Qualitative interview study exploring the perspectives of pregnant women on participating in controlled human infection research in the UK
Qualitative interview study exploring the perspectives of pregnant women on participating in controlled human infection research in the UK
Introduction: pregnant women have been historically excluded from interventional research. While recent efforts have been made to improve their involvement, there remains a disparity in the evidence base for treatments available to pregnant women compared with the non-pregnant population. A significant barrier to the enrolment of pregnant women within research is risk perception and a poor understanding of decision-making in this population.
Objective: assess the risk perception and influences on decision-making in pregnant women, when considering whether to enrol in a hypothetical interventional research study.
Design: semistructured interviews were undertaken, and thematic analysis was undertaken of participant responses.
Participants: twelve pregnant women were enrolled from an antenatal outpatient clinic.
Results: participants were unanimously positive about enrolling in the proposed hypothetical interventional study. Risk perception was influenced by potential risks to their fetus and their previous experiences of healthcare and research. Participants found the uncertainty in quantifying risk for new research interventions challenging. They were motivated to enrol in research by altruism and found less invasive research interventions more tolerable.
Conclusion: it is vital to understand how pregnant women balance the perceived risks and benefits of interventional research. This may help clinicians and scientists better communicate risk to pregnant women and address the ongoing under-representation of pregnant women in interventional research.
Female, Humans, Pregnancy, Pregnant Women, Qualitative Research, United Kingdom, OBSTETRICS, QUALITATIVE RESEARCH, Maternal medicine, NEONATOLOGY, MICROBIOLOGY, Paediatric infectious disease & immunisation
e073992
Dorey, Robert B.
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Theodosiou, Anastasia A.
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Read, Robert C.
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Vandrevala, Tushna
45ccaf5a-cb30-40df-ba91-1ef166672468
Jones, Christine E.
48229079-8b58-4dcb-8374-d9481fe7b426
27 December 2023
Dorey, Robert B.
8d4b042f-1659-4e76-99c2-23cde78ca4f5
Theodosiou, Anastasia A.
c6e63581-c22d-4a2c-9d14-2e66594eb053
Read, Robert C.
b5caca7b-0063-438a-b703-7ecbb6fc2b51
Vandrevala, Tushna
45ccaf5a-cb30-40df-ba91-1ef166672468
Jones, Christine E.
48229079-8b58-4dcb-8374-d9481fe7b426
Dorey, Robert B., Theodosiou, Anastasia A., Read, Robert C., Vandrevala, Tushna and Jones, Christine E.
(2023)
Qualitative interview study exploring the perspectives of pregnant women on participating in controlled human infection research in the UK.
BMJ Open, 13 (12), , [e073992].
(doi:10.1136/bmjopen-2023-073992).
Abstract
Introduction: pregnant women have been historically excluded from interventional research. While recent efforts have been made to improve their involvement, there remains a disparity in the evidence base for treatments available to pregnant women compared with the non-pregnant population. A significant barrier to the enrolment of pregnant women within research is risk perception and a poor understanding of decision-making in this population.
Objective: assess the risk perception and influences on decision-making in pregnant women, when considering whether to enrol in a hypothetical interventional research study.
Design: semistructured interviews were undertaken, and thematic analysis was undertaken of participant responses.
Participants: twelve pregnant women were enrolled from an antenatal outpatient clinic.
Results: participants were unanimously positive about enrolling in the proposed hypothetical interventional study. Risk perception was influenced by potential risks to their fetus and their previous experiences of healthcare and research. Participants found the uncertainty in quantifying risk for new research interventions challenging. They were motivated to enrol in research by altruism and found less invasive research interventions more tolerable.
Conclusion: it is vital to understand how pregnant women balance the perceived risks and benefits of interventional research. This may help clinicians and scientists better communicate risk to pregnant women and address the ongoing under-representation of pregnant women in interventional research.
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e073992.full
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More information
Accepted/In Press date: 11 December 2023
e-pub ahead of print date: 27 December 2023
Published date: 27 December 2023
Additional Information:
Funding Information:
RBD was supported by the University of Southampton National Institute of Health Research Academic Clinical Fellowship Scheme. AAT is supported by the Medical Research Council (Clinical Research Training Fellowship MR/V002015/1).
Publisher Copyright:
© 2023 BMJ Publishing Group. All rights reserved.
Keywords:
Female, Humans, Pregnancy, Pregnant Women, Qualitative Research, United Kingdom, OBSTETRICS, QUALITATIVE RESEARCH, Maternal medicine, NEONATOLOGY, MICROBIOLOGY, Paediatric infectious disease & immunisation
Identifiers
Local EPrints ID: 485909
URI: http://eprints.soton.ac.uk/id/eprint/485909
ISSN: 2044-6055
PURE UUID: b7f7361e-4a06-4990-a3f1-93c871977ef2
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Date deposited: 04 Jan 2024 02:47
Last modified: 18 Mar 2024 03:39
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Contributors
Author:
Robert B. Dorey
Author:
Anastasia A. Theodosiou
Author:
Tushna Vandrevala
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