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Benefit–Risk Monitoring of Vaccines Using an Interactive Dashboard: A Methodological Proposal from the ADVANCE Project

INTRODUCTION: New vaccines are launched based on their benefit–risk (B/R) profile anticipated from clinical development. Proactive post-marketing surveillance is necessary to assess whether the vaccination uptake and the B/R profile are as expected and, ultimately, whether further public health or r...

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Autores principales: Bollaerts, Kaatje, De Smedt, Tom, Donegan, Katherine, Titievsky, Lina, Bauchau, Vincent
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6061437/
https://www.ncbi.nlm.nih.gov/pubmed/29582392
http://dx.doi.org/10.1007/s40264-018-0658-y
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author Bollaerts, Kaatje
De Smedt, Tom
Donegan, Katherine
Titievsky, Lina
Bauchau, Vincent
author_facet Bollaerts, Kaatje
De Smedt, Tom
Donegan, Katherine
Titievsky, Lina
Bauchau, Vincent
author_sort Bollaerts, Kaatje
collection PubMed
description INTRODUCTION: New vaccines are launched based on their benefit–risk (B/R) profile anticipated from clinical development. Proactive post-marketing surveillance is necessary to assess whether the vaccination uptake and the B/R profile are as expected and, ultimately, whether further public health or regulatory actions are needed. There are several, typically not integrated, facets of post-marketing vaccine surveillance: the surveillance of vaccination coverage, vaccine safety, effectiveness and impact. OBJECTIVE: With this work, we aim to assess the feasibility and added value of using an interactive dashboard as a potential methodology for near real-time monitoring of vaccine coverage and pre-specified health benefits and risks of vaccines. METHODS: We developed a web application with an interactive dashboard for B/R monitoring. The dashboard is demonstrated using simulated electronic healthcare record data mimicking the introduction of rotavirus vaccination in the UK. The interactive dashboard allows end users to select certain parameters, including expected vaccine effectiveness, age groups, and time periods and allows calculation of the incremental net health benefit (INHB) as well as the incremental benefit–risk ratio (IBRR) for different sets of preference weights. We assessed the potential added value of the dashboard by user testing amongst a range of stakeholders experienced in the post-marketing monitoring of vaccines. RESULTS: The dashboard was successfully implemented and demonstrated. The feedback from the potential end users was generally positive, although reluctance to using composite B/R measures was expressed. CONCLUSION: The use of interactive dashboards for B/R monitoring is promising and received support from various stakeholders. In future research, the use of such an interactive dashboard will be further tested with real-life data as opposed to simulated data. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s40264-018-0658-y) contains supplementary material, which is available to authorized users.
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spelling pubmed-60614372018-08-09 Benefit–Risk Monitoring of Vaccines Using an Interactive Dashboard: A Methodological Proposal from the ADVANCE Project Bollaerts, Kaatje De Smedt, Tom Donegan, Katherine Titievsky, Lina Bauchau, Vincent Drug Saf Original Research Article INTRODUCTION: New vaccines are launched based on their benefit–risk (B/R) profile anticipated from clinical development. Proactive post-marketing surveillance is necessary to assess whether the vaccination uptake and the B/R profile are as expected and, ultimately, whether further public health or regulatory actions are needed. There are several, typically not integrated, facets of post-marketing vaccine surveillance: the surveillance of vaccination coverage, vaccine safety, effectiveness and impact. OBJECTIVE: With this work, we aim to assess the feasibility and added value of using an interactive dashboard as a potential methodology for near real-time monitoring of vaccine coverage and pre-specified health benefits and risks of vaccines. METHODS: We developed a web application with an interactive dashboard for B/R monitoring. The dashboard is demonstrated using simulated electronic healthcare record data mimicking the introduction of rotavirus vaccination in the UK. The interactive dashboard allows end users to select certain parameters, including expected vaccine effectiveness, age groups, and time periods and allows calculation of the incremental net health benefit (INHB) as well as the incremental benefit–risk ratio (IBRR) for different sets of preference weights. We assessed the potential added value of the dashboard by user testing amongst a range of stakeholders experienced in the post-marketing monitoring of vaccines. RESULTS: The dashboard was successfully implemented and demonstrated. The feedback from the potential end users was generally positive, although reluctance to using composite B/R measures was expressed. CONCLUSION: The use of interactive dashboards for B/R monitoring is promising and received support from various stakeholders. In future research, the use of such an interactive dashboard will be further tested with real-life data as opposed to simulated data. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s40264-018-0658-y) contains supplementary material, which is available to authorized users. Springer International Publishing 2018-03-26 2018 /pmc/articles/PMC6061437/ /pubmed/29582392 http://dx.doi.org/10.1007/s40264-018-0658-y Text en © The Author(s) 2018 Open AccessThis article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
spellingShingle Original Research Article
Bollaerts, Kaatje
De Smedt, Tom
Donegan, Katherine
Titievsky, Lina
Bauchau, Vincent
Benefit–Risk Monitoring of Vaccines Using an Interactive Dashboard: A Methodological Proposal from the ADVANCE Project
title Benefit–Risk Monitoring of Vaccines Using an Interactive Dashboard: A Methodological Proposal from the ADVANCE Project
title_full Benefit–Risk Monitoring of Vaccines Using an Interactive Dashboard: A Methodological Proposal from the ADVANCE Project
title_fullStr Benefit–Risk Monitoring of Vaccines Using an Interactive Dashboard: A Methodological Proposal from the ADVANCE Project
title_full_unstemmed Benefit–Risk Monitoring of Vaccines Using an Interactive Dashboard: A Methodological Proposal from the ADVANCE Project
title_short Benefit–Risk Monitoring of Vaccines Using an Interactive Dashboard: A Methodological Proposal from the ADVANCE Project
title_sort benefit–risk monitoring of vaccines using an interactive dashboard: a methodological proposal from the advance project
topic Original Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6061437/
https://www.ncbi.nlm.nih.gov/pubmed/29582392
http://dx.doi.org/10.1007/s40264-018-0658-y
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