Abstract

Techniques for estimating sample size for randomised trials are well established,1 2 but most texts do not discuss sample size for trials which randomise groups (clusters) of people rather than individuals. For example, in a study of different preparations to control head lice all children in the same class were allocated to receive the same preparation. This was done to avoid contaminating the treatment groups through contact with control children in the same class.3 The children in the class cannot be considered independent of one another and the analysis should take this into account.4 5 There will be some loss of power due to randomising by cluster rather than individual and this should be reflected in the sample size calculations. Here we describe sample size calculations for a cluster randomised trial.