Developing a conceptual framework to support coverage decisions for vaccines adoption: a Delphi consensus process

Article type
Authors
González-Lorenzo M1, Tirani M2, Piatti A3, Coppola L3, Gramegna M3, Auxilia F2, Demicheli V4, Banzi R5, Bertelè V5, Moja L1
1Clinical Epidemiology Unit, IRCCS Galeazzi Orthopaedic Institute, Milan; Diparment of Biomedichal Sciences for Health, University of Milan, Italy
2Deparment of Biomedichal Sciences for Health, University of Milan, Italy
3Direzione Generale Salute, UO Governo della Prevenzione e Tutela Sanitaria, Regione Lombardia, Milan, Italy
4Servizio Regionale di Riferimento per l’Epidemiologia, SSEpi-SeREMI - CochraneVaccines Field, Azienda Sanitaria Locale ASL AL, Alessandria, Italy
5Laboratory of Regulatory Policies, IRCCS-Mario Negri Institute for Pharmacological Research, Milan, Italy
Abstract
Background: Decision makers must make choices about which vaccines to incorporate into the prevention programs of a National Health Service. A transparent, unbiased, and comprehensive framework based on evidence-based criteria is necessary to guide decision-making on vaccine adoption. We developed a potential framework to support vaccine coverage decisions based on the DECIDE Evidence to Decision framework.
Objectives: This study aims to evaluate and validate a framework to support vaccine coverage decisions, and to explore alternative ways of presenting framework criteria to support policy decision-making.
Methods: We adopted a Delphi consensus process to engage a group of experienced healthcare professionals. We constructed a questionnaire based on the six dimensions of the framework (burden of disease, vaccine characteristics and impact of immunisation programme, values and preferences, resource use, equity and feasibility). This resulted in 81 structured questions concerning the relevance of each proposed criterion. We requested participants to rate these criteria on a 9-point Likert scale ranging from 0 (not at all important) to 9 (extremely important). We then conducted a two-round Delphi process through Internet and a discussion group.
Results: Fifty-nine participants from multidisciplinary areas were invited by email; 46 participants accepted the invitation. In the first round, 46 out of 81 criteria achieved consensus. Among those lacking consensus, the major concerns were related to criteria about mortality, morbidity, symptoms, and differences between local and global data. We presented results of the first round in a group discussion. In the second round, 48 criteria were assessed, and 41 achieved consensus.
Conclusions: In order to optimize its application and effectiveness, a vaccine framework should consist of dimensions and criteria that are supported by evidence summaries; these can be presented in graphical or tabular displays. Additional research is required to test the framework for coverage decisions on one or more vaccines, in order to identify their critical elements, and their relative importance in influencing decision-making.