The Patient-Reported Outcomes Measurement Information System Pain Interference (PROMIS-PI) scales are reliable and publicly accessible; however, little is known about how responsive they are to detect change in clinical trials and how their responsiveness compares with legacy measures. The study purpose was to evaluate responsiveness for the PROMIS-PI scales and to compare their responsiveness with legacy pain measures. We used data from 3 clinical trials totaling 759 participants. The clinical trials included patients with chronic low back pain (n = 261), chronic back or osteoarthritis pain (n = 240), and a history of stroke (n = 258). At both baseline and follow-up, participants completed PROMIS-PI scales and legacy pain measures (Brief Pain Inventory Interference scale; Pain, Enjoyment, General Activity scale; 36-Item Short Form Survey (SF-36) Bodily Pain scale; and Roland-Morris Disability Questionnaire). We measured global ratings of pain change, both prospectively and retrospectively, as anchors to identify patients as improved, unchanged, or worsened. Responsiveness was assessed with standardized response means, statistical tests comparing change groups, and area under the curve analysis. The PROMIS-PI scales had largely comparable responsiveness with the Brief Pain Inventory Interference and Pain, Enjoyment, General Activity scales. The 4 PROMIS-PI short forms had comparable responsiveness. For all pain questionnaires, responsiveness varied based on the study population and whether pain improved or worsened. PERSPECTIVE: This article presents 1) how responsive the PROMIS-PI scales were to detect change over time in the context of 3 clinical trials and 2) how their responsiveness compared with legacy pain measures. The findings can help researchers and clinicians choose between different patient-reported pain outcome measures.
Keywords: PROMIS; Pain interference; pain measurement; patient-reported outcome measures; responsiveness.
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