Consolidated Standards of Reporting Trials

CONSORT (Consolidated Standards Of Reporting Trials) encompasses various initiatives developed by the CONSORT Group to alleviate the problems arising from inadequate reporting of randomized controlled trials.

The main product of the CONSORT Group is the CONSORT Statement, which is an evidence-based, minimum set of recommendations for reporting randomized trials. It offers a standard way for authors to prepare reports of trial findings, facilitating their complete and transparent reporting, reducing the influence of bias on their results, and aiding their critical appraisal and interpretation.

The most recent version of the Statement—the CONSORT 2010 Statement—consists of a 25-item checklist and a participant flow diagram, along with some brief descriptive text. The checklist items focus on reporting how the trial was designed, analyzed, and interpreted; the flow diagram displays the progress of all participants through the trial. The Statement has been translated into several languages.

The CONSORT ‘Explanation and Elaboration’ document explains and illustrates the principles underlying the CONSORT Statement. It is strongly recommended that it is used in conjunction with the CONSORT Statement.

Considered an evolving document, the CONSORT Statement is subject to periodic changes as new evidence emerges; the most recent update was published in March 2010. The current definitive version of the CONSORT Statement and up-to-date information on extensions are placed on the CONSORT website.

The main CONSORT Statement is based on the 'standard' two-group parallel design. Extensions of the CONSORT Statement have been developed to give additional guidance for randomized trials with specific designs (e.g., cluster randomized trials, noninferiority and equivalence trials, pragmatic trials,), data (e.g., harms,abstracts), and interventions (e.g., herbals, non-pharmacologic treatments,acupuncture ). This list is, by no means, exhaustive, and work is ongoing.

In 1993, 30 experts - medical journal editors, clinical trialists, epidemiologists, and methodologists - met in Ottawa, Canada to discuss ways of improving the reporting of randomized trials. This meeting resulted in the Standardized Reporting of Trials (SORT) statement, a 32-item checklist and flow diagram in which investigators were encouraged to report on how randomized trials were conducted.

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