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首页> 外文期刊>BMC Pregnancy and Childbirth >A qualitative study on stakeholders’ views on the participation of pregnant women in the APOSTEL VI study: a low-risk obstetrical RCT
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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

机译：利益攸关方对孕妇参与的孕妇参与六六程研究的定性研究：低风险产科rct

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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. 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. 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. 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.
机译：生物肠道主义者认为将孕妇纳入临床研究中应该更多的常规，以增加孕妇和胎儿的证据基础。然而，它尚不清楚孕妇和其他直接参与的其他人是否愿意经常包括在内。因此，我们首先需要建立这些利益相关者对常规怀孕相关研究的研究。但是，对他们看法的研究很少。在我们的研究中，我们储存了一个相对常规的RCT，阿萨沃特尔VI研究，以确定利益相关者在本研究中包含孕妇的观点。我们使用35深入的半结构化访谈和一个焦点小组进行了一项前瞻性的定性研究。我们采访了孕妇（n？=？14）招募了阿萨沃尔六学习，除医疗保健专业人员（n吗？= 14），研究道德委员会成员（res）（n？=？5）和监管机构（n？ =？7）参与孕妇的临床研究。三个主题在阿萨克尔六学研​​究中将利益相关者的意见表征。此外，一项主题是将利益相关者对临床研究中的孕妇兴趣的兴趣表征。首先，孕妇参加阿萨沃特尔六学习，以潜在的个人利益，其次对利他主义的动机，违背假设研究。其次，纳入孕妇招募招募可能有资格和愿意的孕妇，以及有关孕妇的果断能力表面的问题。第三，医疗保健专业人士有时会使用咨询谈话在方向上刺激孕妇。第四，由于保护性情绪，所有利益相关者都犹豫不决。患有孕妇在临床研究中纳入临床研究。孕妇愿意参加阿萨沃特尔六学习，以获取潜在的个人利益和利他主义动机。然而，潜在的保护情绪，导致良住的守护和指令咨询，有时妨碍在奥斯特尔VI研究中招募以及一般临床研究。虽然生物挑战主义者声称包含孕妇应该是习惯的，但我们的研究表明医疗保健专业人员，监管机构，康复团体本身并不一定对包含感兴趣。推进局势和增加孕妇和胎儿的证据基础可能需要额外的措施，例如投资RCT的招募和可行性，并刺激孕妇的果断能力。

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