Authors
Sandra M Eldridge, Ceire E Costelloe, Brennan C Kahan, Gillian A Lancaster, Sally M Kerry
Publication date
2016/6
Journal
Statistical methods in medical research
Volume
25
Issue
3
Pages
1039-1056
Publisher
SAGE Publications
Description
There is currently a lot of interest in pilot studies conducted in preparation for randomised controlled trials. This paper focuses on sample size requirements for external pilot studies for cluster randomised trials. We consider how large an external pilot study needs to be to assess key parameters for input to the main trial sample size calculation when the primary outcome is continuous, and to estimate rates, for example recruitment rates, with reasonable precision. We used simulation to provide the distribution of the expected number of clusters for the main trial under different assumptions about the natural cluster size, intra-cluster correlation, eventual cluster size in the main trial, and various decisions made at the piloting stage. We chose intra-cluster correlation values and pilot study size to reflect those commonly reported in the literature. Our results show that estimates of sample size required for the main trial are …
Total citations
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Scholar articles
SM Eldridge, CE Costelloe, BC Kahan, GA Lancaster… - Statistical methods in medical research, 2016