Transcript Slide 1

Opportunities &
Challenges for
Comparative
Effectiveness Research
Engaging the Community to Enhance CER
Lucy A. Savitz, Ph.D., MBA
January 26, 2009
[email protected]
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Objectives
 Participants will acquire a foundational knowledge
of the policy implications and priorities for CER in
the U.S.
 Participants will be familiarized with the various
steps across the research process--from
development/design through dissemination--and
strategies for actively engaging in CER activities
 Participants will be provided with resources to
support active engagement in CER.
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Value to Clinical Researchers
Clinicians represent a vital community to actively
engage in comparative effectiveness research
(CER) for
3 primary reasons:
1. the quality of the CER is enhanced (meeting real
clinical needs/priorities), strengthening the
evidence base for practice;
2. there is direct translation of the research into
practice; and
3. they see the direct utility of CER results.
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Institute of Medicine (IOM) Report
Released June 30, 2009
The purpose of CER is to
assist
consumers,
clinicians,
purchasers, and
policy makers
to make informed decisions
that
will improve health care at
both
the individual and population
levels. (CER)
Comparative Effectiveness Research
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IOM’s CER Working Definition
 CER is the generation and
synthesis of evidence that
compares the benefits and harms
of alternative methods to prevent,
diagnose, treat, and monitor a
clinical condition or to improve the
delivery of care.
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100 Research
Priorities Identified
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CER Challenges
 Which questions are most appropriately
answered by trials vs. which ones are best
answered via observational study design?
 How do observational studies extend RCTs?
 What are the core team credentials & strategic
issues required for winning awards?
 Can we enhance the evidence base?Knowing
What Works in Health Care (www.nap.edu)
 What do various “community” members want and
need to know?
 How do we effectively engage the “community?”
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What is a “Community?”
 A group of people linked by social ties who share
common perspectives or interests, and may also
share a geographic location (MacQueen et al)
 Examples of communities
• Utah County residents
• Somali immigrants
• Persons with AIDS
• Primary care physicians in Southern Utah
• And many others….
 Communities are not homogeneous and seldom
speak with a single voice
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CER Funding to Date
 Omnibus Appropriations Act, 2009
$50 million to AHRQ
 American Recovery and Reinvestment
Act (ARRA) of 2009 $1.1 billion
• $300 million for AHRQ
• $400 million for NIH
• $400 million to Secretary
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Funding Mechanisms
 Investigator Initiated
 Indefinite Delivery/Indefinite
Quantity (IDIQ) or Master Task
Orders
• DEcIDE
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DEcIDE (Developing Evidence to
Inform Decisions about
Effectiveness) Network
 University of Colorado Center for
Health Outcomes is prime
 AHRQ has indicated that they will
distribute the bulk of CER $ via
DEcIDE
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Rocky Mountain Center for CER
 University of Utah--CCTS CE
 Intermountain Healthcare
 SLC VA Medical Center
 University of Colorado
 Denver Health
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Clinical Translational Science Award or
CTSA http://www.ctsaweb.org/
 Funded by National Institutes of Health (NIH)
 46 medical institutions in 26 states
 University of Utah Center for Clinical &
Translational Science (CCTS)
•9 Core areas:
Administration; Novel Clinical & Translational Methods; Biomedical
Informatics; Biostatistics; Participant & Clinical Interactions; Patient Care;
Community Engagement; Translational Technologies & Resources;
Research Education, Training & Career Development
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CTSA Purpose
To improve the way biomedical
research is conducted
nationwide.
Consortium members share a
common vision to reduce the
time it takes for laboratory
discoveries to become
treatments for patients, to
engage communities in clinical
research efforts, and to train
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CE Core: Primary Functions
Serve as:
•
•
•
Collaboration liaison
Knowledge connector (bidirectional exchange)
Outreach service
GIVE ME A PLACE TO STAND AND I WILL MOVE THE EARTH
A remark of Archimedes quoted by Pappus of Alexandria
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CCTS
Community Engagement (CE) Core
 Leadership
• Lucy Savitz, Ph.D., MBA, Director
• Louisa Stark, Ph.D., Associate Director
• Steve Alder, Ph.D., Technical Advisor
 Leveraging resources to support
participatory research and training
 Annual pilot projects & administrative
supplements
 Creation of the Rocky Mountain
Center for Comparative Effectiveness
Research
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National CTSA KFCs:
Rocky Mountain Center for Comparative
Effectiveness Research (RMCCER)
CE KFC
Community Partners Integration
Outcomes of CE
Educational Competencies
CTSA Strategic Goal 4a & 4b
Other
CCTS
Cores
National
CTSA
Service
AHRQ
ACTION
Denver
VAMC
Local
Consults/
Mentoring
CCTS
CE
Core
COHO
RMCCER
Knowledge
Exchange
Intermountain
Community
Reps
Denver
Health
CO
CTSI
AHRQ
DEcIDE
SLC
VAMC
Org
Community
COHO: Colorado Health Outcomes Program, University of Colorado at Denver
KFC: Key Function Committee
VAMC: Veterans Affairs Medical Center
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A regional, multi-state consortium of vertically integrated health care
organizations and translational research programs designed to leverage
state-of-the-art, existing QI and HIT capacities to support a collective goal
of collaborative, comparative effectiveness research in diverse
populations, health care settings, and information technology environments;
actively bridging the participatory research perspective with:
• state-of-the-art technology and
•scrupulous adherence to rigorous application & advancing CER methods.
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CCTS Community Engagement 2010 Goals
1.
Serve as a connector to bring together academic, institutional,
governmental and community organizations that are working on
complementary programs; submit at least one application for
external funding to support this work.
2.
Continue to build and sustain our regional CTSA collaboration
via RMCCR; produce at least two funded projects and two
manuscripts submitted for publication.
3.
Actively contribute to national CTSA activities via Key Function
Committee participation and attendance at national and regional
meetings.
4.
Measurably provide consultation and technical assistance for
translational research related to bi-directional community
engagement.
5.
Work with communities to identify meaningful and valuable
knowledge exchange opportunities; implement at least 2 of
these “events”.
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Research Training Resources
 CER Certificate at the University of
Utah (forthcoming)
 K award proposal submitted by Carrie
Byington (pending)
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Why are we talking about “community
engagement?”
 Deficiency in traditional
research approaches
 ~98% of Americans receive
their health care outside of
academic medical centers
 The challenge of
“translational research”
• How to reach Dr. Smith and Billy in
Delta, UT?
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The Translational Research Continuum
“Bench”
Basic
Biomedical
Discovery
What is the effect
on population health?
(Outcomes research)
What works under
controlled conditions?
(Up to phase III trials)
T1
Community
Practices
Clinical
Efficacy
T2
T4
Clinical Practice
“Bedside”
T3
How can we
change practice?
(Dissemination and
Implementation Research)
What works in
real world settings?
(e.g., Comparative
Effectiveness
Research)
Clinical
Effectiveness
Community
Practices
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“Community engagement” as a key
component of translational research
 How to reach Dr. Smith
and Billy?
• Include them in the research
process
 The NIH response
• Roadmap, CTSA, etc.
 Issues arise…
• The ethics of conducting
research in communities e.g., who benefits? unique
needs/requirements?
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What is “Community Engagement”?
…community engagement is a process of
inclusive participation that supports mutual
respect of values, strategies, and actions for
authentic partnership of people affiliated with or
self-identified by geographic proximity, special
interest, or similar situations to address issues
affecting the well-being of the community of focus.
NIH Council of Public Representatives, October 2008
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Unpacking Community Engagement…
 A broad framework that includes the full
spectrum of approaches that involve the
community in the research process
• Includes research ranging from that which
incorporates only a few elements of community
engagement with minimal collaboration to research
in which community organizations and researchers
are equal partners throughout the process
 Builds on community strengths
 Emphasis on partnerships and collaboration
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Traditional Research Approach
Researcher or funding source identifies problem
Researcher writes protocol, selects
community to be studied, obtains funding
Researcher recruits subjects from the community
Researcher collects and analyzes data
Researcher writes article, obtains academic
rewards, thanks community (sometimes)
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Community-engaged Research Approaches
COMMUNITY
Problem identified of interest and relevance to the community
Protocol tailored to specific community of interest,
funding obtained and shared as appropriate
Community members are participants in research, not just subjects
Data analyzed and collected with community input as appropriate
Results disseminated to both the academic
world and the community
Studies that recruit subjects in community
settings are not necessarily community-engaged
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Examples of community-engaged
research approaches
 Identifying research topic
• Community members or researcher may make the initial
approach
• Example – chronic pain in Native Americans
• Researcher and community may work together to refine
 Plan developed and funding secured
• Researcher contributes scientific expertise
• Community also contributes;
• Ideas on logistics and recruitment
• Advice on tailoring for community context
• Community receives research funds as appropriate
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Examples of community-engaged
research approaches
 Study conduct
• Community members involved as appropriate
• e.g., hire study staff
• Promote study within the community
• Advice on study problems
 Data analysis and reporting
• Involvement of community as appropriate
 Dissemination of results to the community and to
the academic world
• Community determines appropriate/relevant media for their
members
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Community-based Participatory Research
(CBPR)
 One end of the community-engaged research
spectrum
 Equitable partnership between researcher and
community in all research phases
 Community identifies the problem to be addressed
 Aims at achieving meaningful changes that will
directly improve community health
 Requires major investments of time and energy in
building the relationships necessary for successful
partnerships
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Challenges of community-engaged
research approaches
 Requires considerable investment of time and
energy to build relationships
• And any relationship has high and low points….
• Trust is essential
 Community priorities may not reflect your research
priorities
 Community may have little capacity/experience
with research and follow a different timeline
 Funding mechanisms/study sections may be
unfamiliar with these approaches
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Benefits of community-engaged research
approaches
 Can improve reliability and validity of
study tools and procedures
 Helps recruitment and study flow
 Results more likely to be relevant
 May improve external validity
 Minimizes translation burden
 Expanded opportunities for funding
• NIH expanding RFAs
• Foundation funding
 Relationships have their own rewards
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Successful Community-engaged
Researchers…
 View community partners as knowledgeable
and important contributors to research
 Acknowledge that they and community members bring
their own beliefs to research
 Think that the beliefs and values of community
members should be recognized
 Value relationships with the community as one of
the benefits of research
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Value of Research Partnerships
 Research partnerships can engage multiple
entities to enhance the generalizability and
potential for modeling and spread of results.
 Successful partnerships are engaged beyond a
one-time research opportunity and are able to
keep the flame of change burning and build a
critical mass for change
 Interaction & engagement is bi-directional
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Definitions
 Research partnerships are broadly defined to
include inter-organizational relationships where
resources are shared to advance a collective
purpose—in this case, applied, participatory
research.
 Participatory research then “… is an approach
that involves all potential users of the research
and other stakeholders (as partners)
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Foundation for Participatory Research
 The rich tradition of participatory research is
anchored in community development and since
the mid1960s, has been embraced in
• social, educational, health services, and public health
research.
 Therefore, the literature or evidence base for
participatory research is dispersed
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Organizational-Based Participatory Research
(OBPR)
 a subset of CBPR
 OBPR is distinctly culled out to describe
collaborative work among organizational research
partners are engaged around a shared problem or
goal to improve the quality of care and, ultimately,
patient outcomes.
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Framework for Assessing Partnership Strength
Leadership &
Management
Critical
Characteristics
of the Process
•Individual
Empowerment
•Social Capital
•Synergy
Collaborative
Problem
Solving
Learning from
Demonstrated
Research
Endeavors that
Generate Evidence
Mapping Organizational Needs to
Identified Collaborative Projects
Adapted from RD Lasker & ES Weiss, Journal of Urban Health, 2003—Model of
Community Health Governance
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Evidence: Knowledge that is…
 Explicit (codified)
 Systematic (with transparent &
explicit methods)
 Replicable
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Framework for the Continuum of
Translational Research
seeks to move a basic science discovery into a
candidate health application
T1
T2
assesses value of application for health
practice leading to development of EB
guidelines
T3
attempts to move EB guidelines into
health practice
T4
assesses "real world" health
outcomes of application in practice
Increasing community
engagement
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Conducting real-world, CER that engages the
community.
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