Regression-based estimation of the false negative fraction when multiple negatives are unverified

Abstract

The paper describes a method of estimating the false negative fraction of a multiple-screening test when individuals who test negatively on all K tests do not have their true disease status verified. The method proposed makes no explicit assumptions about the underlying heterogeneity of the population or about serial correlation of test results within an individual. Rather, it is based on estimating false negative fractions conditionally on observed diagnostic histories and extrapolating the observed patterns in these empirical frequencies by using logistic regression. The method is illustrated on, and motivated by, data on a multiple-screening test for bowel cancer.