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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Published in | American journal of obstetrics and gynecology Vol. 219; no. 1; pp. 95.e1 - 95.e10 |
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Main Authors | , , , , , , , , , , , , , , |
Format | Journal Article |
Language | English |
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United States
Elsevier Inc
01.07.2018
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Abstract | 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 <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 our patient 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. |
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AbstractList | 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 <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 our patient 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. BACKGROUNDUterine fibroids are common in premenopausal women, yet comparative effectiveness research on uterine fibroid treatments is rare. OBJECTIVEThe 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 DESIGNWe 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. RESULTSWe 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%. CONCLUSIONIn response to priorities that were identified by our patient 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. |
Author | Catherino, William H. Thomas, Laine Maxwell, George L. Diamond, Michael P. Wegienka, Ganesa R Anchan, Raymond M. Nicholson, Wanda K. Borah, Bijan J. Lytle, Barbara L. Myers, Evan R. Stewart, Elizabeth A. Wallace, Kedra Jacoby, Vanessa Venable, Sateria Marsh, Erica E. |
Author_xml | – sequence: 1 givenname: Elizabeth A. orcidid: 0000-0003-1110-2400 surname: Stewart fullname: Stewart, Elizabeth A. email: stewart.elizabeth@mayo.edu organization: Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Mayo Clinic, Rochester, MN – sequence: 2 givenname: Barbara L. surname: Lytle fullname: Lytle, Barbara L. organization: Duke Clinical Research Institute, Duke University Medical Center, Duke University School of Medicine, Durham, NC – sequence: 3 givenname: Laine surname: Thomas fullname: Thomas, Laine organization: Duke Clinical Research Institute, Duke University Medical Center, Duke University School of Medicine, Durham, NC – sequence: 4 givenname: Ganesa R surname: Wegienka fullname: Wegienka, Ganesa R organization: Department of Public Health Sciences, Henry Ford Health System, Detroit, MI – sequence: 5 givenname: Vanessa surname: Jacoby fullname: Jacoby, Vanessa organization: Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco, CA – sequence: 6 givenname: Michael P. surname: Diamond fullname: Diamond, Michael P. organization: Department of Obstetrics and Gynecology, Augusta University, Augusta GA – sequence: 7 givenname: Wanda K. surname: Nicholson fullname: Nicholson, Wanda K. organization: Center for Women’s Health Research, Department of Obstetrics and Gynecology, UNC School of Medicine, Center for Health Promotion and Disease Prevention, UNC School of Public Health, Chapel Hill, NC – sequence: 8 givenname: Raymond M. surname: Anchan fullname: Anchan, Raymond M. organization: Division of Reproductive Endocrinology and Infertility, Department of Obstetrics, Gynecology and Reproductive Biology, Brigham and Women’s Hospital, Boston, MA – sequence: 9 givenname: Sateria surname: Venable fullname: Venable, Sateria organization: Fibroid Foundation, Bethesda, MD – sequence: 10 givenname: Kedra orcidid: 0000-0003-4511-0046 surname: Wallace fullname: Wallace, Kedra organization: Department of Obstetrics and Gynecology, University of Mississippi Medical Center, Jackson, MS – sequence: 11 givenname: Erica E. surname: Marsh fullname: Marsh, Erica E. organization: Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, University of Michigan Medical School, Ann Arbor, MI – sequence: 12 givenname: George L. surname: Maxwell fullname: Maxwell, George L. organization: Department of Obstetrics and Gynecology, Inova Fairfax Hospital, Falls Church, VA – sequence: 13 givenname: Bijan J. surname: Borah fullname: Borah, Bijan J. organization: Division of Health Care Policy and Research, Mayo Clinic, Rochester, MN – sequence: 14 givenname: William H. surname: Catherino fullname: Catherino, William H. organization: Department of Obstetrics and Gynecology, Uniformed Services University of the Health Sciences, Bethesda, MA – sequence: 15 givenname: Evan R. orcidid: 0000-0002-9053-9864 surname: Myers fullname: Myers, Evan R. organization: Duke Clinical Research Institute, Duke University Medical Center, Duke University School of Medicine, Durham, NC |
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Keywords | comparative effectiveness research uterine leiomyoma uterine fibroid |
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Snippet | Uterine fibroids are common in premenopausal women, yet comparative effectiveness research on uterine fibroid treatments is rare.
The purpose of this study was... BACKGROUNDUterine fibroids are common in premenopausal women, yet comparative effectiveness research on uterine fibroid treatments is rare. OBJECTIVEThe... |
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SubjectTerms | 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 |
Title | The Comparing Options for Management: PAtient-centered REsults for Uterine Fibroids (COMPARE-UF) registry: rationale and design |
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