CONSORT 2010 Statement

作者：Kenneth F. Schulz, Douglas G. Altman, David Moher · 发表于：Obstetrics and Gynecology · 年份：2010 · DOI：10.1097/aog.0b013e3181d9d421 · 被引用次数：532 · 研究领域：Meta-analysis and systematic reviews、Health Systems, Economic Evaluations, Quality of Life、Clinical practice guidelines implementation

Randomized 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 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 organized a CONSORT Group meeting to update the 2001 statement.6–8 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 randomized controlled trials, but focuses on the most common design type—individually randomized, two group, parallel trials. Other trial designs, such as cluster randomized trials and no...