Systematic Review: Adherence to Reporting Standards for Randomized Controlled Trials in Kidney Transplantation

Abstract

The objective of this study was to determine adherence to the 2010 Consolidated Standards of Reporting Trials (CONSORT) standards for reported randomized controlled trials (RCTs) assessing immunosuppressive medications in the kidney transplant population between 2007 and 2013. The study period was divided into two arms, 2007-2010 and 2010-2013. RCTs were extracted from 3 major databases, and adherence to CONSORT 2010 was evaluated using the CONSORT score. Of the 540 RCTs extracted, 110 were selected for the study, comprising 55 RCTs for each study period. The median CONSORT score was 17. Significant differences between the scores were detected for the periods 2007-2010 and 2010-2013 (p < 0.02). No difference in scores was detected when comparing the RCTs involving induction and maintenance therapy (H statistic = 171.5 and p = 2.8). Regression analysis revealed that the year of publication exhibited a significant relationship with the CONSORT score, but no relationship was observed between the year of publication and the number of authors, the impact factor of the journal or the country of publication. Despite recent improvements, significant underreporting of CONSORT items for randomization, allocation concealment, blinding and maintenance, changes of trial protocol, trial registration and accessibility of the full trial protocol was detected.