Developing and Piloting A Value Framework and a Tool to Inform the “Evidence-to-Decision Making” Process

OBJECTIVES: To develop a value framework and a visual tool to inform the "evidence-to-decision making" process to be applied in Health Technology Assessment (HTA). METHODS: We performed a review of the literature to identify the main dimensions used in other frameworks. After an initial selection of dimensions and methods we validated them with a panel of twenty HTA researchers. Selected dimensions were weighted through a Delphi method with nine HTA senior researchers. Also a traffic light based colored scale was developed. The final framework was piloted in 24 rapid HTAs. RESULTS: The three dimensions included were: quality of the evidence; magnitude of net benefit (considering both benefits and adverse effects); and economic and organizational aspects (cost-effectiveness or expected budgetary impact). To classify the domain of evidence we used GRADE. The net benefit was classified as major, considerable, minor and marginal/null/uncertain, similarly to the German HTA agency (IQWiG). Finally, the domain of cost-effectiveness and budgetary impact were defined by consensus of experts taking into account the GDP per capita, catastrophic health expenditures and health budget characteristics in Argentina; and categorized as reasonable, uncertain and unreasonable. The final colored scale had five categories to summarize the assessment and as a decision aid: two poles suggesting positive or negative recommendations; and three intermediate categories where additional information is recommended before making the coverage decision During the pilot we found the framework friendly and easy to understand. From 24 HTAs, one was categorized as positive, eight as negative, and 15 with varying degrees of intermediate results (10 more favorable, 2 uncertain; and 3 less favorable). CONCLUSIONS: Developing and piloting a value framework and a user friendly tool to facilitate evidence informed deliberative process was feasible in Argentina. Further validation and follow-up are recommended to assess its applicability with decision makers.