The CONSORT statement for cluster randomised trials

The CONSORT statement for cluster randomised trials
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DOI:
10.1016/s0025-7753(05)72206-5
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发表时间:
2005-01-01
期刊:
影响因子:
3.9
通讯作者:
Altman, Douglas G.
Altman, Douglas G.
中科院分区:
医学4区
文献类型:
--
作者:
Campbell, Marion K.;Elbourne, Diana R.;Altman, Douglas G.

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随着CONTORT声明的发表,现在人们越来越意识到需要充分报告随机对照试验的结果。CONSORT声明包括一份应在试验报告中解决的项目清单。最初的CONTORT声明是为了确保平行分组随机对照试验的适当报告,在这些试验中,个体参与者被分配到不同的干预组。然而,在分组随机试验中,参与者群体而不是个体被随机分配到研究组。分配参与者分组的过程引起了更多的报告考虑,并导致发布了专门针对分组随机试验的CONSORT声明的扩展。在这篇文章中,我们回顾了COSORT扩展到集群随机试验,概述了必须考虑的集群随机试验的特点。
With the publication of the CONSORT statement there is now increased awareness of the need to adequately report the findings of randomised controlled trials. The CONSORT statement includes a checklist of items that should be addressed in the trial report. The original CONSORT statement was developed to ensure the appropriate reporting of parallel group randomised controlled trials in which individual participants are allocated to different intervention groups. In cluster randomised trials, however, groups of participants, rather than individuals, are randomly allocated to study groups. The process of allocating groups of participants raises additional reporting considerations and led to the publication of an extension to the CONSORT statement specifically for cluster randomised trials. In this paper we review the CONSORT extension to cluster randomised trials, outlining the special features of the cluster randomised trial which must be considered.