Journal
JOURNAL OF CLINICAL EPIDEMIOLOGY
Volume 65, Issue 11, Pages 1212-1218Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.jclinepi.2012.06.002
Keywords
Cluster randomized trials; Sample size; Power; Efficient design; Intraclass correlation; Varying cluster sizes
Funding
- VSNU
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Objective: Simple guidelines for calculating efficient sample sizes in cluster randomized trials with unknown intraclass correlation (ICC) and varying cluster sizes. Methods: A simple equation is given for the optimal number of clusters and sample size per cluster. Here, optimal means maximizing power for a given budget or minimizing total cost for a given power. The problems of cluster size variation and specification of the ICC of the outcome are solved in a simple yet efficient way. Results: The optimal number of clusters goes up, and the optimal sample size per cluster goes down as the ICC goes up or as the cluster-to-person cost ratio goes down. The available budget, desired power, and effect size only affect the number of clusters and not the sample size per cluster, which is between 7 and 70 for a wide range of cost ratios and ICCs. Power loss because of cluster size variation is compensated by sampling 10% more clusters. The optimal design for the ICC halfway the range of realistic ICC values is a good choice for the first stage of a two-stage design. The second stage is needed only if the first stage shows the ICC to be higher than assumed. Conclusion: Efficient sample sizes for cluster randomized trials are easily computed, provided the cost per cluster and cost per person are specified. (C) 2012 Elsevier Inc. All rights reserved.
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