This document discusses stakeholder engagement in patient-centered outcomes research. It begins by explaining the change from a researcher-centered model to including stakeholders. Key stakeholders are identified as patients, providers, drug/device companies, insurers, and advocates. Stakeholder engagement is required by PCORI to support funding, improve enrollment, strengthen research design, and broaden impact. Examples are provided of how a study on uterine fibroid treatment engaged stakeholders in design, recruitment, and dissemination of results. Challenges and new approaches like crowdsourcing input are also discussed.

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

2. Change in Research Model
Design
the Study
Conduct
the Study
Disseminate and
Implement
Results
ResearchersStakeholders

3. 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?

4. 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

5. 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”.

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

7. 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)

8. 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)

9. Stakeholder Advisory Group
Health Insurers
Ob/Gyns
Fibroid Device and Drug
Manufacturers
Health Systems
Government and Nonprofit Agencies
(e.g. ACOG)
Women with Fibroids

10. 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 x x
Ob/Gyns x
x x
Device
manufacturers x x
Health
insurers x

11. 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 x x x
Ob/Gyns x
x x
Device
manufacturers x x
Health
insurers x

12. 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 x x x
Ob/Gyns x
x x
Device
manufacturers x x
Health insurers
x x

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

14. 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

15. 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

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

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

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

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

20. Brainstorming Research Ideas

21. Discussing the Study Protocol

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

23. 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

24. 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

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