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

Randomized controlled trials (RCTs), when appropriately designed, conducted, and reported, represent the gold standard in evaluating health care interventions. That lofty position in the medical research hierarchy does not mean, however, that readers should uncritically accept the results of all RCTs. Indeed, randomized trials can yield biased results if they lack methodological rigor. (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. (2-4) That lack of adequate reporting fueled the development of the original CONSORT (Consolidated Standards of Reporting Trials) Statement in 1996 (5) and its revision five years later. (6-8) While those Statements positively impacted reporting quality for some RCTs, (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 organized a CONSORT Group meeting to update the 2001 Statement. (6-8) We introduce here the result of that process, CONSORT 2010.