Benefit-risk Evaluation for Diagnostics: A Framework (BED-FRAME)

Clin Infect Dis. 2016 Sep 15;63(6):812-7. doi: 10.1093/cid/ciw329. Epub 2016 May 18.


The medical community needs systematic and pragmatic approaches for evaluating the benefit-risk trade-offs 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 2 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 trade-offs of diagnostic alternatives. BED-FRAME is a useful fundamental supplement to the standard analysis of diagnostic studies that will aid in clinical decision making.

Keywords: benefit-risk; diagnostic yield; diagnostics; pragmatism.

Publication types

  • Research Support, N.I.H., Extramural

MeSH terms

  • Actinobacteria
  • Anti-Bacterial Agents / therapeutic use
  • Decision Support Systems, Clinical*
  • Diagnosis, Computer-Assisted*
  • Drug Resistance, Bacterial
  • Gram-Positive Bacterial Infections / drug therapy
  • Humans
  • Models, Statistical
  • Prevalence
  • Risk Assessment / methods*


  • Anti-Bacterial Agents