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.[2-4]

That lack of adequate reporting fuelled 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 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.[6-8] We introduce here the result of that process, CONSORT 2010.