Scientific Publications by FDA Staff

Clin Infect Dis 2016 Sep 15;63(6):812-7

Benefit-risk evaluation for diagnostics: a framework (BED-FRAME).

Evans SR, Pennello G, Pantoja-Galicia N, Jiang H, Hujer AM, Hujer KM, Manca C, Hill C, Jacobs MR, Chen L, Patel R, Kreiswirth BN, Bonomo RA, Antibacterial Resistance Leadership Group (ARLG)

The medical community needs systematic and pragmatic approaches for evaluating the benefit-risk tradeoffs of diagnostics that assist in medical decision-making. Benefit-Risk Evaluation of Diagnostics: A Framework (BED-FRAME) is a strategy for pragmatic evaluation of diagnostics designed to supplement traditional approaches. BED-FRAME evaluates diagnostic yield and addresses two key issues: (1) that diagnostic yield depends on prevalence, and (2) that different diagnostic errors carry different clinical consequences. As such, evaluating and comparing diagnostics depends on prevalence and the relative importance of potential errors. BED-FRAME provides a tool for communicating the expected clinical impact of diagnostic application and the expected tradeoffs of diagnostic alternatives. BED-FRAME is a useful fundamental supplement to the standard analysis of diagnostic studies that will aid in clinical decision-making.