Piloting Women’s Health Registries in EHRs – the ULTRA Study at UCSF:
ULTRA study is a pilot study for Uterine Fibroid led by Dr. Vanessa Jacoby (https://fibroids.ucsf.edu/). This collaborative effort aims to help patients and doctors understand how the treatment changes fibroid symptoms, affects fertility and pregnancy, and impacts the need for additional fibroid treatment in the future.
In a post-market observational cohort study, ULTRA assesses safety and effectiveness of women undergoing AcessaTM treatment. The project recruits women through voluntary referrals from clinicians and engaged clinical sites in a multicenter study. UCSF follows up for 3 years after surgery. The outcomes of the study are operative morbidity, change in fibroid, treatment failure, and pregnancy outcomes. The patient population is queried every 6 months with questionnaires to collect PRO, and medical records are obtained for follow-up imaging. ULTRA collaborates with COMPARE-UF for harmonization of outcome assessments (CRFs and questionnaires) as well as WHT-CRN for opportunities to pilot new data elements in an ongoing post-market device study.
The collaborators created a core minimum data set for surgeries and procedures to treat uterine fibroids with a focus on the use of medical devices during these procedures. The minimum data set draws from data collected at the time of surgery (i.e. intraoperative outcomes and events). These data points are structured to serve as a template for a case report form in the research environment (e.g. post-market surveillance) and/or to embed within the electronic health record for use in a general clinical care workflow.