ORGANIZATIONAL IMPACTS IN HEALTH TECHNOLOGY ASSESSMENT: A DECISION FRAMEWORK FOR EVIDENCE GENERATION
Author(s)
Olivier Marcellin, MSc1, Maryaline Catillon, MPH, PhD2, Christophe Roussel, MSc3, Giovanny Arbelaez-Garces, PhD4, Tess Martin, PharmD, PhD5, Nicolas Martelli, PharmD, PhD5.
1Université Paris Dauphine-PSL, Paris, France, 2Conservatoire national des arts et métiers, Paris, France, 3Edwards Lifesciences, Guyancourt, France, 4Université de Strasbourg, CNRS, ICube, UMR 7357, Strasbourg, France, 5Paris-Saclay University, IDRT-Santé, Faculty of Pharmacy, Pharmacy Department, Georges Pompidou European Hospital, AP-HP, Paris, France.
1Université Paris Dauphine-PSL, Paris, France, 2Conservatoire national des arts et métiers, Paris, France, 3Edwards Lifesciences, Guyancourt, France, 4Université de Strasbourg, CNRS, ICube, UMR 7357, Strasbourg, France, 5Paris-Saclay University, IDRT-Santé, Faculty of Pharmacy, Pharmacy Department, Georges Pompidou European Hospital, AP-HP, Paris, France.
OBJECTIVES: Organizational impacts (OI) are increasingly considered in the context of evolving frameworks for health technology assessment (HTA) in Europe. However, their assessment remains insufficiently operationalized in the absence of consensus on methods for their elicitation, prioritization, and evaluation. This study developed a framework for OI assessment in healthcare (FOIAH) to support elicitation and prioritization of organizational outcomes, and selection of evidence-generation strategies under HTA constraints.
METHODS: We conducted targeted literature reviews (TLRs) of (1) methods for eliciting and prioritizing organizational outcomes and (2) experimental and quasi-experimental methods used for impact assessment. Study selection and data extraction were performed independently by two reviewers. TLR findings provided variables and methods from which methodological scenarios were derived. These were reviewed by experts to develop a framework for OI assessment.
RESULTS: The framework provides a structured process linking organizational analysis to evidence generation. Starting from care pathway and organizational analyses, it defines decision context and perspective(s), elicits and prioritizes organizational outcomes, and supports the selection of methodological scenarios. Prioritized impacts are mapped to scenarios constructed from methodological attributes (e.g., unit of analysis, comparator structure, assessment timeframe, and practice setting). The framework is iterative, allowing feasibility and data constraints to refine earlier prioritization choices and explore methodological scenarios.
CONCLUSIONS: Amid growing expectations for OI assessment in European HTA, FOIAH provides a structured and operational approach to evidence generation. It integrates organizational analysis, outcome prioritization, and methodological selection into a coherent decision process that supports the development of (1) a prioritized catalogue of organizational outcomes aligned with decision perspective(s); and (2) corresponding methodological scenarios for evidence generation. It supports manufacturers in the design, documentation, and justification of evidence-generation strategies, and assists HTA agencies in their assessment of these strategies, thereby facilitating the operationalization of OI evaluation for HTA decision-making.
METHODS: We conducted targeted literature reviews (TLRs) of (1) methods for eliciting and prioritizing organizational outcomes and (2) experimental and quasi-experimental methods used for impact assessment. Study selection and data extraction were performed independently by two reviewers. TLR findings provided variables and methods from which methodological scenarios were derived. These were reviewed by experts to develop a framework for OI assessment.
RESULTS: The framework provides a structured process linking organizational analysis to evidence generation. Starting from care pathway and organizational analyses, it defines decision context and perspective(s), elicits and prioritizes organizational outcomes, and supports the selection of methodological scenarios. Prioritized impacts are mapped to scenarios constructed from methodological attributes (e.g., unit of analysis, comparator structure, assessment timeframe, and practice setting). The framework is iterative, allowing feasibility and data constraints to refine earlier prioritization choices and explore methodological scenarios.
CONCLUSIONS: Amid growing expectations for OI assessment in European HTA, FOIAH provides a structured and operational approach to evidence generation. It integrates organizational analysis, outcome prioritization, and methodological selection into a coherent decision process that supports the development of (1) a prioritized catalogue of organizational outcomes aligned with decision perspective(s); and (2) corresponding methodological scenarios for evidence generation. It supports manufacturers in the design, documentation, and justification of evidence-generation strategies, and assists HTA agencies in their assessment of these strategies, thereby facilitating the operationalization of OI evaluation for HTA decision-making.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HTA313
Topic
Health Service Delivery & Process of Care, Health Technology Assessment, Methodological & Statistical Research
Topic Subcategory
Decision & Deliberative Processes
Disease
No Additional Disease & Conditions/Specialized Treatment Areas