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Stat Med. 1988 Nov;7(11):1195-201.

Sample size formulae for intervention studies with the cluster as unit of randomization.

Author information

Department of Epidemiology and Social Medicine, Albert Einstein College of Medicine, Bronx, New York 10461.

Erratum in

  • Stat Med 1997 Jun 15;16(11):1300.


This paper presents sample size formulae for both continuous and dichotomous endpoints obtained from intervention studies that use the cluster as the unit of randomization. The formulae provide the required number of clusters or the required number of individuals per cluster when the other number is given. The proposed formulae derive from Student's t-test with use of cluster summary measures and a variance that consists of within and between cluster components. Power contours are provided to help in the design of intervention studies that use cluster randomization. Sample size formulae for designs with and without stratification of clusters appear separately.

[Indexed for MEDLINE]

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