Humans ; Publishing ; standards ; Quality Control ; Randomized Controlled Trials as Topic ; standards ; Reproducibility of Results ; Research Design ; standards

要正确理解随机对照试验(randomized controlled trial,RCT)的结果,读者必须了解其设计方案、实施过程、分析方法和结果解释。为达此目的,要求作者必须完整清晰地将这些内容表述出来。虽然经过数十年的教育,RCT的报告方法仍然需要改进。一些研究人员和编辑为此编写了CONSORT(Consolidated Standards of RePorting Trials,临床试验报告的统一标准)声明第一版,采用清单和流程图的方式帮助作者提高报告质量。本文根据读者对第一版的反馈对CONSORT声明进行了修改,并补充了新的证据。清单条目分为题目、、引言、方法、结果和评论共6个部分。修订版清单包括了22项条目,均为经验证据证明如不报告就会导致疗效估计偏倚的信息或作以判断结果可靠性和相关性的基本信息,配以流程图来描述受试者参与RCT的过程。修订版流程图描述了试验的4个步骤(包括登记、干预的分配、随访和分析),并明确注明了原始数据分析中各干预组人数。读者可通过人数判断作者是否进行了意向性分析(ITT)。总之,CONSORT声明旨在改进RCT的报告质量,方便读者了解研究实施情况并判断其结果的真实性。

No abstract available.

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