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CONSORT Statement updated

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26 May 2010

In 1996 and 2001, the CONSORT Group published recommendations on the reporting of randomised controlled trials. These have now been updated as CONSORT 2010. The new version strengthens the reporting of results of such clinical trials. For example, improvements have been made to sections on concealed allocation and blinding and there is a new requirement for trials to be registered before starting. The aim of the guidelines is to improve the quality of trial reporting, aid critical appraisal of the results and facilitate assessment of the quality of healthcare interventions.

It is recommended that authors use the CONSORT checklist, flow diagram and explanation and elaboration document to facilitate completeness and transparency in reporting trial data. This will aid appraisal of published trial reports. Journal editors could incorporate the checklist into the peer review process in order to encourage adherence and improve the quality of published trials.

What is the background to this?
Full and transparent reporting of trial results is necessary for assessing the quality of interventions. CONSORT (Consolidated Standards of Reporting Trials) was first published in 1996 and revised in 2001 in order to address inadequacies in clinical trial reporting.

CONSORT guidance is designed to aid authors in writing randomised controlled trial (RCT) reports, and helps with the review of manuscripts for publication and critical appraisal by readers. The statement does not include recommendations for the design or conduct of RCTs, nor is it intended as an instrument to evaluate the quality of a trial.

A recent study has shown that the quality of published trial reports improved with the publication of the previous CONSORT update in 2001, but that there was still room for improvement in some areas. For example, there was an increase in the proportion of trial papers that included details of the primary outcome, how the sample size had been calculated and how concealed allocation had been achieved. However, there was no difference in the proportion of trials that provided specific details on who was blinded to treatment allocation. Reporting of trial registration details was rare.

The CONSORT 2010 version replaces previous ones and is intended to incorporate experience gained since publication of the 2001 statement, including addressing the deficiencies still found in trial reporting.

What does this Statement say?
Consort 2010 focuses mainly on the two group, parallel RCT, which accounts for over half the trials in the literature. Extensions of the CONSORT Statement covering RCTs with alternative designs (e.g. non-inferiority) are available.

The CONSORT 2010 Statement consists of the published paper, a 25 item checklist of information to include when reporting a randomised trial and a flow diagram depicting the passage of participants through the different stages of an RCT. The whole represents the minimum criteria that a good quality trial would be expected to report.

The principal update concerns increasing the specificity of appraisal. Some wording has been simplified. Improvements have been made to sections on blinding and concealed allocation. New requirements are registration with a clinical trials register before the trial starts; details of where the protocol can be accessed from (if possible); and where funding comes from. A full list of specific changes is provided in the updated statement. CONSORT 2010 has been published in nine leading journals including the BMJ, The Lancet, Annals of Internal Medicine and PLoS Medicine.

We have previously blogged about the CONSORT guidance for reporting conference/ journal abstracts. An overview of study designs and critical appraisal can be found on the Information Mastery skills section of NPC.

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