Background Most medications lack evidence-based information about its safety and efficacy during pregnancy and breastfeeding, because pregnant women are often not included in clinical research. Another way to generate evidence is by using a Learning Healthcare System (LHS) approach. In an LHS, care and research are aligned in such a way that it can accelerate evidence generation and outcomes for patients, based on real-life medication use. For the development of an ethically responsible and sustainable LHS, it is of crucial importance to understand what women think of such an alternative approach to knowledge generation. Therefore, this paper explores their views on an LHS for pregnant and breastfeeding women. Method For this qualitative study, we interviewed 20 women during preconception, pregnancy, or nursing to explore their views on an ethically responsible LHS for pregnant and breastfeeding women. The pseudonymized transcripts were analyzed thematically. Results We identified four main themes describing women’s views on LHSs. The first theme describes that respondents were positive about learning healthcare systems, and considered them to function as a central point for information about their medication, which they felt is currently lacking. The second theme shows that respondents want to contribute to and engage in generating new information because they want to help others and contribute to scientific research. Respondents also mentioned that, currently, not every woman is aware of the risks of the lack of evidence for medication used in pregnancy. The third theme shows that respondents regard their healthcare professional as essential for the translation and interpretation of information, regardless of a learning healthcare system. The last theme describes that respondents will trust a learning healthcare system more if the medical community supports it, and when data collection and processing is transparent. Conclusion Women during preconception, pregnancy and nursing agree that an LHS could be a viable alternative to help close the knowledge gap on the safety of medication used during pregnancy and breastfeeding. The obtained insights from our interviews provide valuable stepping-stones for the development of an ethically responsible and sustainable LHS, as well as for the engagement of women in an LHS.
Background 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. Method 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. Results 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. Conclusions 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.
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