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Information content of stepped wedge designs with unequal cluster‐period sizes in linear mixed models: Informing incomplete designs
Statistics in Medicine ( IF 2 ) Pub Date : 2021-01-12 , DOI: 10.1002/sim.8867
Jessica Kasza 1 , Rhys Bowden 1 , Andrew B Forbes 1
Affiliation  

In practice, stepped wedge trials frequently include clusters of differing sizes. However, investigations into the theoretical aspects of stepped wedge designs have, until recently, typically assumed equal numbers of subjects in each cluster and in each period. The information content of the cluster‐period cells, clusters, and periods of stepped wedge designs has previously been investigated assuming equal cluster‐period sizes, and has shown that incomplete stepped wedge designs may be efficient alternatives to the full stepped wedge. How this changes when cluster‐period sizes are not equal is unknown, and we investigate this here. Working within the linear mixed model framework, we show that the information contributed by design components (clusters, sequences, and periods) does depend on the sizes of each cluster‐period. Using a particular trial that assessed the impact of an individual education intervention on log‐length of stay in rehabilitation units, we demonstrate how strongly the efficiency of incomplete designs depends on which cells are excluded: smaller incomplete designs may be more powerful than alternative incomplete designs that include a greater total number of participants. This also serves to demonstrate how the pattern of information content can be used to inform a set of incomplete designs to be considered as alternatives to the complete stepped wedge design. Our theoretical results for the information content can be extended to a broad class of longitudinal (ie, multiple period) cluster randomized trial designs.

中文翻译:

线性混合模型中簇周期大小不等的阶梯楔形设计的信息内容:告知不完全设计

在实践中,阶梯式楔形试验经常包括不同大小的集群。然而,直到最近,对阶梯楔形设计的理论方面的研究通常假设每个集群和每个时期的受试者数量相同。集群周期单元、集群和阶梯楔形设计周期的信息内容之前已经在假设集群周期大小相等的情况下进行了研究,并表明不完整阶梯楔形设计可能是完整阶梯楔形的有效替代方案。当集群周期大小不相等时,这将如何变化尚不清楚,我们在这里对此进行调查。在线性混合模型框架内工作,我们表明设计组件(集群、序列和周期)提供的信息确实取决于每个集群周期的大小。使用一项评估个体教育干预对康复单位住院时间的影响的特定试验,我们证明了不完整设计的效率取决于哪些细胞被排除在外:较小的不完整设计可能比替代的不完整设计更强大其中包括更多的参与者。这也说明了如何使用信息内容的模式来告知一组不完整的设计,以作为完整阶梯楔形设计的替代方案。我们对信息内容的理论结果可以扩展到广泛的纵向(即多期)整群随机试验设计。我们展示了不完整设计的效率在多大程度上取决于排除哪些细胞:较小的不完整设计可能比包含更多参与者总数的替代不完整设计更强大。这也说明了如何使用信息内容的模式来告知一组不完整的设计,以作为完整阶梯楔形设计的替代方案。我们对信息内容的理论结果可以扩展到广泛的纵向(即多期)整群随机试验设计。我们展示了不完整设计的效率在多大程度上取决于排除哪些细胞:较小的不完整设计可能比包含更多参与者总数的替代不完整设计更强大。这也说明了如何使用信息内容的模式来告知一组不完整的设计,以作为完整阶梯楔形设计的替代方案。我们对信息内容的理论结果可以扩展到广泛的纵向(即多期)整群随机试验设计。这也说明了如何使用信息内容的模式来告知一组不完整的设计,以作为完整阶梯楔形设计的替代方案。我们对信息内容的理论结果可以扩展到广泛的纵向(即多期)整群随机试验设计。这也说明了如何使用信息内容的模式来告知一组不完整的设计,以作为完整阶梯楔形设计的替代方案。我们对信息内容的理论结果可以扩展到广泛的纵向(即多期)整群随机试验设计。
更新日期:2021-03-09
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