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

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

Author information

1
Department of Biostatistics Center for Biostatistics in AIDS Research, Harvard T. H. Chan School of Public Health, Boston, Massachusetts.
2
Division of Biostatistics, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland.
3
Center for Biostatistics in AIDS Research, Harvard T. H. Chan School of Public Health, Boston, Massachusetts.
4
Louis Stokes Cleveland Veterans Affairs Medical Center, Case Western Reserve University School of Medicine, Ohio.
5
Public Health Research Institute, New Jersey Medical School, Rutgers University, Newark.
6
Duke Clinical Research Institute, Duke University, Durham, North Carolina.
7
Mayo Clinic, Rochester, Minnesota.

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.

KEYWORDS:

benefit-risk; diagnostic yield; diagnostics; pragmatism

PMID:
27193750
PMCID:
PMC4996133
DOI:
10.1093/cid/ciw329
[Indexed for MEDLINE]
Free PMC Article

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