{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,16]],"date-time":"2026-05-16T18:50:17Z","timestamp":1778957417974,"version":"3.51.4"},"reference-count":36,"publisher":"The Journal of Rheumatology","issue":"9","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J Rheumatol"],"published-print":{"date-parts":[[2018,9]]},"abstract":"<jats:sec><jats:title>Objective.<\/jats:title><jats:p>In rheumatoid arthritis, composite outcomes constructed from a combination of outcome measures are widely used to enhance responsiveness (sensitivity to change) and comprehensively summarize response. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain is the primary outcome measure in many osteoarthritis (OA) trials. Information from other outcomes, such as rescue medication use and other WOMAC subscales, could be added to create composite outcomes, but the sensitivity of such a composite has not been tested.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods.<\/jats:title><jats:p>We used data from a completed trial of tanezumab for knee OA (<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT00733902\">NCT00733902<\/jats:ext-link>). The WOMAC questionnaire and rescue medication use were measured at several timepoints, up to 16 weeks. Pain and rescue medication outcomes were standardized and combined into 3 composite outcomes through principal components analysis to produce 1 score (composite outcome) and their responsiveness was compared to WOMAC pain, the standard. We pooled all treatment doses of tanezumab into 1 treatment group, for simplicity, and compared this to the control group (placebo).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results.<\/jats:title><jats:p>The composite outcomes showed modestly, but not statistically significantly greater responsiveness when compared to WOMAC pain alone. Adding information on rescue medication to the composite improved responsiveness. While improvements in sensitivity were modest, the required sample sizes for trials using composites was 20\u201340% less than trials using WOMAC pain alone.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion.<\/jats:title><jats:p>Combining information from related but distinct outcomes considered relevant to a particular treatment improved responsiveness, could reduce sample size requirements in OA trials, and might offer a way to better detect treatment efficacy in OA trials.<\/jats:p><\/jats:sec>","DOI":"10.3899\/jrheum.170928","type":"journal-article","created":{"date-parts":[[2018,5,1]],"date-time":"2018-05-01T11:35:12Z","timestamp":1525174512000},"page":"1308-1315","source":"Crossref","is-referenced-by-count":11,"title":["Responsiveness of Single versus Composite Measures of Pain in Knee Osteoarthritis"],"prefix":"10.3899","volume":"45","author":[{"given":"Matthew J.","family":"Parkes","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michael J.","family":"Callaghan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Leslie","family":"Tive","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mark","family":"Lunt","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David T.","family":"Felson","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"2262","published-online":{"date-parts":[[2018,5,1]]},"reference":[{"key":"2018112909385983000_45.9.1308.1","doi-asserted-by":"publisher","DOI":"10.1097\/j.pain.0000000000000613"},{"key":"2018112909385983000_45.9.1308.2","doi-asserted-by":"publisher","DOI":"10.3899\/jrheum.100759"},{"key":"2018112909385983000_45.9.1308.3","doi-asserted-by":"publisher","DOI":"10.1016\/j.joca.2013.03.018"},{"key":"2018112909385983000_45.9.1308.4","doi-asserted-by":"publisher","DOI":"10.1016\/j.pain.2004.09.012"},{"key":"2018112909385983000_45.9.1308.5","doi-asserted-by":"crossref","first-page":"834","DOI":"10.1016\/S0003-4967(24)43382-7","article-title":"Responsiveness of the WOMAC osteoarthritis index as compared with the SF-36 in patients with osteoarthritis of the legs undergoing a comprehensive rehabilitation intervention","volume":"60","author":"Angst","year":"2001","journal-title":"Ann Rheum Dis"},{"key":"2018112909385983000_45.9.1308.6","doi-asserted-by":"publisher","DOI":"10.1136\/ard.49.11.916"},{"key":"2018112909385983000_45.9.1308.7","doi-asserted-by":"publisher","DOI":"10.1136\/ard.51.2.177"},{"key":"2018112909385983000_45.9.1308.8","doi-asserted-by":"crossref","first-page":"272","DOI":"10.1186\/s13063-016-1402-5","article-title":"A systematic review of randomised controlled trials in rheumatoid arthritis: the reporting and handling of missing data in composite outcomes","volume":"17","author":"Ibrahim","year":"2016","journal-title":"Trials"},{"key":"2018112909385983000_45.9.1308.9","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2011.12.980"},{"key":"2018112909385983000_45.9.1308.10","doi-asserted-by":"publisher","DOI":"10.1136\/ard.2010.142901"},{"key":"2018112909385983000_45.9.1308.11","doi-asserted-by":"crossref","first-page":"10","DOI":"10.1371\/journal.pone.0018461","article-title":"Delphi-consensus weights for ischemic and bleeding events to be included in a composite outcome for RCTs in thrombosis prevention","volume":"6","author":"Dechartres","year":"2011","journal-title":"PLoS One"},{"key":"2018112909385983000_45.9.1308.12","doi-asserted-by":"crossref","first-page":"190","DOI":"10.1111\/1471-0528.13764","article-title":"Development of composite outcomes for individual patient data (IPD) meta-analysis on the effects of diet and lifestyle in pregnancy: A Delphi survey","volume":"123","author":"Rogozinska","year":"2016","journal-title":"BJOG An Int J Obstet Gynaecol"},{"key":"2018112909385983000_45.9.1308.13","doi-asserted-by":"crossref","first-page":"1331","DOI":"10.1097\/TP.0000000000000235","article-title":"Consensus conference on a composite endpoint for clinical trials on immunosuppressive drugs in lung transplantation","volume":"98","author":"Monchaud","year":"2014","journal-title":"Transplantation"},{"key":"2018112909385983000_45.9.1308.14","doi-asserted-by":"publisher","DOI":"10.1016\/j.athoracsur.2012.05.027"},{"key":"2018112909385983000_45.9.1308.15","doi-asserted-by":"crossref","first-page":"790","DOI":"10.1016\/j.jpain.2012.05.006","article-title":"Tanezumab reduces osteoarthritic knee pain: results of a randomized, double-blind, placebo-controlled phase III trial","volume":"13","author":"Brown","year":"2012","journal-title":"J Pain"},{"key":"2018112909385983000_45.9.1308.16","first-page":"1324","article-title":"The factor subdimensions of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) help to specify hip and knee osteoarthritis. 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