Methodological study
Reporting guidelines for randomised trials – the CONSORT Statement
Doug Altman with David Moher (Ottawa, Canada), Ken Schulz (Chapel Hill, USA) and the CONSORT Group
Reports of randomised controlled trials (RCTs) are the “gold standard” by which healthcare professionals and others make decisions about treatment effectiveness. To assess the strengths and limitations of RCTs, readers need and deserve to know exactly how the trial was done and what was found.
The Consolidated Standards for Reporting of Trials (CONSORT) Group developed the CONSORT statement, an evidence-based approach to help improve the quality of reports of RCTs. Since its publication in 1996, the CONSORT Statement has been widely supported, has been translated into several languages, and has an Internet presence to facilitate awareness and dissemination. Recent studies suggest that the CONSORT Statement has improved the quality of reports of RCTs, but there is ample evidence that there remains much room for improvement.
Continuous monitoring of the biomedical literature allows CONSORT to be modified depending on the merits of maintaining or dropping current items and including new items. At their 1999 meeting members of the CONSORT group decided to produce a revised statement. The revised CONSORT statement of 2001 includes a 22 item checklist and a flow diagram. It was published simultaneously in three leading journals and subsequently in several others. In addition, a long explanatory paper provided a detailed rationale for all of the checklist items.
The primary aim of the CONSORT statement is to help authors improve the quality of reports of simple two group parallel RCTs. However, the basic philosophy underlying the development of the statement can be applied to any design. CONSORT can also be used by peer reviewers and editors to identify reports with inadequate description of trials and those with potentially biased results. Over the last few years extensions to other designs have been in preparation. So far only that relating to cluster randomised trials has been published but further extensions for crossover, cluster, factorial, and non-inferiority/equivalence trials are in preparation. In addition, extended recommendations for reporting harms have been published and implementations to specific areas of medical research are in progress.
All CONSORT documents are available on the web site.
Website: http://www.consort-statement.org
Publications: 4, 29, 69, 89, 96, 101, 139, 143, 160, 180, 189
