CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials
CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials
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DOI：
10.1016/j.jclinepi.2010.02.005
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发表时间：
2010-03-23
影响因子：
105.7
通讯作者：
Altman, Douglas G.
中科院分区：
文献类型：
--
作者：
Moher, David;Hopewell, Sally;Altman, Douglas G.
大量证据表明，随机对照试验（RCTs）的报告质量并非最佳。没有透明的报告，读者无法判断试验结果的可靠性和有效性，也无法提取信息进行系统评价。最近的方法学分析表明，不充分的报告和设计与治疗效果的偏倚估计有关。这种系统性错误严重损害了随机对照试验，随机对照试验被认为是评估干预措施的黄金标准，因为它们能够最大限度地减少或避免偏差。一组科学家和编辑制定了CONSORT（试验报告综合标准）声明，以提高随机对照试验报告的质量。它于1996年首次出版，并于2001年更新。该声明由一个检查表和流程图组成，作者可以使用它们来报告RCT。许多主要的医学期刊和主要的国际编辑团体都赞同CONSORT声明。该声明有助于对随机对照试验进行批判性评价和解释。在2001年CONSORT修订期间，很明显，解释和阐述CONSORT声明的基本原则将有助于调查人员和其他人撰写或评估试验报告。2001年发表了一篇CONSORT解释和阐述文章，同时发表了2001年版本的CONSORT声明。在2007年1月的一次专家会议之后，对CONSORT声明进行了进一步修订，并发布为CONSORT 2010声明。此次更新改进了以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。这份解释性和详细说明文件——旨在加强CONSORT声明的使用、理解和传播——也进行了广泛修订。它介绍了每个新的和更新的清单项目的含义和基本原理，提供了良好报告的例子，并在可能的情况下引用了相关的实证研究。包括几个流程图的例子。CONSORT 2010声明、修订后的解释性和详细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。
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.