Ottawa Methods Centre, Ottawa Hospital Research Institute, Ottawa Hospital, Ottawa, Ontario, Canada.
J Clin Epidemiol. 2010 Aug;63(8):e1-37. doi: 10.1016/j.jclinepi.2010.03.004. Epub 2010 Mar 25.
Overwhelming evidence shows the quality of reporting of randomised controlled trials (RCTs) is not optimal. Without transparent reporting, readers cannot judge the reliability and validity of trial findings nor extract information for systematic reviews. Recent methodological analyses indicate that inadequate reporting and design are associated with biased estimates of treatment effects. Such systematic error is seriously damaging to RCTs, which are considered the gold standard for evaluating interventions because of their ability to minimise or avoid bias. A group of scientists and editors developed the CONSORT (Consolidated Standards of Reporting Trials) statement to improve the quality of reporting of RCTs. It was first published in 1996 and updated in 2001. The statement consists of a checklist and flow diagram that authors can use for reporting an RCT. Many leading medical journals and major international editorial groups have endorsed the CONSORT statement. The statement facilitates critical appraisal and interpretation of RCTs. During the 2001 CONSORT revision, it became clear that explanation and elaboration of the principles underlying the CONSORT statement would help investigators and others to write or appraise trial reports. A CONSORT explanation and elaboration article was published in 2001 alongside the 2001 version of the CONSORT statement. After an expert meeting in January 2007, the CONSORT statement has been further revised and is published as the CONSORT 2010 Statement. This update improves the wording and clarity of the previous checklist and incorporates recommendations related to topics that have only recently received recognition, such as selective outcome reporting bias. This explanatory and elaboration document-intended to enhance the use, understanding, and dissemination of the CONSORT statement-has also been extensively revised. It presents the meaning and rationale for each new and updated checklist item providing examples of good reporting and, where possible, references to relevant empirical studies. Several examples of flow diagrams are included. The CONSORT 2010 Statement, this revised explanatory and elaboration document, and the associated website (www.consort-statement.org) should be helpful resources to improve reporting of randomised trials.
大量证据表明，随机对照试验（RCT）的报告质量并不理想。如果报告不透明，读者就无法判断试验结果的可靠性和有效性，也无法为系统评价提取信息。最近的方法学分析表明，报告和设计不充分与治疗效果的有偏估计有关。这种系统误差对 RCT 造成了严重损害，由于 RCT 能够最小化或避免偏倚，因此被认为是评估干预措施的金标准。一组科学家和编辑制定了 CONSORT（报告临床试验的统一标准）声明，以提高 RCT 的报告质量。该声明于 1996 年首次发表，并于 2001 年进行了更新。该声明由一个清单和流程图组成，作者可以使用该清单和流程图报告 RCT。许多领先的医学期刊和主要的国际编辑团体都认可了 CONSORT 声明。该声明有助于对 RCT 进行批判性评估和解释。在 2001 年 CONSORT 修订期间，很明显，对 CONSORT 声明背后原则的解释和阐述将有助于调查人员和其他人撰写或评估试验报告。2001 年同时发布了 CONSORT 解释和阐述文章以及 2001 年版的 CONSORT 声明。在 2007 年 1 月的一次专家会议之后，CONSORT 声明进一步修订并发布为 CONSORT 2010 声明。本次更新改进了之前清单的措辞和清晰度，并纳入了与最近才得到认可的主题相关的建议，例如选择性结果报告偏倚。这份解释和阐述文件旨在增强 CONSORT 声明的使用、理解和传播，也进行了广泛修订。它阐述了每个新的和更新的清单项目的含义和基本原理，提供了良好报告的示例，并在可能的情况下引用了相关的实证研究。还包括几个流程图示例。CONSORT 2010 声明、这份修订的解释和阐述文件以及相关网站（www.consort-statement.org）应该是改进随机试验报告的有用资源。
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