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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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