Abstract
Objectives. To develop a prioritised list based on responsiveness for extracting patient-reported outcomes (PROs) measuring pain and disability for performing meta-analyses in knee osteoarthritis (OA). Methods. A systematic search was conducted in 20 highest impact factor general and rheumatology journals chosen a priori. Eligible studies were randomised controlled trials, using two or more PROs measuring pain and/or disability. Results. A literature search identified 402 publications and 38 trials were included, resulting in 54 randomised comparisons. Thirty-five trials had sufficient data on pain and 15 trials on disability. The WOMAC “pain” and “function” subscales were the most responsive composite scores. The following list was developed. Pain: (1) WOMAC “pain” subscale, (2) pain during activity (VAS), (3) pain during walking (VAS), (4) general knee pain (VAS), (5) pain at rest (VAS), (6) other composite pain scales, and (7) other single item measures. Disability: (1) WOMAC “function” subscale, (2) SF-36 “physical function” subscale, (3) SF-36 (Physical composite score), and (4) Other composite disability scores. Conclusions. As choosing the PRO most favourable for the intervention from individual trials can lead to biased estimates, using a prioritised list as developed in this study is recommended to reduce risk of biased selection of PROs in meta-analyses.
Highlights
Measures for patient-reported outcomes (PROs) are used in most osteoarthritis (OA) trials
At the 3rd Outcome Measures in Rheumatology (OMERACT) Conference in 1996, consensus was reached on three domains—pain, disability, and patient global assessment— as measures that should be reported in future OA trials [1]
Biased selection of PROs in metaanalyses can overestimate the effect compared with a systematic approach
Summary
Measures for patient-reported outcomes (PROs) are used in most osteoarthritis (OA) trials. Extracting and combining these data is an essential part of any meta-analysis of such trials. At the 3rd Outcome Measures in Rheumatology (OMERACT) Conference in 1996, consensus was reached on three domains—pain, disability, and patient global assessment— as measures that should be reported in future OA trials [1]. This recommendation only specified which constructs to measure, but not which specific instruments to include [2]. If the choice of PROs is based on which outcome measure reaches statistical significance, the corresponding meta-analytic estimates are likely to be biased [4, 5]
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