All Times EDT
Keywords: sensitivity, specificity, likelihood ratio, positive predictive value, negative predictive value, medical decision making
Pennello (2021 Classification accuracy goals for diagnostic tests based on risk stratification, Biostatistics & Epidemiology, 5:2, 149-168, DOI: 10.1080/24709360.2021.1878406) developed a framework for setting classification accuracy goals that confer clinical usefulness of a diagnostic test. This framework has been used to evaluate diagnostic tests in regulatory submissions (https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160037B.pdf). Developers and manufacturers may benefit from this framework when setting classification accuracy goals at the design stage of a validation study for an investigational diagnostic test. In this roundtable we will highlight key ideas from this paper and encourage dialogue on the use of this approach in practice.