On the Index of Repeatability: Estimation and Sample Size Requirements

Abstract

Background: Repeatability is a statement on the magnitude of measurement error. When biomarkers are used for disease diagnoses, they should be measured accurately. Objectives: We derive an index of repeatability based on the ratio of two variance components. Estimation of the index is derived from the one-way Analysis of Variance table based on the one-way random effects model. We estimate the large sample variance of the estimator and assess its adequacy using bootstrap methods. An important requirement for valid estimation of repeatability is the availability of multiple observations on each subject taken by the same rater and under the same conditions. Methods: We use the delta method to derive the large sample variance of the estimate of repeatability index. The question related to the number of required repeats per subjects is answered by two methods. In first methods we estimate the number of repeats that minimizes the variance of the estimated repeatability index, and the second determine the number of repeats needed under cost-constraints. Results and Novel Contribution: The situation when the measurements do not follow Gaussian distribution will be dealt with. It is shown that the required sample size is quite sensitive to the relative cost. We illustrate the methodologies on the Serum Alanine-aminotransferase (ALT) available from hospital registry data for samples of males and females. Re-peatability is higher among females in comparison to males.