tPregnancy and Heart Disease: Patient and Healthcare Provider Reported Outcomes [30N]

INTRODUCTION: Our objective was to conduct focused interviews with patients, family members and healthcare providers to identify and compare outcomes considered important by each group with what is reported in the literature. METHODS: Pregnant patients with a cardiac condition and their family members were recruited from the Mount Sinai Hospital, Toronto, Canada and an international group of healthcare providers were contacted through email via contact lists assembled by study investigators. Semi-structured interviews with an emphasis on eliciting outcomes were conducted until no new outcomes were identified. RESULTS: Sixteen participants (13 pregnant women and three partners) completed the interviews. Cardiac conditions included arrhythmias (n=5), complex congenital heart disease (n=5) and valvular heart disease (n=3). Ten healthcare providers primarily from Europe and North America, representing cardiology (n-5), obstetrics (n=3), nursing (n=1) and anesthesiology (n=1) were also interviewed. Patients and family members reported 17 unique outcomes, the most frequent of which were: general health and well-being of baby (n=13); congenital defects (n=6); outcomes related to maternal mental health, stress and fatigue (n=5) and appropriate healthcare management (through medications, follow up, continuity of care) (n=4). Healthcare providers reported 65 outcomes, which included maternal mortality (n=7), prematurity (n=7), arrhythmias (n=6), thrombosis, mode of delivery (n=5) and heart failure (n=5). These reflected those encountered in published literature. CONCLUSION: Outcomes considered important by patients and their family members differ from those considered important by clinicians and researchers . Including these outcomes in a core outcome set could improve outcome reporting in studies on cardiac disease in pregnancy.