The CONSORT 2010 statement – a “service history” for clinical trials

The CONSORT 2010 statement was co-published today by eight journals, including the BioMed Central titles Trials and BMC Medicine. Like the original statement published in 1996, the revised guidelines are intended to improve the reporting of randomized controlled trials by providing a checklist of essential items for use by authors, reviewers and editors. The latest revision draws on new evidence and experience gained since the last update in 2001.

CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials
Kenneth F Schulz, Douglas G Altman, David Moher, Consort Group
Trials 2010, 11:32 (24 March 2010)
[Abstract] [Provisional PDF]

In a commentary published today in Trials, Hywel Williams identifies the key additions to the latest version of the CONSORT checklist – a "service history" for clinical trials. Guidelines on transparent reporting of amendments, detailed descriptions of interventions to allow replication and improved reporting of allocation concealment will be welcomed by readers. Perhaps most important, however, is the focus on selective reporting of outcomes, a practice Williams describes simply as "distorting the scientific record".

CONSORT is not the only initiative aimed at improving the reporting of clinical trials – as important are prospective trial registration and protocol publication. The revised checklist requires details of both in published trial reports, providing readers with the necessary tools to establish whether trialists have done what they originally set out to do.

The revised statement alone will not improve reporting of randomized controlled trials – to be effective, the CONSORT statement must be used in practice, which will require commitments from authors, editors and peer reviewers.



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