Benefit-Risk Assessment of Vaccines. Part II: Proposal Towards Consolidated Standards of Reporting Quantitative Benefit-
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ORIGINAL RESEARCH ARTICLE
Benefit‑Risk Assessment of Vaccines. Part II: Proposal Towards Consolidated Standards of Reporting Quantitative Benefit‑Risk Models Applied to Vaccines (BRIVAC) Hugo Arlegui1,2,3 · Kaatje Bollaerts4 · Vincent Bauchau5 · Gaëlle Nachbaur3 · Bernard Bégaud1,2 · Nicolas Praet5
© The Author(s) 2020
Abstract Introduction Quantitative benefit-risk models (qBRm) applied to vaccines are increasingly used by public health authorities and pharmaceutical companies as an important tool to help decision makers with supporting benefit-risk assessment (BRA). However, many publications on vaccine qBRm provide insufficient details on the methodological approaches used. Incomplete and/or inadequate qBRm reporting may affect result interpretation and confidence in BRA, highlighting a need for the development of standard reporting guidance. Objectives Our objective was to provide an operational checklist for improved reporting of vaccine qBRm. Methods The consolidated standards of reporting quantitative Benefit-RIsk models applied to VACcines (BRIVAC) were designed as a checklist of key information to report in qBRm scientific publications regarding the assessed vaccines, the methodological considerations and the results and their interpretation. Results In total, 22 items and accompanying definitions, recommendations, explanations and examples were provided and divided into six main sections corresponding to the classic subdivisions of a scientific publication: title and abstract (items 1–2), introduction (items 3–4), methods (items 5–15), results (items 16–17), discussion (items 18–20) and other (items 21–22). Conclusions The BRIVAC checklist is the first initiative providing an operational checklist for improved reporting of qBRm applied to vaccines in scientific articles. It is intended to assist authors, peer-reviewers, editors and readers in their critical appraisal. Future initiatives are needed to provide methodological guidance to perform qBRm while taking into account the vaccine specificities. Key Points
* Hugo Arlegui [email protected] 1
University of Bordeaux, UMR1219, 33000 Bordeaux, France
2
INSERM, UMR1219, Bordeaux Population Health Research Center, Pharmacoepidemiology Team, 33000 Bordeaux, France
3
GSK, 23, rue François Jacob, 92500 Rueil‑Malmaison, France
4
P95 Pharmacovigilance and Epidemiology Services, 3001 Leuven, Belgium
5
GSK, 1300 Wavre, Belgium
Although quantitative benefit-risk models (qBRm) applied to vaccines are increasingly used as an important tool to help decision makers with supporting benefitrisk assessment, many publications on vaccine qBRm provide insufficient details on the methodological approaches used. The aim of the present paper is to provide an operational checklist for improved reporting of vaccine qBRm in scientific articles: the consolidated standards of reporting quantitative Benefit-RIsk models applied to VACcines (BRIVAC) checklist. The BRIVAC checklist is intended to (1) assist authors in adequately reporting qBRm methodolog
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