Keep learning: Towards an ethically responsible learning healthcare system for pregnant and lactating people

Abstract

Pregnant people are typically excluded from participation in medication studies, primarily due to potential risks to the fetus. Consequently, there is insufficient understanding of the safety and efficacy of medications when used during pregnancy or breastfeeding. This thesis explores a novel approach to address these questions through a learning healthcare system. Such a system uses real-world data to learn from and subsequently enhance the clinical practices, creating an ongoing learning cycle. This methodology proves advantageous for gaining insights into medications used during pregnancy, as many pregnant people regularly use various medications in their daily lives, offering valuable experiential knowledge.

The central question is: how to establish such a learning system in an ethical manner? To address this, the research delved into the details of learning healthcare systems through studying the literature. Additionally, pregnant people were asked their perspectives on a learning healthcare system, as were organizations that are involved in healthcare data collection. The research also investigated how pregnant people could be engaged in this novel learning approach and formulated ethical requirements crucial for the transition to a learning healthcare system.

In essence, this research underscores the importance of involving pregnant people and healthcare providers in shaping a learning healthcare system. It emphasizes that completing the learning cycle is essential, ensuring that new knowledge effectively reaches pregnant people. This is important for them to make well-informed decisions regarding medication use.