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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...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2020
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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. |
format | Online Article Text |
id | pubmed-7157213 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
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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