Abstract
The receiver operating characteristic (ROC) curve is a valuable statistical tool in medical research. It assesses a biomarker’s ability to distinguish between diseased and healthy individuals. The area under the ROC curve (AUC) and the Youden index (J) are common summary indices used to evaluate a biomarker’s diagnostic accuracy. Simultaneously examining AUC and J offers a more comprehensive understanding of the ROC curve’s characteristics. In this paper, we utilize a semiparametric density ratio model to link the distributions of a biomarker for healthy and diseased individuals. Under this model, we establish the joint asymptotic normality of the maximum empirical likelihood estimator of (AUC,J) and construct an asymptotically valid confidence region for (AUC,J). Furthermore, we propose a new test to determine whether a biomarker simultaneously exceeds prespecified target values of AUC0 and J0 with the null hypothesis H0:AUC≤AUC0 or J≤J0 against the alternative hypothesis Ha:AUC>AUC0 and J>J0. Simulation studies and a real data example on Duchenne Muscular Dystrophy are used to demonstrate the effectiveness of our proposed method and highlight its advantages over existing methods.
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