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Evaluation of Diagnostic Tests with Dichotomous Output: A Decision Analytic Approach (307825)
Bipasa Biswas, FDA/CDRH*Arianna Simonetti, US Food and Drug Administration - CDRH
Keywords: diagnostic tests, sensitivity, specificity, binary output, decision analysis
Evaluating performance of a diagnostic test with binary/dichotomous output is not always straightforward and may present with several statistical challenges. Common metrics used for the performance of a single diagnostic test device include sensitivity, specificity, positive and negative predictive values and likelihood ratios. However, employing such metrics for the comparison between two tests, either separately or as summary measures, is complicated. A decision analytic approach using patient threshold for undergoing a diagnostic test may provide a better tool in solving issues related to inference-based comparison and clinical consequences of misclassification associated to the comparison of diagnostic tests. Examples of comparison between two dichotomous diagnostic tests will be presented.