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Incidence Rates of Autoimmune Diseases in European Healthcare Databases: A Contribution of the ADVANCE Project

INTRODUCTION: The public–private ADVANCE collaboration developed and tested a system to generate evidence on vaccine benefits and risks using European electronic healthcare databases. In the safety of vaccines, background incidence rates are key to allow proper monitoring and assessment. The goals o...

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Autores principales: Willame, Corinne, Dodd, Caitlin, van der Aa, Lieke, Picelli, Gino, Emborg, Hanne-Dorthe, Kahlert, Johnny, Gini, Rosa, Huerta, Consuelo, Martín-Merino, Elisa, McGee, Chris, de Lusignan, Simon, Roberto, Giuseppe, Villa, Marco, Weibel, Daniel, Titievsky, Lina, Sturkenboom, Miriam C. J. M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7892524/
https://www.ncbi.nlm.nih.gov/pubmed/33462778
http://dx.doi.org/10.1007/s40264-020-01031-1
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author Willame, Corinne
Dodd, Caitlin
van der Aa, Lieke
Picelli, Gino
Emborg, Hanne-Dorthe
Kahlert, Johnny
Gini, Rosa
Huerta, Consuelo
Martín-Merino, Elisa
McGee, Chris
de Lusignan, Simon
Roberto, Giuseppe
Villa, Marco
Weibel, Daniel
Titievsky, Lina
Sturkenboom, Miriam C. J. M.
author_facet Willame, Corinne
Dodd, Caitlin
van der Aa, Lieke
Picelli, Gino
Emborg, Hanne-Dorthe
Kahlert, Johnny
Gini, Rosa
Huerta, Consuelo
Martín-Merino, Elisa
McGee, Chris
de Lusignan, Simon
Roberto, Giuseppe
Villa, Marco
Weibel, Daniel
Titievsky, Lina
Sturkenboom, Miriam C. J. M.
author_sort Willame, Corinne
collection PubMed
description INTRODUCTION: The public–private ADVANCE collaboration developed and tested a system to generate evidence on vaccine benefits and risks using European electronic healthcare databases. In the safety of vaccines, background incidence rates are key to allow proper monitoring and assessment. The goals of this study were to compute age-, sex-, and calendar-year stratified incidence rates of nine autoimmune diseases in seven European healthcare databases from four countries and to assess validity by comparing with published data. METHODS: Event rates were calculated for the following outcomes: acute disseminated encephalomyelitis, Bell’s palsy, Guillain–Barré syndrome, immune thrombocytopenia purpura, Kawasaki disease, optic neuritis, narcolepsy, systemic lupus erythematosus, and transverse myelitis. Cases were identified by diagnosis codes. Participating organizations/databases originated from Denmark, Italy, Spain, and the UK. The source population comprised all persons registered, with at least 1 year of data prior to the study start, or follow-up from birth. Stratified incidence rates were computed per database over the period 2003 to 2014. RESULTS: Between 2003 and 2014, 148,947 incident cases of nine autoimmune diseases were identified. Crude incidence rates were highest for Bell’s palsy [23.8/100,000 person-years (PYs), 95% confidence interval (CI) 23.6–24.1] and lowest for Kawasaki disease (0.7/100,000 PYs, 95% CI 0.6–0.7). Specific patterns were observed by sex, age, calendar time, and data sources. Rates were comparable with published estimates. CONCLUSION: A range of autoimmune events could be identified in the ADVANCE system. Estimation of rates indicated consistency across selected European healthcare databases, as well as consistency with US published data. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40264-020-01031-1.
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spelling pubmed-78925242021-03-03 Incidence Rates of Autoimmune Diseases in European Healthcare Databases: A Contribution of the ADVANCE Project Willame, Corinne Dodd, Caitlin van der Aa, Lieke Picelli, Gino Emborg, Hanne-Dorthe Kahlert, Johnny Gini, Rosa Huerta, Consuelo Martín-Merino, Elisa McGee, Chris de Lusignan, Simon Roberto, Giuseppe Villa, Marco Weibel, Daniel Titievsky, Lina Sturkenboom, Miriam C. J. M. Drug Saf Original Research Article INTRODUCTION: The public–private ADVANCE collaboration developed and tested a system to generate evidence on vaccine benefits and risks using European electronic healthcare databases. In the safety of vaccines, background incidence rates are key to allow proper monitoring and assessment. The goals of this study were to compute age-, sex-, and calendar-year stratified incidence rates of nine autoimmune diseases in seven European healthcare databases from four countries and to assess validity by comparing with published data. METHODS: Event rates were calculated for the following outcomes: acute disseminated encephalomyelitis, Bell’s palsy, Guillain–Barré syndrome, immune thrombocytopenia purpura, Kawasaki disease, optic neuritis, narcolepsy, systemic lupus erythematosus, and transverse myelitis. Cases were identified by diagnosis codes. Participating organizations/databases originated from Denmark, Italy, Spain, and the UK. The source population comprised all persons registered, with at least 1 year of data prior to the study start, or follow-up from birth. Stratified incidence rates were computed per database over the period 2003 to 2014. RESULTS: Between 2003 and 2014, 148,947 incident cases of nine autoimmune diseases were identified. Crude incidence rates were highest for Bell’s palsy [23.8/100,000 person-years (PYs), 95% confidence interval (CI) 23.6–24.1] and lowest for Kawasaki disease (0.7/100,000 PYs, 95% CI 0.6–0.7). Specific patterns were observed by sex, age, calendar time, and data sources. Rates were comparable with published estimates. CONCLUSION: A range of autoimmune events could be identified in the ADVANCE system. Estimation of rates indicated consistency across selected European healthcare databases, as well as consistency with US published data. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40264-020-01031-1. Springer International Publishing 2021-01-19 2021 /pmc/articles/PMC7892524/ /pubmed/33462778 http://dx.doi.org/10.1007/s40264-020-01031-1 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by-nc/4.0/Open AccessThis article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Original Research Article
Willame, Corinne
Dodd, Caitlin
van der Aa, Lieke
Picelli, Gino
Emborg, Hanne-Dorthe
Kahlert, Johnny
Gini, Rosa
Huerta, Consuelo
Martín-Merino, Elisa
McGee, Chris
de Lusignan, Simon
Roberto, Giuseppe
Villa, Marco
Weibel, Daniel
Titievsky, Lina
Sturkenboom, Miriam C. J. M.
Incidence Rates of Autoimmune Diseases in European Healthcare Databases: A Contribution of the ADVANCE Project
title Incidence Rates of Autoimmune Diseases in European Healthcare Databases: A Contribution of the ADVANCE Project
title_full Incidence Rates of Autoimmune Diseases in European Healthcare Databases: A Contribution of the ADVANCE Project
title_fullStr Incidence Rates of Autoimmune Diseases in European Healthcare Databases: A Contribution of the ADVANCE Project
title_full_unstemmed Incidence Rates of Autoimmune Diseases in European Healthcare Databases: A Contribution of the ADVANCE Project
title_short Incidence Rates of Autoimmune Diseases in European Healthcare Databases: A Contribution of the ADVANCE Project
title_sort incidence rates of autoimmune diseases in european healthcare databases: a contribution of the advance project
topic Original Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7892524/
https://www.ncbi.nlm.nih.gov/pubmed/33462778
http://dx.doi.org/10.1007/s40264-020-01031-1
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