Unified Least Squares Methods for the Evaluation of Diagnostic Tests With the Gold Standard

The article proposes a unified least squares method to estimate the receiver operating characteristic (ROC) parameters for continuous and ordinal diagnostic tests, such as cancer biomarkers. The method is based on a linear model framework using the empirically estimated sensitivities and specificities as input “data.” It gives consistent estimates for regression and accuracy parameters when the underlying continuous test results are normally distributed after some monotonic transformation. The key difference between the proposed method and the method of Tang and Zhou lies in the response variable. The response variable in the latter is transformed empirical ROC curves at different thresholds. It takes on many values for continuous test results, but few values for ordinal test results. The limited number of values for the response variable makes it impractical for ordinal data. However, the response variable in the proposed method takes on many more distinct values so that the method yields valid estimates for ordinal data. Extensive simulation studies are conducted to investigate and compare the finite sample performance of the proposed method with an existing method, and the method is then used to analyze 2 real cancer diagnostic example as an illustration.