title: Applying quantitative benefit-risk analysis to aid regulatory decision making in diagnostic imaging: methods, challenges, and opportunities.
abstract: OBJECTIVE
  Health agencies making regulatory marketing-authorization decisions use qualitative and quantitative approaches to assess expected benefits and expected risks associated with medical interventions. There is, however, no universal standard approach that regulatory agencies consistently use to conduct benefit-risk assessment (BRA) for pharmaceuticals or medical devices, including for imaging technologies. Economics, health services research, and health outcomes research use quantitative approaches to elicit preferences of stakeholders, identify priorities, and model health conditions and health intervention effects.
  
  
  METHODS
  Challenges to BRA in medical devices are outlined, highlighting additional barriers in radiology. Three quantitative methods--multi-criteria decision analysis, health outcomes modeling and stated-choice survey--are assessed using criteria that are important in balancing benefits and risks of medical devices and imaging technologies.
  
  
  RESULTS
  To be useful in regulatory BRA, quantitative methods need to: aggregate multiple benefits and risks, incorporate qualitative considerations, account for uncertainty, and make clear whose preferences/priorities are being used. Each quantitative method performs differently across these criteria and little is known about how BRA estimates and conclusions vary by approach. While no specific quantitative method is likely to be the strongest in all of the important areas, quantitative methods may have a place in BRA of medical devices and radiology.
  
  
  CONCLUSIONS
  Quantitative BRA approaches have been more widely applied in medicines, with fewer BRAs in devices. Despite substantial differences in characteristics of pharmaceuticals and devices, BRA methods may be as applicable to medical devices and imaging technologies as they are to pharmaceuticals. Further research to guide the development and selection of quantitative BRA methods for medical devices and imaging technologies is needed.
authors.affiliation: Pharmaceutical Outcomes Research and Policy Program, Department of Pharmacy, School of Pharmacy, University of Washington, 1959 NE Pacific St, Seattle, WA 98195. Electronic address: magapova@uw.edu.
authors.forename: Maria
authors.initials: M
authors.lastname: Agapova
authors.affiliation: Pharmaceutical Outcomes Research and Policy Program, Department of Pharmacy, School of Pharmacy, University of Washington, 1959 NE Pacific St, Seattle, WA 98195.
authors.forename: Emily Beth
authors.initials: EB
authors.lastname: Devine
authors.affiliation: Department of Radiology, School of Medicine, University of Washington, Seattle, Washington.
authors.forename: Brian W
authors.initials: BW
authors.lastname: Bresnahan
authors.affiliation: General Electric Healthcare, Waukesha, Wisconsin.
authors.forename: Mitchell K
authors.initials: MK
authors.lastname: Higashi
authors.affiliation: Pharmaceutical Outcomes Research and Policy Program, Department of Pharmacy, School of Pharmacy, University of Washington, 1959 NE Pacific St, Seattle, WA 98195.
authors.forename: Louis P
authors.initials: LP
authors.lastname: Garrison
mesh_terms: D003661:Decision Support Techniques; D003952:Diagnostic Imaging / Q000379:methods*; D006302:Health Services Research / Q000379:methods*; D006801:Humans; D018570:Risk Assessment / Q000379:methods