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Causality Assessment Guidelines for Adverse Events Following Immunization with a Focus on Guillain–Barré Syndrome

South Korea operates a National Vaccine Injury Compensation Program (VICP) for people who experience adverse events following immunization (AEFI). To run this program rationally, it is a prerequisite to confirm whether adverse events were caused by immunization. Guillain–Barré syndrome (GBS), a seve...

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Autores principales: Lee, Hankil, Kang, Hye-Young, Cho, Sunghwa, Park, Seonyoung, Kim, Ah-Young, Jung, Sun-Young, Seong, Baik Lin, Lee, Young-Mock
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7157213/
https://www.ncbi.nlm.nih.gov/pubmed/32102455
http://dx.doi.org/10.3390/vaccines8010101
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author Lee, Hankil
Kang, Hye-Young
Cho, Sunghwa
Park, Seonyoung
Kim, Ah-Young
Jung, Sun-Young
Seong, Baik Lin
Lee, Young-Mock
author_facet Lee, Hankil
Kang, Hye-Young
Cho, Sunghwa
Park, Seonyoung
Kim, Ah-Young
Jung, Sun-Young
Seong, Baik Lin
Lee, Young-Mock
author_sort Lee, Hankil
collection PubMed
description South Korea operates a National Vaccine Injury Compensation Program (VICP) for people who experience adverse events following immunization (AEFI). To run this program rationally, it is a prerequisite to confirm whether adverse events were caused by immunization. Guillain–Barré syndrome (GBS), a severe neurological disease with limb pain and muscle weakness as cardinal symptoms, is attracting attention as an AEFI. However, algorithm or guidelines for assessing the causality between vaccination and the incidence of GBS are lacking. We aimed to develop guidelines for causality assessment of GBS as an AEFI and suggest using these guidelines in alignment with the VICP. We systematically searched for other previously published algorithms or guidelines and found a WHO-AEFI guideline used worldwide; however, it only provides general instructions and is not tailored to specific adverse events. We translated and locally adapted the structure of this guideline and then added contents related to GBS. The GBS-specific guideline consists of four steps: case ascertainment of GBS, checklist (including (1) order of incidence, (2) temporal proximity, (3) evidence for other causes and (4) published evidence), an algorithm, and final classification. We listed key information on confirming GBS and whether any other causes of GBS were present. For real world application of the guideline along with the VICP, we collaborated with a panel of neurologists, epidemiologic investigators, and committee members from the VICP. To ensure transparency and a scientific approach, regular updates and collaboration with neurologists are essential. We expect that this guideline will contribute to logical causality assessment and compensation decisions for GBS and will provide the basic structure for causality assessment of other AEFIs.
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spelling pubmed-71572132020-05-01 Causality Assessment Guidelines for Adverse Events Following Immunization with a Focus on Guillain–Barré Syndrome Lee, Hankil Kang, Hye-Young Cho, Sunghwa Park, Seonyoung Kim, Ah-Young Jung, Sun-Young Seong, Baik Lin Lee, Young-Mock Vaccines (Basel) Article South Korea operates a National Vaccine Injury Compensation Program (VICP) for people who experience adverse events following immunization (AEFI). To run this program rationally, it is a prerequisite to confirm whether adverse events were caused by immunization. Guillain–Barré syndrome (GBS), a severe neurological disease with limb pain and muscle weakness as cardinal symptoms, is attracting attention as an AEFI. However, algorithm or guidelines for assessing the causality between vaccination and the incidence of GBS are lacking. We aimed to develop guidelines for causality assessment of GBS as an AEFI and suggest using these guidelines in alignment with the VICP. We systematically searched for other previously published algorithms or guidelines and found a WHO-AEFI guideline used worldwide; however, it only provides general instructions and is not tailored to specific adverse events. We translated and locally adapted the structure of this guideline and then added contents related to GBS. The GBS-specific guideline consists of four steps: case ascertainment of GBS, checklist (including (1) order of incidence, (2) temporal proximity, (3) evidence for other causes and (4) published evidence), an algorithm, and final classification. We listed key information on confirming GBS and whether any other causes of GBS were present. For real world application of the guideline along with the VICP, we collaborated with a panel of neurologists, epidemiologic investigators, and committee members from the VICP. To ensure transparency and a scientific approach, regular updates and collaboration with neurologists are essential. We expect that this guideline will contribute to logical causality assessment and compensation decisions for GBS and will provide the basic structure for causality assessment of other AEFIs. MDPI 2020-02-24 /pmc/articles/PMC7157213/ /pubmed/32102455 http://dx.doi.org/10.3390/vaccines8010101 Text en © 2020 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Lee, Hankil
Kang, Hye-Young
Cho, Sunghwa
Park, Seonyoung
Kim, Ah-Young
Jung, Sun-Young
Seong, Baik Lin
Lee, Young-Mock
Causality Assessment Guidelines for Adverse Events Following Immunization with a Focus on Guillain–Barré Syndrome
title Causality Assessment Guidelines for Adverse Events Following Immunization with a Focus on Guillain–Barré Syndrome
title_full Causality Assessment Guidelines for Adverse Events Following Immunization with a Focus on Guillain–Barré Syndrome
title_fullStr Causality Assessment Guidelines for Adverse Events Following Immunization with a Focus on Guillain–Barré Syndrome
title_full_unstemmed Causality Assessment Guidelines for Adverse Events Following Immunization with a Focus on Guillain–Barré Syndrome
title_short Causality Assessment Guidelines for Adverse Events Following Immunization with a Focus on Guillain–Barré Syndrome
title_sort causality assessment guidelines for adverse events following immunization with a focus on guillain–barré syndrome
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7157213/
https://www.ncbi.nlm.nih.gov/pubmed/32102455
http://dx.doi.org/10.3390/vaccines8010101
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