The revised CONSORT statement: honing the cutting edge of the randomized controlled trial.

A revision of the CONSORT (Consolidated Standards of Reporting Trials) statement is being published this week in major medical journals. 1 Although randomized controlled trials provide our best evidence of the relative efficacy of competing treatments, they are not without controversy. Sometimes debate can help further our understanding; however, debate that springs from confusion about what actually took place in a trial constitutes a diversion of intellectual resources that could be better spent elsewhere. Such debates can generate considerable heat to produce relatively little light. The revised CONSORT statement is designed to help minimize such confusion and promote clarity in reporting the methods and results of randomized controlled trials. Both the original CONSORT statement, which was published in 1995, 2 and the revised version 1 comprise a checklist and flow diagram intended to help ensure the clear reporting of key elements of parallel clinical trials. Several of the differences between the revised and original checklists are stylistic. Many result from the unbundling of compound items. For example, the original checklist included a rather ambitious item relating to a study's primary and secondary outcome measures as well as to the way the target sample size was projected. This item has been deconstructed into 2 separate items in the revision. The flow chart has also been modified. Its revisions introduce a clear demarcation between the different stages of a trial: enrolment, treatment assignment, follow-up and analysis. The changes serve to increase transparency and reduce lingering ambiguity as to who is or is not included in the analysis of a trial. An explanatory document designed to assist authors in using the revised statement is available on the CONSORT Web site. 3 In addition to providing annotated examples of the use of the statement, it contains a helpful glossary. The document should prove a useful adjunct for trial consumers as well as trial producers. Although the CONSORT statement was designed to improve the reporting of clinical trials, it can also play a role at an earlier stage of trialing. In their introduction to the revised CONSORT statement, David Moher and colleagues note that the report of a trial should indicate why the study was undertaken. 1 This objective is reflected in the second item in the checklist: scientific background and explanation of rationale. Although potentially complex, there is an element of the trial background that can be easily conveyed, and should be conveyed, not …