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Type I error control for cluster randomized trials under varying small sample structures

机译:不同小型样本结构下的集群随机试验的I型错误控制

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摘要

In cluster-randomized trials (CRTs), also called group randomized trials, subjects are organized in groups. These groups, rather than the subjects directly, are randomized to the trial interventions [1]. In these studies, outcomes within a cluster – for example, patients within hospitals or students within classrooms – are almost certainly correlated with one another. This clustering complicates data analysis because the common regression assumption that observations are independent is violated. When the response variable of interest is continuous, linear mixed models (LMMs), which require that observations are independent only after conditioning on cluster membership, are a common approach to the data analysis. CRTs are a widely used experimental design (see for example [2–4]), and LMMs are an attractive option for data analysis. Some reasons for this attractiveness are that LMMs are robust to certain missing data mechanisms and can flexibly accommodate nested levels of clustering and/or varying cluster sizes [5].
机译:在簇随机试验(CRT)中,也称为组随机试验,受试者以群体组织。这些群体,而不是直接受试者,随机分为试验干预[1]。在这些研究中,集群内的结果 - 例如,医院内的患者或教室内的学生 - 几乎肯定会相互关联。这种聚类使数据分析复杂化,因为违反了观察的常见回归假设是违反的。当感兴趣的响应变量是连续的,线性混合模型(LMMS),这些模型(LMMS)只有在集群成员资格上的调理后才能独立于数据分析的常见方法。 CRT是一种广泛使用的实验设计(参见例如[2-4]),LMMS是数据分析的有吸引力的选择。这种吸引力的一些原因是LMMS对某些缺失的数据机制具有强大的稳健性,并且可以灵活地容纳嵌套级别的聚类和/或不同群集大小[5]。

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