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Research Methods & Reporting

CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials

BMJ 2010; 340 doi: https://doi.org/10.1136/bmj.c332 (Published 24 March 2010) Cite this as: BMJ 2010;340:c332
  1. Kenneth F Schulz, distinguished scientist and vice president1,
  2. Douglas G Altman, professor2,
  3. David Moher, senior scientist3
  4. for the CONSORT Group
  1. 1Family Health International, Research Triangle Park, NC 27709, USA
  2. 2Centre for Statistics in Medicine, University of Oxford, Wolfson College, Oxford
  3. 3Ottawa Methods Centre, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Canada
  1. Correspondence to: K F Schulz kschulz{at}fhi.org
  • Accepted 9 December 2009

The CONSORT statement is used worldwide to improve the reporting of randomised controlled trials. Kenneth Schulz and colleagues describe the latest version, CONSORT 2010, which updates the reporting guideline based on new methodological evidence and accumulating experience

Introduction

Randomised controlled trials, when appropriately designed, conducted, and reported, represent the gold standard in evaluating healthcare interventions. However, randomised trials can yield biased results if they lack methodological rigour.1 To assess a trial accurately, readers of a published report need complete, clear, and transparent information on its methodology and findings. Unfortunately, attempted assessments frequently fail because authors of many trial reports neglect to provide lucid and complete descriptions of that critical information.2 3 4

That lack of adequate reporting fuelled the development of the original CONSORT (Consolidated Standards of Reporting Trials) statement in 19965 and its revision five years later.6 7 8 While those statements improved the reporting quality for some randomised controlled trials,9 10 many trial reports still remain inadequate.2 Furthermore, new methodological evidence and additional experience has accumulated since the last revision in 2001. Consequently, we organised a CONSORT Group meeting to update the 2001 statement.6 7 8 We introduce here the result of that process, CONSORT 2010.

Intent of CONSORT 2010

The CONSORT 2010 Statement is this paper including the 25 item checklist in the table and the flow diagram. It provides guidance for reporting all randomised controlled trials, but focuses on the most common design type—individually randomised, two group, parallel trials. Other trial designs, such as cluster randomised trials and non-inferiority trials, require varying amounts of additional information. CONSORT extensions for these designs,11 12 and other CONSORT products, can be found through the CONSORT website (www.consort-statement.org). Along with the CONSORT statement, we have updated the explanation and elaboration article,13 which explains …

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