The CONSORT Statement

Reviews of medical literature have highlighted problems in the way randomized controlled trials are reported. These problems range from failing to identify a study as a randomized trial to the omission of methodologies and critical data. Inadequate reporting of clinical trials can disguise intentional and nonintentional bias and present skewed results. Because randomized controlled trials are the type of study most commonly used to advance clinical practice, reporting results accurately is critical. In an effort to clarify the reporting of randomized controlled trials, a group of medical editors and scientists formed the Consolidated Standards of Reporting Trials (CONSORT) group.

 
The CONSORT group first published guidelines for reporting randomized controlled trials in 1996 and published updates in 2001 and 2010. The authors describe the CONSORT guidelines as the “minimum guidelines to avoid bias enabled by inaccurate reporting.”(1) The CONSORT guidelines aim to improve the quality of reporting, but they should also improve the quality of randomized trials themselves—using the CONSORT guidelines reveals problems with trial design to the author and should prompt changes in the design and execution of the trial before results are published.

 
The 2010 guidelines are published as a flow diagram and a 25-item checklist accompanied by in-depth explanations and examples of each item on the checklist. “Identification as a randomized trial in the title” and “statistical methods used to compare groups for primary and secondary outcomes” are two examples of guidelines covered in the checklist. The CONSORT group insists that the CONSORT guidelines are not restrictive and that authors should feel free to add more information to clarify and augment the reporting of their study.(2) Links to all the CONSORT publications are available at the CONSORT website.

 

1. Moher D, Hopewell S, Schulz KF, et al; CONSORT. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. Int J Surg. 2012;10(1):28-55. doi: 10.1016/j.ijsu.2011.10.001.
2. CONSORT. CONSORT Checklist. http://www.consort-statement.org/checklists/view/32-consort/66-title. Accessed June 1, 2015.

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