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Empirical Power and Sample Size Calculations for Cluster-Randomized and Cluster-Randomized Crossover Studies

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  • Nicholas G Reich
  • Jessica A Myers
  • Daniel Obeng
  • Aaron M Milstone
  • Trish M Perl

Abstract

In recent years, the number of studies using a cluster-randomized design has grown dramatically. In addition, the cluster-randomized crossover design has been touted as a methodological advance that can increase efficiency of cluster-randomized studies in certain situations. While the cluster-randomized crossover trial has become a popular tool, standards of design, analysis, reporting and implementation have not been established for this emergent design. We address one particular aspect of cluster-randomized and cluster-randomized crossover trial design: estimating statistical power. We present a general framework for estimating power via simulation in cluster-randomized studies with or without one or more crossover periods. We have implemented this framework in the clusterPower software package for R, freely available online from the Comprehensive R Archive Network. Our simulation framework is easy to implement and users may customize the methods used for data analysis. We give four examples of using the software in practice. The clusterPower package could play an important role in the design of future cluster-randomized and cluster-randomized crossover studies. This work is the first to establish a universal method for calculating power for both cluster-randomized and cluster-randomized clinical trials. More research is needed to develop standardized and recommended methodology for cluster-randomized crossover studies.

Suggested Citation

  • Nicholas G Reich & Jessica A Myers & Daniel Obeng & Aaron M Milstone & Trish M Perl, 2012. "Empirical Power and Sample Size Calculations for Cluster-Randomized and Cluster-Randomized Crossover Studies," PLOS ONE, Public Library of Science, vol. 7(4), pages 1-7, April.
    • Handle: RePEc:plo:pone00:0035564
    DOI: 10.1371/journal.pone.0035564
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    Cited by:

    1. Stephen A Lauer & Ken P Kleinman & Nicholas G Reich, 2015. "The Effect of Cluster Size Variability on Statistical Power in Cluster-Randomized Trials," PLOS ONE, Public Library of Science, vol. 10(4), pages 1-13, April.
    2. Jansen, Stefan & Nsabimana, Epaphrodite & Kagaba, Mediatrice & Mutabaruka, Jean & Rutembesa, Eugene & Slegh, Henny & Mihigo, Bonaventure & Mahwa, Aloys & Ruratotoye, Benoit & Haile, Zelalem, 2022. "A clustered randomized controlled trial to assess whether Living Peace Intervention (LPint) reduces domestic violence and its consequences among families of targeted men in Eastern Democratic Republic," Evaluation and Program Planning, Elsevier, vol. 95(C).

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