Because pregnant and breastfeeding women are not usually included in clinical trials of new medications, we don’t know enough about the safety of medicines during pregnancy and breastfeeding. But clinical research is not the only way to generate evidence. Using a so-called learning healthcare system approach, care and research align to accelerate evidence by looking at real-life medication use. A recent publication in BMC Pregnancy and Childbirth explores women’s views on adopting such a system, before and during pregnancy as well as while breastfeeding. Using the ConcePTION evidence generation ecosystem as a starting point.
20 Dutch women were interviewed to find out how they felt about taking a learning healthcare system approach to generating evidence about medicine safety in pregnancy and breastfeeding. So far, no such learning healthcare system exists. But the ConcePTION project is in the process of constructing an ecosystem for evidence generation that will enable continuous learning about medicine safety in pregnancy and breastfeeding.
“Women were positive towards the ConcePTION ecosystem, and about the possibility of contributing to and engaging in the generation of new knowledge about medicine safety. To them, the learning healthcare system appeared as a way to help other pregnant and breastfeeding women as well as contribute to scientific research. Women with chronic conditions were more inclined to see their contribution to the ecosystem as an important responsibility. But healthy women were not always aware of the vulnerabilities they themselves are subject to as a result of the existing knowledge gap,” says Marieke Hollestelle, PhD Candidate in Bioethics at the University Medical Center Utrecht and one of the authors of the recent BMC Pregnancy and Childbirth paper.
Although the women felt the ecosystem could function as a central point of information about their medication, they also considered their healthcare professional to be an essential translator and interpreter of information. And would continue to do so even with the learning healthcare system in place. According to the authors, to obtain women’s trust in an evidence generation system, it needs to be transparent about data collection, storage and analyses.
“It also became clear that explaining how public and private actors work together to create the system is important to help increase women’s trust in it. And so is broad support for the system from the medical community and government authorities. Beyond those prerequisites, there is also a need to engage women in and inform them about the system would to help increase their trust in it, as would making sure the system also offers additional tools and ways for women to get involved,” says Marieke Hollestelle.
By Anna Holm
Hollestelle, M.J., van der Graaf, R., Hartman, S.D. et al. A Learning Healthcare System for pregnant and breastfeeding women: what do women during preconception, pregnancy, and nursing think? – A qualitative study. BMC Pregnancy Childbirth 22, 334 (2022). DOI: 10.1186/s12884-022-04675-2