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Developing product label information to support evidence-informed use of vaccines in pregnancy.

Identifieur interne : 000032 ( Main/Exploration ); précédent : 000031; suivant : 000033

Developing product label information to support evidence-informed use of vaccines in pregnancy.

Auteurs : Terra A. Manca [Canada] ; Janice E. Graham [Canada] ; Ève Dubé [Canada] ; Melissa Kervin [Canada] ; Eliana Castillo [Canada] ; Natasha S. Crowcroft [Canada] ; Deshayne B. Fell [Canada] ; Michael Hadskis [Canada] ; Jaelene M. Mannerfeldt [Canada] ; Devon Greyson [États-Unis] ; Noni E. Macdonald [Canada] ; Karina A. Top [Canada]

Source :

RBID : pubmed:31594709

Descripteurs français

English descriptors

Abstract

BACKGROUND

Product labelling information describing the use of vaccines in pregnancy continues to contain cautionary language even after clinical and epidemiological evidence of safety becomes available. This language raises safety concerns among healthcare providers who may hesitate to recommend vaccines during pregnancy.

PURPOSE

To develop clear evidence-based language about vaccine safety and effectiveness in pregnancy for inclusion in vaccine product labels.

METHODS

We conducted a three-stage consensus-methods project with stakeholders, including: healthcare providers, vaccine regulators, industry representatives, and experts in public health, communication, law, ethics, and social sciences. Using qualitative and quantitative methods, we held a nominal group technique (NGT) meeting, followed by a Delphi survey, and then a consensus workshop with a subset of Delphi participants. We developed a methodological tool to analyse data for consensus.

PRINCIPAL RESULTS

Stakeholders (N = 14) at the NGT meeting drafted product label statements for evaluation in the Delphi survey. Survey participants (N = 41) provided feedback on statements for five hypothetical vaccines. Workshop participants (N = 27) initiated discussions that demonstrated a lack of awareness that the regulatory purpose of product labels is to provide a scientific summary of product-specific pre-clinical and clinical trial data. Each stage of this project built on earlier stages until we achieved strong consensus on the language, structure, and types of data that stakeholders wanted to include in inactivated influenza vaccine (IIV) and tetanus-diphtheria-acellular pertussis (Tdap) vaccine product labels in Canada.

CONCLUSIONS

The revised statements for IIV and Tdap aligned with workshop participants' goals that the product label be evidence-based, with a consistent structure and language that is easily understood by healthcare providers. Emergent methods uncovered stakeholder concerns about the regulatory purpose, content, and evidence used in product labels. Involving healthcare providers in the development and regular updating of product information could prevent interpretations of that information that contribute to vaccine hesitancy.


DOI: 10.1016/j.vaccine.2019.09.063
PubMed: 31594709


Affiliations:


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


Le document en format XML

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<nlm:affiliation>Department of Medicine, University of Calgary, 2500 University Drive NW T2N 1N4, Calgary, Alberta, Canada; Department of Obstetrics and Gynecology, University of Calgary, 2500 University Drive NW T2N 1N4, Calgary, Alberta, Canada. Electronic address: castillo@ucalgary.ca.</nlm:affiliation>
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<name sortKey="Mannerfeldt, Jaelene M" sort="Mannerfeldt, Jaelene M" uniqKey="Mannerfeldt J" first="Jaelene M" last="Mannerfeldt">Jaelene M. Mannerfeldt</name>
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<name sortKey="Top, Karina A" sort="Top, Karina A" uniqKey="Top K" first="Karina A" last="Top">Karina A. Top</name>
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<nlm:affiliation>Canadian Center for Vaccinology, IWK Health Centre 5850/5980 University Ave, B3K 6R8 Halifax, Nova Scotia, Canada; Department of Pediatrics, Dalhousie University, Halifax, Nova Scotia, Canada. Electronic address: karina.top@dal.ca.</nlm:affiliation>
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<wicri:regionArea>Canadian Center for Vaccinology, IWK Health Centre 5850/5980 University Ave, B3K 6R8 Halifax, Nova Scotia, Canada; Department of Pediatrics, Dalhousie University, Halifax, Nova Scotia</wicri:regionArea>
<wicri:noRegion>Nova Scotia</wicri:noRegion>
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<title level="j">Vaccine</title>
<idno type="eISSN">1873-2518</idno>
<imprint>
<date when="2019" type="published">2019</date>
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<keywords scheme="KwdEn" xml:lang="en">
<term>Adult (MeSH)</term>
<term>Canada (MeSH)</term>
<term>Consensus Development Conferences as Topic (MeSH)</term>
<term>Data Display (MeSH)</term>
<term>Female (MeSH)</term>
<term>Humans (MeSH)</term>
<term>Patient Acceptance of Health Care (MeSH)</term>
<term>Pregnancy (MeSH)</term>
<term>Product Labeling (MeSH)</term>
<term>Public Health Surveillance (MeSH)</term>
<term>Surveys and Questionnaires (MeSH)</term>
<term>Vaccines (administration & dosage)</term>
<term>Vaccines (standards)</term>
</keywords>
<keywords scheme="KwdFr" xml:lang="fr">
<term>Acceptation des soins par les patients (MeSH)</term>
<term>Adulte (MeSH)</term>
<term>Affichage de données (MeSH)</term>
<term>Canada (MeSH)</term>
<term>Conférences de consensus comme sujet (MeSH)</term>
<term>Enquêtes et questionnaires (MeSH)</term>
<term>Femelle (MeSH)</term>
<term>Grossesse (MeSH)</term>
<term>Humains (MeSH)</term>
<term>Surveillance de la santé publique (MeSH)</term>
<term>Vaccins (administration et posologie)</term>
<term>Vaccins (normes)</term>
<term>Étiquetage de produit (MeSH)</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en">
<term>Vaccines</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="standards" xml:lang="en">
<term>Vaccines</term>
</keywords>
<keywords scheme="MESH" type="geographic" xml:lang="en">
<term>Canada</term>
</keywords>
<keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr">
<term>Vaccins</term>
</keywords>
<keywords scheme="MESH" qualifier="normes" xml:lang="fr">
<term>Vaccins</term>
</keywords>
<keywords scheme="MESH" xml:lang="en">
<term>Adult</term>
<term>Consensus Development Conferences as Topic</term>
<term>Data Display</term>
<term>Female</term>
<term>Humans</term>
<term>Patient Acceptance of Health Care</term>
<term>Pregnancy</term>
<term>Product Labeling</term>
<term>Public Health Surveillance</term>
<term>Surveys and Questionnaires</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr">
<term>Acceptation des soins par les patients</term>
<term>Adulte</term>
<term>Affichage de données</term>
<term>Canada</term>
<term>Conférences de consensus comme sujet</term>
<term>Enquêtes et questionnaires</term>
<term>Femelle</term>
<term>Grossesse</term>
<term>Humains</term>
<term>Surveillance de la santé publique</term>
<term>Étiquetage de produit</term>
</keywords>
<keywords scheme="Wicri" type="geographic" xml:lang="fr">
<term>Canada</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front>
<div type="abstract" xml:lang="en">
<p>
<b>BACKGROUND</b>
</p>
<p>Product labelling information describing the use of vaccines in pregnancy continues to contain cautionary language even after clinical and epidemiological evidence of safety becomes available. This language raises safety concerns among healthcare providers who may hesitate to recommend vaccines during pregnancy.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>PURPOSE</b>
</p>
<p>To develop clear evidence-based language about vaccine safety and effectiveness in pregnancy for inclusion in vaccine product labels.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>METHODS</b>
</p>
<p>We conducted a three-stage consensus-methods project with stakeholders, including: healthcare providers, vaccine regulators, industry representatives, and experts in public health, communication, law, ethics, and social sciences. Using qualitative and quantitative methods, we held a nominal group technique (NGT) meeting, followed by a Delphi survey, and then a consensus workshop with a subset of Delphi participants. We developed a methodological tool to analyse data for consensus.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>PRINCIPAL RESULTS</b>
</p>
<p>Stakeholders (N = 14) at the NGT meeting drafted product label statements for evaluation in the Delphi survey. Survey participants (N = 41) provided feedback on statements for five hypothetical vaccines. Workshop participants (N = 27) initiated discussions that demonstrated a lack of awareness that the regulatory purpose of product labels is to provide a scientific summary of product-specific pre-clinical and clinical trial data. Each stage of this project built on earlier stages until we achieved strong consensus on the language, structure, and types of data that stakeholders wanted to include in inactivated influenza vaccine (IIV) and tetanus-diphtheria-acellular pertussis (Tdap) vaccine product labels in Canada.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>CONCLUSIONS</b>
</p>
<p>The revised statements for IIV and Tdap aligned with workshop participants' goals that the product label be evidence-based, with a consistent structure and language that is easily understood by healthcare providers. Emergent methods uncovered stakeholder concerns about the regulatory purpose, content, and evidence used in product labels. Involving healthcare providers in the development and regular updating of product information could prevent interpretations of that information that contribute to vaccine hesitancy.</p>
</div>
</front>
</TEI>
<pubmed>
<MedlineCitation Status="MEDLINE" Owner="NLM">
<PMID Version="1">31594709</PMID>
<DateCompleted>
<Year>2020</Year>
<Month>07</Month>
<Day>29</Day>
</DateCompleted>
<DateRevised>
<Year>2020</Year>
<Month>07</Month>
<Day>29</Day>
</DateRevised>
<Article PubModel="Print-Electronic">
<Journal>
<ISSN IssnType="Electronic">1873-2518</ISSN>
<JournalIssue CitedMedium="Internet">
<Volume>37</Volume>
<Issue>48</Issue>
<PubDate>
<Year>2019</Year>
<Month>11</Month>
<Day>15</Day>
</PubDate>
</JournalIssue>
<Title>Vaccine</Title>
<ISOAbbreviation>Vaccine</ISOAbbreviation>
</Journal>
<ArticleTitle>Developing product label information to support evidence-informed use of vaccines in pregnancy.</ArticleTitle>
<Pagination>
<MedlinePgn>7138-7146</MedlinePgn>
</Pagination>
<ELocationID EIdType="pii" ValidYN="Y">S0264-410X(19)31291-5</ELocationID>
<ELocationID EIdType="doi" ValidYN="Y">10.1016/j.vaccine.2019.09.063</ELocationID>
<Abstract>
<AbstractText Label="BACKGROUND">Product labelling information describing the use of vaccines in pregnancy continues to contain cautionary language even after clinical and epidemiological evidence of safety becomes available. This language raises safety concerns among healthcare providers who may hesitate to recommend vaccines during pregnancy.</AbstractText>
<AbstractText Label="PURPOSE">To develop clear evidence-based language about vaccine safety and effectiveness in pregnancy for inclusion in vaccine product labels.</AbstractText>
<AbstractText Label="METHODS">We conducted a three-stage consensus-methods project with stakeholders, including: healthcare providers, vaccine regulators, industry representatives, and experts in public health, communication, law, ethics, and social sciences. Using qualitative and quantitative methods, we held a nominal group technique (NGT) meeting, followed by a Delphi survey, and then a consensus workshop with a subset of Delphi participants. We developed a methodological tool to analyse data for consensus.</AbstractText>
<AbstractText Label="PRINCIPAL RESULTS">Stakeholders (N = 14) at the NGT meeting drafted product label statements for evaluation in the Delphi survey. Survey participants (N = 41) provided feedback on statements for five hypothetical vaccines. Workshop participants (N = 27) initiated discussions that demonstrated a lack of awareness that the regulatory purpose of product labels is to provide a scientific summary of product-specific pre-clinical and clinical trial data. Each stage of this project built on earlier stages until we achieved strong consensus on the language, structure, and types of data that stakeholders wanted to include in inactivated influenza vaccine (IIV) and tetanus-diphtheria-acellular pertussis (Tdap) vaccine product labels in Canada.</AbstractText>
<AbstractText Label="CONCLUSIONS">The revised statements for IIV and Tdap aligned with workshop participants' goals that the product label be evidence-based, with a consistent structure and language that is easily understood by healthcare providers. Emergent methods uncovered stakeholder concerns about the regulatory purpose, content, and evidence used in product labels. Involving healthcare providers in the development and regular updating of product information could prevent interpretations of that information that contribute to vaccine hesitancy.</AbstractText>
<CopyrightInformation>Copyright © 2019 The Author(s). Published by Elsevier Ltd.. All rights reserved.</CopyrightInformation>
</Abstract>
<AuthorList CompleteYN="Y">
<Author ValidYN="Y">
<LastName>Manca</LastName>
<ForeName>Terra A</ForeName>
<Initials>TA</Initials>
<AffiliationInfo>
<Affiliation>Canadian Center for Vaccinology, IWK Health Centre 5850/5980 University Ave, B3K 6R8 Halifax, Nova Scotia, Canada; Department of Pediatrics, Dalhousie University, Halifax, Nova Scotia, Canada. Electronic address: tmanca@ualberta.ca.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Graham</LastName>
<ForeName>Janice E</ForeName>
<Initials>JE</Initials>
<AffiliationInfo>
<Affiliation>Canadian Center for Vaccinology, IWK Health Centre 5850/5980 University Ave, B3K 6R8 Halifax, Nova Scotia, Canada; Department of Pediatrics, Dalhousie University, Halifax, Nova Scotia, Canada. Electronic address: janice.graham@dal.ca.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Dubé</LastName>
<ForeName>Ève</ForeName>
<Initials>È</Initials>
<AffiliationInfo>
<Affiliation>Department of Anthropology, Laval University Pavillon Charles-De Koninck, 1030, avenue des Sciences humaines, Bureau 3431, Université Laval, G1V 0A6 Québec, Québec, Canada. Electronic address: eve.dube@inspq.qc.ca.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Kervin</LastName>
<ForeName>Melissa</ForeName>
<Initials>M</Initials>
<AffiliationInfo>
<Affiliation>Canadian Center for Vaccinology, IWK Health Centre 5850/5980 University Ave, B3K 6R8 Halifax, Nova Scotia, Canada; Department of Pediatrics, Dalhousie University, Halifax, Nova Scotia, Canada. Electronic address: Melissa.Kervin@iwk.nshealth.ca.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Castillo</LastName>
<ForeName>Eliana</ForeName>
<Initials>E</Initials>
<AffiliationInfo>
<Affiliation>Department of Medicine, University of Calgary, 2500 University Drive NW T2N 1N4, Calgary, Alberta, Canada; Department of Obstetrics and Gynecology, University of Calgary, 2500 University Drive NW T2N 1N4, Calgary, Alberta, Canada. Electronic address: castillo@ucalgary.ca.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Crowcroft</LastName>
<ForeName>Natasha S</ForeName>
<Initials>NS</Initials>
<AffiliationInfo>
<Affiliation>Public Health Ontario, 480 University Avenue, Suite 300, M5G 1V2 Toronto, Ontario, Canada; Institute for Clinical Evaluative Sciences G1 06, 2075 Bayview Avenue, M4N 3M5 Toronto, Ontario, Canada; Dalla Lana School of Public Health, University of Toronto, 155 College Street 6F, M5T 3M7 Toronto, Ontario, Canada. Electronic address: natasha.crowcroft@oahpp.ca.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Fell</LastName>
<ForeName>Deshayne B</ForeName>
<Initials>DB</Initials>
<AffiliationInfo>
<Affiliation>School of Epidemiology and Public Health, University of Ottawa, Alta Vista Campus, Room 101, 600 Peter Morand Crescent, K1G 5Z3 Ottawa, Ontario, Canada; Children's Hospital of Eastern Ontario Research Institute, 401 Smyth Rd, K1H 5B2 Ottawa, Ontario, Canada. Electronic address: dfell@cheo.on.ca.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Hadskis</LastName>
<ForeName>Michael</ForeName>
<Initials>M</Initials>
<AffiliationInfo>
<Affiliation>School of Health Administration and Schulich School of Law, Dalhousie University, Weldon Law Building, 6061 University Avenue, PO Box 15000, B3H 4R2 Halifax, Nova Scotia, Canada. Electronic address: Michael.Hadskis@dal.ca.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Mannerfeldt</LastName>
<ForeName>Jaelene M</ForeName>
<Initials>JM</Initials>
<AffiliationInfo>
<Affiliation>Department of Obstetrics and Gynecology, University of Calgary, 2500 University Drive NW T2N 1N4, Calgary, Alberta, Canada; Department of Family Medicine, University of Calgary, 2500 University Drive NW T2N 1N4, Calgary, Alberta, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Greyson</LastName>
<ForeName>Devon</ForeName>
<Initials>D</Initials>
<AffiliationInfo>
<Affiliation>Department of Communication, N308 Integrative Learning Center, 650 N. Pleasant St, University of Massachusetts Amherst, 01003-1100 Amherst, MA, United States. Electronic address: dgreyson@umass.edu.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>MacDonald</LastName>
<ForeName>Noni E</ForeName>
<Initials>NE</Initials>
<AffiliationInfo>
<Affiliation>Canadian Center for Vaccinology, IWK Health Centre 5850/5980 University Ave, B3K 6R8 Halifax, Nova Scotia, Canada; Department of Pediatrics, Dalhousie University, Halifax, Nova Scotia, Canada. Electronic address: Noni.MacDonald@dal.ca.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Top</LastName>
<ForeName>Karina A</ForeName>
<Initials>KA</Initials>
<AffiliationInfo>
<Affiliation>Canadian Center for Vaccinology, IWK Health Centre 5850/5980 University Ave, B3K 6R8 Halifax, Nova Scotia, Canada; Department of Pediatrics, Dalhousie University, Halifax, Nova Scotia, Canada. Electronic address: karina.top@dal.ca.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<CollectiveName>Canadian Vaccine Product Monograph Working Group</CollectiveName>
</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>2019</Year>
<Month>10</Month>
<Day>05</Day>
</ArticleDate>
</Article>
<MedlineJournalInfo>
<Country>Netherlands</Country>
<MedlineTA>Vaccine</MedlineTA>
<NlmUniqueID>8406899</NlmUniqueID>
<ISSNLinking>0264-410X</ISSNLinking>
</MedlineJournalInfo>
<ChemicalList>
<Chemical>
<RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D014612">Vaccines</NameOfSubstance>
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<CitationSubset>IM</CitationSubset>
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<DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D002170" MajorTopicYN="N" Type="Geographic">Canada</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D003245" MajorTopicYN="N">Consensus Development Conferences as Topic</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D003626" MajorTopicYN="Y">Data Display</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D010342" MajorTopicYN="Y">Patient Acceptance of Health Care</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D011247" MajorTopicYN="N">Pregnancy</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D011356" MajorTopicYN="Y">Product Labeling</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D062486" MajorTopicYN="N">Public Health Surveillance</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D011795" MajorTopicYN="N">Surveys and Questionnaires</DescriptorName>
</MeshHeading>
<MeshHeading>
<DescriptorName UI="D014612" MajorTopicYN="Y">Vaccines</DescriptorName>
<QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName>
<QualifierName UI="Q000592" MajorTopicYN="N">standards</QualifierName>
</MeshHeading>
</MeshHeadingList>
<KeywordList Owner="NOTNLM">
<Keyword MajorTopicYN="Y">Consensus methods</Keyword>
<Keyword MajorTopicYN="Y">Immunization</Keyword>
<Keyword MajorTopicYN="Y">Influenza</Keyword>
<Keyword MajorTopicYN="Y">Pertussis</Keyword>
<Keyword MajorTopicYN="Y">Pregnancy</Keyword>
<Keyword MajorTopicYN="Y">Vaccination</Keyword>
</KeywordList>
</MedlineCitation>
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<Month>05</Month>
<Day>04</Day>
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<Month>09</Month>
<Day>18</Day>
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<Day>9</Day>
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<Month>7</Month>
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<li>États-Unis</li>
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<region>
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<li>Massachusetts</li>
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<settlement>
<li>Amherst (Massachusetts)</li>
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<name sortKey="Castillo, Eliana" sort="Castillo, Eliana" uniqKey="Castillo E" first="Eliana" last="Castillo">Eliana Castillo</name>
<name sortKey="Crowcroft, Natasha S" sort="Crowcroft, Natasha S" uniqKey="Crowcroft N" first="Natasha S" last="Crowcroft">Natasha S. Crowcroft</name>
<name sortKey="Dube, Eve" sort="Dube, Eve" uniqKey="Dube E" first="Ève" last="Dubé">Ève Dubé</name>
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<name sortKey="Hadskis, Michael" sort="Hadskis, Michael" uniqKey="Hadskis M" first="Michael" last="Hadskis">Michael Hadskis</name>
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<name sortKey="Macdonald, Noni E" sort="Macdonald, Noni E" uniqKey="Macdonald N" first="Noni E" last="Macdonald">Noni E. Macdonald</name>
<name sortKey="Mannerfeldt, Jaelene M" sort="Mannerfeldt, Jaelene M" uniqKey="Mannerfeldt J" first="Jaelene M" last="Mannerfeldt">Jaelene M. Mannerfeldt</name>
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<name sortKey="Greyson, Devon" sort="Greyson, Devon" uniqKey="Greyson D" first="Devon" last="Greyson">Devon Greyson</name>
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