PCORI, AHRQ Announce Research Team Selected to Compare Treatments for Uterine Fibroids
Team led by Duke University researcher to build patient registry, study therapies' effectiveness
The Patient-Centered Outcomes Research Institute (PCORI) and the Agency for Healthcare Research and Quality (AHRQ) today announced that AHRQ has selected the research team that will conduct a five-year, $20 million project funded by PCORI to evaluate the effectiveness of different treatment strategies for women with uterine fibroids.
Evan Myers, M.D., M.P.H., of Duke University School of Medicine's Department of Obstetrics and Gynecology and the Duke Clinical Research Institute (DCRI), will lead the team that will conduct the study titled, Comparing Options for Management: Patient-Centered Results for Uterine Fibroids (COMPARE-UF). AHRQ has awarded the team a $3.95 million, first-year award.
Uterine fibroids are the most common noncancerous 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; treatment with drugs or hormones, embolization, or ultrasound; and invasive procedures such as partial or total hysterectomy. However, there is little evidence about the effectiveness of these therapies or their outcomes, including fibroid reoccurrence and women's ability to have children.
"Having little evidence on uterine fibroids therapies' comparative effectiveness means that women, their families, and their clinicians face significant uncertainties when deciding on a course of treatment," said PCORI Executive Director Joe Selby, M.D., M.P.H. "We are pleased to partner with AHRQ on supporting research on this important patient-centered topic. And we are also very pleased with the selection of a very able research team led by Dr. Myers that will carry out this large project."
"We know uterine fibroids are common, and that they disproportionally affect African-American women, who often undergo more invasive treatments," said AHRQ Director Richard Kronick, Ph.D. "We need better evidence on which treatments work best for which patients. Our partnership with PCORI, together with the research team at Duke and the clinical centers, offers an important opportunity to work together so that health care providers and patients have the information they need to achieve the best possible outcomes."
The project team comprises a research and data coordinating center based at Duke Clinical Research Institute 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 the centers will report on what happens to the women 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 PCORI and AHRQ 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, reflecting PCORI's commitment to ensuring that end-users of study results are engaged throughout the research process. Research results are expected to impact clinical care and improve patient outcomes through the development of evidence-based decision aids, clinical practice guidelines, and quality measures, demonstrating AHRQ's priority to ensure that evidence is understood and used.
PCORI and AHRQ agreed in 2013 to collaborate on research to fill the evidence gaps related to uterine fibroids treatment. PCORI is funding 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.
The Patient-Centered Outcomes Research Institute (PCORI) is an independent, nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers, and clinicians with the evidence-based information needed to make better-informed healthcare decisions. PCORI is committed to continuously seeking input from a broad range of stakeholders to guide its work. More information is available at www.pcori.org.
The Agency for Healthcare Research and Quality's (AHRQ) mission is to produce evidence to make health care safer, higher quality, more accessible, equitable, and affordable, and to work within the U.S. Department of Health and Human Services and with other partners to make sure that the evidence is understood and used. More information is available at www.ahrq.gov.
Clinical Research Centers and Principal Investigators
Mayo Clinic Collaborative Network, Elizabeth Stewart, M.D.; University of California Fibroid Network, Vanessa Jacoby, M.D., M.A.S.; Henry Ford Health System, Ganesa Wegienka, Ph.D.; University of Mississippi Medical Center, Kendra Wallace, Ph.D.; Northwestern Memorial Hospital-Chicago Consortium, Erica Marsh, M.D.; University of North Carolina, Wanda Nicholson, M.D., M.P.H.; Brigham and Women’s Hospital/Harvard Medical School, Raymond Anchan, M.D., Ph.D.; Inova Health Systems, G. Larry Maxwell, M.D.; and Department of Defense Clinical Consortium, William H. Catherino, M.D., Ph.D.
Page originally created September 2014