College of Public Health and Human Sciences

We develop a simulation-based procedure for determining the required sample size in binomial regression risk assessment studies when response data are subject to misclassification. A Bayesian average power criterion is used to determine a sample size that provides high probability, averaged over the distribution of potential future data sets, of correctly establishing the direction of association between predictor variables and the probability of event occurrence. The method is broadly applicable to any parametric binomial regression model including, but not limited to, the popular logistic, probit, and complementary log-log models. We detail a common medical scenario wherein ascertainment of true disease status is impractical or otherwise impeded, and in its place the outcome of a single binary diagnostic test is used as a surrogate. These methods are then extended to the two diagnostic test setting. We illustrate the method with categorical covariates using one example that involves screening for human papillomavirus. This example coupled with results from simulated data highlights the utility of our Bayesian sample size procedure with error prone measurements.