Sample size determination for multilevel hierarchical designs using generalized linear mixed models.

Abstract

A unified statistical methodology of sample size determination is developed for hierarchical designs that are frequently used in many areas, particularly in medical and health research studies. The solid foundation of the proposed methodology opens a new horizon for power analysis in presence of various conditions. Important features such as joint significance testing, unequal allocations of clusters across intervention groups, and differential attrition rates over follow up time points are integrated to address some useful questions that investigators often encounter while conducting such studies. Proposed methodology is shown to perform well in terms of maintaining type I error rates and achieving the target power under various conditions. Proposed method is also shown to be robust with respect to violation of distributional assumptions of random-effects.