Comparing Options for Management:PAtient-centered - PowerPoint Presentation

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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

evan.myers@duke.edu

ORGANIZATIONP50 (“Center of Excellence”) GrantBroad 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)

Main AimsCompare duration of symptom relief among available treatmentsInitial 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

PatientsScheduled to undergo treatment at facility affiliated with Clinical SiteOutreach methods vary by site

E-

mai

/letter from attending physician

Subsequent contact by e-mail/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)

Inherent Challenges—Data CollectionDiversity 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

Inherent Challenges—Data CollectionYounger, 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

)

Inherent Challenges-QualityNo 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?

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