Sample size requirements for the design of reliability study: review and new results

The reliability of continuous or binary outcome measures is usually assessed by estimation of the intraclass correlation coefficient (ICC). A crucial step for this purpose is the determination of the required sample size. In this review, we discuss the contributions made in this regard and derive the optimal allocation for the number of subjects k and the number of repeated measurements n that minimize the variance of the estimated ICC. Cost constraints are discussed for both normally and non-normally distributed responses, with emphasis on the case of dichotomous assessments. Tables showing optimal choices of k and n are given along with the guidelines for the efficient design of reliability studies.