Research Translation: General Introduction

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Research Translation General Introduction

• Marcia Ory
• March 20, 2008

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Topics/Activities for Today

• Translational research concepts and examples
• Revisiting RE-AIM model
• Class questions
• Class exercise

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What is Translational Research?
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What is the Popular Usage

• Google Translational Research Images
• Almost 3000 entries
• Confirms wide-spread use of term
• Shows different perceptions and uses

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Translational Research

• Translational research is the application of
  discoveries from basic biomedical and behavioral
  research toward the diagnosis, treatment or
  prevention of human disease, with the ultimate
  goal of improving public health (NIH)
• Translational research focuses on the testing the
  application of evidence-based research to real
  world settings (RWJF).

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Translational Research

• From bench to bedside
• From bedside to community

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Translational Research

• The transition from research to practice
• Applies basic science (laboratory or social
  science) in the development and implementation of
  an intervention or treatment.
•  

Prohaska, UIC School of Public Health
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Re-engineering the Clinical Research
EnterpriseTranslational Research

• Scientific discoveries must be translated into
  practical applications.
• Such discoveries typically begin at "the bench"
  with basic researchin which scientists study
  disease at a molecular or cellular levelthen
  progress to the clinical level, or the patient's
  "bedside.
• Scientists are increasingly aware that this
  bench-to-bedside approach to translational
  research is really a two-way street.
• A stronger research infrastructure could
  strengthen and accelerate this critical part of
  the clinical research enterprise. The NIH Roadmap
  attempts to catalyze translational research in
  various ways.
• NIH Roadmap

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Why isnt Research Being Translated into Practice?
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Considerations for Diabetes Translational Research

• A complex array of social, financial,
• behavioral, and organizational
• barriers impede the application of high
• quality diabetes care.

Garfield et al 2002
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Lessons Learned from Diabetes Prevention Trials

• Behavior is influenced by a combination of
  multilevel forces
• No single best practice is appropriate for all
  patients and practitioners.
• Tailoring to patients and customizing to settings
  is necessary.
• Real-world translation requires flexibility to
  deal with pragmatic issues
• Rigorous nonrandomized study designs including
  quasi-experimental, time-series, and
  observational studies are frequently most
  appropriate.

Garfield et al 2002
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Why Dont Clinicians Follow Clinical Practice
Guidelines?

• Barriers to Adherence?
• Possible Solutions?

Cabana 1999
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Gap in Recommended Services

• Americans only receive 50 of the recommended
  preventive, acute, and long-term health care.
• There are wide variation in health use

McGlynn et al 2003)
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Pathway for Translation and Dissemination
Brownson 2005
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Discovery

• To investigate determinants of health, disease,
  behavior
• To evaluate intervention efficacy
• To test scientific methods

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Translation

• Synthesize research findings
• Apply findings to target population
• Understand intervention context
• Explore needed adaptations
• Examine relative advantage (fit within existing
  systems)

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Dissemination

• Spread of research findings
• Institution and delivery of discovery

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Change

• Long term behavior change
• Program adoption
• Organizational change
• Policy adoption
• Environmental change

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Future of Health Behavior Change Research

• Understanding implications of different research
  emphasizes and approaches
• Efficacy vs Effectiveness
• Internal vs External validity

Glasgow 2003 2004
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Translation of Evidence-Based Prevention Programs

• Old question Does what we are doing work?
• New question Can we do what is known to work?

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What is Evidence-Based Health Promotion?

• A process of
• planning,
• implementing, and
• evaluating programs
• adapted from tested models or interventions
• in order to address health issues at an
  individual level and at a community level

Source Altpeter, M., Schneider, E., Bryant, L.
Beattie, B., Whitelaw, N. (2004).Using the
evidence base to promote healthy aging. National
Council on the Aging Evidence-based Health
Promotion Series, Vol. 1. Washington, DC
National Council on the Aging.
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Target of Evidence-based Health Promotion
Programs Individuals to communities
Source McLeroy et al., 1988, Health Educ Q
Sallis et al., 1998, Am J Prev Med
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5 Crosscutting Themes of Evidence-based Health
Promotion Programs

• Individual level
• Use of effective self-management
• Assessment, goal setting, action planning,
  problem solving, follow-up
• Social and familial context
• Use of peer support, peer health mentors,
  professional support, role modeling, sharing and
  feedback, reinforcement
• Cultural context
• Saliency, appeal and adaptation to community
  norms, language, customs, beliefs

Adapted from Nancy Whitelaw presentation, AHRQ
Conference, 2006
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5 Crosscutting Themes of Evidence-based Health
Promotion Programs (continued)

• Connections to health care
• Partnerships with public health, health care
  providers, hospitals, health care systems
• Outcomes focus
• Track social, mental, physical and functional
  changes
• Objective and self-reported subjective measures

Adapted from Nancy Whitelaw presentation, AHRQ
Conference, 2006
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Anatomy of an Evidence-based Program

• Has a specific target population
• Has specific, measurable goal(s)
• Has a stated reasoning behind it and proven
  benefits
• Describes a well-defined program structure and
  timeframe so others understand how the program
  works
• Specifies staffing needs/skills
• Specifies facility and equipment needs
• Builds in program evaluation to measure program
  quality and health outcomes

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Perceived Advantages of Evidence-based Health
Promotion
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Perceived Advantages of Evidence-based Health
Promotion

• Facilitates the use of common performance
  measures
• Supports continuous quality improvement
• Increases the likelihood of positive outcomes
• Leads to efficient use of resources
• Makes it easier to justify funding
• Helps to establish partnerships esp. with health
  care
• Facilitates the spread of programs

Adapted from Nancy Whitelaw, Director, NCOA
Center on Healthy Aging
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Perceived Disadvantages of an Evidence-Based
Approach
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Perceived Disadvantages of an Evidence-Based
Approach

• Feels like standardization of programs rather
  than site-specific tailoring
• Difficult to build community support many
  prefer home grown to off the shelf
• Tools and processes are unfamiliar
• Requires knowing where to find and how to
  understand/judge the evidence

Adapted from Nancy Whitelaw, Director, NCOA
Center on Healthy Aging
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Fundamental Question

• Do evidence-based successes translate to
  community-settings?
• Are they of same magnitude?
• What does it take to achieve similar results?

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Pilot Study Accomplishments Outcomes

• Significant results for increases in physical
  activity levels
• Results of similar magnitude as research studies
• Anecdotally clinically significant improvements
  in health and health care costs
• Recommendations for next generation of studies

Data Presented at ACSM, 2005
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Implementing Guidelines in Community or Clinical
Settings

• There are many research-based guidelines that can
  improve health
• Guidelines are difficult to implement especially
  in rural areas
• Test out strategies for improving implementation
  and dissemination

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Prevention Research CenterDiabetes Prevention
and Management

• Assessing Current Practice
• Identifying Priority Guidelines
• Collaborative Strategies for Implementation

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RE-AIM FRAMEWORK

• Used in planning and evaluating clinical and
  community based programs
• Provides a tool for talking about elements
  critical to both research and practice

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Components of RE-AIM

• Reach targeted population
• Effectiveness program outcomes
• Adoption participation rate
• among settings
• Implementation delivered as intended
• and consistently
• Maintenance long term effects at individual and
  setting levels

How do I measure the results of my program
(improvements or adverse effects)?
How do I attract my intended audience?
How do I address barriers and develop
organizational support for my program?
How do I ensure the program is delivered properly
and consistently?
Setting level What is the extent to which my
program can be sustained (modified or
discontinued) over time?
Individual level What are the long term effects
of my program on targeted outcomes?
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Partners and Planning (P)RE-AIM

• Find your partners
• Identify and review evidence of health conditions
  and risk factors for older adults in the
  community
• Review scientific evidence on proven, effective
  interventions or models
• Identify core components of effective programs
• Which specific program components contributed to
  the positive results?

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Partners and Planning (P)RE-AIM

• Select interventions/models
• Appropriate for targeted conditions or risk
  factors
• Suitable for targeted populations and locations
• Feasible to implement can preserve core
  components
• Suitable for adoption by a variety of agencies,
  staff with different skills
• Communicate to community leaders, other
  stakeholders

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Reach and Retention - People

• The number, proportion, and representativeness of
  individuals in a given program.
• Key questions
• Do participants truly reflect the targeted
  population?
• How do I reach and retain these high risk,
  diverse older adults?
• Are those who become enrolled the ones who have
  the most to gain?

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How to Improve Reach
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How to Improve Reach

• Build relationships with your community and
  target population.
• Get your target population to help with
  recruitment.
• Track the success of your various recruitment
  materials.
• Offer programs where the target population is.

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Adoption - Organizations

• The number, proportion, and representativeness of
  settings and staff who are willing to offer the
  program.
• Key questions
• How many organizations could implement this
  program? Readiness
• How many of these organizations will actually
  operate the program?
• What will motivate these organizations to
  participate?

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Adoption Organizational Readiness

• Is the agency/partnership willing to do
  evidence-based health programs and stay true to
  the model being implemented?
• Can distinguish between evidence-based health
  programs and other programs
• Can gain and keep the support of health care
  organizations
• Can preserve fidelity to key interventions and
  provide quality control while making necessary
  modifications

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Adoption Organizational Readiness

• Is there funding for the program?
• Can secure sustainable funding for evidence-based
  health promotion and self-management programs
• Can reallocate current funds to support new
  evidence-based health programs

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Adoption Organizational Readiness

• Is there access both to personnel with the
  expertise to do these programs, and to the
  population that needs these programs?
• Can recruit and retain knowledgeable staff or
  contractors
• Can recruit and retain lay leaders, peer
  supporters and other volunteers
• Can offer programming at times and places that
  are convenient for the target population

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Adoption Organizational Readiness

• Is there buy-in from senior leadership and key
  partners as reflected in both programmatic and
  financial support?
• Can ensure that programs receive necessary time
  and attention by knowledgeable staff and agency
  leaders
• Board is aware of move to evidence-based health
  programming and is supportive
• Partners can commit existing funds or have
  identified new funding to build and sustain the
  program

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How to Improve Adoption Success
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How to Improve Adoption Success

• Involve potential participating organizations
  right from the start P Phase
• Ask potential participating organizations to
  assess their willingness, readiness and the fit
  of the model to their setting.
• Track the representativeness of organizations
  that do participate and the number and reasons
  for declining.

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Implementation - Organizations

• How closely do the agency and staff follow the
  program that was developed.
• Key questions
• How many staff within a setting will try this?
• Does training and supervision support
  implementation?
• Do data systems support implementation?
• Do work flow processes support implementation?
• Do policies and procedures support implementation?

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How to Improve Program Implementation
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Prior to implementation

• Recheck fidelity of the developed program to the
  original interventions/model
• Prepare clear intervention protocols and training
  manuals be certain that the program is
  understood
• Automate as many parts as feasible

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During implementation

• Monitor implementation on the front line
• Provide feedback and recognition to
  staff/volunteer
• Routinely assess fidelity of the model as
  implemented to the model as developed

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Maintenance People and Organizations

• At the individual level, the long-term effects of
  a program on outcomes (perhaps 6 or more months).
  
• The extent to which a program or policy becomes
  part of the routine organizational practices and
  policies.

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Maintenance People and Organizations

• Key questions
• Can organizations sustain the program over time?
• Does the program produce lasting effects at
  individual level?
• Are those persons and settings that show
  maintenance those most in need?

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How to Improve Maintenance
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Effectiveness - People

• The impact of the model program on important
  outcomes.
• Unintended, adverse consequences or negative
  effects
• Quality of life
• Health status of participants
• Health status of the targeted community
• Costs
• Satisfaction of participants, staff and agencies

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How to Improve Program Effectiveness
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How to Improve Effectiveness Studies

• Use tools and methods from original studies.
• Tailor interventions to target populations.

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How Do Efficacy and Effectiveness Studies Differ?
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How to Improve Effectiveness Studies

• Thoroughly understanding selected outcomes and
  how they are achieved what are the key program
  components that will achieve desired outcomes.
• Assess a broad set of outcomes including possible
  negative ones.
• Include measures of factors that are likely to
  support or undermine the programs impact on
  participants.
• Analyze the data for various sub-groups.

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Public Health Question
Glasgow, 2003
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Questions About Re-AIM Framework

• www. Re-Aim. org

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Class Questions
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Bowen and Zwi 2005
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Bowen and Zwi, 2005
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Translational Research Example

• There is a new evidence-based program that has
  been shown to be effective for a
• Chronic Disease Management
• Improving Healthy Lifestyles
• Describe the programs essential elements
• What are the barriers/facilitators to translation
  in the Brazos Valley?

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Imagine a Translational Process

• Identify and explain role of change agents?
• Of opinion leaders?
• What will it take for widespread adoption?