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哪种类型的群组随机对照试验,在什么环境下进行?

What type of cluster randomized trial for which setting?

机构信息

Institute of Applied Health Research, University of Birmingham, Birmingham, UK.

MRC Clinical Trials Unit at University College London, London, UK.

出版信息

J Epidemiol Popul Health. 2024 Feb;72(1):202195. doi: 10.1016/j.jeph.2024.202195. Epub 2024 Feb 20.

Abstract

The cluster randomized trial allows a randomized evaluation when it is either not possible to randomize the individual or randomizing individuals would put the trial at high risk of contamination across treatment arms. There are many variations of the cluster randomized design, including the parallel design with or without baseline measures, the cluster randomized cross-over design, the stepped-wedge cluster randomized design, and more recently-developed variants such as the batched stepped-wedge design and the staircase design. Once it has been clearly established that there is a need for cluster randomization, one ever important question is which form the cluster design should take. If a design in which time is split into multiple trial periods is to be adopted (e.g. as in a stepped-wedge), researchers must decide whether the same participants should be measured in multiple trial periods (cohort sampling); or if different participants should be measured in each period (continual recruitment or cross-sectional sampling). Here we outline the different possible options and weigh up the pros and cons of the different design choices, which revolve around statistical efficiency, study logistics and the assumptions required.

摘要

当无法对个体进行随机分组或对个体进行随机分组会使试验在治疗组之间面临高度污染风险时,整群随机试验允许进行随机分组评估。整群随机设计有许多变体,包括具有或不具有基线测量的平行设计、整群随机交叉设计、阶梯式整群随机设计以及最近开发的变体,如分批阶梯式设计和阶梯式设计。一旦明确需要进行整群随机分组,就会出现一个非常重要的问题,即应该采用哪种形式的整群设计。如果要采用时间分为多个试验期的设计(例如,阶梯式),研究人员必须决定是否应在多个试验期对相同的参与者进行测量(队列抽样);还是应在每个时期对不同的参与者进行测量(连续招募或横断面抽样)。在这里,我们概述了不同的可能选择,并权衡了不同设计选择的优缺点,这些选择围绕着统计效率、研究后勤和所需的假设。

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