Klein et al. (2010) provided a detailed dis-
this case, additional items need to be written, more cussion of their development of the NPAT that
data collected, and the item analysis redone. This was presented earlier in this chapter. The validity
scenario is most likely to occur when too few items and reliability of the tool were addressed and a
were developed initially or when many of the copy of the tool was included in the article (see
initial items were poorly written. It may also be a Figure 17-4).
consequence of attempts to operationalize an inad-
equately defined concept (Spector, 1992). Constructing a Scale by Using Item
8. Conduct validity studies. When scale development Response Theory
is judged to be satisfactory, studies must be per- Using item response theory to construct a scale pro-
formed to evaluate the validity of the scale. (See ceeds initially in a fashion similar to that of classic test
the discussion of validity in Chapter 16.) These theory. There is an expectation of a well-defined
studies require the researcher to collect additional concept to operationalize. Items are initially written in
data from large samples. As part of this process, a manner similar to that previously described, and
scale scores must be correlated with scores on item tryouts and field testing are also similar. However,
other variables proposed to be related to the the process changes with the initiation of item analy-
concept being put into operation. Hypotheses must sis. The statistical procedures used are more sophisti-
be generated regarding variations in mean values cated and complex than the procedures used in classic
of the scale in different groups. Exploratory and test theory. Using data from field testing, item charac-
confirmatory factor analysis (discussed in Chap- teristic curves are calculated by using logistic regres-
ters 16 and 23) is usually performed as part of sion models (Hulin et al., 1983; Nunnally & Bernstein,
establishing the validity of the instrument. As 1994). After selecting an appropriate model based on
many different types of evidence of validity as information obtained from the analysis, item param-
possible should be collected (Spector, 1992). eters are estimated. These parameters are used to
9. Evaluate the reliability of the scale. Various sta- select items for the scale. This strategy is used to avoid
tistical procedures are performed to determine the problems encountered with classic test theory
reliability of the scale. These analyses can be per- measures.
formed on the data collected to evaluate validity Scales developed by using classic test theory effec-
for this scale. (See Chapter 16 for a discussion of tively measure the characteristics of subjects near the
the procedures performed to examine reliability.) mean. The statistical procedures used assume a linear
10. Compile norms on the scale. To determine norms, distribution of scale values. Items reflecting responses
the scale must be administered to a large sample of respondents closer to the extremes tend to be dis-
that is representative of the groups to which the carded because of the assumption that scale values
scale is likely to be administered. Norms should should approximate the normal curve. Scales devel-
be acquired for as many diverse groups as possi- oped in this manner often do not provide a clear under-
ble. Data acquired during validity and reliability standing of study participants at the high or low end
studies can be included for this analysis. To obtain of values.
the large samples needed for this purpose, many One purpose of item response theory is to choose
researchers permit others to use their scale with items in such a way that estimates of characteristics at
the condition that data from these studies be pro- each level of the concept being measured are accurate.
vided for compiling norms. To accomplish this goal, researchers use maximal like-
11. Publish the results of development of the scale. lihood estimates. A curvilinear distribution of scale
Scales are often not published for many years values is assumed. Rather than choosing items on the
CHAPTER 17  Measurement Methods Used in Developing Evidence-Based Practice 445

basis of the item remainder coefficient, the researcher Study participants would be asked to select their
specifies a test information curve. The scale can be response to the item and then rank the other options
tailored to have the desired measurement accuracy. By according to the proximity to their choice. The partici-
comparing a scale developed by classic test theory pant might choose a low-calorie diet as number 1, a
with one developed from the same items with item low-carbohydrate diet as number 2, a low-fat diet as
response theory, one would find differences in some number 3, and a vegetarian diet as number 4. Although
of the items retained. Biserial correlations would be the preferences of other study participants would
lower in the scale developed from item response differ, the results can be plotted to reveal patterns of
theory than in the scale developed from classic test an underlying continuum. Items selected for the scale
theory. Item bias is lower in scales developed by using would be the items with evidence of a pattern of
item response theory and occurs when respondents responses.
from different subpopulations having the same amount
of an underlying trait have different probabilities of
responding to an item positively (Hambleton & Translating a Scale
Swaminathan, 2010; Hulin et al., 1983).
to Another Language
Constructing a Scale by Using Contrary to expectations, translating an instrument
Multidimensional Scaling from the original language to a target language is a
Multidimensional scaling is used when the concept complex process. By translating a scale, researchers
being operationalized is actually an abstract construct can compare concepts among respondents of different
believed to be represented most accurately by multiple cultures. The comparison requires that they first infer
dimensions. The scaling techniques used allow the and then validate that the conceptual meaning in
researcher to uncover the hidden structure in the con- which the scale was developed is the same in both
struct. The analysis techniques use proximities among cultures. This process is highly speculative, and con-
the measures as input. The outcome of the analysis is clusions about the similarities of meanings in a
a spatial representation, or a geometrical configuration measure must be considered tentative (Hulin et al.,
of data points, that reveals the hidden structure. The 1983).
procedure tends to be used to examine differences in Four types of translations can be performed: prag-
stimuli rather than differences in people. A researcher matic translations, aesthetic-poetic translations, ethno-
might use this method to measure differences in per- graphic translations, and linguistic translations.
ception of light or pain. Scales developed by using this Pragmatic translations communicate the content from
procedure reveal patterns among items. The procedure the source language accurately in the target language.
is used in the development of rating scales and seman- The primary concern is the information conveyed. An
tic differentials (Borg & Groenen, 2010; Kruskal & example of this type of translation is the use of trans-
Wish, 1990). lated instructions for assembling a computer. Aesthetic-
poetic translations evoke moods, feelings, and affect
Constructing a Scale by Using in the target language that are identical to those evoked
Unfolding Theory by the original material. In ethnographic translations,
oasis-ebl|Rsalles|1476321091

When a scale is being constructed with the use of the purpose is to maintain meaning and cultural
unfolding theory, researchers ask study participants to content. In this case, translators must be familiar with
respond to the items in the rating scale. Next, partici- both languages and cultures. Linguistic translations
pants are asked to rank the various response options strive to present grammatical forms with equivalent
in relation to the response option that they selected meanings. Translating a scale is generally done in the
for that item. This procedure is followed for each item ethnographic mode (Hulin et al., 1983).
in the scale. By using this procedure, the underlying One strategy for translating scales is to translate
continuum for each scale item is “unfolded.” As from the original language to the target language and
an example, suppose researchers developed the fol- then back-translate from the target language to the
lowing item: original language by using translators not involved in
My preference for a diet to lose weight is the original translation (Fawcett & Garity, 2009). Dis-
1. A low-fat diet crepancies are identified, and the procedure is repeated
2. A low-calorie diet until troublesome problems are resolved. After this
3. A low-carbohydrate diet procedure, the two versions are administered to bilin-
4. A vegetarian diet gual subjects and scored by standard procedures. The
446 UNIT TWO  The Research Process

resulting sets of scores are examined to determine the In 1997, the Medical Outcomes Trust introduced
extent to which the two versions yield similar informa- new translation criteria that are much more compre-
tion from the subjects. This procedure assumes that hensive. The discussion of these criteria is available at
the subjects are equally skilled in both languages. One www.outcomes-trust.org/bulletin/0797blltn.htm.
problem with this strategy is that bilingual subjects Hulin et al. (1983) suggested the use of item response
may interpret meanings of words differently from theory procedures to address some of the problems of
monolingual subjects. This difference in interpretation translation. These procedures can provide direct evi-
is a serious concern because the target subjects for dence about the meanings of items in the two lan-
most cross-cultural research are monolingual (Hulin guages. Item characteristic curves for an item in the
et al., 1983). two languages can be compared, as can scale scores in
Yu, Lee, and Woo (2004) provided an excellent the two languages. This procedure eliminates the need
description of their process of translating the Medical for bilingual samples. It also eliminates the need
Outcomes Study Social Support Survey (MOS-SSS) for the two populations to be equivalent in terms of
from English to Chinese. These researchers used the the distributions of their scores on the trait being
forward and backward translation process previously measured.
discussed, and the steps they took are outlined in the Rather than translating an instrument into each lan-
following excerpt. guage, Turner, Rogers, Hendershot, Miller, and Thorn-
berry (1996) tested the use of electronic technology
involving multilingual audio computer-assisted self-
“This translation model includes a cycle of four steps interviewing (Audio-CASI) to enable researchers to
as follows. include multiple linguistic minorities in nationally
Forward translation of the MOS-SSS by representative studies and clinical studies. The Audio-
a bilingual health professional. The translation CASI system uses electronic translation from one lan-
process began with forward translation of the original guage to another. In the funded project to develop and
source language (SL) version (English) of the MOS-SSS test Audio-CASI, a backup phone bank was available
into the target language (TL) of Chinese by a bilingual to provide multilingual assistance if needed. Whether
native Chinese registered nurse.… this strategy will provide equivalent validity of a trans-
Review of the Chinese MOS-SSS by a mono- lated tool is unclear.
lingual reviewer. The Chinese version of the
MOS-SSS was then reviewed by a Chinese monolin-
gual reviewer for incomprehensible or ambiguous KEY POINTS
wordings.…
Backward translation of the Chinese MOS-SSS • Measurement approaches used in nursing research
by a bilingual health professional. In this step, the include physiological measures; observations; in-
reviewed Chinese version of the MOS-SSS (as dis- terviews; questionnaires; scales; and specialized
cussed in Step 2) was back translated by another instruments such as Q-sort method, Delphi tech-
bilingual nurse, who was ‘blinded’ to the original nique, diaries, and analyses using existing data-
English version.… bases.
Comparison of the SL version and back- • Measurements of physiological variables can be
translated version. The researcher, at this stage, either direct or indirect and sometimes require
compared the back-translated version of the MOS-SSS the use of specialized equipment or laboratory
with its original version for linguistic congruence and analysis.
cultural relevancy. Items with apparent discrepancies • The Human Genome Project has increased the
were examined to ascertain whether the problems opportunities for nurses to be involved in genetic
originated in the forward translation or the backward research and to include the measurement of nucleic
translation. The error in items resulting from the acids in their studies.
forward translation had to go through the whole- • To measure observations, every variable is observed
cycle again from Steps 1 to 4, whereas the latter type in a similar manner in each instance, with careful
of error was subjected to further back translation. attention given to training data collectors.
This process was repeated until a maximum equiva- • In structured observational studies, category
lence between the SL and back-translated versions systems must be developed; checklists or rating
was achieved.” (Yu et al., 2004, pp. 309-310) scales are developed from the category systems and
used to guide data collection.
CHAPTER 17  Measurement Methods Used in Developing Evidence-Based Practice 447

• Interviews involve verbal communication between data are usually categorized into secondary data
the researcher and the study participant, during and administrative data.
which the researcher acquires information. Inter- • The choice of tools for use in a particular study is
viewers must be trained in the skills of interview- a critical decision that can have a major impact on
ing, and the interview protocol must be pretested. the significance of the study.
• A questionnaire is a printed or electronic self-report • The researcher first must conduct an extensive
form designed to elicit information through the search for existing tools. Once found, the tools
responses of a study participant. The information must be carefully evaluated. Tools that are selected
obtained through questionnaires is similar to infor- for a study need to be described in great detail in
mation obtained by interview, but the questions the proposal and in the final research report for
tend to have less depth. An item on a questionnaire publication.
usually has two parts: a lead-in question and a • Scale construction is a complex procedure that
response set. should not be undertaken lightly. Theories on which
• Scales, another form of self-reporting, are more scale construction is most frequently based include
precise in measuring phenomena than question- classic test theory, item response theory, multidi-
naires and have been developed to measure psycho- mensional scaling, and unfolding theory. Most
social and physiological variables. The types existing instruments used in nursing research have
of scales included in this text are rating scale, been developed through the use of classic test
Likert scale, semantic differential scale, and visual theory.
analogue scale. • Translating a scale to another language is a complex
• A rating scale is a crude form of measurement that process that allows concepts among respondents of
includes a list of an ordered series of categories of different cultures to be compared if care is taken to
a variable, which are assumed to be based on an ensure that concepts have the same or similar
underlying continuum. A numerical value is meanings across cultures.
assigned to each category.
• The Likert scale contains declarative statements
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UNIT THREE
Putting It All Together for Evidence-Based Health Care
18
CHAPTER

Critical Appraisal of Nursing Studies


  http://evolve.elsevier.com/Grove/practice/

T
he nursing profession continues to strive for to be harsh and traumatic for the researcher (Meleis,
evidence-based practice, which includes criti- 2007). As a consequence of these early unpleasant
cally appraising studies, synthesizing research experiences, nurse researchers began to protect and
findings, and applying sound scientific evidence in shelter their nurse scientists from the threat of criti-
practice. Researchers also critically appraise studies in cism. Public critiques, written or verbal, were rare in
a selected area, develop a summary of current knowl- the 1960s and 1970s. Nurses responding to research
edge, and identify areas for future studies. Critically presentations focused on the strengths of studies, and
appraising research is essential for evidence-based the limitations were either critically not mentioned or
nursing practice and the conduct of future research. were minimized. Thus, the effects of the limitations
The critical appraisal of research involves a system- on the meaning, validity, and significance of studies
atic, unbiased, careful examination of all aspects of were often lost.
studies to judge their strengths, weaknesses, meaning, Incomplete critiques or the absence of critiques
and significance. The ability of a nurse to appraise may have served a purpose as nurses gained basic
studies critically is based on the nurse’s previous research skills. However, the nursing discipline
research experience and knowledge of a topic. To has moved past this point, and it is recognized that
conduct a critical appraisal of research, one must comprehensive critical appraisals of research are
possess analysis and logical reasoning skills to essential to strengthen the scientific investigations
examine the credibility and integrity of a study. This needed for evidence-based practice (EBP; Brown,
chapter provides a background for critically apprais- 2009; Craig & Smyth, 2012; Fawcett & Garity, 2009).
ing studies in nursing and other healthcare disciplines. As a result of advances in the nursing profession over
The expanding roles of nurses in conducting critical the last 30 years, many nurses now have the educa-
appraisals of research are addressed. Detailed guide- tional preparation and expertise to conduct critical
lines are provided to direct you in critically appraising appraisals of research. Nursing research textbooks
both quantitative and qualitative studies. provide detailed information on the critical appraisal
process. Skills in critical appraisal are introduced at
the baccalaureate level of nursing education and are
Evolution of Critical Appraisal expanded at the master’s and doctoral levels. Spe-
cialty organizations provide workshops on the critical
of Research in Nursing appraisal process to promote the use of scientific evi-
The process for critically appraising research has dence in practice.
evolved gradually in nursing from a few to now many The critical appraisal of studies is essential for the
nurses who are prepared to conduct comprehensive, development and refinement of nursing knowledge.
scholarly critiques. During the 1940s and 1950s, pre- Nurses need these skills to examine the meaning
sentations of nursing research were followed by cri- and credibility of study findings and to ask searching
tiques of the studies. These critiques often focused on questions. Was the methodology of a study sound to
the weaknesses or limitations of the studies and tended produce credible findings? Are the findings an

451
452 UNIT THREE  Putting It All Together for Evidence-Based Health Care

accurate reflection of reality? Do they increase our verbal presentations of studies, after a published
understanding of the nature of phenomena that are research report, for an abstract section for a confer-
important in nursing? Are the findings from the present ence, for article selection for publication, and for
study consistent with findings from previous studies? evaluation of research proposals for implementation
The answers to these questions require careful exami- or funding. Nursing students, practicing nurses, nurse
nation of the research problem and purpose, the theo- educators, and nurse researchers all are involved in the
retical or philosophical basis of the study, and the critical appraisal of research.
study’s methodology. Not only must the mechanics of
conducting the study be evaluated, but also the abstract Critical Appraisal of Studies by Students
and logical reasoning the researchers used to plan In nursing education, conducting a critical appraisal
and implement the study (Fawcett & Garity, 2009; of a study is often seen as a first step in learning the
Munhall, 2012). If the reasoning process used to research process. Part of learning this process is being
develop a study has flaws, there are probably flaws in able to read and comprehend published research
interpreting the meaning of the findings, decreasing reports. However, conducting a critical appraisal of a
the credibility of the study. study is not a basic skill, and the content presented in
All studies have flaws, but if all flawed studies were previous chapters is essential for implementing this
discarded, there would be no scientific knowledge process. Nurses usually acquire basic knowledge of
base for practice. In fact, science itself is flawed. the research process and critical appraisal skills early
Science does not completely or perfectly describe, in their nursing education. Advanced analysis skills
explain, predict, or control reality. However, improved are usually taught at the master’s and doctoral levels.
understanding and an increased ability to predict and Performing a critical appraisal of a study involves
control phenomena depend on recognizing the flaws (1) identifying the elements or steps of the study,
in studies and in science. New studies can then be (2) determining the study strengths and limitations,
planned to minimize the flaws or limitations of earlier and (3) evaluating the credibility and meaning of
studies. A researcher must critically analyze previous study findings for nursing knowledge and practice. By
studies to determine their limitations and then inter- critically appraising studies, students expand their
pret the study findings in light of those limitations. The analysis skills, strengthen their knowledge base, and
limitations can lead to inaccurate data, inaccurate out- increase their use of research evidence in practice.
comes of analysis, and decreased ability to generalize
the findings. You must decide if a study is too flawed Critical Appraisal of Research by Practicing Nurses
to be used in a systematic review of knowledge in an Practicing nurses need to appraise studies critically so
area. Although we recognize that knowledge is not that their practice is based on current research evi-
absolute, we need to have confidence in the research dence and not tradition and trial and error (Brown,
evidence synthesized for practice. 2009; Melnyk & Fineout-Overholt, 2011). Nursing
All studies have strengths as well as limitations. actions must be updated in response to the current
Recognition of these strengths is also essential to the evidence that is generated through research and theory
generation of sound research evidence for practice. If development. Practicing nurses need to design methods
only weaknesses are identified, nurses might discount for remaining current in their practice areas. Reading
the value of studies and refuse to invest time in reading research journals and posting or emailing current
and examining research. The continued work of the studies at work can increase nurses’ awareness of
researcher also depends on recognizing the strengths study findings but are insufficient for the purposes of
of the study. If no study is good enough, why invest critical appraisal. Nurses need to question the quality
time conducting research? The strong points of a study, of the studies and the credibility of the findings and
added to the strong points from multiple other studies, share their concerns with other nurses. For example,
slowly build solid research evidence for practice. nurses may form a research journal club in which
studies are presented and critically appraised by
When Are Critical Appraisals of Research members of the group (Gloeckner & Robinson, 2010).
Implemented in Nursing? Skills in critical appraisal of research enable practic-
In general, research is critically appraised to broaden ing nurses to synthesize the most credible, significant,
understanding, summarize knowledge for practice, and appropriate evidence for use in their practice. EBP
and provide a knowledge base for future studies. In is essential in agencies either seeking or maintaining
addition, critical appraisals are often conducted after Magnet status. The Magnet Recognition Program®
CHAPTER 18  Critical Appraisal of Nursing Studies 453

was developed by the American Nurses Credentialing reader’s understanding of the study and the quality of
Center (ANCC, 2012) to recognize healthcare organi- the study findings (American Psychological Associa-
zations that provide nursing excellence with care tion [APA], 2010; Pyrczak, 2008). Another, more
based on the most current research evidence (see informal critique of a published study might appear in
http://www.nursecredentialing.org/Magnet/Program a letter to the editor, in which readers have the oppor-
Overview.aspx). tunity to comment on the strengths and weaknesses of
published studies by writing to the journal editor.
Critical Appraisal of Research by Nurse Educators
Educators critically appraise research to expand their Critical Appraisal of Abstracts
knowledge base and to develop and refine the educa- for Conference Presentations
tional process. The careful analysis of current nursing One of the most difficult types of critical appraisal is
studies provides a basis for updating curriculum examining abstracts. The amount of information avail-
content for use in clinical and classroom settings. Edu- able is usually limited because many abstracts are
cators act as role models for their students by examin- restricted to 100 to 250 words. Nevertheless, reviewers
ing new studies, evaluating the information obtained must select the best-designed studies with the most
from research, and indicating what research evidence significant outcomes for presentation at nursing confer-
to use in practice. In addition, educators collaborate ences. This process requires an experienced researcher
in the conduct of studies, which requires a critical who needs few cues to determine the quality of a study.
appraisal of previous relevant research. Critical appraisal of an abstract usually addresses the
following criteria: (1) appropriateness of the study for
Critical Appraisal of Studies by Nurse Researchers the program; (2) completeness of the research project;
Nurse researchers critically appraise previous research (3) overall quality of the study problem, purpose, meth-
to plan and implement their next study. Many research- odology, and results; (4) contribution of the study to
ers have a program of research in a selected area, and the knowledge base of nursing; (5) contribution of the
they update their knowledge base by critiquing new study to nursing theory; (6) originality of the work (not
studies in this area. The outcomes of these appraisals previously published); (7) implication of the study
influence the selection of research problems and pur- findings for practice; and (8) clarity, conciseness, and
poses, the implementation of research methodologies, completeness of the abstract (APA, 2010).
and the interpretations of findings in future studies.
The critical appraisal and synthesis of previous studies Critical Appraisal of Research Articles
for the literature review section in a research proposal for Publication
or report were described in Chapter 6. Nurse researchers who serve as peer reviewers for
professional journals evaluate the quality of research
Critical Appraisal of Research Presentations articles submitted for publication. The role of these
and Publications scientists is to ensure that the studies accepted for
Critical appraisals following research presentations publication are well designed and contribute to the
can assist researchers in identifying the strengths and body of knowledge. Most of these reviews are con-
weaknesses of their studies and generating ideas ducted anonymously so that friendships or reputa-
for further research. Participants listening to study tions do not interfere with the selection process
critiques might gain insight into the conduct of (Pyrczak, 2008; Tilden, 2002). In most refereed jour-
research. Experiencing the critical appraisal process nals, the experts who examine the research report
can increase the ability of participants to evaluate have been selected from an established group of peer
studies and judge the usefulness of the research evi- reviewers. Their comments or summaries of their
dence for practice. comments are sent to the researcher. The editor also
At the present time, at least two nursing research uses these comments to make selections for publica-
journals, Scholarly Inquiry for Nursing Practice: tion. The process for publishing a study is described
An International Journal and Western Journal of in Chapter 27.
Nursing Research, include commentaries after the
research articles. In these journals, other researchers Critical Appraisal of Research Proposals
critically appraise the authors’ studies, and the authors Critical appraisals of research proposals are conducted
have a chance to respond to these comments. Pub- to approve student research projects; to permit data
lished research critical appraisals often increase the collection in an institution; and to select the best
454 UNIT THREE  Putting It All Together for Evidence-Based Health Care

studies for funding by local, state, national, and inter- TABLE 18-1  Educational Level and Expected
national organizations and agencies. The process Level of Expertise in Critical
researchers use to seek the approval to conduct a study
Appraisal of Research
is presented in Chapter 28. The peer review process
in federal funding agencies involves an extremely Educational Expected Level of Expertise in
complex critical appraisal. Nurses are involved in this Level Critical Appraisal of Research
level of research review through the national funding Baccalaureate Identify the steps of the quantitative
agencies, such as the National Institute of Nursing research process in a study
Research (NINR, 2012), National Institutes of Health, Identify the elements of a qualitative
and the Agency for Healthcare Research and Quality. study
Master’s Determine study strengths and weaknesses
Some of the criteria used to evaluate the quality of a
in quantitative and qualitative studies
proposal for possible funding include the (1) signifi- Evaluate the credibility and meaning of a
cance of the research problem and purpose for nursing, study and its contribution to nursing
(2) appropriate use of methodology for the types of knowledge and practice
questions that the research is designed to answer, (3) Doctorate or Synthesize multiple studies in systematic
appropriate use and interpretation of analysis proce- postdoctorate reviews, meta-analyses, meta-syntheses,
dures, (4) evaluation of clinical practice and forecast- and mixed-methods systematic reviews
ing of the need for nursing or other appropriate
interventions, and (5) construction of models to direct
the research and interpret the findings. The NINR
(2012) website (http://www.ninr.nih.gov/ResearchAnd include (1) systematic review of research, (2) meta-
Funding/) provides details on grant development and analysis, (3) meta-synthesis, and (4) mixed methods
research funding, and Chapter 29 focuses on seeking systematic review (see Table 18-1). These summaries
funding for research. of current research evidence are essential for provid-
ing EBP and directing future research (Craig & Smyth,
2012; Higgins & Green, 2008; Sandelowski & Barroso,
Nurses’ Expertise in Critical 2007; Whittemore, 2005). Definitions of these types
of complex syntheses are presented in Chapter 2, and
Appraisal of Research Chapter 19 provides guidelines for critically apprais-
Conducting a critical appraisal of a study is a complex ing and conducting these syntheses.
mental process that is stimulated by raising questions. The major focus of this chapter is conducting
The level of critique conducted is influenced by the critical appraisals of quantitative and qualitative
sophistication of the individual appraising the study studies. These critical appraisals involve implement-
(Table 18-1). The initial critical appraisal of research ing some initial guidelines that are outlined in Box
by an undergraduate student often involves the iden- 18-1. These guidelines stress the importance of
tification of the steps of the research process in a examining the expertise of the authors, reviewing
quantitative study. Some baccalaureate programs the entire study, addressing the strengths and weak-
include more in-depth research courses that include nesses of the study, and evaluating the credibility of
critical appraisals of the steps of quantitative studies the study findings (Fawcett & Garity, 2009; Marshall
and identification of the aspects of qualitative studies. & Rossman, 2011; Munhall, 2012; Shadish, Cook, &
A critical appraisal of research conducted by a student Campbell, 2002). These guidelines provide a basis
at the master’s level usually involves description of for the critical appraisal process for quantitative
study strengths and weaknesses and evaluation of the research that is discussed in the next section and the
credibility and meaning of the study findings for critical appraisal process for qualitative research dis-
nursing knowledge and practice. Critical appraisals cussed later.
might focus on quantitative, qualitative, and outcomes
studies.
At the doctoral level, students often critically Critical Appraisal Process for
appraise several studies in an area of interest and
perform a complex synthesis of the research findings Quantitative Research
to determine the current empirical knowledge base for The critical appraisal process for quantitative
the phenomenon. These complex syntheses of quanti- research includes three steps: (1) identifying the steps
tative, qualitative, outcomes, and intervention research of the research process, (2) determining study strengths
CHAPTER 18  Critical Appraisal of Nursing Studies 455

Box 18-1 Guidelines for Conducting Critical Appraisals of Quantitative


and Qualitative Research
1. Read and evaluate the entire study. A weaknesses, and you can use the questions
research appraisal requires comprehension of in this chapter to facilitate identification of
a study that includes the identification and them. Address the quality of the problem,
examination of all steps of the research purpose, methodology, results, and findings
process. of quantitative and qualitative studies.
2. Examine the research, clinical, and educational 5. Provide specific examples of the strengths and
background of the authors. The authors need weaknesses of a study. These examples
a clinical and scientific background that is provide a rationale and documentation for
appropriate for the study conducted. your critical appraisal of the study.
3. Examine the organization and presentation of 6. Be objective and realistic in identifying a
the research report. The title of the research study’s strengths and weaknesses. Do not
report needs to indicate clearly the focus of be overly critical when identifying the
the study. The report usually includes an weaknesses of a study or overly flattering
abstract, introduction, methods, results, when identifying the strengths.
discussion, and references. The abstract of the 7. Suggest modifications for future studies.
study needs to present the purpose of the Modifications should increase the strengths
study clearly and to highlight the and decrease the weaknesses in the study.
methodology and major results. The body of 8. Evaluate the study. Indicate the overall quality
the report needs to be complete, concise, of the study and its contribution to nursing
clearly presented, and logically organized. knowledge. Discuss the consistency of the
The references need to be complete and findings of this study with the findings of
presented in a consistent format. previous studies. Discuss the need for further
4. Identify the strengths and weaknesses of research and the potential implications of the
a study. All studies have strengths and findings for practice.

and weaknesses, and (3) evaluating the credibility and Step I: Identifying the Steps of the Research
meaning of a study to nursing knowledge and practice. Process in Studies
These steps occur in sequence, vary in depth, and Initial attempts to comprehend research articles are
presume accomplishment of the preceding steps. often frustrating because the terminology and stylized
However, an individual with critical appraisal experi- manner of the report are unfamiliar. Identification of
ence frequently performs several steps of this process the steps of the research process in a quantitative study
simultaneously. is the first step in critical appraisal. It involves under-
This section includes the three steps of the quantita- standing the terms and concepts in the report; identify-
tive research critical appraisal process and provides ing study elements; and grasping the nature,
relevant questions for each step. These questions are significance, and meaning of the study elements. The
not comprehensive but have been selected as a means following guidelines are presented to direct you in
for stimulating the logical reasoning and analysis nec- identifying the elements or steps of a study.
essary for conducting a study review. Persons experi-
enced in the critical appraisal process formulate Guidelines for Identifying the Steps
additional questions as part of their reasoning pro- of the Research Process
cesses. We cover the identification of the steps of the The first step involves reviewing the abstract and
research process separately because persons who are reading the study from beginning to end (see the
new to critical appraisal start with this step. The ques- guidelines in Box 18-1). As you read, address the
tions for determining the study strengths and weak- following questions about the presentation of
nesses are covered together because this process the study: Does the title clearly identify the focus
occurs simultaneously in the mind of the person con- of the study by including the major study variables
ducting the critical appraisal. Evaluation is covered and the population? Does the title indicate the type
separately because of the increased expertise needed of study conducted—descriptive, correlational, quasi-
to perform this step. experimental, or experimental (Kerlinger & Lee,
456 UNIT THREE  Putting It All Together for Evidence-Based Health Care

2000; Shadish et  al., 2002)? Was the abstract clear? from implicit statements in the
Was the writing style of the report clear and concise? introduction or literature review?
Were the different parts of the research report plainly B. Is the framework based on tentative,
identified (APA, 2010)? Were relevant terms defined? substantive, or scientific theory? Provide
You might underline the terms you do not understand a rationale for your answer.
and determine their meaning from the glossary at C. Does the framework identify, define, and
the end of this textbook. Read the article a second describe the relationships among the
time and highlight or underline each step of the quan- concepts of interest? Provide examples
titative research process. An overview of these steps of this.
is presented in Chapter 3. To write a critical appraisal D. Is a model of the framework provided for
identifying the study steps, you need to identify each clarity? If a model is not presented,
step of the research process concisely and respond develop one that represents the
briefly to the following guidelines and questions: framework of the study and describe it.
I. Introduction E. Link the study variables to the relevant
A. Describe the qualifications of the authors concepts in the model.
to conduct the study, such as research F. How is the framework related to the
expertise, clinical experience, and body of knowledge of nursing (Alligood,
educational preparation. Doctoral 2010; Smith & Liehr, 2008)?
education, such as a PhD, provides VI. List any research objectives, questions, or
experience in conducting research. Have hypotheses.
the researchers conducted previous VII. Identify and define (conceptually and
studies, especially studies in this area? operationally) the study variables or concepts
Are the authors involved in clinical that were identified in the objectives,
practice or certified in their area of questions, or hypotheses. If objectives,
clinical expertise? questions, or hypotheses are not stated,
B. Discuss the clarity of the article title identify and define the variables in the study
(type of study, variables, and population purpose and the results section of the study. If
identified). conceptual definitions are not found, identify
C. Discuss the quality of the abstract possible definitions for each major study
(includes purpose; highlights design, variable. Indicate which of the following
sample, and intervention [if applicable]; types of variables were included in the study.
and presents key results). A study usually includes independent and
II. State the problem. dependent variables or research variables but
A. Significance of the problem not all three types of variables.
B. Background of the problem A. Independent variables: Identify and
C. Problem statement define conceptually and operationally.
III. State the purpose. B. Dependent variables: Identify and define
IV. Examine the literature review. conceptually and operationally.
A. Are relevant previous studies and C. Research variables or concepts: Identify
theories described? and define conceptually and operationally.
B. Are the references current? (Number and VIII. Identify demographic variables and other
percentage of sources in the last 10 years relevant terms.
and in the last 5 years?) IX. Identify the research design.
C. Are the studies described, critically A. Identify the specific design of the study.
appraised, and synthesized (Fawcett & Draw a model of the design by using the
Garity, 2009)? sample design models presented in
D. Is a summary provided of the current Chapter 11.
knowledge (what is known and not B. Does the study include a treatment or
known) about the research problem? intervention? If so, is the treatment
V. Examine the study framework or theoretical clearly described with a protocol and
perspective. consistently implemented, which
A. Is the framework explicitly expressed, or indicates intervention fidelity (Forbes,
must the reviewer extract the framework 2009; Mittlbock, 2008)?
CHAPTER 18  Critical Appraisal of Nursing Studies 457

C. If the study has more than one group, G. Identify the study setting, and indicate if
how were subjects assigned to groups it is appropriate for the study purpose.
(Mittlbock, 2008; Shadish et al., 2002)? XI. Identify and describe each measurement
D. Are extraneous variables identified and strategy used in the study. The following
controlled? Extraneous variables are table includes the critical information about
usually discussed as a part of quasi- two measurement methods, the Beck Likert
experimental and experimental studies scale to measure depression and the
(Shadish et al., 2002). physiological instrument to measure blood
E. Were pilot study findings used to design pressure. Completing this table allows you to
this study? If yes, briefly discuss the cover essential measurement content for a
pilot and the changes made in this study study (Waltz, Strickland, & Lenz, 2010).
based on the pilot. A. Identify each study variable that was
X. Describe the sample and setting. measured.
A. Identify inclusion or exclusion sample or B. Identify the name and author of each
eligibility criteria. measurement strategy.
B. Identify the specific type of probability C. Identify the type of each measurement
or nonprobability sampling method that strategy (e.g., Likert scale, visual
was used to obtain the sample. Did the analogue scale, physiological measure,
researchers identify the sampling frame and existing database).
for the study (Thompson, 2002)? D. Identify the level of measurement
C. Identify the sample size. Discuss the (nominal, ordinal, interval, or ratio)
refusal rate and include the rationale for achieved by each measurement method
refusal if presented in the article. Discuss used in the study (Grove, 2007).
the power analysis if this process was E. Describe the reliability of each scale for
used to determine sample size (Aberson, previous studies and this study. Identify
2010). the precision of each physiological
D. Identify the sample attrition (number and measure (Bialocerkowski, Klupp, &
percentage) and rationale for the study. Bragge, 2010; DeVon et al., 2007).
E. Identify the characteristics of the sample. F. Identify the validity of each scale and the
F. Discuss the institutional review board accuracy of physiological measures
approval. Describe the informed consent (DeVon et al., 2007; Ryan-Wenger,
process used in the study. 2010).

Name of
Measurement Type of
Variable Method/ Measurement Level of Reliability or
Measured Author Method Measurement Precision Validity or Accuracy
Depression Beck Depression Likert scale Interval Cronbach alpha of Construct validity: Content
Inventory/Beck 0.82-0.92 from validity from concept analysis,
previous studies and literature review, and reviews
0.84 for this study. of experts. Convergent validity
Reading level at 6th with Zung Depression Scale.
grade. Prediction validity of patients’
future depression episodes.
Successive use validity with
previous studies and this study.
Blood Omron BP Physiological Ratio Test-retest values of Documented accuracy of
pressure equipment/ measurement BP measurements in systolic and diastolic BPs to
(BP) Health Care method previous studies. BP 1 mm Hg by company
Equipment equipment new and developing Omron BP cuff.
Agency recalibrated every 50 Designated protocol for taking
BP readings in this BP. Average 3 BP readings to
study. Average 3 BP determine BP.
readings to
determine BP.
458 UNIT THREE  Putting It All Together for Evidence-Based Health Care

XII. Describe the procedures for data collection. study: (1) identify the focus (description,
XIII. Describe the statistical techniques performed relationships, or differences) for each
to analyze study data. analysis technique; (2) list the statistical
A. List the statistical procedures conducted analysis technique performed; (3) list
to describe the sample. the statistic; (4) provide the specific
B. Was the level of significance or alpha results; and (5) identify the probability
identified? If so, indicate what it was (p) of the statistical significance
(0.05, 0.01, or 0.001). achieved by the result (Corty, 2007;
C. Complete the following table with the Grove, 2007).
analysis techniques conducted in the

Purpose of Analysis Analysis Technique Statistic Results Probability (p)


Description of subjects’ pulse rate Mean M 71.52
Standard deviation SD 5.62
Range Range 58-97
Difference between men and women in systolic and t-test t 3.75 0.001
diastolic blood pressures respectively t-test t 2.16 0.042
Differences of diet group, exercise group, and Analysis of variance F 4.27 0.04
comparison group for pounds lost by adolescents
Relationship of depression and anxiety in elderly adults Pearson correlation r 0.46 0.03

XIV. Describe the researcher’s interpretation of Richards, 2010; Burns & Grove, 2011; DeVon et al.,
findings. 2007; Doran, 2011; Fawcett & Garity, 2009; Grove,
A. Are the findings related back to the study 2007; Houser, 2008; Morrison et al., 2009; Ryan-
framework? If so, do the findings support Wenger, 2010; Santacroce, Maccarelli, & Grey, 2004;
the study framework? Shadish et al., 2002; Thompson, 2002; Waltz et al.,
B. Which findings are consistent with the 2010). The ideal ways to conduct the steps of the
expected findings? research process are compared with the actual study
C. Which findings were not expected? steps. During this comparison, you examine the extent
D. Are the findings consistent with previous to which the researcher followed the rules for an ideal
research findings (Fawcett & Garity, study and identify the study elements that are strengths
2009)? or weaknesses.
XV. What study limitations did the researcher You also need to examine the logical links connect-
identify? ing one study element with another. For example, the
XVI. How did the researcher generalize the problem needs to provide background and direction
findings? for the statement of the purpose. In addition, you need
XVII. What were the implications of the findings to examine the overall flow of logic in the study. The
for nursing practice? variables identified in the study purpose need to be
XVIII. What suggestions for further study were consistent with the variables identified in the research
identified? objectives, questions, or hypotheses. The variables
XIX. Is the description of the study sufficiently identified in the research objectives, questions, or
clear for replication? hypotheses need to be conceptually defined in light of
the study framework. The conceptual definitions
Step II: Determining Study Strengths provide the basis for the development of operational
and Weaknesses definitions. The study design and analyses need to be
The next step in critically appraising a quantitative appropriate for the investigation of the study purpose
study requires determining the strengths and weak- and for the specific objectives, questions, or hypoth-
nesses of the study. To do this, you must have knowl- eses (Fawcett & Garity, 2009). Most of the limitations
edge of what each step of the research process should or weaknesses in a study result from breaks in logical
be like from expert sources such as this textbook and reasoning. For example, biases caused by sampling
other research sources (Aberson, 2010; Bartlett & and design impair the logical flow from design to
Frost, 2008; Bialocerkowski et al., 2010; Borglin & interpretation of findings (Borglin & Richards, 2010).
CHAPTER 18  Critical Appraisal of Nursing Studies 459

The previous level of critical appraisal addressed con- (Craig & Smyth, 2012; Fawcett & Garity,
crete aspects of the study. During analysis, the process 2009)?
moves to examining abstract dimensions of the study, D. Does the literature review summary
which requires greater familiarity with the logic identify what is known and not known
behind the research process and increased skill in about the research problem and provide
abstract reasoning. direction for the formation of the research
You also need to gain a sense of how clearly the purpose?
researcher grasped the study situation and expressed III. Study framework
it. The clarity of the researchers’ explanation of study A. Is the framework presented with clarity? If
elements demonstrates their skill in using and express- a model or conceptual map of the
ing ideas that require abstract reasoning. With this framework is present, is it adequate to
examination of the study, you can determine which explain the phenomenon of concern?
aspects of the study are strengths and which are weak- B. Is the framework linked to the research
nesses and provide rationale and documentation for purpose? If not, would another framework
your decisions. fit more logically with the study?
C. Is the framework related to the body of
Guidelines for Determining Study Strengths knowledge in nursing and clinical
and Weaknesses practice?
The following questions were developed to assist you D. If a proposition or relationship from a
in examining the different aspects of a study and deter- theory is to be tested, is the proposition
mining if it is a strength or weakness. The intent is not clearly identified and linked to the study
to answer each of these questions but to read the ques- hypotheses (Alligood, 2010; Fawcett &
tions and make judgments about the elements or steps Garity, 2009; Smith & Liehr, 2008)?
in the study. You need to provide a rationale for your IV. Research objectives, questions, or hypotheses
decisions and document from relevant research sources A. Are the objectives, questions, or
such as those listed in the previous section and in the hypotheses expressed clearly?
references at the end of this chapter. For example, you B. Are the objectives, questions, or hypotheses
might decide the study purpose is a strength because logically linked to the research purpose?
it addresses the study problem, clarifies the focus of C. Are hypotheses stated to direct the conduct
the study, and is feasible to investigate (Burns & of quasi-experimental and experimental
Grove, 2011; Fawcett & Garity, 2009; Pyrczak, 2008). research (Kerlinger & Lee, 2000; Shadish
I. Research problem and purpose et al., 2002)?
A. Is the problem sufficiently delimited in D. Are the objectives, questions, or
scope so that it is researchable but not hypotheses logically linked to the concepts
trivial? and relationships (propositions) in the
B. Is the problem significant to nursing and framework (Fawcett & Garity, 2009; Smith
clinical practice (Brown, 2009)? & Liehr, 2008)?
C. Does the purpose narrow and clarify the V. Variables
aim of the study? A. Are the variables reflective of the concepts
D. Was this study feasible to conduct in terms identified in the framework?
of money commitment; the researchers’ B. Are the variables clearly defined
expertise; availability of subjects, (conceptually and operationally) and based
facilities, and equipment; and ethical on previous research or theories (Smith &
considerations? Liehr, 2008)?
II. Review of literature C. Is the conceptual definition of a variable
A. Is the literature review organized to show consistent with the operational definition?
the progressive development of evidence VI. Design
from previous research? A. Is the design used in the study the most
B. Is a theoretical knowledge base developed appropriate design to obtain the needed
for the problem and purpose? data?
C. Is a clear, concise summary presented of B. Does the design provide a means to
the current empirical and theoretical examine all the objectives, questions, or
knowledge in the area of the study hypotheses?
460 UNIT THREE  Putting It All Together for Evidence-Based Health Care

C. Is the treatment clearly described (Forbes, determine the final sample size? Was the
2009)? Is the treatment appropriate for attrition rate projected in determining the
examining the study purpose and final sample size (Aberson, 2010)?
hypotheses? Does the study framework F. Are the rights of human subjects
explain the links between the treatment protected?
(independent variable) and the proposed G. Is the setting used in the study typical of
outcomes (dependent variables) (Sidani & clinical settings (Borglin & Richards,
Braden, 1998)? Was a protocol developed 2010)?
to promote consistent implementation of H. Was the refusal to participate rate a
the treatment to ensure intervention fidelity problem? If so, how might this weakness
(Morrison et al., 2009)? Did the researcher influence the findings?
monitor implementation of the treatment to I. Was sample attrition a problem? Did the
ensure consistency (Santacroce et al., researchers provide a rationale for the
2004)? If the treatment was not attrition of study participants? How did
consistently implemented, what might be attrition influence the final sample and the
the impact on the findings? study results and findings (Aberson, 2010;
D. Did the researcher identify the threats to Fawcett & Garity, 2009)?
design validity (statistical conclusion VIII. Measurements
validity, internal validity, construct validity, A. Do the measurement methods selected for
and external validity) and minimize them the study adequately measure the study
as much as possible (Shadish et al., 2002)? variables?
E. Is the design logically linked to the B. Are the measurement methods sufficiently
sampling method and statistical analyses? sensitive to detect small differences
F. If more than one group is used, do the between subjects? Should additional
groups appear equivalent (Borglin & measurement methods have been used to
Richards, 2010)? improve the quality of the study outcomes
G. If a treatment was implemented, were the (Waltz et al., 2010)?
subjects randomly assigned to the C. Do the measurement methods used in the
treatment group, or were the treatment and study have adequate validity and
comparison groups matched? Were the reliability? What additional reliability or
treatment and comparison group validity testing is needed to improve the
assignments appropriate for the purpose of quality of the measurement methods
the study (Borglin & Richards, 2010)? (Bartlett & Frost, 2008; Bialocerkowski
VII. Sample, population, and setting et al., 2010; DeVon et al., 2007; Roberts &
A. Is the sampling method adequate to Stone, 2004)?
produce a representative sample? D. Respond to the following questions, which
B. What are the potential biases in the are relevant to the measurement
sampling method? Are any subjects approaches used in the study:
excluded from the study because of age, 1. Scales and questionnaires
socioeconomic status, or ethnicity without (a) Are the instruments clearly
a sound rationale (Borglin & Richards, described?
2010; Thompson, 2002)? (b) Are techniques to complete and
C. Did the sample include an understudied score the instruments provided?
population, such as young, elderly, or (c) Are validity and reliability of the
minority subjects? instruments described (DeVon et al.,
D. Were the sampling criteria (inclusion and 2007)?
exclusion) appropriate for the type of study (d) Did the researcher reexamine the
conducted? validity and reliability of
E. Is the sample size sufficient to avoid a type instruments for the present sample?
II error? Was a power analysis conducted (e) If the instrument was developed for
to determine sample size? If a power the study, is the instrument
analysis was conducted, were the results of development process described
the analysis clearly described and used to (Waltz et al., 2010)?
CHAPTER 18  Critical Appraisal of Nursing Studies 461

2. Observation F. Do the data collected address the research


(a) Is what is to be observed clearly objectives, questions, or hypotheses?
identified and defined? G. Did any adverse events occur during data
(b) Is interrater reliability described? collection, and were these appropriately
(c) Are the techniques for recording managed?
observations described (Waltz et al., IX. Data analysis
2010)? A. Are data analysis procedures appropriate
3. Interviews for the type of data collected (Corty, 2007;
(a) Do the interview questions address Grove, 2007)?
concerns expressed in the research B. Are data analysis procedures clearly
problem? described? Did the researcher address any
(b) Are the interview questions relevant problems with missing data and how this
for the research purpose and problem was managed?
objectives, questions, or C. Do the data analysis techniques address the
hypotheses? study purpose and the research objectives,
(c) Does the design of the questions questions, or hypotheses (Fawcett &
tend to bias subjects’ responses? Garity, 2009)?
(d) Does the sequence of questions D. Are the results presented in an
tend to bias subjects’ responses understandable way by narrative, tables, or
(Waltz et al., 2010)? figures, or a combination of methods
4. Physiological measures (APA, 2010)?
(a) Are the physiological measures or E. Are the statistical analyses logically linked
instruments clearly described to the design (Borglin & Richards, 2010)?
(Ryan-Wenger, 2010)? If F. Is the sample size sufficient to detect
appropriate, are the brand names, significant differences if they are present?
such as Space Labs or Hewlett- G. Was a power analysis conducted for
Packard, of the instruments nonsignificant results (Aberson, 2010)?
identified? H. Are the results interpreted appropriately?
(b) Are the accuracy, precision, and X. Interpretation of findings
error of the physiological A. Are findings discussed in relation to each
instruments discussed (Ryan- objective, question, or hypothesis?
Wenger, 2010)? B. Are various explanations for significant
(c) Are the physiological measures and nonsignificant findings examined?
appropriate for the research purpose C. Are the findings clinically significant
and objectives, questions, or (Gatchel & Mayer, 2010; LeFort, 1993;
hypotheses? Melnyk & Fineout-Overholt, 2011)?
(d) Are the methods for recording data D. Are the findings linked to the study
from the physiological measures framework (Smith & Liehr, 2008)?
clearly described? Is the recording E. Are the study findings an accurate
of data consistent? reflection of reality and valid for use in
IX. Data collection clinical practice (Houser, 2008)?
A. Is the data collection process clearly F. Do the conclusions fit the results from the
described (Fawcett & Garity, 2009; data analyses? Are the conclusions based
Kerlinger & Lee, 2000)? on statistically significant and clinically
B. Are the forms used to collect data important results (Gatchel & Mayer,
organized to facilitate computerizing the 2010)?
data? G. Does the study have limitations not
C. Is the training of data collectors clearly identified by the researcher?
described and adequate? H. Did the researcher generalize the findings
D. Is the data collection process conducted in appropriately?
a consistent manner (Borglin & Richards, I. Were the identified implications for
2010)? practice appropriate based on the study
E. Are the data collection methods ethical? findings and the findings from previous
462 UNIT THREE  Putting It All Together for Evidence-Based Health Care

research (Brown, 2009; Fawcett & Garity, III. Do sampling strategies show an improvement
2009)? over previous studies? Does the sample
J. Were quality suggestions made for further selection have the potential for adding
research? diversity to samples previously studied
(Aberson, 2010; Thompson, 2002)?
Step III: Evaluating a Study IV. Does the current research build on previous
Evaluation involves determining the validity, credi- measurement strategies so that measurement is
bility, significance, and meaning of the study by exam- more precise or more reflective of the
ining the links between the study process, study variables (DeVon et al., 2007; Waltz et al.,
findings, and previous studies. The steps of the study 2010)?
are evaluated in light of previous studies, such as an V. How do statistical analyses compare with
evaluation of present hypotheses based on previous analyses used in previous studies (Corty,
hypotheses, present design based on previous designs, 2007)?
and present methods of measuring variables based on VI. Do the findings build on the findings of
previous methods of measurement. The findings of the previous studies?
present study are also examined in light of the findings VII. Is current knowledge in this area identified?
of previous studies. Evaluation builds on conclusions VIII. Does the author indicate the implication of the
reached during the first two stages of the critical findings for practice?
appraisal so that the credibility, validity, and meaning The evaluation of a research report should also
of the study findings can be determined for nursing include a final discussion of the quality of the report.
knowledge and practice. This discussion should include an expert opinion of
the contribution of the study to nursing knowledge and
Guidelines for Evaluating a Study the need for additional research in selected areas. You
You need to reexamine the findings, conclusions, and also need to determine if the empirical evidence gener-
implications sections of the study and the researchers’ ated by this study and previous research is ready for
suggestions for further study. Using the following use in practice (Brown, 2009; Craig & Smyth, 2012;
questions as a guide, summarize your evaluation of Fawcett & Garity, 2009; Melnyk & Fineout-Overholt,
the study, and document your responses. 2011; Whittemore, 2005).
I. What rival hypotheses can be suggested for the
findings?
II. Do you believe the study findings are valid? Critical Appraisal Process for
How much confidence can be placed in the
study findings (Borglin & Richards, 2010; Qualitative Studies
Fawcett & Garity, 2009)? Critical appraisal of qualitative studies requires a dif-
III. To what populations can the findings be ferent approach than the steps and processes used
generalized (Thompson, 2002)? when appraising a quantitative study (Sandelowski,
IV. What questions emerge from the findings, and 2008). However, appraisal of quantitative and qualita-
does the researcher identify them? tive studies has a common purpose—determining the
V. What future research can be envisioned? rigor with which the methods were applied. The integ-
VI. Could the limitations of the study have been rity of the design and methods affects the credibility
corrected? and meaningfulness of the findings and their useful-
VII. When the findings are examined in light of ness in clinical practice (Pickler & Butz, 2007). Burns
previous studies, what is now known and (1989) first described the standards for rigorous quali-
not known about the phenomenon under tative research 20 years ago. Since that time, other
study? criteria have been published (Cesario, Morin, & Santa-
You need to read previous studies conducted in the Donato, 2002; Clissett, 2008; Fossey, Harvey, McDer-
area of the research being examined and summarize mott, & Davidson, 2002; Morse, 1991; Pickler &
your responses to the following questions: Butz, 2007) and have been the source of considerable
I. Are the findings of previous studies used to debate (Cohen & Crabtree, 2008; Mackey, 2012;
generate the research problem and purpose? Nelson, 2008; Stige, Malterud, & Midtgarden, 2009;
II. Is the design an advancement over previous Whittemore, Chase, & Mandle, 2001). Nurses criti-
designs (Borglin & Richards, 2010; Shadish cally appraising qualitative studies need three prereq-
et al., 2002)? uisite characteristics in applying rigorous appraisal
CHAPTER 18  Critical Appraisal of Nursing Studies 463

standards. Without these prerequisites, nurses may and complexity inherent in the lives of the patients we
miss potential valuable contributions qualitative serve. These prerequisites of philosophical founda-
studies might make to the knowledge base of nursing tion, type of qualitative study, and openness to
for practice. These required prerequisite characteris- study participants direct the implementation of the
tics are addressed in the following section. following guidelines for critically appraising qualita-
tive studies.
Prerequisites for Critical Appraisal of
Qualitative Studies Critical Appraisal Guidelines
The first prerequisite for appraising qualitative studies for Qualitative Studies
is an appreciation for the philosophical foundation of
qualitative research. Qualitative researchers design Problem Statement
their studies to be congruent with one of a wide range 1. Identify the clinical problem and research problem
of philosophies, such as phenomenology, symbolic that led to the study. Were the clinical problem and
interactionism, and hermeneutics, each of which research problem explicitly stated?
espouses slightly different approaches to gaining new 2. How did the author establish the significance of the
knowledge (Liamputtong & Ezzy, 2005). Although study? In other words, why should the reader care
unique, the qualitative philosophies are similar in their about this study? Look for statements about human
view of the uniqueness of the individual and the value suffering, costs of treatment, or the number of
of the individual’s perspective. Without an apprecia- people affected by the clinical problem.
tion for the philosophical perspective supporting the 3. Did the researcher identify a personal connection
study being critically appraised, the appraiser may not or motivation for selecting this topic to study? For
appropriately apply the standards of rigor consistent example, the researcher may choose to study the
with that perspective (Sale, 2008). Chapter 4 contains lived experience of men undergoing radiation for
more information on the different philosophies that prostate cancer after the researcher’s father under-
are foundational to qualitative research. went the same treatment. Acknowledging motives
Guided by an appreciation of qualitative philosoph- and potential biases is an expectation for qualita-
ical perspectives, nurses appraising a qualitative study tive researchers (Munhall, 2012).
can evaluate the approach used to gather, analyze, and
interpret the data. A basic knowledge of different Purpose and Research Questions
qualitative approaches is as essential for appraisal of 1. Identify the purpose of the study. Is the purpose a
qualitative studies as knowledge of quantitative logical approach to addressing the research problem
research designs is for appraising quantitative studies. of the study (Fawcett & Garity, 2009; Munhall,
Spending time in the culture, organization, or setting 2012)? Does the purpose have an intuitive fit with
that is the focus of the study is an expectation the problem?
for ethnography studies but would not be expected 2. List research questions that the study was designed
for a phenomenological study. A researcher using a to answer. If the author does not explicitly provide
grounded theory approach is expected to analyze the questions, attempt to infer the questions from
data to extract social processes and construct connec- the answers. What information did the author
tions among emerging concepts. Phenomenological include as findings?
researchers are expected to produce a rich, detailed 3. Were the research questions related to the problem
description of a lived experience. Knowing these dis- and purpose?
tinctions is a prerequisite to fair and objective critical 4. Were qualitative methods appropriate to answer the
appraisal of qualitative studies. What one expects to research questions?
find in a qualitative research report may be the most
important influence on one’s appraisal of the study Literature Review
(Sandelowski & Barroso, 2007). 1. Did the author cite quantitative and qualitative
Appreciating philosophical perspectives and know­ studies relevant to the focus of the study? What
ing qualitative approaches are superficial, however, other types of literature did the author include?
without empathy for the participant’s perspective. 2. Are the references current? For qualitative studies,
Empathy creates an openness to knowing a participant the author may have included studies older than the
within a naturalistic holistic framework. This open- 5-year limit typically used for quantitative studies.
ness allows qualitative researchers and nurses apply- Findings of older qualitative studies may be rele-
ing the findings to acknowledge the depth, richness, vant to a qualitative study.
464 UNIT THREE  Putting It All Together for Evidence-Based Health Care

3. Identify the disciplines of the authors of studies 3. What were the inclusion and exclusion criteria for
cited in the article. Does it appear that the author the sample?
searched databases outside of the Cumulative Index 4. Were the selected participants able to provide data
to Nursing and Allied Health Literature for relevant relevant to the study purpose and research
studies? Research publications in other disciplines questions?
as well as literary works in the humanities may have 5. How many people participated in the study? Did
relevance for some qualitative studies. any potential study participants refuse to partici-
4. Did the author evaluate or indicate the weaknesses pate? Did any of the participants start but not
of the available studies? finish the study, which determines the study attri-
5. Did the literature review include adequate synthe- tion rate?
sized information to build a logical argument?
Another way to ask the question: Did the author Data Collection
provide enough evidence to support the verdict that 1. How were data collected in this study? What ratio-
the study was needed? nale did the author provide for using this data col-
lection method?
Philosophical Foundation 2. Identify the period of time during which data col-
The methods used by qualitative researchers are deter- lection occurred.
mined by the philosophical foundation of their work. 3. Describe the sequence of data collection events for
The researcher may not have stated explicitly the a participant. For example, were data collected
philosophical stance on which the study is based. from one interview or a series of interviews? Were
Despite this omission, a knowledgeable reader can focus group participants given an opportunity to
recognize the philosophy through the description of provide additional data or review the preliminary
the problem, formulation of the research questions, conclusions of the researcher?
and selection of the methods to address the research 4. Did the researcher describe changes that were
questions. A well-designed qualitative study is con- made in the methods in response to the context and
gruent at each stage with the underlying philosophical early data collection? Were data collection proce-
perspective, and it is clearest if the researcher identi- dures proscriptively applied or allowed to emerge
fies this perspective in his or her research report with some flexibility? Flexibility within parameters
(Fawcett & Garity, 2009; Marshall & Rossman, 2011; of the method is considered appropriate for qualita-
Munhall, 2012). tive studies (Fossey et al., 2002).
1. Did the author identify a specific perspective from
which the study was developed? If so, what was it? Protection of Human Study Participants
2. If a broad philosophy, such as phenomenology, was Qualitative studies tend to address areas of human life
identified, did the researcher identify the specific that are “sensitive” and require care in the way they
philosopher, such as Husserl or Heidegger? are addressed by researchers (Cowles, 1988). For
3. Did the researcher cite a primary source for the example, many of the topics studied by qualitative
philosophical foundation? researchers are social or moral issues not talked about
in common society. Other qualitative studies explore
Qualitative Approach emotional topics that may cause the participant dis-
1. Identify the stated or implied research approach comfort, anxiety, or grief. A qualitative report should
used for the study. provide clues that the researcher was aware of these
2. Provide a paraphrased description of the research concerns and addressed them appropriately.
approach used. See Chapter 4 for descriptions of 1. Identify the benefits and risks of participation
the different qualitative research perspectives or addressed by the authors. Were there benefits or
traditions. risks the authors do not identify?
3. Were the methods of the study consistent with the 2. How were recruitment and consent techniques
research tradition? adjusted to accommodate the sensitivity of the
subject matter and psychological distress of poten-
Sampling and Sample tial participants?
1. Identify how study participants were selected. 3. How were data collection and management tech-
2. At what sites were participants recruited for the niques adapted in acknowledgment of participant
study? Did the sites for recruitment fit the sampling sensitivity and vulnerability? For example, did
needs of the study? the authors have a counselor or other resources
CHAPTER 18  Critical Appraisal of Nursing Studies 465

available for participants who might become upset logic and form of the findings are critical to the
or disturbed by the interview? appraisal of the study.
1. Were readers able to hear the voice of the partici-
Data Management and Analysis pants and gain an understanding of the phenome-
1. Describe the data management and analysis non studied?
methods used in the study (Marshall & Rossman, 2. Were readers able to identify easily the elements of
2011; Munhall, 2012). the research report?
2. Did the author discuss how the rigor of the process 3. Did the overall presentation of the study fit its
was ensured? For example, does the author describe purpose, method, and findings (Fawcett & Garity,
maintaining a paper trail of critical decisions that 2009; Marshall & Rossman, 2011; Munhall, 2012)?
were made during the analysis of the data? 4. Was there a coherent logic to the presentation of
3. Analysis of qualitative data is influenced by the findings?
experiences and perspectives of the individuals
doing the analysis. What measures were used to Evaluation Summary
minimize or allow for the effects of researcher “The sense of rightness and feeling of comfort readers
bias? For example, did two researchers indepen- experience reading the report of a study constitute the
dently analyze the data and compare their analy- very judgments they make about the validity or trust-
ses? Some qualitative researchers believe that worthiness of the study itself” (Sandelowski &
comparability of interpretation across researchers Barroso, 2007, p. xix). Critical appraisal is not
is more consistent with a positivist philosophy complete without making judgments about the validity
(Fossey et al., 2002) and would not include this as of the study. Synthesis of the evaluative criteria for
a criterion for appraisal. qualitative studies can be reframed as philosophical
4. Did the data management and analysis methods fit congruence, methodological coherence, intuitive com-
the research purposes and data? prehension, and intellectual contribution (Cesario
et al., 2002; Clissett, 2008; Fossey et al, 2002; Morse,
Findings 1991; Nelson, 2008; Pickler & Butz, 2007; Stige et al.,
1. Did the findings address the purpose of the study 2009).
(Marshall & Rossman, 2011; Munhall, 2012)? 1. Philosophical congruence: Were the development
2. Were the data analyzed sufficiently? Findings in a and implementation of the study congruent with the
qualitative study are expected to be more than the philosophical foundation of the study?
words that participants said. The researcher is 2. Methodological coherence: Did the data collection,
expected to identify themes or abstract concepts analysis, and interpretation processes fit together to
that emerged from the data (Fawcett & Garity, form a coherent approach to address the research
2009). problem?
3. Were the interpretations of data congruent with 3. Intuitive comprehension: Do the findings provide a
data collected? credible reflection of reality and expand the read-
4. Did the researcher address variations in the find- er’s comprehension of the study topic? If so, how
ings by relevant sample characteristics? can the findings be used in nursing practice?
4. Intellectual contribution: What do the findings
Discussion contribute to the current body of knowledge?
1. Did the results offer new information about the 5. State the conclusion of the critical appraisal of the
target phenomenon? study.
2. Were the findings linked to findings in other studies
or other relevant literatures (Fawcett & Garity,
2009; Munhall, 2012)? KEY POINTS
3. Describe the clinical, policy, theoretical, and other
significance of the findings. Does the author explore • Critical appraisal of research involves carefully
these applications? examining all aspects of a study to judge its merits,
limitations, meaning, validity, and significance in
Logic and Form of Findings light of previous research experience, knowledge
The study report is the means of communicating the of the topic, and clinical expertise.
findings. Producing knowledge can occur only through • Critical appraisals of research are conducted (1) to
communication (Sandelowski & Barroso, 2007); the summarize evidence for practice, (2) to provide a
466 UNIT THREE  Putting It All Together for Evidence-Based Health Care

basis for future research, (3) to evaluate presenta- formed a coherent whole to address the research
tions and publications of studies, (4) for abstract problem.
selection for a conference, (5) to select an article • Intuitive comprehension is the enhanced under-
for publication, and (6) to evaluate research pro- standing gained by readers of the participant per-
posals for funding and implementation in clinical spective on the study topic.
agencies. • Intellectual contribution is the degree to which the
• Nurses’ levels of expertise in conducting critical findings add to the knowledge of the discipline.
appraisals depend on their educational preparation;
nurses with baccalaureate, master’s, doctorate, and
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  http://evolve.elsevier.com/Grove/practice/

19
CHAPTER

Evidence Synthesis and Strategies for


Evidence-Based Practice

R
esearch evidence has greatly expanded since profession of nursing toward EBP. This chapter exam-
the 1990s as numerous quality studies in ines the benefits and barriers related to implementing
nursing, medicine, and other healthcare disci- evidence-based care in nursing. Guidelines are pro-
plines have been conducted and disseminated. These vided for synthesizing research to determine the best
studies are commonly communicated via journal pub- research evidence. Two nursing models developed to
lications, the Internet, books, conferences, and televi- facilitate evidence-based practice in healthcare agen-
sion. The expectations of society and the goals of cies are introduced. Expert researchers, clinicians, and
healthcare systems are the delivery of high-quality, consumers—through government agencies, profes-
cost-effective health care to patients, families, and sional organizations, and healthcare agencies—have
communities nationally and internationally. To ensure developed an extensive number of evidence-based
the delivery of quality health care, the care must be guidelines. This chapter offers a framework for
based on the current, best research evidence available. reviewing the quality of these evidence-based guide-
Healthcare agencies are emphasizing the delivery of lines and for using them in practice. The chapter con-
evidence-based health care, and nurses and physicians cludes with a discussion of the nationally designated
are focused on evidence-based practice (EBP). With EBP centers and Institutional Clinical Translational
the emphasis on EBP over the last 2 decades, out- Science Awards. These centers and awards are sup-
comes have improved for patients, healthcare provid- ported by the U.S. government to expand the research
ers, and healthcare agencies (Brown, 2009; Craig & evidence generated, synthesized, and developed into
Smyth, 2012; Doran, 2011; Gerrish et al., 2011; evidence-based guidelines for practice.
Higgins & Green, 2008; Melnyk & Fineout-Overholt,
2011; Sackett, Straus, Richardson, Rosenberg, &
Haynes, 2000). Benefits and Barriers Related to
Evidence-based practice (EBP) is an important
theme in this textbook and was defined earlier as the Evidence-Based Nursing Practice
conscientious integration of best research evidence EBP is a goal for the profession of nursing and
with clinical expertise and patient values and needs in each practicing nurse. At the present time, some
the delivery of quality, cost-effective health care (see nursing interventions are evidence-based, or sup-
Chapter 1) (Craig & Smyth, 2012; Institute of Medi- ported by the best research knowledge available from
cine, 2001; Sackett et al., 2000). Best research evi- systematic reviews, meta-analyses, meta-syntheses,
dence is produced by the conduct and synthesis of and mixed-methods systematic reviews. However,
numerous high-quality studies in a selected health- many nursing interventions require additional research
related area. The concept of best research evidence to generate essential knowledge for making changes
was described in Chapter 2, and the processes for in practice. Some nurses readily use research-based
synthesizing research evidence (systematic review, interventions, and others are slower to make changes
meta-analysis, meta-synthesis, and mixed-methods in their practice based on research. Some clinical
systematic review) are defined. agencies are supportive of EBP and provide resources
This chapter builds on previous EBP discussions to to facilitate this process, but other agencies have
provide you with strategies for implementing the best limited support for the EBP process. This section iden-
research evidence in your practice and moving the tifies some of the benefits and barriers related to EBP

468
CHAPTER 19  Evidence Synthesis and Strategies for Evidence-Based Practice 469

to assist you in promoting EBP in your agency and documents the excellence of nursing care in an agency.
delivering evidence-based care to your patients. Approval for Magnet status is obtained through the
American Nurses Credentialing Center (ANCC).
Benefits of Evidence-Based Practice The national and international healthcare agencies
in Nursing that currently have Magnet status can be viewed
The greatest benefits of EBP are improved outcomes online at the ANCC (2012) website (http://www
for patients, providers, and healthcare agencies. Orga- .nursecredentialing.org/FindaMagnetHospital.aspx).
nizations and agencies nationally and internationally The Magnet Recognition Program® recognizes EBP as
have promoted the synthesis of the best research evi- a way to improve the quality of patient care and to
dence in thousands of healthcare areas by teams of revitalize the nursing environment. Selection criteria
expert researchers and clinicians. These research syn- for Magnet status that require healthcare agencies to
theses, such as systematic reviews and meta-analyses, promote the conduct of research and the use of research
have provided the basis for developing strong evidence- evidence in practice follow.
based guidelines for practice. These guidelines identify
the best treatment plan or gold standard for patient care
in a selected area to promote quality health outcomes.
Healthcare providers have easy access to numerous
evidence-based guidelines to assist them in making “FORCE 6: Quality Care
the best clinical decisions for their patients. These
“Research and Evidence-Based Practice
evidence-based syntheses and guidelines are commu-
nicated by presentations and publications and can be “22. Describe how current literature, appropriate
easily accessed online through the National Guideline to the practice setting, is available,
Clearinghouse (NGC, 2012b) in the United States disseminated, and used to change
(http://www.guidelines.gov/), Cochrane Collaboration administrative and clinical practices.
(2012) in England (http://www.cochrane.org/), and “23. Discuss the institution’s policies and
Joanna Briggs Institute (2012) in Australia (http:// procedures that protect the rights of
www.joannabriggs.edu.au/). participants in research protocols. Include
Individual studies, research syntheses, and evidence- evidence of consistent nursing involvement in
based guidelines assist students, educators, registered the governing body responsible for protection
nurses (RNs), and advanced practice nurses (APNs) to of human subjects in research.
provide the best possible care. Expert APNs, such as “24. Provide evidence that research consultants are
nurse practitioners, clinical nurse specialists, nurse actively involved in shaping nursing research
anesthetists, and nurse midwives, are resources to infrastructure, capacity, and mentorship.
other nurses and facilitate access to evidence-based “25. Provide a copy of the nursing budget or other
guidelines to ensure patient care is based on the best sources of funding for the past year, the
research evidence available (Gerrish et al., 2011). current year-to-date, and the future
Nurse researchers and APNs are involved in the devel- projection, highlighting the allocation and
opment of systematic reviews, meta-analyses, meta- utilization of resources for nursing research.
syntheses, and evidence-based guidelines to manage “26. Supply documentation of all nursing research
patient health problems, prevent illnesses, and promote activities that are ongoing, including internal
health. validation studies, internal and external
Healthcare agencies are highly supportive of EBP research, and participation in surveys
because it promotes quality, cost-effective care for completed within the past twelve (12) month
patients and families and meets accreditation require- period.
ments. The Joint Commission revised their accredita- “27. Provide evidence of education and mentoring
tion criteria to emphasize patient care quality achieved activities that have effectively engaged staff
through EBP. Approximately 25% of chief nursing nurses in research- and/or evidence-based
officers (CNOs) identified the movement toward practice activities.
evidence-based nursing practice as their number one “28. Describe resources available to nursing staff to
priority (Nurse Executive Center, 2005; The Joint support participating in nursing research and
Commission, 2012). nursing research utilization activities.” (Nurse
Many CNOs and healthcare agencies are trying Executive Center, 2005, p. 15)
either to obtain or to maintain Magnet status, which
470 UNIT THREE  Putting It All Together for Evidence-Based Health Care

These selection criteria include critical elements and developmental care of neonates and infants. The
for EBP, especially financial support for and out- authors found a limited association between nursing
comes related to research activities. Important interventions and processes and patient outcomes
research-related outcomes to be documented by agen- in acute care settings. Their findings included the
cies for Magnet status include nursing studies following.
conducted and professional publications and presen-
tations by nurses. For each study, the following needs
to be documented: title of the study, principal investi-
“The strongest evidence was for the use of patient
gator or investigators, role of nurses in the study, and
risk-assessment tools and interventions implemented
study status (Horstman & Fanning, 2010). In working
by nurses to prevent patient harm. We observed sig-
toward EBP, nurses are encouraged to embrace the
nificant variation in the methods to measure the effect
benefits of EBP, use the evidence-based guidelines
of independent variables (nursing interventions) on
available, synthesize current research evidence,
patient outcomes. Results indicate the need for more
and support or participate in the research needed to
research measuring the effect of specific nursing
determine the effectiveness of selected nursing
interventions that may impact acute care patient out-
interventions.
comes.” (Bolton et al., 2007, p. 123S)
Barriers of Evidence-Based Practice
in Nursing
Barriers to the EBP movement have been both practi- Extensive evidence has been generated through
cal and conceptual. One of the most serious barriers nursing research, but additional studies are needed that
is the lack of research evidence available regarding the focus on determining the effectiveness of nursing
effectiveness of many nursing interventions. EBP interventions on patient outcomes (Bolton et al., 2007;
requires synthesizing research evidence from random- Craig & Smyth, 2012; Doran, 2011; Mantzoukas,
ized controlled trials (RCTs) and other types of inter- 2009). Identifying the areas where research evidence
vention studies, and these types of studies are still is lacking is an important first step in developing the
limited in nursing. Mantzoukas (2009) reviewed the evidence needed for practice. Well-designed experi-
research evidence in 10 high-impact nursing journals, mental and quasi-experimental studies are needed to
including Nursing Research, Research in Nursing & test selected nursing interventions and to use that
Health, Western Journal of Nursing Research, Journal understanding to generate sound evidence for practice
of Nursing Scholarship, and Advances in Nursing (see Chapter 14). Nurses also need to be more active
Science, between 2000 and 2006 and found that the in conducting quality syntheses (systematic reviews,
studies were 7% experimental, 6% quasi-experimental, meta-analyses, and meta-syntheses) of research evi-
and 39% nonexperimental. However, RCTs and quasi- dence in selected areas (Finfgeld-Connett, 2010;
experimental studies conducted to determine the Higgins & Green, 2008; Rew, 2011; Sandelowski &
effectiveness of nursing interventions continue to Barroso, 2007). The next section of this chapter pro-
increase. vides guidelines to direct different types of research
Systematic reviews and meta-analyses conducted syntheses.
in nursing have been limited compared with other Another concern is that the research evidence is
disciples. In addition, nurse authors of these research generated based on population data and then is applied
syntheses have sometimes indicated there is inade- in practice to individual patients. Sometimes it is dif-
quate research evidence to support using certain ficult to transfer research knowledge to individual
nursing interventions in practice (Craig & Smyth, patients, who respond in unique ways or have unique
2012; Mantzoukas, 2009). Bolton, Donaldson, Rut- needs (Biswas et al., 2007). More work is needed to
ledge, Bennett, and Brown (2007, p. 123S) conducted promote the use of evidence-based guidelines with
a review of “systematic/integrative reviews and meta- individual patients. The National Institutes of Health
analyses on nursing interventions and patient out- (NIH) is supporting translational research to improve
comes in acute care settings.” Their literature search the use of research evidence with different patient
covered 1999-2005 and identified 4000 systematic/ populations in various settings. Patients who have
integrative reviews and 500 meta-analyses covering poor outcomes when managed according to an
the following seven topics selected by the authors: evidence-based guideline need to be reported, and, if
staffing, caregivers, incontinence, elder care, symptom possible, their circumstances should be published as a
management, pressure ulcer prevention and treatment, case study. Electronic patient records now make it
CHAPTER 19  Evidence Synthesis and Strategies for Evidence-Based Practice 471

possible to determine patient outcomes of care deliv- limited funds to support research projects and research-
ered using EBP guidelines. based changes in practice, and (7) minimal rewards
Best research evidence is generated mainly from for providing evidence-based care to patients and
RCTs and other intervention studies with limited families (Butler, 2011; Eizenberg, 2010; Gerrish et al.,
focus on the contributions of descriptive-correlational 2011). The success of EBP is determined by all
studies, qualitative research, mixed-methods studies, involved including healthcare agencies, administra-
and theories. These types of studies do make contribu- tors, nurses, physicians, and other healthcare profes-
tions to the research evidence in many areas and need sionals. We all need to take an active role in ensuring
to be synthesized for use in practice (Mantzoukas, that the health care provided to patients and families
2009) (see Chapter 10 for mixed-methods studies). is based on the best research available.
Qualitative researchers have developed several syn-
thesis processes for qualitative studies, and these are
discussed later in this chapter. Guidelines for Synthesizing
Another concern of the EBP movement is that the
development of evidence-based guidelines has led to Research Evidence
a “cookbook” approach to health care. Health profes- Many nurses lack the expertise and confidence to syn-
sionals are expected to follow these guidelines in their thesize research evidence in a selected area of nursing.
practice as developed. However, the definition of EBP They need additional knowledge and skills in criti-
describes it as the conscientious integration of best cally appraising studies and synthesizing research evi-
research evidence with clinical expertise and patient dence. Synthesizing research evidence can focus on a
values and needs. Nurse clinicians have a major role specific area or intervention for practice or on complex
in determining how the best research evidence will be clinical problems. Master’s and doctoral students
implemented to achieve quality care and outcomes. often focus on clearly defined interventions when con-
For example, a nurse practitioner uses the national ducting research syntheses. Synthesis of research in
evidence-based guidelines for the treatment of patients complex clinical areas is best done with a team of
with hypertension (Joint National Committee on Pre- expert researchers and clinicians. However, novice
vention, Detection, Evaluation, and Treatment of High researchers need to be included in these teams to
Blood Pressure [JNC 7]) (Chobanian et al., 2003) but increase their understanding of the synthesis processes
also makes clinical decisions based on the needs and for determining the best research evidence in an area.
values of individual patients. If a patient has a dry, In this section, guidelines are provided for conduct-
persistent, irritating cough when taking angiotensin- ing systematic reviews, meta-analyses, meta-syntheses,
converting enzyme inhibitor medications, this type of and mixed-methods systematic reviews to guide you
medication would not be used to manage the patient’s in synthesizing research evidence for nursing practice.
high blood pressure if possible. If a patient refuses a Numerous research syntheses have been conducted in
treatment based on cultural or religious reasons, these nursing and medicine, so be sure to search for an exist-
reasons would be taken into consideration in develop- ing synthesis or review of research in an area before
ing the patient’s treatment plan. Evidence-based undertaking such a project. More recent data suggest
guidelines provide the gold standard for managing a that at least 2500 new systematic reviews are reported
particular health condition, but the healthcare provider in English and indexed in MEDLINE each year (Libe-
and patient individualize the treatment plan. rati et al., 2009). Table 19-1 identifies some common
Another serious barrier is that some healthcare databases and EBP organizational websites for nurses
agencies and administrators do not provide the to search for nursing syntheses of research. The
resources necessary for nurses to implement EBP. Cochrane Collaboration library of systematic reviews
Their lack of support might include the following: (1) is an excellent resource with more than 11,000
inadequate access to research journals and other entries relevant to nursing and health care (http://
sources of synthesized research findings and evidence- www.cochrane.org/cochrane-reviews). In 2009, the
based guidelines, (2) inadequate knowledge on how to Cochrane Nursing Care Field was developed to
implement evidence-based changes in practice, (3) support the conduct, dissemination, and use of system-
heavy workload with limited time to make research- atic reviews in nursing. The Joanna Briggs Institute
based changes in practice, (4) limited authority to also provides resources for locating and conducting
change patient care based on research findings, (5) research syntheses in nursing (see Table 19-1). If you
limited support from nursing administrators or medical can find no synthesis of research for a selected nursing
staff to make evidence-based changes in practice, (6) intervention or the review you find is outdated, you
472 UNIT THREE  Putting It All Together for Evidence-Based Health Care

TABLE19-1  Evidence-Based Practice Resources


Resource Description
Electronic Databases
CINAHL (Cumulative Index to CINAHL is an authoritative resource covering the English-language journal literature
Nursing and Allied Health for nursing and allied health. Database was developed in the U.S. and includes
Literature) sources published from 1982 forward
MEDLINE (PubMed—National Database was developed by the National Library of Medicine in the U.S. and provides
Library of Medicine) access to >11 million MEDLINE citations back to the mid-1960s and additional life
science journals
MEDLINE with MeSH Database provides authoritative medical information on medicine, nursing, dentistry,
veterinary medicine, the healthcare system, preclinical services, and more
PsychINFO Database was developed by the American Psychological Association and includes
professional and academic literature for psychology and related disciplines from
1887 forward
CANCERLIT Database of information on cancer was developed by the U.S. National Cancer Institute
National Library Sites
Cochrane Library Cochrane Library provides high-quality evidence to inform people providing and
receiving health care and people responsible for research, teaching, funding, and
administration of health care at all levels. Included in the Cochrane Library is the
Cochrane Collaboration (2012), which has many systematic reviews of research.
Cochrane Reviews are available at http://www.cochrane.org/reviews/
National Library of Health (NLH) NLH is located in the United Kingdom. You can search for evidence-based sources at
http://www.evidence.nhs.uk/
Evidence-Based Practice Organizations
Cochrane Nursing Care Network Cochrane Collaboration includes 11 different fields, one of which is the Cochrane
Nursing Care Field (CNCF), which supports the conduct, dissemination, and use of
systematic reviews in nursing; see http://cncf.cochrane.org/
National Guideline Clearinghouse Agency for Healthcare Research and Quality (AHRQ) developed NGC to house the
(NGC) thousands of evidence-based guidelines that have been developed for use in clinical
practice. The guidelines can be accessed online at http://www.guidelines.gov
National Institute for Health and NICE was organized in the United Kingdom to provide access to the evidence-based
Clinical Excellence (NICE) guidelines that have been developed. These guidelines can be accessed at http://
nice.org.uk
Joanna Briggs Institute This international evidence-based organization, originating in Australia, has a search
website that includes evidence summaries, systematic reviews, systematic review
protocols, evidence-based recommendations for practice, best practice information
sheets, consumer information sheets, and technical reports; see Search the Joanna
Briggs Institute (2012) at http://www.joannabriggs.edu.au/Search.aspx

might use the following guidelines to conduct a sys- Smyth, 2012; Higgins & Green, 2008; Liberati et al.,
tematic review of relevant research. 2009; Rew, 2011). Systematic reviews are often con-
ducted by two or more researchers or clinicians (or
Guidelines for Implementing and Evaluating researchers and clinicians) in a selected area of interest
Systematic Reviews to determine the best research knowledge in that area.
A systematic review is a structured, comprehensive Systematic reviews need to be conducted with rigor-
synthesis of the research literature to determine the ous research methodology to promote the accuracy of
best research evidence available to address a health- the findings and minimize the reviewers’ bias.
care question. A systematic review involves identify- Table 19-2 is a checklist for critically appraising
ing, locating, appraising, and synthesizing quality the steps of a systematic review, and these steps are
research evidence for expert clinicians to use to discussed in the following section. These steps are
promote an EBP (Bettany-Saltikov, 2010a; Craig & based on the Preferred Reporting Items for Systematic
CHAPTER 19  Evidence Synthesis and Strategies for Evidence-Based Practice 473

TABLE 19-2  Checklist for Critically Appraising Published Systematic Reviews


Step Complete Comments: Quality
Systematic Review Steps (Yes or No) and Rationale
  1.  Was the clinical question clearly expressed and significant? Was the PICOS
(participants, intervention, comparative interventions, outcomes, and study
design) format used to develop the question and focus the review?
  2.  Were the purpose and objectives or aims of the review clearly expressed
and used to direct the review?
  3.  Were the search criteria clearly identified? Was the PICOS format used to
identify the search criteria and were the years covered, language, and
publication status of sources identified in the search criteria?
  4.  Was a comprehensive, systematic search of the literature conducted using
explicit criteria identified in Step 3? Were the search strategies clearly
reported with examples? Did the search include published studies, grey
literature, and unpublished studies?
  5.  Was the process for the selection of studies for the review clearly identified
and consistently implemented? Was the selection process expressed in a
flow diagram such as Figure 19-1?
  6.  Were key elements (population, sampling process, design, intervention,
outcomes, and results) of each study clearly identified and presented in a
table?
  7.  Was a quality critical appraisal of the studies conducted? Were the results
related to participants, types of intervention, outcomes, outcome
measurement methods, and risks of bias clearly discussed related to each
study (i.e., in table and narrative format)?
  8.  Was a meta-analysis conducted as part of the systematic review? Was a
rationale provided for conducting the meta-analysis? Were the details of
the meta-analysis process and results clearly described?
  9.  Were the results of the review clearly described (i.e., in narrative and
table)? Were details of the study interventions compared and contrasted in
a table? Were the outcome variables clearly identified and the quality of
the measurement methods addressed?
10.  Did the report conclude with a clear discussion section?
a.  Were the review findings summarized to identify the current best
research evidence?
b.  Were the limitations of the review and how they might have affected the
findings addressed?
c.  Were the recommendations for further research, practice, and policy
development addressed?
11.  Did the authors of the review develop a clear, concise, quality report for
publication? Was the report inclusive of the items identified in the
PRISMA Statement (Liberati et al., 2009)?

Reviews and Meta-Analyses (PRISMA) Statement article by Liberati et al. (2009). If the review process
and other relevant sources to guide nurses in conduct- is clearly detailed in the report, others can replicate
ing systematic reviews (Bettany-Saltikov, 2010a, the process and verify the findings (Rew, 2011). A
2010b; Higgins & Green, 2008; Rew, 2011). The systematic review conducted by Goulding, Furze, and
PRISMA Statement was developed in 2009 by an Birks (2010) is presented as an example with the dis-
international group of expert researchers and clini- cussion of the review steps outlined in Table 19-2.
cians to improve the quality of reporting for system- Goulding et al. conducted a systematic review of only
atic reviews and meta-analyses. The PRISMA RCTs to determine the best interventions to use in
Statement includes 27 items, which can be found at changing maladaptive illness beliefs of people with
http://prisma-statement.org/ and are detailed in the coronary heart disease (CHD).
474 UNIT THREE  Putting It All Together for Evidence-Based Health Care

Step 1: Formulate a Relevant Clinical Question cognitive behavioral therapy, were compared. The
to Direct the Review intervention group was compared with groups receiv-
A systemic review or meta-analysis is best directed by ing standard care, no treatment, or a variation of the
a relevant clinical question that focuses the review treatment. The primary outcome measured was the
process and promotes the development of a quality change in beliefs about CHD at follow-up. The study
synthesis of research evidence. Formulating the ques- design included synthesis of only RCTs using guide-
tion involves identifying a relevant topic, developing lines from the Cochrane Collaboration handbook
a question of interest that is worth investigating, (Higgins & Green, 2008) (see Chapters 11 and 14
deciding if the question will generate significant infor- about conducting RCTs). The study design (RCTs)
mation for practice, and determining if the question clearly focused the literature review but might have
will clearly direct the review process and synthesis of eliminated some important studies that could have
findings. A well-stated question will define the nature expanded the knowledge related to the intervention of
and scope of the literature search, identify keywords changing illness beliefs.
for the search, determine the best search strategy,
provide guidance in selecting articles for the review, Step 2: State the Purpose and Objectives
and guide the synthesis of results (Bettany-Saltikov, or Aims of the Review
2010a, 2010b; Higgins & Green, 2008; Liberati et al., Most systematic reviews of research include a purpose
2009). and specific aims or objects to guide the synthesis
The question developed might focus on an inter- process (Bettany-Saltikov, 2010a; Rew, 2011). The
vention or therapy, health promotion action, illness purpose identifies the major goal or focus of the
prevention strategy, diagnostic process, prognosis, review. Goulding et al. (2010, p. 948) identified their
causation, or experiences (Bettany-Saltikov, 2010a). purpose as follows: “This systematic review was
One of the most common formats used to develop a therefore necessary to collate and present evidence of
relevant clinical question to guide a systematic review the effectiveness of maladaptive belief change inter-
is the PICO or PICOS format described in the ventions for people with CHD.” The specific aims
Cochrane Handbook for Systematic Reviews of Inter- direct the remaining steps of the research synthesis
ventions (Higgins & Green, 2008). PICOS format and become the focus of the discussion of the findings.
includes the following elements: Goulding et al. (2010) identified the following.
P—Population or participants of interest (see Chapter
15 on sampling)
I—Intervention needed for practice (see Chapter 14
on intervention research) “Aims
C—Comparisons of the intervention with control, “The aims of the systematic review were to establish
placebo, standard care, variations of the same inter- whether interventions can significantly change mal-
vention, or different therapies (see Chapter 14) adaptive illness cognitions in people with CHD and to
O—Outcomes needed for practice (see Chapter 13 on demonstrate which types of intervention are most
outcomes research and Chapter 17 on measurement effective. We also aimed to assess whether change in
methods) cognition was accompanied by changes in behav-
S—Study design (see Chapter 11 on types of study ioural, functional, and psychological outcomes.”
designs) (Goulding et al., 2010, p. 948)
Goulding et al. (2010) noted that interventions to
change maladaptive illness beliefs were beneficial to
people with CHD because positive illness representa-
tions may lead to improved lifestyle behaviors of exer- Step 3: Identify the Literature Search Criteria
cise, smoking cessation, and balanced diet. What was and Strategies
not known was “[w]hich types of intervention to Researchers conducting a systematic review or meta-
change illness cognitions (e.g. counseling, education, analysis need to identify the inclusion and exclusion
or cognitive behavioural) are most effective” (Gould- criteria to be used to direct their literature search. The
ing et al., 2010, p. 948) for people with CHD. The PICOS format might be used to develop the search
population was people with CHD, and the intervention criteria with more detail being developed for each of
was focused on changing maladaptive illness beliefs the elements. These search criteria might focus on the
of these individuals. The different types of this following: (1) type of research methods, such as quan-
intervention, including counseling, education, and titative, qualitative, or outcomes research; (2) the
CHAPTER 19  Evidence Synthesis and Strategies for Evidence-Based Practice 475

population or type of study participants; (3) study Authors of systematic reviews also need to identify
designs, such as description, correlational, quasi- the search strategies that they will use. Many sources
experimental, experimental, qualitative, or mixed are identified through searches of electronic databases
methods; (4) sampling processes, such as probability using the criteria previously discussed. However, pub-
or nonprobability sampling methods; (5) intervention lication bias might best be reduced with more rigorous
and comparison interventions; and (6) specific out- searches of the following areas for grey literature and
comes to be measured. The PICOS format is effective other unpublished studies:
in identifying the key terms to be included in the 1. Review the references of identified studies for
search process. The search criteria also need to indi- additional studies. These are ancestry searches to
cate the years for the review, language, and publica- use citations in relevant studies to identify addi-
tion status. The focus of the review might be narrowed tional studies.
by limiting the years reviewed, the language to 2. Hand search certain journals for selected years,
English, and only studies in print (Bettany-Saltikov, especially for older studies that were not identified
2010b; Higgins & Green, 2008; Rew, 2011). in the electronic search.
Often searches have been limited to published 3. Identify expert researchers in an area and search
sources in common databases, which excludes the their names in the databases.
grey literature from the research synthesis. Grey lit- 4. Contact the expert researchers regarding studies
erature refers to studies that have limited distribu- they have conducted that have not been published
tions, such as theses and dissertations, unpublished yet.
research reports, articles in obscure journals, articles 5. Search thesis and dissertation databases for rele-
in some online journals, conference papers and vant studies.
abstracts, conference proceedings, research reports to 6. Review abstracts and conference reports of rele-
funding agencies, and technical reports (Benzies, vant professional organizations.
Premji, Hayden, & Serrett, 2006; Conn, Valentine, 7. Search the websites of funding agencies for rele-
Cooper, & Rantz, 2003). Most grey literature is dif- vant research reports (Bettany-Saltikov, 2010b;
ficult to access through database searches and is often Conn et al., 2003; Liberati et al., 2009).
not peer-reviewed with limited referencing informa- Often it is best to construct a table that includes the
tion. These are some of the main reasons for not search criteria so that they can be applied consistently
including grey literature in searches for systematic throughout the search process (Liberati et al., 2009)
reviews and meta-analyses. However, excluding grey (see Chapter 6). Goulding et al. (2010) used the
literature from these searches might result in mislead- PICOS format to determine inclusion criteria for the
ing, biased results. Studies with significant findings studies in the search. The participants had to be adults
are more likely to be published than studies with non- with at least one of the following: angina, CHD, myo-
significant findings and are usually published in more cardial infarction, or eligible for or recently received
high-impact, widely distributed journals that are revascularization by percutaneous coronary interven-
indexed in computerized databases (Conn et al., tion or coronary artery bypass graft surgery. The
2003). Studies with significant findings are more studies needed to focus on an intervention to change
likely to have duplicate publications that need to be knowledge, attitudes, perceptions, and misconceptions
excluded when selecting studies to include in a about CHD. The interventions to change maladaptive
research synthesis. Benzies et al. made the following beliefs were compared with different interventions,
recommendations related to including grey literature usual care, or no intervention. The primary outcome
in a systematic review or meta-analysis. was change in beliefs about CDH, and the secondary
outcomes were focused on quality of life, behavior
change, anxiety level, depression, psychological well-
• “Intervention and outcome are complex with being, and modifiable risk factors. The study design
multiple components. was limited to only RCTs that included a comparison
• Lack of consensus is present concerning of the intervention group with a control group or
measurement of outcome. another intervention.
• Context is important to implementing the Goulding et al. (2010) designed their literature
intervention. search strategies and their protocol for conducting
• Availability of research-based evidence is low their systematic review using sources such as the
volume and quality.” (Benzies et al., 2006, p. 60) Cochrane Collaboration handbook (Higgins & Green,
2008) and the Quality of Reporting of Meta-analyses
476 UNIT THREE  Putting It All Together for Evidence-Based Health Care

(QUOROM) Statement (Moher et al., 1999). No date identified in Step 3. The abstracts might be excluded
restriction was applied to the search for studies, but based on the study participants, interventions, out-
because of the lack of funds, only studies reported in comes, or design not meeting the search criteria.
English were identified. The databases searched are Sometimes the abstracts are not in English, are incom-
discussed in Step 4. The researchers did not include plete, or are of studies not attainable. If contacting the
grey literature in their review and recognized this as a authors of the abstracts cannot produce essential infor-
limitation in their discussion section. mation, often the abstracts are excluded from the
review (Bettany-Saltikov, 2010b; Higgins & Green,
Step 4: Conduct a Comprehensive Search 2008; Liberati et al., 2009).
of the Research Literature After the abstracts meeting the designated criteria
The next step for conducting a systematic review or are identified, the next step is to retrieve the full-text
meta-analysis requires an extensive search of the lit- citation for each study. It is best to enter these studies
erature focused by the criteria and strategies identified into a table and document how each study meets the
in Step 3. The different databases searched, date of the eligibility criteria. If studies do not meet criteria, they
search, and search results need to be recorded for each need to be removed with a rationale provided. Two or
database (see Chapter 6 for details on conducting and more authors of the review need to examine the studies
storing searches of databases). Table 19-1 identifies to ensure that the eligibility or inclusion criteria are
common databases that are searched by nurses in con- consistently implemented. Often the study selection
ducting syntheses of research and in searching for process includes all members of the review team. This
evidence-based guidelines. Usually the key search selection process is best demonstrated by a flow
terms are identified in the report. Sometimes authors diagram that was developed by the PRISMA Group
of systematic reviews provide a table that identifies (Liberati et al., 2009). Figure 19-1 shows this diagram,
the search terms and criteria. The PRISMA Statement which has four phases: (1) identification of the sources,
recommends presenting the full electronic search (2) screening of the sources based on set criteria, (3)
strategy used for at least one major database such as determining if the sources meet eligibility require-
CINAHL or MEDLINE (Liberati et al., 2009). The ments, and (4) identifying the studies included in the
search strategies used to identify grey literature and review.
other unpublished studies need to be identified. Goulding et al. (2010) provided the following
Goulding et al. (2010) searched the following elec- description of their section of sources and a flow
tronic databases: MEDLINE, EMBASE, CINAHL, diagram (see Figure 19-2) that documented the final
BNI, PsychINFO, The Cochrane Library (including results of the 13 RCTs included in their systematic
the Cochrane Database of Systematic Reviews, review.
CENTRAL, and DARE), and Web of Knowledge.
They provided an extensive table that detailed their
electronic search of the five databases identified. The
search criteria included the participants with different
types of CHD; interventions of education and cogni- “Search Outcome
tive and behavioral therapies; comparisons with “The electronic search produced 3526 citations,
control, standard care, and placebo groups; outcomes which were reduced to 115 on citation review. A
of health knowledge, attitudes, and illness percep- check of 10% of these citations was undertaken by
tions; and study design of RCT. The authors noted that an independent researcher from another university,
the electronic search identified 3526 citations and that with 100% concordance on abstracts to be retrieved.
they obtained one source from an expert researcher A review of abstracts identified 74 papers to retrieve
and seven by reviewing the references of other studies. in full. A further seven papers were identified from
reference checks, and an additional relevant study
Step 5: Selection of Studies for Review was uncovered via contact with an expert in the field.
The selection of studies for inclusion in the systematic After a consensus meeting between all authors of the
review or meta-analysis is a complex process that review, 13 studies were included. Each of these was
initially involves review and removal of duplicate a published journal article. The study selection flow-
sources. The abstracts of the remaining studies are chart shown in [Figure 19-2] documents this process.”
reviewed by two or more authors and sometimes an (Goulding et al., 2010, p. 950)
external reviewer to ensure they meet the criteria
CHAPTER 19  Evidence Synthesis and Strategies for Evidence-Based Practice 477

Identification
Records identified through Additional records identified
database searching through other sources
(n = ) (n = )

Records after duplicates removed


(n = )
Screening

Records screened Records excluded


(n = ) (n = )

Full-text articles assessed Full-text articles excluded,


Eligibility

for eligibility with reasons


(n = ) (n = )

Studies included in
qualitative synthesis
(n = )
Included

Studies included in
quantitative synthesis
(meta-analysis)
(n = )

Figure 19-1  PRISMA 2009 Flow Diagram. Identification, screening, eligibility, and inclusion of research sources in systematic reviews and meta-
analyses. (From Moher, D., Liberati, A., Tetzlaff, J., Altman, D. G., & PRISMA Group. [2009]. Preferred Reporting Items for Systematic Reviews and
Meta-Analyses: The PRISMA Statement. Retrieved from http://www.prisma-statement.org.)

Step 6: Critical Appraisal of the Studies Included and major results (Bettany-Saltikov, 2010b; Higgins
in Review & Green, 2008; Liberati et al., 2009).
An initial critical appraisal of the methodological It is best if two or more experts independently
quality of the studies occurs during the selection of review the studies and make judgments about their
the studies to be included in the systematic review. quality. The authors of the review usually contact the
Once the studies are selected, a more thorough critical study investigators if needed to obtain important infor-
appraisal takes place. This critical appraisal is best mation about the study design or results not included
done by constructing a table describing the character- in the publication. Chapter 18 provides guidelines
istics of the included studies, such as the purpose of for critically appraising quantitative and qualitative
the studies, population, sampling method, sample size, studies. The critical appraisal of the studies is often
sample acceptance and attrition rates, design, inter- difficult because of the differences in types of partici-
vention (independent variable), dependent variables, pants, designs, sampling methods, intervention proto-
measurement methods for each dependent variable, cols, outcome variables and measurement methods,
478 UNIT THREE  Putting It All Together for Evidence-Based Health Care

Potentially relevant citations identified by a


sensitive electronic search: n = 3526

Citations excluded following


initial screen: n = 3406
Duplicates excluded: n = 5

Abstracts reviewed: n = 115

Abstracts not meeting


inclusion criteria: n = 41
Reasons for exclusion:
• Not English language: 7
• Abstract only: 2
• Design: 7
• Participants: 2
• Intervention: 6
• Outcome measure: 11
• No results: 4
Figure 19-2  Study selection flow chart. (From Goulding, L.,
• Paper unobtainable: 2
Furze, G., & Birks, Y. [2010]. Randomized controlled trials of
interventions to change maladaptive illness beliefs in people
with coronary heart disease: Systematic review. Journal of Studies retrieved in full from
Advanced Nursing, 66[5], 950.) electronic search: n = 74

Further studies identified


through reference search and
author contact: n = 8

Excluded after evaluation of


full text: n = 69
Reasons for exclusion:
• Design: 14
• Participants: 4
• Intervention: 9
• Outcome measure: 38
• Repeat data: 3
• No results: 1

Studies included in the


systematic review: n = 13

and presentation of results. The studies are often rank- of the study; (2) participants and setting; (3) design,
ordered based on their quality and contribution to the sample size per group, and follow-up; (4) intervention;
development of the review (Bettany-Saltikov 2010b; (5) control or comparison group; (6) study outcomes;
Liberati et al., 2009). and (7) results with statistical significance set at
Goulding et al. (2010) developed a detailed table alpha = 0.05. Two reviewers independently assessed
of essential content from the 13 studies included in the the quality of each study. They provided a detailed
systematic review and labeled the headings of the description of the appraisal process and their findings
columns in the table as (1) authors, year, and country for each study. You may want to access this systematic
CHAPTER 19  Evidence Synthesis and Strategies for Evidence-Based Practice 479

review to view their table of studies and examine their Goulding et al. (2010, p. 955) described their par-
critical appraisal process. ticipants for their 13 studies as “male and female
adults of all ages with a diagnosis of CHD (including
Step 7: Conduct a Meta-Analysis If Appropriate people diagnosed with MI [myocardial infarction] or
Some systematic reviews include published meta- angina or those receiving revascularization). There
analyses as sources in the review. Because a meta- was no clear link between patient group and effective-
analysis involves the use of statistics to summarize ness of interventions to change beliefs.” These authors
results of different studies, it usually provides strong, also provided two detailed tables: one addressing the
objective information about the effectiveness of an types of interventions and the other identifying the
intervention or solid knowledge about a clinical measurement methods of the study outcomes and
problem. Other authors conduct a meta-analysis in the quality of these methods. Numerous outcome mea-
synthesis of sources for their systematic review (Libe- sures were used in the 13 studies, and some had poor
rati et al., 2009). The authors of the review need to reliability and validity, which limit the results of this
provide a rationale for conducting the meta-analysis systematic review. Goulding et al. also summarized
and detail the process they used to conduct this analy- key findings related to the effectiveness of the inter-
sis. For example, a meta-analysis might be conducted ventions and reached the following conclusion.
on a small group of similar studies to determine the
effect of an intervention. The next section provides
“Overall, the majority of interventions designed to
more details on conducting a meta-analysis.
elicit positive and correct illness cognitions regarding
The systematic review conducted by Goulding
CHD were effective. Such interventions can be effec-
et al. (2010) did not include a meta-analysis as a
tive either as part of a multifaceted intervention or as
source, and a meta-analysis was not conducted during
a stand-alone intervention. However, because of the
the review process. A meta-analysis was probably not
numerous differences in the structure of each inter-
appropriate because of the limited number of studies
vention, method of belief change, and method of
that had been conducted to examine the effectiveness
delivery, it is difficult to ascertain whether there is a
of the intervention to change maladaptive illness
relationship between type of intervention and effect
beliefs in people with CHD.
on belief change.” (Goulding et al., 2010, p. 956)
Step 8: Results of the Review
The results of the authors’ reviews need to include Step 9: Discussion Section of the Review
a description of the study participants, types of inter- In a systematic review or meta-analysis, the discussion
ventions, and outcomes. The results of the different of the findings needs to include an overall evaluation
types of interventions might be best summarized in of the types of interventions implemented and the
a table that includes the following: (1) study source; outcomes measured. The methodological issues or
(2) structure of the intervention (stand-alone or multi- limitations of the review also need to be addressed.
faceted); (3) specific type of intervention such as The discussion section needs to include a theoretical
physiological treatment, education, counseling, or link back to the studies’ frameworks to indicate the
behavioral therapy; (4) delivery method such as dem- theoretical implications of the findings. Lastly, the
onstration and return demonstration, verbal, video, discussion section needs to provide recommendations
or self-administered; and (5) statistical difference for further research, practice, and policy development
between the intervention and the control, standard (Bettany-Saltikov, 2010b; Higgins & Green, 2008;
care, placebo, or alternative intervention groups Liberati et al., 2009). Goulding et al. (2010) provided
(Liberati et al., 2009). the following discussion of their findings; review limi-
The specific outcomes, including primary and sec- tations; and recommendations for research, practice,
ondary outcomes, of the studies might also be best and policy development.
summarized in a table. This table might include (1)
the study source; (2) outcome variable, with an indica- “We found that interventions to change beliefs can be
tion as to whether it was a primary or secondary successful, with cognitive behavioral interventions
outcome in the study; (3) measurement method used being the most consistently effective. The evidence
for each study outcome variable; and (4) the quality on whether interventions to change maladaptive
of the measurement methods, such as the reliability beliefs can improve psychological, functional, and
and validity of a scale or the precision and accuracy behavioural outcomes was unclear. It is therefore not
of a physiological measure (see Chapter 16).
480 UNIT THREE  Putting It All Together for Evidence-Based Health Care

report should include a title that identifies it as either


possible to determine which types of intervention are a systematic review or a meta-analysis for ease of
most effective in creating improvements in these location in database searches. An abstract also needs
important outcomes. to be included that identifies background, purpose,
data sources, review methods, results, and conclu-
Methodological Issues
sions. The body of the report needs to include the
The major weakness of the review methodology was content discussed in the previous nine steps: (1) clini-
the lack of a search for non-English language litera- cal question to be addressed by the review; (2) purpose
ture, unpublished trials, and grey literature because and aims or objectives to be accomplished by the
of time and resource constraints.… It is therefore review; (3) search criteria and strategies used to iden-
possible that the review has a publication bias. tify essential studies; (4) comprehensive search of the
However, as one of the authors (GF) is internationally literature and results; (5) selection of studies to be
collaborative in the review area, it is unlikely that a included in the review; (6) critical appraisal process
large number of studies of good quality was missed.… and findings; (7) description of the meta-analysis con-
The purpose of including only RCTs was to synthe- ducted and results if appropriate; (8) presentation of
size the results of the best quality research available, the review results in table and narrative format; and
yet some of the included studies did not meet the (9) discussion of the systematic review findings, limi-
anticipated quality standard. This said, the overall tations, and implications for further research, practice,
review methodology was good.… and policy development.
Leventhal’s CSM [Common Sense Model] can be The PRISMA Group developed a 27-item checklist
used to explain the relationships between illness to use in developing the final reports for systematic
beliefs, coping, and medical, psychological, and social reviews and meta-analyses. This PRISMA Group
outcomes. Four of the reports included in the review checklist is presented in Table 19-3 and discussed
explicitly mentioned the theoretical framework of the on PRISMA Group website (http://www.prisma-
CSM as informing the design of the intervention or statement.org) and in the articles by Liberati et al.
interpretation of results.… (2009) and Moher, Liberati, Tetzlaff, Altman, and
PRISMA Group (2009). This checklist is an excellent
Implications for Future Research
guide to use in developing the final report of a
The review demonstrates the need for methodologi- systematic review or meta-analysis for publication.
cally sound and adequately powered trials of interven- This checklist was developed to improve the quality,
tions to change maladaptive illness cognitions.… The completeness, and consistency of the syntheses devel-
follow-up time of such interventions should be long oped and published in nursing, medicine, and other
enough to determine whether any positive effects healthcare professions.
remain stable over time.… Cognitive behavioral
interventions appear promising, and could perhaps Critical Appraisal of a Published Systematic Review
be used in conjunction with education and counseling. Your critical appraisal of a systematic review might be
It is important that researchers choose a valid and guided by the checklist provided in Table 19-2. This
reliable measure to assess change in the cognition(s) table includes the steps of a systematic review, and you
of interest.” (Goulding et  al., pp. 957-959) need to assess if each step was completed or not in the
review. You also need to provide comments and ratio-
nale for the appraised strengths and limitations of the
Goulding et al. stressed the importance of interven- review. Using this checklist, you could develop a
tions to change maladaptive illness beliefs of people formal critical appraisal paper for a systematic review.
with CHD. However, the impact of changing those In developing and critically appraising systematic
beliefs on behavior, functional, and psychological out- reviews, you might also use the articles by Bettany-
comes is unclear. Additional research is needed on the Saltikov (2010a, 2010b), the Cochrane Collaboration
use of cognitive behavioral interventions to change handbook (Higgins & Green, 2008), the EBP manual
maladaptive illness beliefs and how this affects people for nurses by Craig and Smyth (2012), and other
with CHD health outcomes. sources identified by your faculty or experts in this area.
The critical appraisal of a systematic review or
Step 10: Development of the Final Report meta-analysis also needs to include an assessment of
for Publication how current the literature synthesis is. This leads to
The final step is the development of the systematic the following question: How quickly do systematic
review report for publication and presentation. The reviews become out of date? Shojania et al. (2007,
CHAPTER 19  Evidence Synthesis and Strategies for Evidence-Based Practice 481

TABLE 19-3  Checklist of Items to Include When Reporting a Systematic Review or Meta-Analysis
Reported on
Section/Topic No. Checklist Item Page No.
Title
Title 1 Identify the report as a systematic review, meta-analysis, or both
Abstract
Structured 2 Provide a structured summary including, as applicable, background;
summary objectives; data sources; study eligibility criteria, participants, and
interventions; study appraisal and synthesis methods; results; limitations;
conclusions and implications of key findings; systematic review
registration number
Introduction
Rationale 3 Describe the rationale for the review in the context of what is already
known
Objectives 4 Provide an explicit statement of questions being addressed with reference to
PICOS (participants, interventions, comparisons, outcomes, and study
design)
Methods
Protocol and 5 Indicate if a review protocol exists; if and where it can be accessed (e.g.,
registration Web address); and, if available, provide registration information
including registration number
Eligibility criteria 6 Specify study characteristics (e.g., PICOS, length of follow-up) and report
characteristics (e.g., years considered, language, publication status) used
as criteria for eligibility, giving rationale
Information 7 Describe all information sources (e.g., databases with dates of coverage,
sources contact with study authors to identify additional studies) in the search
and date last searched
Search 8 Present full electronic search strategy for at least one database, including
any limits used, such that it could be repeated
Study selection 9 State the process for selecting studies (i.e., screening, eligibility, included in
systematic review, and, if applicable, included in the meta-analysis)
Data collection 10 Describe method of data extraction from reports (e.g., piloted forms,
process independently, in duplicate) and any processes for obtaining and
confirming data from investigators
Data items 11 List and define all variables for which data were sought (e.g., PICOS,
funding sources) and any assumptions and simplifications made
Risk of bias in 12 Describe methods used for assessing risk of bias of individual studies
individual (including specification of whether this was done at the study or outcome
studies level), and how this information is to be used in any data synthesis
Summary 13 State the principal summary measures (e.g., risk ratio, difference in means)
measures
Synthesis of 14 Describe the methods of handling data and combining results of studies, if
results done, including measures of consistency (e.g., I2) for each meta-analysis

From Moher, D., Liberati, A., Tetzlaff, J., Altman, D. G., & PRISMA Group. (2009). Preferred Reporting Items for Systematic Reviews and Meta-Analyses:
The PRISMA Statement. Retrieved from http://www.prisma-statement.org.

p. 224) conducted a survival analysis on 100 quantita- However, 23% of the reviews signaled a need for
tive systematic reviews published from 1995-2005 “to updating within 2 years, and 15% needed updating
estimate the average time to changes in evidence that within 1 year. Shojania et al. (2007) stressed that high-
is sufficiently important to warrant updating system- quality systematic reviews that were directly relevant
atic reviews.” They found the average time before a to clinical practice require frequent updating to stay
systematic review should be updated was 5.5 years. current. There are numerous nursing and medical
482 UNIT THREE  Putting It All Together for Evidence-Based Health Care

sources of systematic reviews, but it is important for Box 19-1 Recommended Reporting
you to know the steps of the systematic review process
for Authors to Facilitate
and to be able to appraise critically the quality of these
reviews. Meta-Analysis
Demographic Variables Relevant to
Conducting Meta-Analyses to Synthesize Population Studied
Research Evidence Age
A meta-analysis is conducted to pool statistically the Gender
results from previous studies into a single quantitative Marital status
analysis that provides one of the highest levels of Ethnicity
evidence about the effectiveness of an intervention Education
(Andrel, Keith, & Leiby, 2009; Craig & Smyth, 2012; Socioeconomic status
Higgins & Green, 2008; Liberati et al., 2009). This
approach has objectivity because it includes analysis Methodological Characteristics
techniques to determine the effect of an intervention Sample size (experimental and control groups)
while examining the influences of variations in the Type of sampling method
studies selected for the meta-analysis. The studies to Sampling refusal rate and attrition rate
be included in the analysis need to be examined for Sample characteristics
variations or heterogeneity in such areas as sample Research design
characteristics, sample size, design, types of interven- Groups included in study—experimental,
tion, and outcomes variables and measurement control, comparison, placebo groups
methods (Higgins & Green, 2008). Heterogeneity in Intervention protocol and fidelity discussion
the studies to be included in a meta-analysis can lead Data collection techniques
to different types of biases, which are detailed in the Outcome measurements
next section. Reliability and validity of instruments
Statistically combining data from several studies Precision and accuracy of physiological
results in a large sample size with increased power to measures
determine the true effect of a specific intervention on
Data Analysis
a particular outcome (see Chapter 15 for discussion of
power). The ultimate goal of a meta-analysis is to Name of statistical tests
determine if an intervention (1) significantly improves Sample size for each statistical test
outcomes, (2) has minimal or no effect on outcomes, Degrees of freedom for each statistical test
or (3) increases the risk of adverse events. Meta- Exact value of each statistical test
analysis is also an effective way to resolve conflicting Exact p value for each test statistic
study findings and controversies that have arisen One-tailed or two-tailed statistical test
related to a selected intervention. When conducting a Measures of central tendency (mean, median,
systematic review, authors might conduct a meta- and mode)
analysis on a group of similar studies to determine the Measures of dispersion (range, standard
oasis-ebl|Rsalles|1476321133

effectiveness of an intervention (Higgins & Green, deviation)


2008). Post hoc test values for ANOVA (Analysis of
Strong evidence for using an intervention in prac- variance) test of three or more groups
tice can be generated from a meta-analysis of multiple,
quality studies such as RCTs and quasi-experimental
studies. However, the conduct of a meta-analysis
depends on the accuracy, clarity, and completeness for developing a report for either a systematic review
of information presented in studies. Box 19-1 provides or a meta-analysis (see Table 19-3) (Liberati et al.,
a list of information that needs to be included in 2009). The following information is provided to
a research report to facilitate the conduct of a increase your ability to appraise critically meta-
meta-analysis. analysis studies and to conduct a meta-analysis for
The steps for conducting a meta-analysis are similar a selected intervention. The PRISMA Statement,
to the steps for conducting a systematic review that Cochrane Collaboration guidelines for meta-analysis
were detailed in the previous section. The PRISMA (Higgins & Green, 2008), and other resources (Andrel
Statement introduced earlier provides clear directions et al., 2009; Conn & Rantz, 2003; Noordzij, Hooft,
CHAPTER 19  Evidence Synthesis and Strategies for Evidence-Based Practice 483

Dekker, Zoccali, & Jager, 2009; Turlik, 2010) were


used to provide detail for conducting a meta-analysis. intervention, sample, and research design
Conn’s (2010) meta-analysis to determine the effect characteristics?
of physical activity interventions on depressive “(3) What are the effects of interventions on
symptom outcomes in healthy adults is presented as depressive symptoms among studies
an example. comparing treatment subjects with before
versus after interventions?” (Conn, 2010,
Clinical Question for Meta-Analysis pp. 128, 129)
The clinical question developed for a meta-analysis is
usually clearly focused as: “What is the effectiveness
of a selected intervention?” The PICOS (participants,
intervention, comparative interventions, outcomes,
and study design) format discussed earlier might be Search Criteria and Strategies for Meta-Analyses
used to generate the clinical question (Higgins & The methods for identifying search criteria and select-
Green, 2008; Liberati et al., 2009; Moher et al., 2009). ing search strategies are similar for meta-analyses and
Conn (2010) indicated that only one previous meta- systematic reviews. The search criteria are usually
analysis had examined the effect of physical activities narrowly focused for meta-analysis to identify selec-
(PA) on depressive symptoms among subjects without tive studies examining the effect of a particular inter-
clinical depression. Thus, she wanted to address the vention. The search needs to be rigorous and include
following clinical question: “What is the effect of PA published sources identified through varied databases
on depressive symptoms in healthy adults?” and unpublished studies and grey literature identified
through other types of searches (see previous section).
Purpose and Questions to Direct Meta-Analysis Conn (2010) clearly identified her search strategies in
Researchers need to identify clearly the purpose of the following excerpt.
their meta-analysis and the questions or objectives
that guide the analysis. The Cochrane Collaboration
identified the following four basic questions to
guide a meta-analysis to determine the effect of an
“Primary Study Search Strategies
intervention:
“Multiple search strategies were used to ensure a
comprehensive search and thus limit bias while
moving beyond previous reviews. An expert refer-
“1. What is the direction of effect?
ence librarian searched 11 computerized databases
“2. What is the size of effect?
(e.g., MEDLINE, PsychINFO, EMBASE) using broad
“3. Is the effect consistent across studies?
search terms.… Search terms for depressive symp-
“4. What is the strength of evidence for the effect?”
toms were not used to narrow the search because
(Higgins & Green, 2008, p. 244)
many PA interventions studies report depressive
symptom outcomes but do not consider these the
main outcomes of the study and thus papers are not
Conn clearly identified the following purpose: indexed by these terms. Several research registers
were examined including Computer Retrieval of
Information on Scientific Projects and mRCT, which
“This meta-analysis synthesized depressive symptom contains 14 active registers and 16 archived registers.
outcomes of supervised and unsupervised PA inter- Computerized author searches were completed for
ventions among healthy adults.… This meta-analysis project principal investigators located from research
addressed the following research questions: registers and for the first three authors on eligible
“(1) What are the overall effects of supervised PA studies. Author searches were completed for disser-
and unsupervised PA interventions on tation authors to locate published papers. Ancestry
depressive symptoms in healthy adults without searches were conducted on eligible and review
clinical depression? papers. Hand searches were completed for 114
“(2) Do interventions’ effects on depressive journals which frequently report PA intervention
symptom outcomes vary depending on research.” (Conn, 2010, p. 129)
484 UNIT THREE  Putting It All Together for Evidence-Based Health Care

Possible Biases for Meta-Analyses in a study can be calculated by determining the differ-
and Systematic Reviews ence between the experimental and control groups for
Even with rigorous literature searches, authors of the outcome variable. The mean difference between
meta-analyses and systematic reviews are often the experimental and control groups for several studies
limited to mainly published studies. The nature of the is easily determined if the outcome variable is mea-
sources can lead to biases and flawed or inaccurate sured by the same scale or instrument in each study
conclusions in the research syntheses. The common (see Chapter 15 for calculation of ES). However, the
biases that can occur in conducting and reporting standardized mean difference (SMD) must be cal-
research syntheses include publication bias such as culated in a meta-analysis when the same outcome,
time lag bias, location bias, duplicate publication such as depression, is measured by different scales or
bias, citation bias, and language bias; bias from poor methods. More details are provided on SMD later in
study methodology; and outcome reporting bias. this section. Figure 19-3 shows a funnel plot of the
Publication bias occurs because studies with positive SMDs from 13 individual studies. The SMDs from the
results are more likely to be published than studies studies are fairly symmetrical or equally divided by
with negative or inconclusive results. Higgins and the line through the middle of the funnel in the graph.
Green (2008) found that the odds were four times A symmetrical funnel plot indicates limited or no pub-
greater that positive study results would be published lication bias. Asymmetry of the funnel plot is due to
versus negative results. Time-lag bias, a type of pub- publication bias, but Egger, Smith, Schneider, and
lication bias, occurs because studies with negative Minder (1997) also believed it reflects methodological
results are usually published later, sometimes 2 to 3 bias, reporting bias, heterogeneity in the studies’
years later, than studies with positive results. Some- sample size and interventions, and chance. In Figure
times studies with negative results are not published 19-3, the studies with small sample sizes are toward
at all, whereas studies with positive results might be the bottom of the graph, and the studies with larger
published more than once (duplicate publication samples are toward the top.
bias). Location bias can occur if studies are pub- Figure 19-4 includes two example funnel plots with
lished in lower impact journals and indexed in less- the plot in Figure 19-4A showing no apparent publica-
searched databases. A citation bias occurs when tion bias. An unbiased sample of studies should appear
certain studies are cited more often than others and basically symmetrical in the funnel with the ORs of
are more likely to be identified in database searchers. the studies fairly equally divided on either side of the
Language bias can occur if searches focus just on line (see Chapter 24 for calculating OR). The funnel
studies in English and important studies exist in other plot shown in Figure 19-4B demonstrates publication
languages. bias in favor of larger studies with positive results
Biases in studies’ methodologies are often related when the studies having smaller effect and sample
to design and data analysis problems. The strengths sizes are removed. This collection of studies in a meta-
and threats to design validity need to be examined analysis could lead to the conclusion that a treatment
during critical appraisal of the studies for inclusion in was effective when it might not be when looking at a
a meta-analysis or systematic review (see Chapter 10 larger collection of studies with negative and positive
for discussion of design validity). The analyses con-
ducted in studies need to be appropriate and complete
(see Chapters 20 through 25 on data analysis).
Outcome reporting bias occurs when study results
are not reported clearly and with complete accuracy.
For example, reporting bias occurs when researchers
selectively report positive results and not negative
Study Size

results; or positive results might be addressed in detail


with limited discussion of negative results. Higgins
and Green (2008) provided a much more detailed dis-
cussion of potential biases in systematic reviews and
meta-analyses.
An analysis method called the funnel plot can be 0.0 0.1 0.2 0.3 0.4 0.5 0.6
used to assess for biases in a group of studies. Funnel Standardized Mean Difference (SMD) for RCTs
plots provide graphic representations of possible effect
sizes (ESs) or odds ratios (ORs) for interventions in Figure 19-3  Funnel plot of standardized mean differences (SMDs) for
selected studies. The ES or strength of an intervention randomized controlled trials (RCTs) with limited bias.
CHAPTER 19  Evidence Synthesis and Strategies for Evidence-Based Practice 485

Funnel plot with pseudo 95% confidence limits


0
Standard Error of Log Odds Ratio

.2

.4

.6

.8
–1 0 1 2
(A) Figure 19-4  A and B, Funnel plots examining
Log Odds Ratio
publication bias. (From Andrel, J. A., Keith, S. W.,
& Leiby, B. E. [2009]. Meta-analysis: A brief
introduction. Clinical & Translational Science, 2[5],
Funnel plot with pseudo 95% confidence limits
376.)
0
Standard Error of Log Odds Ratio

.2

.4

.6

.8
–1 0 1 2
(B) Log Odds Ratio

results as in the plot in Figure 19-4A. Conn (2010) the remainder were dissertations (s=14), book
discussed her search results and risk of publication chapter (s=1), and conference presentation materials
bias in the following excerpt. (s=1; s indicates the number of reports). Publication
bias was evident in the funnel plots for supervised and
unsupervised PA two-group outcome comparisons
“Comprehensive searchers yielded 70 reports.… and for treatment group, pre- vs. post-intervention
The supervised PA two-group comparison included supervised PA and unsupervised PA comparisons. The
1,598 subjects. The unsupervised PA two-group com- control group pre- and post-comparison distributions
parison included 1,081 subjects. The treatment on the funnel plots suggested less publication bias
single-group comparisons included 1,639 supervised than plots of treatment groups. Unless otherwise
PA and 3,420 unsupervised PA subjects.… Most specified, all results are from the treatment vs. control
primary studies were published articles (s=54), and comparisons.” (Conn, 2010, p. 131)
486 UNIT THREE  Putting It All Together for Evidence-Based Health Care

Results of Meta-Analysis for Continuous Outcomes average of the intervention effects estimated in the
Many nursing studies examine continuous outcomes individual studies. A weighted average” is defined by
or outcomes that are measured by methods that pro- Higgins and Green (2008, p. 263) as:
duced interval or ratio level data. Physiological mea-
sures to examine blood pressure produce ratio level sum of (estimate × weight)
data. Likert scales such as the Center for Epidemio- Weighted average =
logic Studies Depression (CES-D) Scale produce sum of weights
interval level data (see Figure 17-8 for a copy of
CES-D Scale). Blood pressure and depression are con- In combining intervention effect estimates across
tinuous outcomes. Meta-analysis includes a two-step studies, a random-effects meta-analysis model or
process: Step 1 is the calculation of a summary statis- fixed-effect meta-analysis model can be used. The
tic for each study to describe the intervention effect, assumption of using the random-effects model is that
and step 2 is the summary (pooled) intervention effect all the studies are not estimating the same intervention
that is the weighted average of the interventions effects effect but related effects over studies that follow a
estimated from the different studies. In step 1, to deter- distribution across studies. When each study is esti-
mine the effect of an intervention on continuous out- mating the exact same quality, a fixed-effect model is
comes, the mean difference between two groups is used. Meta-analysis results can be obtained using soft-
calculated. The mean difference is a standard statistic ware from SPSS and SAS statistical packages (see
that is calculated to determine the absolute difference Chapter 21). Cochrane Collaboration Review Manager
between two groups. It is an estimate of the amount (RevMan) is software that can be used for conducting
of change caused by the intervention (e.g., physical meta-analyses. This chapter provides a very basic dis-
activity) on the outcome (e.g., depression) on average cussion of key ideas related to conducting meta-
compared with the control group. The mean difference analyses, and you are encouraged to review Higgins
can be calculated to determine the effect of an inter- and Green (2008) and other meta-analysis sources to
vention only if the outcome is measured by the same increase your understanding of this process (Andrel
scale in all the studies (Higgins & Green, 2008). et al., 2009; Fernandez & Tran, 2009; Turlik, 2010).
A standardized mean difference (SMD), or d, is We also recommend the assistance of a statistician in
used in studies as a summary statistic that is calculated conducting these analyses.
in a meta-analysis when the same outcome is mea- Conn’s (2010) meta-analysis result identified a
sured by different scales or methods. The SMD is also standardized mean effect size of 0.372 between the
sometime referred to as the standardized mean effect treatment and the control groups for the 38 supervised
size. For example, in the meta-analysis by Conn PA studies and SMD of 0.522 among the 22 unsuper-
(2010), depression was commonly measured with vised PA studies. This meta-analysis documented that
three different scales: Profile of Mood States, Beck supervised and unsupervised PA reduced symptoms of
Depression Inventory, and CES-D Scale. Studies that depression in healthy adults or adults without clinical
have differences in means in the same proportion to depression. Thus, a decrease in depression is another
the standard deviations have the same SMD (d) regard- important reason for encouraging patients to be
less of the scales used to measure the outcome vari- involved in physical activities.
able. The differences in the means and standard
deviations in the studies are assumed to be due to the Results of Meta-Analysis
measurement scales and not variability in the outcome for Dichotomous Outcomes
(Higgins & Green, 2008). The SMD is calculated by If the outcome data to be examined in a meta-analysis
meta-analysis software, and the formula is provided are dichotomous, risk ratios, odds ratios, and risk dif-
as follows: ferences are usually calculated to determine the effect
of the intervention on the measured outcome. These
difference in mean terms are introduced in this chapter but more informa-
outcome between groups tion is available in Craig and Smyth (2012), Higgins
SMD ( d ) =
standard deviation of and Green (2008), and Sackett et al. (2000). With
outcome among participants dichotomous data, every participant fits into one of
two categories, such as clinically improved or no clini-
In step 2 of meta-analysis of summarizing the cal improvement, effective screening device or inef-
effects of an intervention across studies, the pooled fective screening device, or alive or dead. Risk ratio
intervention effect estimate is “calculated as a weighted (RR), also called relative risk, is the ratio of the risk
CHAPTER 19  Evidence Synthesis and Strategies for Evidence-Based Practice 487

of subjects in the intervention group to the risk of analyzed. Column 2 includes the number of partici-
subjects in the control group for having a particular pants with the outcome (n) and total number of par-
health outcome. The health outcome is usually adverse, ticipants in the intervention or experimental group,
such as the risk of a disease (e.g., cancer) or the risk expressed as n/N. Column 3 includes the number of
of complications or death (Higgins & Green, 2008). participants with the outcome and total number in the
The calculation for RR follows and is:. control group. Column 4 graphically presents the OR
with a block and the 95% CI with a line. Column 5
risk of event in provides the percent weights given to each of the three
experimental group studies in this example. Column 6 provides the numer-
Relative risk ( RR) = ical values for the OR and 95% CI.
risk of event in control group The bottom of the forest plot in Figure 19-5 pro-
vides a summary of results and significance including
The odds ratio (OR) is defined as the ratio of the total events for intervention and control groups, test
odds of an event occurring in one group, such as the for heterogeneity, and test for overall effect. The large
treatment group, to the odds of it occurring in another diamond in the plot is the summary of the effect of
group, such as the standard care group. The OR is a the studies included in the analysis. If the diamond is
way of comparing whether the odds of a certain event left of the line that is positioned at 1, the results favor
is the same for two groups (see Chapter 24). An the intervention or treatment, and the CI does not
example is the odds of medication adherence or non- include 1 if the results are statistically significant
adherence for an experimental group receiving an (Fernandez & Tran, 2009). If the point estimates are
intervention of education and specialized medication consistently more on one side of the vertical line, this
packaging intervention versus a group receiving stan- shows homogeneity of the studies. If the point esti-
dard care. The calculation for OR is: mates are fairly equally distributed on both the left
and the right side of the veridical line, this shows
odds of event in heterogeneity of the studies included in the meta-
experimental group analysis. The term heterogeneity was introduced
Odds ratio (OR) =
odds of event in control earlier; heterogeneity can exist in the sample size and
or comparison group characteristics, types of intervention, designs, and
outcomes of the studies. Heterogeneity statistics for
The risk difference (RD), also called the absolute random-effects meta-analyses include chi-square tests
risk reduction, is the risk of an event in the experimen- (see Chapter 25), the I2, and a test for differences
tal group minus the risk of the event in the control or across subgroups if they are appropriate (Higgins &
standard care group. Green, 2008).
Magnus, Ping, Shen, Bourgeois, and Magnus
(2011) conducted a meta-analysis of the effectiveness
Risk difference ( RD) = risk of experimental group
of mammography screening in reducing breast cancer
− risk of control group
mortality in women 39 to 49 years old. Because mam-
mography screening is significant in reducing breast
Meta-analysis results from studies with dichoto- cancer mortality of women older than 50 years and
mous data are often presented using a forest plot. early detection of breast cancer increases survival,
Fernandez and Tran (2009) provided a format for pre- annual routine mammography screening has been rec-
senting a forest plot in a meta-analysis study (Figure ommended for all women 40 to 47 years old in the
19-5). A forest plot usually includes the following United States. Thus, “the primary aim of the current
information: (1) author, year, and name of the study; study was, after a quality assessment of identified ran-
(2) raw data from the intervention and control groups domized controlled trials (RCTs), to conduct a meta-
and total number in each group; (3) point estimate (OR analysis of the effectiveness of mammography
or RR) and confidence internal (CI) for each study screening [intervention] in women aged 39-49 [popu-
shown as a line and block on the graph; (4) numerical lation] in reducing breast cancer mortality [dichoto-
values for point estimate (OR or RR) and CI for each mous outcome]. The second aim was to compare and
study; and (5) percent weights given to each study discuss the results of previously published meta-
(Fernandez & Tran, 2009; Higgins & Green, 2008). In analyses” (Magnus et al., 2011, p. 845). The following
Figure 19-5, column 1 identifies each of the studies excerpts describe the methods, results, and conclu-
using the clearest format for the studies being sions of this meta-analysis.
488 UNIT THREE  Putting It All Together for Evidence-Based Health Care

Review: Intervention A for patients with diagnosis X


Details of the
Comparison: 01 Intervention A vs Control
review
Outcome: 01 Adverse events

Column 1 Column 2 Column 3 Column 4 Column 5 Column 6

Study Intervention Control OR (fixed) Weight OR (fixed)


Details and or sub-category n/N n/N 95% CI % 95% CI
results of the
Study 1 2006 18/168 26/107 63.33 0.37 [0.19, 0.72]
included studies
Study 2 2005 4/53 3/51 6.31 1.31 [0.28,6.15]
Study 3 2005 15/87 17/93 30.36 0.93 [0.43, 2.00]

Study authors

Line of no effect
and year n = Number of Graphical Proportion of Numerical
participants with display of weight of the display of
the outcome outcome study on the outcome
N = Total number of effect combined effect effect
participants

Total (95% CI) 308 251 100.00 0.60 [0.38, 0.96]


Total events: 37 (Intervention), 46 (Control)
Summary Test for heterogeneity: Chi2 = 4.22, df = 2(P = 0.12),
Summary effect
results and I2 = 52.6% Level of heterogeneity
Significance Test for overall effect:
Z = 2.12(P = 0.03) Statistical significance

0.1 0.2 0.5 1 2 5 10


Favors treatment Favors control

Figure 19-5  Meta-analysis graph for dichotomous data. CI, confidence interval; OR, odds ratio. (From Fernandez, R. S., & Tran, D. T. [2009]. The
meta-analysis graph: Clearing the haze. Clinical Nurse Specialist, 23[2], 58.)

“Methods: PubMed/MEDLINE, OVID, COCHRANE, The results of the study were graphically repre-
and Educational Resources Information Center (ERIC) sented using a forest plot (Figure 19-6). The plot
databases were searched, and extracted references clearly identifies the names of the seven studies
were reviewed. Dissertation abstracts and clinical included in the meta-analysis on the left side of the
trials databases available online were assessed to figure. The RR and CI for each study are identified
identify unpublished works. All assessments were with a block and horizontal line. The numerical RR
independently done by two reviewers. All trials and 95% CI values are identified on the right side of
included were RCTs, published in English, included the plot with the percent of weight given to each study.
data on women aged 39-49, and reported relative risk Most of the studies show homogeneity with odds
(RR)/odds ratio (OR) or frequency data. ratios left of the vertical line except for the Stockholm
Results: Nine studies were identified.… The indi- study. The forest plot would have been strengthened
vidual trials were quality assessed, and the data were by including the results from the test for heterogeneity
extracted using predefined forms. Using the DerSi- and test for overall effect. Magnus et al. (2011, p. 845)
monian and Laird random effects model, the results concluded, “Mammography screenings were effective
from the seven RCTs with the highest quality score and generate a 17% reduction in breast cancer mortal-
were combined, and a significant pooled RR estimate ity in women 39-49 years of age. The quality of the
of 0.83 (95% confidence interval [CI] 0.72-0.97) was trials varies, and providers should inform women in
calculated.” (Magnus et al., 2011, p. 845) this age group about the positive and negative aspects
of mammography screenings.”
CHAPTER 19  Evidence Synthesis and Strategies for Evidence-Based Practice 489

Study Name Risk Ratio % Weight


(95% CI)

Stockhoim 1.52 (0.80, 2.88) 5.16

Gothenburg 0.55 (0.31, 0.95) 6.68

Maimo 0.73 (0.51, 1.04) 14.27

Age Trial 0.83 (0.66, 1.04) 26.89

Canada 0.97 (0.74, 1.27) 21.52

HIP 0.77 (0.53, 1.11) 13.45

Edinburgh 0.79 (0.53, 1.17) 12.03

Overall 0.83 (0.72, 0.97)

.25 .5 .75 1 1.25 1.5 1.75 2

Risk Ratio

Figure 19-6  Forest plot showing the individual randomized controlled trials and the overall pooled estimate from the seven original randomized
controlled trials with a high-quality score addressing the impact of mammography screening on breast cancer mortality in women 39 to 49 years old.
CI, Confidence interval. (From Magnus, M. C., Ping, M., Shen, M. M., Bourgeois, J., & Magnus, J. H. [2011]. Effectiveness of mammography screening in
reducing breast cancer mortality in women aged 39-49 years: A meta-analysis. Journal of Women’s Health, 20[6], 848.)

be used in practice and for policy development


Conducting Meta-Synthesis (Barnett-Page & Thomas, 2009; Finfgeld-Connett,
of Qualitative Research 2010; Sandelowski & Barroso, 2007). The Cochrane
Qualitative research synthesis is the process and Collaboration recognizes the importance of synthesiz-
product of systematically reviewing and formally inte- ing qualitative research, and the Cochrane Qualitative
grating the findings from qualitative studies (Sande- Methods Group was developed as a forum for discus-
lowski & Barroso, 2007). The process for conducting sion and development of methodology in this area
a synthesis of qualitative research is still in the devel- (Higgins & Green, 2008).
opmental phase. Various synthesis methods have The qualitative research synthesis method that
appeared in the literature, such as meta-synthesis, seems to be gaining momentum in the nursing literature
meta-ethnography, meta-study, meta-narrative, quali- is meta-synthesis. Methodological articles have been
tative metasummary, qualitative meta-analysis, and published to describe meta-synthesis, but this method
aggregated analysis (Barnett-Page & Thomas, 2009; is still in early phases of development (Finfgeld-
Kent & Fineout-Overholt, 2008; Sandelowski & Connett, 2010; Kent & Fineout-Overholt, 2008; Walsh
Barroso, 2007; Walsh & Downe, 2005). Qualitative & Downe, 2005). Meta-synthesis is defined as the
researchers are not in agreement at the present systematic compiling and integration of qualitative
time about the method to use for synthesizing qualita- study results to expand understanding and develop a
tive research or if one method is possible to accom- unique interpretation of study findings in a selected
plish this process. Although the methodology is not area. The focus is on interpretation rather than the
clearly developed for qualitative research synthesis, combining of study results as with quantitative research
researchers recognize the importance of summarizing synthesis. Meta-synthesis involves the breaking down
qualitative findings to determine knowledge that might of findings from different studies to discover essential
490 UNIT THREE  Putting It All Together for Evidence-Based Health Care

features and then the combining of these ideas into a Searching the Literature and Selecting Sources
unique, transformed whole. Sandelowski and Barroso Most authors agree that a rigorous search of the litera-
(2007) identified metasummary as a step in conducting ture needs to be conducted. The search needs to
meta-synthesis. Metasummary is the summarizing of include databases, books and book chapters, and full
findings across qualitative reports to identify knowl- reports of theses and dissertations. Special search
edge in a selected area. A process for conducting a strategies that were identified earlier need to be
meta-synthesis is described in the following section. A engaged to identify grey literature because qualitative
meta-synthesis conducted by Denieffe and Gooney studies might be published in more obscure journals.
(2011) of the symptom experience of women with The search criteria need to identify the years of the
breast cancer is presented as an example. search, keywords to be searched, and language of
sources. Meta-syntheses are usually limited to qualita-
Framing a Meta-Synthesis Exercise tive studies only and do not included mix-method
Initially, researchers need to provide a frame for the studies (Walsh & Downe, 2005). Also, qualitative
meta-synthesis to be conducted (Kent & Fineout- findings that have not been interpreted but are unana-
Overholt, 2008; Walsh & Downe, 2005). Framing lyzed quotes, field notes, case histories, stories, or
involves identifying the focus and scope of the meta- poems are usually excluded (Finfgeld-Connett, 2010).
synthesis to be conducted. The focus of the meta- The search process is usually very fluid with the
synthesis is usually an important area of interest for conduct of additional computerized and hand searches
the individuals conducting it and a topic with an ade- to identify more studies. Sandelowski and Barroso
quate body of qualitative studies. The scope of a meta- (2007) identified a berry-picking process to search for
synthesis is an area of debate, with some qualitative sources, which includes a dynamic process of modify-
researchers recommending a narrow, precise approach ing search terms and methods to identify relevant
and others recommending a broader, more inclusive sources. However, it is important for researchers to
approach. However, researchers recognize framing is document systematically the strategies that they used
essential for making the synthesis process manageable to search the literature and the sources found through
and the findings meaningful and potentially transfer- these different search strategies.
able to practice. Framing the meta-synthesis is facili- The final selection of studies to include in the meta-
tated by the authors’ research and clinical expertise, synthesis depends on the focus and scope of the syn-
initial review of the relevant qualitative literature, and thesis. Some authors focus on one type of qualitative
discussion with expert qualitative researchers. Usually research, such as ethnography, or one investigator in
a research question is developed to direct the meta- a particular area. Others include studies with different
synthesis process. qualitative methodologies and investigators in a field
Denieffe and Gooney (2011) conducted their meta- or related fields. The search criteria need to be consis-
synthesis based on the stages developed by Sande- tently implemented in determining the studies to be
lowski and Barroso (2007). These stages included included and excluded in the synthesis. A flow diagram
“identifying a research question, collecting relevant might be developed to identify the process for select-
data (qualitative studies), appraising the studies, ing the studies similar to the one identified for system-
performing a metasummary and meta-synthesis” atic reviews and meta-analyses (see Figure 19-1)
(Denieffe and Gooney, 2011, p. 425). Denieffe and (Sandelowski & Barroso, 2007). Denieffe and Gooney
Gooney developed the following question to direct (2011) provided the following description of their lit-
their meta-synthesis and provided a rationale for their erature search, search criteria, and selection of studies
scope and focus. for their meta-synthesis.

“In this study the question was set as ‘What is the


symptom experience of women with breast cancer “Relevant qualitative research studies were located
from time of diagnosis to completion of treatment?’ and retrieved using computer searches in CINAHL,
The time frame selected from time of diagnosis to PsychLIT, Academic Search Premier, Embase, and
completion of treatment, has been conceptualized … MEDLINE. The research reports selected for this
as the ‘acute stage,’ encompassing initial diagnosis and synthesis met the following inclusion criteria: (1) the
treatment in the first of a three-stage process of sur- study focused on women with breast cancer; (2)
vivorship.” (Denieffe & Gooney, 2011, p. 425) there were explicit references to the use of
CHAPTER 19  Evidence Synthesis and Strategies for Evidence-Based Practice 491

the following: time frame from diagnosis, treatment,


qualitative research methods; and (3) the study age range, and ethnic origin. They indicated that the
focused on women’s perspectives and experiences of “final stage of data analysis was the qualitative meta-
symptoms with breast cancer. There were no restric- synthesis, interpreting the findings. Constant targeted
tions related to the date the research was published. comparison within and between study findings was
Keywords used were breast cancer, experience, undertaken, utilizing external literature to facilitate
symptom, and symptom experience.… The search interpretation of the emerging findings” (Denieffe &
using electronic databases was supplemented by … Gooney, 2011, p. 426).
footnote chasing using reference lists, citation search-
ing, in addition to hand searching of journals, and Discussion of Meta-Synthesis Findings
consultation with clinical colleagues and researchers A meta-synthesis report might include findings pre-
in the area. A total of 253 studies were identified as sented in different formats based on the knowledge
being possibly relevant.… Only 31 studies were developed and the perspective of the authors. A syn-
found to be relevant to the research question and thesis of qualitative studies in an area might result in
included in the meta-synthesis. Reasons for this the discovery of unique or more refined themes
reduction included papers that provided limited quali- explaining the area of synthesis. The findings from a
tative data, … did not address the research question, meta-synthesis might be presented in narrative format
… addressed post-treatment/survivor concerns, … or graphically presented in a model. The discussion of
or data given may not have related to patients with findings also needs to include identification of the
breast cancer.” (Denieffe & Gooney, 2011, pp. limitations of the meta-synthesis. The report often
425-426) concludes with recommendations for further research
and possibly implications for practice or policy devel-
opment or both.
The synthesis by Denieffe and Gooney (2011) of
Appraisal of Studies and Analysis of Data 31 qualitative studies in the area of symptoms experi-
The critical appraisal process for qualitative research enced by women with breast cancer resulted in the
varies among sources. We recommend that you use the identification of four emerging themes: (1) breast
critical appraisal guidelines for qualitative research cancer and the impact on self, (2) self-image and
presented in Chapter 18. These guidelines might be stigma, (3) self and self-control, and (4) more than just
used for examining the quality of individual studies a symptom. The researchers linked each of these
and a group of studies for a meta-synthesis. Usually a themes with the appropriate studies and presented this
table is developed as part of the appraisal process, but information clearly in a table. Denieffe and Gooney
this is also an area of debate. The table headings might (2011) also developed a detailed model that linked the
include (1) author and year of source, (2) aim or goal themes about self to the diagnosis and treatment of the
of the study, (3) theoretical orientation, (4), method- women and the symptoms they experienced (Figure
ological orientation, (5) type of findings, (6) sampling 19-7). The following excerpt provides the conclusions
plan, (7) sample size, and (8) other key content rele- from this meta-synthesis.
vant for comparison. This table provides a display of
relevant study elements so that a comparative appraisal
might be conducted (Sandelowski & Barroso, 2007; “The overarching idea emerging from this meta-
Walsh & Downe, 2005). The comparative analysis of synthesis is that the symptoms experience for women
studies involves examining methodology and findings with breast cancer has effects on the very ‘self’ of the
across studies for similarities and differences. The fre- individual. Emerging is women’s need to consider the
quency of similar findings might be recorded. The existential issues that they face while simultaneously
differences or contradictions in studies need to be dealing with a multitude of physical and psychological
resolved or explained (or both). Varied analysis tech- symptoms. This meta-synthesis develops a new, inte-
niques often are used by the researchers to translate grated, and more complete interpretation of findings
the findings of the different studies into a new or on the symptom experience of women with breast
unique description. cancer. The results offer the clinician a greater under-
Denieffe and Gooney (2011) developed a detailed standing in depth and breadth than the findings from
comparative analysis table of the 31 studies they individual studies on symptom experiences.” (Denieffe
included in their meta-synthesis. Their table included & Gooney, 2011, p. 424)
the headings mentioned in the previous paragraph and
492 UNIT THREE  Putting It All Together for Evidence-Based Health Care

Symptom Experience of Women with Breast Cancer

Pre-diagnosis Pain
Existential Issues
Fatigue
Time of Diagnosis

Time Event Line


Self-Image Anxiety
Surgery
Depression

Symptoms
Stigma Anticipations of
Hair loss
Treatment Chemotherapy
Skin changes
Loss of Control Initiation of
Self
and Autonomy Treatment Radiotherapy Weight Gain

Eating and Drinking


Leaving Active Hormone
Change in Roles Treatment therapy Nausea and Vomiting

Smell and Taste


Post Treatment Changes

Sexual Problems

Menopause / Fertility
Problems

Figure 19-7  Overall findings of meta-synthesis. (From Denieffe, S., & Gooney, M. [2011]. A meta-synthesis of women’s symptoms experience and
breast cancer. European Journal of Cancer Care, 20[4], 430.)

Mixed-Methods Systematic Reviews qualitative study designs are referred to as mixed-


In recent years, nurse researchers have been conduct- methods systematic reviews in this text. Mixed-
ing mixed-methods studies that include both quantita- methods systematic reviews have the potential to
tive and qualitative research methods (Creswell, 2009) contribute to Cochrane Interventions reviews for prac-
(see Chapter 10 for different types of mixed-methods tice and health policy in the following ways:
designs). Researchers recognize the importance of
synthesizing the findings of these studies to determine
important knowledge for practice and policy develop-
“1. In forming reviews by using evidence from
ment. For some synthesis areas, researchers need to
qualitative research to help define and refine a
combine the findings from both quantitative and quali-
question… .
tative studies to determine the current knowledge in
“2. Enhancing reviews by synthesizing evidence
that area. Harden and Thomas (2005) identified this
from qualitative research identified whilst
process of combining findings from quantitative and
looking for evidence … .
qualitative studies as mixed-methods synthesis.
“3. Extending reviews by undertaking a search and
Higgins and Green (2008) referred to this synthesis of
synthesis specially of evidence from qualitative
quantitative, qualitative, and mixed-methods studies
studies to address questions directly related to
as a mixed-method systematic review.
the effectiveness review.
The systematic reviews discussed earlier in this
“4. Supplementing reviews by synthesizing
chapter included only studies of a quantitative meth-
qualitative evidence to address questions on
odology, such as meta-analyses, RCTs, and quasi-
aspects other than effectiveness.” (Higgins &
experimental studies, to determine the effectiveness of
Green, 2008, p. 574)
an intervention. Mixed-methods systematic reviews
might include various study designs, such as qualita-
tive research and quasi-experimental, correlational,
and descriptive studies (Bettany-Saltikov, 2010b; Conducting mixed-methods systematic reviews
Higgins & Green, 2008; Liberati et al., 2009). Reviews involves implementing a complex synthesis process
that include syntheses of various quantitative and that includes expertise in synthesizing knowledge
CHAPTER 19  Evidence Synthesis and Strategies for Evidence-Based Practice 493

from quantitative, qualitative, and mixed-methods different types of medication administration technolo-
studies. Higgins and Green (2008) recommended two gies that could compromise patient safety.
types of approaches to integrate the findings from
quantitative, qualitative, and mixed-methods studies:
(1) multilevel syntheses and (2) parallel syntheses. Models to Promote Evidence-
Multilevel synthesis involves synthesizing the find-
ings from quantitative studies separate from qualita- Based Practice in Nursing
tive studies and integrating the findings from these two Two models commonly used to facilitate EBP in
syntheses in the final report. Parallel synthesis nursing are the Stetler Model of Research Utilization
involves the separate synthesis of quantitative and to Facilitate EBP (Stetler, 2001) and the Iowa Model
qualitative studies, but the findings from the qualita- of Evidence-Based Practice to Promote Quality of
tive synthesis are used in interpreting the synthesized Care (Titler et al., 2001). This section introduces these
quantitative studies. two models that might be used to implement evidence-
Further work is needed to develop the methodology based protocols, algorithms, and guidelines in clinical
for conducting a mixed-methods systematic review. agencies.
The steps overlap with the systematic review and
meta-synthesis processes that have been previously Stetler Model of Research Utilization
described. The process might best be implemented to Facilitate Evidence-Based Practice
with a team of researchers with expertise in conducting An initial model for research utilization in nursing
different types of studies and research syntheses. The was developed by Stetler and Marram in 1976 and
basic structure for the mixed-methods systematic expanded and refined by Stetler in 1994 and 2001 to
review might include the following: (1) identify promote EBP for nursing. The Stetler model (2001)
purpose and questions or aims of review; (2) develop (see Figure 19-8) provides a comprehensive frame-
the review protocol that includes search strategies for work to enhance the use of research evidence by
quantitative, qualitative, and mixed-methods studies; nurses to facilitate EBP. The research evidence can be
(3) identify search criteria for quantitative studies; (4) used at the institutional or individual level. At the
identify search criteria for qualitative and mixed- institutional level, synthesized research knowledge is
methods studies; (5) conduct a rigorous search of the used to develop or update protocols, algorithms, poli-
literature; (6) select relevant quantitative, qualitative, cies, procedures, or other formal programs imple-
and mixed-method studies for synthesis; (7) construct mented in the institution. Individual nurses, including
a table of information of studies to allow comparative practitioners, educators, and policy makers, summa-
appraisal of the studies; (8) conduct critical appraisals rize research and use the knowledge to influence edu-
of the quality of quantitative and qualitative studies; cational programs, make practice decisions, and
(9) synthesize study findings; and (10) develop a report impact political decision making. Stetler’s model is
that integrates the results of syntheses for both quan- included in this text to guide individual nurses and
titative, qualitative, and mixed-method studies. The healthcare institutions in using research evidence in
reader is encouraged to refer to the steps in systematic practice. The following sections briefly describe the
review and meta-analysis for conducting quantitative five phases of the Stetler model: (I) preparation, (II)
research syntheses and to the meta-synthesis discus- validation, (III) comparative evaluation and decision
sion for synthesizing qualitative studies. making, (IV) translation and application, and (V)
Wulff, Cummings, Marck, and Yurtseven (2011) evaluation (see Figure 19-8).
conducted a mixed-methods systematic review to
examine the association of medication administration Phase I: Preparation
technologies and patient safety. This review included The intent of the Stetler model (2001) is to make using
12 studies with the following designs: five preinter- research evidence in practice a conscious, critical
vention and postintervention studies, five correlational thinking process that is initiated by the user. The first
studies, and two qualitative studies. The major focus phase (preparation) involves determining the purpose,
of this review was the synthesis of the 10 quantitative focus, and potential outcomes of making an evidence-
studies that identified the benefits of implementing based change in a clinical agency. The agency’s priori-
medication administration technologies to improve ties and other external and internal factors that could
patient safety. However, the problem identified by be influenced by or could influence the proposed prac-
both the quantitative and the qualitative studies was tice change need to be examined. After the purpose of
that nurses develop workarounds in implementing the evidence-based project has been identified and
494

PHASE I: PHASE II: PHASE III: COMPARATIVE PHASE IV: PHASE V:


PREPARATION VALIDATION EVALUATION/DECISION MAKING TRANSLATION/APPLICATION EVALUATION

Evaluate dynamically:
1. Identify goal for
Perform utilization A. Confirm type, level, each “use”
focused critique and and method of application, 2. Obtain evidence re:
synopsis: per details in part II change process and
Search, sort, Identify and, if goal-related progress,
and select applicable, record as well as any
sources of key study details results/outcomes
research and qualifiers 3. Use iterative evidence
evidence Fit of Feasibility to achieve goals
setting (r,r,r) B. Use: Review
Accept operational details
Consider influential Reject
factors Synthesize Substan- Current • Informally: Use in practice
findings and tiating practice
Affirm priority evaluate per evidence • Formally: Identify design
criteria evidence-based document/s;
Define purpose Stop Evaluate as part of
package for dissemination;
and outcomes per as needed, develop routine practice
issue/catalyst E-B change plan,
including evaluation

OR

State decision/s B´. Consider use:


re: use of findings, • Informally: Obtain
per strength of evidence: targeted practice
A. Not use = Stop information; evaluate
• Formally: Do formal details
UNIT THREE  Putting It All Together for Evidence-Based Health Care

B. Use now as in B; plan/implement


a pilot "use" project,
B′. Consider use
with evaluation
• Per results, accept and
extend, with or
without modification,
OR
if reject = Stop

Figure 19-8  Stetler Model, part I: Steps of research utilization to facilitate EBP.
Stetler, C. B. (2001). Updating the Stetler Model of Research Utilization to facilitate evidence-based practice. Nursing Outlook, 42(6), 276.
CHAPTER 19  Evidence Synthesis and Strategies for Evidence-Based Practice 495

approved by the agency, a detailed search of the litera- (improved patient, provider, or agency outcomes) are
ture is conducted to determine the strength of the much greater than the risks (complications, morbidity,
evidence available for use in practice. The research mortality, or increased costs) for the organization, the
literature might be reviewed to solve a difficult clini- individual nurse, or both, using the research-based
cal, managerial, or educational problem; to provide intervention in practice is feasible.
the basis for a policy, standard, algorithm, or protocol; Three types of decisions (decision making) are
or to prepare for an in-service program or other type possible during this phase: (1) to use the research
of professional presentation. evidence, (2) to consider using the evidence, and (3)
not to use the research evidence. The decision to use
Phase II: Validation research knowledge in practice is determined mainly
In the validation phase, research reports are critically by the strength of the evidence. Depending on the
appraised to determine their scientific soundness. If research knowledge to be used in practice, the indi-
the studies are limited in number or are weak or both, vidual practitioner, hospital unit, or agency might
the findings and conclusions are considered inade- make this decision. Another decision might be to con-
quate for use in practice, and the process stops. The sider using the available research evidence in practice.
quality of the research evidence is greatly strength- When a change is complex and involves multiple dis-
ened if a systematic review or meta-analysis has been ciplines, the individuals involved often need additional
conducted in the area where you want to make an time to determine how the evidence might be used and
evidence-based change. If the research knowledge what measures will be taken to coordinate the involve-
base is strong in the selected area, a decision must be ment of different health professionals in the change.
made regarding the priority of using the evidence in A final option might be not to make a change in prac-
practice by the clinical agency. tice because of the poor quality of the research evi-
dence, costs, and other potential problems.
Phase III: Comparative Evaluation
and Decision Making Phase IV: Translation and Application
Comparative evaluation includes four parts: (1) sub- The translation and application phase involves
stantiation of the evidence, (2) fit of the evidence with planning for and using the research evidence in prac-
the healthcare setting, (3) feasibility of using research tice. The translation phase involves determining
findings, and (4) concerns with current practice (Figure exactly what knowledge will be used and how that
19-8). Substantiating evidence is produced by replica- knowledge will be applied to practice. The use of the
tion, in which consistent, credible findings are obtained research evidence can be cognitive, instrumental, or
from several studies in similar practice settings. The symbolic. Cognitive application is a more informal
studies generating the strongest research evidence use of the research knowledge to modify one’s way of
are RCTs and meta-analyses of RCTs and quasi- thinking or appreciation of an issue (Stetler, 2001).
experimental studies, which provide extremely strong Cognitive application may improve the nurse’s under-
evidence about the effectiveness of nursing interven- standing of a situation, allow analysis of practice
tions. To determine the fit of the evidence in the clini- dynamics, or improve problem-solving skills for clini-
cal agency, the characteristics of the setting are cal problems. Instrumental and symbolic applications
examined to determine the forces that would facilitate are formal ways to make changes in practice. Instru-
or inhibit the evidence-based change. Stetler (2001) ment application involves using research evidence to
believed the feasibility of using research evidence in support the need for change in nursing interventions
practice involved examining the three R’s related to or practice protocols, algorithms, and guidelines.
making changes in practice: (1) potential risks, (2) Symbolic or political use occurs when information is
resources needed, and (3) readiness of the people used to support or change an agency policy. The appli-
involved. The final comparison involves determining cation phase includes the following steps for planned
whether the research information provides credible, change: (1) assess the situation to be changed, (2)
empirical evidence for making changes in the current develop a plan for change, and (3) implement the plan.
practice. The research evidence needs to document During the application phase, the protocols, policies,
that an intervention increased the quality in current procedures, or algorithms developed with research
practice by solving practice problems and improving knowledge are implemented in practice (Stetler, 2001).
patient outcomes. By conducting phase III, the overall A pilot project on a single hospital unit might be con-
benefits and risks of using the research evidence in ducted to implement the change in practice, and the
a practice setting can be assessed. If the benefits results of this project could be evaluated to determine
496 UNIT THREE  Putting It All Together for Evidence-Based Health Care

if the change should be extended throughout the fairly strong evidence for developing research-based
healthcare agency or corporation. protocols for practice. The strongest evidence is gen-
erated from meta-analyses of several RCTs, system-
Phase V: Evaluation atic reviews that usually include meta-analyses, and
The final stage is to evaluate the effect of the evidence- individual studies. Systematic reviews provide the
based change on selected agency, personnel, or patient best research evidence for developing evidence-based
outcomes. The evaluation process can include both guidelines. The research-based protocols or evidence-
formal and informal activities that are conducted by based guidelines are pilot-tested on a particular unit
administrators, nurse clinicians, and other health pro- and then evaluated to determine the impact on patient
fessionals (see Figure 19-8). Informal evaluations care (see Figure 19-9). If the outcomes are favorable
might include self-monitoring or discussions with from the pilot test, the change is made in practice and
patients, families, peers, and other professionals. monitored over time to determine its impact on the
Formal evaluations can include case studies, audits, agency environment, staff, costs, and the patient and
quality assurance, and outcomes research projects. family (Titler et al., 2001). An agency can promote
The goal of the Stetler model (2001) is to increase the EBP by using the Iowa model to identify triggers for
use of research evidence in nursing to facilitate EBP. change, implement patient care based on the best
This model provides detailed steps to encourage research evidence, and monitor changes in practice to
nurses to become change agents and make the neces- ensure quality care.
sary improvements in practice based on the best
current research evidence.
Implementing Evidence-Based
Iowa Model of Evidence-Based Practice
Nurses are actively involved in conducting research, Guidelines in Practice
synthesizing research evidence, and developing EBP of nursing and medicine has expanded exten-
evidence-based guidelines for practice. Nurses have a sively since the 1990s. Research knowledge is gener-
strong commitment to EBP and can benefit from the ated every day that needs to be critically appraised
direction provided by the Iowa model to expand their and synthesized to determine the best evidence for
research-based practice. The Iowa Model of Evidence- use in practice (Craig & Smyth, 2012; Higgins &
Based Practice provides direction for the develop- Green, 2008; Melnyk & Fineout-Overholt, 2011). This
ment of EBP in a clinical agency. Titler et al. initially section discusses the development of EBP guidelines
developed this EBP model in 1994 and revised it in and provides a model for using these guidelines
2001. In a healthcare agency, triggers initiate the need in practice. Chobanian et al. (2003) conducted an
for change, and the focus should always be to make excellent systematic review to determine the best
changes based on best research evidence. These trig- research evidence available for assessing, diagnosing,
gers can be problem-focused and evolve from risk and managing hypertension. This systematic review,
management data, process improvement data, bench- which included several meta-analyses and integrative
marking data, financial data, and clinical problems reviews, was used to develop the JNC 7 evidence-
(see Figure 19-9). The triggers can also be knowledge- based guideline for hypertension (U.S. Department of
focused, such as new research findings, changes in Health and Human Services, National Institutes of
national agencies or organizational standards and Health, National Heart, Lung, and Blood Institute,
guidelines, an expanded philosophy of care, or ques- 2003). The JNC 7 evidence-based guideline is pre-
tions from the institutional standards committee. The sented later in this chapter. JNC-8 is being developed
triggers are evaluated and prioritized based on the by a national panel of expert researchers and clinicians
needs of the clinical agency. If a trigger is considered with an expected availability to the public for review
an agency priority, a group is formed to search for the and comment by 2012 and publication to follow (see
best evidence to manage the clinical concern (Titler the status of the guideline at http://www.nhlbi.nih.gov/
et al., 2001). guidelines/hypertension/jnc8/index.htm). This section
In some situations, the research evidence is inad- focuses on the development and use of evidence-based
equate to make changes in practice, and additional guidelines in practice.
studies are needed to strengthen the knowledge base.
Sometimes the research evidence can be combined Development of Evidence-Based Guidelines
with other sources of knowledge (theories, scientific Once a significant health topic or condition has
principles, expert opinion, and case reports) to provide been selected, guidelines are developed to promote
CHAPTER 19  Evidence Synthesis and Strategies for Evidence-Based Practice 497

Problem-focused triggers Knowledge-focused triggers


1. Risk management data 1. New research or other literature
2. Process improvement data 2. National agencies or organizational
3. Internal/external benchmarking data standards and guidelines
4. Financial data 3. Philosophies of care
5. Identification of clinical problem 4. Observation from institutional standards committee

Is this topic
a priority
for the
organization?

No Yes

Consider Form a team


other
triggers
Assemble relevant research and related literature

Critique and synthesize research for use in practice

Is there
a sufficient
Yes research No
base?

Pilot the change in practice Base practice on other types of evidence: Conduct
1. Select outcomes to be achieved 1. Case reports research
2. Collect baseline data 2. Expert opinion
3. Design evidence-based 3. Scientific principles
practice (EBP) guideline(s) 4. Theory
4. Implement EBP on pilot units
5. Evaluate process and outcomes
6. Modify the practice guideline

Is change
appropriate for
No adoption in Yes
practice?

Continue to evaluate quality Institute the change in practice


of care and new knowledge

Monitor and analyze structure,


process, and outcome data
• Environment
• Staff
• Cost
• Patient and family

Disseminate results

Figure 19-9  Iowa Model of Evidence-Based Practice to Promote Quality Care.


Titler, M. G., Kleiber, C., Steelman, V. J., Rakel, B. A., Budreau, G., Everett, L. Q., et al. (2001). The Iowa Model of Evidence-Based Practice to promote
quality care. Critical Care Nursing Clinics of North America, 13(4), 500.
498 UNIT THREE  Putting It All Together for Evidence-Based Health Care

effective management of this health condition. Since Internet access to guidelines is available at http://
the 1980s, the Agency for Healthcare Research and www.guideline.gov. The NGC is updated weekly with
Quality (AHRQ) has had a major role in identifying new content that the AHRQ produces in partnership
health topics and developing evidence-based guide- with the American Medical Association and the Amer-
lines for these topics (http://www.ahrq.gov). In the late ican Association of Health Plans (now America’s
1980s and early 1990s, a panel or team of experts was Health Insurance Plans). The key components of the
often charged with developing guidelines for the NGC and its user-friendly resources can be found
AHRQ. The AHRQ solicited the members of the on the AHRQ website at http://www.guideline.gov/
panel, who usually included nationally recognized index.aspx. Some of the critical information on the
researchers in the topic area; expert clinicians, such as NGC is provided here to show you what is available
physicians, nurses, pharmacists, and social workers; and how to access the NGC resources:
healthcare administrators; policy developers; econo-
mists; government representatives; and consumers. • “Structured abstracts (summaries) about the
The group designated the scope of the guidelines and guideline and its development.
conducted extensive reviews of the literature includ- • Links to full-text guidelines, where available, and/
ing relevant systematic reviews, meta-analyses, quali- or ordering information for print copies.
tative research syntheses, mixed-methods systematic • Downloads of the Complete NGC Summary for
reviews, individual studies, and theories. all guidelines represented in the database.
The best research evidence available was synthe- • A Guideline Comparison utility that gives users
sized to develop recommendations for practice. Most the ability to generate side-by-side comparisons
of the evidence-based guidelines included systematic for any combination of two or more guidelines.
reviews, meta-analyses, and multiple individual • Unique guideline comparisons called Guideline
studies. The guidelines were examined for their use- Syntheses prepared by NGC staff, compare
fulness in clinical practice, their impact on health guidelines covering similar topics, highlighting
policy, and their cost-effectiveness. Consultants, other areas of similarity and difference. NGC Guideline
researchers, and additional expert clinicians often Syntheses often provide a comparison of
were asked to review the guidelines and provide input. guidelines developed in different countries,
Based on the experts’ critique, the AHRQ revised and providing insight into commonalities and
packaged the guidelines for distribution to healthcare differences in international health practices.
professionals. Some of the first guidelines focused on • An electronic forum, NGC-L for exchanging
the following healthcare problems: (1) acute pain information on clinical practice guidelines, their
management in infants, children, and adolescents; (2) development, implementation, and use.
prediction and prevention of pressure ulcers in adults; • An Annotated Bibliography database where users
(3) urinary incontinence in adults; (4) management of can search for citations for publications and
functional impairments with cataracts; (5) detection, resources about guidelines, including guideline
diagnosis, and treatment of depression; (6) screening, development and methodology, structure,
diagnosis, management, and counseling about sickle evaluation, and implementation.
cell disease; (7) management of cancer pain; (8) diag- Other features include the following:
nosis and treatment of heart failure; (9) low back prob- • What’s New enables users to see what guidelines
lems; and (10) otitis media diagnosis and management have been added each week and includes an
in children. index of all guidelines in NGC.
At the present time, standardized guideline devel- • NGC Update Service is a weekly electronic
opment ranges from a structured process such as the mailing of new and updated guidelines posted to
one just discussed to a less structured process in which the NGC Web site.
a guideline might be developed by a healthcare orga- • Detailed Search enables users to create very
nization, healthcare plan, or professional organization. specific search queries based on the various
The AHRQ initiated the National Guideline Clearing- attributes found in the NGC Classification
house (NGC, 2012b) in 1998 to store the evidence- Scheme.
based practice guidelines. Initially, the NGC had 200 • NGC Browse permits users to scan for guidelines
guidelines, but now the collection has expanded to available on the NGC site by disease/condition,
thousands of clinical practice guidelines. The NGC is treatment/intervention, or developing
a publicly available database of evidence-based clini- organization.
cal practice guidelines and related documents. Free
CHAPTER 19  Evidence Synthesis and Strategies for Evidence-Based Practice 499

• Full-text guidelines and/or companion documents • Academic Center for Evidence-Based Nursing:
available through the guideline developer that can http://www.acestar.uthscsa.edu
be downloaded. • Association of Women’s Health, Obstetric, and
• Glossary provides definitions of terms used in Neonatal Nurses: http://awhonn.org
the standardized abstracts (summaries).” (NGC, • Centers for Health Evidence.net: http://www
2012a, http://www.guideline.gov/browse/ .cche.net
by-topic.aspx) • CMA InfoBase: http://mdm.ca/cpgsnew/cpgs/
index.asp
• Guidelines Advisory Committee: http://www
Criteria for submitting clinical practice guidelines .gacguidelines.ca
and the application process are provided online. Fol- • Guidelines International Network: http://
lowing are the criteria that an evidence-based guide- www.g-i-n.net/
line must meet to be submitted to the NGC: • HerbMed: Evidence-Based Herbal Database,
1998, Alternative Medicine Foundation: http://
www.herbmed.org/
• “The guideline must contain systematically • MD Consult: http://www.mdconsult.com/php/
developed recommendations, strategies, or other 286943359-1063/homepage
information to assist healthcare decision-making • National Association of Neonatal Nurses: http://
in specific clinical circumstances. www.nann.org/
• The guideline must have been produced under • National Institute for Clinical Excellence (NICE):
the auspices of a relevant professional http://www.nice.org.uk/catcg2.asp?c=20034
organization (e.g., medical specialty society, • Oncology Nursing Society: http://www.ons.org/
government agency, healthcare organization, or • PIER—the Physicians’ Information and Education
health plan). Resource (authoritative, evidence-based guidance
• The guideline development process must have to improve clinical care; ACP-ASIM members
included a verifiable, systematic literature search only): http://pier.acponline.org/index.html
and review of existing evidence published in • Primary Care Clinical Practice Guidelines: http://
peer-reviewed journals. www.medscape.com/pages/editorial/public/pguide
• The guideline must be current and the most lines/index-primarycare
recent version (i.e., developed, reviewed, or • U.S. Preventive Services Task Force: http://www
revised within the last 5 years).” (NGC, 2012b, .uspreventiveservicestaskforce.org/about.htm
http://www.guideline.gov/)
Implementing the Joint National Committee
The NGC provides varied audiences with an easy- on Prevention, Detection, Evaluation,
to-use mechanism for obtaining objective, detailed and Treatment of High Blood Pressure
information on clinical practice guidelines. In addi- Evidence-Based Guideline in Practice
tion, the NGC (2012a) provides a list of the guidelines Evidence-based guidelines have become the standards
that are in the process of being developed (http:// for providing care to patients in the United States and
www.guideline.gov/browse/by-topic.aspx). other nations. A few nurses have participated in com-
In addition to the evidence-based guidelines, the mittees that have developed these evidence-based
AHRQ has developed many tools to assess the quality guidelines, and many APNs are using these guidelines
of care that is provided by the evidence-based guide- in their practices. An evidence-based guideline for the
lines. You can search the AHRQ (2012a, 2012c) assessment, diagnosis, and management of high blood
website (http://www.qualitymeasures.ahrq.gov/) for pressure is provided as an example. This guideline
an appropriate tool to measure a variable in a research was developed from JNC 7 and was published in the
project or to evaluate outcomes of care in a clinical Journal of the American Medical Association (Choba-
agency. nian et al., 2003). The NIH Department of Health and
Numerous professional organizations, healthcare Human Services National Heart, Lung, and Blood
agencies, universities, and other groups provide Institute developed educational materials to commu-
evidence-based guidelines for practice. Websites are nicate the specifics of this guideline to promote its use
as follows: by healthcare providers. This guideline is presented in
500 UNIT THREE  Putting It All Together for Evidence-Based Health Care

EVALUATION TREATMENT
Classification of blood pressure (BP)* Principles of hypertension treatment
Category SBP mm Hg DBP mm Hg • Treat to BP <140/90 mmHg or BP <130/80 mm Hg
Normal <120 and <80 in patients with diabetes or chronic kidney disease.
• Majority of patients will require two medications
Prehypertension 120–139 or 80–89
to reach goal.
Hypertension, Stage 1 140–159 or 90–99
Hypertension, Stage 2 ≥160 or ≥100 Algorithm for treatment of hypertension
*See Blood Pressure Measurement Techniques (reverse side)
Key: SBP = systolic blood pressure Lifestyle modifications
DBP = diastolic blood pressure
Diagnostic workup of hypertension Not at goal blood pressure (<140/90 mm Hg)
• Assess risk factors and comorbidities. (<130/80 mm Hg for patients with diabetes
• Reveal identifiable causes of hypertension. or chronic kidney disease)
• Assess presence of target organ damage. See Strategies for Improving Adherence to Therapy
• Conduct history and physical examination.
• Obtain laboratory tests: urinalysis, blood glucose, hematocrit.
and lipid panel, serum potassium, creatinine, and calcium. Initial drug choices
Optional: urinary albumin/creatinine ratio.
• Obtain electrocardiogram.
Assess for major cardiovascular disease (CVD) Without compelling With compelling
risk factors indications indications
• Hypertension • Physical inactivity
• Obesity • Microalbuminuria, estimated
(body mass index ≥30 kg/m )
2 glomerular filtration rate <60 mL/min Stage 1 Stage 2 Drug(s) for the
• Dyslipidemia • Age (>55 for men, >65 for women) hypertension hypertension compelling
• Diabetes mellitus • Family history of premature CVD (SBP 140–159 or (SBP ≥160 or indications
(men age <55, women age <65) DBP 90–99 mm Hg) See Compelling
• Cigarette smoking DBP ≥100 mm Hg) Indications for
Thiazide-type diuretics 2-drug combination Individual Drug Classes
Assess for identifiable causes of hypertension for most. May consider for most (usually Other
ACEI, ARB, BB, CCB, thiazide-type diuretic antihypertensive
• Sleep apnea • Cushing’s syndrome or or combination. and ACEI, or ARB, drugs (diuretics, ACEI,
• Drug induced/related steroid therapy
or BB, or CCB). ARB, BB, CCB)
• Chronic kidney disease • Pheochromocytoma
• Primary aldosteronism • Coarctation of aorta as needed.
• Renovascular disease • Thyroid/parathyroid disease

Not at goal blood pressure

Optimize dosages or add additional drugs until goal


blood pressure is achieved. Consider consultation with
hypertension specialist.
See Strategies for Improving Adherence to Therapy

Figure 19-10  Reference card from the seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High
Blood Pressure (JNC 7). U.S. Department of Health and Human Services, National Institutes of Health, National Heart, Lung, and Blood Institute.
(2003). Reference card from the Seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood
Pressure (JNC 7). Bethesda, MD: NIH Publication No. 03-5231. Retrieved from www.nhlbi.nih.gov/guidelines/hypertension/jnc7card.htm.

Figure 19-10 and provides clinicians with direction for implement it in their practice. Figure 19-11 presents
the following: (1) classification of blood pressure as the Grove Model for Implementing Evidence-Based
normal, prehypertension, hypertension stage 1, and Guidelines in Practice. In this model, nurses identify
hypertension stage 2; (2) conduct a diagnostic workup a practice problem, search for the best research evi-
of hypertension; (3) assessment of the major cardio- dence to manage the problem in their practice, and
vascular disease risk factors; (4) assessment of the note that an evidence-based guideline has been devel-
identification of causes of hypertension; and (5) treat- oped. The quality and usefulness of the guideline must
ment of hypertension. An algorithm provides direction be assessed by the healthcare provider before it is used
for the selection of the most appropriate treatment in practice, and that involves examining the following:
methods for each patient diagnosed with hypertension (1) the authors of the guideline, (2) the significance of
(U.S. Department of Health and Human Services, the healthcare problem, (3) the strength of the research
National Institutes of Health, National Heart, Lung, evidence, (4) the link to national standards, and (5) the
and Blood Institute, 2003). cost-effectiveness of using the guideline in practice.
APNs and RNs need to assess the usefulness and The quality of the JNC 7 guideline is examined as an
quality of each evidence-based guideline before they example using the four criteria identified in the Grove
CHAPTER 19  Evidence Synthesis and Strategies for Evidence-Based Practice 501

Practice problem

Search for best evidence yields evidence-based guideline

Quality of evidence-based guideline

Authors of guidelines Significance of Strength of Link to national Cost


healthcare problem research evidence standards effectiveness
analysis

Integration of evidence-based guideline with clinical expertise

Use of evidence-based guideline in practice by


Patient, provider, healthcare agency

Monitor outcomes from use of evidence-based guideline by


Patient, provider, healthcare agency

Refinement of evidence-based guideline

Evidence-based practice

Figure 19-11  Grove Model for Implementing Evidence-Based Guidelines in Practice.

model (see Figure 19-11). The authors of the JNC 7


guideline were expert researchers, clinicians (physi- 35 million office visits as the primary diagnosis.…
cians), policy developers, healthcare administrators, Recent clinical trials have demonstrated that effective
and the National High Blood Pressure Education BP [blood pressure] control can be achieved in most
Program Coordinating Committee. These authors have patients with hypertension, but the majority will
the expertise to develop an evidence-based guideline require 2 or more antihypertensive drugs.” (Choba-
for the significant health problem of hypertension. nian et al., 2003, p. 2562)

“Hypertension is a significant healthcare problem The research evidence for the development of the
because it affects approximately 50 million individuals JNC 7 guideline was extremely strong. The JNC 7
in the United States and approximately 1 billion indi- report included 81 references; 9 (11%) of the refer-
viduals worldwide.… Hypertension is the most ences were meta-analyses, and 35 (43%) were RCTs
common primary diagnosis in the United States with (experimental studies); 44 (54%) sources are consid-
ered extremely strong research evidence. The other
502 UNIT THREE  Putting It All Together for Evidence-Based Health Care

references were strong and included retrospective


analyses or case-controlled studies, prospective or organization and delivery issues—specifically those
cohort studies, cross-sectional surveys or prevalence that are common, expensive, and/or significant for
studies, and clinical intervention studies (nonrandom) the Medicare and Medicaid populations. With this
(Chobanian et al., 2003). The JNC 7 provides the program, AHRQ became a ‘science partner’ with
national standard for the assessment, diagnosis, and private and public organizations in their efforts to
treatment of hypertension. The recommendations improve the quality, effectiveness, and appropriate-
from the JNC 7 are supported by the Department of ness of health care by synthesizing the evidence and
Health and Human Services and disseminated through facilitating the translation of evidence-based research
NIH publication no. 03-5231. Use of the JNC 7 guide- findings. Topics are nominated by non-federal part-
line in practice is cost-effective because the clinical ners such as professional societies, health plans, insur-
trials have shown that “antihypertensive therapy has ers, employers, and patient groups.” (AHRQ, 2012b,
been associated with 35% to 40% mean reductions in http://www.ahrq.gov/clinic/epc/)
stroke incidence; 20% to 25% in myocardial infarction
[MI]; and more than 50% in HF [heart failure]” (Cho-
banian et al., 2003, p. 2562). Under the EPC Program, the AHRQ awards 5-year
The next step is for APNs and physicians to use the contracts to institutions to serve as EPCs. EPCs review
JNC 7 guideline in their practice (see Figure 19-11). all relevant scientific literature on clinical, behavioral,
Healthcare providers can assess the adequacy of the organizational, and financial topics to produce evi-
guideline for their practice and modify the hyperten- dence reports and technology assessments. These
sion treatments based on the individual health needs reports are used to inform and develop coverage deci-
and values of their patients. The outcomes for the sions, quality measures, educational materials, tools,
patient, provider, and healthcare agency need to be guidelines, and research agendas. The EPCs also
examined. The outcomes would be recorded in the conduct research on methodology of systematic
patients’ charts and possibly in a database owing to reviews. The AHRQ developed the following criteria
the electronic medical records and would include the as the basis for selecting a topic to be managed by an
following: (1) blood pressure readings for patients; (2) EPC:
incidence of diagnosis of hypertension based on the
JNC 7 guidelines; (3) appropriateness of the treat-
ments implemented to manage hypertension; and (4) • “High incidence or prevalence in the general
incidence of stroke, MI, and HF over 5, 10, 15, and population and in special populations, including
20 years. The healthcare agency outcomes include the women, racial and ethnic minorities, pediatric
access to care by patients with hypertension, patient and elderly populations, and those of low
satisfaction with care, and the cost related to diagnosis socioeconomic status.
and treatment of hypertension and the complications • Significance for the needs of the Medicare,
of stroke, MI, and HF. This EBP guideline will be Medicaid, and other Federal health programs.
refined in the future based on clinical outcomes, • High costs associated with a condition,
outcome studies, and new controlled clinical trials (see procedure, treatment, or technology, whether
previous discussion of JNC 8). The use of this due to the number of people needing care, high
evidence-based guideline and additional guidelines unit cost of care, or high indirect costs.
promote an EBP for APNs (see Figure 19-10). • Controversy or uncertainty about the
effectiveness or relative effectiveness of available
clinical strategies or technologies.
Evidence-Based Practice Centers • Impact potential for informing and improving
In 1997, the AHRQ launched its initiative to promote patient or provider decision making.
EBP by establishing 12 evidence-based practice • Impact potential for reducing clinically significant
centers (EPCs) in the United States and Canada. variations in the prevention, diagnosis, treatment,
or management of a disease or condition; in the
use of a procedure or technology; or in the
“[The EPCs develop evidence reports and technology health outcomes achieved.
assessments on] topics relevant to clinical, social • Availability of scientific data to support the
science/behavioral, economic, and other health care systematic review and analysis of the topic.
CHAPTER 19  Evidence Synthesis and Strategies for Evidence-Based Practice 503

Consortium in October 2006. The consortium started


• Submission of the nominating organization’s plan with 12 centers located throughout the United States
to incorporate the report into its managerial or and expanded to 39 centers in April 2009. The program
policy decision making, as defined above. is projected to be fully implemented in 2012 with
• Submission of the nominating organization’s plan about 60 institutions involved in clinical and transla-
to disseminate derivative products to its tional science. A website has been developed to
members and plan to measure members’ use of enhance communication and encourage sharing of
these products, and the resultant impact of such information related to translational research projects
use on clinical practice.” (AHRQ, 2012b) at http://www.ctsaweb.org/.
The CTSA Consortium is mainly focused on
expanding the translation of medical research to prac-
tice. Titler (2004, p. S1) defined transitional research
The AHRQ (2012b) website (http://www.ahrq.gov/ for the nursing profession as the: “Scientific investiga-
clinic/epc) provides the names of the EPCs and the tion of methods, interventions, and variables that
focus of each center. This site also provides a link to influence adoption of evidence-based practices (EBPs)
the evidence-based reports produced by these centers. by individuals and organizations to improve clinical
These EPCs have had an important role in the devel- and operational decision making in health care. This
opment of evidence-based guidelines since the 1990s includes testing the effect of interventions on promot-
and will continue to make significant contributions to ing and sustaining the adoption of EBPs.” Baumbusch
EBP in the future. They are also involved in the devel- et al. (2008) developed a collaborative model for
opment of measurement tools to examine the out- knowledge translation between research and practice
comes from EBP. in clinical settings. As you search the literature for
relevant research syntheses and studies, you will note
that translation studies are being published in nursing.
Introduction to Whittemore, Melkus, Wagner, Dziura, Northrup, and
Grey (2009) conducted a translation study to promote
Translational Research the transfer of a Diabetic Prevention Program to
Some of the barriers to EBP have resulted in the primary care. These types of studies will assist you in
development of a new type of research to improve the translating research findings to your practice and
translation of research knowledge to practice. This determining the impact of EBP on patients’ health.
new research methodology is called transitional However, national funding is needed to expand the
research and is being supported by the NIH (2012). conduct of transitional research in nursing.
Translational research is an evolving concept that We hope that the content in this chapter increases
is defined by the NIH as the translation of basic sci- your understanding of EBP, the conduct of research
entific discoveries into practical applications. Basic syntheses, the application of EBP models, and the
research discoveries from the laboratory setting need implementation of EBP guidelines. We encourage you
to be tested in studies with humans. In addition, the to take an active role in moving nursing toward EBP
outcomes from human clinical trials need to be that improves outcomes for patients, healthcare pro-
adopted and maintained in clinical practice. Transla- fessionals, and healthcare agencies.
tional research is being encouraged by both medicine
and nursing to increase the implementation of
evidence-based interventions in practice and to deter- KEY POINTS
mine if these interventions are effective in producing
the outcomes desired in clinical practice (Chesla, • Evidence-based practice (EBP) is the conscientious
2008; NIH, 2012). Translational research was origi- integration of best research evidence with clinical
nally part of the National Center for Research expertise and patient values and needs in the deliv-
Resources. However, in December 2011, the National ery of quality, cost-effective health care. Best
Center for Advancing Translation Sciences (NCATS) research evidence is produced by the conduct and
was developed as part of the NIH Institutes and synthesis of numerous, high-quality studies in a
Centers (NIH, 2012). health-related area.
The NIH wanted to encourage researchers to • There are benefits and barriers associated with
conduct translational research and developed the Clin- EBP. The benefits of EBP are that the standards for
ical and Translational Science Awards (CTSA) hospital accreditation by the Joint Commission
504 UNIT THREE  Putting It All Together for Evidence-Based Health Care

support EBP as does the Magnet Hospital Program® guidelines and the steps for using these guidelines
managed by the American Nurses’ Credentialing in practice.
Center. • An excellent source for evidence-based guidelines
• Guidelines are provided for conducting the research is the National Guideline Clearinghouse (NGC)
synthesis processes of systematic review, meta- that was initiated by the AHRQ in 1998.
analysis, meta-synthesis, and mixed-methods sys- • Evidence-based practice centers (EPCs), created by
tematic review. These synthesis processes are used the AHRQ in 1997, have had an important role in
to determine the best research evidence in a selected the conduct of research, development of systematic
area and the quality of the research evidence avail- reviews, and formulation of evidence-based guide-
able for practice. lines in selected practice areas.
• A systematic review is a structured, comprehensive • Translational research is an evolving concept that
synthesis of the research literature to determine the is defined by the NIH as the translation of basic
best research evidence available to address a scientific discoveries into practical applications.
healthcare question. A systematic review involves
identifying, locating, appraising, and synthesizing
quality research evidence for expert clinicians to REFERENCES
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levels of evidence about the effectiveness of an to improve quality and effectiveness in health care. Retrieved from
intervention. http://www.ahrq.gov/clinic/epc/.
• Meta-synthesis is defined as the systematic compil- Agency for Healthcare Research and Quality (AHRQ). (2012c).
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A., & Nolan, M. (2011). Factors influencing the contribution of and_translational_science_awards/index.asp.
advanced practice nurses to promoting evidence-based practice Noordzij, M., Hooft, L., Dekker, F. W., Zoccali, C., & Jager, K. J.
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506 UNIT THREE  Putting It All Together for Evidence-Based Health Care

Sackett, D. L., Straus, S. E., Richardson, W. S., Rosenberg, W., & Titler, M. G., Kleiber, C., Steelman, V. J., Rakel, B. A., Budreau,
Haynes, R. B. (2000). Evidence-based medicine: How to practice G., Everett, L. Q., et al. (2001). The Iowa Model of Evidence-
& teach EBM (2nd ed.). London, UK: Churchill Livingstone. Based Practice to promote quality care. Critical Care Nursing
Sandelowski, M., & Barroso, J. (2007). Handbook for synthesizing Clinics of North America, 13(4), 497–509.
qualitative research. New York, NY: Springer. Turlik, M. (2010). Evaluating the results of a systematic review/
Shojania, K. G., Sampson, M., Ansari, M. T., Ji, J., Doucette, S., & meta-analysis. Podiatry Management. Retrieved from www
Moher, D. (2007). How quickly do systematic reviews go out of .podiatrym.com.
date? Survival analysis. Annals of Internal Medicine, 147(4), U.S. Department of Health and Human Services, National Institutes
224–234. of Health, National Heart, Lung, and Blood Institute. (2003).
Stetler, C. B. (1994). Refinement of the Stetler/Marram model for Reference card from the Seventh report of the Joint National Com-
application of research findings to practice. Nursing Outlook, mittee on Prevention, Detection, Evaluation, and Treatment of
42(1), 15–25. High Blood Pressure (JNC 7). Bethesda, MD: NIH Publication
Stetler, C. B. (2001). Updating the Stetler Model of Research Uti- No. 03-5231. Retrieved from www.nhlbi.nih.gov/guidelines/
lization to facilitate evidence-based practice. Nursing Outlook, hypertension/jnc7card.htm.
49(6), 272–279. Walsh, D., & Downe, S. (2005). Meta-synthesis method for qualita-
Stetler, C. B., & Marram, G. (1976). Evaluating research findings tive research: A literature review. Journal of Advanced Nursing,
for applicability in practice. Nursing Outlook, 24(9), 559–563. 50(2), 204–211.
The Joint Commission. (2012). About our standards. Retrieved Whittemore, R., Melkus, G., Wagner, J., Dziura, J., Northrup, V., &
from http://www.jointcommission.org/standards_information/ Grey, M. (2009). Translating the diabetes prevention program to
standards.aspx. primary care: A pilot study. Nursing Research, 58(1), 2–12.
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UNIT FOUR
Analyzing Data, Determining Outcomes, and Disseminating Research
20
CHAPTER

Collecting and Managing Data


http://evolve.elsevier.com/Grove/practice/

D
ata collection is one of the most exciting parts
of research. After all the planning, writing, and Data Collection Modes
negotiating, you should be eager and well pre- Data can be collected by interview (face-to-face
pared for this active part of research. The passion that or telephone); observations; focus groups; self-
comes from wanting to know the answer to your administered questionnaires (online or hard copy); or
research question brings a sense of excitement and extraction from existing documents such as patient
eagerness to start collecting your data. However, medical records, motor vehicle department accident
before you leap into data collection, you need to spend records, or state birth records (Figure 20-1). Many
some time carefully planning this adventure and pilot factors need to be considered when a researcher is
test each step. Planning data collection begins with deciding on the mode for collecting data. Harwood
identifying all the data to be collected. The data to be and Hutchinson (2009) describe four factors that need
collected are determined by the research questions, to be part of your decision-making process: (1) purpose
objectives, or hypotheses of the proposed study. As and complexity of the study, (2) availability of finan-
you develop the data collection plan, be sure that you cial and physical resources, (3) characteristics of study
gather all the data needed to answer the research ques- participants and how best to gain access to them from
tions, achieve the study objectives, or test the hypoth- the population, and (4) your skills and preferences as
eses. Chapter 16 includes detailed information about a researcher.
measurement, so the focus in this chapter is on the
logistical and pragmatic aspects of quantitative data Researcher-Administered or Participant-
collection. Data collection strategies for qualitative Administered Instruments
studies are described in Chapter 12. If you need a subject’s accurate blood pressure or
To start planning the data collection process, you height and weight, a self-report measure may be
need to determine the best mode by which the data can neither valid nor reliable for the purpose of your study.
be collected. Factors that influence the plan to collect However, if the purpose of your study can be accom-
and enter data into a database for analysis include cost, plished with a self-report survey method, you must
time, the availability of assistance, and the need for decide whether the format will be researcher-
consistency. The development of the data collection administered or self-administered. It may be best for
plan is followed by developing data collection forms the researcher to administer self-report paper-and-
and a codebook for data entry. Conducting a pilot test pencil instruments if the potential subjects have
with a small group of subjects is the next recommended minimal language or literacy ability, whereas it may
step. The pilot test may result in modifications of the be best to consider electronic data collection or
plan, and then the actual data collection can begin. medical record extraction if the subjects are likely to
During data collection, various problems may arise. have hearing impairments, transportation problems, or
Potential situations are described in this chapter along physical difficulties.
with problem-solving strategies. The chapter concludes If the researcher is administering the survey, will it
with the discussion of data entry and management. be in person or by telephone? If self-administered, will

507
508 UNIT FOUR  Analyzing Data, Determining Outcomes, and Disseminating Research

Researcher Participant
Administered Administered

Healthcare Self-Report
Equipment Survey

Self-Report Web-Based
Survey Survey

Extract from
Existing Records Interview
and databases Electronic
Diary
Device

Figure 20-1  Data collection modes.

the participant complete a pencil-and-paper copy or an page for each potential response. To maintain the
online electronic copy? Internet survey centers spe- precise location of each response on print copies of
cialize in this mode of data collection and have expert these instruments, careful attention must be given to
help or tutorials for assessing the best mode for your printing or copying these forms. The complete form is
study purpose. For example, in deciding on a tele- scanned, and the answers (data) are automatically
phone survey, how many times will you try to reach a recorded in a database. Additional features include
potential subject before you give up, what days of the data accuracy verification, selective data extraction
week or hours of the day will you call and how might and analysis, auditing and tracking, and flexible export
that bias your sample or their responses, and how will interfaces. Figure 20-2 shows the scannable version of
you accurately determine the response rate (Harwood, the Parents and Newborn Screening Survey developed
2009)? If you decide on a mailed paper-and-pencil by Patricia Newcomb, PhD, RN, CPNP, and Barbara
survey, what will you do with undelivered or incom- True, MSN, CNS. Subjects completing the survey fill
plete returns? Will you search for correct mailing in the circle that corresponds to the appropriate option
addresses and try again? Will you send a reminder if for each question.
the survey is not received within a particular time
frame, and, if so, what time frame will you give a Online Data Collection
respondent, and how many reminders will you send Computer software packages developed by a variety
(Harwood, 2009)? of companies (e.g., Zoomerang and SurveyMonkey)
enable researchers to provide an online copy of instru-
Electronic Data Collection ments and other data collection forms. These types of
When you are using an existing instrument, you may software programs have unique features that allow the
oasis-ebl|Rsalles|1476321157

need permission to convert the questions into an researcher to develop point-and-click automated forms
online format, a special type of form that allows the that can be distributed electronically. The following
data to be scanned into a database, or into an applica- questions need to be considered with use of these
tion for a phone or other electronic device. Each of programs. For an online survey, is it a secure site for
these modes of data collection may require special the purposes of confidentiality and anonymity? How
hardware and software. Universities, schools of will you ensure that only eligible participants com-
nursing, and funded researchers are purchasing these plete the survey? Will potential subjects receive a per-
sometimes expensive products because the costs of sonalized email from you with a link to a website?
acquiring the hardware and software are considerably How will you obtain the email addresses? Can you
less than the costs of entering data manually. offer help if the subjects have any questions about
your study?
Scannable Forms Online services can be easy to use for both the
Other software allows the preparation of special data researcher and study participants but may be costly
collection forms that rely on optical character recogni- and require specific assurances about confidentiality
tion (OCR), which requires exact placement on the Text continued on p. 513
CHAPTER 20  Collecting and Managing Data 509

ID
1 0 6 1

Parents and Newborn Screening Survey


The University of Texas at Arlington College of Nursing
Andrews Women’s Hospital

Instructions: Please use a BLACK PEN for Please shade circles like this:
completing the survey. Do not use pencil. Not like this:

1. My age is:

Less than 18 18-24 25-30 31-35 36+

2. My race/ethnic group is:

African-American Asian Caucasian Hispanic Other

3. My highest level of education is:

Less than high school High school diploma Some college Bachelor’s degree Master’s degree or more

4. I work in the healthcare field:

Yes No

5. I started pregnancy care:


In the first 3 months of my pregnancy
In the second 3 months of my pregnancy
In the last 3 months of my pregnancy
I did not get medical care during my pregnancy

6. My care for this pregnancy and birth was paid for by:
Medicaid
Private insurance
I paid for it by myself
I don’t know how it will be paid for

7. I learned about newborn screening from (may circle more than one):
I never heard of newborn screening before this
My doctor or midwife
My child’s doctor or nurse practitioner
A book, video, or brochure
My hospital nurse
My doctor’s nurse
Internet
Friend or family member
Other

109
Parents and Newborn Screening Survey
08/22/2011 Please Turn Over
Page 1 0534001092

Figure 20-2  Scannable form: Parents and Newborn Screening Survey. (Developed by Patricia Newcomb, PhD, RN, CPNPN, and Barbara True, MSN,
CNS; Teleform designed by Denise Cauble and Whitney Mildren, Graduate Research Assistants and PhD students, College of Nursing, The University of
Texas at Arlington.) Continued
510 UNIT FOUR  Analyzing Data, Determining Outcomes, and Disseminating Research

ID

Instructions: Please use a BLACK PEN for Please shade circles like this:
completing the survey. Do not use pencil. Not like this:

8. I have other children.


Yes No
9. I learned about newborn screening before this baby was born.
Yes No
10. The language I speak most of the time is:
English Spanish Other__________

Please put a check in the box that shows how much you agree or disagree with the statement.

Strongly Agree Agree Not sure Disagree Strongly Disagree

11. I understand what I need to know about


newborn screening.

12. I know when my baby should have another


newborn screening.

13. If my baby has a disease that shows up on


newborn screening, serious problems can be
prevented if my baby gets treatment right away.

14. I will get the results of the newborn screening


tests by mail.

15. My baby’s doctor will get the results of the


newborn screening tests by mail.

16. Doing the newborn screening is worth the


discomfort the baby feels.

17. I know what genetic testing is.

18. I know where to take my baby for the second


newborn screening test.

19. Newborn screening can identify babies with


certain serious inherited diseases.

20. I understand what DNA does.

21. If my baby’s newborn test is abnormal, my


baby’s father might have something wrong with his
DNA.

109
Parents and Newborn Screening Survey
08/22/2011 Please Go To Next Page
Page 2 8572001092

Figure 20-2, cont’d


CHAPTER 20  Collecting and Managing Data 511

ID

Instructions: Please use a BLACK PEN for


completing the survey. Do not use pencil.

Strongly Agree Agree Not sure Disagree Strongly Disagree

22. All babies should have genetic testing when


they are born.

23. If my baby’s newborn test is abnormal, I might


have something wrong in my DNA.

24. Newborn screening will test for some, but not


all, serious diseases that run in families.

25. Babies with serious disorders may look healthy


when they are born.

26. I am scared that the newborn test might find


something wrong with my baby.

27. I know what newborn screening bloodspots


are.

28. The state of Texas will keep my baby’s


bloodspots unless I mail them a form telling them
not to.

29. I wish I had more information about newborn


screening.

30. Some of the tests in the newborn screening are


genetic tests.

31. There is DNA in my baby’s blood spots.

32. It would be OK to use my baby’s bloodspots for


research to find treatments for serious diseases.

33. It is OK for the state to keep my baby’s


bloodspots for research without getting special
permission from me.

34. It would be OK to keep my baby’s DNA for


future study if my baby’s name or other private
information is not connected to the DNA sample.

109
Parents and Newborn Screening Survey
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Page 3 6735001091

Figure 20-2, cont’d Continued


512 UNIT FOUR  Analyzing Data, Determining Outcomes, and Disseminating Research

ID

Instructions: Please use a BLACK PEN for Please shade circles like this:
completing the survey. Do not use pencil. Not like this:

35.It would be OK with me for the state to share


my baby’s bloodspots with researchers all over the
nation.

36. It would be OK to let the state share my baby’s


bloodspots with researchers if an ethics committee
reviews the research first.

37. If future research is done on my baby’s


bloodspots I want to know.

38. I do not want the state or any other group to


keep the bloodspots from my baby’s testing for any
reason.

39. I want my baby to have newborn screening.

40. My baby will have another newborn screening,


but I do not really want it.

This is the End. Thank you!


Please share any comments that would help us improve the newborn screening process:

If you would like to learn more about newborn screening, please pick up some of our
information about newborn screening at the desk or from your nurse when you leave today.

109
Parents and Newborn Screening Survey
08/22/2011
Page 4 5991001094

Figure 20-2, cont’d


CHAPTER 20  Collecting and Managing Data 513

of data and anonymity of subjects. The National


Institutes of Health (NIH) supports a secure Internet Internet but were interested in participating in the
environment for building online data surveys and study. Among the 276 participants who were recruited
data management packages (Harris et al., 2009). This through community settings, 246 … used the pen-
service, developed by experts at Vanderbilt University, and-pencil questionnaires. … There were no statisti-
is called REDCap (Research Electronic Data Capture) cally significant differences in psychometric properties
and may be available at your university research site between the Internet format and the pen-and-pencil
(http://project-redcap.org/). format of the questionnaire. … It took an average of
Im et al. (2007) conducted a survey in the United 30-40 minutes for the participants to complete either
States of gender and ethnic differences in the experi- the Internet format or the pen-and-pencil format of
ence of cancer pain. These researchers administered the questionnaire.” (Im et al., 2007, pp. 299-300)
their questionnaire over the Internet and through a
paper-and-pencil format based on subject preference.
The following excerpt describes the data collection Im et al. (2007) maximized their sample size and
procedure for their study: obtained a more representative sample by giving par-
ticipants an option to complete their questionnaire on
the Internet or using paper-and-pencil format. The
“To administer the Internet questionnaire, a Web site researchers took steps to ensure that the data collected
conforming to the Health Insurance Portability and by the two formats were comparable by testing for
Accountability Act standards, the System Administra- significant differences and finding none. The time to
tion, Networking, and Security Institute Federal complete the Internet and paper-and-pencil question-
Bureaus of Investigation recommendations, and the naires did not vary. Im et al. (2007) also ensured that
Institutional Review Board [IRB] policy of the institu- an ethical study was conducted and subjects’ rights
tion where the researchers were affiliated was devel- were protected.
oped and published on an independent, dedicated The additional advantage of Internet data collection
Web site server. When potential participants visited is that responses can be time/date stamped. For
the project Web site, informed consent was obtained example, if subjects are instructed to complete the
by asking them to click a button labeled I agree to questionnaire before bedtime, the time can be verified.
participate. After this, questions on specific diagnoses, If subjects are instructed to complete a daily diary, date
cancer therapies, and medications were asked, and of entry would be documented, and subjects would be
the appropriateness of answers was checked auto- discouraged from entering all diary days on the last
matically through a server-side program; participants day just before returning the diary to the researcher
were connected automatically to the Internet survey (Fukuoka, Kamitani, Dracup, & Jong, 2011).
web page if the answers were appropriate.
“Upon request, pen-and-pencil questionnaires Computer-Based Data Collection
were provided by mail to the community consultants, With the advent of laptop and tablet computers, data
who distributed the questionnaires in person only to collectors can code data directly into an electronic file
those who were identified as cancer patients. These at the data collection site. If a computer is used for
oasis-ebl|Rsalles|1476461039

questionnaires accompanied hard copies of the same data collection, a program must be written for enter-
informed consent form included in the Internet format ing, cleaning, and storing data. A computer enables
of the questionnaire, and the pen-and-pencil ques- users to collect large amounts of data with few errors
tionnaire included a sentence ‘Filling out this question- that can be readily analyzed with a variety of statisti-
naire means that you are aged over 18 years old and cal software packages. In addition to researchers
giving your consent to participate in this survey.’ After using technology at the point of data collection to
the self-administered questionnaires were completed, record data, technology has made it possible to inter-
community consultants retrieved all except five (these face physiological monitoring systems with comput-
were mailed directly to the research team by the ers for data collection. An advantage of using
participants) in person at the community settings and computers for the acquisition and storage of physio-
mailed them to the research team. Supplementing logical data is the increased accuracy and precision
pen-and-pencil questionnaires was essential to recruit that can be achieved by reducing errors associated
the target number of ethnic minority cancer patients with manually recording or transcribing physiological
across the nation who did not have access to the data from a monitor. Another advantage is that more
data points can be recorded electronically than could
514 UNIT FOUR  Analyzing Data, Determining Outcomes, and Disseminating Research

be recorded manually. Computers linked to physio- The computerized systems used to collect and
logical monitoring systems can store multiple data for record data in the study by Savian et al. (2006) are
multiple indicators, such as blood pressures, oxygen detailed in the following excerpt:
saturation levels, and sleep stages. Because data can
be electronically recorded, data collection is less
labor intensive, and the data are ready to analyze
more quickly. The initial cost of equipment may be “PEFR and CO2 [carbon dioxide] production were
high, but it is reasonable when the cost of hiring and measured using a flow and CO2 sensor connected to
training human data collectors is considered. the patient’s airways and to the CO2SMO [carbon
There are some concerns with the use of computer- dioxide] respiratory mechanics monitor (CO2SMO
ized data acquisition systems, but physiological data Plus Model 8000, Novametrix Medical Systems Inc.,
are usually best gathered and stored directly into a Wallingford, CT). All information from the CO2SMO
computer database to ensure accurate, complete data monitor was simultaneously recorded in the Analysis
collection. Physiological data typically require large Plus computer program.
computer storage space. The computer-equipment “Static lung compliance was recorded by the static
interface may require more space in an already measures function device on the Bennett 7200 venti-
crowded clinical setting; when possible, existing lator where a plateau pressure was obtained by
equipment should be used to collect data. Purchasing including an inspiratory pause of 2 seconds into the
the equipment, setting it up, and installing the software mandatory breath. …
can be time-consuming and expensive at the start of “PaO2/FIO2 ratio was calculated from arterial blood
your project. Thus, initial studies usually require sub- samples taken immediately before and immediately
stantial funding. Another concern is that the nurse after MHI and VHI. Four milliliters of arterial blood
researcher may focus on the machine and technology were drawn into a syringe containing heparin and
and neglect observing and interacting with the subject. analyzed by a blood gas machine (Bayer Australian
The most serious disadvantage of computerized Limited 865, Pymble, NSW, CAN 000128 714). This
data collection is the possibility of measurement error procedure was standardized across subjects.
that can occur with equipment malfunctions and soft- “HR and MAP were read directly from the moni-
ware errors. Regular maintenance and calibrations, or toring system (Merlin pressure module M1006A
reliability checks of the equipment and software, Hewlett Packard, Palo Alto, CA) and recorded every
reduce this problem. The benefits of collecting repeated minute before, during, and for 5 minutes after MHI
measures over time may outweigh the risk of missing and VHI.” (Savian et al., 2006, p. 336)
data because of poor compliance. For example, collect-
ing continuous rectal temperature data from a subject
is easier and less burdensome than asking the subject The use of computerized data collection by Savian
to measure an oral temperature every 1 to 2 hours. et al. (2006) enabled them to collect repeated mea-
Savian, Paratz, and Davies (2006) conducted a sures on several physiological variables in an accurate
single-blind randomized, crossover study with 14 and precise way. The data were collected by sensors
mechanically ventilated intensive care unit patients. and stored in the computer to reduce error and facili-
tate data analysis.

“[The purpose of the study was to determine the Phones and Other Electronic Devices
effectiveness of] manual hyperinflation (MHI) and ven- Software applications for mobile phones have evolved
tilator hyperinflation (VHI) on respiratory mechanics from personal digital assistants (PDAs) that allow the
(static compliance [Cst]), oxygenation (arterial oxygen researcher to collect and download data directly into
tension [PaO2]/fraction of inspired oxygen [FIO2] the computer from observations as they occur. Health-
ratio), and secretion removal (wet weight of sputum care providers load applications that facilitate accurate
and peak expiratory flow rate [PEFR]) at different assessment, diagnosis, and pharmacological and non-
levels of PEEP [positive end-expiratory pressure] … pharmacological management of patients. PDAs are
a secondary aim was to investigate the hemodynamics also used to store deidentified data from office com-
heart rate [HR], mean arterial pressure [MAP] and puters in a form that is easily transportable. PDA soft-
metabolic response (carbon dioxide output [VCO2]) ware is currently available that may help nurse
during MHI and VHI.” (Savian et al., 2006, p. 335) practitioners collect data for research. Multiple nurse
practitioners involved in a research project could
CHAPTER 20  Collecting and Managing Data 515

forward data electronically from PDAs to a central would not otherwise be able to participate in your
research site for analysis. Encrypted electronic devices study. In some studies, postage is an additional
are needed to protect the confidentiality of data during expense. There may be costs involved in coding the
transmission. These electronic devices can be mis- data for entry into the computer and for conducting
placed or stolen, threatening confidentiality. Research- data analyses. Consultation with a statistician early in
ers need to protect the data with a security code to the development of a research project and during data
ensure that no one but themselves can access data in analysis must also be budgeted. You may need to hire
these formats. someone who can remain blinded for data entry or
Mobile phones and computers are becoming more analysis or someone who can type the final report,
similar with the increased sophistication of applica- develop graphics or presentations, or type and edit
tions for mobile phones. Some of these applications manuscripts for publication.
can be used to collect various data. Other electronic In addition to the above-described direct costs of a
devices include pill containers that record when pills research project, there are costs associated with the
are accessed and watches with timers to remind researcher’s time and travel to and from the study
participants to take certain health-related actions. site. You also must estimate the expense of presenting
However, the use of these devices for research may the research findings at conferences and include
require considerable preparation. You may need to those expenses in the budget. To prevent unexpected
hire programmers with the needed expertise, and you expenses from delaying the study, examine all costs in
may need to purchase, rent, or borrow the needed an organized manner. A budget is best developed early
number of devices or monitors. in the planning process and revised as plans are modi-
fied. Seeking funding for at least part of the study costs
can facilitate the conduct of a study.
Factors Influencing
Time Factors
Data Collection Researchers often underestimate the time required for
When planning data collection, cost, time, the avail- participants to complete data collection forms and for
ability of assistance, and the need for consistency are the research team to recruit and enroll subjects for a
critical factors to consider. The researcher balances study. The first aspect of time—the participant’s time
these factors with the need to maintain the reliability commitment—must be determined early in the process
and validity of the study in the development of the because the time needed for participant involvement
data collection plan. must be included in the informed consent process and
document. While conducting your pilot study, make
Cost Factors note of the time required to collect data from a subject.
Cost is a major consideration when planning a study. You may need to revise your timeline and consent
Measurement tools, such as continuous electrocardio- form to reflect the expected time commitment
gram monitors (Holter monitor), wrist activity moni- accurately.
tors (accelerometers), spirometers, pulse oximeters, or The second aspect of time—the time needed to
glucometers, used in physiological studies may need complete data collection—is especially challenging
to be rented, purchased, or loaned from the manufac- to predict because events during the data collection
turer or other company. You may need to pay a fee to period sometimes are not under the researcher’s
use instruments or questionnaires. Some instruments control. For example, a sudden heavy staff workload
and questionnaires are available only if a copy is pur- may make data collection temporarily difficult or
chased for each participant. Data collection forms may impossible, or the number of potential subjects might
need to be formatted or developed for electronic use. be reduced for a period. In some situations, research-
In some cases, printing costs for materials such as ers must obtain permission from each subject’s physi-
teaching materials or questionnaires that will be used cian before they are permitted to collect data on that
during the study must be considered. Providing the subject. Activities required for this stipulation, such
required copy of the signed consent form doubles the as contacting physicians, explaining the study, and
expense of consent forms. Small payments to partici- obtaining permission, require extensive time. In some
pants in the form of cash or gift cards should be con- cases, potential subjects are lost before the researcher
sidered as compensation for a subject’s time and effort can obtain the mandatory permission, extending the
in providing the data. Sometimes childcare may need time required to obtain the necessary number of
to be provided for parents and other caregivers who subjects.
516 UNIT FOUR  Analyzing Data, Determining Outcomes, and Disseminating Research

How long will it take to identify potential subjects, Who will collect the data? If you decide to use data
explain the study, and obtain consent? How much collectors, they must be trained in responsible conduct
time will be needed for activities such as completing of research and issues of informed consent, ethics, and
questionnaires or obtaining physiological measures? confidentiality and anonymity (see Chapter 9). They
Novice researchers have difficulty making reasonable must be informed about the research project, familiar
estimates of time and costs related to a study. Vali­ with the instruments to be used, and have equivalent
dating the time and cost estimates with an experi- training in the data collection process. In addition to
enced researcher can be very informative. Experienced training, data collectors need written guidelines or
researchers know the challenges of data collection protocols that indicate which instruments to use, the
and have learned that data collection may take two to order in which to introduce the instruments, how to
three times longer than predicted. If the cost and time administer the instruments, and a time frame for the
factors are prohibitive, you may need to simplify your data collection process (Harwood, 2009; Kang, Davis,
study so that fewer variables are measured, fewer Habermann, Rice, & Broome, 2005).
instruments are used, or fewer subjects are needed. If more than one person is collecting the data, con-
Make the design less complex, and use fewer data sistency among data collectors (interrater reliability)
collectors. A blinded intervention study involves more must be ensured through testing (see Chapter 16). The
research staff and is generally not feasible for a novice training needs to continue until interrater reliability
researcher. These are serious modifications, however, estimates are at least 85% to 90% agreement between
with implications for the validity of the findings, so the expert and the trainee or trainees. Waltz, Strick-
you and your team should thoroughly examine the land, and Lenz (2010) suggest that a minimum of
consequences before making such revisions. If pre- 10% of the data needs to be compared across raters
liminary time or cost estimates go beyond expecta- before interrater reliability can be adequately reported.
tions, you can revise the time schedules and budget The trained data collector’s interrater reliability with
with new projections for completing the study. the expert trainer should be assessed intermittently
throughout data collection to ensure consistency from
Consistency the first to the last participant in the study. Data col-
Consistency in data collection across subjects is criti- lectors also must be encouraged to identify and record
cal. What time of year will data be collected? For any problems or variations in the environment that
example, if you collect data during holiday seasons, affect the data collection process. The description of
data about sleeping, eating, or exercising may vary. the training of the data collectors is usually reported
Pediatric patients with asthma may experience more in the methods section of an article so that others
symptoms during the winter months than during can assess the data collection process (Harwood &
summer. Planning data collection for a study of Hutchinson, 2009).
symptom management with this population would
need to take this possibility into consideration. Availability of Assistance
The specific days and hours of data collection may Who is going to help you with the study? If you are a
influence the consistency of the data collected and student, will your mentor or supervising faculty
must be carefully considered. For example, the energy member participate? Does your mentor or supervising
level and state of mind of subjects from whom data faculty member have research assistants who could
are gathered in the morning may differ from that of assist in your study? Will nurses, physicians, and other
subjects from whom data are gathered in the evening. health professionals assist with recruitment? Do they
With hospitalized study participants, visitors are more have time to do this? Are they willing to help?
likely to be present at certain times of day and may Will the researcher collect all the data, or will data
interfere with data collection or influence participant collectors be employed for this purpose? Can data
responses. Patient care routines vary with the time of collectors be nurses working in the area? Data collec-
day. In some studies, the care recently received or the tion may be delayed when nurses providing patient
care currently being provided may alter the data you care are also expected to be data collectors. Even when
gather. The subjects you approach on Saturday to par- a nurse agrees to help you with subject recruitment or
ticipate in the study may differ from the subjects you data collection, patient care takes priority over data
approach on weekday mornings. Subjects seeking care collection and increases the risk for missing data or
on Saturday may have a full-time job, whereas sub- missing the opportunity to enroll eligible subjects.
jects seeking care on weekday mornings may be either If clinicians are going to recruit subjects or collect
unemployed or too ill to work. data, the clinicians need to complete training for
CHAPTER 20  Collecting and Managing Data 517

protection of human subjects during research. An records or any other written sources, you do not need
IRB requires documentation of this training for each to ask the subject to provide this information. To
person involved in recruitment and data collection. If collect data from a patient’s records, make sure to
you are going to be doing all the data collection include permission to do this in the consent form, and
yourself, will you be available every day of the ensure that the IRB has authorized your team to do this.
week? What hours will you be available? If others
will be involved in collecting data, allow time for Data Collection Forms
training on data collection procedures. You need to Before data collection begins, you may need to develop
be available by telephone or other means for ques- or modify forms on which to record data. These forms
tions and emergencies when others are collecting can be used to record demographic data, information
data for your study. Keeping these factors in mind, from the patient record, observations, or values from
you are now ready to plan the data collection process physiological measures. The demographic variables
for your study. commonly collected in nursing studies include age,
gender, race, education, income, employment status,
diagnosis, and marital status. You may want to collect
Data Collection and Coding Plan additional demographic data if researchers have iden-
The factors of cost, time, availability of assistance, tified participant characteristics that affect the study
and need for consistency shape the data collection plan variables. You also might need to collect other data
that you develop. A data collection plan details how that may be extraneous or confounding variables, such
you will implement your study. The plan for collecting as the subject’s physician, stage of illness, length of
data is specific to the study being conducted and illness or hospitalization, complications, date of data
requires that you consider some common elements of collection, time of day and day of week of data col-
research. You need to map out procedures you will use lection, and any untoward events that occur during
to collect data, anticipate the time and cost of data the data collection period. If there are only women in
collection, develop data collection forms that ease data your sample, the subject’s age and reproductive
entry, and prepare a codebook that will help you to status, parity, and number of children in the home may
code the variables to be entered in a database. This be confounding variables. In a study of patients with
extensive planning increases the accuracy of the data ventilator-associated pneumonia, the researcher needs
collected and the validity of the study findings. The to record the length of time between when the patient
validity and strength of the findings from several was intubated and when ventilator-associated pneu-
carefully planned studies increase the quality of monia was diagnosed. The researcher for this study
the research evidence that is then available for imple- also needs to record whether the patient had a preexist-
menting into clinical practice (Melnyk & Fineout- ing pulmonary disease.
Overholt, 2010). Data collection forms must be designed so that the
Identifying data include variables such as patient data are easily recorded, coded, and entered into the
record number, home address, and date of birth (see computer. You need to decide whether data will be
Chapter 9). Avoid collecting these data unless they are collected in raw form or coded at the time of collec-
essential to answer the research question. For example, tion. Coding in quantitative studies is the process of
collect a patient’s age instead of date of birth. Review transforming data into numerical symbols that can be
regulations by the Health Insurance Portability and entered easily into the computer. For example, vari-
Accountability Act about the participant’s private ables such as race, gender, ethnicity, and diagnoses
health information (www.hhs.gov/ocr/hipaa). can be categorized and given numerical labels. For
The methodology of a study may include contacting gender, the male category could be identified by a “1”
subjects later for additional data collection. In this and the female category by a “2.” You may also want
case, you will need to obtain the subject’s address and to include an “other” category (coded “3”) for partici-
telephone number and protect the information appro- pants who are transgendered or transsexual. To be able
priately. Names and phone numbers of family members to compare your sample with samples in federally
or friends may also be useful if subjects are likely to funded studies, you may need to separate the questions
move or may be difficult to contact. This information about ethnicity and race. In 2003, the Office of Man-
can be obtained only with subjects’ permission as part agement and Budget of the U.S. government directed
of their informed consent. Consider the importance of researchers and others collecting data for federal pur-
each piece of data and the subject’s time required to poses or at federal expense to separate the questions
collect it. If the data can be obtained from patient of race and ethnicity (Office of Minority Health,
518 UNIT FOUR  Analyzing Data, Determining Outcomes, and Disseminating Research

2010). At the same time, the Office of Management ___ (1)  Less than $30,000
and Budget specified the categories for each. The fol- ___ (2)  $30,000 to $49,999
lowing questions are correct according to these federal ___ (3)  $50,000 to $69,999
guidelines. How would a subject who is biracial or ___ (4)  $70,000 or greater
multiracial complete the form? You may want to word Data collection forms offer many response styles.
the question to ask the participant’s primary race or The person completing the form (subject or data col-
allow multiple responses. lector) might be asked to check a blank space before
Ethnicity or after the words “male,” “female,” or “other” or to
(1)  Hispanic or Latino circle one of the words. If code numbers or variable
(2)  Non-Hispanic or Latino name codes are used, the meaning of the codes should
Race be clearly indicated on the collection forms so that the
(1)  American Indian or Alaskan Native individual completing the form understands them and
(2)  Asian is not confused or misled by the code. Developing a
(3)  Black or African American codebook for your data collection forms and data entry
(4)  Native Hawaiian or Other Pacific Islander is discussed later.
(5)  White Placement of the data on the forms is important
The coding categories developed for a study not because careful placement makes it easier for subjects
only must be mutually exclusive but also exhaustive, to complete the form without missing an item and for
which means that the value for a specific variable fits data entry staff to locate responses for computer entry.
into only one category, and each observation must fit Placement of blanks on the left side of the page seems
into a category. For example, a subject is highly unlikely to be most efficient for data entry, but this layout may
to want to reveal his or her exact income but would be prove problematic when subjects are completing the
more willing to indicate that the income is in a particu- forms. The least effective arrangement is when the
lar range. The income ranges would not be mutually data are positioned irregularly on the form because
exclusive or exhaustive if they were categorized in the the risk of data being missed during data entry is high.
following way on a demographic questionnaire: Subjects’ names should not be on the data collection
Income range (please check the range that most accu- forms; only the subject’s identification number should
rately reflects your income) appear. The researcher may keep a master list of sub-
___ (1)  $30,000 to $40,000 jects and their code numbers, which is stored in a
___ (2)  $40,000 to $50,000 separate location and either encrypted in an electronic
___ (3)  $50,000 to $59,000 file or data repository or locked in a file drawer to
___ (4)  $60,000 to $70,000 ensure the subjects’ privacy. Often this master list of
___ (5)  $70,000 or more subjects and codes is kept with the subjects’ consent
These categories are not exclusive because they forms in a locked file drawer. This master list is
overlap, and a subject with a $40,000 income could required if collecting data later or recontacting the
mark category 1 or category 2 or both. The categories subject is a necessary component of your study.
are not exhaustive because a subject may have an You should always organize your data collection
income of either $25,000 or $59,500, yet the ques­ forms and instruments to begin with less personal
oasis-ebl|Rsalles|1476461046

tionnaire does not contain categories that include types of questions about age and education before
each of these incomes. How much detail do you delving into more personal questions about contracep-
need on income? Do you want to know if the par­ tives or feelings and attitudes. Also, you would not
ticipant’s household income is below poverty level? want to save your most important items for the last
To determine poverty level, you must know not page of the questionnaire and risk missing data if a
only the household income but also how many people participant becomes too fatigued or bored to finish the
live in the household and compare this information questions. Different types of questions require more
with federal poverty guidelines (http://aspe.hhs.gov/ or less time to complete, a factor that needs to be
poverty/09poverty.shtml). considered. Also, questions may ask for a response
The following income ranges are both exclusive related to different time frames. For example, if one
and exhaustive and would be appropriate for collect- questionnaire asks about the past week and two other
ing demographic data from subjects: questionnaires ask about the past month, these should
Income range (please check the range that most accu- be organized so that the subject is not confused by
rately reflects your family’s income for a year, going back and forth between time frames. If you have
before taxes) several instruments or forms, you may want to put
CHAPTER 20  Collecting and Managing Data 519

them together in a booklet to minimize the likelihood DATA COLLECTION FORM


that a questionnaire or form will be missed. Demographics
Figure 20-3 provides a sample data collection form. ____Subject Identification Number
It includes four items that could be problematic for ____Age
coding, data analysis, or both. The blank used to enter ____Gender
1. Male
“Surgical Procedure Performed” would lead to prob-
2. Female
lems when it is time to enter the data into a computer- ____Weight (in pounds)
ized data set. Because multiple surgical procedures ____Height (in inches)
could have been performed, developing codes for the __________Surgical Procedure Performed
various surgical procedures would be difficult and __/__/__Surgery Date (Month/Day/Year)
time-consuming. In addition, different words might be __/__/__Surgery Time (Hour/Minute/AM or PM)
used to record the same surgical procedure. It may be Narcotics Ordered After Surgery___________________
necessary to tally the surgical procedures manually. ___________________

Unless this degree of specification of procedures is Narcotic Administration


important to the study, an alternative would be to Date Time Narcotic Dose
develop larger categories of procedures before data 1.
collection and place the categories on the data collec- 2.
tion form. A category of “Other” might be useful for 3.
4.
less commonly performed surgical procedures. This
5.
method would require the data collector to make a
Instruction on Use of Pain Scale
judgment regarding which category was appropriate __/__/__Date (Month/Day/Year)
for a particular surgical procedure. Another option __/__/__Time (Hour/Minute/AM or PM)
would be to write in the category code number for a Comments:
particular surgical procedure after the data collection
form is completed but before data entry. If the specific __Treatment Group
surgical procedure is important to your study, you may 1. TENS
want to record the code the facility uses to bill for the 2. Placebo-TENS
procedure. Similar problems occur with the items 3. No-Treatment Control
“Narcotics Ordered after Surgery” and “Narcotic
Treatment Implemented
Administration.” Unless these data are to be used in __/__/__Date (Month/Day/Year)
statistical analyses, it might be better to categorize this __/__/__Time (Hour/Minute/AM or PM)
information manually for descriptive purposes. If Comments:
these items are needed for planned statistical proce-
dures, use care to develop appropriate coding. You
Dressing Change
may need detailed information if you want to know __/__/__Date (Month/Day/Year)
the appropriateness of the narcotic doses given. The __/__/__Time (Hour/Minute/AM or PM)
researcher might be interested in determining differ- _____Hours since surgery
ences in the amount of narcotics administered in a Comments:
given period in relation to weight and height. For
blinded studies, you do not want to record the treat- Measurement of Pain
ment group assignments on the data collection form. _____Score on Visual Analogue Pain Scale
Placing the treatment group code on the data collec- __/__/__Date Pain Measured
(Month/Day/Year)
tion form would be problematic because the informa-
__/__/__Time Pain Measured
tion is no longer blinded and could influence the data (Hour/Minute/AM or PM)
recorded by the data collectors. _____Hours since surgery
Comments:
Data Collection Detailed Plan
To ensure consistency in the data collection process, _____Data Collector Code
you need to develop a detailed plan. Envision the Comments:
overall activities that will be occurring during data
collection. Write each step and develop the forms,
training, and equipment needed for that step. Focus on
who, what, when, where, why, and how. How will you Figure 20-3  Data collection form.
520 UNIT FOUR  Analyzing Data, Determining Outcomes, and Disseminating Research

recruit subjects? At what point is a subject assigned to that missing response? Your data collection flow chart
a group? It is optimal to assign subjects randomly to should indicate how much missing data will be allowed
an intervention group or control group after baseline per subject. At what point will you decide to exclude
data are collected but before introducing the interven- a participant from your study?
tion. In this way, all subjects demonstrate the ability
to complete the questions and measures and have the Developing a Codebook for Data Definitions
opportunity to decline further participation before We advise that you develop your codebook before
group assignment. When and how will you implement initiating data collection or during the pilot study. A
the intervention? Will data be collected from more than codebook identifies and defines each variable in your
one subject at a time, or is it necessary to focus atten- study and includes an abbreviated variable name
tion on one subject at a time? How much time is needed (income), a descriptive variable label (gross household
to collect data from each subject? The length of time annual income), and the range of possible numerical
per subject is determined by study design, setting, and values for every variable entered in a computer file (0
available space. In addition, if you plan for three sub- = none; 1 = <$30,000; 6 = >$100,000). Some code-
jects in the morning and three in the afternoon, what books also identify the source of each datum, linking
are the contingencies for subjects who arrive late or your codebook with your data collection forms and
need additional time? Some subjects may be available scales. The codebook keeps you in control and pro-
only during their lunch break or in the evening. vides a safety net for when you access the data later.
You might develop a data collection flow diagram Some computer programs, such as SPSS for Windows,
to illustrate the process for collecting data in your allow you to print out your data definitions after
study. An example is shown in Figure 20-4. The Con- setting up a database. Figure 20-5 is an example of
solidated Standards of Reporting Trials (CONSORT) data definitions from SPSS for Windows. Another
guidelines for reporting randomized trials in publica- example of coding is presented in Figure 20-6.
tions (Bennett, 2006) would also be very useful for Developing a logical method of abbreviating vari-
depicting the design and flow of your data collection able names can be challenging. For example, you
process and expected enrollment numbers, expected might use a quality-of-life (QOL) questionnaire in
attrition rates, and final sample sizes for each group your study. It will be necessary for you to develop an
(see Chapter 19). abbreviated variable name for each item in the ques-
tionnaire. For example, the fourth item on a QOL
Decision Points questionnaire might be given the abbreviated variable
Decision points that occur during data collection must name QOL4. A question asking the last time a home
be identified, and all options must be considered. One health nurse visited might be abbreviated HHN Lst-
decision may pertain to whether too few potential visit. Although abbreviated variable names usually
subjects are meeting the sampling inclusion criteria. seem logical at the time the name is created, it is easy
Will you review study progress every week or every to confuse or forget these names unless they are clearly
month? If too few subjects from your potential pool documented with a variable label.
are eligible, at what point will you consider changing During the piloting phase of your research with the
exclusion criteria? For example, if you are recruiting first few pilot subjects, you can easily refine your vari-
only first-time mothers older than 30 years of age, and able names and labels and request your research team
you are turning away willing participants because they or a statistician to review the variables. This practice
are too young, you and your research team need to encourages you to identify places in your forms that
reconsider the rationale for that criterion and perhaps might prove to be a problem during data entry because
decide either to lower the age range or to seek different of lack of clarity. Also, you may find that a single
recruitment sites. question contains not one but five variables. For
Other decisions include whether the subject under- example, an item might ask whether the subject
stands the information needed to give informed received support from her or his mother, father, sister,
consent, whether the subject comprehends instructions brother, or other relatives and ask the subject to circle
related to providing data, and whether the subject has the number that represents those who provided support.
provided all the data needed. As you look through the You might think that you could code mother as “1,”
completed data forms, are all responses completed? If father as “2,” sister as “3,” brother as “4,” and other
the subject skips a page, you will need to return that as “5.” However, because the individual can circle
page to the subject for completion. If the question more than one, each relative must be coded separately.
about income is not completed, how will you handle Thus, mother is one variable and would be a
CHAPTER 20  Collecting and Managing Data 521

ENROLLMENT AND SURVEY ADMINISTRATION PROCEDURES

Begin patient enrollment

Explain surveys
to patients

No
Does the patient Record reason for
agree to participate? patient refusal
Yes
Create patient file Stop

Begin survey Assign unique


administration ID number

Does the patient need Yes Is a family member No Is staff member


assistance to complete or friend available
available to assist?
the surveys? to help?
No Yes Yes No
Give patient the survey Give patient and helper Assist Record reason
packet and pencil the survey packet patient for nonenrollment
and pencil

Stop
Surveys completed

Check data

Are all questions answered?

Yes No
Were any questions Yes Ask patient for answers
answered twice? or clarification
No
Enter data Adjust answers based
on patient clarification

Data quality check


and reports

Create point-of-service Schedule follow-up Send data to project-


reports visit survey management site for
aggregated comparison reports

Figure 20-4  Data collection flow chart.


Q1 Value
Standard Position 2
Attributes Label I was motivated to migrate from my
country because my pay was too low.
Type Numeric
Format F8
Measurement Ordinal
Role Input
Valid Values 1 Strongly Disagree
2 Disagree
3 Neutral
4 Agree
5 Strongly Agree
Missing Values System

Q 39 Value
Standard Position 40
Attributes Label What is your gender?
Type Numeric
Figure 20-5  Example of data definitions from SPSS for Format F8
Windows. (Source: Nurse International Relocation Measurement Nominal
Questionnaire 2 [Gray & Johnson, 2009].)
Role Input
Valid Values 1 Male
2 Female
Missing Values System

Q50 Value
Standard Position 54
Attributes Label Which of the following best describes
your current employment situation?
Type Numeric
Format F8
Measurement Nominal
Role Input
Valid Values 1 Employed and working full time
2 Employed and working part time
3 Employed, currently on leave
4 Self-Employed
5 Unemployed
6 Other
Missing Values System

Variable Variable Source Value Levels Valid Missing Comments


Name Label Range Data

A1 to A5 Family Apgar Q2Family Apgar 1=never 1–5 9 Code as is (CAI)


2=hardly ever
3=some of the time
4=almost always
5=always

MF3 Mother's feeling, Tuesday diary, 1=poor 1–6 9 Code 1 to 6


Day 3 mother 6=good left to right

Figure 20-6  Example of coding.


CHAPTER 20  Collecting and Managing Data 523

dichotomized value, coded “1” if circled and “0” if not information with the people performing data entry
circled. The father would be coded similarly as a and analysis.
second dichotomous variable, and so on. Identifying
these items before data collection may allow you to
restructure the item on the questionnaire or data col- Pilot Study
lection form to simplify computer entry. Completing a pilot study may save you difficulty later
Give the codebook with its data definitions to the when you implement the final steps of the research
individual or individuals who will enter your data into process. Pilot testing helps you to identify problems
the computer before initiating data collection. Deci- you might encounter while collecting data and helps
sion rules for data entry should also be finalized. For you develop strategies for addressing potential prob-
example, if a subject selects two responses for a single lems. Chapter 3 provides reasons to conduct a pilot
item, will the variable be coded as missing, or does study. Following approval of the study by your IRB,
convention dictate that the lowest or highest value use your research plan to recruit three to five subjects
should be entered? Individuals who are entering data who meet your eligibility criteria. Use the data collec-
need to have clarity on the distinctions between coding tion methods that you have selected and prepared. Pay
a missing value or nonapplicable value as blank rather attention to how long it takes to recruit a subject,
than entering a “0” value. obtain informed consent, and collect the data. Ask the
In addition, provide the following information to participant to identify questions or aspects of the
the person entering the data: process that were unclear or confusing. Based on the
• Dates for data collection initiation and completion pilot study and feedback of the first subjects, modify
• Estimated number of subjects to be included in the your data collection forms and methods of data col-
study and how often batches of subjects’ data will lection to ensure the feasibility, validity, and reliability
be entered of the study.
• Plan for documenting refusal rate, sample size, and
attrition during the study
• Copies of all scales, questionnaires, and data col- Collecting Data
lection forms to be used in the study Data collection is the process of selecting subjects
• Location of every variable on scales, question- and gathering data from these subjects. The actual
naires, or data collection forms steps of collecting the data are specific to each study
• Statistical package to be used for analysis of the and depend on the research design and measurement
data methods. Data may be collected on subjects by observ-
• Statistical analyses to be conducted to describe the ing, testing, measuring, questioning, recording, or any
sample and to address the research purpose and the combination of these methods. The researcher is
objectives, questions, or hypotheses actively involved in this process either by collecting
• Contact information for the statistician or project data or by supervising data collectors. You will apply
director who is available to consult about data entry ethical principles, people-management strategies, and
questions or data analysis problem-solving skills constantly as data collection
• Computer directory location of the database in tasks are implemented. Even after pilot testing, snags
which the data will be entered and copied for in the research plan can occur, and support systems
backup are needed for data collectors who encounter situa-
• Timeline for receiving the data—for example, tions in the home or clinic that require reporting to
whether you will deliver the data in batches or wait legal authorities. For example, during a home visit, a
until all the data have been gathered before deliver- data collector may find that family members are
ing it neglecting a subject in the study who cannot get out
With this information, the assistant can develop of bed. Frequent interactions with data collectors
the database in preparation for receiving the data. on your team are also essential for assessing any
The time needed to prepare the database varies minor or major risks and reporting adverse effects to
depending on the number of variables and the com- your IRB.
plexity of the response categories. Approximate dates
for completion of the data entry, analyses, or both Data Collection Tasks
must be negotiated before beginning data collection. In both quantitative and qualitative research, the
If you have a deadline for completing the study investigator performs four tasks during the process of
or presenting your results, you should share this data collection. These tasks are interrelated and occur
524 UNIT FOUR  Analyzing Data, Determining Outcomes, and Disseminating Research

concurrently rather than in sequence. The tasks are (1) generally do not provide enough space for the
selecting subjects, (2) collecting data in a consistent researcher to describe the problems encountered, and
way, (3) maintaining research controls as indicated in inexperienced researchers may get a false impression.
the study design, and (4) solving problems that threaten Some of the problems are hinted at in a published
to disrupt the study. Selecting subjects is discussed in paper in either the limitations section or in a discus-
Chapter 15. Collecting data may involve administer- sion of areas for future research. A more realistic sense
ing Internet or paper-and-pencil scales; asking sub- of the problems encountered by a researcher can be
jects to complete data collection forms in person or obtained through personal discussions with the
online; or recording data from observations, patient primary author about his or her process of data collec-
medical records, or monitoring equipment (Chapters tion for a particular sample or using a particular
16 and 17 provide information on measurement strate- method or instrument. Some common problems expe-
gies). Data collection tasks for qualitative studies are rienced by researchers are discussed in the following
discussed in more detail in Chapter 12. section.
A problem can be perceived either as a frustration
Maintaining Control or as a challenge. The fact that the problem occurred
Maintaining control and consistency of the design and is not as important as successfully resolving it. The
methods during subject selection and data collection final and perhaps most important task during the data
protects the integrity or validity of the study. Research- collection period may be debriefing with your research
ers build controls into the design to minimize the team in weekly meetings for problem resolution.
influence of intervening forces on the study findings.
Maintenance of these controls is essential. For Data Collection Problems
example, a study to describe the changes in sleep Murphy’s law (if anything can go wrong, it will, and
stages during puberty may require controlling the at the worst possible time) seems to prevail in research,
environment of the bedroom to such an extent that a just as in other dimensions of life. For example, data
sleep laboratory is the only setting in which integrity collection frequently requires more time than was
can be maintained. Control is not always realistic in a anticipated, and collecting the data is often more dif-
natural field setting, and, in some cases, these controls ficult than expected. Even following a pilot study, you
can fail without the researcher realizing it. Often the may encounter challenges during the data collection
researcher must opt for a randomized controlled study process. Sometimes changes must be made in the way
to address potential control failures so that they are the data are collected, in the specific data collected, or
equally likely to occur in either group. in the timing of data collection. People react to the
In addition to maintaining controls identified in the study in unpredictable ways. Institutional changes
research plan, you must continually watch for previ- may force modifications in the research plan, or
ously unidentified extraneous variables that might unusual or unexpected events may occur. You must be
have an impact on the data being collected. These as consistent as possible during the data collection
variables are often specific to a study and tend to process, but you must also be flexible in dealing with
become apparent during the data collection period. unforeseen problems. Sometimes, sticking with the
The extraneous variables identified during data collec- original plan at all costs is a mistake. Skills in finding
tion must be considered during data analysis and inter- ways to resolve problems that protect the integrity of
pretation. These variables also must be noted in the the study can be critical.
research report to allow future researchers to control In preparation for data collection, possible prob-
them. For example, Lee and Gay (2011) studied sleep lems must be anticipated, and solutions for these prob-
quality in new mothers and asked about the infant’s lems must be explored. The following discussion
sleep location, but the location at the beginning of the describes some common problems and concerns and
night was often not the same by morning and could presents possible solutions. Problems that tend to
not be controlled in the home setting. occur with some regularity in studies have been cat-
egorized as people problems, researcher problems,
Problem Solving institutional problems, and event problems.
Little has been written about the problems encoun-
tered by nurse researchers. Research reports often read People Problems
as though everything went smoothly. The implication Nurses cannot place a subject in a laboratory test
is that if you are a good researcher, you will have no tube, instill one drop of the independent variable,
problems, which is not true. Research journals and then measure the effect. Nursing studies are
CHAPTER 20  Collecting and Managing Data 525

often conducted by examining subjects as they inter- or may not be home for a scheduled visit. Although
act with their environments. Many aspects of the you have invested time to collect data from these
environment can be controlled by using a laboratory subjects, their data may have to be excluded from
setting, but other studies require the natural setting analysis because of incompleteness. Generally, the
to have external validity. When research involves more data collection time points you require as part of
people, nothing is completely predictable. People, in your design, the higher the risk for attrition. Attrition
their complexity and wholeness, have an impact on can occur because of subject burden accumulating
all aspects of nursing studies. Researchers, potential over time, because healthy adults relocate for employ-
subjects, family members of subjects, healthcare pro- ment or family reasons, or because of death in a more
fessionals, institutional staff members, and others critically ill population.
(“innocent bystanders”) interact within the study sit- Sometimes subjects must be dropped from the
uation. You will need to observe closely and evalu- study by the research team because of changes in
ate these interactions to determine their impact on health status. For example, a patient may be trans-
your study. ferred out of the intensive care unit where the study is
being conducted. Another possibility might be that the
Problems Selecting a Sample patient’s condition may worsen and the patient no
The first step in initiating data collection—selecting a longer meets the inclusion criteria. The limits of third-
sample—may be the beginning of people problems. party reimbursement may force the healthcare pro-
You may find that few people are available who fit vider to discontinue the services you are studying.
your inclusion criteria or that many people you Subject attrition occurs to some extent in all longi-
approach refuse to participate in the study even though tudinal studies. One way for you to deal with this
the request seems reasonable. Appropriate subjects, problem is to anticipate the attrition rate and increase
who were numerous a month earlier, seem to have the planned number of subjects to ensure that a mini-
disappeared. Institutional procedures may change, mally desired number will complete the full study.
which might make many potential subjects ineligible Review similar studies to anticipate the attrition rate.
for participation in the study. You may have to evalu- For example, Lim, Chiu, Dohrmann, and Tan (2010)
ate the inclusion and exclusion criteria or seek addi- reported a 31% attrition rate in their quasi-experimental
tional sources for potential subjects. In research study of the knowledge of registered nurses employed
institutions that care for the indigent, patients tend to in long-term care. The investigators collected pretest
be reluctant to participate in research. This lack of data from 58 subjects and 4 weeks later collected post-
participation might arise because these patients are test data from 40 subjects. If subject attrition is higher
frequently exposed to studies, feel manipulated, or than expected, consider additional small incentives
misunderstand the research. Patients may feel that along the way or a bonus for completing the final
they are being used or fear that they will be harmed assessment to achieve an adequate final sample size.
in some way. For example, recruiting Spanish- Attrition is usually higher in the placebo or control
speaking women for a study of stress and acculturation group, but a well-designed, attention-control group
may be met with high refusal rates if these women are should have an attrition rate that is similar to the attri-
worried about revealing their legal status in the United tion seen in your intervention group. Sometimes a
States. Recruiting women who are planning a preg- study might end with a smaller than expected sample
nancy in the next 6 months may not yield participants size. If so, the effect of a smaller sample on the power
because they are fearful that others (work colleagues of planned statistical analyses must be considered
or friends) will find out about their plan. because this smaller sample may be inadequate to test
the hypotheses.
Subject Attrition Researchers should report information about sub-
After you have selected a sample, certain problems jects’ acceptance to participate in a study and attrition
might cause subject attrition (a loss of subjects from during the study to determine if the sample is
the study over time). For example, some subjects may representative of the study target population. Journal
agree to participate but then fail to follow through. editors often require that manuscripts include a flow
Some may not complete needed forms and question- chart indicating the number of subjects meeting
naires or may fill them out incorrectly. To reduce these sample criteria, the numbers refusing to participate,
problems, a research team member can be available to and the reasons for refusal. If data are collected over
subjects while they complete essential questions. time (repeated measures) or the study intervention is
Some subjects may not return for a second interview implemented over time, subjects often drop out of a
526 UNIT FOUR  Analyzing Data, Determining Outcomes, and Disseminating Research

Assessed for eligibility


(n  165)

Excluded (n  68)

Not meeting inclusion criteria


(n  25)
Enrollment
Refused to participate
(n  18)
Is it Randomized? YES Other reasons: Did not speak
English (n  25)

Allocated to interventions
Telephone Counseling
(n  38 women and 38 partners)
Exercise Allocated to control intervention
(n  23 women and 23 partners) (n  37 women and 37 partners)
Received allocated intervention Received allocated intervention
Telephone Counseling Allocation (n  36)
(n  38 women and 38 partners) Did not receive allocated intervention
Exercise (n  1)
(n  23 women and 23 partners) Give reasons-Not interested
Did not receive allocated intervention
(n  0)

Lost to follow-up
Lost to follow-up (n  3 women, 7 partners by T3)
(n  2 women, 4 partners lost in Give reasons: Not interested
exercise condition by T3) Follow-Up Discontinued intervention
Give reasons-not interested (n  2)
Discontinued intervention Give reasons-Not interested
(n  0)

Analyzed Analyzed
(n  38 women, and partners for (n  33 women, 30 partners)
counseling; 21 women and 19 partners Excluded from analysis
Analysis
for exercise) (n  3 women, 7 partners)
Excluded from analysis Give reasons-No T3 data
(n  2 women and 4 partners in collected
exercise)
Give reasons-No T3 data collected

Figure 20-7  Sample selection and allocation.


T3 = Tumor more than 5cm across. (From Badger, T., Segrin, C., Dorros, S., Meek, P., & Lopez, A. M. [2007]. Depression and anxiety in women with
breast cancer and their partners. Nursing Research, 56[1], 44–53.)

study, and it is important to document when and how process and reasons for attrition. This information
much attrition occurred. Using the CONSORT guide- enables researchers and clinicians to evaluate the rep-
lines published by Bennett (2006), Badger, Segrin, resentativeness of their sample for external validity
Dorros, Meek, and Lopez (2007) provided a flow chart and for any potential bias in interpreting the results.
to document participants’ selection, refusal rate,
assignment to group, and attrition over the weeks Subject as an Object
of data collection (see Figure 20-7). The flow chart The quality of interactions between the researcher and
clearly identifies important aspects of the sampling subjects during the study is a critical dimension for
CHAPTER 20  Collecting and Managing Data 527

maintaining subject participation. When researchers returned at a later time, the probability of influence by
are under pressure to complete a study, people can be others increases, and return of the questionnaire packet
treated as objects rather than as subjects, particularly becomes less likely, even if the subject is provided
if electronic data collection is used. In addition to being with a stamped return envelope. The impact of this
unethical, such impersonal treatment alters interac- problem on the integrity of the data depends on the
tions, diminishes subject satisfaction, and increases nature of the questionnaire items. For example, a
likelihood for missing data and subject attrition. Sub- marital relationship questionnaire may have different
jects are scarce resources and must be treated with responses if the subject is allowed to complete it alone
care. Treating the subject as an object can affect and return it immediately to the researcher or have to
another researcher’s ability to recruit from this popula- complete it aloud with the spouse in attendance.
tion in the future. Treating the subject as an object can
be minimized by building strategies into the consent Passive Resistance
process, such as offering them a personal copy of their Healthcare professionals and institutional staff mem­
results, recognizing their valuable participation with bers working with the study participants in clinical
small gifts as tokens of appreciation, or providing settings may affect the data collection process. Some
monetary reimbursement for their time and effort. professionals verbalize strong support for the study
and yet passively interfere with data collection. For
External Influences on Subject Responses example, nurses providing care may fail to follow the
People interacting with the subject, the researcher, or guidelines agreed on for providing the specific care
both can have an important impact on the data collec- activities being studied, or information needed for the
tion process. Family members may not agree to the study may be left off patient records. The researcher
subject’s participation in the study or may not under- may not be informed when a potential subject has been
stand the study process. These individuals often influ- admitted, and a physician who has agreed that his or
ence the subject’s decision to participate. Researchers her patients can be participants may decide as each
benefit from taking the time to explain the study and patient is admitted that this one is not quite right for
seeking cooperation of family members. Family coop- the study. In addition, when the permission of the
eration is essential when the potential subject is criti- physician or nurse practitioner is required, the pro-
cally ill and unable to give informed consent. vider might be unavailable to the researcher.
Family members or other patients may also influ- Nonprofessional staff members may not realize the
ence the subject’s responses to scales or interview impact of the data collection process on their work
questions. In some cases, subjects may ask family patterns until the process begins. The data collection
members, friends, or other patients to complete study process may violate their beliefs about how care
forms for them. The subject may discuss questions on should be provided (or has been provided). If ignored,
the forms with other people who happen to be in the their resistance can completely undo a carefully
room, and therefore the data recorded do not reflect designed study. For example, research on skin care
the subject’s real feelings. If interviews are conducted may disrupt a nursing aide’s bathing routine, so he or
while others are in the room, the subject’s responses she may continue the normal routine regardless of the
may depend on his or her need to meet the expecta- study protocol and invalidate the study findings. When
tions of the other persons. Sometimes a family member there is funding to support subject recruitment and
may answer questions addressed verbally to the data collection, funds can be used to reimburse the
patient. The setting in which a questionnaire is com- clinic or hospital staff members for their time, to
pleted or an interview is conducted may determine the create a raffle for one substantial gift, to offer a gift
extent to which the answers are a true reflection of a certificate to buy something needed for the clinic, or
subject’s feelings. If the privacy afforded by the setting to send a nurse to a continuing education course.
varies from one subject to another, the subjects’ When funding is limited, staff members’ enthusiasm
responses may also vary and threaten both the internal for your study may be enhanced if they are able to
and the external validity of the findings. participate in the research as authors or presenters in
Usually, the most desirable setting for an interview dissemination of the research findings.
is a private area away from distractions. If it is not Because of the potential impact of these problems,
possible to arrange for such a setting, the researcher the researcher must maintain open communication and
can be present at the time the questionnaire is com- nurture positive relationships with other professionals
pleted to decrease the influence of others. If the ques- and staff members during data collection. Problems
tionnaire is to be completed later or taken home and that you and your team recognize early and deal with
528 UNIT FOUR  Analyzing Data, Determining Outcomes, and Disseminating Research

promptly have fewer serious consequences than prob- which skills improve may vary across time and data
lems you try to ignore. However, not all problems can collectors. The consistency of data collectors must be
be resolved. Sometimes you may need to seek creative evaluated during the study to detect any changes in
ways to work around an individual or to counteract their data collection techniques.
the harmful consequences of passive resistance.
Researcher Role Conflict
Researcher Problems As a researcher, one is observing and recording events.
Some problems are a consequence of the researcher’s Nurses who conduct clinical research often experience
interaction with the study situation or lack of skill in a conflict between their researcher role and their clini-
data collection techniques. These problems are often cian role during data collection. In some cases, the
difficult to identify because of the researcher’s per- researcher’s involvement in the event, such as provid-
sonal involvement. However, their effect on the study ing physical or emotional care to a patient during data
can be serious. collection, could alter the event and bias the results. It
would be difficult to generalize the findings to other
Researcher Interactions situations in which the researcher was not present to
Researcher interactions can interfere with data collec- intervene. However, the needs of patients must take
tion in interview situations. To gain the cooperation of precedence over the needs of the study.
the subject, the researcher needs to develop rapport The dilemma is to determine when the needs of
with the subject. One way to do this is to select data patients are great enough to warrant researcher inter-
collectors who resemble the types of subjects being vention. Some patient questions or situations are life-
recruited as much as possible. Rapport may suffer if threatening, such as respiratory distress and changes
a young man collects data from female caregivers of in cardiac function, and require immediate action by
elderly adults about their experience with end-of-life anyone present. Other patient needs are simple, can be
care. Similarly, a white middle-aged woman collecting addressed by any nurse available, and can be answered
data from young African American men or Hispanic if the response is not likely to alter the results of your
teens is likely to be more disadvantaged than a data study. Examples of these interventions include giving
collector who is more similar to the population of the patient a bedpan, informing the nurse of the
interest. patient’s need for pain medication, or helping the
A balance is needed between rapport and over- patient to open food containers. These situations
involvement. The researcher can become so involved seldom cause a dilemma.
in interactions with a study participant that data col- Solutions to other situations are not as easy. For
lection on that particular subject is not completed. If example, suppose that your study involves examining
you are collecting data from patient records while you the emotional responses of patients’ family members
are surrounded by professionals with whom you inter- during and immediately after the patient’s surgery.
act socially and professionally, it is sometimes diffi- Your study includes an experimental group that
cult to focus completely on the study situation. This receives one 30-minute family support session before
lack of attention usually leads to loss of data. and during the patient’s surgery and a control group
that receives no support session. Both sets of families
Lack of Skill in Data Collection Techniques are being monitored for 1 week after surgery to
The researcher’s skill in using a particular data collec- measure level of anxiety and coping strategies. You
tion technique can affect the quality of the data col- are currently collecting data on the control group. The
lected. A researcher who is unskilled at the beginning data consist of demographic information and scales
of data collection might practice the data collection measuring anxiety and coping. One of the family
techniques with the assistance of an experienced members is in great distress. After completing the
researcher. A pilot study to test data collection tech- demographic information, she verbally expresses her
niques is always helpful. If data collectors are being fears and the lack of support she has received from the
used, they also need opportunities to practice data nursing staff. Two other subjects from different fami-
collection techniques before the study is initiated. lies hear the expressed distress and concur; they move
Sometimes a skill is developed during the course of a closer to the conversation and look to you for informa-
study; if this is the case, as one’s skill increases, the tion and support.
data being collected may change and confound the In this situation, a supportive response from you is
study findings and threaten the validity of the study. likely to modify the results of the study because these
If more than one data collector is used, the degree to responses are part of the treatment to be provided to
CHAPTER 20  Collecting and Managing Data 529

the experimental group only. This interaction is likely objectivity during the process and yet not take them-
to narrow the difference between the two groups and selves too seriously. A sense of humor is invaluable.
decrease the possibility that your results will show a You must be able to experience the emotions and then
significant difference between the two groups. How become the rational problem solver. Management
should you respond? Are you obligated to provide skills and mental health are as invaluable to a research
support? To some extent, almost any response would career as being obsessive about data collection and
be supportive. One alternative is to provide the needed data management.
support and not include these family members in the
control group. Another alternative is to recruit the help Institutional Problems
of a nonprofessional to collect the data from the Institutions are in a constant state of change. They will
control group. However, most people would provide not stop changing for the period of a study, and these
some degree of support in the described situation, changes often affect data collection. A nurse who has
even though their skills in supportive techniques may been most helpful in your study may be promoted or
vary. transferred. The unit on which your study is conducted
Other dilemmas include witnessing unethical may be reorganized, moved, or closed during data
behavior that interferes with patient care or witnessing collection. An area used for subject interviews may be
subjects’ unethical or illegal behavior (Humphreys transformed into an office or a storeroom. Patient
et al., 2011). Consent forms are often required to stipu- record forms may be revised, omitting data that you
late that any member of the research team is legally and your team are collecting. The medical record per-
required to report illegal behaviors, such as neglect or sonnel may be reorganizing files and temporarily
abuse of children and elderly adults. Try to anticipate unable to provide needed records.
these dilemmas before data collection whenever pos- These problems for the most part are completely
sible and include this information in the consent form outside of the researcher’s control. Pay attention to
(Wong, Tiwari, Fong, Humphreys, & Bullock, 2011). the internal communication network of the institution
Pilot studies can help you to identify dilemmas likely for advanced warning of impending changes. Con-
to occur in a study, and you can build strategies into tacts within the institution’s administrative decision
the design to minimize or avoid them. However, some makers could warn you about the impact of proposed
dilemmas cannot be anticipated, and you must respond changes on an ongoing study. In many cases, the IRB
to these problems spontaneously. There is no pre- in the local hospital will have a nurse representative
scribed way to handle difficult dilemmas; each case who can provide the needed consultation. However,
must be dealt with individually. You should discuss any in many cases, data collection strategies might have
unethical and illegal behavior with members of your to be modified to meet the newly emerging situation.
IRB or ethics committee or with legal advisors. These Balancing flexibility with maintaining the integrity
situations must be reported to the IRB, and experts of the study may be the key to successful data col-
there can advise you on the next step or course of lection. As a data collection site, the subject’s home
action. After you have resolved the dilemma, it is wise setting may be more desirable and convenient for a
to reexamine the situation for its effect on study results subject than a complex facility or institution, and
and consider options in case the situation arises again. response rates may improve. The disadvantage is
Another type of conflict arises when a subject that home visits are time intensive for the researcher,
makes inaccurate statements or asks a question about and the subject may not be home at the agreed
health practices or treatment. Rather than offering pro- appointment time despite confirmed appointments
fessional advice or responding to the question, the and reminder calls.
research nurse should acknowledge that it is a good
question, but that the research protocol does not allow Event Problems
for a response during data collection. When data Unpredictable events can be a source of frustration
collection is complete, the research nurse can help during a study. Research tools ordered from a testing
formulate the question for the subject’s healthcare company may be lost in the mail. The printer may
provider or provide a readily available pamphlet or break down just before 500 data collection forms are
website for more information. to be printed, or a machine to be used in data collec-
tion may break down and require 6 weeks for repair.
Maintaining Perspective A computer ordered for data collection may not arrive
Data collection includes both joys and frustrations. when promised or may malfunction. Data collection
Researchers must be able to maintain some degree of forms may be misplaced, misfiled, or lost.
530 UNIT FOUR  Analyzing Data, Determining Outcomes, and Disseminating Research

Local, national, or world events can also influence studies, researchers often become aware of elements
a subject’s response to a questionnaire or ability to or relationships that they had not previously identified.
enroll in a study. For example, a researcher conducting These aspects may be closely related to the study
a study of the effects of fatigue on the health of air being conducted or have little connection with it. They
traffic controllers encounters a rash of national media come from increased awareness and close observation
reports about controllers falling asleep while on duty. of the study situation. Because the researcher is
This event could be expected to modify subjects’ focused on close observation, other elements in the
responses. In attempting to deal with the impact of the situation can come into clearer focus and take on new
event on the study, the researcher could obtain IRB meaning. Serendipitous findings are important to the
approval for a modification that would allow for con- development of new insights in nursing theory. They
tinued data collection from the intended sample but to can be important for understanding the totality of the
examine the impact of news such as this on subjects’ phenomenon being examined. Additionally, they lead
responses rather than the original purpose. However, to areas of research that generate new knowledge. A
the emotional climate of the airports participating in relatively easy way to capture these insights as they
the study may not be conducive to this option. The occur is to keep a research journal. These events must
researcher may choose to wait 3 months before col- be carefully recorded, even if their impact or meaning
lecting additional data and examine the data before is not understood at the time.
and after the event for statistically significant differ- Serendipitous findings can also lead the researcher
ences in responses. If no differences are found, the astray. Sometimes researchers forget the original plan
researcher could justify using all the data for and redirect their attention to the newly discovered
analysis. dimensions. Although modifying data collection to
Other, less dramatic events can also have an impact include data related to the new discovery may be
on data collection. If data collection for the entire valid, there has not been time to plan carefully a study
sample is planned for a single time, a snowstorm or a related to the new findings. The study’s approval by
flood may require that the researcher cancel the the IRB covers only information included in the sub-
session. Weather may decrease attendance far below mitted study proposal. Examination of the new data
that expected at a support group or series of teaching should be an offshoot only of the initial study and
sessions. A bus strike can disrupt transportation would require seeking additional IRB approval.
systems to such an extent that subjects can no longer
get to the data collection site. A new health agency
may open in the city, which may decrease demand for Having Access to
the care activities being studied. Conversely, an exter-
nal event can also increase attendance at clinics to Support Systems
such an extent that existing resources are stretched and The researcher must have access to individuals or
data collection is no longer possible. These events are groups who can provide mentorship, support, and con-
also outside the researcher’s control and are impossi- sultation during the data collection period. Support
ble to anticipate. In most cases, however, restructuring can usually be obtained from academic committees,
the data collection period can salvage the study. To do from IRB staff, and from colleagues on your research
so, it is necessary to examine all possible alternatives team.
for collecting the study data. In some cases, data col-
lection can simply be rescheduled; in other situations, Support of Academic Committees
the changes may need to be more complex. For Although thesis and dissertation committees are basi-
example, recruiting women to participate in a study cally seen as stern keepers of the sanctity of the
that requires an hour or longer of their time may research process, they also serve as support systems
necessitate that the researcher provide childcare. Pro- for novice researchers. Committee members must be
viding childcare would be more costly and add com- selected from faculty who are willing and able to
plexity to the process, but it may be the best alternative provide the needed expertise and support. Experi-
for increasing participation. enced academic researchers are usually more knowl-
edgeable about the types of support needed. Because
they are directly involved in research, they tend to be
Serendipity sensitive to the needs of a novice researcher and more
Serendipity is the accidental discovery of something realistic about what can be accomplished in the des-
useful or valuable. During the data collection phase of ignated time frame.
CHAPTER 20  Collecting and Managing Data 531

Institutional Support Chapter 14 for more information on conducting inter-


A support system within the institution where the vention studies.
study is being conducted is also important. Support
might come from people serving on the institutional
research committee or from nurses working on the Managing Data
unit where the study is conducted. These people Once data collection begins, you have to be prepared
may have knowledge of how the institution functions, to handle large quantities of data. To avoid a state of
and their closeness to the study can increase their total confusion, make careful plans before data collec-
understanding of the problems experienced by the tion begins. Plans are needed to keep all data from a
researcher and subjects. Do not overlook their ability single subject together until analysis is initiated. Write
to provide useful suggestions and assistance. Your the subject code number on each form, and check the
ability to resolve some of the problems encountered forms for each subject to ensure that they all are
during data collection may depend on having someone present. Researchers have been known to sort their
within the power structure of the institution who can data by form, such as putting all the scales of one kind
intervene. together, only to realize afterward that they had failed
to code the forms with subject identification numbers
Colleague Support first. They then had no idea which scale belonged to
In addition to professional support, having at least one which subject, and valuable data were lost.
peer in your research world with whom to share the Allot space as needed for storing forms. Purchase
joys, frustrations, and current problems of data collec- file folders, and design a labeling method to allow
tion is important. This colleague can often serve as a easy access to data; color coding is often useful. If you
mirror to allow you to see the situation clearly and are using multiple forms, the subject’s demographic
perhaps more objectively. With this type of support, sheet could be one light color, with a different pastel
the researcher can share and release feelings and gain color for the pain questionnaire and a contrasting light
some distance from the data collection situation. color for all the physiological data sheets used to
Alternatives for resolving the problem can be dis- record blood pressure, pulse, and respiration readings.
cussed in a less emotional context. Data collection is Use envelopes to hold small pieces of paper or note
demanding but rewarding. With time, confidence and cards that might fall out of a file folder. Plan to code
expertise of the novice researcher increase. data and enter them into the computer as soon as pos-
sible after data collection to reduce the loss or disor-
Data Safety and Monitoring Board as Source ganization of data. If data are collected on a computer,
of Support make sure the data are backed up and stored in a sepa-
If you are conducting an intervention study that is rate space so that they are not lost if the computer fails.
deemed to be of low risk to the patient, such as a
behavioral intervention to improve sleep quality, a Preparing Data for Computer Entry
data safety and monitoring plan will suffice. In these Data must be carefully checked and problems cor-
situations, less support for you as a researcher is rected before you initiate the data entry phase. The
needed. This plan is deemed adequate when it con- data entry process should be essentially automatic and
oasis-ebl|Rsalles|1476461052

forms to the IRB requirements for reporting any require no decisions regarding the data. Anything that
adverse event and includes annual progress reports. It alters the rhythm of data entry increases errors. For
requires that the researcher explicitly states the plan example, the subject’s entry should be coded as it
to review the data from each set number of subjects appears, and any reverse coding that may be needed
or from each 3-month or 6-month batch of recruited should be done at a later time by computer manipula-
subjects, depending on the extent of the study. tion in a consistent manner rather than trying to have
If the study involves an intervention protocol that the data entry person recode during data entry.
is higher risk to patient safety, a data safety and moni- Such simplicity in data entry reduces the number
toring board is required. This board includes members of data entry errors and markedly decreases the time
who are not directly involved in the study and who required for entry. It is not sufficient to establish
can be objective about the findings to date. This board general rules for individuals entering data such as “in
should meet at regular intervals and discuss whether this case always do X.” This action still requires the
the study should continue or be stopped based on the person who is entering data to recognize a problem,
data collected to date. The board should consist of refer to a general rule, and correct the data before
very experienced researchers and clinical experts. See entry. Correcting the data requires using a different
532 UNIT FOUR  Analyzing Data, Determining Outcomes, and Disseminating Research

color ink from the subject’s mark, and the correction should be randomly checked for accuracy. Data check-
should be initialed by the researcher making the ing is discussed in Chapter 21.
correction.
1. Missing data. Provide the data if possible or deter- Storage and Retrieval of Data
mine the impact of the missing data on your analy- In this time of flash drives and thumb drives, it is
sis. In some cases, the subject must be excluded relatively easy to store data. The original data forms
from at least some of the analyses, so you must and database must be stored for a specified number of
determine what data are essential. years dictated by the funding source or by the journal
2. Items in which the subject provided two responses publisher. There are several reasons to store data. The
when only one was requested. For example, if the data can be used for secondary analyses. For example,
question asked the subject to mark the most impor- researchers participating in a project related to a par-
tant item in a list of 10 items and the subject ticular research focus may pool data from various
selected 2 items, you must decide how to resolve studies for access by all members of the group. Data
this problem; do not leave the decision to an assis- should be available to document the validity of your
tant who is entering the data. In the codebook and analyses and the published results of your study.
on the form itself, indicate how that particular Because of nationally publicized incidents of scien-
datum is to be coded and entered. tific misconduct, where researchers fabricated data
3. Items in which the subject has marked a response and published multiple manuscripts, you would be
between two options. This problem commonly wise to preserve documentation that your data were
occurs with Likert-type scales, particularly scales obtained as you claim. Issues that have been raised
using forced choice options. Given four options, include how long data should be stored, the need
the subject places a mark on the line between for institutional policy regarding data storage, and
response 2 and response 3. In the codebook and on whether graduate students who conduct a study
the form, indicate how the datum is to be coded. should leave a copy of their data at the university.
This is often best coded as a missing value, but Some researchers store their data for 5 years after
coding rules should be consistent. A rationale can publication, whereas others store their data until they
be made to take the highest value, the lowest value, retire from a research career. Researchers should
or code toward the center value. check with their funding sponsors and publishers for
4. Items that ask the subject to write in some informa- guidelines on how long to keep the data. Most
tion such as occupation or diagnosis. Such items researchers store data in their office or laboratory;
are a data enterer’s nightmare. Develop a list of others archive their data in a central location with
codes for entering such data. Rather than leaving it storage fees or retrieval fees. Graduate students do
up to the assistant to determine which code matches have a responsibility to keep and securely store data
the subject’s written response, the researcher from their studies.
should enter this code in a different color and initial
that change before turning the data over for entry.
After the data have been checked and needed codes KEY POINTS
written in, it is prudent to make a copy rather than
turning over the only set of your data to an • Careful planning is needed before collecting and
assistant. managing data.
• The researcher may need to develop data collection
Data Entry Period forms and format these forms to promote accuracy
If you are entering your own data, develop a rhythm and ease of data entry.
to your data entry process. Avoid distractions while • The researcher must determine exactly how and in
entering data, and limit your data entry periods to what sequence data will be collected and the timing
2-hour intervals to reduce fatigue, errors, and repeti- of the process. Information about the procedures to
tive wrist strain or injury. Backup the database after be used must be described in the subject’s informed
each data entry period, and store it on an encrypted consent.
flash drive, on a secure website, or in a fireproof safe. • The researcher must decide who will collect the
It is possible for the computer to crash and lose all of data.
your data. If an assistant is entering your data, make • If data collectors are used, they must be provided
yourself as available as possible to respond to ques- information about the research project, the instru-
tions and address problems. After entry, the data ments, and data collection protocol.
CHAPTER 20  Collecting and Managing Data 533

• Consistency in data collection across subjects is Harris, P. A., Taylor, R., Thielke, R., Payne, J., Gonzalez, N., &
critical, and training is required to promote consis- Conde, J. G. (2009). Research electronic data capture (REDCap)
tency among data collectors if more than one data —A metadata-driven methodology and workflow process for pro-
viding translational research informatics support. Journal of
collector is used.
Biomedical Informatics, 42(2), 377–381.
• After training, data collectors must be evaluated Harwood, E. M. (2009). Data collection methods series: Part 3:
periodically and randomly to determine their Developing protocols for collecting data. Journal of Wound
consistency. Ostomy Continence Nursing, 36(3), 246–250.
• Decision points that occur during data collection Harwood, E. M. & Hutchinson E. (2009). Data collection methods
must be identified, and all options must be series: Part 2: Select the most feasible data collection mode.
considered. Journal of Wound Ostomy Continence Nursing, 36(2), 129–135.
• Data collection also involves maintaining research Humphreys, J., Epel, E. S., Cooper, B. A., Lin, J., Blackburn, E. H.,
controls and solving problems that threaten to & Lee, K. A. (2011, March 8). Telomere shortening in formerly
disrupt the study. abused and never abused women. Biological Research for
Nursing. Available from http://brn.sagepub.com/content/early
• Problems that arise during data collection involve
/2011/03/07/1099800411398479.
recruitment and attrition issues, treatment of the Im, E., Chee, W., Guevara, E., Liu, Y., Lim, H., Tsai, H., et al.
subject as an object, external influences on subject (2007). Gender and ethnic differences in cancer pain experience:
responses, passive resistance from staff members A multiethnic survey in the United States. Nursing Research,
or family, researcher interactions, lack of skill in 56(5), 296–306.
data collection techniques, and researcher role Kang, D. H., Davis, L., Habermann, B., Rice, M., & Broome, M.
conflicts. (2005). Hiring the right people and management of research staff.
• A successful study requires support that is often Western Journal of Nursing Research, 27(8), 1059–1066.
obtained from academic committees, healthcare Lee, K. A. & Gay, C. L. (2011). Can modifications to the bedroom
agencies, and work colleagues. environment improve the sleep of new parents? Two randomized
controlled trials. Research in Nursing & Health, 34(1), 7–19.
• Data collected during a study must be accurately
Lim, L. M., Chiu, L. H., Dohrmann, J., & Tan, K. (2010). Registered
entered in an encrypted computer and safely stored nurses’ medication management of the elderly in aged care facili-
in either a data repository or on an encrypted flash ties. International Nursing Review, 57(1), 98–106.
drive. Melnyk, B. M. & Fineout-Overholt, E. (2010). Evidence-based
practice in nursing and healthcare: A guide to best practice (2nd
ed.). Philadelphia, PA: Lippincott Williams & Wilkins.
REFERENCES Office of Minority Health. (2010). OMB standards for data on race
Badger, T., Segrin, C., Dorros, S., Meek, P., & Lopez, A. M. (2007). and ethnicity. Retrieved from http://minorityhealth.hhs.gov/.
Depression and anxiety in women with breast cancer and their Savian, C., Paratz, J., & Davies, A. (2006). Comparison of the
partners. Nursing Research, 56(1), 44–53. effectiveness of manual and ventilator hyperinflation at different
Bennett, J. M. (2006). The consolidated standards of reporting trials levels of positive end-expiratory pressure in artificially ventilated
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insights into compliance with a mobile phone diary and pedometer in nursing and health research (4th ed.). New York, NY: Springer
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  http://evolve.elsevier.com/Grove/practice/

21
CHAPTER

Introduction to Statistical Analysis

D
ata analysis is often considered one of the most This chapter and the following four chapters provide
exciting steps of the research process. During you with the information needed for critical appraisal
this phase, you will finally obtain answers to of the results sections of published studies and for
the questions that led to the development of your performance of statistical procedures to analyze data
study. Nevertheless, nurses probably experience in studies and in clinical practice. This chapter intro-
greater anxiety about this phase of the research process duces the concepts of statistical theory and discusses
than any other, as they question issues that range from some of the more pragmatic aspects of quantitative
their knowledge about critically appraising published data analysis: the purposes of statistical analysis, the
studies to their ability to conduct research. Critical process of performing data analysis, the method for
appraisal of the results section of a quantitative study choosing appropriate statistical analysis techniques
requires you to be able to (1) identify the statistical for a study, and resources for conducting statistical
procedures used; (2) judge whether these statistical analysis procedures. Chapter 22 explains the use of
procedures were appropriate for the hypotheses, ques- statistics for descriptive purposes, such as describing
tions, or objectives of the study and for the data avail- the study sample or variables. Chapter 23 focuses on
able for analysis; (3) comprehend the discussion of the use of statistics to examine proposed relationships
data analysis results; (4) judge whether the author’s among study variables, such as the relationships
interpretation of the results is appropriate; and (5) among the variables dyspnea, anxiety, and quality of
evaluate the clinical importance of the findings (see life. Chapter 24 explores the use of statistics for pre-
Chapter 18 for more details on critical appraisal). diction, such as using independent variables of age,
As a neophyte researcher performing a quantitative gender, cholesterol values, and history of hypertension
study, you are confronted with many critical decisions to predict the dependent variable of cardiac risk level.
related to data analysis that require statistical knowl- Chapter 25 guides you in using statistics to determine
edge. To perform statistical analysis of data from a differences between groups, such as determining the
quantitative study, you need to be able to (1) determine difference in muscle strength and falls (dependent
the necessary sample size to power your study ade- variables) between an experimental or intervention
quately; (2) prepare the data for analysis; (3) describe group receiving a strength training program (indepen-
the sample; (4) test the reliability of measures used in dent variable) and a comparison group receiving stan-
the study; (5) perform exploratory analyses of the dard care.
data; (6) perform analyses guided by the study objec-
tives, questions, or hypotheses; and (7) interpret the
results of statistical procedures. We recommend con- Concepts of Statistical Theory
sulting with a statistician or expert researcher early in One reason nurses tend to avoid statistics is that many
the research process to help you develop a plan for were taught the mathematical mechanics of calculat-
accomplishing these seven tasks. A statistician is also ing statistical formulas and were given little or no
invaluable in conducting data analysis for a study and explanation of the logic behind the analysis procedure
interpreting the results. or the meaning of the results (Grove, 2007). This
Critical appraisal of the results of studies and sta- mathematical process is usually performed by com-
tistical analyses both require an understanding of the puter, and information about it offers little assistance
statistical theory underlying the process of analysis. to the individuals making statistical decisions or

534
CHAPTER 21  Introduction to Statistical Analysis 535

explaining results. We approach data analysis from the error) and (2) the probability of retaining the null
perspective of enhancing your understanding of the hypothesis when it is in fact false (beta [β], Type II
meaning underlying statistical analysis. You can use error). In nursing research, alpha is usually set at
this understanding either for critical appraisal of 0.05, meaning that the researcher will allow a 5% or
studies or for conducting data analyses. lower chance of making a Type I error. The beta is
The ensuing discussion explains some of the con- frequently set at 0.20, meaning that the researcher will
cepts commonly used in statistical theory. The logic allow for a 20% or lower chance of making a Type II
of statistical theory is embedded within the explana- error.
tions of these concepts. The concepts presented in this After conducting the study, the researcher culmi-
chapter include probability theory, classical hypothe- nates the hypothesis testing process by making a ratio-
sis testing, Type I and Type II errors, statistical power, nal decision either to reject or to retain the null
statistical significance versus clinical importance, hypothesis, based on the statistical results. The follow-
inference, samples and populations, descriptive and ing steps outline each of the components of statistical
inferential statistical techniques, measures of central hypothesis testing.
tendency, the normal curve, sampling distributions, 1. State your primary null hypothesis. (Chapter 8 dis-
symmetry, skewness, modality, kurtosis, variation, cusses the development of the null hypothesis.)
confidence intervals, and parametric and nonparamet- 2. Set your study alpha (Type I error); this is usually
ric types of inferential statistical analyses. α = 0.05.
3. Set your study beta (Type II error); this is usually
Probability Theory β = 0.20.
Probability theory addresses statistical analysis as 4. Conduct power analyses (Aberson, 2010; Cohen,
the likelihood of accurately predicting an event or the 1988).
extent of an effect. Nurse researchers might be inter- 5. Design and conduct your study.
ested in the probability of a particular nursing outcome 6. Compute the appropriate statistic on your obtained
in a particular patient care situation. For example, data.
what is the probability of patients older than 75 years 7. Compare your obtained statistic with its corre-
of age with cardiac conditions falling when hospital- sponding theoretical distribution in the tables pro-
ized? With probability theory, you could determine vided in the Appendices at the back of this book.
how much of the variation in your data could be For example, if you analyzed your data with a t-
explained by using a particular statistical analysis. In test, you would compare the t value from your
probability theory, the researcher interprets the study with the critical values of t in the table.
meaning of statistical results in light of his or her 8. If your obtained statistic exceeds the critical value
knowledge of the field of study. A finding that would in the distribution table, you can reject your null
have little meaning in one field of study might be hypothesis. If not, you must accept your null
important in another (Good, 1983; Kerlinger & Lee, hypothesis. These ideas are discussed in more
2000). Probability is expressed as a lowercase p, with depth in Chapters 23 through 25 when the results
values expressed as percentages or as a decimal value of statistics are presented.
ranging from 0 to 1. For example, if the exact prob- Cox (1958, p. 159) stated, “Significance tests, from
ability is known to be 0.23, it would be expressed as this point of view, measure the adequacy of the data
p = 0.23. The p in statistics is defined as the probability to support the qualitative conclusion that there is a true
of rejecting the null hypothesis when the null is actu- effect in the direction of the apparent difference.”
ally true. Nurse researchers typically consider a p = Thus, the decision is a judgment and can be in error.
0.05 value or less to indicate a real effect. The level of statistical significance attained indicates
the degree of uncertainty in taking the position that the
Classical Hypothesis Testing difference between the two groups is real. Classical
Classical hypothesis testing refers to the process of hypothesis testing has been largely criticized for such
testing a hypothesis to infer the reality of an effect. errors in judgments (Cohen, 1994; Loftus 1993). Much
This process starts with the statement of a null hypoth- emphasis has been placed on researchers providing
esis, which assumes no effect (e.g., no difference indicators of effect, rather than just relying on p values,
between groups, or no relationship between variables). specifically, providing the magnitude of the obtained
The researcher sets the values of two theoretical prob- effect (e.g., a difference or relationship) as well as
abilities: (1) the probability of rejecting the null confidence intervals associated with the statistical find-
hypothesis when it is in fact true (alpha [α], Type I ings. These additional statistics give consumers of
536 UNIT FOUR  Analyzing Data, Determining Outcomes, and Disseminating Research

TABLE 21-1  Type I and Type II Errors


Decision
Reject Null Accept Null
True Population Status Null Is True Type I Error Correct Decision
α 1−α
Null Is False Correct Decision Type II Error
1−β β

research more information about the phenomenon means that the power of the planned statistic has been
being studied (Cohen 1994). set to 0.80. In other words, the statistic will have an
80% chance of detecting an effect if it actually exists.
Type I and Type II Errors Reported studies failing to reject the null hypoth-
We choose the probability of making a Type I error esis (in which power is unlikely to have been exam-
when we set alpha, and if we decrease the probability ined) often have a low power level to detect an effect
of making a Type I error, we increase the probability if one exists. Until more recently, the researcher’s
of making a Type II error. The relationships between primary interest was in preventing a Type I error.
Type I and Type II errors are defined in Table 21-1. Therefore, great emphasis was placed on the selection
Type II error occurs as a result of some degree of of a level of significance, but little emphasis was
overlap between the values of different populations, placed on power. This point of view is changing as we
so in some cases a value with a greater than 5% prob- recognize the seriousness of a Type II error in nursing
ability of being within one population may be within studies.
the dimensions of another population. As stated in the steps of classical hypothesis testing
It is impossible to decrease both types of error previously, step 4 is “conducting a power analysis.”
simultaneously without a corresponding increase in Power analysis involves determining the required
sample size. The researcher needs to decide which risk sample size needed to conduct your study after per-
poses the greatest threat within a specific study. In forming steps 1, 2, and 3. Cohen (1988) identified four
nursing research, many studies are conducted with parameters of power: (1) significance level, (2) sample
small samples and instruments that lack precision and size, (3) effect size, and (4) power (standard of 0.80).
accuracy in the measurement of study variables. Many If three of the four are known, the fourth can be cal-
nursing situations include multiple variables that inter- culated by using power analysis formulas. Signifi-
act to lead to differences within populations. However, cance level and sample size are straightforward.
when one is examining only a few of the interacting Chapter 15 provides a detailed discussion of determin-
variables, small differences can be overlooked and ing sample size in quantitative studies that includes
could lead to a false conclusion of no differences power analysis. Effect size is “the degree to which the
between the samples. In this case, the risk of a Type phenomenon is present in the population or the degree
II error is a greater concern, and a more lenient level to which the null hypothesis is false” (Cohen, 1988,
of significance is in order. Nurse researchers usually pp. 9-10). For example, suppose you were measuring
set the level of significance or α = 0.05 for their changes in anxiety levels, measured first when the
studies versus a more stringent α = 0.01 or 0.001. patient is at home and then just before surgery. The
Setting α = 0.05 reduces the risk of a Type II error effect size would be large if you expected a great
of indicating study results are not significant when change in anxiety. If you expected only a small change
they are. in the level of anxiety, the effect size would be small.
Small effect sizes require larger samples to detect
Statistical Power these small differences (see Chapter 15 for a detailed
Power is the probability that a statistical test will discussion of effect size). If the power is too low, it
detect an effect when it actually exists. Power is the may not be worthwhile conducting the study unless a
inverse of Type II error and is calculated as 1 − β. Type large sample can be obtained because statistical tests
II error is the probability of retaining the null hypoth- are unlikely to detect differences or relationships that
esis when it is in fact false. When the researcher sets exist. Deciding to conduct a study in these circum-
Type II error at 0.20 before conducting a study, this stances is costly in time and money, frequently does
CHAPTER 21  Introduction to Statistical Analysis 537

TABLE 21-2  Software Applications for magnitude of the difference between the groups or the
Statistical Analysis
relationship between two variables. The magnitude of
group differences can best be determined through cal-
Software Application Website culating effect sizes and confidence intervals (see
NCSS (Number Cruncher www.ncss.com Chapters 22 through 25).
Statistical System)
SPSS (Statistical Packages for www.spss.com Inference
the Social Sciences)
Statisticians use the terms inference and infer in a
SAS (Statistical Analysis System) www.sas.com
S+ spotfire.tibco.com
similar way that a researcher uses the term generalize.
Stata www.stat.com Inference requires the use of inductive reasoning. One
JMP www.jmp.com infers from a specific case to a general truth, from a
part to the whole, from the concrete to the abstract,
from the known to the unknown. When using inferen-
tial reasoning, you can never prove things; you can
not add to the body of nursing knowledge, and can never be certain. However, one of the reasons for the
lead to false conclusions. Power analysis can be con- rules that have been established with regard to statisti-
ducted via hand calculations, computer software, or cal procedures is to increase the probability that infer-
online calculators and should be performed to deter- ences are accurate. Inferences are made cautiously
mine the sample size necessary for a particular study and with great care. Researchers use inferences to
(Aberson, 2010). Power analysis can be calculated by infer from the sample in their study to the larger
using the free power analysis software G*Power population.
(Faul, Erdfelder, Lang, & Buchner, 2007) or statisti-
cal software such as NCSS, SAS, and SPSS (Table Samples and Populations
21-2). In addition, many free sample size calculators Use of the terms statistic and parameter can be con-
are available online that are easy to use and under- fusing because of the various populations referred to
stand. If you have questions, you could consult a in statistical theory. A statistic, such as a mean (X), is
statistician. a numerical value obtained from a sample. A param-
The power achieved should be reported with the eter is a true (but unknown) numerical characteristic
results of the studies, especially studies that fail to of a population. For example, µ is the population mean
reject the null hypothesis (have nonsignificant results). or arithmetic average. The mean of the sampling dis-
If power is high, it strengthens the meaning of the tribution (mean of samples’ means) can also be shown
findings. If power is low, researchers need to address to be equal to µ. A numerical value that is the mean
this issue in the discussion of limitations and implica- (X) of the sample is a statistic; a numerical value that
tions of the study findings. Modifications in the is the mean of the population (µ) is a parameter
research methodology that resulted from the use of (Barnett, 1982).
power analysis also need to be reported. Relating a statistic to a parameter requires an infer-
ence as one moves from the sample to the sampling
Statistical Significance versus distribution and then from the sampling distribution to
Clinical Importance the population. The population referred to is in one
The findings of a study can be statistically significant sense real (concrete) and in another sense abstract.
but may not be clinically important. For example, one These ideas are illustrated as follows:
group of patients might have a body temperature 0.1°
F higher than that of another group. Data analysis Abstract
might indicate that the two groups are statistically Infer Infer
Sample Sampling Population Infer
significantly different. However, the findings have distribution
little or no clinical importance because of the small Concrete
difference in temperatures between groups. It is often
important to know the magnitude of the difference For example, perhaps you are interested in the cho-
between groups in studies. However, a statistical test lesterol levels of women in the United States. Your
that indicates significant differences between groups population is women in the United States. You cannot
(e.g., a t-test) provides no information on the magni- measure the cholesterol level of every woman in the
tude of the difference. The extent of the level of sig- United States; therefore, you select a sample of women
nificance (0.01 or 0.0001) tells you nothing about the from this population. Because you wish your sample
538 UNIT FOUR  Analyzing Data, Determining Outcomes, and Disseminating Research

to be as representative of the population as possible, variable or variables being studied. A frequency dis-
you obtain your sample by using random sampling tribution is a plot of one variable, whereby the x-axis
techniques (see Chapter 15). To determine whether the consists of the possible values of that variable, and the
cholesterol levels in your sample are similar to those y-axis is the tally of each value. For example, if you
in the population, you must compare the sample with assessed a sample for a variable such as pain using a
the population. One strategy would be to compare the visual analogue scale, and your subjects reported par-
mean of your sample with the mean of the entire ticular values for pain, you could create a frequency
population. However, it is highly unlikely that you distribution as illustrated in Figure 21-1.
know the mean of the entire population; you must
make an estimate of the mean of that population. You Measures of Central Tendency
need to know how good your sample statistics are as The measures of central tendency are descriptive sta-
estimators of the parameters of the population. First, tistics. The statistics that represent measures of central
you make some assumptions. You assume that the tendency are the mean, median, and mode. All of these
mean scores of cholesterol levels from multiple, ran- statistics are representations or descriptions of the
domly selected samples of this population would be center or middle of a frequency distribution. The
normally distributed. This assumption implies another mean is the arithmetic average of all of the values of
assumption: that the cholesterol levels of the popula- a variable. The median is the exact middle value (or
tion will be distributed according to the theoretical the average of the middle two values if there is an
normal curve—that difference scores and standard even number of observations). The mode is the most
deviations can be equated to those in the normal curve. commonly occurring value in a data set (Grove,
The normal curve is discussed later in this chapter. 2007; Munro, 2005). It is possible to have more
If you assume that the population in your study is than one mode in a sample, which is discussed
normally distributed, you can also assume that this later in this chapter. In a normal curve, the mean,
population can be represented by a normal sampling median, and mode are equal or approximately equal
distribution. You infer from your sample to the sam- (see Figure 21-2).
pling distribution, the mathematically developed theo-
retical population made up of parameters such as the Normal Curve
mean of means and the standard error. The parameters The theoretical normal curve is an expression of sta-
of this theoretical population are the measures of the tistical theory. It is a theoretical frequency distribution
dimensions identified in the sampling distribution. of all possible scores (see Figure 21-2). However, no
You can infer from the sampling distribution to the real distribution fits the normal curve exactly. The idea
population. You have both a concrete population and of the normal curve was developed by an 18-year-old
an abstract population. The concrete population con- mathematician, Gauss, in 1795, who found that data
sists of all the individuals who meet your study sample measured repeatedly in many samples from the same
criteria, whereas the abstract population consists of population by using scales based on an underlying
individuals who will meet your sample criteria in the continuum can be combined into one large sample.
future or the groups addressed theoretically by your From this large sample, one can develop a more accu-
framework. rate representation of the pattern of the curve in that
population than is possible with only one sample. In
Types of Statistics most cases, the curve is similar, regardless of the spe-
There are two major classes of statistics: descriptive cific data that have been examined or the population
statistics and inferential statistics. Descriptive statis- being studied. This theoretical normal curve is sym-
tics are computed to reveal characteristics of the metrical and unimodal and has continuous values. The
sample and to describe study variables. Inferential mean, median, and mode are equal. The distribution
statistics are computed to draw conclusions and make is completely defined by the mean and standard devia-
inferences about the greater population, based on the tion, which are calculated and discussed further in
sample data set. The following sections define the Chapter 22.
concepts and rationale associated with descriptive and
inferential statistics. Sampling Distributions
The shape of the distribution provides important
Descriptive Statistics information about the data. The outline of the distri­
A basic yet important way to begin describing a bution shape is obtained by using a histogram. Within
sample is to create a frequency distribution of the this outline, the mean, median, mode, and standard
CHAPTER 21  Introduction to Statistical Analysis 539

Frequency 5

0
1 2 3 4 5 6 7 8
Pain scores

Figure 21-1  Frequency distribution of visual analogue scale pain scores.

Mean
Median
Mode

2.28% 13.59% 34.13% 34.13% 13.59% 2.28%

Standard
deviation –2 s –1 s X +1 s +2 s

Figure 21-2  Normal curve.

deviation can be graphically illustrated (see Figure means obtained from that skewed population tends to
21-2). This visual presentation of combined summary fit the pattern of the normal curve. This phenomenon
statistics provides insight into the nature of the distri- is referred to as the central limit theorem.
bution. As the sample size becomes larger, the shape
of the distribution more accurately reflects the shape Symmetry
of the population from which the sample was taken. Several terms are used to describe the shape of the
Even when statistics, such as means, come from a curve (and the nature of a particular distribution). The
population with a skewed (asymmetrical) distribution, shape of a curve is usually discussed in terms of
the sampling distribution developed from multiple symmetry, skewness, modality, and kurtosis. A
540 UNIT FOUR  Analyzing Data, Determining Outcomes, and Disseminating Research

symmetrical curve is one in which the left side is a occurrence of chronic illness by age in a population
mirror image of the right side (see Figure 21-3). In are negatively skewed, with most chronic illnesses
these curves, the mean, median, and mode are equal occurring in older age groups. Figure 21-4 includes
and are the dividing point between the left and right both a positively skewed distribution and a negatively
sides of the curve. skewed distribution.
In a skewed distribution, the mean, median, and
Skewness mode are not equal. Skewness interferes with the
Any curve that is not symmetrical is referred to as validity of many statistical analyses; therefore, statisti-
skewed or asymmetrical. Skewness may be exhib- cal procedures have been developed to measure the
ited in the curve in various ways. A curve may be skewness of the distribution of the sample being
positively skewed, which means that the largest studied. Few samples are perfectly symmetrical;
portion of data is below the mean. For example, data however, as the deviation from symmetry increases,
on length of enrollment in hospice are positively the seriousness of the impact on statistical analysis
skewed. Most people die within the first 3 weeks of increases. In a positively skewed distribution, the
enrollment, whereas increasingly smaller numbers mean is greater than the median, which is greater than
survive as time increases. A curve can also be nega- the mode. In a negatively skewed distribution, the
tively skewed, which means that the largest portion mean is less than the median, which is less than the
of data is above the mean. For example, data on the mode (see Figure 21-4).

Modality
Mean Another characteristic of distributions is their modal-
Median ity. Most curves found in practice are unimodal,
Mode
which means that they have one mode, and frequen-
cies progressively decline as they move away from the
mode. Symmetrical distributions are usually uni-
modal. However, curves can also be bimodal (see
Figure 21-5) or multimodal. When you find a bimodal

Figure 21-3  Symmetrical curve. Figure 21-5  Bimodal distribution.

Mode Mode
Median Median

Mean Mean

Positively skewed Negatively skewed

Figure 21-4  Skewness.


CHAPTER 21  Introduction to Statistical Analysis 541

Leptokurtic Mesokurtic Platykurtic

Figure 21-6  Kurtosis.

sample, it usually means that you have not defined these statistics to be reported in the literature is the
your population adequately. standard deviation because of its direct association
with the normal curve. If the frequency distribution of
Kurtosis any given variable is approximately normal, knowing
Another term used to describe the shape of the distri- the standard deviation of that variable allows us to
bution curve is kurtosis. Kurtosis explains the degree know what percentages of subjects’ values on that
of peakedness of the curve, which is related to the variable fall between +1 and −1 standard deviation.
spread or variance of scores. An extremely peaked Referring back to the hypothetical frequency distribu-
curve is referred to as leptokurtic, an intermediate tion of pain in Figure 21-1, when we calculate a stan-
degree of kurtosis is referred to as mesokurtic, and a dard deviation, we know that 34.13% of the subjects’
relatively flat curve is referred to as platykurtic (see pain scores were between the mean pain score and 1
Figure 21-6). Extreme kurtosis can affect the validity standard deviation above the mean pain score. We also
of statistical analysis because the scores have little know that 34.13% of the subjects’ pain scores were
variation in a leptokurtic curve. Many computer pro- between the mean pain score and 1 standard deviation
grams analyze kurtosis before conducting statistical below the mean. The middle 95.44% of the subjects’
analyses. A kurtosis of zero indicates that the curve is scores were between −2 standard deviations and +2
mesokurtic. Kurtosis values above zero indicate that standard deviations.
the curve is leptokurtic, and values below zero that are
negative indicate a platykurtic curve (Box, Hunter, & Confidence Intervals
Hunter, 1978). When the probability of including the value of the
parameter within the interval estimate is known, this
Tests of Normality is referred to as a confidence interval. Calculating a
oasis-ebl|Rsalles|1476461060

Statistics are computed to obtain an indication of the confidence interval involves the use of two formulas
skewness and kurtosis of a given frequency distribu- to identify the upper and lower ends of the interval
tion. The Shapiro-Wilk’s W test is a formal test of (see Chapter 22 for calculations). Confidence intervals
normality that assesses whether the distribution of a are usually expressed as “(38.6, 41.4),” with 38.6
variable is skewed or kurtotic or both. This test has being the lower end and 41.4 being the upper end of
the ability to calculate both skewness and kurtosis for the interval. Theoretically, we can produce a confi-
a study variable such as pain measured with a visual dence interval for any parameter of a distribution. It
analog scale. For large samples (n > 2000), the is a generic statistical procedure. Confidence intervals
Kolmogorov-Smirnov D test is an alternative test of can also be developed around correlation coefficients
normality for large samples. (Glass & Stanley, 1970). Estimation can be used for a
single population or for multiple populations. In esti-
Variation mation, we are inferring the value of a parameter from
The range, standard deviation, and variance are statis- sample data and have no preconceived notion of the
tics that describe the extent to which the values in the value of the parameter. In contrast, in hypothesis
sample vary from one another. The most common of testing, we have an a priori theory about the value of
542 UNIT FOUR  Analyzing Data, Determining Outcomes, and Disseminating Research

the parameter or parameters or some combination of researchers often analyze data from a Likert scale with
parameters. A formula is provided for calculating con- strong reliability and validity as though they are inter-
ference intervals and example confidence intervals are val level data (see Chapter 17 for a description of
provided for different analysis results in Chapters 22 Likert scales).
through 25.

Inferential Statistics Practical Aspects of


Inferential statistics are computed to draw conclusions
and make inferences about the greater population, Data Analysis
based on the sample data set. There are two classes of Statistics can be used for a variety of purposes, such
inferential statistics: parametric and nonparametric as to (1) summarize, (2) explore the meaning of devia-
statistics. tions in the data, (3) compare or contrast descriptively,
(4) test the proposed relationships in a theoretical
Parametric Statistics model, (5) infer that the findings from the sample are
The most commonly used type of statistical analysis indicative of the entire population, (6) examine causal-
is parametric statistics. The analysis is referred to as ity, (7) predict, or (8) infer from the sample to a
parametric statistical analysis because the findings theoretical model. These different purposes for data
are inferred to the parameters of a normally distributed analysis are addressed in Chapters 22 through 25.
population. These approaches to analysis emerged The process of quantitative data analysis consists
from the work of Fisher (1935) and require meeting of several stages: (1) preparation of the data for analy-
the following three assumptions before they can justi- sis; (2) description of the sample; (3) testing the reli-
fiably be used. ability of measurement; (4) exploratory analysis of the
1. The sample was drawn from a population for which data; (5) confirmatory analysis guided by the hypoth-
the variance can be calculated. The distribution is eses, questions, or objectives; and (6) post hoc analy-
usually expected to be normal or approximately sis. Statisticians such as Tukey (1977) divided the role
normal (Conover, 1971, Munro, 2005). of statistics into two parts: exploratory data analysis
2. Because most parametric techniques deal with con- and confirmatory data analysis. You can perform
tinuous variables rather than discrete variables, the exploratory data analysis to obtain a preliminary
level of measurement should be at least interval indication of the nature of the data and to search the
level data or ordinal data with an approximately data for hidden structure or models. Confirmatory
normal distribution. data analysis involves traditional inferential statistics,
3. The data can be treated as random samples (Box which you can use to make an inference about a popu-
et al., 1978). lation or a process based on evidence from the study
sample.
Nonparametric Statistics Although not all of these six stages are reflected in
Nonparametric statistical analysis, or distribution- the final published report of the study, they all contrib-
free techniques, can be used in studies that do not meet ute to the insight you can gain from analyzing the data.
the first two assumptions of normal distribution and at Many novice researchers do not plan the details of
least interval level data. Most nonparametric tech- data analysis until the data are collected and they are
niques are not as powerful as their parametric coun- confronted with the analysis task. This research tech-
terparts (Tanizaki, 1997). In other words, nonparametric nique is poor and often leads to the collection of unus-
techniques are less able to detect differences and have able data or the failure to collect the data needed to
a greater risk of a Type II error if the data meet the answer the research questions. Plans for data analysis
assumptions of parametric procedures; this is gener- need to be made during development of the study
ally because nonparametric statistics are actually per- methodology. The following section covers the six
formed on ranks of the original data. When data have stages of quantitative data analysis.
been converted into ranks, they inevitably lose accu-
racy. Because nonparametric statistics have lower sta- Preparing the Data for Analysis
tistical power, many researchers choose to submit Except in very small studies, computers are almost
ordinal data to parametric statistical procedures. If the universally used for data analysis. Use of computers
instrument or measurement procedure yielding ordinal has increased over the last decade with easy-to-use
data has been rigorously evaluated, parametric statis- data analysis packages becoming available for per-
tics are justified (Fife-Schaw, 1995). For example, sonal computers (PCs). When computers are used
CHAPTER 21  Introduction to Statistical Analysis 543

for analysis, the first step of the process is entering of statistical applications. The seminal publication on
the data into the computer. Table 21-2 lists examples the subject of missing data imputation was written by
of common statistical packages used for nursing Rubin (1976).
research.
Before entering data into the computer, the com- Data Transformations
puter file that will contain the data needs to be care- Skewed or non–normally distributed data that do not
fully prepared with information from the codebook as meet the assumptions of parametric analysis can
described in Chapter 20. The location of each variable sometimes be transformed in such a way that the
in the computer file needs to be identified. Each vari- values are distributed closer to the normal curve.
able must be labeled in the computer so that the vari- Various mathematical operations are used for this
ables involved in a particular analysis are clearly purpose. Examples of these operations include squar-
designated on the computer printouts. Develop a sys- ing each value, calculating the square root of each
tematic plan for data entry that is designed to reduce value, or calculating the logarithm of each value.
errors during the entry phase, and enter data during These operations can allow the researcher to yield a
periods when you have few interruptions. frequency distribution that more closely approximates
In some cases, data must be reverse-scored before normality, freeing the researcher to compute paramet-
initiating data analysis. Items in scales are often ar­ ric statistics.
ranged so that sometimes a higher numbered response
indicates more of the construct being studied, and Data Calculations and Scoring
sometimes a higher numbered response indicates less Sometimes a variable used in the analysis is not col-
of the construct being studied. This arrangement pre- lected but calculated from other variables and is
vents the subject from giving a global response to all referred to as a calculated variable. For example, if
items in the scale. To reduce errors, the values on these data are collected on the number of patients on a
items need to be entered into the computer exactly as nursing unit and on the number of nurses on a shift,
they appear on the data collection form. Values on the one might calculate a ratio of nurse to patient for a
items are reversed by computer commands. particular shift. The data are more accurate if this
calculation is performed by computer rather than man-
Cleaning the Data ually. The results can be stored in the data file as a
Print the data file so that the data can be examined for variable rather than being recalculated each time
errors. When the size of the data file allows, you need the variable is used in an analysis (Shortliffe &
to cross-check every datum on the printout with the Cimino, 2006).
original datum for accuracy. Otherwise, randomly
check the accuracy of data points. Correct all errors Data Storage and Documentation
found in the computer file. Perform a computer analy- When the data-cleaning process is complete, backups
sis of the frequencies of each value of every variable need to be made again; labeled as the complete,
as a second check of the accuracy of the data. Search cleaned data set; and carefully stored. Data cleaning
for values outside the appropriate range of values for is a time-consuming process that you will not wish to
that variable. Data that have been scanned into a com- repeat unnecessarily. If your data are being stored on
puter are less likely to have errors but should still be a PC hard disk drive, be sure to back up the informa-
checked. tion each time you enter more data. It is wise to keep
a second copy of the data filed at a separate, carefully
Identifying Missing Data protected site. If your data are being stored on a
Identify all missing data points. Determine whether network, ensure that the network drive is being backed
the information can be obtained and entered into the up at least once a day. After data entry, you need to
data file. If a large number of subjects have missing store the original data in secure files for safekeeping.
data on specific variables, you need to make a judg- The data files need to be secured as designated by
ment regarding the availability of sufficient data to institutional review board policies. This usually
perform analysis with those variables. In some cases, includes password protecting computer data files or
subjects must be excluded from the analysis because storing data on encrypted flash drives to which only
of missing essential data. Missing data can also be the research team has access.
imputed via missing data statistical procedures. The Results of data analysis can easily become lost in
rules involving the appropriateness of missing data the mountain of printer paper. Rather than keep paper
imputations are complex, and there are many choices printouts of statistical output, it is recommended that
544 UNIT FOUR  Analyzing Data, Determining Outcomes, and Disseminating Research

you make pdf (portable document format) files of each Testing the Reliability
output file and store these files in the same folder as of Measurement Methods
your data sets and reports. There are many free pdf Examine the reliability of the methods of measure-
converters available on the Internet for download. A ment used in the study. The reliability of observational
pdf converter allows you to convert any file into a pdf measures or physiological measures may have been
file, which can be read by most computer operating obtained during the data collection phase, but it needs
systems. Converting output files into pdf files allows to be noted at this point. Additional examination of the
the researcher to transport those files and read reliability of measurement methods, such as a Likert
them on any computer, even a computer that does not scale, is possible at this point. If you used a multiple-
house the statistical software that created the original item Likert scale in data collection, alpha coefficients
output file. need to be calculated (Waltz, Strickland, & Lenz,
All files, including data sets and output files, need 2010). The value of the coefficient needs to be com-
to be systematically named to allow easy access later pared with values obtained for the instrument in previ-
when theses or dissertations are being written or ous studies. If the alpha coefficient is unacceptably
research papers are being prepared for publication. We low (<0.6), you need to determine if you are justified
recommend naming files by time sequence. Name the in performing analysis on data from the instrument
file by its contents, and at the end of the file name, (see Chapter 16).
identify the date (month, day, and year) that the file
was created or the analysis was performed. For Exploratory Analysis of the Data
example, the files named “Rehab Outcomes Data Examine all the data descriptively, with the intent of
03-29-12” and “Means and Standard Deviations of becoming as familiar as possible with the nature of the
Pain Subscales 06-23-12” represent a data file saved data. You might explore the data by conducting mea-
on March 29, 2012, and a statistical output file con- sures of central tendency and dispersion and examin-
taining means and standard deviations of subscale ing outliers of the data. Neophyte researchers often
scores saved on June 23, 2012. omit this step and jump immediately into the analyses
When you are preparing papers that describe your that were designed to test their hypotheses, questions,
study, the results of each analysis reported in the paper or objectives. However, they omit this step at the risk
need to be cross-indexed with the output file for refer- of missing important information in the data and per-
ence as needed. As interpretation of the results pro- forming analyses that are inappropriate for the data.
ceeds and you attempt to link various findings, you The researcher needs to examine data on each variable
may question some of the results. Selected results may by using measures of central tendency and dispersion.
not seem to fit with the rest of the results, or they may Are the data skewed or normally distributed? What is
not seem logical. You may find that you have failed to the nature of the variation in the data? Are there outli-
include necessary statistical information. When rewrit- ers with extreme values that appear different from the
ing a paper for publication, you may need to report rest of the sample that cause the distribution to be
additional results requested by reviewers. The search skewed? The most valuable insights from a study
for a particular output can be time-consuming and sometimes come from careful examination of outliers
frustrating if the printouts have not been carefully (Tukey, 1977).
organized. It is easy to lose needed results and have In many cases, as a part of exploratory analysis,
to repeat the analysis. inferential statistical procedures are used to examine
differences and associations within the sample. From
Description of the Sample an exploratory perspective, these analyses are relevant
After the data have been successfully entered in the only to the sample under study. There should be no
computer and stored, researchers start conducting the intent to infer to a population. If group comparisons
essential analysis techniques for their studies. The first are made, effect sizes need to be determined for the
step is to obtain as complete a picture as possible of variables involved in the analyses.
the sample. The demographic variables, such as age, In some nursing studies, the purpose of the study
gender, and economic status, are analyzed with the is exploratory analysis. In such studies, it is often
appropriate analysis techniques and used to develop found that sample sizes are small, power is low, mea-
the characteristics of the sample. The analysis tech- surement methods have limited reliability and validity,
niques used in describing the sample are covered in and the field of study is relatively new. If treatments
Chapter 22. are tested, the procedure might be approached as a
CHAPTER 21  Introduction to Statistical Analysis 545

pilot study. The most immediate need is tentative the extreme statistical values that occur in a single
exploration of the phenomena under study. Confirming tail of the curve are of interest. In a two-tailed
the findings of these studies requires more rigorously test of significance, the hypothesis is nondirec-
designed studies with much larger samples. Many of tional or null, and the extreme statistical values in
these exploratory studies are reported in the literature both ends of the curve are of interest. Tailedness
as confirmatory studies, and attempts are made to is discussed in more detail in Chapter 25.
infer to larger populations. Because of the unaccept- 5. Determine the sample size available for the analy-
ably high risk of a Type II error in these studies, sis. If several groups will be used in the analysis,
negative findings should be viewed with caution. identify the size of each group.
6. Evaluate the representativeness of the sample (see
Using Tables and Graphs for Exploratory Analysis Chapter 15).
Although tables and graphs are commonly thought of 7. Determine the risk of a Type II error in the analy-
as a way of presenting the findings of a study, these sis by performing a power analysis.
tools may be even more useful in helping the researcher 8. Develop dummy tables and graphics to illustrate
to become familiar with the data (see Figure 21-1 of the methods that you will use to display your
the frequency distribution of visual analogue scale results in relation to your hypotheses, questions,
pain scores). Tables and graphs need to illustrate the or objectives.
descriptive analyses being performed, even though 9. Determine the degrees of freedom for your analy-
they will probably not be included in a research report. sis. Degrees of freedom (df) involve the freedom
These tables and figures are prepared for the sole of a score’s value to vary given the other existing
purpose of helping researchers to identify patterns in scores’ values. The calculation of df varies based
their data and interpret exploratory findings, but they on the analysis techniques conducted; Chapters
are sometimes useful in reporting study results to 22 through 25 provide additional information and
selected groups (Munro, 2005). Visualizing the data in examples of df.
various ways can greatly increase insight regarding 10. Perform the analyses with a computer and rarely
the nature of the data (see Chapter 22). manually.
11. Compare the statistical value obtained with the
Confirmatory Analysis table value by using the level of significance,
As the name implies, confirmatory analysis is per- tailedness of the test, and df previously identified.
formed to confirm expectations regarding the data that 12. Most analyses are conducted by computer, and the
are expressed as hypotheses, questions, or objectives. computer printout includes the statistical value
The findings are inferred from the sample to the popu- obtained by analyzing the data, p value, and df for
lation. Thus, inferential statistical procedures are used. each inferential analysis technique.
The design of the study, the methods of measurement, 13. Reexamine the analysis to ensure that the proce-
and the sample size must be sufficient for this confir- dure was performed with the appropriate vari-
matory process to be justified. A written analysis plan ables and that the statistical procedure was
needs to describe clearly the confirmatory analyses correctly specified in the computer program.
that will be performed to examine each hypothesis, 14. Interpret the results of the analysis in terms of the
question, or objective. hypothesis, question, or objective.
1. Identify the level of measurement of the data avail- 15. Interpret the results in terms of the framework.
able for analysis with regard to the research objec-
tive, question, or hypothesis (see Chapter 16). Post Hoc Analysis
2. Select a statistical procedure or procedures appro- Post hoc analyses are commonly performed in studies
priate for the level of measurement that will with more than two groups when the analysis indicates
respond to the objective, answer the question, or that the groups are significantly different but does not
test the hypothesis. indicate which groups are different. For example, an
3. Select the level of significance that you will use analysis of variance is conducted to examine the dif-
to interpret the results, which is usually α = 0.05. ferences among three groups—experimental group,
4. Choose a one-tailed or two-tailed test if appropri- control group, and placebo group—and the groups are
ate to your analysis. The extremes of the normal found to be significantly different. A post hoc analysis
curve are referred to as tails. In a one-tailed test must be performed to determine which of the three
of significance, the hypothesis is directional, and groups are significantly different. Post hoc analysis is
546 UNIT FOUR  Analyzing Data, Determining Outcomes, and Disseminating Research

discussed in more detail in Chapter 25. In other 1. How many variables does the problem involve?
studies, the insights obtained through the planned 2. How do you want to treat the variables with
analyses generate further questions that can be exam- respect to the scale of measurement?
ined with the available data. 3. What do you want to know about the distribution
of the variable?
4. Do you want to treat outlying cases differently
Choosing Appropriate Statistical from others?
5. What is the form of the distribution?
Procedures for a Study 6. Is a distinction made between a dependent and an
Multiple factors are involved in determining the suit- independent variable?
ability of a statistical procedure for a particular study. 7. Do you want to test whether the means of the two
These factors can be related to the nature of the study, variables are equal?
the nature of the researcher, and the nature of statisti- 8. Do you want to treat the relationship between
cal theory. Specific factors include (1) the purpose of variables as linear?
the study; (2) hypotheses, questions, or objectives; (3) 9. How many of the variables are dichotomous?
design; (4) level of measurement; (5) previous experi- 10. Is the dichotomous variable a collapsing of a con-
ence in statistical analysis; (6) statistical knowledge tinuous variable?
level; (7) availability of statistical consultation; (8) 11. Do you want to treat the ranks of ordered catego-
financial resources; and (9) access to computers. Use ries as interval scales?
items 1 to 4 to identify statistical procedures that meet 12. Do the variables have the same distribution?
the requirements of the study, and narrow your options 13. Do you want to treat the ordinal variable as
further through the process of elimination based on though it were based on an underlying normally
items 5 through 9. distributed interval variable?
The most important factor to examine when choos- 14. Is the interval variable dependent?
ing a statistical procedure is the study hypothesis. The 15. Do you want a measure of the strength of the
hypothesis that is clearly stated indicates the statistics relationship between the variables or a test of the
needed to test it. An example of a clearly developed statistical significance of differences between
hypothesis is, “There is a difference in employment groups (Kenny, 1979)?
rates between veterans who receive vocational reha- 16. Are you willing to assume that an interval-scaled
bilitation and veterans who are on a wait-list control.” variable is normally distributed in the popula-
This statement tells the researcher that a statistic to tion?
determine differences between two groups is appropri- 17. Is there more than one dependent variable?
ate to address this hypothesis. 18. Do you want to statistically remove the linear
One approach to selecting an appropriate statistical effects of one or more covariates from the depen-
procedure or judging the appropriateness of an analy- dent variable?
sis technique is to use a decision tree. A decision tree 19. Do you want to treat the relationships among the
directs your choices by gradually narrowing your variables as additive?
options through the decisions you make. A decision 20. Do you want to analyze patterns existing among
tree that can been helpful in selecting statistical pro- variables or among individual cases?
cedures is presented in Figure 21-7. 21. Do you want to find clusters of variables that are
One disadvantage of decision trees is that if you more strongly related to one another than to the
make an incorrect or uninformed decision (guess), you remaining variables?
can be led down a path where you might select an Each question confronts you with a decision. The
inappropriate statistical procedure for your study. decision you make narrows the field of available sta-
Decision trees are often constrained by space and do tistical procedures (see Figure 21-7). Decisions must
not include all the information needed to make an be made regarding the following:
appropriate selection. A more extensive decision tree 1. Number of variables (one, two, or more than two)
can be found in A Guide for Selecting Statistical Tech- 2. Level of measurement (nominal, ordinal, or
niques for Analyzing Social Science Data by Andrews, interval)
Klem, Davidson, O’Malley, and Rodgers (1981). The 3. Type of variable (independent, dependent, or
following examples of questions designed to guide the research)
selection or evaluation of statistical procedures were 4. Distribution of variable (normal or non-normal)
extracted from this book: 5. Type of relationship (linear or nonlinear)
Nature of Research Measurement Scale of Number of Groups Research Recommended
Question Dependent Variable (or Levels of Design Statistic
or Research Variable Independent Variable)

One-sample
One Group
chi square ( c 2)

Independent Fisher’s exact


samples test or c 2
Two Groups
Nominal
Paired McNemar
samples test

Independent
samples c2
More than
two groups
Paired Cochran’s Q
samples statistic

Independent Mann-
samples Whitney U
Two Groups
Paired Wilcoxon signed-
samples rank test
Differences
Ordinal
Independent Kruskal-
samples Wallis test
More than
two groups
Paired
Friedman test
samples

One-sample
One Group
t-test

Independent Independent
samples samples t-test
Two Groups

Interval/Ratio Paired Paired samples


samples t-test

One-way
Independent analysis
samples of variance
More than (ANOVA)
oasis-ebl|Rsalles|1476461066

two groups
Paired Repeated
measures
samples ANOVA

Phi, Contingency
Nominal coefficient,
Cramer’s V

Spearman rank-order
Associations Ordinal correlation, Kendall’s, tau,
Somer’s D

Pearson product-moment
Interval/Ratio correlation coefficient,
Simple linear regression

Figure 21-7  Statistical decision tree for selecting an appropriate analysis technique.
548 UNIT FOUR  Analyzing Data, Determining Outcomes, and Disseminating Research

6. What you want to measure (strength of relationship • The quantitative data analysis process consists of
or difference between groups) several stages: (1) preparation of the data for analy-
7. Nature of the groups (equal or unequal in size, sis; (2) description of the sample; (3) testing the
matched or unmatched, dependent [paired] or reliability of measurement; (4) exploratory analysis
independent) of the data; (5) confirmatory analysis guided by
8. Type of analysis (descriptive, classification, meth- hypotheses, questions, or objectives; and (6) post
odological, relational, comparison, predicting out- hoc analysis.
comes, intervention testing, causal modeling, • A decision tree is provided to assist you in selecting
examining changes across time) appropriate analysis techniques to use in analyzing
Selecting and evaluating statistical procedures study or clinical data.
requires that you make many judgments regarding the
nature of the data and what you want to know. Knowl-
edge of the statistical procedures and their assump- REFERENCES
tions is necessary for selecting appropriate procedures. Aberson, C. L. (2010). Applied power analysis for the behavioral
You must weigh the advantages and disadvantages of sciences. New York, NY: Routledge Taylor & Francis Group.
various statistical options. Access to a statistician can Andrews, F. M., Klem, L., Davidson, T. N., O’Malley, P. M., &
be invaluable in selecting the appropriate procedures. Rodgers, W. L. (1981). A guide for selecting statistical techniques
for analyzing social science data (2nd ed.). Ann Arbor, MI:
Survey Research Center, Institute for Social Research, University
of Michigan.
KEY POINTS Barnett, V. (1982). Comparative statistical inference. New York,
NY: Wiley.
• This chapter introduces you to the concepts of Box, G. E. P., Hunter, W. G., & Hunter, J. S. (1978). Statistics for
statistical theory and discusses some of the more experimenters. New York, NY: Wiley.
pragmatic aspects of quantitative data analysis, Cohen, J. (1988). Statistical power analysis for the behavioral sci-
including the purposes of statistical analysis, the ences (2nd ed.). New York, NY: Academic Press.
process of performing data analysis, the choice of Cohen, J. (1994). The earth is round (p<.05). American Psycholo-
gist, 49(12), 997–1003.
the appropriate statistical procedures for a study,
Conover, W. J. (1971). Practical nonparametric statistics. New
and resources for statistical analysis. York, NY: Wiley.
• Two types of errors can occur when making deci- Cox, D. R. (1958). Planning of experiments. New York, NY: Wiley.
sions about the meaning of a value obtained from Faul, F., Erdfelder, E., Lang, A.-G., & Buchner, A. (2007). G*Power
a statistical test: Type I errors and Type II errors. 3: A flexible statistical power analysis program for the social,
• A Type I error occurs when the researcher con- behavioral, and biomedical sciences. Behavior Research Methods,
cludes a significant effect when no significant 39(2), 175–191.
effect actually exists. Fife-Schaw, C. (1995). Levels of measurement. In G. M. Breakwell,
• A Type II error occurs when the researcher con- S. Hammond, & C. Fife-Schaw (Eds.), Research methods in psy-
cludes no significant effect when an effect actually chology. Thousand Oaks, CA: Sage.
Fisher, R. A., Sir. (1935). The designs of experiments. New York,
exists.
NY: Hafner.
• The formal definition of the level of significance, Glass, G. V. & Stanley, J. C. (1970). Statistical methods in education
or alpha (α), is the probability of making a Type I and psychology. Englewood Cliffs, NJ: Prentice-Hall.
error when the null hypothesis is true. Good, I. J. (1983). Good thinking: The foundations of probability
• The p value is the exact value that can be calculated and its applications. Minneapolis, MN: University of Minnesota
during a statistical computation to indicate the Press.
probability of making a Type I error. Grove, S. K. (2007). Statistics for health care research: A practical
• Power is the probability that a statistical test will workbook. St. Louis, MO: Saunders.
detect a significant effect when it actually exists. Kenny, D. A. (1979). Correlation and causality. New York, NY:
• Statistics can be used for various purposes, such as Wiley.
Kerlinger, F. N. & Lee, H. B. (2000). Foundations of behavioral
to (1) summarize, (2) explore the meaning of devia-
research (4th ed.). New York, NY: Harcourt Brace.
tions in the data, (3) compare or contrast descrip- Loftus, G. R. (1993). A picture is worth a thousand p values: On
tively, (4) test the proposed relationships in a the irrelevance of hypothesis testing in the microcomputer age.
theoretical model, (5) infer that the findings from Behavior Research Methods, Instrumentation, & Computers,
the sample are indicative of the entire population, 25(2), 250–256.
(6) examine causality, (7) predict, or (8) infer from Munro, B. H. (2005). Statistical methods for health care research
the sample to a theoretical model. (5th ed.). Philadelphia, PA: Lippincott Williams & Wilkins.
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Rubin, D. B. (1976). Inference and missing data. Biometrika, 63(3), Tukey, J. W. (1977). Exploratory data analysis. Reading, MA:
581–592. Addison-Wesley.
Shortliffe, E. H. & Cimino, J. J. (2006). Biomedical informatics: Waltz, C. F., Strickland, O. L., & Lenz, E. R. (2010). Measurement
Computer applications in health care and biomedicine. New in nursing and health research (4th ed.). New York, NY: Springer
York, NY: Springer Science. Publishing Company.
Tanizaki, H. (1997). Power comparison of non-parametric tests:
Small-sample properties from Monte Carlo experiments. Journal
of Applied Statistics, 24(5), 603–632.
  http://evolve.elsevier.com/Grove/practice/

22
CHAPTER

Using Statistics to Describe Variables

T
here are two major classes of statistics: organizing the data by listing every possible value in
descriptive statistics and inferential statistics. the first column of numbers and the frequency (tally)
Descriptive statistics are computed to reveal of each value in the second column of numbers. For
characteristics of the sample data set. Inferential sta- example, consider the following hypothetical age data
tistics are computed to gain information about effects for patients from a primary care clinic. The ages of 20
in the population being studied. For some types of patients were:
studies, descriptive statistics are the only approach to
analysis of the data. For other studies, descriptive sta- 45, 26, 59, 51, 42, 28, 26, 32, 31, 55,
tistics are the first step in the data analysis process, 43, 47, 67, 39, 52, 48, 36, 42, 61, 57
to be followed by inferential statistics. For all studies
that involve numerical data, descriptive statistics are First, we must sort the patients’ ages from lowest to
crucial in understanding the fundamental properties of highest values:
the variables being studied. This chapter focuses on
26
descriptive statistics and includes the most common
26
descriptive statistics conducted in nursing research
28
with examples from clinical studies.
31
32
36
Using Statistics to 39
Summarize Data 42
42
Frequency Distributions 43
A basic yet important way to begin describing a 45
sample is to create a frequency distribution of the 47
variable or variables being studied. A frequency dis- 48
tribution can be displayed in a table or figure. A line 51
graph figure can be used to plot one variable, whereby 52
the x-axis consists of the possible values of that vari- 55
able, and the y-axis is the tally of each value. The 57
frequency distributions presented in this chapter 59
include values of continuous variables. With a con- 61
tinuous variable, the higher numbers represent more 67
of that variable, and the lower numbers represent less
of that variable. Common examples of continuous Next, each age value is tallied to create the frequency.
variables are age, income, blood pressure, weight, This is an example of an ungrouped frequency distri-
height, pain levels, and perception of quality of life. bution. In an ungrouped frequency distribution,
The frequency distribution of a variable can be researchers list all categories of the variable on which
presented in a frequency table, which is a way of they have data and tally each datum on the listing

550
CHAPTER 22  Using Statistics to Describe Variables 551

TABLE 22-1  Grouped Frequency Distribution of Patient Ages with Percentages


Adult Age Range Frequency (f) Percentage Cumulative Percentage
20-29 3 15% 15%
30-39 4 20% 35%
40-49 6 30% 65%
50-59 5 25% 90%
60-69 2 10% 100%
Total 20 100%

(Corty, 2007). In this example, all the different 7


ages of the 20 patients are listed and then tallied for
6
each age.
Age Frequency 5

Frequency
26 2
4
28 1
31 1 3
32 1
36 1 2
39 1
1
42 2
43 1 0
45 1 20-29 30-39 40-49 50-59 60-69
47 1 Age Range
48 1
51 1 Figure 22-1  Frequency distribution of patient age ranges.
52 1
55 1
57 1
Table 22-1 presents a grouped frequency distribution
59 1
of patient ages classified by ranges of 10 years. The
61 1
67 1
range starts at “20” because there are no patient
ages lower than 20; also, there are no ages higher
Because most of the ages in this data set have than 69.
frequencies of “1,” it is better to group the ages into Table 22-1 also includes percentages of patients
ranges of values. These ranges must be mutually with an age in each range and the cumulative percent-
exclusive. A patient’s age can be classified into only ages for the sample, which should add to 100%. This
one of the ranges. In addition, the ranges must be table provides an example of a percentage distribu-
exhaustive, meaning that each patient’s age fits into tion that indicates the percentage of the sample with
at least one of the categories. For example, we may scores falling in a specific group or range (Corty,
choose to have ranges of 10, so that the age ranges 2007; Munro, 2005). Percentage distributions are par-
are 20 to 29, 30 to 39, 40 to 49, 50 to 59, and 60 to ticularly useful in comparing the data of the present
69. We may choose to have ranges of 5, so that the study with results from other studies.
age ranges are 20 to 24, 25 to 29, 30 to 34, and so As discussed earlier, frequency distributions can be
on. The grouping should be devised to provide the presented in figures. Frequencies are commonly pre-
greatest possible meaning to the purpose of the sented in graphs, charts, histograms, and frequency
study. If the data are to be compared with data in polygons. Figure 22-1 is a line graph of the frequency
other studies, groupings should be similar to group- distribution for age ranges, where the x-axis (horizon-
ings of other studies in this field of research. Classi- tal line) represents the different age ranges, and the
fying data into groups results in the development of y-axis (vertical line) represents the frequencies of
a grouped frequency distribution (Munro, 2005). patients with ages in each of the ranges.
552 UNIT FOUR  Analyzing Data, Determining Outcomes, and Disseminating Research

TABLE 22-2  Frequency Table of Smoking Status TABLE 22-3  Data of Medication Use in
Smoking Status Frequency Percentage (%) Veterans with Rheumatoid
Current smoker 1 10% Arthritis
Former smoker 6 60% Duration of Medication Use (years)
Never smoked 3 30%
0.1
Total 10 100%
0.3
1.3
1.5
1.5
2.0
2.2
70%
3.0
60% 3.0
50% 4.0
40%
30%
20% (MD), and mean (X) (Corty, 2007; Munro, 2005). The
10% mode, median, and mean are defined and calculated in
0% this section using data collected from veterans with
Current Never Former rheumatoid arthritis (Tran et al., 2009). The data were
Smoker Smoked Smoker extracted from a larger sample of veterans who had
a history of biologic medication use. Examples of
Figure 22-2  Histogram of smoking status. common biologic medications used to treat rheuma-
toid arthritis are adalimumab, etanercept, and inflix-
imab (Deighton, O’Mahony, Tosh, Turner, & Rudolf,
2009). Table 22-3 contains the data collected from 10
A frequency table is also an important method to veterans who had stopped taking biologic medica-
represent nominal data (Corty, 2007; Munro, 2005; tions, and the variable represents the number of years
Tukey, 1977). For example, a common nominal vari- that each veteran had taken the medication before the
able is smoking history. Many researchers assess sub- veteran stopped. Because the number of study subjects
jects’ history of smoking using nominal categories represented is 10, the correct statistical notation to
such as “never smoked,” “former smoker,” and reflect that number is:
“current smoker.” Table 22-2 presents frequency and
n = 10
percentage distributions for data extracted from a
sample of veterans with rheumatoid arthritis (Tran, The letter “n” is lowercase because we are referring
Hooker, Cipher, & Reimold, 2009). to a sample of veterans. If the data being presented
As shown in Table 22-2, the frequencies indicate represented the entire population of veterans, the
that 6 of 10 (60%) veterans were former smokers, and correct notation would be uppercase “N” (Zar, 1999).
3 (30%) never smoked. For nominal variables such as Because most nursing research is conducted using
smoking status, tables are a helpful method to inform samples, not populations, all formulas in Chapters 22
researchers and others about the variable being studied. to 25 incorporate the sample notation, n.
Graphically representing the values in a frequency
table can yield visually important trends. Figure 22-2 Mode
is a histogram that was developed to represent the The mode is the numerical value or score that occurs
smoking status data visually. with the greatest frequency in a data set. It does not
indicate the center of the data set. The data in Table
Measures of Central Tendency 22-3 contain two modes: 1.5 years and 3.0 years of
A measure of central tendency is a statistic that rep- medication use. Each of these numbers occurred twice
resents the center or middle of a frequency distribution in the data set. When two modes exist, the data set is
(Corty, 2007; Glass & Stanley, 1970; Grove, 2007). referred to as bimodal (see Chapter 21). A data set
The three measures of central tendency commonly that contains more than two modes is referred to as
reported in nursing studies include mode, median multimodal (Zar, 1999).
CHAPTER 22  Using Statistics to Describe Variables 553

Median 3.0
The median (MD) is the score at the exact center of
2.5
the ungrouped frequency distribution. It is the 50th
percentile. To obtain the MD, sort the values from 2.0

Frequency
lowest to highest. If the number of values is an uneven
number, exactly 50% of the values are above the MD 1.5
and 50% are below it. If the number of values is an
1.0
even number, the MD is the average of the two middle
values; thus, the MD may not be an actual value in the 0.5
data set (Zar, 1999). For example, the data in Table
22-3 consist of 10 observations, and the MD is calcu- 0.0
lated as the average of the two middle values. 0-.9 1-1.9 2-2.9 3-3.9 4-4.9
A Years of Biologic Medication Use
(1.5 + 2.0)
MD = = 1.75 3.0
2
2.5
Mean
2.0

Frequency
The mean is the arithmetic average of all the values
of a variable in a study and is the most commonly 1.5
reported measure of central tendency. The mean is the 1.0
sum of the scores divided by the number of scores
being summed. Similar to the MD, the mean may not 0.5
be a member of the data set. The formula for calculat- 0.0
ing the mean is as follows:

1- 9
9
9

4- 9
9

6- 9
9

8- 9
9- 9
10 9.9
11 0.9

9
.
1.
2.
3.
4.
5.
6.
7.
8.

1.
0-

2-
3-

5-

7-

-1
-1
ΣX B Years of Biologic Medication Use
X =
n
where Figure 22-3  A and B, Frequency distribution of years of biologic
X = mean medication use, without outlier and with outlier.
Σ = sigma, the statistical symbol for summation
X = a single value in the sample
n = total number of values in the sample
The mean number of years that the veterans used a The mean is sensitive to extreme scores such as
biologic medication is calculated as follows: outliers. An outlier is a value in a sample data set that
is unusually low or unusually high in the context of
(0.1 + 0.3 + 1.3 + 1.5 + 1.5 the rest of the sample data (Zar, 1999). An example of
+ 2.0 + 2.2 + 3.0 + 3.0 + 4.0) an outlier in the data presented in Table 22-3 might be
X = a value such as medication use for 11 years. The exist-
10
ing values range from 0.1 to 4.0, indicating that no
18.9
X = = 1.89 years veteran used a biologic medication beyond 4 years. If
10 an additional veteran was added to the sample, and
that person used a biologic medication for 11 years,
The mean is an appropriate measure of central ten- the mean would be much larger: 2.72 years (mean =
dency to calculate for approximately normally distrib- 18.9 + 11 = 29.9 ÷ 11 = 2.718 rounded to 2.72). Simply
uted populations with variables measured at the adding this outlier to the sample nearly doubled the
interval or ratio levels. It is also appropriate for ordinal mean value. The outlier would also change the fre-
level data such as Likert scale or rating scale values quency distribution. Without the outlier, the frequency
(as described in Chapter 17), where higher numbers distribution is approximately normal, as shown in
represent more of the construct being measured, and Figure 22-3. The inclusion of the outlier changes the
lower numbers represent less of the construct, such as shape from an approximately normal distribution to a
a 10-point pain rating scale, where 1 represents no positively skewed distribution (see Figure 22-3) (Zar,
noticeable pain and 10 represents dramatically intense 1999). The median is a better measure of central ten-
pain (Clifford & Cipher, 2005). dency than the mean for these data that are positively
554 UNIT FOUR  Analyzing Data, Determining Outcomes, and Disseminating Research

skewed by the outlier (see Chapter 21 for discussion the two extreme scores for the comparison. The range
of skewness). is generally reported in published studies but is not
used in further analyses.

Using Statistics to Explore Difference Scores


Difference scores are obtained by subtracting the
Deviations in the Data mean from each score. Sometimes a difference score
Although the use of summary statistics has been the is referred to as a deviation score because it indicates
traditional approach to describing data or describing the extent to which a score deviates from the mean.
the characteristics of the sample before inferential sta- Most variables in nursing research are not “scores”;
tistical analysis, the ability of summary statistics to however, the term difference score is used to represent
clarify the nature of data is limited. For example, using the deviation of a value from the mean. The difference
measures of central tendency, particularly the mean, score is positive when the score is above the mean,
to describe the nature of the data obscures the impact and it is negative when the score is below the mean.
of extreme values or deviations in the data. Significant The difference scores (both positive and negative) add
features in the data may be concealed or misrepre- to zero or approximately zero based on rounding. Dif-
sented. Often, anomalous, unexpected, problematic ference scores are the basis for many statistical analy-
data and discrepant patterns are evident, but these are ses and can be found within many statistical equations.
not regarded as meaningful. Measures of dispersion, The formula for difference scores is:
such as the range, difference scores, variance, and
standard deviation, provide important insight into the X−X
nature of the data. The mean deviation is the average difference
score, using the absolute values. The formula for the
Measures of Dispersion mean deviation is:
Measures of dispersion or variability are measures
of individual differences of the members of the pop- ΣX−X
ulation and sample (Munro, 2005). They indicate X deviation =
how values in a sample are dispersed around the n
mean. These measures provide information about the 1.8 + 1.6 + 0.6 + 0.4 + 0.4
data that is not available from measures of central + 0.1 + 0.3 + 1.1 + 1.1 + 2.1
tendency. They indicate how different the scores X deviation =
10
are—the extent to which individual values deviate
from one another. If the individual values are 9.5
X deviation =
similar, measures of variability are small, and the 10
sample is relatively homogeneous in terms of those
values. When there are wide variations or differ- X deviation = 0.95
ences in the scores, the sample is considered hetero-
geneous. The heterogeneity of sample scores or In this example using the data from Table 22-4, the
oasis-ebl|Rsalles|1476461070

values is determined by measures of dispersion or mean deviation is 0.95. The result indicates that, on
variability (Zar, 1999). The measures of dispersion average, subjects’ duration of biologic medication use
most commonly reported in nursing research are deviated from the mean by 0.95 year.
range, difference scores, variance, and standard
deviation. Variance
Variance is another measure of dispersion commonly
Range used in statistical analysis. The equation for a sample
The simplest measure of dispersion is the range variance (s2) is provided. The lowercase letter “s2” is
(Corty, 2007; Munro, 2005). In published studies, used to represent a sample variance. The lowercase
range is presented in two ways: (1) the range is the Greek sigma “σ2” is used to represent a population
lowest and highest scores, or (2) the range is calcu- variance, in which the denominator is “N” instead of
lated by subtracting the lowest score from the highest “n − 1.” Because most nursing research is conducted
score. The range for the scores in Table 22-3 is 0.3 to using samples, not populations, all formulas in the
4.0 or can be calculated as follows: 4.0 − 0.3 = 3.7. In next several chapters that contain a variance or stan-
this form, the range is a difference score that uses only dard deviation incorporate the sample notation and use
CHAPTER 22  Using Statistics to Describe Variables 555

TABLE 22-4  Difference Scores of Duration of TABLE 22-5  Calculation of Variance for
Biologic Medication Use Duration of Medication Use
X −X X−X X X X−X (X − X)2
0.1 −1.9 −1.8 0.1 −1.9 −1.8 3.24
0.3 −1.9 −1.6 0.3 −1.9 −1.6 2.56
1.3 −1.9 −0.6 1.3 −1.9 −0.6 0.36
1.5 −1.9 −0.4 1.5 −1.9 −0.4 0.16
1.5 −1.9 −0.4 1.5 −1.9 −0.4 0.16
2.0 −1.9 0.1 2.0 −1.9 0.1 0.01
2.2 −1.9 0.3 2.2 −1.9 0.3 0.09
3.0 −1.9 1.1 3.0 −1.9 1.1 1.21
3.0 −1.9 1.1 3.0 −1.9 1.1 1.21
4.0 −1.9 2.1 4.0 −1.9 2.1 4.41
Σ of absolute values = 9.5 Σ 13.41

“n − 1” as the denominator. Statistical software pack- Table 22-5 displays the computations for the vari-
ages compute the variance and standard deviation ance. To compute the standard deviation, simply take
using the sample formulas, not the population the square root of the variance. You know that the
formulas. variance of biologic medication duration use is s2 =
1.49. Therefore, the standard deviation of biologic
duration is s = 1.22. In published studies, sometimes
Σ (X − X )
2

s2 = the statistic reported by researchers for standard devia-


n −1 tion is SD. Either SD or s might be used in a research
report to indicate the standard deviation for a study
The variance is always a positive value and has no variable.
upper limit. In general, the larger the calculated vari- The standard deviation is an important statistic,
ance for a study variable is, the larger the dispersion both for understanding dispersion within a distribution
or spread of scores is for the variable. The variance is and for interpreting the relationship of a particular
most often computed to derive the standard deviation value to the distribution. Grove’s (2007) statistical
because in contrast to the variance, the standard devia- workbook provides you with a resource for calculating
tion reflects important properties about the frequency and interpreting the measures of central tendency and
distribution of the variable it represents. Table 22-4 measures of dispersion in published studies. The fol-
displays how you might compute a variance by hand, lowing section summarizes the properties of the stan-
using the medication use duration data. Table 22-5 dard deviation as it relates to a normal distribution.
shows calculation of variance for duration of medica-
tion use. Normal Curve
The standard deviation of a variable tells researchers
13.41 much about the entire sample of values. A frequency
s =
2
9 distribution of a variable that is perfectly normally
distributed is shown in Figure 22-4, otherwise known
s2 = 1.49 as the normal curve.
The normal curve is a perfectly symmetrical fre-
quency distribution. The value at the exact center of a
Standard Deviation
normal curve is the mean of the values. Note the lines
Standard deviation (s) is a measure of dispersion that to the left and to the right of the mean. Those lines are
is the square root of the variance. The equation for drawn at +1 standard deviation (which indicates 1 s
obtaining a standard deviation is: above the mean) and −1 standard deviation (which
indicates 1 s below the mean), +2 standard deviations
above the mean, −2 standard deviations below the
Σ (X − X )
2

s= mean, and so forth. When a frequency distribution is


n −1 shaped like the normal curve, we know that 34.13%
556 UNIT FOUR  Analyzing Data, Determining Outcomes, and Disseminating Research

2.28% 13.59% 34.13% 34.13% 13.59% 2.28%

–2 s –1 s X +1 s +2 s

Figure 22-4  Normal curve. s = Standard deviation

2.28% 13.59% 34.13% 34.13% 13.59% 2.28%

30 40 50 60 70
X

Figure 22-5  Frequency distribution of SF-36 Physical Functioning Scale values.

of the subjects scored between the mean and 1 stan- Sherbourne, 1992). The subscales have been normed
dard deviation above the mean, and 34.13% of the on populations of respondents as having a mean of 50
subjects scored between the mean and 1 standard and standard deviation of 10. The frequency distribu-
deviation below the mean. Because the normal curve tion of responses for the subscale “Physical Function-
is perfectly symmetrical, we also know that 50% of ing” can be drawn as seen in Figure 22-5.
the subjects scored above the mean, and 50% of the The mean is marked as “50” in the middle, and the
subjects scored below the mean. standard deviations are marked at the lines. Therefore,
You can also say that 68.26% of the subjects scored you know that 34.13% of the population scores
between −1 and +1 standard deviation. This number between a 50 and a 60 on the Physical Functioning
is obtained by adding 34.13% and 34.13%. Further- subscale. You also know that 95.44% of the population
more, we can say that 95.44% of the subjects scored scores between 30 and 70 on the Physical Functioning
between −2 and +2 standard deviations. If we are subscale. Figure 22-5 shows that only 2.28% of the
given a mean and a standard deviation value for any population scores above a value of 70 (this is com-
variable that is normally distributed, we know certain puted by subtracting 34.13% and 13.59% from 50%).
facts about those data. For example, consider a score Likewise, only 2.28% of the population scores below
obtained on a subscale of the Short Form (36) Health a value of 30.
survey (SF-36). The SF-36 is a widely used health When using examples such as these, researchers
survey that yields eight subscales that each represent often use the statistic “z” instead of the term “standard
a domain of subjective health status (Ware & deviation.” A z value is synonymous with a standard
CHAPTER 22  Using Statistics to Describe Variables 557

deviation unit. A z value of 1.0 represents 1 standard The distribution of the normal curve is drawn once
deviation unit above the mean. A z value of −1.0 rep- more in Figure 22-6 but this time with the z statistic,
resents 1 standard deviation unit below the mean. where z represents 1 standard deviation unit. Common
Although a standard deviation value cannot have a values of z are smaller values and closer to the mean.
negative value, a z value can be negative or positive. Uncommon and unusual z values are farther away
A z of 0 represents exactly the mean value. Any value from the mean (either lower than the mean or higher
in a data set can be converted to a z by using the fol- than the mean). When a variable is normally distrib-
lowing formula: uted, 95% of z values for that variable fall somewhere
between a z of −1.96 and 1.96; 99% of z values for
z=
(X − X ) that variable fall somewhere between a z of −2.58 and
s 2.58 (see Figure 22-6). A table of z values can be
found in Appendix A.
For example, a person scoring a 61 on the SF-36 Phy­
sical Functioning scale would have a z value of 1.1: Sampling Error
A standard error describes the extent of sampling
error. A standard error of the mean is calculated to
(61 − 50)
z= determine the magnitude of the variability associated
10 with the mean. A small standard error is an indication
that the sample mean is close to the population mean.
z = 1.1 A large standard error yields less certainty that the
sample mean approximates the population mean. The
It is important to note how z values represent stan- formula for the standard error of the mean (sX ) is:
dard deviations on the normal curve because this
knowledge becomes necessary when performing sig- s
sX =
nificance testing in inferential statistics. For example, n
observe how a z value of 1.0 or −1.0 is much more
common than a z value of 3.0 or −3.0. The farther the where
z value is from the mean, the more uncommon, sX = standard error of the mean
unusual, and unlikely that value is to occur. This prin- s = standard deviation
ciple is revisited in Chapters 23 through 25. n = sample size

–2.58 z –1.96 z –1 z 0 +1 z +1.96 z +2.58 z

Unusual z values Unusual z values

Figure 22-6  Distribution of z values.


558 UNIT FOUR  Analyzing Data, Determining Outcomes, and Disseminating Research

Using the biologic medication duration data, we 2.77. If we were to compute a 99% confidence inter-
know that the standard deviation of biologic duration val, we would require the t value that is referenced at
is s = 1.22. Therefore, the standard error of the mean α = 0.01. The 99% confidence interval for the mean
for biologic duration is computed as follows: duration of biologic medication use is computed as
follows:
1.22
sX = 1.89 ± (0.39)(3.25)
10
sX = 0.39 1.89 ± 1.27

The standard error of the mean for biologic duration As referenced in Appendix B, the t value required
is 0.39. for the 99% confidence interval with df = 9 is 3.25.
The previous computation results in a lower limit
Confidence Intervals of 0.62 and an upper limit of 3.16. Thus, it is 99%
To determine how closely the sample mean approxi- probable that the population mean is between 0.62
mates the population mean, the standard error of the and 3.16.
mean is used to build a confidence interval. A confi-
dence interval can be created for many statistics, such Degrees of Freedom
as a mean, proportion, and odds ratio. To build a The concept of degrees of freedom was used in refer-
confidence interval around a statistic, you must have ence to computing a confidence interval. For any sta-
the standard error value and the t value to adjust tistical computation, degrees of freedom is the
the standard error. The t is a statistic for the t-test number of independent pieces of information that are
that is calculated to determine group differences free to vary to estimate another piece of information
and is discussed in more detail in Chapter 25. The (Zar, 1999). In the case of the confidence interval, the
degrees of freedom (df) to use to compute a confidence degrees of freedom (df) is n − 1. This means that there
interval is: are n − 1 independent observations in the sample that
are free to vary (to be any value) to estimate the lower
df = n − 1 and upper limits of the confidence interval.

To compute the confidence interval for a mean, the


lower and upper limits of that interval are created by KEY POINTS
multiplying the sX by the t statistic, where df = n − 1.
For a 95% confidence interval, the t value should be • Data analysis begins with descriptive statistics in
selected at alpha (α) = 0.05. For a 99% confidence any study in which the data are numerical, includ-
interval, the t value should be selected at α = 0.01. ing demographic variables for samples in quantita-
Using the biologic medication duration data, we tive and qualitative studies.
know that the standard error of the mean duration of • Descriptive statistics allow the researcher to orga-
biologic medication use is sX = 0.39. The mean dura- nize the data in ways that facilitate meaning and
tion of biologic medication use is 1.89. The 95% con- insight.
fidence interval for the mean duration of biologic • Three measures of central tendency are the mode,
medication use is computed as follows: median, and mean.
• The measures of dispersion most commonly
X ± sX t reported in nursing studies are range, difference
scores, variance, and standard deviation.
1.89 ± (0.39)(2.26) • The standard deviation and z represent certain
properties of the normal curve that are used in
1.89 ± .88 significance testing.
• Standard error indicates the extent of sampling
As referenced in Appendix B, the t value required error, and a formula is provided for calculation of
for the 95% confidence interval with df = 9 is 2.26. sampling error.
The previous computation results in a lower limit of • To determine how closely the sample mean approx-
1.01 and an upper limit of 2.77. Thus, it is 95% prob- imates the population mean, the standard error of
able that the population mean is between 1.01 and the mean is used to build a confidence interval. The
CHAPTER 22  Using Statistics to Describe Variables 559

formulas and calculations for the 95% and 99% Glass, G. V. & Stanley, J. C. (1970). Statistical methods in education
confidence intervals are presented. and psychology. Englewood Cliffs, NJ: Prentice-Hall.
• For any statistical computation, degrees of free­ Grove, S. K. (2007). Statistics for health care research: A practical
workbook. St. Louis, MO: Saunders Elsevier.
dom are the number of independent pieces of
Munro, B. H. (2005). Statistical methods for health care research
information that are free to vary to estimate another (5th ed.). Philadelphia, PA: Lippincott Williams & Wilkins.
piece of information. Tran, S., Hooker, R. S., Cipher, D. J., & Reimold, A. (2009). Pat-
terns of biologic use in inflammatory diseases: Older males.
Drugs & Aging, 26(7), 607–615.
REFERENCES Tukey, J. W. (1977). Exploratory data analysis. Reading, MA:
Addison-Wesley.
Clifford, P. A. & Cipher, D. J. (2005). The Geriatric Multidimen-
Ware, J. E. & Sherbourne, C. D. (1992). The MOS 36-Item Short-
sional Pain and Illness Inventory: A new instrument measuring
Form Health Survey (SF-36(r)): Conceptual framework and item
pain and illness in long-term care. Clinical Gerontologist, 28(3),
selection. Medical Care, 30(6), 473–483.
45–61.
Zar, J. H. (1999). Biostatistical analysis (4th ed.). Upper Saddle
Corty, E. W. (2007). Using and interpreting statistics: A practical
River, NJ: Prentice-Hall.
text for the health, behavioral, and social sciences. St. Louis, MO:
Mosby Elsevier.
Deighton, C., O’Mahony, R., Tosh, J., Turner, C., & Rudolf, M.
(2009). Guideline Development Group. Management of rheuma-
toid arthritis: Summary of NICE guidelines. BMJ, 338, b702.
  http://evolve.elsevier.com/Grove/practice/

23
CHAPTER

Using Statistics to Examine


Relationships

C
orrelational analyses identify relationships or by plotting the values of two variables on an x-axis
associations among variables. There are many and y-axis. As shown in Figure 23-1, pain levels from
different kinds of statistics that yield a measure 14 long-term care residents were plotted against their
of correlation. All of these statistics address a research number of behavioral disturbances (Cipher, Clifford,
question or hypothesis that involves an association or & Roper, 2006). Specifically, each resident’s pair of
a relationship. Examples of research questions that are values (pain score, behavior value) was plotted on the
answered with correlation statistics are as follows: “Is diagram. Pain was measured with the Geriatric Multi­
there an association between weight loss and depres- dimensional Pain and Illness Inventory (GMPI), and
sion?” “Is there a relationship between patient satis- behavioral disturbances were measured by the Geriat-
faction and health status?” A hypothesis is developed ric Level of Dysfunction Scale (Clifford, Cipher, &
to identify the nature (positive or negative) of the Roper, 2005). The resulting scatter plot reveals a linear
relationship between the variables being studied. For trend whereby higher levels of pain tend to correspond
example, a researcher may hypothesize that better with higher behavioral disturbance values. The line
self-reported health is associated with higher levels of drawn in Figure 23-1 is a regression line that repre-
patient satisfaction (Cipher & Hooker, 2006). sents the concept of least-squares. A least-squares
This chapter presents the common analysis tech- regression line is a line drawn through a scatter plot
niques used to examine relationships in studies. that represents the smallest deviation of each value
The analysis techniques discussed include the use of from the line (Cohen & Cohen, 1983). Regression
scatter diagrams before correlational analysis, bivari- analysis is discussed in detail in Chapter 24.
ate correlational analysis, testing the significance of a
correlational coefficient, spurious correlations, corre-
lations between two raters or measurements, the role Bivariate Correlational Analysis
of correlation in understanding causality, and multi- Bivariate correlational analysis measures the mag-
variate correlational procedure–factor analysis. nitude of linear relationship between two variables
and is performed on data collected from a single
sample (Munro, 2005). The particular correlation sta-
Scatter Diagrams tistic that is computed depends on the scale of mea-
Scatter plots or scatter diagrams provide useful pre- surement of each variable. Correlational techniques
liminary information about the nature of the relation- are available for all levels of data: nominal (phi, con-
ship between variables (Corty, 2007; Munro, 2005). tingency coefficient, Cramer’s V, and lambda), ordinal
The researcher should develop and examine scatter (Spearman rank order correlation coefficient, gamma,
diagrams before performing a correlational analysis. Kendall’s tau, and Somers’ D), or interval and ratio
Scatter plots may be useful for selecting appropriate (Pearson’s product-moment correlation coefficient).
correlational procedures, but most correlational proce- Figure 21-7 in Chapter 21 illustrates the level of mea-
dures are useful for examining linear relationships surement for which each of these statistics is appropri-
only. A scatter plot can easily identify nonlinear rela- ate. Many of the correlational techniques (Kendall’s
tionships; if the data are nonlinear, the researcher tau, contingency coefficient, phi, and Cramer’s V) are
should select statistical alternatives such as nonlinear used in conjunction with contingency tables, which
regression analysis (Zar, 1999). A scatter plot is created illustrate how values of one variable vary with values

560
CHAPTER 23  Using Statistics to Examine Relationships 561

Number of Behavioral Disturbances 9 TABLE 23-1  Strength of Relationships


8 Strength of Positive Negative
7 Relationship Relationship Relationship
6 Weak relationship 0.00 to <0.30 0.00 to <−0.30
(y axis)

5 Moderate relationship 0.30 to 0.50 −0.30 to −0.50


4 Strong relationship >0.50 >−0.50
3
2
r = 0.0
1
0
0 2 4 6 8 10
Pain Subscale Score (x axis)

Figure 23-1  Scatter plot of pain and behavioral disturbances.

Variable Y on y axis
for a second variable. Contingency tables are explained
further in Chapter 25.
Correlational analysis provides two pieces of infor-
mation about the data: the nature or direction of the
linear relationship (positive or negative) between
the two variables and the magnitude (or strength) of
the linear relationship. Correlation statistics are not
an indication of causality, no matter how strong the
statistical result.
In a positive linear relationship, the values being Variable X on the x axis
correlated vary together (in the same direction). When
one value is high, the other value tends to be high; Figure 23-2  Scatter plot of r equal to approximately 0.00 representing
no relationship between two variables.
when one value is low, the other value tends to be low.
The relationship between weight and blood pressure
is considered positive because the more a patient Pearson’s Product-Moment
weighs, usually the higher his or her blood pressure. Correlation Coefficient
In a negative linear relationship, when one value is Pearson’s product-moment correlation was the first
high, the other value tends to be low. There is a nega- of the correlation measures developed and is the most
tive linear relationship between calories consumed commonly used (Corty, 2007; Munro, 2005). This
and weight loss because the more calories a person coefficient (statistic) is represented by the letter r, and
consumes, the less his or her weight loss. A negative the value of r is always between −1.00 and +1.00. A
linear relationship is sometimes referred to as an value of zero indicates no relationship between the
inverse linear relationship—the terms negative and two variables. A positive correlation indicates that
inverse are synonymous in correlation statistics. higher values of X are associated with higher values
Sometimes the relationship between two variables of Y, and lower values of X are associated with lower
is curvilinear, which reflects a relationship between values of Y. A negative or inverse correlation indicates
the variables that changes over the range of both vari- that higher values of X are associated with lower
ables. For example, one of the most famous curvilin- values of Y. The r value is indicative of the slope of
ear relationships is that of stress and test performance. the line (called a regression line) that can be drawn
Test performance tends to be better as test-takers have through a standard scatter plot of the values of two
more stress but only up to a point. When students paired variables. The strengths of different relation-
experience very high stress levels, test performance ships are identified in Table 23-1 (Aberson, 2010;
deteriorates (Lupien, Maheu, Tu, Fiocco, & Schramek, Cohen, 1988). Figure 23-2 represents an r value
2007; Yerkes & Dodson, 1908). Analyses designed to approximately equal to zero, indicating no relation-
test for linear relationships or associations between ship or association between the two variables. An r
two variables, such as Pearson’s correlation, cannot value is rarely, if ever, equal to exactly zero. Figure
detect a curvilinear relationship. 23-3 shows an r value equal to 0.50, which is a
562 UNIT FOUR  Analyzing Data, Determining Outcomes, and Disseminating Research

r = 0.50
TABLE 23-2  Computation of Pearson’s
Correlation
Variable Y on the y axis

Patient X (Behaviors) Y (Pain) X2 Y2 XY


1 2 1.0 4 1.0 2.0
2 4 2.3 16 5.3 9.2
3 3 5.0 9 25.0 15.0
4 8 7.7 64 59.3 61.6
5 5 8.7 25 75.7 43.5
6 2 4.3 4 18.5 8.6
7 2 1.0 4 1.0 2.0
8 2 2.0 4 4.0 4.0
9 6 3.3 36 10.9 19.8
10 2 4.7 4 22.1 9.4
Variable X on the x axis
11 1 4.7 1 22.1 4.7
12 3 2.0 9 4.0 6.0
Figure 23-3  Scatter plot of variables where r is 0.50, representing a 13 3 3.0 9 9.0 9.0
moderate positive correlation.
14 6 5.3 36 28.1 31.8
Total 49 55 225 286 226.6
r = –0.50

words, for every value of X, the distribution of Y


Variable Y on the y axis

values should have equal variability. If the data for the


two variables being correlated are not homoscedastic,
inferences made during significance testing could be
invalid (Cohen & Cohen, 1983).

Calculation
Pearson’s product-moment correlation coefficient is
computed using one of several formulas; the following
formula is considered the “computational formula”
Variable X on the x axis
because it makes computation by hand easier (Zar,
Figure 23-4  Scatter plot of variables where r is −0.50, representing a 1999).
moderate inverse correlation. nΣXY − ΣXΣY
r=
[ nΣX − (ΣX )2 ][ nΣY 2 − (ΣY )2 ]
2

moderate positive relationship. Figure 23-4 shows an where


r value equal to −0.50, which is a moderate negative r = Pearson’s correlation coefficient
or inverse relationship. n = total number of subjects
As discussed earlier, Pearson’s product-moment X = value of the first variable
correlation coefficient is used to determine the rela- Y = value of the second variable
tionship between two variables measured at least at XY = X multiplied by Y
the interval level of measurement. The formula for Table 23-2 displays how one would set up data to
Pearson’s correlation coefficient is based on the fol- compute a Pearson’s correlation coefficient. This
lowing assumptions: example includes a subset of data from a study intro-
1. Interval or ratio measurement of both variables duced earlier in this chapter of long-term care resi-
(e.g., age, income, blood pressure, cholesterol dents (n = 14) with the most severe levels of dementia
levels) (Cipher et al., 2006). A subset of data was selected for
2. Normal distribution of at least one variable this illustration so that the computation example
3. Independence of observational pairs would be small and manageable. In actuality, studies
4. Homoscedasticity involving correlational analysis need to be adequately
Data that are homoscedastic are evenly dispersed powered and involve a larger sample than is used
above and below the regression line, which indicates here (Aberson, 2010; Cohen, 1988). However, all
a linear relationship on a scatter plot. Homoscedastic- data presented in this chapter are actual, unmodified
ity reflects equal variance of both variables. In other clinical data.
CHAPTER 23  Using Statistics to Examine Relationships 563

The first variable in Table 23-2 is the number is 14 − 2 = 12. With r of 0.56 and df = 12, you need
of behavioral disturbances being exhibited by the to consult the table in Appendix C to identify the
residents. The second variable is the residents’ scores critical value of r. The critical r value at α = 0.05,
on the Pain and Suffering subscale of the GMPI df = 12 is 0.532. Our obtained r was 0.56, which
(Clifford & Cipher, 2005). The GMPI is a compre- exceeds the critical value in the table. Therefore, we
hensive pain assessment instrument that was designed can conclude that: There was statistically significant
to be used by nurses, social workers, and psycholo- positive correlation between pain and behavioral dis-
gists to assess pain experienced by a person residing turbances exhibited in long-term care residents with
in a long-term care facility. The GMPI Pain and Suf- severe dementia, r (12) = 0.56, p < 0.05. The null
fering subscale is scored on a scale of 1 to 10, with hypothesis is rejected.
higher numbers indicating more severe pain. Higher Every inferential statistic can be reflected by a
numbers are also indicative of more behavioral dis- probability distribution of that statistic. The table we
turbances. The null hypothesis being tested is: There referred to in Appendix C to determine the signifi-
is no significant association between pain and behav- cance of our obtained r was actually drawn from the
ioral disturbances among long-term care residents probability distribution of r. Chapter 22 illustrated the
with severe dementia. The data in Table 23-2 are probability distribution of z, which appears identical
arranged in columns, which correspond to the ele- to the normal curve. The Pearson’s r can be reflected
ments of the formula. The summed values in the last by a theoretical distribution of r values. The shape of
row of Table 23-2 are inserted into the appropriate this distribution changes, depending on the size of the
place in the formula: sample. When a Pearson’s correlation is computed
using a large number of values (n > 120), the corre-
14(226.6) − (49)(55) sponding distribution of r values appears similar to the
r=
[14(225) − 492 ][14(286) − 552 ] normal curve. The smaller the sample size, the flatter
the r distribution, and the larger the sample size, the
14(226.6) − (49)(55) more the r distribution approximates the normal curve
r=
(749)(979) reflecting the range of paired values obtained. Sample
size matters because the shape of the probability dis-
477.4 tribution determines whether our obtained statistic is
r= = 0.56
856.3 statistically significant (Zar, 1999).
For example, consider our obtained r of 0.56, pre-
Interpretation of Results viously calculated. At 12 df, the r probability distribu-
The r value is 0.56, indicating a strong positive rela- tion looks like that of Figure 23-5. With a sample size
tionship between pain and behavioral disturbances of 14 (and 12 df), the middle 95% of the r probability
among long-term care residents with severe demen- distribution is marked by −0.53 and 0.53. The mean r,
tia. To determine whether this relationship is improb- theoretically, is r = 0. That is, most correlation coef-
able to have been caused by chance alone, we consult ficients computed between two variables equal zero,
the r probability distribution table. The formula for reflecting no relationships between the two variables.
degrees of freedom (df) for a Pearson’s r is n − 2. Therefore, an r value of 0 is the most common and
Recall from Chapter 22 that every inferential statistic probable r value. It is much more improbable to obtain
has its own formula for degrees of freedom (numbers a high r value. At 12 df, r values within the limits of
of values that are free to vary). In our analysis, the df −0.53 and 0.53 are considered common and likely, and

Middle 95% of
2½% of r distribution; 2½% of r distribution;
r distribution
Improbable values of r Improbable values of r
–0.53 0.53

Figure 23-5  Probability distribution of r at df = 12.


564 UNIT FOUR  Analyzing Data, Determining Outcomes, and Disseminating Research

Middle 95% of
2½% of r distribution; 2½% of r distribution;
r distribution
Improbable values of r Improbable values of r
–0.19 0.19

Figure 23-6  Probability distribution of r at df = 100.

values outside of these limits are uncommon, unlikely, same variance. More specifically, 31% of the variance
and improbable to have occurred by chance. The in pain levels can be explained by knowing the resi-
values outside of these limits constitute 5% of the r dent’s level of behavioral disturbances, and, vice
distribution, which is where the concept of alpha versa, 31% of the variance in behavioral disturbances
(Type I error) originates. We obtained an r of 0.56 and can be explained by knowing the resident’s pain level
rejected the null hypothesis. In rejecting the null (Cipher et al., 2006).
hypothesis, there is less than a 5% chance that we are
making a Type I error. Nonparametric Alternatives
Compare Figure 23-5 with Figure 23-6, in which If one or both of your variables do not meet the
the probability distribution of r at df = 100 is dis- assumptions for a Pearson’s correlation, or if your
played. Appendix C tells us that the critical r value at variables are scaled on an ordinal scale of measure-
alpha (α) = 0.05, df = 100 (and a sample size of 102) ment (rather than interval or ratio), both Spearman’s
is r = 0.19. This means that the middle 95% of the r rank-order correlation coefficient and Kendall’s tau
probability distribution at df = 100 is marked by −0.19 are more appropriate statistics. The Spearman’s rank-
and 0.19. Furthermore, r values within the limits of order correlation coefficient and Kendall’s tau calcula-
−0.19 and 0.19 are considered common and likely, and tions involve converting the data to ranks, discarding
values outside of these limits are uncommon, unlikely, any variance or normality issues associated with the
and improbable to have occurred by chance. Observe original values.
the difference that the larger sample size makes in the If your data meet the assumptions for the Pearson’s
critical r value to achieve significance. The larger the correlation coefficient, it is the preferred analysis pro-
sample size, the smaller the obtained r value can be to cedure. You would calculate a nonparametric alterna-
be considered still statistically significant. tive only if your data violate those assumptions.
oasis-ebl|Rsalles|1476461078

Because Spearman’s correlation and Kendall’s tau are


Effect Size based on ranks of the data, the properties of the origi-
After establishing the statistical significance of r, the nal data are lost when they are converted to ranks.
relationship subsequently must be examined for clini- Because of this fact, most nonparametric statistics of
cal importance. There are ranges for strength of asso- association yield lower statistical power (Daniel,
ciation suggested by Cohen (1988), as displayed in 2000). Grove’s (2007) statistical workbook provides
Table 23-1. One can also assess the magnitude of examples of Spearman’s rank-order correlation coef-
association by obtaining the coefficient of determina- ficient from published studies and provides guidance
tion for the Pearson’s correlation. Computing the in the interpretation of these results.
coefficient of determination simply involves squaring If both of your variables are dichotomous, the phi
the r value. The r2 (multiplied by 100%) represents the coefficient is the appropriate statistic to determine an
percentage of variance shared between the two vari- association. If both of your variables are nominal and
ables (Cohen & Cohen, 1983). In our example, r was one or both has more than two categories, Cramer’s V
0.56, and therefore r2 was 0.31; this indicates that pain statistic is the appropriate statistic. Spearman’s rank-
levels and behavioral disturbance shared 31% of the order correlation coefficient, Kendall’s tau, phi, and
CHAPTER 23  Using Statistics to Examine Relationships 565

Cramer’s V are addressed in detail by Daniel (2000)


and Munro (2005). Bland and Altman Plots
Bland and Altman plots are used to examine the
Role of Correlation extent of agreement between two measurement tech-
in Understanding Causality niques. In nursing research, Bland and Altman plots
In any situation involving causality, a relationship are used to display visually the extent of interrater
exists between the factors involved in the causal agreement and test-retest agreement (see Chapter 16
process. Therefore, the first clue to the possibility for discussion of reliability). For both instances, pairs
of a causal link is the existence of a relationship. of data are collected from each subject (from rater 1
However, a relationship does not mean causality. For and rater 2, or administration 1 and administration 2),
example, blood glucose level may be related to or and each subject’s two values are subtracted from one
correlated with body temperature; however, this does another. The differences are plotted on a graph, dis-
not mean that one causes the other. Two variables can playing a scatter diagram of the differences plotted
be highly correlated but have no causal relationship. against the averages. Limits of agreement are defined
However, as the strength of a relationship increases, as twice the standard deviation above and below the
the possibility of a causal link increases. The absence mean. Bland and Altman plots are primarily used to
of a relationship precludes the possibility of a causal see how many of the values are outside these limits.
connection between the two variables being exam- Acceptable interrater or test-retest agreement is con-
ined, given adequate measurement of the variables sidered to be reflected when at least 95% of the values
and absence of other variables that might mask the are within the limits of agreement on the plot (Altman,
relationship (Cohen & Cohen, 1983). A correlational 1991).
study can be the first step in determining the dynamics
important to nursing practice within a particular popu- Example
lation. Determining these dynamics can allow us to Table 23-3 displays test-retest data obtained from the
increase our ability to predict and control the situation Clifford and Cipher (2005) study introduced earlier.
studied. However, correlation cannot be used to show The GMPI was administered to 22 long-term care
causality. residents twice within 48 hours. The score from the
GMPI subscale Activity Interference was analyzed for
Spurious Correlations test-retest agreement. This subscale is indicative of the
Spurious correlations are relationships between level of functional impairment secondary to pain,
variables that are not logical. In some cases, these rated on a scale of 1 to 10, with 1 representing no
significant relationships are a consequence of chance impairment and 10 representing extreme impairment
and have no meaning. When you choose a level of (Clifford & Cipher, 2005). Each subject’s subscale
significance of α = 0.05, 1 in 20 correlations that you score at Assessment 1 and Assessment 2 is displayed
compute will be statistically significant by chance in Table 23-3, along with the difference between each
alone. There is really no true relationship between pair of scores.
the two variables under study in the population; you A Bland and Altman plot of these data is illustrated
just happened to draw a sample that showed a rela- in Figure 23-7. The line of perfect agreement is drawn
tionship where there typically is not one. Other pairs as a dotted line in the exact horizontal middle of the
of variables may be correlated because of the influ- graph, and the limits of agreement are the two outside
ence of other unrelated or confounding variables. dotted lines. Only one value is outside of the limits of
For example, you might find a positive correlation agreement. Therefore, 21 of the 22 pairs (95.5%) were
between the number of deaths on a nursing unit and within the limits of agreement. Incidentally, the r
the number of nurses working on the unit. The between the first and second administrations of the
number of deaths cannot be explained as occurring subscale was 0.96. However, the Bland and Altman
because of increases in the number of nurses. It is plot does not always corroborate a Pearson’s correla-
more likely that a third variable (units having patients tion coefficient, and vice versa, because they are dis-
with more critical conditions) explains both the tinctly different methods (Bland & Altman, 1986).
increased number of nurses and the increased number The coefficient of repeatability was created by
of deaths. In many cases, the “other” variable remains Bland and Altman (1986) as an indication of the
unknown, although the researcher can use reasoning repeatability of a single method of measurement.
to identify and exclude most of these spurious Because the same method is being measured repeat-
correlations. edly, the mean difference should be zero. Use the
566 UNIT FOUR  Analyzing Data, Determining Outcomes, and Disseminating Research

following formula to calculate a coefficient of repeat- Table 23-3 displays each difference score, of which
ability (CR), where sx1 − x2 is the standard deviation of sx1 − x2 = 0.42. Therefore, the CR is calculated as:
the difference scores. CR = 1.96 (0.42)
CR = 1.96 (sx1 − x2 ) CR = 0.82

Interpretation of Results
TABLE 23-3  Test-Retest Data from the Geriatric In their study, Clifford and Cipher (2005) found the
Multidimensional Pain and   CR value was 0.82. This value is used to compute
Illness Inventory Activity lower and upper limits of agreement (Bland & Altman,
Interference Subscale 1986). The mean difference between the two assess-
ments of Activity Interference was 0.10. In other
Activity Activity words, the average difference between the first and
Interference, Interference, Difference second administrations of this subscale was 0.10. A
Time 1 Time 2 Score perfect average agreement would be 0, meaning that
2.0 2.8 0.8 on average the two sets of scores were exactly the
3.0 3.6 0.6
same. The CR value, 0.82, is added to and subtracted
3.8 4.0 0.2
3.6 3.8 0.2
from the mean difference to create lower and upper
3.2 3.2 0.0 limits of acceptable agreement: 0.10 ± 0.82. Differ-
4.4 4.6 0.2 ences within 0.10 ± 0.82 would not be deemed clini-
3.6 3.0 −0.6 cally important, according to Bland and Altman
2.8 2.6 −0.2 (2010). Differences between the two administrations
3.4 3.4 0.0 that are less than −0.72 and greater than 0.92 are
5.8 5.6 −0.2 “unacceptable for clinical purposes” (Bland & Altman,
6.8 7.2 0.4 2010). The CR is not an inferential statistic, and values
3.0 3.6 0.6 of lower and upper limits of agreement are not inter-
5.0 5.6 0.6
preted the way one would interpret a confidence inter-
4.8 4.0 −0.8
3.4 3.2 −0.2
val. Rather, they are formulas invented by Bland and
6.6 6.0 −0.6 Altman for heuristic purposes to make decisions on
3.0 3.0 0.0 the extent of agreement between two measurements.
5.8 6.2 0.4
4.8 5.2 0.4
7.0
5.8
7.2
6.0
0.2
0.2
Factor Analysis and Principal
6.0 6.0 0.0 Components Analysis
Data from Clifford, P. A., & Cipher, D. J. (2005). The Geriatric
Factor analysis and principal components analysis
Multidimensional Pain and Illness Inventory: A new instrument measuring (PCA) are statistical techniques designed to examine
pain and illness in long-term care. Clinical Gerontologist, 28(3), 49. interrelationships among large numbers of variables to

4
3
2
Upper limit of agreement
1
0 Perfect agreement
–1 Lower limit of agreement
–2
–3
One value outside limit of
–4 agreement
2 3 4 5 6 7 8

Figure 23-7  Bland and Altman plot of test-retest data.


CHAPTER 23  Using Statistics to Examine Relationships 567

reduce them to a smaller set of variables and to iden- TABLE 23-4  Item Factor Loadings on Three
tify clusters of variables that are most closely linked
GMPI Subscales
together (factors). Factors are hypothetical constructs
created from the original variables. The difference Factor Loading GMPI Item
between factor analysis and PCA lies in the method in Scale 1: Pain and
which the variance of the data is extracted and ana- Suffering
lyzed (Tabachnick & Fidell, 2006). PCA is the proce- .88 Current level of pain
dure of choice for a researcher who is primarily .86 Level of pain in the last week
.67 Level of suffering in the past week
interested in reducing a large number of variables
Scale 2: Activity
down to a smaller number of components. Interference
A common reason for performing PCA is to assist .67 Pain’s interference with walking
with validity investigations of a new measurement .60 Pain’s interference with sitting up
method or scale, particularly subjective assessments .84 Pain’s interference with leaving
or instruments that pertain to attitudes, beliefs, values, room
or opinions. When researchers develop a new instru- .91 Pain’s interference with social
ment, PCA can serve to assist the researcher in inves- activities
tigating its content and construct validity, as described .75 Pain’s interference with
in Chapter 16. The results of PCA assist researchers satisfaction/enjoyment
Scale 3: Emotional
in understanding which questions are redundant (or
Distress
assess the same concept), which questions represent .85 Lonely because of pain
subsets of variables, and which items stand alone and .63 Irritable due to pain
reflect unique concepts. .69 Anxious due to pain
Mathematically, PCA extracts maximum variance .73 Coping with problems
(explanatory “power” to predict one variable’s value
from another’s value) from the data set with each Clifford, P. A., & Cipher, D. J. (2005). The Geriatric Multidimensional Pain
and Illness Inventory: A new instrument measuring pain and illness in
“component” (often used interchangeably with long-term care. Clinical Gerontologist, 28(3), 51.
“factor”). The first principal component is the linear
combination of the variables (or instrument items) that
maximizes the variance of their component scores.
The second component is formed from residual cor- by individuals in long-term care facilities. Of the
relations. Subsequent components are formed from 14 items, 12 items were retained to be included in
the residual correlations that have not yet been created. the final version of the GMPI scale. Using factor anal-
Once the factors have been identified mathemati- ysis, three factors were identified and are listed in
cally, the researcher attempts to explain why the vari- Table 23-4.
ables are grouped as they are. Factor analysis aids in The first factor accounted for 40% of the variance
the identification of theoretical constructs. Factor extracted from the PCA solution, followed by 16%
analysis is also used to confirm the accuracy of a theo- and 9% from the second and third factors. Table 23-4
retically developed construct. For example, a theorist lists the factor loadings of each item. Factor loadings
might state that the concept “hope” consists of the are the correlations between the item and the new
elements (1) anticipation of the future, (2) belief that factor. The first factor, named Pain and Suffering by
things will work out for the best, and (3) optimism. the researchers, was correlated with three of the GMPI
Instruments could be developed to measure these three items—current level of pain, level of pain in the last
elements, and factor analysis could be conducted to week, and level of suffering. All other GMPI items
determine whether subject responses clustered into were not highly correlated with factor 1 (the factor
these three groupings. loadings were < 0.30) and are not listed in Table 23-4.
The second factor, named Activity Interference, was
Example correlated with five of the GMPI items, all of which
The following example describes how PCA was used pertained to life interference secondary to the pain.
to investigate content and construct validity for the The factor loadings ranged from 0.60 to 0.91. The
GMPI (Clifford & Cipher, 2005). There were 14 items third factor, named Emotional Distress, was correlated
from the GMPI administered to 401 long-term care with four of the GMPI items, all of which pertained
residents. GMPI, a scale introduced earlier in this to emotional distress secondary to the pain. The factor
chapter, was developed to assess pain experienced loadings ranged from 0.63 to 0.85.
568 UNIT FOUR  Analyzing Data, Determining Outcomes, and Disseminating Research

In this analysis, the items loaded highly on only Individual’s factor score for pain
one factor, which is not always the case in PCA. For and suffering = 8 + 7 + 9 = 24
example, the first GMPI item was “How bad is your
pain right now?” This item loaded highly on factor 1 Another common method of computing a factor
(Pain and Suffering) but had low loadings of less than score is using the factor loadings to weight each study
0.30 on the other two factors. The fourth GMPI item participant’s score. Applying the same hypothetical
was “How much has your pain interfered with you scores as before, the factor loadings are multiplied by
being able to walk around?” This item loaded highly the item scores to create the factor score:
on factor 2 (Activity Interference) but had low load-
ings of less than 0.30 on the other two factors. This (0.88) 8 + (0.86) 7 + (0.67) 9 = 19.09
was the case for all GMPI items, with the exception
of two items that did not load highly on any of the In the first method, each item is weighted equally
factors. Those two items were permanently dropped in the equation because the weight is essentially “1.”
from the instrument. In the second method, each item is adjusted for the
extent to which that item loads on that factor. The
“Naming” the Factor advantages and disadvantages of these factor score
The three factors generated from the PCA were named methods, in addition to descriptions of other methods
according to the nature of the items that loaded on for obtaining factor scores, are reviewed by DiSte-
those factors. When naming the factor, the researcher fano, Zhu, & and Mîndrilă (2009).
must examine the items that cluster together in a factor
and seem to explain that clustering. Variables with
high loadings on the factor must be included, even if KEY POINTS
they do not fit the researcher’s preconceived theoreti-
cal notions of which items “fit” together because they • Correlational analyses identify relationships or
reflect a similar concept. The purpose is to identify the associations between or among variables.
broad construct of meaning that has caused these par- • The purpose of the analysis is also to clarify rela-
ticular variables to be so strongly intercorrelated. tionships among theoretical concepts or help to
Naming this construct is an important part of the pro- identify potentially causal relationships, which can
cedure because naming of the factor provides theoreti- be tested by inferential analysis.
cal meaning. • All data for the analysis should have been obtained
from a single population from which values are
Factor Scores available on all variables to be examined.
After the initial factor analysis, additional studies are • Correlational analysis provides two pieces of infor-
conducted to examine changes in the phenomenon mation about the data: the nature of a linear rela-
in various situations and to determine the relation- tionship (positive or negative) between the two
ships of the factors with other concepts. Factor variables and the magnitude (or strength) of the
scores are used during data analysis in these addi- linear relationship.
tional studies. To obtain factor scores, the variables • Pearson’s product-moment correlation coefficient
included in the factor are identified, and the scores is the preferred computation when investigating the
on these variables are summed for each study par- association among two variables measured at the
ticipant. Thus, each participant has a score for each interval or ratio level and when the variables meet
factor in the instrument. There are several methods the other required statistical assumptions.
of computing factor scores. One of the most common • Spearman’s rank-order correlation coefficient and
methods involves simply adding the participant’s Kendall’s tau are both nonparametric statistics that
scores on the items that load on a factor. Using the are calculated when the assumptions of Pearson’s
GMPI data as an example, to obtain a factor score correlation cannot be met, such as variables mea-
for Pain and Suffering, a study participant’s scores sured at the ordinal level or non-normal distribution
on current level of pain, pain in the past week, and of values for a variable.
level of suffering would be summed. For example, • The first clue to the possibility of a causal link is
if a participant scored an 8 on current pain, 7 on the existence of a relationship, but a relationship
pain the past week, and 9 on level of suffering, the does not mean causality.
participant’s factor score for Pain and Suffering • Bland and Altman plots are a graphical display of
would equal 24. agreement between two administrations of an
CHAPTER 23  Using Statistics to Examine Relationships 569

instrument or two raters of a clinician-rated Clifford, P. A., & Cipher, D. J. (2005). The Geriatric Multidimen-
instrument. sional Pain and Illness Inventory: A new instrument measuring
• The coefficient of repeatability is a value that is pain and illness in long-term care. Clinical Gerontologist, 28(3),
used to determine acceptable lower and upper 45–61.
Clifford, P. A., Cipher, D. J., & Roper, K. D. (2005). Assessing
limits of interrater agreement and test-retest agree-
dysfunctional behaviors in long-term care. Journal of the Ameri-
ment. can Medical Director’s Association, 6(5), 300–309.
• Principal components analysis is a procedure that Cohen, J. (1988). Statistical power analysis for the behavioral sci-
reduces a large number of variables down to a ences (2nd ed.). Hillsdale, NJ: Lawrence Erlbaum Associates.
smaller number of components and is most often Cohen, J., & Cohen, P. (1983). Applied multiple regression/
used during the construction of a new measurement correlation analysis for the behavioral sciences (2nd ed.). Hills-
method or scale. dale, NJ: Erlbaum.
• The results of principal components analysis assist Corty, E. W. (2007). Using and interpreting statistics: A practical
the researcher in understanding which questions text for the health, behavioral, and social sciences. St. Louis, MO:
assess the same concept and are redundant, which Mosby.
Daniel, W. W. (2000). Applied nonparametric statistics (2nd ed.).
questions represent subsets of variables, and which
Pacific Grove, CA: Duxbury Press.
items stand alone. DiStefano, C., Zhu, M., & Mîndrilă, D. (2009). Understanding and
using factor scores: Considerations for the applied researcher.
Practical Assessment, Research & Evaluation, 14(20), 1–9.
REFERENCES Grove, S. K. (2007). Statistics for health care research: A practical
Aberson, C. L. (2010). Applied power analysis for the behavioral workbook. St. Louis, MO: Saunders.
sciences. New York, NY: Routledge Taylor & Francis Group. Lupien, S. J., Maheu, F., Tu, M., Fiocco, A., & Schramek, T. E.
Altman, D. G. (1991). Practical statistics for medical research (1st (2007). The effects of stress and stress hormones on human cogni-
ed.). London, UK: Chapman & Hall. tion: Implications for the field of brain and cognition. Brain &
Bland, J. M., & Altman, D. M. (1986). Statistical methods for Cognition, 65(3), 209–237.
assessing agreement between two methods of clinical measure- Munro, B. H. (2005). Statistical methods for health care research
ment. Lancet, 1(8476), 307–310. (5th ed.). Philadelphia, PA: Lippincott Williams, & Wilkins.
Bland, J. M., & Altman, D. M. (2010). Statistical methods for Tabachnick, B. G., & Fidell, L. S. (2006). Using multivariate sta-
assessing agreement between two methods of clinical measure- tistics (5th ed.). Needham Heights, MA: Allyn & Bacon.
ment. International Journal of Nursing Studies, 47(8), 931–936. Yerkes, R. M., & Dodson, J. D. (1908). The relation of strength of
Cipher, D. J., Clifford, P. A., & Roper, K. D. (2006). Behavioral stimulus to rapidity of habit-formation. Journal of Comparative
manifestations of pain in the demented elderly. Journal of the Neurology & Psychology, 18(5), 459–482.
American Medical Director’s Association, 7(6), 355–365. Zar, J. H. (1999). Biostatistical analysis (4th ed.). Upper Saddle
Cipher, D. J., & Hooker, R. S. (2006). Are patients satisfied with River, NJ: Prentice-Hall.
PAs and NPs? Journal of the American Association of Physician
Assistants, 19(1), 36–44.
  http://evolve.elsevier.com/Grove/practice/

24
CHAPTER

Using Statistics to Predict

I
n nursing practice, the ability to predict future regression is an effort to explain the dynamics within
events is crucial. Clinical researchers might inves- the scatter plot by drawing a straight line (the line
tigate if length of hospital stay of patients can be of best fit) through the plotted scores. This line
predicted by severity of illness. Health outcome is drawn to explain best the linear relationship
researchers want to know what factors play an impor- or association between two variables. Knowing that
tant role in responses of patients to health promotion, linear relationship, we can, with some degree of
illness prevention, and rehabilitation interventions. accuracy, use regression analysis to predict the value
Educators are interested in knowing what variables are of one variable if we know the value of the other
most effective in predicting scores of undergraduate variable (Cohen & Cohen, 1983). Figure 24-1 illus-
nurses on the registered nurse (RN) licensure exami- trates the linear relationship between treatment com-
nation. Advanced practice nurses are interested in pliance (independent variable) and posttreatment
what variables predict their success in passing their functional impairment (dependent variable) among
national certification examinations. patients with chronic pain. As shown in the scatter
The statistical procedure most commonly used for plot, there is a strong inverse relationship between
prediction is regression analysis. The purpose of a the two variables. Higher levels of treatment compli-
regression analysis is to identify which factor or ance are associated with lower levels of functional
factors predict or explain the value of a dependent impairment.
(outcome) variable. In some cases, the analysis is In simple linear regression, the dependent variable
exploratory, and the focus is prediction. In others, is continuous, and the predictor can be any scale of
selection of variables is based on a theoretical proposi- measurement. However, if the predictor is nominal, it
tion, and the purpose is to develop an explanation that must be correctly coded. When the data are ready,
confirms the theoretical proposition. the parameters a and b are computed to obtain a
In regression analysis, the independent (predictor) regression equation. To understand the mathematical
variable or variables influence variation or change in process, recall the algebraic equation for a straight
the value of the dependent variable. The goal is to line:
determine how accurately one can predict the value of
an outcome (or dependent) variable based on the value y = bx + a
or values of one or more predictor (or independent)
variables. This chapter describes some common sta- where
tistical procedures used for prediction. These proce- y = dependent variable (outcome)
dures include simple linear regression, multiple x = independent variable (predictor)
regression, logistic regression, and Cox proportional b = slope of the line (beta, or what the increase in
hazards regression. value is along the x-axis for every unit of
increase in the y value)
a = y-intercept (the point where the regression line
Simple Linear Regression intersects the y-axis)
Simple linear regression provides a means to esti- A regression equation can be generated with a data
mate the value of a dependent variable based on set containing participants’ x and y values. When this
the value of an independent variable. Simple linear equation is generated, it can be used to predict y values

570
CHAPTER 24  Using Statistics to Predict 571

of future participants, given only their x values. In that when the b is calculated, that value is inserted into
simple or bivariate regression, predictions are made in the formula for a.
cases with two variables. The score on variable y
(dependent variable) is predicted from the same indi- nΣXY − ΣXΣY ΣY − bΣX
vidual’s known score on variable x (independent b= a=
nΣX 2 − ( ΣX ) 2 n
variable).
No single regression line can be used to predict
with complete accuracy every y value from every x Calculation of Simple Linear Regression
value. You could draw an infinite number of lines Table 24-1 displays how one would arrange data to
through the scattered paired values. However, the perform linear regression by hand. Regression analy-
purpose of the regression equation is to develop the sis is conducted by a computer for most studies, but
line that allows the highest degree of prediction this calculation is provided to increase your under-
possible—the line of best fit. The procedure for devel- standing of the aspects of regression analysis and how
oping the line of best fit is the method of least squares. to interpret the results. This example uses actual clini-
The formulas for the beta (b) and y-intercept (a) of the cal data obtained from adults with a painful injury who
regression equation are computed as follows. Note received multidisciplinary pain management. The cal-
culation in this chapter includes a subset of the study
data belonging to those patients (n = 12) with the
highest levels of coping skills (Cipher, Fernandez, &
6 Clifford, 2002). A subset was selected for this illustra-
tion so that the computation example would be small
5 and manageable. In actuality, studies involving linear
Functional Impairment

regression need to be adequately powered, so they


4
employ a larger sample (Aberson, 2010; Cohen &
3 Cohen, 1983). The strength of this example is that the
data are actual, unmodified clinical data from a study.
2 The first variable in Table 24-1 is the patient’s level
of treatment compliance—the predictor or independent
1 variable (x) in this analysis. The second variable is the
patient’s posttreatment level of functional impairment—
0 the dependent variable (y). Treatment compliance was
2.0 3.0 4.0 5.0 6.0
Treatment Compliance assessed by patients’ scores on the Cognitive Psy­
chophysiological Treatment Clinical Rating Scales
Figure 24-1  Linear relationship between treatment compliance and (Clifford, Cipher, & Schumacker, 2003), which yields
posttreatment functional impairment. an overall compliance score with higher numbers

TABLE 24-1  Computation of Linear Regression Equation


Patient X (Compliance) Y (Functional Impairment) X2 XY
1 4.9 0.3 24.01 1.47
2 5.5 0.5 30.25 2.75
3 4.0 1.1 16.00 4.40
4 4.1 2.3 16.81 9.43
5 4.4 2.9 19.36 12.76
6 2.9 2.9 8.41 8.41
7 4.0 3.6 16.00 14.40
8 3.1 3.8 9.61 11.78
9 3.8 4.0 14.44 15.20
10 3.6 4.7 12.96 16.92
11 3.8 4.7 14.44 17.86
12 3.0 5.3 9.00 15.90

Σ 47.10 36.10 191.29 131.28


572 UNIT FOUR  Analyzing Data, Determining Outcomes, and Disseminating Research

representing better levels of compliance with the pain 10

Y (Functional Impairment)
management treatment regimen. Functional impair- 9
ment was represented by patients’ scores on the 8
yˆ = –1.62X + 9.37
7
Interference subscale of the Multidimensional Pain 6
Inventory (Kerns, Turk, & Rudy, 1985), with higher 5
scores representing more functional impairment. The 4
null hypothesis being tested is: Treatment compliance 3
is not a significant predictor of posttreatment func- 2
tional impairment among patients undergoing pain 1
0
management. The data in Table 24-1 are arranged in 0 1 2 3 4 5 6
columns, which correspond to the elements of the X (Treatment Compliance)
formula. The summed values in the last row of Table
24-1 are inserted into the appropriate places in the Figure 24-2  Regression line represented by regression equation.
formula.

Calculation Steps
Step 1: Calculate b. The predicted ŷ is 1.43. This procedure would be
From the values in Table 24-1, we know that n = 12, continued for the rest of the subjects, and the Pearson
ΣX = 47.10, ΣY = 36.10, ΣX2 = 191.29, and ΣXY = correlation between the actual functional impairment
131.28. These values are inserted into the formula for levels (y) and the predicted functional impairment
b, as follows: levels (ŷ) would yield the multiple R value. In this
12 (131.28) − (47.10) (36.10) example, R = 0.75. The higher R, the more likely that
b= the new regression equation accurately predicts y
12 (191.29) − 47.102
because the higher the correlation, the closer the
b = −1.62 actual y values are to the predicted ŷ values. Figure
24-2 displays the regression line where the x-axis
Step 2: Calculate a. represents possible treatment compliance values, and
From Step 1, we know that b = −1.62, and we plug the y-axis represents the predicted functional impair-
this value into the formula for a: ment levels (ŷ values).
36.10 − (−1.62) (47.10) Step 5: Determine whether the predictor variable sig-
a= nificantly predicts y.
12
To know whether the predictor significantly predicts
a = 9.37 y, the value of beta must be tested against zero because
Step 3: Write the new regression equation: zero reflects the presence of no significant association
between the variables, or null hypothesis. In simple
y = −1.62 X + 9.37 regression, this is most easily accomplished by using
the R value from Step 4:
Step 4: Calculate R
The multiple R is defined as the correlation between
the actual y values and the predicted y values using n−2
t = R
the new regression equation. The predicted y value 1 − R2
using the new equation is represented by the symbol
12 − 2
ŷ to differentiate it from y, which represents the actual t = 0.75
y values in the data set. We can use our new regression 1 − 0.56
equation from Step 3 to compute predicted functional t = 3.58
impairment levels for each participant, the outcome of
interest, using his or her compliance rating. For The t value is compared with the t probability dis­
example, the compliance rating of patient no. 1 is 4.9, tribution table (see Appendix B). The df for this t
and the predicted functional impairment for patient no. statistic is n − 2. The critical t value at alpha (α) =
1 is calculated as: 0.05, df = 10 is 2.23. Our obtained t was 3.58, which
yˆ = −1.62 (4.9) + 9.37 exceeds the critical value in the table, indicating a
significant association between the predictor (x) and
yˆ = 1.43 outcome (y).
CHAPTER 24  Using Statistics to Predict 573

Step 6: Calculate R2. multiple regression are presented by Stevens (2009)


After establishing the statistical significance of the R and Tabachnick and Fidell (2006).
value, it must be examined for clinical importance. Interpretations of multiple regression findings are
This examination is accomplished by obtaining the the same as with simple regression. The beta (b)
coefficient of determination for regression—which values of each predictor are tested for significance,
simply involves squaring the R value. R2 represents and a multiple R and R2 are computed. The only dif-
the percentage of variance in y explained by the pre- ference is that in multiple regression, when all predic-
dictor. In our example, R was 0.75, and R2 was 0.56. tors are tested simultaneously, each b has been adjusted
Multiplying 0.56 × 100% indicates that 56% of the for every other predictor in the regression model. The
variance in posttreatment functional impairment can b represents the independent relationship between that
be explained by knowing the patients’ level of treat- predictor and y, even after controlling for (or account-
ment compliance (Cohen & Cohen, 1983). ing for) the presence of every other predictor in the
R2 is most helpful in testing the contribution of the model.
predictors in explaining an outcome when more than Mancuso (2010) conducted a study of 102 subjects
one predictor is included in the regression model. In with diabetes to develop a predictive model of glyce-
contrast to R, R2 for one regression model can be mic control, as measured by glycosylated hemoglobin
compared with another regression model that contains (HbA1c). The five predictors for HbA1c were health
additional predictors (Cohen & Cohen, 1983). For literacy, patient trust, knowledge of diabetes, perfor-
example, Cipher et al. (2002) added another predictor, mance of self-care activities, and depression. The five
the patients’ coping style, to the regression model of predictors of glycemic control were tested with mul-
functional impairment. The R2 values of both models tiple regression analysis. The analysis yielded five b
were compared, the first with treatment compliance as values, each with a corresponding p value. As shown
the sole predictor and the second with treatment com- in Table 24-2, patient trust and depression were sig-
pliance and copying style as predictors. The R2 values nificant predictors of glycemic control (HbA1c), even
of the two models were statistically compared to indi- after adjusting for the presence or contribution of
cate whether the proportion of variance in ŷ was sig- every other predictor in the model. Health literacy,
nificantly increased by including the second predictor diabetes knowledge, and performance of self-care
of coping style in the model. activities did not significantly predict HbA1c levels. R2
was 0.285, indicating that patient trust and depression
Interpretation of Results accounted for 28.5% of the variance in HbA1c (the
The b (beta or slope of the line) was −1.62, indicat­ measure of glycemic control).
ing an inverse relationship between treatment com­ The findings from this study have potential im­
pliance and posttreatment functional impairment. plications for the management of patients with dia-
The t statistic was significant, indicating that we can betes. Because lower levels of patient trust were
reject our null hypothesis and conclude that: Treat­ associated with higher HbA1c values, fostering com-
ment compliance significantly predicted posttreat­ munication and trusting collaboration between the
ment functional impairment levels among adults with patient and the healthcare provider could directly or
chronic pain. Higher levels of treatment compliance indirectly improve glycemic control. Higher levels of
significantly predicted lower levels of functional depression were also associated with higher HbA1c
impairment. values, and early interventions or referrals aimed at
addressing depressive symptoms could be important
in improving glycemic control. Regression analysis
Multiple Regression is not an indication of cause and effect. However,
Multiple regression analysis is an extension of these results can serve as a benchmark for further re-
simple linear regression in which more than one inde- search aimed at investigating the influence of patient
pendent variable is entered into the analysis (Munro, factors such as trust and depression on glycemic
2005). Because the relationships between multiple control.
predictors and y are tested simultaneously, the cal­
culations involved in multiple regression analysis are Multicollinearity
very complex. Multiple regression is best conducted Multicollinearity occurs when the independent vari-
using a statistical software package such as those pre- ables in a multiple regression equation are strongly
sented in Table 21-2. However, full explanations and correlated with one another. The presence of multi-
examples of the matrix algebraic computations of collinearity does not affect predictive power (the
574 UNIT FOUR  Analyzing Data, Determining Outcomes, and Disseminating Research

TABLE 24-2  Predictors of Hemoglobin A1c in Patients with Diabetes


Unstandardized Coefficients Standarized Coefficient
Independent Variable B SE β t Significance (p)
Health literacy −0.063 0.080 −0.070 −0.0782 0.436
Patient trust −0.873 0.165 −0.459 −5.288 0.000*
Diabetes knowledge 0.012 0.011 0.100 1.116 0.267
Performance of self-care activities 0.005 0.135 0.003 0.040 0.968
Depression 0.036 0.014 0.226 2.589 0.011*

From Mancuso, J. M. (2010). Impact of health literacy and patient trust on glycemic control in an urban USA populations. Nursing & Health Sciences, 12(1),
94–104.
*p < 0.05, significant.

capacity of the independent variables to predict values describes the various terms used as variables in regres-
of the dependent variable in that specific sample); sion equations.
rather, it causes problems related to generalizability
and the stability of the findings. If multicollinearity is Dummy Variables
present, the equation lacks predictive validity, and To use categorical variables in regression analysis, a
the amount of variance explained by each variable in coding system is developed to represent group mem-
the equation is inflated. Additionally, when cross- bership. Categorical variables of interest in nursing
validation is performed, the b values do not remain that might be used in regression analysis include
consistent across samples (Cohen & Cohen, 1983). gender, income, ethnicity, social status, level of educa-
Multicollinearity is minimized by carefully selecting tion, and diagnosis. If the variable is dichotomous,
the independent variables and thoroughly determining such as gender, members of one category are assigned
their presence before the regression analysis. If highly the number 1, and all others are assigned the number
correlated independent variables are found, the cor- 0. In this case, for gender the coding could be:
related predictors might be combined into one score 1 = female
or value yielding one predictor, or only one of the 0 = male
measures (scores) might be included in the regression If the categorical variable has three values, two
equation. dummy variables are used; for example, social class
The first step in identifying multicollinearity is to could be classified as lower class, middle class, or
examine the bivariate correlations among the indepen- upper class. The first dummy variable (X1) would be
dent variables. You would perform multiple correla- classified as:
tion analyses before conducting the regression 1 = lower class
analyses. The correlation matrix is carefully examined 0 = not lower class
for evidence of multicollinearity. Most researchers The second dummy variable (X2) would be classified
consider multicollinearity to exist if a bivariate cor- as:
oasis-ebl|Rsalles|1476461084

relation is greater than 0.65. However, some research- 1 = middle class


ers use a stronger correlation of 0.80 or greater as an 0 = not middle class
indication of multicollinearity (Schroeder, 1990). The three social classes would be represented in the
data set in the following manner:
Lower class X1 = 1, X2 = 0
Types of Independent Variables Used in Middle class X1 = 0, X2 = 1
Regression Analyses Upper class X1 = 0, X2 = 0
Variables in a regression equation can take many The variables lower class and middle class would
forms. Traditionally, as with most multivariate analy- be entered as predictors in the regression equation, in
ses, variables are measured at the interval or ratio which both are tested against the reference category,
level. However, researchers also use categorical or upper class. Specifically, the b values for these two
dichotomous variables (referred to as dummy vari- variables would represent whether y differs by lower
ables), multiplicative terms, and transformed terms. class versus upper class and middle class versus upper
A mixture of types of variables may be used in a class. When more than three categories define the
single regression equation. The following discussion values of the variable, increased numbers of dummy
CHAPTER 24  Using Statistics to Predict 575

TABLE 24-3  Association between Angiotensin- TABLE 24-4  Notation in Cells of the Odds
Converting Enzyme (ACE) Inhibitor Ratio Table
Use and Colon Polyps Polyps No polyps
Polyps No polyps ACE inhibitor use a b
ACE inhibitor use 251 1508 No ACE inhibitor c d
No ACE inhibitor 603 2284
ACE, Angiotensin-converting enzyme.
ACE, Angiotensin-converting enzyme.

variables are used. The number of dummy variables is ad (251) (2284) 573, 284
OR = = = = 0.63
always one less than the number of categories (Aiken bc (1508) (603) 909, 324
& West, 1991). An example of how one might analyze
dichotomous dummy variables is presented in the next OR = 0.63
section. Interpretation
An OR of ≅ −1 indicates that the probability of the
Odds Ratio event (polyps) is the same for both groups.
An OR of >1 indicates that the probability of the event
When both the predictor and the dependent variable (polyps) is higher among subjects exposed (to ACE
are dichotomous, the odds ratio (OR) is a commonly inhibitors).
used statistic to obtain an indication of association. An OR of <1 indicates that the probability of the event
The odds ratio is defined as the ratio of the odds of (polyps) is lower among subjects exposed (to ACE
an event occurring in one group to the odds of it occur- inhibitors).
ring in another group (Gordis, 2008). Put simply, the
OR is a way of comparing whether the odds of a The OR for the study was 0.63, indicating the odds
certain event is the same for two groups. For example, of polyps among veterans using ACE inhibitors is
the odds of a myocardial infarction occurring in men lower than among veterans who did not use ACE
versus women could be compared. This research inhibitors. We can further note that veterans who used
evidence would be valuable in predicting myocardial ACE inhibitors were 37% less likely to have polyps
infarctions in men and women in clinical practice (Kedika et al., 2011). This value was computed by
(Melnyk & Fineout-Overholt, 2011; Sackett, Straus, subtracting the OR from 1.00 (1.00 − 0.63 = 0.37 ×
Richardson, Rosenberg, & Haynes, 2000). 100% = 37%). The difference between the obtained
OR and 1.00 represents the extent of the lesser or
Calculation greater likelihood of the event occurring.
The formula for the OR is:
ad
Confidence Intervals
OR = OR values are often accompanied by a confidence
bc interval, which consists of a lower and upper limit
A study examining the use of angiotensin- value. The 95% confidence interval is interpreted as
converting enzyme (ACE) inhibitors in 4646 veterans there is a 95% probability that the population value
is presented as an example. The use of ACE inhibitors lies between [lower limit] and [upper limit]. If the
was examined in relation to having advanced ade­ confidence interval does not include the number 1.00,
nomatous colon polyps in this population (Kedika this would indicate a significant association between
et al., 2011). These data are presented in Table 24-3. the medication use and the polyps. The 95% confi-
The formula for the OR designates the predictor’s dence interval for the OR for ACE inhibitor use and
ratios of 1’s to 0’s within the positive outcome in the polyps was 0.54 to 0.74; this means that there is a 95%
numerator and the predictor’s ratios of 1’s to 0’s probability that the population value lies between the
within the negative outcome in the denominator. The values of 0.54 and 0.74. Because this interval excludes
values must be coded accordingly. Table 24-4 displays the value of 1.00, it indicates that there is a statistically
the following notation to assist you in calculating the significant association between ACE inhibitor use and
OR: polyps.
576 UNIT FOUR  Analyzing Data, Determining Outcomes, and Disseminating Research

as natural logarithms, it allows the result to yield a


Logistic Regression probability (a value between 0 and 1).
Logistic regression replaces linear regression when Recall the example from the ACE inhibitor and
the researcher wants to test a predictor or predictors polyps data (Kedika et al., 2011). If a person used
of a dichotomous dependent variable. Some common ACE inhibitors, the probability of that patient having
examples of dependent variables that are analyzed colon polyps is calculated:
with logistic regression are: patient lived or died, Given: For these data, b = −0.46, and the y-intercept
responded or did not respond to treatment, and (a) is −1.33.
employed or unemployed. The logistic regression
model can be considered more flexible than linear e −0.46 (1) + −1.33
Yˆ =
regression in the following ways: 1 + e −0.46 (1) + −1.33
1. Logistic regression can have continuous predictors,
e −1.79 0.167
nominal predictors, or a combination of the two, Yˆ = so Yˆ = = 0.14
with no assumptions regarding normality of the 1 + e −1.79 1.167
distribution.
2. Logistic regression can test predictors with a non- The probability of having colon polyps if the patient
linear relationship between the predictor and the used ACE inhibitors is only 0.14, or 14%. The prob-
dependent variable. ability of having colon polyps if the patient did not
3. With a logistic regression model, you can compute use ACE inhibitors is 21%, as shown next. The risk of
the odds of a person’s outcome. Each predictor is having polyps is greater if the patient did not use ACE
associated with an OR that represents the indepen- inhibitors.
dent association between that predictor and the
outcome y (Tabachnick & Fidell, 2006). e −0.46 ( 0 ) + −1.33
Yˆ =
Because the dependent variable is either 1 or 0, 1 + e −0.46 ( 0 ) + −1.33
logistic regression analysis produces a regression
e −1.33 0.26
equation that yields probabilities of the outcome Yˆ = so Yˆ = = 0.21
occurring for each person. If the predictor is continu- 1 + e −1.33 1.26
ous, we can determine the probability of the outcome
occurring with a predictor score of some value X. If Odds Ratio (OR) in Logistic Regression
the predictor is dichotomous, we can determine the Each predictor is associated with an OR in a logistic
probability of the outcome occurring with a predictor regression model. If the predictor is dichotomous, the
value of “1” and a predictor value of “0.” OR is interpreted as: with an X value of “yes,” the
odds of the outcome occurring is [OR value] times as
Calculation likely. The ACE inhibitor and polyps example yielded
Logistic regression is best conducted using a statistical an OR of 0.63. As was stated previously, this OR
software package such as those presented in Table indicates that veterans using ACE inhibitors were
21-2. Full explanations and examples of the computa- 0.63 times as likely to have polyps. Another way of
tions of logistic regression are presented by Tabach- stating this is that veterans who used ACE inhibitors
nick and Fidell (2006). A brief overview is provided were 37% less likely to have polyps. Thus, patients
in this chapter, with an example of simple logistic treated with ACE inhibitors to lower their blood pres-
regression using actual clinical data. sure have a decreased likelihood of developing colon
Because the dependent variable in logistic regres- polyps.
sion is dichotomous, the predicted ŷ is always in the If the predictor is continuous, the OR is interpreted
range of 0 to 1, which is interpreted as a probability. as: for every 1-unit increase in X, the odds of the
Similar to linear regression, the predicted ŷ values are outcome occurring are [OR value] times as likely. For
calculated from a b (or more than one b in the case of example, the association between years of education
multiple predictors) and a y-intercept. In contrast to and obtaining employment among persons with a
linear regression, the b and y-intercept are the expo- spinal cord injury was investigated (Ottomanelli,
nents of the number e (2.718). An exponent of e is Sippel, Cipher, & Goetz, 2011). The predictor was
commonly referred to as the natural logarithm. In age, and the dependent variable was employment (yes/
other words, the natural logarithm of a given number no). The OR was 1.10, indicating that for every year
is the power to which e would have to be raised to older in age, the patient was 1.10 times as likely (or
equal that number. When the b and y-intercept serve 10% more likely) to have obtained employment.
CHAPTER 24  Using Statistics to Predict 577

In the same study, the association between being of depressed adults completes a cognitive therapy
male and obtaining employment among persons with program. What variables predict the time elapsed from
spinal cord injury was investigated (Ottomanelli et al., the end of treatment until a patient’s first relapse?
2011). The predictor was being male (yes/no), and the The major difference between using Cox regression
dependent variable was employment (yes/no). The OR as opposed to linear regression is the ability of sur-
was 1.00, indicating that patients who were male were vival analysis to handle cases where survival time is
1.00 times as likely (or just as likely) as females to have unknown. For example, in the study of treatment for
obtained employment. In other words, the likelihood of streptococcal pharyngitis (strep throat), perhaps only
employment was equal among males and females. 20% of cases relapse. The other 80% do not relapse
by the end of the researcher’s study. Thus, it is
unknown how long it will be until the patients relapse.
Cox Proportional Survival times that are known only to exceed a certain
value are called censored data. Censored data can
Hazards Regression also occur when a participant drops out of the study.
When testing predictors of a dependent variable that Cox regression calculations take into account cen-
is time-related, the appropriate statistical procedure is sored data when estimating the relationships between
Cox proportional hazards regression (or Cox regres- predictors and y—in contrast to linear regression anal-
sion) (Hosmer, Lemeshow, & May, 2008). The depen- yses, which would delete or exclude those cases from
dent variable in Cox regression is called the hazard, analysis (Hosmer et al., 2008).
a neutral word intended to describe the risk of event Logistic regression yields odds ratios for each pre-
occurrence (e.g., risk of obtaining an illness, risk of dictor to represent the relationship between that pre-
complications from medications, or risk of relapse). dictor and y, whereas Cox regression yields hazard
The primary output in a Cox regression analysis rep- ratios. A hazard ratio (HR) is interpreted almost iden-
resents the relationship between each predictor vari- tically to an OR with the exception that the HR repre-
able and the hazard, or rate of event occurrence. sents the risk of the event occurring sooner.
Cox regression is a type of survival analysis that An example of Cox regression used in clinical
can answer questions pertaining to the amount of time research is presented in Table 24-5. Predictors of
that elapses until an event occurs. Examples of the major adverse cardiovascular events (MACE) in a
types of questions that can be answered using Cox sample of 312 veterans with rheumatoid arthritis were
regression follow. A group of nurse practitioners tested with Cox regression (Banerjee et al., 2008).
begins a doctoral program. What variables predict There were 10 predictors of cardiovascular events
how long it will take the students to graduate? A group tested, and the analysis yielded 10 hazard ratios, each

TABLE 24-5  Cox Proportional Hazards Regression Results of Major Adverse Cardiovascular Events in
Veterans with Rheumatoid Arthritis
Hazard Ratio Hazard Ratio
Predictor (Unadjusted)* p Value (Adjusted)† p Value
oasis-ebl|Rsalles|1476461087

DAS score 1.29 0.02 1.31 0.01


Age 1.01 0.62 0.99 0.83
Hypertension 2.55 0.03 2.43 0.08
Tobacco use 1.37 0.33 1.12 0.78
Diabetes 1.3 0.33 0.99 0.99
Hyperlipidemia 2.63 < 0.01 2.45 0.01
History of vascular disease 2.36 < 0.01 2.54 <0.01
DMARD use 0.63 0.06 0.52 <0.01
aTNF-α use 0.65 0.23 0.81 0.02
DMARD + aTNF-α use 0.68 0.34 0.82 0.83

Note: Full explanations and examples of the computations of Cox regression are presented in Hosmer, Lemeshow, & May (2008).
aTNF-α, Anti–tumor necrosis factor-α medication; DAS, disease activity score; DMARD, disease-modifying antirheumatic drug.
*Adjusted for all other model predictors.
From Banerjee, S. D., et al. (2008). Cardiovascular outcomes in male veterans with rheumatoid arthritis. American Journal of Cardiology, 101(8), 1204.
Hosmer, D. W., Lemeshow, S., & May, S. (2008). Applied survival analysis: Regression modeling of time to event data (2nd ed.). Hoboken, NJ: John Wiley &
Sons.
578 UNIT FOUR  Analyzing Data, Determining Outcomes, and Disseminating Research

with a corresponding p value. As shown in Table 24-5, • Multicollinearity occurs when the independent vari-
the disease activity score (DAS) for extent of rheu­ ables in a multiple regression equation are strongly
matoid arthritis, hypertension, hyperlipidemia, and correlated and results in unstable findings.
history of vascular disease all were significant predic- • The odds ratio is a way of comparing whether
tors of a cardiovascular event when each predictor was the odds of a certain event is the same for two
tested separately. However, when all 10 predictors groups.
were tested simultaneously, the hazard ratios were • Logistic regression replaces linear regression when
called adjusted hazard ratios, which means that each you want to test a predictor or predictors of a
HR has been adjusted for every other predictor in the dichotomous dependent variable.
regression model. The results of the adjusted HR • When testing predictors of a dependent variable
values indicated that DAS, hyperlipidemia, history of that is time-related, the appropriate statistical pro-
vascular disease, disease-modifying antirheumatic cedure is Cox proportional hazards regression (or
drug (DMARD) use, and anti–tumor necrosis factor Cox regression).
(anti-TNF) medication use all were significant predic- • The hazard ratio represents the risk of the event
tors of a MACE, even after controlling for the pres- occurring sooner.
ence of every other predictor in the model. Full
explanations and examples of the computations of
Cox regression are presented by Hosmer et al. (2008). REFERENCES
The findings from this study could have indications Aberson, C. L. (2010). Applied power analysis for the behavioral
for the treatment of rheumatoid arthritis in clinical sciences. New York, NY: Routledge Taylor & Francis Group.
practice. Because higher levels of rheumatoid arthritis Aiken, L. S., & West, S. G. (1991). Multiple regression: Testing and
disease activity were associated with a greater likeli- interpreting interactions. Newbury Park, UK: Sage.
hood of MACE, it could be that the successful control Banerjee, S. B., Compton, A. P., Hooker, R. S., Cipher, D. J.,
of rheumatoid arthritis symptoms could directly or Reimold, A., Brilakis, E. S., et al. (2008). Cardiovascular out-
indirectly reduce the risk of MACE. DMARD and comes in male veterans with rheumatoid arthritis. American
Journal of Cardiology, 101(8), 1201–1205.
anti-TNF use were associated with a lower risk of
Cipher, D. J., Fernandez, E., & Clifford, P. A. (2002). Coping style
MACE, and so proper medication management of influences compliance with multidisciplinary pain management.
these patients might be an important factor in reducing Journal of Health Psychology, 7(5), 665–673.
the risk of MACE. Traditional cardiovascular risk Clifford, P. A., Cipher, D. J., & Schumacker, R. E. (2003). Compli-
factors studied in other populations (e.g., age, diabe- ance and stages of change in multidisciplinary pain centers. The
tes, smoking history) did not predict MACE in this Pain Clinic, 15(4), 355–368.
sample (D’Agostino et al., 2000; Kannel, McGee, & Cohen, J., & Cohen, P. (1983). Applied multiple regression/
Gordon, 1976). Therefore, male veterans with rheu- correlation analysis for the behavioral sciences (2nd ed.). Hills-
matoid arthritis seem to be unique with regard to the dale, NJ: Erlbaum.
experience of MACE and may require tailored treat- D’Agostino, R. B., Russell, M. W., Huse, D. M., Ellison, R. C.,
Silbershatz, H., Wilson, P. W., et al. (2000). Primary and
ment specific to their demographics to minimize car-
subsequent coronary risk appraisal: New results from the
diovascular events. Framingham Study. American Heart Journal, 139(2 Pt 1),
272–281.
KEY POINTS Gordis, L. (2008). Epidemiolology (4th ed.). Philadelphia, PA:
Saunders.
• The purpose of a regression analysis is to predict Hosmer, D. W., Lemeshow, S., & May, S. (2008). Applied survival
or explain as much of the variance in the value of analysis: Regression modeling of time to event data (2nd ed.).
the dependent variable as possible. Hoboken, NJ: John Wiley & Sons.
• The independent (predictor) variable or variables Kannel, W. B., McGee, D., & Gordon, T. (1976). A general cardio-
cause variation in the value of the dependent vascular risk profile: The Framingham Study. American Journal
of Cardiology, 38(1), 46–51.
(outcome) variable.
Kedika, R., Patel, M., Pena Sahdala, H. N., Mahgoub, A., Cipher,
• Simple linear regression provides a means to esti- D. J., & Siddiqui, A. A. (2011). Long-term use of angiotensin
mate the value of a dependent variable based on the converting enzyme inhibitors is associated with decreased inci-
value of an independent variable. dence of advanced adenomatous colon polyps. Journal of Clinical
• Multiple regression analysis is an extension of Gastroenterology, 45(2), e12–e16.
simple linear regression in which more than one Kerns, R. D., Turk, D. C., & Rudy, T. E. (1985). The West-Haven
independent variable is entered into the analysis to Yale Multidimensional Pain Inventory (WHYMPI). Pain, 23(4),
predict a dependent variable. 345–356.
CHAPTER 24  Using Statistics to Predict 579

Mancuso, J. M. (2010). Impact of health literacy and patient trust Sackett, D. L., Straus, S. E., Richardson, W. S., Rosenberg, W., &
on glycemic control in an urban USA populations. Nursing & Haynes, R. B. (2000). Evidence-based medicine: How to practice
Health Sciences, 12(1), 94–104. and teach EBM. London, UK: Churchill Livingstone.
Melnyk, B. M., & Fineout-Overholt, E. (2011). Evidence-based Schroeder, M. A. (1990). Diagnosing and dealing with multi­
practice in nursing & healthcare: A guide to best practice (2nd collinearity. Western Journal of Nursing Research, 12(2),
ed.). Philadelphia, PA: Lippincott Williams & Wilkins. 175–187.
Munro, B. H. (2005). Statistical methods for health care research Stevens, J. P. (2009). Applied Multivariate Statistics for the Social
(5th ed.). Philadelphia, PA: Lippincott Williams & Wilkins. Sciences (5th ed.). London, UK: Psychology Press.
Ottomanelli, L., Sippel, J., Cipher, D. J., & Goetz, L. (2011). Factors Tabachnick, B. G., & Fidell, L. S. (2006). Using Multivariate Sta-
associated with employment among veterans with spinal cord tistics (5th ed.). Needham Heights, MA: Allyn & Bacon.
injury. Journal of Vocational Rehabilitation, 34(1), 141–150.
  http://evolve.elsevier.com/Grove/practice/

25
CHAPTER

Using Statistics to Determine


Differences

T
he statistical procedures in this chapter examine assumptions, there are nonparametric alternatives that
differences between or among groups. Statisti- do not require those assumptions to be met, usually
cal procedures are available for nominal, because nonparametric statistical procedures convert
ordinal, and interval/ratio level data. The procedures the original data to rank-ordered or ordinal level data.
vary considerably in their power to detect differences Many statistical tests can assist the researcher in
and in their complexity. How one interprets the results determining whether his or her data meet the assump-
of these statistics depends on the design of the study. tions for a given parametric test. The most common
If the design is quasi-experimental or experimental assumption (that accompanies all parametric tests) is
and the study is well designed and has no major issues the assumption that the data are normally distributed.
in regard to threats to internal and external validity, The K2 test and the Shapiro-Wilk test are formal tests
causality can be considered, and the results can be of normality that assess whether distribution of a vari-
inferred to the associated population. If the design is able is non-normal—that is, skewed or kurtotic (see
comparative descriptive, differences identified are Chapter 21) (D’Agostino, Belanger, & D’Agostino,
associated only with the sample under study. The para- 1990). The Shapiro-Wilk test is used with samples
metric statistics used to determine differences that are with less than 1000 subjects. When the sample is
discussed in this chapter are the independent samples larger, the Kolmogorov-Smirnov D test is more appro-
t-test, paired or dependent samples t-test, and analysis priate. All of these statistics are found in mainstream
of variance (ANOVA). If the assumptions for paramet- statistical software packages and are accompanied by
ric analyses are not achieved or if study data are at the a p value. Significant normality tests with p ≤ 0.05
ordinal level, the nonparametric analyses of Mann- indicate that the distribution being tested is signifi-
Whitney U, Wilcoxon signed-rank test, and Kruskal- cantly different from the normal curve, violating the
Wallis H are appropriate techniques to use to test the normality assumption. The nonparametric statistical
researcher’s hypotheses. The chapter concludes with alternative is listed in each section in the event that
a discussion of the chi-square test of independence, the data do not meet the assumptions of each paramet-
which is a nonparametric analysis technique for ana- ric test illustrated in this chapter.
lyzing nominal level data.

t-tests
Choosing Parametric versus One of the most common parametric analyses used to
Nonparametric Statistics to test for significant differences between group means
of two samples is the t-test. The independent t-test
Determine Differences analysis technique was developed to examine differ-
Parametric statistics are always associated with a ences between two independent groups; the paired or
certain set of assumptions that the data must meet; this dependent t-test analysis technique was developed
is because the formulas of parametric statistics yield to examine differences between two matched or paired
valid results only when the properties of the data are groups, or a comparison of pretest and posttest mea-
within the confines of these assumptions (Munro, surements. The details of the independent and paired
2005). If the data do not meet the parametric t-tests are described in this section.

580
CHAPTER 25  Using Statistics to Determine Differences 581

t-test for Independent Samples s1 = group 1 variance


The most common parametric analysis technique used s2 = group 2 variance
in nursing studies to test for significant differences If the two groups have the same number of subjects
between two independent samples is the independent in each group, one can use this simplified formula:
samples t-test. The samples are independent if the
study participants in one group are unrelated to or
s12 + s22
different from the participants in the second group. sX1 − X1 =
Use of the t-test for independent samples involves the n
following assumptions:
1. Sample means from the population are normally where
distributed. n = sample size in each group and not the total
2. The dependent or outcome variable is measured at sample of both groups
the interval/ratio level. Using an example from a study examining the
3. The two samples have equal variance. levels of depression among 16 elderly long-term care
4. All observations within each sample are indepen- residents, differences between residents with and
dent. without dementia were investigated (Cipher & Clif-
The t-test is robust to moderate violation of its ford, 2004). A subset of data for these patients was
assumptions. Robustness means that the results of selected for this example so that the computation
analysis can still be relied on to be accurate when an would be small and manageable (Table 25-1). In actu-
assumption has been violated. The t-test is not robust ality, studies involving t-tests need to be adequately
with respect to the between-samples or within-samples powered to identify significant differences between
independence assumptions, and it is not robust with groups accurately (Aberson 2010; Cohen & Cohen,
respect to an extreme violation of the normality 1983). All data presented in this chapter are actual,
assumption unless the sample sizes are extremely unmodified clinical data for a small number of study
large. Sample groups do not have to be equal for this participants.
analysis—instead, the concern is for equal variance. A The independent variable in this example was level
variety of t-tests have been developed for various of dementia and included two levels—a “no demen-
types of samples. The formula and calculation of the tia” group and a “severe dementia” group. The level
independent samples t-test is presented next. of dementia was based on clinical ratings of neuropsy-
chologists using the Functional Assessment Staging
Calculation Tool (Reisberg, Ferris, Deleon, & Crook, 1982). The
The formula for the t-test is: dependent variable was the score of the long-term care
resident on the Geriatric Depression Scale (GDS)
X1 − X 2 (Yesavage, Brink, & Rose, 1983). The GDS assesses
t =
sX1 − X2
where
X1 = mean of group 1 TABLE 25-1  Depression Scores by Dementia
X 2 = mean of group 2
Level among Elderly Long-Term
sX1 − X2 = to the standard error of the difference
Care Residents
between the two groups.
To compute the t-test, one must compute the No Dementia
denominator in the formula, which is the standard Patient Group GDS Patient Severe Dementia
error of the difference between the means. If the two No. Score No. Group GDS Score
groups have different sample sizes, one must use this 1 5 9 3
formula: 2 5 10 6
3 10 11 5
(n1 − 1)s12 + (n2 − 1)s22  1 1 4 11 12 4
sX1 − X2  +  5 8 13 9
n1 + n2 − 2 n1 n2
6 8 14 7
7 10 15 4
where 8 10 16 7
n1 = group 1 sample size
n2 = group 2 sample size GDS, Geriatric depression scale.
582 UNIT FOUR  Analyzing Data, Determining Outcomes, and Disseminating Research

the level of depression in elderly adults, with higher Step 5: Compute degrees of freedom (df):
numbers indicative of more depressive symptoms. df = n1 + n2 − 2
The null hypothesis is: There are no significant
differences between elderly adults with dementia df = 8 + 8 − 2
and elderly adults without dementia on depression
scores. df = 14
The computations for the t-test are as follows: Step 6: Locate the critical t value in the t distribution
Step 1: Compute means for both groups, which table in Appendix B at the back of your textbook
involves the sum of scores for each group divided and compare the critical t value with the obtained
by the number in the group. t value.
The mean for Group 1, No Dementia: X1 = 8.38 The critical t value for 14 degrees of freedom at
The mean for Group 2, Severe Dementia: X 2 = 5.63 alpha (α) = 0.05 is 2.15. This means that if we
Step 2: Compute the numerator of the t-test: viewed the t distribution for df = 14, the middle
95% of the distribution would be marked by −2.15
X1 − X 2 = 2.75 and 2.15, as shown in Figure 25-1.
Step 3: Compute the standard error of the difference. Interpretation of Results
a. Compute the variances for each group: Our obtained t is 2.55, exceeding the critical value,
s2 for Group 1 = 5.41 which means that our t-test is significant and repre-
s2 for Group 2 = 3.98 sents a real difference between the two groups. We can
b. Plug into the standard error of the difference reject the null hypothesis and state: An independent
formula: samples t-test computed on GDS scores revealed long-
term residents with no dementia had significantly
s12 + s22 higher depression scores than long-term residents who
sX1 − X2 = had severe dementia, t (14) = 2.55, p < 0.05; X = 8.4
n
versus 5.6. Prior research suggests that elderly resi-
5.41 + 3.98 dents with dementia do not experience less depression,
sX1 − X2 = but rather they have difficulty communicating their
8
distress (Ott & Fogel, 2004; Scherder et al., 2005).
sX1 − X2 = 1.08 With additional research in this area, this knowledge
might be used to facilitate improvements in methods
Step 4: Compute t value: used by healthcare professionals to assess emotional
X1 − X 2 distress accurately among elderly adults with demen-
t = tia (Cipher, Clifford, & Roper, 2006; Thakur & Blazer,
sX1 − X2
2008).
2.75
t = Nonparametric Alternative
1.08 If the data do not meet the assumptions involving
t = 2.55 normality or equal variances for an independent

2½% of t distribution; 2½% of t distribution;


Improbable values of t Improbable values of t
Middle 95% of t
distribution; Probable
values of t
–2.15 2.15

Figure 25-1  Probability distribution of t at df = 14.


CHAPTER 25  Using Statistics to Determine Differences 583

samples t-test, the nonparametric alternative is the Calculation


Mann-Whitney U test. Mann-Whitney U calcula- The formula for the paired samples t-test is:
tions involve converting the data to ranks, discarding
any variance or normality issues associated with the D
original values. In some studies, the data collected are t=
SD
ordinal level, and the Mann-Whitney U test is appro-
priate for analysis of the data. The Mann-Whitney U where
test is 95% as powerful as the t-test in determining D = mean difference of the paired data
differences between two groups. For a more detailed SD = standard error of the difference
description of the Mann-Whitney U test, see the sta- To compute the t-test, one must compute the
tistical textbooks by Daniel (2000) and Munro (2005). denominator in the formula, the standard error of the
The statistical workbook for healthcare research by difference:
Grove (2007) has exercises for expanding your under-
standing of t-tests and Mann-Whitney U results from sD
published studies. sD =
N
t-tests for Paired Samples where
When samples are related, the formula used to calcu- sD = standard deviation of the differences between
late the t statistic is different from the formula previ- the paired data
ously described for independent groups. One type of N = number of subjects in the sample
paired samples refers to a research design that repeat- Using an example from a study examining the level
edly assesses the same group of people, a design com- of functional impairment among 10 adults receiving
monly referred to as a repeated measures design. rehabilitation for a painful injury, changes over time
Another research design for which a paired samples were investigated (Cipher, Kurian, Fulda, Snider, &
t-test is appropriate is the case-control research design. Van Beest, 2007). These data are presented in Table
Case-control designs involve a matching procedure 25-2. A subset was selected for this example so that
whereby a control subject is matched to each case, in the computations would be small and manageable. In
which the cases and controls are different people but actuality, studies involving both independent and
matched demographically (Gordis, 2008). Paired or dependent samples t-tests need to be adequately
dependent samples t-tests can also be applied to a powered (Aberson 2010; Cohen & Cohen, 1983).
crossover study design, in which subjects receive one The independent variable in this example was treat-
kind of treatment and subsequently receive a compari- ment over time, meaning that the whole sample
son treatment (Gordis, 2008). However, similar to the received rehabilitation for their injury for 3 weeks.
independent samples t-test, this t-test requires that dif- The dependent variable was functional impairment,
ferences between the paired scores be independent and which was represented by patients’ scores on the
normally or approximately normally distributed. Interference subscale of the Multidimensional Pain

TABLE 25-2  Functional Impairment Levels at Baseline and after Treatment


Baseline Functional Post-Treatment Functional
Subject No. Impairment Scores Impairment Scores Difference
1 2.9 1.7 1.2
2 5.7 2.9 2.8
3 2.3 2.9 −0.6
4 3.9 3 0.9
5 3.8 3.1 0.7
6 3.3 3.2 0.1
7 2.9 3.2 −0.3
8 4.7 3.2 1.5
9 3.2 2.1 1.1
10 4.9 3.4 1.5
584 UNIT FOUR  Analyzing Data, Determining Outcomes, and Disseminating Research

Inventory (MPI) (Kerns, Turk, & Rudy, 1985), with Interpretation of Results
higher scores representing more functional impair- Our obtained t = 2.84 exceeds the critical t value in the
ment. The null hypothesis is: There is no significant table, which means that our t-test is statistically signifi-
reduction in functional impairment from baseline cant and represents a real difference between partici-
to posttreatment for patients in a rehabilitation pant’s preintervention and postintervention functional
program. impairment scores. We can reject our null hypothesis
The computations for the t-test are as follows: and state: A paired samples t-test computed on MPI
Step 1: Compute the difference between each subject’s functional impairment scores revealed that the patients
pair of data (see last column of Table 25-2). undergoing rehabilitation had significantly lower func-
Step 2: Compute the mean of the difference scores, tional impairment levels from baseline to posttreat-
which becomes the numerator of the t-test: ment, t (9) = 2.84, p < 0.05; X = 3.8 versus 2.9. During
the 3-week rehabilitation program, patients success-
D = 0.89 fully reduced their functional impairment levels. With
additional research in this area, this knowledge might
Step 3: Compute the standard error of the difference. be used to facilitate evidence-based practice interven-
a.  Compute the standard deviation of the differ­ tions in rehabilitation facilities to improve patients’
ence scores: functional status (Melnyk & Fineout-Overholt, 2011).
s = 0.99 Nonparametric Alternative
If the interval/ratio level data do not meet the normal-
b.  Plug into the standard error of the difference
ity assumptions for a paired samples t-test, the non-
formula:
parametric alternative is the Wilcoxon signed-rank
s test. The Wilcoxon signed-rank test calculations
sD = D
N involve converting the data to ranks, discarding any
variance or normality issues associated with the origi-
0.99 nal values. This analysis technique is also appropriate
sD =
10 when the study data are ordinal level, such as self-care
sD = 0.313 abilities identified as low, moderate, and high based
on the Orem Self-Care Model (Orem, 2001). This test
Step 4: Compute t value: is thoroughly addressed by Daniel (2000) and Munro
(2005) in their statistical textbooks. Grove (2007) has
D an exercise for expanding your understanding of the
t =
sD Wilcoxon signed-rank results from published studies.
0.89
t =
0.313 One-Way Analysis of Variance
t = 2.84 Analysis of variance (ANOVA) is a statistical proce-
dure that compares data between two or more groups
Step 5: Compute degrees of freedom: or conditions to investigate the presence of differences
df = n − 1 between those groups on some continuous dependent
or outcome variable. The formulas for ANOVA
df = 10 − 1 compute two estimates of variance: (1) differences
among (within) the data and (2) differences between
df = 9 the groups or conditions.
Step 6: Locate the critical t value on the t distribution Why perform ANOVA and not a t-test? A t-test is
table and compare with our obtained t value. formulated to compare two sets of data or two groups
The critical t value for 9 degrees of freedom at at one time. Data generated from a clinical trial that
alpha (α) = 0.05 is 2.26. Our obtained t is 2.84, has four experimental groups, treatment 1, treatment
exceeding the critical value (see t—Table in 2, treatments 1 and 2 combined, and a control, would
Appendix B). This means that if we viewed require six t-tests. As a result, the chance of making a
the t distribution for df = 9, the middle 95% Type I error (alpha error) increases substantially (or is
of the distribution would be marked by −2.26 inflated) because so many computations are being per-
and 2.26. formed. Specifically, the chance of making a Type I
CHAPTER 25  Using Statistics to Determine Differences 585

TABLE 25-3  Monthly Medical Costs of Three Treatment Groups*


Multidisciplinary Group Costs Standard Care Group Costs Pharmacotherapy Group Costs
74 168 603
748 328 707
433 186 868
422 199 286
297 154 919
Σ = Sum = 1974 1035 3382
Grand total = 6392

*Costs were U.S. dollars averaged monthly.

error is the number of comparisons multiplied by the accurately among study groups (Aberson 2010; Cohen
alpha level. ANOVA is the better statistical technique & Cohen, 1983).
for examining differences among more than two The independent variable in this example was the
groups. type of study treatment or intervention. Patients
ANOVA is a procedure that culminates in a statistic received multidisciplinary treatment, standard care
called the F statistic. This value is compared against (primary care physician only), or pharmacotherapy by
an F distribution (see Appendix D) to determine an anesthesiologist. The dependent variable was the
whether the groups significantly differ from one medical costs incurred per month during the year after
another on the dependent variable studied. The basic treatment. The null hypothesis was: There is no sig-
formula for the F is: nificant difference between the treatment groups in
posttreatment monthly medical costs.
The steps to perform an ANOVA are as follows:
Mean square between groups
F = Step 1: Compute correction term, C.
Mean square within groups Square the grand sum (G), and divide by total N:

The term mean square (MS) is used interchange- 63922


ably with the word “variance.” The formulas for C = = 2, 723, 844.3
15
ANOVA compute two estimates of variance: the
between-groups variance and the within-groups vari- Step 2: Compute total sum of squares.
ance. The between-groups variance represents differ- Square every value in data set, sum, and subtract
ences between the groups or conditions being C:
compared, and the within-groups variance represents
differences among (within) each group’s data. The (742 + 7482 + 4332 + 4222 + 2972 + 1682 + 3282 …
formula is: + 9192 ) − 2, 723, 844.3 = 3, 795, 722
MS between − 2, 723, 844.3 = 1, 071, 877.7
F =
MS within
Step 3: Compute between groups sum of squares.
Calculation Square the sum of each column and divide by N.
Using an example from a study examining medical Add each, and then subtract C.
costs among 15 women receiving treatment for a
19742 10352 33822
chronic pain condition, monthly medical costs for 1 + + − 2723, 844.3
year incurred after treatment ended were examined 5 5 5
(Cipher, Fernandez, & Clifford, 2001). The data from (779, 335.2 + 214, 245 + 2, 288, 937.8)
this study are presented in Table 25-3. A subset of data − 2, 723, 844.3 = 558, 673.7
was selected from the unmodified clinical data of this
study for this example so that the computation would Step 4: Compute within groups sum of squares.
be manageable. In actuality, studies involving ANOVA Subtract the between groups sum of squares (Step
need to be adequately powered to detect differences 3) from total sum of squares (Step 2).
586 UNIT FOUR  Analyzing Data, Determining Outcomes, and Disseminating Research

TABLE 25-4  Analysis of Variance Summary Table However, the F does not tell us which treatment
groups differ from one another. Further testing, termed
Source of multiple comparison tests or post hoc tests, are
Variation SS df MS F required to complete the ANOVA process and deter-
Between groups 558,673.73 2 279,336.9 6.53 mine all the significant differences among the study
Within groups 513,204 12 42,767
groups.
Total 1,071,877.7 14
Post hoc tests have been developed specifically to
determine the location of group differences after
ANOVA is performed on data from more than two
groups. These tests were developed to reduce the inci-
1, 071, 877.7 − 558, 673.7 = 513, 204 dence of a Type I error. Frequently used post hoc tests
are the Newman-Keuls test, the Tukey Honestly Sig-
Step 5: Create an ANOVA summary table (Table nificant Difference (HSD) test, the Scheffe test, and
25-4). the Dunnett test (Munro, 2005). When these tests are
a.  Insert the sum of squares values in the first calculated, the alpha level is reduced in proportion to
column. the number of additional tests required to locate sta-
b.  The degrees of freedom are in the second tistically significant differences. For example, for
column. Because the F is a ratio of two separate several of the aforementioned post hoc tests, if many
statistics (mean square between groups and groups’ mean values are being compared, the magni-
mean square within groups) both have different tude of the difference is set higher than if only two
df formulas—one for the “numerator” and one groups are being compared. Post hoc tests are tedious
for the denominator: to perform by hand and are best handled with statisti-
cal computer software programs.
Mean square between groups df
After computing post hoc tests for our example, the
= number of groups − 1
final interpretation is: Analysis of variance performed
Mean square within groups df on monthly medical costs revealed significant differ-
= (number of groups − 1) (n − 1) ences between the three treatment groups, F (2, 12) =
6.53, p < 0.05. Post hoc comparisons using the Tukey
For this example, the df for the numerator is 3 HSD comparison test indicated that the patients in the
− 1 = 2. The df for the denominator is (3 − 1) pharmacotherapy group incurred significantly higher
(5 − 1) = 12. medical costs after treatment than the patients in the
c.  The mean square between groups and mean standard care group ($676.60 versus $207.00).
square within groups are in the third column. However, there were no significant differences between
These values are computed by dividing the the monthly medical costs of the multidisciplinary
SS by the df. Therefore, the MS between = group and the standard care group or between the
558,673.73 ÷ 2 = 279,336.9. The MS within = multidisciplinary group and the pharmacotherapy
513,204 ÷ 12 = 42,767. group. Grove’s (2007) statistical workbook for health-
d.  The F is the final column and is computed by care research has exercises for expanding your inter-
dividing the MS between by the MS within. pretation and understanding of ANOVA and post hoc
Therefore, F = 279,336.9 ÷ 42,767 = 6.53. procedure results from published studies.
Step 6: Locate the critical F value on the F distribution
table (see Appendix D) and compare our obtained Nonparametric Alternative
F value with it. The critical F value for 2 and 12 If the data do not meet the normality assumptions for
df at alpha (α) = 0.05 is 3.88. Our obtained F is an ANOVA, the nonparametric alternative is the
6.53, which exceeds the critical value. Kruskal-Wallis test. Calculations for the Kruskal-
Wallis test involve converting the data to ranks, dis-
Interpretation of Results carding any variance or normality issues associated
with the original values. Similar to the ANOVA, the
Our obtained F = 6.53 exceeds the critical value in the Kruskal-Wallis test is a nonparametric analysis tech-
table, which means that our F is statistically signifi- nique that can accommodate the comparisons of more
cant and that the population means are not equal. We than two groups. The Kruskal-Wallis test is also the
can reject our null hypothesis that the three groups appropriate analysis technique to use if the study
have the same monthly posttreatment medical costs. data being analyzed are ordinal level. This test is
CHAPTER 25  Using Statistics to Determine Differences 587

thoroughly addressed in textbooks by Daniel (2000) Assumptions


and Munro (2005). One assumption of the chi-square test is that only one
datum entry is made for each subject in the sample. If
Other ANOVA Procedures repeated measures from the same subject are being
The ANOVA example presented earlier used equal used for analysis, such as pretests and posttests, chi-
sample sizes in each group. The calculations for an square is not an appropriate test (the McNemar test
ANOVA with unequal sample sizes are slightly is the appropriate test) (Munro, 2005). Another
different. Moreover, there are other kinds of ANOVA assumption is that for each variable, the categories are
that accommodate other research designs involving mutually exclusive and exhaustive. No cells may have
various numbers of independent and dependent an expected frequency of zero. However, in the actual
variables, such as factorial ANOVA, repeated mea- data, the observed cell frequency may be zero. Until
sures ANOVA, and mixed factorial ANOVA. These more recently, each cell was expected to have a fre-
ANOVA procedures are presented and explained quency of at least five, but this requirement has been
in comprehensive statistics textbooks such as Zar’s mathematically shown to be unnecessary. However,
text (2007). no more than 20% of the cells should have fewer than
five (Conover, 1971). The test is distribution-free, or
nonparametric, which means that no assumption has
Chi-Square Test been made for a normal distribution of values in the
population from which the sample was taken.
of Independence
The chi-square (χ2) test compares differences in pro- Calculation
portions of nominal level variables. When a study The computations for a two-way chi-square test are
requires that researchers compare proportions (per- presented in this section. A study examining the pres-
centages) in one category versus another category, the ence of candiduria (presence of Candida species in the
χ2 is a statistic that reveals if the difference in propor- urine) among 97 adults with a spinal cord injury is
tion is statistically improbable. The χ2 has its own presented as an example. The differences in the use of
theoretical distribution and associated χ2 table (see antibiotics were investigated using chi-square analysis
Appendix E). (Goetz, Howard, Cipher & Revankar, 2010).The data
A one-way chi-square is a statistic that compares for this study are presented in Table 25-5, as a contin-
different levels of one variable only. For example, a gency table. A contingency table is a table that dis-
researcher may collect information on gender and plays the relationship between two or more categorical
compare the proportions of males to females. If the variables (Daniel, 2000).
one-way chi-square is statistically significant, it would The formula for a two-way chi-square is:
indicate that proportions of one gender are signifi-
cantly higher than proportions of the other gender n[(A)(D) − (B)(C)]2
than what would be expected by chance (Daniel, χ2 =
(A + B)(C + D)(A + C)(B + D)
2000). A two-way chi-square is a statistic that tests
whether proportions in levels of one variable are where the contingency table is labeled as such:
significantly different from proportions of the second
variable. For example, the presence of advanced A B
colon polyps was studied in three groups of patients:
C D
patients having a normal body mass index (BMI),
patients who were overweight, and patients who Fitting the cells into the formula would appear as:
were obese (Siddiqui et al., 2009). The research ques-
tion tested was: Is there a significant difference
between the three groups (normal, overweight, and
obese) in the presence of advanced colon polyps? The
results of the chi-square analysis indicated that a larger TABLE 25-5  Candiduria and Antibiotic Use in
proportion of obese patients fell into the category of Adults with Spinal Cord Injuries
having advanced colon polyps compared with normal- Candiduria No candiduria
weight and overweight patients, suggesting that Antibiotic use 15 43
obesity may be a risk factor for developing advanced No antibiotic use 0 39
colon polyps.
588 UNIT FOUR  Analyzing Data, Determining Outcomes, and Disseminating Research

97 [(15)(39) − (43)(0)]2 nonparametric alternatives that do not adhere to the


χ2 = assumptions of the parametric test.
(15 + 43)(0 + 39)(15 + 0)(43 + 39) • The t-test is one of the most commonly used para-
33,195, 825 metric analyses to test for significant differences
χ2 = between statistical measures of two samples or
2, 782, 260
groups.
χ2 = 11.93 • The independent samples t-test indicates a differ-
ence between two groups of subjects, whereas the
With any chi-square analysis, the degrees of paired samples t-test indicates a difference in two
freedom (df) must be calculated to determine the sig- assessments of the same subjects or two groups
nificance of the value of the statistic. The following matched on selected variables.
formula is used for this calculation: • The Mann-Whitney U test is the nonparametric
alternative to the independent samples t-test when
df = ( R − 1)(C − 1) the study data violate one or more of the indepen-
where dent samples t-test assumptions.
R = number of rows • The Wilcoxon signed-rank test is the nonparamet-
C = number of columns ric alternative to the paired or dependent samples
In the example, the chi-square value was 11.93, and t-test when the study data violate one or more of
df was 1, which was calculated as follows: the paired samples t-test assumptions.
• ANOVA can be used to examine data from two or
df = (2 − 1)(2 − 1) = 1 more groups and compares the variance within
each group with the variance between groups.
• ANOVA conducted on three or more groups that is
Interpretation of Results significant requires the use of post hoc analysis
The chi-square statistic is compared with the chi- procedures to determine the location of group
square values in the table in Appendix E. The table differences.
includes the critical values of chi-square for specific • The Kruskal-Wallis test is the nonparametric alter-
degrees of freedom at selected levels of significance. native to the ANOVA when the study data violate
If the value of the statistic is equal to or greater than one or more of the ANOVA assumptions.
the value identified in the chi-square table, the differ- • The chi-square test compares proportions (percent-
ence between the two variables is statistically signifi- ages) in one category of a variable of interest with
cant. The critical χ2 for df = 1 is 3.84, and our obtained proportions in another category.
χ2 is 11.93, exceeding the critical value and indicating • McNemar test is the appropriate statistical test to
a significant difference between antibiotic users and use when analyzing nominal level data obtained
nonusers in the presence of candiduria. Subjects who from repeated measures from the same subject,
used antibiotics had significantly higher rates of can- such as pretests and posttests.
diduria than subjects who did not use antibiotics (26%
versus 0%). This finding suggests that antibiotic use
may be a risk factor for developing candiduria, and REFERENCES
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  http://evolve.elsevier.com/Grove/practice/

26
CHAPTER

Interpreting Research Outcomes

W
hen data analysis is complete, there is a The interpretation of research outcomes is usually
feeling that the answers are known and the the final chapter of theses or dissertations and the
study is finished. However, the results of final section of research articles, which is often enti-
statistical analysis alone are inadequate to complete a tled “Discussion.” Presentations of studies often con-
study. The researcher may know the results, but without clude with an interpretation of the research outcomes.
careful intellectual examination, these results are of This chapter focuses on the interpretation of research
little use to others or to the body of nursing knowledge. outcomes from quantitative, outcomes, and inter­
To be useful, the evidence from data analysis needs to vention research. The interpretations of research
be carefully examined, organized, and given meaning, outcomes for qualitative research are presented in
and the statistical significance and clinical importance Chapter 12. The process of interpreting research out-
need to be assessed with implications for practice and comes for quantitative, outcomes, and intervention
directions for further research. This process is referred studies includes the following: (1) examining study
to as the interpretation of research outcomes. evidence, (2) determining findings, (3) forming con-
Interpretation is one of the most important parts of clusions, (4) identifying limitations, (5) generalizing
a study because some of the most profound insights the findings, (6) considering implications for practice,
of the entire research process occur during this step of and (7) suggesting further studies. Each of these
the study. There is a tendency to rush this important activities is discussed in this chapter with examples
step to finish the study, but it is not a step to be mini- from a quantita­tive descriptive, predictive correla-
mized or hurried. The process takes time for reflection. tional study by Rutkowski and Connelly (2011).
Often, a researcher becomes too close to the details to
be able to see the big picture. At this point, dialogue
with colleagues or mentors can add clarity and expand Examining Evidence
meaning to the interpretation of study findings and The first step in interpretation involves considering
formation of conclusions. the evidence available that supports or contradicts the
Data collection and analysis are action-oriented validity of study results related to the research purpose
activities that require concrete thinking. However, and objectives, questions, or hypotheses. The process
when interpreting the results of the study, one tends to is similar to conducting a critical appraisal of your
implement abstract thinking, including the creative own study. Your temptation is to ignore flaws—
use of introspection, reasoning, and intuition. In some certainly not to point them out. However, an honest
ways, these last steps in the research process are the completion of this process is essential to build a body
most difficult. They require you to synthesize the logic of knowledge. It is not a time for confession, remorse,
used to develop the research plan, implement the strat- and apology but rather for thoughtful reflection. You
egies used in the data collection phase, and examine need to identify the limitations of your study and con-
the mathematical logic or insight and pattern forma- sider how these might affect the study findings and
tion obtained in data analysis. Evaluating the research conclusions (Fawcett & Garity, 2009).
process used in the study, producing meaning from the
results, and forecasting the usefulness of the findings Evidence from the Research Plan
are all part of interpretation and require high-level The initial evidence regarding the validity of the study
intellectual processes. results is derived from reexamining the research plan.

590
CHAPTER 26  Interpreting Research Outcomes 591

Reexamination requires that you reexplore the logic used to measure anxiety truly reflect the anxiety expe-
of the methodology. Analyze the logical links among rienced in the study population? What was the effect
the problem statement, purpose, research questions, size? Were the validity and reliability of instruments
variables, framework, design, sample, measurement examined in the present study? Can this information
methods, and types of analyses. These elements of the be used to interpret the results? The validity and reli-
study should logically link together and be consistent ability of measurement methods are critical to the
with the research problem. Remember the old adage: validity of results
a chain is only as strong as its weakest link. This saying A descriptive, predictive correlational study by
is also true of research because all studies have limita- Rutkowski and Connelly (2011) is presented as an
tions. This examination of the study needs to identify example throughout this chapter. The purpose of this
its weakest links or limitations as well as its strengths. study was “to examine the relationships between
You need to examine these limitations in terms of parent physical activity, parent-adolescent obesity
their impact on the results. Could the results, or some risk knowledge, and adolescent physical activity”
of the results, be a consequence of a weakness in the (Rutkowski & Connelly, 2011, p. 52). These research-
methodology rather than a true test of the hypotheses? ers based their study on the significant problem of
Can the research objectives, questions, or hypotheses childhood obesity in the United States and the need to
be answered from the methodology used in the study? determine knowledge of adolescents and their parents
Could the results be a consequence of an inappropriate of obesity risk and their physical activity. The study
conceptual or operational definition of a variable? Do included three mea­surement methods, Obesity Risk
the research questions clearly emerge from the frame- Knowledge Scale (ORK-10) (Swift, Glazebrook, &
work? Can the results be related back to the frame- Mcdonald, 2006), International Physical Activity
work? Are the analyses logically planned to address Questionnaire (IPAQ, 2001), and Patient Centered
the research objectives, questions, or hypotheses? Assessments and Counseling for Exercise Plus Nutri-
If the types of analyses are inappropriate for exam- tion + Moderate Vigorous Physical Activity (PACE+
ining the research questions, what do the results of MVPA) (Prochaska, Sallis, & Long, 2001). The
analyses mean? For example, if the design failed to researchers clearly linked the study variables (obesity
control extraneous variables, could some of these vari- risk knowledge, physical activity of adults, and physi-
ables explain the results, rather than the results being cal activity of adolescents) to the three measurement
explained by the variables measured and examined methods in Table 26-1. The measurement methods,
through statistical analysis? Was the sample studied a validity, and reliability were addressed in the follow-
logical group on which to test the hypotheses? The ing study excerpt.
researcher must carefully evaluate each link in the
design to determine potential weaknesses. Every link “The ORK-10 (Swift et al., 2006) is a 10-item self-
is clearly related to the meaning given to the study report instrument that measures knowledge regard-
results. If the researcher is reviewing a newly com- ing the health risks associated with obesity.… Internal
pleted study and determines that some of the analyses consistency reliability estimates have been reported
were inappropriate, then these analyses need to be with Cronbach’s alpha coefficient [r] of .83 (Swift
redone. If the study has several weaknesses or breaks et al., 2006). The measure has not been tested with
in logical links, the findings may need to be seriously children, but Swift encourages its use with children
questioned. 12 years and older (J. Swift, personal communication,
July 10, 2007). In this study, the coefficient alphas for
Evidence from Measurement the adolescent scale scores are .53 and .59 for
One assumption often made in interpreting study parents.…
results is that the study variables were adequately The PACE+ Adolescent Physical Activity Measure
measured. This adequacy is determined by examining (MVPA; Prochaska et al., 2001) was originally devel-
the fit of operational definitions with the framework oped as a screening tool for use by clinical staff to
and through validity and reliability information. measure physical activity levels in adolescents seeking
Although you should determine the reliability and treatment in primary care.… Although brief, this
validity of measurement strategies before using them instrument is practical and assesses targeted behavior
in your study, you need to reexamine the measures at that offers clinical information to practitioners.…
this point to determine the strength of evidence avail- The IPAQ has been developed to provide a set
able from the results (Fawcett & Garity, 2009; Waltz, of well-developed instruments that are used
Strickland, & Lenz, 2010). For example, did the scale
592 UNIT FOUR  Analyzing Data, Determining Outcomes, and Disseminating Research

TABLE 26-1  Summary of Study Measures and Scoring


Variable Measure
Obesity Risk Knowledge
Adults and adolescents ORK-10 (data from Swift et al., 2006): includes 10 items that yield responses of either 1 or 0 points.
Scores range from 0-10 with higher scores indicating higher levels of knowledge.
Physical Activity
Adults IPAQ (http://www.ipaq.ki.se/IPAQ.asp?mnu_sel=EEF&pg_sel=DDE): Data analyzed in minutes/day and
sorted into the following three categories: (1) low—no activity is reported or some activity is reported
but not enough to meet categories 2 or 3; (2) moderate—≥3 days of vigorous activity of at least 20
minutes or ≥5 days of moderate-intensity activity or walking of at least 30 minutes per day or ≥5 days
of any combination of walking, moderate-intensity, or vigorous-intensity activities achieving a
minimum of at least 600 MET-minutes/week; (3) high—either vigorous-intensity activity on at least 3
days and accumulating at least 1500 MET-minutes/week or ≥7 days of any combination of walking,
moderate-intensity, or vigorous-intensity activities accumulating at least 3000 MET-minutes/week.
Adolescents PACE+ Adolescent Physical Activity Measure (data from Prochaska et al., 2001): each response has a
scale of 0-7 days. The scores for each question are added together, and the total is divided by 2. A score
of <5 indicates that the Healthy People 2010 guideline for adolescent physical activity is not being met.

MET, Metabolic equivalent of the task.


Rutkowski, E. M., & Connelly, C. D. (2011). Obesity risk knowledge and physical activity in families of adolescents. Journal of Pediatric Nursing, 26(1), 53.

reliability of the ORK-10 is a study limitation that


internationally to obtain comparable estimates of might have influenced the study findings. The research-
[adult] physical activity (IPAQ, 2001). This instrument ers recognized the limitation of the ORK-10 scale
is designed in both a short version including four reliability for both adolescents and adults, which is
generic items and a long version that reflects five discussed later in this chapter.
activity domains (IPAQ). The study presented here
incorporates the short version because it is able to Evidence from the Data Collection Process
capture the general conditions of parental activity Many activities that occur during data collection
without being burdensome to complete.… Validity affect the meaning of study results. Did the study
and reliability evaluation in 14 countries and across have a high refusal rate for subject participation, or
six continents has been reported (IPAQ). In this study, was the attrition high? Was the sample size sufficient
coefficient alpha [r] is .80.” (Rutkowski & Connelly, (Aberson, 2010; Fawcett & Garity, 2009; Thompson,
2011, pp. 53-54) 2002)? Did strategies for acquiring a sample eliminate
important groups whose data would have influenced
the results? Did the research team achieve interven-
Rutkowski and Connelly (2011) provided a detailed tion fidelity when the treatment was implemented
description of their measurement methods and how (Stein, Sargent, & Rafaels, 2007)? Did unforeseen
they were scored (see Table 26-1). The validity and events occur during the study that might have changed
reliability of the IPAQ are very strong because the or had an impact on the data? Were measurement
scale has been used internationally in several countries techniques consistent? What impact do inconsisten-
and had strong reliability in this study (r = 0.80). The cies have on interpreting results? Sometimes data col-
PACE+ MVPA is recognized to have test-retest reli- lection does not proceed as planned. Unforeseen
ability and concurrent validity, but no specific infor- situations alter the collection of data. What were these
mation was provided. The ORK-10 has evidence of variations in the study? What impact do they have on
strong internal consistency reliability with adults in interpreting the results? Sometimes someone other
previous studies but has not been used with adoles- than the subject completes data collection forms.
cents and had low internal reliability alpha coefficients Also, variations may occur when scales are adminis-
in this study (r = 0.053 for adolescents and r = 0.59 tered. For example, an anxiety scale may be given to
for parents). The discussion of the measurement one subject immediately before a painful procedure
methods would have been strengthened by an expanded and to another subject on awakening in the morning.
description of the ORK-10 scale validity and the reli- Values on these measures cannot be considered com-
ability and validity for the PACE+ MVPA. The parable. Data integrity also depends on the responses
CHAPTER 26  Interpreting Research Outcomes 593

of the research participants, which could be compro- Evidence from the Data Analysis Process
mised by anxiety, time constraints, denial, or other The process of data analysis is an important factor in
factors not in the direct control of the researcher. The evaluating the meaning of results. One important part
researcher must be on the alert for these subject of this examination is to summarize the study weak-
factors that could compromise the integrity of the nesses related to the data analysis process. Ask your-
data. Values on these measures cannot be considered self these questions concerning the meaning of your
comparable. These types of differences are seldom results: Were the data checked to ensure that limited
reported and sometimes not even recorded. To some or no errors occurred during data entry into the com-
extent, only the researcher knows how consistently puter? How many subjects have missing data, and
the measurements were taken. Reporting of this infor- how was missing data managed to decrease the effects
mation depends on the integrity of the researcher on the study results? Were the analyses accurately
(Fawcett & Garity, 2009; Kerlinger & Lee, 2000; implemented and calculated? Were statistical assump-
Pyrczak & Bruce, 2005; Stein et al., 2007). tions violated? Were the statistics used appropriate for
Rutkowski and Connelly (2011) clearly identified the data? It is best to address these issues initially
their sampling method as purposive, convenience and before analyses are performed and again when com-
noted appropriate inclusion sampling criteria. A power pleting the analyses and preparing the final report.
analysis was conducted to determine that the sample Researchers should consult with a biostatistician
size of 94 adolescent/parent dyads was adequate for during the planning of a study and during data analy-
this study. There was no sample attrition noted in the sis to ensure the appropriateness of the statistical tests
study, but it would have been helpful if the researchers selected. The biostatistician could also be helpful in
had discussed the refusal rate of potential participants. interpreting the results. Before submitting a study for
The procedures for collecting data in this study were publication, we recommend rechecking each analysis
clearly described as indicated in the following excerpt. reported in the paper. We also encourage reexamining
However, the researchers might have provided a little the analysis statements in the article for accuracy and
more detail about the self-administration of the scales clarity. Are you correctly interpreting the results of
by the adults and adolescents. the analysis? Documentation on each statistical value
or analysis statement reported in the paper is filed
with a copy of the article. The documentation includes
the date of the analysis, the page number of the com-
“All study procedures including protocols for recruit- puter printout showing the results (the printout is
ing participants and obtaining informed consent had stored in a file by date of analysis), the sample size
been reviewed and approved by the appropriate for the analysis, and the number of missing values
administrative and university institutional review (Corty, 2007; Grove, 2007; Fawcett & Garity, 2009).
boards for the protection of human subjects prior to Rutkowski and Connelly (2011) identified their data
study initiation.… The study protocol was presented, analysis with a separate heading that is presented in
questions addressed, and informed consent was the following excerpt.
obtained from the parent as well as parents’ permis-
sion to approach their child regarding participation.
Next, parents self-administered a survey containing “Data Analysis
demographic questions and several standardized
instruments including the Obesity Risk Knowledge The sample size for the analysis is 94 dyads, which is
Scale (ORK-10; Swift et al, 2006) and the IPAQ. sufficient to detect a moderate standardized effect
Surveys were collected by the PI [principal investiga- size (ES) (d = 0.32) using a two-tailed significance test
tor] immediately. with a power of 0.80 and a significance level of 0.05.
Following the collection of parent surveys, a Data have been analyzed using the software package
follow-up meeting was held with those adolescents Statistical Package for Social Sciences, Version 15 (SPSS,
who met the criteria and whose parents signed con- Inc, 2008). Descriptive and multivariate statistics have
sents for their participation. Adolescents who signed been used in this study.” (Rutkowski & Connelly,
assent forms were then asked to self-administer both 2011, p. 54)
the demographic survey and several standardized
measures including the ORK-10 and PACE+ MVPA
(Prochaska et al., 2001).” (Rutkowski & Connelly, The data analysis section clearly addressed the
2011, pp. 52-53) sample size of the study, analysis software package
used, and the types of analyses conducted. This section
594 UNIT FOUR  Analyzing Data, Determining Outcomes, and Disseminating Research

would have been strengthened by including a power nonsignificant results, it is important to determine if
analysis that discussed the effect size for relationships adequate power of 0.8 or higher was achieved for the
because the study examined both differences between data analysis. The researcher needs to conduct a
the adolescents and their parents and relationships of power analysis to determine if the sample size was
obesity risk knowledge with physical activities for adequate to prevent the risk of a Type II error
adolescents and adults (Aberson, 2010). This section (Aberson, 2010; Shadish et al., 2002). A Type II error
mentioned the inferential statistic conducted for group means that in reality the findings are significant, but
differences, the two-tailed t-test, but did not mention because of weaknesses in the methodology, the sig-
that relationships were examined with the Pearson nificance was not detected.
product-moment correlation and regression analysis Negative results could also be due to inappropriate
techniques. methodology, a deviant sample, problems with inter-
nal validity, inadequate measurement, use of weak
Evidence from Data Analysis Results statistical techniques, or faulty analysis. Unless these
The outcomes of data analysis are the most direct weak links are detected, the reported results could
evidence of the results. The researcher has intimate lead to faulty information in the body of knowledge
knowledge of the research and needs to evaluate its (Angell, 1989). It is easier for the researcher to blame
strengths and limitations carefully when judging the faulty methodology for nonsignificant findings than to
validity of the results. In descriptive and correlational find failures in theoretical or logical reasoning. If
studies, the validity of the results depends on how faulty methodology is blamed, the researcher needs to
accurately the variables were measured in selected explain exactly how the breakdown in methodology
samples and settings. Interpretation of results from led to the negative results. Negative results, in any
quasi-experimental and experimental studies is often case, do not mean that there are no relationships
based on decision theory, with five possible results: among the variables or differences between groups;
(1) significant results that are in keeping with the they indicate that the study failed to find any relation-
results predicted by the researcher, (2) nonsignificant ships or differences.
results, (3) significant results that oppose the results
predicted by the researcher, (4) mixed results, and Significant and Not Predicted Results
(5) unexpected results (Shadish, Cook, & Campbell, Significant results that are the opposite of those pre-
2002). dicted, if the results are valid, are an important addi-
tion to the body of knowledge. An example would be
Significant and Predicted Results a study in which the researchers proposed that social
Significant results that coincide with the researcher’s support and ego strength were positively related. If the
predictions are the easiest to explain and, unless study showed that high social support was related to
weaknesses are present, validate the proposed logical low ego strength, the result would be the opposite of
links among the elements of the study. These results that predicted. Such results, when verified by other
support the logical links developed by the researcher studies, indicate that the theory being tested needs
among the purpose, framework, questions, variables, modification and refinement. Because these types of
and measurement methods (Shadish et al., 2002). studies can affect nursing practice, this information is
This outcome is very satisfying to the researcher. important.
However, the researcher needs to consider alternative
explanations for the positive findings. What other ele- Mixed Results
ments could possibly have led to the significant Mixed results are probably the most common
results? outcome of studies. In this case, one variable may
uphold the characteristics predicted, whereas another
Nonsignificant Results does not, or two dependent measures of the same
Unpredicted nonsignificant or inconclusive results variable may show opposite results. These results
are the most difficult to explain. These results are might be an accurate reflection of reality but also
often referred to as negative results. The negative might be due to study limitations (Shadish et al.,
results could be a true reflection of reality. In this 2002). The study limitations might include differing
case, the reasoning of the researcher or the theory reliability or validity of two methods of measuring
used by the researcher to develop the hypothesis is variables, varying data collection processes, small
in error. If so, the negative findings are an sample size, or missing subject data. Additional
important addition to the body of knowledge. With research is indicated to examine mixed study results.
CHAPTER 26  Interpreting Research Outcomes 595

Mixed results may also indicate a need to modify TABLE 26-2  Characteristics of the Adolescent-
existing theory. Parent Dyads
Unexpected Results Adolescent Parent
Unexpected results are relationships found between Age, M (SD), range 12.8 (1.0), 44.1 (5.2),
variables that were not hypothesized and not pre- 11.8-13.8 31-60
dicted from the framework guiding the study. These Ethnicity, n (%)
Caucasian 70 (74.5) 69 (74.2)
unexpected results are also called serendipitous
Hispanic 14 (14.9) 16 (17.2)
results. Most researchers examine as many elements Asian 5 (5.3) 6 (6.5)
of data as possible in addition to the elements directed Other 5 (5.3) 2 (2.2)
by the research objectives, questions, or hypotheses. Gender, n (%)
The researchers can use these findings to develop or Male 56 (59.6) 19 (20.2)
refine theories and to formulate later studies. In addi- Female 38 (40.4) 75 (79.8)
tion, serendipitous results are as important as evi- BMI, M (SD), range 19.4 (2.7), 24.1 (4.9),
dence in developing the implications of the study. 13.6-32.9 24.1-43.2
However, researchers must deal carefully with seren- Household size, M (SD), 4.41 (0.9), 4.41 (0.9),
dipitous results when considering their meaning range 2-6 2-6
Grade in school, n (%)
because the study was not designed to examine these
6th 17 (18.3)
results. 7th 28 (30.1)
8th 35 (37.6)
Evidence from Previous Studies 9th 8 (8.6)
The results of the present study should always be 10th 5 (5.4)
examined in light of previous findings. It is important Grade point average, n (%)
for the researcher to know whether the results are 2.0-2.9 10 (11.6)
consistent with past research. Consistency in findings 3.0-3.9 53 (61.6)
across studies is important for developing theories and 4.0 or higher 23 (24.5)
refining scientific knowledge for the nursing profes- Marital status, n (%)
Married 85 (91.4)
sion. Therefore, any inconsistencies need to be
Single 2 (2.2)
explored to determine reasons for the differences. Divorced 5 (5.4)
Replication of studies and synthesis of findings from Widowed 1 (1.1)
existing studies using meta-analyses and systematic Number of years with 17.5 (4.9),
reviews are critical for the development of empirical partner, M (SD), range 2-31
knowledge for an evidence-based practice (Brown, Education, n (%)
2009; Craig & Smyth, 2012; Melnyk & Fineout- Less than high school 2 (2.3)
Overholt, 2011). High school diploma 14 (16.1)
College 46 (51.7)
Graduate school 26 (29.9)
Determining Findings Work outside the home, 31 (33.3)
yes, n (%)
Findings are developed by evaluating evidence (dis-
cussed previously in this chapter) and translating and BMI, Body mass index; M (SD), mean (standard deviation).
interpreting study results. Although much of the From Rutkowski, E. M., & Connelly, C. D. (2011). Obesity risk knowledge
process of developing findings from results occurs in and physical activity in families of adolescents. Journal of Pediatric
Nursing, 26(1), 54.
the mind of the researcher, evidence of such thinking
can be found in published research reports (Pyrczak
& Bruce, 2005). It is important during this process to
talk with colleagues or mentors to clarify meanings or and presented the sample characteristics of the adoles-
expand implications of the research findings. The cents and their parents in Table 26-2. Rutkowski
study results and findings are presented for Rutkowski and Connelly (2011, p. 55) noted that “This sample is
and Connelly’s (2011) research examining the rela- not representative of families living in southern Cali-
tionships among the variables parent and adolescent fornia; however, it is representative of families living
physical activities and parent and adolescent obesity in the community sampled.” The study objectives
risk knowledge. As part of the study results, the (aims), results, and findings are presented in the fol-
researchers described the participants of the study lowing excerpt.
596 UNIT FOUR  Analyzing Data, Determining Outcomes, and Disseminating Research

Objective 1 was to describe and compare the obesity SD = 1,285), and 14.9% report physical activity at a low
risk knowledge and physical activity level of the parents level [see Table 26-3].” (Rutkowski & Connelly, 2011,
and adolescents. p. 55)
“Results. In this sample of adolescent/parent dyads, “Findings. The ORK-10 scores of both the adoles-
the mean score for adolescents’ obesity risk knowledge cents and parents are low, with adolescent scores sta-
(ORK-10) is 4.69 (SD = 1.63), and the mean score for tistically lower than parental scores. This is not
the parents is 5.54 (SD = 1.84 [Table 26-3]). These unexpected because parents have acquired more expe-
scores are based upon 10 being the score that reflects riences that would provide insight into some of the
the most knowledge and 0 reflecting the least knowl- questions included in this measure. When selecting the
edge. t-tests have been conducted to determine ORK-10 for use in this study, most of the scale items
whether youth differ significantly from parents on the seemed to be relevant.… Despite this perceived rele-
ORK-10. The results indicated that adolescent obesity vance, several of the participating youth questioned the
risk knowledge is statistically significantly lower than measure’s content and stated unfamiliarity with some
their parents t(1,92) = 3.45, p < .001. of the questions, particularly those items posed in the
Both the parents and adolescents are active at levels negative, for example, ‘Obesity does not increase
measured to meet standardized guidelines (U.S. Depart- the risk of developing high blood pressure.’ These
ment of Health and Human Services [USDHHS], 2000). same youth identified words that, if substituted, would
The level of physical activity as measured by the PACE+ increase the level of comprehension of the scale items,
indicates that most adolescent participants are meeting which may consequently impact overall scores. An addi-
the recommended level of daily activity (M = 5.33, SD tional finding of interest indicates that in this group of
= 1.23 [see Table 26-3]). Among the parent participants, experts, both adolescent and parent mean scores are
IPAQ scores range from 0 to 12,558 (M = 3741.07, SD higher than for the nonexpert group in the Swift et al.
= 3135.4); categories of activity levels indicate 61.7% (2006) original research.” (Rutkowski & Connelly, 2011,
report physical activity at a vigorous level (M = 1960, pp. 55-56)
SD = 2,164), 18.1% report a moderate level (M = 872,

TABLE 26-3  Obesity Risk Knowledge and


“Results. A statistically significant inverse relation-
Physical Activity of Family Dyads
ship has been found between parental ‘sitting’ activi-
(N = 94) ties (including commute time) and the adult ORK
Obesity Risk Knowledge, Adolescent Parent scores (r = −.23, p < .05) as well as parent activity
4.69 (1.63) 5.54 (1.84) levels and the PACE+ score for activity levels of ado-
  M (SD), range 0-10 0-10 lescents (r = −.23, p < .05). There is no significant
Physical Activity relationship between adolescent obesity risk knowl-
edge and adolescent physical activity (r = .15, p >
PACE+, M (SD) 5.33(1.23)
.05).” (Rutkowski & Connelly, 2011, p. 55)
IPAQ, M (SD) 3741.07
(3135.4) “Findings. Among our sample of adolescent/parent
  Vigorous level, n (%) 58 (61) dyads, our findings indicate obesity risk knowledge is
  Moderate level, n (%) 17 (18.1) not associated with adolescent physical activity. This
  Low walking, n (%) 14 (14.9) study does however provide important information
on the association between parent physical activity
From Rutkowski, E. M., & Connelly, C. D. (2011). Obesity risk knowledge and adolescent physical activity. Especially notable is
and physical activity in families of adolescents. Journal of Pediatric
Nursing, 26(1), 55.
the inverse relationship between parent activity level
and the PACE+ scores of adolescents. This is note-
worthy because it is consistent with findings reported
a decade earlier by researchers from the School of
Objective 2 was to examine the relationships of Public Health at the University of Minnesota (Luepker,
obesity risk knowledge and physical activities for the 1999). They noted that seriously committed parents
parents and adolescents. who follow exercise routines that are vigorous in
CHAPTER 26  Interpreting Research Outcomes 597

nature are frequently engaged in fitness activities that to include their children in their physical activities. Seri-
involve only themselves.… Typically these parents do ously active parents often work out early in the morning
not share their physical activity time with family before work, on lunch breaks, after work before return-
members, especially younger age children (Luepker, ing home, or at night after the children go to bed. Their
1999). Many parents participate in their routines outside children never benefit from a role modeling relationship
of ‘family time’ and in essence exclude children pur- in the area of physical activity (Bandura, 1997). As
posefully because they may impede the intensity and explained by Luepker, the paradoxical situation of having
duration goals of the parental activity. Luepker con- a very fit, athletic parent and a less than adequately
cluded that parents who are moderate and less ‘serious’ active child is often the result of this absent role model.”
are better role models because their children actually (Rutkowski & Connelly, 2011, p. 55)
see them being physical.… These parents are more apt

Objective 3 includes the variables of “adolescent and ORK-10 scale for the adolescents and their parents. The
parental obesity risk knowledge, parent physical activity, low reliability of this scale for both groups might have
and selected adolescent characteristics examined to had an impact on the study results.
determine their prediction of the adolescent’s physical “It should be noted that the data from our sample of
activity” (Rutkowski & Connelly, 2001, p. 52). family dyads have produced lower internal reliabilities
“Results. Simultaneous multiple regression was con- than the Swift et al. (2006) original study. This is not
ducted to determine the accuracy of the independent unexpected because inconsistent internal reliabilities are
variables of parent physical activity, parent ORK-10 often found for instruments in ‘early development’
score, and adolescent ORK-10 score in predicting ado- (Frank-Stromborg & Olsen, 2004). In our study, the
lescent physical activity [dependent variable] while con- measure has been used with participants from a differ-
trolling for adolescent gender, ethnicity, and age. ent culture and age groups than those of the original
Regression results indicate the overall model does not research. Based upon our findings, further refinement
significantly predict adolescent physical activity, R2 = of the measure is needed to avoid contextual confusion
0.116, R2adj = 0.048, F(6,78) = 1.70, p = 0.13.” (Rutkowski and to increase cultural and international application.
& Connelly, 2011, p. 55) Use of the ORK-10 is an initial step in assessing obesity
“Findings. The researchers did not discuss the non- risk knowledge. Further research into the scale refine-
significant regression analysis results but did address the ment, reliability, and validity is warranted.” (Rutkowski
low Cronbach alpha reliability coefficients for the & Connelly, 2011, p. 56)

Forming Conclusions qualified. It would be more appropriate to state in the


Conclusions are derived from the study findings and study that if A occurred, then B occurred under con­
are a synthesis of findings. Forming conclusions for ditions x, y, and z (Kerlinger & Lee, 2000; Shadish
a study requires a combination of logical reasoning, et al., 2002), or that if A occurred, then B had an 80%
creative formation of a meaningful whole from pieces probability of occurring. Because this was a descrip-
of information obtained through data analysis and tive, predictive correlational study and some of the
findings from previous studies, receptivity to subtle results were nonsignificant, Rutkowski and Connelly
clues in the data, and use of an open context in con- (2011) presented only tentative conclusions that are
sidering alternative explanations of the data. included in the statement of findings. One conclusion
When forming conclusions, it is important to is the adults’ obesity risk knowledge is related to their
remember that research never proves anything; rather, physical activity but the adolescents’ obesity risk
research offers support for a position. Proof is a logical knowledge is not related to their physical activity. The
part of deductive reasoning, but not of the research main study conclusion was that parents’ activity levels
process. Therefore, formulation of causal statements (vigorous, moderate, or low) are inversely related to
is risky. For example, the causal statement that A the adolescents’ activity levels. Thus, children’s activ-
causes B (absolutely, in all situations) cannot be sci- ity levels are most positively impacted when parents
entifically proved. It is more credible to state conclu- role model physical activity and exercise with their
sions in the form of conditional probabilities that are children.
598 UNIT FOUR  Analyzing Data, Determining Outcomes, and Disseminating Research

One of the risks in developing conclusions in with limited reliability and validity, limited control
research is going beyond the data—specifically, over data collection, and improper use of statistical
forming conclusions that the data do not warrant. The analyses (Fawcett & Garity, 2009; Kerlinger & Lee,
most common example is a study that examines rela- 2000; Shadish et al., 2002).
tionships between A and B by correlational analysis Ideally, the theoretical and methodological limita-
and then concludes that A causes B. Going beyond the tions are identified before the conduct of the study, and
data is due to faulty logic and occurs more frequently the researchers minimize these limitations as much as
in published studies than one would like to believe. possible. However, some limitations are not identified
Be sure to check the validity of arguments related to until the study is conducted and are usually identified
conclusions before revealing findings. in the discussion section of the study report with
implications of how they might have influenced the
study findings. Despite a researcher’s higher motives
Identifying Limitations to be objective, subjective judgments and biases some-
Limitations are restrictions or problems in a study times creep into the study conclusions. Re­searchers
that may decrease the generalizability of the findings. need to control subjectivity and biases and recognize
All studies have limitations, and these might be theo- any theoretical or methodological limitations of their
retical or methodological in nature. Theoretical limi- study before forming conclusions. Limitations and
tations are weaknesses in a study framework and their impact on the study findings must be included in
conceptual and operational definitions of variables the research report. Rutkowski and Connelly (2011)
that restrict the abstract generalization of the findings. clearly identified their study limitations, which did
At this stage of the research process, theoretical and limit the conclusions drawn in this study. The reli-
methodological limitations often overlap. Concerns ability limitation of the ORK-10 scale was previously
are raised about the theoretical basis of the study discussed in the findings for Objective 3. In addition,
because of unexpected findings. Some of the follow- the study would have been strengthened by the conduct
ing theoretical limitations might be identified by of a power analysis for each of the nonsignificant
researchers: results to determine the power for detecting relation-
1. A concept might not be as clearly defined as needed ships and the potential for a type II error. The other
within the theory used as the study framework. study limitations are described in the following study
2. The relationships among some concepts from the excerpt.
theory are not presented as clearly as needed in the
study framework.
3. A study variable might not be as clearly linked to
a concept in the framework as needed. “Limitations
4. An objective, question, or hypothesis might not be The findings of this study must be considered in rela-
clearly linked to a relationship or proposition in the tion to the study’s limitations. First, the sample is a
study framework. purposive convenience sample that is relatively
Theoretical limitations are one explanation for homogenous with respect to ethnicity, geographic
study results that are nonsignificant or unexpected. For location, and social economic status (SES), not ran-
example, the study framework included a relationship domly selected or matched. This nonrandom proce-
between self-efficacy and health decisions. However, dure may influence the findings through self-selection
the data analysis did not reveal a statistically signifi- bias. Second, the cross-sectional design disallows for
cant relationship between these two concepts. The changes over time and may not capture the complex
underlying reasons may be that the theory was unclear phenomena under study.” (Rutkowski & Connelly,
related to the definitions of concepts or identification 2011, p. 56)
of relationships or that the measurements of the con-
cepts were not valid or reliable.
Methodological limitations are weaknesses in
the study design that can limit the credibility of the
findings and restrict the population to which the find- Generalizing the Findings
ings can be generalized. Methodological limitations Generalization extends the implications of the find-
result from factors such as nonrepresentative samples, ings from the sample studied to a larger population or
weak designs, single setting, limited control over from the situation studied to a larger situation. For
treatment (intervention) implementation, instruments example, if the study were conducted on diabetic
CHAPTER 26  Interpreting Research Outcomes 599

patients, it may be possible to generalize the findings view of the study findings. A clinically important
to persons with other chronic illnesses or to well indi- study should result in altered decisions or actions by
viduals. Studies such as randomized clinical trials nurses that improve patient and family outcomes
usually have large heterogeneous samples, which (Gatchel & Mayer, 2010). The study implications
increase the ability to generalize the findings (Shadish provide specific suggestions for implementing the
et al., 2002). findings in practice. You need to consider the areas
How far can generalizations be made? The answer of nursing for which your study findings would be
to this question is debatable. From a narrow perspec- useful. In presenting their implications for practice,
tive, one cannot really generalize from the sample on Rutkowski and Connelly (2011) discussed the role of
which the study was conducted. Any other sample is nurses in educating parents to be role models to their
likely to be different in some way. The conservative children regarding physical activity.
position, represented by Kerlinger and Lee (2000),
recommends caution in considering the extent of gen-
eralization. Conservatives consider generalization par-
ticularly risky if the sample was small, homogeneous,
and not randomly selected. However, as discussed in “Clinical Implications
Chapter 15, generalizations are often made to abstract “Pediatric nurses, community health nurses, pediatric
or theoretical populations. Thus, conclusions need to nurse practitioners, school nurses, and clinical nurse
address applications to theory. Judgments about the specialists all have opportunities to interface with
reasonableness of generalizing need to address issues families of adolescents. Nurses practicing in primary
related to external validity, as discussed in Chapter 10. care settings are the first-line defenders against the
Generalizations based on accumulated evidence pandemic of childhood obesity.…
from many studies are called empirical generaliza- “Because prevention is the focus of primary care
tions. These generalizations are important for verify- settings, nurses have opportunities to implement
ing theoretical statements or developing new theories. promising strategies with families of adolescents
Empirical generalizations are the base of a science and (Larson & Story, 2007). Such encounters are ideal for
contribute to scientific conceptualization, which dissemination of the findings of this study in the area
provide a basis for generating evidence-based guide- of role modeling by parents for adolescents as a
lines to manage specific practice problems (Brown, means of impacting behavior change. Discussions
2009; Craig & Smyth, 2012; Melnyk & Fineout- regarding the need for parental role modeling should
Overholt, 2011). Chapter 19 provides a detailed dis- be encouraged.
cussion of research synthesis processes and strategies “It is imperative for parents to acknowledge that
for promoting evidence-based nursing practice. taking the time to be physically active with their chil-
Rutkowski and Connelly (2011) made no general- dren may have a positive outcome in increasing the
izations in their study, and their findings were reflec- activity levels of their children, which will reduce
tive only of the sample studied. Because this is a future chronic health problems.… Children need
relatively new area of research that was examined with exemplars to establish lifestyle routines that include
a descriptive, predictive correlational design, the lack physical activity. Parents are in an ideal position to be
of generalization of findings seems appropriate. In such role models. The patterns of physical activity
addition, the limitations of the ORK-10 scale reliabil- developed in adolescents will inoculate them against
ity, the nonrandom homogeneous sample, and the becoming sedentary adults (Luepker, 1999).” (Rut-
cross-sectional design would not support generaliza- kowski & Connelly, 2011, p. 56)
tion of the findings from the study sample to the target
population (see Chapter 15 for more details on
generalization).
Recommending Further
Considering Implications Research
Implications of research findings for nursing are
the meanings of the conclusions for the body of Completing a study and examining its implications
nursing knowledge, theory, and practice. Implications should culminate in recommendations for further
for practices are often based, in part, on whether treat- research that emerge from the present study and from
ment decisions or outcomes would be different in previous studies in the same area of interest.
600 UNIT FOUR  Analyzing Data, Determining Outcomes, and Disseminating Research

Suggested studies or recommendations for further the findings, considering implications, and suggest-
study may include replications or repeating the design ing further research.
with a different or larger sample or different popula- • The first step in interpretation is considering all of
tion. In every study, the researcher gains knowledge the evidence available that supports or contradicts
and experience that can be used to design “a better the validity of the results. Evidence is obtained
study next time.” Formulating recommendations for from various sources, including the research plan,
future studies will stimulate you to define more clearly measurement reliability and validity (or precision
how to improve your study. From a logical or theoreti- and accuracy), data collection process, data analy-
cal point of view, the findings should lead you directly sis process, data analysis results, and previous
to more hypotheses to further test the framework you studies.
are using. Improvements could involve an alternative • The outcomes of data analysis are the most direct
methodology, a refined measurement tool, changes in evidence available of the results related to the
sampling criteria, or a different setting. research purpose and the objectives, questions, or
Rutkowski and Connelly (2011) provided the fol- hypotheses.
lowing suggestions for future research: • Five possible results are (1) significant results that
are in keeping with those predicted by the
researcher, (2) nonsignificant results, (3) significant
“Directions for Future Studies results that are opposite those predicted by the
researcher, (4) mixed results, and (5) unexpected
Future research examining obesity risk knowledge in results.
relationship to physical activity is needed to stem the • Findings are a consequence of evaluating evidence,
tide of the epidemic of childhood obesity. There is a which includes the findings from previous studies.
critical need for a reliable and valid measure to assess • Conclusions are derived from the findings and are
the level of knowledge that both children and adults a synthesis of the findings.
have regarding the consequences of being overweight • The limitations of a study might be theoretical or
(Swift et al., 2006). Behavior changes are the remedy methodological and need to be clearly identified
for this catastrophic health issue and will not be pos- and discussed in relation to the study conclusions.
sible without the development of interventions that • Generalization extends the implications of the find-
are effective in reducing the weight-gaining lifestyles ings from the sample studied to a larger target
of many Americans, especially children. In addition, population.
research is needed to learn what the public does not • Implications of the study for nursing are the mean-
know about obesity’s risks and its long-term effects. ings of study conclusions for the body of nursing
To this end, research is currently being conducted in knowledge, theory, and practice.
the refinement of the ORK-10 to enhance its applica- • Completion of a study and examination of implica-
tion with multicultural and international populations. tions should culminate in recommending future
A reliable and valid measure could become the studies that emerge from the present study and pre-
impetus in guiding discussion in primary care settings vious studies.
regarding the choices in lifestyle to avoid obesity and
the concomitant illnesses that are undermining the
healthy futures of adolescents and their families.”
REFERENCES
(Rutkowski & Connelly, 2011, p. 56)
Aberson, C. L. (2010). Applied power analysis for the behavioral
sciences. New York, NY: Routledge Taylor & Francis Group.
Angell, M. (1989). Negative studies. New England Journal of Medi-
cine, 321(7), 464–466.
KEY POINTS Bandura, A. (1997). Self-efficacy: The exercise of control. New
York, NY: W.H. Freeman & Company.
Brown, S. J. (2009). Evidence-based nursing: The research-practice
• To be useful, evidence from data analysis needs to
connection. Sudbury, MA: Jones & Bartlett Publishers.
be carefully examined, organized, and given Corty, E. W. (2007). Using and interpreting statistics: A practical
meaning; and this process is referred to as text for the health, behavioral, and social sciences. St. Louis, MO:
interpretation. Mosby.
• Interpretation includes several intellectual activi- Craig, J. V., & Smyth, R. L. (2012). The evidence-based practice
ties, such as examining evidence, forming conclu- manual for nurses (3rd ed.). Edinburgh, UK: Churchill
sions, identifying study limitations, generalizing Livingstone.
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Fawcett, J., & Garity, J. (2009). Evaluating research for evidence- Pyrczak, F., & Bruce, R. R. (2005). Writing empirical research
based nursing practice. Philadelphia, PA: F. A. Davis. reports (5th ed.). Glendale, CA: Pyrczak.
Frank-Stromborg, M., & Olsen, S. (2004). Instruments for clinical Rutkowski, E. M., & Connelly, C. D. (2011). Obesity risk knowl-
healthcare research (3rd ed.). Sudbury, MA: Jones & Bartlett. edge and physical activity in families of adolescents. Journal of
Gatchel, R. J., & Mayer, T. G. (2010). Testing minimal clinically Pediatric Nursing, 26(1), 51–57.
important difference: Consensus or conundrum? The Spine Shadish, W. R., Cook, T. D., & Campbell, D. T. (2002). Experimen-
Journal, 35(19), 1739–1743. tal and quasi-experimental designs for generalization causal
Grove, S. K. (2007). Statistics for health care research: A practical inference. Chicago, IL: Rand McNally.
workbook. St. Louis, MO: Saunders. Statistical Package for the Social Sciences (SPSS), Inc. (2008).
International Physical Activity Questionnaires (IPAQ). (2001). SPSS for windows. Chicago, IL: SPSS.
International Physical Activity Questionnaire. Retrieved from Stein, K. F., Sargent, J. T., & Rafaels, N. (2007). Intervention
http://www.ipaq.ki.se/ipaq.htm. research: Establishing fidelity of the independent variable in
Kerlinger, F. N., & Lee, H. P. (2000). Foundations of behavioral nursing clinical trials. Nursing Research, 56(1), 54–62.
research (4th ed.). Fort Worth, TX: Harcourt College. Swift, J., Glazebrook, C., & Mcdonald, I. (2006). Validation of a
Larson, N., & Story, M. (2007). The pandemic of obesity among brief, reliable scale to measure knowledge about the health risks
children and adolescents: What actions are needed to reverse associated with obesity. International Journal of Obesity, 30(4),
current trends? [Editorial]. Journal of Adolescent Health, 41, 661–668.
521–522. Thompson, S. K. (2002). Sampling (2nd ed.). New York, NY: John
Luepker, R. (1999). How physically active are American children Wiley & Sons.
and what can we do about it? International Journal of Obesity, U.S. Department of Health and Human Services (USDHHS).
23(Suppl. 2), S12–S17. (2000). Health people 2010. Washington, D.C.: U.S. Government
Melnyk, B. M., & Fineout-Overholt, E. (2011). Evidence-based Printing Office.
practice in nursing & healthcare: A guide to best practice (2nd Waltz, C. F., Strickland, O. L., & Lenz, E. R. (2010). Measurement
ed.). Philadelphia, PA: Lippincott Williams & Wilkins. in nursing and health research (4th ed.). New York, NY: Springer
Prochaska, J., Sallis, J., & Long, B. (2001). A physical activity Publishing Company.
screening measure for use with adolescents in primary care.
Archives of Pediatric & Adolescent Medicine, 155(5), 554–559.
  http://evolve.elsevier.com/Grove/practice/

27
CHAPTER

Disseminating Research Findings

I
magine that as a nurse researcher you are con­ replication of studies, and identifies additional research
ducting a study in which you describe a unique problems. Over time, the findings from many studies
phenomenon, detect a previously unrecognized are synthesized with the ultimate goal of providing
relationship, or determine the effectiveness of an inter­ evidence-based health care to patients, families, and
vention. This information might make a difference in communities (Craig & Smyth, 2012; Melnyk &
nursing practice; however, you feel unskilled in pre­ Fineout-Overholt, 2010).
senting the information and overwhelmed by the idea To facilitate the communication of research find­
of publishing. You place the study documents in a ings for nurse clinicians and researchers, regardless of
drawer with the intent to communicate the findings whether the research is a primary study, a secondary
someday. Because many nurses have these types of analysis, or a meta-analysis, this chapter describes the
feelings, many valuable nursing studies are not com­ basic content of a research report, the audiences for
municated, and the information is lost. Failure to com­ communicating study findings, and the processes for
municate research findings is considered a violation presenting and publishing research reports.
of ethics and a form of scientific misconduct. After
involving members of an institutional review board
committee to approve your study, and after subjects Content of a Research Report
consented and participated in your study, you have an Both quantitative and qualitative research reports
ethical obligation to complete your end of the process. include four major sections or content areas: (1) intro­
Without disseminating the findings, funding is wasted, duction, (2) methods, (3) results, and (4) discussion
subject time and data are wasted, and knowledge for of the findings (Pyrczak & Bruce, 2007). The type
nursing practice is not advanced. and depth of information included in these sections
Communicating research findings, the final step depend on the study, the intended audiences, and
in the research process, involves developing a research the mechanisms for disseminating the report. For
report and disseminating it through presentations and example, theses and dissertations are research reports,
publications to audiences of nurses, healthcare profes­ written to demonstrate the student’s depth in under­
sionals, policy makers, and healthcare consumers. standing of the research problem and process to
Disseminating study findings provides many advan­ faculty members. Research reports developed for
tages for the researcher, the nursing profession, and publication in journals are written to communicate
the consumer of nursing services. By presenting and study findings efficiently and effectively to nurses
publishing findings, researchers advance the knowl­ and other healthcare professionals. Some journals
edge of a discipline, which is essential for providing limit the introduction to two or three brief paragraphs
evidence-based practice. For individual researchers, that include a statement about the theoretical frame­
communicating study findings often leads to pro­ work for the study, a sufficient review of the literature
fessional advancement, personal recognition, and to state what the gap in knowledge is, and the clear
other psychological and financial compensations. purpose of the study. The methods, results, and dis­
These rewards are extremely important for the con­ cussion sections of qualitative studies are usually
tinuation of research in a discipline. By communicat­ more detailed than those sections of quantitative
ing research findings, the researcher also promotes the studies because of the complex data collection and
critical analysis of previous studies, encourages the analysis procedures. Finally, the discussion section

602
CHAPTER 27  Disseminating Research Findings 603

briefly acknowledges the limitations of the study,


presents the findings in relation to other literature, more effectively improve HRQOL in this population
and discusses the implications of the findings for the [problem].
intended journal audience. Objective: The purpose of this study was to compare
HRQOL and physical, psychologic, clinical, and
Quantitative Research Report sociodemographic status in older adults with and
This section provides direction to novice researchers without heart failure.
writing their first quantitative research report. To Methods: The HRQOL of 90 older adults with heart
begin, the title of your research report needs to indi­ failure and 116 healthy older adults was compared.
cate what you have studied and attract the attention of The factors best associated with HRQOL in each
interested readers. The title should be concise and group were determined using multiple regression
consistent with the study purpose and the research model.
objectives, questions, or hypotheses. Often a title Results: HRQOL was substantially worse among
includes the major study variables and population and older adults with heart failure than among healthy
indicates the type of study conducted, but it should not older adults. Older adults with heart failure had more
include the results or conclusions of a study (Pyrczak severe physical and emotional symptoms, poorer
& Bruce, 2007). Heo, Moser, Lennie, Zambroski, and functional status, and worse health perceptions. Phys-
Chung (2007, p. 16) provided the following title for ical symptom status was the strongest predictor of
their study: “A Comparison of Health-Related Quality HRQOL in both groups. In addition, in older adults
of Life between Older Adults with Heart Failure and with heart failure, physical symptom status, age, and
Healthy Older Adults.” This title is concise, states the anxiety were related to HRQOL.
focus of the study (comparative descriptive), identifies Conclusions: The poor HRQOL seen in patients
a key study variable (health-related quality of life with heart failure is not just a reflection of aging.
[HRQOL]), and includes the populations studied Comprehensive interventions targeted toward the
(older adults with heart failure and healthy older factors that specifically negatively impact HRQOL are
adults). However, this study is also predictive, and this essential in older adults with heart failure.” (Heo
is not indicated in the study title. The researchers et al., 2007, p. 16)
studied additional independent variables (health per­
ception, functional status, physical symptom status,
emotional symptom status, and social support) to
predict the dependent variable HRQOL in older adults Heo et al. (2007) concisely organized their abstract
with and without heart failure. An alternative title with headings and clearly indicated the problem
would be “Predictors of Health-Related Quality of (background), sample size (90 older adults with heart
Life in Older Adults with and without Heart Failure.” failure and 116 healthy older adults), results, and con­
Some journals limit the length for titles of manu­ clusions. The purpose of the study was clearly stated
scripts, whereas other journals discourage use of under the heading “Objective” as required in the jour­
colons. nal’s instructions. The “Methods” section was less
Most research reports also include an abstract that clear on the type of study design, variables studied,
summarizes the key aspects of the study. An abstract measurement methods, and data collection process.
is usually about 200 to 300 words and describes the This abstract is a strong abstract but could have been
problem, purpose, framework, methods, sample size, improved if the authors had been allowed to expand
key results, and conclusions (Pyrczak & Bruce, 2007). the “Methods” section.
We provide details for developing an abstract of a Following the abstract are the four major sections
study later in this chapter. Heo et al. (2007) included of a research report: introduction, methods, results,
the following abstract for their study. and discussion. Table 27-1 provides an outline of
the content covered in each of these sections for a
quantitative research report. The research report by
Heo et al. (2007) is used as an example when discuss­
“Background: Health-related quality of life (HRQOL) ing these sections. The complete research article
in older adults with heart failure may be affected by can be accessed through the Cumulative Index to
a variety of variables, including aging. It is important Nursing and Allied Health Literature (CINAHL).
to determine the unique impact of heart failure to Also, because Heo et al. (2007) received funding from
the National Institutes of Health to conduct the study,
604 UNIT FOUR  Analyzing Data, Determining Outcomes, and Disseminating Research

TABLE 27-1  Outline for a Quantitative


“Despite advances in treatment and care, approxi-
Research Report
mately five million people have heart failure in the
Introduction United States. The number is increasing each year
Background and significance of the problem despite high mortality [significance].… In patients with
Purpose of study heart failure, health-related quality of life (HRQOL) is
Brief review of relevant literature (may include theoretical an important outcome that is closely related to clinical
framework and conceptual definitions) outcomes including rehospitalization and even mor-
Gap in knowledge study will address tality [background].… It is essential to compare these
Research objectives, questions, or hypotheses variables and their effects on HRQOL between older
Methods adults with and without heart failure to determine the
Research design and intervention if applicable
unique impact of heart failure and more effectively
Setting improve HRQOL in older adults with heart failure
Sampling method, consent process [problem statement].
Measurement methods (instrument descriptions and scoring) The purpose of this study was to compare HRQOL
Data collection process between older adults with and without heart failure.
Data analysis The specific aims [objectives] were to (1) compare
Results physical, psychologic, and social variables in older
adults with heart failure with those in healthy older
Description of sample (may use tables or figures)
adults, and (2) determine the best model predicting
Results organized by objectives, questions, or hypotheses
Use narrative, tables, and figures to present results
HRQOL in each group from among the physical, psy-
chologic, and social variables.” (Heo et al., 2007, pp.
Discussion 16-17)
Major findings compared with previous research
Limitations of study
Conclusions Review of Literature
Implications The review of literature section of a research report
Future studies that are needed
documents the current knowledge of the problem
References investigated. The sources included in the literature
Include references cited in paper, using format specified by review are the sources that you used to develop your
journal study and interpret the findings. A review of literature
can be two or three paragraphs or several pages long.
In journal articles, the review of literature is concise
and usually includes 15 to 20 sources. Theses and
the publication is also available at no cost from dissertations frequently include an extensive literature
PubMed Central (http://www.ncbi.nlm.nih.gov/pmc/ review to document the student’s knowledge of the
articles/). research problem. The summary of the literature
review clearly identifies what is known, what is not
Introduction known or the gap in knowledge, and the contribution
The introduction of a research report discusses the of this study to the current knowledge base. The objec­
background and significance of the problem; identi­ tives, questions, or hypotheses that were used to direct
fies the problem statement and purpose, reviews the the study often are stated at the end of the literature
relevant empirical and theoretical literature, describes review. Heo et al. (2007) provided a brief summary of
the study framework, and identifies the research the relevant literature and included what is known and
purpose (aims, objectives, questions, or hypotheses not known about the effects of heart failure on
if applicable). You will have developed this content HRQOL. See Chapter 6 for more information on
for the research proposal; you summarize it in the writing a review of the literature.
final report. Depending on the type of research report,
the review of literature and framework might be Framework
separate sections or separate chapters as in a thesis A research report needs to include an explicitly identi­
or dissertation. Key content from the introduction of fied framework. In this section, you identify and define
the study by Heo et  al. (2007) is presented as an the major concepts in the framework and describe the
example. relationships among the concepts (see Chapter 7). You
CHAPTER 27  Disseminating Research Findings 605

Biological/ Design
physiological The study design should be explicitly stated. Heo et al.
status (2007) implied a descriptive comparison study by indi­
Physical and
emotional Health- cating that their purpose was to compare two groups,
Individual
character-
symptom Health- related and this was reinforced with their first aim—to
status perception quality “compare physical, psychologic, and social variables
istics
Functional of life
status in older adults with heart failure with those in healthy
Environ- older adults” (Heo et al., 2007, p. 17). The design
mental
character- should match with the stated purpose and link to the
istics planned analysis. For example, it is clear that one
(social group is older adults with heart failure and they will
support) be compared with a group of older adults who are
healthy. The two groups will be compared on three
Figure 27-1  Conceptual framework. Factors affecting health-related types of variables (physical, psychologic, and social).
quality of life. From Heo, S., Moser, D. K., Lennie, T. A., Zambroski, C.
However, the abstract also includes HRQOL as a vari­
H., & Chung, M. L. (2007). A comparison of health-related quality of life
between older adults with heart failure and healthy older adults. Heart
able. The second aim—to “determine the best model
& Lung, 36(1), 107. predicting HRQOL in each group from among the
physical, psychologic, and social variables” (Heo
can develop a schematic map or model to clarify the et al., 2007, p. 17)—is actually a different study design.
logic within the framework. If a particular proposition It is still a descriptive design rather than an intervention
or relationship is being tested, that proposition should or experiment. However, the word “predictive”
be clearly stated. Developing a framework and iden­ assumes a longitudinal design with predictor variables
tifying the proposition or propositions examined in a measured at an initial point in time and an outcome
study connect the framework and the research purpose variable measured at a later point in time. The type of
to the objectives, questions, or hypotheses. The con­ design is most accurately described as a longitudinal
cepts in the framework need to be linked to the study descriptive correlational study. From the way in which
variables and are used to define the variables concep­ the second aim is written, the reader can expect to see
tually. Heo et al. (2007, p. 17) clearly identified the two predictive models tested—one for the healthy
framework of their study as the Wilson and Cleary group and one for the group with heart failure.
(1995) HRQOL model (see Figure 27-1). The vari­ A descriptive correlational study design could be
ables were conceptually and operationally defined and longitudinal, as in the case just described, or it could
presented in a table that is included later in this chapter. be a cross-sectional descriptive correlational study. A
If the journal allowed more space, the researchers cross-sectional study design includes the same vari­
might have expanded the literature review section ables and the same type of analysis (correlations and
based on this framework to include effects of age, model testing), but data are collected at only one point
health perception, functional status, physical symptom in time to describe correlates of HRQOL. In both
status, emotional symptom status, and social support longitudinal and cross-sectional descriptive study
on HRQOL in individuals with and without heart designs, the researchers test the correlations or rela­
failure. tionships between variables and test models with a
particular outcome of interest, but conclusions can be
Methods interpreted only as associations or relationships
The methods section of a research report describes between variables rather than causal.
how the study was conducted. This section needs to If your design includes an intervention or treatment,
be concise yet provide sufficient detail for nurses to your report needs to describe the treatment, including
appraise critically or replicate the study procedures. In the protocol for implementing the treatment, training
this section you will describe the study design, sample, of people (interventionalists) to implement the proto­
setting, methods of measurement, data collection col, and a discussion of the consistency of administra­
process, and plan for data analysis. If the research tion of the treatment (Santacroce, Maccarelli, & Grey,
project included a pilot study, the planning, implemen­ 2004). The reliable and competent implementation of
tation, and results obtained from the pilot study are an experimental treatment is referred to as intervention
briefly described. You will also describe any changes fidelity. As discussed in Chapter 14, intervention
made in the research project based on the pilot study fidelity includes two core components: (1) adherence
(Pyrczak & Bruce, 2007). to the delivery of the prescribed treatment behaviors,
606 UNIT FOUR  Analyzing Data, Determining Outcomes, and Disseminating Research

session, or course and (2) competence of the researcher et al. (2007) used the heading “Sample and Setting”
or interventionalist in delivering the intervention to introduce the following description of their sam­
(Stein, Sargent, & Rafaels, 2007). Santacroce et al. pling process.
(2004) and Stein et al. (2007) provide detailed direc­
tions to promote intervention fidelity in various quasi-
experimental studies and clinical trials.
Heo et al. (2007, p. 17) implemented a combined “Patients hospitalized with an exacerbation of heart
comparative descriptive and predictive design to failure at one of the three hospitals in a large Mid-
accomplish the two aims of their study. A more western city [setting] were screened during admis-
complex study design, such as a randomized clinical sion for inclusion in the study [convenience sample].
trial, might be presented in a table or figure, such as Patients aged more than 55 years were included. The
the examples provided in Chapter 11. Most journals other inclusion criteria were as follows: (1) a primary
require that these more complex studies be depicted diagnosis of heart failure with either preserved or
in a flow chart using the CONSORT guidelines nonpreserved left ventricular systolic function; (2)
(Bennett, 2006) as discussed in Chapter 20. New York Heart Association (NYHA) functional clas-
sification II to IV; (3) discharged home; and (4) living
Sample and Setting within the greater metropolitan area. Exclusion crite-
This section of the research report should describe the ria were as follows: (1) discharged to an extended
sampling method, criteria for selecting the sample, care facility; (2) referred for hospice or home care;
sample size, and sample characteristics. When a clini­ (3) referred to cardiac rehabilitation; or (4) cognitive
cal trial or experiment is involved, the report must also or psychiatric problems [inclusion and exclusion
address the statistical power analysis used to deter­ criteria].
mine how many subjects per group would be needed “Healthy older adults were recruited from three
to find a statistically significant difference if signifi­ local senior centers [setting] by using flyers and word
cance is set at α ≤ 0.05 or another alpha level. If fewer of mouth [sample of convenience]. Individuals aged
subjects enroll or complete the study than what more than 55 years were included. Those with the
was indicated in the original power analysis, the dif­ following characteristics were excluded from partici-
ference may not be statistically significant even if pation: (1) cognitive or psychiatric problems that pre-
the same group difference is clinically relevant. This cluded informed consent; (2) diagnosis of heart
is known as a Type 2 statistical error if the researchers disease or heart failure; and (3) other serious chronic
conclude that there was no difference between the illnesses including stroke, chronic lung diseases, and
two groups when the same difference would be statis­ cancer. Older adults with the common comorbidities
tically significant if the sample had been larger (see of hypertension and diabetes were not excluded so
Chapter 15). individuals with characteristics typical of older adults
Details about subject recruitment, including refusal that are also seen in older adults with heart failure
or acceptance rates, should be reported. The number could be included [inclusion and exclusion criteria].”
of subjects completing the study should be provided (Heo et al., 2007, p. 17)
if it differs from the initial sample size, and attrition
or retention rate needs to be addressed. If your subjects
were divided into groups (experimental and compari­ The researchers identified inclusion and exclusion
son or control groups), identify the method for assign­ sample criteria used to determine the target popula­
ing subjects to groups and the number of subjects in tions for the study (older adults with and without heart
each group. The protection of subjects’ rights and the failure). They also clearly indicated the sample size of
process of informed consent should be explicitly 90 older adults with heart failure and 116 healthy older
stated. In a published study, the setting is often adults. This sample may be sufficient for a descriptive
described in one or two sentences, and agencies are study, but the adequacy of the sample size would have
not identified by name unless permission has been been better justified for the group comparisons identi­
obtained. Researchers can present the sample charac­ fied in aim 1 if the researchers had conducted a power
teristics in narrative format; however, most research­ analysis. By identifying the refusal and attrition rates
ers present the characteristics of their sample in a table for the study, the researchers would have increased the
(see Chapter 8). Although some researchers report the readers’ understanding about the representativeness of
subject characteristics in this section, these are often the sample and ability to generalize to the larger popu­
presented in the first part of the results section. Heo lation. The more people who refuse or drop out of the
CHAPTER 27  Disseminating Research Findings 607

study, the less one can generalize to the target popula­ & Bruce, 2007). In a section titled “Measures,” Heo
tion. The sampling method appeared to be a sample of et al. (2007, pp. 17-19) described all of their measures
convenience, but it was not clearly stated. A conve­ in detail. Each variable was clearly identified, concep­
nience sampling method increases the potential for tually defined and linked to the framework, and
sampling error and decreases the ability of the operationally defined to indicate how it was measured.
researchers to generalize the study findings to the The conceptual and operational definitions (instru­
larger population of interest. Recruitment from three ments used) were clearly presented in a table (Table
local senior centers and three hospital sites increases 27-2). These researchers provided an excellent link
the likelihood that findings can be generalized to between the framework and the methodology of their
the larger population of older adults, and at least the study.
samples are representative of the local area in the
Midwest United States. Data Collection Process and Procedures
The description of the data collection process in the
Measures research report details who collected the data, the pro­
This section of the report describes the measurement cedure for collecting data, and the type and frequency
methods, which is how variables were operationalized of measurements obtained. In describing who col­
and measured in the study. Details about the measures lected the data, your report needs to specify the experi­
or instruments used in the data collection process are ence of the data collector and any training provided.
crucial if nurses are to appraise critically and replicate If more than one person collected data, describe the
a study. The details include the measure’s scaling and precautions taken to ensure consistency and interrater
range of scores and the frequency with which the reliability (Pyrczak & Bruce, 2007).
instrument was used; any reliability and validity infor­ Heo et al. (2007) detailed their data collection
mation previously published on the instrument should process in a section of their report titled “Procedure,”
also be provided. In addition, the report needs to which is presented in the following excerpt. The data
include the instrument’s reliability in the current study collection process was clear and concise, institutional
and any further support of validity for the current review board approval was indicated, subjects’
study’s sample. If you have used physiological mea­ informed consent was described, use of trained data
sures, be sure to address their accuracy, precision, collectors was addressed, and timing and setting were
selectivity, sensitivity, and sources of error (Pyrczak discussed.

TABLE 27-2  Variables and Instruments


Instrument
Variable (Conceptual Definition) Older Adults with Heart Failure Healthy Older Adults
Health-related quality of life (perception of Minnesota Living with Heart Failure
effects of a clinical condition or its
treatment on daily life)
Health perception (perception of overall health) One item from SF-36
Functional status (physical functional Composite measure from New York Composite measure from Duke
impairments in daily activities) Heart Association functional class Activity Status Index
Physical symptom status (dyspnea and fatigue) Composite measure from Dyspnea Composite measure from two items
and Fatigue Index (dyspnea and fatigue) of Memorial
Symptom Assessment Scale
Emotional symptom status (anxiety and Subscales (depression and anxiety)
depression) of Brief Symptom Inventory
Biological/physiological status (number of Clinical characteristics questionnaire
comorbidities)
Individual characteristic (age and gender) Demographic questionnaire
Environmental characteristics (social support) Marital status and having a confidant
by demographic questionnaire

SF-36, 36-item short-form health survey.


From Heo, S., Moser, D. K., Lennie, T. A., Zambroski, C. H., & Chung, M. L. (2007). A comparison of health-related quality of life between older adults
with heart failure and healthy older adults. Heart & Lung, 36(1), 18.
608 UNIT FOUR  Analyzing Data, Determining Outcomes, and Disseminating Research

“Procedure three senior centers. Investigators explained the


research purpose and procedures, obtained informed
Institutional review board approval was obtained for the
consent, and answered participants’ questions. All gave
conduct of this study. Eligible older adults with heart
written, informed consent. Questionnaires were com-
failure were identified by trained nurse research assis-
pleted at the senior centers [see Table 27-2].
tants, and those who gave written, informed consent to
Completion of instruments required 30 to 45 minutes,
participate in the study were included. All data on
and trained research nurses were available to assist both
HRQOL, health perception, functional status, physical
older adults with heart failure and healthy older adults.
symptom status, emotional symptom status, biologic/
In addition, the instruments were checked to make sure
physiologic status, individual characteristics, and envi-
participants did not inadvertently leave any items unan-
ronment characteristics (social support) were collected
swered. Participants were free to leave items unan-
by nurse research assistants after hospital discharge [see
swered.” (Heo et al., 2007, p. 20)
Table 27-2]. Eligible healthy older adults were identified
by investigators among older adults who appeared at

Analysis Plan format and organized into figures and tables. Table 1
Heo et al. (2007) provided an excellent description of is typically the descriptive characteristics of the
the analysis techniques used to obtain their results. sample. Because Aim 1 was to compare the healthy
group with the heart failure group, the reader would
expect to see sample demographic and clinical char­
acteristics described in two columns (healthy group
“Data were analyzed using SPSS (Statistical Packages
and heart failure group samples). The reader would
for the Social Sciences) for Windows (version 12.0,
also expect to see the statistics showing any group
SPSS Inc., Chicago, IL). Descriptive statistics including
differences in these characteristics. The presentation
mean, standard deviation, frequency, and percentage
of results depends on the end product of the data
were used to present demographic and clinical char-
analysis and your own preference and any journal
acteristics. Mann-Whitney U test, t-test, or chi-square
instructions. Generally, what is presented in a table is
test was used to examine differences in individual
not restated in the text of the narrative. When reporting
characteristics and biologic/physiologic status in older
results in a narrative format, the value of the calculated
adults with heart failure. To address specific aim 1,
statistic (t, F, r, or χ2), the degrees of freedom (df), and
the Mann-Whitney U test was used to determine the
probability (p value) should be included. When report­
difference in HRQOL, health perception, functional
ing any nonsignificant results, it is important to include
status, physical and emotional symptom status, and
the effect size and power level for that analysis so that
environmental characteristics (social support) because
readers would be able to evaluate the risk of a Type II
the distribution of each variable in healthy older adults
error (see Chapter 15).
did not show normality. To address specific aim 2,
Students often have difficulty putting all of these
stepwise multiple regression was used to identify
Greek-letter statistical findings back into words for the
variables as a group best associated with HRQOL in
text of the results section. Pallant (2007) provides
each group. A p value of less than 0.05 was consid-
useful and specific examples of how to translate the
ered statistically significant.” (Heo et al., 2007, p. 20)
Greek symbol results back into English for the text of
your report. The Publication Manual of the American
Psychological Association (American Psychological
Results Association [APA], 2010) provides direction for how
The results section reveals what was learned from to present various statistical results in a research
the study and includes the results generated from report. The format for reporting chi-square results is a
your statistical analyses. The results section is best symbol χ2 with degrees of freedom and sample size in
organized by the research objectives, questions, or parentheses followed by the χ2 statistic value and p
hypotheses that are linked to the conceptual frame­ value. For example, when APA format is required, a
work. Heo et al. (2007) organized their results by chi-square value should be presented in the following
characteristics of the sample and the two research format in the text of a research report: χ2 (4, N = 90)
aims. Research results can be presented in narrative = 11.14, p = 0.025. Statistical values need to be
CHAPTER 27  Disseminating Research Findings 609

reported with two decimal digits of accuracy. Although Psychological Association (APA, 2010). For meta-
a computer output of data may include results reported analysis reports that synthesize the results of many
to several decimal places, this is unnecessary for the studies, particular figures, called forest plots, are very
report. For example, reporting the χ2 value as 11.14 is important in the presentation of results (Floyd, Galvin,
sufficient even if the computer output says 11.13965 Roop, Oermann, & Nordstom, 2010).
(APA, 2010). The p value should be reported as the Figures
exact value, but when the computer output says p = Figures are diagrams or pictures that illustrate
0.0000, it should be reported as p < 0.001 because the the results. Researchers often use computer programs
computer calculates the value only out so far before it to generate sophisticated black-and-white or color
rounds off to zero. figures. Common figures included in nursing research
Heo et al. (2007) presented their results in narrative reports are bar graphs and line graphs. Journals often
and table formats. Some of these results are repre­ require high-resolution images for reproduction. The
sented in the next section as example tables. Because APA manual (APA, 2010, p. 167) has a figure checklist
journals have space limitations, results are best for you to review when deciding whether or not to
depicted in tables and should not duplicate what is in include a figure. Generally, figures require specific
the text. formatting and may have less detail than readers want,
so potential authors should carefully check with the
Presentation of Results in Figures and Tables journal guidelines (Saver, 2006).
Figures and tables are used to present a large Bar graphs typically have horizontal or vertical
amount of detailed information concisely and clearly. bars that represent the size or amount of the group or
Researchers use figures and tables to demonstrate rela­ variable studied. The bar graph is also a means of
tionships, document change over time, and reduce the comparing one group with another. Goyal, Gay, and
number of words in the text of the report (APA, 2010; Lee (2010) conducted a study to describe how socio­
Saver, 2006). However, figures and tables are useful economic status influences the risk of postpartum
only if they are appropriate for the results you have depressive symptoms in first-time mothers. As part of
generated and if they are well constructed (Saver, a larger study, the researchers asked women to com­
2006). Table 27-3 provides guidelines for developing plete a depression measure, the 20-item Center for
accurate and clear figures and tables for a research Epidemiologic Studies–Depression [CES-D] scale,
report. More extensive guidelines and examples for (see Chapter 17) during their third month of pregnancy
developing tables and figures for research reports can and again at 1 month, 2 months, and 3 months post­
be found in the Publication Manual of the American partum. The researchers compared groups based on
prenatal depression risk and presented their results in
a vertical bar graph (see Figure 27-2). This figure
indicates that the women with high prenatal risk scores
TABLE 27-3  Guidelines for Developing Tables
(CES-D ≥16) were more likely to have high postpar­
and Figures in Research Reports
tum scores at all three time points. The text indicates
Select results to include in report that this was significant (χ2 [1] = 19.9 to 32.5; all
Identify a few key tables and figures that explain or support p < 0.001).
major points A line graph is developed by joining a series of
Develop simple tables and figures
points with a line and shows how a variable varies
Ensure tables and figures are complete and clear without
referring to the narrative over time. In this type of graph, the horizontal scale
Give each table or figure a brief title (x-axis) is used to measure time, and the vertical scale
Tables and figures are numbered separately in the report (e.g., (y-axis) is used to measure number or quantity. A line
Table 1, 2; Figure 1, 2) graph figure needs at least three data points over time
Use descriptive headings, labels, and symbols—may need to on the horizontal axis to show a trend or pattern.
provide a key for abbreviations or symbols However, complexity does not enhance the ability to
Include probability values as actual values or indicate whether convey the data in a meaningful way, so it is recom­
less or more stringent by asterisks mended that no more than 10 time points should be
Refer to each table and figure in the narrative (e.g., Table 1 included on a single line graph, and there should be
presents…)
no more than four lines or groups per graph. Figure
Use narrative to summarize main ideas, but do not repeat
specifics that are in figures and tables 27-3 is a line graph developed by Goyal et al. (2010,
p. 100) to depict the pattern of depressive symptoms
Compiled from APA, 2010; Pallant, 2007; and Pyrczak & Bruce, 2007. over time by contrasting two groups of childbearing
610 UNIT FOUR  Analyzing Data, Determining Outcomes, and Disseminating Research

women from their third trimester to their 3-month for the two groups (F [3192] = 2.76; p = 0.044), with
postpartum assessment. Figure 27-3 is well con­ the low-income group improving at 1 month and 2
structed because it includes four data points per line months postpartum. The figures could be improved by
along the x-axis (mean depressive symptom score at having the sample sizes (n) for each group depicted
four visits) and two lines representing the study groups within the figure or in the legend.
(low income and high income) being examined for Tables
differences in depressive symptoms after the birth of Tables are used more frequently in research reports
their first infant. The third dashed line at the value of than figures and can be developed to present results
16 on the y-axis is helpful for readers to orient the from numerous statistical analyses without additional
scores for the two groups in context to the score that software programs. In tables, the results are presented
indicates clinical depression. The discussion of this in columns and rows so that the reader can review
graph in the text indicated that the pattern of depres­ them easily. The sample tables included in this section
sive symptoms over the four time points was different present means ( X ), standard deviations (SD), t values,
chi-square (χ2) values, Mann-Whitney U values (Z),
correlations (r), and regression analysis (R2) results.
Low prenatal depression risk Means and standard deviations of the study variables
High prenatal depression risk should be included in the published study because of
Depressive Risk (CES-D≥16)

60% their importance to future research. A variable’s mean


% with High Postpartum

54%
and standard deviation are essential for (1) providing
38%
42% a basis for comparison across studies, (2) calculating
40% the effect size to determine sample size for future
studies, and (3) conducting future meta-analyses
21%
20% (Conn & Rantz, 2003; Sandelowski, 2008). The
9% 7% sample size for each column should be included if the
N varies from the total sample.
0%
Heo et al. (2007) presented the results of their
1mo PP 2mo PP 3mo PP
study about HRQOL for older adults with and without
Postpartum depression risk by heart failure in four tables; three are included in this
prenatal depression risk (n = 198). chapter. Table 27-4 compares individual characteris­
tics (demographic variables) and biological and physi­
Figure 27-2  Postpartum (PP) depression risk by prenatal depression
risk (n = 198). CES-D, Center for Epidemiologic Studies–Depression.
ological status of the two groups. This table includes
(From Goyal, D., Gay, C., & Lee, K. A. (2010). How much does low means and standard deviations (SDs) for variables
socioeconomic status increase the risk of prenatal and postpartum measured at the interval or ratio level (age, education
depressive symptoms in first-time mothers? Women’s Health Issues, in years, and number of comorbidities) and frequen­
20(2), 101.) cies and percentages (%) for variables measured at the

Depressive symptoms over time by income group (n = 198).

Cut-off for depression risk


16
Depressive Symptoms

Figure 27-3  Depressive symptoms over time by Low income group


12
(CES-D score)

income group (n = 198). CES-D, Center for


Epidemiologic Studies–Depression; PP,
postpartum. (From Goyal, D., Gay, C., & Lee, K. A.
8
(2010). How much does low socioeconomic status
increase the risk of prenatal and postpartum High income group
depressive symptoms in first-time mothers? 4
Women’s Health Issues, 20(2), 101.)

0
Pregnancy 1mo PP 2mo PP 3mo PP
Time
CHAPTER 27  Disseminating Research Findings 611

TABLE 27-4  Comparison between Older Adults with Heart Failure and Healthy Older Adults:
Individual Characteristics and Biological and Physiological Status
Older Adults with Heart Healthy Older Adults
Failure (N = 90), no. (%) (N = 116), no. (%) or Total (N = 206),
Characteristics or M ± SD (Range) M ± SD (Range) no. (%) or M ± SD Statistic p Value
Age 74.8 ± 8.1 (57-93) 74.2 ± 6.3 (58-92) 74.5 ± 7.1 t = 0.56 0.57
Education (yr) 11.7 ± 2.6 (3-20) 13.0 ± 2.7 (4-20) 12.4 ± 2.7 Z = −3.69 <0.001
No. comorbidities 2.3 ± 1.2 (0-5) 1.0 ± 0.9 (0-4) 1.6 ± 1.2 Z = −7.18 <0.001
Sex (male) 48 (53.3) 27 (23.3) 75 (36.4) χ2 = 18.26 <0.001
Marital status
Married 42 (46.7) 46 (39.7) 88 (42.7) χ2 = 1.27 0.74
Divorced/separated 8 (8.9) 13 (11.2) 21 (10.2)
Widowed 33 (36.6) 45 (38.8) 78 (37.9)
Other 7 (7.8) 12 (10.3) 19 (9.2)
Living arrangements 48 (53.3) 61 (52.6) 109 (52.9) χ2 = 0.01 0.92
(live alone)

M, Mean; SD, standard deviation.


From Heo, S., Moser, D. K., Lennie, T. A., Zambroski, C. H., & Chung, M. L. (2007). A comparison of health-related quality of life between older adults
with heart failure and healthy older adults. Heart & Lung, 36(1), 19.

nominal level (sex, marital status, and living arrange­ develop evidence-based interventions to manage these
ments). The two groups were compared for differ­ needs.
ences on selected variables using t-test (t) (variables Tables are used to identify correlations among vari­
measured at interval or ratio level), Mann-Whitney ables, and often the table presents a correlation matrix
U (Z) (variables measured at ordinal level), and chi- generated from the data analysis. The correlation
square (χ2) (variables measured at nominal level). matrix indicates the correlation values (coefficients)
Nonsignificant results (p > 0.05) between the two obtained when examining the relationships between
groups in regard to age, marital status, and living variables, two variables at a time (bivariate correla­
arrangements indicate the groups are comparable in tions). The table also includes information about the
these areas. It was expected that the older adults with significance (p value) of each correlation coefficient,
heart failure would have significantly more comor­ but the significance will be sample-size dependent.
bidities (p < 0.001) than the healthy adults; however, Borge, Wahl, and Moum (2010) conducted a study
the significant differences for education (p < 0.001) entitled, “Association of Breathlessness with Multiple
and sex (p < 0.001) were unexpected. Researchers Symptoms in Chronic Obstructive Pulmonary
desire their groups to be comparable on demographic Disease.” One of the questions in their study was
variables, so any differences found between the groups “What are the relationships between … multiple
on study outcome variables of interest are less likely symptoms (breathlessness, depression, anxiety, sleep­
to be due to basic demographic differences. Any dif­ ing difficulties, fatigue and pain)?” (Borge et al.,
ferences on baseline characteristics need to be con­ 2010, p. 2690). The researchers presented their results
trolled in the remaining statistical analyses. in a correlation matrix, shown in Table 27-6. The six
Heo et al. (2007) conducted a Mann-Whitney U (Z) symptom variables are listed horizontally across the
analysis to address aim 1 to determine differences in top of the table and vertically down the left side of the
two groups for HRQOL, health perception, functional table. The relationship of Breathlessness with itself
status, physical status, emotional symptoms status (Breathlessness) is always a perfect positive relation­
(anxiety and depression), and social support (Table ship of 1.00. Breathlessness is correlated with Fatigue
27-5). Older adults with heart failure reported signifi­ (r = 0.51***). The asterisks (***) indicate that this
cantly (p < 0.001) poorer HRQOL, health perceptions, correlation is significant at p ≤ 0.001 (some journals
functional status, physical symptoms status, anxiety, would require the exact p value). This table identifies
and depression than healthy older adults. Only social the correlation coefficients (Pearson r value) between
support did not significantly differ between the two the variables, and the significance of each of these
groups (p = 0.66). The results indicate the increased coefficients. Borge et al. (2010) described this table in
needs of individuals with heart failure and the need to the text of their article in the following way.
612 UNIT FOUR  Analyzing Data, Determining Outcomes, and Disseminating Research

TABLE 27-5  Comparison between Older Adults with Heart Failure and Healthy Older Adults: Health-
Related Quality of Life, Health Perception, Functional Status, Physical Symptom Status,
Emotional Symptoms Status, and Social Support.
Mean ± SD
Older Adults with Healthy Older Adults
Scale Heart Failure (N = 90) (N = 116) Statistic p Value
LHFQ total* 50.8 ± 22.1 14.4 ± 15.9 Z = −9.9 <0.001
LHFQ physical* 23.1 ± 10.4 7.1 ± 8.1 Z = −9.3 <0.001
LHFQ emotional* 11.4 ± 7.2 2.3 ± 3.7 Z = −9.1 <0.001
Health perception* 2.6 ± 0.8 2.1 ± 0.6 Z = −4.9 <0.001
Functional status* 2.6 ± 0.5 1.7 ± 0.6 Z = −8.6 <0.001
Physical symptom status† 4.9 ± 2.2 11.0 ± 1.9 Z = −11.8 <0.001
Emotional symptom status
Anxiety* 0.9 ± 0.7 0.3 ± 0.5 Z = −6.7 <0.001
Depression* 1.0 ± 0.8 0.4 ± 0.6 Z = −5.7 <0.001
Social support† 2.9 ± 0.8 2.8 ± 1.1 Z = −0.4 0.661

*Higher scores indicate poor status.



Higher scores mean better status.
LHFQ, Minnesota Living with Heart Failure Questionnaire; SD, standard deviation.
From Heo, S., Moser, D. K., Lennie, T. A., Zambroski, C. H., & Chung, M. L. (2007). A comparison of health-related quality of life between older adults
with heart failure and healthy older adults. Heart & Lung, 36(1), 21.

TABLE 27-6  Correlation Matrix between Symptoms of Patients with Chronic Obstructive Pulmonary
Disease (N = 154)
Breathlessness Fatigue Anxiety Depression Sleeping difficulties Pain intensity
Breathlessness 1
Fatigue 0.51*** 1
Anxiety 0.34*** 0.45*** 1
Depression 0.38*** 0.53*** 0.65*** 1
Sleeping difficulties 0.42*** 0.58*** 0.56*** 0.50*** 1
Pain intensity 0.26** 0.48*** 0.41*** 0.32*** 0.51*** 1

**Statistically significant at 0.01 level.


***Statistically significant at 0.001 level.
From Borge, C. R., Wahl, A. K., & Moum, T. (2010). Association of breathlessness with multiple symptoms in chronic obstructive pulmonary disease.
Journal of Advanced Nursing, 66(12), 2695.
oasis-ebl|Rsalles|1476726447

higher all other symptom scores will be for that


“[Table 27-6] shows a significant positive (p < 0.001–p patient. These relationships make sense; a nurse
< 0.01) bivariate relationship between all symp- would not see one of these symptoms improve if
toms… Pearson’s r ranged from 0.26 (breathlessness- another symptom worsened (a negative or inverse
pain intensity) to 0.65 (depression-anxiety)” (Borge relationship). Readers should also look for the strength
et al., 2010, p. 2693). of the relationship (is it > 0.20 or > −0.20 regardless
of the direction or the p value?). All correlations were
greater than 0.20, and all symptoms would likely be
For many reasons, it would be important to exam­ considered in the next, more complex analysis using
ine this type of correlation matrix before proceeding multiple regression models. Readers should also look
with other, more complex statistical analyses. Readers for multicolinearity between variables (r > 0.70),
should first examine the matrix for the direction of a which would indicate that two variables are measur­
relationship: is it positive or negative? All of the rela­ ing the same concept. There was no multicolinearity
tionships in this matrix were positive, indicating that between symptoms, but anxiety and depression were
the higher a patient’s self-reported breathlessness, the highly correlated (r = 0.65) in this sample. If these
CHAPTER 27  Disseminating Research Findings 613

TABLE 27-7  Models Best Associated with Health-Related Quality of Life in Older Adults with Heart
Failure (N = 90)
Scale Variables Beta* Unique R2 Accumulated R2 F p Value
LHFQ Physical symptom status −0.501 ‡
0.359 0.359 25.050 <0.001
Total Age −0.221† 0.071 0.430
Anxiety 0.218† 0.037 0.466

*Standardized slope coefficient.



p < 0.05.

p < 0.001.
LHFQ, Minnesota Living with Heart Failure Questionnaire.
From Heo, S., Moser, D. K., Lennie, T. A., Zambroski, C. H., & Misook, L. C. (2007). A comparison of health-related quality of life between older adults
with heart failure and healthy older adults. Heart & Lung, 36(1), 21.

two variables were correlated (r > 0.70), researchers further research. Your major findings, which are gen­
would need to consider their overlapping variance erated through an interpretation of the results, should
when testing a multiple regression model. See Chap­ be discussed in relation to the overriding conceptual
ters 21-25 for additional explanation of specific statis­ framework as well as the research problem, purpose,
tical tests. and questions or hypotheses. Researchers should
Heo et al. (2007, p. 17) conducted a stepwise compare their findings with the findings from previous
regression (R2) to address aim 2 in their study “to research and describe how the new findings extend
determine the best model predicting HRQOL in each existing knowledge. Discussion of the findings also
group from among the physical, psychologic, and includes the limitations that were identified while
social variables.” The researchers reported, “In older conducting the study. A study might have limitations
adults with heart failure, physical symptom status, related to sample (e.g., size, response rate, attrition),
age, and one of the emotional symptoms status, design (e.g., convenience sample, only one clinical
anxiety, were associated with HRQOL (F [3, 86] = site, lack of randomization), or instruments (e.g.,
25.05, p < 0.001)” (Heo et al., 2007, pp. 20-21). The measure self-report alcohol intake rather than blood
results from the regression analysis are presented in alcohol level). These limitations influence the gener­
Table 27-7. The table clearly presents the variables alizability of the findings (Pyrczak & Bruce, 2007).
included in the regression analysis, the beta result for The research report includes the conclusions or the
each variable (physical symptoms status, age, and knowledge generated from the findings. Conclusions
anxiety), the unique R2 (percentage of variance in are frequently stated in tentative or speculative terms
HRQOL explained by each variable), and the accumu­ because one study by itself does not produce conclu­
lated R2 (0.466 or 46.6% variance in HRQOL explained sive findings that can be generalized to the larger
by the three variables). An analysis of variance population. You might provide a brief rationale for
(ANOVA) was conducted to determine significance, accepting certain conclusions and rejecting others. The
and the result (F test with df) and significance (p conclusions need to be discussed in light of their impli­
value) are provided (see Table 27-7). To be useful for cations for knowledge, theory, and practice. Describe
calculating effect sizes and doing meta-analyses, exact how the findings and conclusions might be imple­
p values are more useful, but some journal formats mented in specific practice areas. Conclude your
require this type of asterisk notation. However, when research report with recommendations for further
the p value in a computer output is listed as “0.0000,” research. Identify specific problems that require inves­
it stops at this point, and the author should report this tigation, and describe procedures for replicating the
as p < 0.001. study. The discussion section of the report demon­
strates the value of conducting the study and stimu­
Discussion lates the reader to conduct additional research that is
The discussion section ties the other sections of your needed to provide evidence-based practice (Craig &
research report together and gives them meaning. It Smyth, 2012; Melnyk & Fineout-Overholt, 2010). As
includes your major findings, limitations of the study, is often the case, by the time the study is published,
conclusions drawn from the findings, implications of the researchers are conducting the next study to address
the findings for nursing, and recommendations for their own recommendations for future research.
614 UNIT FOUR  Analyzing Data, Determining Outcomes, and Disseminating Research

Heo et al. (2007) linked their study findings with TABLE 27-8  Outline for a Qualitative Research
findings from previous research, identified the limita­ Report
tions of their study, formed conclusions, indicated
areas for future research, and made recommendations Introduction
Background & Significance of the phenomenon to be
for practice. The researchers concluded:
studied
Aims or purpose of the study
Brief review of relevant literature (may include theoretical
“Despite marked differences in physical, psychologic, framework and conceptual definitions)
and HRQOL status between the two groups [healthy Gap in knowledge study will address
Study questions and qualitative approach to be used
older adults and older adults with heart failure] physi-
Methods
cal symptom status was the variable most strongly Describe qualitative method (phenomenology, historical,
related to HRQOL in both groups. Both health care grounded theory, ethnographical or exploratory
providers and patients who often dismiss negative descriptive qualitative)
symptomatology as normal signs of aging need to be Rationale for and basic steps involved in using this method
aware that they are not so appropriate intervention Sampling method, consent process
can be undertaken” (Heo et al., 2007, p. 23). Setting and researcher access to setting
Data collection process
Data analysis plan
Results
The complete research report for this study can be Description of sample (may use table or figure)
accessed through CINAHL or PubMed. We recom­ Results organized by question or themes, depending on the
mend you review the study to increase your under­ method
standing of the content and organization of a Use narrative and quotations to present findings
quantitative research report. Discussion
Major findings compared to previous research
Limitations of the study
Reference Citations Conclusions
The final section of the research report is the reference Implications
list, which includes all sources that were cited in the Future studies that are needed
report. Most of the sources in the reference list are References
relevant studies that provided a knowledge base for Include those cited in paper, using format specified by
conducting the study. These sources need to have journal
complete citations recorded in a consistent manner.
The APA (2010) format is required by the editors of
many nursing and psychology journals. Sources need
to be cited in the text of the report using a consistent research report. Similar to a quantitative report, a
format. It is very important to follow the format guide­ qualitative research report needs a clear, concise title
lines for the journal to which you plan to submit your that identifies the focus of the study. A study by Chun,
manuscript for publication. Some journals request that Chesla, and Kwan (2011), titled, “So We Adapt ‘Step
reference citations include only the past 5 years, by Step’: Acculturation Experiences Affecting Diabe­
whereas other journals may limit the number of refer­ tes Management and Perceived Health for Chinese
ences to less than 50 (Nursing Research limits the American Immigrants,” is used as an example to
number of references to 40 at this time). present aspects of a qualitative research report.
The abstract for a qualitative research report briefly
Qualitative Research Report summarizes the key parts of the study and usually
Reports for qualitative research are as diverse as the includes the following: (1) aim of the study; (2) quali­
different types of qualitative studies. The different tative approach (e.g., phenomenology, grounded
types of qualitative research are presented in Chapter theory, ethnography, or historical); (3)methods includ­
4, and methods from specific qualitative studies are ing sample, setting, and methods of data collection;
presented in Chapter 12. The intent of a qualitative (4) brief synopsis of findings; and (5) implications of
research report is to describe the dynamic implemen­ the findings (Munhall, 2012). Detailed guidelines for
tation of the research project and the unique, creative developing an abstract for a qualitative study are pre­
findings obtained (Marshall & Rossman, 2010). Table sented later in this chapter. The abstract for the study
27-8 provides guidelines for developing a qualitative by Chun et al. (2011) follows.
CHAPTER 27  Disseminating Research Findings 615

“This study examines how acculturation affects type 2 investigations. Furthermore, the salience and impact of
diabetes management and perceived health for Chinese specific acculturation experiences respective to diabetes
American immigrants in the U.S. Acculturation experi- management and perceived health varied across partici-
ences or cultural adaptation experiences affecting diabe- pants due to individual, family, developmental, and envi-
tes management and health were solicited from an ronmental factors. In regards to salience, maintaining
informant group of immigrant patients and their spouses filial and interdependent family relations in the U.S. was
(N = 40) during group, couple and individual interviews of particular concern for older participants and coping
conducted from 2005 to 2008. A separate respondent with inadequate health insurance in the U.S. was espe-
group of immigrant patients and their spouses (N = 19) cially distressing for self-described lower-middle to
meeting inclusion criteria reviewed and confirmed middle-class participants. In terms of impact, family
themes generated by the informant group. Using inter- separation and relocating to ethnically similar neighbor-
pretive phenomenology, three key themes in patients’ hoods in the U.S. differentially affected diabetes manage-
and spouses’ acculturation experiences were identified: ment and health due to participants’ varied family
a) utilizing health care, b) maintaining family relations and relations and pre-migration family support levels and
roles, and c) establishing community ties and grounded- diverse cultural and linguistic backgrounds, respectively.
ness in the U.S. Acculturation experiences reflecting Implications for expanding current conceptualizations
these themes were broad in scope and not fully captured and measures of acculturation to better comprehend its
by current self-report and proxy acculturation mea- dynamic and multidimensional properties and complex
sures. In the current study, shifting family roles and effects on health are discussed. Additionally, implications
evaluations of diabetes care and physical environment in for developing culturally-appropriate diabetes manage-
the U.S. significantly affected diabetes management and ment recommendations for Chinese immigrants and
health, yet are overlooked in acculturation and health their families are outlined” (Chun et al., 2011, p. 256).

Chun et al.’s (2011) abstract clearly identifies the the significance by citing current and relevant litera­
aim of the study, the type of study conducted (inter­ ture (Sandelowski, 2010). The evolution of the
pretive phenomenology), the population (Chinese study is described to provide a context for the phe­
immigrants to the United States with type 2 diabetes nomenon being studied. Provide a rationale for con­
and their spouses), and sample size (40). The abstract ducting the study, and place the study within both a
met the word limit for this particular journal but historical and experiential context. The historical
might have been clearer if authors had indicated that context provides a basis for the study and situates
their sample was Cantonese-speaking and sample the study in a period of time. The experiential context
size was 20 couples or dyads. It is not until the presents your involvement in the research experience
methods section that the researchers describe partici­ and your understanding of the phenomenon under
pants as a convenience sample residing in one area of study.
California. Some qualitative reports include a brief literature
Following the abstract, qualitative research reports review in the introduction or in a separate section of
usually include four major sections: introduction, the report after a brief introduction. Other reports
methods, results, and discussion. The content included include literature only near the end of the report in the
in each of these sections is identified in Table 27-8 and discussion of the findings. The following text was
presented next. abstracted from the introduction of Chun et al.’s
(2011) interpretive phenomenology study of accul­
Introduction turation experiences affecting diabetes management
The introduction section of the report identifies the and perceived health for Chinese American immi­
research topic or life experience under investigation grants. This study is an example of a multidisciplinary
and specifies the type of qualitative study that was study funded by the National Institute of Nursing
conducted. The study aim or purpose and specific Research. The complete article can be accessed
research questions flow from the phenomenon, clarify through PubMed. Because this research was federally
the study focus, and identify expected outcomes of the funded by the National Institutes of Health, the article
investigation. The introduction is used to describe can be accessed at no cost from PubMed Central by
the significance of the study topic for nursing knowl­ searching on the author’s name (http://www.ncbi.nlm.
edge and practice and to provide documentation of nih.gov/pmc/).
616 UNIT FOUR  Analyzing Data, Determining Outcomes, and Disseminating Research

Lastly, both proxy and self-report acculturation mea- Chinese immigrants in the U.S. Special attention was
sures do not directly evaluate the context in which given in identifying key acculturation experiences,
acculturation unfolds, thus important family, cultural and including instances of stressful or successful cultural
sociopolitical contexts shaping cultural adaptation and adaptation, which respectively complicated or facilitated
health are overlooked. Consequently, fundamental their diabetes management. Qualitative research
questions concerning the nature of acculturation and its methods were utilized to comprehend the multidimen-
relationship to diabetes management and health— sional and dynamic properties of acculturation based on
namely, how do Chinese immigrants actually experience immigrant participants’ extended narratives of their cul-
acculturation, and how do these experiences complicate tural adaptation experiences. Qualitative methods also
or support their diabetes management and health?— allowed for findings and interpretations that were
largely remain a matter of conjecture. culturally-anchored in immigrant participants’ daily dia-
A primary goal of this study was to articulate the betes management and health practices.” (Chun et al.,
complex ways in which acculturation affects diabetes 2011, p. 257)
management and perceived health for first-generation

Methods In the methods section of a qualitative report,


The methods section includes three parts: general it is helpful to describe your relevant educational and
method of inquiry, specific methods of inquiry used clinical background for conducting the study. This
in the study, and data analysis plan (Table 27-8). The documentation helps evaluate the worth of the
general methods section includes the specific qualita­ study because the researcher serves as a primary data-
tive approach (e.g., phenomenology, grounded theory, gathering instrument and analyses occur within the
or ethnography) used to conduct the study and pro­ reasoning processes of the researcher (Munhall, 2012).
vides a brief background or reference to that method. In the report of your qualitative study, you need to
The philosophical basis for and the assumptions of the describe the site and participants selected for the
qualitative method are provided and documented from study. Your unique role as the researcher should also
the current literature. The methodology steps used to be detailed, including training of project staff, entry
conduct a qualitative study vary based on the philo­ into the setting, selection of participants, and ethical
sophical basis of the study, the topic studied, and the considerations extended to the participants during data
experiences of the researcher conducting the study. collection and analysis (see Table 27-8).
When developing a report of a qualitative study, you The research report includes a description of your
need to discuss the steps of the qualitative method, the data collection tools, such as observation guides, open-
procedures, and the outcomes and provide a rationale ended interviews, direct participation, documents, life
for selecting this qualitative method to guide your histories, audiovisual media (photographs, DVDs,
investigation (Denzin & Lincoln 2005; Marshall & videos, or audiotapes), biographies, and diaries. The
Rossman, 2010). Chun et al. (2011) described the flexible, dynamic way in which the researcher collects
qualitative method used to conduct their investigation data is described, including the time spent collecting
oasis-ebl|Rsalles|1476726464

in the following way. data, how data were recorded, and amount of data col­
lected. For example, if your data collection involved
participant observation, you should describe the
“Method number, length, structure, and focus of the observation
This interpretive comparative interview study was and participation periods. In addition, you should iden­
conducted from 2005 to 2008 with an informant tify the tools (e.g., audiotapes) for recording the data
group of 20 foreign-born Chinese American couples from these periods of observation and participation.
in which at least one member was diagnosed with Chun et al. (2011) described the methods applied in
type 2 diabetes.… their study in the following way.
Narrative and thematic analyses were conducted
by a multicultural and multidisciplinary team of
Chinese American and European American nurses “A convenience sample was recruited from commu-
and psychologists (Benner, 1994; Cohen, Kahn, & nity clinics, community service organizations and via
Steeves, 2000).” (Chun et al., 2011, pp. 257-258) public notices in the San Francisco Bay Area in
CHAPTER 27  Disseminating Research Findings 617

California. Six semi-structured interviews with couples Inclusion criteria included a diabetes diagnosis for at
in individual, couple and group contexts focused on least one year, aged 35 to 75, married for a minimum
illness understandings, perceptions of diabetes care, of 1 year, self-identified as Chinese American or Chinese,
acculturation histories and concrete positive, negative immigrated to the U.S. from mainland China or Hong
and memorable narratives of diabetes care. Couples Kong and having a spouse who would agree to partici-
narrated in each other’s presence (2 couple interviews) pate. Exclusion criteria for patients included major
and in group interviews with those who shared their diabetes complications (proliferative retinopathy, cere-
experience as a patient (2 group interviews) or spouse brovascular accident or myocardial infarction within the
(2 group interviews). A subset of these informants (n = last 12 months, renal insufficiency, or amputations)
13) was also interviewed individually if extra time was because our intent was to study patients who were
needed to complete interview questions or if nondisclo- early enough in the disease progression to benefit from
sure in shared interview settings suggested a private behavioral and family interventions [participant selec-
interview would yield more complete data. Interviews tion].” (Chun et al., 2011, p. 257)
were conducted in Cantonese and audiotaped text was “… Ethical approval for this study was obtained from
simultaneously translated from Cantonese to English the human subjects review boards at University of Cali-
and transcribed verbatim by skilled bilingual bicultural fornia, San Francisco and the University of San Francisco
staff. Each audiofile was then reviewed and checked for [ethical considerations].” (Chun et al., 2011, p. 258)
accuracy by a separate bilingual bicultural staff member
who had conducted the interview [procedures and data
collection].

Analysis Plan
The plan for analyzing the data should include who in the context of the holistic analysis of each couple’s
will be coding the data, how they were trained, any acculturation experiences.
issues regarding interrater reliability for coding, and To address generalizability, findings were presented
the software product used, if any. Chun et al. (2011) to a separate respondent group of patients and
described their analysis plan as follows. spouses who met the same inclusion criteria as the
informant group, a process known as member check-
ing. Respondents (13 patients and 6 spouses) repre-
sented 16 separate families.… Respondents met in
“After all text was coded for thematic codes in Atlas-ti, separate patient groups and spouse groups for two
complete text for two codes—‘acculturation positive’ 2-hour interviews to review themes presented in this
and ‘acculturation negative’—were reviewed. ‘Accul- manuscript for adequacy, and to add personal varia-
turation positive’ included examples of positive cul- tions to the presented themes.” (Chun et al., 2011,
tural adaptation experiences in the U.S. that supported p. 258)
diabetes management, including acculturation buffers
or protective factors that mitigated acculturation
stress and enhanced positive health perceptions.
‘Acculturation negative’ included examples of negative Results
cultural adaptation experiences that made diabetes The results section of the research report includes data
management difficult, including acculturation stress- analysis procedures and presentation of the findings.
ors and challenges that compromised health percep- The data, in the form of notes, tapes, and other materi­
tions. The analyzed text comprised over 465 pages als from observations and interviews, must be synthe­
of extracted text, and represented a broad inclusive sized into meaningful categories or organized into
portion of narratives drawn from interviews con- common themes by the researcher. The data analysis
ducted in all three contexts (couple, group and indi- procedures are performed during and after the data
vidual interviews). Simultaneous to this thematic collection process (Marshall & Rossman, 2010;
analysis, summaries for each couple were also con- Munhall, 2012). These analysis procedures and the
structed. Thus text for this manuscript was analyzed process for implementing them are described in Chun
et al.’s (2011) research report.
618 UNIT FOUR  Analyzing Data, Determining Outcomes, and Disseminating Research

“Results “Relocating to ethnically-matched


neighborhoods
“Acculturation experiences affecting type 2 diabetes
management and perceived health were identified Participants reported strong community ties and
from the narratives of Chinese immigrant patients (P) groundedness when relocating to ethnically-matched
and spouses (S) in the current study. These accultura- neighborhoods like San Francisco Chinatown because
tion experiences centered on three key themes: a) it diffused language stressors, made them feel at ease
utilizing health care, b) maintaining family relations and at home, and permitted gradual cultural adjust-
and roles, and c) establishing community ties and ment to the U.S. It also supported cultural mainte-
groundedness in the U.S. Participants reported vari- nance of valued Chinese dietary practices to manage
able acculturative stress levels across these themes their diabetes.
that differentially affected their diabetes management Mr. P22 (70-years old): We don’t have any big prob-
practices and perceived health.” (Chun et al., 2011, lems … there are a lot of Chinese here.… People can
p. 258) help and communicate with each other.… So we
adapt step by step.… It’s as if I’m in my home country
and village.… The foods we eat, the living customs
are more or less the same….” (Chun et al., 2011, p.
Present your results in a manner that clarifies for 261)
the reader the phenomenon under investigation.
These results include descriptions, themes, social
processes, and theories that emerged from the study
of life experiences, cultures, or historical events. Discussion
Sometimes, these theoretical ideas are organized The discussion section includes conclusions, study
into conceptual maps, models, or tables. Researchers limitations, implications for nursing, and recommen­
often gather additional data or reexamine existing dations for further research. The conclusions are a
data to verify their theoretical conclusions, and this synthesis of the study findings and the relevant theo­
process is described in the report (Denzin & Lincoln, retical and empirical literature. Limitations are identi­
2005; Marshall & Rossman, 2010). Some qualitative fied and their influence on the formulation of the
study findings lack clarity and quality, which makes conclusions is addressed. Conclusions include the
it difficult for practitioners to understand and apply study aim and the research questions, which were
them. Some of the problems with qualitative study used to guide the conduct of the study. Implications of
findings are misuse of quotes and theory, lack of the findings for nursing practice and theory develop­
clarity in identifying patterns and themes in the ment are explored, and suggestions are provided for
data, and misrepresentation of data and data analysis further research (Denzin & Lincoln, 2005). Chun
procedures in the report (Sandelowski, 2010). et al. (2011) formed conclusions with support from
Researchers must clearly and accurately develop the relevant literature, identified study limitations, and
their findings and present them in a way that a provided implications for practice. They also pro­
diverse audience of practitioners and researchers can vided direction for further research in the following
understand. excerpt.
Chun et al. (2011) presented their results in narra­
tive form. Each of these themes had supporting
themes that were extrapolated from the interviews. “The current study’s findings reveal a complex and
Each theme was presented with supporting data ver­ multifaceted relationship between acculturation and
batim to substantiate the researchers’ process in diabetes management and perceived health. This was
identifying themes for the reader to grasp a full illustrated by the broad scope, varying salience, and
understanding of the participant’s experience. In the differential impact of participants’ acculturation expe-
final major theme, “establishing community ties and riences. In regard to scope, participants reported a
sense of groundedness,” Chun et al. (2011) identified wide range of acculturation experiences covering
three subthemes substantiated with eight rich quotes three key themes.… Such a broad scope of accultura-
from their participant couples. The following excerpt tion experiences highlights the need to expand the
from their report is particularly meaningful, as it parameters in which acculturation is conceptualized
served to provide the authors with the title for their and measured in health research.
manuscript.
CHAPTER 27  Disseminating Research Findings 619

Audiences for Communication


Most studies employ proxy or self-report accul-
turation measures that do not directly or comprehen- of Research Findings
sively assess such broad acculturation influences on Before developing a research report, you need to
diabetes and health (Chun, 2006; Perez-Escamilla & determine who will benefit from knowing the findings.
Putnik, 2007; Salant & Lauderdale, 2003). The greatest impact on nursing practice can be
Limitations to the current study include the focus achieved by communicating nursing research findings
on Cantonese-speaking Chinese immigrants. This lin- to a variety of audiences, including nurses, other
guistic dialect is predominant among Chinese immi- health professionals, healthcare consumers, and policy
grants in the San Francisco region where this study makers. Nurses, including administrators, educators,
was conducted. Future studies should include the practitioners, and researchers, must be aware of
growing numbers of Mandarin-speaking Chinese research findings for use in practice and as a basis for
immigrants in the U.S. with distinct sociocultural conducting additional studies. Other health profes­
backgrounds and life experiences. Additionally, future sionals need to be aware of the knowledge generated
investigations should include the perspectives of by nurse researchers and facilitate the use of that
other family members such as children, siblings, and knowledge in the healthcare system as part of the
extended family in multigenerational immigrant delivery of evidence-based practice (Craig & Smyth,
households and the perspectives of widowed or 2012). Consumers are interested in research findings
unmarried persons with diabetes. Expanded analyses about illnesses that they or family members have.
of different family relationships and structures can Policy makers at the local, state, and federal levels use
deepen our understanding of Chinese immigrant research findings to generate health policy that has an
family acculturation processes and their significance impact on consumers, individual practitioners, and the
to diabetes management and health. Also, potential healthcare system. Rather than the more common
age-related differences in acculturation experiences research with individuals as the source of data,
were not fully examined in this study and should thus Chapman, Wides, and Spetz (2010) provided an
be included in future research. Lastly, future investiga- excellent example of communicating policy-related
tions should identify culturally-appropriate diabetes research findings using the Medicare Claims Process-
interventions, including bicultural competencies and ing Manual, reports from the National Council of
skills development, that facilitate diabetes manage- State Boards of Nursing, and congressional reports as
ment in different cultural settings” (Chun et al., 2011, their source of data. They tabulated their data and
pp. 262-263). concluded that more data are needed in these docu­
ments about the type of care provided. They also con­
cluded from their analysis that the payment system for
advanced practice nurses needs to be remodeled
Theses and Dissertations (Chapman et al., 2010).
Theses and dissertations are research reports that stu­
dents develop in depth as part of the requirements for a Strategies for Communicating Research
degree. The content included in a thesis or dissertation to Different Audiences
depends on the university requirements, the research Research findings can be communicated or dissemi­
guidelines of the nursing college or school, and the nated as oral podium presentations, visual posters, and
members of the student’s research committee. Most written reports. Each type of report can reach addi­
theses and dissertations are organized by chapters, with tional audiences in electronic format. Table 27-9 out­
the college or university specifying the content of each lines various strategies for disseminating findings to
chapter. The content included in a thesis follows the nurses, healthcare professionals, policy makers, and
general outline of quantitative and qualitative research consumers.
reports (Tables 27-7 and 27-8). Chapter 28 also pro­
vides guidelines for the content of theses and disserta­ Audience of Nurses
tion proposals. Baggs (2011) discussed the option of The most common mechanisms nurses use to com­
publishable papers as chapters for a dissertation and municate research findings to their peers are presen­
issues to consider regarding copyright and intellectual tations at conferences and meetings. Sigma Theta
property. The APA (2010) website has a chapter on Tau, the international honor society for nursing,
converting a thesis or dissertation to a journal article sponsors international, national, regional, and local
(http://supp.apa.org/style/pubman-ch08.pdf ). research conferences. Specialty organizations, such
620 UNIT FOUR  Analyzing Data, Determining Outcomes, and Disseminating Research

TABLE 27-9  Audience and Strategies for Communicating Research


Strategies for Communicating Research
Audience Oral and Visual Presentation Written Report Electronic Media
Nurses—administrators, Nursing research conferences Nursing-refereed journals DVD
educators, clinicians,
practitioners, researchers
Professional nursing meetings Nursing books Podcast
and conferences Monographs Video and audio recordings
Collaborative nursing groups Research newsletters Websites
Thesis and dissertation defenses Theses and dissertations
Foundation reports
Electronic databases
Other healthcare Professional conferences and Professional journals and books DVD
professionals meetings Newsletters Podcast
Interdisciplinary collaboration Foundation reports Video and audio recordings
Electronic databases Websites
Policy makers Testimony on health problems to Written testimony Video recorded testimony
state and federal legislators Reports to legislators
Reports to funding agencies
AHRQ and NINR reports and
presentations to policy makers
Healthcare consumers Television and radio interviews Newspaper Websites
Community meetings News and popular magazines Podcast
Patient and family teaching Electronic databases

AHRQ, Agency for Healthcare Research and Quality; NINR, National Institute for Nursing Research.

as the American Association of Critical Care Nurses, track record for publishing in a timely manner, and
Oncology Nurses’ Society, and Association of (4) the impact factor for the journal. The content for
Women’s Health, Obstetrics, and Neonatal Nursing, your work may be most applicable to a small spe­
sponsor research conferences. Many universities and cialty group, or perhaps a broader audience would
some healthcare agencies sponsor or cosponsor find it interesting and useful to their practice. You
research conferences. For various reasons, nurses are should not limit your options to a nursing journal if a
not always able to attend these research conferences. wider audience of health professionals needs to know
To increase the communication of research findings the findings of your research. You can look at your
and disseminate the new knowledge more diffusely, list of reference citations to get an idea of journals
conference sponsors often provide podcasts or DVDs that have an interest in publishing on your topic. If
of the research presentations. Some sponsors publish it is important for your findings to be reported as
abstracts of studies with the conference proceedings, soon as possible, consider an online journal or a
publish the abstracts in a research journal supple­ journal that has monthly issues rather than quarterly
ment, or provide materials electronically on their issues. Finally, the impact factor for a journal is
websites. important to consider (see Publishing Research Find­
The publishing opportunities in nursing continue ings section of this chapter). The 74 nursing journals
to increase, with 74 journals currently listed and eval­ listed by Polit and Northam (2011) give you a place
uated by Journal Citation Reports (Polit & Northam, to start.
2011). Opportunities to publish research have grown Many researchers disseminate their findings by
with the expansion of research journals. When decid­ publishing books or chapters in books. Foundations
ing on a potential journal for your work, four criteria and federal agencies that sponsor a research project
should be considered: (1) the intended readers you often provide reports of studies that have been con­
want to reach with your research findings, (2) the fit ducted or are in progress. The American Nurses’
of your topic to the journal’s focus, (3) the journal’s Foundation publishes a newsletter, Nursing Research
CHAPTER 27  Disseminating Research Findings 621

Report, which identifies studies they funded and published in other papers across the United States.
includes abstracts of these studies. The National Insti­ Nurse researchers also need to make their findings
tute for Nursing Research provides reports on its available through electronic means. An increasing
funded grants, including research project titles, names amount of healthcare information is available elec­
and addresses of researchers, period of support, a tronically on various websites, but often this informa­
brief description of each project, and any publication tion is not based on research. There is a need to provide
citations that result from the research (www.nih.gov/ consumers with evidence-based guidelines and educa­
ninr). tional materials to assist them in making quality
healthcare decisions.
Audience of Healthcare Professionals Nursing research findings should be communicated
and Policy Makers to consumers by being published in news magazines,
Nurse researchers communicate their research to such as Time and Newsweek, or popular health maga­
other health professionals at meetings and conferences zines, such as American Baby and Health. Health
sponsored by organizations such as the American articles published for consumer magazines and online
Heart Association, American Public Health Associa­ distribution reach millions of readers at a time (e.g.,
tion, American Cancer Society, American Lung Asso­ webmd.com or WebMD the Magazine). Television and
ciation, National Hospice Organization, and National radio are other valuable media for communicating
Rural Health Association. Nurses must believe in the research findings to consumers and other healthcare
value of their research and present their findings at providers. Another important method of communicat­
conferences that attract a variety of healthcare profes­ ing research findings to consumers is through patient
sionals. Nurse researchers and other health profession­ and family teaching. Nursing interventions and prac­
als conducting research on the same problem might tice protocols based on research are more credible to
collaborate to publish an article, a series of articles, a consumers than unresearched actions, and the ultimate
book chapter, or a book. This type of interdisciplinary goal is evidence-based practice (Craig & Smyth,
collaboration increases communication of research 2012). Freelance journalists often contact authors of
findings and facilitates synthesis of research knowl­ scientific articles, and these writers have the skills to
edge to promote evidence-based practice. translate research findings into language for consum­
The Agency for Healthcare Research and Quality ers. Lee and Gay (2011) published a study entitled,
(2011) was one of the first national organizations to “Can Modifications to the Bedroom Environment
develop and distribute evidence-based guidelines for Improve the Sleep of New Parents? Two Randomized
practice. The Agency for Healthcare Research and Controlled Trials.” A skilled journalist writing for Par-
Quality implemented the “Evidence-based Practice enting Magazine subsequently was able to catch con­
Centers (EPC) Program,” which includes the award­ sumers’ attention with the title, “Desperately Seeking
ing of contracts to institutions in the United States Sleep,” to disseminate the same data contained in the
and Canada to serve as an EPC. EPCs review all research publication but for a targeted public audience
relevant scientific literature on clinical, behavioral, (Bernstein, 2011).
and organization and financing topics to produce
evidence reports and technology assessments. These
reports are used for informing and developing cover­
age decisions, quality measures, educational materials Presenting Research Findings
and tools, guidelines, and research agendas (Donald­ Research findings are communicated at conferences
son, Rutledge, & Geiser, 2008). The institutions and meetings through verbal and poster presentations.
with EPCs and the activities of these centers can With presentations, researchers have an opportunity
be viewed online at www.ahrq.gov/clinic/epc (see to share their preliminary findings, answer questions
Chapter 19). about their studies, interact with other interested
researchers, and receive immediate feedback on their
Audience of Healthcare Consumers study. Research project findings are frequently pre­
Healthcare consumers as an audience are frequently sented at conferences as preliminary findings based
neglected by nurse researchers. The findings from on the quality of the abstract submitted by the
nursing studies can be communicated rapidly to the researchers. When research findings are published,
public through news releases. A nursing research the data must not be published elsewhere, and any
article published in a local paper has the potential of presentation of these data at a conference should be
being picked up by a national wire service and acknowledged.
622 UNIT FOUR  Analyzing Data, Determining Outcomes, and Disseminating Research

Verbal Presentations Box 27-1 Outline for Quantitative


Researchers communicate their findings through
Study Abstract
verbal presentations at local, national, and interna­
tional conferences. Presenting findings at a conference I. Title of the Study
requires receiving acceptance of your abstract as a II. Introduction
presenter, developing a research report, delivering the Statement of the problem and purpose
report, and responding to questions. Identification of the framework
III. Methodology
Design
Receiving Acceptance as a Presenter Sample size
Most research conferences require researchers to Identification of data analysis methods
submit an abstract, and acceptance as a presenter is IV. Results
based on the quality of the abstract. The abstract Major findings
should be based on the theme of the conference and Conclusions
the organizers’ criteria for reviewing the abstract. Implications for nursing
As noted earlier, an abstract is a clear, concise Recommendations for further research
summary of a study that is usually limited to 100 Note: The title and authors with affiliations, a
to 250 words. The abstract submitted for a verbal conflict of interest statement, a brief reference list
presentation is usually based on results from a of one or two key citations, and the
acknowledgment of funding source are not usually
completed study that is not yet published. Findings
considered in the word limitations for the abstract.
from a pilot study or preliminary findings would
be acceptable for a poster presentation (Pyrczak
& Bruce, 2007). The sponsors of a research confer­
ence circulate a call for abstracts 9 months to 1 year Box 27-2 Outline for a Qualitative
before the conference. Many research journals and Study Abstract
newsletters publish these requests for abstracts, and
they are available electronically. In addition, confer­ I. Title of the Study
ence sponsors email requests for abstracts to univer­ II. Introduction
sities, major healthcare agencies, and known nurse Identification of phenomenon to be
researchers. studied
The call for abstracts stipulates the format for the Statement of the aim of the study
abstract. Frequently, abstracts are limited to 1 page, Identification of the qualitative method
single-spaced, and include the content outlined in Box used to conduct the study
27-1 (for an abstract of a quantitative study) and Box Evolution of the study (rationale for
27-2 (for an abstract of a qualitative study). When conducting the study, historical context,
abstracts are submitted online, you may be limited to and experiential context)
a specific number of words or characters. For elec­ III. Methodology
tronic submissions, write and revise the abstract in a Discussion of the background, philosophy,
separate document. Depending on the instructions, and assumptions for the method used to
you may copy and paste the text in a box on the conduct the study
webpage or attach the file. Brief description of the sample, setting,
The title of your abstract must create interest, and and data collection process
the body of your abstract “sells” the study to the IV. Results
reviewers. An example of an abstract is presented in Brief description of data analysis
Box 27-3. Names and affiliations would be removed procedures
for review. Writing an abstract requires practice; fre­ Major findings
quently, a researcher rewrites an abstract many times Conclusions
until it meets all the criteria, including the word limit, Implications for nursing
outlined by the conference sponsors. Careful atten­ Recommendations for further research
tion to the criteria of the sponsoring agency should Note: The title and authors with affiliations, a
conflict of interest statement, a brief reference list
assist you in developing and refining your abstract
of one or two key citations, and the
and increase your chances of having the abstract acknowledgment of funding source are not usually
accepted for either a podium or poster presentation. considered in the word limitations for the abstract.
The Western Institute of Nursing (WIN) has an
CHAPTER 27  Disseminating Research Findings 623

Box 27-3 Example of an Abstract: “Sleep Adequacy and Environmental Demands


among Racially Diverse Women”
Dawn E. Dailey, RN, MSN, Harvey C. Davis, RN, PhD Prevention’s (CDC) 2002 Behavioral Risk Factor
APRN, BC Assistant Professor Surveillance System (BRFSS) database. BRFSS is
Doctoral Candidate Department of Health and an ongoing data collection program designed to
Department of Family Human Services measure behavioral risk factors in random
Health Care Nursing San Francisco State University samples of adults 18 years and older. Of the
University of California San Francisco, CA 32,503 adults surveyed, 29,465 were Caucasian
San Francisco and 3,040 were African American women
San Francisco, CA ranging in age from 18 to 65 years (mean = 42
years). Participants were asked to report the
Bruce A. Cooper, PhD Kathryn A. Lee, RN, PhD, FAAN number of days they did not get enough sleep
Senior Statistician Professor within the last month. Days of inadequate sleep
Office of Research Department of Family Health in the past month were re-coded as adequate
University of California Care Nursing (0-11 days), moderate (12-23 days), or severe
San Francisco University of California San (24-30 days). Comparative analyses (t-test,
San Francisco, CA Francisco chi-square) were used to describe differences in
San Francisco, CA health-related characteristics and sleep
Aim: To describe environmental demands adequacy between the two groups of women.
associated with sleep inadequacy among Multiple regression analysis was used to identify
Caucasian and African American women. key factors related to insufficient sleep.
Background: Sleep deprivation is purported Results: While more Caucasian women (32%)
to affect an individual’s health through reported overall sleep inadequacy (moderate
physiological, cognitive, emotional, and social and severe) than African American women
mechanisms. Regardless of age, women are (30%), significantly more African American
more likely to suffer from poor sleep. However, women (22%) compared to Caucasians (16%)
little is known about sleep adequacy in reported severe problems with sleep (X2 = 61.02;
subgroups of American women. p = .0001). Preliminary findings indicate that
Conceptual basis: This study is based on an sleep inadequacy is associated with specific
adaptation of a framework developed by Lee health behaviors, chronic medical conditions,
and colleagues (1994) that describes internal and psychological symptoms.
and external environmental demands that Implications: Preliminary results indicate that
result in sleep disturbance and daytime perception of inadequate sleep permeates the
fatigue. Internal environmental demands are lives of women. Findings suggest that African
characterized as physical illness, depression, age, American women suffer from more severe sleep
smoking patterns, alcohol use, physical activity, problems than their Caucasian counterparts.
mental health, stress, and energy levels. External Inadequate sleep has a profound impact on
environmental demands are characterized as health, functioning, and well-being. These
marital status, income, employment status, findings build upon existing knowledge of sleep
educational level, number of children, role disturbances and can lead to the development
demands, and life events. of effective interventions to enhance sleep
Methods: A secondary analysis was conducted quality in diverse groups of women.
using the Centers for Disease Control and
Source: Dailey, D. E., Davis, H. C., Cooper, B.A., & Lee, K. A. (2005). Sleep inadequacy and environmental demands
among racially diverse women. Abstract for presentation at Western Institute of Nursing Conference, San
Francisco, CA.

excellent tutorial called, “Writing a WINning abstract” Some sponsors ask that you specify whether you
by Lentz (2011b) from University of Washington want to be considered for an oral podium presentation
School of Nursing. This tutorial can be accessed or a poster presentation, whereas other sponsors decide
at the WIN website (http://www.ohsu.edu/son/win/ on a poster versus oral podium presentation based
pcorner.shtml). on their own criteria or scoring system. Generally,
624 UNIT FOUR  Analyzing Data, Determining Outcomes, and Disseminating Research

abstracts that describe smaller sample sizes and read because someone will be introducing you after settling
more like a small unfinished pilot work are less likely the audience, the previous speaker may be running
to be accepted for an oral podium presentation. Some late, and you do not want to be encroaching on the
sponsoring agencies require that you submit two next speaker’s time. The WIN website also has a tuto­
versions of your abstract: one with names and affilia­ rial on how to do a 10-minute oral research presenta­
tions that would be in their program or published tion developed by Lentz (2011b) (http://www.ohsu.edu/
abstracts and another that removes all names and son/win/pcorner.shtml). Your audience is there to hear
affiliations so that the abstract is anonymous and what is new in your area of research, not to hear all
reviewers are blinded. Read the sponsor’s instructions the background review of literature that brought you
carefully because they usually require that content to this current research. For guidance, you should
of the abstract has not been published or presented spend 20% (2 minutes or 2 slides) of your time on the
elsewhere. Instructions also indicate whether or not title and introduction, 20% on the methodology, 40%
accepted abstracts are published, usually as a supple­ on the results, and 20% on the discussion and implica­
mental issue of the sponsor’s affiliated professional tions for practice and research.
journal. Your title slide should provide the audience with
the gap in knowledge that you are addressing in your
Developing an Oral Research Presentation presentation. Your introduction should acknowledge
The presentation developed depends on the focus of funding sources and collaborators if applicable as well
the conference, the audience, and the time designated as any conflict of interest. A very brief review of key
for each presentation. Some conferences focus on background literature and a simple diagram of the
certain sections of the research report, such as tool conceptual framework should lead directly into the
development, data collection and analysis, findings, or research questions or hypotheses that address the gap
implications of the findings for nursing practice. It is in knowledge. The methodology content includes a
important to address the major sections of a research brief identification of the design, sampling method,
report (introduction, methods, results, and discussion) measurement techniques, and analysis plan. The
in your presentation. The content of a presentation content covered in the results section should start with
varies depending on whether the audience consists of a table of your sample characteristics followed by a
mainly researchers or clinical nurses. You would be slide of results for each question or hypothesis. The
best prepared for this type of presentation if you presentation should conclude with a brief discussion
attended a previous meeting and if you practice your of findings, implications of your findings for clinical
presentation on a local audience of peers. If you are practice, and recommendations for future research.
unsure who your conference audience represents (cli­ Most presenters find that the shorter the presentation
nicians or researchers, students or experienced time, the greater the preparation time needed. If you
researchers) or how large the audience will be (a con­ are limited to 10 minutes, you must be very selective
current session with an audience that specifically about which one or two research questions or hypoth­
selects your presentation based on the title and their eses you will focus on. If you have 15 or 20 minutes,
interest or a general session with the entire audience you may still limit your presentation to three research
of conference participants), it is important to ask the questions or hypothesis but allow more time to discuss
contact person for the conference. In planning your the details regarding the strengths and limitations of
allotted time for the presentation, it also is helpful to your research.
know if questions from the audience will be allowed The longer the presentation, the more important
during your presentation, allowed at the end of your figures and pictures, or some animation, become. The
presentation, or held until the end of your entire information presented on each slide should be limited
session when participants direct their questions to any to eight lines or fewer, with six or fewer words per
one of the presenters in your session. line. A single slide should contain information that can
Time is probably the most important factor in be easily read and examined in 30 seconds to 1 minute.
developing a presentation because many presenters Only major points are presented on visuals, so use
are limited to 10 or 15 minutes, with an additional 5 single words, short phrases, or bulleted points to
minutes for questions. As a guideline, you want to aim convey ideas, not complete sentences. Figures such as
for one slide per minute. Your title slide, acknowledg­ bar graphs and line graphs usually convey ideas more
ment slide, and final slide of references or slide calling clearly than tables. Pictures of the research setting,
for questions from the audience should be included in equipment, and photographs of the research team help
the formula. These slides are included in the timing the audience to visualize the research project better. A
CHAPTER 27  Disseminating Research Findings 625

laser pointer may be useful to guide the audience to time, there will be no opportunity for questions from
your key point on the slide, but the deliberate and the audience. When preparing for a presentation, try
careful use of color is more appealing to the audience, to anticipate the questions that members of the audi­
can increase the clarity of the information presented, ence might ask and rehearse your answers. Practice
and can call attention to a particular important statisti­ your presentation with colleagues and ask them to
cal test and p value without need for a laser pointer. raise questions. If you practice making clear, concise
However, avoid using particular shades of red color responses to specific questions, you will be less
for bulleted points or highlighted wording, particularly anxious during your presentation. When giving a pre­
if you have a dark background; red may appear fine sentation, have someone make notes of the audience’s
on your computer as you develop the slide, but becomes questions, suggestions, or comments because they are
difficult to see when projected to a large audience. often useful when preparing a manuscript for publica­
Preparing the script and visuals for a presentation tion or developing the next study.
is difficult, so enlist the assistance of an experienced
researcher and audiovisual expert. Rehearse your pre­ Poster Sessions
sentation with experienced researchers, and use their Your research abstract may be accepted at a confer­
comments to refine your script, visuals, and presenta­ ence as a poster session rather than podium presenta­
tion style. If your presentation is too long, synthesize tion. A poster session is a visual presentation of your
your script and provide handouts for important content. study, all on one surface, with either three or four
PowerPoint slides provide an excellent format for columns. Before developing a poster, follow the con­
presenting an oral research report; they include ference sponsor’s directions for (1) the size limitations
easy-to-read fonts, color, creative backgrounds, visuals or format restrictions for the poster, (2) the size of the
or pictures to clarify points, and animation options. poster display area, and (3) the background and poten­
However, consulting an audiovisual expert will ensure tial number of conference participants. Your institu­
that your materials are clear and properly constructed, tion may have a template with the logo that you are
with the print large enough and dark enough for the required to use for the audience to identify your affili­
audience to read. When the PowerPoint slides have ation more easily. A poster usually includes the fol­
been developed, view them from the same vantage lowing content: the title of the study; investigator
point as the audience to ensure that each slide is clear and institution names; purpose; research objectives,
and can be visualized without totally darkening the questions, or hypotheses (if applicable); framework;
room. design; sample; instruments; essential data collection
procedures; results; conclusions; implications for
Delivering a Research Report nursing; recommendations for further research; a few
and Responding to Questions key references; and acknowledgments.
A novice researcher might attend conferences and For clarity and conciseness, a poster often includes
examine the presentation style of other researchers pictures, tables, or figures to communicate the study.
before presenting an oral report. Even though each Figure 27-4 presents the award-winning WIN poster
researcher needs to develop his or her own presenta­ developed by Dr. Dawn Dailey when she was a doc­
tion style, observing others can promote an effective toral student at University of California, San Fran­
style. An effective presentation requires practice. You cisco. This poster was presented at the WIN meeting
need to rehearse your presentation several times, with in 2005, based on acceptance of the abstract pre­
the script, until you are comfortable with the timing, sented in Box 27-3. It has a polished, professional
the content, and your presentation style. When practic­ look and presents the key aspects of the study using
ing, use the visuals so that you are comfortable with a balance of text, figures, and color in a 3-column
the equipment. It is always advantageous to check out format. Conference sponsors often provide boards
the room where you will be presenting to see how for displaying posters, so the poster can be rolled
chairs are arranged and how the podium and screen to prevent creases and easily transported to the con­
are situated. ference in a protective tube. Online services (e.g.,
Most conferences organize their oral presentations Makesigns.com) will ship the poster to your hotel
by topic into a session moderated by an expert in the destination for an extra fee; this avoids any problem
field. The session usually includes a presentation by with airport security or risk of misplacing your poster
the researcher, a comment by the session’s moderator, while traveling.
and a question period before moving to the next A quality poster completely presents a study, yet
speaker. If your presentation is too long for the allotted can be comprehended in 5 minutes or less. Bold
626

UNIVERSITY OF CALIFORNIA SAN FRANCISCO


UCSF Sleep Adequacy and Environmental Demands among
Racially Diverse Women
University of California
DE Dailey, HC Davis, BA Cooper, & KA Lee UCSF School of Nursing
San Francisco

Introduction Results Summary


Sleep disturbance is purported to affect an individual’s health through 1. In this sample of women, African Americans were younger and fewer
Table 1: Selected Sample Characteristics Figure 2: Differences in Sleep Severity between
physiological, cognitive, emotional, and social mechanisms. were married. African American women also had lower incomes,
Caucasian and African American women
Regardless of age, women are more likely to suffer from poor sleep. more children in the home, and less education.
White Black
However, little is known about sleep inadequacy in subgroups of
n=29465 n=3040 2. Whites and Blacks experienced the same percentage of sleep
American women. 25
inadequacy. However, a higher percentage of Blacks reported severe
Internal sleep inadequacy.
Purpose
• Describe environmental demands associated with sleep inadequacy Age (years) 43 40
among Caucasian and African American women. 20 3. Internal variables accounted for 15% of the variance in sleep
Anxiety (days/month) 6.6 6.1
inadequacy. Very little (<4%) was due to external role demands.
Depression (days/month) 3.8 4.4
This study is based on an adaptation of a framework developed by Lee
and colleagues (1994) that describes internal and external Perceived health (days/month) 2.3 2.6 4. In this sample, anxiety, depression, age and perceived health were
15
environmental demands resulting in sleep disturbances and fatigue White the strongest predictors of sleep inadequacy. Ethnicity was not a
Weight (pounds) 156 172
(Figure 1 below). significant predictor of sleep inadequacy. These 3 variable accounted
Black for 15% of the variance in sleep inadequacy.
Smoker 26% 23%
10

Percentage
Internal External BMI (normal limits) 18% 29% 5. The strongest predictors of sleep inadequacy in the Caucasian
Environmental Environmental
Physical illness 49% 57% sample were anxiety, perceived health, age, depression,
Demands Demands
5 and number of children in the home.
Alcohol consumption (times/month) 2.6 1.5
Physical illness* External 6. The strongest predictors of sleep inadequacy in the African American
Material status*
Menstrual cycle <High school 7% 11% sample were anxiety, depression, age, physical illness and
Income* 0
phase employment.
Occupation <25,000 per year 24% 45%
Depression* Moderately Severely
Employment
Anxiety* Children in home 41% 56%
status*
Self-esteem Sleep Sleep Inadequacy
Level of education* Married 59% 27% Conclusions/Further Study
Age* Adequacy Number of Employed 68% 67%
Smoking*
children*
Sleeping patterns
Age of children • Sleep inadequacy permeates the lives of women.
Diet patterns*
Role demands
Weight*
Social support • Findings suggest that African American women suffer from more severe
Caffeine/alcohol Table 2: Multiple Regression Procedure, with Sleep Inadequacy Score as the Dependent Variable and 14
Positive life events sleep inadequacy than Caucasian women.
intake* Internal and External Demands as Independent Variables
Negative life events
Exercise patterns*
• Inadequate sleep is associated with health and functioning,
Explanatory Variables Cummulative R2 beta p
* Variables in CDC BRFSS 2002 database R2 Change • These finding support existing knowledge of sleep disturbances and its
Race/ethnicity .001 association with anxiety and depression.
Internal Variables .147 .146
Methods Physical illness .080 .0001 • Further research is needed to understand variables that affect sleep in
subgroups of women to promote the development of
Depression .013 .0001 effective interventions to enhance sleep quality.
• Secondary analysis using the Center for Disease Control and Anxiety .019 .0001
Prevention’s (CDC) 2002 Behavioral Risk Factor Surveillance System
Age –.007 .0001
(BRFSS) database. Reference:
• BRFSS is an ongoing data collection program designed to measure Smoker –.083 .0001
Lee, KA et al (1994). Fatigue as a response to environmental demands in
behavioral risk factors in random samples of adults 18 years and older Diet patterns –.001 .840
women’s lives. Image:Journal of Nursing Scholarship, 26(2),149-154
• Of the 62,341 individuals surveyed, 53% were women with ages Weight .001 .011
ranging from 18 to 65 years. Alcohol consumption –.054 .005 For additional information contact:
Exercise –.062 .0001 Dawn E. Dailey, RN, MSN, PhD(c)
Department of Family Health Care Nursing
External Variables .184 .038
Sleep Assessment University of California San Francisco
Marital status .013 .189
Sleep adequacy was assessed by asking: Income .001 .686
During the past 30 days, for about how many days have your felt Employment status .033 .001
UNIT FOUR  Analyzing Data, Determining Outcomes, and Disseminating Research

you did not get enough rest or sleep?


Educational level .008 .118
Recoded categories: Children in home .053 .0001
• Adequate= 0-11 days
• Moderately inadequate = 12-23 days
• Severely inadequate = 24-30 days

Figure 27-4  Poster of “Sleep Adequacy and Environmental Demands Among Racial Diverse Women.” (From University of California San Francisco.)
CHAPTER 27  Disseminating Research Findings 627

headings are used for the different parts of the research hand to record comments and contact information for
report, followed by concise narratives or bulleted individuals conducting similar research. Exchanging
phrases. Print size on a poster needs to be large enough business cards and writing key information on the
to be read at 3 feet (approximately 20 font size), but back of the card is a useful practice. Poster sessions
the title or banner should be readable at 20 feet provide an excellent opportunity to begin networking
(Shelledy, 2004). There may be an extra cost for with other researchers involved in the same area of
glossy finish, but the crisp appearance and readability research. Conference participants occasionally request
may be worth the price to you. Poster sessions usually your study instruments or other items, so it is essential
last 1 to 2 hours; you should remain by your poster that you keep a record of their contact information and
during this time and offer to answer any questions specific requests.
when a viewer is present. Most researchers provide
conference participants with a copy of the 1-page
accepted abstract or a 1-page color handout of the Publishing Research Findings
poster tacked to the poster board with contact informa­ Oral and poster presentations are a valuable means of
tion, particularly if you cannot stand by your poster rapidly communicating findings, but their impact is
for the entire allotted time. Websites are available to limited and the contents should not be previously pub­
assist you with research posters. You can also search lished. Even if the accepted abstract is published in a
the Internet for “research poster” to view current web­ supplemental volume of a journal associated with the
sites or a commercially available product (http:// conference sponsors, you should be planning publica­
www.makesigns.com), or visit the University of tion of the full findings for a research journal as you
Buffalo website at http://ublib.buffalo.edu/libraries/ prepare for the oral podium or poster presentation.
asl/guides/bio/posters.html. Published research findings are permanently recorded
Conferences include both quantitative and qualita­ in a journal or book and usually reach a larger audi­
tive research posters. Narrative content does not lend ence than presentations do. There should be an
itself to the crisp presentation required on a poster. The acknowledgment in the published report that the con­
number of words on a poster, even for a qualitative tents of your paper were presented at a particular
study, should be kept to a minimum, so you must research conference. The presentation and comments
select the most critical information to include. It is from the audience can provide a basis for finalizing
recommended that sections of the poster be color- your article for publication. Many journal editors are
coordinated; research has been conducted on use conference attendees and may request your paper for
of color to attract people to a poster (Keegan & an article when they hear your oral presentation or see
Bannister, 2003). your poster. Many researchers present their findings at
Summary and implications sections are frequently a conference and never submit the paper for publica­
where a viewer looks first, given the limited time for tion; this could create the impression on a vita that a
viewing many posters during a session. Because rich researcher’s efforts are more focused on traveling than
narrative text is so meaningful in qualitative studies, on research dissemination. Studies with negative find­
authors are advised to bold and enlarge the font for a ings (no significant difference or relationship) are fre­
few particularly meaningful quotes, and use artwork quently not submitted for publication. These negative
or photos that conceptualize the quote in a visual way. findings can be as important to the development of
Posters usually take 10 to 20 hours to develop based knowledge as positive findings because they direct
on the complexity of the study and the experience of future research, and they should find a venue for pub­
the researcher. Novice researchers usually need more lication and broad dissemination. Many authors strat­
than 20 hours to develop a poster. Important points in egize placing these nonsignificant findings within a
poster development include planning ahead, seeking publication that does have a key positive finding.
the assistance of others, and limiting the information Publishing research findings is a rewarding experi­
on the poster (Shelledy, 2004). Your school or work­ ence, but the process demands a great deal of time
place should have a template and color scheme for you and energy. The manuscript rejections or requests for
to use with the appropriate logos and colors. major revisions that most authors receive can be dis­
One major advantage of a poster session is the couraging. However, you can take certain steps to
opportunity for one-to-one interaction between the increase the probability of having a manuscript
researcher and the viewer. At the end of the poster accepted for publication. While you are developing
session, individuals interested in a study frequently your study and writing the proposal, outline your plans
stay to speak to the researcher. Have a notepad on for publishing the findings. At this time, you and other
628 UNIT FOUR  Analyzing Data, Determining Outcomes, and Disseminating Research

members of your research team should discuss and Having a manuscript accepted for publication
determine authorship credit. Authorship can become a depends not only on the quality of the manuscript
complex issue when the research is a collaborative but also on how closely the manuscript matches the
project among individuals from different disciplines. goals of the journal and its subscribers or audience
Some researchers develop the entire manuscript and (Dougherty, Freda, Kearney, Baggs & Broome, 2011).
then face the decision of who will be first, second, It is a good idea to review articles recently published
third, or last author. There are many ways to determine in the journal to which you plan to submit a manu­
authorship credit, but the decision should be accept­ script. This detailed review lets you know whether a
able to all investigators involved. Authorship credit research topic has recently been addressed and whether
should be given only to the individuals who made the research findings would be of interest to that jour­
substantial contributions to developing and imple­ nal’s readers. This process enables you to identify and
menting a study and to writing the manuscript (Baggs, prioritize a few journals that would be appropriate for
2008). Some journals require that all authors sign a publishing your findings. Checking the references in
written statement and checklist of their contributions. your own manuscript may reveal certain journals that
A novice author may want to consider seeking help publish research on your topic. Reviewing the journal’s
from a more experienced author who can either be a impact factor, the time line for their review process,
coauthor on the manuscript or receive an acknowledg­ and the waiting period from acceptance to publication
ment for their contribution in the acknowledgment date can also influence your decision on where to
section. In many cases, the last author is usually the submit your manuscript for review and publication.
senior mentor or leader of the team who secured the
resources (funding, space, and equipment) for con­ Journal Impact Factor
ducting the study. Journal Citation Report provides quantitative mea­
sures to evaluate scientific journals, including data
Publishing a Journal Article on journal impact factors. Journal Citation Report
Developing a manuscript for publication includes the is produced by Thomson Institute for Scientific Infor­
following steps: (1) selecting a journal, (2) developing mation. The impact factor is a measure of the fre­
a query letter, (3) preparing a manuscript, (4) submit­ quency with which the “average article” in a journal
ting the manuscript for review, and (5) revising the has been cited in a given period of time (Garfield,
manuscript. 2006). A list of selected impact factors can also be
found by professional field (e.g., nursing, law, educa­
Selecting a Journal tion, economics) at http://www.sciencegateway.org/
Selecting a journal for publication of your study rank/index.html.
requires knowledge of the basic requirements of the The impact factor for a journal is calculated based
journal, the journal’s review process, and recent arti­ on a 3-year period and can be considered to be the
cles published in the journal. A refereed journal average number of times published papers are cited up
is peer-reviewed and uses referees or expert reviewers to 2 years after publication. The impact factor cannot
to determine whether a manuscript is acceptable for be calculated until all of the year’s publications are
publication. In nonrefereed journals, the editor makes included; the most current impact factor may be 1 to
the decisions to accept or reject manuscripts, but these 2 years old. The impact factor for a journal can usually
decisions are usually made after consultation with a be found at the journal’s website. Here is an example
nursing expert. Most refereed journals require manu­ of information found at one journal website in 2011:
scripts to be reviewed anonymously, or blinded, by 2009 IMPACT FACTOR: 4.357
two or three reviewers. In some cases, there are two 2009 IMPACT FACTOR RANKING: 2nd out of
reviewers for the scientific content and one reviewer 70 reproductive medicine journals
for particular attention to the statistical content (Henly, TIMING: 84% of manuscripts published within 6
Bennett, & Dougherty, 2010). The reviewers are asked months
to determine the strengths and weaknesses of a manu­ Generally, specialty journals in nursing have lower
script, and their comments are anonymously sent impact factors than broad-based journals such as
from the journal editor to the contact author. Most Journal of the American Medical Association or New
academic institutions support the refereed system England Journal of Medicine. Your work is important
and may recognize only publications that appear in to publish, and there is a journal that will match your
peer-reviewed journals for faculty seeking tenure and needs and the needs of its readership, but it would
promotion. be important to aim for the higher impact nursing
CHAPTER 27  Disseminating Research Findings 629

journals that command a higher respect for the quality journal. In a review of 65 nursing journals, Northam,
of their reviewers and their review process and hence Yarbough, Haas, and Duke (2010) noted that 36 (55%)
the quality of their publications. require APA format.
A quality research report has no errors in punc­
Developing a Query Letter tuation, spelling, or sentence structure. It is also
A query letter determines an editor’s interest in important to avoid confusing words, clichés, jargon,
reviewing your manuscript. This letter should be no and excessive wordiness and abbreviations. Word pro­
more than 1 page and usually includes the abstract and cessing programs have “tools” commands that have
the researcher’s qualifications for writing the article. the capacity to proofread manuscripts for errors.
The length of the manuscript and the numbers of However, as the author, you still need to respond and
tables or figures may be useful, and the editor may be correct sentences that the software program has identi­
interested to know when, if ever, something on this fied as problematic. These program tools also do a
topic was last published in their journal. Some editors word count to ensure that your manuscript adheres to
appreciate a list of potential reviewers that you might the limitations specified in the journal guidelines.
suggest. Address your query letter in an email to the Knowledge about the author guidelines provided
current editor of a journal. Indicate in the letter the by the journal and a background in technical writing
title of the manuscript you would like to submit, why will help you to develop an outline for a proposed
publishing the manuscript is important, and why the manuscript. The brief outlines presented in Tables
readers of the journal would be interested in reading 27-1 and 27-8 must be expanded in detail to guide
the manuscript. Even if a letter is not required by a your writing of a manuscript. You can use the outline
journal, some researchers send a query letter because to develop a rough draft of your article, which you will
the response (positive or negative) enables them to revise numerous times. Present the content of your
make the final selection of a journal for submitting article logically and concisely under clear headings,
their manuscript. Often an editor responds that the and select a title that creates interest and reflects the
journal is planning a special issue on a particular topic content. The APA manual (APA, 2010) provides
and provides the due dates so that you can prepare detailed directions regarding appropriate terms to use
well in advance. Other journals, such as Advances in in describing study results and manuscript prepara­
Nursing Science, accept manuscripts submitted only tion. Consider using an article from the journal as a
for their special topic issues, and their website will guide or template; this can help you see the general
indicate due dates by topic. length of an introduction and discussion section, how
tables are presented, how references are cited, and
Preparing a Manuscript how acknowledgments are worded.
A manuscript is written according to the format out­ Developing a well-written manuscript is difficult.
lined by the journal. Guidelines for developing a Often, universities and other agencies offer writing
manuscript are usually published in the issue of the seminars to assist students and faculty in preparing a
journal or on the journal’s website. Follow these publication. Some faculty members who chair thesis
guidelines explicitly to increase the probability of and dissertation committees also assist their students
your manuscript being accepted for publication. Infor­ in developing an article for publication. In this situa­
mation provided for authors includes (1) directions for tion, the faculty member is almost always the second
manuscript preparation, (2) discussion of copyright author for the article. The APA manual (APA, 2010)
and conflict of interest, and (3) guidelines for submis­ has a section on how to reduce the content of a thesis
sion of the manuscript. or dissertation for publication.
Writing research reports for publication requires When you are satisfied with your manuscript, ask
skills in technical writing that are not used in other one or two colleagues to review it for organization,
types of publications. Technical writing condenses completeness of content, and writing style. Colleagues’
information and is stylistic. The Publication Manual comments can guide you in making any final revisions.
of the American Psychological Association (APA, You may also want to ask a friend or family member
2010); A Manual for Writers of Research Papers, to read the paper. Although your friend may not under­
Theses, Dissertations (Turabian, Booth, Colomb, & stand the topic or statistical results, he or she should
Williams, 2007); and the Chicago Manual of Style be able to read the paper and understand the message
(University of Chicago Press Staff, 2010) are consid­ you are trying to communicate. The manuscript
ered useful sources for quality technical writing. Most should be expertly typed according to the journal’s
journals stipulate the format style required for their specifications. If the journal has an international focus,
630 UNIT FOUR  Analyzing Data, Determining Outcomes, and Disseminating Research

it would be important to specify that your sample is findings are trustworthy and correctly interpreted. For
from a particular geographic area such as the United example, if results were not statistically significant,
States. For example, if the journal is British, appropri­ was a power analysis performed? Reviewers also
ate spelling is important (e.g., “labor” would be spelled evaluate whether the discussion was appropriate given
“labour”); software spell check tools have options for the findings and whether the author adequately dis­
American English, British English, and other lan­ cussed the clinical implications of the findings without
guages. The reference list for the manuscript needs to going beyond the actual data. Reviewers are also
be in a complete and correct format. Computer pro­ asked to comment on the relevancy of the reference
grams are available with bibliography systems that citations, the usefulness of any tables or figures, and
enable you to compile a consistent reference list for­ the consistency between the title, abstract, and text of
matted in any commonly accepted journal style. With the manuscript. Reviewers also look for the strengths
these programs, you can maintain a permanent file of and limitations of the study, which the authors should
reference citations. When you need a reference list for convey in their discussion. Every study has its limita­
a manuscript, you can select the appropriate references tions, and a limitation is not a reason for rejecting the
from the collection and use the program to format for manuscript. However, reviewers want to see that the
the requirements of a particular journal. authors have accurately identified and addressed limi­
tations for the readers.
Submitting a Manuscript for Review
Guidelines in each journal indicate the name of the Responding to Requests to Revise a Manuscript
editor and the address for manuscript submission. After reviewing your manuscript, the journal editor
Submit your manuscript to only one journal at a time; will reach one of four possible decisions: (1) accept
only when you confirm that your manuscript is not the manuscript as submitted, (2) accept the manuscript
accepted should you submit to a different journal. pending minor revisions, (3) tentative acceptance of
Most journals now accept only manuscripts submitted the manuscript pending major revisions, or (4) rejec­
electronically, and the editor provides a Portable Doc­ tion of the manuscript. Accepting a manuscript as sub­
ument Format (PDF) version to reviewers when they mitted is extremely rare. The editor will send you a
accept the offer to review the manuscript. When sub­ letter that indicates acceptance and the likely date of
mitting the manuscript, include your complete mailing publication.
address, phone number, fax number, and email address. Most manuscripts are returned to the author for
The corresponding author who submits the manuscript minor or major revisions before they are published.
usually receives notification of receipt of the manu­ Many of these returned manuscripts are never revised.
script within 1 to 2 days if sent by email, and in many If a reviewer identifies a major or minor limitation of
cases the notification is sent to all authors listed on the the study, that limitation should be considered and can
title page of the manuscript. be added to your other limitations in the discussion
section. An author may also incorrectly interpret the
Peer Review request for revision as a rejection and assume that
Most journals use some form of peer review process a revised manuscript would also be rejected. This
to evaluate the quality of manuscripts submitted for assumption is not usually true because revising a man­
publication. The manuscript is usually sent to two or uscript based on reviewers’ comments improves the
three reviewers with guidelines from the editor for quality of the manuscript. When editors return a man­
performing the review. In most cases, the review is uscript for revision, they include the reviewers’ actual
“blinded,” which means that the reviewers do not comments or a summary of the comments to direct the
know who the author is, and the author does not know revision. These reviewers and the editor have devoted
who is reviewing the paper. For reviewers to be time to reviewing your manuscript, and you should
blinded, journal instructions will indicate that any make the necessary revisions or respond with your
materials in the manuscript that identify the authors or rationale for not making a specific change requested
institutions should be omitted and replaced with by a reviewer and return the revised manuscript to the
brackets to indicate that something was intentionally same journal for reconsideration.
removed from the text—“[removed for blind review].” It is important to review each comment from a
For research papers, reviewers are asked to evalu­ reviewer carefully and make the revisions that improve
ate the validity of the study. Reviewers consider the quality of the research report without making inac­
whether the methodology was adequate to address the curate statements about the study. Often an editor will
research question or hypotheses and whether the provide guidance about how to respond to a reviewer
CHAPTER 27  Disseminating Research Findings 631

if you ask for help. When you have revised your man­ these issues and their mean frequencies. “Timeliness
uscript based on the reviewers’ comments, it should of the topic” was more important than “contribution
be resubmitted with a cover letter explaining exactly to theory” and reflected the predominance of review­
how you responded to each review comment or rec­ ers who review for nursing research journals. When
ommendation. It is helpful to number each comment you receive a rejection notice, give yourself a cooling-
and recommendation, followed by your response and off period and then ask colleagues to help you deter­
description of your modification as well as page mine what the reviewers were saying about why the
number in your manuscript for that revision. You can manuscript was rejected. The editor’s introductory
also provide a table with a column for the requested comments to the author in a rejection letter can often
changes and a second column with the changes made help to guide you in your responses to reviewers’
or the rationale for why a change could not be made. concerns. Most manuscripts, especially those that are
The second column should also include the number of poorly written, can be revised and submitted to a dif­
the page where a change was made. Often an editor ferent journal that was your second choice.
requests that the changes in the manuscript be identi­
fied with “track changes” or highlighting. In some Publishing Research Findings
cases, you may disagree with a reviewer’s recommen­ in Online Journals
dation. If so, provide a rationale for your dis­agreement, Many print journals are moving to online formats.
but do not ignore any comment or recommendation. These journals continue to provide their traditional
Sometimes the revised manuscript and your cover print version but also have a website with access to
letter are returned to the reviewers, and still further some or all of the articles in the printed journal. The
modification is requested in the paper before it is pub­ number of online nursing journals is also growing.
lished. Although these experiences are frustrating, These online-only journals have some distinct advan­
they provide the opportunity to improve your writing tages for authors. Email links from author to editor
skills and logical development of ideas. Frequently, and editor to reviewer allow papers to be submitted
editors request that the final manuscript be submitted and sent electronically and allow reviewer comments
electronically as a clean copy with no track changes to be sent back to the editor more quickly. Reviewer
or highlights. comments are compiled by the editor more quickly
An author who receives a rejection can feel devas­ and sent to the author by email. When the author
tated, but he or she is not alone and should never take revises the article and resubmits it by email, the editor
it personally. All authors, even experienced ones, have can ask the same reviewers to evaluate the article
had manuscripts rejected. Manuscripts are rejected for again. Once the article is judged to be satisfactory, it
various reasons. When a group of nursing journal is accepted for publication. This process is particularly
editors surveyed manuscript reviewers and asked them important for international scientific communications.
to identify the most important indicators for a manu­ Online journals use “continuous publication,” which
script’s contribution to nursing, there were five key means that there is no wait for approved articles to
factors (Dougherty et a., 2011). Table 27-10 identifies be published because the editor does not have to
wait until the next issue is scheduled for publication.
The notion of an “issue” is becoming antiquated as a
result of electronic publishing. Approved articles are
TABLE 27-10  Important Indicators of a placed online almost immediately, which is important
Manuscript’s Contribution   for research reports because there is more rapid access
to Nursing to recent research findings by other researchers and
Factor Number (%) clinicians interested in facilitating evidence-based
Knowledge or research evidence 1404 (83.8%)
practice. There may be added fees for publishing in
Timeliness/topic of current interest 1153 (68.8%) an online format, but the possibilities of dialogue
Newly emerging idea 1141 (68.1%) with readers, including other researchers in the same
Generalizability across population 698 (41.7%) field of study, are great. However, additional work
or international boundaries needs to be done to ensure that online publications
Contribution to theory 534 (31.9%) are secured and that each publication is permanently
available with a permanent identifier for citation and
From Dougherty, M. C., Freda, M. C., Kearney, M. H., Baggs, J. G., &
Broome, M. (2011). Online survey of nursing journal peer reviewers:
linking. Journal publishers have begun to assign
Indicators of quality in manuscripts. Western Journal of Nursing Research, a Digital Object Identifier (DOI) to each article. The
33(4), 506–521. DOI system is managed by the International DOI
632 UNIT FOUR  Analyzing Data, Determining Outcomes, and Disseminating Research

Foundation, and identifiers are assigned to all types of (5) how it will be marketed. The researcher must fulfill
digital work. The DOI will never change, even if the the obligations of the contract by producing the pro­
location for that work does change. The use of DOIs posed book within the agreed time frame. Publishing
is expected to increase and become accepted as the a book is a significant accomplishment and an effec­
permanent identifier for scientific and scholarly pub­ tive, but sometimes slow, means of communicating
lications (DOI Handbook, 2006). research findings.
Not all online journals are refereed or provide peer
review. You may wish to check for information on the Duplicate Publications and Self-Plagiarism
peer review process at the online journal website. Peer Duplicate publication is the practice of publishing
review is essential to scholars in the university tenure the same article or major portions of the article in two
track system. Electronic publishing may result in a or more print or electronic media without notifying the
more open peer review process. Baggs (2011) dis­ editors or referencing the other publication in the ref­
cussed some issues to be aware of when considering erence list (Baggs, 2008). Duplicate publication is a
Internet postings, particularly related to multiple ver­ form of plagiarism (self-plagiarism) and is not only
sions and intellectual property issues. unethical but also poor practice because it limits an
Publishing in an online journal has potential advan­ opportunity for others to publish new knowledge, arti­
tages. The constraint on length of the manuscript, ficially inflates the importance of a study topic, clut­
imposed because of the cost of print publishing, ters the literature with redundant information, rewards
usually does not exist. Multiple tables, figures, graph­ researchers for publishing the same content twice,
ics, and even streaming audio and video are possibili­ and may violate copyright law. Many journal editors
ties with online journals. Animations can be created screen a manuscript for plagiarism using software pro­
to assist the reader in visualizing ideas. Links may be grams. If portions of the material have been presented
established with full-text versions of citations from at a scientific meeting in the form of an oral podium
other online sources. It is possible to track the number or poster presentation, this should be acknowledged
of times the article has been accessed to assess its along with funding sources and any potential conflict
impact on the scientific community. Electronic list­ of interest.
servs and chat rooms may be available to discuss the Journals require the submission of an original man­
paper. All of these capabilities are not currently avail­ uscript, not previously published, so submitting a
able with every online journal. The technology to manuscript that has been previously published without
provide them exists, but online journals with some referencing the duplicate work or notifying the editor
of these advanced technologies cover their costs of the previous publication is unethical and a form of
by charging subscription fees or obtaining financing scientific misconduct (see Chapter 9). Previous publi­
through advertisements. Online journals are rapidly cations related to the study must be cited in the text
emerging, and websites are available (www.medscape. of the manuscript and the reference list. Editors have
com/pages/public/publications) that provide a listing the responsibility of developing a policy on duplicate
and electronic access to the online health journals. publications and informing all authors, reviewers, and
readers of this policy. In addition, editors must ensure
Publishing Research Findings in Books that readers are informed of duplicate materials by
Some qualitative studies and large, complex quantita­ adequate citation of the materials in the article’s text
tive studies are published as chapters within books, and reference list. A duplicate publication can result
monographs, or books. Publishing a book requires in retractions and refusal to accept other manuscripts
extensive commitment on the part of the researcher. for review from the author (Baggs, 2008; International
In addition, the researcher must select a publisher and Committee of Medical Journal Editors, 2011).
convince the publisher to support the book project. A
prospectus must be developed that identifies the pro­
posed content of the book, describes the market KEY POINTS
readership for the book, and includes a rationale for
publishing the book. The publisher and researcher • Communicating research findings, the final step
must negotiate a contract that is mutually acceptable in the research process, involves developing a
regarding (1) the content and length of the book, (2) research report and disseminating it through pre­
the time required to complete the book, (3) the per­ sentations and publications to audiences of nurses,
centage of royalties that the author will receive, (4) healthcare professionals, policy makers, and health­
any financial coverage to be offered in advance, and care consumers.
CHAPTER 27  Disseminating Research Findings 633

• Both quantitative and qualitative research reports in two or more print or electronic media without
include four basic sections: (1) introduction, (2) notifying the editors or referencing the other pub­
methods, (3) results, and (4) discussion. lication in the reference list.
• In a quantitative research report, the introduction
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dian Medical Association Journal, 169(12), 1291–1292. (2007). A manual for writers of research papers, theses, disserta-
Lee, K. A., Lentz, M. J., Taylor, D. L., Mitchell, E. S., & Woods, tions, seventh edition: Chicago style for students and research-
N. F. (1994). Fatigue as a response to environmental demands in ers. Chicago, IL: University of Chicago Press.
women’s lives. Image: Journal of Nursing Scholarship, 26(2), University of Chicago Press Staff. (2010). The Chicago manual of
149-154. style (16th ed.). Chicago, IL: University of Chicago Press.
Lee, K. A., & Gay, C. L. (2011). Can modifications to the Wilson, I. B., & Cleary, P. D. (1995). Linking clinical variables with
bedroom environment improve the sleep of new parents? Two health-related quality of life: A conceptual model of patient out­
randomized controlled trials. Research in Nursing & Health, comes. Journal of the American Medical Association, 273(1),
34(1), 7–19. 59–65.
UNIT FIVE
Proposing and Seeking Funding for Research
28
CHAPTER

Writing Research Proposals


  http://evolve.elsevier.com/Grove/practice/

W
ith a background in the quantitative, qualita- qualifications of the researchers; and generates support
tive, outcomes, and intervention research for the project. Conducting research requires precision
methodologies, you are ready to propose a and rigorous attention to detail. Reviewers often judge
study. A research proposal is a written plan that iden- a researcher’s ability to conduct a study by the quality
tifies the major elements of a study, such as the research of the proposal. A quality study proposal is clear,
problem, purpose, and framework, and outlines the concise, and complete. Writing a quality proposal
methods and procedures to conduct the proposed study. involves (1) developing ideas logically, (2) determin-
A proposal is a formal way to communicate ideas about ing the depth or detail of the content of the proposal,
a study to seek approval to conduct the study and (3) identifying critical points in the proposal, and
obtain funding. Researchers who are seeking approval (4) developing an esthetically appealing copy (Martin
to conduct a study submit the proposal to a select group & Fleming, 2010; Merrill, 2011; Offredy & Vickers,
for review and, in many situations, verbally defend the 2010).
proposal. Receiving approval to conduct research has
become more complicated because of the increasing Developing Ideas Logically
complexity of nursing studies, the difficulty involved The ideas in a research proposal must logically build
in recruiting study participants, and increasing con- on each other to justify or defend a study, just as a
cerns over legal and ethical issues. In many large lawyer would logically organize information in the
hospitals and healthcare corporations, both the lawyer defense of a client. The researcher builds a case to
and the institutional review board (IRB) evaluate the justify why a problem should be studied and proposes
research proposals. The expanded number of health- the appropriate methodology for conducting the
care studies being conducted has led to conflict among study. Each step in the research proposal builds on the
investigators over who has the right to recruit potential problem statement to give a clear picture of the study
research participants. The increased number of pro- and its merit (Merrill, 2011). Universities, medical
posed studies has resulted in greater difficulty in centers, federal funding agencies, and grant writing
obtaining funding. Researchers need to develop a consultants have developed websites to help research-
quality study proposal to facilitate university and clini- ers write successful proposals for quantitative, qualita-
cal agency IRB approval, obtain funding, and conduct tive, outcomes, and intervention research. For example,
the study successfully. This chapter focuses on writing the University of Michigan provides an online guide
a research proposal and seeking approval to conduct a for proposal development (http://www.drda.umich.
study. Chapter 29 presents the process of seeking edu/proposals/PWG/pwgcomplete.html). The National
funding for research. Institute of Nursing Research (NINR, 2012) provides
online training for developing nurse scientists at http://
www.ninr.nih.gov/Training/OnlineDevelopingNurse
Writing a Research Proposal Scientists/. You can use a search engine of your choice,
A well-written proposal communicates a signifi­ such as Google, and search for research proposal
cant, carefully planned research project; shows the development training; proposal writing tips; courses

635
636 UNIT FIVE  Proposing and Seeking Funding for Research

on proposal development; and proposal guidelines appealing copy is legible (the print is dark enough to
for different universities, medical centers, and govern- be read) with appropriate tables and figures to com-
ment agencies. In addition, various publications have municate essential information. You need to submit
been developed to help individuals improve their sci- the proposal by the means requested as a mailed hard
entific writing skills (American Psychological Asso- copy, an email attachment, or uploaded file.
ciation [APA], 2010; Offredy & Vickers, 2010;
Turabian, Booth, Colomb, & Williams, 2007; Univer-
sity of Chicago Press Staff, 2010). Content of a Research Proposal
The content of a proposal is written with the interest
Determining the Depth of a Proposal and expertise of the reviewers in mind. Proposals
The depth or detail of the content of a proposal is are typically reviewed by faculty, clinical agency
determined by guidelines developed by colleges or IRB members, and representatives of funding insti-
schools of nursing, funding agencies, and institutions tutions. The content of a proposal varies with the
where research is conducted. Guidelines provide spe- reviewers, the guidelines developed for the review,
cific directions for the development of a proposal and and the type of study (quantitative or qualitative)
should be followed explicitly. Omission or misinter- proposed. This section addresses the content of
pretation of a guideline is frequently the basis for (1) a student proposal for both quantitative and
rejection or requiring revision. In addition to follow- qualitative studies, (2) condensed research proposals,
ing the guidelines, you need to determine the amount and (3) preproposals.
of information necessary to describe each step of your
study clearly. Often the reviewers of your proposal Content of a Student Proposal
have varied expertise in the area of your study. The Student researchers develop proposals to communi-
content in a proposal needs to be detailed enough to cate their research projects to the faculty and members
inform different types of readers yet concise enough to of university and agency IRBs (see Chapter 9 for
be interesting and easily reviewed (Martin & Fleming, details on IRB membership and the approval process).
2010). The guidelines often stipulate a page limit, Student proposals are written to satisfy requirements
which determines the depth of the proposal. The rele- for a degree and are usually developed according to
vant content of a research proposal is discussed later in guidelines outlined by the faculty. The faculty member
this chapter and varies based on the purpose of the who will be assisting with the research project (the
proposal. chair of the student’s thesis or dissertation committee)
generally reviews these guidelines with the student.
Identifying Critical Points Each faculty member has a unique way of interpreting
The key or critical points in a proposal must be evident, and emphasizing aspects of the guidelines. In addition,
even to a hasty reader. You might highlight your criti- a student needs to evaluate the faculty member’s back-
cal points with bold or italicized type. Sometimes ground regarding a research topic of interest and deter-
researchers create headings to emphasize critical mine whether a productive working relationship can
content, or they may organize the content into tables be developed. Faculty members who are actively
or graphs. It is critical in a proposal to detail the back- involved in their own research have extensive knowl-
ground and significance of the research problem and edge and expertise that can be helpful to a novice
purpose, study methodology, and research production researcher. Both the student and the faculty member
plans (data collection and analysis plan, personnel, benefit when a student becomes involved in an aspect
schedule, and budget) (APA, 2010; Offredy & Vickers, of the faculty member’s research. This collaborative
2010; Turabian et al., 2007). relationship can lead to the development of essential
knowledge for providing evidenced-based nursing
Developing an Esthetically Appealing Copy practice (Brown, 2009; Craig & Smyth, 2012; Melnyk
An esthetically appealing copy is typed without spell- & Fineout-Overholt, 2011).
ing, punctuation, or grammatical errors. A proposal The content of a student proposal usually requires
with excellent content that is poorly typed or formatted greater detail than a proposal developed for an agency
is not likely to receive the full attention or respect of or funding organization. The proposal is often the first
the reviewers. The format used in typing the proposal three or four chapters of the student’s thesis or dis-
should follow the guidelines developed by the review- sertation, and the proposed study is discussed in the
ers or organization. If no particular format is requested, future tense—that is, what the student will do in
researchers commonly follow APA (2010) format. An conducting the research. A student research proposal
CHAPTER 28  Writing Research Proposals 637

TABLE 28-1  Quantitative Research Proposal Guidelines for Students


Chapter I Introduction
A. Background and significance of the problem
B. Statement of the problem
C. Statement of the purpose
Chapter II Review of Relevant Literature
A. Review of theoretical literature
B. Review of relevant research
C. Summary
Chapter III Framework
A. Development of a framework
(Develop a map of the study framework, define concepts in the map, describe relationships or propositions in
the map, indicate the focus of the study, and link concepts to study variables)
B. Formulation of objectives, questions, or hypotheses
C. Definitions (conceptual and operational) of study variables
D. Definition of relevant terms
Chapter IV Methods and Procedures
A. Description of the research design
(Model of the design, strengths and weaknesses of the design validity)
B. Identification of the population and sample
(Sample size, use of power analysis, sample criteria, and sampling method including strengths and weaknesses)
C. Selection of a setting
(Strengths and weaknesses of the setting)
D. Presentation of ethical considerations
(Protection of subjects’ rights and university and healthcare agency review processes)
E. Description of the intervention if appropriate for the type of study
(Provide a protocol for implementing the intervention, detail who will implement the intervention, and describe
how intervention fidelity is ensured)
F. Selection of measurement methods
(Reliability, validity, scoring, and level of measurement of the instruments as well as plans for examining
reliability and validity of the instruments in the present study; precision and accuracy of physiological
measures)
G. Plan for data collection
(Data collection process, training of data collectors if appropriate, schedule, data collection forms, and
management of data)
H. Plan for data analysis
(Analysis of demographic data; analyses for research objectives, questions, or hypotheses; level of significance
if appropriate; and other analysis techniques)
I. Identification of limitations
(Methodological and theoretical limitations)
J. Discussion of communication of findings
References Include references cited in the proposal and follow APA (2010) format
Appendices Presentation of a study budget and timetable

usually includes a title page with the title of the pro- or sections: (1) introduction, (2) review of relevant
posal, the name and credentials of the investigator, literature, (3) framework, and (4) methods and pro­
university name, and the date. You need to devote time cedures. Some graduate schools require in-depth
to developing the title so that it accurately reflects the development of these sections, whereas others require
scope and content of the proposed study (Martin & a condensed version of the same content. Another
Fleming, 2010). approach is that proposals for theses and dissertations
be written in a format that can be transformed into a
Content of a Quantitative Research Proposal publication. Table 28-1 outlines the content often
A quantitative research proposal usually includes a covered in the chapters of a student quantitative
table of contents that reflects the following chapters research proposal.
638 UNIT FIVE  Proposing and Seeking Funding for Research

Introduction to contribute to the nursing knowledge needed for


The introductory chapter identifies the research topic evidence-based practice.
and problem and discusses their significance and
background. The significance of the problem addresses Framework
its importance in nursing practice and the expected A framework provides the basis for generating and
generalizability of the findings. The magnitude of a refining the research problem and purpose and linking
problem is partly determined by the interest of nurses; them to the relevant theoretical knowledge in nursing
other healthcare professionals; policy makers; and or related fields. The framework includes concepts and
healthcare consumers at the local, state, national, or relationships among concepts or propositions, which
international level. You can document this interest are sometimes represented in a model or a map (see
with sources from the literature. The background Chapter 7). Middle-range theories from nursing and
describes how the problem was identified and histori- other disciplines are frequently used as frameworks
cally links the problem to nursing practice. Your back- for quantitative studies, and the proposition or propo-
ground information might also include one or two sitions to be tested from the theory need to be identi-
major studies conducted to resolve the problem, some fied (Smith & Liehr, 2008). The framework needs to
key theoretical ideas related to the problem, and pos- include the concepts to be examined in the study, their
sible solutions to the problem. The background and definitions, and their link to the study variables (see
significance form the basis for your problem state- Table 28-1). If you use another theorist’s or research-
ment, which identifies what is not known and the need er’s model from a journal article or book, letters docu-
for further research. Follow your problem statement menting permission to use this model from the
with a succinct statement of the research purpose or publisher and the theorist or researcher need to be
the goal of the study (see Chapter 5) (Martin & included in your proposal appendices.
Fleming, 2010; Merrill, 2011). In some studies, research objectives, questions, or
hypotheses are developed to direct the study (see
Review of Relevant Literature Chapter 8). The objectives, questions, or hypotheses
The review of relevant literature provides an over- evolve from the research purpose and study frame-
view of the essential information that will guide you work, in particular the proposition to be tested, and
as you develop your study and includes relevant the- identify the study variables. The variables are concep-
oretical and empirical literature (see Table 28-1). tually defined to show the link to the framework, and
Theoretical literature provides a background for they are operationally defined to describe the proce-
defining and interrelating relevant study concepts, dures for manipulating or measuring the study vari-
whereas empirical literature includes a summary and ables. You also will need to define any relevant terms
critical appraisal of previous studies. Here you will and to identify assumptions that provide a basis for
discuss the recommendations made by other research- your study.
ers, such as changing or expanding a study, in rela-
tion to the proposed study. The depth of the literature Methods and Procedures
review varies; it might include only recent studies The researcher describes the design or general strategy
and theorists’ works, or it might be extensive and for conducting the study, sometimes including a
include a description and critical appraisal of many diagram of the design (see Chapter 11). Designs for
past and current studies and an in-depth discussion of descriptive and correlational studies are flexible and
theorists’ works. The literature review might be pre- can be unique to the study being conducted (Kerlinger
sented in a narrative format or in a pinch table that & Lee, 2000). Because of this uniqueness, the descrip-
summarizes relevant studies (see Chapter 6) (Pinch, tions need to include the design’s strengths and weak-
1995). The literature review shows that you have a nesses. Presenting designs for quasi-experimental and
command of the current empirical and theoretical experimental studies involves (1) describing how the
knowledge regarding the proposed problem (Merrill, research situation will be structured; (2) detailing the
2011; Offredy & Vickers, 2010). treatment to be implemented (Chlan, Guttormson, &
This chapter concludes with a summary. The Savik, 2011); (3) explaining how the effect of the
summary includes a synthesis of the theoretical litera- treatment will be measured; (4) specifying the vari-
ture and findings from previous research that describe ables to be controlled and the methods for controlling
the current knowledge of a problem (Merrill, 2011). them; (5) identifying uncontrolled extraneous vari-
Gaps in the knowledge base are also identified, with ables and determining their impact on the findings; (6)
a description of how the proposed study is expected describing the methods for assigning subjects to
CHAPTER 28  Writing Research Proposals 639

the treatment group, comparison or control group, or of the proposal. With the implementation of the Health
placebo group; and (7) exploring the strengths and Insurance Portability and Accountability Act (HIPAA),
weaknesses of the design (Shadish, Cook, & Camp- healthcare agencies and providers must have a signed
bell, 2002). The design needs to account for all the authorization form from patients to release their health
objectives, questions, or hypotheses identified in the information for research. You must also address the
proposal. If a pilot study is planned, the design should risks and potential benefits of the study for the institu-
include the procedure for conducting the pilot and for tion (Martin & Fleming, 2010; Offredy & Vickers,
incorporating the results into the proposed study (see 2010). If your study places the agency at risk, outline
Table 28-1). the steps you will take to reduce or eliminate these
Your proposal should identify the target popula- risks. It is also necessary for you to state that the pro-
tion to which your study findings will be generalized posal will be reviewed by the thesis or dissertation
and the accessible population from which the sample committee, university IRB, and agency IRB.
will be selected. You need to outline the inclusion and Some quantitative studies are focused on testing the
exclusion criteria you will use to select a study par- effectiveness of an intervention, such as quasi-
ticipant or subject and present the rationale for these experimental studies or randomized controlled trials.
sample criteria. For example, a participant might be In these types of studies, the elements of the interven-
selected according to the following sample criteria: tion and the process for implementing the intervention
female, age 18 to 60 years, hospitalized, and 1 day must be detailed (Bulecheck, Butcher, & Dochterman,
status post abdominal surgery. The rationale for these 2008). You need to develop a protocol that details the
criteria might be that the researcher wants to examine elements of the intervention and the process for imple-
the effects of a selected pain management interven- menting them (see Chapter 14 and the example quasi-
tion on women who have recently undergone hospi- experimental study proposal at the end of this chapter).
talization and abdominal surgery. The sampling Intervention fidelity needs to be ensured during a
method and the approximate sample size are dis- study so that the intervention is consistently imple-
cussed in terms of their adequacy and limitations in mented to designated study participants (Chlan et al.,
investigating the research purpose (Thompson, 2002). 2011; Santacroce, Maccarelli, & Grey, 2004).
A power analysis usually is conducted to determine Describe the methods you will use to measure
an adequate sample size to identify significant rela- study variables, including each instrument’s reliabil-
tionships and differences in studies (see Chapter 15) ity, validity, methods of scoring, and level of measure-
(Aberson, 2010). ment (see Chapter 16). A plan for examining the
A proposal includes a description of the proposed reliability and validity of the instruments in the present
study setting, which frequently includes the name of study needs to be addressed. If an instrument has no
the agency and the structure of the units or sites where reported reliability and validity, you may need to
the study is to be conducted. The specific setting is conduct a pilot study to examine these qualities. If the
often identified in the proposal but not in the final intent of the proposed study is to develop an instru-
research report. The agency you select should have the ment, describe the process of instrument development
potential to generate the type and size of sample (Waltz, Strickland, & Lenz, 2010). If physiological
required for the study. Your proposal might include the measures are used, address the accuracy, precision,
number of individuals who meet the sample criteria sensitivity, selectivity, and error rate of the instrument
and are cared for by the agency in a given time period. (Ryan-Wenger, 2010). A copy of the interview ques-
In addition, the structure and activities in the agency tions, questionnaires, scales, physiological measures,
need to be able to accommodate the proposed design or other tools to be used in the study is usually included
of the study. If you are not affiliated with this agency, in the proposal appendices (see Chapter 17). You must
it would be helpful if you had a letter of support for obtain permission from the authors to use copyrighted
your study from the agency. instruments, and letters documenting that permission
Ethical considerations in a proposal include the has been obtained must be included in the proposal
rights of the subjects and the rights of the agency appendices.
where the study is to be conducted. Describe how you The data collection plan clarifies what data are to
plan to protect subjects’ rights as well as the risks and be collected and the process for collecting the data. In
potential benefits of your study. Also, address the steps this plan you will identify the data collectors, describe
you will take to reduce any risks that the study might the data collection procedures, and present a schedule
present. Many agencies require a written consent for data collection activities. If more than one person
form, and that form is often included in the appendices will be involved in data collection, it is important to
640 UNIT FIVE  Proposing and Seeking Funding for Research

describe methods used to train your data collectors to equipment; consultants for data analysis; computer
ensure consistency. The method of recording data is time; travel related to data collection and analysis;
often described, and sample data recording sheets are typing; copying; and developing, presenting, and pub-
placed in the proposal appendices. Also, discuss any lishing the final report. Study budgets requesting
special equipment you will use or develop to collect external funding for researchers’ time include investi-
data for the study, and address data security, including gators’ salaries and secretarial costs. You need a time-
the methods of data storage (see Chapter 20). table to direct the steps of your research project and
The plan for data analysis identifies the analysis increase the chance that you will complete the project
techniques that will be used to summarize the demo- on schedule. A timetable identifies the tasks to be
graphic data and answer the research objectives, done, who will accomplish these tasks, and when these
questions, or hypotheses. The analysis section is best tasks will be completed. An example proposal for a
organized by the study objectives, questions, or quasi-experimental study is presented at the end of this
hypotheses. The analysis techniques identified need to chapter to guide you in developing your study
be appropriate for the type of data collected (Grove, proposal.
2007). For example, if an associative hypothesis
is developed, correlational analysis is planned. If a Content of a Qualitative Research Proposal
researcher plans to determine differences among Qualitative research proposal guidelines are unique
groups, the analysis techniques might include a t-test for the development of knowledge and theories using
or analysis of variance (ANOVA) (Munro, 2005). A various qualitative research methods. A qualitative
level of significance (α = 0.05, 0.01, or 0.001) is also proposal usually includes the following content areas:
identified (see Chapters 21 through 25). Often, a (1) introduction; (2) research philosophy and general
researcher projects the type of results that will be gen- method; (3) applied method of inquiry; and (4) current
erated from data analysis. Dummy tables, graphs, and knowledge, limitations, and plans for communication
charts can be developed to present these results and are of the study findings (Marshall & Rossman, 2011;
included in the proposal appendices if required by the Munhall, 2012; Patton, 2002; Sandelowski, Davis, &
guidelines. The researcher might project possible find- Harris, 1989). Guidelines are presented in Table 28-2
ings for a study and indicate what support or nonsup- to assist you in developing a qualitative research
port of a proposed hypothesis would mean in light of proposal.
the study framework and previous research findings.
The methods and procedures chapter of a pro- Introduction
posal usually concludes with a discussion of the The introduction usually provides a general back-
study’s limitations and a plan for communication of ground for the proposed study by identifying the phe-
the findings. Both methodological and theoretical nomenon, clinical problem, issue, or situation to be
limitations are addressed. Methodological limitations investigated and linking it to nursing knowledge. The
might include areas of weakness in the design, sam- general aim or purpose of the study is identified and
pling method, sample size, measurement tools, data provides the focus for the qualitative study to be con-
collection procedures, or data analysis techniques; ducted. The study purpose might be followed by
theoretical limitations set boundaries for the general- research questions that direct the investigation
ization of study findings. The accuracy with which (Munhall, 2012; Offredy & Vickers, 2010). For
the conceptual definitions and relational statements example, a possible aim or purpose for an ethno-
in a theory reflect reality has a direct impact on the graphic study might be to “describe the coping pro-
generalization of study findings. Theory that has cesses of Mexican American adults with type 2
withstood frequent testing through research provides diabetes receiving care in a federally funded clinic.”
a stronger framework for the interpretation and gen- The research questions might focus on the influences
eralization of findings. A plan is included for com- of real-world problems, cultural elements, and the
municating the research through presentations to clinic environment on the coping processes of these
audiences of nurses, other health professionals, adults. Thus, the study questions might include any
policy makers, and healthcare consumers and publi- of the following: How do Mexican American adults
cation (see Chapter 27). respond to a new diagnosis of type 2 diabetes? What
A budget and timetable are frequently included in is the impact of type 2 diabetes on Mexican American
the proposal appendices. The budget projects the adults and their families over time? What community,
expenses for the study, which might include the cost clinic, and family types of support exist for Mexican
for data collection tools and procedures; special American adults with type 2 diabetes? What does it
CHAPTER 28  Writing Research Proposals 641

TABLE 28-2  Qualitative Research Proposal Guidelines for Students


Chapter I Introduction
A. Identify the phenomenon to be studied
B. Identify the study purpose or aim and its significance
C. State the study questions or objectives
D. Describe the evolution of the study
  1. Provide a rationale for conducting study
  2. Place the study in context historically
  3. Discuss the researcher’s experience with phenomenon
  4. Discuss the relevance of the study to nursing
Chapter II Philosophical and Conceptual Foundation and General Method for the Proposed Study
A. Identify the type of qualitative research (phenomenological research, grounded theory research, ethnographic
research, exploratory-descriptive qualitative research, and historical research) to be conducted
B. Describe the philosophical and theoretical basis for the research method
C. Explain the research assumptions
D. Discuss the general steps, procedures, and outcomes for this method
E. Translation of concepts or terms
Chapter III Method of Inquiry
A. Demonstrate the researcher’s credentials for conducting this qualitative study
B. Select a site and population
C. Describe the plan for the researcher’s role in the following
  1. Entry into the site and approval to collect data
  2. Selection of study participants
  3. Ethical considerations
D. Describe the plan for data collection
  1. Data to be collected
  2. Procedures for data collection
  3. Procedures for recording data during data collection
E. Describe the plan for data analysis conducted with data collection
  1. Steps for coding information
  2. Use of specific data analysis procedures advanced in the specific research method (phenomenology research,
grounded theory research, ethnography research, exploratory-descriptive qualitative research, and historical
research)
  3. Steps to be taken to verify the information
Chapter IV Current Knowledge, Limitations, and Plans for Communication of the Study
A. Summarize and reference relevant literature as appropriate for the type of qualitative study
B. Disclose anticipated findings, hypotheses, and hunches
C. Discuss procedures to remain open to unexpected information
D. Discuss limitations of the study
E. Identify plans for communication of findings (Marshall & Rossman, 2011; Munhall, 2012)
References Include references cited in the proposal and follow APA (2010) format
Appendices Present the study budget and timetable

mean to Mexican American adults to have their dia- the study purpose needs to be documented from the
betes under control? literature (Munhall, 2012). The significance of a
The introduction also includes the evolution of the study may include the number of people affected,
study and its significance to nursing practice, patients, how this phenomenon affects health and quality of
the healthcare system, and health policy. The discus- life, and the consequences of not understanding this
sion of the evolution of the study often includes how phenomenon. Marshall and Rossman (2011) identi-
the problem developed (historical context), who or fied the following questions to assess the significance
what is affected by the problem, and the researcher’s of a study: (1) Who has an interest in this domain of
experience with the problem (experiential context). inquiry? (2) What do we already know about the
Whenever possible, the significance and evolution of topic? (3) What has not been answered adequately in
642 UNIT FIVE  Proposing and Seeking Funding for Research

previous research and practice? (4) How will this relationship with an experienced qualitative researcher.
research add to knowledge, practice, and policy in The role of the researcher and the intricate techniques
this area? The introduction section concludes with an of data collection and analysis are thought to be best
overview of the remaining sections that are covered communicated through a one-to-one relationship.
in the proposal. Thus, planning the methods of a qualitative study
requires knowledge of relevant sources that describe
Philosophical and Conceptual Foundation and the different qualitative research techniques and proce-
General Methods for the Proposed Study dures (Marshall & Rossman, 2011; Miles & Huberman,
This section introduces the philosophical and concep- 1994; Munhall, 2012; Patton, 2002), in addition to
tual foundation for the qualitative research method requiring interaction with a qualitative researcher.
(phenomenological research, ethnographic research, The proposal needs to reflect the researcher’s
grounded theory research, exploratory-descriptive credentials for conducting the particular type of quali-
qualitative research, or historical research) selected tative study proposed (see Chapter 12 for details on
for the proposed study. The researcher provides a qualitative research methods).
rationale for the qualitative method selected and dis- Identifying the methods for conducting a qualita-
cusses its ability to generate the knowledge needed in tive study is a difficult task because sometimes the
nursing (see Table 28-1). The investigator introduces specifics of the study design emerge during the study.
the philosophy, essential elements of the philosophy, In contrast to quantitative research, in which the
and the assumptions for the specific type of qualitative design is a fixed blueprint for a study, the design in
research to be conducted. qualitative research emerges or evolves as the study is
The philosophy varies for the different types of conducted. You must document the logic and appro-
qualitative research and guides the conduct of the priateness of the qualitative method and develop a
study. For example, a proposal for a phenomenologi- tentative plan for conducting your study. Because this
cal study might indicate the purpose of the study is to plan is tentative, researchers reserve the right to
understand the experience of young and middle-aged modify or change the plan as needed during the
women receiving news about a family BRCA 1/2 conduct of the study (Sandelowski et al., 1989). How­
genetic mutation. “The specific study aims are to (a) ever, the design or plan must be (1) consistent with
describe the experiences of women learning about a the philosophical approach, study purpose, and spe-
family BRCA 1/2 mutation, (b) describe the meaning cific research aims or questions; (2) be well conceived;
of genetic risk to female biologic relatives of BRCA and (3) address prior criticism, as appropriate (Fawcett
1/2 mutation carriers, and (3) gain an understanding & Garity, 2009). The tentative plan describes the
of practical knowledge used in living with risk” process for selecting a site and population and the
(Crotser & Dickerson, 2010, p. 367). Genetic testing initial steps taken to gain access to the site. Having
has determined that 5% to 10% of breast cancers are access to the site includes establishing relationships
caused by inherited gene mutations such as BRCA 1 that facilitate recruitment of the participants necessary
or BRCA 2. “Heideggerian hermeneutic phenomenol- to address the research purpose and answer the
ogy was selected to guide this study.… By listening research questions. For the research question, “How
to the stories of women who lived the experience, do Mexican American adults cope with a new diagno-
HCPs [healthcare providers] will understand the sis of type 2 diabetes while receiving care in federally
meaning of living with risk through the language used funded clinics?” the participants might be identified in
to express their life view (Heidegger, 1975)” (Crotser a specific clinic or by contacting particular healthcare
& Dickerson, 2010, p. 358). Assumptions about the providers. Although initial contact might be made
nature of the knowledge and the reality that underlie through a clinic, the interviews and observations
the type of qualitative research to be conducted are might occur in the community, at family gatherings,
also identified. The assumptions and philosophy or in the participants’ homes.
provide a theoretical perspective for the study that The researcher must gain entry into the setting,
influences the focus of the study, data collection and develop a rapport with the participants that will facili-
analysis, and articulation of the findings. tate the detailed data collection process, and protect
the rights of the participants (Marshall & Rossman,
Method of Inquiry 2011; Sandelowski et al., 1989). You need to address
Developing and implementing the methodology of the following questions in describing the researcher’s
qualitative research require an expertise that some role: (1) What is the best setting for the study? (2)
believe can be obtained only through a mentorship How will I ease my entry into the research site? (3)
CHAPTER 28  Writing Research Proposals 643

How will I gain access to the participants? (4) What determine meaning (see Chapter 12) (Patton, 2002).
actions will I take to encourage the participants to Researchers also need to identify software programs
cooperate? (5) What precautions will I take to protect they plan to use for data analysis.
the rights of the participants and to prevent the setting
and the participants from being harmed? You need to Current Knowledge Base, Limitations, and
describe the process you will follow to obtain informed Plans for Communication of the Study
consent and the actions you will take to decrease study This section of the proposal summarizes and docu-
risks. The sensitive nature of some qualitative studies ments all relevant literature that was reviewed for the
increases the risk for participants, which makes ethical study. Similar to quantitative research, qualitative
concerns and decisions a major focus of the proposal studies require a literature review to provide a basis
(Munhall, 2012; Patton, 2002). for the study purpose and to clarify how this study will
The primary data collection techniques used expand nursing knowledge (Marshall & Rossman,
in qualitative research are observation and in-depth 2011; Munhall, 2012). This initial literature review is
interviewing. Observations can range from highly often conducted to establish the significance of the
detailed, structured notations of behaviors to ambigu- study and to develop research questions to guide the
ous descriptions of behaviors or events. The interview study. In phenomenological and grounded theory
can range from structured, closed-ended questions research, an additional literature review is usually con-
to unstructured, open-ended questions (Marshall & ducted toward the end of the research project. The
Rossman, 2011; Munhall, 2012). You need to address findings from a phenomenological study are compared
the following questions when describing the proposed and combined with findings from the literature to con-
data collection process: (1) What data will be col- tribute to the current knowledge of the phenomenon.
lected? For example, will the data be field notes from In grounded theory research, the literature is used to
memory, audio recordings of interviews, transcripts of explain, support, and extend the theory generated in
conversations, DVDs of events, or examination of the study (Glaser & Strauss, 1965). In all types of
existing documents? (2) What techniques or proce- qualitative studies, the findings obtained are examined
dures will the research team use to collect the data? in light of the existing literature (see Chapter 4).
For example, if interviews are to be conducted, will a You need to describe how the literature reviewed
list of the proposed questions be included in the has influenced your proposed research methods.
appendix? (3) Who will collect data and provide any Biases and previous experience with the research
training required for the data collectors? (4) Where problem need to be addressed, as does their potential
will sources of data be located? In historical research, impact on the proposed study. Often, anticipated find-
data are collected through an exhaustive review of ings, hypotheses, and hunches are identified before the
published and unpublished literature. (5) How will the study is conducted, followed by a discussion of the
data be recorded and stored? procedures that might be used to remain open to new
The methods section also needs to address how you information. You will also need to address the limita-
will document the research process. For example, you tions of your proposed study in the context of limita-
might keep a research journal or diary during the tions of similar studies.
course of the study. These notes can document the Conclude your proposal by describing how you
day-to-day activities, methodological events, decision- plan to communicate your findings to various audi-
making procedures, and personal notes about the ences through presentations and publications. Often, a
informants. This information becomes part of the audit realistic budget and timetable are provided in the
trail that you can provide to ensure the quality of the appendix. A qualitative study budget is similar to a
study (Miles & Huberman, 1994; Munhall, 2012; quantitative study budget and includes costs for data
Patton, 2002). collection tools, software, and recording devices; con-
The methods section of the proposal also includes sultants for data analysis; travel related to data collec-
the analysis techniques and the steps for conducting tion and analysis; transcription of recordings; copying
these techniques. In qualitative research, data collec- related to data collection and analysis; and developing,
tion and analysis often occur simultaneously. The data presenting, and publishing the final report. However,
are usually in the form of notes, digital files, audio one of the greatest expenditures in qualitative research
recordings, DVDs, and other material obtained from is the researcher’s time. Develop a timetable to project
observation, interviews, and completing question- how long the study will take; often a period of 2 years
naires. Through qualitative analysis techniques, these or more is designated for data collection and analysis
data are organized to promote understanding and (Marshall & Rossman, 2011; Munhall, 2012; Patton,
644 UNIT FIVE  Proposing and Seeking Funding for Research

2002). You can use your budget and timetable to make frequently includes a brief description of the study, the
decisions regarding the need for funding. significance of the study to the institution, a timetable,
Excellent websites have been developed to assist and a budget. Most of these proposals are brief and
novice researchers in identifying an idea for quali­ might contain a 1-page summary sheet or abstract at
tative study and developing a qualitative research the beginning of the proposal that summarizes the
proposal and reports (see www.nova.edu/ssss/QR/ steps of the study. The salient points of the study are
qualres.html). The Office of Behavior and Social Sci- included on this page in easy-to-read, nontechnical
ences Research within the National Institutes of Health terminology. Some proposal reviewers for funding
has a website to assist researchers in developing quali- institutions are laypersons with no background in
tative and quantitative research proposals for funding research or nursing. An inability to understand the
(http://grants.nih.gov/grants/writing_application terminology might put the reviewer on the defensive
.htm). You can use these websites and other publica- or create a negative reaction, which could lead to
tions to promote the quality of your qualitative research disapproval of the study. When a funding institution
proposal. The quality of a proposal is based on the is examining multiple studies, the summary sheet is
potential scientific contribution of the research to often the basis for final decisions. The summary
nursing knowledge; the research philosophy guiding should be concise, informative, and designed to sell
the study; the research methods; and the knowledge, the study.
skills, and resources available to the investigators In proposals for both clinical and funding agencies,
(Marshall & Rossman, 2011; Munhall, 2012; Patton, the investigator needs to document his or her research
2002). background and supply a curriculum vitae if requested.
The research review committee for approval of funding
Content of a Condensed Proposal will be interested in previous research, research pub-
The content of proposals developed for review by lications, and clinical expertise, especially if a clinical
clinical agencies and funding institutions is usually a study is proposed. If you are a graduate student, the
condensed version of the student proposal. However, committee may request the names of the university
even though these proposals are condensed, the logical committee members and verification that your pro-
links between components of the study need to be posal has been approved by the student’s thesis or
clearly shown. A condensed proposal often includes dissertation committee and the university IRB. Chapter
a statement of the problem and purpose; previous 29 provides details on proposals submitted for funding.
research that has been conducted in the area (usually
limited to three to five studies); the framework, vari- Content of a Preproposal
ables, design, sample, ethical considerations, and Sometimes a researcher sends a preproposal or query
plans for data collection and analysis; and plans for letter rather than a proposal to a funding institution. A
dissemination of findings. preproposal is a short document of 4 to 5 pages plus
A proposal submitted to a clinical agency needs to appendices that explores the funding possibilities for
identify the specific setting clearly, such as the emer- a research project. The parts of the preproposal are
gency department or intensive care unit, and the pro- logically ordered as follows: “(1) letter of transmittal,
jected time span for the study. Members of clinical (2) proposal for research, (3) personnel, (4) facilities,
agencies are particularly interested in the data collec- and (5) budget” (Malasanos, 1976, p. 223). The pro-
tion process and involvement of institutional person- posal provides a brief overview of the proposed
nel in the study. The researcher needs to identify any project, including the research problem, purpose, and
expected disruptions in institutional functioning, with methodology (brief description), and, most important,
plans for preventing these disruptions when possible. a statement of the significance of the work to knowl-
The researcher must recognize that anything that edge in general and the funding institution in particu-
slows down or disrupts employee functioning costs lar. By developing a preproposal, researchers are able
the agency money and can interfere with the quality to determine the agencies interested in funding their
of patient care. By showing that you are aware of these study and limit submission of their proposals to only
concerns and have proposed ways to minimize their institutions that indicate an interest.
effects, you increase the probability of obtaining
approval to conduct your study.
Various companies, corporations, and organiza- Seeking Approval for a Study
tions provide funding for research projects. A proposal Seeking approval to conduct a study is an action that
developed for these types of funding institutions should be based on knowledge and guided by purpose.
CHAPTER 28  Writing Research Proposals 645

Obtaining approval for a study from a research review of that committee generally being accepted by the
committee or IRB requires understanding the approval other committees. For example, if the university IRB
process, writing a research proposal for review, and, examined and approved a proposal for the protection
in many cases, verbally defending the proposal. Little of human subjects, funding agencies usually recognize
has been written to guide the researcher who is going that review as sufficient. Reviews in other committees
through the labyrinth of approval mechanisms. This focus on approval to conduct the study within the
section provides a background for obtaining approval institution or decisions to provide study funding.
to conduct a study. As part of the approval process, the researcher must
Clinical agencies and healthcare corporations determine the agency’s policy regarding (1) the use of
review studies for the following reasons: (1) to evalu- the name of the clinical facility in reporting findings,
ate the quality of the study, (2) to ensure that adequate (2) the presentation and publication of the study, and
measures are being taken to protect human subjects, (3) the authorship of publications. The facility’s name
and (3) to evaluate the impact of the study on the is used when presenting or publishing a study only
reviewing institution (Merrill, 2011; Offredy & with prior written administrative approval. The
Vickers, 2010). What does the researcher hope to researcher may feel freer to report findings that could
result from this institutional review? Most researchers be interpreted negatively in terms of the institution if
hope to receive approval to collect data at the review- the agency is not identified. Some institutions have
ing institution and to obtain support for the proposed rules that limit what is presented or published in a
study. IRB reviews sometime identify potential risks study, where it is presented or published, and who is
or problems related to studies that can be resolved the presenter or author. Before conducting a study,
before the studies are implemented. researchers, especially employees of healthcare agen-
cies, must clarify the rules and regulations of the
Approval Process agency regarding authorship, presentations, and pub-
An initial step in seeking approval is to determine lications. In some cases, recognition of these rules
exactly what committees in which agencies must grant must be included in the proposal if it is to be approved.
approval before the study can be conducted. You need
to take the initiative to determine the formal approval Preparing Proposals for Review Committees
process rather than assume that you will be told if a The initial proposals for theses and dissertations are
formal review system exists. Information on the often developed as part of a formal class. The faculty
formal research review system might be obtained from members teaching the class provide students with spe-
administrative personnel, an online website, special cific proposal guidelines approved by the graduate
projects or grant officers, chairs of IRBs in clinical faculty and assist them in developing their initial pro-
agencies, clinicians who have previously conducted posals. If students elect to conduct a thesis, they ask
research, university IRB chairs, and university faculty an appropriate faculty member to serve as chair. With
who are involved in research. the assistance of the chair, the student identifies com-
Graduate students usually require approval from mittee members with expertise in the focus of the
their thesis or dissertation committee, the university proposed study or in conducting research who can
IRB, and the agency IRB where the data are to be work effectively together to refine the final proposal.
collected. University faculty members conducting The number of committee members varies for theses
research seek approval for the studies from the univer- (usually a chair and two members) and dissertations
sity IRB and the agency IRB. Nurses conducting (often a chair and four members) and with the univer-
research in an agency where they are employed must sity requirements. This proposal requires approval
seek approval only at that agency. If the researcher by the thesis or dissertation committee and the univer-
seeks outside funding, additional review committees sity IRB.
are involved. Not all studies require full review by the Conducting research in a clinical agency requires
IRB (see Chapter 9 for the types of studies that qualify approval by the agency IRB. This committee has the
for exempt or expedited review). However, the IRB, responsibility to (1) provide researchers with copies
not the researcher, determines the type of review that of institutional policies and requirements, (2) screen
the study requires for conduct in that agency. proposals for conducting research in the agency, and
When multiple committees must review a study, (3) assist the researcher with the IRB process. The
sometimes the respective committees agree that the approval process policy and proposal guidelines are
review for the protection of human subjects will be usually available from the chair of the IRB; and the
done by only one of the committees, with the findings guidelines should be followed carefully, particularly
646 UNIT FIVE  Proposing and Seeking Funding for Research

page limitations. Some committees refuse to review proposal to elicit a favorable response. It is wise to
proposals that exceed these limitations. Reviewers on meet with the chair of the agency IRB early in the
these committees are usually evaluating proposals in development of a proposal. This meeting could facili-
addition to other full-time responsibilities, and their tate proposal development, rapport between the
time is limited. researcher and agency personnel, and approval of the
Investigators also need to be familiar with the research proposal.
IRB’s process for screening proposals. Most agency In addition to the formal committee approval mech-
IRBs screen proposals for (1) scientific merit, (2) pro- anisms, you will need the tacit approval of the admin-
tection of human rights, (3) congruence of the study istrative personnel and staff who are affected by the
with the agency’s research agenda, and (4) impact of conduct of your study. Obtaining informal approval
the study on patient care (Merrill, 2011). Researchers and support often depends on the way in which a
need to develop their proposal with these ideas in person is approached. Demonstrate interest in the
mind. They also need to determine whether the com- institution and the personnel as well as interest in the
mittee requires specific forms to be completed and research project. The relationships formed with agency
submitted with the research proposal. Other important personnel should be equal, sharing ones because these
information can be gathered by addressing the follow- people can often provide ideas and strategies for con-
ing questions: (1) How often does the committee ducting the study that you may not have considered.
meet? (2) How long before the next meeting? (3) What The support of agency personnel during data collec-
materials should be submitted before the meeting? tion can also make the difference between a successful
(4) When should these materials be submitted? and an unsuccessful study (Merrill, 2011).
(5) How many copies of the proposal are required? Conducting nursing research can benefit the institu-
(6) What period of time is usually involved in com- tion as well as the researcher. Clinicians have an
mittee review? opportunity to see nursing research in action, which
can influence their thinking and clinical practice if the
Social and Political Factors relationship with the researcher is positive. These cli-
Social and political factors play an important role in nicians may be having their first close contact with a
obtaining approval to conduct a study. You need to researcher, and interpretation of the researcher’s role
treat the review process with as much care as devel- and the aspects of the study may be necessary. In addi-
opment of the study. The dynamics of the relation- tion, clinicians tend to be more oriented in the present
ships among committee members is important to than researchers are, and they need to see the immedi-
assess. This detail is especially important in the ate impact that the study findings can have on nursing
selection of a thesis or dissertation committee to practice in their institution. Interactions with research-
ensure that the members are willing to work together ers might help clinicians see the importance of research
productively. Thorough assessment of the social and in providing evidence-based practice and encourage
political situation in which the study will be reviewed them to become involved in study activities in the
and implemented may be crucial to success of future (Offredy & Vickers, 2010). Conducting research
the study. and providing evidence-based practice are essential if
Clinical agency IRBs may include nurse clinicians a hospital is to achieve and maintain Magnet status.
who have never conducted research, nurse research- The award of Magnet status from the American Nurses
ers, and researchers in other disciplines. The reactions Credentialing Center (ANCC, 2012) is prestigious to
of each of these groups to a study could be very dif- an institution and validates the excellence in evidence-
ferent. Sometimes IRB committees are made up pri- based nursing care provided by the facility.
marily of physicians, which is frequently the case in
health science centers. Physicians are often not ori- Verbal Presentation of a Proposal
ented to nursing research methods and might need Graduate students writing theses or dissertations are
additional explanations related to the research meth- frequently required to present their proposals verbally
odology. However, most physicians are strong sup- to university committee members, which are called
porters of nursing research, helpful in suggesting thesis or dissertation proposal defenses. Most clinical
changes in design to strengthen the study, and eager agencies require researchers to meet with the IRB to
to facilitate access to subjects. discuss their proposals. In a verbal presentation of a
The researcher needs to anticipate potential proposal, reviewers can evaluate the researcher as a
responses of committee members and prepare the person, the researcher’s knowledge and understanding
CHAPTER 28  Writing Research Proposals 647

of the content of the proposal, and his or her ability to explore with the committee the impact of the changes
reason and provide logical explanations related to the on the proposed study, and try to resolve any conflicts.
study. These face-to-face meetings give the researcher Usually reviewers make valuable suggestions that
the opportunity to encourage committee members to might improve the quality of a study or facilitate the
approve his or her study. data collection process. Revision of the proposal is
Appearance is important in a personal presentation often based on these suggestions before the study is
because it can give an impression of competence or implemented.
incompetence. These presentations are business-like, Sometimes a study requires revision while it is
with logical and rational interactions, so one should being conducted because of problems with data col-
dress in a business-like manner. The committee might lection tools or subjects’ participation. However, if
perceive individuals who are casually dressed as not clinical agency personnel or representatives of funding
valuing the review process. institutions have approved a proposal, the researcher
Nonverbal behaviors are important during the needs to examine the situation seriously before making
meeting as well; appearing calm, in control, and con- major changes in the study. Before revising a proposal,
fident projects a positive image. Plan and rehearse address three questions: (1) What needs to be changed?
your presentation to reduce anxiety. Obtain informa- (2) Why is the change necessary? (3) How will the
tion on the personalities of committee members, their change affect implementation of the study and the
relationships with each other, the vested interests of study findings? Students need to seek advice from
each member, and their areas of expertise because this the faculty before revising their studies. Sometimes it
can increase your confidence and provide a sense of is beneficial for seasoned researchers to discuss their
control. It is important to arrive at the meeting early proposed study changes with other researchers or
to assess the environment for the meeting and select agency personnel for suggestions and additional
a seat carefully. Because you are the presenter, all viewpoints.
members of the committee need to be able to see you. If a revision is necessary, revise your proposal
However, selecting a seat on one side of a table with and discuss the change with members of the IRB in
all the committee members on the other side could the agency where the study is being conducted. The
make you feel uncomfortable and simulate an inter- IRB members might indicate that the investigators
rogation rather than a scholarly interaction. Sitting at can proceed with the study or that the revised pro-
the side of a table rather than at the head might be a posal might need additional review. If a study is
strategic move to elicit support. funded, the study changes must be discussed with the
The verbal presentation of the proposal usually representatives of the funding agency. The funding
begins with a brief overview of the study. Your pre- agency has the power to approve or disapprove the
sentation needs to be carefully planned, timed, and changes. However, realistic changes that are clearly
rehearsed. Salient points should be highlighted, which described and backed with a rationale will probably
you can accomplish with the use of audiovisuals. After be approved.
the presentation, the reviewers will ask questions, so
be prepared to defend or justify the methods and pro-
cedures used in your study. Sometimes it is beneficial Example of a Quantitative
to practice responding to questions related to the study
with a friend; this rehearsal will help you to determine Research Proposal
the best way to defend your ideas without appearing An example proposal of a quasi-experimental study
defensive. When the meeting ends, you need to thank is included to guide you in developing a research
the members of the committee for their time. If the proposal for a thesis, dissertation, or research project
committee did not make a decision regarding the study in your clinical agency. The content of this proposal
during the meeting, ask when the decision will be is brief and does not include the detail normally pre-
made. sented in a thesis or dissertation proposal. However,
the example provides you ideas regarding the content
Revising a Proposal areas that would be covered in developing a proposal
Reviewers sometimes suggest changes in a proposal for a quasi-experimental study. This proposal was
that improve the study methodology; however, some developed by Dr. Kathy Daniel (2011), faculty at
of the changes requested may benefit the institution The University of Texas at Arlington College of
but not the study. Remain receptive to the suggestions, Nursing.
648 UNIT FIVE  Proposing and Seeking Funding for Research

“THE EFFECT OF NURSE PRACTITIONER reimbursed for subsequent hospitalizations. In 2004,


DIRECTED TRANSITIONAL CARE ON premature CHF readmissions cost the Medicare
MEDICATION ADHERENCE AND system an estimated 17.4 billion dollars (Jencks et al.,
READMISSION OUTCOMES OF ELDERLY 2009).
CONGESTIVE HEART FAILURE PATIENTS Prognosis remains poor once CHF is diagnosed. From
the date of index hospitalization, the 30-day mortality
Kathryn Daniel, PhD, RN, ANP-BC, GNP-BC rate is between 10 and 20%. Mortality at one year,
and five years is estimated between 30 to 40% and
60 to 70% respectively. Most individuals will die with
Chapter 1 progressively worsening symptoms while others will
Introduction succumb to fatal arrhythmias (Mosterd & Hoes, 2007;
Solomon et al., 2005). With these high morbidity
Hospitalized patients with chronic health diagnoses such
and mortality rates, individuals with CHF need addi-
as congestive heart failure (CHF), pneumonia, and
tional healthcare in the community to manage their
stroke are often readmitted to acute care hospitals
disease and decrease their rates of premature hospital
within a 30 day interval for potentially preventable eti-
readmission.
ologies. These unnecessary readmissions carry a signifi-
cant cost to Medicare and have been targeted for Chapter 2
non-reimbursement. Hospitals and healthcare systems
Review of Relevant Literature
are eager to implement programs that can safely and
effectively reduce unnecessary readmissions. Their Care for this population is fragmented and uncoordi-
interests are also tempered by the realization that either nated. Systems of care today often are connected to
way, whether by administrative non-reimbursement sites of care, so when patients are discharged from
policy or actual prevention of unnecessary readmissions, acute care settings to home or to other settings and
such admissions will no longer be the source of revenue, back again, there are many opportunities for gaps in
but rather a cost to the organization. Even though some care. Vulnerable complex frail patients with new prob-
readmissions will not be preventable, the burden will lems or questions about management of existing prob-
likely be on the hospital organization to justify payment lems have few knowledgeable resources to help them
(Stauffer et al., 2011). navigate the new landscape of their health. More and
Estimates of the prevalence of heart failure vary. more hospital care is rendered by hospitalist providers
However, older adults, defined as those 65 years of age who do not follow patients after discharge from the
and older, have documented higher rates of CHF, acute care setting, but refer patients back to their out-
6-10%. The trends over the past decade are an older patient providers for care after discharge. Communica-
age at first hospital admission for adults with CHF and tion between inpatient and outpatient silos of care may
an older age at death. This is probably secondary to be absent and is frequently delayed.
technological advances and evidence-based guidelines Medically complex patients who have multiple chronic
for the care of individuals with heart failure. Despite diseases and few socioeconomic resources are the most
these trends, the cost for management of CHF in the vulnerable within this group and most likely
United States (U.S.) accounts for nearly 2% of the total to be readmitted. Silverstein, Qin, Mercer, Fong, and
cost of health care in the country (Mosterd & Hoes, Haydar (2008) found that male African American
2007; Solomon et al., 2005). patients over age 75 with multiple medical comorbidi-
CHF patients have one of the highest readmission ties, admitted for a medicine service admission (not
rates to the hospital within 30 days of any diagnosis. surgical) and who had Medicare only as a payer source
Nationally 25% of patients discharged from the hospi- have the highest risk of readmission. CHF was the
tal after an acute care stay for heart failure, are read- highest single predictor of readmission, but other
mitted to the hospital within 30 days (Jencks, Williams, co-morbidities such as cancer, COPD, or chronic renal
& Coleman, 2009). Reports are as high as 50% of failure were also contributing factors. The period of
those readmitted from the community had no greatest vulnerability for readmission is within the first
follow-up with their primary care provider prior to month after hospitalization and before patients have
readmission. When patients are readmitted to the hos- been seen in the office by their primary care provider
pital within the 30 day period, hospitals may not be (PCP) after hospital discharge.
CHAPTER 28  Writing Research Proposals 649

Adverse drug events are a leading cause of readmis- Chapter 3


sion (Morrissey, McElnay, Scott, & McConnell, 2003).
Framework
Medication reconciliation and adherence are important
in the post discharge situation. Patients and families do The Transitional Care Model provides comprehensive
the best they can to relay their drug information to in-hospital planning and home follow-up for chronically
inpatient providers, but they may forget things or ill, high-risk older adults hospitalized for common
assume the provider knows what they are taking. medical and surgical conditions [see Figure 28-1]. This
Because patients have had an acute change in their model was initially developed by Dorothy Brooten in
health, their medication regimens are often modified the 1980s with a population of high risk pregnant
during their hospital stay. In addition, inpatient medica- women and low birth weight infants (Brooten et al.,
tion choices are influenced by hospital formularies. Even 1987; Brooten et al., 1994). Later Naylor and colleagues
when diligent providers discharge patients with pre- (2004) developed it further in high risk elderly popula-
scriptions for their new or modified medications, these tions focusing on patients with CHF (Brooten et al.,
choices may not be available on the patients’ drug for- 2002; Naylor et al., 2004). Multiple randomized con-
mulary plan. So when they present these prescriptions trolled trials (RCTs) support its effectiveness in reducing
to their local pharmacy after discharge from the hospi- unnecessary readmissions (Naylor et al., 2004; Neff
tal, the new medication may not be available to them et al., 2003; Ornstein, Smith, Foer, Lopez-Cantor, &
or is too costly for them to afford. Inpatient providers Soriano, 2011; Williams, Akroyd, & Burke, 2010; Zhao
may also be unaware of all the medications the patient & Wong, 2009).
already has at home and duplicate drugs or drug classes The goals of care provided by the transitional care
that the patient has on hand (Corbett, Setter, Daratha, model focus on empowering the patient and family
Neumiller, & Wood, 2010). through coordination of care and medical management
Nurse practitioners (NPs) are educated to manage of disease and co-morbidities as needed with the ability
chronic diseases and understand systems of care. Thus, to make changes immediately based on set protocols,
NPs are in a unique position within the healthcare health literacy, self-care management, and collaboration
system to have significant positive effects on patient with other providers and families to prevent unneces-
outcomes, thereby decreasing readmissions, improving sary hospital readmissions. Figure 28-1 illustrates the
patient physical and mental health outcomes, and inter-relationship of concepts of this model (Transitional
decreasing the costs of care (Naylor et al., 2004). Trials care model—when you or a loved one requires care).
using the transitional care model have been very favor- Patients who are more vulnerable, either socially or
able, both in controlled research settings and in real physically, or complex, would utilize more aspects of the
world settings. Patients followed by a transitional care transitional care model, whereas patients with more
NP have had substantial reduction in 30 day readmis- resources (social and physical) need less support during
sions (Naylor et al., 2004; Neff, Madigan, & Narsavage, transitions of care. According to this model’s conceptual
2003; Stauffer et al., 2011; Zhao & Wong, 2009). Yet in relationships, when advanced practice nurses educate
spite of success in prevention of unnecessary readmis- patients about self-management skills, they are more
sions, balancing the cost of such programs must be adherent to the overall plan of care. Thus, these chroni-
weighed against decreasing revenue streams before cally ill individuals have fewer unnecessary readmissions
hospitals will support them (Stauffer et al., 2011). and greater medication adherence (Brooten, Youngblut,
“Transitional care programs utilizing advanced prac- Kutcher, & Bobo, 2004).
tice nurses have consistently reduced readmissions of The purpose of this study is to determine the effect
vulnerable patients. Medication management is an of an NP directed transitional care program on medica-
important part of the transitional care NP role. What is tion adherence and hospital readmission rate of dis-
not known is the effect of a transitional care NP program charged elderly adults with CHF. The independent
focused on medication management on readmission variable (IV) is the NP directed transitional care program
rates and medication adherence of elderly individuals and the dependent variables (DVs) are medication
with CHF. Thus, the purpose of this study is to examine adherence and hospital readmission rates. This study
the effects of an NP directed transitional care program will compare the medication adherence and read­mission
on the hospital readmission rate and medication adher- rate of medically complex elderly CHF patients who
ence of elderly CHF patients. receive NP directed transitional care with medication
650 UNIT FIVE  Proposing and Seeking Funding for Research

Screening

Maintaining
relationship Engaging
elder/caregiver

Coordination of care Managing symptoms


Patient

Educating/promoting
Assuring continuity
self-management

Collaborating

Figure 28-1  Transitional Care Model. (From Transitional Care Model. Retrieved from http://www.transitionalcare.info/)

management, and those who receive standard home Conceptual Operational


health nursing services. The following table summarizes Variables Definitions Definitions
the conceptual and operational definitions for the inde-
pendent (IV) and dependent variables (DV) in this study. DV: hospital Outcome which reflects Any unplanned
readmission inadequate training and readmission to an
Conceptual Operational rate preparation of patients/ acute care hospital
Variables Definitions Definitions family to manage new/ reported to study
IV: nurse Time-limited services Enrollment and chronic health conditions or investigators within 30
practitioner delivered by specially trained participation in a breakdown in communication days of hospital
directed nurse practitioners to at risk nurse practitioner between patient/family and discharge. Number of
transitional populations designed to directed transitional provider (Coleman & Boult, days from hospital
care program ensure continuity and avoid care program 2003). discharge to
preventable poor outcomes as including medication readmission will be
they move across sites of care management after an measured.
and among multiple providers acute care hospital
(Brooten et al., 1987; stay for CHF (see
Coleman & Boult, 2003). protocol in Appendix
A).
CHAPTER 28  Writing Research Proposals 651

Conceptual Operational explain the opportunity to participate in the study after


Variables Definitions Definitions discharge from the hospital. Patients who consent to
participate will be randomized into either the experi-
DV: medication Adherence to the medical Score on the Morisky mental (intervention) group or the comparison (stan-
adherence plan of care which reflects Medication Adherence
shared values, goals, and Scale measured on
dard care) group. Demographic information, medical
decision making between intake and at 30 days status, and pretest medication adherence will be col-
patients, families, and from index lected from all patients who consent to be in the study
providers (Rich, Gray, hospitalization before discharge from the hospital. Outcome measures
Beckham, Wittenberg, & discharge (Morisky, (hospital readmission rate and posttest medication
Luther, 1996). Ang, Krousel-Wood, & adherence) will be recorded at 30 days after discharge
Ward, 2008). using the data collection form in Appendix C. The
pretest and posttest design with a comparison group
has uncontrolled threats to validity due to selection,
Hypotheses:
maturation, instrumentation, and the possible interac-
1. CHF patients receiving an NP directed transitional
tion between selection and history (Burns & Grove,
care program with medication management will
2009; Shadish, Cook, & Campbell, 2002). Randomiza-
have greater medication adherence than CHF
tion of subjects to the treatment, controlled implemen-
patients who receive standard home health nursing
tation of the study treatment, and quality measurement
services after discharge from an acute care
methods strengthen the study design.
hospitalization for CHF.
2. CHF patients receiving an NP directed transitional
Ethical Considerations
care program with medication management will
University and Clinical Agency IRB approvals will be
have fewer readmissions within 30 days of
obtained. All study personnel who have access to the
discharge from index hospitalization and number of
data or to participants will complete human subject
days to readmission will be greater than CHF
protection training before beginning to participate in
patients who receive standard home health nursing
study delivery. All participants will have the study
services after discharge from an acute care
explained to them in detail and have all their questions
hospitalization for CHF.
answered before signing consent forms to participate in
Chapter 4 the study. The consent form for this study is presented
in Appendix D. The participants will receive a copy of
Methods and Procedures
their signed consent form.
Design Time frame: This entire study is projected to take
The design for this study will be a quasi-experimental one year. Subject recruitment will begin after IRB
pretest posttest design comparing readmission out- approval and informational in-services are presented to
comes of patients who received NP led transitional care the nursing and social work staff in the participating
with similar patients who did not receive transitional hospitals. Data collection and analysis of readmission
care at 30 days after index hospitalization discharge outcomes and mortality will begin with the recruitment
(Burns & Grove, 2009). Figure 28-2 provides a model of participants and will end 30 days after the last partici-
of the study design identifying the implementation of the pant is recruited (see the Study Protocol in Appendix B).
IV (see Appendix A) and the measurement of the DVs.
The study will also compare pretest posttest medication Intervention and Procedures
adherence scores between the experimental and stan- Patients who consent to participate in the study will be
dard care groups at 30 days. The protocol for conduct- visited by the transitional care NP who will be following
ing the study is presented in Appendix B. The proposal them after discharge for an intake visit before they are
will be submitted to the Institutional Review Boards discharged from the hospital. The same NP will visit the
(IRBs) of The University of Texas at Arlington (UTA) and patient in their home within 24 hours of discharge from
a selected healthcare system for approval. After approv- the hospital to monitor the patient’s condition, review
als are obtained, patients admitted to one of the partici- the goals of care and plans for care, provide patient
pating hospitals in the system who have an admitting education as needed, and manage any new issues as they
diagnosis of CHF will be screened for eligibility. Eligible emerge. The NP will also manage all aspects of the
patients will be approached by study personnel who will patients’ medications. The NP will make at least weekly
652 UNIT FIVE  Proposing and Seeking Funding for Research

Measurement of Manipulation of Measurement of


dependent variable(DV) independent variable(IV) dependent variable(DV)

Randomized Pretest Treatment Posttest


experimental group
of discharged CHF Medication adherence NP directed transitional Medication adherence
patients care program Hospital readmission rate

Randomized control
Pretest Posttest
group of discharged
CHF patients Medication adherence Medication adherence
Hospital readmission rate

Treatment: Under control of researcher

Approach to analysis:
Comparison of pretest and posttest scores
Comparison of comparison and experimental groups
Comparison of pretest/posttest differences between samples

Uncontrolled threats to validity:


Testing
Instrumentation
Mortality
Restricted generalizability as control increases

Figure 28-2  Classic experimental design.

home visits for the entire study period, carefully inquir- (weekly visits) and study related measures. Since only
ing about any interval emergency department visits or 40 patients will be in the intervention group, one NP is
hospital admissions. Patients who are readmitted to the expected to be able to manage 40 patients over a one
hospital may be retained in the study for the full study year period. To ensure study continuity and coverage
period (30 days) even though they have already reached for holidays and scheduled absences, a second NP
the end-point of readmission so that medication adher- employed in the agency will also be trained. Study
ence can be measured. At the end of the 30 days, all recruitment and outcome measures will be accom-
patients in the study will be contacted and/or visited at plished via a study registered nurse who will be trained
home by study staff to capture outcome measures. The on study information and procedures (see Appendix B)
intervention and study protocols were developed to and the patient consent process.
ensure intervention fidelity (see Appendices A and B)
(Dumas, Lynch, Laughlin, Smith, & Prinz, 2001; Erlen & Subjects and Setting
Sereika, 2006; Moncher & Prinz, 1991). Sample criteria: An electronic search of the inpatient
NPs who will be delivering transitional care to study database each night at midnight will reveal all patients in
patients will receive study related training that explicitly the participating hospitals with qualifying diagnosis of
reviews the 2009 Focused Update incorporated into the CHF who are age 75 or older. Other inclusion criteria
American College of Cardiology Foundation/American are the patient must be at least 75 years old, have a
Heart Associated (ACCF/AHA) 2005 Guidelines for the minimum of three chronic disease states, male gender,
Diagnosis and Management of Heart Failure in Adults and have Medicare, Medicaid, and or charity status as a
(Jessup et al., 2009) as well as training in study protocols payer source. These criteria are selected based on
CHAPTER 28  Writing Research Proposals 653

information from Silverstein and colleagues (2008), with poor blood pressure control, while high adhering
which revealed these characteristics specifically increased patients (80.3%) were more likely to have blood pres-
risk of readmission in a similar population. Study person- sure controlled (Morisky et al., 2008). Test-retest pro-
nel will eliminate any patients who have already been cedures were utilized to produce consistency of
offered participation. Patients who are on ventilator performance measures from one group of subjects on
support or vaso-active drips will be deferred until they two separate occasions which were then correlated
are stable enough to begin discharge planning. Patients with the norm reference of actual blood pressure mea-
who are being discharged on hospice or who have surements (Waltz, Strickland, & Lenz, 2010). Item-total
already participated are not eligible to participate. correlations were >0.30 for each of the eight items in
Patients who are on dialysis will be excluded due to their the scale with Cronbach’s alpha of 0.83. Confirmatory
unique needs and resources. factor analysis revealed a unidimensional scale with all
A power analysis was conducted to determine the items loading to a single factor.
desired sample size. Since this intervention is known to The Morisky Medication Adherence Scale is appropri-
be effective in preventing readmission with a moderate ate for the proposed study because it was validated on
effect size, the effect size of 0.45 was chosen with α = a similar population of older outpatients who were
0.05 and power of 0.80, indicating a sample size of 70 was mostly minority (76.5% black). The questions specifi-
required for the study with 35 participants in both the cally ask about ‘blood pressure medicines’ which are the
intervention and comparison groups (Aberson, 2010). primary medications utilized in CHF management. This
Ten percent will be added to each group to accommo- eight question instrument is derived from a previously
date for attrition. This leaves a final required sample size validated four question version (Morisky, Green, &
of 40 for each group. When the required sample size of Levine, 1986).
80 has been secured, recruitment will stop. Due to the
large population of elderly CHF patients in these hospi- Procedure
tals, the sample is hoped to be obtained in 4-6 months. Eligible participants will have the study explained to
Demographic variables of interest will be collected to them by the study recruiter who will obtain consent
describe the study sample and compare the sample with from those who are willing to participate. The recruiter,
the population for representativeness. Race, gender, a registered nurse who is part of the study team, will
age, chronic illnesses, marital status, educational level, also capture demographic and medical data, and admin-
and healthcare insurance will be collected using the data ister the Morisky Medication Adherence Scale to all
collection form in Appendix C. Socioeconomic status participants (see Appendix E). Patients assigned to the
and literacy are known predictors of health status and transitional care intervention will be visited by a transi-
utilization (Silverstein et al., 2008). Describing relation- tional care NP before being discharged home (see
ships between these factors and patient outcomes may Appendix B for Study Protocol).
be important in explaining study outcomes. The study On the day after discharge, the transitional care NP
participants’ addresses will be obtained also for contact will visit the patient in their home to evaluate their
by NPs following hospital discharge. home situation and resources as well as review the plan
of care. For the next 30 days, the transitional care NP
Instruments will visit the patient on at least a weekly basis. The visit
The Morisky Medication Adherence Scale will be admin- will conform to the transitional care visit guideline in
istered to all subjects who agree to participate in the Appendix A so that intervention fidelity will be main-
study during intake and at 30 days post initial hospital tained. At all times a transitional care NP will be
discharge (Morisky et al., 2008). This tool has estab- available by telephone. Outcome measures (hospital
lished sensitivity of 93% and specificity of 53% when readmissions and medication adherence) will be mea-
utilized with a similar population of older adults taking sured at 30 days after discharge using the data collection
anti-hypertensive medications. It consists of eight form in Appendix C and the Morisky Medication Adher-
questions, seven asking for yes/no answers about the ence Scale in Appendix E. The study recruiter will also
patient’s self-reported adherence over the preceding do these measures to decrease potential for bias.
two weeks and a final question with a five point Likert
style question. High adherence is associated with a Plan for Data Management and Analysis
score greater than 6 on the scale (see Appendix E). “Demographic data will be analyzed and NP actions
Low/medium adherence was significantly associated and their frequency of use will be examined using
654 UNIT FIVE  Proposing and Seeking Funding for Research

descriptive statistics. All encounter content with patients generation of evidence (6th ed.). St. Louis, MO:
will be recorded in the electronic health record, which Saunders.
all transitional care staff will have access to at all times. Coleman, E. A., & Boult, C. (2003). Improving the
The documentation of weekly scheduled visits from the quality of transitional care for persons with complex
transitional care NP will follow a template so that all care needs. Journal of the American Geriatrics Society,
areas are consistently addressed with all study partici- 51(4), 556–557.
pants and intervention fidelity is assured (Erlen & Corbett, C. F., Setter, S. M., Daratha, K. B., Neumiller,
Sereika, 2006). Differences in the interval level data J. J., & Wood, L. D. (2010). Nurse identified hospital
produced by the Morisky Medication Adherence Scale to home medication discrepancies: Implications for
will be examined with t-test at pre-test between the improving transitional care. Geriatric Nursing, 31(3),
intervention and comparison groups to ensure the 188–196.
groups were similar at the start of the study. Differences Dumas, J. E., Lynch, A. M., Laughlin, J. E., Smith, E. P.,
will also be examined between pretest and posttest, and & Prinz, R. J. (2001). Promoting intervention fidelity.
at posttest between the intervention and comparison conceptual issues, methods, and preliminary results
groups. Differences in readmission rates will be exam- from the EARLY ALLIANCE prevention trial.
ined at 30 days between the intervention and compari- American Journal of Preventive Medicine, 20(1),
son groups. IBM Statistical Package for Social Sciences 38–47.
Statistics 19 will be used to analyze the data. Alpha will Erlen, J. A., & Sereika, S. M. (2006). Fidelity to a
be set at 0.05 to conclude statistical difference. The 12-week structured medication adherence interven-
statistical tests will be an independent t-test between tion in patients with HIV. Nursing Research, 55(2),
two groups and a dependent t-test comparing pre- and S17-S22.
posttests. Bonferroni correction for multiple t-tests will Jencks, S. F., Williams, M. V., & Coleman, E. A. (2009).
be done to reduce the risk of a type I error (Maxwell, Rehospitalizations among patients in the Medicare
& Delaney, 2004). fee-for-service program. New England Journal of
Medicine, 360(14), 1418–1428. Retrieved from
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behavioral sciences. New York, NY: Routledge Taylor M., Francis, G. S., Ganiats, T. G. et al. (2009). 2009
& Francis Group. focused update: ACCF/AHA guidelines for the
Brooten, D., Kumar, S., Brown, L. P., Butts, P., Finkler, diagnosis and management of heart failure in adults:
S. A., Bakewell-Sachs, S., et al. (1987). A random- A report of the American College of Cardiology
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home follow-up of very-low-birth-weight infants. In on practice guidelines: Developed in collaboration
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Brooten, D., Naylor, M. D., York, R., Brown, L. P., experiments and analyzing data: A model comparison
Munro, B. H., Hollingsworth, A. O., et al. (2002). perspective (2nd ed.). Mahwah, NJ: Lawrence
Lessons learned from testing the quality cost model Erlbaum Associates.
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Journal of Nursing Scholarship, 34(4), 369–375. in outcome studies. Clinical Psychology Review, 11(3),
Brooten, D., Roncoli, M., Finkler, S., Arnold, L., 247–266.
Cohen, A., & Mennuti, M. (1994). A randomized Morisky, D. E., Ang, A., Krousel-Wood, M., & Ward,
trial of early hospital discharge and home follow-up H. J. (2008). Predictive validity of a medication
of women having cesarean birth. Obstetrics and adherence measure in an outpatient setting. Journal
Gynecology, 84(5), 832–838. of Clinical Hypertension, 10(5), 348–354.
Brooten, D., Youngblut, J. M., Kutcher, J., & Bobo, C. Morisky, D. E., Green, L. W., & Levine, D. M. (1986).
(2004). Quality and the nursing workforce: APNs, Concurrent and predictive validity of a self-reported
patient outcomes and health care costs. Nursing measure of medication adherence. Medical Care,
Outlook, 52(1), 45–52. 24(1), 67–74.
Burns, N., & Grove, S. K. (2009). The practice Morrissey, E. F. R., McElnay, J. C., Scott, M., &
of nursing research: Appraisal, synthesis, and McConnell, B. J. (2003). Influence of drugs,
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demographics and medical history on hospital Silverstein, M. D., Qin, H., Mercer, S. Q., Fong, J., &
readmission of elderly patients: A predictive model. Haydar, Z. (2008). Risk factors for 30-day hospital
Clinical Drug Investigation, 23(2), 119–128. readmission in patients over 65 years of age. Baylor
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Maislin, G., McCauley, K. M., & Schwartz, J. S. Sudden death in patients with myocardial infarction
(2004). Transitional care of older adults hospitalized and left ventricular dysfunction, heart failure, or
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& Luther, P. (1996). Effect of a multidisciplinary tion of the transitional care model in chronic heart
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Shadish, W. R., Cook, T. D., & Campbell, D. T. (2002). postdischarge transitional care programme for
Experimental and quasi-experimental designs for patients with coronary heart disease in China: A
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Mifflin and Company. Nursing, 18(17), 2444–2455.

APPENDIX A: Intervention Protocol for Transitional Care Nurse Practitioner (TCNP)


Visit Protocol

1. Patients are visited for their initial visit within 24-48 b. On all visits after the initial visit, inquire about any
hours of discharge from the hospital. unplanned visits to any hospital.
2. Only NPs who have been trained on CHF protocols c. Ask about any new problems, issues, or
and transitional care protocols and are included on symptoms that have arisen since hospital
the study IRB protocol may visit/interact with study discharge.
patients. d. Conduct a brief review of systems, looking
3. On the first visit the TCNP will review the hospital specifically for any changes since discharge from
discharge plan of care with the patient. A family the hospital.
caregiver is identified on the hospital visit or first e. Review log of daily weights/teach if needed to do
home visit. This person should be present and daily weights before breakfast and after voiding
included in all visits and supervise the patient’s each morning.
needs in the home. On every visit the following will f. Conduct a focused physical exam with careful
be addressed by the TCNP. attention to cardiovascular and respiratory exam
a. Review the plan of care given to the patient on on every visit; other systems as indicated by any
discharge from the hospital. patient complaints.
656 UNIT FIVE  Proposing and Seeking Funding for Research

g. Review all recommended medications with o. Communicate any changes in medication regimen
the patient and caregiver by physically viewing in writing for patient/caregiver.
the supply. On the first visit to the home, if the p. Record visit in electronic health record (EHR);
patient does not have a ‘medminder,’ the forward copy to patient’s PCP for review. Visit
TCNP will provide one to the patient/family at template in EHR will include fields to capture the
no cost and set up the medications for the first above items ‘c-p.’
week. The available quantities and dosages on q. On final home visit at the end of 4th week,
hand will be monitored on all medications, not collect Morisky Medication Adherence Scale for
just CHF medications. (Anticipate unexpected study.
problems to arise here with possible r. After final visit at the end of the 4th week,
duplication of drug classes, unavailable compose discharge summary and send to PCP.
meds, etc.)
Study RN Protocol for Comparison Group
h. Review indication, rationale, schedule, and
possible side effects of every medication. a. The study RN will recruit, consent, and randomize
i. Provide patient/family education as needed on patients. After consent is obtained, she will also
dietary choices, exercise, as needed medications, obtain demographic information and the pre-test
etc. Morisky Medication Adherence Scale on all
j. When possible and needed the TCNP will adjust participants.
medications as required to accommodate b. The study RN will contact all usual care patients by
individual patient plan formulary. telephone at the end of each week during the study
k. Adjust/titrate meds as indicated to achieve goals period of four weeks to inquire about any interval
of care. hospital admissions.
l. Order lab tests necessary to monitor patient c. On the final telephone call to the usual care
response to medication changes. participant at the end of week four, the study RN
m. Order any other medications/tests/referrals will also collect the post-test Morisky Medication
indicated by patient exam and complaints. Adherence Scale.
n. Consult immediately with primary care provider d. The study RN will also contact all transitional care
(PCP)/cardiologist for any unexpected participants at the end of week four to collect
deterioration in patient condition. post-test Morisky Medication Adherence Scale.

APPENDIX B: Study Protocol

Recruiting/Intake—Study Registered 4. Exclusion sample criteria:


Nurse (RN) a. Patients discharged home on hospice.
b. Patients on dialysis.
1. Generate CHF list from hospital IT. c. Patients on ventilators or vaso-active drips
2. Compare list to track daily discharges of patients should not be approached until they are in the
already recruited. discharge planning stage.
3. Screening for eligibility: Inclusion sample criteria 5. If patient meets all above inclusion and exclusion
a. Service area is 30 miles from the hospital: sample criteria: they will be approached for study
Use Internet directions program if you are participation
unsure how far the patient lives from the 6. Introduce yourself to the patient and family.
facility. 7. Explain the opportunity to participate in the study
b. Must have heart failure diagnosis after discharge from the hospital and what is
c. 75 and + in age involved. If patients agree to participate, give them
d. African American consent to read or read to them if desired.
e. Male gender 8. a Ask them to sign consent if they wish to
f. Medicare, non-funded or Medicaid participate.
g. Patient resides in a private residence, assisted 9. If they decline to participate, thank them for giving
living facility, or residential care home. you their time. Make a note in the chart that they
CHAPTER 28  Writing Research Proposals 657

were offered study participation and have refused, a. Heart failure has more hospital readmissions than
that they are not in the study. any other problem in the United States
10. For those patients who consent to participate in b. 20% of all people discharged with this problem
the study: return to the hospital within 30 days
a. Collect patients’ demographic, medical, and c. Patients followed in transitional care programs
educational information. have had lower readmission rates.
b. Administer the Morisky medication adherence 3. This is how the program works:
scale. a. I meet you here in the hospital (probably only
c. Confirm their address and phone number. one time).
d. Give them your card and phone number. b. I come to see you very soon after you go home; I
e. Randomize participant to either the intervention will be there within 24-48 hours.
or comparison group. Let them know which c. I will see you every week for one month at a
group they will be in and when to expect minimum; we can add more visits to this if
contact again. needed for you and your family.
f. Intervention group will be visited by NP in 4. I work with your doctors and keep them informed
hospital and within 24 hours of discharge from of how things are going at home. I am a nurse
hospital in their residence, then weekly practitioner; I am not a home healthcare nurse,
throughout study period. Place a transitional although I will work with your home healthcare
care ‘sticker’ on the chart to alert inpatient staff nurse as needed. Go into more explanation re:
that we are following the patient who was differences etc. as needed, give them brochure on
assigned to the intervention group. ‘what is a nurse practitioner.’
g. Usual care group will receive weekly phone a. Why NPs can do more.
call from study RN to determine any hospital b. NP can prescribe and make medication
readmissions, plus one end of study data changes if necessary and keep your physician
collection of Morisky medication adherence informed.
scale. c. NP can address new problems which might come
up.
Intervention Group: d. Your Medicare benefit and supplemental insur-
A transitional care nurse practitioner is preferably certi- ance will pay for my visits; you will not
fied as an Adult/Gerontology Primary Care Nurse Prac- be billed for any uncovered co-pays.
titioner, although other nurse practitioners with 5. The goal of the program is not to slow you down,
significant geriatric expertise will be considered. Other we do not want to interfere with your other
types of advanced practice nurses will not be included activities, and we want you to continue to be able
in this trial although they were included in much of the to do as much as you can do.
original studies by Brooten et al. (2004) and Naylor a. We will review your medications at every visit.
et al. (2004). All transitional care nurse practitioners will b. I will ask you each week about any
complete a standardized orientation and training readmissions to any hospital since the previous
oasis-ebl|Rsalles|1476726504

program focusing on a review of national heart failure visit.


guidelines as well as principles of geriatric care, patient c. Each week we will review your plan of care, how
and caregiver goal setting, and educational and behav- you are doing, and about any new problems or
ioral strategies focused on patient and caregiver needs. issues that arise.
d. The study RN who recruited you to the study
Scripting for Transitional Care Program will contact you at the end of the study and ask
Introduction during Inpatient Visit you the same questions that she asked after you
1. Introduction of yourself to the patient/family initially consented to participate (Morisky
2. You were randomly chosen to be in the Medication Adherence Scale).
Transitional Care group. The goal of the program 6. There will be different levels of coordination
is to help people (and their families) with heart involved with each patient.
problems learn how to best manage their illness a. I may discuss your case with your hospital nurse
at home. and hospitalist/cardiologist if needed.
658 UNIT FIVE  Proposing and Seeking Funding for Research

b. I may discuss your case with your primary care update the database on any hospitalizations that
provider if needed during intervention period; have occurred since the last interval data collection
he/she will receive a copy of the record for every (specifically how many days since discharge to
visit. readmission). On the final call, the Morisky
c. I will provide a comprehensive discharge summary Medication Adherence Scale will also be collected.
to your PCP when discharged from transitional
care service after one month.
Study RN—Data Collection on Comparison
Group Patients
1. Call all usual care patients at 7, 14, 21, and 30 days
after discharge. On each occasion he/she will

APPENDIX C: Data Collection Form

Days since Discharge


Data Collection Form without Readmission
All Other
Pretest Heart Diagnoses Post-test
Morisky Failure (One End End End End Morisky
Medication Diagnosis Line/ of of of of Medication
Study Years of Adherence (ICD-9 ICD-9 Week Week Week Week Adherence
ID Age Gender Race Education Score Code) Code) 1 2 3 4 Score
CHAPTER 28  Writing Research Proposals 659

APPENDIX D: Informed Consent

Principal Investigator Name: introduce herself to you before you are discharged from
the hospital. You will also receive the care ordered by
Kathryn Daniel, PhD, RN, ANP-BC, GNP-BC
your doctor after you are discharged from the hospital
Title of Project: including at least weekly visits and telephone support
from the transitional care nurse practitioner. The tran-
The Effect of Nurse Practitioner Directed Transitional
sitional care nurse practitioner will work with you and
Care on Medication Adherence and Read­mission Out-
your doctors to bridge the gap between hospital dis-
comes of Elderly Congestive Heart Failure Patients
charge and your return to your usual primary healthcare
Introduction provider as you learn to manage the changes in your
health.
You are being asked to participate in a research study.
Your participation is voluntary. Please ask questions if Possible Benefits
there is anything you do not understand.
There are no direct benefits to you for participating in
Purpose this research; however your participation will help us to
determine whether or not nurse practitioner led tran-
This study is designed to examine the effects of nurse
sitional care can decrease unnecessary hospital readmis-
practitioner directed transitional care program on medi-
sions and improve medication adherence. It is possible
cation adherence and hospital readmission of elderly
that having direct access to the transitional care nurse
patients who have congestive heart failure. Nationally,
practitioner may provide you with more timely evalua-
20% or more of patients who are hospitalized with
tion and management of problems that occur during the
congestive heart failure are readmitted to the hospital
4 weeks after discharge from the hospital.
within 30 days, often for reasons that are preventable.
Transitional care using nurse practitioners has been Compensation
shown to have positive benefits for many people like
You will not receive any compensation for your partici-
you after they are discharged from the hospital. This
pation in this study.
study is designed to determine whether medication
adherence is also related to decreased hospital Possible Risks/Discomforts
readmissions.
You may return to your usual state of health and activi-
Duration ties rapidly and thus not feel the need for a visit from
This study will last for 4 weeks after you are discharged the nurse practitioner or a phone call from the study
from the hospital. nurse every week for 4 weeks.

Procedures Alternative Procedures/Treatments


After you have read this form and agreed to participate, There are no alternatives to participation, except not
the intake nurse will gather some basic information from participating. You will always receive the care ordered
you. Then you will be randomly assigned to receive by your physician.
usual care or transitional care after you are discharged Withdrawal from the Study
from the hospital.
If you are assigned to the usual care group, you will You may discontinue your participation in this study at
be given the care your physician orders for you to any time without any penalty or loss of benefits.
receive upon discharge from the hospital. In addition,
Number of Participants
you will be telephoned at your home once per week for
4 weeks by a study nurse who will ask you whether or We expect 80 participants to enroll in this study.
not you have been back to the hospital. On the 4th and
Confidentiality
final week’s call, she will also ask you some additional
questions about how you take your medications. If in the unlikely event it becomes necessary for the
“If you are assigned to the transitional care nurse Institutional Review Board to review your research
practitioner group, your assigned transitional care records, then The University of Texas at Arlington
nurse practitioner will come to your room and will protect the confidentiality of those records to the
660 UNIT FIVE  Proposing and Seeking Funding for Research

extent permitted by law. Your research records will not Signature and printed name of principal investigator
be released without your consent unless required by or person obtaining consent/Date
law or a court order. The data resulting from your par- By signing below, you confirm that you have read or
ticipation may be made available to other researchers had this document read to you.
in the future for research purposes not detailed within You have been informed about this study’s purpose,
this consent form. In these cases, the data will contain procedures, possible benefits and risks, and you have
no identifying information that could associate you with received a copy of this form. You have been given the
it, or with your participation in any study. opportunity to ask questions before you sign, and you
If the results of this research are published or pre- have been told that you can ask other questions at any
sented at scientific meetings, your identity will not be time.
disclosed. You voluntarily agree to participate in this study. By
signing this form, you are not waiving any of your legal
Contact for Questions rights. Refusal to participate will involve no penalty or
Questions about this research or your rights as a research loss of benefits to which you are otherwise entitled, and
subject may be directed to Kathryn Daniel at (xxx)xxx- you may discontinue participation at any time without
xxxx. You may contact the chairperson of the UT Arling- penalty or loss of benefits, to which you are otherwise
ton Institutional Review Board at (xxx)-xxx-xxxx in the entitled.
event of a research-related injury to the subject. ____________________________________________
_________________________
Consent Signatures Signature of volunteer/Date
As a representative of this study, I have explained the
purpose, the procedures, the benefits, and the risks that
are involved in this research study:
____________________________________________
______________________________

APPENDIX E: Morisky Medication Adherence Scale

Please complete the following scale by circling the sticking to your blood pressure treatment plan?
best response that fits you. Yes/no
1. Do you sometimes forget to take your medications? 8. How often do you have difficulty remembering to
Yes/no take all your medications? (Select one)
2. Over the past 2 weeks, were there any days when Never
you did not take your medication? Yes/no Occasionally, but less than half the time
3. Have you ever cut back or stopped taking your About half the time
medication without telling your doctor because you More than half the time
felt worse when you took it? Yes/no Almost all the time
4. When you travel or leave home, do you sometimes
forget to bring along your medications? Yes/no Morisky, D. E., Ang, A., Krousel-Wood, M., & Ward,
5. Did you take your medicine yesterday? Yes/no H. J. (2008). Predictive validity of a medication adher-
6. When you feel like your blood pressure is under ence measure in an outpatient setting. Journal of Clinical
control, do you sometimes stop taking your Hypertension, 10(5), 348-354. doi:10.1111/j.1751-7176.
medication? Yes/no 2008.07572.x.
7. Taking medication everyday is a real inconvenience
for some people. Do you ever feel hassled about

KEY POINTS • A research proposal is a written plan that identifies


the major elements of a study, such as the problem,
• This chapter focuses on writing a research proposal purpose, and framework, and outlines the methods
and seeking approval to conduct a study. and procedures to conduct a study.
CHAPTER 28  Writing Research Proposals 661

• Writing a quality proposal involves (1) developing American Psychological Association (APA). (2010). Publication
the ideas logically, (2) determining the depth or manual of the American Psychological Association (6th ed.).
detail of the proposal content, (3) identifying the Washington, DC: Author.
Brown, S. J. (2009). Evidence-based nursing: The research-practice
critical points in the proposal, and (4) developing
connection. Sudbury, MA: Jones & Bartlett Publishers.
an esthetically appealing copy. Bulecheck, G., Butcher, H., & Dochterman, J. (Eds.). (2008).
• A quantitative research proposal usually has four Nursing interventions classification (NIC) (5th ed.). St. Louis,
chapters or sections: (1) introduction, (2) review of MO: Elsevier.
relevant literature, (3) framework, and (4) methods Chlan, L. L., Guttormson, J. L., & Savik, K. (2011). Methods:
and procedures. Tailoring a treatment fidelity framework for an intensive care unit
• A qualitative research proposal generally includes clinical trial. Nursing Research, 60(5), 348–353.
the following chapters or sections: (1) introduction; Craig, J. V., & Smyth, R. L. (2012). The evidence-based practice
(2) philosophical and conceptual foundation and manual for nurses (3rd ed.). Edinburgh, UK: Churchill
general method; (3) method of inquiry; and (4) Livingstone.
Crotser, C. B., & Dickerson, S. S. (2010). Women receiving news
current knowledge, limitations, and plans to com-
of a family BRCA 1/2 mutation: Messages of fear and empower-
municate the study. ment. Journal of Nursing Scholarship, 42(4), 367–378.
• Most clinical agencies and funding institutions Daniel, K. (2011). The effect of nurse practitioner directed transi-
require a condensed proposal, which usually tional care on medication adherence and readmission outcomes of
includes a problem, a purpose, previous research elderly congestive heart failure patients. Unpublished proposal.
conducted in the area, a framework, variables, Fawcett, J., & Garity, J. (2009). Evaluating research for evidence-
design, sample, ethical considerations, plan for data based nursing practice. Philadelphia, PA: F. A. Davis Company.
collection and analysis, and plan for dissemination Glaser, B., & Strauss, A. L. (1965). Discovery of substantive theory:
of findings. A basic strategy underlying qualitative research. American Behav-
• Sometimes a researcher will send a preproposal or ioral Scientist, 8(1), 5–12.
Grove, S. K. (2007). Statistics for health care research: A practical
query letter to a funding institution rather than a
workbook. St. Louis, MO: Saunders.
proposal; and the parts of the preproposal are logi- Heidegger, M. (1975). Poetry, language, thought (A. Hofstadter
cally ordered as follows: (1) letter of transmittal, Trans.). New York, NY: Harper & Row (original work published
(2) proposal for research, (3) personnel, (4) facili- 1971).
ties, and (5) budget. Kerlinger, F. N., & Lee, H. B. (2000). Foundations of behavioral
• Seeking approval for the conduct or funding research (4th ed.). Fort Worth, TX: Harcourt College.
of a study is a process that involves submission Malasanos, L. J. (1976). What is the preproposal? What are its
of a proposal to a selected group for review component parts? Is it an effective instrument in assessing funding
and, in many situations, verbally defending that potential of research ideas? Nursing Research, 25(3), 223–224.
proposal. Marshall, C., & Rossman, G. B. (2011). Designing qualitative
research (5th ed.). Los Angeles, CA: Sage.
• Research proposals are reviewed to (1) evaluate the
Martin, C. J. H., & Fleming, V. (2010). A 15-step model for writing
quality of the study, (2) ensure that adequate mea- a research proposal. British Journal of Midwifery, 18(12),
sures are being taken to protect human subjects, 791–798.
and (3) evaluate the impact of conducting the study Melnyk, B. M., & Fineout-Overholt, E. (2011). Evidence-based
on the reviewing institution. practice in nursing & healthcare: A guide to best practice (2nd
• Proposals sometimes require revision before or ed.). Philadelphia, PA: Lippincott Williams & Wilkins.
during the implementation of a study; if a change Merrill, K. C. (2011). Developing an effective quantitative research
is necessary, the researcher needs to discuss the proposal. The Art & Science of Infusion Nursing, 34(3),
change with the members of the university and 181–186.
clinical agency IRBs and the funding institution. Miles, M. B., & Huberman, A. M. (1994). Qualitative data analysis:
A source book of new methods (2nd ed.). Beverly Hills, CA: Sage.
• An example of a brief quantitative research pro-
Munhall, P. L. (2012). Nursing research: A qualitative perspective
posal of a quasi-experimental study is provided. (5th ed.). Sudbury, MA: Jones & Bartlett.
Munro, B. H. (2005). Statistical methods for health care research
(5th ed.). Philadelphia, PA: Lippincott.
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sciences. New York, NY: Routledge Taylor & Francis Group. .gov/Training/OnlineDevelopingNurseScientists/.
American Nurses Credentialing Center (ANCC). (2012). Magnet Offredy, M., & Vickers, P. (2010). Developing a healthcare research
program overview. Retrieved from http://www.nursecredentialing proposal: An interactive student guide. Oxford, United Kingdom:
.org/Magnet/ProgramOverview.aspx. Wiley-Blackwell.
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Patton, M. Q. (2002). Qualitative research and evaluation methods Smith, M. J., & Liehr, P. R. (2008). Middle range theory for nursing
(3rd ed.). Thousand Oaks, CA: Sage. (2nd ed.). New York, NY: Springer Publishing Company.
Pinch, W. J. (1995). Synthesis: Implementing a complex process. Thompson, S. K. (2002). Sampling (2nd ed.). New York, NY: John
Nurse Educator, 20(1), 34–40. Wiley & Sons.
Ryan-Wenger, N. A. (2010). Evaluation of measurement precision, Turabian, K. L., Booth, W. C., Colomb, G. G., & Williams, J. M.
accuracy, and error in biophysical data for clinical research and (2007). A manual for writers of research papers, theses, disserta-
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Measurement in nursing and health research (4th ed.) (pp. 371– ers. Chicago, IL: University of Chicago Press.
383). New York, NY: Springer Publishing Company. University of Chicago Press Staff. (2010). The Chicago manual of
Sandelowski, M., Davis, D. H., & Harris, B. G. (1989). Artful style (16th ed.). Chicago, IL: University of Chicago Press.
design: Writing the proposal for research in the naturalist para- Waltz, C. F., Strickland, O. L., & Lenz, E. R. (2010). Measurement
digm. Research in Nursing & Health, 12(2), 77–84. in nursing and health research (4th ed.). New York, NY: Springer
Santacroce, S. J., Maccarelli, L. M., & Grey, M. (2004). Methods: Publishing Company.
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tal and quasi-experimental designs for generalized causal infer-
ence. Chicago, IL: Rand McNally.
  http://evolve.elsevier.com/Grove/practice/

29 CHAPTER

Seeking Funding for Research

S
eeking funding for research is important both for the release time to conduct research and gain the
the researcher and for the profession. Well- needed experience. One way of resolving this dilemma
designed studies can be expensive. As the rigor is to design initial studies that can realistically be done
and complexity of the study design increase, the cost without release time and with little or no funding.
tends to increase. By obtaining funding, the researcher This approach requires a commitment to put in extra
can conduct a complex, well-designed study. Funding hours of work, which is often unrewarded monetarily
indicates that others have reviewed the study and rec- or socially. However, when well carried out and pub-
ognize its scientific and social merit. The scientific lished, these types of studies provide the credibility
credibility of the profession is related to the quality of one needs to begin the process toward major grant
studies conducted by its researchers. Thus, scientific funding. Guidelines for proposals for federal funding
credibility and funding for research are interrelated. usually include a section of the proposal in which
The nursing profession has invested a great deal researchers are expected to describe their own research
of energy in increasing the sources of funding and studies that serves as evidence of their ability to con-
amount of money available for nursing research. Each ceptualize, implement, and complete a study, includ-
award of funding enhances the status of the researcher ing disseminating the findings. Funders want assurance
and increases the possibilities of greater funding for that if they fund a proposal, their money will not be
later studies. In addition, funding provides practical wasted and that the findings of the study will be
advantages. For example, funding may reimburse published.
part or all of the researcher’s salary and release the An aspiring career researcher needs to initiate a
researcher from other responsibilities, allowing the program of research in a specific area of study and seek
researcher to devote time to conducting the study. funding in this area. A program of research consists of
Funding provides you with the resources to hire the studies that a researcher conducts, starting with
research assistants and study coordinators to facilitate small, simple studies and moving to larger, complex
data collection and enhance your productivity. Thus, studies over time. For example, if your research inter-
skills in seeking funding for research are as important est is to promote health in rural areas, you need to
as skills in the conduct of research. plan a series of studies that focus on promoting rural
health. Early studies may be small with each single
successive study building on the findings of the previ-
Building a Program of Research ous study. Finckeissen (2008) described this approach
As a novice researcher, you may have had the dream as having a meta-model of research with alternative
of writing a grant proposal to the federal government solutions to a research problem. The findings of each
or a national foundation for your first study and receiv- study suggest new solutions or provide evidence that
ing a large grant that covers your salary, the salaries another solution is ineffective. Dr. Jean McSweeney,
of research assistants and secretarial support, equip- PhD, RN, FAHA, FAAN, Professor at the College of
ment, computers, and payments to subjects for their Nursing, University of Arkansas of Medical Sciences,
time and effort. In reality, this scenario seldom occurs is an example of a nurse researcher who has built a
for an inexperienced researcher. A new researcher is program of research. Dr. McSweeney’s area of clinical
usually caught in the difficult position of needing practice was critical care, and she became very inter-
experience to get funded and needing funding to get ested in cardiac patients. To complete her PhD, she

663
664 UNIT FIVE  Proposing and Seeking Funding for Research

TABLE 29-1  Publications Reflecting a Program of Research: Exemplar of McSweeney’s Program of


Research in Cardiovascular Health of Women
Citations from Oldest to Most Recent
McSweeney, J. C. (1993). Explanatory models of a myocardial event: Linkages between perceived causes and modifiable health
behaviors. Rehabilitation Nursing Research, 2(1), 39–49.
McSweeney, J. C. & Crane, P. B. (2001). An act of courage: Women’s decision-making processes regarding outpatient cardiac
rehabilitation attendance. Rehabilitation Nursing, 26(4), 132–140.
Crane, P. B. & McSweeney, J. C. (2003). Exploring older women’s lifestyle changes after myocardial infarction. Medsurg Nursing,
12(3), 170–076.
McSweeney, J. C., Cody, M., O’Sullivan, P., Elberson, D., Moser, D. K., & Gavin, B. J. (2003). Women’s early warning symptoms of
acute myocardial infarction. Circulation, 108(21), 2619–2623.
McSweeney, J. C., O’Sullivan, P., Cody, M., Crane, P. B. (2004). Development of the McSweeney Acute and Prodromal Myocardial
Infarction Symptom Survey. Journal of Cardiovascular Nursing, 19(1), 58–67.
McSweeney, J. C. & Coon, S. (2004). Women’s inhibitors and facilitators associated with making behavioral changes after myocardial
infarction. Medsurg Nursing, 13(1), 49–56.
McSweeney, J. C., Lefler, L. L., & Crowder, B. F. (2005). What’s wrong with me? Women’s coronary heart disease diagnostic
experiences. Progress in Cardiovascular Nursing, 20(2), 48–57.
McSweeney, J. C., Lefler, L. L., Fischer, E. P., Naylor, A. J., & Evans, L. K. (2007). Women’s prehospital delay associated with
myocardial infarction: Does race really matter? The Journal of Cardiovascular Nursing, 22(4), 279–285.
McSweeney, J. C., Pettey, C. M., Fischer, E. P., & Spellman (2009). Going the distance. Research in Gerontological Nursing, 2(4),
256–264.
McSweeney, J. C., Cleves, J. A., Zhao, W., Lefler, L. L., & Yang, S. (2010). Cluster analysis of women’s prodromal and acute
myocardial infarction by race and other characteristics. The Journal of Cardiovascular Nursing, 25(4), 104–110.
McSweeney, J. C., O’Sullivan, P., Cleves, M. A., Lefler, L. L., Cody, M., et al. (2010). Racial differences in women’s prodromal and
acute symptoms of myocardial infarction. American Journal of Critical Care, 19(1), 63–73.
Beck, C., McSweeney, J. C., Richards, K. C., Roberson, P. K., Tsai, P.-F., & Souder, E. (2010). Challenges in tailored intervention
research. Nursing Outlook, 58(2), 104–110.
McSweeney, J. C., Pettey, C. M., Souder, E., & Rhoads, S. (2011). Disparities in women’s cardiovascular health. Journal of Obstetric,
Gynecologic, and Neonatal Nursing, 40(3), 362–371.

conducted a qualitative study with patients and their


significant others to explore behavior changes after a
myocardial infarction. Her first post-dissertation study Contribution
was a qualitative study of women’s motivations to
change their behavior after a myocardial infarction.
She continued by conducting a series of quantitative
studies that built on the findings of the previous studies. Capacity Capital
Table 29-1 lists publications by Dr. McSweeney that
indicate the trajectory of her research program. Publi-
cation of the studies increased the credibility of the
Indicates the overlap of contribution,
researcher and provided the foundation for future
capacity, and capital which constitutes
funding. an ideal focus for a program of research
How do you decide on the focus of your program
of research? The ideal focus of a program of research Figure 29-1  Ideal focus for a program of research.
is the intersection of a potential contribution to science,
your capacity, and the capital that you can assemble.
Figure 29-1 shows the ideal study as overlapping
circles of contribution, capacity, and capital. reviewing the literature and finding a significant gap
in knowledge. Maybe this knowledge is needed to
Contribution solve a health problem, or it is the evidence needed
Contribution refers to the gap in knowledge that your to advance nursing science. The research focus is
research will address. This gap will be identified by broader than a single study. For example, a program
CHAPTER 29  Seeking Funding for Research 665

of research could be developed related to adherence Capital


to antihypertensive medications. The first study might People and funding are the capital you need to conduct
be a qualitative study of the reasons patients give for research over time. The primary purpose of this
not taking their antihypertensive medications. Build- chapter is to describe how to increase your monetary
ing on that knowledge, the next study might be a capital. When a potential contribution to science, your
descriptive quantitative study of differences in atti- capacity, and available capital overlap, you have found
tudes of men and women toward antihypertensive an ideal focus for your research career. This chapter
medications. A later study might measure the out- also provides suggestions on how to develop your
comes of antihypertensive patients who received an grantsmanship and increase your capacity in the area
adherence intervention compared with a group of in which you believe you can make a meaningful
patients who did not receive an intervention. Another contribution.
consideration related to the research focus is your
capacity to study the problem.
Getting Started
Capacity
Capacity consists of the internal resources you Level of Commitment
possess, such as your intellect, emotional maturity, Developing your capacity as a researcher in a specific
knowledge, and skills. Because a program of research area takes a great deal of time and effort. Writing
develops over several years, perseverance and com- proposals for funding is hard work. Before you begin,
mitment are necessary elements of your capacity. reflect on whether your motivation is external or inter-
Which areas of nursing and health stimulate your nal. If your motivation is external, you are committed
curiosity and sustain your interest? Think about the to seeking funding because of the potential to receive
topics or areas of nursing practice in which you are rewards from your employer, to earn the high regard
the most interested. Which patients or clinical areas of your peers, or to be eligible for a promotion. If your
stimulate your curiosity? Maybe you have a personal motivation is internal, you are convinced that more
connection to a particular area, such as a nurse knowledge is needed to benefit your patients. Both
researcher who is studying autism because she is the external and internal motivations are valid reasons to
mother of a son with autism. Maybe a family member be committed to a program of research; however, an
died at a young age from undiagnosed cardiac disease, internally motivated researcher will conduct studies
and now you are passionate to understand the with limited funding and continue to seek additional
decision-making process related to diagnosis of funding even in the absence of external rewards. As
cardiac disease. Your research focus may evolve over an element of capacity, your level of commitment will
time, but, ideally, your passion for a specific topic or determine your ability to persevere and develop a
group of patients would provide the basis for a long program of research.
research career.
Knowledge related to your research area is another Support of Other People
element of your capacity related to a specific research Even the most internally motivated person may
topic. This knowledge may come from educational experience times of discouragement and need the
programs, personal study, and clinical experience. If support of peers. Peers who share common values,
you are interested in genomic research, what is your ways of thinking, and activities can be a reference
knowledge of genes and interactions among them group for a novice researcher. This occurs when you
and the environment? Have you had a course in identify with the group, take on group values and
genetics or learned the laboratory skills to gather and behavior, and evaluate your own values and behavior
analyze cellular level data? If you are interested in in relation to those of the group. A new researcher
the effects of positioning on the hemodynamics of moving into grantsmanship may need to switch from
unstable, acute patients, have you ever worked in a a reference group that views research and grant
critical care unit? One aspect of building a research writing to be either over their heads or not worth
career is to continue to expand your capacity in your their time to a group that values this activity. From
focus area, but in the beginning, selecting an area in this group, you may receive support and feedback
which you have baseline knowledge is helpful. Your necessary to develop grant-writing skills and enact a
capacity also includes grantsmanship, the knowl- program of research. In addition, you will have the
edge and skill you have related to securing and man- opportunity to provide similar support and feedback
aging grants. to your peers.
666 UNIT FIVE  Proposing and Seeking Funding for Research

Networking is a process of developing channels of other, from which a close working relationship can be
communication among people with common interests developed. The relationship usually continues for a
who may not work for the same employer or may be long period.
geographically scattered. Contacts may be made
through social media, computer networks, mail, tele- Grantsmanship
phone, or arrangements to meet at a conference (Adeg- Grantsmanship is not an innate skill; it must be learned.
bola, 2011). Strong networks are based on reciprocal Learning grant-related skills requires a commitment of
relationships. A professional network can provide both time and energy. However, the rewards can be
opportunities for brainstorming, sharing ideas and great. Strategies used to learn grantsmanship are
problems, and discussing grant-writing opportunities. described in the following sections and are listed in
In some cases, networking may lead to the members order of increasing time commitment, involvement,
of a professional network writing a grant that will be and level of expertise needed. These strategies are
a multisite study with data collected in each member’s attending grantsmanship courses, working with experi-
home institution. When a proposal is being developed, enced researchers, joining research organizations, and
the network, which may become a reference group, can participating on research committees or review panels.
provide feedback at various stages of development of
the proposal. Adegbola (2011) provides practical tips Attending Courses and Workshops
on how to develop and maintain a professional network. Some universities offer elective courses on grantsman-
Through networking, nurses interested in a particu- ship. Continuing education programs or professional
lar area of study can find peers, content experts, conferences sometimes offer topics related to grants-
and mentors. A content expert may be a clinician or manship. The content of these sessions may include the
researcher who is known for his or her work in the process of grant writing, techniques for obtaining grant
area in which you are also interested. Through your funds, and sources of grant funds. In some cases, rep-
review of the literature, you identify a researcher who resentatives of funding agencies are invited to explain
has developed an instrument to measure a variable that funding procedures. This information is useful for
you have decided must be included in your proposed developing skill in writing proposals. Not all courses
study. For example, you want to measure a biological or educational opportunities for learning grantsman-
marker of stress and you have read several studies in ship require attendance at a conference because some
which an experienced researcher measured the vari- seminars are offered as webinars or online courses.
able using a specific piece of equipment. You can also
search the Virginia Henderson International Nursing Apprenticeship
Library to find funded and unfunded researchers Volunteering to assist with the activities of another
on different topics (http://www.nursinglibrary.org/vhl/ researcher is an excellent way to learn research and
pages/aboutus.html). Contact the researcher through grantsmanship. Graduate students can gain this expe-
email to make a telephone appointment to discuss the rience by becoming graduate research assistants.
strengths and weaknesses of this particular measure- Through an apprenticeship, you may gain experience
ment, or you may arrange to meet at an upcoming in writing grants and reading proposals that have been
conference. funded. Examining proposals that have been rejected
A mentor is a person who is more experienced can be useful if the comments of the review committee
professionally and willing to work with a less experi- are available. The criticisms of the review committee
enced professional to achieve his or her goals. Because point out the weaknesses of the study and clarify the
funded nursing researchers are few, the need for men- reasons why the proposal was rejected. Examining
toring is greater than the number of available mentors these comments on the proposal can increase your
(Maas, Conn, Buckwalter, Herr, & Tripp-Reimer, insight as a new grant writer and prepare you for
2009). Finding a mentor may take time and require similar experiences. However, some researchers are
significant effort. Much of the information needed is sensitive about these criticisms and may be reluctant
transmitted verbally, requires actual participation in to share them. If an experienced researcher is willing,
grant-writing activities, and is best learned in a mentor it is enlightening to hear his or her perceptions and
relationship. This type of relationship requires a will- opinions about the criticisms. Ideally, by working
ingness by both professionals to invest time and closely with an experienced researcher, you have the
energy. A mentor relationship has characteristics of opportunity to demonstrate your commitment, and the
both a teacher-learner relationship and a close friend- researcher invites you to become a permanent member
ship. Each individual must have an affinity for the of a research team.
CHAPTER 29  Seeking Funding for Research 667

TABLE 29-2  Regional Nursing Research Organizations


Region Website Email
Eastern Nursing Research Society http://www.enrs-go.org info@enrs-go.org
Southern Nursing Research Society http://www.snrs.org info@snrs.org
Midwest Nursing Research Society http://www.mnrs.org info@mnrs.org
Western Institute of Nursing http://www.winursing.org/ win@ohsu.edu

Regional Nursing Research Organizations care was provided. The emphasis is on implementing
In the United States, nurse researchers in each region the project, not on conducting research. Research
have formed regional research organizations. Table grants provide funding to conduct a study. Although
29-2 lists these organizations and their websites. Each the two types of grant proposals have similarities, they
of these regional organizations has an annual confer- have important differences in writing techniques, flow
ence and provides opportunities for nursing students of ideas, and content. This chapter focuses on seeking
to display a poster or present a small study of their funding for research. Within research grants, propos-
early research projects. These conferences are an als vary depending on the source of funding. Proposals
excellent opportunity to network and meet more expe- for federal funding are the most complex and include
rienced researchers (Adegbola, 2011). a significant amount of information about your institu-
tion’s resources and capacity to support the study. The
Serving on Research Committees section on Government Funding provides additional
Research committees and institutional review boards information on types of federal proposals.
exist in many healthcare and professional organiza-
tions. Through membership on these committees, con- Nongovernment Funding
tacts with researchers can be made. Also, many
research committees are involved in reviewing pro- Private or Local Funding
posals for the funding of small grants or granting The next step is to determine potential sources for
approval to collect data in an institution. Often reading small amounts of research money. In some cases, man-
proposals for approval for research involving human agement in the employing institution can supply
subjects or for funding can give the novice researcher limited funding for research activities if a good case
insight into the importance of clarity and organization is presented for the usefulness of the study to the
in the research proposal. Reviewing proposals and institution. In many universities, funds are available
making decisions about funding help researchers for intramural grants, which you can obtain competi-
become better able to critique and revise their own tively by submitting a brief proposal to a university
proposals before submitting them for review. committee. Local chapters of nursing organizations
have money available for research activities. Sigma
Theta Tau International, the honor society for nurses,
Identifying Funding Sources provides small grants for nursing research that can
be obtained through submission to local, regional,
Types of Grants national, or international review committees. Another
Two main types of grants are sought in nursing: project source are organizations, such as the local chapters of
grants and research grants. Project grant proposals the American Cancer Society and the American Heart
are written to obtain funding for the development of Association. Although grants from the national offices
new educational programs in nursing, such as a of these organizations require sophisticated research,
program designed to teach nurses to provide a new local or state levels of the organization may have small
type of nursing care or as a project to support nursing amounts of funds available for studies in the organiza-
students seeking advanced degrees. These grants may tion’s area of interest.
fund a project manager to achieve the goals of the Private individuals who are locally active in phi-
grant. Although these programs may involve evalua- lanthropy may be willing to provide financial assis-
tion, they seldom involve research. For example, the tance for a small study in an area appealing to them.
effectiveness of a new approach to patient care may You need to know who to approach and how and when
be evaluated, but the findings can seldom be general- to make the approach to increase the probability of
ized beyond the unit or institution in which the patient successful funding. Sometimes this approach requires
668 UNIT FIVE  Proposing and Seeking Funding for Research

knowing someone who knows someone who might be TABLE 29-3  National Specialty Nursing
willing to provide financial support. Acquiring funds
Organizations That Fund Research
from private individuals requires more assertiveness
than other approaches to funding. Organization or
Requests for funding need not be limited to a single Association Website
source. If you need a larger amount of money than one Academy of Medical http://www.amsn.org/
source can supply, seek funds from one source for a Surgical Nurses
specific research need and from another source for American Association of http://www.aacn.org/
Critical Care Nurses
another research need. Also, one source may be able
to provide funds for a small segment of time; you can Association of Women’s http://www.awhonn.org./
Health, Obstetric, and awhonn/
then approach another source to seek funding for
Neonatal Nurses
another phase of the study. You can also combine these
Emergency Nurses http://www.ena.org/Pages/
two strategies.
Association default.aspx
Seeking funding from local sources is less demand-
Hospice and Palliative Care http://www.hpna.org/
ing in terms of formality and length of the proposal
Nurses
than is the case with other types of grants. Often, the
National Association of http://www.orthonurse.org/
process is informal and may require only a 2- or 3-page Orthopaedic Nurses
description of the study. Provide a clear, straightfor-
National Gerontological http://www.ngna.org/
ward description of the study and how the findings Nursing Association
will contribute to practice or future studies. The impor-
Oncology Nursing Society http://www.ons.org/
tant thing is to know what funds are available and
Society of Pediatric Nurses http://www.pedsnurses.org/
how to apply for them. Some of these funds go unused
index.html
each year because nurses are unaware of the existence
Wound Ostomy and http://www.wocn.org/
of the funds or think that they are unlikely to be suc-
Continence Nurses Society
cessful in obtaining the money. This unused money
leads granting agencies or potential donors to conclude
that nurses do not need more money for research.
Small grants do more than just provide the funds These grants are usually for less than $7500 each year,
necessary to conduct the research. They are the first are very competitive, and are awarded to new investi-
step in your being recognized as a credible researcher gators with promising ideas. Receiving funding from
and in being considered for more substantial grants for these organizations is held in high regard. Information
later studies. When you receive a grant, no matter how regarding these grants is available from the American
small, include this information on your curriculum Nurses Foundation (http://www.anfonline.org/) and
vitae. Also, list your participation in funded studies, Sigma Theta Tau International (http://www.nursing
even if you were not the principal investigator (PI). society.org/default.aspx).
These entries are evidence of first-level recognition as
a researcher. Industry
Industry may be a good source of funding for nursing
National Nursing Organizations studies, particularly if one of their company’s products
Many specialty nursing organizations provide support is involved in the study. For example, if a particular
for studies relevant to their specialty, including nurse type of equipment is being used during an experimen-
practitioner groups. These organizations often provide tal treatment, the company that developed the equip-
guidance to budding new researchers who need assis- ment may be willing to provide equipment for the
tance in beginning the process of planning and seeking study or may be willing to fund the study. If a compari-
funding for research. To determine the resources pro- son study examining outcomes of one type of dressing
vided by a particular nursing organization, search the versus another is to be conducted, the company that
organization’s website or contact the organization by produces one of the products might provide the product
email, letter, or phone. Table 29-3 provides informa- or fund the study. Industry-supported research is being
tion on 10 large specialty nursing organizations that scrutinized because of publicized incidents in which
provide grant funding. possible conflicts of interest resulted in harm to
Two national nursing organizations that provide a subject or may have prevented the publication of
small grants not linked to a specialty are the American unfavorable findings (Fry-Revere & Malmstrom,
Nurses Foundation and Sigma Theta Tau International. 2009). The ethics of seeking such funding should be
CHAPTER 29  Seeking Funding for Research 669

carefully con­sidered because there is sometimes a risk Foundation Directory, which is available online to
that the researcher might not be unbiased in interpret- subscribers at http://fconline.fdncenter.org. Check
ing study results. with your hospital or university administrators to find
out if you have access to this resource.
Foundations
Many foundations in the United States provide funding Government Funding
for research, but the problem is to determine which The largest source of grant monies is the federal
foundations have interests in a particular field of study. government—so much so that the federal government
The board of a foundation may evaluate the founda- influences what is studied and what is not. Information
tion’s priorities each year, resulting in different priori- on funding agencies can be obtained from a document
ties each year. You must learn the characteristics of compiled by the federal government, The Catalog
the foundation, such as what it will fund. A foundation of Federal Domestic Assistance, which is available
may fund only studies by female researchers, or it may online at www.cfda.gov. The National Institutes of
be interested only in studies of low-income groups. A Health (NIH), particularly the National Institute for
foundation may fund only studies being conducted in Nursing Research, and Agency for Healthcare Research
a specific geographical region. The average amount of and Quality are interested in receiving nursing propos-
money awarded for a single grant and the ranges of als. Each agency has areas of focus and priorities for
awards need to be determined for each foundation. If funding that change over time. It is important to know
the average award of a particular foundation is $2500 this information and prepare proposals within these
and if $30,000 is needed, that foundation is not the areas to obtain funding. This information is available
most desirable source of funds. Identify foundations online at www.grants.gov, a searchable listing of all
that match your research topic, geographical location, federal research funding opportunities.
and funding needs. Review carefully the foundation’s Two approaches can be used to seek federal funding
guidelines for submitting funding requests. Making a for research. As the researcher, you can identify a
personal visit to the foundation or contacting the staff significant problem, develop a study to examine it, and
person responsible for funding is desirable in some submit a proposal for the study to the appropriate
cases. You can increase your likelihood of funding by federal funding agency. This type of proposal is called
revising your proposal to align with the foundation’s an investigator-initiated research proposal. Alterna-
priorities. tively, an agency within the federal government can
Several publications list foundations and their identify a significant problem, develop a plan by
interests. If you are affiliated with a university that is which the problem can be studied, and publish a
a subscriber, a computerized information system, the request for proposals (RFP) or a request for appli-
Sponsored Programs Information Network, can assist cations (RFA) from researchers (Figure 29-2).
you in locating the most appropriate funding sources
to support your research interests. The database con- Investigator-Initiated Proposals
tains approximately 2000 programs that provide infor- If the study is initiated by the investigator, it is useful
mation on federal agencies, private foundations, and for the researcher to contact an official within the
corporate foundations. Another useful resource is the government agency early in the planning process to

Investigator- Agency-
Initiated Initiated
Research Research

Figure 29-2  Types of federal research proposals.


Program Request for
Request for
Announcement Applications
Proposals (RFP)
(PA) (RFA)
Reminder of Narrow focus, Well-defined area
Agency specific desired with objectives to
Priorities outcome be met
670 UNIT FIVE  Proposing and Seeking Funding for Research

inform the agency of the intent to submit a proposal. TABLE 29-4  Funding Agencies Included in
Each agency has established dates, usually three times the National Institutes of Health
a year, when proposals are reviewed. You will need to
Research Portfolio Online
start preparing your proposal months ahead of this
deadline, and some agencies are willing to provide Reporting Tools—Expenditures  
assistance and feedback to the researcher during and Results (RePORTER)
development of the proposal. This assistance may Agency for Health Care Research and Quality (AHRQ)
occur through email, telephone conversations, or feed- Centers for Disease Control and Prevention (CDC)
back on a draft of the proposal. Proposals submitted Food and Drug Administration (FDA)
in response to a program announcement (PA) are Health Resources and Services Administration (HRSA)
National Institutes of Health (NIH)
considered investigator-initiated proposals. An agency
Substance Abuse and Mental Health Services (SAMHSA)
or group of agencies may release a PA to remind Veterans Affairs
researchers of priority areas and generate interest in a
priority area.
Washington to meet with an agency representative.
Requests for Proposals and Applications This type of contact allows the researcher to modify
The NIH issues an RFP when scientists advising the the proposal to fit more closely within agency guide-
institutes have identified a specific need to move an lines, increasing the probability of funding. In many
area of knowledge forward. An RFA may be broader cases, proposals will fit within the interests of more
than an RFP but will still have a focus and a list of than one government agency at the time of submis-
objectives that an institute or center within the NIH sion. It is permissible and perhaps desirable to request
has identified. An RFA will have a single application that the proposal be assigned to two agencies for
deadline. The amount that has been budgeted for the review and potential funding.
successful applications is indicated, and the RFA is
usually open for several funding cycles. Verifying Institutional Support
Grant awards are most commonly made to institutions
rather than to individuals. It is important to determine
Submitting a Proposal the willingness of the institution to receive the grant
and support the study. This willingness needs to be
for a Federal Grant documented in the proposal. Supporting the study
involves appropriateness of the study topic; adequacy
Ensuring a Unique Proposal of facilities and services; availability of space needed
During your review of the literature, you may have for the study; contributions that the institution is
read the findings of funded studies, but the literature willing to make to the study, such as staff time, equip-
does not include recently completed or ongoing funded ment, or data processing; and provision for overseeing
studies. Early in the process of planning a study for the rights of human subjects. The study’s budget will
which you intend to seek federal funding, it is wise to include a category called indirect costs to pay the
determine what studies on your topic of interest have institution’s expenses. For federal grants, indirect
been funded previously and what funded studies are costs may by as high as 50% of the direct costs, the
currently in process. This information is available on funds necessary to conduct the study. Direct costs are
the NIH Research Portfolio Online Reporting Tools— used to pay a portion of the researcher’s salary, the
Expenditures and Results (RePORTER), which is salaries of data collectors or other research assistants,
maintained by the Office of Extramural Research at obtain equipment for the study, and provide a small
the NIH (http://projectreporter.nih.gov/reporter.cfm). payment to study participants to acknowledge their
The institutes and agencies that fund studies and proj- time and effort.
ects and are included in the RePORTER are listed in
Table 29-4. You can search the database by state, Making Time to Write
subject, type of grant, funding agency, or investigator. Set aside sufficient time to develop your proposal
Reviewing proposals that are funded by a particular carefully, beginning with a thorough literature review.
agency can be helpful. Although the agency cannot See Chapter 28 for how to write a proposal. Read the
provide these proposals, researchers can sometimes funding agency’s guidelines carefully and completely
obtain them by contacting the PI of the study person- before starting to write. Keep the guidelines nearby as
ally. In some cases, the researcher may travel to you write so that you can easily refer back to them.
CHAPTER 29  Seeking Funding for Research 671

Strictly adhere to the page limitations and required Because of this process, researchers may not receive
font sizes. The sections of the proposal may be grant money for up to 1 year after submitting the
uploaded separately. Be sure that all the sections agree proposal.
with each other on details such as names of instru- Often, researcher-initiated proposals are rejected
ments and inclusion criteria for subjects. (or scored but not funded) after the first submission.
Writing your first proposal on a tight deadline is The critique of the scientific committee, called a
unwise. Proposals require refining the idea and method summary statement, is available to the researcher via
and rewriting the text several times. Plan on 6 to 12 his or her eRA Commons account. Frequently, the
months for proposal development from the point of agency staff encourages the researcher to rewrite the
early development of your research ideas. As soon as proposal with guidance from the comments and resub-
you have a complete draft, ask a peer or mentor to read mit it to the same agency. The probability of funding
the proposal to check for errors in logic. As people is often greater the second time if the researcher has
review your proposal informally, recognize their followed the suggestions.
questions as indications that an idea was not clearly
presented and may need to be rewritten. Before sub- Responding to Rejected Grant Proposals
mission, it is highly recommended that you have a The researcher’s reaction to a rejected proposal is
content expert or other researcher who is not at your usually anger and then depression. The frustrated
institution critique the proposal (Office of Manage- researcher may abandon the proposal, stuff it in a
ment and Budget, 2011). bottom drawer somewhere, and forget it. There seems
to be no way to avoid the anger and depression after
Understanding the Review Process a rejection because of the significant emotion and time
The Center for Scientific Review has the administra- invested in writing it. However, after a few weeks it
tive responsibility for ensuring a fair, equitable review is advisable to examine the rejection letter again. The
of all proposals submitted to NIH or other Public comments can be useful in rewriting the proposal for
Health Services agencies. After submission, the staff resubmission. The learning experience of rewriting the
person assigned to your grant will determine which proposal and evaluating the comments will provide a
integrated review group will review your proposal for background for seeking funding for another study.
its technical and scientific merit. Within the integrated A skilled grant writer will have approximately one
review group, each grant is assigned to a study section proposal funded for every five submitted. The average
for scientific evaluation. The study section comprises is far less than this. Thus, the researcher needs to be
active funded researchers. The study sections have no committed to submitting proposals repeatedly to
alignment with the funding agency. Thus, staff persons achieve grant funding.
in the agencies have no influence on the committee’s
work of judging the scientific merit of the proposal.
The proposal is given to two or more reviewers who Grant Management
are considered qualified to evaluate the proposal and Receiving notice that a grant proposal is funded is one
have no conflicts of interest. The reviewers rate the of the highlights in a researcher’s career and warrants
proposal on the core criteria and overall impact and a celebration. However, begin work on the study as
submit a written critique of the study. Each member soon as possible. You included a detailed plan of activ-
may have 50 to 100 proposals to read in a 1- to ities in the proposal that is ready to be implemented.
2-month period. A meeting of the full study section is To avoid problems, you need to consider managing the
then held. The persons who critiqued the proposal budget, hiring and training research personnel, main-
discuss each application, and other members comment taining the promised timetable, and coordinating
or ask questions before recording their scores. activities of the study.
Proposals are assigned a numerical score used to
develop a priority rating for funding. A study that is Managing the Budget
scored is not necessarily funded. The PI may review Although the supporting institution is ultimately
the progress of the proposal through the stages of responsible for dispensing and controlling grant
review by accessing an online system, called the Elec- monies, the PI is responsible for monitoring budget
tronic Research Administration (eRA) Commons. expenditures and making decisions about how the
Funding begins with the proposal that has the highest money is to be spent (Devine, 2009). If this grant is
rank order and continues until available funds are the first one received, a PI who has no previous admin-
depleted. This process can take 6 months or longer. istrative experience may need guidance in how to keep
672 UNIT FIVE  Proposing and Seeking Funding for Research

records and make reasonable budget decisions. If obtain funding. It may be wise to have several ongoing
funding is through a federal agency, the PI will be studies in various stages of implementation. For
required to provide interim reports as well as updates example, you could be planning a study, collecting
on the progress of the study. data on a second study, analyzing data on a third study,
and writing papers for publication on a fourth study.
Training Research Personnel A full-time researcher could have completed one
When a new grant is initiated, set aside time to inter- funded study, be in the last year of funding for a
view, hire, and train grant personnel (Martin & second study, be in the first year of funding for a third
Fleming, 2010). The personnel who will be involved study, and be seeking funding for a fourth study. This
in data collection need to learn the process, and then scenario may sound unrealistic, but with planning, it
data collection needs to be refined to ensure that each is not. This strategy not only provides continuous
data collector is consistent with the other data collec- funding for research activities but also facilitates a
tors. This process helps evaluate interrater reliability. rhythm of research that prevents time pressures and
The PI needs to set aside time to oversee the work of makes use of lulls in activity in a particular study. To
personnel hired for the grant. increase the ease of obtaining funding, the studies
need to be within the same area of research, each
Maintaining the Study Schedule building on previous studies.
The timetable submitted with the proposal needs to be
adhered to whenever possible, which requires careful
planning. Otherwise, other work activities are likely KEY POINTS
to take precedence and delay the grant work. Unex-
pected events do happen. However, careful planning • Building a program of research requires conducting
can minimize their impact. The PI needs to refer back a series of studies on a topic, with each study build-
to the timetable constantly to evaluate progress. If the ing on the findings of the previous one.
project falls behind schedule, action needs to be taken • The ideal topic around which to build a research
to return to the original schedule or to readjust the program can be identified by considering topics for
timetable. which the researcher has or can gain the expertise
to conduct studies (capacity), funding is available
Coordinating Activities (capital), and the potential exists for the researcher
During a large study with several investigators and to make a difference (contribution).
other grant personnel, coordinating activities can be a • Writing a grant proposal for funding requires a
problem. Arrange meetings of all grant workers at commitment to working extra hours.
intervals to share ideas and solve problems. Keep • To receive funding, researchers need to learn
records of the discussions at these meetings. These grantsmanship skills.
actions can lead to a more smoothly functioning team. • The first studies are usually conducted with per-
sonal funding or small grants.
Submitting Reports • Nongovernmental sources of funding include
Federal grants require the submission of interim private donors, local organizations, nursing organi-
reports according to preset deadlines. The notice of a zations, and foundations.
grant award sent as a PDF (Portable Document • Before submitting a proposal to seek federal
Format) document via email will include guidelines funding, the researcher should successfully com-
for the content of the reports, which will consist of a plete two or more small studies and disseminate the
description of grant activities. Set aside time to prepare findings.
the report, which usually requires compiling figures • The researcher identifies a significant problem,
and tables. In addition to the written reports, it is often develops a study to examine it, and submits a pro-
useful to maintain contact with the appropriate staff at posal for the study to an appropriate federal funding
the federal agency. agency.
• The PI is responsible for keeping within the budget,
training research personnel, maintaining the sched-
Planning Your Next Grant ule, and coordinating activities.
The researcher should not wait until funding from the • Grants require the submission of interim and
first grant has ended to begin seeking funds for a final reports of expenditures, activities, and
second study because of the length of time required to achievements.
CHAPTER 29  Seeking Funding for Research 673

• A researcher should not wait until funding from right questions? Journal of Law, Medicine, and Ethics, 29(3),
one grant ends before seeking funds for the next 420–430.
grant. Martin, C. J. H. & Fleming, V. (2010). A 15-step model for writing
a research proposal. British Journal of Midwifery, 18(12),
791–798.
Maas, M. L., Conn, V., Buckwalter, K. C., Herr, K., & Tripp-
REFERENCES Reimer, T. (2009). Increasing nurse faculty research: The Iowa
Adegbola, M. (2011). Soar like geese: Building developmental Gerontological Nurse Research and Regional Research Consor-
network relationships for scholarship. Nursing Education Per- tium Strategies. Journal of Nursing Scholarship, 41(4),
spectives, 32(1), 51–53. 411–419.
Devine, E. B. (2009). The art of obtaining grants. American Journal Office of Management and Budget (2011). Appendix VI: Develop-
of Health-System Pharmacy, 66(6), 580–587. ing and writing grant proposals (pp. 2700–2702). In: Catalog of
Finkeissen, E. (2008). Steps from erratic projects toward structured Federal Domestic Assistance. Retrieved from https://www.cfda
programs of research. Foundations of Science, 13(2), 143–148. .gov/downloads/CFDA_2011.pdf.
Fry-Revere, S. & Malmstrom, D. B. (2009). More regulation
of industry-supported biomedical research: Are we asking the
Appendix A
Z Values Table

z Score From Mean to z (%) z Score From Mean to z (%)


.00 .00 .46 17.72
.01 .40 .47 18.08
.02 .80 .48 18.44
.03 1.20 .49 18.79
.04 1.60 .50 19.15
.05 1.99 .51 19.50
.06 2.39 .52 19.85
.07 2.79 .53 20.19
.08 3.19 .54 20.54
.09 3.59 .55 20.88
.10 3.98 .56 21.23
.11 4.38 .57 21.57
.12 4.78 .58 21.90
.13 5.17 .59 22.24
.14 5.57 .60 22.57
.15 5.96 .61 22.91
.16 6.36 .62 23.24
.17 6.75 .63 23.57
.18 7.14 .64 23.89
.19 7.53 .65 24.22
.20 7.93 .66 24.54
.21 8.32 .67 24.86
.22 8.71 .68 25.17
.23 9.10 .69 25.49
.24 9.48 .70 25.80
.25 9.87 .71 26.11
.26 10.26 .72 26.42
.27 10.64 .73 26.73
.28 11.03 .74 27.04
.29 11.41 .75 27.34
.30 11.79 .76 27.64
.31 12.17 .77 27.94
.32 12.55 .78 28.23
.33 12.93 .79 28.52
.34 13.31 .80 28.81
.35 13.68 .81 29.10
.36 14.06 .82 29.39
.37 14.43 .83 29.67
.38 14.80 .84 29.95
.39 15.17 .85 30.23
.40 15.54 .86 30.51
.41 15.91 .87 30.78
.42 16.28 .88 31.06
.43 16.64 .89 31.33
.44 17.00 .90 31.59
.45 17.36 .91 31.86

674
APPENDIX A  Z Values Table 675

z Score From Mean to z (%) z Score From Mean to z (%)


.92 32.12 1.48 43.06
.93 32.38 1.49 43.19
.94 32.64 1.50 43.32
.95 32.89 1.51 43.45
.96 33.15 1.52 43.57
.97 33.40 1.53 43.70
.98 33.65 1.54 43.82
.99 33.89 1.55 43.94
1.00 34.13 1.56 44.06
1.01 34.38 1.57 44.18
1.02 34.61 1.58 44.29
1.03 34.85 1.59 44.41
1.04 35.08 1.60 44.52
1.05 35.31 1.61 44.63
1.06 35.54 1.62 44.74
1.07 35.77 1.63 44.84
1.08 35.99 1.64 44.95
1.09 36.21 1.65 45.05
1.10 36.43 1.66 45.15
1.11 36.65 1.67 45.25
1.12 36.86 1.68 45.35
1.13 37.08 1.69 45.45
1.14 37.29 1.70 45.54
1.15 37.49 1.71 45.64
1.16 37.70 1.72 45.73
1.17 37.90 1.73 45.82
1.18 38.10 1.74 45.91
1.19 38.30 1.75 45.99
1.20 38.49 1.76 46.08
1.21 38.69 1.77 46.16
1.22 38.88 1.78 46.25
1.23 39.07 1.79 46.33
1.24 39.25 1.80 46.41
1.25 39.44 1.81 46.49
1.26 39.62 1.82 46.56
1.27 39.80 1.83 46.64
1.28 39.97 1.84 46.71
1.29 40.15 1.85 46.78
1.30 40.32 1.86 46.86
1.31 40.49 1.87 46.93
1.32 40.66 1.88 46.99
1.33 40.82 1.89 47.06
1.34 40.99 1.90 47.13
1.35 41.15 1.91 47.19
1.36 41.31 1.92 47.26
1.37 41.47 1.93 47.32
1.38 41.62 1.94 47.38
1.39 41.77 1.95 47.44
1.40 41.92 1.96 47.50
1.41 42.07 1.97 47.56
1.42 42.22 1.98 47.61
1.43 42.36 1.99 47.67
1.44 42.51 2.00 47.72
1.45 42.65 2.01 47.78
1.46 42.79 2.02 47.83
1.47 42.92 2.03 47.88
Continued
676 APPENDIX A  Z Values Table

z Score From Mean to z (%) z Score From Mean to z (%)


2.04 47.93 2.53 49.43
2.05 47.98 2.54 49.45
2.06 48.03 2.55 49.46
2.07 48.08 2.56 49.48
2.08 48.12 2.57 49.49
2.09 48.17 2.58 49.51
2.10 48.21 2.59 49.52
2.11 48.26 2.60 49.53
2.12 48.30 2.61 49.55
2.13 48.34 2.62 49.56
2.14 48.38 2.63 49.57
2.15 48.42 2.64 49.59
2.16 48.46 2.65 49.60
2.17 48.50 2.66 49.61
2.18 48.54 2.67 49.62
2.19 48.57 2.68 49.63
2.20 48.61 2.69 49.64
2.21 48.64 2.70 49.65
2.22 48.68 2.71 49.66
2.23 48.71 2.72 49.67
2.24 48.75 2.73 49.68
2.25 48.78 2.74 49.69
2.26 48.81 2.75 49.702
2.27 48.84 2.76 49.711
2.28 48.87 2.77 49.720
2.29 48.90 2.78 49.728
2.30 48.93 2.79 49.736
2.31 48.96 2.80 49.744
2.32 48.98 2.81 49.752
2.33 49.01 2.82 49.760
2.34 49.04 2.83 49.767
2.35 49.06 2.84 49.774
2.36 49.09 2.85 49.781
2.37 49.11 2.86 49.788
2.38 49.13 2.87 49.795
2.39 49.16 2.88 49.801
2.40 49.18 2.89 49.807
2.41 49.20 2.90 49.813
2.42 49.22 2.91 49.819
2.43 49.25 2.92 49.825
oasis-ebl|Rsalles|1476813894

2.44 49.27 2.93 49.831


2.45 49.29 2.94 49.836
2.46 49.31 2.95 49.841
2.47 49.32 2.96 49.846
2.48 49.34 2.97 49.851
2.49 49.36 2.98 49.856
2.50 49.38 2.99 49.861
2.51 49.40 3.00 49.865
2.52 49.41
Appendix B
Critical Values for Student’s t Distribution

Level of Significance (α), One-Tailed Test


.001 .005 .01 .025 .05 .10

Level of Significance (α), Two-Tailed Test


df .002 .01 .02 .05 .10 .20
2 22.327 9.925 6.965 4.303 2.920 1.886
3 10.215 5.841 4.541 3.182 2.353 1.638
4 7.173 4.604 3.747 2.776 2.132 1.533
5 5.893 4.032 3.365 2.571 2.015 1.476
6 5.208 3.707 3.143 2.447 1.943 1.440
7 4.785 3.499 2.998 2.365 1.895 1.415
8 4.501 3.355 2.896 2.306 1.860 1.397
9 4.297 3.250 2.821 2.262 1.833 1.383
10 4.144 3.169 2.764 2.228 1.812 1.372
11 4.025 3.106 2.718 2.201 1.796 1.363
12 3.930 3.055 2.681 2.179 1.782 1.356
13 3.852 3.012 2.650 2.160 1.771 1.350
14 3.787 2.977 2.624 2.145 1.761 1.345
15 3.733 2.947 2.602 2.131 1.753 1.341
16 3.686 2.921 2.583 2.120 1.746 1.337
17 3.646 2.898 2.567 2.110 1.740 1.333
18 3.610 2.878 2.552 2.101 1.734 1.330
19 3.579 2.861 2.539 2.093 1.729 1.328
20 3.552 2.845 2.528 2.086 1.725 1.325
21 3.527 2.831 2.518 2.080 1.721 1.323
22 3.505 2.819 2.508 2.074 1.717 1.321
23 3.485 2.807 2.500 2.069 1.714 1.319
24 3.467 2.797 2.492 2.064 1.711 1.318
25 3.450 2.787 2.485 2.060 1.708 1.316
26 3.435 2.779 2.479 2.056 1.706 1.315
27 3.421 2.771 2.473 2.052 1.703 1.314
28 3.408 2.763 2.467 2.048 1.701 1.313
29 3.396 2.756 2.462 2.045 1.699 1.311
30 3.385 2.750 2.457 2.042 1.697 1.310
31 3.375 2.744 2.453 2.040 1.696 1.309
32 3.365 2.738 2.449 2.037 1.694 1.309
33 3.356 2.733 2.445 2.035 1.692 1.308
34 3.348 2.728 2.441 2.032 1.691 1.307
35 3.340 2.724 2.438 2.030 1.690 1.306
36 3.333 2.719 2.434 2.028 1.688 1.306
37 3.326 2.715 2.431 2.026 1.687 1.305
38 3.319 2.712 2.429 2.024 1.686 1.304
39 3.313 2.708 2.426 2.023 1.685 1.304
40 3.307 2.704 2.423 2.021 1.684 1.303
45 3.281 2.690 2.412 2.014 1.679 1.301

Continued

677
678 APPENDIX B  Critical Values for Student’s t Distribution

Level of Significance (α), Two-Tailed Test—cont’d


df .002 .01 .02 .05 .10 .20
50 3.261 2.678 2.403 2.009 1.676 1.299
55 3.245 2.668 2.396 2.004 1.673 1.297
60 3.232 2.660 2.390 2.000 1.671 1.296
65 3.220 2.654 2.385 1.997 1.669 1.295
70 3.211 2.648 2.381 1.994 1.667 1.294
75 3.202 2.643 2.377 1.992 1.665 1.293
80 3.195 2.639 2.374 1.990 1.664 1.292
85 3.189 2.635 2.371 1.988 1.663 1.292
90 3.183 2.632 2.368 1.987 1.662 1.291
95 3.178 2.629 2.366 1.985 1.661 1.291
100 3.174 2.626 2.364 1.984 1.660 1.290
200 3.131 2.601 2.345 1.972 1.653 1.286
300 3.118 2.592 2.339 1.968 1.650 1.284
∞ 3.1 2.58 2.33 1.96 1.65 1.28
Appendix C

Critical Values of r for Pearson Product Moment Correlation Coefficient


Level of Significance (α), One-Tailed Test
.05 .025 .01 .005 .05 .025 .01 .005

Level of Significance (α), Two-Tailed Test


df = N – 2 .10 .05 .02 .01 df = N – 2 .10 .05 .02 .01
1 .9877 .9969 .9995 .9999 39 .2605 .3081 .3621 .3978
2 .9000 .9500 .9800 .9900 40 .2573 .3044 .3578 .3932
3 .8054 .8783 .9343 .9587 41 .2542 .3008 .3536 .3887
4 .7293 .8114 .8822 .9172 42 .2512 .2973 .3496 .3843
5 .6694 .7545 .8329 .8745 43 .2483 .2940 .3458 .3801
6 .6215 .7067 .7887 .8343 44 .2455 .2907 .3420 .3761
7 .5822 .6664 .7498 .7977 45 .2429 .2876 .3384 .3721
8 .5493 .6319 .7155 .7646 46 .2403 .2845 .3348 .3683
9 .5214 .6021 .6851 .7348 47 .2377 .2816 .3314 .3646
10 .4973 .5760 .6581 .7079 48 .2353 .2787 .3281 .3610
11 .4762 .5529 .6339 .6835 49 .2329 .2759 .3249 .3575
12 .4575 .5324 .6120 .6614 50 .2306 .2732 .3218 .3542
13 .4409 .5140 .5923 .6411 55 .2201 .2609 .3074 .3385
14 .4259 .4973 .5742 .6226 60 .2108 .2500 .2948 .3248
15 .4124 .4821 .5577 .6055 65 .2027 .2404 .2837 .3126
16 .4000 .4683 .5426 .5897 70 .1954 .2319 .2737 .3017
17 .3887 .4555 .5285 .5751 75 .1888 .2242 .2647 .2919
18 .3783 .4438 .5155 .5614 80 .1829 .2172 .2565 .2830
19 .3687 .4329 .5034 .5487 85 .1775 .2108 .2491 .2748
20 .3598 .4227 .4921 .5368 90 .1726 .2050 .2422 .2673
21 .3515 .4132 .4815 .5256 95 .1680 .1996 .2359 .2604
22 .3438 .4044 .4716 .5151 100 .1638 .1946 .2301 .2540
oasis-ebl|Rsalles|1476813899

23 .3365 .3961 .4622 .5052 120 .1496 .1779 .2104 .2324


24 .3297 .3882 .4534 .4958 140 .1386 .1648 .1951 .2155
25 .3233 .3809 .4451 .4869 160 .1297 .1543 .1827 .2019
26 .3172 .3739 .4372 .4785 180 .1223 .1455 .1723 .1905
27 .3115 .3673 .4297 .4705 200 .1161 .1381 .1636 .1809
28 .3061 .3610 .4226 .4629 250 .1039 .1236 .1465 .1620
29 .3009 .3550 .4158 .4556 300 .0948 .1129 .1338 .1480
30 .2960 .3494 .4093 .4487 350 .0878 .1046 .1240 .1371
31 .2913 .3440 .4031 .4421 400 .0822 .0978 .1160 .1283
32 .2869 .3388 .3973 .4357 450 .0775 .0922 .1094 .1210
33 .2826 .3338 .3916 .4297 500 .0735 .0875 .1038 .1149
34 .2785 .3291 .3862 .4238 600 .0671 .0799 .0948 .1049
35 .2746 .3246 .3810 .4182 700 .0621 .0740 .0878 .0972
36 .2709 .3202 .3760 .4128 800 .0581 .0692 .0821 .0909
37 .2673 .3160 .3712 .4076 900 .0548 .0653 .0774 .0857
38 .2638 .3120 .3665 .4026 1000 .0520 .0619 .0735 .0813

679
Appendix D
Critical Values of F for α = 0.05 and α = 0.01

Please see page 681

680
Critical Values of F for α = 0.05

df Degrees of Freedom (df) Numerator


Denominator 1 2 3 4 5 6 7 8 9 10 12 15 20 24 30 40 60 120 ∞
1 161.4 199.5 215.7 224.6 230.2 234.0 236.8 238.9 240.5 241.9 243.9 245.9 248.0 249.1 250.1 251.1 252.2 253.3 254.3
2 18.51 19.00 19.16 19.25 19.30 19.33 19.35 19.37 19.38 19.40 19.41 19.43 19.45 19.45 19.46 19.47 19.48 19.49 19.50
3 10.13 9.55 9.28 9.12 9.01 8.94 8.89 8.85 8.81 8.79 8.74 8.70 8.66 8.64 8.62 8.59 8.57 8.55 8.53
4 7.71 6.94 6.59 6.39 6.26 6.16 6.09 6.04 6.00 5.96 5.91 5.86 5.80 5.77 5.75 5.72 5.69 5.66 5.63
5 6.61 5.79 5.41 5.19 5.05 4.95 4.88 4.82 4.77 4.74 4.68 4.62 4.56 4.53 4.50 4.46 4.43 4.40 4.36
6 5.99 5.14 4.76 4.53 4.39 4.28 4.21 4.15 4.10 4.06 4.00 3.94 3.87 3.84 3.81 3.77 3.74 3.70 3.67
7 5.59 4.74 4.35 4.12 3.97 3.87 3.79 3.73 3.68 3.64 3.57 3.51 3.44 3.41 3.38 3.34 3.30 3.27 3.23
8 5.32 4.46 4.07 3.84 3.69 3.58 3.50 3.44 3.39 3.35 3.28 3.22 3.15 3.12 3.08 3.04 3.01 2.97 2.93
9 5.12 4.26 3.86 3.63 3.48 3.37 3.29 3.23 3.18 3.14 3.07 3.01 2.94 2.90 2.86 2.83 2.79 2.75 2.71
10 4.96 4.10 3.71 3.48 3.33 3.22 3.14 3.07 3.02 2.98 2.91 2.85 2.77 2.74 2.70 2.66 2.62 2.58 2.54
11 4.84 3.98 3.59 3.36 3.20 3.09 3.01 2.95 2.90 2.85 2.79 2.72 2.65 2.61 2.57 2.53 2.49 2.45 2.40
12 4.75 3.89 3.49 3.26 3.11 3.00 2.91 2.85 2.80 2.75 2.69 2.62 2.54 2.51 2.47 2.43 2.38 2.34 2.30
13 4.67 3.81 3.41 3.18 3.03 2.92 2.83 2.77 2.71 2.67 2.60 2.53 2.46 2.42 2.38 2.34 2.30 2.25 2.21
14 4.60 3.74 3.34 3.11 2.96 2.85 2.76 2.70 2.65 2.60 2.53 2.46 2.39 2.35 2.31 2.27 2.22 2.18 2.13
15 4.54 3.68 3.29 3.06 2.90 2.79 2.71 2.64 2.59 2.54 2.48 2.40 2.33 2.29 2.25 2.20 2.16 2.11 2.07
16 4.49 3.63 3.24 3.01 2.85 2.74 2.66 2.59 2.54 2.49 2.42 2.35 2.28 2.24 2.19 2.15 2.11 2.06 2.01
17 4.45 3.59 3.20 2.96 2.81 2.70 2.61 2.55 2.49 2.45 2.38 2.31 2.23 2.19 2.15 2.10 2.06 2.01 1.96
18 4.41 3.55 3.16 2.93 2.77 2.66 2.58 2.51 2.46 2.41 2.34 2.27 2.19 2.15 2.11 2.06 2.02 1.97 1.92
19 4.38 3.52 3.13 2.90 2.74 2.63 2.54 2.48 2.42 2.38 2.31 2.23 2.16 2.11 2.07 2.03 1.98 1.93 1.88
20 4.35 3.49 3.10 2.87 2.71 2.60 2.51 2.45 2.39 2.35 2.28 2.20 2.12 2.08 2.04 1.99 1.95 1.90 1.84
21 4.32 3.47 3.07 2.84 2.68 2.57 2.49 2.42 2.37 2.32 2.25 2.18 2.10 2.05 2.01 1.96 1.92 1.87 1.81
22 4.30 3.44 3.05 2.82 2.66 2.55 2.46 2.40 2.34 2.30 2.23 2.15 2.07 2.03 1.98 1.94 1.89 1.84 1.78
23 4.28 3.42 3.03 2.80 2.64 2.53 2.44 2.37 2.32 2.27 2.20 2.13 2.05 2.01 1.96 1.91 1.86 1.81 1.76
24 4.26 3.40 3.01 2.78 2.62 2.51 2.42 2.36 2.30 2.25 2.18 2.11 2.03 1.98 1.94 1.89 1.84 1.79 1.73
25 4.24 3.39 2.99 2.76 2.60 2.49 2.40 2.34 2.28 2.24 2.16 2.09 2.01 1.96 1.92 1.87 1.82 1.77 1.71
26 4.23 3.37 2.98 2.74 2.59 2.47 2.39 2.32 2.27 2.22 2.15 2.07 1.99 1.95 1.90 1.85 1.80 1.75 1.69
27 4.21 3.35 2.96 2.73 2.57 2.46 2.37 2.31 2.25 2.20 2.13 2.06 1.97 1.93 1.88 1.84 1.79 1.73 1.67
28 4.20 3.34 2.95 2.71 2.56 2.45 2.36 2.29 2.24 2.19 2.12 2.04 1.96 1.91 1.87 1.82 1.77 1.71 1.65
29 4.18 3.33 2.93 2.70 2.55 2.43 2.35 2.28 2.22 2.18 2.10 2.03 1.94 1.90 1.85 1.81 1.75 1.70 1.64
30 4.17 3.32 2.92 2.69 2.53 2.42 2.33 2.27 2.21 2.16 2.09 2.01 1.93 1.89 1.84 1.79 1.74 1.68 1.62
40 4.08 3.23 2.84 2.61 2.45 2.34 2.25 2.18 2.12 2.08 2.00 1.92 1.84 1.79 1.74 1.69 1.64 1.58 1.51
60 4.00 3.15 2.76 2.53 2.37 2.25 2.17 2.10 2.04 1.99 1.92 1.84 1.75 1.70 1.65 1.59 1.53 1.47 1.39
120 3.92 3.07 2.68 2.45 2.29 2.17 2.09 2.02 1.96 1.91 1.83 1.75 1.66 1.61 1.55 1.50 1.43 1.35 1.25
∞ 3.84 3.00 2.60 2.37 2.21 2.10 2.01 1.94 1.88 1.83 1.75 1.67 1.57 1.52 1.46 1.39 1.32 1.22 1.00

From Merrington, M., and Thompson, C.M. (1943). Tables of percentage points of the inverted beta (F) distribution. Biometrika, 33(1), 73–78.
Critical Values of F for α = 0.01

df df Numerator
Denominator 1 2 3 4 5 6 7 8 9 10 12 15 20 24 30 40 60 120 ∞
1 4052 4999.5 5403 5625 5764 5859 5928 5982 6022 6056 6106 6157 6209 6235 6261 6287 6313 6339 6366
2 98.50 99.00 99.17 99.25 99.30 99.33 99.36 99.37 99.39 99.40 99.42 99.43 99.45 99.46 99.47 99.47 99.48 99.49 99.50
3 34.12 30.82 29.46 28.71 28.24 27.91 27.67 27.49 27.35 27.23 27.05 26.87 26.69 26.60 26.50 26.41 26.32 26.22 26.13
4 21.20 18.00 16.69 15.98 15.52 15.21 14.98 14.80 14.66 14.55 14.37 14.20 14.02 13.93 13.84 13.75 13.65 13.56 13.46
5 16.26 13.27 12.06 11.39 10.97 10.67 10.46 10.29 10.16 10.05 9.89 9.72 9.55 9.47 9.38 9.29 9.20 9.11 9.02
6 13.75 10.92 9.78 9.15 8.75 8.47 8.26 8.10 7.98 7.87 7.72 7.56 7.40 7.31 7.23 7.14 7.06 6.97 6.88
7 12.25 9.55 8.45 7.85 7.46 7.19 6.99 6.84 6.72 6.62 6.47 6.31 6.16 6.07 5.99 5.91 5.82 5.74 5.65
8 11.26 8.65 7.59 7.01 6.63 6.37 6.18 6.03 5.91 5.81 5.67 5.52 5.36 5.28 5.20 5.12 5.03 4.95 4.86
9 10.56 8.02 6.99 6.42 6.06 5.80 5.61 5.47 5.35 5.26 5.11 4.96 4.81 4.73 4.65 4.57 4.48 4.40 4.31
10 10.04 7.56 6.55 5.99 5.64 5.39 5.20 5.06 4.94 4.85 4.71 4.56 4.41 4.33 4.25 4.17 4.08 4.00 3.91
11 9.65 7.21 6.22 5.67 5.32 5.07 4.89 4.74 4.63 4.54 4.40 4.25 4.10 4.02 3.94 3.86 3.78 3.69 3.60
12 9.33 6.93 5.95 5.41 5.06 4.82 4.64 4.50 4.39 4.30 4.16 4.01 3.86 3.78 3.70 3.62 3.54 3.45 3.36
13 9.07 6.70 5.74 5.21 4.86 4.62 4.44 4.30 4.19 4.10 3.96 3.82 3.66 3.59 3.51 3.43 3.34 3.25 3.17
14 8.86 6.51 5.56 5.04 4.69 4.46 4.28 4.14 4.03 3.94 3.80 3.66 3.51 3.43 3.35 3.27 3.18 3.09 3.00
15 8.68 6.36 5.42 4.89 4.56 4.32 4.14 4.00 3.89 3.80 3.67 3.52 3.37 3.29 3.21 3.13 3.05 2.96 2.87
16 8.53 6.23 5.29 4.77 4.44 4.20 4.03 3.89 3.78 3.69 3.55 3.41 3.26 3.18 3.10 3.02 2.93 2.84 2.75
17 8.40 6.11 5.18 4.67 4.34 4.10 3.93 3.79 3.68 3.59 3.46 3.31 3.16 3.08 3.00 2.92 2.83 2.75 2.65
18 8.29 6.01 5.09 4.58 4.25 4.01 3.84 3.71 3.60 3.51 3.37 3.23 3.08 3.00 2.92 2.84 2.75 2.66 2.57
19 8.18 5.93 5.01 4.50 4.17 3.94 3.77 3.63 3.52 3.43 3.30 3.15 3.00 2.92 2.84 2.76 2.67 2.58 2.49
20 8.10 5.85 4.94 4.43 4.10 3.87 3.70 3.56 3.46 3.37 3.23 3.09 2.94 2.86 2.78 2.69 2.61 2.52 2.42
21 8.02 5.78 4.87 4.37 4.04 3.81 3.64 3.51 3.40 3.31 3.17 3.03 2.88 2.80 2.72 2.64 2.55 2.46 2.36
22 7.95 5.72 4.82 4.31 3.99 3.76 3.59 3.45 3.35 3.26 3.12 2.98 2.83 2.75 2.67 2.58 2.50 2.40 2.31
23 7.88 5.66 4.76 4.26 3.94 3.71 3.54 3.41 3.30 3.21 3.07 2.93 2.78 2.70 2.62 2.54 2.45 2.35 2.26
24 7.82 5.61 4.72 4.22 3.90 3.67 3.50 3.36 3.26 3.17 3.03 2.89 2.74 2.66 2.58 2.49 2.40 2.31 2.21
25 7.77 5.57 4.68 4.18 3.85 3.63 3.46 3.32 3.22 3.13 2.99 2.85 2.70 2.62 2.54 2.45 2.36 2.27 2.17
26 7.72 5.53 4.64 4.14 3.82 3.59 3.42 3.29 3.19 3.09 2.96 2.81 2.66 2.58 2.50 2.42 2.33 2.23 2.13
27 7.68 5.49 4.60 4.11 3.78 3.56 3.39 3.26 3.15 3.06 2.93 2.78 2.63 2.55 2.47 2.38 2.29 2.20 2.10
28 7.64 5.45 4.57 4.07 3.75 3.53 3.36 3.23 2.12 3.03 2.90 2.75 2.60 2.52 2.44 2.35 2.26 2.17 2.06
29 7.60 5.42 4.54 4.04 3.73 3.50 3.33 3.20 3.09 3.00 2.87 2.73 2.57 2.49 2.41 2.33 2.23 2.14 2.03
30 7.56 5.39 4.51 4.02 3.70 3.47 3.30 3.17 3.07 2.98 2.84 2.70 2.55 2.47 2.39 2.30 2.21 2.11 2.01
40 7.31 5.18 4.31 3.83 3.51 3.29 3.12 2.99 2.89 2.80 2.66 2.52 2.37 2.29 2.20 2.11 2.02 1.92 1.80
60 7.08 4.98 4.13 3.65 3.34 3.12 2.95 2.82 2.72 2.63 2.50 2.35 2.20 2.12 2.03 1.94 1.84 1.73 1.60
120 6.85 4.79 3.95 3.48 3.17 2.96 2.79 2.66 2.56 2.47 2.34 2.19 2.03 1.95 1.86 1.76 1.66 1.53 1.38
∞ 6.63 4.61 3.78 3.32 3.02 2.80 2.64 2.51 2.41 2.32 2.18 2.04 1.88 1.79 1.70 1.59 1.47 1.32 1.00

From Merrington, M., and Thompson, C.M. (1943). Tables of percentage points of the inverted beta (F) distribution. Biometrika, 33(1), 73–78.
Appendix E
Critical Values of the χ2 Distribution

Alpha (α) Level


df .10 .05 .025 .01 .001
1 2.7055 3.8415 5.0239 6.6349 10.8276
2 4.6052 5.9915 7.3778 9.2103 13.8155
3 6.2514 7.8147 9.3484 11.3449 16.2662
4 7.7794 9.4877 11.1433 13.2767 18.4668
5 9.2364 11.0705 12.8325 15.0863 20.5150
6 10.6446 12.5916 14.4494 16.8119 22.4577
7 12.0170 14.0671 16.0128 18.4753 24.3219
8 13.3616 15.5073 17.5345 20.0902 26.1245
9 14.6837 16.9190 19.0228 21.6660 27.8772
10 15.9872 18.3070 20.4832 23.2093 29.5883
11 17.2750 19.6751 21.9200 24.7250 31.2641
12 18.5493 21.0261 23.3367 26.2170 32.9095
13 19.8119 22.3620 24.7356 27.6882 34.5282
14 21.0641 23.6848 26.1189 29.1412 36.1233
15 22.3071 24.9958 27.4884 30.5779 37.6973
16 23.5418 26.2962 28.8454 31.9999 39.2524
17 24.7690 27.5871 30.1910 33.4087 40.7902
18 25.9894 28.8693 31.5264 34.8053 42.3124
19 27.2036 30.1435 32.8523 36.1909 43.8202
20 28.4120 31.4104 34.1696 37.5662 45.3147
21 29.6151 32.6706 35.4789 38.9322 46.7970
22 30.8133 33.9244 36.7807 40.2894 48.2679
23 32.0069 35.1725 38.0756 41.6384 49.7282
24 33.1962 36.4150 39.3641 42.9798 51.1786
25 34.3816 37.6525 40.6465 44.3141 52.6197
26 35.5632 38.8851 41.9232 45.6417 54.0520
27 36.7412 40.1133 43.1945 46.9629 55.4760
28 37.9159 41.3371 44.4608 48.2782 56.8923
29 39.0875 42.5570 45.7223 49.5879 58.3012
30 40.2560 43.7730 46.9792 50.8922 59.7031
31 41.4217 44.9853 48.2319 52.1914 61.0983
32 42.5847 46.1943 49.4804 53.4858 62.4872
33 43.7452 47.3999 50.7251 54.7755 63.8701
34 44.9032 48.6024 51.9660 56.0609 65.2472
35 46.0588 49.8018 53.2033 57.3421 66.6188
36 47.2122 50.9985 54.4373 58.6192 67.9852
37 48.3634 52.1923 55.6680 59.8925 69.3465
38 49.5126 53.3835 56.8955 61.1621 70.7029
39 50.6598 54.5722 58.1201 62.4281 72.0547
40 51.8051 55.7585 59.3417 63.6907 73.4020
41 52.9485 56.9424 60.5606 64.9501 74.7449
42 54.0902 58.1240 61.7768 66.2062 76.0838
43 55.2302 59.3035 62.9904 67.4593 77.4186
44 56.3685 60.4809 64.2015 68.7095 78.7495
45 57.5053 61.6562 65.4102 69.9568 80.0767

From Corty, E. (2007). A Practical Text for the Health, Behavioral and Social Sciences. St. Louis, MO: Mosby.

683
Appendix F
Statistical Power Tables (Δ = Effect Size)

5% Level, One-Tailed Test


Power
Δ 99 95 90 80 70 60 50 40 30 20 10
0.01 157695 108215 85634 61823 47055 36031 27055 19363 12555 6453 1321
0.02 39417 27050 21405 15454 11763 9007 6764 4841 3139 1614 331
0.03 17514 12019 9511 6867 5227 4003 3006 2152 1396 718 148
0.04 9848 6578 5348 3861 2939 2251 1691 1210 785 404 84
0.05 6299 4323 3421 2470 1881 1440 1082 775 503 259 54
0.06 4372 3000 2375 1715 1305 1000 751 538 349 180 38
0.07 3209 2203 1744 1259 959 734 552 395 257 133 29
0.08 2455 1685 1334 963 734 562 422 303 197 102 23
0.09 1938 1330 1053 761 579 444 334 239 156 81 18
0.10 1568 1076 852 616 469 359 270 194 126 66 15
0.11 1294 889 704 508 387 297 223 160 104 54 13
0.12 1086 746 590 427 325 249 188 135 88 46 11
0.13 924 635 503 363 277 212 160 115 75 39 10
0.14 796 546 433 313 238 183 138 99 65 34 *
0.15 692 475 376 272 207 159 120 86 56 30 *
0.16 607 417 330 239 182 140 105 76 50 27 *
0.17 537 369 292 211 161 124 93 67 44 24 *
0.18 478 328 260 188 144 110 83 60 39 21 *
0.19 428 294 233 169 129 99 75 54 35 19 *
0.20 385 265 210 152 116 89 67 49 32 17 *
0.22 317 218 173 125 96 74 56 40 27 15 *
0.24 265 182 144 105 80 62 47 34 23 12 *
0.26 224 154 122 89 68 52 40 29 19 11 *
0.28 192 132 105 76 58 45 34 25 17 10 *
0.30 166 114 91 66 51 39 30 22 15 * *
0.32 145 100 79 58 44 34 26 19 13 * *
0.34 127 88 70 51 39 30 23 17 12 * *
0.36 113 78 62 45 35 27 20 15 10 * *
0.38 100 69 55 40 31 24 18 14 * * *
0.40 89 62 49 36 28 21 16 12 * * *
0.45 69 48 38 28 21 17 13 10 * * *
0.50 54 37 30 22 17 13 10 * * * *
0.55 43 30 24 17 14 11 * * * * *
0.60 34 24 19 14 11 * * * * * *
0.65 28 19 16 12 * * * * * * *
0.70 23 16 13 10 * * * * * * *
0.75 18 13 10 * * * * * * * *
0.80 15 10 * * * * * * * * *
0.85 12 * * * * * * * * * *
0.90 * * * * * * * * * * *

From Kraemer, H.C., and Thiemann, S. (1987). How Many Subjects: Statistical Power Analysis in Research. Newbury Park, CA: Sage.

684
APPENDIX F  Statistical Power Tables (Δ = Effect Size) 685

1% Level, One-Tailed Test


Power
Δ 99 95 90 80 70 60 50 40 30 20 10
0.01 216463 157695 130162 100355 81264 66545 54117 42972 32469 22044 10917
0.02 54106 39417 32535 25085 2031 16634 13528 10742 8117 5511 2730
0.03 24040 17514 14456 11146 9026 7391 6011 4773 3607 2449 1214
0.04 13517 9848 8128 6267 5075 4156 3380 2684 2029 1378 683
0.05 8646 6299 5200 4009 3247 2659 2163 1718 1298 882 437
0.06 6000 4372 3609 2783 2254 1846 1501 1192 901 612 304
0.07 4405 3209 2649 2043 1655 1355 1102 876 662 450 224
0.08 3369 2455 2027 1563 1266 1037 843 670 507 344 171
0.09 2660 1938 1600 1234 999 819 666 529 400 272 136
0.10 2152 1568 1295 998 809 663 539 428 324 220 110
0.11 1776 1294 1069 824 668 547 445 354 268 182 91
0.12 1490 1086 897 692 560 459 374 297 225 153 77
0.13 1268 924 763 589 477 391 318 253 191 130 65
0.14 1092 796 657 507 411 337 274 218 165 112 56
0.15 949 692 571 441 357 293 238 190 144 98 49
0.16 833 607 501 387 314 257 209 166 126 86 43
0.17 736 537 443 342 277 277 185 147 112 76 39
0.18 655 478 395 305 247 202 165 131 100 68 34
0.19 587 428 353 273 221 181 148 118 89 61 31
0.20 528 385 318 246 199 163 133 106 81 55 29
0.22 434 317 262 202 164 135 110 87 66 46 24
0.24 363 265 219 169 137 113 92 73 56 38 21
0.26 307 224 185 143 116 95 78 62 47 33 18
0.28 263 192 159 123 100 82 67 53 41 29 16
0.30 227 166 137 106 86 71 58 46 35 25 14
0.32 198 145 120 93 75 62 51 41 31 22 12
0.34 174 127 105 82 66 55 45 36 28 20 11
0.36 154 113 93 72 59 48 40 32 25 18 10
0.38 137 100 83 64 52 43 35 29 22 16 *
0.40 122 89 74 57 47 39 32 26 20 15 *
0.45 94 69 57 44 36 30 25 20 16 12 *
0.50 73 54 45 35 29 24 20 16 13 * *
0.55 58 43 36 28 23 19 16 13 11 * *
0.60 47 34 29 23 19 16 13 11 * * *
0.65 38 28 23 18 15 13 11 * * * *
0.70 30 23 19 15 12 11 * * * * *
0.75 25 18 15 12 10 * * * * * *
0.80 20 15 12 10 * * * * * * *
0.85 16 12 10 * * * * * * * *
0.90 12 * * * * * * * * * *

From Kraemer, H.C., and Thiemann, S. (1987). How Many Subjects: Statistical Power Analysis in Research. Newbury Park, CA: Sage.
Glossary

A agencies, and others not directly involved in providing


absolute zero point  Point at which a value of zero indi- patient care.
cates the absence of the property being measured. Ratio- Agency for Healthcare Research and Quality (AHRQ) 
level measurements, such as weight scales, vital signs, Federal government agency created in 1989 to carry out
and laboratory values, have an absolute zero point. research, demonstration projects, evidence-based guide-
abstract  Clear, concise summary of a study, usually line development, training, and research dissemination
limited to 100 to 250 words. activities with respect to healthcare services and systems.
abstract thinking  Oriented toward the development of an Focus of this agency is to promote evidence-based health
idea without application to or association with a particular care; see the website for details at www.ahrq.gov. AHRQ
instance, and independent of time and space. Abstract was previously named Agency for Health Care Policy and
thinkers tend to look for meaning, patterns, relationships, Research, with a name change in 1999.
and philosophical implications. alpha (α)  Level of significance or cutoff point used to
abstract thought processes  Enable both science and the- determine whether the samples being tested are members
ories to be blended into a cohesive body of knowledge, of the same population (nonsignificant) or different popu-
guided by a philosophical framework and applied to clini- lations (significant); alpha is commonly set at 0.05, 0.01,
cal practice. or 0.001. Alpha is also the probability of making a type I
acceptance rate  Number or percentage of the subjects who error.
agree to participate in a study. The percentage is calculated alternate-forms reliability  Also referred to as parallel
by dividing the number of subjects agreeing to participate forms reliability, which involves comparing the equiva-
by the number of subjects approached. For example, if lence of two versions of the same paper-and-pencil
100 subjects are approached and 90 agree to participate, instruments.
the acceptance rate is 90% (90 ÷ 100 × 100% = 90%). analysis of covariance (ANCOVA)  Statistical procedure
accessible population  Portion of a target population to designed to reduce the error term (or variance within
which the researcher has reasonable access. groups) by partialing out the variance resulting from a
accidental or convenience sampling  Nonprobability confounding variable by performing regression analysis
sampling technique in which subjects are included in the before performing analysis of variance (ANOVA).
study because they happened to be in the right place at analysis of sources  Process of determining the value of a
the right time. Available subjects are simply entered into reference for a particular study. The source is critically
the study until the desired sample size is reached. appraised and then compared with that of other studies to
accuracy  The closeness of the agreement between the determine the existing body of knowledge in relation to
measured value and the true value of the quantity being the research problem.
measured. analysis of variance (ANOVA)  Statistical technique used
accuracy in physiological measures  Comparable to to examine differences among two or more groups by
validity in that it addresses the extent to which the instru- comparing the variability between the groups with the
ment measured the domain that is defined in the study. variability within the groups.
accuracy of a screening test  Test used to confirm a diag- ancestry searches  Use of citations in relevant studies to
nosis, evaluating it in terms of its ability to correctly identify additional studies. Especially important in con-
assess the presence or absence of a disease or condition ducting a systematic review of research.
in comparison with a gold standard. anonymity  In research, the condition in which a subject’s
adjusted  Term used when each hazard ratio (HR) has been identity cannot be linked, even by the researcher, with his
adjusted for every other predictor in the regression model. or her individual responses.
administrative databases  Databases with standardized applied or practical research  Scientific investigations
sets of data for enormous numbers of patients and provid- conducted to generate knowledge that will directly influ-
ers that are created by insurance companies, government ence or improve practice.

686
Glossary 687

apprenticeship  A volunteer position in which one works to do what is best for the individual on the basis of balanc-
closely with an experienced researcher in order to develop ing risks and benefits in a study.
one’s research skills. best research evidence  The strongest empirical knowl-
assent  A child’s affirmative agreement to participate in edge available that is generated from the synthesis of
research. quality study findings to address a practice problem.
associative hypothesis  Identifies or predicts the relation- between-group variance  Variance of the group means
ship between or among variables that occur or exist around the grand mean (the mean of the total sample) that
together in the real world. It is usually developed to guide is examined in analysis of variance (ANOVA).
a correlational study. bias  Any influence or action in a study that distorts the
associative relationship  Identifies concepts that occur or findings or slants them away from the true or expected.
exist together in the real world; thus, when one concept biased coin design  Technique used to randomly assign
changes, the other concept changes. These relationships subjects to groups in which selection of the group to
are part of theory and can be tested through research. which a particular subject will be assigned is biased in
assumptions  Statements taken for granted or considered favor of groups that have smaller sample sizes at the point
true, even though they have not been scientifically tested. of the assignment of that subject.
asymmetrical relationship  If A occurs (or changes), then bibliographical database  Database that either consists of
B will occur (or change), but there may be no indication citations relevant to a specific discipline or is a broad
that if B occurs (or changes), A will occur (or change). collection of citations from a variety of disciplines.
delete A_B; A—B. bimodal  Distribution of scores from a study has two
attrition rate  The number and percentage of subjects or modes (or most frequently occurring scores), which
study participants who drop out of a study before comple- usually means that the researcher has not adequately
tion, which creates a threat to the study’s internal defined the study population.
validity. bivariate analysis  Statistical procedures that involve
authority  Person with expertise and power who is able to comparison of summary values from two groups of 
influence opinion and behavior. the same variable or from two variables within a single
autoethnography  The formal study of one’s own culture group.
or social context. bivariate correlation analysis  Analysis techniques that
measure the extent of the linear relationship between two
B variables.
background for a research problem  Part of the research Bland and Altman plot  Analysis technique for examining
problem that indicates what is known or the key research the extent of agreement between two physiological mea-
that has been done in the problem area to be studied. surement techniques. Generally used to compare a new
bar graphs  Figures or illustrations that provide a picture technique with an established one.
of the results from a study. These graphs can be horizontal blinding  Structure of a design whereby either the patient
or vertical bars that represent the size or amount of the or those providing care to the patient are unaware whether
group or variable studied. the patient is in the experimental group or the control
basic or pure research  Scientific investigations for the group.
pursuit of knowledge for knowledge’s sake or for the blocking  Part of the randomized block design, in which
pleasure of learning and finding truth. the subjects are rank ordered in relation to the blocking
being  A term in phenomenological research whereby a variable to control the effects of this variable, thus
person’s experiences of the world are unique to that improving the validity of study findings.
person. body of knowledge  Information, principles, theories, and
being-in-time  Term from phenomenological research that empirical evidence that are organized by the beliefs
indicates that a person experiences life situations within accepted in a discipline at a given time.
the framework of time and that the past and the future Bonferroni procedure  Parametric analysis technique that
influence the now and thus are part of being-in-time. controls for escalation of significance and that can be used
beneficence, principle of  Encourages the researcher to do if various t-tests must be performed on different aspects
good and, above all, to do no harm. of the same data.
benefit-risk ratio  Means by which researchers and borrowing  Appropriation and use of knowledge from
reviewers of research judge the potential benefits and other disciplines to guide nursing practice.
risks in a study to promote the conduct of ethical research. bracketing  Qualitative research technique of suspending
best interest standard  In determining whether an indi- or laying aside what is known about an experience being
vidual should participate in a study, the researcher needs studied.
688 Glossary

breach of confidentiality  Accidental or direct action that observed frequencies within the data and frequencies that
allows an unauthorized person to have access to raw study were expected.
data or subject identity information. citation  Act of quoting a source, using it as an example,
or presenting it as support for a position taken.
C citation bias  Occurs when certain studies are cited more
calculated variable  A variable used in the analysis is not often than others and are more likely to be identified in
collected but calculated from other variables. database searches.
canonical correlation  Extension of multiple regression classical hypothesis testing  Refers to the process of
with more than one dependent variable. testing a hypothesis to infer the reality of an effect.
care bundles  Combinations of interrelated nursing cleaning data  Checking raw data to determine errors in
actions. data recording, coding, or entry.
care maps  Type of map developed in intervention research client treatment matching  Also called treatment match-
of the intervention theory that illustrates the elements of ing; is used in intervention research to compare the rela-
the intervention and the causal links among them, and that tive effectiveness of various treatments when the following
should show all the causal pathways described in the conditions are met: (1) there is no clearly superior treat-
intervention theory. ment for individuals with a problem, (2) a number of
carryover effect  Application of one treatment can influ- treatments have some proven efficacy for undifferentiated
ence the response to following treatments. subjects, and (3) there is evidence of differential outcomes
case-control design  Involves a matching procedure with and among treatments for defined subtypes of
whereby a control subject is matched to each case, so that patients.
the cases and controls are different people matched clinical databases  Databases of patient, provider, and
demographically. healthcare agency information that are developed by
case study design  A design that guides the intensive healthcare agencies and sometimes providers to document
exploration of a single unit of study, such as a person, care delivery and outcomes.
family, group, community, or institution. clinical expertise  Consists of a practitioner’s knowledge,
causal connection  The link between the independent vari- skills, and past experience in accurately assessing, diag-
able (cause) and the dependent variable (outcome or nosing, and managing an individual’s health needs.
effect) that is examined in quasi-experimental, experi- clinical guidelines  Standardized, current national and
mental, and intervention research. international guidelines for the assessment, diagnosis, and
causal explanation  The description or explanation of the management of patient conditions that are developed by
effect(s) of the independent variable (cause or interven- clinical guideline panels or professional groups to improve
tion) on the dependent variable (outcome). the outcomes of care and promote evidence-based health
causal hypothesis or relationship  Relationship between care (see www.guideline.gov).
two variables in which one variable (independent variable) clinical judgment  The use of clinical expertise to make
is thought to cause or determine the presence of the other sound decisions in the provision of evidence-based health
variable (dependent variable). Some causal hypotheses care.
include more than one independent or dependent variable. clinical pathways  Critical pathways or guidelines devel-
causality  Has three conditions: (1) there must be a oped by healthcare agencies to define the expected care
strong relationship between the proposed cause and activities and outcomes of care in specific patient care
effect, (2) the proposed cause must precede the effect in situations. These pathways are developed on the basis of
time, and (3) the cause has to be present whenever the previous research, agency data, and clinical experience to
effect occurs. provide evidence-based practice.
cell  Intersection between the row and column in a table clinical trial  A study conducted to determine the effect of
where a specific numerical value is inserted. a selected intervention (such as a drug or nursing or
censored data  Survival times that are known only to medical procedure) on identified patient outcomes using
exceed a certain value. a structured experimental design. Produces a strong type
central limit theorem  States that even when statistics, of research evidence that can be synthesized with other
such as means, come from a population with a skewed study findings to determine the current best research evi-
(asymmetrical) distribution, the sampling distribution dence in a practice area.
developed from multiple means obtained from that skewed cluster sampling  A sampling frame is developed that
population will tend to fit the pattern of the normal curve. includes a list of all the states, cities, institutions, or orga-
chi-square test of independence (χ2)  Used to analyze nizations (clusters) that could be used in a study, and a
nominal data to determine significant differences between randomized sample is drawn from this list. Cluster
Glossary 689

sampling is used when it is not possible to use simple usual healthcare, and (4) groups that receive a second
random sampling or the individual elements of the popu- experimental treatment or a different treatment dose for
lation are unknown, preventing development of the sam- comparison with the first experimental treatment.
pling frame. complete IRB review  Extensive review by an institu-
code  A symbol or abbreviation used to label words or tional review board (IRB) for studies with greater than
phrases in the data. minimal risk.
codebook  Identifies and defines each variable in a study complete observation  The researcher is passive and has
and includes an abbreviated variable name, a descriptive no direct social interaction in the setting.
variable label, and the range of possible numerical values complete participation  The researcher becomes a mem­
of every variable entered into a computer file. ber of the group and conceals the researcher role.
coding  In quantitative studies, the process of transforming complex hypothesis  Predicts the relationship (associative
qualitative data into numerical symbols that can be com- or causal) among three or more variables; thus, the
puterized. In qualitative studies, the process of labeling hypothesis could include two (or more) independent and
phrases and quotations to identify themes and patterns. two (or more) dependent variables.
coefficient of determination (R2)  Computed from a comprehending a source  Involves reading the entire
matrix of correlation coefficients; provides important source carefully and focusing on understanding the 
information on multicollinearity. This value indicates the major concepts and the logical flow of ideas within the
degree of linear dependencies among the variables. source.
coefficient of stability  Result of a correlational analysis computer searches  Conducted to scan the citations in dif-
of the scores of two educational tests or scales given two ferent databases and identify sources relevant to a research
to four weeks apart. problem.
coercion  Overt threat of harm or excessive reward inten- computerized database  Structured compilation of infor-
tionally presented by one person to another to obtain mation that can be scanned, retrieved, and analyzed by
compliance, such as offering subjects a large sum of computer and can be used for decisions, reports, and
money to participate in a dangerous research project. research.
cognitive application of research  Use of research-based concept  Term that abstractly describes and names an
knowledge to affect a person’s way of thinking about, object or phenomenon, thus providing it with a separate
approaching, and observing situations. identity or meaning.
cohorts  Samples in time-dimensional studies within the concept analysis  Strategy through which a set of attributes
field of epidemiology. or characteristics essential to the connotative meaning or
communicating research findings  Developing a research conceptual definition of a concept are identified.
report and disseminating it through presentations and concept derivation  Process of extracting and defining
publications to a variety of audiences. concepts from theories in other disciplines. May require
comparative analysis  Involves examining methodology a concept analysis that examines the use of the concept
and findings across studies for similarities and differ- in the nursing literature, compares the results with the
ences. The frequency of similar findings might be existing conceptual definition, and, if the two are differ-
recorded. ent, modifies the definition to be consistent with nursing
comparative descriptive design  Used to describe differ- usage.
ences in variables in two or more groups in a natural concept synthesis  Process of describing and naming a
setting. previously unrecognized concept.
comparative evaluation  Has four parts: (1) substantiation conceptual definition  Provides a variable or concept with
of the evidence, (2) fit of the evidence with the healthcare connotative (abstract, comprehensive, theoretical) mean­
setting, (3) feasibility of using research findings, and  ing and is established through concept analysis, concept
(4) concerns with current practice. derivation, or concept synthesis. The conceptual defini-
comparative experimental design  Less rigorous experi- tion of a variable in a study is often developed from the
mental design in which random sampling is difficult if not study framework and is the link between the study frame-
impossible. The studies include convenience samples work and the operational definition of the variable.
with random assignment to groups. conceptual map  Strategy for expressing a framework of
comparison group  A group of subjects that is not selected a study that diagrammatically shows the interrelationships
through random sampling and usually does not receive a of the concepts and statements.
treatment. There are four types of comparison groups:  conceptual model  Set of highly abstract, related con-
(1) groups that receive no treatment, (2) groups that receive structs that broadly explains phenomena of interest,
a placebo treatment, (3) groups that receive standard or expresses assumptions, and reflects a philosophical stance.
690 Glossary

conclusions  Synthesis and clarification of the meaning of relevant to the construct being measured. Evidence for
study findings. content-related validity is obtained from the literature,
concrete thinking  Thinking that is oriented toward and representatives of the relevant populations, and content
limited by tangible things or events observed and experi- experts.
enced in reality. content validity ratio  Calculated by researchers for each
concurrent relationship  Relationship in which both vari- item on a scale by rating it a 0 (not necessary), 1 (useful),
ables and concepts occur simultaneously. or 3 (essential).
concurrent triangulation strategy  This design model is content validity index  Developed to obtain a numerical
selected when a researcher wishes to use quantitative and value that reflects the level of content-related validity
qualitative methods in an attempt to confirm, cross-vali- evidence for a measurement method.
date, or corroborate findings within a single study. contingent relationship  Occurs only if a third variable or
condensed proposal  A brief or shortened proposal devel- concept is present.
oped for review by clinical agencies and funding continuous variable  Variable in which higher numbers
institutions. represent more of that variable and the lower numbers
confidence interval  Range in which the value of the popu- represent less of that variable.
lation parameter is estimated to be. control  Imposing of rules by the researcher to decrease
confidentiality  Management of private data in research so the possibility of error and increase the probability that
that subjects’ identities are not linked with their responses. the study’s findings are an accurate reflection of reality.
confirmatory data analysis  Use of inferential statistics to control group  Group of elements or subjects not exposed
confirm expectations regarding the data that are expressed to the experimental treatment. The term control group is
as hypotheses. used in studies with random sampling methods.
confirmatory studies  Conducted only after a large body convenience sampling  See accidental sampling.
of knowledge has been generated with exploratory convergent validity  Type of measurement validity
studies; are expected to have large samples and to use obtained by using two instruments to measure the same
random sampling techniques. variable, such as depression, and correlating the results
confounding variables  Variables that have the potential from these instruments. Evidence of validity from examin-
to affect the outcome of a study, which are recognized ing convergence is achieved if the data from the two instru-
before the study is initiated but that cannot be controlled, ments have a moderate to strong positive correlation.
or variables not recognized until the study is in process. correlational analysis  Statistical procedure conducted to
consensus knowledge building  Outcomes design that determine the direction (positive or negative) and magni-
requires critical appraisal and synthesis of an extensive tude (or strength) of the relationship between two
international search of the literature on the topic of variables.
concern, including unpublished studies, studies in prog- correlational coefficient  Indicates the degree of rela­
ress, dissertations, and theses. tionship between two variables; coefficients range in
consent form  Written form, audio recording, or video value from +1.00 (perfect positive relationship) to 0.00
recording used to document a subject’s agreement to par- (no relationship) to −1.00 (perfect negative or inverse
ticipate in a study. relationship).
concurrent validity  Ability to predict the current value of correlational matrix  A table of the bivariate correlations
one measure on the basis of the value obtained on the of every pair of variables in a data set. Along the diagonal
measure of another concept. through the matrix the variables are correlated with them-
construct validity  Examines the fit between conceptual selves, with the left and right sides of the table being
and operational definitions of variables and determines mirror images of each other.
whether the instrument actually measures the theoretical correlational research  Systematic investigation of rela-
construct that it purports to measure. tionships between two or more variables to explain the
constructs  Concepts at very high levels of abstraction that type (positive or negative) and strength of relationships
have general meanings. in the world and not to examine cause and effect.
content analysis  Qualitative analysis technique used to correlational study designs  Variety of study designs
classify words in a text into a few categories chosen developed to examine relationships among variables.
because of their theoretical importance. counterbalancing  Administration of various treatments in
content expert  A clinician or researcher who is known for random order rather than consistently in the same
his or her work in a specific area. sequence.
content validity  Examines the extent to which the mea- covert data collection  Occurs when subjects are unaware
surement method includes all the major elements that research data are being collected.
Glossary 691

criterion-referenced testing  Comparison of a subject’s data coding sheet  A sheet for organizing and recording
score with a criterion of achievement that includes the data for rapid entry into a computer.
definition of target behaviors. When the subject has mas- data collection  Precise, systematic gathering of informa-
tered the behaviors, he or she is considered proficient in tion relevant to the research purpose or the specific objec-
these behaviors, such as being proficient in the behaviors tives, questions, or hypotheses of a study.
of a nurse practitioner. data collection forms  Forms developed or modified for a
critical appraisal of research  Systematic, unbiased, study to use for recording demographic data, information
careful examination of all aspects of a study to judge the from patient records, observations, or values from physi-
merits, limitations, meaning, and significance based on ological measures.
previous research experience and knowledge of the topic. data collection plan  Details on how a study will be
critical appraisal process for qualitative research  Eval- implemented.
uating the quality of a qualitative study by examining its data saturation  In qualitative research, occurs when addi-
philosophical congruence, methodological coherence, tional sampling provides no new information, only redun-
intuitive comprehension, and intellectual contribution. dancy of previous collected data.
critical appraisal process for quantitative research  data use agreement  Limits how the data set for a study
Examination of the quality of a quantitative study using may be used and how it will be protected to meet Health
the following three steps: (1) identifying the steps of  Insurance Portability and Accountability Act (HIPAA)
the research process, (2) determining the study’s requirements.
strengths and weaknesses, and (3) evaluating the credi- datum  Single piece of information collected for research.
bility and meaning of a study to nursing knowledge and debriefing  Complete disclosure of the study purpose and
practice. results at the end of a study.
critical cases  Cases that make a point clearly or are deception  Misinforming subjects for research purposes.
extremely important in understanding the purpose of the decision making  Cognitive process of assessing a situa-
study and are identified through purposive sampling. tion and deciding on a course of action, which is impor-
critical pathways  See clinical pathways. tant for conducting research and providing health care.
critical value  In quantitative data analysis, the value at Declaration of Helsinki  Ethical code based on the
which statistical significance is achieved in a study. Nuremberg Code that differentiated therapeutic from non-
crossover or counterbalanced design  Includes the therapeutic research.
administration of more than one treatment to each subject, deductive reasoning  Reasoning from the general to the
and the treatments are provided sequentially rather than specific, or from a general premise to a particular situation.
concurrently; comparisons are then made of the effects of deductive thinking  Thinking that begins with a theory
the different treatments on the same subject. or abstract principle that guides the selection of methods
cross-sectional designs  Used to examine groups of sub- to gather data to support or refute the theory or
jects in various stages of development simultaneously principle.
with the intent of inferring trends over time. degrees of freedom (df )  Freedom of a score’s value to
cultural immersion  The spending of extended periods in vary given the other existing scores’ values and the estab-
the culture one is studying using ethnographic methods to lished sum of these scores (df = N − 1).
gain increased familiarity with such things as language, de-identifying health data  Involves removing the 18 ele-
sociocultural norms, and traditions in a culture. ments that could be used to identify an individual or his
curvilinear relationship  A relationship between two vari- or her relatives, employer, or household members; this
ables that varies depending on the relative values of the term is part of the Health Insurance Portability and
variables. The graph of the relationship is a curved line Accountability Act (HIPAA).
rather than a straight one. Delphi technique  Method of measuring the judgments of
cutoff point  In factor analysis, variables’ factor loading a group of experts for assessing priorities or making
must be at least 0.30 to explain a meaningful portion of forecasts.
the variance within a factor, and these variables are demographic or attribute variables  Specific variables
included as elements of the factor. such as age, gender, and ethnicity that are collected in a
study to describe the sample.
D denominator  The number on the bottom part of a
data  (plural) Pieces of information that are collected fraction
during a study (singular: datum). denotative definition  Dictionary definition of a word.
data analysis  Conducted to reduce, organize, and give dependent groups  Groups in which the subjects or obser-
meaning to data. vations selected for data collection are in some way
692 Glossary

related to the selection of other subjects or observations. them by merging them into a single unit or idea that is
For example, if subjects serve as their own control by greater than either alone.
using the pretest as a control, the observations (and there- diary  Record of events kept by a subject over time that is
fore the groups) are dependent. Use of twins in a study or collected and analyzed by a researcher.
matching subjects on a selected variable, such as medical difference scores  See deviation score.
diagnosis or age, results in dependent groups. diminished autonomy  Describes subjects with decreased
dependent variable  Response, behavior, or outcome that ability to voluntarily give informed consent because of
is predicted and measured in research; changes in the legal or mental incompetence, terminal illness, or confine-
dependent variable are presumed to be caused by the ment to an institution.
independent variable. direct costs  Specific costs for materials and equipment to
description  Involves identifying and understanding the conduct a study that are identified in a grant proposal.
nature and attributes of nursing phenomena and some- direct measurement  Measurement object and measure-
times the relationships among these phenomena. This is ment strategies are specific and straightforward, such as
an outcome of research. those for measuring the concrete variables of height,
descriptive correlational design  Used to describe vari- weight, or temperature.
ables and examine relationships that exist in a study direction of a relationship  The direction of a relationship
situation. can be positive or negative. With a positive relationship,
descriptive design  Used to identify a phenomenon of the two variables change in the same direction (increase
interest, identify variables within the phenomenon, or decrease together). With a negative relationship, the
develop conceptual and operational definitions of vari- variables change in opposite directions; thus, as one vari-
ables, and describe variables in a study situation. able increases, the other decreases.
descriptive research  Provides an accurate portrayal or directional hypothesis  Predicts the specific nature of the
account of the characteristics of a particular individual, interaction or relationship between two or more variables.
event, or group in real-life situations for the purpose of disproportionate sampling  In stratification, when each
discovering new meaning, describing what exists, deter- stratum has an equivalent number of subjects in the
mining the frequency with which something occurs, and sample, versus each stratum having a number of subjects
categorizing information. in proportion to its occurrence in the population, which is
descriptive statistics  Summary statistics that allow the proportionate sampling.
researcher to organize the data in ways that give meaning dissemination of research findings  Diffusion or com­
and facilitate insight, such as frequency distributions and munication of research findings by presentations and pub-
measures of central tendency and dispersion. lications to a variety of audiences, such as nurses, other
descriptive study designs  Variety of designs developed to health professionals, policy developers, and consumers.
gain more information about characteristics within a par- dissertation  Extensive, usually original, research project
ticular field of study and to provide a picture of situations that is completed as the final requirement for a doctoral
as they naturally happen. degree.
descriptive theory  Describes the causal process occurring distribution-free  No assumption has been made for a
in intervention research. normal distribution of values in the population from
design  Blueprint for conducting a study that maximizes which the sample was taken.
control over factors that could interfere with the validity distribution  Spread of scores in a study or database.
of the findings. divergent validity  Type of measurement validity obtained
design validity  Strength of a design to produce accurate by finding an instrument that measures the opposite of the
results, which is determined by examining statistical con- concept or variable being studied and correlating the data
clusion validity, internal validity, construct validity, and collected with an instrument that measures the concept or
external validity. variable studied. For example, if the focus of a study is
deterministic relationship  Causal statement of what to measure hope, one instrument would measure hope and
always occurs in a particular situation, such as a scientific another would measure despair.
law. dose-intensity  The amount of the intervention delivered
deviation score  Difference score, which is obtained by in terms of the (1) components of the intervention, (2)
subtracting the mean from each score; indicates the extent duration of a single session for the intervention, (3) fre-
to which a score deviates from the mean. quency with which the intervention is delivered (e.g.,
dialectic reasoning  Involves the holistic perspective, in daily, times per week, times per month), and (4) cumula-
which the whole is greater than the sum of the parts, and tive intervention intensity (number of treatments received
examining factors that are opposites and making sense of and duration).
Glossary 693

double-blinding in a study design  Structure of a design equivalence reliability  Compares two versions of the
in which neither the patient nor the caregivers are aware same paper-and-pencil instrument or two observers mea-
of the group (experimental or control) to which the patient suring the same event.
is assigned during a study. error score  Amount of random error in the measurement
dummy variables  Categorical or dichotomous variables process.
used in regression analysis. errors in physiological measures  Sources of erroneous
duplicate publication bias  Practice of publishing the measurement with physiological instruments; include
same article or major portions of the article in two or more environment, user, subject, machine, and interpretation
print or electronic media without notifying the editors or errors.
referencing the other publication in the reference list. escalates significance  During analysis of study data, there
duration of an intervention  The time required to deliver is an increased identification of significant findings that
a treatment in a study, which includes examining the time might not be an accurate reflection of reality and might
for each individual treatment and the total time the treat- be a type I error (saying something is significant when it
ment is delivered during the study. is not). For example, performing multiple t-tests to
dwelling with the data  Immersion in the data as part of analyze study data can cause an increase or escalation of
the process of data management and reduction in significant findings and an increased incidence of type I
phenomenology. error.
estimator  Statistic that produces a value as a function of
E the scores in a sample. Much of inferential statistical
ebooks  Books available in a digital or electronic format. analysis involves the use of point estimation to evaluate
effect size  Degree to which the phenomenon is present in the fit between the estimator (a statistic) and the popula-
the population or to which the null hypothesis is false. tion parameter.
effectiveness  A treatment or intervention indicates that it ethical principles  Principles of respect for persons, benef-
is capable of producing positive results in a usual or icence, and justice relevant to the conduct of research.
routine care condition. ethnographic research  Qualitative research methodology
element  Person (subject or participant), event, behavior, developed within the discipline of anthropology for inves-
or any other single unit of a study. tigating cultures that involves collection, description, and
eligibility criteria  See sampling criteria. analysis of data to develop a theory of cultural behavior.
eliminative induction  Qualitative data analysis technique ethnographies  The written reports of a culture from the
that is part of a process referred to as analytic induction perspective of insiders. These reports were initially the
and requires that the hypothesis generated from the analy- products of anthropologists who studied primitive,
sis be tested against alternatives. foreign, or remote cultures.
embodied  Heideggerian phenomenologist’s belief that the ethnography  A word derived by combining the Greek
person is a self within a body; thus the person is referred roots of ethno (folk or people) and graphos (picture or
to as embodied. portrait).
embodiment  The unity of body and mind that eliminates ethnonursing research  Emerged from Leininger’s theory
the idea of a subjective and objective world. of transcultural nursing and focuses mainly on observing
emic view  Anthropological research approach of studying and documenting interactions with people to determine
behavior from within the culture. how daily life conditions and patterns are influencing
empirical generalizations  Statements that have been human care, health, and nursing care practices.
repeatedly tested through research and have not been dis- etic approach  Anthropological research approach of
proved. Scientific theories have empirical generalizations. studying behavior from outside the culture and examining
empirical literature  Includes relevant studies published in similarities and differences across cultures.
journals, in books, and online, as well as unpublished evaluation step of critical appraisal  Determining the
studies, such as master’s theses and doctoral dissertations. validity, credibility, significance, and meaning of the
empirical world  Experienced through our senses; the study by examining the links among the study process,
concrete portion of our existence. study findings, and previous studies.
endogenous variables  Variables whose variations are evaluation apprehension  Shown when subject’s respons-
explained within the theoretical model as part of a study es in the experiment are due to apprehension rather than
with a model-testing design. the effects of the independent variable.
environmental variable  Type of extraneous variable event-partitioning designs  Merger of the longitudinal
related to the setting in which a study is conducted. and trend designs to increase sample size and avoid the
epistemology  A view of knowing and knowledge. effects of history on the validity of findings.
694 Glossary

evidence-based practice (EBP)  Conscientious integra- exploratory-descriptive qualitative research  Research


tion of best research evidence with clinical expertise and conducted to address an issue or problem in need 
patient values and needs in the delivery of quality, cost- of a solution and/or understanding using qualitative 
effective health care. methodology.
evidence-based practice centers  Universities and health- exploratory factor analysis  Similar to stepwise regres-
care agencies identified by the Agency for Healthcare sion, in which the variance of the first factor is partialed
Research and Quality (AHRQ) as centers for the conduct, out before analysis is begun on the second factor. It is
communication, and synthesis of research knowledge in performed when the researcher has few prior expectations
selected areas to promote evidence-based health care. about the factor structure.
evidence-based practice guidelines  Rigorous, explicit exploratory regression analysis  Used when the research-
clinical guidelines developed on the basis of the best er may not have sufficient information to determine which
research evidence available (such as findings from sys- independent variables are effective predictors of the de-
tematic reviews, metaanalyses, mixed-methods system- pendent variable; thus, many variables may be entered into
atic reviews, meta-syntheses, and extensive clinical trials); the analysis simultaneously. This type is the most com-
supported by consensus from recognized national experts monly used regression analysis strategy in nursing studies.
and affirmed by outcomes obtained by clinicians. exploratory studies  Designed to increase the knowledge
exclusion sampling criteria  Sampling requirements iden- of a field of study and not intended for generalization to
tified by the researcher that prevent an element or subject large populations. Exploratory studies provide the basis
from being in a sample. for confirmatory studies.
execution errors  Errors that occur because of a defect in external criticism  Method of determining the validity of
the data collection procedure. source materials in historical research that involves
exempt from review  Studies that have no apparent risks knowing where, when, why, and by whom a document
for the research subjects might be designated as exempt was written.
from review by the chair of the institutional review board external validity  Extent to which study findings can be
(IRB). generalized beyond the sample used in the study.
existence statement  Declares that a given concept exists extraneous variables  Exist in all studies and can affect
or that a given relationship occurs. the measurement of study variables and the relationships
exogenous variables  Variables within the theoretical among these variables.
model that are caused by factors from outside the model;
these variables are examined in a study with a model- F
testing design. F statistic  Value or result obtained from conducting a type
expedited IRB review  Review process for studies that of analysis of variance.
have some risks, which are minimal or no greater than fabrication in research  Type of misconduct in research
those ordinarily encountered in daily life or during the that involves making up study results and recording or
performance of routine physical or psychological exami- reporting them.
nations. face validity  Verifies that the instrument looked like or
experimental group  Subjects who are exposed to the gave the appearance of measuring the content desired for
experimental treatment or intervention. a study.
experimental research  Objective, systematic, controlled factor  Hypothetical construct created by factor analysis
investigation to examine probability and causality among and includes the clustering of like variables that are
selected independent and dependent variables for the named based on the focus of the clustered variables.
purpose of predicting and controlling phenomena. factor analysis  Analysis that examines interrelationships
experimental study designs  Designs that provide the among large numbers of variables and disentangles those
greatest amount of control possible to examine causality relationships to identify clusters of variables that are most
more closely. closely linked together. Two types of factor analysis are
experimenter expectancy  Researcher’s belief or projec- exploratory and confirmatory.
tion of the outcome of a study. factor loading  The regression coefficient for the variable
explanation  Achieved when research clarifies the rela- on the factor determined by factor analysis.
tionships among phenomena and identifies why certain factor scores  Variables included in a factor are identified,
events occur. and the scores on these variables are summed for each
exploratory data analysis  Examining the data descrip- subject; thus, each subject will have a score for each
tively to become as familiar as possible with the nature factor in the instrument.
of the data and to search for hidden structures and factorial analysis of variance  Mathematically, the analy-
models. sis technique is simply a specialized version of multiple
Glossary 695

regression; a number of types of factorial ANOVA have funnel plot  Provides graphic representations of possible
been developed to analyze data from specific experimen- effect sizes (ESs) or odds ratios (ORs) for interventions
tal designs. in selected studies
factorial design  Study design that includes two or more
different characteristics, treatments, or events that are G
independently varied within a study. general proposition  Highly abstract statement of the rela-
fair treatment  Ethical principle that promotes fair selec- tionship between two or more concepts that is found in a
tion and treatment of subjects during the course of a study. conceptual model.
false negative  Result of a diagnostic or screening test that generalization  Extends the implications of the findings
indicates a disease is not present when it is. from the sample that was studied to the larger population
false positive  Result of a diagnostic or screening test that or from the situation studied to a larger situation.
indicates a disease is present when it is not. geographical analyses  Used to examine variations in
falsification of research  Type of research misconduct that health status, health services, patterns of care, or patterns
involves either manipulating research materials, equip- of use by geographical area.
ment, or processes or changing or omitting data or results going native  In ethnographic research, when the researcher
such that the research is not accurately represented in the becomes part of the culture and loses all objectivity and,
research record. with it, the ability to observe clearly.
fatigue effect  When a subject becomes tired or bored with gold standard  Most accurate means of currently diagnos-
a study; can affect the findings from the study. ing a particular disease; serves as a basis for comparison
feasibility of a study  Determined by examining the time with newly developed diagnostic or screening tests.
and money commitment; the researcher’s expertise; avail- government report  Document with facts that can be used
ability of subjects, facility, and equipment; cooperation of to develop the significance and background section of a
others; and the study’s ethical considerations. research proposal or report.
field notes  Notes made during and immediately following grant  Research funding from private or public institutions
the observations. to support the conduct of a study.
field work  Data collection process for a qualitative study. grantsmanship  Expertise and skill in successfully devel-
findings  Translated and interpreted results from a study. oping proposals to obtain funding for selected studies.
fishing  Conducting multiple statistical analyses of rela- grey literature  Studies that have limited distributions,
tionships or differences searching for significant study such as theses and dissertations, unpublished research
findings; can increase the risk for type I error. reports, articles in obscure journals, some online jour-
fixed-effect model  Model used when each study is esti- nals, conference papers and abstracts, conference pro-
mating the exact same quality ceedings, research reports to funding agencies, and
focus groups  Groups that are designed to obtain partici- technical reports.
pants’ perceptions in a specific (or focused) area in a grounded theory research  Qualitative, inductive research
setting that is permissive and nonthreatening. technique based on symbolic interaction theory that is
forced choice  Response set for items in a scale that have conducted to discover what problems exist in a social
an even number of choices, such as four or six, in which scene and the processes people use to handle them. The
the respondents cannot choose an uncertain or neutral research process involves formulation, testing, and rede-
response and must indicate support for or against the topic velopment of propositions until a theory is developed.
measured. grouped frequency distribution  Presents a count of
forest plots  Particular figures that are very important in patient characteristics that are divided by subsets. For
the presentation of results in meta-analysis reports that example, instead of providing number of subjects for all
synthesize the results of many studies. ages, provides number of subjects from ages 20 to 29 and
framework  The abstract, logical structure of meaning that 30 to 39.
guides development of the study and enables the researcher Grove Model for Implementing Evidence-Based Guide-
to link the findings to the body of knowledge for nursing. lines in Practice  Model developed by one of the text-
frequency distribution  Statistical procedure that involves book authors (Grove) to promote the use of national,
listing all possible measures of a variable and tallying standardized evidence-based guidelines in clinical
each datum on the listing. The two types of frequency practice.
distributions are ungrouped and grouped.
frequency table  A way of organizing the data by listing H
every possible value in the first column of numbers and Hawthorne effect  Psychological response in which sub-
the frequency (tally) of each value in the second column jects change their behavior simply because they are sub-
of numbers. jects in a study, not because of the research treatment.
696 Glossary

hazard  A neutral word intended to describe the risk of I


event occurrence. immersed  Being fully invested in the data and spending
hazard ratio (HR)  Interpreted almost identically to an extensive amounts of time reading and thinking about the
odds ratio (OR), with the exception that the HR represents data.
the risk of the event’s occurring sooner. immersion in the data  Initial phase of qualitative data
heterogeneity  Researcher’s attempt to obtain subjects analysis when researchers become very familiar with the
with a wide variety of characteristics to reduce the risk of data by reading and rereading notes and transcripts,
bias in studies not using random sampling. recalling observations and experiences, listening to audio
hierarchical statement sets  Composed of a general prop- tapes, and viewing videos.
osition, specific proposition, and hypothesis or research implications of research findings for nursing  Meaning
question, moving from abstract statements to more con- of research conclusions for the body of knowledge,
crete statements proposition and a hypothesis or research theory, and practice in nursing.
question. inclusion sampling criteria  Sampling requirements iden-
highly controlled settings  Artificially constructed envi- tified by the researcher that must be present for the
ronments that are developed for the sole purpose of con- element or subject to be included in the sample.
ducting research, such as laboratories, experimental incomplete disclosure  Subjects are not completely
centers, and research medical units. informed about the purpose of a study because that
HIPAA Privacy Rule  Federal regulations implemented in knowledge might alter the subjects’ actions. After the
2003 to protect an individual’s health information. The study, the subjects must be debriefed about the complete
HIPAA Privacy Rule affects not only the healthcare envi- purpose of the study and the findings.
ronment but also the research conducted in this independent groups  Groups in which the selection of one
environment. subject is totally unrelated to the selection of other sub-
historical research  Qualitative research method that jects. An example is when subjects are randomly selected
includes a narrative description or analysis of events that and assigned to the treatment and control groups.
occurred in the remote or recent past. independent samples t-test  The most common paramet-
history  An event that is not related to the planned study ric analysis technique used in nursing studies to test for
but that occurs during the time of the study. significant differences between two independent samples.
history effect  Event that is not related to the planned study independent variable  Treatment, intervention, or exper-
but occurs during the time of the study and could influ- imental activity that is manipulated or varied by the
ence the responses of subjects to the treatment. researcher to create an effect on the dependent
homogeneity  Degree to which objects are similar or a variable.
form of equivalence, such as limiting subjects to only one indirect costs  Expenses related to a research project but
level of an extraneous variable to reduce its impact on the not specifically part of the implementation of the steps of
study findings. the study, such as administrative costs. Grants that fund
homogeneity reliability  Type of reliability testing used indirect costs provide researchers greater freedom to
with paper-and-pencil tests that addresses the correlation conduct studies.
of various items within the instrument. Also referred to as indirect measurement  Used with abstract concepts; the
internal consistency reliability. concepts are not measured directly, but instead, indicators
homoscedastic  Data are evenly dispersed both above and or attributes of the concepts are used to represent the
below the regression line, which indicates a linear rela- abstraction, such as a perception of pain scale to measure
tionship on a scatter diagram (plot). chronic pain.
horizontal axis  The x axis in a scatterplot or graph of a individually identifiable health information (IIHI)  Any
regression line. information collected from an individual, including
human rights  Claims and demands that have been justi- demographic information, that is created or received by
fied in the eyes of an individual or by the consensus of a healthcare providers, a health plan, or a healthcare clear-
group of individuals and are protected in research. inghouse, that is related to the past, present, or future
hypothesis  Formal statement of the expected relationship(s) physical or mental health or condition of an individual,
between two or more variables in a specified population. and that identifies the individual.
hypothesis guessing  Occurs when subjects within a study inductive reasoning  Reasoning from the specific to the
guess the hypothesis of the researcher. general in which particular instances are observed and
hypothetical population  A population that cannot be then combined into a larger whole or general statement.
defined according to sampling theory rules, which require inference  Use of inductive reasoning to move from a spe-
a list of all members of the population. cific case to a general truth. Thus, statistics are used to
Glossary 697

infer from the specific study results to a general statement intermediate mediation  Level of casual assertion that
about the larger population. considers causal factors operating between molar and
inferential statistics  Statistics designed to allow inference micro levels.
from a sample statistic to a population parameter; com- internal consistency  Maintaining the integrity of the dif-
monly used to test hypotheses of similarities and differ- ferent steps of the research process, such as sample selec-
ences in subsets of the sample under study. tion, measurement of study variables, implementation of
inferred causality  Cause-and-effect relationship is identi- study treatment, and data collection.
fied from numerous studies conducted over time to deter- internal consistency reliability  See homogeneity reli-
mine risk factors or causal factors in selected situations. ability.
informants  People interviewed to learn more about the internal criticism  Involves examination of the reliability
meaning of observations. of historical documents.
information-rich cases  Cases selected during the purpo- internal validity  Extent to which the effects detected in
sive sampling process from which qualitative researchers the study are a true reflection of reality rather than being
can learn a great deal about the central focus of their the result of the effects of extraneous variables.
study. interpretation  Process of information that occurs in the
informed consent  Prospective subject’s agreement to mind of the reader.
voluntarily participate in a study, which is reached after interpretation of research outcomes  Involves examining
the subject assimilates essential information about the the results of data analysis, forming conclusions, consid-
study. ering the implications for nursing, exploring the signifi-
inherent variability  Data can be naturally expected to cance of the findings, generalizing the findings, and
have a few random observations included in the extreme suggesting further studies.
ends of the tails. interrater reliability  Degree of consistency between two
institutional review  Process of examining studies for raters who are independently assigning ratings to a vari-
ethical concerns by a committee of peers to determine if able or attribute being investigated.
the study can be conducted in a selected agency. interrupted time-series designs  Designs similar to
institutional review board (IRB)  Committee that reviews descriptive time designs except that a treatment is applied
research to ensure that the investigator is conducting the at some point in the observations.
research ethically. Universities, hospital corporations, and interval data  Numerical information collected during a
many managed care centers have IRBs to promote the study that has equal distances between a continuum of
conduct of ethical research and to protect the rights of values and the data also follows the rules of mutually
prospective subjects at their institutions. exclusive categories, exhaustive categories, and rank
instrumentation  A component of measurement that ordering, which influences the type of statistical analyses
involves the application of specific rules to develop a that can be conducted.
measurement device or instrument. interval estimate  Researcher identifies a range of values
integration  Making connections between ideas, theories, on a number line where the population parameter is
and experience. thought to be.
intention to treat  An analysis based on the principle that interval level of measurement  Interval scales have equal
participant data are analyzed according to the groups into numerical distances between intervals or values of the
which they were randomly assigned regardless of what scale in addition to following rules of mutually exclusive
happens to them in the study. categories, exhaustive categories, and rank ordering, such
interaction effects  Influence on the design validity by the as temperature.
interaction of different facets of the study, such as selec- intervening variable  Mediating variable that can
tion of subjects and treatment, setting and treatment, or affect the occurrence, strength, or direction of a
history and treatment. relationship.
interaction of different treatments  A threat to construct intervention fidelity  Reliable and competent implementa-
validity; occurs when subjects receive more than one tion of an experimental treatment that includes two core
treatment in a study. components: (1) adherence to the delivery of the pre-
intercept  The point where the regression line crosses (or scribed treatment behaviors, session, or course, and 
intercepts) the y axis; is represented by the letter a. (2) competence in the researcher or interventionalist’s
intermediate end points  Events or markers that act as skillfulness in delivery of the intervention.
precursors to the final outcome. intervention research  Methodology for investigating the
intermediate outcome  Mediating variables in theory- effectiveness of a nursing intervention in achieving the
guided intervention research. desired outcome or outcomes in a natural setting.
698 Glossary

intervention taxonomy  An organized categorization of K


interventions performed by nurses. key informants  Participants in qualitative studies who
intervention theory  This theory includes a careful provide quality information during the conduct of the
description of the problem that the intervention will study.
address, intervening actions that must be implemented to keywords  Major concepts or variables that must be
address the problem, moderating variables that might included in your literature search. Keywords or terms can
change the impact of the intervention, mediating variables be identified by determining the concepts relevant to your
that might alter the effect of the intervention, and expected study, the populations of particular interest in your study,
outcomes of the intervention. interventions to be implemented, and measurement
interventionist  In intervention research, a person who methods to be used in the study, or possible outcomes for
has been formally prepared to provide a particular inter- the study.
vention and is accountable for the fidelity of the interven- knowledge  Essential content or body of information for a
tion. discipline that is acquired through traditions, authority,
interventions  Treatments, therapies, procedures, or ac- borrowing, trial and error, personal experience, role-mod-
tions that are implemented by researchers to determine eling and mentorship, intuition, reasoning, and research.
their outcomes in a study, and if effective, are imple- Kolmogorov-Smirnov two-sample test  Nonparametric
mented by healthcare professionals to and with patients, test used to determine whether two independent samples
in a particular situation, to move the patients’ conditions have been drawn from the same population.
toward desired health outcomes that are beneficial to  kurtosis  Degree of peakedness (platykurtic, mesokurtic,
them. or leptokurtic) of the curve shape that is related to the
intervention reliability  Ensures that the research treat- spread or variance of scores.
ment is standardized and applied consistently each time
it is administered in a study. L
interview  Structured or unstructured verbal communica- landmark studies  Major projects that generate knowl-
tion between the researcher and subject during which edge that influences a discipline and sometimes society in
information is obtained for a study. general and marks an important stage of development or
introspection  Process of turning your attention inward a turning point in a field of research.
toward your own thoughts to provide increased awareness language bias  Can occur if searches focus just on
and understanding of the flow and interplay of feelings studies in English and important studies exist in other
and ideas. languages.
intuition  Insight or understanding of a situation or event latent transition analysis (LTA)  Outcomes research strat-
as a whole that usually cannot be logically explained. egy used in situations in which stages or categories of
intuitive comprehension  Reader recognizes the findings recovery have been defined and transitions across stages
of a qualitative study as being a credible representation can be identified. To use this analysis method, each
of reality. member of the population is placed in a single category
invasion of privacy  When private information is shared or stage for a given point of time.
without an individual’s knowledge or against his or her least-squares  The fact that when deviations from the
will. mean are squared, the sum is smaller than the sum of
investigator-initiated research proposal  Researcher squared deviations from any other value in a sampling
identifies a significant problem, develops a study to distribution.
examine it, and submits a proposal for the study to the least-squares regression line  A line drawn through a scat-
appropriate federal funding agency. terplot that represents the smallest deviation of each value
inverse linear relationship  Indicates that as one variable from the line.
or concept changes, the other variable or concept changes legally authorized representative  Individual or other
in the opposite direction; also referred to as a negative body authorized under applicable law to consent on behalf
linear relationship. of a prospective subject to the subject’s participation in
Iowa Model of Evidence-Based Practice  Model devel- the procedures involved in the research.
oped in 1994 and revised in 2001 by Titler and colleagues leptokurtic  Term used to describe an extremely peaked-
to promote evidence-based practice in clinical agencies. shape distribution of a curve, which means that the scores
in the distribution are similar and have limited variance.
J level of significance  See alpha (α).
justice, principle of  States that human subjects should be levels of measurement  The rules for assigning numbers
treated fairly. to objects so that a hierarchy in measurement was
Glossary 699

established, and the levels of measurement from lower to maturation  Unplanned and unrecognized changes experi-
higher are nominal, ordinal, interval, and ratio. enced during a study, such as subjects growing older,
Likert scale  Instrument designed to determine the opinion wiser, stronger, hungrier, or more tired, that can influence
or attitude of a subject; it contains a number of declarative the findings of a study.
statements with a scale after each statement. mean  Value obtained by summing all the scores and divid-
limitations  Theoretical and methodological restrictions or ing that total by the number of scores being summed.
weaknesses in a study that may decrease the generaliz- mean deviation  The average difference score, using the
ability of the findings. absolute values.
line graphs  Figures or illustrations that are used to repre- mean difference  A standard statistic that is calculated to
sent the results from studies. Often line graphs are used determine the absolute difference between two groups.
to show changes in different groups over time. measurement  Process of assigning numbers to objects,
line of best fit  The use of a regression equation to develop events, or situations in accord with some rule.
the line that allows the highest degree of prediction  measurement error  Difference between what exists in
possible in a predictive correlational study, in which  reality and what is measured by a research instrument.
independent variables are used to predict the dependent measures of central tendency  Statistical procedures
variable. (mode, median, and mean) for determining the center of
linear relationship  Relationship between two variables or a distribution of scores.
concepts will remain consistent regardless of the values measures of dispersion  Statistical procedures (range, dif-
of each of the variables or concepts. ference scores, sum of squares, variance, and standard
literature review  See review of relevant literature. deviation) for examining how scores vary or are dispersed
location bias  Can occur if studies are published in lower- around the mean.
impact journals and indexed in less searched databases. median  Score at the exact center of the ungrouped fre-
logic  Science that involves valid ways of relating ideas to quency distribution.
promote human understanding; includes abstract and con- mediator variables  Variables that bring about the effects
crete thinking and logistic, inductive, and deductive of the intervention after it has occurred and thus influence
reasoning. the outcomes of an intervention study.
logical positivism  Branch of philosophy that operates on memo  Developed by the researcher to record insights or
strict rules of logic, truth, laws, axioms, and predictions. ideas related to notes, transcripts, or codes during qualita-
Quantitative research emerged from logical positivism. tive data analysis.
logistic reasoning  Used to break the whole into parts that mentee  The protégé who is guided by a mentor in the
can be carefully examined, as can the relationships among mentorship process.
the parts; one can understand the whole by examining the mentor  Someone who serves as a teacher, sponsor, guide,
parts. exemplar, or counselor for a novice or protégé. For
longitudinal designs  Panel designs used to examine example, an expert nurse serves as a guide or role model
changes in the same subjects over an extended period. for a novice nurse or mentee.
low statistical power  When the strength or power of a mentorship  Intense form of role-modeling in which an
study to detect relationships between variables of differ- expert nurse serves as a teacher, sponsor, guide, exemplar,
ences between groups is below the acceptable standard or counselor for a novice nurse.
power (0.8) needed to conduct a study. Low statistical mesokurtic  Term that describes a normal curve with an
power increases the likelihood of a type II error. intermediate degree of kurtosis and intermediate variance
of scores.
M meta-analysis  Involves the statistical pooling of the
manipulation  Implementation or controlled movement of results from several previous studies into a single quanti-
a treatment or an independent variable in a study to deter- tative analysis that provides one of the highest levels of
mine its effect on the study dependent variable. evidence for an intervention’s efficacy.
Mann-Whitney U test  Used to analyze ordinal data with metasummary, qualitative  Synthesis or summing of
95% of the power of the t-test to detect differences findings across qualitative reports to determine the current
between groups of normally distributed populations. knowledge in an area.
matching  Technique used when an experimental subject meta-synthesis, qualitative  Synthesis of qualitative stud­
is randomly selected and a subject similar in relation to ies that provides a fully integrated, novel description or
important extraneous variables is randomly selected for explanation of a target event or experience versus a sum­
inclusion in the control or comparison group. This process mary view of that event or experience. Meta-synthesis
results in dependent or related groups. requires more complex, integrative thought in developing
700 Glossary

a new perspective or theory based on the findings of previ- monomethod bias  More than one measure of a variable
ous qualitative studies. is used in a study, but all measures use the same method
method of least squares  Procedure in regression analysis of recording, such as using two paper-and-pencil scales
for developing the line of best fit. to measure depression in a study.
methodological designs  Used to develop the validity and mono-operation bias  Occurs when only one method of
reliability of instruments to measure research concepts measurement is used to measure a variable or concept in
and variables. a study, such as the use of one paper-and-pencil scale to
methodological limitations  Restrictions or weaknesses in measure chronic pain.
the study design that limit the credibility of the findings multicausality  Recognition that a number of interrelat-
and the population to which the findings can be ing variables can be involved in having a particular
generalized. effect.
metric ordinal scale  Scale that has unequal intervals; its multicollinearity  Occurs when the independent variables
use to collect data during a study results in ordinal data. in a regression equation are strongly correlated.
micromediation  Examines causal connections at the level multidimensional scaling  A measurement method that
of small particles such as atoms; is part of multicausality was developed to examine many aspects or elements of a
theory. concept or variable.
middle-range theories  Theories that are less abstract and multilevel analysis  Used in epidemiology to study how
address more specific phenomena than grand theories, environmental factors and individual attributes and
that are directly applicable to practice, and that focus on behavior interact to influence individual-level health
explanation and implementation. behavior and disease risk.
minimal risk  Risk of harm anticipated in the proposed multilevel synthesis  Involves synthesizing the findings
research is not greater, with regard to probability and from quantitative studies separate from qualitative studies
magnitude, than that ordinarily encountered in daily life and then integrating the findings from these two syntheses
or during the performance of routine physical or psycho- in the final report.
logical examinations. multimethod-multitrait technique  When a variety of
mixed-method approach  Offers investigators the oppor- data collection methods, such as interview and observa-
tunity to utilize the strengths of both qualitative and quan- tion, are used and different measurement methods are
titative research designs in the conduct of a study. used for each concept in a study.
mixed-method systematic review  Synthesis of any of a multitrait-multimethod  The approach of combining con-
variety of study designs, such as qualitative research and vergent and divergent validity testing of instruments.
quasi-experimental, correlational, and/or descriptive multimodal  A distribution of scores that has more than
study, to determine the current knowledge in an area. two modes or most frequently occurring scores.
mixed results  Study results including a combination of multiple regression analysis  Extension of simple linear
significant and nonsignificant outcomes, which are prob- regression with more than one independent variable
ably the most common results of studies. entered into the analysis.
modal percentage  Appropriate for nominal data; indi- multistage cluster sampling  Type of cluster sampling
cates the relationship of the number of data scores repre- when the random selection of the sample continues
sented by the mode with the total number of data scores. through several stages.
mode  Numerical value or score that occurs with the great-
est frequency in a distribution; however, it does not neces- N
sarily indicate the center of the data set. narrative analysis  Qualitative means of formally analyz-
model-testing designs  Used to test the accuracy of a ing text including stories.
hypothesized causal model or map. natural settings  Field settings or uncontrolled, real-life
moderator variable  Variable that occurs with the inter- settings where research is conducted, such as subjects’
vention (independent variable) and alters the causal rela- homes, worksites, or schools.
tionship between the intervention and outcomes. It necessary relationship  One variable or concept must
includes characteristics of the subjects and the person occur for the second variable or concept to occur.
implementing the intervention. negative likelihood ratio  Ratio of true-negative results
molar  Causal laws related to large and complex objects to false-negative results; is calculated as follows: 
that are part of the theory of multicausality. Negative likelihood ratio = 100% − Sensitivity ÷ Speci­
monographs  Books, booklets of conference proceedings, ficity.
or pamphlets, which are usually written once and may be negative linear relationship  See inverse linear relation-
updated with a new edition. ship.
Glossary 701

negative results  Unpredicted nonsignificant or inclusive nonsignificant results  Negative results or results contrary
results from a study that are often the most difficult to to the researcher’s hypotheses that can be an accurate
explain. reflection of reality or can be caused by study weaknesses.
negatively skewed  Data are not normally distributed in a Also see negative results.
study; characterized by a curve in which the largest nontherapeutic research  Research conducted to generate
portion of data is above the mean. knowledge for a discipline and in which the results from
nested design  Design that allows the researcher to con- the study might benefit future patients but will probably
sider the effect of variables that are found only at some not benefit those acting as research subjects.
levels of the independent variables being studied. normal curve  A symmetrical, unimodal bell-shaped curve
nested variables  Variables found only at certain levels of that is a theoretical distribution of all possible scores, but
the independent variable, such as gender, race, socioeco- no real distribution exactly fits the normal curve.
nomic status, and education. normally distributed  Data points that follow the spread
naturalistic inquiry  encompasses studies designed to or distribution of a normal curve.
study people and situations in their natural states. norm-referenced testing  Test performance standards that
network sampling  Nonprobability sampling method that have been carefully developed over years with large, rep-
includes a snowballing technique that takes advantage of resentative samples through the use of standardized tests
social networks and the fact that friends tend to hold with extensive reliability and validity.
characteristics in common. Subjects meeting the sample null hypothesis  States that there is no relationship between
criteria are asked to assist in locating others with similar the variables being studied; a statistical hypothesis used
characteristics. for statistical testing and interpreting statistical outcomes.
networking  Process of developing channels of communi- number needed to treat  A metric that is defined as the
cation between people with common research interests number of patients who would have to be treated with the
throughout the country. new intervention to avoid one event that might have
nominal data  Lowest level of data that can only be orga- occurred with standard treatment.
nized into categories that are exclusive and exhaustive, Nuremberg Code  Ethical code of conduct to guide inves-
but the categories cannot be compared or rank ordered tigators when conducting research.
and can only be analyzed by the lowest level of statistical numerator  The number on the top part of a fraction.
analyses. Nursing Care Report Card  Evaluation of hospital
nominal level of measurement  Lowest level of measure- nursing care using 10 indicators (2 structure indicators, 2
ment that is used when data can be organized into catego- process indicators, and 6 outcome indicators). This report
ries that are exclusive and exhaustive, but the categories card could facilitate benchmarking or setting a desired
cannot be compared or rank ordered, such as gender, race, standard that would allow comparisons of hospitals in
marital status, and diagnoses. terms of their nursing care quality.
noncoercive disclaimer  A statement that participation is nursing interventions  Deliberative cognitive, physical,
voluntary and refusal to participate will involve no penalty or verbal activities performed with or on behalf of indi-
or loss of benefits to which the subject is entitled. viduals and their families that are directed toward accom-
nondirectional hypothesis  States that a relationship plishing particular therapeutic objectives relative to
exists but does not predict the exact nature of the individuals’ health and well-being.
relationship. nursing research  Scientific process that validates and
nonequivalent control group designs  Designs in which refines existing knowledge and generates new knowledge
the control group is not selected by random means, such that directly and indirectly influences the delivery of
as the one-group posttest-only design, posttest-only evidence-based nursing practice.
design with nonequivalent groups, and one-group pretest- nursing-sensitive patient outcomes  Patient outcomes
posttest design. that are influenced by or associated with nursing.
nonparametric statistical analysis  Statistical techniques
used when the assumptions of parametric statistics are not O
met, and most commonly used to analyze nominal- and oblique rotation  Type of rotation in factor analysis used
ordinal-level data. to accomplish the best fit (best-factor solution) and in
nonprobability sampling  Nonrandom sampling in which which the factors are allowed to be correlated.
not every element of the population has an opportunity observation  Collection of data through listening, smelling,
for selection in the sample, such as convenience (acciden- touching, and seeing, with an emphasis on what is seen.
tal) sampling, quota sampling, purposive sampling, and observational checklist  Form used to record whether a
network sampling. behavior occurred.
702 Glossary

observational measurement  Use of structured and operator, positional  Search operator used to look for
unstructured observation to measure study variables. requested terms within certain distance of one another.
observed level of significance  The actual level of signifi- Common positional operators are NEAR, WITH, and
cance that is achieved or observed in a study. ADJ.
observed score  Actual score or value obtained for a ordinal data  Data that can be ranked, but the intervals
subject on a measurement tool. between the ranked data are not necessarily equal, such
observer as participant  Researcher’s time is spent mainly as military ranks. This level of data is analyzed by non-
observing and interviewing subjects and less in the par- parametric statistical techniques.
ticipation role. ordinal level measurement  Measurement that yields data
odds ratio (OR)  The ratio of the odds of an event occur- that can be ranked, but the intervals between the ranked
ring in one group, such as the treatment group, with the data are not necessarily equal, such as levels of coping.
odds of it occurring in another group, such as the standard outcomes of care  The dependent variables or clinical
care group. results of health care that are measured to determine the
one-group posttest-only design  Preexperimental design impact of the process of care management techniques.
with numerous threats to validity that is inadequate for The outcomes from the Medical Outcomes Study Frame-
making causal references. work include clinical end points, functional status, general
one-group pretest-posttest design  Quasi-experimental well-being, and satisfaction with care.
design in which the pretest scores serve as the comparison outcome reporting bias  Occurs when study results are
group and the posttest scores after the treatment serve as not reported clearly and with complete accuracy.
the experimental group. outcomes research  Important scientific methodology that
one-tailed test of significance  Analysis used with direc- was developed to examine the end results of patient care.
tional hypotheses in which extreme statistical values of The strategies used in outcomes research are a departure
interest are thought to occur in a single tail of the curve. from traditional scientific endeavors and incorporate eval-
one-way chi-square  A statistic that compares different uation research, epidemiology, and economic theory
levels of one variable only measured at the nominal level. perspectives.
open-label extension  A term that usually applies to ran- outliers  Extreme scores or values in a set of data that are
domized controlled trials or other clinical trials whereby exceptions to the overall findings.
participants in the active treatment group are offered an out-of-pocket costs  Those expenses incurred by the
opportunity to continue treatment and those in the placebo patient, family, or both that are not reimbursable by the
or control group are given the option to transition to the insurance company; they might include costs of buying
active treatment at the conclusion of the intervention supplies, dressings, selected medications, or special foods.
period.
operational definition  Description of how variables or P
concepts will be measured or manipulated in a study. paired or dependent samples  Samples that are related or
operational reasoning  Involves identification and dis- matched in some way. See dependent groups.
crimination among many alternatives or viewpoints and paradigm  Particular way of viewing a phenomenon in the
focuses on the process of debating alternatives. world.
operationalizing a variable or concept  Development of parallel-forms reliability  See alternate-forms reliability.
the conceptual definition of a concept or variable to link parallel synthesis  Involves the separate synthesis of
it to the study framework and the operational definition quantitative and qualitative studies, but the findings from
of a concept or variable so it can be measured or manipu- the qualitative synthesis are used in interpreting the syn-
lated in a study. thesized quantitative studies.
operator  Permits grouping of ideas, selection of places to parameter  Measure or numerical value of a population.
search in a database record, and ways to show relation- parametric statistical analyses  Statistical techniques
ships within a database record, sentence, or paragraph. used when three assumptions are met: (1) the sample was
The most common operators are Boolean, locational, and drawn from a population for which the variance can be
positional. calculated, and the distribution is expected to be normal
operator, Boolean  The three words AND, OR, and NOT or approximately normal, (2) the level of measurement
are used with the researcher’s identified concepts in con- should be interval or ratio with an approximately normal
ducting searches of databases. distribution, and (3) the data can be treated as though they
operator, locational  Search operator that identifies terms were obtained from random samples.
in specific areas or fields of a record, such as article title, paraphrasing  Involves expressing clearly and concisely
author, and journal name. the ideas of an author in your own words.
Glossary 703

partially controlled setting  Environment that the re- framework within which thinking, knowing, with doing
searcher manipulates or modifies in some way when it is occur.
used as a setting for a study. physiological measures  Techniques used to measure
participant observervation  Special form of observation physiological variables either directly or indirectly, such
in which researchers immerse themselves in the setting so as techniques to measure heart rate or mean arterial
they can hear, see, and experience the reality as the par- pressure.
ticipants do. However, the participants are aware of the philosophical perspective  The worldview of the re-
dual roles of the researcher (participant and observer). searcher that guides the questions asked and the methods
participants  Individuals who participate in qualitative selected for conducting a specific study.
and quantitative research; also referred to as subjects in PICOS Format  An abbreviation that stands for Popula-
quantitative research. tion or participants of interest; Intervention needed for
path coefficient  Effect of the independent variable on the practice; Comparisons of the intervention with control,
dependent variable that is determined through path placebo, standard care, variations of the same interven-
analysis. tion, or different therapies; Outcomes needed for practice;
patient  Someone who has already gained access to care. and Study design. PICOS is one of the most common
pattern  Analysis of qualitative data to determine the formats used to develop a relevant clinical question to
trends and links among the facets of the data that can guide a systematic review of research.
become the meaningful findings from the study. pilot study  Smaller version of a proposed study conducted
Pearson’s product-moment correlation coefficient (r)  to develop or refine the methodology, such as the treat-
Parametric test used to determine the relationship between ment, instrument, or data collection process.
two variables. placebo  An intervention intended to have no effect;
percentage distribution  Indicates the percentage of the however, it is like the test intervention or is experienced
sample with scores falling within a specific group or like the real study intervention to account for how study
range. participants would respond without actually receiving the
percentage of variance  Amount of variability explained real intervention.
by a linear relationship; the value is obtained by squaring plagiarism  Type of research misconduct that involves the
Pearson’s correlation coefficient (r). For example, if an r appropriation of another person’s ideas, processes, results,
= 0.5 in a study, the percentage of variance explained is or words without giving appropriate credit, including
r2 = 0.25, or 25%. those obtained through confidential review of others’
periodicals  Subset of serials with predictable publication research proposals and manuscripts.
dates, such as journals that are published over time and platykurtic  Term that indicates a relatively flat curve with
are numbered sequentially for the years published. the scores having large variance among them.
permission to participate in a study  Agreement of population  All elements (individuals, objects, events, or
parents or guardians to the participation of their child or substances) that meet the sample criteria for inclusion
ward in research. in a study; sometimes referred to as a target popula-
person  Someone who may or may not have gained access tion.
to care. population-based studies  Important type of outcomes
personal experience  Gaining of knowledge by being research that involves studying health conditions in the
personally involved in an event, situation, or circum- context of the community rather than the context of the
stance. medical system.
phenomena  experiences that cannot be explained by population parameter  A true but unknown numerical
examining causal relations but need to be studied as the characteristic of a population. Parameters of the popula-
very things they are. tion are estimated with statistics.
phenomenological research  Inductive, descriptive quali- population studies  Studies that target the entire popula-
tative methodology developed from phenomenological tion.
philosophy for the purpose of describing experiences as position papers  Papers disseminated by professional
they are lived by the study participants. organizations and government agencies to promote a par-
phenomenological researcher  Researcher who focuses ticular viewpoint on a debatable issue.
on describing experiences as they are lived by the study positive likelihood ratio  Likelihood ratio calculated to
participants rather than large samples with generalizable determine the likelihood that a positive test result 
findings. is a true positive and a negative test result is a true 
philosophy  Broad, global explanation of the world that negative. Positive Likelihood Ratio = Sensitivity ÷ (100%
gives meaning to the world of nursing and provides a − Specificity).
704 Glossary

positive linear relationship  Indicates that as one variable prediction  Ability to estimate the probability of a specific
changes (value of the variable increases or decreases),  outcome in a given situation that can be achieved through
the second variable will also change in the same research.
direction. prediction equation  Outcome of regression analysis
positively skewed  Data from a study having a non-normal whereby a formula or equation is developed to predict a
distribution that is characterized by a curve that has the dependent variable.
largest portion of data below the mean. predictive design  Developed to predict the value of the
post hoc tests  Statistical tests developed specifically to dependent variable on the basis of values obtained from
determine the location of differences in studies with more the independent variables; one approach to examining
than two groups, such as when ANOVA results are sig- causal relationships between variables.
nificant in a study that has three or more groups. Fre- predictive validity  Type of construct instrument validity
quently used post hoc tests are Bonferroni’s procedure, in which future performance or attitudes are proposed or
the Newman-Keuls test, the Tukey HSD test, the Scheffé predicted on the basis of an instrument’s scores—for
test, and Dunnett’s test. example, measuring health-related behaviors with an
poster session  Visual presentation of a study by using instrument to predict future health status of indivi­duals.
pictures, tables, and illustrations on a display board. premise  Statement that identifies the proposed relation-
posttest-only design with comparison group  Preexperi- ship between two or more variables or concepts.
mental design conducted to examine the difference preproposal  Short document (four to five pages plus
between the experimental group that receives a treatment appendices) written to explore the funding possibilities
and the comparison group that does not. for a research project.
power  Probability that a statistical test will detect a sig- prescriptive theory  Specifies what must be done to
nificant difference or relationship that exists, which is the achieve the desired effects, including (1) the components,
capacity to correctly reject a null hypothesis. Standard intensity, and duration required, (2) the human and mate-
power of 0.8 is used to conduct power analysis to deter- rial resources needed, and (3) the procedures to be fol-
mine the sample size for a study. lowed to produce the desired outcomes.
power analysis  Used to determine the risk of a type II presentation  The sharing of research findings verbally by
error so that the study can be modified to decrease the delivering a research report and responding to questions,
risk, if necessary. Conducting a power analysis involves or by displaying a poster of a study at a conference or
alpha, effect size, and standard power of 0.8 to determine meeting.
the sample size for a study. Power analysis is also con- pretest and posttest design with a comparison group 
ducted when nonsignficant results are obtained to deter- Type of quasi-experimental design frequently imple-
mine the power of the analysis conducted. mented to determine the effect of a treatment by compar-
practical or clinical significance  Associated with its ing the experimental group (treatment group) with the
importance to the body of knowledge that applies to comparison group.
nursing; sometimes referred to as clinical significance. pretest-posttest control group design  Classic experi-
practice effect  Occurs when subjects improve as they mental design in which two randomized groups—one
become more familiar with the experimental protocol. receiving the experimental treatment and one receiving no
practice pattern  Usual care that is provided on a unit or treatment, a placebo treatment, or usual or standard
in a setting. care—are examined for differences to determine the
practice pattern profiling  Epidemiological technique impact of a treatment.
used in outcomes research that focuses on patterns of care primary prevention studies  Specially designed studies
rather than individual occurrences of care. that attempt to measure things that do not happen. Changes
practice styles  Particular ways to implement health care in a community are examined and inferred to be a conse-
that affect health outcomes and are examined in outcomes quence of the effectiveness of the prevention program
research. Practice styles are part of the construct process (treatment).
of care from Donabedian’s theory of health care. primary source  Source that is written by the person who
practice theories  Another name for middle-range theories originated or is responsible for generating the ideas
that are usefulness in practice. published.
precision  Accuracy with which the population parameters primary theoretical source  Source that is written by the
have been estimated within a study. Also used to describe theorist who developed the theory or conceptual content.
the degree of consistency or reproducibility of measure- primordial cell  Concept from Donabedian’s framework
ments with physiological instruments. that is the physical-physiological function of the
Glossary 705

individual patient being cared for by the individual (structure, process, and outcomes of care) in Donabedi-
practitioner. an’s theory of health care.
principal component analysis  Second step in exploratory project grant proposal  Paper written to obtain funding
factor analysis that provides preliminary information that for the development of new educational programs in
the researcher needs so that decisions can be made before nursing, such as a program designed to teach nurses to
the final factoring. provide a new type of nursing care or as a project to
principal investigator (PI)  In a research grant, the indi- support nursing students seeking advanced degrees.
vidual who will have primary responsibility for adminis- proportionate sampling  In stratification, each stratum
tering the grant and interacting with the funding agency. should have numbers of subjects selected in proportion to
privacy  The freedom an individual has to determine the their occurrence in the population.
time, extent, and general circumstances under which proposal, research  Written plan identifying the major ele-
private information will be shared with or withheld from ments of a study, such as the problem, purpose, and
others. framework, and outlining the methods to conduct the
probability  Addresses relative, rather than absolute, cau- study; a formal way to communicate ideas about a pro-
sality. Probability of a relationship and significance of posed study to receive approval to conduct the study and
interventions are examined in research. to seek funding.
probability distributions  Distributions of values for dif- proposition  Abstract, formal statement of the relationship
ferent statistical analysis techniques, such as tables of r between two concepts.
values for Pearson Product Moment Correlation, t values prospective cohort study  Epidemiological study in which
for t-test, or F values for analysis of variance. Some a group of people are identified who are at risk for expe-
common probability distribution tables are found in the riencing a particular event.
appendices of this text. protection from discomfort and harm  A right of research
probability sampling method  Random sampling tech- subjects based on the ethical principle of beneficence,
niques in which each member (element) in the population which holds that one should do good and, above all, do
should have a greater than zero opportunity to be selected no harm. The levels of discomfort and harm are (1) no
for the sample; examples are simple random sampling, anticipated effects, (2) temporary discomfort, (3) unusual
stratified random sampling, cluster sampling, and system- levels of temporary discomfort, (4) risk of permanent
atic sampling. damage, and (5) certainty of permanent damage.
probability statement  Expresses the likelihood that providers of care  Individuals responsible for delivering
something will happen in a given situation and addresses care, such as nurse practitioners and physicians, who are
relative rather than absolute causality. part of the structure of care of Donabedian’s theory of
probability theory  Theory that addresses relative rather health care.
than absolute causality. Thus, from a probability perspec- publication bias  Bias that occurs when studies with posi-
tive, a cause will not produce a specific effect each time tive results are more likely to be published than studies
that particular cause occurs, but the probability value indi- with negative or inconclusive results.
cates how frequently the effect might occur with the published research  Studies that are permanently recorded
cause. in hard copies of journals or books or are posted online
probing  Technique interviewers use to obtain more infor- for readers to access.
mation in a specific area of the interview. purposive sampling  Judgmental or selective sampling
problem statement  Single statement that follows the sig- method that involves conscious selection by the
nificance and background of a problem and identifies the researcher of certain subjects or elements to include in
gap in the knowledge base needed for practice. a study. Purposive sampling is a type of nonprobability
problematic reasoning  Involves identifying a problem, sampling.
selecting solutions to the problem, and resolving the
problem. Q
procedural rigor  In critical appraisal of qualitative Q-sort methodology  Technique of comparative rating in
studies, the standard of methodological congruence which a subject sorts cards with statements on them into
includes procedural rigor, which involves examining a designated piles (usually 7-10 piles in the distribution of
study for the researcher’s detail in applying selected pro- a normal curve) that might range from best to worst.
cedures or steps of a qualitative study. qualitative research  Systematic, interactive, subjective
process of care  Construct that includes mechanisms approach used to describe life experiences and give them
for delivering health care; is one of three constructs meaning.
706 Glossary

qualitative research proposal  A document developed by random error  Error that causes individuals’ observed
a researcher of a proposed qualitative study that often scores to vary haphazardly around their true score without
includes an introduction, philosophical base, and method- a pattern.
ology for conducting the study. random heterogeneity  Subjects in a treatment or inter-
qualitative research synthesis  Process and product of vention group differing in ways that correlate with the
systematically reviewing and formally integrating the dependent variable.
findings from qualitative studies. Qualitative research random sampling methods  See probability sampling
synthesis consists of two categories, metasummary and method.
meta-synthesis. random variation  Expected difference in values that
qualitative research reports  The intent of a qualitative occurs when one examines different subjects from the
research report is to describe the dynamic implementation same sample.
of the research project and the unique, creative findings randomization  From a sampling theory point of view,
obtained. The report usually includes introduction, each individual in the population should have a greater
methods, results, and discussion sections. than zero opportunity to be selected for a sample, which
quantitative research  Formal, objective, systematic is achieved by random sampling. The methods of assign-
study process to describe and test relationships and to ing subjects to groups can also be random and promote
examine cause-and-effect interactions among variables. randomization in the final study groups.
quantitative research proposal  A document developed randomized blocking design  Experimental design in
by a researcher of a proposed quantitative study that often which the researcher includes subjects with various levels
includes the introduction, review of the literature, frame- of an extraneous variable in the sample but controls the
work, and methodology proposed for the study. numbers of subjects at each level of the variable and their
quantitative research report  Report that includes an random assignment to groups within the study.
introduction, methods, results, and a discussion of find- randomized controlled trials (RCTs)  Classic means of
ings for a quantitative study. examining the effects of various treatments in which the
quasi-experimental research  Type of quantitative re- effects of a treatment are examined by comparing the
search conducted to explain relationships, clarify why treatment group with the no-treatment group.
certain events happen, and examine causality between range  Simplest measure of dispersion, obtained by sub-
selected independent and dependent variables. tracting the lowest score from the highest score or just
quasi-experimental study designs  Designs with limited identifying the lowest and highest scores in a distribution
control that were developed to provide alternative means of scores.
of examining causality in situations not conducive to rating scales  Crudest form of measure using scaling tech-
experimental controls. niques; ratings are chosen from an ordered series of cat-
query letter  Letter sent to an editor of a journal to deter- egories of a variable assumed to be based on an underlying
mine interest in publishing an article, or a letter sent to a continuum—for example, rating acute pain on a scale
funding agency to determine interest in funding a study. from 1 to 10, with 1 being minimal pain and 10 being
questionnaire  Printed self-report form designed to elicit extreme pain.
information that can be obtained through written responses ratio level of measurement  Highest measurement form
of the subject. that meets all the rules of other forms of measure: mutu-
quota sampling  Nonprobability convenience sampling ally exclusive categories, exhaustive categories, rank
technique with an added strategy to ensure the inclusion ordering, equal spacing between intervals, and a con­
of subject types likely to be underrepresented in the con- tinuum of values; also has an absolute zero, such as
venience sample, such as women, minority groups, and weight.
the undereducated. readability  The degree of difficulty of a text to be read
and comprehended; can be determined by a readability
R formula such as the Fog Index. The readability of a scale
random assignment to groups  Procedure used to assign can influence the reliability and validity of a scale used
subjects to treatment or comparison groups in which the in a study.
subjects have an equal opportunity to be assigned to either repeated measures design  A research design that repeat-
group. edly assesses or measures study variables for the same
random-effect model  A method of analyzing studies that group of people.
are not all estimating the same intervention effect but reasoning  Processing and organizing ideas to reach con-
related effect over studies that follows a distribution clusions; examples are problematic, operational, dialectic,
across studies. and logistic types of reasoning.
Glossary 707

recommendations for further research  Ideas that emer­ reliable measure  A measurement method used in research
ged from the present study and previous studies in the that provides consistent data from subjects.
same area that provide directions for future studies. replication  Reproducing or repeating a study to determine
recruiting research participants  The process of obtain- whether similar findings will be obtained.
ing subjects or participants for a study that includes iden- replication, approximate  Operational replication that
tifying potential subjects, approaching them to participate involves repeating the original study under similar condi-
in the study, and gaining their acceptance to participate. tions and following the methods as closely as possible.
refereed journal  Publication that uses expert reviewers replication, concurrent  Involves collection of data for
(referees) to determine whether a manuscript will be the original study and simultaneous replication of the data
accepted for publication. to provide a check of the reliability of the original study.
reference group  Group of individuals who constitute the Confirmation of the original study findings through repli-
standard against which individual subjects’ scores are cation is part of the original study’s design.
compared. replication, exact  Involves precise or exact duplication of
referencing  Comparing a subject’s score against a stan- the initial researcher’s study to confirm the original
dard; used in norm-referenced and criterion-referenced findings.
testing. replication, systematic  Constructive replication that is
reflexivity  Self-awareness and critical examination of the done under distinctly new conditions in which the
interaction between self and the data during collection and researchers conducting the replication do not follow 
analysis of qualitative data. May lead the researcher to the design or methods of the original researchers; instead,
explore personal feelings and experiences that influence the second investigative team begins with a similar
the study. problem statement but formulates new means to verify the
refusal rate  Percentage of potential subjects who decide first investigator’s findings.
not to participate in a study. The refusal rate is calculated representativeness of the sample  Sample must be like
by dividing the number refusing to participate by the the population in as many ways as possible.
number of potential subjects approached. For example, if request for applications (RFA)  Similar to an RFP except
100 subjects are approached and 15 refuse to participate, that the government agency not only identifies the problem
the refusal rate is 15 ÷100 = 0.15, or 15%. of concern but also describes the design of the study.
regression analysis  Analysis wherein the independent Researchers bid for this contract.
(predictor) variable or variables influence variation or request for proposals (RFP)  An opportunity for funding
change in the value of the dependent variable. where an agency within the federal government seeks
regression coefficient R  Statistic for regression analysis. proposals from researchers dealing with a specific
regression line  Line that best represents the values of the problem. Federal Register publishes opportunities for
raw scores plotted on a scatter diagram. The procedure funding that usually have deadlines that are only a few
for developing the line of best fit is the method of least weeks after the publication, and researchers need to have
squares. a strong background in the area of concern to submit a
relational statement  Declares that a relationship or link proposal.
of some kind (positive or negative) exists between two or research  Diligent, systematic inquiry or investigation to
more concepts. Relational statements are also called prop- validate and refine existing knowledge and generate new
ositions in theory and become the focus of testing in knowledge.
quantitative research. research benefit  Something of health-related, psychoso-
relative risk  Type of risk associated with conducting any cial, or other value to an individual research subject, or
diagnostic and screening test for determining the health something that will contribute to the acquisition of gen-
problems of patients. eralizable knowledge. Assessing research benefits is part
relevant literature  Sources that are pertinent or highly of the ethical process of balancing benefits and risks for
important in providing the in-depth knowledge needed to a study.
make changes in practice or to study a selected problem. research design  See design.
reliability  Represents the consistency of the measure research grant  Funding awarded specifically for conduct-
obtained. Also see reliability testing. ing a study.
reliability testing  Measure of the amount of random error research hypothesis  Alternative hypothesis to the null
in the measurement technique. Reliability testing of mea- hypothesis, stating that there is a relationship or a differ-
surement methods focuses on the following three aspects ence between two or more variables.
of reliability: stability, equivalence, and internal consis- research methodology  The process or plan for conduct-
tency or homogeneity. ing the specific steps of the study.
708 Glossary

research misconduct  Fabrication, falsification, or plagia- responder analysis  An additional technique to identify
rism in processing, performing, or reviewing research, or variables associated with a beneficial response to an inter-
in reporting research results; it does not include honest vention or to determine outcomes of potential importance
error or differences in opinion. to the treatment.
research objectives (or aims)  Clear, concise, declarative response set  Parameters within which the question or item
statements that are expressed to direct a study and are is to be answered in a questionnaire.
focused on identification and description of variables  results  Outcomes from data analysis that are generated for
or determination of the relationships among variables,  each research objective, question, or hypothesis.
or both. retention rate  The number and percentage of subjects
research problem  Area of concern where there is a gap completing the study.
in the knowledge base needed for nursing practice. retaining research participants  Specific actions taken by
Research is conducted to generate essential knowledge to the researcher to keep subjects participating in a study and
address the practice concern, with the ultimate goal of to prevent their attrition; provides a more representative
providing evidence-based nursing care. sample for the study and decreases the threats to design
research proposal  See proposal, research. validity.
research purpose  Concise, clear statement of the specific retrospective study  Epidemiological study in which a
goal or aim of the study that is generated from the group of people are identified who have experienced a
problem. particular event—for example, studying occupational
research questions  Concise, interrogative statements exposure to chemicals to determine cause-and-effect
developed to direct studies that are focused on description relationships.
of variables, examination of relationships among vari- review of relevant literature  Analysis and synthesis of
ables, determination of differences between two or more research sources to generate a picture of what is known
groups, and prediction of dependent variable using inde- and not known about a particular situation or research
pendent variables. problem.
research topics  Concepts or broad problem areas that right to self-determination  See self-determination, right
indicate the foci of essential research knowledge needed to.
to provide evidence-based nursing practice. Research rigor  Striving for excellence in research through the use
topics include numerous potential research problems. of discipline, scrupulous adherence to detail, and strict
research utilization  Process of synthesizing, disseminat- accuracy.
ing, and using research-generated knowledge to make an risk ratio  The ratio of the risk of those subjects in the
impact on or a change in the existing practices in society. intervention group to the risk of those in the control group
research variables or concepts  Qualities, properties, or for having a particular health outcome.
characteristics identified in the research purpose and rival hypothesis  Alternate explanation of cause in a
objectives or questions that are observed or measured in study.
a study. Research variables or concepts are often used in robustness  Analysis procedure that will yield accurate
qualitative studies or descriptive and correlational quan- results even if some of the assumptions are violated by
titative studies, in which the intent is to observe or the data being analyzed.
measure variables as they exist in a natural setting without role-modeling  Learning by imitating the behavior of an
the implementation of a treatment. exemplar or role model.
research participants or informants  See subjects.
researcher-participant relationships  In qualitative re- S
search, the specific interactions between the researcher sample  Subset of the population that is selected for a
and the study participants to accomplish the purpose of study.
the study. sample attrition  See attrition rate.
residual variables  Type of variable in a model testing sample characteristics  Description of the research sub-
design that indicates the effect of unmeasured variables jects obtained by analyzing data acquired from the mea-
not included in the model. These variables explain some surement of the demographic variables (e.g., age, gender,
of the variance found in the data but not the variance ethnicity, medical diagnoses).
within the model. sample size  Number of subjects or participants recruited
respect for persons, principle of  Indicates that persons and consenting to take part in a study.
have the right to self-determination and the freedom to sampling  Selecting groups of people, events, behaviors,
participate or not participate in research. or other elements with which to conduct a study.
Glossary 709

sampling criteria  List of the characteristics essential for self-determination, right to  Based on the ethical princi-
membership in the target population. Sampling criteria ple of respect for persons, which states that humans are
consist of both inclusion and exclusion criteria. capable of controlling their own destiny. The right to self-
sampling error  Difference between a sample statistic determination is violated through the use of coercion,
used to estimate a population parameter and the actual but covert data collection, and deception in the research
unknown value of the parameter. process.
sampling frame  Listing of every member of the popula- semantic differential scale  Instrument that consists of
tion with membership defined by the sampling criteria. two opposite adjectives with a seven-point scale between
sampling method  Process of selecting a group of people, them. The subject selects one point on the scale that best
events, behaviors, or other elements that are representa- describes his or her view of the concept being examined
tive of the population being studied; includes probability on the opposite adjectives.
or random and nonprobability or nonrandom sampling seminal study  Study that prompted the initiation of a field
methods. of research.
sampling plan  Describes the strategies that will be used sensitivity of physiological measures  Related to the
to obtain a sample for a study and may include either amount of change of a parameter that can be measured
probability or nonprobability sampling methods. precisely.
scale  Self-report form of measurement composed of sensitivity of screening or diagnostic test  The accuracy
several items that are thought to measure the construct of a screening or diagnostic test; the proportion of patients
being studied, in which the subject responds to each item with the disease who have a positive test result or true
on the continuum or scale provided, such as a pain percep- positive.
tion scale or state anxiety scale. sequential explanatory strategy  Method whereby the
scatter diagrams or scatterplots  Figures that provide researcher collects and analyzes quantitative data fol-
useful preliminary information about the nature of  lowed by the collection and analysis of qualitative data.
the relationship between variables that should be devel- sequential exploratory strategy  Method in which the
oped and examined before correlational analysis is per- collection and analysis of qualitative data precedes the
formed. collection of quantitative data.
science  Coherent body of knowledge composed of sequential transformative strategy  Strategy in which
research findings, tested theories, scientific principles, either qualitative or quantitative data collection and anal-
and laws for a discipline. ysis can come first. The results are integrated during the
scientific method  All procedures that scientists have used, interpretation phase.
currently use, or may use in the future to pursue knowl- sequential relationship  Relationship in which one con­
edge, such as quantitative, qualitative, outcomes, and cept occurs later than the other.
intervention research. serendipitous results  Unexpected results from a study
scientific theory  Theory with valid and reliable methods that were not the original focus of the study.
of measuring each concept and relational statements that serendipity  Accidental discovery of something valuable
have been repeatedly tested through research and demon- or useful during the conduct of a study.
strated to be valid. serials  Literature published over time or in multiple
secondary analysis design  Involves studying data previ- volumes; serials do not necessarily have a predictable
ously collected in another study, but using different publication date.
methods of organization of the data and different statisti- setting  Location for conducting research; may be natural,
cal analyses to reexamine the data. partially controlled, or highly controlled.
secondary source  Source that summarizes or quotes sham  Interventions are often used with procedures, and
content from primary sources. are a variation of a “fake” intervention that omits the
seeking approval to conduct a study  Process that essential therapeutic element of the intervention.
involves submission of a research proposal to a selected Shapiro-Wilk’s W test  A formal test of normality that
group for review and often verbally defending that assesses whether a variable’s distribution is skewed and/
proposal. or kurtotic.
selection  The process by which subjects are chosen to take significance of a problem  Part of the research problem that
part in a study and how subjects are grouped within a study. indicates the importance of the problem to nursing and to
selectivity in physiological measures  Element of accu- the health of individuals, families, and communities.
racy that involves the ability to identify the signal under significant results  Results that are in keeping with those
study correctly to distinguish it from other signals. identified by the researcher.
710 Glossary

simple hypothesis  Predicts the relationship (associative or stage-based interventions  Interventions tailored to a spe-
causal) between two variables. cific phase of recovery, response to treatment, or change
simple interrupted time-series design  Similar to the in behavior.
descriptive time-series design, with the addition of a treat- standard deviation (SD)  Measure of dispersion that is
ment that occurs or is applied (interrupts the time series) calculated by taking the square root of the variance.
at a given point in time. standard of care  The national designation of the type of
simple linear regression  Parametric analysis technique care that patients should receive from healthcare agencies
that provides a means to estimate the value of a dependent and providers.
variable based on the value of an independent variable. standard scores  Used to express deviations from the
simple random sampling  Selection of elements at random mean (difference scores) in terms of standard deviation
from the sampling frame for inclusion in a study. Each units, such as Z scores, in which the mean is 0 and the
study element has a probability greater than zero of being standard deviation is 1.
selected for inclusion in the study. standardized mean difference  Calculated in a meta-anal-
situated  The way a person is in a specific context and time ysis when the same outcome, such as depression, is mea-
that shapes his or her experiences, paradoxically freeing sured by different scales or methods.
and constraining the person’s ability to establish meanings standardized mortality ratio  Observed number of deaths
through language, culture, history, purposes, and values. divided by the expected number of deaths and multiplied
situated freedom  The amount of freedom a patient has in by 100.
healthcare options as a result of his or her specific statement synthesis  Development of statements propos-
circumstance. ing specific relationships among the concepts being
skewed  A curve that is asymmetrical (positively or nega- studied. This step is a part of developing a framework for
tively skewed) because of an asymmetrical distribution of a study.
scores from a study. statistic  Numerical value obtained from a sample that is
skimming a source  Quickly reviewing a source to gain a used to estimate the parameters of a population.
broad overview of the content. statistical conclusion validity  Concerned with whether
slope  Determines the direction and angle of the regression the conclusions about relationships and differences drawn
line within the graph. The value is represented by the from statistical analyses are an accurate reflection of
letter b. reality.
small area analyses  Geographical analyses used to statistical hypothesis  See null hypothesis.
examine variations in health status, health services, pat- statistical regression  Movement or regression of extreme
terns of care, or patterns of use by geographical areas. scores toward the mean in studies using a pretest-posttest
Spearman rank-order correlation coefficient  Nonpara- design.
metric analysis technique for ordinal data that is an adap- statistical significance  Results are unlikely to be due to
tation of the Pearson’s product-moment correlation used chance; thus, there is a difference between groups, or
to examine relationships among variables in a study. there is a significant relationship between variables.
specific propositions  Statements found in theories that are Stetler model  Model developed by Stetler that provides
at a moderate level of abstraction and provide the basis a comprehensive framework to enhance the use of re-
for the generation of hypotheses to guide a study. search findings by nurses to facilitate evidence-based
specificity of a screening or diagnostic test  Proportion of practice.
patients without disease who have a negative test result stratification  Used in a design so that subjects are distrib-
or true negative. Specificity indicates the accuracy of a uted throughout the sample by using sampling techniques
screening or diagnostic test. similar to those used in blocking, but the purpose of the
split-half reliability  Process used to determine the homo- procedure is even distribution throughout the sample.
geneity of an instrument’s items; the items are split in stratified random sampling  Used when the researcher
half, and a correlational procedure is performed between knows some of the variables in the population, which are
the two halves. critical to achieving representativeness. These identified
spurious correlations  Relationships between variables variables are used to divide the sample into strata or
that are not logical. In some cases, these significant rela- groups.
tionships are a consequence of chance and have no strength of a relationship  Amount of variation explained
meaning. by the relationship.
stability reliability  Concerned with the consistency of structured interviews  Use of strategies that give the
repeated measures of the same attribute with the use of researcher an increasing amount of control over the
the same scale or instrument over time. content of the interview.
Glossary 711

structured observation  Clearly identifying what is to be systematic error  Measurement error that is not random
observed and precisely defining how the observations are but occurs consistently, such as a scale that inaccurately
to be made, recorded, and coded. weighs subjects 3 pounds heavier than they are.
structures of care  The elements of organization and systematic review  Structured, comprehensive synthesis
administration, as well as provider and patient character- of quantitative studies in a particular healthcare area to
istics, that guide the processes of care. determine the best research evidence available for expert
study validity  Measure of the truth or accuracy of a claim clinicians to use to promote an evidence-based practice.
that is an important concern throughout the research systematic sampling  Conducted when an ordered list of
process. all members of the population is available and involves
study variables  Concepts at various levels of abstraction selecting every kth individual on the list, starting from a
that are measured, manipulated, or controlled in a study. point that is selected randomly.
subject attrition  See attrition rate.
subjects  Individuals participating in a study. T
subject term  Term included in a database thesaurus that table  Presentation of the results of a study in columns and
one needs identified. rows for easy review by the reader.
substantive theory  Theory of social process developed tails  Extremes of the normal curve where significant sta-
by the discovery mode to explain a particular social tistical values can be found.
world. target population  Group of individuals who meet the
substitutable relationship  Relationship in which a similar sampling criteria and to which the study findings will be
concept can be substituted for the first concept and the generalized.
second concept will occur. tentative theory  Theory that is newly proposed, has had
substituted judgment standard  In the ethical conduct of minimal exposure to critical appraisal by the discipline,
research, it is a standard concerned with determining the and has had little testing.
course of action that incompetent individuals would take testable hypothesis  Contains variables that are measur-
if they were capable of making a choice. able or can be manipulated in the real world.
sufficient relationship  States that when the first variable test-retest reliability  Determination of the stability or
or concept occurs, the second will occur regardless of the consistency of a measurement technique by correlating
presence or absence of other factors. the scores obtained from repeated measures.
sum of squares  Mathematical manipulation involving textbooks  Monographs written to be used in formal edu-
summing the squares of the difference scores that is used cational programs
as part of the analysis process for calculating the standard themes  In qualitative data analysis, the concepts or pat-
deviation. terns that emerge after researchers have spent extensive
summary statistics  See descriptive statistics. time examining the data.
summated scales  Scales in which various items are theoretical limitations  Weaknesses in the study frame-
summed to obtain a single score. work and conceptual and operational definitions that
survey  Data collection technique in which questionnaires restrict abstract generalization of the findings.
or personal interviews are used to gather data about an theoretical literature  Concept analyses, maps, theories,
identified population. and conceptual frameworks that support a selected
symbolic meanings  In qualitative data analysis, the research problem and purpose.
meaning attached to particular ideas or clusters of  theoretical sampling  Often used in grounded theory
data. research to advance the development of a theory through-
symmetrical curve  A curve in which the left side is a out the research process. The researcher gathers data from
mirror image of the right side. any individual or group that can provide relevant data for
symmetrical relationship  Complex relationship that con- theory generation.
sists of two statements: If A occurs (or changes), B will theory  An integrated set of defined concepts, existence
occur (or change); if B occurs (or changes), A will occur statements, and relational statements that present a view
(or change); A ↔ B. of a phenomenon and can be used to describe, explain,
synthesis of sources  Clustering and interrelating ideas predict, or control that phenomenon.
from several sources to form a gestalt or new, complete therapeutic research  Research that provides the patient
picture of what is known and not known in an area. an opportunity to receive an experimental treatment that
systematic bias or variation  Consequence of selecting might have beneficial results.
subjects whose measurement values are different or vary thesis  Research project completed by a master’s student
in some way from the population. as part of the requirements for a master’s degree.
712 Glossary

threats to statistical conclusion validity  The reasons for true positive  Result of a diagnostic or screening test that
the false conclusions that might be obtained from the indicates accurate identification of the presence of a
results of data analyses. disease.
time-lag bias  A type of publication bias. Occurs because true score  Score that would be obtained if there were no
studies with negative results are usually published later, error in measurement; some measurement error always
sometimes 2 or 3 years later, than studies with positive occurs.
results. t-test  A parametric analysis technique used to determine
time-dimensional designs  Designs used to examine the significant differences between measures of two samples;
sequence and patterns of change, growth, or trends over t-test analysis techniques exist for dependent and inde-
time. pendent groups.
total variance  The sum of the within-group variance and two-tailed test of significance  Type of analysis used for
the between-group variance; determined by conducting a nondirectional hypothesis in which the researcher
analysis of variance (ANOVA). assumes that an extreme score can occur in either tail.
traditions  Truths or beliefs that are based on customs and two-way chi-square  A statistic that tests whether propor-
past trends and provide a way of acquiring knowledge. tions in levels of one variable are significantly different
translation/application  Transforming from one language from proportions of the second variable.
to another to facilitate understanding; part of the process type I error  Error that occurs when the researcher con-
of interpreting research outcomes in which results are cludes that the samples tested are from different popula-
translated and interpreted into findings. tions (the difference between groups is significant) when,
translational research  An evolving concept that is in fact, the samples are from the same population (the
defined by the National Institutes of Health as the  difference between groups is not significant). The null
translation of basic scientific discoveries into practical hypothesis is rejected when it is true.
applications. type II error  Error that occurs when the researcher
treatment  Independent variable or intervention that is concludes that there is no significant difference between
manipulated in a study to produce an effect on the depen- the samples examined when, in fact, a difference exists.
dent variable. The treatment or independent variable is The null hypothesis is regarded as true when it is
usually detailed in a protocol to ensure consistent imple- false.
mentation in the study.
treatment diffusion  Occurs when the control group sub- U
jects communicate with the experimental subjects and are unexpected results  Relationships found between vari-
exposed to aspects of the study treatment. ables or differences between groups that were not hypo­
treatment fidelity  The accuracy, consistency, and thor- thesized or predicted from the framework guiding the
oughness in how an intervention is delivered according to study.
the specified protocol, treatment program, or intervention ungrouped frequency distribution  Process whereby
model. researchers list all categories of the variable on which
treatment standardization  A process of ensuring that the they have data and tally each datum on the listing.
research treatment is applied consistently each time the unimodal  Distribution of scores in a sample has one mode
treatment is administered; part of intervention fidelity. or most frequently occurring score.
trend designs  Designs used to examine changes in the unstructured interview  Interview initiated with a broad
general population in relation to a particular phenomenon. question, after which subjects are usually encouraged to
trial and error  An approach with unknown outcomes that elaborate on particular dimensions of a topic.
is used in a situation of uncertainty when other sources of unstructured observations  Spontaneously observing and
knowledge are unavailable. recording what is seen with a minimum of planning.
triple-blinded  Type of study in which participants,
researchers, and those involved in data management are V
unaware of group assignment. validation  Phase in which the research reports are criti-
truncated  In correlational designs, if the range of scores cally appraised to determine their scientific soundness.
is truncated, the obtained correlational value will be arti- validity of instrument  The extent to which an instrument
ficially depressed. The lowest values and the highest actually reflects or is able to measure the construct being
values for a variable either are not measured or are con- examined.
densed and merged with less extreme values. variables  Qualities, properties, or characteristics of per­
true negative  Result of a diagnostic or screening test that sons, things, or situations that change or (vary) and are
indicates accurately when a disease is not present. manipulated, measured, or controlled in research.
Glossary 713

variance  Measure of dispersion that is the mean or average voluntary consent  Indication that prospective subject has
of the sum of squares. decided to take part in a study of his or her own volition
variance analysis  Outcomes research strategy to track without coercion or any undue influence.
individual and group variance from a specific critical
pathway. The goal is to decrease preventable variance in W
the process, thus helping patients and their families Wilcoxon matched-pairs signed-ranks test  Nonpara-
achieve optimal outcomes. metric analysis technique used to examine changes that 
vary  To be different; numerical values associated with occur in pretest-posttest measures or matched-pairs
variables will change from one instance to another. measures.
verbal presentation  The communication of a research within-group variance  Variance that results when indi-
report at a professional conference or meeting. vidual scores in a group vary from the group mean.
vertical axis  The y axis in a graph of a regression line or
scatterplot. Y
visual analog scale  A line 100 mm in length with right- y intercept  Point where the regression line crosses (or
angle stops at each end on which subjects are asked to intercepts) the y axis. At this point on the regression line,
record their response to a study variable. Also referred to x = 0.
as magnitude scale.
volunteer sample  Those willing to participate in the Z
study. All samples with human subjects must be volunteer Z scores  Standardized scores developed from the normal
samples. curve.
Index

Page numbers followed by “f” indicate figures, “t” indicate tables, and “b” indicate boxes.

A Agency for Healthcare Research and Analysis of variance (ANOVA), 371,


AAALAC. See American Association for Quality (Continued) 584-587
Accreditation of Laboratory Animal evidence-based practice centers and, ANCC. See American Nurses
Care 502-503 Credentialing Center; American
AACN. See American Association of Aggregate, 294-295 Nursing Credentialing Center
Critical Care Nurses AHCPR. See Agency for Health Care Animal subjects, 190-191
Absolute zero point, 387 Policy and Research Annual Review of Nursing Research,
Abstract concept, 151 AHRQ. See Agency for Healthcare 21
as qualitative study focus, 151-152 Research and Quality Anonymity, 171-172, 177-178
Abstract thinking, 2 AHSR. See Agency for Health Services ANOVA. See Analysis of variance
Abstract thought process, 4-7 Research Anxiety, learning and, 121
Abstracts, 622, 623b AIDS. See Acquired immunodeficiency AONE. See American Organization of
for conference presentations, critical syndrome Nurse Executives
appraisal of, 453 Alternate-forms reliability, 390 APN. See Advanced practice nurse
Academic committees, as support system, American Association for Accreditation of Applicability, as outcomes assessment
530 Laboratory Animal Care (AAALAC), instrument, 316t
ACNP. See Acute care nurse practitioners 191 Application, Stetler Model of Research
Acquired immunodeficiency syndrome American Association of Critical Care Utilization to Facilitate Evidence-
(AIDS) Nurses (AACN), 79 Based Practice phase, 495-496
coping interventions for, 238 American Nurses Association (ANA) Applied research, 35-36
research for, 169 APN, types of, 305 Approximate replication, 77
Acute care nurse practitioners (ACNP), Commission on Nursing Research, 20 ARIMA. See Autoregressive integrated
care from, 221 mission of, 23 moving average
Adjusted hazard ratios, 577-578 nursing, definition of, 1 Articles for publication, critical appraisal
Administrative databases, 307 Nursing Care Report Card, 303 of research, 453
Advanced beginner nurse, 10 nursing functions and activities, 19 Assent form, 166-167, 168b
Advanced practice nurse (APN) research conferences by, 19 Assistance availability, data collection
evidence-based practice and, 1 American Nurses Credentialing Center and, 516-517
outcomes classification, 305 (ANCC), 22, 469 Association of Collegiate Schools of
outcomes research and, 305-306 American Nurses Foundation, 19 Nursing, 19
role of, 3 American Organization of Nurse Associative hypothesis
Advanced testing, 344-345 Executives (AONE), 79-80 causal hypothesis versus, 144-146
Advances in Nursing Science, 20 American Psychological Association, expression of, 144
African Americans Publication Manual of, 107 variables of, 144-145
hypertension in, 12f American Recovery and Reinvestment Associative relationship, 144
TM program for BP in, 35, 37-38, 50, Act, 300-301 Assumption, making explicit, 41-42
51f ANA. See American Nurses Association Asymmetrical curve, 540
Agency for Health Care Policy and Analysis Asymmetrical relationship, 122
Research (AHCPR), 22, 300 of change, 315 Attrition, 37
Agency for Health Services Research of data, 45-48, 491 Authority, 9
(AHSR), 300 of questionnaires, 429 Authors, 105
Agency for Healthcare Research and techniques, 371 Autoethnography, 64
Quality (AHRQ), 11-12, 22-23, 80, of improvement, 315 Autonomous agent, 164
297, 300 of ITT, 334 Autonomy
evidence-based guidelines and, multilevel, 317-318 diminished, 165-169
496-499 responder, 334-335 right to, 171-173

714
Index 715

Autonomy-enabling structure, Borrowing, 9 Citation, 76


302-303 BP. See Blood pressure Citation bias, 484
Autoregressive integrated moving average Bracketing, 60 Citation search index, 103
(ARIMA), 241-242 Burgess Report, 19 Classic experimental design, 652f
Classic test theory, scale construction
B C using, 442-444
Baseline observation carried forward Calculated variable, 543 Classical hypothesis testing, 535-536
(BOCF), 334 Calculation, 571-573 Client treatment matching (CTM), 337
Basic research, 34-35 result interpretation, 573 Clinical and Translational Science Awards
Behavioral research, National California Nursing Outcomes Coalition (CTSA) Consortium, 503
Commission for Protection of, (CalNOC), 304 Clinical databases, 306-307
162-163 CalNOC. See California Nursing Clinical expertise, 12
Being and Time, 60-61 Outcomes Coalition Clinical importance, statistical
Being-in-time, 61 Carryover effect, 249 significance vs., 537
The Belmont Report, 162 Case study, designing, 224 Clinical Laboratory Standards Institute
Benefit-risk ratio, 175-176 Case-control designs, 583 (CLSI), 395
Benefits, research, assessment of, Category systems, 421-422 Clinical practice
175-176 Causal connection, 326-327 research priority for, 79-81
Best interest standard, 168 Causal explanation, 326-327 research problem, as source of, 75-76
Best research evidence, 468 Causal hypothesis Clinical trials, 250-251
definition of, 11-12, 28-30 associative hypothesis versus, methodology for, 250
introduction to, 28-31 144-146 preference, 336-337
levels of, 30-31 variables of, 145-147 CLSI. See Clinical Laboratory Standards
Biased coin design, 232 Causal relationship, 123, 145 Institute
Biases, 197 Causality, 195 Cluster randomized controlled trials, 336
citation, 484 understanding, role of correlation, 565 Cluster sampling, 360-361
language, 484 Causality theory multistage, 360-361
location, 484 conditions of, 195 Cochrane, Archie, 20-21
for meta-analysis, 484-485 experimental study design examining, Cochrane Center, 20-21
outcome reporting, 484 231 Cochrane Collaboration, 20-21, 31
publication, 484, 485f nursing philosophy and, 196-197 Cochrane Nursing Care Field, 471-472
systematic, 354-356 Causation, probability and, 196 Code of Federal Regulations (CFR),
for systematic reviews, 484-485 Cause-and-effect relationship, 50 162-163
time-lag, 484 CEA. See Cost-effectiveness analysis Codebook, development of, for data
Bibliographical database, 103, 104t Censored data, 577 definitions, 520-523, 522f
Bimodal distribution, 540-541, 540f Center for Epidemiological Studies Coding plan, 517-523, 522f
Biomedical research, National Depression Scale (CES-D), 431, Coefficient of determination, 573
Commission for Protection of, 431b, 432f, 486 Coefficient of stability, 390
162-163 Central limit theorem, 538-539 Coercion, 164
Bivariate correlational analysis, 560-565 Central tendency, measures of, 538, Cognitive application, 495-496
Bland-Altman plots, 566 552-554 Cohort, 218
example of, 565-566, 566t CES-D. See Center for Epidemiological Cohort design, 222
result interpretation, 566 Studies Depression Scale Cohort study
of systolic blood pressure, 406f CFA. See Confirmatory factor analysis prospective, 309
of test-retest data, 566f CFR. See Code of Federal Regulations retrospective, 310-311
Blinding, open label vs., 331-332 Chain sampling. See Network sampling Colleague support, 531
Blocking, 206-207 Change, analysis of, 315 Common-Sense Model of Illness
accomplishing effects of, 246 Child Representation, 142-143, 143f
examples using age and ethnicity, 206t assent form, sample of, 168b Comparative descriptive design
studies using control strategies for, 205t end-of-life study on, 169 example of, 218f
Blood pressure (BP), TM program for, in as research subject, 166-167 purpose of, 217-218
monitoring African Americans, 35, Chi-square test (X2), 371, 587-588 Comparative evaluation, Stetler Model
37-38, 50, 51f Chronic obstructive pulmonary disease of Research Utilization to Facilitate
BOCF. See Baseline observation carried (COPD), 67-68 Evidence-Based Practice phase,
forward CINAHL. See Cumulative Index to 495
Body of knowledge, 1, 10 Nursing and Allied Health Literature Comparative experimental design, 232
Books, published research in, 632 CIOMS. See Council for International Comparative treatment efficacy (CTE)
Boolean operator, 105, 105f Organizations of Medical Sciences trial, 251
716 Index

Comparison group, 203, 356-357 Confidentiality Correlational study design (Continued)


nonequivalent design of, 234-240 assurance of, 177-178 predictive, 226-227, 226f
one-group posttest-only design with, breach of, 172 purpose of, 224-228
234, 235f maintaining in research, 172-173 Cost factors, data collection and, 515
one-group pretest-posttest design with, right to, 171-173 Cost-benefit analysis, 312
234-236, 236f Confirmatory analysis, 545 Cost-effectiveness analysis (CEA),
posttest-only design with, 234, 235f Confirmatory data analysis, 542 312-313
pretest and posttest design with, Confirmatory factor analysis (CFA), 398 Costs of care
237-238, 237f-239f Confirmatory studies, 370 to maintain quality, 297-298
removed, 238-240, 239f Confounding variable, 152, 342 studies examining, 298t
reversed, 240, 240f Consensus knowledge building, 308 Council for International Organizations of
selection of, 233-234 Consent. See also Informed consent Medical Sciences (CIOMS), 169
Competent nurse, 10 recording of, 182 Council of Nurse Researchers, 20
Complex hypothesis, 146-147 sample form for, 181f Counterbalanced design, 249-250
Complexity of care, dimension of, 229 voluntary, 180 Counterbalancing, 204, 205t
Comprehension, as informed consent, waiving, 180 Covert data collection, 165
178-180 written documents for, 180-182 Cox proportional hazards regression,
Comprehensiveness, as outcomes Consistency, data collection and, 516 577-578, 577t
assessment instrument, 316t Consolidated Standards for Reporting Criterion-referenced testing, 388
Computer search, 104 Trials (CONSORT), 251-253, 252f, Critical appraisal
Computer-based data collection, 513-514 331, 520 of abstracts for conference
Computerized databases, 103 CONSORT. See Consolidated Standards presentations, 453
Concept analysis, 119 for Reporting Trials of published systematic review,
how to conduct, publications on, 119t Construct 480-482
published examples of, 119t confounding and levels of, 201 of research, 451
Concept derivation, 118-119 preoperational clarification of, 200-201 articles for publication, 453
Concept synthesis, 118 validity, 200-202 evolution of, 451-454
Concepts, 41, 116 Content analysis, 281-282 implemented in nursing, 452-454
abstract, 151 Content expert, 666 by nurse educators, 453
as abstract, 151-152 Content validity, 394-397 by nurse researchers, 453
definition of, 116, 132 Content validity index (CVI), 395 nurses’ expertise in, 454, 454t
for frameworks, 132 Content validity ratio (CVR), 395, 396t by practicing nurses, 452-453
linking to concept, 133 Contingent relationship, 123-124 presentations, 453
operationalizing, 155-156 Continuous outcomes, meta-analysis proposals, 453-454
research, 151-152 results for, 486 publications, 453
research variables and, 151-152 Control, 13-14 of studies by students, 452
as variable, 138, 151-152 of environment, 199, 203 Critical cases, 365
Conceptual definition, 43 of extraneous variables of, 204-207 Critical pathway, 309
denotative definition versus, 118 group, 203, 205t, 233-234, 356-357 Critical social theory
importance of, 119-120 of measurement, 204 problem and purpose of, 93t
Conceptual map in quantitative research, 36-38, 37t topics, problems, and purpose of, 92t
construction of, 132-134 in research, 197 Critical-Care Pain Observation Tool,
example of, 133f settings for, 37 419b
Conceptual model, 117 subject, controlling equivalence of, 203 Cronbach’s alpha coefficient, 391-392
Orem’s model of self-care as, 125 of treatment, 203-204 Crossover design, 249-250
Conclusions, 48 Convenience sampling, 363-364 Crossover randomized controlled trials,
formation of, 597-598 Convergent validity, 400-401 336
Concrete thinking, 2 COPD. See Chronic obstructive Cross-sectional design, 43-44
Concrete-abstract continuum, 2-3 pulmonary disease example of, 220f
Concurrent relationship, 123 Correlational analyses, 560 purpose of, 220-221
Concurrent replication, 77 Correlational research, 26, 49-50 Cross-sectional study, 222f
Concurrent triangulation strategy, 211, decision tree for, 258f CTE. See Comparative treatment efficacy
211f purpose of, 87 trial
Condensed proposal, content of, 644 topics, problems, and purpose of, CTM. See Client treatment matching
Conduct and Utilization of Research in 88t-89t CTSA. See Clinical and Translational
Nursing (CURN), 21 Correlational study design Science Awards Consortium
Confidence intervals, 541-542, 558 descriptive, 225-226, 225f Cumulative Index to Nursing and Allied
odds ratio and, 575 focus and purpose statement of, 244t Health Literature (CINAHL), 103
Index 717

CURN. See Conduct and Utilization of Data analysis (Continued) Databases (Continued)
Research in Nursing significant and nonpredicted, 594 as sample source, 306-308
Curvilinear relationship, 121 significant and predicted, 594 saved searches and alerts, 108
example of, 122f unexpected, 595 searching, 103
CVI. See Content validity index techniques, 371 terms, arrangement of, 108-109
CVR. See Content validity ratio Data collection, 45-46, 345-347, types emanating from patient care,
523-530 306f
D covert, 165 Debriefed, subjects, 178
Damage, permanent external influences on subject Deception, 165
certainty of, 175 responses, 527 Decision making, Stetler Model of
protection from, 174-175 factors influencing, 515-517 Research Utilization to Facilitate
risk of, 175 assistance availability, 516-517 Evidence-Based Practice phase,
Data consistency, 516 495
calculations, 543 cost, 515 Decision points, 520
definitions, codebook development for, time, 515-516 Decision tree
520-523, 522f flow chart, 521f for correlational studies, 258f
deviation exploration using statistics, forms, 517-519, 519f, 658 for descriptive studies, 258f
554-558 maintaining control, 524 for experimental studies, 260f
confidence intervals, 558 methods of, 268-276 for quasi-experimental studies, 259f
degrees of freedom, 558 modes of, 507-515, 508f for statistical procedure, 546, 547f
measures of dispersion, 554-558 computer-based, 513-514 for type of study selection, 257f
normal curve, 555-557 electronic, 508-515 Declaration of Helsinki, 160
sampling error, 557-558 online, 508-513 Deductive reasoning, 7, 36
documentation, 543-544 participant-administered instruments, Deductive thinker, 148
entry period, 532 507-508 Deductive thinking, 58
exploratory analysis of, 544-545 phones, 514-515 Degrees of freedom (df), 545, 558, 563
tables and graphs for, 545 researcher-administered instruments, De-identifying health data, 170
management of, 531-532 507-508 Delphi technique, 435-437, 436f
preparation of, for computer entry, scannable forms, 508, 509f-512f Demographic variable, 154, 154t
531-532 passive resistance, 527-528 Denominator, 575
quality of, 372 people problems, 524-528 Department of Health, Education, and
retrieval of, 532 plan, 517-523 Welfare, U.S. (DHEW)
saturation of, 371 detailed, 519-520 regulations set by, 162
scoring, 543 problems, 524 Tuskegee Syphilis Study, 161
storage of, 532, 543-544 with sample selection, 525, 526f Department of Health and Human
summarizing of, with statistics, solving, 524 Services, U.S. (DHHS), 300
550-554 researcher problems in, 528-530 human research subjects, protection of,
central tendency measures, 552-554 event problems, 529-530 163, 164t
frequency distributions, 550-552 institutional problems, 529 IRB/privacy board responsibilities,
transformations, 543 interactions, 528 188t
Data analysis, 45-48, 491 lack of skill in technique, 528-529 Dependent t-test analysis technique,
confirmatory, 542 maintaining perspective, 529 580
exploratory, 542 role conflict, 528-529 Dependent variable, 145, 151
packages, sources of, 537t subject as object, 526-527 Depression, guided imagery and, 113
practical aspects of, 542-546 subject attrition, 525-526, 526f Description, 12-13
preparation, 542-544 subject mortality, 525-526 Descriptive correlational design, 43-44
cleaning, 543 tasks, 523-524 example of, 225f
identification of missing, 543 Data collection process, evidence purpose of, 225-226
process, evidence examination from, examination from, 592-593 Descriptive research, 26, 49
593-594 Data safety and monitoring board, as purpose of, 87
quantitative, stages of, 542 support system, 531 topics, problems, and purpose of,
of questionnaires, 429 Data use agreement, 170-171 88t-89t
results Databases Descriptive statistics, 538
evidence examination from, 594-595 administrative, 307 Descriptive study design
mixed, 594-595 classification schemes used in, 308 complexity of, 215-216
negative, 594 clinical, 306-307 example of, 216f
nonsignificant, 594 examples of, 307t focus and purpose statement of, 244t
serendipitous, 595 measurement using existing, 439-440 purpose of, 215-224
718 Index

Descriptive study design (Continued) Dummy variables, used in regression Ethical study, 314
uses for, 215 analysis, 574-575 Ethics, research and, 159
using questionnaires, 217 Ethnographic research, 27, 63-65
Descriptive theory, 327 E literature review and, 98
Designs, 36. See also Research eBooks, 100 methodology for, 286-287
comparison of, 244t EBP. See Evidence-based practice philosophical orientation of, 64-65
concepts important to, 195-197 Economic study, 312-314 problem and purpose of, 92
definition of, 214 ECPs. See Emergency contraceptive pills topics, problems, and purpose of,
descriptive correlational, 43-44 Eddy, David, 22 90t-91t
development of, 214 Education, nursing, 19 Ethnographies, 63-64
nonexperimental, 337-338 EFA. See Exploratory factor analysis nursing science contribution from, 65
purpose of, 218 Effect size (ES), 121, 330, 368-369, 536 types of, 64-65, 64t
selection, decision tree for, 257f Effectiveness Ethnonursing research, 65
studies using control strategies for, 205t efficacy vs., 329-330, 330t Evaluation, Stetler Model of Research
Deterministic relationship, 123 testing variations in Utilization to Facilitate Evidence-
df. See Degrees of freedom based on intervener characteristics, Based Practice phase, 496
DHEW. See Department of Health, 345 Evaluation apprehension, 201
Education, and Welfare, U.S. based on intervention strength, 345 Event-partitioning design, 222-223
DHHS. See Department of Health and based on patient characteristics, Evidence, examination of, 590-595
Human Services, U.S. 344-345 from data analysis process, 593-594
Diagrams, scatter, 560 based on setting, 345 from data analysis results, 594-595
Dialectic reasoning, 6 Effectiveness and Efficiency: Random from data collection process, 592-593
Diary, 437-439 Reflections on Health Services, from measurement, 591-592
key points when selecting, 437 20-21 from research plan, 590-591
sample page of, 438f Efficacy, effectiveness vs., 329-330, 330t Evidence-based practice (EBP), 297, 468
Dichotomous outcomes, meta-analysis Electronic data collection, 508-515 advanced practice nurse and, 1
results for, 486-488, 488f Electronic database, 102 barriers related to, 468-471
Difference scores, as measure of Electronic monitoring benefits related to, 468-471
dispersion, 554, 555t physiologic measures obtained through, best research evidence for, 28-31
Digital object identifiers (DOIs), 107 415-417 definition of, 17
Diminished autonomy, 165-169 process of, 415f for elderly African American women
Direct measurement, 382-383 Elements, 351-352 with HTN, 12f
Direct physiological measures, 413-414 Eligibility criteria, 352-353 ethical research in, 159
Direct recall, 310 Emergency contraceptive pills (ECPs), guidelines
Directional hypothesis, 148-149 qualitative study and, 366-367 development of, 496-499
Directory of Nurse Researchers, Sigma Empirical generalizations, 599 implementation of, 496-502
Thata Tau, 440-441 Empirical literature, 100 introduction to, 31
Disclosure, consent to incomplete, 178 discussion of, 111-112 websites for, 499
Discomfort Empirical world, 3 models of, 11f-12f, 493-496
protection from, 174-175 End-of-life study, 169 nurses promoting, 1
temporary, 174-175 Endogenous variable research, significance of, 11-14
unusual levels of, 175 cause of, 227 resources, 472t
Discriminant analysis, validity from, 401 measurement of, 227-228 Stetler Model of Research Utilization
Dispersion, measures of, 558 Entry period, 532 to Facilitate, 474, 493-496
difference scores, 554, 555t Environment, control of, 199, 203 Evidence-based practice centers (EPCs),
range, 554 Environmental variable, 153-154 502-503
standard deviation, 555 Epidemiological study, 218-219 Exact replication, 77
variance, 554-555, 555t Epistemology, 58 Exclusion sampling criteria, 353
Disproportionate sampling, 360 Equivalence, of subjects and groups, 203 Exempt from review, 183-185, 185b
Divergent validity, 401 Equivalence reliability, 390-391 Existing healthcare data, 439-440
Documentation. See also Informed Error rate, 198 Exogenous variable
consent Error score, 383 cause of, 227
written consent form, 180-182 ES. See Effect size measurement of, 227-228
DOIs. See Digital object identifiers Essentialist, 196 Experience
Domain concepts, 126t Estimation, 541-542 of competent nurse, 10
Donabedian, Avedis, 294 Ethical codes of expert nurse, 10
Dose-intensity, of interventions, 332-333 development of, 159-163 levels of, 10
Double-blinded, 331 in research, 159 personal, 10
Index 719

Experimental designs, 335-337 Fair treatment, 173-174 Framework (Continued)


classic, 652f subject selection, 173-174 relational statement, extracting, 132
Experimental posttest-only comparison, of subjects, 174 relational statements, examination of,
246f False negative, 406 120-124
group design, 246 False positive, 406 statement synthesis and, 132
Experimental research, 26-27 Falsification, 188 terms relating to, 116-117
elements of, 244 FAST. See Facts for Action to Stroke Framingham study, 219
purpose of, 53 Treatment Freedom from drift, 404
Sir Ronald Fisher and, 34 Fatigue countermeasures program for Frequency distributions, 539f, 550-552,
topics, problems, and purpose of, nurses (FCMPN), 145-146, 151, 154, 551f
88t-89t 155b-156b grouped, 551, 551t
variables in, 156 Fatigue effect, 249 with outlier, 553f
Experimental study, 37 FCMPN. See Fatigue countermeasures without outlier, 553f
decision tree for, 260f program for nurses of SF-36 Physical Functioning scale,
intervention development in, 228-231 FDA. See Food and Drug Administration, 556, 556f
manipulation in, 197 U.S. ungrouped, 550-551
research design for, 43 Federal grant, proposal submission for, Frequency response, 404
settings and conditions for, 87 670-671 Frequency table, 550
Experimental study design, 244-254 institutional support verification, 670 of smoking status, 552t
causality, examination of, 231 rejection of, 671 Functional Outcomes of Sleep
as classic/original, 218f, 245 review process, understanding of, 671 Questionnaire (FOSQ), 335
focus and purpose statement of, 244t uniqueness of, 670, 670t Fundamentalists, 387-388
posttest-only comparison group, 246, Field setting. See Natural setting Funding, for research
246f Field work, 286 application requests, 670
types of, 244t Findings apprenticeship, 666
Experimenter expectancy, 201 communication of, 49 capacity, 665
Expert nurse, 10 determination of, 595, 595t-596t capital, 665
Explanation, 13 interpretation of, 48 commitment level, 665
causal, 326-327 Fisher, Sir Ronald, 34 contribution, 664-665
Exploratory data analysis, 542, 544-545 Fishing, 198 course attendance, 666
tables and graphs for, 545 Fixed-effects model, 486 foundations, 669
Exploratory factor analysis (EFA), 398 Focus group, 274-276 government, 669-670, 669f
Exploratory studies, 370 assumptions of, 274 grants types for, 667
Exploratory-descriptive qualitative data collection from, 274 grantsmanship, 666
research, 27, 66-68 example study using, 276 industry, 668-669
nursing research contribution from, facilitator role in, 275-276 investigator-initiated proposals,
66-68 participants of, recruitment of, 275 669-670
philosophical orientation, 66 purpose of, 274 local, 667-668
External validity, 202 questions for, 276 national nursing organizations, 668,
Extraneous factors, 342 setting of, 275 668t
Extraneous variable, 199, 342 Fog formula, 398b, 442 nongovernment, 667-669
control of, 204-207 Food and Drug Administration, U.S. private, 667-668
types of, 152-154 (FDA) program building, 663-665, 664f, 664t
Amendments Act of 2007, 163 proposal requests, 670
F human research subjects, protection of, regional nursing research organizations,
F statistic, 585 163 667, 667t
Fabrication, 188 IRB/privacy board responsibilities, 188t research committees, serving on, 667
Face validity, 394-397 research, regulations in, 164t sources for, 667-670
Faces pain thermometer (FPT), 418, Forced choice, 430 support of other people, 665-666
419b Forest plot, 488, 489f workshop attendance, 666
Factor analysis, 566-568 FOSQ. See Functional Outcomes of Sleep Funnel plot, 484, 484f-485f
validity from, 398-400 Questionnaire
Factor scores, 568 FPT. See Faces pain thermometer G
Factorial design Framework GDS. See Geriatric depression scale
example of, 247f conceptually defining, 132 General proposition, 124
overview of, 247 definition of, 116 Generalizations, 25
Facts for Action to Stroke Treatment development of, 41-42 empirical, 599
(FAST), 230-231 map, 41, 42f of findings, 598-599
720 Index

Generalizing, 36, 352 Health and Psychological Instruments Hospitalized patients, as research subjects,
Geographical analysis, 311-312 Online (HAPI), 440 169
as small area analysis, 311 Health care, theory of, 294 HPLPII. See Health-Promoting Lifestyle
Geographical information system (GIS), Health Care Finance and Quality Act of Profile II
299 1999, 22 HR. See Hazard ratio (HR)
Geriatric depression scale (GDS), Health Insurance Portability and HRQoL. See Health-related quality of life
581-582 Accountability Act (HIPAA), 439 HTN. See Hypertension
GI. See Guided imagery data use agreement, 170-171 Human Genome Project, U.S., 417
GIS. See Geographical information enactment of, 159 Human immunodeficiency virus (HIV),
system IRB/privacy board responsibilities, coping interventions for, 238
Going native, 286 188t Human rights, protection of, 163-175
Gold standard, 31, 406 objective and applicability of, 164t Human subjects
Goldmark Report, 19 PHI, authorization to use, 182-183, AIDS patients as, 169
Google, 106 184f as autonomous agent, 164
Government funding, for research, Privacy Rule and, 163, 170 children as, 166-167
669-670, 669f Privacy Rule influence on IRB, 187 coercion of, 164
Government reports, 100 Health Promotion/Transtheoretical Model, comprehension of, 178-180
Graduate Record Examination (GRE), 78-79, 79f confidentiality of, 171-173
388 Healthcare data, existing, 439-440 deception of, 165
Grand theories, 125, 125t-126t Health-Promoting Lifestyle Profile II DHEW, regulations set by, 162
Grants. See also Research, funding for (HPLPII), 45b with diminished capacity, 167-169
management of, 671-672 Health-related quality of life (HRQoL), discomfort, protection from, 163
budget, 671-672 603 fair treatment of, 174
coordinating activities, 672 self-care program on, 245-246 harm, protection from, 163
research personnel training, 672 Healthy People 2000, 22 informed consent form, 176-183
study schedule, 672 Healthy People 2010, 22 legally and mentally incompetent,
submitting reports, 672 Healthy People 2020, 22, 80-81 165-169
planning future, 672 Heidegger, Martin, 60-61 National Commission for Protection of,
GRE. See Graduate Record Examination Helsinki, Declaration of, 160 162-163
Grey literature, 475 Heterogeneity, 205t, 206, 482, 554 neonate as, 165-166
Grounded theory research, 27, 62-63 Heterogenous, 554 permanent damage to, 175
definition of, 62 population, 352-353 pregnant women as, 167
methodology for, 285-286 HHCC. See Home Health Care prisoners as, 169
nursing research contribution from, 63 Classification System selection of, 173-174
pain management theory, 142 Hierarchical statement set, 132 terminally ill as, 169
philosophical orientation, 63 Highly controlled setting, 373-374 unethical treatment of, 159-160
purpose of, 87-92 for research, 37 Humane Care and Use of Laboratory
topics, problems, and purpose of, 90t-91t Hinshaw, Ada Sue, 21 Animals Regulations, 191
Group, random assignment to, 232-233 HIPAA. See Health Insurance Portability Husserl, Edmund, 60
Grouped frequency distribution, 551, 551t and Accountability Act Hypertension (HTN)
Grove Model for Implementing Histogram, of smoking status, 552f evidence-based practice model for, 12f
Evidence-Based Guidelines in Historical research, 27, 68 research relating to, 11-12
Practice, 500-501, 501f data analysis of, 289 Hypotheses, 124, 150
Guided imagery (GI), 113 literature review and, 98 associative, 144-146
depression and, 113 methodology for, 289-290 causal, 144-146
nursing science contribution from, 68 complex, 146-147
H philosophical orientation, 68 development of, 148-149
HAPI. See Health and Psychological problem and purpose of, 92 directional, 147-149
Instruments Online sources for, 289 formulation of, 142-149
Harm, protection from, 174-175 topics, problems, and purpose of, generating for research, 150t
Harvard Nurse Health Study, 309 90t-91t guessing, 201
Hawthorne effect, 38 History, treatment and, 202 nondirectional, 147
Hazard ratio (HR), 577 History effect, 199 null, 147-148
adjusted, 577-578 HIV. See Human immunodeficiency virus purpose of, 142
Health Home Health Care Classification System research, 147-148
concept of, 294 (HHCC), 325 rival, 199
definition of, 295 Homogeneity, 205t, 206, 391 simple, 146-147
nurses promoting, 22 Homoscedastic, 562 sources of, 142-144
Index 721

Hypotheses (Continued) Institutional review board (IRB) Intervention research (Continued)


statistical, 147 approval for research participation, planning of, 338-339
testable, 149 168 problems of, 326-329, 327f
testing, 541-542 benefit-risk ratio, 176 project planning in, 338
types of, 144-148 complete review, 186 project team formation, 338
Hypotheses testable, 149 expedited versus complete, 185-186, project team work, 338-339
Hypothetical population, 352 186b purpose of, 74-75, 93
HIPAA Privacy Rule influence on, 187 systematic replication and, 77
I levels of reviews conducted by, Intervention studies, problems examined
IIHI. See Individually identifiable health 183-187 by, 325, 326b
information members of, 163 Intervention theory, 327
Illness Representation, 143 purpose of, 183 elements of, 328b
IM. See Index Medicus Institutional support, 531 Intervention-based research
Image, 20 Institutions. See Hospitalized patients; critical appraisal of, 346b-347b, 347
Improvement, analysis of, 315 Prisoners nursing conducted, 323-324
Incompetence, 167-168 Instrumentation, 44-45, 199 phases of, 340f
Incomplete disclosure, consent to, 178 assessing readability levels of, 442 terminology for, 329-335
Independent samples t-test, 581-583 evaluation of existing, 442 Interventions
calculation of, 581-582 locating existing, 440-441 definition of, 324
nonparametric alternative, 582-583 reliability of, 397-398 designing of, 229-231, 339-342,
result interpretation, 582 selection of existing, 440-442, 441f 341b
Independent t-test analysis technique, 580 Intellectual contribution, 465 dose-intensity of, 332-333
Independent variable, 145, 151 Intention-to-treat (ITT), analysis of, 334 formal testing of, 344
Index Medicus (IM), 103 Intermediate end points, 314-315 in NIC, 229
Indicator Intermediate mediation, 196 pilot test of, 343-344
nursing-sensitive quality indicators, 304 Intermediate outcomes, 342 placebo, 330-331
of quality nursing practice, 303-304 Internal consistency, 391-393 scientific rationale for, 328-329
Indirect measurement, 383 Internal validity, 199-200 sham, 330-331
Indirect physiological measures, 413-414 International Journal of Nursing stage-based, 325
Indirect recall, 310 Terminology and Classifications, 20 taxonomy, 325
Individual, 294-295 International Organization of testing process of, 339-345
Individually identifiable health Standardization (IOS), 395 theory-based, 327-328
information (IIHI), 170 Internet. See also Online data collection validation of, 342-343
Inductive reasoning, 7 literature search using, 106, 106t Interviewers, training of, 424
Inductive thinker, 148 research problems and, 76 Interviews, 271-274, 422-425
Inductive thinking, 58 studies, searching for, 86 advantages of, 424-425
Industry funding, for research, 668-669 Interpretation, of research outcomes, 48, conducting an effective, 272-273
Infer, 537 590 designing questions for, 422
Inference, 537 Interrater reliability, 390 disadvantages of, 424-425
Inferential statistics, 538, 542 Interrupted time-series design learning to, 272
Informants, 65, 351-352, 352f with multiple treatment replications, pilot testing protocol for, 424
Information, gathering of, 339, 339b-340b 242f, 244 positive environment for, 272
Information-rich cases, 365 with nonequivalent no-treatment preparation for, 424
Informed consent, 659-660 comparison group time series, problems with, 273
for child research subject, 166, 166t 242f, 243 recording data, 424
competence to give, 180 purpose of, 241-244 structured, 422-424, 425b
comprehension of, 178-180 simple, 241f, 242-243 Introspection, 5
documentation of, 180-182 Interval data, 388 Intuition, 5-6
from legally authorized representative, Interval level, of measurement, 387 Intuitive comprehension, 465
182-183 Intervening variable, 123-124 Inverse linear relationship, 561
from mentally ill, 182 Intervention fidelity, 37, 198-199, Investigator-initiated research proposal,
obtaining from subjects, 176-183 605-606 669-670
simplification of, 179b Intervention label, 229 IOS. See International Organization of
voluntary, 180 Intervention reliability, 198-199 Standardization
Ingenta Connect, 106 Intervention research, 3, 8, 28 Iowa Model of Evidence-Based Practice
Institute for Research and Service in focus of, 74-75 to Promote Quality of Care, 493,
Nursing Education, 19 information gathering for, 339, 496, 497f
Institutional review, 183-187 339b-340b IRB. See Institutional review board
722 Index

Item response theory, scale construction Life Orientation Test (LOT-R), 45b Logical positivism, 24
using, 444-445 Likelihood ratios (LRs), 408 Logistic reasoning, 6-7, 36
ITT. See Intention-to-treat Likert scale, 45, 45b, 388, 430-431 Logistic regression, 576-577
Limitations, identification of, 598 calculation, 576
J Limited data set, 170-171 odds ratio in, 576-577
JCAHO. See Joint Commission on Limited recall, 310 Longitudinal design
Accreditation of Healthcare Line of best fit, 570-571 example of, 219f
Organizations Linear regression equation, computation purpose of, 219-220
Jewish Chronic Disease Hospital Study, of, 571t with treatment partitioning, 223f
162, 165 Linear relationship, 560-561, 570, 571f LOT-R. See Life Orientation Test
Joanna Briggs Institute, 31 example of, 121f Low statistical power, 198
The Joint Commission, 304 inverse, 561 LRs. See Likelihood ratios
Joint Commission on Accreditation of negative, 561 LTA. See Latent transition analysis
Healthcare Organizations (JCAHO), positive vs., 121 Lung damage, smoking and, 7-8
22 positive, 561
Joint National Committee on Prevention, negative vs., 121 M
Detection, Evaluation, and Treatment value of, 121 MacArthur Competency Assessment Tool
of High Blood Pressure, 499-502, Literature for Clinical Research (MacCAT-CR),
500f empirical, 100 168
Journal article, 628-631 discussion of, 111-112 MacCAT-CR. See MacArthur Competency
manuscript preparation, 629-630 searching of, 490 Assessment Tool for Clinical
manuscript revision requests, 630-631 types of, 97 Research
manuscript submission for review, 630 Literature review, 40-41 MACE. See Major adverse cardiovascular
peer review, 630 course papers, writing, 98 events
query letter development, 629 definition of, 97-98 Magnet Hospital Designation Program for
selection of, 628-629 example of, 112-114 Excellence in Nursing Services, 22,
Journal Citation Report, 628 nursing journals, 98 452-453, 469
Journal impact factor, 628-629 processing of, 108-110 Magnitude scaling, 433
Journal of Nursing Scholarship, 20 purpose of, 98-100 Major adverse cardiovascular events
Journals, online, published research in, qualitative research and, 98 (MACE), 577-578, 577t
631-632 quantitative review and, 98-100, 99t Manipulation, 197
Judgemental sampling. See Purposive sources included in, 101-102 Manipulation checks, 332, 333b
sampling stages of, 98, 102-108 Mann-Whitney U test, 582-583
strength of evidence, examining, 98 Manuscript
K summary of, 109, 109t preparation of, 629-630
Kendall’s tau, 564 synthesis of study to generate, 104t revision requests, 630-631
Keyword, 101-102 systems model of, 102, 102f submission for review, 630
Knowledge, 8-10 time frame for, 101 Matching, 205t, 207
acquiring, ways to, 8-10 writing of, 110-112 Maturation, 199
body of, 1, 10 Literature search, 102 McNernar test, 587
clinical expertise and, 12 by author, 105 MD. See Median
Kolmogorov-Smirnov D test, 541 databases for, 103 Mead, George Herbert, 63
Kurtosis, 541, 541f keyword selection for, 104-105 Mean, 538, 539f, 553-554
limitation of, 106 deviation, 554
L performing complex, 105-106 standard error of, 557
Laboratory tests, physiological measures plan development, 102-103, 103t Measurement error, 383-385, 383f
from, 414-415 relevant, location of, 106-107 types of, 383-385
Landmark study, 100 saved, 108 Measurement sensitivity, 370-371
Language, 106 strategy for, 104-106 Measurements
Language bias, 484 using Internet, 106, 106t control of, 204
Last observation carried forward (LOCF), written record of, 103, 103t direct, 382-383
334 Local funding, for research, 667-668 directness of, 382-383
Latent transition analysis (LTA), 317 Location bias, 484 evidence examination from, 591-592
Law, 8 Locational operator, 105 indirect, 383
Learning, anxiety and, 121 LOCF. See Last observation carried interval level of, 387
Legally authorized representative, 168 forward levels of, 385-388, 386f
Leptokurtic, 541, 541f Logic, 6 controversy over, 387-388
Levels of measurement, 385-388, 386f Logical Investigations, 60 for statistical analyses, 387
Index 723

Measurements (Continued) Midwest Nursing Research Society National Database of Nursing Quality
methods, reliability testing of, 544 (MNRS), 19 Indicators (NDNQI), 303-304,
methods of, 44-45, 314-315 Minimal risk, 185-186 439-440, 440b
nominal level of, 386 Minnesota Multiphasic Personality National Guideline Clearinghouse (NGC),
observational, 421-422 Inventory (MMPI), 388 31
ordinal level of, 386-387 Misconduct, in research, 159 National Human Genome Research
ratio level of, 387 Mixed methods, 208-212 Institute (NHGRI), 35
reference testing of, 388 approaches, 208 priorities of, 35-36
reliability of, 198 concurrent procedures, 208-209 National Institute of Nursing Research
using existing databases, 439-440 sequential procedures, 208 (NINR), 21, 23
Median (MD), 538, 539f, 553 transformative procedures, 209 mission of, 23
Mediating variable, 123-124 Mixed results, 594-595 research priorities for, 80
Mediator variable, 154-155 Mixed-methods systematic reviews, science of nursing, 80
Medical Outcomes Study (MOS), 301-302 29-30, 492-493 National League for Nursing (NLN), 20
conceptual framework for, 301f basic structure for, 493 National Library of Medicine
MEDLINE, 103 MMPI. See Minnesota Multiphasic (MEDLINE), 103
Memoing, 283 Personality Inventory National Nursing Home Survey (NNHS),
Mental illness, informed consent from MNRS. See Midwest Nursing Research 362
patient, 167-169 Society National nursing organizations, 668,
Mentor, 666 Modality, 540-541 668t
Mentorship, 10 Mode, 538, 539f, 552 National Quality Forum (NQF),
role-modeling, as form of, 10 Model-testing design 304-305
Merleau-Ponty, 61 example of, 227f Natural setting, 373
Mesokurtic, 541, 541f requirements for, 227-228 for research, 37
Meta-analysis, 29 Moderator variable, 154-155 Naturalistic inquiry, 66
biases for, 484-485 Molar causal law, 196 Nazi medical experiments, 160
clinical question for, 483 Monographs, 100 NCATS. See National Center for
conduction, guidelines for synthesizing Monomethod bias, 201 Advancing Translation Sciences
research evidence, 479, 481t Mono-operation bias, 201 NCNR. See National Center for Nursing
for continuous outcomes, 486 Montag, Mildred, 19 Research
for dichotomous outcomes, 486-488, Morisky medication adherence scale, 660 NDNQI. See National Database of
488f MOS. See Medical Outcomes Study Nursing Quality Indicators
directions and purpose to direct, 483 MTQ: Purposeful Action, 395-397 Near-infrared spectroscopy, 419b
facilitation of, reporting for authors, Multicausality, 196 NEBHE. See New England Board of
482b Multicollinearity, 573-574 Higher Education
search criteria for, 483 Multidimensional scaling, scale Necessary relationship, 123
strategies for, 483 construction using, 445 Need-Driven Dementia-Compromised
Metasearcher, 106 Multilevel synthesis, 492-493 Behavior Model, 327
Metasummary, 489-490 Multimethod-multitrait technique, Negative likelihood ratio, 408
Meta-synthesis, 29 384-385 Negative linear relationship, 121, 121f,
conduction, of qualitative research, Multiple R, 572 561
489-491 Multiple regression analysis, 573-575, Negative results, 594
oasis-ebl|Rsalles|1476813940

definition of, 489-490 574t Negatively skewed, 540


exercise, framing of, 490 Multistage cluster sampling, 360-361 Neonate, as research subject, 165-166
findings, discussion of, 491, 492f Nested design
Method of least squares, 571 N example of, 248f-249f
Methodological coherence, 465 NANDA. See North American Nursing overview of, 248
Methodological congruence, 465 Diagnosis Association Nested variable, 248
Methodological design, 255 Narrative analysis, 282-283 Network sampling, 366
Methodological limitations, 598 National Association of Neonatal Nurses, Networking, 666
Metric ordinal scale, 387 31 New England Board of Higher Education
Micromediation, 196 National Center for Advancing (NEBHE), 19
Middle development, 251 Translation Sciences (NCATS), 503 NGC. See National Guideline
Middle-range theories, 117 National Center for Nursing Research Clearinghouse
application of, 125-126 (NCNR), 21 NHGRI. See National Human Genome
in nursing, 127t-128t National Commission for Protection of Research Institute
qualitative research and, 125-126 Human Subjects of Biomedical and NIC. See Nursing Intervention
used in nursing, 127t-128t Behavioral Research, 162-163 Classification
724 Index

Nightingale, Florence Nurses (Continued) Nursing research (Continued)


data collection and statistical analyses, critical appraisal of research by, framework for exploring, 2-11, 2f
17 452-453 HIPAA affecting, 170
nursing, influence on, 17-19 expert, 10 historical development of, 17-23
research by, 17 expertise, in critical appraisal of historical events influencing, 18t
NILT. See The Nursing Intervention research, 454, 454t in other countries, 80
Lexicon and Taxonomy intervention-based research conducted prediction of, 13-14
NINR. See National Institute of Nursing by, 323-324 requirements for, 2-3
Research novice, 10 in twenty-first century, 22-23
NLN. See National League for Nursing pain management role of, 327f Nursing Research, 19
NNHS. See National Nursing Home proficient, 10 Nursing science, 7-8
Survey research, levels participating in, 21 Nursing situation
NNT. See Numbers needed to treat Nursing questions, generation of, 81-82
NOC. See Nursing Outcome Classification body of knowledge, 1, 10 study problem formulation, 81-83
Nominal level, of measurement, 386 clinical expertise in, 12 Nursing-sensitive patient outcome
Noncoercive disclaimer, 178 critical appraisal of research (NSPO), 303-305
Nondirectional hypothesis, 147 implemented in, 452-454 Nutting Report, 19
Nonexperimental designs, 337-338 definition of, 1
Nongovernment funding, for research, education for, 19 O
667-669 in empirical world, 3 Objective. See also Research objectives
Nonparametric statistical analysis, 542 goal of, 11-12 formats for developing, 138
Nonparametric statistics, 542 middle-range theories used in, formulation of, 138-140
parametric statistics vs., to determine 127t-128t in qualitative research, 139-140, 150
differences, 580 NIC, work relating to, 230t in quantitative research, 138-139, 150
Nonpredicted results, significant and, 594 NOC, work relating to, 230t Observational checklist, 422
Nonprobability sampling methods outcomes research and, 302-306 Observational measurement, 421-422
in qualitative research, 358t, 364-367 philosophy and, 10-11 Observations
in quantitative research, 362-364 Nursing Care Report Card, 303 physiological measures by, 413
Nontherapeutic research, 160 Nursing Diagnosis Conference, 20 structured, 421-422
Nonverbal Pain Assessment Tool (NPAT), Nursing education, 19 Observed score, 383
413, 423f Nursing History Review, 68 OCS. See Omaha Classification System
Normal curve, 538, 539f, 555-557, 556f Nursing Intervention Classification (NIC), Odds ratio (OR), 487, 575, 575t
Normality, tests of, 541 229, 325 confidence intervals and, 575
Norm-referenced testing, 388 nursing work relating to, 230t interpretation of, 575
North American Nursing Diagnosis The Nursing Intervention Lexicon and in logistic regression, 576-577
Association (NANDA), 20, 325 Taxonomy (NILT), 325 Office for Human Research Protection
Notes on Nursing, 17 Nursing interventions. See also (OHRP), 162-163
Novice nurse, 10 Interventions Office for Protection from Research Risks
NPAT. See Nonverbal Pain Assessment definition of, 324 (OPRR), 191
Tool taxonomies, 325 Office of Laboratory Animal Welfare
NQF. See National Quality Forum variations in, 324-325 (OLAW), 190-191
NRS. See Numerical Rating Scale Nursing knowledge, acquiring, ways to, Office of Research Integrity (ORI),
NSPO. See Nursing-sensitive patient 8-10 188-189
outcome Nursing Outcome Classification (NOC), OHRP. See Office for Human Research
Nucleic acids, genetic advancements in 229, 230t Protection
measuring, 417-418 Nursing research OLAW. See Office of Laboratory Animal
Null hypotheses, 147-148 in 1900s, 19 Welfare
Numbers needed to treat (NNT), 333-334 in 1950s-1960s, 19 Omaha Classification System (OCS), 338
Numerator, 575 in 1970s, 20-21 The Omaha System, 325
Numerical Rating Scale (NRS), 430f in 1980s-1990s, 21-22 Oncology Nursing Society, 31, 305
Nuremberg Code, 160, 161b case study designs in, 223-224 One-group posttest-only design, 234, 235f
Nurse educators, critical appraisal of controlling outcome of, 13-14 One-group pretest-posttest design,
research by, 453 definition of, 1-2 234-236, 236f
Nurse researchers, critical appraisal of description of, 12-13 One-tailed test of significance, 545
research by, 453 effective enterprise, ensuring, 23 Online data collection, 508-513
Nurses evolution of, 17 Open label
advanced beginner, 10 explanation of, 13 blinding vs., 331-332
competent, 10 federal funds for, 21 designs, 337
Index 725

Open label extension, 331-332 Paraphrasing, 110-111 Phones, for data collection, 514-515
Operational definition, 43 Parent theory, 129 Physical activity counseling, 237
Operational reasoning, 6 Parents and Newborn Screening Theory, Physiologic measures
Operationalizing variable, 155-156 509f-512f electronic monitoring and, 415-417
Operator, 105, 141 Partially controlled setting, 373 new development of, 418-419
OPRR. See Office for Protection from for research, 37 obtaining across time, 419-420
Research Risks Participant-administered instruments, in selection of, 420-421
OR. See Odds ratio data collection, 507-508 Physiological measures, 402, 411-421
Ordinal level, of measurement, 386-387 Participant-observation, 65 accuracy of, 402-406
Orem’s model of self-care Path coefficient, 227-228 direct, 413-414
as conceptual model, 125 Patient, definition of, 294-295 error of, 402-406
theories relating to, 126t Patient outcomes evaluation, 316t indirect, 413-414
ORI. See Office of Research Integrity PCA. See Principle components from laboratory tests, 414-415
Outcome assessment instruments, 316t analysis by observation, 413
Outcome reporting bias, 484 PDAs. See Personal digital assistants precision of, 402-406
Outcomes Pearson, Karl, 34 by self-report, 412-413
of care, 296 Pearson’s product-moment correlation sensitivity of, 404
continuous, meta-analysis results for, coefficient, 561-564 PICOS format, 474-475
486 calculation of, 562-563, 562t Pilot study, 46, 343-344, 523
evaluation of, 308-309 coefficient of determination for, 564 Pilot testing, of interventions, 343-344
intermediate, 342 effect size of, 564 Placebo interventions, 330-331
observation process steps and, 342b results interpretation, 563-564, 563f Plagiarism, 188
proximate, 296 Peer, researcher interaction with, 76 Platykurtic, 541, 541f
Outcomes research, 3, 27-28. See also People for Ethical Treatment of Animals Population-based study, 311
Research (PETA), 190 Populations, 351-352, 352f, 537-538
advanced practice nursing and, Perceived Stress Scale (PSS-10), 45b definition of, 44
305-306 Perceived view, 66 heterogenous, 352-353
classification of, 305 Periodical, 100 hypothetical, 352
database usage in, 306-308 Permanent damage. See Damage, parameter, 354
disseminating findings, 318 permanent studies, 352
federal government involvement in, Permission to participate, in study, target, 351-352, 352f
300-302 166 Position papers, 100
focus of, 74-75 Person, 294-295 Positional operator, 105-106
methodology for, 306-318 Personal digital assistants (PDAs), Positive likelihood ratio, 408
nursing practice and, 302-306 514-515 Positive linear relationship, 120-121,
overview of, 294 Personal experience, 10 121f, 561
purpose of, 83 PETA. See People for Ethical Treatment Positively skewed, 540
statistical methods for, 315-318 of Animals Post hoc analysis, 545-546
strategies for, 308-312 Phenomena, 60 Poster sessions, for research findings
theoretical basis of, 294-298 Phenomenological research, 27, 60-62 presentation, 625-627, 626f
topics, problems, and purpose of, nursing science contribution from, Posttest design. See Pretest and posttest
92-93, 92t 61-62 design
Out-of-pocket cost, 298 purpose of, 87 Posttest-only design, 234, 235f
topics, problems, and purpose of, Power, 367, 536
P 90t-91t Power analysis, 219-220, 367
Pain management theory, 142 The Phenomenology of Perception, 61 Practical research, 35
Paired samples, t-tests for, 583-584 PHI. See Protected health information Practicality, as outcomes assessment
Paired t-test analysis technique, 580 Philosophical analysis instrument, 316t
Parallel group randomized controlled problem and purpose of, 93 Practice effect, 249
trials, 335-336 topics, problems, and purpose of, 93t Practice pattern, 297
Parallel synthesis, 492-493 Philosophical congruence, 465 profiling, 308-309
Parallel-forms reliability, 390 Philosophical perspective, 57 Practice style, influencing quality, 297
Parameter, 537 Philosophy, 10-11 Practice theories, 125
population, 354 describes view of science, 57-58, Pragmatists, 387-388
Parametric statistical analysis, 542 58f Precision, 354
Parametric statistics, 542 guides criteria of rigor, 58-59, 58f Predicted results, significant and, 594
nonparametric statistics vs., to guides methods, 58, 58f Prediction, 13-14
determine differences, 580 qualitative research and, 57-59 Predictive correlational design, 227
726 Index

Predictive design Problem. See Research problem Qualitative research (Continued)


example of, 226f Problem statement, 73 goals of, 74-75
purpose of, 226-227 Problematic reasoning, 6 introduction to, 57
Predictive validity, 573-574 Process, evaluation of, 296 literature review and, 98
Preference clinical trials, 336-337 Professional standards review meta-synthesis conduction of,
Preferred Reporting Items for Systematic organizations (PSROs), 22 489-491
Reviews and Meta-Analyses Proficient nurse, 10 methods of, 27
(PRISMA) Statement, 472-473, 477f Profiling, practice pattern, 308-309 middle-range theory and, 125-126
Pregnancy, research during, 167 Project grant proposals, 667 nonprobability sampling methods in,
Premature infant study, 250 Project team 358t, 364-367
Preparation, Stetler Model of Research formation of, 338 objective, formulation of, 139-140
Utilization to Facilitate Evidence- work of, 338-339 objective, questions, hypothesis,
Based Practice phase, 493-495 Proportionate sampling, 360 selection of, 150, 150t
Preproposal proposal, content of, 644 Proposals perspective of, 57-59
Prescriptive theory, 327 critical appraisal of research, 453-454 philosophical orientation of, 60-61
Presentations, critical appraisal of revision of, 647 philosophical origin of, 24
research, 453 verbal presentation of, 646-647 philosophy and, 57-59
Pretest and posttest design Prospective cohort study, 219, 309 purpose of, 87-92
with comparison group, 237, 237f Protected health information (PHI), 163 quantitative research, comparing to,
with removed treatment, 238-240, 239f authorization to use, 182-183, 184f 23-25
with reversed treatment, 240, 240f de-identifying under Privacy Rule, questions, generation of, 141-142
with two comparison treatments, 170 rigor and, 58-59
237-238, 238f-239f HIPAA, DHHS, FDA, comparison of, sample size in, 371-373
Pretest sensitization, 246 188t topics, problems, and purpose of,
Pretest-posttest control group design, 245 Providers of care, 295 90t-91t
example of, 245f Proximate outcomes, 296 types of, 26b
Primary prevention study, 254 PSROs. See Professional standards review uniqueness of conducting, 25
Primary source, 101 organizations variables in, 156
Primary study strategies, 483b PSS-10. See Perceived Stress Scale Qualitative research proposal, content of,
Primordial cell, 295-296 Publication bias, 484, 485f 640-644, 641t
Principle, 8 Publications, critical appraisal of research, communication plans, 643-644
Principle components analysis (PCA), 453 inquiry method, 642-643
566-568 Published research, 627-632 introduction, 640-642
example of, 567-568, 567t in books, 632 knowledge base, 643-644
factors generated from, 568 duplicate publications, 632 limitations, 643-644
Principle of beneficence, 162 journal article, 628-631 philosophical and conceptual
Principle of justice, 162 manuscript preparation, 629-630 foundation, 642
Principle of respect for persons, 162 manuscript revision requests, Qualitative research report, outline for,
PRISMA. See Preferred Reporting Items 630-631 614-618
for Systematic Reviews and manuscript submission for review, analysis plan, 617
Meta-Analyses Statement 630 discussion, 618
Prisoners, as research subjects, 169 peer review, 630 dissertations, 619
Privacy, 169-171 query letter development, 629 introduction, 615
invasion of, 169-170 selection of, 628-629 methods, 616, 616b
Privacy Rule in online journals, 631-632 results, 617-618, 618b
de-identifying PHI under, 170 self-plagiarism, 632 theses, 619
enactment of, 163 Pure research, 34 Qualitative research synthesis, 29, 489
individually identifiable health Purposive sampling, 365-366 Qualitative study
information and, 170 critical appraisal process for, 462-465
IRB, influence on, 187 Q approach, 464
Private funding, for research, 667-668 Q-sort methodology, 434-435 data collection, 464
Probability, 196 Qualitative meta-synthesis, 29 data management and analysis, 465
Probability distribution, 563, 564f Qualitative research discussion, 465
Probability sampling methods, 357-362, approaches to, 59-68, 60t evaluation summary, 465
358t characteristics of, 24t findings, 465
Probability theory, 535 data for, 25 guidelines, 463-465
Probably statement, 123 definition of, 3, 23 human study participant protection,
Probing, 424 focus of, 24-25 464-465
Index 727

Qualitative study (Continued) Quantitative research reports, 590, Randomization, 356-357


literature review, 463-464 603-614 Randomized blocking design, 206,
logic form of findings, 465 outline for, 604t 246-247
philosophical foundation, 464 analysis plan, 608 Randomized controlled trial (RCT),
prerequisites for, 463 data collection process, 607 26-28, 232, 251-254
problem statement, 463 design, 605-606 cluster, 336
purpose, 463 discussion, 613-614 crossover, 336
research questions, 463 framework, 604-605, 605f efficacy studies and, 329-330
sampling, 464 instruments, 607t of nurses role in pain management,
emergency contraceptive pills and, introduction, 604-605 327f
366-367 measures, 607 parallel group, 335-336
Qualitative study abstract, outline for, methods, 605-608 Range, as measure of dispersion, 554
622b reference citations, 614 Rating scales, 422, 429-430
Quality health care result presentation, 609-613, 609t, Ratio level, of measurement, 387
evaluation of, 294 610f, 611t-613t RCT. See Randomized controlled trial
theory of, 294, 295f review of literature, 604 RD. See Risk difference
Quantitative data analysis, stages of, 542 sample and setting, 606-607 Reality testing, 3-4
Quantitative research variables, 607t Reasoning, 6-7
characteristics of, 24t Quantitative study abstract, outline for, deductive, 7
concepts relevant to, 34-38 622b dialectic, 6
control in, 36-38, 37t Quasi-experimental designs, 231-244, inductive, 7
critical appraisal process for, 454-462, 335-337 logistic, 6-7
455b development of, 231 operational, 6
evaluation, 462 focus and purpose statement of, 244t problematic, 6
step identification, 455-458 Quasi-experimental research, 26 types of, 6
strengths in, 458-462 topics, problems, and purpose of, 88t-89t Recall, bases of, 310
weaknesses in, 458-462 variables in, 156 Recording interview data, 424
definition of, 3, 23 Quasi-experimental studies, 37 Recruiting research participants, 374-379,
focus of, 24-25 decision tree for, 259f 378t
goals of, 74-75 intervention development in, 228 Reference
introduction to, 34 manipulation in, 197 citation errors, 112, 112b
literature review of, 98-100, 99t process, steps of, 50b-53b literature review, verifying for, 112
methods of, 26-27 purpose of, 50 systemically recording of, 107-108
nonprobability sampling methods in, research design for, 43 Reference management software, 107-108
362-364 Query letter development, 629 Referencing, 388
objective, formulation of, 138-139 Questionnaires, 425-429 Referred journal, 628
objective, questions, hypothesis, data analysis, 429 Refusal rate, 355
selection of, 150, 150t development of, 426-428 Registered nurse (RN), 2
philosophical origin of, 24 validity of, 428-429 Regression analysis, 570
process, steps of, 38-43, 39f Questions independent variable types used in,
purpose of, 87 focus of, 140 574-575
qualitative research, comparing to, generating for research, 81-82, 150t dummy, 574-575
23-25 for qualitative research, 141-142 Regulation
questions, generation of, 140-141 for quantitative research, 140-141 in research, 159-163, 164t
rigor in, 36 research, formulation of, 42 set by DHEW, 162
sample size in, 367-371 Quota sampling, 364 Relational statement, 41, 116-117
topics, problems, and purpose of, characteristics of, 120-124
88t-89t R development of, 132
types of, 26b, 49-53 Random assignment, 205t, 206 examination of, 120-124
uniqueness of conducting, 25 to groups, 232-233 Relationships
Quantitative research proposal Random error, 384 associative, 144
content of, 637-640, 637t Random heterogeneity, 199 asymmetrical, 122
framework, 638 Random sampling, 205-206, 205t, causal, 123, 145
introduction, 638 356-357 characteristics of, 124t
methods, 638-640 Random sampling methods. See concurrent, 123
procedures, 638-640 Probability sampling methods contingent, 123-124
relevant literature review, 638 Random variation, 354 curvilinear, 121
example of, 647 Random-effects model, 486 example of, 122f
728 Index

Relationships (Continued) Research (Continued) Research (Continued)


deterministic, 123 ethical codes and regulations in, 159 natural setting for, 37
direction of, 120-121 ethical considerations for, 86 ORI role in, 188-189
necessity of, 123 ethnonursing, 65 outcomes, interpretation of, 48
negative linear, 121, 121f evidence, focus of, 12 partially controlled setting for, 37
positive linear, 120-121, 121f evidence-based practice and, 11-14, phenomenological, 27
probability, 123 159 practical, 35
sequential, 123, 123f experimental, variables in, 156 prediction of, 13-14
shape of, 121 explanation of, 13 priority, for clinical practice, 79-81
strength of, 121-122, 122f, 561t facility/equipment availability for, 86 pure, 34
substitutable, 123 feasibility of, 84-86 questions. See Questions
sufficient, 123-124 by Florence Nightingale, 17 reality testing using, 3-4
symmetrical, 122, 122f funding for recommendations for further, 599-600
Relative risk, 486-487 application requests, 670 regulations for, 164t
Relevant literature apprenticeship, 666 report, content of, 602-619
location of, 106-107 capacity, 665 settings, 22-23, 373-374
review of, 40-41 capital, 665 time commitment for, 84
Reliability, 45, 389-393 commitment level, 665 topics, 73, 81
alternate-forms, 390 contribution, 664-665 development of, 83-84
equivalence, 390-391 course attendance, 666 unethical treatment of subjects in,
interrater, 390 foundations, 669 159-160
as outcomes assessment instrument, government, 669-670, 669f utilization, 22, 493
316t grants types for, 667 variable, 151-152
parallel-forms, 390 grantsmanship, 666 definition of, 42-43, 151
split-half, 391 industry, 668-669 Research evidence
stability, 389-390 investigator-initiated proposals, conducting meta-analysis, 482-488
testing, 389 669-670 guidelines for synthesizing, 471-493
test-retest, 389 local, 667-668 aims of, 474, 474b
Reliable measure, 198 national nursing organizations, 668, clinical question formulation, 474
Repeated measures design, 583 668t comprehensive search conduction,
Replication nongovernment, 667-669 476
approximate, 77 private, 667-668 critical appraisal of studies,
concurrent, 77 program building, 663-665, 664f, 477-479
exact, 77 664t discussion section, 479-480
of studies, 77-78 proposal requests, 670 final report for publication, 480
systematic, 77 regional nursing research literature search criteria and
types of, 77 organizations, 667, 667t strategies identification,
Representative, 353-354 research committees, serving on, 474-476
Request for applications (RFA), 669 667 meta-analysis conduction, 479, 481t
Request for proposals (RFP), 669 sources for, 667-670 review results, 479
Research, 159 support of other people, 665-666 state purpose and objectives, 474
AIDS patients as subjects of, 169 workshop attendance, 666 study selection, 476
applied, 35-36 generating hypotheses for, 150t levels of, 30-31, 30f
benefits and risks of, 175-176, 175f highly controlled setting for, 37 methodologies for developing, 23-25
bias in, 197 historical, 27 synthesizing, process used to, 29t
compensation for participation, 178 historical development of, 17-23 Research findings
concepts, 151-152 historical events influencing, 18t audiences for communication of,
controlling outcome of, 13-14 hypothesis, 147-148 619-621
critical appraisal of. See Critical formulation of, 42 of healthcare professionals, 621
appraisal informed consent for, 166, 166t of nurses, 619-621
definition of, 1-2 legally and mentally incompetent of policy makers, 621
description of, 12-13 subjects, 165-169 strategies for, 619-621, 620t
designs levels participating in, 21 communication of, 602
algorithms for selecting, 256 methodology implications of, 599
definition of, 195 classification of, 25-28 presentation of, 621-627
selection of, 43-49 quantitative/qualitative research, 26b poster sessions, 625-627, 626f
types of, 215b, 335-338 misconduct in, 159, 187-190 verbal, 622-625
education of nurses participating in, 21 money commitment for, 84-85 publishing of, 627-632
Index 729

Research in Nursing & Health, 20 Retrospective cohort study, 310-311 Sampling methods (Continued)
Research objectives. See also Objective Retrospective descriptive studies, 338 systematic, 361-362
formats for developing, 138 Retrospective study, 219 theoretical, 366-367
formulation of, 42, 138-140 Review of relevant literature, 40-41 Saturation of data, 371
in qualitative research, 139-140 RFA. See Request for applications Scales, 429-434
in quantitative research, 138-139 RFP. See Request for proposals construction of, 442-445
Research participants, 351-352, 352f Rigor, 36 using classic test theory, 442-444
recruiting of, 374-379, 378t qualitative research and, 58-59 using item response theory,
retaining of, 374-379 Risk difference (RD), 487 444-445
Research plan Risk ratio (RR), 486-487 using multidimensional scaling, 445
evidence examination from, 590-591 Risks, research, assessment of, 176 using unfolding theory, 445
implementing, 45-48 Rival hypothesis, 199 Likert, 45, 45b, 388, 430-431
Research problem, 73-75 RN. See Registered nurse rating, 422, 429-430
background for, 73 Robustness, 581 semantic differential, 431-433, 433f
clarifying and refining, 82-83 Role-modeling, 10 summated, 429
clinical practice as source of, 75-76 Roper, William, 22 translation of, 445-446
definition of, 73 Rosenthal effect, 201 visual analog, 222-223, 433-434, 434f
development of, 83-84 Roy adaptation model, 125 Scannable forms, data collection and, 508,
formulation of, 39-40, 81-83, 81f RR. See Risk ratio 509f-512f
literature, review of, 76-78 Scatter diagrams, 560
personal interest in, 82 S Scatterplots, 560, 561f-562f
researcher and peer interactions, 76 Sackett, David, 22 Science, 7-8
significance of, 73 Sample size Scientific American, 17
sources of, 75-81 in qualitative research, 371-373 Scientific method, 23
theories generating, 78-79 in quantitative research, 367-371 Scientific misconduct, 189-190
Research proposal, 635 Samples, 351, 352f, 537-538, 537f Scientific rationale, for interventions,
content of, 636-644 attrition, 355-356 328-329
condensed, 644 characteristics, 154 Scientific theory, 117
preproposal, 644 database as source of, 306-308, 306f, Screening test
qualitative, 640-644 307t accuracy of, 406
quantitative, 637-640, 637t definition of, 44 sensitivity of, 406, 406t
by students, 636-644 description of, 544 specificity of, 406, 406t
writing, 635-636 methods of obtaining, 306-308 SDAT. See Senile dementia of Alzheimer
critical point identification, 636 random, 356-357 type
depth of proposal, 636 representativeness, 353-354 Search engine, 106
esthetically appealing copy volunteer, 357 Secondary analysis design, 254-255
development, 636 Sampling, 37, 351 Secondary source, 101
idea development logically, 635-636 disproportionate, 360 Selection
Research purpose, 74-75 distributions, 538-541 interactions with, 200
development of, 83-84 error, 354-356, 354f, 557-558 process of, 199-200
formulation of, 39-40, 81-83, 81f frame, 357 of research subjects, 173-174
generation of, 83 plan, 351, 357 treatment interaction and, 202
subject availability for, 85 proportionate, 360 Selective sampling. See Purposive
Research Utilization to Facilitate EBP theory, 351-357 sampling
Model, 22 Sampling criteria, 352-353 Self-care, HRQoL, 245-246
Researcher exclusion, 353 Self-determination
expertise of, 85 Sampling methods, 357 right to, 164-169
peer interaction with, 76 cluster, 360-361 violation of, 164-165
replication and, 78 convenience, 363-364 Self-plagiarism, 632
study problem formulation, 81 network, 366 Self-report, physiological measures by,
Researcher-administered instruments, in nonprobability 412-413
data collection, 507-508 in qualitative research, 358t, 364-367 Self-Report College Student Risk
Residual variable, 227 in quantitative research, 362-364 Behavior Questionnaire, 427, 428f
Responder analysis, 334-335 probability, 357-362, 358t Semantic differential scale, 431-433,
Responsiveness, as outcomes assessment purposive, 365-366 433f
instrument, 316t quota, 364 Seminal study, 100
Retaining research participants, 374-379 simple random, 358-359, 359t Senile dementia of Alzheimer type
Retention rate, 356 stratified random, 359-360 (SDAT), 168
730 Index

Sensitivity Sources Statistical theory, concepts of (Continued)


of physiological measures, 404 appraisal and analysis of, 108-109 sampling distributions, 538-541
screening test of, 406, 406t comprehension of, 108 statistic types, 538
Sequencing, 123, 123f reading and critiquing, 108 statistical significance, 537
Sequential explanatory strategy, 209-210, selection of, 490 Type I error, 535-537, 536t
209f skimming, 108 Type II error, 536-537, 536t
Sequential exploratory strategy, 210, 210f sorting by relevance, 109-110 variation, 541
Sequential relationship, 123 synthesis of, 110, 110f Statistics, 537
Sequential transformative strategy, Southern Regional Education Board data deviation exploration using,
210-211, 211f (SREB), 19 554-558
Serendipitous results, 595 Spearman’s rank-order correlation confidence intervals, 558
Serendipity, 530 coefficient, 564 degrees of freedom, 558
Serial, 100 Specific proposition, 124 measures of dispersion, 554-558
Settings, 373 Specificity, screening test of, 406, 406t normal curve, 555-557
for control, 37 Spielberger State-Trait Anxiety Inventory, sampling error, 557-558
for experimental study, 87 383, 385 data summarizing with, 550-554
highly controlled, 373-374 Split-half reliability, 391 central tendency measures, 552-554
natural, 373 Spurious correlations, 565 frequency distributions, 550-552
partially controlled, 373 SREB. See Southern Regional Education descriptive, 538
research, 37, 373-374 Board inferential, 538, 542
for treatment, 202 Stability reliability, 389-390 nonparametric, 542
SF-36. See Short Form (36) Health survey Stage-based interventions, 325 parametric, 542
Sham interventions, 330-331 Standard deviation, as measure of types of, 538
Shape, of relationships, 121 dispersion, 555 Stetler Model of Research Utilization to
Shapiro-Wilk’s W test, 541 Standard error of mean, 557 Facilitate Evidence-Based Practice,
Short Form (36) Health survey (SF-36), Standardized mean difference (SMD), 474, 493-496
frequency distributions of, 556, 556f 484, 484f, 486 phases of, 493
Sigma Thata Tau, 20 Standardized mortality ratio (SMR), 310 application, 495-496
Directory of Nurse Researchers, Standardized Reporting of Trials (SORT), comparative evaluation, 495
440-441 251 decision making, 495
Simple hypothesis, 146-147 Standards for Privacy of Individually evaluation, 496
Simple interrupted time-series design, Identifiable Health Information, 163 preparation, 493-495
241f, 242-243 Standards of care, 296-297 translation, 495-496
Simple linear regression, 570-573 Statement analysis, 132 validation, 495
Simple random sampling, 358-359, 359t Statement hierarchy, 124 Stratification, 205t, 207
Single-blinded, 331 Statistical analyses, measurement levels Stratified random sampling, 359-360
Situated freedom, 61 for, 387 Strength, 121-122
Situation, nursing Statistical conclusion validity, 198-199 Structural analysis, validity from, 400
questions, generation of, 81-82 Statistical control, 205t, 207 Structural equation modeling, 227-228
study problem formulation, 81 Statistical hypothesis, 147 Structure
Skewed, 540 Statistical power, 536-537 evaluation of, 298-300
distribution, 540 Statistical procedures, choice of studies examining aspects of, 299t
negatively, 540 appropriate, 546-548, 547f Structured interviews, 422-424, 425b
positively, 540 Statistical significance, clinical Structured observations, 421-422
Skewness, 540, 540f importance vs., 537 Studies
Slope of line, 570 Statistical tests, violated assumptions of, appraisal of, 491
Small area analysis, geographical analysis 198 approval for, 644-647
as, 311 Statistical theory, concepts of, 534-542 political factors in, 646
SMD. See Standardized mean difference classical hypothesis testing, 535-536 preparation for review committees,
Smoking, lung damage from, 7-8 clinical importance, 537 645-646
Smoking status confidence intervals, 541-542 process of, 645
frequency table of, 552t descriptive statistics, 538 social factors in, 646
histogram of, 552f inference, 537 benefits and risks of, 175-176, 175f
SMR. See Standardized mortality ratio inferential statistics, 542 classification of, opinions about, 231
Snowball sampling. See Network normal curve, 538, 539f confirmatory, 370
sampling populations, 537-538 design, selection of, 256
SORT. See Standardized Reporting of probability theory, 535 development/implementation of, 37
Trials samples, 537-538, 537f ethical considerations for, 86
Index 731

Studies (Continued) Support systems, access to, 530-531 Therapeutic nursing intervention, 228-231
as exempt from review, 183-185, 185b academic committees, 530 Therapeutic research, 160
exploratory, 370 colleague support, 531 ThermoSENSOR, 416-417, 416f-417f
facility/equipment availability for, 86 data safety and monitoring board, 531 Threats
feasibility of, 84-86 institutional support, 531 designs to reduce, 203
money commitment for, 84-85 Survey, 224 to interrupted time-series designs, 241
researcher expertise for, 85 Symbolic interaction theory, 63 to statistical conclusion validity, 198
scope of, 371-372 Symbolic meanings, 63 Time factors, data collection and, 515-516
statistical procedures choice for, Symmetrical curve, 539-540, 540f Time-dimensional design, 218-223
546-548, 547f Symmetrical relationship, 122 Time-lag bias, 484
by students, critical appraisal of, 452 Symmetry, 539-540 TM. See Telemonitoring; Treatment
subject availability for, 85 of relationships, 122, 122f mechanism trial
subject knowledge of, 38 Systematic bias, 354-356 Tolerability, 251
time commitment for, 84, 122 Systematic error, 384, 384f Topic, nature of, 372
types of, 369-370 Systematic replication, 77 Tradition, 9
variables, measurement of, 38 Systematic reviews, 28-29 Transitional Care Model, 650f
Study design, 195, 372-373 biases for, 484-485 Transitional care nurse practitioner
development and implementation of, critically appraising checklist for, 473t (TCNP), intervention protocol for,
questions to direct, 207-208 guidelines for, 472-482 655-656
Study outcomes. See Outcomes mixed-methods, 29-30, 492-493 Translation, Stetler Model of Research
Study protocol, 645 basic structure for, 493 Utilization to Facilitate Evidence-
Study section flow chart, 478f published, critical appraisal of, 480-482 Based Practice phase, 495-496
Study validity, 197-202 Systematic sampling, 361-362 Translational research, introduction to,
threats to, 345b, 347 Systematic variation, 354-356 503
Study variables, 138 Treatment
Subject attrition, 200 T compensatory equalization and rivalry
Subject terms, 104 Target population, 351-352, 352f of, 200
Subjects, 351-352, 352f Taxonomy, nursing intervention, 325 control of, 203-204
AIDS patients as, 169 TCNP. See Transitional care nurse different, interaction of, 202
animals as, 190-191 practitioner diffusion or irritation of, 200
as autonomous agent, 164 Telemonitoring (TM) history and, 202
availability for research, 85 applied research using, 35-36 removed, pretest and posttest designs
of care, 294-295 effects of, 51f with, 201, 239f
children as, 166-167 intervention study using, 37-38 reversed, pretest and posttest designs
coercion of, 164 program, for BP in African Americans, with, 201, 240f
comprehension of, 178-180 35, 37-38, 50, 51f selection and, 202
confidentiality of, 171-173 quasi-experimental study using, 50-51 setting and, 202
controlling equivalence of, 203 Tentative theory, 132 testing and, 202
deception of, 165 Terminally ill, research on, 169 tolerability of, 251
discomfort, protection from, 174-175 Testable hypothesis, 149 two-treatment design, 237-238,
fair treatment of, 174 Testing effect, 199 238f-239f
harm, protection from, 174-175 Test-retest reliability, 389 Treatment fidelity, 332
informed consent from, 176-183 Textbooks, 100 Treatment mechanism (TM) trial, 251
legally and mentally incompetent, Theoretical limitations, 598 Treatment partitioning
165-169 Theoretical literature, 100 cohort designs with, 222
National Commission for Protection of, discussion of, 111 cross-sectional study with, 222f
162-163 Theoretical sampling, 366-367 longitudinal design with, 223f
neonate as, 165-166 Theories, 7, 41, 117 Trend design
permanent damage to, 175 definition of, 117 example of, 221f
prisoners as, 169 descriptive, 327 purpose of, 235f
selection of, 173-174 intervention, 327 Trial and error, 9-10
terminally ill as, 169 Orem’s model of self-care, 126t Triple-blinded, 331
unethical treatment of, 159-160 parent, 129 True negative, 406
Substitutable relationship, 123 practice, 125 True positive, 406
Substituted judgement standard, 168 prescriptive, 327 True score, 383
Sufficient relationship, 123 research problems and, 78-79 Truncation, 225
Summary, 112 scientific, 117 t-tests, 371, 580-584
Summated scales, 429 Theory-based interventions, 327-328 for paired samples, 583-584
732 Index

Tuskegee Syphilis Study, 160-161 Variables W


permanent damage to subjects, 175 of associative hypothesis, 144-145 Walter Reed Army Institute of Research,
Twenty Thousand Nurses Tell Their Story, of causal hypothesis, 145-147 19
19 concept as, 138, 151-152 Washout period, 249
Two-tailed test of significance, 545 confounding, 152, 342 Ways of Coping-Cancer Version
Type I error, 535-537, 536t definition of, 42-43, 138-139, 150-151 (WOC-CA) scale, 211-212
Type II error, 536-537, 536t demographic, 154, 154t Wennberg’s design, 337
Type III error, 338 dependent, 145, 151 Western Interstate Commission on Higher
environmental, 153-154 Education (WICHE), 19, 21
U in experimental research, 156 Western Journal of Nursing Research,
Unexpected results, 595 extraneous, 152-154, 199, 204-207, 20
Unfolding theory, scale construction 342 WHO. See World Health Organization
using, 445 identifying and defining, 150-155 WICHE. See Western Interstate
Ungrouped frequency distribution, independent, 145, 151 Commission on Higher Education
550-551 mediator, 154-155 Wilcoxon signed-rank test, 584
Urn randomization, 232 moderator, 154-155 Willowbrook Study, 161-162
number of, 355 WOC-CA. See Ways of Coping-Cancer
V operationalizing, 155-156 Version scale
Validation, Stetler Model of Research in qualitative research, 156 WOCF. See Worst observation carried
Utilization to Facilitate Evidence- in quasi-experimental research, 156 forward
Based Practice phase, 495 study, 138 Wong-Baker FACES Pain Rating Scale,
Validity, 45, 393-402, 393f types of, 151-155 382, 430f
construct, 200-202 Variance, as measure of dispersion, World Health Organization (WHO), 80
content, 394-397 554-555, 555t World Wide Web. See Internet
from contrasting groups, 401 Variance analysis, 315-317 Worldviews on Evidence-Based Nursing,
convergent, 400-401 Variation, in statistical theory, 541 22
from discriminant analysis, 401 VAS. See Visual analog scale Worst observation carried forward
divergent, 401 Verbal presentation, of research findings, (WOCF), 334
from event prediction, 401-402 622-625
external, 202 oral research presentation development, X
face, 394-397 624-625 X2. See Chi-square test
from factor analysis, 398-400 question response, 625
internal, 199-200 receiving acceptance as presenter, Y
of questionnaires, 428-429 622-624 y-intercept, 570
statistical conclusion, 198-199 research report delivery, 625
of structural analysis, 400 Visual analog scale (VAS), 222-223, Z
study, 197-202 433-434, 434f z value, distribution of, 557f
successive verification of, 402 Voluntary consent, 180 Zelen’s randomized consent design,
types of, 198 Volunteer samples, 357 337
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Strongest or Best Research Evidence

Systematic Review of experimental studies (well designed randomized


controlled trials [RCTs])

Meta-analyses of experimental (RCT) and quasi-experimental studies

Integrative Reviews of experimental (RCT) and quasi-experimental

Single Experimental study (RCT)

Single Quasi-experimental study

Meta-analysis of correlational studies

Integrative Reviews of correlational and descriptive studies

Qualitative Research Metasynthesis and Metasummaries

Single Correlational study

Single Qualitative or Descriptive study

Opinions of respected authorities based upon clinical evidence, reports


of expert committees

Weakest Research Evidence

Levels of research evidence


Methods of Statistical Data Analyses for Quantitative Nursing Research: Quick-Access Chart
Bivariate Data Analyses
Two Samples Three or More Samples
Independent groups, Nominal data Chi-square, p. 587 Chi-square, p. 587
two variables Odds ratio, p. 575
Logistic regression, p. 576
Ordinal data Spearman rank-order correlation
coefficient, p. 564
Kendall’s tau, p. 564
Mann-Whitney U, p. 588
Interval or ratio data t-Test for independent samples, p. 580 Analysis of variance, p. 584
Pearson’s product-moment correlation Multiple regression, p. 573
coefficient, p. 561
One-way analysis of variance, p. 584
Simple linear regression, p. 570
Bland and Altman plots, p. 565
Cox proportional hazard regression, p. 577
Dependent groups, Interval or ratio data t-Test for related samples, p. 583
two variables
Multivariate Data Analyses
Dependent groups, Interval or ratio data Multiple regression, p. 573
three or more variables Factor analysis and principal components
analysis, p. 566

TABLE 2-3  Processes Used to Synthesize Research Evidence


Analysis for
Synthesis Types of Research Included in the Achieving
Process Purpose of Synthesis Synthesis (Sampling Frame) Synthesis
Systematic Use of specific, systematic methods to identify, Usually includes quantitative studies with Narrative and
review select, critically appraise, and synthesize similar methodology, such as statistical
research evidence to address a particular randomized controlled trials (RCTs), and
problem in practice (Craig & Smyth, 2012; can also include meta-analyses focused
Higgins & Green, 2008). on an area of the practice problem.
Meta-analysis Synthesis or pooling of the results from several Includes quantitative studies with similar Statistical
previous studies using statistical analysis to methodology, such as quasi-experimental
determine the effect of an intervention or the and experimental studies focused on the
strength of relationships (Higgins & Green, effect of an intervention or correlational
2008). studies focused on relationships.
Meta-synthesis Systematic compiling and integration of Uses original qualitative studies and Narrative
qualitative studies to expand understanding summaries of qualitative studies to
and develop a unique interpretation of the produce the synthesis.
studies’ findings in a selected area (Barnett-
Page & Thomas, 2009; Finfgeld-Connett,
2010; Sandelowski & Barroso, 2007).
Mixed methods Synthesis of the findings from independent Synthesis of a variety of quantitative, Narrative
systematic studies conducted with a variety of methods qualitative, and mixed methods studies.
review (both quantitative and qualitative) to
determine the current knowledge in an area
(Higgins & Green, 2008).

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