EVIDENCE BASED HEALTH CARE OR COLONIALISM BY PROXY

A Social Constructivist Perspective

Peter Wyer MDCo-Chair, Section on Evidence Based Health Care

New York Academy of MedicineDepartment of Medicine, Columbia University Medical Center

Where Did EBHC Come From?

EB GuidelinesCanadian

screening 1979

EB PolicyVariations research

1973

EB ReviewsCochrane –RCTs

1972

EB MedicineClin epi

Feinstein /Sackett 1968

Health Care DeliveryKnowledge Translation

“EVIDENCE BASED HEALTH CARE“

David Eddy 1990  GRADE 2003

Where Did EBHC Come From?

Gordon Guyatt   1991

“Evidence-Based………”

• Medicine• Clinical practice• Health policy• Clinical guidelines• Quality improvement• Clinical reasoning• Diagnosis

THEY DON’T WORK!!

The Rationalist Fallacy

Dualism in Thought and Action

• “Cogito ergo sum”• “I think therefore I am”• I know, therefore you should do• I discover, therefore you should implement

“Evidence-Based………”

• medicine--doesn’t change behavior• clinical practice--?• health policy—adversarial politics• clinical guidelines—adopted blindly or not at all• quality improvement—not implemented• clinical reasoning—too theoretical• diagnosis—misapplication

Development of a Research Idea For Application to Clinical Practice

Ideas

BenchResearch

Earlyhuman trials

RCT SR Clinical Practice

Clinical Practice

The “Evidence Transfer Gap”

RCT SR

Haynes ACP Journal Club 2005

The Path From Research to Improved Health Outcomes

Glasziou, Haynes ACP Journal Club 2005

"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 FreireEducation for Critical Consciousness Continuum Books London 1974

Silva, Charon Wyer J Eval Clin Pract 2011

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

• Explicitly aligned with established tendencies– Schon: Reflective action – Engel: Biopsychosocial model

Relationship Centered Care• Extended applications of RCC-Pew/Fetzer

– Complexity theory in health care organizations– Critique of methodology of research into health care

communications and interactions– Integration of relationship-based and evidence-based care

• Additional elaborations– Connection to organizational knowledge creation (Nonaka)– Affinity with social constructivism (Freire)

Wyer, Silva, Post, Quinlan J Eval Clin Pract 2014

“Evidence-based” versus

• Evidence-informed• Evidence-influenced• Evidence-guided• Scientifically-informed

EXAMPLE

Rivers-NEJM 2001(Early Goal Directed Therapy)

• Early administration of a bundle of interventions

• 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

Renewed Interest in Sepsis Care

• ‘Hemodynamic optimization’ previously rejected• Problem previously owned by intensivists• Now shared by emergency medicine

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

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

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

“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

Second Try-SSC 2008• SSC continued to receive support from Lilly, Edwards• Divested from direct sponsorship of guideline• Switched to GRADE: can’t tell how applied• Lead author + other panel members- enhanced

disclosures of ties to industry including Lilly, Edwards • No change in recommendations, including Xigris, EGDT• Ratings applied to individual components of EGDT• Evidence on different bundled sepsis interventions

ignored

Dellinger et al Critical Care Med 2008;36:396-327

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

Third Try-SSC 2013

• Recommendations largely unchanged• Xigris recommendation dropped due to

unavailability of drug• Marginal pruning of COI since 2008• Still can’t tell how GRADE being used• Minimal attention to new evidence

Dellinger et al Critical Care Med 2013;41:580-637

IOM 2011 Standards• 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%

Updating

Lactate 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

Updating

ProCESS-2014• Multi-center RCT-largest sepsis trial to date• Comparative effectiveness design

– EGDT– Protocol driven control-SBP sole optimization

• Hgb > 7.5 g/dL– Standard care –no protocol

• Adherence high in EGDT, some X-overs in controls• Mortality trends (ns) favored standard arms

ProCESS Investigators N Engl J Med 2014;370:1683-1693

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

• Constructivist approach to guidelines• Complexity theory

Relationship Centered vs Patient Centered

• “Patient Centered” coined over 50 years ago • Practitioner included in the concept• Not “consumerism”• Not only “patient satisfaction”

RCC and SSC: What happened?

• The patients want to live, for the most part• For some the ICU experience may not be

worth it• SSC: the practitioners were left out• It was an industry affair + with a few

epidemiologists

SSC in the US

• Open rebellion against SSC• Academics, researchers, practitioners• Opposition a rare partnership• No one bought the need for the catheter• The guidelines were not trusted• Research was mounted to discredit EGDT• Only the “E” part was retained (“early”)

SSC Outside US

• Spanish before-after study• 59 medical/surgical ICUs• Education program based on EGDT• On-sight champions• Compliance <50% for all components• Compliance ~11% for Edwards catheter• Absolute increase in 28-d survival 5%

Ferrer JAMA 2008;299:2294-2303

Sepsis Care in Developing Countries

• SSC aggressively implemented in Brazil due to influence of European opinion leader within intensive care circles

• The leader in question among the most conflicted member of the guideline effort

• The leader in question never divested his ties to industry

Sepsis Care in Developing CountriesHarms vs Benefits

• Brazilian lives were saved • 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

Sepsis Care in Developing CountriesColonialism by Proxy

• Externally developed guidelines require adaptation, not adoption

• Dangers of blanket adoption may be substantial

• Proprietary interests supercede patient and social interests

• Blind adoption impedes local capacity building

SUMMARY• Relational principles govern research use • Research methodology, no matter how strong, is, in

itself, an inadequate basis for improving health care• 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