James G. Wright

This paper describes the development of an evaluative outcome measure for patients with upper extremity musculoskeletal conditions. The goal is to produce a brief, self-administered measure of symptoms and functional status, with a focus on physical function, to be used by clinicians in daily practice and as a research tool. This is a joint initiative of the American Academy of Orthopedic Surgeons (AAOS), the Council of Musculoskeletal Specialty Societies (COMSS), and the Institute for Work and Health (Toronto, Ontario). Our approach is consistent with previously described strategies for scale development. In Stage 1, Item Generation, a group of methodologists and clinical experts reviewed 13 outcome measurement scales currently in use and generated a list of 821 items. In Stage 2a, Initial Item Reduction, these 821 items were reduced to 78 items using various strategies including removal of items which were generic, repetitive, not reflective of disability, or not relevant to the upper extremity or to one of the targeted concepts of symptoms and functional status. Items not highly endorsed in a survey of content experts were also eliminated. Stage 2b, Further Item Reduction, will be based on results of field testing in which patients complete the 78-item questionnaire. This field testing, which is currently underway in 20 centers in the United States, Canada, and Australia, will generate the final format and content of the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire. Future work includes plans for validity and reliability testing.

BACKGROUND: The purpose of this study was to develop a short, reliable, and valid measure of physical function and symptoms related to upper-limb musculoskeletal disorders by shortening the full, thirty-item DASH (Disabilities of the Arm, Shoulder and Hand) Outcome Measure. METHODS: Three item-reduction techniques were used on the cross-sectional field-testing data derived from a study of 407 patients with various upper-limb conditions. These techniques were the concept-retention method, the equidiscriminative item-total correlation, and the item response theory (Rasch modeling). Three eleven-item scales were created. Data from a longitudinal cohort study in which the DASH questionnaire was administered to 200 patients with shoulder and wrist/hand disorders were then used to assess the reliability (Cronbach alpha and test-retest reliability) and validity (cross-sectional and longitudinal construct) of the three scales. Results were compared with those derived with the full DASH. RESULTS: The three versions were comparable with regard to their measurement properties. All had a Cronbach alpha of > or = 0.92 and an intraclass correlation coefficient of > or = 0.94. Evidence of construct validity was established (r > or = 0.64 with single-item indices of pain and function). The concept-retention method, the most subjective of the approaches to item reduction, ranked highest in terms of its similarity to the original DASH. CONCLUSIONS: The concept-retention version is named the QuickDASH. It contains eleven items and is similar with regard to scores and properties to the full DASH. A comparison of item-reduction approaches suggested that the retention of clinically sensible and important content produced a comparable, if not slightly better, instrument than did more statistically driven approaches.

Orthopaedic surgeons have always based their clinical care on evidence. Surgeons use evidence to make decisions tailored to an individual patient's needs and circumstances. The primary sources of evidence for clinicians are studies published in the medical and surgical literature, such as The Journal of Bone and Joint Surgery. In June 2000, The Journal introduced the quarterly Evidence-Based Orthopaedics section 1. This section introduces orthopaedic surgeons to recent randomized trials relevant to the practice of orthopaedic surgery published in forty-two journals other than The Journal of Bone and Joint Surgery. Structured abstracts of these studies are published along with solicited commentaries to place the evidence into context. Beginning this month, The Journal is making an addition to its clinical articles. All such articles will include a Level-of-Evidence Rating . Levels of evidence are hierarchical rating systems for classifying study quality. Several systems for rating levels of evidence are available (minerva.minervation.com/cebm/docs/levels.html). The one chosen by The Journal has five levels for each of four different study types—i.e., therapeutic, prognostic, diagnostic, and economic or decision modeling. The Journal is accordingly modifying its Instructions to Authors: authors submitting articles must now clearly specify the primary research question of their study; they must classify the type of study as therapeutic, prognostic, diagnostic, or economic/decision analysis; and they must provide a Level-of-Evidence Rating of their approach to the primary research question. Every Level-of-Evidence Rating will be reviewed by the editors. The addition of the Level-of-Evidence Ratings to The Journal will have several benefits. Authors, reviewers, and readers will become familiar with the concept of levels of evidence, and studies will be improved by an explicit articulation of the primary research question. In addition, The Journal will be able to monitor and to periodically report trends in the quality of orthopaedic clinical research. Most important, the ratings will place a clinical research study into context for the reader. Higher levels of evidence should be more convincing to surgeons attempting to resolve clinical dilemmas 2. However, when using levels of evidence, readers need to consider several caveats. First, levels of evidence provide only a rough guide to study quality. In-depth assessment requires a critical appraisal of the specific study. Second, as randomized clinical trials are not always possible 3, Level-I evidence may not be available for all clinical situations. Level-III or IV evidence can still be of great value to the practicing orthopaedic surgeon. Finally, an answer to a clinical question must be based on a composite assessment of all evidence of all types. No single study provides a definitive answer. We look forward to your comments about this Journal initiative, feedback on the process, comments on its usefulness to orthopaedic surgeons, and debates about the Level-of-Evidence Ratings applied to individual studies. —James G. Wright, MD, MPH, FRCSC, Deputy Editor —Marc F. Swiontkowski, MD, Deputy Editor for Outcome Studies —James D. Heckman, MD, Editor-in-Chief - Levels of Evidence for Primary Research Question Types of Studies Therapeutic Studies—Investigating the Results of Treatment Prognostic Studies—Investigating the Outcome of Disease Diagnostic Studies—Investigating a Diagnostic Test Economic and Decision Analyses—Developing an Economic or Decision Model Level I 1. Randomized controlled trial, a. Significant difference, b. No significant difference but narrow confidence intervals, 2. Systematic review 2 of Level-I randomized controlled trials (studies were homogeneous) 1. Prospective study 1, 2. Systematic review 2 of Level-I studies 1. Testing of previously developed diagnostic criteria in series of consecutive patients (with universally applied reference "gold" standard), 2. Systematic review 2 of Level-I studies 1. Clinically sensible costs and alternatives; values obtained from many studies; multiway sensitivity analyses, 2. Systematic review 2 of Level-I studies Level II 1. Prospective cohort study 3, 2. Poor-quality randomized controlled trial (e.g., <80% follow-up), 3. Systematic review 2, a. Level-II studies, b. nonhomogeneous Level-I studies 1. Retrospective study 4, 2. Study of untreated controls from a previous randomized controlled trial, 3. Systematic review 2 of Level-II studies 1. Development of diagnostic criteria on basis of consecutive patients (with universally applied reference "gold" standard), 2. Systematic review 2 of Level-II studies 1. Clinically sensible costs and alternatives; values obtained from limited studies; multiway sensitivity analyses, 2. Systematic review 2 of Level-II studies Level III 1. Case-control study 5, 2. Retrospective cohort study 4, 3. Systematic review 2 of Level-III studies 1. Study of nonconsecutive patients (no consistently applied reference "gold" standard), 2. Systematic review 2 of Level-III studies 1. Limited alternatives and costs; poor estimates, 2. Systematic review 2 of Level-III studies Level IV Case series (no, or historical, control group) Case series 1. Case-control study, 2. Poor reference standard No sensitivity analyses Level V Expert opinion Expert opinion Expert opinion Expert opinion 1. All patients were enrolled at the same point in their disease course (inception cohort) with ≥80% follow-up of enrolled patients. , 2. A study of results from two or more previous studies. , 3. Patients were compared with a control group of patients treated at the same time and institution. , 4. The study was initiated after treatment was performed. , 5. Patients with a particular outcome ("cases" with, for example, a failed total arthroplasty) were compared with those who did not have the outcome ("controls" with, for example, a total hip arthroplasty that did not fail).

BACKGROUND: The role of bracing in patients with adolescent idiopathic scoliosis who are at risk for curve progression and eventual surgery is controversial. METHODS: We conducted a multicenter study that included patients with typical indications for bracing due to their age, skeletal immaturity, and degree of scoliosis. Both a randomized cohort and a preference cohort were enrolled. Of 242 patients included in the analysis, 116 were randomly assigned to bracing or observation, and 126 chose between bracing and observation. Patients in the bracing group were instructed to wear the brace at least 18 hours per day. The primary outcomes were curve progression to 50 degrees or more (treatment failure) and skeletal maturity without this degree of curve progression (treatment success). RESULTS: The trial was stopped early owing to the efficacy of bracing. In an analysis that included both the randomized and preference cohorts, the rate of treatment success was 72% after bracing, as compared with 48% after observation (propensity-score-adjusted odds ratio for treatment success, 1.93; 95% confidence interval [CI], 1.08 to 3.46). In the intention-to-treat analysis, the rate of treatment success was 75% among patients randomly assigned to bracing, as compared with 42% among those randomly assigned to observation (odds ratio, 4.11; 95% CI, 1.85 to 9.16). There was a significant positive association between hours of brace wear and rate of treatment success (P<0.001). CONCLUSIONS: Bracing significantly decreased the progression of high-risk curves to the threshold for surgery in patients with adolescent idiopathic scoliosis. The benefit increased with longer hours of brace wear. (Funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases and others; BRAIST ClinicalTrials.gov number, NCT00448448.).