Abstract

Poorly conducted randomised controlled trials and inadequate reporting are susceptible to different forms of bias, which can have a detrimental effect on the interpretation and application of clinical evidence. This study examines the effect of Consolidated Standards of Reporting Trials (CONSORT) statement on the quality of the reporting of randomised controlled trials by comparing those published before and after the advent of the CONSORT. A systematic review was performed using a MEDLINE search to find all randomised controlled trials published in JAMA and the Lancet in the years 1995, 1997 and 2002. For each trial, the quality of reporting of sample size calculation, trial period, randomisation, and blinding was assessed. There was a substantial increase in the proportion of trials reporting sample size calculation, event rates, randomisation, and blinding in the RCTs post-CONSORT. However, the improvement in the quality of those reporting appears to be slow. This increase in quantity in the post-CONSORT period may be due to reporting and publication bias, where authors are trying to comply with the CONSORT guidelines and increasingly reporting favourable results, while at the same time not clearly explaining their methodology clearly. Authors and journal editors should strictly adhere with the CONSORT guidelines to ensure transparent, unbiased, and complete reporting so that we can reap the maximum benefit from clinical trials.

Key words: Consolidated Standards of Reporting Trials (CONSORT), sample size, randomisation, reporting, bias.