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CAM offers lens on health care by T29G78H

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									Advancing from CAM to
Integrative Pediatrics –
 Research Barriers and
     Opportunities
           “… a series of great
        opportunities disguised as
          insoluble problems.”

                     John Gardner
          Founder, Common Cause
   Late 20th century
conventional care: TTDD
      • Triage and Test;
      • Diagnose and Dispense
      • Diagnosis must precede
        treatment.
      • Silver bullets (clean) vs.
        Cocktails (messy/dirty)
 Pros and Cons: TTDD, Bullet
          Pros                           Cons
• Specific                  •   Patients don’t always fit
• Tidy                          a specific diagnosis
• Reduce side effects due   •   Won’t always accept a
  to unnecessary                diagnosis
  treatments                •   Don’t always want a
                                med
                            •   Side effects, costs
                            •   Missed opportunities for
                                health promotion
                            •   Culturally appropriate?
            Enter CAM, 70’s-90’s
              (American view)
• 1970’s AHMA formed; AMSA interest group
• 1980’s guided imagery/hypnosis (Olness)
• 1991 NIH Office of Alternative Medicine
  formed
• 1994 Linda Spigelblatt’s pediatric Epi survey
• 1996 The Holistic Pediatrician; Pediatrics in
  Review “Separation or Synthesis”; beginning
  of Contemp Pediatr series on CAM
• 1997 APA SIG on Holistic Pediatrics
• 1998 NIH OAM becomes NCCAM (def follows)
• 1998 Boston Children’s; first pediatric resident
  elective in holistic medicine
     NIH NCCAM- CAM Def
“….a group of diverse medical and health care
systems, practices, and products that are not
presently considered to be part of conventional
medicine.
 While some scientific evidence exists regarding some
CAM therapies, for most there are key questions that
are yet to be answered through well-designed
scientific studies
 --questions such as whether these therapies are safe
and whether they work for the diseases or medical
conditions for which they are used.”
Complementary, Alternative
and Mainstream Therapies


Alternative                   Mainstream




              Complementary
    US PedsCAM, 21st century
• 2000 NIH funding for 1st R25 Pediatric Holistic
  Education/Research Ctr.
• 2003 CARE program in Edmonton, Alberta
• 2004 AAP Member Survey about CAM use
• 2005 AAP SOCIM provisional
• 2006 AAP Pediatrics in Review series starts
  (Vohra)
• 2007 Pediatric Clinics of North America – special
  Peds CAM issue
• 2008 AAP SOCIM official; 12/08 Clinical Report
• 2010 Integrative Pediatrics textbook published
  (eds: Culbert, Olness)
Ethical framework for Therapies

                 Effective

               Yes                     No

Safe Yes Use/Recommend              Tolerate

     No   Monitor closely      Advise against

                            Cohen M. Pediatrics, 2005
         Effectiveness?
– What therapy? (acupuncture is NOT herbs
  is NOT massage)
– For whom? (adults vs. kids; men vs.
  women)
– For what condition? (cancer, colds)
– Under what circumstances/context?
– For what desired outcome?
– Costs/benefits – immediate and long-term

                       Kemper. Arch Dis Child, 2001
    Surgery for Appendicitis
               Effective

               Yes                     No


Safe Yes Use/Recommend              Tolerate

     No   Monitor closely      Advise against

                            Cohen M. Pediatrics, 2005
  Surgery for Common Cold
              Effective

               Yes                    No

Safe Yes Use/Recommend            Tolerate

     No   Monitor closely   Advise against

                            Cohen M. Pediatrics, 2005
      Pain: Does CAM work?
           Acupuncture

                     Effective
               Yes                    No
         Use/Recommend
          ? For children;
Safe Yes acute vs. chronic        Tolerate

      No   Monitor closely   Advise against
                             Cohen M. Pediatrics, 2005
  Conventional or CAM CE
     Treatment Trial
1) Medication (TAU) vs
    2) TAU + Acup                 Pain Score +/-
         Vs.                                       Primary
                                Biomarker Change
 3)Acupuncture alone
    4) Sham Acup.
                                                       HR-QOL
                                                      Well-being
                                                         Cost
                                          Secondary   Satisfaction
                         PAIN                         Recurrence


                                     Treatment and Disease-
                                     focused research and care
       Integrative Pediatrics:
       Research Opportunities
• Comparative effectiveness using traditional
  model
• Single vs. multiple or system interventions
• Patient-centered research
• Research on PROCESS of care; relationships,
  communication, presence, intention
• Research on TRANSLATION (education,
  policy, systems of care)
      Hypericum vs. Imipramine
           for Depression
80                                                                      Hypericum
70                                                                      Imipramine
60
50
40
30
20
10
0
     Effectiveness (%)   Side Effects (%)   Cost per Month ($)

                                                 Harrer, G. Phytomedicine. 1994;1:3-8.
Weight of Evidence of DS
Weaker Evidence
       Questions – CAM research
•   Probiotics for diarrhea
•   Acupuncture for pediatric pain
•   Mindful eating for obesity
•   Herbs for asthma
•   Homeopathy for otitis media
•   Vitamin D to prevent influenza
•   Massage for sleep, anxiety
   Research Opportunities:
  Comparative Effectiveness
• Beyond placebo-controls
• Comparative effectiveness
  – Learn from 104 CE studies of medications, only 11
    of which compared meds to non-med
    interventions
  – Look at safety
  – Look at effectiveness
  – Satisfaction
  – Costs and side effects, including opportunity costs,
    interactions, side benefits
  – Long-term results (not just 8 week trials)
       Hochman and McCormick, JAMA, 2010;303: 951
       Integrative Pediatrics:
       Research Opportunities
• Comparative effectiveness using traditional
  model
• Single vs. multiple or system interventions
• Patient-centered research
• Research on PROCESS of care; relationships,
  communication, presence, intention
• Research on TRANSLATION (education,
  policy, systems of care)
 Single vs. Multiple interventions
• Mindfulness treatment for obesity vs.
  mindfulness + diet + support group + activity
• Acupuncture for headache vs. acupuncture +
  B2 + Mg + avoid triggers + stress
  management

• Benefits: More realistic
• CHALLENGEs: MULTIPLE CONTROLS,
  sequential, simultaneous? Cost? Analysis?
Complex System Evaluations
Heart Center    Oncology     Neuroscience   Bone & Joint
  Fitness      Acupuncture   Acupuncture    Acupuncture
                             Biofeedback      Fitness




                                                            CAM
                                                           Center
                    Massage
                    Nutrition
                Pharmacy/ RNs
                PT/ Psych/ Soc
Limits of focus on TREATMENTS
       • CAM defined by “otherness”;
         foreign, strange, untrustworthy
       • Moving target, changes over
         time (Massage? Probiotics? Fish
         oil? Vitamin D? acupuncture?)
       • Relies on diagnosis-driven model
         to test effectiveness (efficacy)
         and safety/costs for specific
         conditions
       • E.g., is acupuncture good for
         pain? Might acupuncture help
         YOU feel better?
 CAM is a SUBSET of tools
within Integrative Medicine
  Integrative Medicine is a system of
 comprehensive care that emphasizes wellness
 and healing of the whole person, with special
 emphasis on patient participation, and
 attention to mental and spiritual health. The
 knowledge and use of Complementary and
 Alternative Medicine (CAM) is an important
 aspect of Integrative Medicine.

           Section on Integrative Medicine, Internal Medicine, UNM
       Consortium of Academic Health
          Centers for Integrative
                 Medicine:
   “Integrative Medicine is the practice of
medicine that reaffirms the importance of the
relationship between practitioner and patient,
focuses on the whole person, is informed by
evidence, and makes use of all appropriate
therapeutic approaches, healthcare
professionals and disciplines to achieve
optimal health and healing.”
      COMMUNICATION and COUNSELING
       Patient-Centered Care
• Place the PATIENT at the center
• Individualize Care
• “ The sources of suffering are in
  separateness, and the remedy is in
  remembering that we are all in this together.
  Integration, if it is to thrive, is the name of a
  duty to contribute what we can to a troubled
  and suffering planet.”
             Don Berwick, MD. IOM report, 2009
 Patient-Centered Medical Home
      Movement (GHC trial)
• Goal: “Maintain continuous healing, care-
  providing relationships”
• How: Reduce # patients per primary care
  clinician; Increase time available per visit
  (from 20 to 30 minutes at GHC); Pre-visit
  chart review; Ongoing quality audits
• Outcome: Improved patient experience,
  quality, clinician experience; decreased
  hospitalizations and ED visits

             Larson EB, Reid R. JAMA, 2010 (April 28)
       Integrative Pediatrics:
       Research Opportunities
• Comparative effectiveness using traditional
  model
• Single vs. multiple or system interventions
• Patient-centered research
• Research on PROCESS of care; relationships,
  communication, presence, intention
• Research on TRANSLATION (education,
  policy, systems of care)
Patients’ Goals for Health
          "First say to yourself
     what you would be; and then do
           what you have to do."
                             Epitectus

    “You got to be careful if you don't
        know where you're going,
        because you might not get
                  there.”
                            Yogi Berra
What do we want? HEALTHY
 Children and Adolescents
• What IS holistic health?
   –   Physical
   –   Emotional
   –   Mental
   –   Spiritual
   –   Social
• Research opportunity!
   – Develop and
     validate
     (objective)
     measures of
     pediatric health
Optimal Physical health
         •   Strength
         •   Vitality
         •   Flexibility
         •   Stamina/Endurance
         •   Coordination
         •   Resilience
         •   Skills
         •   Comfort
   Other dimensions of health
• Emotional: mood, confidence,
  resilience in face of stress
• Mental: attention, focus, skills
• Spiritual: meaning, love, wisdom,
  gratitude, forgiveness
• Social: connection with friends,
  community, culture, school, work,
  autonomy, freedom, respect,
  communication

• Daily function   PRIORITIES
 Goals for Health
YANG-type/ Specific         YIN-type/Global,
Cure                        Connection/Support/
Manage symptoms               Trust
Prevent specific disease    Meaning/Transcendence
Reduce or manage specific   Harmony
  toxin                     Peace
                            Well-being/ Resilience
EASIER TO MEASURE           Reduce dependence

                            HARDER TO MEASURE
Research Opportunity!
   • Develop ways to reliably
     identify patients’ goals and
     priorities
   • Compare and contrast goals
     and priorities with typical
     diagnoses
   • Can we predict who has
     what goals?
Strategies to Achieve Goals
                            Interventions

          Specialist care



         Home Remedies/
          Primary Care




    Individual Behavior/Lifestyle



               Society
Genes          Culture        Environment
Healthy Habits, Healthy Habitat

       Relationships   Food




                       Fitness
    Manage Stress
      More strategies
(following fundamentals)
    • 1st DO NO HARM; SAFETY FIRST
    • Behavior management;
      psychotherapy; counseling; peer
      support
    • Supplements and Herbs (OTC)
    • Massage, Acupuncture, Biofield
    • Medications, Surgical
      interventions
        Models for Treatment
                    Disease in
    Treatment                       Symptoms           QOL
                    Organ or
                                                     Well-being
                      Tissue

      Yang                          Primary          Secondary



B                                    Peace
                                                     Symptoms
    Treatment        Person        Connection
                                                         or
                                     Trust
                                                      Disease
                                    Harmony
       Yin
                                   Primary           Secondary

         CHALLENGE: Measuring YIN Primary Outcomes
       Yin Treatment/Therapy
                             Peace
                           Connection
                             Trust
                            Harmony

                              Primary
                                               Less pain
                                           Less depression
                  Person                     Less anxiety
                                        Better immune function
                                         Less Heart Disease
    Social                                   Less cancer
Support; music;                             Secondary
      HT;
  acupuncture          Measurement issues?????
       Community-based
   participatory research ->
   Patient-centered research
• Ask the community what the important issues
  are
  – Ask the patient what they’d like help with
• Ask the community what the resources and
  barriers are
  – Ask the patient what they’d like to try
• Ask the community to identify relevant
  outcomes
  – Ask the patient “how will we know this has
    worked?”
       Integrative Pediatrics:
       Research Opportunities
• Comparative effectiveness using traditional
  model
• Single vs. multiple or system interventions
• Patient-centered research
• Research on PROCESS of care; relationships,
  communication, presence, intention
• Research on TRANSLATION (education,
  policy, systems of care)
                 Preference Trials
• What do patients want? Preferences
  affect enrollment in RCTs
• Simultaneous preference (prospective
  cohort or quasi-experimental or
  observational) and RCT strengthen
  generalizability and address bias
                     King M, et al. Health Technol Assessment, 2005
   Pediatric studies: Paradise J (T&A for r. sore throat) NEJM, 1984
               Reddihough DS (education for children with CP) 1998
                   Rovers MM (ear tubes for OME) J Clin Epid, 2001
  Preference Trials in CAM
1. Preferences can affect outcomes (those
   who get what they prefer in RCTs have
   better outcomes)
    Preference Collaborative Review Group. BMJ, 2008;37:a1864
2. Patients can seek many CAM therapies
    without a prescription; admit it, we have
    little control
3. Consistent with respect for autonomy and
    patient-centered care values
                        Service
    Who           Restaurant       Conventional        Pt-centered
  decides?                            Care                 Care

Greeting.            Hello,        Hello. Sorry I’m   Hello.
Problem           welcome, my      late. I see you    Welcome. How
assessment         name is __.     have migraine      can I help you
                  What can I get   headaches.         today? What
                    for you?       Anything else?     are your goals?
Who decides           Diner        Doctor. E.g.,      Patient/family
on the relevant                    Drug A, B or C     counseled by
intervention                                          clinician
Who decides           Diner        Doctor. E.g.,      Patient/Family
on the                             Headache           counseled by
outcome?                           frequency,         MD; how will
                                   severity           we know we
                                                      succeeded?
   Patient-centered Research
 Characteristic     Conventional     Pt-centered         Pt-centered
                      Research           Care             Research

Who decides on       Researcher/   Patient/Family     Patient/ family /
the problem?           Funder      helped to set      researcher
                                   priorities by MD
Who decides on       Researcher    Patient/family     Patient/ family /
the relevant                       counseled by       researcher
outcome                            physician or other
                                   clinician
Who decides on       Researcher/   Patient/Family     Patient/ family /
the intervention?      chance      counseled by MD    researcher
       Integrative Pediatrics:
       Research Opportunities
• Comparative effectiveness using traditional
  model
• Single vs. multiple or system interventions
• Patient-centered research
• Research on PROCESS of care; relationships,
  communication, presence, intention
• Research on TRANSLATION (education,
  policy, systems of care)
Research on the Process of
          Care
What we Know and
 Do
 - Knowledge
 - Skills
Who and Why We’re
 Here
 - Presence
 - Intention
 (Compassion)
     TEAMWORK
       Integrative Pediatrics:
       Research Opportunities
• Comparative effectiveness using traditional
  model
• Single vs. multiple or system interventions
• Patient-centered research
• Research on PROCESS of care; relationships,
  communication, presence, intention
• Research on TRANSLATION (education,
  policy, systems of care)
Translational science

      Translating scientific
      findings from one level
      of research into activity
             in another
            Translational CAM
              Opportunities

                T2           Health Services Research: health
                             effects, costs, satisfaction, impact on
                             work, quality of life in populations        T3
             Clinical Research:                                  Clinical
            efficacy and safety in                               Behavior
T1              special groups                                   and Advice
                                                                 for Individual
Basic Research:                                                  Patients
 in vitro/animals:                   Health-related
    mechanism                          Behavior
                      External Factors affecting
                             translation

                T2           Health Services Research: health
                             effects, costs, satisfaction, impact on
                             work, quality of life in populations        T3
             Clinical Research:                                  Clinical
            efficacy and safety in                               Behavior
                                        Internet                 and Advice
T1              special groups          /Media                   for Individual
Basic Research:                                                  Patients
 in vitro/animals:              Human Health-related
    mechanism                       Behavior
           External factors -> TS
Environment: Built, Culture, Income, Education, Access,
               Power, Politics, Profit

                 T2           Health Services Research: health
                              effects, costs, satisfaction, impact on
                              work, quality of life in populations        T3
              Clinical Research:                                  Clinical
             efficacy and safety in                               Behavior
                                         Internet                 and Advice
 T1              special groups          /Media                   for Individual
 Basic Research:                                                  Patients
  in vitro/animals:              Human Health-related
     mechanism                       Behavior
      Integrative Pediatrics:
      Research Opportunities
• Comparative effectiveness using
  traditional model
• Patient-centered research
• Research on PROCESS of care;
  relationships, communication, presence,
  intention
• Research on TRANSLATION
Research and Advocacy
 “You’re not done with your research
until there’s been a change in policy or
                practice.”
                           Abe Bergman
Allies: Citizen, Media, and
     Clinician Demand
          Demand for clinical change –
             access to CAM providers
             and therapies
          +
          Demand for education for
             conventional providers to
             become knowledgable
          Leads to

          Demand for research to
             evaluate
Accelerating Change
   “When the wind changes
    direction, there are those
    who build walls and those
    who build windmills.”
                 Chinese saying
Take heart from Progress
    • Hypnosis and biofeedback
      considered CAM 40 years ago; now
      practiced widely
    • Acupuncture considered CAM 30
      years ago, now offered in over 1/3
      of pediatric pain treatment
      programs in North America
    • Therapeutic and Healing Touch
      considered CAM 25 years ago, now
      taught in over 80 nursing schools in
      US
              Overcoming
           Barriers to Change
• Tradition/inertia; pre-contemplative stage
• Power threatened
   FOCUS ON EARLY ADAPTERS and MAJORITY
  Innovation
“If all you ever do is all you’ve
  ever done, then all you’ll ever
  get is all you ever got.”
               Texas folk wisdom

• “The path is made by
  walking.”
            African folk wisdom
          Collaboration


“Never doubt that a small group of
  thoughtful, committed citizens can
  change the world. Indeed, it is the only
  thing that ever has.”
                           Margaret Mead
    Thank you for all you do to
     promote better health for
           children!!!!
• Comparative effectiveness using
  traditional model
• Patient-centered research
• Research on PROCESS of care;
  relationships, communication, presence,
  intention
• Research on TRANSLATION

								
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