Objective. To conduct a systematic review of the measurement properties of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and to evaluate the quality of WOMAC measurement studies using COSMIN (Consensus-Based Standards for the Selection of Health Measurement Instruments) criteria. Methods. A search was conducted in the MEDLINE, CINAHL, Embase, PsycINFO, Scopus, and SPORTDiscus databases through September 2013. Data that assessed the WOMAC measurement model, reliability, validity, respondent burden, and equivalence across methods of administration were extracted. Overall study quality was rated following COSMIN criteria. Results. A total of 76 articles from 22 countries were included. Internal consistency reliability was consistently high (>0.90) for the function scale and acceptable (>0.70) for the pain and stiffness scales. Test-retest reliability was acceptable. Score equivalence was demonstrated across paper and electronic methods of data collection. Floor and ceiling effects were low except for notable (24 -38%) proportions of patients achieving the best possible scores on the pain and stiffness scales 1-23 years after arthroplasty. Five exploratory factor analyses did not support a measurement model in which the pain and function items were distinct. Correlations between the WOMAC pain and function scales were high (median 0.79). The WOMAC pain and function scales had similar correlations with other pain measures, and therefore the WOMAC pain scale did not show divergent validity. COSMIN criteria were not fully met in most studies. Conclusion. The WOMAC scales were reliable, but its pain scale was highly related to physical function. Further research into joint-specific pain measures that have broader content validity is needed.
INTRODUCTIONThe Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) has been used in research for more than 25 years (1,2). Available in more than 80 language versions and measuring 3 domains (pain, stiffness, and function) viewed as central to the assessment of patientreported outcomes (PROs) in osteoarthritis (OA), the WOMAC has been recommended for use in clinical trials (3,4) and studied in more than 1,000 peer-reviewed articles.A comprehensive review of the WOMAC measurement properties was conducted in 2001 (5), and the WOMAC has been included in subsequent reviews of outcome measures used in OA (6 -9). However, much of the WOMAC measurement literature published since 2001 has not been cited in these reviews. In addition, the reviews have not examined key WOMAC measurement issues in depth, such as the relationship between its pain and function scales.This systematic review provides an updated summary of the literature on the WOMAC measurement properties in relation to criteria proposed by the Scientific Advisory Committee of the Medical Outcomes Trust (MOT) for evaluating the measurement properties of PRO instruments (10). It also evaluates the overall methodologic quality of WOMAC measurement studies using the COSMIN (Consensus-Ba...