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Evaluation of the decision-making process underlying the initial off-label use of vaccines: a scoping review protocol

INTRODUCTION: Vaccination has become a central part of public health prevention. Vaccines are introduced after licensure by national regulatory authorities, whereas recommendations for use of licensed vaccines are made by national or international advisory committees and may include off-label use. T...

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Autores principales: Diallo, Dieynaba, Quach, Caroline
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7934726/
https://www.ncbi.nlm.nih.gov/pubmed/33664073
http://dx.doi.org/10.1136/bmjopen-2020-042748
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author Diallo, Dieynaba
Quach, Caroline
author_facet Diallo, Dieynaba
Quach, Caroline
author_sort Diallo, Dieynaba
collection PubMed
description INTRODUCTION: Vaccination has become a central part of public health prevention. Vaccines are introduced after licensure by national regulatory authorities, whereas recommendations for use of licensed vaccines are made by national or international advisory committees and may include off-label use. The methodological and decision-making processes that are used to assess novel initial off-label vaccine use are unclear. This review aims to examine the off-label assessment processes to map evidence and concepts used in the decision-making process and present a common approach between all recommendations and specifics of each decision. METHODS AND ANALYSIS: The methodological framework described at the Joanna Briggs Institute will be applied to this scoping review. A search strategy was developed, in collaboration with an experienced senior health research librarian, by combining Mesgarpour’s highly sensitive search strategies. Peer-reviewed and grey literature will be systematically identified using PubMed, Medline and EMBASE; governmental agency and pharmaceutical websites; and search engines, such as Google Scholar. Reports and studies on off-label vaccine use in public health will be included. Screening will be independently undertaken by two reviewers. Data will be extracted using a standard form. Results will be narratively summarised to highlight relevant findings and guide the development of an analytical framework for off-label vaccination recommendations. ETHICS AND DISSEMINATION: This research does not require ethical approval. This scoping review will provide decision-making elements and a synthesis of knowledge on vaccines off-label use. Findings will be relevant to decision-makers/advisory committees and public health. These will be disseminated through peer-reviewed articles and conferences.
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spelling pubmed-79347262021-03-19 Evaluation of the decision-making process underlying the initial off-label use of vaccines: a scoping review protocol Diallo, Dieynaba Quach, Caroline BMJ Open Public Health INTRODUCTION: Vaccination has become a central part of public health prevention. Vaccines are introduced after licensure by national regulatory authorities, whereas recommendations for use of licensed vaccines are made by national or international advisory committees and may include off-label use. The methodological and decision-making processes that are used to assess novel initial off-label vaccine use are unclear. This review aims to examine the off-label assessment processes to map evidence and concepts used in the decision-making process and present a common approach between all recommendations and specifics of each decision. METHODS AND ANALYSIS: The methodological framework described at the Joanna Briggs Institute will be applied to this scoping review. A search strategy was developed, in collaboration with an experienced senior health research librarian, by combining Mesgarpour’s highly sensitive search strategies. Peer-reviewed and grey literature will be systematically identified using PubMed, Medline and EMBASE; governmental agency and pharmaceutical websites; and search engines, such as Google Scholar. Reports and studies on off-label vaccine use in public health will be included. Screening will be independently undertaken by two reviewers. Data will be extracted using a standard form. Results will be narratively summarised to highlight relevant findings and guide the development of an analytical framework for off-label vaccination recommendations. ETHICS AND DISSEMINATION: This research does not require ethical approval. This scoping review will provide decision-making elements and a synthesis of knowledge on vaccines off-label use. Findings will be relevant to decision-makers/advisory committees and public health. These will be disseminated through peer-reviewed articles and conferences. BMJ Publishing Group 2021-03-04 /pmc/articles/PMC7934726/ /pubmed/33664073 http://dx.doi.org/10.1136/bmjopen-2020-042748 Text en © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/ http://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
spellingShingle Public Health
Diallo, Dieynaba
Quach, Caroline
Evaluation of the decision-making process underlying the initial off-label use of vaccines: a scoping review protocol
title Evaluation of the decision-making process underlying the initial off-label use of vaccines: a scoping review protocol
title_full Evaluation of the decision-making process underlying the initial off-label use of vaccines: a scoping review protocol
title_fullStr Evaluation of the decision-making process underlying the initial off-label use of vaccines: a scoping review protocol
title_full_unstemmed Evaluation of the decision-making process underlying the initial off-label use of vaccines: a scoping review protocol
title_short Evaluation of the decision-making process underlying the initial off-label use of vaccines: a scoping review protocol
title_sort evaluation of the decision-making process underlying the initial off-label use of vaccines: a scoping review protocol
topic Public Health
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7934726/
https://www.ncbi.nlm.nih.gov/pubmed/33664073
http://dx.doi.org/10.1136/bmjopen-2020-042748
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