Sample size in guidelines trials.

Abstract

In clinical trials, the statistical concepts of significance and power are used in the determination of sample size for trials. The trialist must provide an estimate of standard deviation and a hypothetical population difference to be detected. This must be modified to deal with the designs encountered in guideline research. These are cluster randomized trials, because the patients of a single doctor or practice form a cluster. The trialist must be able to provide information about the effects of clustering, in the form of an intraclass correlation coefficient.