Evidence-Based Medicine, Person Centered Care, Relationship Centered Care

1. Evidence-Based Medicine, Person Centered Care, Relationship Centered Care (Why you need the skills being taught in this course) Peter Wyer MD Co-Chair, Section on Evidence Based Health Care New York Academy of Medicine Department of Medicine, Columbia University Medical Center

2. “EBM/MBE”: Many Things or Everything?

3. What Is “MBE”?

4. The Many Faces of “MBE”Possible Answers • Control of over-utilization • Rationalization of resource allocation • Decreasing unwanted variation in services • Doing research • Basing decisions on research • Refuting and rejecting research

5. EB Policy Variations research 1973 EB Reviews Cochrane–RCTs 1971 EB Medicine Clinical epidemiology 1968 EB Guidelines Canadian screening 1979 David Eddy 1990 GRADE 2003 Gordon Guyatt 1990 “SCIENTIFICALLY INFORMED HEALTHCARE“

6. Are Clinical Guidelines Trustworthy?

7. New Standards for Clinical Guidelines Institute of Medicine 2011 Clinical Practice Guidelines We Can Trust • Transparent • Minimal conflict of interest • Appropriate mix of stakeholders • Systematic reviews on all questions • Explicit evidence grading system • Recommendations • actionable • reflect consideration of benefits and harms • Externally reviewed • Up to date

8. Pitfalls of the Best GuidelinesLinear Research DesignsBoyd et al JAMA 2005;294:716-724 • Prototype elderly patient with multiple conditions • Diabetes • Hypertension • Osteoarthritis and osteoporosis • COPD • Reviewed guidelines relevant to the conditions • Screened guidelines for quality • Extracted recommendations

9. It’s Not Easy Living with Multiple Chronic Conditions Boyd et al. JAMA 2005;294:716-724

10. Care Maps http://durgastoolbox.com/2012/09/19/durga-tool-9-my-care-map-or-the-picture-that-tells-a-thousand-words/

11. Multiple Chronic Conditions is Common Percentage of Major Chronic Disease in Isolation Among Women Aged 65 or Older: NHANES, 1999-2004 Weiss CO et al. JAMA 2007;298:1160-1162

12. So what does this have to do with “relationship centered care”?

13. No man is an island,Entire of itself.Each is a piece of the continent,A part of the main ………….Therefore, send not to knowFor whom the bell tolls,It tolls for thee - John Donne 1624, “Meditation 17”

14. "Repetimos que o conhecimento não se estende do que se julga sabedor  até aqueles que se julga não saberem; o conhecimento se constitui nas  relações homem-mundo; relações de transformação, e se aperfeiçoa na  problematização crítica destas relações.“ Paulo Freire Education for Critical ConsciousnessContinuum Books London 1974

15. Relationship Centered Care • 1993-94: Pew Commission/Fetzer Institute • Tasked to integrate psychosocial and biomedical issues in health care • Epistemologically defined construct • Polanyi: tacit dimension • Merleau-Ponty: predecessor of complexity theory • Aligned with established tendencies • Schon: Reflective action • Engel: Biopsychosocial model Wyer, Silva, et al J Eval Clin Pract 2014

16. EXAMPLEEvidence Based Health Care or Colonialism by Proxy A Story

17. Rivers-NEJM 2001(Early Goal Directed Therapy) • 263 patients with severe sepsis • Randomized to early administration of a bundle of interventions vs standardized control • Bundle based on a set of fixed parameters for hemodynamic optimization • Required monitoring of central venous O2 sat via special catheter • 16% absolute increase in survival Rivers et al NEJM 2001;345:1368-1377

18. Renewed Interest in Sepsis Care • ‘Hemodynamic optimization’ previously rejected • Problem previously owned by intensivists • Now shared by emergency medicine

19. The effect of a quantitative resuscitation strategy on mortality in patients with sepsis: A meta-analysis* Alan E. Jones, MD; Michael D. Brown, MD, MSc; Stephen Trzeciak, MD, MPH. Critical Care Medicine 2008

20. Surviving Sepsis Campaign(and 2004 guidelines) • Adopted the Rivers protocol • Used grading system based solely on evidence rating • Evidence rating based on design only • Recommended the bundle as a whole and all of the components • Recommended activated protein C (Xigris) Dellinger et al Critical Care Med 2004;22:858-873

21. By 2004 the principal challenge facing sepsis care appeared to be getting the practice community to adopt and adhere to the Surviving Sepsis Campaign guidelines BUT Trouble appeared

22. “Trouble Right Here in Rivers City”(American Hit Musical Comedy: “The Rain Maker”) • Rivers’ study funded by Edwards • Surviving Sepsis guideline funded 90% by Eli Lilly, maker of Xigris, also by Edwards • Lead author of SSC had ties to Lilly • Rivers found to have ties to Lilly, Edwards • Many others with ties to industry including Lilly and Edwards Eichaker N Engl J Med 2006;355:1640-1642

23. Second Try-SSC 2008 • SSC still supported by Lilly, Edwards • Divested `direct sponsorship of guideline • Switched to GRADE: ? how applied • Lead author + other panel members- disclose ties to industry including Lilly, Edwards • Recommendations for Xigris, EGDT unchanged • Ratings applied to individual components of EGDT • Evidence ignored on different bundled interventions Dellinger et al Critical Care Med 2008;36:396-327

24. The effect of a quantitative resuscitation strategy on mortality in patients with sepsis: A meta-analysis* Alan E. Jones, MD; Michael D. Brown, MD, MSc; Stephen Trzeciak, MD, MPH. Critical Care Medicine 2008

25. Third Try-SSC 2013 • Recommendations unchanged • Xigris recommendation dropped (drug pulled by maker) • Slight industry support from 2008 • Use of GRADE still unclear • Minimal attention to new evidence Dellinger et al Critical Care Med 2013;41:580-637

26. UpdatingLactate Clearance-2010 • Adhered to fixed HD optimization goals • Non-inferiority RCT • ScvO2 group: CVP, MAP, ScvO2 70% (EGDT) • Lactate clearance group: CVP, MAP, lactate by 10% • 6% absolute decrease in-patient mortality • Satisfied non-inferiority criteria • SSC recommended “if ScvO2 not available” Jones et al JAMA 2010;303:739-746

27. UpdatingProCESS, ARISE-2014 • Multi-center RCTs-largest sepsis trials to date • Almost 3000 patients enrolled • Common trial design • Comparative effectiveness design • EGDT • No invasive monitoring required in controls • Adherence high in EGDT • No survival advantage of EGDT N Engl J Med 2014;370:1683-1693 and 371:1496-1506

28. SSC: IOM 2011 Checklist • Transparency • Conflicts of Interest • Balanced representation • Based on systematic reviews • Rating of evidence quality and recommendations • Articulate recommendations • External review • Updating IOM Score for SSC = 25% √ √

29. SSC in the US • Open rebellion against SSC by academics, researchers, practitioners • No one believed the need for the catheter • The guidelines perceived as conflicted • Research mounted to discredit EGDT

30. SSC in Brazil • SSC aggressively implemented in Brazil through influence of highly conflicted European member • EGDT protocol followed more strictly than in the US • Brazilian lives (likely) were saved

31. SSC in Brazil Harms • Clinical harms • Harms from EGDT protocol • Hypoglycemia due to inadequately monitored insulin drips • Harms from use of Edwards catheter • Systems harms • Large unnecessary consumption of resources • Limited dissemination due to complexity

32. So what does this have to do with “relationship centered care”? • SSC developed by a single interest group • No practitioners • No care managers • No patients • Lacked ‘relational validity’ • Adaptation to a different setting would have required analogous social process

33. Colonialism by ProxyUncritical Importation of Clinical Guidelines by Developing Countries • Proprietary interests supercede patient and social interests • Externally developed guidelines require adaptation, not adoption • Dangers of blanket adoption may be substantial • Blind adoption impedes local capacity building

34. SUMMARY • Relational principles govern use research • Relational validity is required for information from research to contribute to knowledge for practice • Blind importation of health technology is a poor alternative to developing needed relational capacity • Take charge !