Pharmaceutical Statistics

Optimal Cut‐Point Selection Methods Under Binary Classification When Subclasses Are Involved

ABSTRACTIn practice, we often encounter binary classification problems where both main classes consist of multiple subclasses. For example, in an ovarian cancer study where biomarkers were evaluated for their accuracy of distinguishing noncancer cases from cancer cases, the noncancer class consists of healthy subjects and benign cases, while the cancer class consists of subjects at both early and late stages. This article aims to provide a large number of optimal cut‐point selection methods for such setting. Furthermore, we also study confidence interval estimation of the optimal cut‐points. Simulation studies are carried out to explore the performance of the proposed cut‐point selection methods as well as confidence interval estimation methods. A real ovarian cancer data set is analyzed using the proposed methods.

Flexible diagnostic measures and new cut‐point selection methods under multiple ordered classes

AbstractMedical diagnosis is essentially a classification problem and usually it is done with multiple ordered classes. For example, cancer diagnosis might be “non‐malignant,” “early stage,” or “late stage.” Therefore, appropriate measures are needed to assess the accuracy of diagnostic markers under multiple ordered classes. However, all existing measures fail to differentiate among some distinctly different biomarkers. This paper presents a multi‐step procedure for evaluating biomarker accuracy under multiple ordered classes. This procedure leads to two new flexible overall measures as well as three new cut‐point selection methods with great computational ease. The performance of proposed measures and cut‐point selection methods are numerically explored via a simulation study. In the end, an ovarian cancer dataset from the Prostate, Lung, Colorectal, and Ovarian cancer study is analyzed. The proposed accuracy measures were estimated for markers CA125 and HE4, and cut‐points were estimated for the risk of ovarian malignancy algorithm score.