Timeline cluster: a graphical tool to identify risk of bias in cluster randomised trials
Timeline cluster: a graphical tool to identify risk of bias in cluster randomised trials
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DOI：
10.1136/bmj.i4291
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发表时间：
2016-08-16
影响因子：
105.7
通讯作者：
Giraudeau, Bruno
中科院分区：
文献类型：
--
作者：
Caille, Agnes;Kerry, Sally;Giraudeau, Bruno
与医疗保健的政策、实践和组织相关的干预措施的有效性的有力证据通常来自于良好的整群随机试验。然而，这些试验容易出现招募偏倚，这取决于参与者是否在随机分组之前招募，以及招募人员是否对分配状态不知情。在大多数情况下，受试者和试验工作人员不能对干预措施设盲，这可能导致性能和检测偏倚。不幸的是，群集试验报告通常没有提供试验过程和设盲时间的明确描述，并且这些方面没有被当前的报告工具所涵盖。本文提出了一个图形工具，描绘的时间顺序的步骤和盲态的整群随机试验。该工具可能有助于在方案和报告撰写阶段澄清过程，并帮助识别集群随机试验中的潜在偏倚。
Robust evidence of the effectiveness of interventions relating to policy, practice, and organisation of healthcare often comes from well conducted cluster randomised trials. Such trials are, however, prone to recruitment bias depending on whether participants are recruited before the randomisation of clusters and whether the recruiter is blinded to the allocation status. In most cases, participants and trial staff cannot be blinded to the intervention, which might lead to performance and detection bias. Unfortunately, cluster trial reports often do not provide a clear description of the timing of trial processes and blinding, and these aspects are not covered by current reporting tools. This article proposes a graphical tool depicting the time sequence of steps and blinding status in cluster randomised trials. The tool might be helpful at both the protocol and the report writing stages to clarify the process and to help identify potential bias in cluster randomised trials.