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

Scott R. Evans, Gene Pennello, Norberto Pantoja-Galicia, Hongyu Jiang, Andrea M. Hujer, Kristine M. Hujer, Claudia Manca, Carol Hill, Michael R. Jacobs, Liang Chen, Robin Patel, Barry N. Kreiswirth, Robert A. Bonomo

Research output: Contribution to journalArticle

9 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)812-817
Number of pages6
JournalClinical Infectious Diseases
Volume63
Issue number6
DOIs
StatePublished - Sep 15 2016

Keywords

  • benefit-risk
  • diagnostic yield
  • diagnostics
  • pragmatism

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases

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    Evans, S. R., Pennello, G., Pantoja-Galicia, N., Jiang, H., Hujer, A. M., Hujer, K. M., Manca, C., Hill, C., Jacobs, M. R., Chen, L., Patel, R., Kreiswirth, B. N., & Bonomo, R. A. (2016). Benefit-risk Evaluation for Diagnostics: A Framework (BED-FRAME). Clinical Infectious Diseases, 63(6), 812-817. https://doi.org/10.1093/cid/ciw329