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Randomization by Cluster, But Analysis by Individual Without Accommodating Clustering in the Analysis Is Incorrect: Comment.
Annals of Behavioral Medicine ( IF 4.871 ) Pub Date : 2020-01-24 , DOI: 10.1093/abm/kaz065
Carmen D Tekwe 1 , David B Allison 1
Affiliation  

We recently read the article by Morgan et al. addressing the important topic of physical activity and obesity among girls [1]. The article focused on testing a novel program designed to increase physical activity levels among fathers/male guardians and their daughters. The study design involved a cluster randomized controlled trial involving 115 fathers and 153 daughters where family units were randomized into either the Dads And Daughters Exercising and Empowered (DADEE) intervention group or a wait-list control group. The primary outcome of interest, physical activity levels among fathers and daughters, was assessed at baseline, 2 months post-intervention, and also at 9 months post-intervention. Thus, clusters of families were randomized into their respective intervention groups while longitudinal data were collected on all study participants. Intention-to-treat mixed effects models were used by the authors to determine the intervention effects and according to the Morgan et al., paper was done without taking the clustering into account. This would be an incorrect approach to analyze cluster randomized trials. We therefore have contacted the authors, alerted them to the issue, and advised that different analyses were needed than those described in the published article.

中文翻译:

通过聚类随机化,但是在分析中不包含聚类的个体分析是不正确的:评论。

我们最近阅读了Morgan等人的文章。解决女孩体育锻炼和肥胖的重要课题[1]。本文重点测试了旨在提高父亲/男性监护人及其女儿之间的体育锻炼水平的新颖程序。该研究设计涉及一项包括115名父亲和153名女儿的整群随机对照试验,该试验将家庭单位随机分为“爸爸和女儿锻炼和赋权”(DADEE)干预组或候补对照组。在基线,干预后2个月以及干预后9个月评估了主要的关注结局,即父母之间的体育锻炼水平。因此,将家庭集群随机分为各自的干预组,同时收集所有研究参与者的纵向数据。作者使用意向治疗混合效应模型来确定干预效果,根据Morgan等人的观点,论文并未考虑聚类。这是分析聚类随机试验的错误方法。因此,我们已经与作者联系,提醒他们注意该问题,并建议与发表的文章中所述的分析方法不同。
更新日期:2020-04-17
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