Completeness of Reporting Is Suboptimal in Randomized Controlled Trials Published in Rehabilitation Journals, With Trials With Low Risk of Bias Displaying Better Reporting: A Meta-research Study.

ABSTRACT

OBJECTIVE: Primary To evaluate the completeness of reporting of randomized controlled trials (RCTs) published in rehabilitation journals through the evaluation of the adherence to the Consolidated Standards of Reporting Trials (CONSORT) checklist and investigate the relationship between reporting and risk of bias (ROB). Secondary To study the association between completeness of reporting and the characteristics of studies and journals. DATA SOURCES A random sample of 200 RCTs published between 2011 and 2020 in 68 rehabilitation journals indexed under the "rehabilitation" category in the InCites Journal Citation Report. STUDY SELECTION One reviewer evaluated the completeness of reporting operationalized as the adherence to the CONSORT checklist. Two independent reviewers evaluated the ROB using the Cochrane risk-of-bias 2.0 tool. DATA EXTRACTION Overall adherence and adherence to each CONSORT section were calculated. Regression analyses investigated the association between completeness of reporting, ROB, and other characteristics (quartile range, publication modalities, study protocol registration). DATA SYNTHESIS: The mean overall CONSORT adherence across studies was 65%. Studies with high ROB have less adherence than those with low ROB (-5.5%; CI, -10.9 to 0.0). There was a 10.2% (% CI, 6.2-14.3) increase in adherence if the RCT protocol was registered. Studies published in first quartile journals displayed an overall adherence of 11.7% (% CI 17.1-6.4) higher than those published in the fourth quartile. CONCLUSIONS: Reporting completeness is still suboptimal and is associated with ROB, journal impact ranking, and registration of the study protocol. Trial authors should improve adherence to the CONSORT guideline, and journal editors should adopt new strategies to improve the reporting.