Executive Summary
The Duke Clinical Research Institute is working with nine centers across the United States in a five-year project to evaluate the effectiveness of different treatment strategies for women with uterine fibroids.
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The project, a collaboration between the Patient-Centered Outcomes Research Institute and the Agency for Healthcare Research and Quality, is designed to help patients and clinicians make more informed choices about treatment options.
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Uterine fibroids result in more than 200,000 hysterectomies every year. In the United States, it is estimated that approximately 1% of women with employer-provided insurance have clinically significant uterine fibroids, and the direct costs associated with treating uterine fibroids are more than $1 billion annually.
The Duke Clinical Research Institute in Durham, NC, is working with nine centers across the United States in a five-year 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 and the Agency for Healthcare Research and Quality, is designed to help patients and clinicians make more informed choices about treatment options.
In addition to the Research Institute’s role as a leader in patient registries, Duke Medicine and the Institute have been involved in research on fibroids treatment for more than a decade, said Evan Myers, MD, MPH, chief of the Division of Clinical and Epidemiological Research for the Department of Obstetrics and Gynecology at Duke University School of Medicine and senior fellow at its Center for Clinical Health Policy Research.
"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," said Myers in a statement accompanying the announcement of the research team. "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, said Myers. Scientists also will have ongoing input from experts in observational research, as well as from professional societies, insurers, and fibroid treatment manufacturers.
Myers will lead the team that will conduct the study titled, "Comparing Options for Management: Patient-Centered Results for Uterine Fibroids" (COMPARE-UF). The Agency for Healthcare Research and Quality has awarded the team a $3.95 million first-year award. Institutions participating in the research include the following, along with their principal investigators:
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Mayo Clinic Collaborative Network, Elizabeth Stewart, MD;
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University of California Fibroid Network, Vanessa Jacoby, MD, MAS;
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Henry Ford Health System, Ganesa Wegienka, PhD;
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University of Mississippi Medical Center, Kedra Wallace, PhD;
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Northwestern Memorial Hospital — Chicago Consortium, Erica Marsh, MD, MSci;
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University of North Carolina, Wanda Nicholson, MD, MPH;
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Brigham and Women’s/Harvard, Raymond Anchan, MD, PhD;
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Inova Health Systems, Larry Maxwell, MD;
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Department of Defense Clinical Consortium, William Catherino, MD, PhD.
Fibroids, also known as uterine leiomyomas, are the most common benign uterine tumors in women of reproductive age.1 Fibroids can cause anemia from heavy bleeding, pelvic pain, pressure, dysmenorrhea, reduced quality of life, and infertility. 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.
Uterine fibroids result in more than 200,000 hysterectomies every year. In the United States, it is estimated that approximately 1% of women with employer-provided insurance have clinically significant uterine fibroids, and the direct costs associated with treating uterine fibroids are more than $1 billion annually.2
"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 Joe Selby, MD, MPH, executive director of the Patient-Centered Outcomes Research Institute.
Women need more information about how the various fibroid treatment options compare in efficacy and long-term durability, says Vanessa Jacoby, MD, assistant professor of obstetrics, gynecology and reproductive sciences at the University of California, San Francisco. Unfortunately, there is not very much data to help inform these treatment decisions for women.
The benefit of a nationwide registry is that researchers will have a large volume of patients with fibroids, in a diverse patient population, which will allow scientists to better explore and compare the efficacy of surgical treatments, as well as medical management and even expectant management, Jacoby states.
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How do women present with uterine fibroids? Symptoms include menstrual cramps and pain, heavy menstrual bleeding and anemia, problems with fertility or pregnancy, or bladder or bowel symptoms.3
Black women are disproportionately affected by fibroids.3 They report more symptoms: 40% report menstrual pain and cramps, with a three-fold increased risk of anemia. Black women also face an elevated risk of hysterectomy or myomectomy.4
Clinicians now look to such treatment options for symptomatic uterine fibroids as watchful waiting; nonprocedural treatments such as hormonal therapies, oral contraceptives, and nonsteroidal anti-inflammatory drugs; and several procedural treatments ranging from surgical or incisional such as hysterectomy or myomectomy, to nonsurgical or minimally invasive treatments as uterine artery embolization and magnetic resonance image-guided focused ultrasound.2
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Wallach EE, Vlahos NF. Uterine myomas: an overview of development, clinical features, and management. Obstet Gynecol 2004; 104:393-406.
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Gliklich RE, Leavy MB, Velentgas P, et al. Identification of Future Research Needs in the Comparative Management of Uterine Fibroid Disease. A Report on the Priority-Setting Process, Preliminary Data Analysis, and Research Plan. Effective Healthcare Research Report No. 31. Rockville, MD: Agency for Healthcare Research and Quality. March 2011.
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Laughlin-Tommaso S. Uterine Fibroids: an Introduction. Presented at the Food and Drug Administration Center for Devices and Radiological Health Medical Devices Advisory Committee, Obstetrics and Gynecology Devices Panel. Accessed at http://1.usa.gov/1C5G9j2.
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Eltoukhi HM, Modi MN, Weston M, et al. The health disparities of uterine fibroid tumors for African American women: a public health issue. Am J Obstet Gynecol 2014; 210(3):194-199.
