 Cluster-randomized trial

A cluster-randomized trial assigns whole groups, such as institutions, to an intervention rather than assigning individuals separately. Positive intraclass correlation reduces independent information: the equal-size exchangeable approximation has design effect $1+(m-1)\rho$ for cluster size $m$. The number of independent randomized clusters also matters for inference. Cluster assignment does not itself remove requirements for informed consent or justify dropping outcome ascertainment in the control arm.