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POTH 401 Research Methods

Introduction to Research
Dr. Ana Maria Rodriguez

Acknowledgement to Dr. Nancy Mayo and Dr Judith Soicher

Learning Objectives
Understand the role of research in evidence-based practice Identify different types and spheres of rehabilitation research Understand the stages of the health research cycle Identify the components and formulate clinical and research questions related to rehabilitation

Why do research?
Hyppocratic Oath (460-370 BC): I will apply measures for the benefit of the sick according to my ability and judgment; I will keep them from harm and injustice.

Evidence-based Practice
Health professionals must use the best practices available not to inflict harm on patients. The integration of the best research evidence with clinical expertise and patients values Our professional responsibility : Research is the means by which we test the beliefs that we are improving patients lives with our interventions.

What is Evidence-Based Practice


Evidence-based medicine (EBM) is the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients. The practice of EBM means integrating individual clinical expertise with the best available external clinical evidence from systematic research
Sackett et al. BMJ 312:71, 1996

Slide from Aliki Thomas, OCC1 545 notes, 2010

3 main components of EBP


Research studies Published work Research evidence is only one element in a complex set of relationships

Evidence

(Davidoff, 1999)

Objectives Interests Expectations Clinician's judgment Patient input

Clinical decisions about client treatment

Experience Knowledge Expertise in a domain


Slide from Aliki Thomas, OCC1 545 notes, 2010

A professional responsibility
It is not good enough to simply report that patients are doing better or are satisfied with our services. Demanded by patients and third-party payers. We must be willing to search, and in many instances, to create the evidence about the values of our practices and modify our practices in response to this evidence.

Learning about rehabilitation research is not an easy task


New sets of knowledge and skills that are different to the typical set of skills commonly learned in rehabilitation. Leads to the re-examination of the status-quo. Can lead to doubt about previous learning.

Research in Rehabilitation

Careful examination and systemic evaluation of the subject at hand. A friendly, welcoming attitude regarding change.

Research:
Challenges the status-quo:
Identifying gaps in knowledge Collective wisdom has not always been carefully reviewed. Novel treatments.

Creative Systematic:
Much of our clinical knowledge is anecdotal.

What is research about?


Research is about answering important and interesting questions (not about collecting data)
Without bias With precision

Bias is about how close you can get to the truth related to design Precision is about how much uncertainty remains - related to sample size

Bias vs. Precision

Bias vs. Precision

Getting it right

Research is about getting the right answer, not just any answer

The right answer is hard to find

Types of Research Questions


How does the world work? What does the world look like? How to make the world better?
Mechanisms/ determinants

Population health/health services

Evaluative research

Most Common in Rehabilitation


Mechanisms Determinants Evaluation (Measurement)

Biological/Physiological Mechanisms
Identified using a series of experiments Highly controlled Small studies in selected samples to reduce extraneous variables Replication is important Outcomes physiological in nature Used to build a theory

Determinants of health
Factors that influence a disease or health state Could be environmental, sociodemographic, psychosocial, etc. Observational studies with larger samples Used to build / test theory

Evaluative Research

How to make ______________ better? cells, tissues, organs individuals groups

Targets for Evaluative Research


Organ or tissue Rehabilitation Strategy Rehabilitation Intervention Rehabilitation Program

Medical Model

Definition of Rehabilitation Strategies


Single modalities (approaches or techniques) that seek to normalize body structures or physiological function at the tissue or organ level such as muscle, articular structures, brain, heart, lung or skin

Examples of Rehabilitation Strategies


Dietary restrictions Medications Exercise Biofeedback Body-weight support Application of an orthosis Physical modalities

Definition of Rehabilitation Intervention


A selection of approaches or techniques that seek to normalize an individuals capacity for activity

Examples of Interventions

Physical activity Balance training Healthy eating Stress reduction

Definition of Rehabilitation Program


Rehabilitation programs comprise a number of interventions that seek to normalize (for individuals with a particular health condition) participation in family and community life and quality of life

Examples of Programs
Stroke Rehabilitation (stroke unit, early supported discharge) Spinal Cord Rehabilitation TBI Work hardening . Etc. Geriatric Day program

Rehabilitation Model

Progression of Research Stages

Mechanism

Rehabilitation strategy

Rehabilitation intervention

Rehabilitation program

Rehabilitation Research Cycle


Consequences of disease

Implementation

Mechanism

Program Intervention

Strategy

Cycle of Rehabilitation Research


Population health
Health services Research/
Implementation
Consequences of Disease

Basic science / determinants of health


Bio-psycho-social mechanisms

Knowledge Translation

Program Intervention

Strategy

Evaluative Research

Example of research cycle in action


Mechanisms of gait and posture translate into strategies Strategies are tested for safety and efficacy Strategies are incorporated into interventions Interventions are evaluated for their ability to improve the individual (without harm) Interventions are bundled into programs where they can do the most good, for the greatest number of people at the least cost

Research Cycle
Burden of disease Implementation Mechanisms/ Associations

Efficiency
Effectiveness

Efficacy

After P Tugwell, 1985

The 3 Es
Efficacy does more good than harm when delivered exactly as directed, i.e. under optimal conditions Effectiveness does more good than harm when delivered under usual conditions (e.g. fluctuating patient compliance) Efficiency considers cost and resources

Research is about Relationships


Links one variable or factor to another One variable is thought (hypothesized) to be associated with or cause the second variable Note that association and causation are different

Variable
A property or characteristic that can be measured and that varies across people, places, and time Term used in research methods and statistics Examples ?

Terms used to describe Relationships

Discipline Epidemiology Medical/clinical Psychology Statistical Mathematical

Cause Exposure* Risk factor Independent Stimulus X

Effect Outcome* Disease Dependent Response y

Outcome

Characteristic of an individual that is expected to change owing to an intervention or exposure

Adapted from Dr. Nancy Mayo

/www.clinepi.mcgill.ca/610/Lecture3Measures_Rehab_Mayo_Print.pdf, accessed 1/27/11

The Research Question (= Objective/Purpose/Goal)

Why is the Research Question so important ?

Research is about answering important and interesting questions Research is not about collecting data Good research questions are about what you WANT TO KNOW Not about WHAT YOU WANT TO DO

In order to get the right answer at the endwe must ask the right question at the beginning

Nancy E. Mayo

A Framework for Asking Questions


Population Intervention (Exposure level 1) Comparison (Exposure level 2) Outcome Time
PICOT (PECOT)

PICOT Format
In people with ______________________ (P) Does a new intervention ______________ (I) In Comparison to usual care __ ________ (C) Affect outcome characteristic __________ (O) At Time __________________________ (T)

PECOT Format
In people with ______________________ (P) Does a higher level of an exposure _____ (Exposure level 1) In Comparison to a lower level of exposure (Exposure level 2) Affect outcome characteristic __________ (O) At Time __________________________ (T)

A Good Question is:


CLEAR Population, Intervention/Ex posure, Outcome Time may not be relevant in some studies

OPERATIONAL A study could be designed A results table could be drafted

You be the judge ..


The aim of our study was to measure quality of life (QOL) in a clinic-based sample of children who had a diagnosis of attention deficit (ADHD), and to consider the impact of symptom severity on Quality of Life Population: Intervention or Exposure: Comparator: Outcome:

Or ..
In children with AHDH, the objectives of this study were:
To determine the level of quality of life scores To estimate the association of symptom severity with quality of life

Actually 2 separate objectives, as each will have its own statistical analysis and results table

Population: Intervention or Exposure: Comparator: Outcome:

How do we conduct Research?


During this course, you will be learn how to distinguish between the different types of studies. You should also be able to identify the appropriateness and the strengths and weakness of each design You should be able to apply different study designs to the same research question

Types of Research Questions & Designs


How does the world work? What does the world look like?

Observational design
e.g. estimating relationships, associations or mechanisms

Observational design
e.g. estimating relationships, associations or mechanisms

How to make the world better?

Experimental design
e.g. estimating the effect of a treatment or intervention; also called evaluative research

Two broad Categories of Study Designs


Observational These types of design are those where you observe but dont intervene Experimental These are designs where you intervene and record what happens

Hierarchy of Study Types


Descriptive Case report Case series Survey Analytic Observational Cross sectional Case-control Cohort studies Experimental Randomized controlled trials Quasiexperimental Cross-over Single subject

Strength of evidence for causality between a risk factor and outcome

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