Outcome Measures Used in Arthroplasty Trials: Systematic Review of the 2008 and 2013 Literature.

Abstract

Previously published literature assessing the reporting of outcome measures used in joint replacement randomized controlled trials (RCT) has revealed disappointing results. It remains unknown whether international initiatives have led to any improvement in the quality of reporting and/or a reduction in the heterogeneity of outcome measures used. Our objective was to systematically assess and compare primary outcome measures and the risk of bias in joint replacement RCT published in 2008 and 2013. We searched MEDLINE, EMBASE, and CENTRAL for RCT investigating adult patients undergoing joint replacement surgery. Two authors independently identified eligible trials, extracted data, and assessed risk of bias using the Cochrane tool. Seventy RCT (30 in 2008, 40 in 2013) met the eligibility criteria. There was no significant difference in the number of trials judged to be at low overall risk of bias (n = 6, 20%) in 2008 compared with 2013 [6 (15%); chi-square = 0.302, p = 0.75]. Significantly more trials published in 2008 did not specify a primary outcome measure (n = 25, 83%) compared with 18 trials (45%) in 2013 (chi-square = 10.6316, p = 0.001). When specified, there was significant heterogeneity in the measures used to assess primary outcomes. While less than a quarter of trials published in both 2008 and 2013 were judged to be at low overall risk of bias, significantly more trials published in 2013 specified a primary outcome. Although this might represent a temporal trend toward improvement, the overall frequency of primary outcome reporting and the wide heterogeneity in primary outcomes reported remain suboptimal.