The Comparing Options for Management: PAtient-centered REsults for Uterine Fibroids (COMPARE-UF) registry: rationale and design

Read the complete article in BJOG An International Journal of Obstetrics and Gynaecology


Journal: American Journal of Obstetrics & Gynecology

Authors: Stewart EA, Lytle BL, Thomas L, et al.

Year Published: 2018


Uterine fibroids are common in premenopausal
women, yet comparative effectiveness research on uterine fibroid treatments is rare.


The purpose of this study was to design and establish a uterine fibroid registry based in the United States to provide comparative effectiveness data regarding uterine fibroid treatment.

Study Design

We report here the design and initial recruitment for the Comparing Options for Management: Patient-centered REsults for Uterine Fibroids (COMPARE-UF) registry (, NCT02260752), funded by the Agency for Healthcare Research and Quality in collaboration with the Patient-Centered Outcomes Research Institute. COMPARE-UF was designed to help answer critical questions about treatment options for women with symptomatic uterine fibroids. Women who undergo a procedure for uterine fibroids (hysterectomy, myomectomy [abdominal, hysteroscopic, vaginal, and laparoscopic/robotic], endometrial ablation, radiofrequency fibroid ablation, uterine artery embolization, magnetic resonanceeguided focused ultrasound, or progestin-releasing intrauterine device insertion) at 1 of the COMPARE-UF sites are invited to participate in a prospective registry with 3 years follow up for postprocedural outcomes. Enrolled participants provide annual follow-up evaluation through an online portal or through traditional phone contact. A central data abstraction center provides information obtained from imaging, operative or procedural notes, and pathology reports. Women with uterine fibroids and other stakeholders are a key part of the COMPARE-UF registry and participate at all points from study design to dissemination of results.


We built a network of 9 clinical sites across the United States with expertise in the care of women with uterine fibroids to capture geographic, racial, ethnic, and procedural diversity. Of the initial 2031 women who were enrolled in COMPARE-UF, 42% are self-identified as black or African American, and 40% are 40 years old, with 16% of participants <35 years old. Women who undergo myomectomy comprise the largest treatment group at 46% of all procedures, with laparoscopic or robotic myomectomy comprising the largest subset of myomectomies at 19% of all procedures. Hysterectomy is the second most common treatment within the registry at 38%.


In response to priorities that were identified by ourpatient stakeholders, the initial aims within COMPARE-UF will address how different procedures that are used to treat uterine fibroids compare in terms of long-lasting symptom relief, potential for recurrence, medical complications, improvement in quality of life and sexual function, age at menopause, and fertility and pregnancy outcomes. COMPARE-UF will generate evidence on the comparative effectiveness of different procedural options for uterine fibroids and help patients and their caregivers make informed decisions that best meet an individual patient’s short- and long-term preferences. Building on this infrastructure, the COMPARE-UF team of investigators and stakeholders, including patients, collaborate to identify future priorities for expanding the registry, such as assessing the efficacy of medical therapies for uterine fibroids. COMPARE-UF results will be disseminated directly to patients, providers, and other stakeholders by traditional academic pathways and by innovative methods that include a variety of social media platforms. Given demographic differences among women who undergo different uterine fibroid treatments, the assessment of comparative effectiveness for this disease through clinical trials will remain difficult. Therefore, this registry provides optimized evidence to help patients and their providers better understand the pros and cons of different treatment options so that they can make more informed decisions.

Epidemiology of uterine fibroids: a systematic review

Read the complete article in BJOG An International Journal of Obstetrics and Gynaecology


Journal: BJOG An International Journal of Obstetrics and Gynaecology

Authors: EA Stewart, CL Cookson, RA Gandolfo, R Schulze-Rath

Year Published: 2017



Uterine fibroids (UFs) are the most common neoplasm affecting women that can cause significant morbidity and may adversely impact fertility.


To examine UF epidemiology and to evaluate the relative strengths of putative risk factors.

Search strategy

MEDLINE and Embase were searched for studies published in English between January 1995 and April 2015.

Selection criteria

Publications reporting relevant data from registries and other observational studies with over 1000 patients and single-centre studies with over 100 patients were selected.

Data collection and analysis

Data on UF incidence, prevalence and associated risk factors were extracted from 60 publications.

Main results

Wide ranges were reported in both UF incidence (217–3745 cases per 100 000 women-years) and prevalence (4.5–68.6%), depending on study populations and diagnostic methods. Black race was the only factor that was recurrently reported to increase UF risk, by two–threefold compared with white race. Eleven other factors affected UF risk to a magnitude similar to or greater than race. Age, premenopausal state, hypertension, family history, time since last birth, and food additive and soybean milk consumption increased UF risk; use of oral contraceptives or the injectable contraceptive depot medroxyprogesterone acetate, smoking in women with low body mass index and parity reduced UF risk.


We identified 12 risk factors that play an important role in UF epidemiology. The UF risk factor with the strongest evidence is black race. High-quality prospective observational data are needed to improve our understanding of UF epidemiology, and thus its aetiology and optimal management.

Michigan Chronicle Announces COMPARE-UF

May 11, 2016: The Michigan Chronicle publishes an announcement about the COMPARE-UF registry. See page 2 of the e-edition.

The Michigan Chronicle is a weekly newspaper based in Detroit, Michigan, serving the African-American community. It was founded in 1936 by John H. Sengstacke, owner of the Chicago Defender. Together with the Defender and a handful of other African-American newspapers, it is owned by Detroit-based Real Times Inc. Its headquarters are in the Real Times offices in Midtown Detroit. [source: Wikipedia]

Study Seeks Women’s Insights on What Works Best for Uterine Fibroids

For Immediate Release: Monday May 9, 2016

DURHAM, N.C. – A new registry that launches this month gives women who have uterine fibroids the opportunity to help determine which strategies are most effective in treating the common condition.

The registry, called Comparing Options for Management: Patient-Centered Results for Uterine Fibroids (COMPARE-UF), will enroll more than 10,000 women at clinics affiliated with nine medical centers across the country. Participating women will be asked at annual intervals specific questions about the treatments they’ve elected to receive, and how well the treatments seem to be working for them.

compare-uf_study_the-problem_13oct2015Approximately three years after initial treatment, researchers at the Duke Clinical Research Institute (DCRI) will analyze the patients’ feedback to determine which procedures provide the greatest benefit to women – insights that have been lacking for both women and their physicians.

Specifically, studies will focus on symptom relief, reproductive effects, and effectiveness among different patient subgroups, including African-American women, who are disproportionately affected by uterine fibroids.

“This is a common condition – it affects up to 75 percent of women to varying degrees and is the leading cause of hysterectomies in the country – yet we don’t know which treatment works best for a given patient,” said the study’s principal investigator, Evan Myers, M.D., professor in the Department of Obstetrics and Gynecology at Duke University School of Medicine.

“Patients have clearly stated that they wanted these questions answered, but preferred a registry to randomized trials, particularly because hysterectomy is one of the current options,” Myers said.

The registry was funded in 2013 with a $20 million funding award from the Patient-Centered Outcomes Research Institute (PCORI), in partnership with the Agency for Healthcare Research and Quality (AHRQ), which provides scientific oversight and administration.

The DCRI serves as the research and data coordinating center for the five-year project. Enrollments sites include Mayo Clinic Collaborative Network, University of California Fibroid Network, Henry Ford Health System, University of Mississippi Medical Center, University of North Carolina, Brigham and Women/Harvard Clinical Center, Inova Health Systems and the Department of Defense Clinical Consortium. The University of Michigan will become an enrollment site later this year.

Potential participants must have a documented diagnosis of uterine fibroids and be older than 18 and young enough to still have menstrual periods. Current treatments to be evaluated are hysterectomy (removal of the uterus), myomectomy (removal of the fibroids within the uterus), endometrial ablation (laser or heat treatments to destroy the uterine lining), radiofrequency ablation (using radio waves to destroy the fibroid), uterine artery embolization (blocking blood supply to the uterus), and magnetic resonance guided focused ultrasound (using ultrasound to destroy the fibroids). The study will add other treatments, including medications.

“Uterine fibroids have a big impact on women’s quality of life, affecting their ability to work and to participate in the things that they enjoy,” Myers said. “There are also high costs, both in treatments and in managing the pain and heavy bleeding that many women experience.

“One of the things that makes fibroids difficult to study is that they cause lots of different kinds of symptoms, and the symptoms can be complex, ranging from fairly minor discomfort to infertility,” Myers said. “This registry for the first time will help us collect strong, relevant information from the patients themselves that can then be analyzed to determine what treatments work best for which women.”

Patient advocacy groups, which had been integral in helping design the study, said the registry launch this month is a much-anticipated milestone.

“There are far too many women suffering with complications from uterine fibroids. This research effort initiated by AHRQ and PCORI is groundbreaking and crucial,” said Sateria Venable, founder & executive director of the Fibroid Foundation. “My hope is that COMPARE-UF will lead the way to more consistently and adequately funded fibroid research. If we focus our efforts, we will reap the rewards – health, fertility and quality of life.”


About the Duke Clinical Research Institute

The DCRI is the largest academic research organization in the world, with a mission to develop and share knowledge that improves the care of patients through innovative clinical research. The DCRI conducts groundbreaking multinational clinical trials, manages major national patient registries, and performs landmark outcomes research. DCRI research spans multiple disciplines, from pediatrics to geriatrics, primary care to subspecialty medicine, and genomics to proteomics. The DCRI also is home to the Duke Databank for Cardiovascular Diseases, the largest and oldest institutional cardiovascular database in the world, which continues to inform clinical decision-making 40 years after its founding.

Contact: Mark Slagle
Phone: 919-668-8031