C H A P T E R zzzzzzzzzzzzzzzzzzzzzzzzzzz

24
Evaluation of Outcomes for Musculoskeletal Injury

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William T. Obremskey, M.D., M.P.H. Marc F. Swiontkowski, M.D.

OUTCOMES ASSESSMENT

zzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzz Outcomes research has rapidly become the focus of clinical researchers, insurance companies, health care delivery corporations, and hospitals. What is the source of this interest, from what did it evolve, and how does it differ from clinical research that has traditionally taken place in the orthopaedic community? In a research methodology termed small-area analysis, Wennberg and co-workers147, 148 noted that health care interventions varied widely in terms of population-based rates. In one example, they noted that residents of the New Haven, Connecticut, region were twice as likely to undergo spinal surgery for disc disease as their age- and sexmatched counterparts in Boston, Massachusetts. In contradistinction, the residents of Boston were twice as likely to undergo total hip replacement as their New Haven counterparts.71, 72 These and other elective conditions have a large (three- to vefold) variation in incidence in a given population.2, 74 The incidence of hip fracture surgery and both bone forearm fracture surgery is fairly constant in all regions in the United States.73, 74 Similar confusing results were noted for medical and other surgical conditions. The explanation for these phenomena is not clear. However, in general, it seems to be due in part to physicians uncertainty regarding the best way to treat patients and incomplete knowledge of what works and how well it works for patients. These uncertainties seem to be founded in the weakness of the clinical literature, poor research design, and difculties in conducting high-quality clinical research in orthopaedic surgery.75 Outcome can be dened as the patients end result from treatment of a disease. Interestingly, the term end result is from Codman,34, 35 an orthopaedic surgeon in Massachusetts best known for his work in shoulder diseases, who proposed that knowledge of the end result for patients in hospitals be the fundamental yardstick by which medical or surgical treatment be judged worthy to be loosed on the public. Although his concept fell on deaf ears at the time,
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it served as a catalyst for further evolution of the concept of assessing the result of treatment. In 1949 Karnofsky and Burchenal67 rst established the survey format to measure outcomes of cancer treatment. The use of surveys has become central to our ability to measure the outcome of treatment. In 1966 Donabedian45 introduced the framework for conceptualization of medical care by identifying three separate elements: structure, process, and outcomes. He was the rst to express Codmans concept of the end result using the term outcome.34, 35 Other highlights of the history of outcomes measurement include Lembcke79 using patients outcomes as an assessment of quality of care (a central concept now widely accepted and imitated); Katz and co-workers68, 69 measuring the outcomes of elderly patients by activities of daily living scales in 1963; Bradburn21 measuring psychologic well-being in 1969; Breslow23 devising scales for measuring physical, mental, and social well-being for the World Health Organizations denition of health; and Bush and associates27 in 1973 introducing the Health Status Index and the Quality of Well Being scale, the rst validated and widely accepted scale of this type.104 Since that time, many health and well-being assessment instruments have been developed. A partial list includes the Sickness Impact Prole, the Functional Limitations Prole, the McMaster Health Index Questionnaire, the University of North Carolina Health Prole, the Western Ontario and McMaster University Osteoarthritis Index, the Nottingham Health Prole, the Functional Status Questionnaire, and the Medical Outcomes Study Short Form 36 (SF-36) and Short Form 12 (SF-12).* The types of outcomes that are important for patients include clinical outcomes, functional outcomes, healthrelated outcomes, and satisfaction with the process of care. Clinical outcomes (e.g., range of motion, radiographic union, implant loosening, and infection) were nearly the singular focus of clinical research in orthopaedic surgery
*See references 9, 1113, 30, 62, 63, 66, 81, 96, 97, 110, 111, 113, 127, 133, 134, 143, 145.

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before the 1990s.51, 57 Functional outcomes primarily involve the patients function at the most complete level, not in terms of a joint or musculoskeletal condition (or fracture) but as an individual in society.7072 These outcomes were typically not evaluated until later. The areas of individual function covered herein include mental health, social function, role function (e.g., worker, spouse, parent), physical function, and activities of daily living.58, 59, 112 Health-related quality of life involves patients perception of how they are functioning as affected by their overall health. The paradoxical ndings in smallarea variation in medical care of Wennberg and coworkers147, 148 have driven the new interest in discovering how treatmentsmedical, psychologic, and surgical affect patients function at these levels. The interest in outcomes research is founded in these historical roots. The published clinical literature regarding management of musculoskeletal injury is generally retrospective in design, with rare exception, and is focused on clinical outcomes.129, 141 These include traditional orthopaedic measures such as range of motion, alignment, stability, healing, and radiographic assessments. The relative lack of controlled trials in the entire eld of orthopaedics has made the denition of optimal management strategies impossible. Even in the most highly investigated areas of the eld (e.g., joint replacement), deciencies are severe.51, 57 Both Gartland51 and Gross57 have conrmed that research regarding hip arthroplasty has been process based, meaning that it is focused on elements important to the technical aspects of the procedure (e.g., cement lucency, dislocation rates) or to the delivery of the care and not on the effect of the procedure on patients function. Examples of process-based elements frequently examined for injured patients include length of intensive care unit stay, ventilator days, wound infection, and knee range of motion. This paucity of patient-oriented functional outcome data is true for injured patients as well. When these data are assessed, important and interesting ndings result.10, 61 It is the opinion of many researchers that this fundamental lack of end-result information, relevant to patients function, is responsible for the variations in medical and orthopaedic practice that have become quite apparent.70, 147 Improvement in the situation requires new emphasis on clinical trial methodology in studying musculoskeletal injury and, when this is not feasible because of low incidences, the use of standardized outcome assessment in multicenter settings whenever possible.120 Outcome assessment must include relevant clinical outcomes important to the process of care as well as patient-derived health-oriented outcomes generally obtained by questionnaire.71, 76, 131 In addition, improved training for clinician researchers in the appropriate use of statistics must be undertaken.141 The retrospective clinical literature is replete with scales used to divide patients results into good, fair, or poor. These scales are generally derived from surgeons, are rarely used in more than one retrospective review, and have internal weighting for scoring (e.g., value of pain relative to that of range of motion, alignment) that is determined by the author and not by input from patients.44, 131 This lack of use of validated scales has further undermined the utility of the literature for the assessment of efcacy of

injury treatment strategies. A current example of clinical debate is that of the effect of early stabilization of long bone fractures in the patient with multiple injuries. Although the sense of the literature would push us to a more aggressive clinical protocol, we are limited by the existence of only one published controlled trial on the subject.16, 17, 49, 64, 98, 121 The lack of adequate numbers of randomized trials for most topics in trauma surgery makes the technique of meta-analysis unavailable for addressing effectiveness issues.16, 20, 53, 77, 78, 87, 95, 139 All of these factors contribute to current inadequate knowledge on which to base treatment decisions and recommendations.

CLINICAL OUTCOMES: CURRENT UTILIZATION Trauma Registries

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Injury is a major public health problem, being responsible for more death and disability than any other cause in people 1 to 44 years of age.5, 15, 3840, 56, 118, 135 Trauma care systems have been denitively shown to improve mortality rates.* Despite the major societal impact of injury, relatively few resources are directed toward studying prevention and optimizing treatment. Data are the key component required to study the major issues that clinicians face in optimizing both prevention and treatment.26, 117 As dened by the American College of Surgeons (ACS) Committee on Trauma, the trauma registry forms the backbone for the evaluation of effectiveness and quality for each institutions trauma program.39, 146 Details regarding the data elements that should be collected are provided in Resources for the Optimal Care of the Injured Patient.39 The critical elements used to monitor the trauma program include timing of prehospital care; mechanism of injury; vital signs in the eld and on arrival; and outcome measures such as ventilator days, intensive care unit days, and mortality. In 1934 Codman34, 35 suggested that all hospitals should have a good grasp of their patients outcomes so that the effectiveness of care from the physician and institutional aspects could be improved. Much later in the century, cancer registries began to be developed to measure systematically the effectiveness of chemotherapy and radiotherapy protocols.43 To deal with the widespread difference of opinion about what trauma registries should monitor,19 the Centers for Disease Control and Prevention (which has been given the responsibility for studying prevention and treatment of the disease of injury) convened a lengthy workshop on trauma registries in 1988.114, 115 Participants included organizations with a major interest in the eld, such as the ACS Committee on Trauma, the American College of Emergency Physicians, the American Medical Associations Committee on Emergency Medical Services, and the National Highway Trafc Safety Administration. Criteria for inclusion of patients and core data elements were
*See references 28, 33, 42, 46, 50, 85, 91, 106, 122, 136138, 149, 150.

Copyright 2003 Elsevier Science (USA). All rights reserved.

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SECTION I General Principles

dened by consensus methodology.110 Further study sponsored by the ACS has led to the development of a standardized preformatted software package available to all institutions for trauma program monitoring.103 Before this development, many institutions had developed their own registries, and two states (Pennsylvania and Oregon) and several Canadian provinces had successfully implemented statewide or provincewide programs.140 By 1992, 48% of states had implemented trauma registries.123 The ACS Tracs system will save important registry development costs for institutions and regional systems in the future.103 Systems have been developed to document and record severity of injury. These include critical data elements.18, 31, 32, 41, 55, 88, 99 The Committee on Medical Aspects of Automotive Safety published the Abbreviated Injury Scale (AIS) in 1971 primarily to characterize blunt trauma.37 The AIS assigns a score of 1 (minor) to 6 (total) to each of six different body areas (i.e., chest, abdomen, pelvis, extremities). It did not summarize a single score for multiple injuries. The Injury Severity Score (ISS) was developed in 1974 by summing the square of the AIS scores in the three most severely injured areas.6 For example, a patient with a moderate liver laceration with AIS = 3 and a femur fracture with AIS = 3 as the only injuries, would have an ISS of 18. Controversy exists regarding the inclusion or exclusion of lower energy trauma cases in comprehensive regional trauma system registries. Many of the patients with ISS less than 10 are elderly patients with limited physiologic reserve and are at risk for signicant morbidity and even mortality as a result of these lower energy injuries.24 Because of this high potential for long-term disability and the fact that populations throughout the world are aging, it is thought to be appropriate to include cases with lower levels of injury in these surveillance registries. This would increase the utility of such registries as injury prevention tools in addition to serving the other key functions of quality assessment and monitoring of outcome for this population.109, 151 In many, if not most, hospital systems, discharge databases form a critical source of data elements for the trauma registry. The addition of the E codes (injury mechanism codes) to the universally applied DiagnosisRelated Groups and codes of the International Classication of Diseases, 9th revision, has greatly enhanced the utility of this data source for trauma registries.108, 126 These data, when combined with ISS,4, 5, 7 length of stay, mortality, and resource utilization information, make the hospital discharge database a useful tool for monitoring trauma programs.140 It is anticipated that the use of standardized databases for the monitoring of trauma programs,103 because of the uniformity of data collection, will allow greater ease of monitoring for regional and statewide systems. These data will be important for monitoring programs that have been established in response to U.S. Public Law 101-590, the Trauma Care Systems and Planning Act of 1990. However, non mortality-based functional outcomes are widely available and need to be incorporated.100, 118 Trauma registries and discharge databases use as their measure of injury severity the ISS, which grew out of the AIS.4, 37 Although analysis of this data element has proved

useful for analysis of mortality risk for a given ISS,24, 151 the level of detail regarding musculoskeletal injury is insufcient. A criticism of the ISS has been that it underestimates the severity of injury with multiple injuries to a given body area.22 For example, a patient with extremity fractures of the femur, tibia, and humerus would have an ISS of 9, the same as that of a patient with an isolated femur fracture. Penetrating trauma is also underestimated, as injury is often concentrated in one area (i.e., abdomen), and a patient with a liver, kidney, and mesenteric injury would have an ISS of 16, as would a patient with an isolated signicant splenic laceration. The ISS also fails to consider more severe injuries in one body area over less severe injuries in another body area. The New ISS (NISS) was proposed to correct these idiosyncrasies of the ISS by calculating the ISS from the three most severe injuries regardless of body location.107 The NISS has increased patients scores in approximately two thirds of cases and was found to predict more accurately patients mortality risk107 and risk of multiple organ failure.8 Critical components of injury severity (e.g., soft tissue injury detail), fracture classication, details of treatment, and, most critically, nonmortality-based clinical outcomes are totally lacking. This has led the Orthopaedic Trauma Association to develop a software package, available to its members, that allows tracking of more detailed skeletal and soft tissue injury information, details regarding treatment, and a patient-based outcome module inclusive of relevant clinical outcomes (e.g., range of motion, fracture union) and health status (SF-36 and Musculoskeletal Functional Assessment).47, 93, 127 This type of decentralized data collection tool is critical to developing information on the effectiveness of management strategies for musculoskeletal injury. Regionalization of specialized surgical services has been shown to be an important concept for reducing morbidity and mortality; however, without functional outcome data, this issue cannot be well studied for musculoskeletal injury.65, 86 Resources are required to develop and use such registries in a trauma center, proportional to the volume of patients seen. Data forms are most accurately completed by the most senior treating individuals for purposes of injury classication and treatment description. Commitment by the departmental chief and members of the attending staff is required for the registry to be comprehensive for the institution. Data entry clerks are needed to enter data and obtain complete information where forms are lacking. Program updates are available from the Orthopaedic Trauma Association that allow the surgeon to enter data directly, thus bypassing the forms. Generally speaking, one clerk is required for every 1500 orthopaedic injuries per year, more if radiographs are being stored with the injury data. A research coordinator is necessary to develop a program to obtain functional outcome data systematically as a routine for injuries under investigation. It is strongly suggested that specic research questions or quality assurance program issues be studied using this approach. Routinely obtaining functional outcome data for all trauma patients is expensive and impractical, resulting in the collection of huge volumes of data that are generally not used in any meaningful analysis. In essence, because of the broad range of injury (in

Copyright 2003 Elsevier Science (USA). All rights reserved.

CHAPTER 24 Evaluation of Outcomes for Musculoskeletal Injury

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terms of bone and soft tissue severity) dealt with in the eld of musculoskeletal traumatology, the best way to gather sufcient cases to study outcome is with multicenter study designs. The use of the decentralized database format should become the necessary linking component allowing all centers to collect the same data in the same format, greatly enhancing data management. Internet Web-based databases may further link centers with a common database. The complexity and range of skeletal injuries have led to a plethora of injury classication systems. The lack of uniformity of fracture classication systems utilized in the published literature has further limited the utility of the literature for assessing effectiveness. Colton36 has critically analyzed the situation, noting, as an example, 22 different published classication schemes for olecranon fractures. His recommendation of editorial insistence on the use of a broadly accepted classication scheme has been endorsed by the Orthopaedic Trauma Association and incorporated in the software package described earlier.101 High interobserver and intraobserver variation in applying skeletal and soft tissue injury schemes has become apparent in multiple publications.25, 52, 124, 125 The explanation for the poor performance in these analyses is that injury is essentially a continuous variable and classication schemes are by denition dichotomous variables. Forcing the innite variable into these schemes requires judgments that are individual and nonuniform. The solution to this issue is not to create new classication schemes but rather to recognize the problem and have the injury classied by multiple individuals (preferably three) blinded to outcomes and, where discrepancies are evident, use consensus methods to reach a nal classication. The use of a standard classication scheme in this manner would greatly enhance the utility of the literature for effectiveness analyses.

Format Selection Format selection consists of scaled responses or endorsed statements; the former yield better discrimination but are more difcult for patients; the latter format is much easier for patients. Pretesting This consists of administration of the questionnaire with an interviewer present to discover poorly worded or confusing items. Reproducibility and Responsiveness Reproducibility is evaluated by reviewing the variability in responses in relation to the variability in clinical status. This review is addressed by a test-retest exercise in which the same patients complete the questionnaire twice within a short interval during which no clinical change has taken place. Responsiveness is the measure of the questionnaires ability to detect clinically important changes even if they are small. Responsiveness is assessed by administering the questionnaire twice at a minimal 3-month interval after a clinical intervention of known efcacy. Validity Face validity is assessed by clinician review to ensure intuitive rationale; construct validity is assessed by developing hypotheses about how the scores should change between and within subjects and comparing results with already validated instruments. Criterion validity is addressed by comparing scores with objective tests (e.g., range of motion, self-selected walking speed) and clinician evaluations of the same group of patients. Several well-validated general health status instruments have been developed and are available for use in assessing patients function after musculoskeletal injury (Table 241). The four most widely used and evaluated scales that are appropriate for use in musculoskeletal disease or injury are SF-36, the Sickness Impact Prole (SIP), the Nottingham Health Prole, and the Quality of Well-Being Scale (QWB), which forms the backbone of the qualityadjusted life years (QALY) methodology.151 These scales have the common characteristic of assessing all domains of human activity including physical, psychological, social, and role functioning. In addition, they share the characteristic of assessing the patient as a whole (from the patients perspective) and not as an organ system, disease, or limb. They are internally consistent, reproducible, and discriminate between clinical conditions of different severity. They are also sensitive to change in health status over time.81 They are not physician administered, which increases their reliability. Brief descriptions of these instruments follow. The SF-36 was developed by Ware and colleagues128, 134, 143145 and the Rand Corporation as a part of the Medical Outcomes Study. It is perhaps the most widely applied general health status instrument and has certain features that make it the most appealing for studying musculoskeletal injury. Its 36 scaled questions relate to eight different functional subscales: bodily pain, role function-physical, role function-emotional, social function, physical function, energy or fatigue, mental health, and general health perceptions. The scales are scored separately with no total score. It has been validated to be a reliable and reproducible questionnaire that has been applied to numerous health conditions. Furthermore, it has been shown to be reliable as administered by the

HEALTH-RELATED QUALITY OF LIFE INSTRUMENTS IN COMMON USE FOR MUSCULOSKELETAL PROBLEMS

zzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzz Questionnaires should not be derived by aggregating questions that seem important on the basis of a clinicians experience. Questions that are reective of patients function cannot simply be developed on the basis of clinical experience, as physicians perceptions of functional issues are often inaccurate. Guyatt and associates60 described the following steps in the development of a functional assessment questionnaire: Item Development The population of patients to be evaluated must be described, and functional issues of concern to this group must be selected from interviewing patients and clinicians or, alternatively, from a literature and validated questionnaire review. Item Reduction Item reduction is determined by the frequency and importance of item endorsement in a sample cohort of patients or by statistical methods such as factor analysis.

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TABLE 241

SECTION I General Principles

HR-QOL Instruments and Scoring Resources

Method of Administration Self or interviewer Self or interviewer Self Training Time Required 2 hr

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Length of Time to Complete 510 min Populations Designed For All Conditions Used On General health status/ quality of life measures General health status/quality of life measures Arthritis

Instrument SF-36

Where/How to Get It Medical Outcomes Trust, 20 Park Plaza, Suite 1014, Boston, MA 02116-4313 Ann Skinner, 624 North Broadway, Room 647, Baltimore, MD 21205 Jane Campbell, London Health Science Center, Suite 303, South Campus 375, South Street, London, Ontario N6A 4G5, Canada Jim McEwan, Department of Public Health, University of Glasgow, Glasgow G128QQ, Scotland, UK Holly Teetzel, Department of Family and Preventive Medicine, Box 0622, University of California, San Diego, 9500 Gilman Drive, La Jolla, CA 92093 Director, Research and Scientic Affairs, American Academy of Orthopaedic Surgeons, 6300 North River Road, Rosemont, IL 60018

SIP WOMAC

1 wk 1 wk

30 min 10 min

All Arthritis patients

Nottingham Health Prole QWB

Self

1 wk

10 min

All

General health status/quality of life measures General health status/quality of life measures

Trained interviewer

2 wk

12 min

All

Separate AAOS Instruments for upper extremity, lower extremity, spine, and pediatrics MFA

Self or interviewer

1 wk

Variable, depending on which modules used; 1040 min 15 min

Patients with specic regions of disease or injury or specic age Patients with musculoskeletal disease

Quality of life measure applied to regional (or specic age group) musculoskeletal populations Quality of life measure applied to musculoskeletal disease

Self or interviewer

2 hr

www.ortho.umn.edu/research/ clinicaloutcomes.htm

Abbreviations: AAOS, American Academy of Orthopaedic Surgeons; MFA, Musculoskeletal Functional Assessment; QWB, Quality of Well-Being Scale; SF-36, Short Form 36; SIP, Sickness Impact Prole; WOMAC, Western Ontario and McMaster University Osteoarthritis Index.

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patient or by an interviewer and when administered by telephone or by mail, and it takes only 5 to 7 minutes to complete. These features make its use appealing; it is the most practical for use in a busy ofce or clinic setting. This instrument, however, may have a ceiling effect (scores are concentrated at best function) for musculoskeletal conditions. This means that clinically important functional problems may not be adequately characterized by this scale because the disability is too minimal to be picked up by the questions in the scale. Patients with mild to moderate dysfunction (repetitive motion disorders, minor sprains and fractures) may score near the highest possible scores and further improvement cannot be measured. This scale is recommended more often than the other scales discussed here to researchers who wish to study musculoskeletal injury. Our experience in administering the SF-36 shows that patients with musculoskeletal disease or injury tend to misinterpret the questions on general health as being exclusive of their musculoskeletal disease.47, 93 It has particular weakness in assessing upper extremity function.

The SIP, a questionnaire developed by Bergner and associates1113 at the University of Washington, is best administered by trained interviewers and takes 25 to 35 minutes to complete. It has 12 different domains that are addressed by 136 endorsable statements (patients simply say yes or no if the statement of function applies to their current situation). These 12 areas are scored independently and aggregated into a physical and a psychosocial subscale as well as one aggregate score. The scale is 0 to 100 points; the higher the score, the worse the disability. Patients with scores in excess of the mid-30s have seriously diminished quality of life. The SIP has also been used for patients with multiple health conditions and makes comparisons of the impact of disease on health possible. It has been used in musculoskeletal trauma with good success.89, 90 Because of the difculty and length of its administration, it may be most useful for well-funded outcome studies or controlled trials. It also suffers from the ceiling effect that lesser degrees of musculoskeletal function are not identied.94 The Nottingham Health Prole is interviewer adminis-

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tered and has been used successfully to assess functional outcomes of limb salvage versus early amputation.54, 96, 97 It has been shown to be valid in trials in Great Britain and Sweden. Part I of the prole measures subjective health status through a series of 38 weighted questions that assess impairments in the categories of sleep, emotional reaction, mobility, energy level, pain, and social isolation. In each category, 100 points represents maximal disability and 0 represents no limitations. Part II consists of seven statements that require a yes or no response. These assess the inuence of health problems on job, home, family life, sexual function, recreation, and enjoyment of holidays. The responses to both parts of the prole can be compared with the average scores for the general age- and sexmatched population. The QWB is interviewer administered. Using data from large populations and multiplying them by years of life expectancy and cost per intervention gives the QALY cost per year of well life expectancy. QALYs provide a methodology for making difcult decisions regarding resource allocation. When orthopaedic interventions such as hip arthroplasty and hip fracture xation have been studied using this methodology, they have fared well.109, 151 The QWB physical function scale also probably suffers from ceiling effects. In 1993, the American Academy of Orthopaedic Surgeons (AAOS) and members of the Council of Musculoskeletal Specialty Societies began to pool resources to develop a general health questionnaire and disease-specic questionnaires that could be used for musculoskeletal injuries or conditions130 in an ofce setting and allow local, regional, and national collection of patient-derived outcome data. The database incorporated the SF-36 and demographic and co-morbidity information and included questionnaires specic for the upper extremity, lower extremity, pediatric patients, and patients with spinal conditions. The database was named the Musculoskeletal Outcomes Data Collection and Management System (MODEMS). The AAOS established a research institute to oversee the MODEMS project. The instruments were validated and take 10 to 30 minutes to complete. The AAOS conducted a trial project to post national data and collected data for more than 30,000 patients in 3 months.130 The AAOS sponsored a national database for MODEMS collection but discontinued it in April 2000. The MODEMS questionnaires are still available for use (www.aaos.org). These questionnaires provide healthrelated quality of life (HR-QOL) data with the SF-36 as well as area- and disease-specic information and thus are a good choice for comprehensive evaluation. If a clinic or practitioner wishes to use only a single instrument for all conditions being studied, the Musculoskeletal Functional Assessment (MFA) and Short Musculoskeletal Functional Assessment (SMFA) questionnaires provide general healthand area-specic information with fewer oor and ceiling effects for musculoskeletal conditions than the SF-36 (see later).105 The AAOS is also to manage the distribution and utilization of the SMFA. These examples are general health status instruments that have broad acceptance and have the ability to compare the functional impact of various diseases. Instruments specic to a disease or condition offer increased sensitivity

and limit the oor and ceiling effects.80 Table 241 lists the general health status instruments individually with their attributes and identies a source for the reader. All of these HR-QOL scores are signicantly affected by a patients co-morbidities, age, and sex. This has been best described with the SF-36. Xuan and colleagues153 have shown that co-morbidities of arthritis, back pain, and depression have the greatest effect on altering a QOL score.142 Understanding this effect is important in the interpretation of HR-QOL scores. The SF-36 has been published with norms of scores for the U.S. population and also for patients with co-morbidities: hypertension, diabetes, congestive heart failure, myocardial infection, chronic obstructive pulmonary disease, angina, back pain, osteoarthritis, benign prostatic hypertrophy, varicosities, and dermatitis. These co-morbidities affect the mean scores of the SF-36 subscales of physical function, role-physical, bodily pain, general health, and vitality.142 Normative values of the SF-36 also vary with age and sex.142 This variation is most evident in comparing physical function scores across age groups. For example, the mean physical function score for the U.S. population is 84.15 (scale of 0 to 100). The mean for the 18- to 24-year-old age group is 92.13, and the mean for the 75 and older age group is 53.20.142 Specic subscales of the SF-36 have also been analyzed and stratied for age and sex. Investigators need to be aware of these variances when using an HR-QOL survey to assess a patients functional recovery, and patients may need to be compared with their appropriate age group to obtain a more accurate assessment of their true functional capacity. The MFA has also been published with reference values to population norms.48

DEVELOPMENT OF A MUSCULOSKELETAL OUTCOMES RESEARCH TOOL

zzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzz In response to the need for a validated instrument that would allow clinicians to determine the functional outcome of patients with musculoskeletal disease or injury (extremity trauma, overuse syndromes, osteoarthritis, or rheumatoid arthritis), the MFA was developed under the sponsorship of the National Institutes of Health, National Institute of Child Health and Human Development.47, 93 This 100-item instrument allows clinicians to assess their patients function in 10 distinct domains (self-care, emotional, recreation, household work, employment, sleep and rest, relationships, thinking, activities using arms and legs, and activities using hands). The instrument requires 15 to 17 minutes to complete and can be either self-administered or interviewer administered. When used by members of the orthopaedic and trauma communities who treat the diseases mentioned earlier, it allows analysis of the effectiveness of treatment and comparisons of the functional impact of various diseases and injuries. It is anticipated that incremental improvement will be made in avoiding the ceiling effect evident in other general health status instruments.

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SECTION I General Principles

The MFA was eld tested on patients with extremity trauma (upper and lower), overuse syndromes, osteoarthritis, and rheumatoid arthritis. These specic populations were chosen because they account for signicant health care costs both to the patient and to society. Extremity trauma costs range from $75 billion to $150 billion annually.92, 100, 102 Overuse injuries accounted for 48% of the reported occupational injuries in 1988.26 Operative procedures related to carpal tunnel syndrome alone cost over $1 billion.116 Arthritis and related diseases have associated costs, because of resultant morbidity, that are estimated to be as high as $41.6 billion.116 Numerous evaluation scales are currently in use (e.g., Harris Hip Score, Indiana Knee Scale), but these arbitrarily mix pain, clinical, and functional outcomes. Few have been subjected to rigorous statistical evaluation. The MFA is a quality of life instrument with applicability to musculoskeletal disease at both the low and high ends of severity. Its domains are functionally designed to give physicians categories with which they can identify and which they can use to help target where individual patients may be having difculty and thus provide appropriate assistance as indicated. These domains also help physicians to address immediate postinjury concerns or early disease onset concerns of patients about what the future might hold for them. Because it is a single instrument dealing with all musculoskeletal disorders, it alleviates the need for community practice physicians to have many outcome tools available for patients use and different skills to interpret them. The MFA was developed using unstructured openended interviews with 136 patients and 12 clinicians, resulting in 7800 statements in 35 domains. These items, using the patients own wording whenever possible, were reduced to a 12-domain, 177-item questionnaire. Three hundred and twenty-seven patients from the Seattle Hand Clinic, Valley Medical Center (Level II trauma center), Northwest Foot and Ankle Clinic, and Harborview Medical Center (Level I trauma center) participated in the rst eld trial of the MFA.47, 93 Reliability was between 72.6% and 100% for all items. Internal consistency was .85 on the basis of Cronbachs alpha. Validity was assessed by comparing objective measures (e.g., range of motion, self-selected walking speed, grip dynamometer strength, and isokinetic testing) for 119 patients with relevant domains. Signicant relationships (r > .33) were found between category scores in mobility, housework, ne motor, self-care, and connement and objective measure

scores.90 Physicians assessments on the basis of review of medical records and radiographs for a sample of 24 patients demonstrated correlation between .04 and .50. Signicant relationships were also found on comparing survey scores with the presence of co-morbidities, complications, gender, joint degeneration (arthritis), functional level (overuse), and ISS. The survey was then reduced to its nal 100-item format by removing items that were unstable, unclear, unresponsive, signicantly intercorrelated, or internally inconsistent using accepted statistical methodology.47 The MFA has been given to 557 patients to evaluate its responsiveness, validity, and reliability. It was developed as a tool useful for funded outcome research projects and randomized controlled trials. The MFA may provide the community clinician with more detail and be more demanding for staff and patients than is necessary for routine use or for participation in local, state, and national outcome assessments. Therefore, the Short Musculoskeletal Functional Assessment (SMFA) has been developed131 and validated.132 Clinicians wishing to compare patients progress over time routinely and quantitatively, as well as against patients from other settings, need a self-administered instrument that requires no lengthy explanations to patients and does not disrupt the daily ow of the ofce or create huge costs. The SMFA is designed to meet those needs and to be a stand-alone tool for the routine assessment of orthopaedic outcomes, regardless of the disease or injury being evaluated. To formulate the SMFA, investigators selected 46 questions from the longer instrument on the basis of universality, applicability, uniqueness, reliability, and validity as demonstrated by the MFA data. The SMFA has been eld tested in academic and community ofces with excellent compliance and utility.1 The SF-36, MODEMS instruments, MFA, and SMFA can be obtained from several web sites (Table 242).

RECOMMENDATIONS FOR CLINICAL OUTCOMES RESEARCH AND OUTCOMES ASSESSMENT

zzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzz Keller and associates70, 72, 75 made the important differentiation between outcomes research and outcomes assessment for the orthopaedic community. Outcomes research

TABLE 242

Useful Web Sites

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www.ota.org www.aaos.org/ www.ahcpr.gov www.sf-36.com/general www.aaos.org/wordhtm/outcomes/question.htm www.ortho.umn.edu/research/clinicaloutcomes.htm www.cochrane.org/

Orthopaedic Trauma Association American Academy of Orthopaedic Surgeons Agency for Healthcare Research and Quality (AHRQ) SF-36 Questionnaire MODEMS Questionnaires MFA/SMFA Cochrane Collaboration

Abbreviations: MFA, Musculoskeletal Functional Assessment; MODEMS, Musculoskeletal Outcomes Data Collection and Management System; SF-36, Short Form 36; SMFA, Short MFA.

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CHAPTER 24 Evaluation of Outcomes for Musculoskeletal Injury

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involves the systematic study of an individual disease process or injury. Such projects generally involve individuals who are trained in research methodology (often health services researchers), are frequently multicenter trials to satisfy targets for accrual of patients, and most often require outside sources of funding to pay individuals responsible for data collection, monitoring of the study, and analysis of data. Results of these studies frequently result in changes in practice informally and through the modication of existing practice guidelines. The procedure for initiation of such a study involves identifying a condition that has a substantial impact on patients function or longevity and analyzing retrospective data to identify key elements in the process of treatment that need further study. This is one of the major uses of trauma registry data such as those developed by the Orthopaedic Trauma Association. Once the process issues are identied, a study design based on the data reviewed must be developed and a power calculation performed to determine the number of patients who must be enrolled to detect a clinically important difference in outcome. A trial enrollment period of 1 to 2 months at each potential site gives the investigators a good idea of whether the volume of patients is present to complete the study. As a part of the study design phase, it is determined which assessment questionnaires are optimal for the study and the intervals at which patients should complete them. It is also determined in this phase which clinical data are to be collected and which physical measurements (e.g., strength, range of motion, self-selected walking speed, and hand-held dynamometer strength) should be collected at follow-up intervals. Data that are not to be used to answer a specic study hypothesis should not be gathered as this overburdens the process. Practicality in terms of stafng for enrollment of patients, tracking and data management, patients transportation needs, cultural and language issues (which differ from site to site depending on the local population), and institutional cooperation must be considered in the study planning phase for each potential site. Funding of studies allows more rapid accrual of patients, more data collection and analysis, and more clear responsibility lines. These studies are constructed to address specic hypotheses, and attention must be directed to collecting the data necessary to address the hypotheses. The tendency is often to collect data because we may nd some interesting use for it later. This approach is resource intensive and frustrating for individuals collecting the data and should be avoided. The current gold standard of orthopaedic research is the prospective, randomized, double-blind study.29 This experimental model was designed for pharmaceutical research, and some of these principles are difcult in surgical, interventional studies. It is difcult to make many studies double blind, especially an operative versus a nonoperative trial. Surgeons tend to have strong opinions or particular skills that make pure randomization of patients difcult or raise ethical questions for the participating surgeons. Rudicel and Esdaile119 proposed that surgeon randomization is a valid way to limit bias in procedure-based trials. Surgeon randomization has

been done successfully in some well-designed surgical trials.60, 84, 152 Much of the earlier published literature in orthopaedics was based on case studies without adequate study design, controls, or statistical analysis.51, 57 Peer review requirements are improving the quality of the literature to answer hypothesis-driven questions.3, 8, 14, 60, 83 All studies should enlist a statistician to provide an unbiased assessment of power analysis to avoid a statistical type II or B error (stating that no statistical difference exists when one actually does) because too few patients are enrolled in the study and to ensure that the appropriate statistical analysis is performed. This process of outcomes research is to be contrasted with outcomes assessment, which involves the collection of HR-QOL data for samples of patients to evaluate effectiveness of care. It is often done at the ofce, group, or health plan level and includes the type of data in which payers are interested. The routine collection of data on patients satisfaction and HR-QOL is done on a preidentied segment of a practice at predetermined intervals, before and after treatment, forming the basis for outcome assessment. A common approach is to begin such a process by collecting data for all patients in a practice. However, this is to be discouraged. It results in accumulation of data in large volumes, which can be time consuming, if not impossible, to analyze. The collection process quickly leads to frustration of the ofce staff responsible for form administration and collection. Patients cooperation and support of these projects are rarely a problem. Patients have been found to be most receptive to completing these types of questionnaires and believe that this process, as well as satisfaction surveys, represents an effort on behalf of the practice to meet their needs. During eld testing of the MFA instrument, Harborview Medical Center (a worst-case scenario for patients compliance) was able to obtain adequate follow-up of more than 95% of patients enrolled.47 The best approach in beginning outcomes assessment within a practice or trauma group is to select a musculoskeletal condition or injury that is frequently seen within the practice as a target condition. As a rough indicator, it is best for the staff involved in data collection if an eligible patient is seen 5 to 10 times per week. The patient should be approached before treatment and asked to complete an HR-QOL questionnaire and told that she or he will be notied at predetermined intervals to complete the same survey. The physicians responsible for the project should decide before enrolling patients which clinical data they need to collect to analyze the HR-QOL data properly. Data points involving clinical, demographic, or radiographic assessments should be collected before treatment and at selected intervals. The exact timing of data collection is not standardized, and the appropriate time intervals may be different for different musculoskeletal injuries or conditions. A patient with an isolated ankle fracture returns to normal function more quickly than a patient with a tibial plafond fracture and may require more frequent data collection. Studies are in process and need to be performed that better characterize the rate of functional recovery from a variety of musculoskeletal injuries to answer patients questions as

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SECTION I General Principles

well as address work-related and legal issues with more accuracy. A minimalistic approach, in terms of the number of conditions studied, is most fruitful when starting to assess outcomes in clinical practice. Identifying a condition that is common to the practice (and thus important to the success of the practice) and collecting data on patients with this condition lead to a product that is useful for evaluating current practice and planning for changes in the process of care. Meta-analysis is a technique that has been developed to pool results for randomized controlled trials. It has a rigorous methodology of analysis to grade the rigor of the study design by assigning a quality score and to identify the magnitude of the overall effect of the treatment under study. It was designed to deal with the problem of multiple controlled trials of a given treatment where an overall effect was the desired end-point. Several orthopaedic and traumatic conditions have been studied using these techniques.82 Because of the invasiveness of surgery and the need for surgeons to follow their own beliefs in recommending treatments to patients in their ethical role as patients advocates, the classical randomized clinical trial is rarely seen in our eld. Surgeon randomization has been suggested as a scientically sound way around some of these difcult issues,119 as noted earlier, but has rarely been used.60, 84 Attempts at meta-analysis have been made for spinal stenosis, hip arthroplasty, tibia fractures, hip fractures, and other conditions.79, 83, 88, 89, 141 All of these reviews have found serious deciencies in study design, control subjects, follow-up, and outcome assessment that seriously limited any conclusions concerning treatment or efcacy. Thus, without the available literature on highquality, controlled, prospective trials, meta-analysis fails as a technique. The orthopaedic literature is improving with increased awareness of study design and statistical impact and adequate follow-up of clinical and functional outcomes.3, 14, 20, 61, 77, 84, 85 Regional and statewide organizations such as the Maine Medical Assessment Foundation can be effective in collecting data. The information from pooled orthopaedic data would be instrumental in improving the quality of musculoskeletal care that we are able to provide. It would allow rapid accrual of patients and timely analysis of clinical uncertainties. These data must be collected efciently at minimal cost in community and academic settings. Cost-benet analysis of orthopaedic surgery interventions has been shown to be quite favorable109, 151 and will continue to be to the benet of orthopaedists and their patients. Evidence-based medicine has been dened by Sackett and colleagues as the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients.119a The practice of evidence-based medicine requires integrating individual clinical expertise with the best available evidence from systematic research. As noted earlier, randomized clinical trials are thought to provide the highest quality evidence to inuence clinical decision making. Evidence-based medicine has become the new buzzword in outcomes literature. The Journal of Bone and Joint Surgery introduced a quarterly section on evidence-based orthopaedics in

June 2000 to assist busy clinicians with real-world questions.151a The Cochrane Collaboration (www.cochrane.org), an international consortium, was developed in 1992 to 1993 to help practitioners and patients make well informed decisions about health care by a systematic review of the effects of health care interventions. This consortium has multidisciplinary review groups in over 40 areas of health care that systematically collect, review, and electronically publish summaries of randomized clinical trials. The Cochrane Library is maintained on line and includes databases of systematic reviews, randomized control trials (RCTs), and abstracts. There is a Cochrane musculoskeletal injuries group with more than 30 systemic reviews completed and on line. The Cochrane Collaboration is a potentially powerful resource for clinicians and patients who wish to obtain the best available data to help make clinical decisions.
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Acknowledgments The authors appreciate the editorial assistance of Renee Schurtz and Jean Godwin.

REFERENCES 1. Agel, J. The Feasibility of the SMFA. Orthopaedic Trauma Association meeting; Charlotte, NC, 1999. 2. Atlas, S.J.; Deyo, R.A.; Keller, R.B.; et al. The Maine Lumbar Spine Study II. Spine 21:1777, 1996. 3. Aune, A.K.; Ekeland, A.; Odegaard, B.; et al. Gamma nail vs compression screw for trochanteric femoral fractures: 15 reoperations in a prospective, randomized study of 278 patients. Acta Orthop Scand 65:127, 1994. 4. Baker, S.; ONeill, B.; Haddlon, W. The Injury Severity Score: A method for describing patients with multiple injuries and evaluating emergency care. J Trauma 14:187, 1974. 5. Baker, S.P. Injuries: The neglected epidemic. Stone Lecture, 1985 American Trauma Society Meeting. J Trauma 27:343, 1987. 6. Baker, S.P.; ONeill, B.; Haddon, W.; et al. The Injury Severity Score. J Trauma 14:187, 1974. 7. Baker, S.P.; ONeill, B. The Injury Severity Score: An update. J Trauma 16:882, 1976. 8. Balogh, Z.; Offner, P.J.; Moore, E.E.; Biff, W.L. NISS predicts post-injury mortality better than the ISS. J Orthop Trauma 48:624, 2000. 9. Bellamy, N.; Buchanan, W.W.; Goldsmith, C.H.; et al. Validation study of WOMAC: A health status instrument for measuring clinically important patient relevant outcomes following total hip or knee arthroplasty in osteoarthritis. J Orthop Rheumatol 1:95, 1988. 10. Benirschke, S.K.; Melder, I.; Henley, M.B.; et al. Closed interlocking nailing of femoral shaft fractures: Assessment of technical complications and functional outcomes by comparison of a prospective database with retrospective review. J Orthop Trauma 7:118, 1993. 11. Bergner, M.; Bobbitt, R.A.; Carter, W.B.; et al. The Sickness Impact Prole: Development and nal revision of a health status measure. Med Care 19:787, 1981. 12. Bergner, M.; Bobbitt, R.A.; Kressel, S.; et al. The Sickness Impact Prole: Conceptual formulation and methodological development of a health status index. Int J Health Serv 6:393, 1976. 13. Bergner, M.; Bobbitt, R.A.; Pollaro, W.E.; et al. The Sickness Impact Prole: Validation of a health status measure. Med Care 14:57, 1976. 14. Blanchut, P.A.; OBrien, P.J.; Meck, R.N.; Brockhuyse, H.M. Interlocking IM nailing with and without reaming of closed fractures of the tibial shaft: A prospective, randomized study. J Bone Joint Surg Am 79:640, 1997. 15. Bondurant, F Cotler, H.B.; Buckle, R.; et al. The medical and .; economic impact of severely injured lower extremities. J Trauma 28:1270, 1988. 16. Bone, L.B.; Johnson, K.D.; Weigelt, J.; Scheinbeng, R. Early versus

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CHAPTER 24 Evaluation of Outcomes for Musculoskeletal Injury delayed stabilization of fractures: A prospective randomized study. J Bone Joint Surg Am 71:336, 1989. Bone, L.B.; McNamara, K.; Shine, B.; Border, J. Mortality in multiple trauma patients with fractures. J Trauma 37:262, 1994. Boyd, C.R.; Tolson, M.A.; Copes, W.S. Evaluating trauma care: The TRISS method. J Trauma 27:370, 1987. Boyd, D.R. Trauma registries revisited. Editorial. J Trauma 25:186, 1985. Bracken, M.B.; Shepard, M.J.; Collins, W.F et al. A randomized .; controlled trial of methylprednisolone or naloxone in the treatment of spinal cord injury. N Engl J Med 322:1405, 1990. Bradburn, N.M. The Structure of Psychological Well Being. Chicago, Aldine Publishing, 1969. Brennemen, F .D.; Boulange, B.R.; McLellan, B.A.; et al. Measuring injury severity: Time for a change? J Orthop Trauma 44:580, 1998. Breslow, L. A quantitative approach to the World Health Organization denition of health: Physical, mental and social well-being. Int J Epidemiol 1:347, 1972. Brotman, S.; McMinn, D.L.; Copes, W.S.; et al. Should survivors with an Injury Severity Score less than 10 be entered in a statewide trauma registry? J Trauma 31:1233, 1991. Brumback, R.J.; Jones, A.L. Interobserver agreement in the classication of open fractures of the tibia: The results of a survey of two hundred and forty-ve orthopaedic surgeons. J Bone Joint Surg Am 76:1162, 1994. Bureau of Labor Statistics. Occupational injuries and illnesses in the United States by industry in 1988. Bur Labor Stat Bull August: 2368, 1990. Bush, J.W.; Chen, M.M.; Patrick, D.L. Health status index in cost effectiveness and analysis of PKU program. In: Berg, R.L., ed. Health Status Indexes. Chicago, Hospital Research and Educational Trust, 1973, p. 172. Cales, R.; Trunkey, D. Preventable trauma deaths: A review of trauma care systems development. JAMA 254:1059, 1985. Chalmers, I.G.; Collins, R.E.; Dickerson, K. Controlled trials and meta-analysis can help resolve disagreements among orthopedic surgeons. Editorial. J Bone Joint Surg Br 74:7641, 1992. Chambers, L.W. The McMaster Health Index Questionnaire (MHIQ): Methodological Documentation and Report of Second Generation of Investigators. Hamilton, Ontario, Canada, Department of Clinical Epidemiology and Biostatistics, 1982. Champion, H.R.; Copes, W.S.; Sacco, W.J.; et al. The Major Trauma Outcome Study: Establishing national norms for trauma care. J Trauma 30:1356, 1990. Champion, H.R.; Sacco, W.J.; Hannan, D.S.; et al. Assessment of injury severity: The Triage Index. Crit Care Med 8:201, 1980. Champion, H.R.; Teter, H. Trauma care systemsThe federal role. J Trauma 28:877, 1988. Codman, E.A. The product of a hospital. Surg Gynecol Obstet 18:491, 1914. Codman, E.A. The Shoulder. Malaber, FL, Krieger Publishing, 1934, p. 1. Colton, C.L. Telling the bones. Editorial. J Bone Joint Surg Br 73:362, 1991. Committee on Medical Aspects of Automotive Safety. Rating the severity of tissue damage. JAMA 215:277, 1971. Committee on Trauma, American College of Surgeons. Advanced Trauma Life Support Manual. Chicago, American College of Surgeons, 1993. Committee on Trauma, American College of Surgeons. Resources for the Optimal Care of the Injured Patient. Chicago, American College of Surgeons, 1990. Committee on Trauma Research. Injury in America: A Continuing Public Health Problem. Washington, DC, National Academy Press, 1985. Copes, W.S.; Champion, H.R.; Sacco, W.J.; et al. The Injury Severity Score revisited. J Trauma 28:69, 1988. Court-Brown, C.M. The treatment of the multiply injured patient in the United Kingdom. J Bone Joint Surg Br 72:345, 1990. Cutler, S.J.; Latourette, H.B. A national cooperative program for the evaluation of end results in cancer. J Natl Cancer Inst 22:633, 1959. Deyo, R.A.; Inui, T.S.; Leninger, J.D.; Overman, S.S. Measuring functional outcomes in chronic disease: A comparison of traditional scales and a self-administered health status questionnaire in patients with rheumatoid arthritis. Med Care 21:180, 1983.

679

17. 18. 19. 20. 21. 22. 23. 24. 25.

26. 27.

28. 29. 30.

31. 32. 33. 34. 35. 36. 37. 38. 39. 40. 41. 42. 43. 44.

45. Donabedian, A. Evaluating the quality of medical care. Milbank Memorial Fund Quarterly 44(3)(Suppl):166, 1966. 46. Eastman, A.; Lewis, F Jr.; Champion, H.; Mattox, K. Regional ., trauma system design: Critical concepts. Am J Surg 154:79, 1987. 47. Engelberg, R.; Martin, D.P.; Agel, J.; et al. The Musculoskeletal Functional Assessment instrument: Criterion and construct validity. J Orthop Res 14:182, 1996. 48. Engelberg, R.; Martin, D.P.; Agel, J.; Swiontkowski, M.F MFA: . Reference values for patient and non-patient samples. J Orthop Res 17:101, 1999. 49. Fakhry, S.M.; Rutledge, R.; Dahners, L.E.; Kessler, D. Incidence, management and outcome of femoral shaft fracture: A statewide population based analysis of 2805 adult patients in a rural state. J Trauma 37:255, 1994. 50. Fortner, G.S.; Oreskovich, M.R.; Copass, M.K.; Carrico, C.J. The effects of prehospital trauma care on survival from a 50 meter fall. J Trauma 23:976, 1983. 51. Gartland, J.J. Orthopaedic clinical researchDeciencies in experimental design and determination of outcome. J Bone Joint Surg Am 70:1357, 1988. 52. Gehrchen, P.M.; Nielson, J.O.; Olesen, B. Poor reproducibility of Evans classication of the trochanteric fracture: Assessment of four observers in fty-two cases. Acta Orthop Scand 64:71, 1993. 53. Geisler, F .H.; Dorsey, F .C.; Coleman, W.P. Recovery of motor function after spinal cord injuryA randomized, placebo controlled trial with GM1 ganglioside. N Engl J Med 324:1829, 1991. 54. Georgiadis, G.M.; Behrens, F .; Joyce, M.J.; et al. Open tibial .F fractures with severe soft tissue lossLimb salvage compared with below knee amputation. J Bone Joint Surg Am 75:1431, 1993. 55. Greenspan, L.; McLellan, B.A.; Greig, H. Abbreviated Injury Scale and Injury Severity Score: A scoring chart. J Trauma 22:60, 1985. 56. Gregory, R.T.; Gould, R.J.; Peclet, M.; et al. The mangled extremity syndrome (MES): A severity grading system for multisystem injury of the extremity. J Trauma 5:1147, 1985. 57. Gross, M. A critique of the methodologies used in clinical studies of hip joint arthroplasty published in the English literature. J Bone Joint Surg Am 70:1364, 1988. 58. Guyatt, G.H.; Feeney, D.H.; Patrick, D.L. Measuring health related quality of life. Basic Sci Rev 118:622, 1993. 59. Guyatt, G.H.; Kirshner, B.; Jaeschke, R. Measuring health status: What are the necessary measurement properties? J Clin Epidemiol 45:1341, 1992. 60. Hardy, D.D.; Descamps, P.Y.; Krallis, P.; et al. Use of an intermedullary hip-screw compared with compression hip-screw with a plate for intertrochanteric femoral fractures. J Bone Joint Surg Am 81:618, 1999. 61. Horne, G.; Iceton, G.; Twist, J.; Malony R. Disability following fractures of the tibial shaft. Orthopedics 13:423, 1990. 62. Hunt, S.M.; McKenna, S.P.; McEwen, J.; et al. The Nottingham Health Prole: Subjective health status and medical consultations. Soc Sci Med 15A:221, 1981. 63. Jette, A.M.; Davies, A.R.; Cleary, P.D.; et al. The Functional Status Questionnaire: Reliability and validity when used in primary care. J Gen Intern Med 1:143, 1986. 64. Johnson, K.D.; Cadambi, A.; Seibert, G.B. Incidence of adult respiratory distress syndrome in patients with multiple musculoskeletal injuries: Effect of early operative stabilization of fractures. J Trauma 25:375, 1985. 65. Jollis, J.G.; Peterson, E.D.; DeLong, E.R.; et al. The relation between the volume of coronary angioplasty procedures at hospitals treating Medicare beneciaries and short term mortality. N Engl J Med 331:1625, 1994. 66. Kaplan, R.M.; Anderson, J.P.; Wu, A.; et al. The Quality of Well-being Scale: Applications in AIDS, cystic brosis and arthritis. Med Care 27(Suppl 3):S27, 1989. 67. Karnofsky, D.A.; Burchenal, J.H. The clinical evaluation of chemotherapeutic drugs. In: MacLeod, C.M., ed. Evaluation of Chemotherapeutic Agents. New York, Columbia University Press, 1949, p. 191. 68. Katz, J.N.; Larson, M.G.; Phillips, C.B.; et al. Comparative measurement sensitivity of short and longer health status instruments. Med Care 30:917, 1992.

Copyright 2003 Elsevier Science (USA). All rights reserved.

680

SECTION I General Principles Short Form-36, the Western Ontario and McMaster Universities Osteoarthritis Index, and the Sickness Impact Prole health-status measures. J Bone Joint Surg Am 79:1323, 1997. 95. Mattox, K.L.; Bickell, W.H.; Pepe, P.E.; Mangelsdorff, A.D. Prospective randomized evaluation of antishock MAST in post-traumatic hypotension. J Trauma 26:779, 1986. 96. McDowell, I.; Newell, C.; eds. Measuring Health: A Guide to Rating Scales and Questionnaires. New York, Oxford University Press, 1987, p. 125. 97. McEwen, J. The Nottingham Health Prole: A measure of perceived health. In: Teeling-Smith, G., ed. Measuring the Social Benets of Medicine. London, Ofce of Health Economics, 1983, p. 75. 98. Meek, R.; Vivoda, E.; Pirani, S. A comparison of mortality in patients with multiple injuries according to the method of fracture treatment: A retrospective age and injury matched series. Injury 17:2, 1986. 99. Morris, J.A.; Auerbach, P.S.; Marshall, G.A.; et al. The Trauma Score as a triage tool in the prehospital setting. JAMA 256:1319, 1986. 100. Morris, J.A.; Sanchez, A.A.; Bass, S.M.; MacKenzie, E.J. Trauma patients return to productivity. J Trauma 31:827, 1991. 101. Muller, M.E.; Nazarian, S.; Koch, P.; Scatzker, J. The Comprehensive Classication of Fractures of Long Bones. Berlin, Springer-Verlag, 1990. 102. National Safety Council. Accident Facts. Chicago, National Safety Council, 1990. 103. National Trends. Chicago, American College of Surgeons, October 1992. 104. Nelson, E.C.; Wasson, J.; Kirk, A.; et al. Assessment of function in routine clinical practice: Description of the COOP chart method and preliminary ndings. J Chronic Dis 40:15S, 1987. 105. Obremskey, W.T.; Brown, O.; Driver, R.; Dirschl, D.R. Comparison of SMFA vs SF-36 in Recovery of Unstable Ankle Fractures. Orthopaedic Trauma Association meeting, San Antonio, TX, October 2000. 106. Ornato, J.; Craren, E.; Nelsonk, N.; Kimball, K. Impact of improved emergency medical services and emergency trauma care on reduction in mortality from trauma. J Trauma 25:575, 1985. 107. Oslen, T.; Baker, S.; Long, W. A modication of the ISS that both improves accuracy and simplies scoring. J Orthop Trauma 43:922, 1997. 108. Pal, J.; Brown, R.; Fleiszer, D. The value of the Glasgow Coma Scale and ISS: Predicting outcome in multiple trauma patients with head injury. J Trauma 29:746, 1989. 109. Parker, M.J.; Myles, J.W.; Anand, J.K.; Drewett, R. Cost benet analysis of hip fracture treatment. J Bone Joint Surg Br 74:261, 1992. 110. Parkerson, G.R.; Broadhead, W.E.; Tse, C.K.J. The Duke Health Prole: A 17-item measure of health and dysfunction. Med Care 28:1056, 1990. 111. Parkerson, G.R.; Gehlbach, S.H.; Wagner, E.H.; et al. The Duke-UNC Health Prole: An adult health status instrument for primary care. Med Care 19:806, 1981. 112. Patrick, D.L.; Bergner, M. Measurement of health status in the 1990s. Annu Rev Public Health 11:65, 1990. 113. Patrick, D.L.; Deyo, R.A.; Atlas, S.J.; et al. Assessing health related quality of life in patients with sciatica. Spine 20:1899, 1995. 114. Pollock, D.A.; McClain, P.W. Report from the 1988 trauma registry workshop, including recommendations for hospital based trauma registries. J Trauma 29:827, 1989. 115. Pollock, D.A.; McClain, P.W. Trauma registriesCurrent status and future prospects. JAMA 262:2280, 1989. 116. Praemer, A.; Furner, S.; Rice, D.P. Musculoskeletal Conditions in the United States. Park Ridge, IL, American Academy of Orthopaedic Surgeons, 1992. 117. Rhodes, M.; Aronsen, J.; Moerkirk, G.; Petrash, E. Quality of life after the trauma center. J Trauma 28:931, 1987. 118. Rice, D.P.; MacKenzie, E.J. Cost of Injury in the United StatesA Report to Congress. San Francisco, Institute for Health and Aging; University of California and Injury Prevention Center; Baltimore, The Johns Hopkins University, 1989. 119. Rudicel, S.; Esdaile, J. The randomized clinical trial in orthopaedics: Obligation or option? J Bone Joint Surg Am 67:1284, 1995. 119a. Sackett, D.L.; Rosenberg, W.M.; Gray, J.A.; et al. Evidence-based medicine: What it is and what it isnt. BMJ 312:71, 1996.

69. Katz, S.; Ford, A.B.; Moskowitz, R.W.; et al. Studies of illness in the aged. JAMA 185:914, 1963. 70. Keller, R.; Soule, D.N.; Wennberg, J.E.; Hanley, D.F Dealing with . geographic variations in the use of hospitals: The experience of the Maine Medical Assessment Foundation Orthopaedic Study Group. J Bone Joint Surg Am 72:1286, 1990. 71. Keller, R.B. Outcomes research in orthopaedics. J Am Acad Orthop Surg 1:122, 1993. 72. Keller, R.B.; Rudicel, S.A.; Liang, M.H. Outcomes research in orthopaedics. J Bone Joint Surg Am 75:1562, 1993. 73. Keller, R.B.; Soule, D.N.; Wennberg, J.E.; Hanley, D.F Dealing with . geographic variations in the use of hospitals. J Bone Joint Surg Am 72:1286, 1990. 74. Keller, R.B.; Wennberg, D.E.; Soule, D.N. Changing physician behavior: Maine Medical Assessment Foundation. Qual Manag Health Care 5:1, 1997. 75. Keller, R.B; Rudicel, S.; Liang, M.H. Outcomes research in orthopedics. J Bone Joint Surg Am 75:1562, 1993. 76. Kristianson, T.K.; Ryaby, J.P.; McCabe, J.; et al. Accelerated healing of distal radius fractures with the use of specic, low-intensity ultrasound: A multi-center, prospective, randomized, doubleblinded, placebo controlled study. J Bone Joint Surg Am 79:961, 1997. 77. LAbbe, K.A.; Detsky, A.S.; ORourke, K. Meta-analysis in clinical research. Ann Intern Med 107:224, 1987. 78. Labelle, H.; Guibert, R.; Joncas, J.; et al. Lack of scientic evidence for the treatment of lateral epicondylitis of the elbow: An attempted meta-analysis. J Bone Joint Surg Br 74:646, 1992. 79. Lembcke, P.A. Measuring the quality of medical care through vital statistics based on hospital service areas: A comparative study of appendectomy rates. Am J Health 42:276, 1952. 80. Levine, D.W.; Simmons, B.P.; Koris, M.J.; et al. A self-administered questionnaire for the assessment of severity of symptoms and functional status in carpal tunnel syndrome. J Bone Joint Surg Am 75:1585, 1993. 81. Liang, M.H.; Fossel, A.H.; Larson, M.G. Comparisons of ve health status instruments for orthopaedic evaluation. Med Care 28:632, 1990. 82. Littenberg, B.; Weinstein, L.P.; McCarren, M.; et al. Closed fractures of the tibial shaft: A meta-analysis of three methods of treatment. J Bone Joint Surg Am 80:174, 1998. 83. Long, G.T.; Richardson, M.; Bosse, M.J.; et al. Efcacy of surgical wound drainage in orthopaedic trauma patients: A randomized, prospective trial. J Orthop Trauma 12:348, 1998. 84. Loucks, C.; Buckley, R. Bohlers angle: Correlation with outcome in displaced intra-articular calcaneal fractures. J Orthop Trauma 13:554, 1999. 85. Lowe, D.K.; Gately, H.L.; Gross, J.R.; et al. Patterns of death, complications and error in management of motor vehicle accident victims: Implications for a regional system of trauma care. J Trauma 23:503, 1983. 86. Luft, H.; Bunker, J.; Enthoven, A. Should operations be regionalized? The empirical relation between surgical volume and mortality. N Engl J Med 301:1364, 1979. 87. LuYao, G.L.; Keller, R.B.; Littenberg, B.; et al. A meta-analysis of 106 published reports. J Bone Joint Surg Am 76:15, 1994. 88. MacKenzie, E.J. Injury severity scales: Overview and directions for future research. Am J Emerg Med 2:537, 1984. 89. MacKenzie, E.J.; Burgess, A.R.; McAndrew, M.P.; et al. Patientoriented functional outcome after unilateral lower extremity fracture. J Orthop Trauma 7:393, 1993. 90. MacKenzie, E.J.; Cushing, B.M.; Jurkovich, G.J.; et al. Physical impairment and functional outcomes six months after severe lower extremity fractures. J Trauma 34:528, 1993. 91. MacKenzie, E.J.; Morris, J.A.; Smith, G.S.; Fahey, M. Acute hospital costs of trauma in the United States: Implications for regionalized systems of care. J Trauma 30:1096, 1990. 92. MacKenzie, E.J.; Siegel, J.H.; Shapiro, S.; et al. Functional recovery and medical costs of trauma: An analysis by type and severity of injury. J Trauma 28:281, 1988. 93. Mrin, D.; Engelberg, R.; Agel, J.; Snapp, D. Development of the Musculoskeletal Functional Assessment Instrument. J Orthop Res 14:173, 1996. 94. Martin, D.; Engelberg, R.; Agel, J.; Swiontkowski, M.F Comparison . of the Musculoskeletal Function Assessment Questionnaire with the

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CHAPTER 24 Evaluation of Outcomes for Musculoskeletal Injury 120. Schroder, S.A. Outcome assessment 70 years later: Are we ready? N Engl J Med 316:160, 1987. 121. Seibel, R.; LaDuca, J.; Hassett, J.M.; et al. Blunt multiple trauma (ISS 36), femur traction, and the pulmonary failure-septic state. Ann Surg 202:283, 1985. 122. Shakford, S.R.; Hollingsworth Fridlund, P.; Cooper, G.F Eastman, .; A.B. The effect of regionalization upon the quality of trauma care assessed by concurrent audit before and after the institution of a trauma system: A preliminary report. J Trauma 26:812, 1986. 123. Shapiro, M.J.; Cole, K.E., Jr.; Keegan, M.; et al. National survey of state trauma registries1992. J Trauma 37:835, 1994. 124. Sidor, M.L.; Zuckerman, J.D.; Lyon, T.; et al. The Neer classication for proximal humerus fractures. An assessment of interobserver reliability and intraobserver reproducibility. J Bone Joint Surg Am 75:1745, 1993. 125. Siebenrock, K.A.; Gerber, C. The reproducibility of classication of fractures of the proximal end of the humerus. J Bone Joint Surg Am 75:1751, 1993. 126. Sniezek, J.E.; Finklea, J.F Graciter, P.L. Injury coding and hospital .; discharge data. JAMA 262:2270, 1989. 127. Stewart, A.L.; Hays, R.D.; Ware, J.E. The MOS short form general health survey: Reliability and validity in a patient population. Med Care 26:724, 1988. 128. Stewart, A.L.; Ware, J.E.; Brook, R.H.; Davies Avery, A. Conceptualization and Measurement of Health for Adults in the Health Insurance Study, Vol. II: Physical Health in Terms of Functioning. Publication R1987/3HEW. Santa Monica, CA, The Rand Corporation, 1978. 129. Swiontkowski, M.F Outcomes measurement in orthopaedic trauma . surgery. Injury 26:653, 1995. 130. Swiontkowski, M.F Buckwelter, J.A.; Keller, R.B.; Haralson, R. The .; outcomes movement in orthopaedic surgery: Where we are and where we should go. J Bone Joint Surg Am 81:732, 1999. 131. Swiontkowski, M.F Chapman, J.R. Cost and effectiveness issues in .; care of injured patients. Clin Orthop 318:17, 1995. 132. Swiontkowski, M.F Engelberg, R.; Martin, D.P.; Agel, J. SMFA .; Questionnaire: Validity, reliability and responsiveness. J Bone Joint Surg Am 81:1245, 1999. 133. Tarlov, A.R. Multiple inuences propel outcomes eld. Med Outcomes Trust Bull 3:5, 1995. 134. Tarlov, A.R.; Ware, J.E.; Greeneld, S.; et al. The Medical Outcomes Study: An application of methods for monitoring the results of medical care. JAMA 262:925, 1989. 135. Trauma Care Systems. Setting the national agenda for injury control in the 1990s. Position paper, Third National Injury Control Conference, Atlanta, U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, 1991. 136. Trunkey, D. Trauma. Sci Am 249(2):28, 1983.

681

137. Trunkey, D.D. Trauma care systems. Emerg Med Clin North Am 2:913, 1990. 138. Trunkey, D.D.; Lim, R. Analysis of 425 consecutive trauma fatalities: An autopsy study. J Am Coll Emerg Physicians 3:1364, 1974. 139. Turner, J.A.; Ersek, M.; Herron, L.; Deyo, R. Surgery for lumbar spinal stenosis: Attempted meta-analysis of the literature. Spine 17:1, 1992. 140. Vestrup, J.A.; Phang, T.; Vertresi, L.; et al. The utility of a multicenter regional trauma registry. J Trauma 37:375, 1994. 141. Vrbos, L.A.; Lorenz, M.A.; Peabody, E.H.; McGregor, M. Clinical methodologies and incidence of appropriate statistical testing in orthopaedic spine literature: Are statistics misleading? Spine 18:1021, 1993. 142. Ware, J.E. SF-36 Health Survey: Manual and Interpretations Guide. Boston, The Health Institute, New England Medical Center, 1996, pp. 10:610:13. 143. Ware, J.E.; Johnston, S.A.; Davies Avery, A.; Brook, R.H. Conceptualization and Measurement of Health for Adults in the Health Insurance Study. Vol. III. Mental Health. Publication R1987/3 HEW. Santa Monica, CA, The Rand Corporation, 1979. 144. Ware, J.E.; Sherbourne, C.D. The MOS 36 item short form health survey (SF36). Med Care 30:473, 1992. 145. Ware, J.E.; Sherbourne, C.D.; Davies, A.R. Developing and testing the MOS 20 item short form health survey: A general population application. In: Stewart, A.L.; Ware, J.E.; eds. Measuring Function and Well Being; The Medical Outcomes Study Approach. Durham, NC, Duke University Press, 1992, p. 277. 146. Weddel, J.M. Registers and registries: A review. Int J Epidemiol 2:221, 1973. 147. Wennberg, J.; Gittelsohn, A. Small area variations in health care delivery. Science 182:1102, 1973. 148. Wennberg, J.E.; Roos, N.; Sola, L.; et al. Use of claims data systems to evaluate health care outcomes: Mortality and reoperation following prostatectomy. JAMA 257:933, 1987. 149. West, J.G.; Cales, R.H.; Gazzinga, A.B. Impact of regionalization: The Orange County experience. Arch Surg 118:740, 1983. 150. West, J.G.; Trunkey, D.D.; Lim, R.C. Systems of trauma care: A study of two counties. Arch Surg 114:455, 1979. 151. Williams, A. Setting priorities in health care: An economists view. J Bone Joint Surg Br 73:365, 1991. 151a. Wright, J.G.; Swiontkowski, M.F Introducing a new journal . section: Evidence-based orthopaedics. J Bone Joint Surg Am 82:759, 2000. 152. Wyrsch, B.; McFerran, M.A.; McAndrew, M.; et al. Operative treatment of fractures of the tibial plafond: A prospective, randomized study. J Bone Joint Surg Am 78:1646, 1996. 153. Xuan, J.; Kirchdoerter, L.J.; Boyer, J.G.; Norwood, G.J. Effects of co-morbidity on HR-QOL scores: An analysis of clinical trial data. Clin Ther 21:303, 1999.

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Copyright 2003 Elsevier Science (USA). All rights reserved.