NEW METHODS FOR PARTICIPATORY
COMMUNITY-BASED INTERVENTION
RESEARCH –
HOW CAN WE DEVELOP A
SYSTEMATIC UNDERSTANDING OF
CHANGE THAT MATTERS?
Bruce D. Rapkin, PhD
Professor of Epidemiology and Population Health
Division of Community Collaboration and Implementation Science
Albert Einstein College of Medicine
Conclusions
• Participatory models of intervention research are
superior to top down models.
• Scientific rigor does not equal the randomized
controlled trial.
• Communities of shared interest must form around
Learning Systems - with successive studies leading to
refinement of key distinctions among interventions, types
populations and settings
• Comprehensive dynamic trials are intended to support
the learning system, by inventing and evolving
interventions in place, drawing upon multiple sources of
information gained during the conduct of an intervention.
Why do we need alternatives to the
Randomized Clinical Trial model?
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The community argument
The business practices argument
The statistical argument
The scientific argument
The psychological argument
Community-Academic Relationships
Imposed by the Medical Model
• Funders resist changing interventions promoted as
national standards (despite absence of external validity)
• Communities must figure out how to fit themselves to the
program – the program dictates the terms
• What communities know about prevention or engaging
clients is only relevant if it pertains to the manual
• A tightly scripted protocol does not respond to
collaborators’ circumstances
• Danger that lessons learned will be framed as “what the
community did wrong to make the program fail”
• Unwillingness to consider limits of research theories and
methods, local problems will remain unsolved
Is this any way to run a
business?
• Businesses including clinics examine their
practices continually to seek improvements
• Research protocols are designed to resist or
restrict change over the course of a study, to
ensure “standardization”
• Lessons learned must be “ignored” until the next
study
• Valuing fidelity over quality impedes progress to
optimal intervention approaches
What is a “Treatment Effect”?
• The RCT is designed to determine an
estimate of a population “treatment effect”
• Is the “treatment effect” a useful
construct?
– How is the effect determined by the initial
composition of the sample?
– Is information beyond aggregate change error
variance or meaningful trajectories?
– How does the control condition determine the
effect’? Is this ignorable?
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Does a Successful RCT Mean that
Faithful Replication of an
Intervention will Ensure Outcomes?
• Not necessarily because…
– Original RCT findings do not generalize to a
“universe” – too dependent on context
– Mechanics of interventions have different
implications, depending on setting norms
– Even the meaning & impact of core elements
may be transformed by local ecology
• We don’t know because of the lack of
attention to external validity!
Desirable Features for Study Designs
• Must take into account diversity inherent in the
determinants of health and risk behavior
• Must recognize that different people can respond to the
same intervention in different ways, or in the same way
for different reasons
• Must accommodate diversity and personal preferences
• Must avoid ethical dilemmas associated with
substandard treatment of some participants
• Must be responsive to evolving understanding of how to
best administer an intervention, and to local innovations
and ideas
• Must contribute to community capacity building and
empowerment at every step of the research process
The Research Paradigm
We Need…
• A Learning System
• A Community Science = A “WIKI”
• Who has input
– True integration of multiple methods and perspectives
• Who makes decisions?
– The peer review process
– The community review process
• Progress toward adequate intervention theory
and practice can be quantified
We have (some of)
the building blocks
But bridges are always built
Somewhere -
Comprehensive Dynamic
Trials Designs
• Comprehensive => use complete
information from multiple sources to
understand what is happening in a trial
• Dynamic => built-in mechanisms for
feedback to respond to different needs
and changing circumstances
• Trials => Systematic, replicable activities
that yield high quality information useful for
testing causal hypotheses
The Multi-way Decision Matrix
What outcomes
distinct are
associated with
different
intervention
approaches?
Oipc|t
How do characteristics of
target population affect
outcomes?
The conditional
probability
of an outcome,
for this type of
intervention with
this population in
this context, given
what is known at
the present time.
How are outcomes
affected by history,
resources, and
contexts?
Three CDT Designs
• Community Empowerment to enable
communities to create new interventions
• Quality Improvement to adapt existing
manuals and procedures to new contexts
• Titration-Mastery to optimize algorithms for
delivering a continuum of services
Rapkin & Trickett(2005)
CDT Community
Empowerment Design
• Closest to the “orthodox” model of CBPR
– No pre-conceived “intervention”
– No need for externally-imposed explanation of
the problem or theory of change
• Common process of planning
• Common criteria for evaluating
implementation across multiple settings
and/or multiple “epochs”
CDT Quality
Improvement Design
• Starting point
– An evidence-based intervention
– A established standard of practice
– An innovation ready for diffusion
• Alternative to the traditional “top-down”
model of intervention dissemination
• Begin with a baseline intervention, then
systematically evolve and optimize it
CDT Titration to
Mastery Design
• Suited to practice settings committed to
the client/patient/participant
• Does NOT ask about intervention effects?
• Rather, asks what combination of
interventions will get closest to 100%
positive outcome most efficiently?
• Begins with a tailoring algorithm to
systematically apply a tool kit, which is
then evolved and optimized
Ingredients of a
Comprehensive Dynamic Trial
Just add community and stir…
How does the CDT
Feedback Loop Work?
What Types of Data Are Needed?
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Outcome Indicators
Fidelity
Mechanistic Measures
Intervention Processes
Structural Impediments
Adverse Events
Propitious Events
Context Measures
The Deliberation Process
• Key stakeholders should be involved in
deliberation
• Research systematically provides data to
stakeholders to make decisions about how to
modify and optimize interventions
• Timing is based upon the study design
• The nature and extent of changes should be
measurable, and expressed in terms of
intervention components and procedures
• Deliberation process should be bounded by
theory
Ethical Principles –
Lounsbury et al.
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Transparency
Shared Authority
Specific Relevance
Rights of Research Participants
– Self-Determination
– Third-Party Rights
– Employees’ Rights
• Privacy
• Sound Business Practice
• Shared Ownership
A Model for Maximizing Partnership Success: Key Considerations
for Planning, Development, and Self-Assessment – Weiss et al.
Composition, Structure
and Functions
Characteristics of
the Group Process
Environmental Factors
Intermediate
Indicators of
Partnership
Effectiveness
Development &
Implementation of
Programs & Activities
Outcome Indicators of
Partnership Effectiveness
A CDT-QI Model to
Disseminate an EvidencedBased Approach to Promote
Breast Cancer Screening
The Bronx ACCESS Project
The Albert Einstein Cancer Center
Program Project Application Under Development
Exchange of Information Among ACCESS
Projects & Research Cores
a
Project 3. Academic
Consultation to Build
Organizational
Capacity, Competence
and Commitment
b
f
Project 1. Reach
and Effectiveness of
Adapted Strategies
for BrCa Screening
i
d
g
Data
Acquisition
&
Geospatial
Core
e
c
h
j
Project 2.
Community
Involvement in
Intervention
Adaptation
k
m
l
n
Lay Health
Advisors
Core
Intervention
Core
o
Statistical
Analysis &
Modeling
Core
Schema for the Bronx ACCESS Plus
Comprehensive Dynamic Trial
CBPR Repeated Over Multiple Cycles to Optimize Performance and
Outcomes in Different Settings
C
o
n
t
e
x
t
s
Program
Implementation
Intervention
Components
Performance
Deliberation
Processes
Research
Staff
Support
Agency
Leadership
& Staff
Community
Stakeholders
Screening
Outcomes
Changing the Rules to Conduct
Research in the Real World
• How to incorporate local input in an evidence
based paradigm?
– Solution: Fidelity gets a vote, but not a veto
• How to deal with cultural and risk specificity of
mammography screening interventions?
– Solution: disseminate a “suite” of theoretically
equivalent strategies as a tool kit
• How to address agencies’ many priorities?
– Solution: Encompass these as “community targeted
strategies” for outreach & retention
How Do You Get
Science Out of
All That Data?
In Any One CDT …
• Analyses are intrinsic to intervention
• The program should get better as it goes along
• Experimental effects may be examined in context
• Particularly interested in accounting for diverse
trajectories and patterns of responses
• Ability to steer toward optimal intervention components
• Case study of community problem solving
• Able to examine setting impacts, sustainability
The Real Payoff – Science
as a Community Process
The Epistemology of CDT
• A Community Science = A “WIKI”
• A learning system
• Who has input
– True integration of multiple methods
• Who makes decisions?
– the peer review process
• Progress toward theory development can be
quantified
• Theory can be (provisionally) completed
The Multi-way Decision Matrix
What outcomes
distinct are
associated with
different
intervention
approaches?
Oipc|t
How do characteristics of
target population affect
outcomes?
The conditional
probability
of an outcome,
for this type of
intervention with
this population in
this context, given
what is known at
the present time.
How are outcomes
affected by history,
resources, and
contexts?
Wiring Up the Decision Matrix:
Systems Dynamics? Neural Networks? Genetic
Algorithms?
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2
1) An intervention
3
Tx
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5
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2) experienced
by different
people
4) may lead
to different
outcomes.
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3) in different
contexts
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ARROWS indicate probabilistic pathways Oipc|t at time T
Scientific Enterprise Needed to
Support this paradigm
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Evaluation for funding will consider soundness of
researchers’ relationships with communities
Multiple sources of data will gain importance
Emphasis on practice-based evidence
Case studies of planning, decision making and
community involvement will be highly important
Awareness that results depend on context, so a single
trial will not receive undue weight
Investigators will work in tandem to create service
suites and knowledge bases
Meta-analysis will grow more important, as a way of
integrating multiple types of studies
Where’s the Science?
• In community process.
• In understanding how researchers’ roles
and activities impact CBPR.
• In the evolution and refinement of
intervention implementation strategies,
through dynamic exchange and reflection.
• It emerges out of the synthesis of CBPR
findings
Conclusions
• Participatory models of intervention research are
superior to top down models.
• Scientific rigor does not equal the randomized
controlled trial.
• Communities of shared interest must form around
Learning Systems - with successive studies leading to
refinement of key distinctions among interventions, types
populations and settings
• Comprehensive dynamic trials are intended to support
the learning system, by inventing and evolving
interventions in place, drawing upon multiple sources of
information gained during the conduct of an intervention.
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New Methods For Participatory Community