CHICAGO – Northwestern Medicine® will be one of ten investigational sites for a landmark study that seeks to improve the way uterine fibroids, one of the most prevalent health issues impacting women, are treated.
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.
Erica E. Marsh, MD, a reproductive endocrinologist with Northwestern Fertility and Reproductive Medicine, serves as the principal investigator for Northwestern's portion of the $20 million research project, which evaluates the effectiveness of different treatment strategies for women with uterine fibroids by building a national database tracking patients, treatments and outcomes.
"Right now there's very, very little clinical trial data on fibroid outcomes," said Marsh, who is also an assistant professor of Obstetrics and Gynecology-Reproductive Endocrinology & Infertility at Northwestern University Feinberg School of Medicine. "This type of study with a huge sample size in the thousands across the nation will allow us to start to tease apart some of those questions we've always asked ourselves as physicians who take care of women with fibroids. What can I tell my patients about the risk of occurrence after one treatment versus another? The impact on fertility? The likelihood that her symptoms will return? Having this type of outcomes data will allow us to answer some of those questions."
The project, a collaboration between PCORI and the AHRQ, combines the unique expertise and patient population of ten of the country's most successful uterine fibroid programs.
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.
The research team is composed of a research and data coordinating center based at the Duke Clinical Research Institute, and nine top-tier clinical centers, each contributing information about geographically, racially, ethnically, and clinically diverse women who have received medical or surgical treatment for uterine fibroids. Patients will be reporting on what happens to them over time after their treatment. 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.
"Dr. Erica Marsh has assembled an outstanding research team at Northwestern and earned us a very important role in this national research effort," said Serdar Bulun, MD, Northwestern Medicine's chair of obstetrics and gynecology and a partner with Marsh at Northwestern's Uterine Leiomyoma Research Center Program, the nation's only National Institute of Health-funded science center looking at the basic physiology of uterine fibroids. "The Department of Obstetrics and Gynecology is extremely proud of Dr. Marsh for this exceptional accomplishment."
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, which is being administered by AHRQ. 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 along with Northwestern and Duke include: Mayo Clinic Collaborative Network; University of California Fibroid Network; Henry Ford Health System; University of Mississippi Medical Center; Brigham and Women's Hospital/Harvard Medical School; Inova Health Systems; University of North Carolina; and Department of Defense Clinical Consortium.
In additional to PCORI, Marsh's research is funded by the National Institute of Health, The Woman's Board of Northwestern Hospital, the Evergreen Invitational and the Friends of Prentice.
To learn more about Marsh's research, or fibroid care at Northwestern, visit fertility.nm.org or call (312) 695-7269.