It has long been recognized that sample size calculations for cluster randomized trials require consideration of the correlation between multiple observations within the same cluster. When measurements are taken at anything other than a single point in time, these correlations depend not only on the cluster but also on the time separation between measurements and additionally, on whether different participants (cross-sectional designs) or the same participants (cohort designs) are repeatedly measured. This is particularly relevant in trials with multiple periods of measurement, such as the cluster cross-over and stepped-wedge designs, but also to some degree in parallel designs. Several papers describing sample size methodology for these designs have been published, but this methodology might not be accessible to all researchers. In this article we provide a tutorial on sample size calculation for cluster randomized designs with particular emphasis on designs with multiple periods of measurement and provide a web-based tool, the Shiny CRT Calculator, to allow researchers to easily conduct these sample size calculations. We consider both cross-sectional and cohort designs and allow for a variety of assumed within-cluster correlation structures. We consider cluster heterogeneity in treatment effects (for designs where treatment is crossed with cluster), as well as individually randomized group-treatment trials with differential clustering between arms, for example designs where clustering arises from interventions being delivered in groups. The calculator will compute power or precision, as a function of cluster size or number of clusters, for a wide variety of designs and correlation structures. We illustrate the methodology and the flexibility of the Shiny CRT Calculator using a range of examples.

译文

长期以来,人们已经认识到,集群随机试验的样本量计算需要考虑同一集群内多个观察值之间的相关性。当在单个时间点以外的任何地方进行测量时,这些相关性不仅取决于聚类,还取决于测量之间的时间间隔,此外还取决于不同参与者 (横截面设计) 还是相同参与者 (队列设计) 重复测量。这在具有多个测量周期的试验中尤其重要,例如群集交叉和阶梯状楔形设计,但在某种程度上在并行设计中也很重要。已经发表了几篇描述这些设计的样本量方法的论文,但是并非所有研究人员都可以使用这种方法。在本文中,我们提供了一个关于集群随机设计的样本大小计算的教程,特别强调了具有多个测量周期的设计,并提供了一个基于网络的工具,即闪亮的CRT计算器,以使研究人员能够轻松地进行这些样本大小计算。我们同时考虑横截面设计和队列设计,并允许各种假定的簇内相关结构。我们考虑了治疗效果中的聚类异质性 (针对治疗与聚类交叉的设计),以及单独的随机分组治疗试验,其中手臂之间存在差异聚类,例如,聚类源于分组干预的设计。计算器将计算功率或精度,作为集群大小或集群数量的函数,用于各种设计和相关结构。我们使用一系列示例说明了Shiny CRT计算器的方法和灵活性。

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