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

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 fi...

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Bibliographic Details
Published in:American journal of obstetrics and gynecology 2018-07, Vol.219 (1), p.95.e1-95.e10
Main Authors: Stewart, Elizabeth A., Lytle, Barbara L., Thomas, Laine, Wegienka, Ganesa R, Jacoby, Vanessa, Diamond, Michael P., Nicholson, Wanda K., Anchan, Raymond M., Venable, Sateria, Wallace, Kedra, Marsh, Erica E., Maxwell, George L., Borah, Bijan J., Catherino, William H., Myers, Evan R.
Format: Article
Language:English
Subjects:
Adolescent
Adult
comparative effectiveness research
Endometrial Ablation Techniques
Female
High-Intensity Focused Ultrasound Ablation
Humans
Hysterectomy
Intrauterine Devices, Medicated
Leiomyoma - therapy
Magnetic Resonance Imaging
Middle Aged
Patient Outcome Assessment
Progestins - administration & dosage
Quality of Life
Radiofrequency Ablation
Registries
Surgery, Computer-Assisted
Treatment Outcome
Uterine Artery Embolization
uterine fibroid
uterine leiomyoma
Uterine Myomectomy
Uterine Neoplasms - therapy
Young Adult
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Summary: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. We report here the design and initial recruitment for the Comparing Options for Management: Patient-centered REsults for Uterine Fibroids (COMPARE-UF) registry (Clinicaltrials.gov, 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 resonance–guided 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
ISSN:0002-9378
1097-6868
DOI:10.1016/j.ajog.2018.05.004