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.ijsu.2011.10.001
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发表时间：
2012-01-01
影响因子：
15.3
通讯作者：
Altman, Douglas G.
中科院分区：
文献类型：
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作者：
Moher, David;Hopewell, Sally;Altman, Douglas G.
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，也无法提取系统评价的信息。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。这样的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倚。一组科学家和编辑制定了CONSORT（报告试验的统一标准）声明，以提高随机对照试验的报告质量。它于1996年首次出版，并于2001年更新。该声明包括一个检查表和流程图，作者可以使用它们来报告RCT。许多领先的医学期刊和主要的国际编辑团体都支持CONSORT声明。在2001年CONSORT修订期间，CONSORT声明的基本原则的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年发表了一篇CONSORT的解释和阐述文章，与2001年版本的CONSORT声明一起发表。在2007年1月的一次专家会议之后，CONSORT声明得到了进一步修订，并作为CONSORT 2010年声明发表。此更新改进了以前的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，例如选择性结局报告偏倚。此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。它介绍了清单中每一新的和更新的项目的含义和理由，提供了良好报告的实例，并在可能的情况下提供了相关经验研究的参考。CONSORT 2010声明，这份修订的解释性和详细说明文件，以及相关网站（www.consort-statement.org）应该是改善随机试验报告的有用资源。(C)2010 Moher等人，由Elsevier Ltd代表Surgical Associates Ltd转载。这是一篇开放获取的文章，根据知识共享署名许可证（http：//creativecommons.org/licenses/by/2.0）的条款分发，允许在任何媒体上不受限制地使用、分发和复制，前提是原作者和来源都是可信的。
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. (C) 2010 Moher et al, reprinted by Elsevier Ltd on behalf of Surgical Associates Ltd. This is an open-access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0) which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.