Estimation of sensitivity and specificity of site‐specific diagnostic tests

Abstract
Clinical trials designed to estimate the sensitivity and specificity of periodontal diagnostic tests often use multiple sites per patient as experimental units of analyses. Since site-specific test results within a patient are dependent observations, a correlated binomial model should be employed to estimate the sensitivity and specificity of these diagnostic tests. Ignoring the within-patient correlation can result in an over- or underestimation of the true standard errors.