Continuous Stakeholder Engagement in CER On Uterine Fibroids Ellen Tambor, MA | June 3, 2019 | Academy Health ARM CENTER FOR MEDICAL TECHNOLOGY POLICY
Fibroids 101 Uterine Fibroids (UFs): Benign tumors of uterine smooth muscle and extracellular connective tissue Symptoms can include: Profound bleeding Anemia Black women may Pelvic pressure & pain develop fibroids at Urinary frequency & UTI younger ages, have more and larger Abnormal bowel function fibroids, and more Pain during sex severe symptoms than women of Infertility other races. Miscarriage or premature delivery
UF Treatment • Hysterectomy (removal of the uterus) and myomectomy (removal of fibroids while preserving the uterus) account for 90-95% of all procedures for symptomatic fibroids in the U.S. • Other treatments include uterine artery embolization, endometrial ablation, radiofrequency ablation, and magnetic resonance-guided focused ultrasound • Currently no FDA approved medications for UFs but many medications are used off-label • High degree of practice variability among providers High quality evidence regarding UF therapies to help inform treatment decisions is very limited 3
UF CER Project History Retrospective CER COMPARE-UF Topic Identification Study Using Claims Prospective and Prioritization and EMR Data Registry AHRQ PCORI AHRQ/PCORI2 2009-2010 2014-2015 2014-2020 4
UF CER Project History Retrospective CER COMPARE-UF Topic Identification Study Using Claims Prospective and Prioritization and EMR Data Registry AHRQ PCORI AHRQ/PCORI2 2009-2010 2014-2015 2014-2020 5
Project 1: Topic Prioritization Process Technical Working Group US Payers Patients/Advocates Clinician/ Clinician/ Resear esearcher hers
Project 1: Topic Prioritization Stakeholder Committee (4 Professional Associations)
Project 1: Topic Prioritization Stakeholder Committee Process
UF CER Project History Retrospective CER COMPARE-UF Topic Identification Study Using Claims Prospective and Prioritization and EMR Data Registry AHRQ PCORI AHRQ/PCORI2 2009-2010 2014-2015 2014-2020 9
Project 2: Retrospective Study Stakeholder Objectives Partnership Council Refine proposed study protocol to ensure: • Outcomes and comparators relevant to decision makers • Important subpopulations included • Other factors relevant to analysis or interpretation of data considered 10
Project 2: Retrospective Study Changes to Analysis Plan as a Result of Stakeholder Input • Extend duration of follow-up from 1 year to 2 Study Period • Exclude individuals with diagnosis of gynecologic cancers Inclusion/Exclusion • Extend period of index date from 2 to 4 weeks in some cases • List of medications • Pregnancy Additional Patient • Insurance characteristics • Specialty of health care provider Characteristics & • Height and weight variables • Health system characteristics Control Variables • Distinguish between types of surgeries Interventions/ Comparators • Eight symptoms added Outcomes • Add analyses based on obesity and pregnancy status Subgroup Analyses 11
UF CER Project History Retrospective CER COMPARE-UF Topic Identification Study Using Claims Prospective and Prioritization and EMR Data Registry AHRQ PCORI AHRQ/PCORI2 2009-2010 2014-2015 2014-2020 12
Project 3: COMPARE-UF Registry Stakeholder Objectives Advisory Group Provide input on: • Research question US Payers priorities • Study protocols Regulators • Study materials • Recruitment and Clinicians/Researchers retention (4 Professional Associations) • Industry Dissemination & Representatives implementation Patients/Advocates 13
Project 3: COMPARE-UF Registry Patients/Advocates ➢ Comprise over 30% of Stakeholder Advisory Group ➢ Critical that composition reflect increased rate of UF and severity of symptoms in black women 14
Project 3: COMPARE-UF Registry Sample SAG Contributions Logo Design Brochure Website Portal Dashboard 15
Project 3: COMPARE-UF Registry Sample SAG Contributions Logo Design Brochure Website Portal Dashboard 16
Project 3: COMPARE-UF Registry Sample SAG Contributions Logo Design Brochure Website Portal Dashboard 17
Project 3: COMPARE-UF Registry Sample SAG Contributions Logo Design Brochure Website Portal Dashboard 18
Impact of Engagement Project Stakeholder Impact Topic Prioritization Clear differences in priorities between stakeholder groups had an impact on the research questions that emerged as highest priority Retrospective Multiple protocol changes related to: study period, inclusion/exclusion Study criteria, comparators, outcomes, subgroup analyses COMPARE-UF Significant input on registry design, data collection tools, and Registry recruitment and retention strategies; central role in developing and implementing dissemination strategy as findings emerge; input on registry sustainability plan 19
Project Team • Evan Myers, MD, MPH Duke Clinical Research Institute • Barbara Lytle, MS Duke Clinical Research Institute • Donna Messner, PhD Center for Medical Technology Policy • Susan Chang, MD, MPH Center for Medical Technology Policy Thank You! ellen.tambor@cmtpnet.org http://www.cmtpnet.org/ 20
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