Transcript CAM offers lens on health care - American Academy of Pediatrics

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
• 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
Safe Yes Use/Recommend
No
Monitor closely
No
Tolerate
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
No
Monitor closely
Tolerate
Advise against
Cohen M. Pediatrics, 2005
Surgery for Common Cold
Effective
Yes
Safe Yes Use/Recommend
No
Monitor closely
No
Tolerate
Advise against
Cohen M. Pediatrics, 2005
Pain: Does CAM work?
Acupuncture
Effective
Yes
Use/Recommend
? For children;
Safe Yes acute vs. chronic
No
Monitor closely
No
Tolerate
Advise against
Cohen M. Pediatrics, 2005
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
Secondary
PAIN
HR-QOL
Well-being
Cost
Satisfaction
Recurrence
Treatment and Diseasefocused 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
Imipramine
70
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, careproviding 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
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
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
Manage Stress
Food
Fitness
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
Treatment
Disease in
Organ or
Tissue
Yang
B
Treatment
Person
Symptoms
QOL
Well-being
Primary
Secondary
Peace
Connection
Trust
Harmony
Symptoms
or
Disease
Primary
Secondary
Yin
CHALLENGE: Measuring YIN Primary Outcomes
Yin Treatment/Therapy
Peace
Connection
Trust
Harmony
Primary
Person
Social
Support; music;
HT;
acupuncture
Less pain
Less depression
Less anxiety
Better immune function
Less Heart Disease
Less cancer
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, 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
decides?
Restaurant
Conventional
Care
Pt-centered
Care
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?
Greeting.
Problem
assessment
Patient-centered Research
Characteristic
Conventional
Research
Pt-centered
Care
Pt-centered
Research
Patient/ family /
researcher
Who decides on
the problem?
Researcher/
Funder
Patient/Family
helped to set
priorities by MD
Who decides on
the relevant
outcome
Researcher
Patient/family
Patient/ family /
counseled by
researcher
physician or other
clinician
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
T2
T1
Health Services Research: health
effects, costs, satisfaction, impact on
work, quality of life in populations
Clinical
Behavior
and Advice
for Individual
Patients
Clinical Research:
efficacy and safety in
special groups
Basic Research:
in vitro/animals:
mechanism
T3
Health-related
Behavior
External Factors affecting
translation
T2
T1
Health Services Research: health
effects, costs, satisfaction, impact on
work, quality of life in populations
Clinical Research:
efficacy and safety in
special groups
Basic Research:
in vitro/animals:
mechanism
Internet
/Media
Human Health-related
Behavior
T3
Clinical
Behavior
and Advice
for Individual
Patients
External factors -> TS
Environment: Built, Culture, Income, Education, Access,
Power, Politics, Profit
T2
T1
Health Services Research: health
effects, costs, satisfaction, impact on
work, quality of life in populations
Clinical Research:
efficacy and safety in
special groups
Basic Research:
in vitro/animals:
mechanism
Internet
/Media
Human Health-related
Behavior
T3
Clinical
Behavior
and Advice
for Individual
Patients
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