Abstract
BACKGROUND: A core outcome set for studies on cardiac disease in pregnancy is being developed. Incorporating perspectives of patients and health care providers (HCPs) is an essential step in developing this core outcome set, and eliciting these outcomes is the objective of this study. METHODS: We interviewed pregnant women with heart disease, family members, and HCPs, until data saturation was attained. Participants were asked to share experiences and perspectives, and comment on outcomes they deemed important. Interviews were recorded and transcribed verbatim, and interpretive analysis was used to translate experiences into measurable outcomes. These were classified under 5 core outcome areas, based on a taxonomy of outcomes for medical research. A comparison of the distribution of outcomes within outcome areas, between patients and HCPs, and between interviews and published literature is presented. RESULTS: We obtained 17 outcomes from 13 patients and 3 family members, mostly related to general wellness of the baby, congenital anomalies, mental health, and health care delivery; and 45 outcomes from 10 HCPs, which were mostly clinical. Outcomes in published literature when compared with participant interviews put greater emphasis on clinical outcomes (94% vs 76.5%, P = 0.03) and limited emphasis on life impact (0% vs 17.6%, P < 0.001). CONCLUSIONS: Although clinical outcomes are the main focus of published research in heart disease and pregnancy, patients and HCPs emphasize the importance of outcomes related to general maternal and fetal well-being and life impact, which are seldom reported. Including these outcomes in future studies is essential to facilitating patient-centred care for pregnant women with cardiac disease.