Advancing from CAM to Integrative Pediatrics – Research Barriers and Opportunities “… a series...

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