Monday, April 29, 2024
4/29/2024
The lifetime cumulative incidence of uterine leiomyomas (fibroids or UF) is >80% among Black women and ~70% in White women. UF are the most common reason for hysterectomy in the U.S. and can cause heavy menstrual bleeding requiring blood transfusion(s), pelvic pain, urinary and bowel problems, infertility, and substantial impairment of quality of life (QOL). While alternatives to hysterectomy are available including myomectomy (fibroid removal), uterine artery embolization (UAE), endometrial ablation (EA), and radiofrequency ablation (RFA), there are significant knowledge gaps that preclude the development of evidence-based clinical guidelines to select an appropriate UF treatment. Prior studies of UF treatments have several key deficits including limited follow-up time (<2 years) and failure to assess important confounders, such as pre-procedure fibroid characteristics, baseline QOL, and pregnancy intention. Two multisite registries with harmonized data, COMPARE-UF (Myomectomy, EA and UAE patients) and ULTRA (RFA patients), have the capacity to address critical evidence gaps and significantly improve care for women with UF. This project will be led by COMPARE-UF/ULTRA investigators (MPIs) and extend the follow-up of 700 COMPARE-UF and ULTRA participants who have had a uterine-sparing fibroid treatment for up to 10 years after the index procedure. Long term follow-up through menopause is critical to assess the durability of symptom improvement and the rates of hysterectomy or other uterine procedures following the index treatment. Currently, women in COMPARE-UF/ULTRA are followed only for 1-3 years post treatment; the additional follow-up in this proposal, will have a major impact on clinical decision-making, provide relevant data in a racially diverse (>40% Black) population, and include detailed imaging information (UF size, number and location), and self-reported desire for future fertility obtained prior to the index fibroid treatment. Among women who have undergone one of four uterine-sparing procedures (myomectomy, EA, UAE and RFA), validated questionnaires from pre-procedure will be repeated annually up to 10 years post-procedure, to achieve the following: Aim 1: Compare changes in fibroid symptoms and quality of life from pre-procedure up to 10 years post-procedure among four uterine-sparing procedures: myomectomy, EA, UAE, and RFA. Aim 2: Compare the rate of and time until treatment failure up to 10 years after the index treatment among participants who had myomectomy, EA, UAE, and RFA. Aim 3: Identify baseline factors that predict clinical effectiveness after myomectomy, EA, UAE, and RFA and with patient and provider input, create a clinical prediction tool (Fibroid Treatment Calculator) that supports informed decision-making. Our preliminary data demonstrate ongoing active engagement of these participants. This project is a time-limited opportunity that uses two well-designed longitudinal cohorts with comprehensive baseline information collected with validated questionnaires and will yield results for immediate application in clinical care.
HHS’ Tracking Accountability in Government Grants System (TAGGS) website provides access to detailed descriptions of grants, loans, aggregated direct payments and other types of financial assistance awarded by the HHS Operating Divisions (OPDIVs) and the Office of the Secretary Staff Divisions (STAFFDIVs).
