JSM 2005 Online Program

Abstract #304739

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Activity Number:	439
Type:	Topic Contributed
Date/Time:	Wednesday, August 10, 2005 : 2:00 PM to 3:50 PM
Sponsor:	Section on Statistics in Epidemiology
Abstract - #304739
Title:	Evaluation of Accuracy and Optimal Cutoff of Diagnostic Devices in the Same Study
Author(s):	Marina Kondratovich*+ and Waleed Yousef
Companies:	U.S. Food and Drug Administration and U.S. Food and Drug Administration
Address:	HFZ 550, Rockville, MD, 20850, United States
Keywords:	Diagnostic Devices ; Accuracy ; Sensitivity and specificity
Abstract:	Consider the case when the diagnostic test is univariate (i.e., free prostate-specific antigen assay) and the cutoff is not predefined but selected in the study according to some rule of optimality. If the same study is used to find the optimal cutoff and then used to evaluate the sensitivity and specificity for this cutoff, incorrect conclusions about the performance of the diagnostic tests can be made. Then, the question is raised whether the selection of the optimal cutoff in the study requires the independent dataset to obtain unbiased estimates of accuracy (sensitivity and specificity) with unbiased estimates of uncertainty about accuracy. There is no need for the independent dataset because, by using the appropriate bootstrap technique, the unbiased estimates of the accuracy and uncertainties can be obtained from the same study. Different types of the optimal cutoff selection will be considered, such as a percentile for specificity, maximizing sensitivity over a certain value of specificity, maximizing the weighted linear combination of sensitivity and specificity. The results of simulation will be presented.

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