Estimation and sample size considerations for clustered binary responses

Stat Med. 1994 Jun 30;13(12):1241-52. doi: 10.1002/sim.4780131206.


Although there is much literature on sample size determination for clinical trials or experiments with independent responses, there is a lack of methodology to obtain sample sizes for dependent outcomes. This paper presents a simple way to calculate sample size for estimating treatment effects and diagnostic accuracy in the case of correlated binary outcomes. The proposed weighted procedure also has use in estimation, whose advantages we demonstrate through simulation. Recommendations are made for practical application.

Publication types

  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Clinical Trials as Topic / statistics & numerical data*
  • Cluster Analysis
  • Humans
  • Models, Statistical
  • Sample Size
  • Treatment Outcome