GrippeCanadaV3, Main, Exploration, bibRecord, 000049

Incidence rates of narcolepsy diagnoses in Taiwan, Canada, and Europe: The use of statistical simulation to evaluate methods for the rapid assessment of potential safety issues on a population level in the SOMNIA study.

Identifieur interne : 000049 ( Main/Exploration ); précédent : 000048; suivant : 000050

Incidence rates of narcolepsy diagnoses in Taiwan, Canada, and Europe: The use of statistical simulation to evaluate methods for the rapid assessment of potential safety issues on a population level in the SOMNIA study.

Auteurs : Caitlin N. Dodd [Pays-Bas] ; Maria De Ridder [Pays-Bas] ; Wan-Ting Huang [Taïwan] ; Daniel Weibel [Pays-Bas] ; Maria Giner-Soriano [Espagne] ; Silvia Perez-Vilar [Pays-Bas, Espagne] ; Javier Diez-Domingo [Espagne] ; Lawrence W. Svenson [Canada] ; Salahddin M. Mahmud [Canada] ; Bruce Carleton [Canada] ; Monika Naus [Canada] ; Jeffrey C. Kwong [Canada] ; Brian J. Murray [Canada] ; Lisen Arnheim-Dahlstrom [Suède] ; Lars Pedersen [Danemark] ; Rosa Morros [Espagne] ; Francisco Javier Puertas [Espagne] ; Steven Black [États-Unis] ; Miriam Sturkenboom [Pays-Bas]

Source :

PloS one [ 1932-6203 ] ; 2018.

RBID : pubmed:30332477

Descripteurs français

KwdFr :
- Adjuvants immunologiques (effets indésirables), Adolescent, Adulte, Adulte d'âge moyen, Canada (épidémiologie), Enfant, Enfant d'âge préscolaire, Europe (épidémiologie), Facteurs de risque, Femelle, Grippe humaine (), Grippe humaine (immunologie), Humains, Incidence, Jeune adulte, Modèles statistiques, Mâle, Narcolepsie (diagnostic), Narcolepsie (épidémiologie), Narcolepsie (étiologie), Nourrisson, Nouveau-né, Simulation numérique, Sous-type H1N1 du virus de la grippe A (immunologie), Sujet âgé, Sujet âgé de 80 ans ou plus, Sécurité, Taïwan (épidémiologie), Vaccination (effets indésirables), Vaccins antigrippaux (effets indésirables).
MESH :
- diagnostic : Narcolepsie.
- effets indésirables : Adjuvants immunologiques, Vaccination, Vaccins antigrippaux.
- immunologie : Grippe humaine, Sous-type H1N1 du virus de la grippe A.
- épidémiologie : Canada, Europe, Narcolepsie, Taïwan.
- étiologie : Narcolepsie.
- Adolescent, Adulte, Adulte d'âge moyen, Enfant, Enfant d'âge préscolaire, Facteurs de risque, Femelle, Grippe humaine, Humains, Incidence, Jeune adulte, Modèles statistiques, Mâle, Nourrisson, Nouveau-né, Simulation numérique, Sujet âgé, Sujet âgé de 80 ans ou plus, Sécurité.
Wicri :
- geographic : Canada, Taïwan.

English descriptors

KwdEn :
- Adjuvants, Immunologic (adverse effects), Adolescent, Adult, Aged, Aged, 80 and over, Canada (epidemiology), Child, Child, Preschool, Computer Simulation, Europe (epidemiology), Female, Humans, Incidence, Infant, Infant, Newborn, Influenza A Virus, H1N1 Subtype (immunology), Influenza Vaccines (adverse effects), Influenza, Human (complications), Influenza, Human (immunology), Male, Middle Aged, Models, Statistical, Narcolepsy (diagnosis), Narcolepsy (epidemiology), Narcolepsy (etiology), Risk Factors, Safety, Taiwan (epidemiology), Vaccination (adverse effects), Young Adult.
MESH :
- chemical , adverse effects : Adjuvants, Immunologic, Influenza Vaccines.
- geographic , epidemiology : Canada, Europe, Taiwan.
- adverse effects : Vaccination.
- complications : Influenza, Human.
- diagnosis : Narcolepsy.
- epidemiology : Narcolepsy.
- etiology : Narcolepsy.
- immunology : Influenza A Virus, H1N1 Subtype, Influenza, Human.
- Adolescent, Adult, Aged, Aged, 80 and over, Child, Child, Preschool, Computer Simulation, Female, Humans, Incidence, Infant, Infant, Newborn, Male, Middle Aged, Models, Statistical, Risk Factors, Safety, Young Adult.

Abstract

BACKGROUND & OBJECTIVES

Vaccine safety signals require investigation, which may be done rapidly at the population level using ecological studies, before embarking on hypothesis-testing studies. Incidence rates were used to assess a signal of narcolepsy following AS03-adjuvanted monovalent pandemic H1N1 (pH1N1) influenza vaccination among children and adolescents in Sweden and Finland in 2010. We explored the utility of ecological data to assess incidence of narcolepsy following exposure to pandemic H1N1 virus or vaccination in 10 sites that used different vaccines, adjuvants, and had varying vaccine coverage.

METHODS

We calculated incidence rates of diagnosed narcolepsy for periods defined by influenza virus circulation and vaccination campaign dates, and used Poisson regression to estimate incidence rate ratios (IRRs) comparing the periods during which wild-type virus circulated and after the start of vaccination campaigns vs. the period prior to pH1N1 virus circulation. We used electronic health care data from Sweden, Denmark, the United Kingdom, Canada (3 provinces), Taiwan, Netherlands, and Spain (2 regions) from 2003 to 2013. We investigated interactions between age group and adjuvant in European sites and conducted a simulation study to investigate how vaccine coverage, age, and the interval from onset to diagnosis may impact the ability to detect safety signals.

RESULTS

Incidence rates of narcolepsy varied by age, continent, and period. Only in Taiwan and Sweden were significant time-period-by-age-group interactions observed. Associations were found for children in Taiwan (following pH1N1 virus circulation) and Sweden (following vaccination). Simulations showed that the individual-level relative risk of narcolepsy was underestimated using ecological methods comparing post- vs. pre-vaccination periods; this effect was attenuated with higher vaccine coverage and a shorter interval from disease onset to diagnosis.

CONCLUSIONS

Ecological methods can be useful for vaccine safety assessment but the results are influenced by diagnostic delay and vaccine coverage. Because ecological methods assess risk at the population level, these methods should be treated as signal-generating methods and drawing conclusions regarding individual-level risk should be avoided.

DOI: 10.1371/journal.pone.0204799
PubMed: 30332477

Affiliations:

Links toward previous steps (curation, corpus...)

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Le document en format XML

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<author><name sortKey="Diez Domingo, Javier" sort="Diez Domingo, Javier" uniqKey="Diez Domingo J" first="Javier" last="Diez-Domingo">Javier Diez-Domingo</name>
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<author><name sortKey="Morros, Rosa" sort="Morros, Rosa" uniqKey="Morros R" first="Rosa" last="Morros">Rosa Morros</name>
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<affiliation wicri:level="1"><nlm:affiliation>Physiology Department, University of Valencia, Valencia, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>Physiology Department, University of Valencia, Valencia</wicri:regionArea>
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<author><name sortKey="Black, Steven" sort="Black, Steven" uniqKey="Black S" first="Steven" last="Black">Steven Black</name>
<affiliation wicri:level="2"><nlm:affiliation>Cincinnati Children's Hospital, Center for Global Health, Cincinnati, Ohio, United States of America.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Cincinnati Children's Hospital, Center for Global Health, Cincinnati, Ohio</wicri:regionArea>
<placeName><region type="state">Ohio</region>
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<author><name sortKey="Sturkenboom, Miriam" sort="Sturkenboom, Miriam" uniqKey="Sturkenboom M" first="Miriam" last="Sturkenboom">Miriam Sturkenboom</name>
<affiliation wicri:level="3"><nlm:affiliation>Julius Center Global Health, University Medical Center Utrecht, Utrecht, The Netherlands.</nlm:affiliation>
<country xml:lang="fr">Pays-Bas</country>
<wicri:regionArea>Julius Center Global Health, University Medical Center Utrecht, Utrecht</wicri:regionArea>
<placeName><settlement type="city">Utrecht</settlement>
<region nuts="2" type="province">Utrecht (province)</region>
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<sourceDesc><biblStruct><analytic><title xml:lang="en">Incidence rates of narcolepsy diagnoses in Taiwan, Canada, and Europe: The use of statistical simulation to evaluate methods for the rapid assessment of potential safety issues on a population level in the SOMNIA study.</title>
<author><name sortKey="Dodd, Caitlin N" sort="Dodd, Caitlin N" uniqKey="Dodd C" first="Caitlin N" last="Dodd">Caitlin N. Dodd</name>
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<affiliation wicri:level="3"><nlm:affiliation>Julius Center Global Health, University Medical Center Utrecht, Utrecht, The Netherlands.</nlm:affiliation>
<country xml:lang="fr">Pays-Bas</country>
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<author><name sortKey="De Ridder, Maria" sort="De Ridder, Maria" uniqKey="De Ridder M" first="Maria" last="De Ridder">Maria De Ridder</name>
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<wicri:regionArea>Erasmus Medical Center, Rotterdam</wicri:regionArea>
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<author><name sortKey="Huang, Wan Ting" sort="Huang, Wan Ting" uniqKey="Huang W" first="Wan-Ting" last="Huang">Wan-Ting Huang</name>
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<country xml:lang="fr">Taïwan</country>
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<wicri:noRegion>Taipei</wicri:noRegion>
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<author><name sortKey="Weibel, Daniel" sort="Weibel, Daniel" uniqKey="Weibel D" first="Daniel" last="Weibel">Daniel Weibel</name>
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<author><name sortKey="Giner Soriano, Maria" sort="Giner Soriano, Maria" uniqKey="Giner Soriano M" first="Maria" last="Giner-Soriano">Maria Giner-Soriano</name>
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<country xml:lang="fr">Espagne</country>
<wicri:regionArea>Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Barcelona</wicri:regionArea>
<placeName><settlement type="city">Barcelone</settlement>
<region nuts="2" type="region">Catalogne</region>
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<affiliation wicri:level="4"><nlm:affiliation>Universitat Autònoma de Barcelona, Bellaterra (Cerdanyola del Vallès), Barcelona, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>Universitat Autònoma de Barcelona, Bellaterra (Cerdanyola del Vallès), Barcelona</wicri:regionArea>
<placeName><settlement type="city">Barcelone</settlement>
<region nuts="2" type="region">Catalogne</region>
</placeName>
<orgName type="university">Université autonome de Barcelone</orgName>
</affiliation>
</author>
<author><name sortKey="Perez Vilar, Silvia" sort="Perez Vilar, Silvia" uniqKey="Perez Vilar S" first="Silvia" last="Perez-Vilar">Silvia Perez-Vilar</name>
<affiliation wicri:level="3"><nlm:affiliation>Erasmus Medical Center, Rotterdam, The Netherlands.</nlm:affiliation>
<country xml:lang="fr">Pays-Bas</country>
<wicri:regionArea>Erasmus Medical Center, Rotterdam</wicri:regionArea>
<placeName><settlement type="city">Rotterdam</settlement>
<region nuts="2" type="province">Hollande-Méridionale</region>
</placeName>
</affiliation>
<affiliation wicri:level="1"><nlm:affiliation>Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat (FISABIO), Vaccine Research, Valencia, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat (FISABIO), Vaccine Research, Valencia</wicri:regionArea>
<wicri:noRegion>Valencia</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Diez Domingo, Javier" sort="Diez Domingo, Javier" uniqKey="Diez Domingo J" first="Javier" last="Diez-Domingo">Javier Diez-Domingo</name>
<affiliation wicri:level="1"><nlm:affiliation>Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat (FISABIO), Vaccine Research, Valencia, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat (FISABIO), Vaccine Research, Valencia</wicri:regionArea>
<wicri:noRegion>Valencia</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Svenson, Lawrence W" sort="Svenson, Lawrence W" uniqKey="Svenson L" first="Lawrence W" last="Svenson">Lawrence W. Svenson</name>
<affiliation wicri:level="1"><nlm:affiliation>University of Alberta, Division of Preventative Medicine, Alberta, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>University of Alberta, Division of Preventative Medicine, Alberta</wicri:regionArea>
<wicri:noRegion>Alberta</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Mahmud, Salahddin M" sort="Mahmud, Salahddin M" uniqKey="Mahmud S" first="Salahddin M" last="Mahmud">Salahddin M. Mahmud</name>
<affiliation wicri:level="4"><nlm:affiliation>University of Manitoba, Rady Faculty of Health Sciences, Winnipeg, Manitoba, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>University of Manitoba, Rady Faculty of Health Sciences, Winnipeg, Manitoba</wicri:regionArea>
<orgName type="university">Université du Manitoba</orgName>
<placeName><settlement type="city">Winnipeg</settlement>
<region type="state">Manitoba</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Carleton, Bruce" sort="Carleton, Bruce" uniqKey="Carleton B" first="Bruce" last="Carleton">Bruce Carleton</name>
<affiliation wicri:level="1"><nlm:affiliation>University of British Columbia, Faculty of Medicine, Vancouver, British Columbia, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>University of British Columbia, Faculty of Medicine, Vancouver, British Columbia</wicri:regionArea>
<wicri:noRegion>British Columbia</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Naus, Monika" sort="Naus, Monika" uniqKey="Naus M" first="Monika" last="Naus">Monika Naus</name>
<affiliation wicri:level="1"><nlm:affiliation>University of British Columbia, Faculty of Medicine, Vancouver, British Columbia, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>University of British Columbia, Faculty of Medicine, Vancouver, British Columbia</wicri:regionArea>
<wicri:noRegion>British Columbia</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Kwong, Jeffrey C" sort="Kwong, Jeffrey C" uniqKey="Kwong J" first="Jeffrey C" last="Kwong">Jeffrey C. Kwong</name>
<affiliation wicri:level="1"><nlm:affiliation>Institute for Clinical Evaluative Sciences, Toronto, Ontario, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Institute for Clinical Evaluative Sciences, Toronto, Ontario</wicri:regionArea>
<wicri:noRegion>Ontario</wicri:noRegion>
</affiliation>
<affiliation wicri:level="1"><nlm:affiliation>Public Health Ontario, Toronto, Ontario, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Public Health Ontario, Toronto, Ontario</wicri:regionArea>
<wicri:noRegion>Ontario</wicri:noRegion>
</affiliation>
<affiliation wicri:level="4"><nlm:affiliation>Department of Family & Community Medicine, University of Toronto, Toronto, Ontario, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Department of Family & Community Medicine, University of Toronto, Toronto, Ontario</wicri:regionArea>
<orgName type="university">Université de Toronto</orgName>
<placeName><settlement type="city">Toronto</settlement>
<region type="state">Ontario</region>
</placeName>
</affiliation>
<affiliation wicri:level="4"><nlm:affiliation>Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario</wicri:regionArea>
<orgName type="university">Université de Toronto</orgName>
<placeName><settlement type="city">Toronto</settlement>
<region type="state">Ontario</region>
</placeName>
</affiliation>
<affiliation wicri:level="1"><nlm:affiliation>University Health Network, Toronto, Ontario, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>University Health Network, Toronto, Ontario</wicri:regionArea>
<wicri:noRegion>Ontario</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Murray, Brian J" sort="Murray, Brian J" uniqKey="Murray B" first="Brian J" last="Murray">Brian J. Murray</name>
<affiliation wicri:level="1"><nlm:affiliation>Division of Neurology, Department of Medicine, Sunnybrook Health Sciences Centre, Toronto, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Division of Neurology, Department of Medicine, Sunnybrook Health Sciences Centre, Toronto</wicri:regionArea>
<wicri:noRegion>Toronto</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Arnheim Dahlstrom, Lisen" sort="Arnheim Dahlstrom, Lisen" uniqKey="Arnheim Dahlstrom L" first="Lisen" last="Arnheim-Dahlstrom">Lisen Arnheim-Dahlstrom</name>
<affiliation wicri:level="3"><nlm:affiliation>Karolinska Institut, Department of Medical Epidemiology and Biostatistics, Stockholm, Sweden.</nlm:affiliation>
<country xml:lang="fr">Suède</country>
<wicri:regionArea>Karolinska Institut, Department of Medical Epidemiology and Biostatistics, Stockholm</wicri:regionArea>
<placeName><settlement type="city">Stockholm</settlement>
<region nuts="2">Svealand</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Pedersen, Lars" sort="Pedersen, Lars" uniqKey="Pedersen L" first="Lars" last="Pedersen">Lars Pedersen</name>
<affiliation wicri:level="1"><nlm:affiliation>Aarhus University, Department of Clinical Epidemiology, Aarhus, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Aarhus University, Department of Clinical Epidemiology, Aarhus</wicri:regionArea>
<wicri:noRegion>Aarhus</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Morros, Rosa" sort="Morros, Rosa" uniqKey="Morros R" first="Rosa" last="Morros">Rosa Morros</name>
<affiliation wicri:level="3"><nlm:affiliation>Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Barcelona, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Barcelona</wicri:regionArea>
<placeName><settlement type="city">Barcelone</settlement>
<region nuts="2" type="region">Catalogne</region>
</placeName>
</affiliation>
<affiliation wicri:level="4"><nlm:affiliation>Universitat Autònoma de Barcelona, Bellaterra (Cerdanyola del Vallès), Barcelona, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>Universitat Autònoma de Barcelona, Bellaterra (Cerdanyola del Vallès), Barcelona</wicri:regionArea>
<placeName><settlement type="city">Barcelone</settlement>
<region nuts="2" type="region">Catalogne</region>
</placeName>
<orgName type="university">Université autonome de Barcelone</orgName>
</affiliation>
</author>
<author><name sortKey="Puertas, Francisco Javier" sort="Puertas, Francisco Javier" uniqKey="Puertas F" first="Francisco Javier" last="Puertas">Francisco Javier Puertas</name>
<affiliation wicri:level="1"><nlm:affiliation>Sleep Unit, Neurophysiology Department, La Ribera University Hospital, Valencia, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>Sleep Unit, Neurophysiology Department, La Ribera University Hospital, Valencia</wicri:regionArea>
<wicri:noRegion>Valencia</wicri:noRegion>
</affiliation>
<affiliation wicri:level="1"><nlm:affiliation>Physiology Department, University of Valencia, Valencia, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>Physiology Department, University of Valencia, Valencia</wicri:regionArea>
<wicri:noRegion>Valencia</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Black, Steven" sort="Black, Steven" uniqKey="Black S" first="Steven" last="Black">Steven Black</name>
<affiliation wicri:level="2"><nlm:affiliation>Cincinnati Children's Hospital, Center for Global Health, Cincinnati, Ohio, United States of America.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Cincinnati Children's Hospital, Center for Global Health, Cincinnati, Ohio</wicri:regionArea>
<placeName><region type="state">Ohio</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Sturkenboom, Miriam" sort="Sturkenboom, Miriam" uniqKey="Sturkenboom M" first="Miriam" last="Sturkenboom">Miriam Sturkenboom</name>
<affiliation wicri:level="3"><nlm:affiliation>Julius Center Global Health, University Medical Center Utrecht, Utrecht, The Netherlands.</nlm:affiliation>
<country xml:lang="fr">Pays-Bas</country>
<wicri:regionArea>Julius Center Global Health, University Medical Center Utrecht, Utrecht</wicri:regionArea>
<placeName><settlement type="city">Utrecht</settlement>
<region nuts="2" type="province">Utrecht (province)</region>
</placeName>
</affiliation>
</author>
</analytic>
<series><title level="j">PloS one</title>
<idno type="eISSN">1932-6203</idno>
<imprint><date when="2018" type="published">2018</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
</fileDesc>
<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adjuvants, Immunologic (adverse effects)</term>
<term>Adolescent</term>
<term>Adult</term>
<term>Aged</term>
<term>Aged, 80 and over</term>
<term>Canada (epidemiology)</term>
<term>Child</term>
<term>Child, Preschool</term>
<term>Computer Simulation</term>
<term>Europe (epidemiology)</term>
<term>Female</term>
<term>Humans</term>
<term>Incidence</term>
<term>Infant</term>
<term>Infant, Newborn</term>
<term>Influenza A Virus, H1N1 Subtype (immunology)</term>
<term>Influenza Vaccines (adverse effects)</term>
<term>Influenza, Human (complications)</term>
<term>Influenza, Human (immunology)</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Models, Statistical</term>
<term>Narcolepsy (diagnosis)</term>
<term>Narcolepsy (epidemiology)</term>
<term>Narcolepsy (etiology)</term>
<term>Risk Factors</term>
<term>Safety</term>
<term>Taiwan (epidemiology)</term>
<term>Vaccination (adverse effects)</term>
<term>Young Adult</term>
</keywords>
<keywords scheme="KwdFr" xml:lang="fr"><term>Adjuvants immunologiques (effets indésirables)</term>
<term>Adolescent</term>
<term>Adulte</term>
<term>Adulte d'âge moyen</term>
<term>Canada (épidémiologie)</term>
<term>Enfant</term>
<term>Enfant d'âge préscolaire</term>
<term>Europe (épidémiologie)</term>
<term>Facteurs de risque</term>
<term>Femelle</term>
<term>Grippe humaine ()</term>
<term>Grippe humaine (immunologie)</term>
<term>Humains</term>
<term>Incidence</term>
<term>Jeune adulte</term>
<term>Modèles statistiques</term>
<term>Mâle</term>
<term>Narcolepsie (diagnostic)</term>
<term>Narcolepsie (épidémiologie)</term>
<term>Narcolepsie (étiologie)</term>
<term>Nourrisson</term>
<term>Nouveau-né</term>
<term>Simulation numérique</term>
<term>Sous-type H1N1 du virus de la grippe A (immunologie)</term>
<term>Sujet âgé</term>
<term>Sujet âgé de 80 ans ou plus</term>
<term>Sécurité</term>
<term>Taïwan (épidémiologie)</term>
<term>Vaccination (effets indésirables)</term>
<term>Vaccins antigrippaux (effets indésirables)</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Adjuvants, Immunologic</term>
<term>Influenza Vaccines</term>
</keywords>
<keywords scheme="MESH" type="geographic" qualifier="epidemiology" xml:lang="en"><term>Canada</term>
<term>Europe</term>
<term>Taiwan</term>
</keywords>
<keywords scheme="MESH" qualifier="adverse effects" xml:lang="en"><term>Vaccination</term>
</keywords>
<keywords scheme="MESH" qualifier="complications" xml:lang="en"><term>Influenza, Human</term>
</keywords>
<keywords scheme="MESH" qualifier="diagnosis" xml:lang="en"><term>Narcolepsy</term>
</keywords>
<keywords scheme="MESH" qualifier="diagnostic" xml:lang="fr"><term>Narcolepsie</term>
</keywords>
<keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Adjuvants immunologiques</term>
<term>Vaccination</term>
<term>Vaccins antigrippaux</term>
</keywords>
<keywords scheme="MESH" qualifier="epidemiology" xml:lang="en"><term>Narcolepsy</term>
</keywords>
<keywords scheme="MESH" qualifier="etiology" xml:lang="en"><term>Narcolepsy</term>
</keywords>
<keywords scheme="MESH" qualifier="immunologie" xml:lang="fr"><term>Grippe humaine</term>
<term>Sous-type H1N1 du virus de la grippe A</term>
</keywords>
<keywords scheme="MESH" qualifier="immunology" xml:lang="en"><term>Influenza A Virus, H1N1 Subtype</term>
<term>Influenza, Human</term>
</keywords>
<keywords scheme="MESH" qualifier="épidémiologie" xml:lang="fr"><term>Canada</term>
<term>Europe</term>
<term>Narcolepsie</term>
<term>Taïwan</term>
</keywords>
<keywords scheme="MESH" qualifier="étiologie" xml:lang="fr"><term>Narcolepsie</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Adolescent</term>
<term>Adult</term>
<term>Aged</term>
<term>Aged, 80 and over</term>
<term>Child</term>
<term>Child, Preschool</term>
<term>Computer Simulation</term>
<term>Female</term>
<term>Humans</term>
<term>Incidence</term>
<term>Infant</term>
<term>Infant, Newborn</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Models, Statistical</term>
<term>Risk Factors</term>
<term>Safety</term>
<term>Young Adult</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr"><term>Adolescent</term>
<term>Adulte</term>
<term>Adulte d'âge moyen</term>
<term>Enfant</term>
<term>Enfant d'âge préscolaire</term>
<term>Facteurs de risque</term>
<term>Femelle</term>
<term>Grippe humaine</term>
<term>Humains</term>
<term>Incidence</term>
<term>Jeune adulte</term>
<term>Modèles statistiques</term>
<term>Mâle</term>
<term>Nourrisson</term>
<term>Nouveau-né</term>
<term>Simulation numérique</term>
<term>Sujet âgé</term>
<term>Sujet âgé de 80 ans ou plus</term>
<term>Sécurité</term>
</keywords>
<keywords scheme="Wicri" type="geographic" xml:lang="fr"><term>Canada</term>
<term>Taïwan</term>
</keywords>
</textClass>
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</teiHeader>
<front><div type="abstract" xml:lang="en"><p><b>BACKGROUND & OBJECTIVES</b>
</p>
<p>Vaccine safety signals require investigation, which may be done rapidly at the population level using ecological studies, before embarking on hypothesis-testing studies. Incidence rates were used to assess a signal of narcolepsy following AS03-adjuvanted monovalent pandemic H1N1 (pH1N1) influenza vaccination among children and adolescents in Sweden and Finland in 2010. We explored the utility of ecological data to assess incidence of narcolepsy following exposure to pandemic H1N1 virus or vaccination in 10 sites that used different vaccines, adjuvants, and had varying vaccine coverage.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>METHODS</b>
</p>
<p>We calculated incidence rates of diagnosed narcolepsy for periods defined by influenza virus circulation and vaccination campaign dates, and used Poisson regression to estimate incidence rate ratios (IRRs) comparing the periods during which wild-type virus circulated and after the start of vaccination campaigns vs. the period prior to pH1N1 virus circulation. We used electronic health care data from Sweden, Denmark, the United Kingdom, Canada (3 provinces), Taiwan, Netherlands, and Spain (2 regions) from 2003 to 2013. We investigated interactions between age group and adjuvant in European sites and conducted a simulation study to investigate how vaccine coverage, age, and the interval from onset to diagnosis may impact the ability to detect safety signals.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>RESULTS</b>
</p>
<p>Incidence rates of narcolepsy varied by age, continent, and period. Only in Taiwan and Sweden were significant time-period-by-age-group interactions observed. Associations were found for children in Taiwan (following pH1N1 virus circulation) and Sweden (following vaccination). Simulations showed that the individual-level relative risk of narcolepsy was underestimated using ecological methods comparing post- vs. pre-vaccination periods; this effect was attenuated with higher vaccine coverage and a shorter interval from disease onset to diagnosis.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>CONCLUSIONS</b>
</p>
<p>Ecological methods can be useful for vaccine safety assessment but the results are influenced by diagnostic delay and vaccine coverage. Because ecological methods assess risk at the population level, these methods should be treated as signal-generating methods and drawing conclusions regarding individual-level risk should be avoided.</p>
</div>
</front>
</TEI>
<pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">30332477</PMID>
<DateCompleted><Year>2019</Year>
<Month>03</Month>
<Day>14</Day>
</DateCompleted>
<DateRevised><Year>2019</Year>
<Month>03</Month>
<Day>14</Day>
</DateRevised>
<Article PubModel="Electronic-eCollection"><Journal><ISSN IssnType="Electronic">1932-6203</ISSN>
<JournalIssue CitedMedium="Internet"><Volume>13</Volume>
<Issue>10</Issue>
<PubDate><Year>2018</Year>
</PubDate>
</JournalIssue>
<Title>PloS one</Title>
<ISOAbbreviation>PLoS ONE</ISOAbbreviation>
</Journal>
<ArticleTitle>Incidence rates of narcolepsy diagnoses in Taiwan, Canada, and Europe: The use of statistical simulation to evaluate methods for the rapid assessment of potential safety issues on a population level in the SOMNIA study.</ArticleTitle>
<Pagination><MedlinePgn>e0204799</MedlinePgn>
</Pagination>
<ELocationID EIdType="doi" ValidYN="Y">10.1371/journal.pone.0204799</ELocationID>
<Abstract><AbstractText Label="BACKGROUND & OBJECTIVES">Vaccine safety signals require investigation, which may be done rapidly at the population level using ecological studies, before embarking on hypothesis-testing studies. Incidence rates were used to assess a signal of narcolepsy following AS03-adjuvanted monovalent pandemic H1N1 (pH1N1) influenza vaccination among children and adolescents in Sweden and Finland in 2010. We explored the utility of ecological data to assess incidence of narcolepsy following exposure to pandemic H1N1 virus or vaccination in 10 sites that used different vaccines, adjuvants, and had varying vaccine coverage.</AbstractText>
<AbstractText Label="METHODS">We calculated incidence rates of diagnosed narcolepsy for periods defined by influenza virus circulation and vaccination campaign dates, and used Poisson regression to estimate incidence rate ratios (IRRs) comparing the periods during which wild-type virus circulated and after the start of vaccination campaigns vs. the period prior to pH1N1 virus circulation. We used electronic health care data from Sweden, Denmark, the United Kingdom, Canada (3 provinces), Taiwan, Netherlands, and Spain (2 regions) from 2003 to 2013. We investigated interactions between age group and adjuvant in European sites and conducted a simulation study to investigate how vaccine coverage, age, and the interval from onset to diagnosis may impact the ability to detect safety signals.</AbstractText>
<AbstractText Label="RESULTS">Incidence rates of narcolepsy varied by age, continent, and period. Only in Taiwan and Sweden were significant time-period-by-age-group interactions observed. Associations were found for children in Taiwan (following pH1N1 virus circulation) and Sweden (following vaccination). Simulations showed that the individual-level relative risk of narcolepsy was underestimated using ecological methods comparing post- vs. pre-vaccination periods; this effect was attenuated with higher vaccine coverage and a shorter interval from disease onset to diagnosis.</AbstractText>
<AbstractText Label="CONCLUSIONS">Ecological methods can be useful for vaccine safety assessment but the results are influenced by diagnostic delay and vaccine coverage. Because ecological methods assess risk at the population level, these methods should be treated as signal-generating methods and drawing conclusions regarding individual-level risk should be avoided.</AbstractText>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Dodd</LastName>
<ForeName>Caitlin N</ForeName>
<Initials>CN</Initials>
<Identifier Source="ORCID">0000-0002-8784-696X</Identifier>
<AffiliationInfo><Affiliation>Erasmus Medical Center, Rotterdam, The Netherlands.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>Julius Center Global Health, University Medical Center Utrecht, Utrecht, The Netherlands.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>de Ridder</LastName>
<ForeName>Maria</ForeName>
<Initials>M</Initials>
<AffiliationInfo><Affiliation>Erasmus Medical Center, Rotterdam, The Netherlands.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Huang</LastName>
<ForeName>Wan-Ting</ForeName>
<Initials>WT</Initials>
<AffiliationInfo><Affiliation>Taiwan Centers for Disease Control, Taipei, Taiwan.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Weibel</LastName>
<ForeName>Daniel</ForeName>
<Initials>D</Initials>
<AffiliationInfo><Affiliation>Erasmus Medical Center, Rotterdam, The Netherlands.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Giner-Soriano</LastName>
<ForeName>Maria</ForeName>
<Initials>M</Initials>
<AffiliationInfo><Affiliation>Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Barcelona, Spain.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>Universitat Autònoma de Barcelona, Bellaterra (Cerdanyola del Vallès), Barcelona, Spain.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Perez-Vilar</LastName>
<ForeName>Silvia</ForeName>
<Initials>S</Initials>
<AffiliationInfo><Affiliation>Erasmus Medical Center, Rotterdam, The Netherlands.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat (FISABIO), Vaccine Research, Valencia, Spain.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Diez-Domingo</LastName>
<ForeName>Javier</ForeName>
<Initials>J</Initials>
<AffiliationInfo><Affiliation>Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat (FISABIO), Vaccine Research, Valencia, Spain.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Svenson</LastName>
<ForeName>Lawrence W</ForeName>
<Initials>LW</Initials>
<AffiliationInfo><Affiliation>University of Alberta, Division of Preventative Medicine, Alberta, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Mahmud</LastName>
<ForeName>Salahddin M</ForeName>
<Initials>SM</Initials>
<AffiliationInfo><Affiliation>University of Manitoba, Rady Faculty of Health Sciences, Winnipeg, Manitoba, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Carleton</LastName>
<ForeName>Bruce</ForeName>
<Initials>B</Initials>
<AffiliationInfo><Affiliation>University of British Columbia, Faculty of Medicine, Vancouver, British Columbia, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Naus</LastName>
<ForeName>Monika</ForeName>
<Initials>M</Initials>
<AffiliationInfo><Affiliation>University of British Columbia, Faculty of Medicine, Vancouver, British Columbia, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Kwong</LastName>
<ForeName>Jeffrey C</ForeName>
<Initials>JC</Initials>
<AffiliationInfo><Affiliation>Institute for Clinical Evaluative Sciences, Toronto, Ontario, Canada.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>Public Health Ontario, Toronto, Ontario, Canada.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>Department of Family & Community Medicine, University of Toronto, Toronto, Ontario, Canada.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>University Health Network, Toronto, Ontario, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Murray</LastName>
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<AffiliationInfo><Affiliation>Division of Neurology, Department of Medicine, Sunnybrook Health Sciences Centre, Toronto, Canada.</Affiliation>
</AffiliationInfo>
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<Author ValidYN="Y"><LastName>Arnheim-Dahlstrom</LastName>
<ForeName>Lisen</ForeName>
<Initials>L</Initials>
<AffiliationInfo><Affiliation>Karolinska Institut, Department of Medical Epidemiology and Biostatistics, Stockholm, Sweden.</Affiliation>
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</AffiliationInfo>
<AffiliationInfo><Affiliation>Universitat Autònoma de Barcelona, Bellaterra (Cerdanyola del Vallès), Barcelona, Spain.</Affiliation>
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</Author>
<Author ValidYN="Y"><LastName>Puertas</LastName>
<ForeName>Francisco Javier</ForeName>
<Initials>FJ</Initials>
<AffiliationInfo><Affiliation>Sleep Unit, Neurophysiology Department, La Ribera University Hospital, Valencia, Spain.</Affiliation>
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<AffiliationInfo><Affiliation>Physiology Department, University of Valencia, Valencia, Spain.</Affiliation>
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<ForeName>Steven</ForeName>
<Initials>S</Initials>
<AffiliationInfo><Affiliation>Cincinnati Children's Hospital, Center for Global Health, Cincinnati, Ohio, United States of America.</Affiliation>
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<ForeName>Miriam</ForeName>
<Initials>M</Initials>
<AffiliationInfo><Affiliation>Julius Center Global Health, University Medical Center Utrecht, Utrecht, The Netherlands.</Affiliation>
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</AuthorList>
<Language>eng</Language>
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<ArticleDate DateType="Electronic"><Year>2018</Year>
<Month>10</Month>
<Day>17</Day>
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<MedlineTA>PLoS One</MedlineTA>
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<MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName>
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<MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D000369" MajorTopicYN="N">Aged, 80 and over</DescriptorName>
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<MeshHeading><DescriptorName UI="D002648" MajorTopicYN="N">Child</DescriptorName>
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<MeshHeading><DescriptorName UI="D002675" MajorTopicYN="N">Child, Preschool</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D003198" MajorTopicYN="N">Computer Simulation</DescriptorName>
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<MeshHeading><DescriptorName UI="D005060" MajorTopicYN="N" Type="Geographic">Europe</DescriptorName>
<QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName>
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<MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName>
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</MeshHeading>
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</MeshHeading>
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<QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName>
</MeshHeading>
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<QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName>
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<QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName>
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<MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName>
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<MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D015233" MajorTopicYN="N">Models, Statistical</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D009290" MajorTopicYN="N">Narcolepsy</DescriptorName>
<QualifierName UI="Q000175" MajorTopicYN="N">diagnosis</QualifierName>
<QualifierName UI="Q000453" MajorTopicYN="Y">epidemiology</QualifierName>
<QualifierName UI="Q000209" MajorTopicYN="N">etiology</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D012307" MajorTopicYN="N">Risk Factors</DescriptorName>
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<MeshHeading><DescriptorName UI="D012449" MajorTopicYN="N">Safety</DescriptorName>
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<MeshHeading><DescriptorName UI="D013624" MajorTopicYN="N" Type="Geographic">Taiwan</DescriptorName>
<QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D014611" MajorTopicYN="N">Vaccination</DescriptorName>
<QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D055815" MajorTopicYN="N">Young Adult</DescriptorName>
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<CoiStatement>MGS, as an employee of IDIAP Jordi Gol, worked on projects funded by pharmaceutical companies unrelated to this study. RM, as an employee of IDIAP Jordi Gol, worked on projects funded by pharmaceutical companies unrelated to this study. SB is a consultant for GSK Vaccines and chairs a data monitoring committee for GSK. SMM has received funding for unrelated projects from GSK, Merck, Pfizer and Sanofi and sat on advisory boards for GSK and Sanofi. LAD has received funding from MSD Sanofi Pasteur, Merck Sharp & Dome and GlaxoSmithKline for studies other than the study presented here. MS has led a research unit that occasionally conducted research for pharmaceutical companies, including Novartis, Boehringer, Lilly, and Pfizer. None of this work is related to these activities. All other authors have declared that no competing interests exist.</CoiStatement>
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<Month>05</Month>
<Day>16</Day>
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<Month>09</Month>
<Day>07</Day>
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Incidence rates of narcolepsy diagnoses in Taiwan, Canada, and Europe: The use of statistical simulation to evaluate methods for the rapid assessment of potential safety issues on a population level in the SOMNIA study.

Incidence rates of narcolepsy diagnoses in Taiwan, Canada, and Europe: The use of statistical simulation to evaluate methods for the rapid assessment of potential safety issues on a population level in the SOMNIA study.

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