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Edwin gale.egypt guidelines 2012
 

Edwin gale.egypt guidelines 2012

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    Edwin gale.egypt guidelines 2012 Edwin gale.egypt guidelines 2012 Presentation Transcript

    • Evidence and Guidelines in Diabetes Treatment Edwin Gale
    • Guidelines1. Where does judgement come from?2. The rise of the robot physician3. Guidelines for the politically incorrect4. The politics of guidelines
    • Life is short,The Art [medicine] is long to learn, Experience may be misleading, And judgement is difficult Hippocrates
    • Where does Judgement come from? 1. Tradition 2. Authority 3. Science 4. Analysis of the evidence 5. The personal factor
    • Supportive Model Based on a long-term personal relationship between patient and physicianPalliation more important than interventionThe role of the physician was often to bear witness:
    • Supportive Model Based on a long-term personal relationship between patient and physicianPalliation more important than interventionThe role of the physician was often to bear witness: “To cure sometimes, to relieve often, to comfort always”
    • Where does Judgement come from? 1. Tradition 2. Authority • Individual • Collective • Geographical 3. Science 4. Analysis of the Evidence 5. The personal factor
    • Where does Judgement come from? 1. Tradition 2. Authority 3. Science • Experiment • Population studies • RCTs 4. Analysis of the Evidence 5. The personal factor
    • Where does Judgement come from? 1. Tradition 2. Authority 3. Science • Experiment • Population studies • RCTs 4. Analysis of the Evidence 5. The personal factor
    • What do we mean by evidence?
    • What do we mean by evidence?“The concept of „evidence-based medicine‟ has been originally formulated in the English language and it rapidly appeared that the word „evidence‟ as used by Sackett et al was not easy to be adequately translated in other languages”… Pierre Lefebvre
    • … English Included! The word “evidence” is used in quite different senses, to mean• The raw material upon which a judgement is made• The key piece of data which proves the case one way or another
    • Evidence-based medicineOften used in the sense that “what I do isevidence based; what other people do is not”More accurately, it is a technique for makingbest use of the information available, and forreplacing circumstantial (suggestive) evidencewith direct (experimental) evidence, generallyobtained through RCTs
    • Evidence-based medicine works well forsituations involving well-defined patient groups, binary alternatives, and well defined outcomes…
    • But…You cannot make one good study out of 17 badstudiesEven good information is only relevant in thecontext (age group, inclusion criteria etc) inwhich that information was obtained
    • The Evidence Gap…“Evidence-based review … (must) … also besupplemented by value judgments, where thebenefits of treatment are weighed against risksand costs in a subjective fashion ...We realise that others may have differentjudgments …” ADA/EASD Consensus, Diabetologia (2009) 52:17-30
    • Where does Judgement come from? 1. Tradition 2. Authority 3. Science • Experiment • Population studies • RCTs 4. Analysis of the Evidence 5. The personal factor
    • Medical students are trained… … to share the same knowledge base, and to think and react the same way in the same situation
    • The stage beyond training …To express yourself creatively through what you do To learn how to do better To achieve mastery
    • Guidelines1. Where does judgement come from?2. The rise of the robot physician3. Guidelines for the politically incorrect4. The politics of guidelines
    • Symptoms, concernsLipids Patient DoctorObesity Advice, treatment
    • The Therapeutic Transition Before the 1970s, a disease was something that made you ill.A disease then became something that might turn into something that made you illMore recently, a disease became something thatmight turn into something that might make you ill
    • Advice, treatmentLipids Patient Doctor Doctor PatientObesity “But I feel fine”
    • Doctor DoctorPublic Professional Patienthealth Societies “But I feel fine” Big Pharma
    • Franklin D Roosevelt (1882-1945) Re-elected 1944 BP 200/100 Died of a massive brain haemorrhage 6 months later…
    • “The town that changed America‟s heart”“Has resulted in an average of four extra years of life” C Lenfant, Shattuck Lecture, 2003
    • “The town that changed America‟s heart”Risk Factors These have the Smoking highest risk Hypertension Hyperlipidaemia Hyperglycaemia “Has resulted in an average of four extra years of life” C Lenfant, Shattuck Lecture, 2003
    • “The town that changed America‟s heart”Risk Factors Smoking Hypertension Hyperlipidaemia Hyperglycaemia ] The Hyperdiseases “Has resulted in an average of four extra years of life” C Lenfant, Shattuck Lecture, 2003
    • The HyperdiseasesDefined not by their cause, or by theirmechanism, but by their consequences
    • All hyperdiseases have circular definitionsThe level of BP/Cholesterol/BG that is harmful Is defined as the level that does harm
    • Diabetes is defined by the risk ofretinopathy (2 hr value after OGTT) 11 mmol/l Retinopathy
    • Diabetes is defined by the risk ofretinopathy (2 hr value after OGTT) Same result in Arizona, UK and Egypt 11 mmol/l Retinopathy
    • But what is the glucose threshold for arterial disease?Arterial disease 11 mmol/l
    • Arterial disease Multiple determinants, absolute risk varies from one population to another
    • Arterial disease ? 11 mmol/l
    • The robot physician• The treatment of hyperdisease is based upon analysis of populations• The cut-off for benefit is hard to define• The outcomes are probabilistic• The patient has no symptoms• The treatment has no visible outcome• Diagnosis requires no skill• Doctors aren‟t very good at it
    • Guidelines1. Where does judgement come from?2. The rise of the robot physician3. Guidelines for the politically incorrect4. The politics of guidelines
    • Guidelines … For the politically incorrect
    • Guidelines: 5 politically incorrect propositions1. If you have a guideline, you don‟t have the evidence: if you have the evidence, you don‟t need a guideline2. Guidelines are an assertion of authority3. Guidelines extend the boundaries of disease4. Guidelines aspire to the point of therapeutic futility5. Guidelines are least reliable in the evaluation of new therapies
    • What is a guideline?“A guideline is a statement by which todetermine a course of action. A guideline aimsto streamline particular processes according toa set routine or sound practice.By definition, following a guideline is nevermandatory. Guidelines are not binding and arenot enforced”. http://www.va.gov/trm/TRMGlossaryPage.asp
    • Why Guidelines are Issued: 1. The Angelic versionGuidelines help doctors to offer the best, safestand most cost-effective treatment to their patientsThey are issued as a service to humanity
    • Why Guidelines are Issued: 2. The Satanic version Guidelines are a statement of authority They assert the right of competing organizations to legislate for the diabetes community
    • “Guidelines are aStatement of Authority” Do you doubt this assertion? Then ask yourself this question:
    • Are guidelines judged according to their scientific quality?… or according to the status of the organization that issued them?
    • See what I mean? Are guidelines judged according to their scientific quality?… or according to the status of the organization that issued them?
    • “The Satanic version”There are 3 types of guideline: Ontological Territorial Imperial
    • The Ontological Guideline: “I think, therefore I exist” René Descartes
    • The Ontological Guideline:“We issue guidelines, therefore we exist” Any professional organisation
    • …the territorial guideline
    • …the territorial guideline The IDF will define the metabolicsyndrome and diabetes
    • …the territorial guideline No, EASD and ADA The IDF will will! define the metabolicsyndrome and diabetes
    • The Imperial Guideline: “Plus Ultra”Reclassifies previously unconsidered biological variation as disease.
    • Guidelines Extend DiseaseExamples:Hypertension: “Prehypertension”Diabetes: “Prediabetes”Cardiology: The NSTEMIHepatology: Fatty liver to NAFLDBut the prize goes to:
    • Guidelines Extend DiseaseExamples:Hypertension: “Prehypertension”Diabetes: “Prediabetes”Cardiology: The NSTEMIHepatology: Fatty liver to NAFLDBut the prize goes to:Nephrology: Reduced GFR of ageing becomes CKD!
    • “All individuals with a Glomerular filtration rate (GFR) <60mL/min/1.73 m2 for 3 months are classified as havingchronic kidney disease, irrespective of the presence orabsence of kidney damage.. NKF (2002). clinical practice guidelines for chronic kidney disease
    • See what I mean?Guidelines do not set out to reduce the boundaries of disease They set out to increase it
    • According to current guidelines ~95%of the extreme elderly have a cardiovascular risk factor that requires treatment…
    • According to current guidelines ~95%of the extreme elderly have a cardiovascular risk factor that requires treatment… … because it might stop them growing old!
    • Guidelines: 5 politically incorrect propositions1. If you have a guideline, you don‟t have the evidence: if you have the evidence, you don‟t need a guideline2. Guidelines are an assertion of authority3. Guidelines extend the boundaries of disease4. Guidelines aspire to the point of therapeutic futility5. Guidelines are least reliable in the evaluation of new therapies
    • The Therapeutic ImperativeBy extending the boundaries of disease,guidelines also extend the boundaries oftreatment…
    • The U-shaped curveRisks of therapy Risks of disease>risks of disease >risks of therapy Therapeutic optimum
    • Guidelines define the therapeutic maximum, not the therapeutic optimumRisks of therapy Risks of disease>risks of disease >risks of therapy Therapeutic optimum
    • The therapeutic optimum is a one-person solutionRisks of therapy Risks of disease>risks of disease >risks of therapy Therapeutic optimum
    • Guidelines: 5 politically incorrect propositions1. If you have a guideline, you don‟t have the evidence: if you have the evidence, you don‟t need a guideline2. Guidelines are an assertion of authority3. Guidelines extend the boundaries of disease4. Guidelines aspire to the point of therapeutic futility5. Guidelines are least reliable in the evaluation of new therapies
    • Guidelines and new therapiesThe global market for drugs for diabetes & lipidswas $70.8 billion in 2010*In 2009, an adverse comment by the ASDA/EASDPanel wrote 20% off the share price of GSKPharmaceutical money is the oxygen upon whichacademic medicine depends •IMS Health Midas, December 2010. http://www.imshealth.com/portal/site/ims
    • Conflicts of InterestProfessional society meetings depend uponpharmaceutical supportThe journals benefit from pharmaceutical supportMedical education benefits from pharmaceuticalsupportMost of us benefit from pharmaceutical support
    • Data access and presentationThe trials are designed by the companiesThe data are collected and analysed by thecompaniesThe companies decide if, where and how the dataare publishedThe companies support almost all the experts in agiven area directly or indirectly
    • The Circuit Pharma of InfluenceSocieties ExpertsGuidelines Journals
    • The Circuit Pharma of Influence Societies Experts Guidelines Journals Health Auditadministrators reimbursement
    • What do clinicians want?1. Access to the best available information and analysis2. Advice as to best use of this information3. Common standards of care4. Best use of resources5. Better training of young physicians
    • Strengths of the current systemAn insistence upon good quality informationThe quest for better evidenceUse of clinical expertise in translation of evidenceinto guidelinesEasy access to electronic sources of information
    • WeaknessesSubstitutes pseudo-certainty for uncertaintyOpen to competing interests (societies, industry)“One size fits all” recommendationsEasily misused by administratorsConverts individuals into statisticsPromotes the abdication of the clinician
    • “The most valuable lesson that knowledge can teach us is that its creation depends upon a continuous line of human relationships and traditions that go far back into the past.That continuity is an unbroken thread. It links cultures and peoples;it brings tolerance and understanding; it delivers hope and compassion” Richard Horton (2004)
    • We are the people we treat.We are defined by the way we look after them