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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 20 th century conventional care: TTDD Triage and Test; Diagnose and Dispense

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Advancing from CAM to Integrative Pediatrics – Research Barriers and Opportunities

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Advancing from cam to integrative pediatrics research barriers and opportunities l.jpg

Advancing from CAM to Integrative Pediatrics – Research Barriers and Opportunities

“… a series of great opportunities disguised as insoluble problems.”

John Gardner

Founder, Common Cause


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Late 20th century conventional care: TTDD

  • Triage and Test;

  • Diagnose and Dispense

  • Diagnosis must precede treatment.

  • Silver bullets (clean) vs. Cocktails (messy/dirty)


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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?

Pros and Cons: TTDD, Bullet


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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


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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.”


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Complementary, Alternative and Mainstream Therapies

Alternative

Mainstream

Complementary


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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)


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Ethical framework for Therapies

Cohen M. Pediatrics, 2005


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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


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Surgery for Appendicitis

Effective

Cohen M. Pediatrics, 2005


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Surgery for Common Cold

Effective

Cohen M. Pediatrics, 2005


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Pain: Does CAM work? Acupuncture

Effective

Cohen M. Pediatrics, 2005


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Conventional or CAM CE Treatment Trial

1) Medication (TAU) vs

2) TAU+ Acup

Vs.

3)Acupuncture alone

4) Sham Acup.

Pain Score +/-

Biomarker Change

Primary

HR-QOL

Well-being

Cost

Satisfaction

Recurrence

PAIN

Secondary

Treatment and Disease-focused research and care


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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)


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Hypericum vs. Imipramine for Depression

Harrer, G. Phytomedicine. 1994;1:3-8.


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Weight of Evidence of DS


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Weaker Evidence


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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


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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


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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)


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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?


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Heart Center

Fitness

Oncology

Acupuncture

Neuroscience

Acupuncture

Biofeedback

Bone & Joint

Acupuncture

Fitness

Nutrition

Pharmacy/ RNs

Massage

PT/ Psych/ Soc

Complex System Evaluations

CAM Center


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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?


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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


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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


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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


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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)


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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)


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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


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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


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Optimal Physical health

  • Strength

  • Vitality

  • Flexibility

  • Stamina/Endurance

  • Coordination

  • Resilience

  • Skills

  • Comfort


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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 functionPRIORITIES


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YANG-type/ Specific

Cure

Manage symptoms

Prevent specific disease

Reduce or manage specific toxin

EASIER TO MEASURE

YIN-type/Global,

Connection/Support/

Trust

Meaning/Transcendence

Harmony

Peace

Well-being/ Resilience

Reduce dependence

HARDER TO MEASURE

Goals for Health


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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?


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Strategies to Achieve Goals


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Interventions

Society

Culture

Environment


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Healthy Habits, Healthy Habitat

Relationships

Food

Fitness

Manage Stress


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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


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Models for Treatment

Disease in

Organ or

Tissue

Symptoms

QOL

Well-being

Treatment

Treatment

Yang

Primary

Secondary

Person

Symptoms

or

Disease

Peace

Connection

Trust

Harmony

B

Yin

Primary

Secondary

CHALLENGE: Measuring YIN Primary Outcomes


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Yin Treatment/Therapy

Peace

Connection

Trust

Harmony

Social

Support; music; HT; acupuncture

Primary

Person

Less pain

Less depression

Less anxiety

Better immune function

Less Heart Disease

Less cancer

Secondary

Measurement issues?????


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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?”


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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)


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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


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Preference Trials in CAM

  • 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


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Service


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Patient-centered Research


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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)


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Research on the Process of Care

What we Know and Do

- Knowledge

- Skills

Who and Why We’re Here

- Presence

- Intention (Compassion)

TEAMWORK


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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)


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Translational science

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


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Translational CAM Opportunities

T2

Health Services Research: health effects, costs, satisfaction, impact on work, quality of life in populations

T3

Clinical Behavior and Advice for Individual Patients

Clinical Research: efficacy and safety in special groups

T1

Basic Research: in vitro/animals: mechanism

Health-related Behavior


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External Factors affecting translation

T2

Health Services Research: health effects, costs, satisfaction, impact on work, quality of life in populations

T3

Clinical Behavior and Advice for Individual Patients

Clinical Research: efficacy and safety in special groups

Internet/Media

T1

Basic Research: in vitro/animals: mechanism

Human Health-related Behavior


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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 Behavior and Advice for Individual Patients

Clinical Research: efficacy and safety in special groups

Internet/Media

T1

Basic Research: in vitro/animals: mechanism

Human Health-related Behavior


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Integrative Pediatrics: Research Opportunities

  • Comparative effectiveness using traditional model

  • Patient-centered research

  • Research on PROCESS of care; relationships, communication, presence, intention

  • Research on TRANSLATION


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Research and Advocacy

“You’re not done with your research

until there’s been a change in policy or practice.”

Abe Bergman


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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


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Accelerating Change

“When the wind changes direction, there are those who build walls and those who build windmills.”

Chinese saying


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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


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Overcoming Barriers to Change

  • Tradition/inertia; pre-contemplative stage

  • Power threatened

    FOCUS ON EARLY ADAPTERS and MAJORITY


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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


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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


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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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