The broad, long-term objective of this project is to enable patients with uterine fibroids (UF) to make informed decisions about management options based on the highest possible quality evidence. To help achieve this objective, we propose a multi-center registry of a geographically, racially, ethnically, and clinically diverse group of women who have received medical or surgical treatment for UF, Comparing Options for Management: Patient-centered Results for Uterine Fibroids (COMPARE-UF), designed to address the following specific aims:
AIM 1) Develop the infrastructure necessary to implement large-scale observational comparative effectiveness research (CER) studies of management options for women with UF, including (a) a governance structure, policies, and procedures conducive to collaborative research involving patients, clinicians, methodologists, and other stakeholders, (b) an experienced Research and Data Coordinating Center, and (c) nine geographically diverse Clinical Centers (CCs) representing a broad range of patients and providers.
AIM 2) Use this infrastructure to implement 3 projects addressing high-priority evidence gaps related to the effect of different management strategies on patient-centered outcomes. These include PROJECT 1: Comparing management options for symptom relief PROJECT 2: Comparing management options for preserving reproductive function PROJECT 3: Comparing effectiveness in different subpopulations.
AIM 3) Evaluate innovative methods for the design, conduct, and analysis of observational comparative effectiveness research in this population.
AIM 4) Translate research results into improved patient care, through both traditional peer-reviewed publications and collaborations with stakeholders to integrate the research findings into evidence-based patient decision making tools, clinical practice guidelines, and quality measures.

Public Health Relevance

Uterine fibroids are a common problem for women, causing heavy bleeding, pain, and other problems. Many women with fibroids eventually have surgery to remove their uterus (hysterectomy). This study will try to determine how well other available treatments work compared to each other and to hysterectomy, and whether they work better for some patients than others.

Agency
National Institute of Health (NIH)
Institute
Agency for Healthcare Research and Quality (AHRQ)
Type
Specialized Center (P50)
Project #
1P50HS023418-01
Application #
8786631
Study Section
Special Emphasis Panel (ZHS1-HSR-X (01))
Program Officer
Berliner, Elise
Project Start
2014-09-30
Project End
2019-09-29
Budget Start
2014-09-30
Budget End
2015-09-29
Support Year
1
Fiscal Year
2014
Total Cost
Indirect Cost
Name
Duke University
Department
Obstetrics & Gynecology
Type
Schools of Medicine
DUNS #
044387793
City
Durham
State
NC
Country
United States
Zip Code
27705