A Learning Healthcare System for pregnant and breastfeeding women: what do women during preconception, pregnancy, and nursing think? – A qualitative study

Abstract

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.

Building a Sustainable Learning Health Care System for Pregnant and Lactating People: Interview Study Among Data Access Providers

“…We conducted semistructured interviews with a topic list (refer to the general topic list in Textbox 2). The topic list was based on the topic list used for another qualitative interview study, in which we asked women during preconception, pregnancy, and nursing what they thought about an LHS for pregnant and lactating women [20]. The topic list was also based on an analysis of the challenges of public-private partnerships, LHSs, and responsible data sharing [1,10,21], as well as discussions among the research team.…”

“…The above-described perceptions of trust are of course important; however, both the literature and our previous interview study with women during preconception, pregnancy, and nursing show that public trust is also of crucial importance for the development of an LHS [20]. In the literature, it is emphasized that it is important to meet the public expectations for transparency when developing an LHS, which in turn will strengthen or maintain trust in not only the LHS but also the institutions working within the LHS [26].…”

An ethics framework for the transition to an operational learning healthcare system

“…Formulating new goals dedicated to advancing equity and justice, these might include the following: communities in translating and disseminating new insights could prove pivotal. 27 Stakeholders with numerous responsibilities, such as designing research protocols, performing data analyses, interpreting outcomes, and translating new insights for the clinical practice, can actively prioritize inclusivity and responsiveness to the group of pregnant and lactating people. Responsiveness can be maintained when relevant stakeholders and communities are continuously engaged in the LHS design, transition, and evaluation processes, which brings us to the next ethical requirement.…”

“…During our qualitative study, published elsewhere, our respondents (women during preconception, pregnancy, and nursing) also emphasized that obtaining recognition by these institutions is pivotal for acknowledging the ConcePTION LHS. 27 Lastly, during the project phase, there may be experts involved to guide and give advice regarding ethical, legal, and social implications (ELSI). The prominence of ELSI necessitates continued attention, even after the LHS's establishment.…”

“…To ensure equitable benefits and access, requires recognizing differences among pregnant and lactating people, including differences in their health needs. The involvement of HCPs and representative groups or communities in translating and disseminating new insights could prove pivotal 27 …”