This is the 16th annual National Women’s Health Week, an opportunity to focus on how to give women the information and tools they need to help them make good health a high priority. It’s also a chance for us at PCORI to highlight the research we support on critical women’s health issues. This year, we focus on a particularly compelling project, a large-scale study designed to produce useful evidence about treating uterine fibroids, a problem faced by millions of women worldwide each year.
Uterine fibroids—tumors in the uterus that are almost always benign—usually appear during a woman’s childbearing years. They occur in greater frequency in African-American women than in others. Many women who have uterine fibroids never experience any symptoms and do not require medical treatment. However, uterine fibroids sometimes cause pelvic pain and pressure, as well as heavy bleeding and anemia. They also sometimes decrease fertility or cause pregnancy problems.
Women who experience symptoms caused by uterine fibroids face a range of treatment options. These include medicines to control symptoms, as well as surgical procedures that reduce or remove the fibroids (see table). Information about which treatments lead to the best outcomes is incomplete. Before deciding on a treatment, women should talk with their physicians about which treatment goals are most important to them.
Few research studies have followed women to determine whether their treatment for uterine fibroids was successful. To understand what potential research questions are most important to patients and other healthcare stakeholders in this area, the Agency for Healthcare Research and Quality (AHRQ) funded a 2010 project that engaged stakeholders in developing a prioritized list of research questions. In March 2013, PCORI convened a multi-stakeholder workgroup. This workgroup concluded that it’s most important to produce evidence about the relative effectiveness of available treatments on symptom relief and reproductive outcomes. The workgroup also said that it was important to understand whether certain treatments work better for certain subgroups of women.
|Medical Options||Surgical Options|
|Nonsteroidal anti-inflammatory drugs (NSAIDs) to alleviate pain||Hysterectomy (removes the uterus)|
|Myomectomy (removes the fibroid but not the uterus)|
|Hormonal therapies, including oral contraceptives, to control bleeding||Hysteroscopy with removal of small intracavity fibroids|
|Endometrial ablation (destroys the uterine lining(|
|Gonadotropin-releasing hormone (Gn-RH) agonists to reduce fibroid volume and control bleeding||Uterine artery embolization (stops blood flow to the fibroid)|
|Focused ultrasound ablation using magnetic resonance guidance (breaks down the fibroid)|
Generating Evidence to Support Informed Decision Making
To provide needed information for women with uterine fibroids and their clinicians, PCORI is funding a five-year research project that will be administered by the AHRQ. The study led by Duke University School of Medicine aims to develop a multi-center registry of women who have received surgical treatments for uterine fibroids. This registry, which is referred to as COMPARE—UF (Comparing Options for Management: Patient-centered REsults for Uterine Fibroids), will establish the infrastructure necessary to support patient-centered comparative clinical effectiveness research.
- Mayo Clinic Collaborative Network
- University of California Fibroid Network
- Henry Ford Health System
- University of Mississippi Medical Center
- Northwestern Memorial Hospital - Chicago Consortium
- University of North Carolina
- Brigham and Women's Hospital/Harvard Clinical Center
- Inova Health Systems
- Department of Defense Clinical Consortium
The research team will implement three research studies that use the registry to address questions of importance to patients and other stakeholders. These research studies will compare different treatment options with regard to
- Safety and symptom relief
- Reproductive effects
- Effectiveness in different patient subgroups
To collect data from a geographically, racially, ethnically, and clinically diverse population, the registry will partner with nine diverse networks and institutions.
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 stakeholders will also advise the researchers on appropriate means of data collection and use. Ultimately, other researchers will have the opportunity to use the registry infrastructure and data.
With the high-quality evidence that the project will generate, women with uterine fibroids and their clinicians can together make better-informed treatment decisions—a major step forward in women’s health.
PCORI is also funding many other research and community-engagement projects aimed at increasing the information available to women as they make healthcare decisions. Topics include reproductive health, cancer, depression, and lupus. You can learn more by searching our database of funded projects. We hope to have some early results to share with you by Women’s Health Week next year.