Advancing stated-preference
methods for measuring the
preferences of patients with type 2 diabetes
Second DAB Meeting
November 20, 2014
Baltimore, MD
How do we engage patients
and the community?
Second DAB
meeting
November 20, 2014
Johns Hopkins Bloomberg School of Public Health
Section Outline
•  What does PCORI view as engagement
- Bridges
•  Patient and Stakeholder Engagement
- Bone & Evans
© 2014, Johns Hopkins University. All rights reserved.
What does PCORI view as
engagement?
John F.P, Bridges, PhD
Principle Investigator
Associate Professor
Department of Health Policy and Management
Johns Hopkins Bloomberg School of Public Health
PCORI Vision and Mission
Patients and the public have information they can use to
make decisions that reflect their desired health outcomes.
- PCORI vision
PCORI helps people make informed healthcare decisions,
and improves healthcare delivery and outcomes, by
producing and promoting high-integrity, evidence-based
information that comes from research guided by patients,
caregivers, and the broader healthcare community.
- PCORI mission
© 2014, Johns Hopkins University. All rights reserved.
What is PCOR
“Research that helps patients “make informed healthcare
decisions, [while] allowing their voices to be heard in
assessing the value of healthcare options.”
- PCORI, working definition of PCOR
“When assessing potential beneficial and harmful effects,
patient-relevant endpoints and not their surrogates (i.e.
disease-relevant aspects) should primarily be taken into
consideration.”
- IQWiG Methods (2005)
© 2014, Johns Hopkins University. All rights reserved.
PCOR Research Questions
This research answers patient-centered questions such as:
1.  “Given my personal characteristics, conditions and
preferences, what should I expect will happen to me?”
2.  “What are my options and what are the potential
benefits and harms of those options?”
3.  “What can I do to improve the outcomes that are most
important to me?”
4.  “How can clinicians and the care delivery systems they
work in help me make the best decisions about my
health and healthcare?”
© 2014, Johns Hopkins University. All rights reserved.
PCOR Strategies
•  Assess the benefits and harms of preventive,
diagnostic, therapeutic, palliative, or health delivery
system interventions to inform decision making,
highlighting comparisons and outcomes that matter
to people
•  Include an individual’s preferences, autonomy and
needs, focusing on outcomes that people notice and
care about
•  Incorporate a wide variety of settings and diversity of
participants to address individual differences and
barriers to implementation and dissemination
•  Investigate (or may investigate) optimizing outcomes
while addressing burden to individuals, resource
availability, and other stakeholder perspectives
© 2014, Johns Hopkins University. All rights reserved.
Patient and Stakeholder
Engagement Lee Bone, MPH, RN
Associate Professor
Health Behavior and Society
Crystal Evans, MS
Community Engagement
Program Manager
Johns Hopkins Institute for
Clinical and Translational
Research
Johns Hopkins Bloomberg School of Public Health
Outline This presentation will focus on
–  Brief overview of Community Based Participatory
Research (CBPR)
–  Advancing patient and stakeholder Engagement
(PCORI)
–  Activities and contributions of local advisory
boards (C-RAC)
© 2014, Johns Hopkins University. All rights reserved.
Brief overview of Community
Based Participatory Research
(CBPR)
CBPR Definition
“A collaborative approach to research that equitably
involves all partners in the research process and
recognizes the unique strengths that each brings”.
--W.K. Kellogg Foundation (2001)
© 2014, Johns Hopkins University. All rights reserved.
What CBPR is NOT
1.  “Community-placed” research
2. 
Sporadic or symbolic inclusion of communities
3. 
Basic research
© 2014, Johns Hopkins University. All rights reserved.
CBPR Characteristics 1. 
2. 
3. 
4. 
5. 
Collaborative, equitable partnership in all phases of
research
Community is the unit of identity
CBPR builds on strengths and resources of
community
CBPR fosters co-learning and capacity building
Balance between knowledge generation and
benefit for community partners
© 2014, Johns Hopkins University. All rights reserved.
CBPR Characteristics (cont..)
6. 
7. 
8. 
CBPR focuses on problems of local relevance
CBPR disseminates results to all partners and
involves them in wider dissemination of results
CBPR involves a long-term process and
commitment to sustainability
Israel, Eng, Schulz, & Parker (2005). Introduction to Methods in
Community-Based Participatory Research for Health. In Methods in
Community-Based Participatory Research for Health.
© 2014, Johns Hopkins University. All rights reserved.
Rationale for Conducting CBPR
1. 
2. 
3. 
4. 
5. 
CBPR can support the development of research
questions that reflect health issues of real concern
to community members
CBPR joins together partners with diverse skills,
knowledge, and expertise
CBPR can enhance the capacity of all partners
CBPR can provide funding and employment
opportunities for community partners
CBPR can improve cultural sensitivity and the
reliability and validity of measurement tools
© 2014, Johns Hopkins University. All rights reserved.
Rationale for Conducting CBPR
(cont…)
6. 
7. 
8. 
9. 
CBPR can improve recruitment and retention efforts for
research studies
CBPR can increase the relevance of intervention
approaches and the likelihood of their success
CBPR can help increase accuracy and cultural
sensitivity in the interpretation of research findings
CBPR can increase the relevance and usefulness of
research findings
-Minkler (2005)
© 2014, Johns Hopkins University. All rights reserved.
Questions and Concerns
© 2014, Johns Hopkins University. All rights reserved.
Advancing Community
and
Stakeholder Engagement (PCORI) Patient Engagement • 
• 
• 
• 
Who are the relevant patients for engagement?
How to identify and recruit them?
How can they engage?
How can their engagement result in changes in research
design, conduct, analysis and dissemination?
- Mayo Clinic
© 2014, Johns Hopkins University. All rights reserved.
Additional Questions •  What is authentic/meaningful patient engagement?
•  How do you maximize and sustain patient engagement?
•  How are researchers using the feedback from patients as
a way to both clarify and prepare for dissemination?
•  What methods do you use to evaluate patientcenteredness?
- L.Bone Questions
© 2014, Johns Hopkins University. All rights reserved.
PCORI Standards
Pa$ent-­‐centered does not always mean pa$ent reported Clinical outcomes are not always pa$ent-­‐centered Objec$ve measures vs. symptoms Link pa$ent-­‐centeredness to the decision-­‐making process Data must be meaningful and interpretable to pa$ents Meaningfulness needs to be defined Dissemina$on and implementa$on plans are crucial Primary preven$on and self-­‐care should be considered Caregiver burden should be addressed Researchers need training on how to engage (i.e., complete online module in understanding PCOR) Do research par$cipants understand what the research is about? Evalua$on of the engagement Resource intensive nature PCORI Principles: Workshop on Incorpora-ng the Pa-ent Perspec-ve into Pa-ent-­‐Centered Outcomes Research hKp://www.pcori.org/sites/default/files/Workshop-­‐on-­‐Incorpora$ng-­‐the-­‐Pa$ent-­‐Perspec$ve-­‐into-­‐PCOR1.pdf © 2014, Johns Hopkins University. All rights reserved.
PCORI Engagement Challenges • 
• 
• 
• 
• 
Impediments to ‘two-way learning’
Dissemination
Impact on the greater population
Bias
Communication and transparency with study participants
and affected communities
•  Level of specificity of the standards is limited due to a
lack of knowledge
•  Limited evidence
•  Principal investigator acceptance/understanding
Targeting the population
© 2014, Johns Hopkins University. All rights reserved.
PCORI Considerations •  Who to engage?
•  How do you build trust and culturally sensitive strategies
for engagement/interventions?
•  How do you assure privacy and confidentiality?
•  What are the training needs?
© 2014, Johns Hopkins University. All rights reserved.
Soliciting Patient Views •  Patient involvement
•  Patient stakeholder and advocacy groups
•  Broadly and inclusive stakeholder boards in which
patients serve as members of the board
•  All through the phases of the research including:
developing the research question, planning the project,
project implementation plan and evaluation,
dissemination, and building for sustainability
•  in depth interviews
•  Focus groups
•  Forums
© 2014, Johns Hopkins University. All rights reserved.
Consequences of Patient Engagement •  Improved relevance of the research results to
patients
•  Improved research recruitment and retention rates
•  Improved construct and content validity
- JAMA 2014
© 2014, Johns Hopkins University. All rights reserved.
Negative Consequences of
Patient Engaged Research •  Added financial and staff resources necessary to
establish and maintain engagement
•  Perceived work burden among patient participants
- JAMA 2014
© 2014, Johns Hopkins University. All rights reserved.
Ideas and Suggestions on How Best
to Contribute to this Discourse on
Patient Engagement?
© 2014, Johns Hopkins University. All rights reserved.
Activities and contributions of
local advisory boards (C-RAC)
Community Research Advisory
Council •  The Community Research Advisory Council’s (C-RAC)
East Baltimore Medical Campus Chapter was
established in 2009.
•  The C-RAC leads projects that promote the trust,
understanding and involvement of the Greater Baltimore
community in research activities and educates
researchers about community priorities.
•  Members volunteer to serve on one (or more) of the
following committees: Board Development, Community
Education and Research Review.
© 2014, Johns Hopkins University. All rights reserved.
Research Participant and Community
Partnership Core – Vision Statement •  Ensure that the communities both inside and outside of Johns
Hopkins understand and value the critical contribution made
by research participants and community partners. We
promote:
•  Efficient and effective stakeholder engagement
•  Recruitment and retention of diverse communities of research
participants
•  The safe and ethical conduct of research
© 2014, Johns Hopkins University. All rights reserved.
DAB C-RAC Subcommittee Members • 
• 
• 
• 
• 
• 
• 
Barbara Bates - Community Engagement Coordinator,
Johns Hopkins Center in Urban Environmental Health;
Environmental Justice Partnership
Roger Clark, MBA - Medical Home Group, Inc
Crystal Evans, MS - Community Engagement Program
Manager, Johns Hopkins Institute for Clinical and
Translational Research
Charlotte Johnson - President, Ashland Commons
Tenants Council
Tracy Newsome - American Diabetes Association
Inez Robb, Chair - Baltimore City Police Department
Community Affairs Committee
Patricia Tracey- Community Engagement Coordinator,
Johns Hopkins Center in Urban Environmental Health;
Environmental Justice Partnership
© 2014, Johns Hopkins University. All rights reserved.
Activities and Contributions of
the C-RAC
•  Proposal preparation
•  Formation of C-RAC Diabetes subcommittee
•  Research team and subcommittee meetings (July and September
2014)
•  White Paper and lay summary review
•  Presentation and discussion of case study on patient
centered research project/Duchene’s Muscular Dystrophy
•  Development of an MOU describing roles and responsibilities of
research team and C-RAC subcommittee
•  Recruitment planning for focus groups
•  Recruitment activities and feedback of successful recruitment
(weekly subcommittee meetings)
•  Developing dissemination plans (focus group manuscript, lay
summary describing focus group findings)
© 2014, Johns Hopkins University. All rights reserved.
Sources Hosted By The Patient-Centeredness Work Group, Of The PatientCentered Outcomes Research Institute, and Methodology Committee.
Workshop on Incorporating the Patient Perspective into PatientCentered Outcomes Research. Patient Centered Outcomes Research
Institute, 6 Mar. 2012. Web. 10 Nov. 20.
–  hKp://www.pcori.org/sites/default/files/Workshop-­‐on-­‐
Incorpora$ng-­‐the-­‐Pa$ent-­‐Perspec$ve-­‐into-­‐PCOR1.pdf JAMA: The PCORI Perspective on Patien- Centered Outcomes
Research
–  hKp://jama.jamanetwork.com/ar$cle.aspx?
ar$cleid=1901303 © 2014, Johns Hopkins University. All rights reserved.