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 of...

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Veröffentlicht in:Drug safety 2021-03, Vol.44 (3), p.383-395
Hauptverfasser: 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.
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container_end_page 395
container_issue 3
container_start_page 383
container_title Drug safety
container_volume 44
creator 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.
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.
doi_str_mv 10.1007/s40264-020-01031-1
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J. M.</creator><creatorcontrib>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.</creatorcontrib><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.</description><identifier>ISSN: 0114-5916</identifier><identifier>EISSN: 1179-1942</identifier><identifier>DOI: 10.1007/s40264-020-01031-1</identifier><identifier>PMID: 33462778</identifier><language>eng</language><publisher>Cham: Springer International Publishing</publisher><subject>Age ; Autoimmune diseases ; Autoimmune Diseases - epidemiology ; Bell Palsy - epidemiology ; Bell's palsy ; Calendars ; Chronic conditions ; Codes ; Collaboration ; Confidence intervals ; Consistency ; Data processing ; Delivery of Health Care ; Drug Safety and Pharmacovigilance ; Encephalomyelitis ; Guillain-Barre syndrome ; Health care ; Humans ; Idiopathic thrombocytopenic purpura ; Incidence ; Kawasaki disease ; Lupus ; Medicine ; Medicine &amp; Public Health ; Mucocutaneous Lymph Node Syndrome ; Myelitis ; Narcolepsy ; Neuritis ; Optic neuritis ; Original ; Original Research Article ; Paralysis ; Pharmacology/Toxicology ; Population ; Primary care ; Purpura ; Sex ; Sleep disorders ; Software ; Systemic lupus erythematosus ; Thrombocytopenia ; Vaccination ; Vaccines</subject><ispartof>Drug safety, 2021-03, Vol.44 (3), p.383-395</ispartof><rights>The Author(s) 2021</rights><rights>Copyright Springer Nature B.V. 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J. M.</creatorcontrib><title>Incidence Rates of Autoimmune Diseases in European Healthcare Databases: A Contribution of the ADVANCE Project</title><title>Drug safety</title><addtitle>Drug Saf</addtitle><addtitle>Drug Saf</addtitle><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. 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J. M.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Incidence Rates of Autoimmune Diseases in European Healthcare Databases: A Contribution of the ADVANCE Project</atitle><jtitle>Drug safety</jtitle><stitle>Drug Saf</stitle><addtitle>Drug Saf</addtitle><date>2021-03-01</date><risdate>2021</risdate><volume>44</volume><issue>3</issue><spage>383</spage><epage>395</epage><pages>383-395</pages><issn>0114-5916</issn><eissn>1179-1942</eissn><abstract>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.</abstract><cop>Cham</cop><pub>Springer International Publishing</pub><pmid>33462778</pmid><doi>10.1007/s40264-020-01031-1</doi><tpages>13</tpages><orcidid>https://orcid.org/0000-0002-6310-6019</orcidid><oa>free_for_read</oa></addata></record>
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subjects Age
Autoimmune diseases
Autoimmune Diseases - epidemiology
Bell Palsy - epidemiology
Bell's palsy
Calendars
Chronic conditions
Codes
Collaboration
Confidence intervals
Consistency
Data processing
Delivery of Health Care
Drug Safety and Pharmacovigilance
Encephalomyelitis
Guillain-Barre syndrome
Health care
Humans
Idiopathic thrombocytopenic purpura
Incidence
Kawasaki disease
Lupus
Medicine
Medicine & Public Health
Mucocutaneous Lymph Node Syndrome
Myelitis
Narcolepsy
Neuritis
Optic neuritis
Original
Original Research Article
Paralysis
Pharmacology/Toxicology
Population
Primary care
Purpura
Sex
Sleep disorders
Software
Systemic lupus erythematosus
Thrombocytopenia
Vaccination
Vaccines
title Incidence Rates of Autoimmune Diseases in European Healthcare Databases: A Contribution of the ADVANCE Project
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