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A qualitative study on stakeholders’ views on the participation of pregnant women in the APOSTEL VI study: a low-risk obstetrical RCT

BACKGROUND: Bioethicists argue that inclusion of pregnant women in clinical research should be more routine to increase the evidence-base for pregnant women and foetuses. Yet, it is unknown whether pregnant women and others directly involved are willing to be routinely included. Therefore, we first...

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Autores principales: van der Zande, Indira S. E., van der Graaf, Rieke, Oudijk, Martijn A., van Vliet-Lachotzki, Elsbeth H., van Delden, Johannes J. M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6371564/
https://www.ncbi.nlm.nih.gov/pubmed/30744577
http://dx.doi.org/10.1186/s12884-019-2209-7
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author van der Zande, Indira S. E.
van der Graaf, Rieke
Oudijk, Martijn A.
van Vliet-Lachotzki, Elsbeth H.
van Delden, Johannes J. M.
author_facet van der Zande, Indira S. E.
van der Graaf, Rieke
Oudijk, Martijn A.
van Vliet-Lachotzki, Elsbeth H.
van Delden, Johannes J. M.
author_sort van der Zande, Indira S. E.
collection PubMed
description BACKGROUND: Bioethicists argue that inclusion of pregnant women in clinical research should be more routine to increase the evidence-base for pregnant women and foetuses. Yet, it is unknown whether pregnant women and others directly involved are willing to be routinely included. Therefore, we first need to establish what these stakeholders think about research participation in regular pregnancy-related research. However, studies on their views are scarce. In our study, we piggy-backed on a relatively conventional RCT, the APOSTEL VI study, to identify the views of stakeholders on inclusion of pregnant women in this study. METHODS: We conducted a prospective qualitative study using 35 in-depth semi-structured interviews and one focus group. We interviewed pregnant women (n = 14) recruited for the APOSTEL VI study, in addition to healthcare professionals (n = 14), Research Ethics Committee members (RECs) (n = 5) and regulators (n = 7) involved in clinical research in pregnant women. RESULTS: Three themes characterise stakeholders’ views on inclusion of pregnant women in the APOSTEL VI study. Additionally, one theme characterises stakeholders’ interest in inclusion of pregnant women in clinical research in general. First, pregnant women participate in the APOSTEL VI study for potential individual benefit and secondarily for altruistic motives, contrary to hypothetical studies. Second, a gatekeeping tendency hampers recruitment of pregnant women who might be eligible and willing, and questions about pregnant women’s decisional capacities surface. Third, healthcare professionals sometimes use the counselling conversation to steer pregnant women in a direction. Fourth, all stakeholders are hesitant about inclusion of pregnant women in clinical research in general due to a protective sentiment. CONCLUSIONS: Pregnant women are willing to participate in the APOSTEL VI study for potential individual benefit and altruistic motives. However, an underlying protective sentiment, resulting in gatekeeping and directive counselling, sometimes hampers recruitment in the APOSTEL VI study as well as in clinical research in general. While bioethicists claim that inclusion of pregnant women should be customary, our study indicates that healthcare professionals, regulators, RECs and pregnant women themselves are not necessarily interested in inclusion. Advancing the situation and increasing the evidence-base for pregnant women and foetuses may require additional measures such as investing in the recruitment and feasibility of RCTs and stimulating pregnant women’s decisional capacities. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s12884-019-2209-7) contains supplementary material, which is available to authorized users.
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spelling pubmed-63715642019-02-21 A qualitative study on stakeholders’ views on the participation of pregnant women in the APOSTEL VI study: a low-risk obstetrical RCT van der Zande, Indira S. E. van der Graaf, Rieke Oudijk, Martijn A. van Vliet-Lachotzki, Elsbeth H. van Delden, Johannes J. M. BMC Pregnancy Childbirth Research Article BACKGROUND: Bioethicists argue that inclusion of pregnant women in clinical research should be more routine to increase the evidence-base for pregnant women and foetuses. Yet, it is unknown whether pregnant women and others directly involved are willing to be routinely included. Therefore, we first need to establish what these stakeholders think about research participation in regular pregnancy-related research. However, studies on their views are scarce. In our study, we piggy-backed on a relatively conventional RCT, the APOSTEL VI study, to identify the views of stakeholders on inclusion of pregnant women in this study. METHODS: We conducted a prospective qualitative study using 35 in-depth semi-structured interviews and one focus group. We interviewed pregnant women (n = 14) recruited for the APOSTEL VI study, in addition to healthcare professionals (n = 14), Research Ethics Committee members (RECs) (n = 5) and regulators (n = 7) involved in clinical research in pregnant women. RESULTS: Three themes characterise stakeholders’ views on inclusion of pregnant women in the APOSTEL VI study. Additionally, one theme characterises stakeholders’ interest in inclusion of pregnant women in clinical research in general. First, pregnant women participate in the APOSTEL VI study for potential individual benefit and secondarily for altruistic motives, contrary to hypothetical studies. Second, a gatekeeping tendency hampers recruitment of pregnant women who might be eligible and willing, and questions about pregnant women’s decisional capacities surface. Third, healthcare professionals sometimes use the counselling conversation to steer pregnant women in a direction. Fourth, all stakeholders are hesitant about inclusion of pregnant women in clinical research in general due to a protective sentiment. CONCLUSIONS: Pregnant women are willing to participate in the APOSTEL VI study for potential individual benefit and altruistic motives. However, an underlying protective sentiment, resulting in gatekeeping and directive counselling, sometimes hampers recruitment in the APOSTEL VI study as well as in clinical research in general. While bioethicists claim that inclusion of pregnant women should be customary, our study indicates that healthcare professionals, regulators, RECs and pregnant women themselves are not necessarily interested in inclusion. Advancing the situation and increasing the evidence-base for pregnant women and foetuses may require additional measures such as investing in the recruitment and feasibility of RCTs and stimulating pregnant women’s decisional capacities. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s12884-019-2209-7) contains supplementary material, which is available to authorized users. BioMed Central 2019-02-11 /pmc/articles/PMC6371564/ /pubmed/30744577 http://dx.doi.org/10.1186/s12884-019-2209-7 Text en © The Author(s). 2019 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Research Article
van der Zande, Indira S. E.
van der Graaf, Rieke
Oudijk, Martijn A.
van Vliet-Lachotzki, Elsbeth H.
van Delden, Johannes J. M.
A qualitative study on stakeholders’ views on the participation of pregnant women in the APOSTEL VI study: a low-risk obstetrical RCT
title A qualitative study on stakeholders’ views on the participation of pregnant women in the APOSTEL VI study: a low-risk obstetrical RCT
title_full A qualitative study on stakeholders’ views on the participation of pregnant women in the APOSTEL VI study: a low-risk obstetrical RCT
title_fullStr A qualitative study on stakeholders’ views on the participation of pregnant women in the APOSTEL VI study: a low-risk obstetrical RCT
title_full_unstemmed A qualitative study on stakeholders’ views on the participation of pregnant women in the APOSTEL VI study: a low-risk obstetrical RCT
title_short A qualitative study on stakeholders’ views on the participation of pregnant women in the APOSTEL VI study: a low-risk obstetrical RCT
title_sort qualitative study on stakeholders’ views on the participation of pregnant women in the apostel vi study: a low-risk obstetrical rct
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6371564/
https://www.ncbi.nlm.nih.gov/pubmed/30744577
http://dx.doi.org/10.1186/s12884-019-2209-7
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