Epidemiol Health.  2014;36:e2014029. 10.4178/epih/e2014029.

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

• Lee JS
• Ahn S
• Lee KH
• Kim JH
• Schulz KF
• Altman DG
• Moher D

• KMID: 2380573
• DOI: http://doi.org/10.4178/epih/e2014029

Abstract

The Consolidated Standards of Reporting Trials (CONSORT) statement is used worldwide to improve the reporting of randomized, controlled trials. Schulz and colleagues describe the latest version, CONSORT 2010, which updates the reporting guideline based on new methodological evidence and accumulating experience. Randomized, controlled trials, when appropriately designed, conducted, and reported, represent the gold standard in evaluating health care interventions. However, randomized trials can yield biased results if they lack methodological rigor. 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. That lack of adequate reporting fueled the development of the original CONSORT statement in 1996 and its revision 5 years later. While those statements improved the reporting quality for some randomized, controlled trials, many trial reports still remain inadequate. Furthermore, new methodological evidence and additional experience has accumulated since the last revision in 2001. Consequently, we organized a CONSORT Group meeting to update the 2001 statement. We introduce here the result of that process, CONSORT 2010.

Keyword

Randomized controlled trials; Research design; Guideline

MeSH Terms

Bias (Epidemiology)
Delivery of Health Care
Group Processes
Research Design