Accounting for correlation and compliance in cluster randomized trials

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Abstract
This paper discusses causal inference with survival data from cluster randomized trials. It is argued that cluster randomization carries the potential for post‐randomization exposures which involve differentially selective compliance between treatment arms, even for an all or nothing exposure at the individual level. Structural models can be employed to account for post‐randomization exposures, but should not ignore clustering. We show how marginal modelling and random effects models allow to adapt structural estimators to account for clustering. Our findings are illustrated with data from a vitamin A trial for the prevention of infant mortality in the rural plains of Nepal. Copyright © 2001 John Wiley & Sons, Ltd.