Journal
STATISTICS IN MEDICINE
Volume 36, Issue 18, Pages 2831-2843Publisher
WILEY
DOI: 10.1002/sim.7329
Keywords
permutation test; cluster-randomized trials; pair-matched design; stepped-wedge design; time-to-event endpoints
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Funding
- National Institutes of Health [R37 AI51164, R01 AI24643]
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We investigate the use of permutation tests for the analysis of parallel and stepped-wedge cluster-randomized trials. Permutation tests for parallel designs with exponential family endpoints have been extensively studied. The optimal permutation tests developed for exponential family alternatives require information on intraclass correlation, a quantity not yet defined for time-to-event endpoints. Therefore, it is unclear how efficient permutation tests can be constructed for cluster-randomized trials with such endpoints. We consider a class of test statistics formed by a weighted average of pair-specific treatment effect estimates and offer practical guidance on the choice of weights to improve efficiency. We apply the permutation tests to a cluster-randomized trial evaluating the effect of an intervention to reduce the incidence of hospital-acquired infection. In some settings, outcomes from different clusters may be correlated, and we evaluate the validity and efficiency of permutation test in such settings. Lastly, we propose a permutation test for stepped-wedge designs and compare its performance with mixed-effect modeling and illustrate its superiority when sample sizes are small, the underlying distribution is skewed, or there is correlation across clusters. Copyright (c) 2017 John Wiley & Sons, Ltd.
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