Advancing from CAM to Integrative Pediatrics – Research Barriers and Opportunities

2. Advancing from CAM to Integrative Pediatrics – Research Barriers and Opportunities “… a series of great opportunities disguised as insoluble problems.” John Gardner Founder, Common Cause

3. Late 20th century conventional care: TTDD • Triage and Test; • Diagnose and Dispense • Diagnosis must precede treatment. • Silver bullets (clean) vs. Cocktails (messy/dirty)

4. 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

5. 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

6. 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.”

7. Complementary, Alternative and Mainstream Therapies Alternative Mainstream Complementary

8. 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)

9. Ethical framework for Therapies Cohen M. Pediatrics, 2005

10. 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

11. Surgery for Appendicitis Effective Cohen M. Pediatrics, 2005

12. Surgery for Common Cold Effective Cohen M. Pediatrics, 2005

13. Pain: Does CAM work? Acupuncture Effective Cohen M. Pediatrics, 2005

14. 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

15. 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)

16. Hypericum vs. Imipramine for Depression Harrer, G. Phytomedicine. 1994;1:3-8.

17. Weight of Evidence of DS

18. Weaker Evidence

19. 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

20. 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

22. 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)

23. 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?

24. Heart Center Fitness Oncology Acupuncture Neuroscience Acupuncture Biofeedback Bone & Joint Acupuncture Fitness Nutrition Pharmacy/ RNs Massage PT/ Psych/ Soc Complex System Evaluations CAM Center

25. 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?

26. 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

27. 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

28. 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

29. 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)

30. 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)

31. 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

32. 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

33. Optimal Physical health • Strength • Vitality • Flexibility • Stamina/Endurance • Coordination • Resilience • Skills • Comfort

34. 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

35. 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

36. 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?

38. Strategies to Achieve Goals

39. Interventions Society Culture Environment

40. Healthy Habits, Healthy Habitat Relationships Food Fitness Manage Stress

41. 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

42. 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

43. 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?????

44. 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?”

45. 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)

46. 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

47. 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

48. Service

49. Patient-centered Research

50. 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)