The Duke Clinical Research Institute (DCRI) will serve as the research and data coordinating center for a 5-year, $20-million project to evaluate the effectiveness of different treatment strategies for women with uterine fibroids.
The project, a collaboration between the Patient-Centered Outcomes Research Institute (PCORI) and the Agency for Healthcare Research and Quality (AHRQ), will be led by Evan Myers, MD, MPH, of Duke University School of Medicine’s Department of Obstetrics and Gynecology and the DCRI.
AHRQ has awarded the team a $3.95-million, first-year grant for the project, called Comparing Options for Management: Patient-Centered Results for Uterine Fibroids (COMPARE-UF).
“In addition to the DCRI’s role as a leader in patient registries, Duke and the DCRI have been involved in research on fibroids treatment for more than a decade,” Myers says. “We are excited to have the opportunity to continue to address questions that will help patients and clinicians make more informed choices about treatment options.”
Myers says the investigators at the clinical centers are among the leading experts on fibroid treatments in the country and treat a diverse group of women with this condition. The project will obtain input from experts in observational research as well as members of major professional societies, insurers, and manufacturers of fibroid treatments.
Treatment options for fibroids include watchful waiting; treatments with drugs, hormones, embolization, or ultrasound; or invasive procedures such as partial or total hysterectomy. To date, little evidence exists about the effectiveness of these therapies or their outcomes, including recurrence or the effect on women's ability to have children.
The project team comprises a research and data coordinating center based at DCRI, and 9 clinical centers (listed below), each contributing information about geographically, racially, ethnically, and clinically diverse women who have been treated for uterine fibroids; these groups will report on outcomes over time.
The overall design of this patient registry, which emphasizes the importance of capturing real treatment experiences and focusing on outcomes that matter most to patients, comes directly from conferences funded by AHRQ and PCORI that sought input from patients and other stakeholders.
Women who have had uterine fibroids, as well as other stakeholders, are directly involved in determining the direction of the research and are participating as active members of the research team.
The DCRI will be involved in finalizing COMPARE-UF’s research design, as well as data management and analysis. The goal, Myers says, is to create an infrastructure that can be used for similar projects in the future.
“We are very interested in using this opportunity to explore innovative ways of doing this type of research,” he says. “Hopefully, we will find new ways of answering other questions about other conditions.”
Institutions (and their principal investigators) participating in the collaborative effort include:
- Mayo Clinic Collaborative Network (Elizabeth Stewart, MD)
- University of California Fibroid Network (Vanessa Jacoby, MD, MAS)
- Henry Ford Health System (Ganesa Wegienka, PhD)
- University of Mississippi Medical Center (Kedra Wallace, PhD)
- Northwestern Memorial Hospital-Chicago Consortium (Erica Marsh, MD, MSci)
- University of North Carolina (Wanda Nicholson, MD, MPH)
- Brigham and Women’s/Harvard (Raymond Anchan, MD, PhD)
- Inova Health Systems (G. Larry Maxwell, MD)
- Department of Defense Clinical Consortium (William H. Catherino, MD, PhD).