Inclusion of people with multiple long-term conditions in pregnancy research: patient, public and stakeholder involvement and engagement in a randomised controlled trial.

ABSTRACT

BACKGROUND: Both pregnant women and those with multiple long-term conditions are under-served groups in clinical research. Informing and improving research through patient and public involvement, including pregnant women with two or more long-term health conditions, is critical to increasing their inclusion in maternity research. Giant PANDA is a randomised controlled trial, evaluating the effect of a treatment initiation strategy with nifedipine versus labetalol on severe maternal hypertension and a composite outcome of fetal/neonatal death, or neonatal unit admission. We aimed to undertake a mixed methods study-within-a-project within the Giant PANDA trial to understand barriers and facilitators to participation, understand and optimise current representativeness of clinical trial delivery of those with multiple long-term conditions and co-create a checklist to support their inclusion in pregnancy research. METHODS: We undertook online workshops with women with lived experience and hybrid workshops with healthcare professionals who look after women with multiple long-term conditions. A site audit of Giant PANDA sites provided insights into research delivery capacity and health system set-up, and how this influences inclusion. An extension to the Giant PANDA screening log captured data on multiple long-term conditions enabling analysis of the impact of these health conditions on women's inclusion in the trial. We co-created a checklist of recommendations for those designing and recruiting to similar clinical trials. RESULTS: Five key recommendations were identified including a need to (1) involve women with multiple long-term conditions as partners in maternity research and (2) minimise barriers that stop them from taking part through (3) designing and delivering research that is flexible in time and place (4) consider research as part of care for everyone, including those with multiple long-term conditions and (5) measure and report inclusion of those with two or more health conditions in maternity research. Multiple long-term conditions were not a barrier to recruitment or randomisation in the Giant PANDA trial. CONCLUSION: Women with multiple long-term conditions would like opportunities to find out about and participate in research which accounts for their needs. Our checklist aims to support those designing and delivering maternity research to optimise inclusion of individuals with multiple-long term conditions. TRIAL REGISTRATION Giant PANDA EudraCT number 2020-003410-12, ISRCTN 12,792,616.

Pregnant women with two or more long-term health problems may be less likely to be included in research. Including them in research is important to ensure we give the best care. Giant PANDA is a study comparing two medicines (nifedipine or labetalol) to manage high blood pressure in pregnancy. As part of the study, we looked at the number of women with two or more long-term health conditions included. We talked to women with experience of two or more long-term health conditions in pregnancy, and healthcare staff who look after these women. Finally, we looked at how maternity research is set up in Giant PANDA study sites. We found that women with two or more health conditions were taking part in the Giant PANDA study. Women with two or more long-term conditions would like the choice to be included in research which considers their needs. This includes being involved in the planning and ongoing support for studies. Research needs to be part of routine care, flexible, and not time consuming to help those with two or more health conditions take part. Our findings have been used to make a checklist to help plan and support studies for women and birthing people with two or more long-term health conditions.