GrippeFranceV1, Main, Exploration, bibRecord, 000174

Application of Probabilistic Multiple-Bias Analyses to a Cohort- and a Case-Control Study on the Association between Pandemrix™ and Narcolepsy.

Identifieur interne : 000174 ( Main/Exploration ); précédent : 000173; suivant : 000175

Application of Probabilistic Multiple-Bias Analyses to a Cohort- and a Case-Control Study on the Association between Pandemrix™ and Narcolepsy.

Auteurs : Kaatje Bollaerts [Belgique] ; Vivek Shinde [États-Unis] ; Gaël Dos Santos [Belgique] ; Germano Ferreira [Belgique] ; Vincent Bauchau [Belgique] ; Catherine Cohet [Belgique] ; Thomas Verstraeten [Belgique]

Source :

PloS one [ 1932-6203 ] ; 2016.

RBID : pubmed:26901063

Descripteurs français

KwdFr :
- Adolescent (MeSH), Adulte (MeSH), Enfant (MeSH), Enfant d'âge préscolaire (MeSH), Femelle (MeSH), Finlande (épidémiologie), France (épidémiologie), Grippe humaine (prévention et contrôle), Grippe humaine (épidémiologie), Humains (MeSH), Mâle (MeSH), Narcolepsie (induit chimiquement), Narcolepsie (épidémiologie), Pandémies (MeSH), Sous-type H1N1 du virus de la grippe A (MeSH), Suède (épidémiologie), Vaccins antigrippaux (administration et posologie), Vaccins antigrippaux (effets indésirables), Études cas-témoins (MeSH).
MESH :
- administration et posologie : Vaccins antigrippaux.
- effets indésirables : Vaccins antigrippaux.
- induit chimiquement : Narcolepsie.
- prévention et contrôle : Grippe humaine.
- épidémiologie : Finlande, France, Grippe humaine, Narcolepsie, Suède.
- Adolescent, Adulte, Enfant, Enfant d'âge préscolaire, Femelle, Humains, Mâle, Pandémies, Sous-type H1N1 du virus de la grippe A, Études cas-témoins.
Wicri :
- geographic : Finlande, France, Suède.

English descriptors

KwdEn :
- Adolescent (MeSH), Adult (MeSH), Case-Control Studies (MeSH), Child (MeSH), Child, Preschool (MeSH), Female (MeSH), Finland (epidemiology), France (epidemiology), Humans (MeSH), Influenza A Virus, H1N1 Subtype (MeSH), Influenza Vaccines (administration & dosage), Influenza Vaccines (adverse effects), Influenza, Human (epidemiology), Influenza, Human (prevention & control), Male (MeSH), Narcolepsy (chemically induced), Narcolepsy (epidemiology), Pandemics (MeSH), Sweden (epidemiology).
MESH :
- chemical , administration & dosage : Influenza Vaccines.
- chemical , adverse effects : Influenza Vaccines.
- geographic , epidemiology : Finland, France, Sweden.
- chemically induced : Narcolepsy.
- epidemiology : Influenza, Human, Narcolepsy.
- prevention & control : Influenza, Human.
- Adolescent, Adult, Case-Control Studies, Child, Child, Preschool, Female, Humans, Influenza A Virus, H1N1 Subtype, Male, Pandemics.

Abstract

BACKGROUND

An increase in narcolepsy cases was observed in Finland and Sweden towards the end of the 2009 H1N1 influenza pandemic. Preliminary observational studies suggested a temporal link with the pandemic influenza vaccine Pandemrix™, leading to a number of additional studies across Europe. Given the public health urgency, these studies used readily available retrospective data from various sources. The potential for bias in such settings was generally acknowledged. Although generally advocated by key opinion leaders and international health authorities, no systematic quantitative assessment of the potential joint impact of biases was undertaken in any of these studies.

METHODS

We applied bias-level multiple-bias analyses to two of the published narcolepsy studies: a pediatric cohort study from Finland and a case-control study from France. In particular, we developed Monte Carlo simulation models to evaluate a potential cascade of biases, including confounding by age, by indication and by natural H1N1 infection, selection bias, disease- and exposure misclassification. All bias parameters were evidence-based to the extent possible.

RESULTS

Given the assumptions used for confounding, selection bias and misclassification, the Finnish rate ratio of 13.78 (95% CI: 5.72-28.11) reduced to a median value of 6.06 (2.5th- 97.5th percentile: 2.49-15.1) and the French odds ratio of 5.43 (95% CI: 2.6-10.08) to 1.85 (2.5th-97.5th percentile: 0.85-4.08).

CONCLUSION

We illustrate multiple-bias analyses using two studies on the Pandemrix™-narcolepsy association and advocate their use to better understand the robustness of study findings. Based on our multiple-bias models, the observed Pandemrix™-narcolepsy association consistently persists in the Finnish study. For the French study, the results of our multiple-bias models were inconclusive.

DOI: 10.1371/journal.pone.0149289
PubMed: 26901063
PubMed Central: PMC4762678

Affiliations:

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

to stream Main, to step Corpus: 000167
to stream Main, to step Curation: 000167

Le document en format XML

<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Application of Probabilistic Multiple-Bias Analyses to a Cohort- and a Case-Control Study on the Association between Pandemrix™ and Narcolepsy.</title>
<author><name sortKey="Bollaerts, Kaatje" sort="Bollaerts, Kaatje" uniqKey="Bollaerts K" first="Kaatje" last="Bollaerts">Kaatje Bollaerts</name>
<affiliation wicri:level="3"><nlm:affiliation>P95 Pharmacovigilance and Epidemiology Services, Koning Leopold III Laan 1, 3001 Leuven, Belgium.</nlm:affiliation>
<country xml:lang="fr">Belgique</country>
<wicri:regionArea>P95 Pharmacovigilance and Epidemiology Services, Koning Leopold III Laan 1, 3001 Leuven</wicri:regionArea>
<placeName><region type="province" nuts="2">Province du Brabant flamand</region>
<settlement type="town">Heverlee</settlement>
<settlement type="city">Louvain</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Shinde, Vivek" sort="Shinde, Vivek" uniqKey="Shinde V" first="Vivek" last="Shinde">Vivek Shinde</name>
<affiliation wicri:level="2"><nlm:affiliation>GSK Vaccines, 2301 Renaissance Boulevard, King of Prussia, PA 19406, United States of America.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>GSK Vaccines, 2301 Renaissance Boulevard, King of Prussia, PA 19406</wicri:regionArea>
<placeName><region type="state">Pennsylvanie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Dos Santos, Gael" sort="Dos Santos, Gael" uniqKey="Dos Santos G" first="Gaël" last="Dos Santos">Gaël Dos Santos</name>
<affiliation wicri:level="1"><nlm:affiliation>Business & Decision Life Sciences (contractor for GSK Vaccines), Rue Saint Lambert 141, 1200 Brussels, Belgium.</nlm:affiliation>
<country xml:lang="fr">Belgique</country>
<wicri:regionArea>Business & Decision Life Sciences (contractor for GSK Vaccines), Rue Saint Lambert 141, 1200 Brussels</wicri:regionArea>
<placeName><settlement type="city">Bruxelles</settlement>
<region nuts="2">Région de Bruxelles-Capitale</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Ferreira, Germano" sort="Ferreira, Germano" uniqKey="Ferreira G" first="Germano" last="Ferreira">Germano Ferreira</name>
<affiliation wicri:level="1"><nlm:affiliation>GSK Vaccines, Avenue Fleming 20, B-1300 Wavre, Belgium.</nlm:affiliation>
<country xml:lang="fr">Belgique</country>
<wicri:regionArea>GSK Vaccines, Avenue Fleming 20, B-1300 Wavre</wicri:regionArea>
<wicri:noRegion>B-1300 Wavre</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Bauchau, Vincent" sort="Bauchau, Vincent" uniqKey="Bauchau V" first="Vincent" last="Bauchau">Vincent Bauchau</name>
<affiliation wicri:level="1"><nlm:affiliation>GSK Vaccines, Avenue Fleming 20, B-1300 Wavre, Belgium.</nlm:affiliation>
<country xml:lang="fr">Belgique</country>
<wicri:regionArea>GSK Vaccines, Avenue Fleming 20, B-1300 Wavre</wicri:regionArea>
<wicri:noRegion>B-1300 Wavre</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Cohet, Catherine" sort="Cohet, Catherine" uniqKey="Cohet C" first="Catherine" last="Cohet">Catherine Cohet</name>
<affiliation wicri:level="1"><nlm:affiliation>GSK Vaccines, Avenue Fleming 20, B-1300 Wavre, Belgium.</nlm:affiliation>
<country xml:lang="fr">Belgique</country>
<wicri:regionArea>GSK Vaccines, Avenue Fleming 20, B-1300 Wavre</wicri:regionArea>
<wicri:noRegion>B-1300 Wavre</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Verstraeten, Thomas" sort="Verstraeten, Thomas" uniqKey="Verstraeten T" first="Thomas" last="Verstraeten">Thomas Verstraeten</name>
<affiliation wicri:level="3"><nlm:affiliation>P95 Pharmacovigilance and Epidemiology Services, Koning Leopold III Laan 1, 3001 Leuven, Belgium.</nlm:affiliation>
<country xml:lang="fr">Belgique</country>
<wicri:regionArea>P95 Pharmacovigilance and Epidemiology Services, Koning Leopold III Laan 1, 3001 Leuven</wicri:regionArea>
<placeName><region type="province" nuts="2">Province du Brabant flamand</region>
<settlement type="town">Heverlee</settlement>
<settlement type="city">Louvain</settlement>
</placeName>
</affiliation>
</author>
</titleStmt>
<publicationStmt><idno type="wicri:source">PubMed</idno>
<date when="2016">2016</date>
<idno type="RBID">pubmed:26901063</idno>
<idno type="pmid">26901063</idno>
<idno type="doi">10.1371/journal.pone.0149289</idno>
<idno type="pmc">PMC4762678</idno>
<idno type="wicri:Area/Main/Corpus">000167</idno>
<idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Corpus" wicri:corpus="PubMed">000167</idno>
<idno type="wicri:Area/Main/Curation">000167</idno>
<idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Curation">000167</idno>
<idno type="wicri:Area/Main/Exploration">000167</idno>
</publicationStmt>
<sourceDesc><biblStruct><analytic><title xml:lang="en">Application of Probabilistic Multiple-Bias Analyses to a Cohort- and a Case-Control Study on the Association between Pandemrix™ and Narcolepsy.</title>
<author><name sortKey="Bollaerts, Kaatje" sort="Bollaerts, Kaatje" uniqKey="Bollaerts K" first="Kaatje" last="Bollaerts">Kaatje Bollaerts</name>
<affiliation wicri:level="3"><nlm:affiliation>P95 Pharmacovigilance and Epidemiology Services, Koning Leopold III Laan 1, 3001 Leuven, Belgium.</nlm:affiliation>
<country xml:lang="fr">Belgique</country>
<wicri:regionArea>P95 Pharmacovigilance and Epidemiology Services, Koning Leopold III Laan 1, 3001 Leuven</wicri:regionArea>
<placeName><region type="province" nuts="2">Province du Brabant flamand</region>
<settlement type="town">Heverlee</settlement>
<settlement type="city">Louvain</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Shinde, Vivek" sort="Shinde, Vivek" uniqKey="Shinde V" first="Vivek" last="Shinde">Vivek Shinde</name>
<affiliation wicri:level="2"><nlm:affiliation>GSK Vaccines, 2301 Renaissance Boulevard, King of Prussia, PA 19406, United States of America.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>GSK Vaccines, 2301 Renaissance Boulevard, King of Prussia, PA 19406</wicri:regionArea>
<placeName><region type="state">Pennsylvanie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Dos Santos, Gael" sort="Dos Santos, Gael" uniqKey="Dos Santos G" first="Gaël" last="Dos Santos">Gaël Dos Santos</name>
<affiliation wicri:level="1"><nlm:affiliation>Business & Decision Life Sciences (contractor for GSK Vaccines), Rue Saint Lambert 141, 1200 Brussels, Belgium.</nlm:affiliation>
<country xml:lang="fr">Belgique</country>
<wicri:regionArea>Business & Decision Life Sciences (contractor for GSK Vaccines), Rue Saint Lambert 141, 1200 Brussels</wicri:regionArea>
<placeName><settlement type="city">Bruxelles</settlement>
<region nuts="2">Région de Bruxelles-Capitale</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Ferreira, Germano" sort="Ferreira, Germano" uniqKey="Ferreira G" first="Germano" last="Ferreira">Germano Ferreira</name>
<affiliation wicri:level="1"><nlm:affiliation>GSK Vaccines, Avenue Fleming 20, B-1300 Wavre, Belgium.</nlm:affiliation>
<country xml:lang="fr">Belgique</country>
<wicri:regionArea>GSK Vaccines, Avenue Fleming 20, B-1300 Wavre</wicri:regionArea>
<wicri:noRegion>B-1300 Wavre</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Bauchau, Vincent" sort="Bauchau, Vincent" uniqKey="Bauchau V" first="Vincent" last="Bauchau">Vincent Bauchau</name>
<affiliation wicri:level="1"><nlm:affiliation>GSK Vaccines, Avenue Fleming 20, B-1300 Wavre, Belgium.</nlm:affiliation>
<country xml:lang="fr">Belgique</country>
<wicri:regionArea>GSK Vaccines, Avenue Fleming 20, B-1300 Wavre</wicri:regionArea>
<wicri:noRegion>B-1300 Wavre</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Cohet, Catherine" sort="Cohet, Catherine" uniqKey="Cohet C" first="Catherine" last="Cohet">Catherine Cohet</name>
<affiliation wicri:level="1"><nlm:affiliation>GSK Vaccines, Avenue Fleming 20, B-1300 Wavre, Belgium.</nlm:affiliation>
<country xml:lang="fr">Belgique</country>
<wicri:regionArea>GSK Vaccines, Avenue Fleming 20, B-1300 Wavre</wicri:regionArea>
<wicri:noRegion>B-1300 Wavre</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Verstraeten, Thomas" sort="Verstraeten, Thomas" uniqKey="Verstraeten T" first="Thomas" last="Verstraeten">Thomas Verstraeten</name>
<affiliation wicri:level="3"><nlm:affiliation>P95 Pharmacovigilance and Epidemiology Services, Koning Leopold III Laan 1, 3001 Leuven, Belgium.</nlm:affiliation>
<country xml:lang="fr">Belgique</country>
<wicri:regionArea>P95 Pharmacovigilance and Epidemiology Services, Koning Leopold III Laan 1, 3001 Leuven</wicri:regionArea>
<placeName><region type="province" nuts="2">Province du Brabant flamand</region>
<settlement type="town">Heverlee</settlement>
<settlement type="city">Louvain</settlement>
</placeName>
</affiliation>
</author>
</analytic>
<series><title level="j">PloS one</title>
<idno type="eISSN">1932-6203</idno>
<imprint><date when="2016" type="published">2016</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
</fileDesc>
<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adolescent (MeSH)</term>
<term>Adult (MeSH)</term>
<term>Case-Control Studies (MeSH)</term>
<term>Child (MeSH)</term>
<term>Child, Preschool (MeSH)</term>
<term>Female (MeSH)</term>
<term>Finland (epidemiology)</term>
<term>France (epidemiology)</term>
<term>Humans (MeSH)</term>
<term>Influenza A Virus, H1N1 Subtype (MeSH)</term>
<term>Influenza Vaccines (administration & dosage)</term>
<term>Influenza Vaccines (adverse effects)</term>
<term>Influenza, Human (epidemiology)</term>
<term>Influenza, Human (prevention & control)</term>
<term>Male (MeSH)</term>
<term>Narcolepsy (chemically induced)</term>
<term>Narcolepsy (epidemiology)</term>
<term>Pandemics (MeSH)</term>
<term>Sweden (epidemiology)</term>
</keywords>
<keywords scheme="KwdFr" xml:lang="fr"><term>Adolescent (MeSH)</term>
<term>Adulte (MeSH)</term>
<term>Enfant (MeSH)</term>
<term>Enfant d'âge préscolaire (MeSH)</term>
<term>Femelle (MeSH)</term>
<term>Finlande (épidémiologie)</term>
<term>France (épidémiologie)</term>
<term>Grippe humaine (prévention et contrôle)</term>
<term>Grippe humaine (épidémiologie)</term>
<term>Humains (MeSH)</term>
<term>Mâle (MeSH)</term>
<term>Narcolepsie (induit chimiquement)</term>
<term>Narcolepsie (épidémiologie)</term>
<term>Pandémies (MeSH)</term>
<term>Sous-type H1N1 du virus de la grippe A (MeSH)</term>
<term>Suède (épidémiologie)</term>
<term>Vaccins antigrippaux (administration et posologie)</term>
<term>Vaccins antigrippaux (effets indésirables)</term>
<term>Études cas-témoins (MeSH)</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Influenza Vaccines</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Influenza Vaccines</term>
</keywords>
<keywords scheme="MESH" type="geographic" qualifier="epidemiology" xml:lang="en"><term>Finland</term>
<term>France</term>
<term>Sweden</term>
</keywords>
<keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Vaccins antigrippaux</term>
</keywords>
<keywords scheme="MESH" qualifier="chemically induced" xml:lang="en"><term>Narcolepsy</term>
</keywords>
<keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Vaccins antigrippaux</term>
</keywords>
<keywords scheme="MESH" qualifier="epidemiology" xml:lang="en"><term>Influenza, Human</term>
<term>Narcolepsy</term>
</keywords>
<keywords scheme="MESH" qualifier="induit chimiquement" xml:lang="fr"><term>Narcolepsie</term>
</keywords>
<keywords scheme="MESH" qualifier="prevention & control" xml:lang="en"><term>Influenza, Human</term>
</keywords>
<keywords scheme="MESH" qualifier="prévention et contrôle" xml:lang="fr"><term>Grippe humaine</term>
</keywords>
<keywords scheme="MESH" qualifier="épidémiologie" xml:lang="fr"><term>Finlande</term>
<term>France</term>
<term>Grippe humaine</term>
<term>Narcolepsie</term>
<term>Suède</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Adolescent</term>
<term>Adult</term>
<term>Case-Control Studies</term>
<term>Child</term>
<term>Child, Preschool</term>
<term>Female</term>
<term>Humans</term>
<term>Influenza A Virus, H1N1 Subtype</term>
<term>Male</term>
<term>Pandemics</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr"><term>Adolescent</term>
<term>Adulte</term>
<term>Enfant</term>
<term>Enfant d'âge préscolaire</term>
<term>Femelle</term>
<term>Humains</term>
<term>Mâle</term>
<term>Pandémies</term>
<term>Sous-type H1N1 du virus de la grippe A</term>
<term>Études cas-témoins</term>
</keywords>
<keywords scheme="Wicri" type="geographic" xml:lang="fr"><term>Finlande</term>
<term>France</term>
<term>Suède</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en"><p><b>BACKGROUND</b>
</p>
<p>An increase in narcolepsy cases was observed in Finland and Sweden towards the end of the 2009 H1N1 influenza pandemic. Preliminary observational studies suggested a temporal link with the pandemic influenza vaccine Pandemrix™, leading to a number of additional studies across Europe. Given the public health urgency, these studies used readily available retrospective data from various sources. The potential for bias in such settings was generally acknowledged. Although generally advocated by key opinion leaders and international health authorities, no systematic quantitative assessment of the potential joint impact of biases was undertaken in any of these studies.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>METHODS</b>
</p>
<p>We applied bias-level multiple-bias analyses to two of the published narcolepsy studies: a pediatric cohort study from Finland and a case-control study from France. In particular, we developed Monte Carlo simulation models to evaluate a potential cascade of biases, including confounding by age, by indication and by natural H1N1 infection, selection bias, disease- and exposure misclassification. All bias parameters were evidence-based to the extent possible.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>RESULTS</b>
</p>
<p>Given the assumptions used for confounding, selection bias and misclassification, the Finnish rate ratio of 13.78 (95% CI: 5.72-28.11) reduced to a median value of 6.06 (2.5th- 97.5th percentile: 2.49-15.1) and the French odds ratio of 5.43 (95% CI: 2.6-10.08) to 1.85 (2.5th-97.5th percentile: 0.85-4.08).</p>
</div>
<div type="abstract" xml:lang="en"><p><b>CONCLUSION</b>
</p>
<p>We illustrate multiple-bias analyses using two studies on the Pandemrix™-narcolepsy association and advocate their use to better understand the robustness of study findings. Based on our multiple-bias models, the observed Pandemrix™-narcolepsy association consistently persists in the Finnish study. For the French study, the results of our multiple-bias models were inconclusive.</p>
</div>
</front>
</TEI>
<pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">26901063</PMID>
<DateCompleted><Year>2016</Year>
<Month>07</Month>
<Day>14</Day>
</DateCompleted>
<DateRevised><Year>2019</Year>
<Month>02</Month>
<Day>22</Day>
</DateRevised>
<Article PubModel="Electronic-eCollection"><Journal><ISSN IssnType="Electronic">1932-6203</ISSN>
<JournalIssue CitedMedium="Internet"><Volume>11</Volume>
<Issue>2</Issue>
<PubDate><Year>2016</Year>
</PubDate>
</JournalIssue>
<Title>PloS one</Title>
<ISOAbbreviation>PLoS ONE</ISOAbbreviation>
</Journal>
<ArticleTitle>Application of Probabilistic Multiple-Bias Analyses to a Cohort- and a Case-Control Study on the Association between Pandemrix™ and Narcolepsy.</ArticleTitle>
<Pagination><MedlinePgn>e0149289</MedlinePgn>
</Pagination>
<ELocationID EIdType="doi" ValidYN="Y">10.1371/journal.pone.0149289</ELocationID>
<Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">An increase in narcolepsy cases was observed in Finland and Sweden towards the end of the 2009 H1N1 influenza pandemic. Preliminary observational studies suggested a temporal link with the pandemic influenza vaccine Pandemrix™, leading to a number of additional studies across Europe. Given the public health urgency, these studies used readily available retrospective data from various sources. The potential for bias in such settings was generally acknowledged. Although generally advocated by key opinion leaders and international health authorities, no systematic quantitative assessment of the potential joint impact of biases was undertaken in any of these studies.</AbstractText>
<AbstractText Label="METHODS" NlmCategory="METHODS">We applied bias-level multiple-bias analyses to two of the published narcolepsy studies: a pediatric cohort study from Finland and a case-control study from France. In particular, we developed Monte Carlo simulation models to evaluate a potential cascade of biases, including confounding by age, by indication and by natural H1N1 infection, selection bias, disease- and exposure misclassification. All bias parameters were evidence-based to the extent possible.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">Given the assumptions used for confounding, selection bias and misclassification, the Finnish rate ratio of 13.78 (95% CI: 5.72-28.11) reduced to a median value of 6.06 (2.5th- 97.5th percentile: 2.49-15.1) and the French odds ratio of 5.43 (95% CI: 2.6-10.08) to 1.85 (2.5th-97.5th percentile: 0.85-4.08).</AbstractText>
<AbstractText Label="CONCLUSION" NlmCategory="CONCLUSIONS">We illustrate multiple-bias analyses using two studies on the Pandemrix™-narcolepsy association and advocate their use to better understand the robustness of study findings. Based on our multiple-bias models, the observed Pandemrix™-narcolepsy association consistently persists in the Finnish study. For the French study, the results of our multiple-bias models were inconclusive.</AbstractText>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Bollaerts</LastName>
<ForeName>Kaatje</ForeName>
<Initials>K</Initials>
<AffiliationInfo><Affiliation>P95 Pharmacovigilance and Epidemiology Services, Koning Leopold III Laan 1, 3001 Leuven, Belgium.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Shinde</LastName>
<ForeName>Vivek</ForeName>
<Initials>V</Initials>
<AffiliationInfo><Affiliation>GSK Vaccines, 2301 Renaissance Boulevard, King of Prussia, PA 19406, United States of America.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Dos Santos</LastName>
<ForeName>Gaël</ForeName>
<Initials>G</Initials>
<AffiliationInfo><Affiliation>Business & Decision Life Sciences (contractor for GSK Vaccines), Rue Saint Lambert 141, 1200 Brussels, Belgium.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Ferreira</LastName>
<ForeName>Germano</ForeName>
<Initials>G</Initials>
<AffiliationInfo><Affiliation>GSK Vaccines, Avenue Fleming 20, B-1300 Wavre, Belgium.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Bauchau</LastName>
<ForeName>Vincent</ForeName>
<Initials>V</Initials>
<AffiliationInfo><Affiliation>GSK Vaccines, Avenue Fleming 20, B-1300 Wavre, Belgium.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Cohet</LastName>
<ForeName>Catherine</ForeName>
<Initials>C</Initials>
<AffiliationInfo><Affiliation>GSK Vaccines, Avenue Fleming 20, B-1300 Wavre, Belgium.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Verstraeten</LastName>
<ForeName>Thomas</ForeName>
<Initials>T</Initials>
<AffiliationInfo><Affiliation>P95 Pharmacovigilance and Epidemiology Services, Koning Leopold III Laan 1, 3001 Leuven, Belgium.</Affiliation>
</AffiliationInfo>
</Author>
</AuthorList>
<Language>eng</Language>
<PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType>
<PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType>
</PublicationTypeList>
<ArticleDate DateType="Electronic"><Year>2016</Year>
<Month>02</Month>
<Day>22</Day>
</ArticleDate>
</Article>
<MedlineJournalInfo><Country>United States</Country>
<MedlineTA>PLoS One</MedlineTA>
<NlmUniqueID>101285081</NlmUniqueID>
<ISSNLinking>1932-6203</ISSNLinking>
</MedlineJournalInfo>
<ChemicalList><Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D007252">Influenza Vaccines</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="C556153">pandemrix</NameOfSubstance>
</Chemical>
</ChemicalList>
<CitationSubset>IM</CitationSubset>
<MeshHeadingList><MeshHeading><DescriptorName UI="D000293" MajorTopicYN="N">Adolescent</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D016022" MajorTopicYN="N">Case-Control Studies</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D002648" MajorTopicYN="N">Child</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D002675" MajorTopicYN="N">Child, Preschool</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D005387" MajorTopicYN="N" Type="Geographic">Finland</DescriptorName>
<QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D005602" MajorTopicYN="N" Type="Geographic">France</DescriptorName>
<QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D053118" MajorTopicYN="Y">Influenza A Virus, H1N1 Subtype</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D007252" MajorTopicYN="N">Influenza Vaccines</DescriptorName>
<QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName>
<QualifierName UI="Q000009" MajorTopicYN="Y">adverse effects</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D007251" MajorTopicYN="N">Influenza, Human</DescriptorName>
<QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName>
<QualifierName UI="Q000517" MajorTopicYN="Y">prevention & control</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D009290" MajorTopicYN="N">Narcolepsy</DescriptorName>
<QualifierName UI="Q000139" MajorTopicYN="N">chemically induced</QualifierName>
<QualifierName UI="Q000453" MajorTopicYN="Y">epidemiology</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D058873" MajorTopicYN="Y">Pandemics</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D013548" MajorTopicYN="N" Type="Geographic">Sweden</DescriptorName>
<QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName>
</MeshHeading>
</MeshHeadingList>
</MedlineCitation>
<PubmedData><History><PubMedPubDate PubStatus="received"><Year>2015</Year>
<Month>09</Month>
<Day>22</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="accepted"><Year>2015</Year>
<Month>12</Month>
<Day>24</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="entrez"><Year>2016</Year>
<Month>2</Month>
<Day>23</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
<PubMedPubDate PubStatus="pubmed"><Year>2016</Year>
<Month>2</Month>
<Day>24</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
<PubMedPubDate PubStatus="medline"><Year>2016</Year>
<Month>7</Month>
<Day>15</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
</History>
<PublicationStatus>epublish</PublicationStatus>
<ArticleIdList><ArticleId IdType="pubmed">26901063</ArticleId>
<ArticleId IdType="doi">10.1371/journal.pone.0149289</ArticleId>
<ArticleId IdType="pii">PONE-D-15-41968</ArticleId>
<ArticleId IdType="pmc">PMC4762678</ArticleId>
</ArticleIdList>
<ReferenceList><Reference><Citation>Int J Epidemiol. 2010 Feb;39(1):107-17</Citation>
<ArticleIdList><ArticleId IdType="pubmed">19948779</ArticleId>
</ArticleIdList>
</Reference>
<Reference><Citation>BMJ. 2013;346:f794</Citation>
<ArticleIdList><ArticleId IdType="pubmed">23444425</ArticleId>
</ArticleIdList>
</Reference>
<Reference><Citation>Vaccine. 2010 Nov 29;28(51):8157-61</Citation>
<ArticleIdList><ArticleId IdType="pubmed">20937310</ArticleId>
</ArticleIdList>
</Reference>
<Reference><Citation>PLoS One. 2011;6(4):e17919</Citation>
<ArticleIdList><ArticleId IdType="pubmed">21533034</ArticleId>
</ArticleIdList>
</Reference>
<Reference><Citation>Euro Surveill. 2011;16(27). pii: 19908</Citation>
<ArticleIdList><ArticleId IdType="pubmed">21794216</ArticleId>
</ArticleIdList>
</Reference>
<Reference><Citation>Ann Neurol. 2011 Sep;70(3):410-7</Citation>
<ArticleIdList><ArticleId IdType="pubmed">21866560</ArticleId>
</ArticleIdList>
</Reference>
<Reference><Citation>Neurology. 2013 Apr 2;80(14):1315-21</Citation>
<ArticleIdList><ArticleId IdType="pubmed">23486871</ArticleId>
</ArticleIdList>
</Reference>
<Reference><Citation>Brain. 2013 Aug;136(Pt 8):2486-96</Citation>
<ArticleIdList><ArticleId IdType="pubmed">23884811</ArticleId>
</ArticleIdList>
</Reference>
<Reference><Citation>Influenza Other Respir Viruses. 2013 Sep;7(5):872-86</Citation>
<ArticleIdList><ArticleId IdType="pubmed">23331969</ArticleId>
</ArticleIdList>
</Reference>
<Reference><Citation>Sleep Med. 2013 Sep;14(9):867-71</Citation>
<ArticleIdList><ArticleId IdType="pubmed">23773727</ArticleId>
</ArticleIdList>
</Reference>
<Reference><Citation>Euro Surveill. 2013;18(45):20628</Citation>
<ArticleIdList><ArticleId IdType="pubmed">24229790</ArticleId>
</ArticleIdList>
</Reference>
<Reference><Citation>Sleep. 2014 Jan;37(1):19-25</Citation>
<ArticleIdList><ArticleId IdType="pubmed">24381371</ArticleId>
</ArticleIdList>
</Reference>
<Reference><Citation>J Intern Med. 2014 Feb;275(2):172-90</Citation>
<ArticleIdList><ArticleId IdType="pubmed">24134219</ArticleId>
</ArticleIdList>
</Reference>
<Reference><Citation>Sleep Med. 2014 Feb;15(2):262-5</Citation>
<ArticleIdList><ArticleId IdType="pubmed">24468101</ArticleId>
</ArticleIdList>
</Reference>
<Reference><Citation>Ann Neurol. 2013 Apr;73(4):560</Citation>
<ArticleIdList><ArticleId IdType="pubmed">23225098</ArticleId>
</ArticleIdList>
</Reference>
<Reference><Citation>Epidemiol Infect. 2014 May;142(5):964-74</Citation>
<ArticleIdList><ArticleId IdType="pubmed">24139316</ArticleId>
</ArticleIdList>
</Reference>
<Reference><Citation>Euro Surveill. 2014;19(17):15-25</Citation>
<ArticleIdList><ArticleId IdType="pubmed">24821121</ArticleId>
</ArticleIdList>
</Reference>
<Reference><Citation>Sleep Med. 2014 May;15(5):502-7</Citation>
<ArticleIdList><ArticleId IdType="pubmed">24780133</ArticleId>
</ArticleIdList>
</Reference>
<Reference><Citation>Int J Epidemiol. 2014 Dec;43(6):1969-85</Citation>
<ArticleIdList><ArticleId IdType="pubmed">25080530</ArticleId>
</ArticleIdList>
</Reference>
<Reference><Citation>Vaccine. 2015 Jun 8;33 Suppl 2:B6-B13</Citation>
<ArticleIdList><ArticleId IdType="pubmed">26022571</ArticleId>
</ArticleIdList>
</Reference>
<Reference><Citation>Hum Vaccin Immunother. 2016;12(1):187-93</Citation>
<ArticleIdList><ArticleId IdType="pubmed">26379011</ArticleId>
</ArticleIdList>
</Reference>
<Reference><Citation>Epidemiology. 2003 Jul;14(4):459-66</Citation>
<ArticleIdList><ArticleId IdType="pubmed">12843772</ArticleId>
</ArticleIdList>
</Reference>
<Reference><Citation>Am J Epidemiol. 2004 Aug 15;160(4):384-92</Citation>
<ArticleIdList><ArticleId IdType="pubmed">15286024</ArticleId>
</ArticleIdList>
</Reference>
<Reference><Citation>Int J Epidemiol. 1996 Dec;25(6):1107-16</Citation>
<ArticleIdList><ArticleId IdType="pubmed">9027513</ArticleId>
</ArticleIdList>
</Reference>
<Reference><Citation>Pharmacoepidemiol Drug Saf. 2006 May;15(5):291-303</Citation>
<ArticleIdList><ArticleId IdType="pubmed">16447304</ArticleId>
</ArticleIdList>
</Reference>
<Reference><Citation>Clin Chest Med. 2010 Jun;31(2):371-81</Citation>
<ArticleIdList><ArticleId IdType="pubmed">20488294</ArticleId>
</ArticleIdList>
</Reference>
<Reference><Citation>BMJ. 2011;343:d5956</Citation>
<ArticleIdList><ArticleId IdType="pubmed">21994316</ArticleId>
</ArticleIdList>
</Reference>
<Reference><Citation>PLoS One. 2012;7(3):e33536</Citation>
<ArticleIdList><ArticleId IdType="pubmed">22470453</ArticleId>
</ArticleIdList>
</Reference>
<Reference><Citation>PLoS One. 2012;7(3):e33723</Citation>
<ArticleIdList><ArticleId IdType="pubmed">22470463</ArticleId>
</ArticleIdList>
</Reference>
<Reference><Citation>PLoS One. 2012;7(7):e39496</Citation>
<ArticleIdList><ArticleId IdType="pubmed">22808039</ArticleId>
</ArticleIdList>
</Reference>
<Reference><Citation>Vaccine. 2013 Jan 30;31(6):994-1007</Citation>
<ArticleIdList><ArticleId IdType="pubmed">23246545</ArticleId>
</ArticleIdList>
</Reference>
<Reference><Citation>Vaccine. 2013 Feb 6;31(8):1246-54</Citation>
<ArticleIdList><ArticleId IdType="pubmed">23246544</ArticleId>
</ArticleIdList>
</Reference>
<Reference><Citation>Sleep. 2009 Aug;32(8):979-83</Citation>
<ArticleIdList><ArticleId IdType="pubmed">19725248</ArticleId>
</ArticleIdList>
</Reference>
</ReferenceList>
</PubmedData>
</pubmed>
<affiliations><list><country><li>Belgique</li>
<li>États-Unis</li>
</country>
<region><li>Pennsylvanie</li>
<li>Province du Brabant flamand</li>
<li>Région de Bruxelles-Capitale</li>
</region>
<settlement><li>Bruxelles</li>
<li>Heverlee</li>
<li>Louvain</li>
</settlement>
</list>
<tree><country name="Belgique"><region name="Province du Brabant flamand"><name sortKey="Bollaerts, Kaatje" sort="Bollaerts, Kaatje" uniqKey="Bollaerts K" first="Kaatje" last="Bollaerts">Kaatje Bollaerts</name>
</region>
<name sortKey="Bauchau, Vincent" sort="Bauchau, Vincent" uniqKey="Bauchau V" first="Vincent" last="Bauchau">Vincent Bauchau</name>
<name sortKey="Cohet, Catherine" sort="Cohet, Catherine" uniqKey="Cohet C" first="Catherine" last="Cohet">Catherine Cohet</name>
<name sortKey="Dos Santos, Gael" sort="Dos Santos, Gael" uniqKey="Dos Santos G" first="Gaël" last="Dos Santos">Gaël Dos Santos</name>
<name sortKey="Ferreira, Germano" sort="Ferreira, Germano" uniqKey="Ferreira G" first="Germano" last="Ferreira">Germano Ferreira</name>
<name sortKey="Verstraeten, Thomas" sort="Verstraeten, Thomas" uniqKey="Verstraeten T" first="Thomas" last="Verstraeten">Thomas Verstraeten</name>
</country>
<country name="États-Unis"><region name="Pennsylvanie"><name sortKey="Shinde, Vivek" sort="Shinde, Vivek" uniqKey="Shinde V" first="Vivek" last="Shinde">Vivek Shinde</name>
</region>
</country>
</tree>
</affiliations>
</record>

Pour manipuler ce document sous Unix (Dilib)

EXPLOR_STEP=$WICRI_ROOT/Sante/explor/GrippeFranceV1/Data/Main/Exploration

HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 000174 | SxmlIndent | more

HfdSelect -h $EXPLOR_AREA/Data/Main/Exploration/biblio.hfd -nk 000174 | SxmlIndent | more

Pour mettre un lien sur cette page dans le réseau Wicri

{{Explor lien
   |wiki=    Sante
   |area=    GrippeFranceV1
   |flux=    Main
   |étape=   Exploration
   |type=    RBID
   |clé=     pubmed:26901063
   |texte=   Application of Probabilistic Multiple-Bias Analyses to a Cohort- and a Case-Control Study on the Association between Pandemrix™ and Narcolepsy.
}}

Pour générer des pages wiki

HfdIndexSelect -h $EXPLOR_AREA/Data/Main/Exploration/RBID.i   -Sk "pubmed:26901063" \
       | HfdSelect -Kh $EXPLOR_AREA/Data/Main/Exploration/biblio.hfd   \
       | NlmPubMed2Wicri -a GrippeFranceV1

This area was generated with Dilib version V0.6.35.
Data generation: Sun Aug 9 07:31:43 2020. Site generation: Thu Mar 25 22:05:26 2021

	Serveur d'exploration sur la grippe en France
	Attention, ce site est en cours de développement ! Attention, site généré par des moyens informatiques à partir de corpus bruts. Les informations ne sont donc pas validées.

Serveur d'exploration sur la grippe en France

Application of Probabilistic Multiple-Bias Analyses to a Cohort- and a Case-Control Study on the Association between Pandemrix™ and Narcolepsy.

Application of Probabilistic Multiple-Bias Analyses to a Cohort- and a Case-Control Study on the Association between Pandemrix™ and Narcolepsy.

Source :

Descripteurs français

English descriptors

Abstract

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

Le document en format XML

Pour manipuler ce document sous Unix (Dilib)

Pour mettre un lien sur cette page dans le réseau Wicri

Pour générer des pages wiki