Benefit-Risk Assessment of Vaccines. Part II: Proposal Towards Consolidated Standards of Reporting Quantitative Benefit-Risk Models Applied to Vaccines (BRIVAC)
| Autor: | Kaatje Bollaerts, Hugo Arlegui, Nicolas Praet, Bernard Bégaud, Gaëlle Nachbaur, Vincent Bauchau |
|---|---|
| Přispěvatelé: | Bordeaux population health (BPH), Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM) |
| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
medicine.medical_specialty
Biomedical Research Pharmacology toxicology Toxicology Models Biological Risk Assessment 030226 pharmacology & pharmacy 03 medical and health sciences 0302 clinical medicine Humans Medicine Pharmacology (medical) Original Research Article 030212 general & internal medicine Pharmacology PharmacoEpi-Drugs Vaccines Actuarial science business.industry Public health Checklist 3. Good health Critical appraisal Communicable Disease Control Benefit risk assessment [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie business |
| Zdroj: | Drug Safety Drug Safety, Springer Verlag, 2020, 43 (11), pp.1105-1120. ⟨10.1007/s40264-020-00982-9⟩ |
| ISSN: | 0114-5916 |
| DOI: | 10.1007/s40264-020-00982-9⟩ |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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