title: Systematic assessment of benefits and risks: study protocol for a multi-criteria decision analysis using the Analytic Hierarchy Process for comparative effectiveness research.
abstract: BACKGROUND
  Regulatory decision-making involves assessment of risks and benefits of medications at the time of approval or when relevant safety concerns arise with a medication. The Analytic Hierarchy Process (AHP) facilitates decision-making in complex situations involving tradeoffs by considering risks and benefits of alternatives. The AHP allows a more structured method of synthesizing and understanding evidence in the context of importance assigned to outcomes. Our objective is to evaluate the use of an AHP in a simulated committee setting selecting oral medications for type 2 diabetes.
  
  
  METHODS
  This study protocol describes the AHP in five sequential steps using a small group of diabetes experts representing various clinical disciplines. The first step will involve defining the goal of the decision and developing the AHP model. In the next step, we will collect information about how well alternatives are expected to fulfill the decision criteria. In the third step, we will compare the ability of the alternatives to fulfill the criteria and judge the importance of eight criteria relative to the decision goal of the optimal medication choice for type 2 diabetes. We will use pairwise comparisons to sequentially compare the pairs of alternative options regarding their ability to fulfill the criteria. In the fourth step, the scales created in the third step will be combined to create a summary score indicating how well the alternatives met the decision goal. The resulting scores will be expressed as percentages and will indicate the alternative medications' relative abilities to fulfill the decision goal. The fifth step will consist of sensitivity analyses to explore the effects of changing the estimates. We will also conduct a cognitive interview and process evaluation.
  
  
  CONCLUSIONS
  Multi-criteria decision analysis using the AHP will aid, support and enhance the ability of decision makers to make evidence-based informed decisions consistent with their values and preferences.
authors.affiliation: Department of Medicine, The Johns Hopkins University School of Medicine, Baltimore MD, 21205, USA ; Department of Epidemiology, The Johns Hopkins University Bloomberg School of Public Health, Baltimore MD, 21205, USA ; The Welch Center for Prevention, Epidemiology, and Clinical Research, Baltimore MD, 21205, USA.
authors.forename: Nisa M
authors.initials: NM
authors.lastname: Maruthur
authors.affiliation: Department of Health Policy and Management, The Johns Hopkins University Bloomberg School of Public Health, Baltimore MD, 21205, USA.
authors.forename: Susan
authors.initials: S
authors.lastname: Joy
authors.affiliation: Department of Public Health Sciences, University of Rochester School of Medicine and Dentistry, Rochester NY, 14642, USA.
authors.forename: James
authors.initials: J
authors.lastname: Dolan
authors.affiliation: Department of Medicine, The Johns Hopkins University School of Medicine, Baltimore MD, 21205, USA ; Department of Epidemiology, The Johns Hopkins University Bloomberg School of Public Health, Baltimore MD, 21205, USA ; Department of Health Policy and Management, The Johns Hopkins University Bloomberg School of Public Health, Baltimore MD, 21205, USA.
authors.forename: Jodi B
authors.initials: JB
authors.lastname: Segal
authors.affiliation: Department of Medicine, The Johns Hopkins University School of Medicine, Baltimore MD, 21205, USA.
authors.forename: Hasan M
authors.initials: HM
authors.lastname: Shihab
authors.affiliation: Department of Medicine, The Johns Hopkins University School of Medicine, Baltimore MD, 21205, USA ; Department of Epidemiology, The Johns Hopkins University Bloomberg School of Public Health, Baltimore MD, 21205, USA ; Department of Health Policy and Management, The Johns Hopkins University Bloomberg School of Public Health, Baltimore MD, 21205, USA.
authors.forename: Sonal
authors.initials: S
authors.lastname: Singh