Department of Bioethics and Health Humanities, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
Department Data science & Biostatistics, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
BMC Med Ethics. 2023 Jun 27;24(1):44. doi: 10.1186/s12910-023-00924-x.
Pregnant people have been overlooked or excluded from clinical research, resulting in a lack of scientific knowledge on medication safety and efficacy during pregnancy. Thus far, both the opportunities to generate evidence-based knowledge beyond clinical trials and the role of pregnant people in changing their status quo have not been discussed. Some scholars have argued that for rare disease patients, for whom, just like pregnant people, a poor evidence base exists regarding treatments, solidarity has played an important role in addressing the evidence gap. This paper explores whether and how the enactment of solidarity among pregnant people can be stimulated to help address the poor evidence base on medications used during pregnancy.
We use the concept of solidarity formulated by Prainsack and Buyx and enrich their concept by providing an account for stimulating the enactment of solidarity. Then we apply this account to the case of pregnant people who use medication.
Solidarity means enacted commitment on the part of an individual to assisting others with whom the person recognizes a similarity in a relevant respect. Although solidarity cannot be imposed, we argue that the empowerment of people is a crucial concept in understanding how solidarity can be stimulated. Empowerment in the context of pregnant people means creating awareness about their status quo, explaining how scientific research can help close the knowledge gap, and how pregnant people can themselves contribute. In particular, how pregnant people can contribute to the collection of health data to strengthen the evidence base for medications used during pregnancy.
We conclude that acting in solidarity can help change the status quo for pregnant people. Furthermore, we argue that the empowerment of pregnant people and other relevant stakeholders is a way to stimulate the enactment of solidarity. The process of empowerment starts by raising awareness about the lack of evidence on medications used during prengnacy and by explaining to pregnant people how they can contribute to changing the way knowledge is being generated by, for example, sharing data on the health effects of medications.
孕妇在临床研究中被忽视或排除在外，导致缺乏关于怀孕期间药物安全性和疗效的科学知识。到目前为止，无论是在临床试验之外生成基于证据的知识的机会，还是孕妇在改变自身现状方面的作用，都没有得到讨论。一些学者认为，对于那些像孕妇一样，治疗方法的证据基础较差的罕见病患者，团结在解决证据差距方面发挥了重要作用。本文探讨了在解决怀孕期间使用药物的证据基础较差的问题上，是否以及如何激发孕妇之间的团结。
我们使用 Prainsack 和 Buyx 提出的团结概念，并通过提供一个关于激发团结的叙述来丰富他们的概念。然后，我们将这一概念应用于使用药物的孕妇案例。
团结是指个人对与自己在相关方面具有相似性的他人的协助表示承诺。虽然团结不能强加于人，但我们认为，赋予人民权力是理解如何激发团结的关键概念。在孕妇的背景下，赋予权力意味着让人们意识到自己的现状，解释科学研究如何有助于缩小知识差距，以及孕妇如何为自己做出贡献。特别是，孕妇如何为收集用于增强怀孕期间使用药物的证据基础的健康数据做出贡献。
我们的结论是，团结一致的行动可以帮助改变孕妇的现状。此外，我们认为，赋予孕妇和其他相关利益相关者权力是激发团结的一种方式。赋权过程始于提高对怀孕期间药物使用缺乏证据的认识，并向孕妇解释他们如何通过分享药物对健康影响的数据等方式为改变知识生成方式做出贡献。
