The FIBROID Registry

Report of Structure, Methods, and Initial Results

The Fibroid Registry for Outcomes Data (FIBROID) was developed to prospectively collect high-quality data on uterine artery embolization. From the first patient in December 2000 until the Registry's closure 2 years later, 3,319 patients were logged into it through 72 Web sites.

Analysis of the data presented here was supported by the Agency for Healthcare Research and Quality (AHRQ) and the Office of Women's Health of the Food and Drug Administration.

Contents

Preface
Summary
Chapter 1. Background and Significance
    Prevalence Estimates
    Incidence of Symptom Development
    Racial Differences
    Severity of Disease
    Uterine Artery Embolization
    Overview on the Safety Profile of the UAE Procedure
    Summary of Background and Significance
    Development of a Research Agenda for UAE
    Development of a Disease-specific Quality-of-Life Instrument
Chapter 2. Methods
    UAE Registry: Background
    UAE Registry: Organization
    UAE Registry Sites
    Data Collection
    Data Management/Data Quality
    Subjects
    Data Collected
    Baseline and 30-Day Data
       Patient Characteristics
       Procedure Characteristics
       In-Hospital Outcomes
       30-Day Outcomes
       Long-term Outcomes (6 and 12 months)
    Imaging Measures
    Definitions
       Technical Success
       Clinical Failure
       Adverse Events
    Methods for Data Collection
       Identification of Eligible Subjects
       Mailing of Questionnaires
       Methods for Contacting/Locating Patients
       Data Management for Questionnaires
    Data Analysis: General Approach
       Description of Baseline Characteristics
       Description of Outcomes
       Analysis of Adverse Events
       General Methodology for Predictors of Outcomes
       Predictors of Time to Events
       Missing Data
Chapter 3. Results
    Site and Patient Enrollment
    Baseline Characteristics
    The UAE Procedure
       Adverse Events
       Analysis of Predictors of Adverse Events
    One Year Outcome
       Symptom and HRQOL Outcomes
       Need for Additional Fibroid-Related Care
       Menstrual Cycles after Embolization
       Additional Outcome Measure
    Analysis of Failure of Symptom Control at 12 months
    Pregnancy After Uterine Embolization
Chapter 4. Discussion
    Thirty-day Outcome
    Six- and 12-month Outcome
    Potential Limitations
    UAE FIBROID Registry Project Dissemination Plan
    Conclusion
References
Tables
Figures
Acknowledgments

AHRQ Publication No. 05(06)-RG008
Current as of October 2005

Internet Citation:

The FIBROID Registry: Report of Structure, Methods, and Initial Results. AHRQ Publication No. 05(06)-RG008, October 2005. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/research/fibroid/