Journal
STATISTICAL METHODS IN MEDICAL RESEARCH
Volume 30, Issue 11, Pages 2459-2470Publisher
SAGE PUBLICATIONS LTD
DOI: 10.1177/09622802211037073
Keywords
Cluster-randomised; cluster trial; sample size; imprecision; intra-cluster correlation coefficient; intra-cluster correlation
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Sample size calculations for cluster-randomised trials need to consider uncertainty in the estimate of the intra-cluster correlation coefficient to avoid potential impacts on sample size and power of the main trial.
Sample size calculations for cluster-randomised trials require inclusion of an inflation factor taking into account the intra-cluster correlation coefficient. Often, estimates of the intra-cluster correlation coefficient are taken from pilot trials, which are known to have uncertainty about their estimation. Given that the value of the intra-cluster correlation coefficient has a considerable influence on the calculated sample size for a main trial, the uncertainty in the estimate can have a large impact on the ultimate sample size and consequently, the power of a main trial. As such, it is important to account for the uncertainty in the estimate of the intra-cluster correlation coefficient. While a commonly adopted approach is to utilise the upper confidence limit in the sample size calculation, this is a largely inefficient method which can result in overpowered main trials. In this paper, we present a method of estimating the sample size for a main cluster-randomised trial with a continuous outcome, using numerical methods to account for the uncertainty in the intra-cluster correlation coefficient estimate. Despite limitations with this initial study, the findings and recommendations in this paper can help to improve sample size estimations for cluster randomised controlled trials by accounting for uncertainty in the estimate of the intra-cluster correlation coefficient. We recommend this approach be applied to all trials where there is uncertainty in the intra-cluster correlation coefficient estimate, in conjunction with additional sources of information to guide the estimation of the intra-cluster correlation coefficient.
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