Updated Guidelines for Reporting Parallel Group Randomized Trials

R controlled trials, when appropriately designed, conducted, and reported, represent the gold standard in evaluating healthcare interventions. However, randomized 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 19965 and its revision five years later.6–8 While those statements improved the reporting quality for some randomized From Family Health International, Research Triangle Park, North Carolina; the Centre for Statistics in Medicine, University of Oxford, Wolfson College, Oxford, United Kingdom; and the Ottawa Methods Centre, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Ontario, Canada.