CONSORT 2010 Statement: updated guidelines for reporting parallel group randomized trials.
CONSORT 2010 Statement: updated guidelines for reporting parallel group randomized trials.
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DOI：
10.1016/j.jclinepi.2010.03.004
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发表时间：
2010-01-01
期刊：
影响因子：
--
通讯作者：
Moher, David
中科院分区：
文献类型：
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作者：
Schulz, Kenneth F;Altman, Douglas G;Moher, David
大量证据表明，随机对照试验（RCT）的报告质量并不理想。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，也无法提取信息用于系统综述。近期的方法学分析表明，报告不充分和设计不合理与治疗效果的偏倚估计有关。这种系统性错误对RCT损害严重，由于RCT能够最小化或避免偏倚，它被视为评估干预措施的金标准。一组科学家和编辑制定了CONSORT（试验报告统一标准）声明，以提高RCT的报告质量。它于1996年首次发布，并于2001年更新。该声明包括一个清单和流程图，作者可用于报告一项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进行批判性评价和解读。在2001年CONSORT修订期间，很明显，对CONSORT声明所依据的原则进行解释和阐述将有助于研究者和其他人撰写或评价试验报告。2001年，一篇CONSORT解释和阐述文章与2001年版的CONSORT声明一同发表。2007年1月一次专家会议之后，CONSORT声明进一步修订，并作为CONSORT 2010声明发布。此次更新改进了之前清单的措辞和清晰度，并纳入了与一些近期才受到关注的主题相关的建议，比如选择性结果报告偏倚。这份旨在加强CONSORT声明的使用、理解和传播的解释和阐述文件也进行了大量修订。它阐述了每个新增和更新的清单条目的含义和原理，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。文中还包含了几个流程图的示例。CONSORT 2010声明、这份修订后的解释和阐述文件以及相关网站（www.consort - statement.org）应该是有助于提高随机试验报告质量的资源。
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.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.