We don’t know enough about the safety of medicines during pregnancy. Pregnant women are usually left out of clinical trials. A learning healthcare system would allow real-life data from the healthcare system to be used for research – helping to fill this knowledge gap. Marieke Hollestelle, one of the PhD students working in the ConcePTION project, defended her thesis on 16 April.
“Pregnant people and healthcare providers can help us shape a learning healthcare system that does not only sound nice in theory but also works in practice. The people directly affected by it are pivotal in ensuring the system’s effectiveness and ethical implementation of it. An inclusive approach helps us ensure the system is relevant and that there is acceptance for it among healthcare professionals,” says Marieke Hollestelle, now PhD in the ethics of learning healthcare systems and research with pregnant women.
Recommendations
- Advocate for including pregnant women in clinical trials to gather essential data on the safety and efficacy of medications during pregnancy and breastfeeding.
- Encourage healthcare organisations to adopt learning healthcare systems, utilising real-world data to continually improve clinical practices and address knowledge gaps surrounding medication use during pregnancy.
- Promote active involvement of pregnant women, healthcare providers, and organisations involved in healthcare data collection in shaping and implementing learning healthcare systems to ensure their effectiveness and ethicality.
- Develop and adhere to clear ethical guidelines regarding data privacy, informed consent, and the dissemination of knowledge to ensure the ethical implementation of learning healthcare systems in addressing medication use during pregnancy.
- Increase education and awareness among pregnant women about the importance of participating in medication studies, as well as their role in shaping and benefiting from learning healthcare systems, empowering them to make informed decisions about medication use during pregnancy.
- Closing the learning cycle to make sure pregnant people, including their healthcare professional, can fully benefit from the insights generated by the learning healthcare system. These insights, derived from data analyses, should inform decision-making to improve the clinical practice, which subsequently shapes the content of future data collection.
About the dissertation
Hollestelle, Marieke Johanna. Keep learning: Towards an ethically responsible learning healthcare system for pregnant and lactating people. (2024) UMC Repository. (Dissertation) DOI: 10.33540/2235
Papers included in the dissertation
Hollestelle, M. J., van der Graaf, R., Sturkenboom, M.C.M, van Delden J.J.M. An ethics framework for the transition to an operational learning healthcare system. Learning Health Systems (2024). DOI: 10.1002/lrh2.10414
Hollestelle, M. J., van der Graaf, R., Sturkenboom, M.C.M, Cunnington, M., van Delden J.J.M. Building a Sustainable Learning Health Care System for Pregnant and Lactating People: Interview Study Among Data Access Providers. JMIR Pediatrics and Parenting 7 (2024). DOI: 10.2196/47092
Hollestelle, M.J., van der Graaf, R., Sturkenboom, M.C.M, van Delden J.J.M. Stimulating solidarity to improve knowledge on medications used during pregnancy. BMC Med Ethics 24, 44 (2023). DOI: 10.1186/s12910-023-00924-x
Hollestelle, M.J., van der Graaf, R., Hartman, S.D., van Delden J.J.M. 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
About the defence
Supervisors
Prof. dr. J.J.M. van Delden
Prof. dr. M.C.J.M. Sturkenboom
Co-supervisors
Dr. R. van der Graaf
Review committee
Prof. dr. L.J. Bont
Prof. dr. M.L. Bots
Prof. dr. K.W.M. Bloemenkamp
Prof. dr. M.A. van den Hoven
Prof. dr. M.C. de Vries