Design of Experiments and Sample Surveys Commons^™

Testing Hypotheses About Medical Test Accuracy: Considerations For Design And Inference, Adam J. Branscum, Dunlei Cheng, J Jack Lee

Dunlei Cheng

Developing new medical tests and identifying single biomarkers or panels of biomarkers with superior accuracy over existing classifiers promotes lifelong health of individuals and populations. Before a medical test can be routinely used in clinical practice, its accuracy within diseased and non-diseased populations must be rigorously evaluated. We introduce a method for sample size determination for studies designed to test hypotheses about medical test or biomarker sensitivity and specificity. We show how a sample size can be determined to guard against making type I and/or type II errors by calculating Bayes factors from multiple data sets simulated under null and/or …