Engaging Patients and Other
Stakeholders in Clinical Research
Kim Bailey
Engagement Officer
Health Action 2015
1/24/2015
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Objectives for Today
What is PCORI?
What is PCOR?
Why patients and family members should be
engaged in research?
How we engage patients, family members, and
other stakeholders in research?
About PCORI
We are an independent research institute
that was authorized by Congress in 2010
We fund comparative clinical
effectiveness research (CER) that
engages patients and other stakeholders
throughout the research process
We seek answers to real-world questions
about what works best for patients based
on their circumstances and concerns
Why PCORI?
For all the advances it
produces, research still
has not answered many
questions patients face
People want to know
which treatment is best for
them
Patients and their
clinicians need information
they can understand and
use
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Our Mission
PCORI helps people make informed health care decisions,
and improves health care delivery and outcomes, by
producing and promoting high integrity, evidence-based
information that comes from research guided by patients,
caregivers and the broader health care community.
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Our Broad and Complex Mandate
“The purpose of the Institute is to assist
patients, clinicians, purchasers, and policymakers in making informed health
decisions by advancing the quality and
relevance of evidence concerning the manner
in which diseases, disorders, and other health
conditions can effectively and appropriately be
prevented, diagnosed, treated, monitored, and
managed through research and evidence
synthesis...
… and the dissemination of research
findings with respect to the relative health
outcomes, clinical effectiveness, and
appropriateness of the medical treatments,
services...”
-- from PCORI’s authorizing legislation
What is Patient-Centered Outcomes
Research?
Helps people and their families communicate and make
better-informed healthcare decisions
Actively engages patients and other key stakeholders
throughout the research process
Compares the effectiveness of important clinical
management options
Evaluates the outcomes that are the most important to
patients and families
Addresses implementation of findings in real life clinical
environments
Snapshot of Funded Projects
Number of projects:
360
Amount awarded:
$671 million
Number of states where
we are funding research:
39 (plus the District of Columbia
and Quebec)
As of September 30, 2014
The Research We Fund is Guided by Our
National Priorities for Research
Assessment of
Prevention, Diagnosis,
and Treatment Options
Improving
Healthcare Systems
Addressing
Disparities
Communication &
Dissemination
Research
Accelerating PCOR
and Methodological
Research
We Focus Attention On…
Conditions
• Conditions that affect large numbers of people across
a range of populations
• Conditions that place a heavy burden on individuals,
families, specific populations, and society
• Rare diseases, which are difficult to study
Populations
•
•
•
•
Racial and ethnic minorities
Older adults
Low-income and rural populations
Children
We Follow a Unique Proposal Review
Process
Applications are reviewed against five criteria:
Impact of the condition on the
health of individuals/populations
Potential for the study to improve
healthcare and outcomes
Technical merit
Patient-centeredness
Patient and stakeholder
engagement
• Applications are reviewed by
a panel of two scientists, one
patient, and one other
stakeholder
• PCORI’s Board of Governors
makes funding decisions
based on merit review and
staff recommendations
We Require Patient-Centeredness and
Patient and Stakeholder Engagement
Patient-Centeredness
Does the project aim to answer questions or examine outcomes
that matter to patients within the context of patient preferences?
Research questions and outcomes should reflect what is important
to patients and caregivers
Patient and Stakeholder Engagement
Patients are partners in research, not just “subjects”
Active and meaningful engagement between scientists, patients,
and other stakeholders
Community, patient, and caregiver involvement already in
existence or a well-thought out plan
Engagement as a Path To Useful,
High-Quality Research
Proposal Review;
Design and Conduct
of Research
Topic Selection
and Research
Prioritization
ENGAGEMENT
Evaluation
Dissemination and
Implementation of
Results
Who Are Our Stakeholders?
Patient/
Consumer
Purchaser
Caregiver/
Family
Member
of Patient
Payer
Clinician
PCORI
Community
Patient/
Caregiver
Advocacy
Org
Industry
Hospital/
Health
System
Policy
Maker
Training
Institution
Engagement Goals
Build a patient-centered outcomes
research, or PCOR, community
Engage the PCOR community in research
Promote dissemination and
implementation of PCOR research findings
Engagement in Research
PCORI encourages awardees to engage
patients and other stakeholders at every stage of
their project
• Planning the study
• Conducting the study
• Disseminating study results
PCORI encourages creativity and innovation in
engagement
Spectrum of engagement: from subject to co-PI
Engagement should fit the project aims and
objectives
The 5 Ws & H of Engagement
Why engage?
Who to engage?
What to engage around?
When to engage?
Where to find patients and stakeholders to
engage?
How to engage?
Engagement Rubric
PCORI has developed a four-part Engagement Rubric to provide
guidance to applicants, merit reviewers, awardees, and
engagement/ program officers regarding engagement in the
conduct of research
Planning the Study: How patient and stakeholder partners
will participate in study planning and design
Conducting the Study: How patient and stakeholder partners
will participate in the study conduct
Disseminating the Study Results: How patient and
stakeholder partners will be involved in plans to disseminate
study findings, and ensure that findings are communicated in
understandable, usable ways
PCOR Engagement Principles: Reciprocal Relationships;
Co-learning; Partnership; Trust, Transparency, Honesty
Find Us Online
www.pcori.org
Thank You
Kim Bailey
Engagement Officer
kbailey@pcori.org
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