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Advancing from CAM to Integrative Pediatrics – Research Barriers and
Opportunities “… a series of great
opportunities disguised as insoluble problems.”
John GardnerFounder, 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• Specific• Tidy• Reduce side effects
due to unnecessary treatments
Cons• Patients don’t always
fit a specific diagnosis• Won’t always accept
a diagnosis • 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
Yes No
Safe Yes Use/Recommend Tolerate
No Monitor closely Advise against
Cohen M. Pediatrics, 2005
Effective
Surgery for Common Cold
Yes No
Safe Yes Use/Recommend Tolerate
No Monitor closely Advise against
Cohen M. Pediatrics, 2005
Effective
Pain: Does CAM work? Acupuncture
Yes No
Safe Yes
Use/Recommend ? For children;
acute vs. chronic Tolerate
No Monitor closely Advise against
Cohen M. Pediatrics, 2005
Effective
Conventional or CAM CE Treatment Trial
1) Medication (TAU) vs 2) TAU + Acup
Vs. 3)Acupuncture alone
4) Sham Acup.
PAIN
Pain Score +/-Biomarker Change
HR-QOLWell-being
CostSatisfactionRecurrence
Primary
Secondary
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
0
10
20
30
40
50
60
70
80
Effectiveness (%) Side Effects (%) Cost per Month ($)
Hypericum
Imipramine
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
Fitness
Oncology
Acupuncture
Neuroscience
Acupuncture
Biofeedback
Bone & Joint
Acupuncture
Fitness
PT/ Psych/ Soc
Nutrition
Pharmacy/ RNs
Massage
CAM Center
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/ SpecificCureManage symptomsPrevent specific diseaseReduce or manage
specific toxin
EASIER TO MEASURE
YIN-type/Global,Connection/Support/
TrustMeaning/TranscendenceHarmonyPeaceWell-being/ ResilienceReduce 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
Specialist care
Home Remedies/Primary Care
Individual Behavior/Lifestyle
Genes Environment
Society
Culture
Interventions
Healthy Habits, Healthy Habitat
Food
FitnessManage
Stress
Relationships
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
TreatmentDisease inOrgan orTissue
Symptoms QOLWell-being
Treatment PersonPeace
ConnectionTrust
Harmony
Symptoms or
Disease
Primary Secondary
Primary Secondary
B
Yang
Yin
CHALLENGE: Measuring YIN Primary Outcomes
Yin Treatment/Therapy
Social Support; music;
HT; acupuncture
Person
PeaceConnection
TrustHarmony
Less painLess depression
Less anxietyBetter immune function
Less Heart DiseaseLess cancer
Primary
Secondary
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, 2005Pediatric studies: Paradise J (T&A for r. sore throat) NEJM, 1984
Reddihough DS (education for children with CP) 1998Rovers 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
ServiceWho
decides?Restaurant Convention
al CarePt-centered
Care
Greeting.Problem assessment
Hello, welcome, my name is __. What can I get for you?
Hello. Sorry I’m late. I see you have migraine headaches. Anything else?
Hello. Welcome. How can I help you today? What are your goals?
Who decides on the relevant intervention
Diner Doctor. E.g., Drug A, B or C
Patient/family counseled by clinician
Who decides on the outcome?
Diner Doctor. E.g., Headache frequency, severity
Patient/Family counseled by MD; how will we know we succeeded?
Patient-centered Research
Characteristic ConventionalResearch
Pt-centered Care
Pt-centered Research
Who decides on the problem?
Researcher/ Funder
Patient/Family helped to set priorities by MD
Patient/ family / researcher
Who decides on the relevant outcome
Researcher Patient/family counseled by physician or other clinician
Patient/ family / researcher
Who decides on the intervention?
Researcher/ chance
Patient/Family counseled by MD
Patient/ family / 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
Basic Research: in vitro/animals:
mechanism
Clinical Research: efficacy and safety in
special groups
Health Services Research: health effects, costs, satisfaction, impact on work, quality of life in populations
T1
T2
Health-related Behavior
Clinical Behavior and Advice for Individual Patients
T3
External Factors affecting translation
Basic Research: in vitro/animals:
mechanism
Clinical Research: efficacy and safety in
special groups
Health Services Research: health effects, costs, satisfaction, impact on work, quality of life in populations
T1
T2
Human Health-related Behavior
Clinical Behavior and Advice for Individual Patients
T3
Internet/Media
External factors -> TS
Basic Research: in vitro/animals:
mechanism
Clinical Research: efficacy and safety in
special groups
Health Services Research: health effects, costs, satisfaction, impact on work, quality of life in populations
T1
T2
Human Health-related Behavior
Clinical Behavior and Advice for Individual Patients
T3
Environment: Built, Culture, Income, Education, Access, Power, Politics, Profit
Internet/Media
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 threatenedFOCUS 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