title: Benefit-risk Evaluation for Diagnostics: A Framework (BED-FRAME).
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.
authors.affiliation: Department of Biostatistics Center for Biostatistics in AIDS Research, Harvard T. H. Chan School of Public Health, Boston, Massachusetts.
authors.forename: Scott R
authors.initials: SR
authors.lastname: Evans
authors.affiliation: Division of Biostatistics, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Gene
authors.initials: G
authors.lastname: Pennello
authors.affiliation: Division of Biostatistics, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Norberto
authors.initials: N
authors.lastname: Pantoja-Galicia
authors.affiliation: Center for Biostatistics in AIDS Research, Harvard T. H. Chan School of Public Health, Boston, Massachusetts.
authors.forename: Hongyu
authors.initials: H
authors.lastname: Jiang
authors.affiliation: Louis Stokes Cleveland Veterans Affairs Medical Center, Case Western Reserve University School of Medicine, Ohio.
authors.forename: Andrea M
authors.initials: AM
authors.lastname: Hujer
authors.affiliation: Louis Stokes Cleveland Veterans Affairs Medical Center, Case Western Reserve University School of Medicine, Ohio.
authors.forename: Kristine M
authors.initials: KM
authors.lastname: Hujer
authors.affiliation: Public Health Research Institute, New Jersey Medical School, Rutgers University, Newark.
authors.forename: Claudia
authors.initials: C
authors.lastname: Manca
authors.affiliation: Duke Clinical Research Institute, Duke University, Durham, North Carolina.
authors.forename: Carol
authors.initials: C
authors.lastname: Hill
authors.affiliation: Louis Stokes Cleveland Veterans Affairs Medical Center, Case Western Reserve University School of Medicine, Ohio.
authors.forename: Michael R
authors.initials: MR
authors.lastname: Jacobs
authors.affiliation: Public Health Research Institute, New Jersey Medical School, Rutgers University, Newark.
authors.forename: Liang
authors.initials: L
authors.lastname: Chen
authors.affiliation: Mayo Clinic, Rochester, Minnesota.
authors.forename: Robin
authors.initials: R
authors.lastname: Patel
authors.affiliation: Public Health Research Institute, New Jersey Medical School, Rutgers University, Newark.
authors.forename: Barry N
authors.initials: BN
authors.lastname: Kreiswirth
authors.affiliation: Louis Stokes Cleveland Veterans Affairs Medical Center, Case Western Reserve University School of Medicine, Ohio.
authors.forename: Robert A
authors.initials: RA
authors.lastname: Bonomo
mesh_terms: D039903:Actinobacteria; D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D020000:Decision Support Systems, Clinical; D003936:Diagnosis, Computer-Assisted; D024881:Drug Resistance, Bacterial; D016908:Gram-Positive Bacterial Infections / Q000188:drug therapy; D006801:Humans; D015233:Models, Statistical; D015995:Prevalence; D018570:Risk Assessment / Q000379:methods*
chemical_list: D000900:Anti-Bacterial Agents
keywords: benefit-risk; diagnostic yield; diagnostics; pragmatism