Examination of Randomized Trials and Corresponding Trial Registry Entries: Registration Timing and Primary Outcome Analysis in the Journal of Arthroplasty

Abstract

BackgroundProspective trial registration enhances transparency and rigor of trial reporting. We conducted an in-depth examination of randomized clinical trials (RCTs) published in The Journal of Arthroplasty (JOA) from 2010 to 2020 and their associated trial registries. MethodsWe examined all RCTs published in the JOA during the even years between 2010 and 2020. We determined the proportion of trials that were registered and prospectively registered as well as the extent of consistency between primary outcome characteristics in the trials vs the registries. Trial characteristics published between 2010 and 2014 were compared to trials published between 2016 and 2020. ResultsA total of 57 (33.7%) of 169 primary RCTs over the study period reported being registered and of these, 20 (11.8%) were prospectively registered. For the registered primary RCTs, 75% reported primary outcome findings that were inconsistent with the corresponding registry. Trial registration proportion substantially improved from 13.6% between 2010 and 2014 to 53% between 2016 and 2020 (z-test = −5.315, P < .001). ConclusionHigh proportions of retrospectively registered or unregistered trials and a very high proportion of inconsistencies in reporting of primary outcomes compared to the trial registries were found. These data argue for a well-developed strategy by JOA to enhance editorial policies, reviewer and editorial board member training and oversight, and improved arthroplasty researcher awareness to improve the current state of RCT reporting in JOA.