Quality of reports on randomized controlled trials published in Iranian journals: application of the new version of consolidated standards of reporting trials (CONSORT).

Abstract

The Consolidated Standards for Reporting of Trials (CONSORT) statement is a device to standardize reporting and improve the quality of controlled trials. The aim of this study is to determine the quality of controlled clinical trial reports by national peer-reviewed journals in Iran. In a cross-sectional study, we evaluated clinical trial reports by national peer-reviewed Iranian journals between 2008 and 2010 by CONSORT2010. The sample was selected from Iran Medex. The proportion of adherence to each item of the CONSORT checklist was assessed for each clinical trial. The reliability of evaluation by reviewers was calculated by Pearson correlation coefficient, and was determined to be 0.73 - 0.89, with a significance level of P < 0.01 between reviewers. A total of 509 articles published in 80 peer-reviewed national journals were evaluated. The average adherence of evaluated randomized controlled trials (RCTs) to the 37 items of the CONSORT statement was 43.8%. The mean CONSORT score significantly differed across each year of publication. None of the articles mentioned the location where the full trial protocol could be accessed. The quality of reporting RCTs published in national peer-reviewed journals needs significant improvement as the majority did not adhere to CONSORT guidelines. It is necessary for the editors of Iranian journals to consider CONSORT criteria for evaluation of all future RCTs.