Showing Clinical Utility of a Diagnostic Test by Evaluating Agreement with a Reference Test: Study DesignIissues
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*Ann Olmsted, CV Therapeutics, Inc.  *Whedy Wang, CV Therapeutics, Inc. 

Keywords: kappa, agreement, non-inferiority

The goal is to establish the clinical utility of a medical test used to guide patient management when no generally accepted gold standard test exists. Our approach is to show sufficient agreement with a reference test of known clinical utility to ensure that the new test will have comparable utility. Some of the many issues in designing studies that follow this approach will be discussed, including choice of primary measure of agreement, choice of primary test of hypotheses, and choice of non-inferiority margin.