Reporting of stepped wedge cluster randomised trials: extension of the CONSORT 2010 statement with explanation and elaboration.

Reporting of stepped wedge cluster randomised trials: extension of the CONSORT 2010 statement with explanation and elaboration.
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DOI:
10.1136/bmj.k1614
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发表时间:
2018-11-09
期刊:
BMJ (Clinical research ed.)
影响因子:
--
通讯作者:
Grimshaw JM
Grimshaw JM
中科院分区:
其他
文献类型:
--
作者:
Hemming K;Taljaard M;McKenzie JE;Hooper R;Copas A;Thompson JA;Dixon-Woods M;Aldcroft A;Doussau A;Grayling M;Kristunas C;Goldstein CE;Campbell MK;Girling A;Eldridge S;Campbell MJ;Lilford RJ;Weijer C;Forbes AB;Grimshaw JM

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本报告介绍了分级楔形分组随机试验(SW-CRT)的试验报告统一标准(CONSORT)扩展。SW-CRT涉及将群集随机分配到不同序列,这些序列规定了每个群集切换到干预条件的顺序(或时间)。制定该声明是为了考虑到这种日益使用的研究设计的独特特征。该指南是使用德尔菲调查和共识会议制定的;并参考了个体和群集随机试验的CONSORT声明。报告项目沿着说明和示例。我们包括一个词汇表,并探讨在其报告中需要特别考虑的SW-CRT的关键属性。
This report presents the Consolidated Standards of Reporting Trials (CONSORT) extension for the stepped wedge cluster randomised trial (SW-CRT). The SW-CRT involves randomisation of clusters to different sequences that dictate the order (or timing) at which each cluster will switch to the intervention condition. The statement was developed to allow for the unique characteristics of this increasingly used study design. The guideline was developed using a Delphi survey and consensus meeting; and is informed by the CONSORT statements for individual and cluster randomised trials. Reporting items along with explanations and examples are provided. We include a glossary of terms, and explore the key properties of the SW-CRT which require special consideration in their reporting.
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