Pregnant women's perceptions of risks and benefits when considering participation in vaccine trials.

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Abstrakt

Tytuł:: Pregnant women's perceptions of risks and benefits when considering participation in vaccine trials.
Autorzy:: Jaffe E; Center for Bioethics and Department of Social Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States; Department of Maternal, Child, and Family Health, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.
Lyerly AD; Center for Bioethics and Department of Social Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States; Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.
Goldfarb IT; Department of Obstetrics and Gynecology, Massachusetts General Hospital, Boston, MA, United States. Electronic address: .
Źródło:: Vaccine [Vaccine] 2020 Oct 14; Vol. 38 (44), pp. 6922-6929. Date of Electronic Publication: 2020 Sep 04.
Typ publikacji:: Journal Article; Research Support, N.I.H., Extramural
Język:: English
Imprint Name(s):: Publication: Amsterdam, The Netherlands : Elsevier Science
Original Publication: [Guildford, Surrey, UK] : Butterworths, [c1983-
MeSH Terms:: Clinical Trials as Topic*
Decision Making*
Patient Acceptance of Health Care/*psychology
Pregnant Women/*psychology
Zika Virus Infection/*prevention & control
Adult ; Female ; Humans ; Interviews as Topic ; Pregnancy ; Pregnancy Complications, Infectious/prevention & control ; Risk Assessment ; Vaccination ; Vaccines ; Viral Vaccines
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Grant Information:: R01 AI108368 United States AI NIAID NIH HHS; R01 AI127024 United States AI NIAID NIH HHS
Contributed Indexing:: Keywords: Decision-making; Pregnancy; Vaccine research; Zika vaccines
Substance Nomenclature:: 0 (Vaccines)
0 (Viral Vaccines)
Entry Date(s):: Date Created: 20200907 Date Completed: 20201019 Latest Revision: 20231118
Update Code:: 20240104
PubMed Central ID:: PMC7471759
DOI:: 10.1016/j.vaccine.2020.08.059
PMID:: 32893036
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Introduction: Despite historical exclusion, there has been recent recognition of the need to address the health of pregnant women in research on vaccines against emerging pathogens. However, pregnant women's views and decision-making processes about vaccine research participation during infectious disease outbreaks remain underexplored. This study aims to examine women's decision-making processes around vaccine research participation during infectious disease outbreaks.
Methods: We conducted qualitative semi-structured in-depth interviews with pregnant and recently pregnant women (n = 13), eliciting their views on four hypothetical Zika Virus vaccine research scenarios and probing their decision-making processes around participation. After recorded interviews were transcribed, thematic analysis was conducted based on a priori and emergent themes.
Results: Most women interviewed were accepting of vaccine research scenarios. Three broad themes-evidence, risk, and trust-characterized women's decision-making processes. Women varied in how different types and levels of evidence impacted their considerations, which risks were most salient to their decision-making processes, and from whom they trusted recommendations about vaccine research participation. Exemplary quotes from each theme are presented, and lessons for vaccine development during the current COVID-19 pandemic and future outbreaks are discussed.
Conclusion: Some pregnant women are accepting of participation in vaccine research during infectious disease outbreaks. Incorporating their priorities into trial design may facilitate their participation and generation of evidence for this important population.
Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2020 Elsevier Ltd. All rights reserved.)

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