Stakeholder Engagement for Patient-Centered Outcomes Research Vanessa Jacoby, MD, MAS Associate Professor Obstetrics, Gynecology, and Reproductive Sciences University of California, San Francisco

Change in Research Model Design the Study Conduct the Study Disseminate and Implement Results Researchers Stakeholders

Who are the Key Stakeholders? Researchers Patients and their families Health care providers Drug and device companies Health Insurers Government agencies Disease Advocates/Foundations Others?

Why include stakeholders in research? Design the Study Conduct the Study Disseminate and Implement Results Support Funding Help Enrollment Diverse opinions strengthen design Broaden impact of results Deliver message effectively

Why include stakeholders in research?  Required by Patient Centered Outcomes Research Institute  Authorized by Congress in 2010 as part of the Affordable Care Act  PCORI supports “research that addresses the questions and concerns most relevant to patients, and we involve patients, caregivers, clinicians, and other healthcare stakeholders, along with researchers, throughout the process”.

Stakeholder Engagement  No standard approach  Include stakeholders in all phases of research  Example of common stakeholder engagement strategy

COMPARING OPTIONS FOR MANAGEMENT: PATIENT-CENTERED RESULTS FOR UTERINE FIBROIDS  Nationwide prospective cohort study  10,000 women undergoing treatment for uterine fibroids  Compare symptoms and fertility/ pregnancy outcomes among fibroid treatments  Funded by PCORI and AHRQ (Agency for Healthcare Research and Quality)

Stakeholder Engagement  Patients representatives involved in grant development  One patient is voting member of Steering Committee  Stakeholder Advisory Group is key study committee (20 members)

Stakeholder Advisory Group Government and Nonprofit Agencies (e.g. ACOG) Women with Fibroids

Stakeholders and Study Design What are the most important outcomes of fibroid treatment? STAKEHOLDER Heavy Bleeding Pregnancy and fertility Treatment failure Women with fibroids x xx Ob/Gyns x x x Device manufacturers x x Health insurers x

Stakeholders and Study Design What are the most important outcomes of fibroid treatment? STAKEHOLDER Heavy Bleeding Pregnancy and fertility Treatment failure Sexual Function and Mental health Women with fibroids x xx x Ob/Gyns x x x Device manufacturers x x Health insurers x

Stakeholders and Study Design What are the most important outcomes of fibroid treatment? STAKEHOLDER Heavy Bleeding Pregnancy and fertility Treatment failure Sexual Function and Mental Health Cost effectiveness Women with fibroids x xxx Ob/Gyns x x x Device manufacturers x x Health insurers x x

Stakeholders and Recruitment How do we successfully enroll participants? STAKEHOLDER Clinical encounters AdvertisingSocial media Women with fibroids x Ob/Gyns x Device manufacturers x Health insurers x

Challenges with Stakeholder Representatives Do stakeholders, especially patients, accurately represent their community?  High health literacy  Get along with researchers  Able to attend meetings Thousands of women with fibroids Input from 1 patient on Steering Committee

New approach to Stakeholder Engagement  Crowdsource participation in research Thousands of women with fibroids Input from Thousands of women with fibroids  Create online platform for stakeholder collaboration

 Proposals developed, discussed, and revised online  Academic medical center faculty and staff only

 Crowdsourcing Research to Diverse Stakeholders Welcome all perspectives: “Research is stronger when all voices are heard and valued”

 Build trust  Respect privacy  Support open discussions  MOSAIC ◦Website open to public ◦Registration required to post comments ◦Select identity settings

 PCORI funded Community Engaged Network for All  Patient Powered Research Network (PPRN)  Joubert Syndrome and Related Disorders Foundation (JSRDF) plan for research protocol

Brainstorming Research Ideas

Discussing the Study Protocol

Maintaining Engagement  Opportunity to “follow” the research  Real time /text message updates as research is conducted

Disseminate and Implement Results  Medical journals have limited audience  Stakeholders engaged in their community  Stakeholders can support implementation of results ---AMA changes guidelines ---Blue Cross changes coverage decisions

Challenges with Mosaic  Need to connect to broader audience (e.g. text messaging)  Need core study team with enthusiastic partners Women who Access Mosaic Input from Thousands of women with fibroids

Stakeholder Engagement  Improves and strengthens clinical research  Involve stakeholders from the start of research  Many approaches to engagement…more innovations soon!