Continuous Stakeholder Engagement in CER On Uterine Fibroids Ellen - - PowerPoint PPT Presentation

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Continuous Stakeholder Engagement in CER On Uterine Fibroids Ellen - - PowerPoint PPT Presentation

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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

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CENTER FOR MEDICAL TECHNOLOGY POLICY

Continuous Stakeholder Engagement in CER On Uterine Fibroids

Ellen Tambor, MA | June 3, 2019 | Academy Health ARM

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Fibroids 101

Uterine Fibroids (UFs): Benign tumors of uterine smooth muscle and extracellular connective tissue Symptoms can include:

Profound bleeding Anemia Pelvic pressure & pain Urinary frequency & UTI Abnormal bowel function Pain during sex Infertility Miscarriage or premature delivery

Black women may develop fibroids at younger ages, have more and larger fibroids, and more severe symptoms than women of

  • ther races.
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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

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High quality evidence regarding UF therapies to help inform treatment decisions is very limited

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UF CER Project History

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Topic Identification and Prioritization Retrospective CER Study Using Claims and EMR Data COMPARE-UF Prospective Registry AHRQ 2009-2010 PCORI 2014-2015 AHRQ/PCORI2 2014-2020

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UF CER Project History

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Topic Identification and Prioritization Retrospective CER Study Using Claims and EMR Data COMPARE-UF Prospective Registry AHRQ 2009-2010 PCORI 2014-2015 AHRQ/PCORI2 2014-2020

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Project 1: Topic Prioritization

Technical Working Group Process

Patients/Advocates Clinician/ Clinician/ Resear esearcher hers US Payers

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Project 1: Topic Prioritization

Stakeholder Committee

(4 Professional Associations)

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Project 1: Topic Prioritization

Process Stakeholder Committee

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UF CER Project History

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Topic Identification and Prioritization Retrospective CER Study Using Claims and EMR Data COMPARE-UF Prospective Registry AHRQ 2009-2010 PCORI 2014-2015 AHRQ/PCORI2 2014-2020

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Stakeholder 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

Objectives

Project 2: Retrospective Study

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Changes to Analysis Plan as a Result of Stakeholder Input

Study Period

  • Extend duration of follow-up from 1 year to 2

Inclusion/Exclusion

  • Exclude individuals with diagnosis of gynecologic cancers
  • Extend period of index date from 2 to 4 weeks in some cases

Additional Patient Characteristics & Control Variables

  • List of medications
  • Insurance characteristics
  • Height and weight variables
  • Pregnancy
  • Specialty of health care provider
  • Health system characteristics

Interventions/ Comparators

  • Distinguish between types of surgeries

Outcomes

  • Eight symptoms added

Subgroup Analyses

  • Add analyses based on obesity and pregnancy status

Project 2: Retrospective Study

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UF CER Project History

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Topic Identification and Prioritization Retrospective CER Study Using Claims and EMR Data COMPARE-UF Prospective Registry AHRQ 2009-2010 PCORI 2014-2015 AHRQ/PCORI2 2014-2020

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Stakeholder Advisory Group

Patients/Advocates US Payers Industry Representatives Regulators Clinicians/Researchers

(4 Professional Associations)

Project 3: COMPARE-UF Registry

Provide input on:

  • Research question

priorities

  • Study protocols
  • Study materials
  • Recruitment and

retention

  • Dissemination &

implementation

Objectives

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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

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Project 3: COMPARE-UF Registry

Sample SAG Contributions Logo Design Brochure Website Portal Dashboard

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Project 3: COMPARE-UF Registry

Sample SAG Contributions Logo Design Brochure Website Portal Dashboard

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Project 3: COMPARE-UF Registry

Sample SAG Contributions Logo Design Brochure Website Portal Dashboard

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Project 3: COMPARE-UF Registry

Sample SAG Contributions Logo Design Brochure Website Portal Dashboard

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Impact of Engagement

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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 Study Multiple protocol changes related to: study period, inclusion/exclusion criteria, comparators, outcomes, subgroup analyses COMPARE-UF Registry Significant input on registry design, data collection tools, and recruitment and retention strategies; central role in developing and implementing dissemination strategy as findings emerge; input on registry sustainability plan

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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

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Thank You!

ellen.tambor@cmtpnet.org http://www.cmtpnet.org/