1. Mapping and ranking outcomes for the evaluation of seasonal influenza vaccine efficacy and effectiveness: a delphi study
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Chiara de Waure, Elisabetta Alti, Vincenzo Baldo, Paolo Bonanni, Michele Conversano, Alberto Fedele, Giovanni Gabutti, Roberto Ieraci, Francesco Landi, Raffaele Landolfi, Andrea Orsi, Caterina Rizzo, Alessandro Rossi, Alberto Villani, Francesco Vitale, and Alexander Domnich
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Influenza ,influenza vaccines ,vaccine efficacy ,vaccine effectiveness ,outcome assessment ,Delphi method ,Internal medicine ,RC31-1245 - Abstract
Background Protection provided by seasonal influenza vaccination (SIV) may be measured against numerous outcomes, and their heterogeneity may hamper decision-making. The aim of this study was to explore outcomes used for estimation of SIV efficacy/effectiveness (VE) and obtain expert consensus on their importance.Research design and methods An umbrella review was first conducted to collect and map outcomes considered in systematic reviews of SIV VE. A Delphi study was then performed to reach expert convergence on the importance of single outcomes, measured on a 9-point Likert scale, in principal target groups, namely children, working-age adults, older adults, subjects with co-morbidities and pregnant women.Results The literature review identified 489 outcomes. Following data reduction, 20 outcomes were selected for the Delphi process. After two Delphi rounds and a final consensus meeting, convergence was reached. All 20 outcomes were judged to be important or critically important. More severe outcomes, such as influenza-related hospital encounters and mortality with or without laboratory confirmation, were generally top-ranked across all target groups (median scores ≥8 out of 9).Conclusions Rather than focusing on laboratory-confirmed infection per se, experimental and observational VE studies should include more severe influenza-related outcomes because they are expected to exercise a greater impact on decision-making.
- Published
- 2024
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