Duke To Lead $20 Million Project to Study Uterine Fibroids
DURHAM, N.C. -- The Duke Clinical Research Institute (DCRI) will serve as the research and data coordinating center for a five-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, M.D., 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 over a decade,” Myers said. “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. The investigators at the clinical centers are among the leading experts on fibroid treatments in the country, treating a very diverse group of women with this condition. In addition, patients are playing a major role in helping guide this research, and we’ll have ongoing input from experts in observational research as well as major professional societies, insurers, and manufacturers of fibroid treatments.”
Uterine fibroids are the most common, non-cancerous tumors in women of childbearing age and the second most common reason these women undergo surgery. Uterine fibroids can lead to significant pain, bleeding, and fertility problems. Treatment options include watchful waiting; treatments with drugs or hormones, embolization, or ultrasound; or invasive procedures such as partial or total hysterectomy. However, there is little evidence about the effectiveness of these therapies or their outcomes, including reoccurrence or the impact on women’s ability to have children.
The project team comprises a research and data coordinating center based at DCRI, and nine clinical centers (see list below), each contributing information about geographically, racially, ethnically, and clinically diverse women who have been treated for uterine fibroids, and will report on what happens to them over time.
The overall design of this patient registry, which emphasizes 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 said, 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 said. “Hopefully we will find new ways of answering other questions about other conditions.”
PCORI and AHRQ agreed in 2013 to collaborate on research to fill the evidence gaps related to uterine fibroids treatment. PCORI committed up to $20 million to fund the project, and AHRQ is providing scientific oversight and administration. The research team will receive up to $4 million per year for up to five years to build the registry and conduct the research.
Institutions participating in the collaborative effort and the principal investigator include:
--Mayo Clinic Collaborative Network (Elizabeth Stewart, M.D.)
--University of California Fibroid Network (Vanessa Jacoby, M.D., MAS)
--Henry Ford Health System (Ganesa Wegienka, Ph.D.)
--University of Mississippi Medical Center (Kedra Wallace, Ph.D.)
--Northwestern Memorial Hospital-Chicago Consortium (Erica Marsh, M.D., MSci)
--University of North Carolina (Wanda Nicholson, M.D., MPH)
--Brigham and Women’s/Harvard (Raymond Anchan, M.D., PhD)
--Inova Health Systems (G. Larry Maxwell, M.D.)
--Department of Defense Clinical Consortium (William H. Catherino, M.D., Ph.D.)
Stakeholder engagement is being coordinated by the Center for Medical Technology Policy. Sateria Venable of the Fibroid Foundation is the patient representative on the Steering Committee.