1. Comparing Options for Management:PAtient-centered REsults for Uterine Fibroids
Evan R. Myers, MD, MPH
Department of Obstetrics & Gynecology and Duke Clinical Research Institute, Duke University, Durham, NC

2. ORGANIZATION P50 (“Center of Excellence”) Grant
Broad aim is to put infrastructure in place to conduct a range of studies
Funding by PCORI, administered by AHRQ
Data Coordinating Center at Duke Clinical Research Institute
9 Clinical Centers
Stakeholder Advisory Group (patients, payers, professional societies, government agencies, industry)

3. Main Aims
Compare duration of symptom relief among available treatments
Initial focus on procedures
Compare impact of treatments on reproductive outcomes (time to menopause, fertility, pregnancy outcomes)
Identify important subgroup effects (heterogeneity of treatment effect)
Data elements driven by emphasis on comparative effectiveness

4. Patients
Scheduled to undergo treatment at facility affiliated with Clinical Site
Outreach methods vary by site
E-mai/letter from attending physician
Subsequent contact by /phone/in-person
Electronic portal for
E-consent
Completion of baseline and follow-up data
Other communications with patients
Follow-up at post-procedure visit, 12, 24, 36 (and potentially more)

5. Inherent Challenges—Data Collection
Diversity of
Symptom type and severity
Uterine anatomy
Patient goals
Hysterectomy still most common procedure (50%), followed by myomectomy (25-30%)
Lower numbers of alternatives
Substantial differences in patient characteristics by procedure type
Limited time between identification of eligible patients and treatment for introduction, consent, collection of baseline PRO data
Office-based treatments (ablation, IUD, ultimately drugs) even harder to identify

6. Inherent Challenges—Data Collection
Younger, more mobile patient population
Very few Medicare patients (and those unique in some way)
State-based all payer claims limited if patient moves out of state
Lack of standardization of
Symptom description (validated disease-specific QoL available but not widely used in clinical practice)
Uterine anatomy (FIGO recommendations in progress)
Procedure description/details
Devices
No analogy to mesh, sterilization in terms of implants
Device issues would involve failure or injury at time of procedure, or uncomplicated use in inappropriate patient (morcellation)

7. Inherent Challenges-Quality
No equivalent of “30 day risk-adjusted mortality”
Ongoing patient concerns about counseling about all options, availability of all options
Constrained by overall lack of comparative effectiveness data
Consider “phased” development of registry for QA/QI
Did clinician have all relevant information needed for decision making available and documented?
Were all appropriate options discussed with patient?
Did patient receive treatment from appropriate options?
Were outcomes of treatment within expected range given patient characteristics?

8. Goals for “COMPARE 2.0”
Continue collaboration with CRN, ACOG efforts at developing methods for facilitating provider data entry
Continue development and enhancement of patient-centered data collection, particularly on reliably patient-reported outcomes over the long-term by incorporating tools for
Use of registry data as personal fibroid medical history
“How do I compare to other patients in the registry?” feedback
Tools for involvement with educating other patients
Incorporate medical therapies, both existing off-label uses and drugs currently in Phase II/III