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Challenges of Harnessing the
Informatics Landscape to Promote
     Health Behavior Change
               David B. Abrams, PhD

Executive Director, The Schroeder Institute for Tobacco Research
                       and Policy Studies
    The Johns Hopkins Bloomberg School of Public Health
             Georgetown University Medical Center

                          KEYNOTE PRESENTED AT THE AMERICAN ACADEMY OF HEALTH BEHAVIOR
                                                                         AUSTIN, TEXAS
                                                                        MARCH 19, 2012
Population Impact: The
                                                   Example of Tobacco




                                                                                      FDA
                                                                                       act




Source: Mendez, Warner. Tobacco control. Nicotine & Tobacco Research., August 11, 2010.
Revisit Goal of
                                                      Population Impact

Impact = Reach x Efficacy

Efficiency: Continuous optimization of quality of
evidence-based intervention

      delivery at scale, cost-effectively

RE-AIM: multi-level integration


SOURCES: (1) Abrams et al. (1996). Integrating individual and public health perspectives
for treatment of tobacco: A combined stepped care matching model. Annals of Beh
Med,18,290-304. (2) Glasgow, Green, Klesges, Abrams et al. (2006). External validity: we
need to do more. Ann Behav Med,31(2),105-108.
Back in 2005…

• Internet adoption in US: from 15% in 1995 to 75% in 2006
     – More than 70 million adults go online each day
• ~ 80% of Internet users have searched online for health
  information at some point in their lives (Pew, 2005)

BUT…
• In spite of a surge of technologic capability, research and
  evaluation methodologies have not kept pace with rapid
  evolution & proliferation of communication technologies
• Nor has the dissemination of effective eHealth interventions
  achieved the level of penetration one might have hoped, given
  the number of people who now access the Internet
Source: Atienza, Hesse, Abrams, Rimer, et al. Critical Issues in eHealth Research. Am J
Prev Med. 2007 May; 32(5 Suppl): S71–S74.
5+ Years Later: Where
                                                      Are We Now?

Crounse commentary (2007):

 “Even though robust communication and collaboration
solutions exist to speed scientific discovery and the
delivery of care, all too often our methodology falls
back on that which we know and have always done
before… But we must not dig in our heels, resist
change, and continue to conduct business as we have
always done before just because it suits our comfort
level. Others around the world will not indulge in or
tolerate that luxury.”
Source: Crounse B. The newspaper, the wristwatch, and the clinician. Am J Prev Med.
2007 May;32(5 Suppl):S134.
Assumptions

1. The promise of informatics and technology to change
   public health can be realized using traditional scientific
   theories and methods (with perhaps only some fine
   tuning)

2. Single level interventions delivered at scale (mass
   customization) can change health behavior at the
   population level and make a timely impact.

3. Integration across platforms in real time can overcome
   barriers to reach, engagement, and efficient delivery of
   behavior change interventions and their seamless
   integration into delivery systems and policy
Assumption 1:
                                                   Traditional Science

              The Individual Effectiveness to
                Population Impact Chasm




Source: Abrams, D (1999). Transdisciplinary paradigms for tobacco research. Nicotine
& Tobacco Research, 1, S15.
A New Definition of
                                                              Translational Research

              T1                     T2                         T3                                 T4
     Potential Application         Efficacy           Effectiveness                    Population-Based

Basic Science        Potential                   Evidence-                    Clinical Care                 Health of
Discovery            Clinical                     Based                             or                      Community
                     Application                 Guidelines                   Intervention                  or Population

 Basic              Theoretical                  Efficacy                     Applied                   Public Health
Knowledge            Knowledge                  Knowledge                     Knowledge                 Knowledge


 Types                         • Phase 3 trials            • Phase 4 clinical trials
         • Phase 1, 2 trials                                                              •T3 type studies in community
   of                          • Systematic reviews        • Implementation
         • Observational                                                                  • Population / outcome studies
Research                       • Health services studies   • Communication
                                                                                          • Cost-benefits, policy impact
                               • Observational studies     • Dissemination
                                                                                          • Studies beyond clinical care
                                                           • Diffusion
                                                           • Systematic reviews




    Sources: 1) Szilagyi P. 2010: From Research to Dissemination Implementation:
    http://www.research-practice.org/presentations.aspx. 2) Khoury M, et al. Gen Med,
    2007;9:665-674. 3) Glasgow et al., RE-AIM.
Assumption 2:
           Single-level interventions



Outside
the skin




 Under
the skin
Assumption 3:
Multi-level integration
Source: Lazer et al. (2009). Life in the network: the coming age of computational social
science. Science. 323(5915): 721–723.
Iterative Continuous
                                    Improvement

Dynamic model of research for multi-level impact:
 Theory to mechanisms to practice to policy loop
Example:
 Multiphase Optimization
        Strategy (MOST)

• Collins, Murphy, Strecher. The
  multiphase optimization strategy
  (MOST) and the sequential
  multiple assignment randomized
  trial (SMART): new methods for
  more potent eHealth
  interventions. Am J Prev Med.
  2007 May;32(5 Suppl):S112-8.
  PMCID: PMC2062525.

• Collins et al. The Multiphase
  Optimization Strategy for
  Engineering Effective Tobacco
  Use Interventions. Ann Behav
  Med. 2011 Apr;41(2):208-26.
  PMCID: PMC3053423.
From Gene Chip Arrays
                                                              To Population Arrays

                                                    Multi-level tailoring at:
                                                    • biological level
                                                    • individual level
                                                    • proximal socio-behavioral level
                                                    • community level
                                                    • population level

                                                         GENOMICS TO POPULOMICS




Source: Murray et al. (2006). Eight Americas: Investigating Mortality Disparities across
Races, Counties, and Race-Counties in the United States. PLoS Medicine: Vol 3,
15139, e260.
Illustrative Examples from
                                 the Schroeder Institute

1. The iQUITT Study - Internet (Graham, PI)

2. Facebook (Cobb, PI)

3. POSSE (Kirchner, PI)

4. Adaptive designs in clinical trials (Niaura)
Assumptions

1. The promise of informatics and technology to change
   public health can be realized using traditional scientific
   theories and methods (with perhaps only some fine
   tuning)

2. Single level interventions delivered at scale (mass
   customization) can change health behavior at the
   population level and make a timely impact.

3. Integration across platforms in real time can overcome
   barriers to reach, engagement, and efficient delivery of
   behavior change interventions and their seamless
   integration into delivery systems and policy
Internet and Telephone Treatment for Smoking Cessation
              Amanda L. Graham, PhD (PI)
                 National Cancer Institute
                    5 R01 CA104836
                       2004 – 2010
Initial Evaluation of
                                          QuitNet

• Observational study in December 2002
• Total # surveyed = 1,501
• Responders: 25.6% (N=385)
Initial Evaluation of
                                       QuitNet
                                 Least conservative

ADHERENCE SAMPLE (N=223):                30.0%
  – Respondents only


     • Used site ≥ 2x (N=336):         13.1%
     • Used site >1x (N=488):           9.8%
     • Excluding bounced (N=892):       8.0%


INTENTION TO TREAT (N=1,024):            7.0%
   – Counts all non-responders as smokers
                                 Most conservative
2005 participants
                                                                          Recruited online
                                                                          Randomized to
                                                                          “real world”
                                                                          Internet or phone
                                                                          treatments
                                                                          ~ 70% follow-up
                                                                          rates 3-18
                                                                          months

Source: Graham AL, Bock BC, Cobb NK, Niaura R, Abrams DB. Characteristics of smokers reached
and recruited to an internet smoking cessation trial: a case of denominators. Nicotine Tob Res. 2006
Dec;8 Suppl 1:S43-8.
Control Condition


 Static site designed
  by research team
 “look and feel” of
  QuitNet
 Extracted content
  from QuitNet
 No interactive
  features
 No online
  community
Recruitment Approach

         “Active User
         Interception
          Sampling”

     Google, AOL, MSN,
          Yahoo!
        Quit smoking
        Stop smoking
        Quitting smoking
        Stopping smoking
Informed Consent



  3 explicit steps:
Do you give informed
consent?

Contact information

“Digital signature”
Recruitment
      Results


1. Denominator,
   denominator,
   wherefore art
   thou denominator
2. Generalizability
Research Questions

1. Informed Consent: For low-risk, population-based studies
   focused on dissemination and implementation research (i.e.,
   evaluating interventions as they are used in the “real world”),
   what is the appropriate and optimal level of informed
   consent? How might informed consent be a barrier that
   actually limits the reach and understanding of the target
   population in fundamental ways?

2. Control/Comparison Group: What is the appropriate
   control condition or comparison condition? Is one needed at
   all? How can we move away from traditional RCTs and
   consider SMART/adaptive designs, practical & comparative
   efficacy trials, and other approaches?
30 day abstinence
Population Impact

Impact = Reach x Efficacy

Efficiency: Continuous optimization of quality of
evidence-based intervention

      delivery at scale, cost-effectively

RE-AIM: multi-level integration


SOURCES: (1) Abrams et al. (1996). Integrating individual and public health perspectives
for treatment of tobacco: A combined stepped care matching model. Annals of Beh
Med,18,290-304. (2) Glasgow, Green, Klesges, Abrams et al. (2006). External validity: we
need to do more. Ann Behav Med,31(2),105-108.
Population Impact
IMPACT:
                                Secondary Analyses

• Of funnels and tunnels and rabbit holes…
• From community newspaper to Internet tx seekers…
• From 10+ million to 99,900 to 2,005…
• Who do we have here, who is NOT here, and how much
  implementation dissemination, generalizability and
  scalability do we REALLY have here?
• Oh (nearest and dearest) denominator wherefore art
  thou?
IMPACT:
Utilization & Outcomes
User Engagement &
                                                           Outcomes
Pilot study 2002:
• Use of any social support and
     2-month continuous abstinence:                               OR = 4.03
 • Intensity of website use and
     2-month continuous abstinence:                               OR = 6.07

 iQUITT Study 2011:
 Compared to no treatment:
• 3+ logins were 1.9x more likely to quit (p < .05)
• 3+ calls were 2.4x more likely to quit (p < .01)

NOTE: to date we can’t explain the growth of the static minimal Internet comparison
(control) group
Engagement:
             Social Networks & Cessation


NEXT STUDY
Sequential Multiple
Assignment Randomized
         Trial (SMART)
Assumptions

1. The promise of informatics and technology to change
   public health can be realized using traditional scientific
   theories and methods (with perhaps only some fine
   tuning)

2. Single level interventions delivered at scale (mass
   customization) can change health behavior at the
   population level and make a timely impact.

3. Integration across platforms in real time can overcome
   barriers to reach, engagement, and efficient delivery of
   behavior change interventions and their seamless
   integration into delivery systems and policy
Am J Public Health. 2010 Jul;100(7):1282-9.




J Med Internet Res. 2011 Dec 19;13(4):e119.
QuitNet By the
                                                    Numbers

     • Website overview 2007
        – 1.17 million unique visitors to the web site
        – 76.45 million “page views”
        – 123,927 unique registered users
        – 160,000 active users
     • Internal communications 2007
        – 1.36 million internal email (“Qmail”) messages
        – 815,070 forum posts, ~ equal numbers in “Clubs”



37
QuitNet Scope

• One of the 1st examples of large-scale, web-based therapeutic social network
• > 750,00 members – approx. 30-50K are active in any given month
• Growth rates of up to 22,000 members in a month.
QuitNet Data
                                           Applications

A: Longitudinal Social Network Analysis
   – 5+ years of detailed network data
B: Content Analysis
   – 10+ years of forum postings, chat logs, private
     message history, blog posts, personal profiles and
     testimonials.
C: Agent Based Modeling
   – Recreation of QuitNet as a dynamic, synthetic
     network that can be manipulated.
Source: http://instagr.am/p/nm695/
Example: Facebook

• 65 M users/month (US
  alone)
   – Covers over 50% of
     people aged 15-24
• Age:
   – 45% of the population
     is over 25
   – Over 35 population
     doubling every 2
     months
• Gender:
   – Women are fastest
     growing segment
Why Online Networks?

• For Interventions:
   – Faster intervention development
   – Better diffusion and dissemination
• For Evaluation:
   – Faster recruitment
   – Fewer barriers to enrollment
   – Fewer barriers to follow-up
   – Broader conceptualization of impact
Network Impact
Network Impact
“Impact 2.0”

• Traditional View:

     Impact = Reach X Efficacy

• Network View:

     Impact = (Initial Reach X R) X Effectiveness

Where R is the reproductive ratio or viral spread of
           an intervention or behavior.
Network Impact
“Impact 2.0+”

      Impact = (Initial Reach X R) X Effectiveness
                                + Externalities




Source: Christakis NA. Social networks and collateral health effects. BMJ 2004, Jul
24;329(7459):184-5329.
Bringing the
“mountain to
Mohammed”
Example: Facebook
                 R01

• Nate Cobb, PI (2012 – 2015)
• Planned >12,000 participants
  in factorial design
• Outcome is R - diffusion of
  the application from one
  member to another. Not
  effect!
• Answers question of what
  drives diffusion and spread?
• Entire process is automated
  from enrollment to tracking of
  diffusion.
Diffusion Model
Assumptions

1. The promise of informatics and technology to change
   public health can be realized using traditional scientific
   theories and methods (with perhaps only some fine
   tuning)

2. Single level interventions delivered at scale (mass
   customization) can change health behavior at the
   population level and make a timely impact.

3. Integration across platforms in real time can overcome
   barriers to reach, engagement, and efficient delivery of
   behavior change interventions and their seamless
   integration into delivery systems and policy
Ecological Momentary Tobacco Control

          Thomas R. Kirchner, PhD (PI)
National Institute on Drug Abuse / DC Department
                      of Health
     RC1 DA028710 / CDC CPPW Contract
                    2009 – 2012
Real-time Exposure
Ecological Momentary
       “Surveillance”




        IVR
        MMS
        SMS
        Email
        GPS
Amazon Mechanical
            Turk
Amazon Mechanical
            Turk
Socio-economic
            POST Variation

Average pack price: Newport
 M = $7.75 block-group white
 M = $7.29 block-group non-white
 p = 0.004

Low pack price: All cigarette brands
 M = $6.73

Average pack price: LCC
 M = $3.71
Low cost LCCs more prevalent in
non-white block-groups
    (2 = 4.31, p=0.04).
Real-time Exposure




Jan 6 – Jan 9, 2012:
  M = 2.3 touches, 6 outlets
  M Newport $7.13 LCC $3.53
Relapse Dynamics




SOURCE: Kirchner et al. Relapse dynamics during smoking cessation: Recurrent
abstinence violation effects and lapse-relapse progression. J Abn Psych; 2012: 121(1).
SOURCE: Shiyko MP, Lanza ST,
Tan X, Li R, Shiffman S. Using the
Time-Varying Effect Model
(TVEM) to Examine Dynamic
Associations between Negative
Affect and Self Confidence on
Smoking Urges: Differences
between Successful Quitters and
Relapsers. Prev Sci. 2012 Jan 14.
[Epub ahead of print].
Simulation Modeling
Summary &
Conclusions
Solutions & Future
                                                            Directions

Crounse commentary (2007):

     “all too often our methodology falls back on that
    which we know and have always done
    before....But we must...not dig in our heels,
    resist change and continue to conduct business
    as we’ve always done so before just because it
    suits our comfort level. Others around the world
    will not indulge in or tolerate that luxury”

Source: Crounse B. The newspaper, the wristwatch, and the clinician. Am J Prev Med.
2007 May;32(5 Suppl):S134.
Iterative Continuous
                                    Improvement

Dynamic model of research for multi-level impact:
 Theory to mechanisms to practice to policy loop
Assumptions

1. The promise of informatics and technology to change
   public health can be realized using traditional scientific
   theories and methods (with perhaps only some fine
   tuning)

2. Single level interventions delivered at scale (mass
   customization) can change health behavior at the
   population level and make a timely impact.

3. Integration across platforms in real time can overcome
   barriers to reach, engagement, and efficient delivery of
   behavior change interventions and their seamless
   integration into delivery systems and policy
Promises Promises…

Bio + behavioral + social + population - based sciences MAY
finally make the dream of efficient population behavior change
a reality if and only if:
• Rapid innovation across: platforms, modes, capacity in near
  or in real time, will overcome prior barriers to:
   – reach
   – engagement
   – utilization of efficient tailored behavior change
     interventions
   – and their seamless proximal and distal integration into
     contexts (i.e. traditional and new -- social media, Internet,
     community, low SES subgroups, health and public health
     delivery systems and aligned policy at scale)
• “Today, the hurricane and earthquake do not pose the
  greatest danger.

• It is the unanticipated effects of our own actions, effects
  created by our inability to understand the complex
  systems we have created and in which we are
  embedded.

• Creating a healthy, sustainable future requires a
  fundamental shift in the way we generate, learn from,
  and act on evidence about the delayed and distal
  effects of our technologies, policies, and institutions.”

Source: Sterman JD. Learning from evidence in a complex world. Am J Public Health.
2006 Mar;96(3):505-14. Epub 2006 Jan 31.
Embrace Complexity

•   The world is complex, contextual, dynamic, multi-causal (causal
    loops), multi-level, multiply determined…
     – For every complex problem there is a simple solution….and it is
       usually wrong
•   Research designs, methods and measures should take this into
    account and capitalize on advances in computer sciences,
    technology, informatics, imaging, knowledge management,
    networking and communications
•   Vertical integration: cells to society across varying time units
    (seconds to centuries)
•   Solid basic behavioral and social and population science is needed
    as a firm foundation to build systems within systems models
•   Aligned incentives at every level of the system can change
    populations
WE NEED EVIDENCE IN T2-T4 THAT…

       IS MORE                    IS LESS

Contextual              Isolated, de-contextualized

Practical, efficient    Abstract, intensive

Robust, generalizable   Singular (Setting, staff,
                        population)
Comparative             Academic

Comprehensive           Single outcome

Representative          From ideal settings

                                                    75
www.re-aim.org                                                EXTENDED CONSORT DIAGRAM

  RE-AIM Issue                                                     Content                                                                  Critical
                                                                                                                                         Considerations
                                                              Total number potential settings


                                          Settings Eligible                        Excluded by Investigator
                                              n and %                                 n, %, and reasons
  ADOPTION
                                          Setting and Agents             Setting and Agents             Other                                 Characteristics
                                           Who Participate                  Who Decline                n and %
                                                n and %                  n, %, and reasons
                                                                                                                                          Of Adopters vs Non


                                          Total Potential
                                          Participants, n


                                                                        Excluded by Investigator
  REACH                                    Individuals Eligible
                                                                           N, %, and reasons
                                                 n and %


                                                   Individuals Enroll                       Individuals                                       Characteristics
                                                                                                                     Not Contacted/
                                                        N and %                               Decline                    Other                Of Enrolles vs.
                                                                                         N, %, and reasons              N and %                    Decliners
                                                  Extent Tx Delivered                Component A = XX%                                             Extent Tx
   IMPLEMENTATION                                 By Different Agents                Component B = YY%                                           Delivered as
                                                     as in Protocol                        Etc.
                                                                                                                                                    Intended

                                                  Complete Tx                            Drop out of TX
                                                                                                                                             Characteristics
                                                                                       N,%, and Reasons;
       EFFICACY                                   (n and % and
                                                                                      And Amount of change                                   of Drop-outs vs
                                                Amount of Change
                                                 (By Condition)                          (By Condition)                                          Completers

    MAINTENANCE                                    Present at Follow-up                   Lost to Follow-up
                                                                                                                                             Characteristics
                                                  (n and %) and Amount                    N, %, and Reasons
                                                                                                                                            of Drop-outs vs.
  a) Individual                                   of Change or Relapse                   Amount of change or
                                                      (By Condition)                    Relapse (By Condition)                                   Completers
     Level
                                                                                                                                             Characteristics
  b) Setting                                                                                                                                 of Settings that
                                           Settings in which Program is                   Settings in which
     Level                                Continued And/or Modified after                    Program not                                        Continue vs
                                                 Research is Over                             Maintained                                              Do Not
                                                (n, %, and reasons)                      (n, %, and reasons)


      *At each step, record qualitative and quantitative information and factors affecting each RE-AIM dimension and step in flowchart
The Challenge: If we have it all,
                          then will they really come?


• Impact = Efficacy x Reach /cost +
  externalities
                                        Not nearly as
                                        much as we
                                         could be!
End
dabrams@legacyforhealth.org

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Challenges of Harnessing the Informatics Landscape to Promote Health Behavior Change

  • 1. Challenges of Harnessing the Informatics Landscape to Promote Health Behavior Change David B. Abrams, PhD Executive Director, The Schroeder Institute for Tobacco Research and Policy Studies The Johns Hopkins Bloomberg School of Public Health Georgetown University Medical Center KEYNOTE PRESENTED AT THE AMERICAN ACADEMY OF HEALTH BEHAVIOR AUSTIN, TEXAS MARCH 19, 2012
  • 2. Population Impact: The Example of Tobacco FDA act Source: Mendez, Warner. Tobacco control. Nicotine & Tobacco Research., August 11, 2010.
  • 3. Revisit Goal of Population Impact Impact = Reach x Efficacy Efficiency: Continuous optimization of quality of evidence-based intervention  delivery at scale, cost-effectively RE-AIM: multi-level integration SOURCES: (1) Abrams et al. (1996). Integrating individual and public health perspectives for treatment of tobacco: A combined stepped care matching model. Annals of Beh Med,18,290-304. (2) Glasgow, Green, Klesges, Abrams et al. (2006). External validity: we need to do more. Ann Behav Med,31(2),105-108.
  • 4.
  • 5. Back in 2005… • Internet adoption in US: from 15% in 1995 to 75% in 2006 – More than 70 million adults go online each day • ~ 80% of Internet users have searched online for health information at some point in their lives (Pew, 2005) BUT… • In spite of a surge of technologic capability, research and evaluation methodologies have not kept pace with rapid evolution & proliferation of communication technologies • Nor has the dissemination of effective eHealth interventions achieved the level of penetration one might have hoped, given the number of people who now access the Internet Source: Atienza, Hesse, Abrams, Rimer, et al. Critical Issues in eHealth Research. Am J Prev Med. 2007 May; 32(5 Suppl): S71–S74.
  • 6. 5+ Years Later: Where Are We Now? Crounse commentary (2007): “Even though robust communication and collaboration solutions exist to speed scientific discovery and the delivery of care, all too often our methodology falls back on that which we know and have always done before… But we must not dig in our heels, resist change, and continue to conduct business as we have always done before just because it suits our comfort level. Others around the world will not indulge in or tolerate that luxury.” Source: Crounse B. The newspaper, the wristwatch, and the clinician. Am J Prev Med. 2007 May;32(5 Suppl):S134.
  • 7. Assumptions 1. The promise of informatics and technology to change public health can be realized using traditional scientific theories and methods (with perhaps only some fine tuning) 2. Single level interventions delivered at scale (mass customization) can change health behavior at the population level and make a timely impact. 3. Integration across platforms in real time can overcome barriers to reach, engagement, and efficient delivery of behavior change interventions and their seamless integration into delivery systems and policy
  • 8. Assumption 1: Traditional Science The Individual Effectiveness to Population Impact Chasm Source: Abrams, D (1999). Transdisciplinary paradigms for tobacco research. Nicotine & Tobacco Research, 1, S15.
  • 9. A New Definition of Translational Research T1 T2 T3 T4 Potential Application Efficacy Effectiveness Population-Based Basic Science Potential Evidence- Clinical Care Health of Discovery Clinical Based or Community Application Guidelines Intervention or Population Basic Theoretical Efficacy Applied Public Health Knowledge Knowledge Knowledge Knowledge Knowledge Types • Phase 3 trials • Phase 4 clinical trials • Phase 1, 2 trials •T3 type studies in community of • Systematic reviews • Implementation • Observational • Population / outcome studies Research • Health services studies • Communication • Cost-benefits, policy impact • Observational studies • Dissemination • Studies beyond clinical care • Diffusion • Systematic reviews Sources: 1) Szilagyi P. 2010: From Research to Dissemination Implementation: http://www.research-practice.org/presentations.aspx. 2) Khoury M, et al. Gen Med, 2007;9:665-674. 3) Glasgow et al., RE-AIM.
  • 10. Assumption 2: Single-level interventions Outside the skin Under the skin
  • 12. Source: Lazer et al. (2009). Life in the network: the coming age of computational social science. Science. 323(5915): 721–723.
  • 13. Iterative Continuous Improvement Dynamic model of research for multi-level impact: Theory to mechanisms to practice to policy loop
  • 14. Example: Multiphase Optimization Strategy (MOST) • Collins, Murphy, Strecher. The multiphase optimization strategy (MOST) and the sequential multiple assignment randomized trial (SMART): new methods for more potent eHealth interventions. Am J Prev Med. 2007 May;32(5 Suppl):S112-8. PMCID: PMC2062525. • Collins et al. The Multiphase Optimization Strategy for Engineering Effective Tobacco Use Interventions. Ann Behav Med. 2011 Apr;41(2):208-26. PMCID: PMC3053423.
  • 15. From Gene Chip Arrays To Population Arrays Multi-level tailoring at: • biological level • individual level • proximal socio-behavioral level • community level • population level GENOMICS TO POPULOMICS Source: Murray et al. (2006). Eight Americas: Investigating Mortality Disparities across Races, Counties, and Race-Counties in the United States. PLoS Medicine: Vol 3, 15139, e260.
  • 16. Illustrative Examples from the Schroeder Institute 1. The iQUITT Study - Internet (Graham, PI) 2. Facebook (Cobb, PI) 3. POSSE (Kirchner, PI) 4. Adaptive designs in clinical trials (Niaura)
  • 17. Assumptions 1. The promise of informatics and technology to change public health can be realized using traditional scientific theories and methods (with perhaps only some fine tuning) 2. Single level interventions delivered at scale (mass customization) can change health behavior at the population level and make a timely impact. 3. Integration across platforms in real time can overcome barriers to reach, engagement, and efficient delivery of behavior change interventions and their seamless integration into delivery systems and policy
  • 18. Internet and Telephone Treatment for Smoking Cessation Amanda L. Graham, PhD (PI) National Cancer Institute 5 R01 CA104836 2004 – 2010
  • 19. Initial Evaluation of QuitNet • Observational study in December 2002 • Total # surveyed = 1,501 • Responders: 25.6% (N=385)
  • 20. Initial Evaluation of QuitNet Least conservative ADHERENCE SAMPLE (N=223): 30.0% – Respondents only • Used site ≥ 2x (N=336): 13.1% • Used site >1x (N=488): 9.8% • Excluding bounced (N=892): 8.0% INTENTION TO TREAT (N=1,024): 7.0% – Counts all non-responders as smokers Most conservative
  • 21. 2005 participants Recruited online Randomized to “real world” Internet or phone treatments ~ 70% follow-up rates 3-18 months Source: Graham AL, Bock BC, Cobb NK, Niaura R, Abrams DB. Characteristics of smokers reached and recruited to an internet smoking cessation trial: a case of denominators. Nicotine Tob Res. 2006 Dec;8 Suppl 1:S43-8.
  • 22. Control Condition  Static site designed by research team  “look and feel” of QuitNet  Extracted content from QuitNet  No interactive features  No online community
  • 23. Recruitment Approach “Active User Interception Sampling” Google, AOL, MSN, Yahoo!  Quit smoking  Stop smoking  Quitting smoking  Stopping smoking
  • 24. Informed Consent 3 explicit steps: Do you give informed consent? Contact information “Digital signature”
  • 25. Recruitment Results 1. Denominator, denominator, wherefore art thou denominator 2. Generalizability
  • 26. Research Questions 1. Informed Consent: For low-risk, population-based studies focused on dissemination and implementation research (i.e., evaluating interventions as they are used in the “real world”), what is the appropriate and optimal level of informed consent? How might informed consent be a barrier that actually limits the reach and understanding of the target population in fundamental ways? 2. Control/Comparison Group: What is the appropriate control condition or comparison condition? Is one needed at all? How can we move away from traditional RCTs and consider SMART/adaptive designs, practical & comparative efficacy trials, and other approaches?
  • 28. Population Impact Impact = Reach x Efficacy Efficiency: Continuous optimization of quality of evidence-based intervention  delivery at scale, cost-effectively RE-AIM: multi-level integration SOURCES: (1) Abrams et al. (1996). Integrating individual and public health perspectives for treatment of tobacco: A combined stepped care matching model. Annals of Beh Med,18,290-304. (2) Glasgow, Green, Klesges, Abrams et al. (2006). External validity: we need to do more. Ann Behav Med,31(2),105-108.
  • 30. IMPACT: Secondary Analyses • Of funnels and tunnels and rabbit holes… • From community newspaper to Internet tx seekers… • From 10+ million to 99,900 to 2,005… • Who do we have here, who is NOT here, and how much implementation dissemination, generalizability and scalability do we REALLY have here? • Oh (nearest and dearest) denominator wherefore art thou?
  • 32. User Engagement & Outcomes Pilot study 2002: • Use of any social support and  2-month continuous abstinence: OR = 4.03 • Intensity of website use and  2-month continuous abstinence: OR = 6.07 iQUITT Study 2011: Compared to no treatment: • 3+ logins were 1.9x more likely to quit (p < .05) • 3+ calls were 2.4x more likely to quit (p < .01) NOTE: to date we can’t explain the growth of the static minimal Internet comparison (control) group
  • 33. Engagement: Social Networks & Cessation NEXT STUDY
  • 35. Assumptions 1. The promise of informatics and technology to change public health can be realized using traditional scientific theories and methods (with perhaps only some fine tuning) 2. Single level interventions delivered at scale (mass customization) can change health behavior at the population level and make a timely impact. 3. Integration across platforms in real time can overcome barriers to reach, engagement, and efficient delivery of behavior change interventions and their seamless integration into delivery systems and policy
  • 36. Am J Public Health. 2010 Jul;100(7):1282-9. J Med Internet Res. 2011 Dec 19;13(4):e119.
  • 37. QuitNet By the Numbers • Website overview 2007 – 1.17 million unique visitors to the web site – 76.45 million “page views” – 123,927 unique registered users – 160,000 active users • Internal communications 2007 – 1.36 million internal email (“Qmail”) messages – 815,070 forum posts, ~ equal numbers in “Clubs” 37
  • 38. QuitNet Scope • One of the 1st examples of large-scale, web-based therapeutic social network • > 750,00 members – approx. 30-50K are active in any given month • Growth rates of up to 22,000 members in a month.
  • 39.
  • 40. QuitNet Data Applications A: Longitudinal Social Network Analysis – 5+ years of detailed network data B: Content Analysis – 10+ years of forum postings, chat logs, private message history, blog posts, personal profiles and testimonials. C: Agent Based Modeling – Recreation of QuitNet as a dynamic, synthetic network that can be manipulated.
  • 42. Example: Facebook • 65 M users/month (US alone) – Covers over 50% of people aged 15-24 • Age: – 45% of the population is over 25 – Over 35 population doubling every 2 months • Gender: – Women are fastest growing segment
  • 43. Why Online Networks? • For Interventions: – Faster intervention development – Better diffusion and dissemination • For Evaluation: – Faster recruitment – Fewer barriers to enrollment – Fewer barriers to follow-up – Broader conceptualization of impact
  • 46. “Impact 2.0” • Traditional View: Impact = Reach X Efficacy • Network View: Impact = (Initial Reach X R) X Effectiveness Where R is the reproductive ratio or viral spread of an intervention or behavior.
  • 48. “Impact 2.0+” Impact = (Initial Reach X R) X Effectiveness + Externalities Source: Christakis NA. Social networks and collateral health effects. BMJ 2004, Jul 24;329(7459):184-5329.
  • 50. Example: Facebook R01 • Nate Cobb, PI (2012 – 2015) • Planned >12,000 participants in factorial design • Outcome is R - diffusion of the application from one member to another. Not effect! • Answers question of what drives diffusion and spread? • Entire process is automated from enrollment to tracking of diffusion.
  • 52. Assumptions 1. The promise of informatics and technology to change public health can be realized using traditional scientific theories and methods (with perhaps only some fine tuning) 2. Single level interventions delivered at scale (mass customization) can change health behavior at the population level and make a timely impact. 3. Integration across platforms in real time can overcome barriers to reach, engagement, and efficient delivery of behavior change interventions and their seamless integration into delivery systems and policy
  • 53. Ecological Momentary Tobacco Control Thomas R. Kirchner, PhD (PI) National Institute on Drug Abuse / DC Department of Health RC1 DA028710 / CDC CPPW Contract 2009 – 2012
  • 54.
  • 56.
  • 57. Ecological Momentary “Surveillance” IVR MMS SMS Email GPS
  • 58.
  • 61.
  • 62. Socio-economic POST Variation Average pack price: Newport M = $7.75 block-group white M = $7.29 block-group non-white p = 0.004 Low pack price: All cigarette brands M = $6.73 Average pack price: LCC M = $3.71 Low cost LCCs more prevalent in non-white block-groups (2 = 4.31, p=0.04).
  • 63. Real-time Exposure Jan 6 – Jan 9, 2012: M = 2.3 touches, 6 outlets M Newport $7.13 LCC $3.53
  • 64. Relapse Dynamics SOURCE: Kirchner et al. Relapse dynamics during smoking cessation: Recurrent abstinence violation effects and lapse-relapse progression. J Abn Psych; 2012: 121(1).
  • 65. SOURCE: Shiyko MP, Lanza ST, Tan X, Li R, Shiffman S. Using the Time-Varying Effect Model (TVEM) to Examine Dynamic Associations between Negative Affect and Self Confidence on Smoking Urges: Differences between Successful Quitters and Relapsers. Prev Sci. 2012 Jan 14. [Epub ahead of print].
  • 68. Solutions & Future Directions Crounse commentary (2007): “all too often our methodology falls back on that which we know and have always done before....But we must...not dig in our heels, resist change and continue to conduct business as we’ve always done so before just because it suits our comfort level. Others around the world will not indulge in or tolerate that luxury” Source: Crounse B. The newspaper, the wristwatch, and the clinician. Am J Prev Med. 2007 May;32(5 Suppl):S134.
  • 69.
  • 70. Iterative Continuous Improvement Dynamic model of research for multi-level impact: Theory to mechanisms to practice to policy loop
  • 71. Assumptions 1. The promise of informatics and technology to change public health can be realized using traditional scientific theories and methods (with perhaps only some fine tuning) 2. Single level interventions delivered at scale (mass customization) can change health behavior at the population level and make a timely impact. 3. Integration across platforms in real time can overcome barriers to reach, engagement, and efficient delivery of behavior change interventions and their seamless integration into delivery systems and policy
  • 72. Promises Promises… Bio + behavioral + social + population - based sciences MAY finally make the dream of efficient population behavior change a reality if and only if: • Rapid innovation across: platforms, modes, capacity in near or in real time, will overcome prior barriers to: – reach – engagement – utilization of efficient tailored behavior change interventions – and their seamless proximal and distal integration into contexts (i.e. traditional and new -- social media, Internet, community, low SES subgroups, health and public health delivery systems and aligned policy at scale)
  • 73. • “Today, the hurricane and earthquake do not pose the greatest danger. • It is the unanticipated effects of our own actions, effects created by our inability to understand the complex systems we have created and in which we are embedded. • Creating a healthy, sustainable future requires a fundamental shift in the way we generate, learn from, and act on evidence about the delayed and distal effects of our technologies, policies, and institutions.” Source: Sterman JD. Learning from evidence in a complex world. Am J Public Health. 2006 Mar;96(3):505-14. Epub 2006 Jan 31.
  • 74. Embrace Complexity • The world is complex, contextual, dynamic, multi-causal (causal loops), multi-level, multiply determined… – For every complex problem there is a simple solution….and it is usually wrong • Research designs, methods and measures should take this into account and capitalize on advances in computer sciences, technology, informatics, imaging, knowledge management, networking and communications • Vertical integration: cells to society across varying time units (seconds to centuries) • Solid basic behavioral and social and population science is needed as a firm foundation to build systems within systems models • Aligned incentives at every level of the system can change populations
  • 75. WE NEED EVIDENCE IN T2-T4 THAT… IS MORE IS LESS Contextual Isolated, de-contextualized Practical, efficient Abstract, intensive Robust, generalizable Singular (Setting, staff, population) Comparative Academic Comprehensive Single outcome Representative From ideal settings 75
  • 76. www.re-aim.org EXTENDED CONSORT DIAGRAM RE-AIM Issue Content Critical Considerations Total number potential settings Settings Eligible Excluded by Investigator n and % n, %, and reasons ADOPTION Setting and Agents Setting and Agents Other Characteristics Who Participate Who Decline n and % n and % n, %, and reasons Of Adopters vs Non Total Potential Participants, n Excluded by Investigator REACH Individuals Eligible N, %, and reasons n and % Individuals Enroll Individuals Characteristics Not Contacted/ N and % Decline Other Of Enrolles vs. N, %, and reasons N and % Decliners Extent Tx Delivered Component A = XX% Extent Tx IMPLEMENTATION By Different Agents Component B = YY% Delivered as as in Protocol Etc. Intended Complete Tx Drop out of TX Characteristics N,%, and Reasons; EFFICACY (n and % and And Amount of change of Drop-outs vs Amount of Change (By Condition) (By Condition) Completers MAINTENANCE Present at Follow-up Lost to Follow-up Characteristics (n and %) and Amount N, %, and Reasons of Drop-outs vs. a) Individual of Change or Relapse Amount of change or (By Condition) Relapse (By Condition) Completers Level Characteristics b) Setting of Settings that Settings in which Program is Settings in which Level Continued And/or Modified after Program not Continue vs Research is Over Maintained Do Not (n, %, and reasons) (n, %, and reasons) *At each step, record qualitative and quantitative information and factors affecting each RE-AIM dimension and step in flowchart
  • 77. The Challenge: If we have it all, then will they really come? • Impact = Efficacy x Reach /cost + externalities Not nearly as much as we could be!
  • 78.