Evidence and Guidelines in Diabetes            Treatment            Edwin Gale
Guidelines1. Where    does judgement     come from?2.   The rise of the robot     physician3.   Guidelines for the politic...
Life is short,The Art [medicine] is long to learn,  Experience may be misleading,    And judgement is difficult           ...
Where does Judgement come from?     1. Tradition     2. Authority     3. Science     4. Analysis of the evidence     5. Th...
Supportive Model Based on a long-term personal relationship      between patient and physicianPalliation more important th...
Supportive Model Based on a long-term personal relationship      between patient and physicianPalliation more important th...
Where does Judgement come from?  1.    Tradition  2.    Authority    •     Individual    •     Collective    •     Geograp...
Where does Judgement come from?  1. Tradition  2. Authority  3. Science    •     Experiment    •     Population studies   ...
Where does Judgement come from?  1.    Tradition  2.    Authority  3.    Science    •     Experiment    •     Population s...
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 langu...
… English Included!    The word “evidence” is used in quite different    senses, to mean•    The raw material upon which a...
Evidence-based medicineOften used in the sense that “what I do isevidence based; what other people do is not”More accurate...
Evidence-based medicine works well forsituations involving well-defined patient  groups, binary alternatives, and well    ...
But…You cannot make one good study out of 17 badstudiesEven good information is only relevant in thecontext (age group, in...
The Evidence Gap…“Evidence-based review … (must) … also besupplemented by value judgments, where thebenefits of treatment ...
Where does Judgement come from?  1.    Tradition  2.    Authority  3.    Science    •     Experiment    •     Population s...
Medical students are trained… … to share the same knowledge base, and to think   and react the same way in the same situat...
The stage beyond training …To express yourself creatively through what you                      do          To learn how t...
Guidelines1.   Where does judgement come     from?2. The   rise of the robot     physician3.   Guidelines for the politica...
Symptoms, concernsLipids          Patient         DoctorObesity             Advice, treatment
The Therapeutic Transition Before the 1970s, a disease was something that                  made you ill.A disease then bec...
Advice, treatmentLipids          Patient          Doctor          Doctor           PatientObesity              “But I feel...
Doctor              DoctorPublic                       Professional             Patienthealth                        Socie...
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”  ...
“The town that changed                     America‟s heart”Risk Factors      These have the          Smoking highest risk ...
“The town that changed                     America‟s heart”Risk Factors          Smoking          Hypertension          Hy...
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 th...
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 Arizon...
But what is the glucose threshold for            arterial disease?Arterial disease                          11 mmol/l
Arterial disease                    Multiple determinants,                   absolute risk varies from                   o...
Arterial disease                   ?   11 mmol/l
The robot physician•   The treatment of hyperdisease is based    upon analysis of populations•   The cut-off for benefit i...
Guidelines1.   Where does judgement come     from?2.   The rise of the robot     physician3. Guidelines     for the     po...
Guidelines …       For the      politically      incorrect
Guidelines: 5 politically incorrect                 propositions1.   If you have a guideline, you don‟t have the evidence:...
What is a guideline?“A guideline is a statement by which todetermine a course of action. A guideline aimsto streamline par...
Why Guidelines are Issued: 1. The Angelic versionGuidelines help doctors to offer the best, safestand most cost-effective ...
Why Guidelines are Issued: 2. The Satanic version Guidelines are a statement of authority They assert the right of competi...
“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 iss...
See what                  I mean?  Are guidelines judged according    to their scientific quality?… or according to the st...
“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         ...
The Imperial Guideline:     “Plus             Ultra”Reclassifies previously unconsidered  biological variation as disease.
Guidelines Extend DiseaseExamples:Hypertension:            “Prehypertension”Diabetes:                “Prediabetes”Cardiolo...
Guidelines Extend DiseaseExamples:Hypertension:            “Prehypertension”Diabetes:                “Prediabetes”Cardiolo...
“All individuals with a Glomerular filtration rate (GFR) <60mL/min/1.73 m2 for 3 months are classified as havingchronic ki...
See what                   I mean?Guidelines do not set out to reduce the         boundaries of disease     They set out t...
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… …...
Guidelines: 5 politically incorrect                 propositions1.   If you have a guideline, you don‟t have the evidence:...
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                         >ris...
Guidelines define the therapeutic                  maximum,        not the therapeutic optimumRisks of therapy            ...
The therapeutic optimum is a            one-person solutionRisks of therapy                          Risks of disease>risk...
Guidelines: 5 politically incorrect                 propositions1.   If you have a guideline, you don‟t have the evidence:...
Guidelines and new therapiesThe global market for drugs for diabetes & lipidswas $70.8 billion in 2010*In 2009, an adverse...
Conflicts of InterestProfessional society meetings depend uponpharmaceutical supportThe journals benefit from pharmaceutic...
Data access and presentationThe trials are designed by the companiesThe data are collected and analysed by thecompaniesThe...
The Circuit             Pharma             of InfluenceSocieties             ExpertsGuidelines            Journals
The Circuit              Pharma             of Influence Societies             Experts Guidelines             Journals   H...
What do clinicians want?1.   Access to the best available information     and analysis2.   Advice as to best use of this i...
Strengths of the current systemAn insistence upon good quality informationThe quest for better evidenceUse of clinical exp...
WeaknessesSubstitutes pseudo-certainty for uncertaintyOpen to competing interests (societies, industry)“One size fits all”...
“The most valuable lesson       that knowledge can teach us       is that its creation depends     upon a continuous line ...
We are the people we treat.We are defined by the way we look after them
Edwin gale.egypt guidelines 2012
Edwin gale.egypt guidelines 2012
Edwin gale.egypt guidelines 2012
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Transcript of "Edwin gale.egypt guidelines 2012"

  1. 1. Evidence and Guidelines in Diabetes Treatment Edwin Gale
  2. 2. Guidelines1. Where does judgement come from?2. The rise of the robot physician3. Guidelines for the politically incorrect4. The politics of guidelines
  3. 3. Life is short,The Art [medicine] is long to learn, Experience may be misleading, And judgement is difficult Hippocrates
  4. 4. Where does Judgement come from? 1. Tradition 2. Authority 3. Science 4. Analysis of the evidence 5. The personal factor
  5. 5. 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:
  6. 6. 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”
  7. 7. Where does Judgement come from? 1. Tradition 2. Authority • Individual • Collective • Geographical 3. Science 4. Analysis of the Evidence 5. The personal factor
  8. 8. Where does Judgement come from? 1. Tradition 2. Authority 3. Science • Experiment • Population studies • RCTs 4. Analysis of the Evidence 5. The personal factor
  9. 9. Where does Judgement come from? 1. Tradition 2. Authority 3. Science • Experiment • Population studies • RCTs 4. Analysis of the Evidence 5. The personal factor
  10. 10. What do we mean by evidence?
  11. 11. 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
  12. 12. … 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
  13. 13. 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
  14. 14. Evidence-based medicine works well forsituations involving well-defined patient groups, binary alternatives, and well defined outcomes…
  15. 15. 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
  16. 16. 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
  17. 17. Where does Judgement come from? 1. Tradition 2. Authority 3. Science • Experiment • Population studies • RCTs 4. Analysis of the Evidence 5. The personal factor
  18. 18. Medical students are trained… … to share the same knowledge base, and to think and react the same way in the same situation
  19. 19. The stage beyond training …To express yourself creatively through what you do To learn how to do better To achieve mastery
  20. 20. Guidelines1. Where does judgement come from?2. The rise of the robot physician3. Guidelines for the politically incorrect4. The politics of guidelines
  21. 21. Symptoms, concernsLipids Patient DoctorObesity Advice, treatment
  22. 22. 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
  23. 23. Advice, treatmentLipids Patient Doctor Doctor PatientObesity “But I feel fine”
  24. 24. Doctor DoctorPublic Professional Patienthealth Societies “But I feel fine” Big Pharma
  25. 25. Franklin D Roosevelt (1882-1945) Re-elected 1944 BP 200/100 Died of a massive brain haemorrhage 6 months later…
  26. 26. “The town that changed America‟s heart”“Has resulted in an average of four extra years of life” C Lenfant, Shattuck Lecture, 2003
  27. 27. “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
  28. 28. “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
  29. 29. The HyperdiseasesDefined not by their cause, or by theirmechanism, but by their consequences
  30. 30. All hyperdiseases have circular definitionsThe level of BP/Cholesterol/BG that is harmful Is defined as the level that does harm
  31. 31. Diabetes is defined by the risk ofretinopathy (2 hr value after OGTT) 11 mmol/l Retinopathy
  32. 32. Diabetes is defined by the risk ofretinopathy (2 hr value after OGTT) Same result in Arizona, UK and Egypt 11 mmol/l Retinopathy
  33. 33. But what is the glucose threshold for arterial disease?Arterial disease 11 mmol/l
  34. 34. Arterial disease Multiple determinants, absolute risk varies from one population to another
  35. 35. Arterial disease ? 11 mmol/l
  36. 36. 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
  37. 37. Guidelines1. Where does judgement come from?2. The rise of the robot physician3. Guidelines for the politically incorrect4. The politics of guidelines
  38. 38. Guidelines … For the politically incorrect
  39. 39. 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
  40. 40. 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
  41. 41. 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
  42. 42. 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
  43. 43. “Guidelines are aStatement of Authority” Do you doubt this assertion? Then ask yourself this question:
  44. 44. Are guidelines judged according to their scientific quality?… or according to the status of the organization that issued them?
  45. 45. See what I mean? Are guidelines judged according to their scientific quality?… or according to the status of the organization that issued them?
  46. 46. “The Satanic version”There are 3 types of guideline: Ontological Territorial Imperial
  47. 47. The Ontological Guideline: “I think, therefore I exist” René Descartes
  48. 48. The Ontological Guideline:“We issue guidelines, therefore we exist” Any professional organisation
  49. 49. …the territorial guideline
  50. 50. …the territorial guideline The IDF will define the metabolicsyndrome and diabetes
  51. 51. …the territorial guideline No, EASD and ADA The IDF will will! define the metabolicsyndrome and diabetes
  52. 52. The Imperial Guideline: “Plus Ultra”Reclassifies previously unconsidered biological variation as disease.
  53. 53. Guidelines Extend DiseaseExamples:Hypertension: “Prehypertension”Diabetes: “Prediabetes”Cardiology: The NSTEMIHepatology: Fatty liver to NAFLDBut the prize goes to:
  54. 54. 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!
  55. 55. “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
  56. 56. See what I mean?Guidelines do not set out to reduce the boundaries of disease They set out to increase it
  57. 57. According to current guidelines ~95%of the extreme elderly have a cardiovascular risk factor that requires treatment…
  58. 58. According to current guidelines ~95%of the extreme elderly have a cardiovascular risk factor that requires treatment… … because it might stop them growing old!
  59. 59. 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
  60. 60. The Therapeutic ImperativeBy extending the boundaries of disease,guidelines also extend the boundaries oftreatment…
  61. 61. The U-shaped curveRisks of therapy Risks of disease>risks of disease >risks of therapy Therapeutic optimum
  62. 62. Guidelines define the therapeutic maximum, not the therapeutic optimumRisks of therapy Risks of disease>risks of disease >risks of therapy Therapeutic optimum
  63. 63. The therapeutic optimum is a one-person solutionRisks of therapy Risks of disease>risks of disease >risks of therapy Therapeutic optimum
  64. 64. 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
  65. 65. 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
  66. 66. Conflicts of InterestProfessional society meetings depend uponpharmaceutical supportThe journals benefit from pharmaceutical supportMedical education benefits from pharmaceuticalsupportMost of us benefit from pharmaceutical support
  67. 67. 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
  68. 68. The Circuit Pharma of InfluenceSocieties ExpertsGuidelines Journals
  69. 69. The Circuit Pharma of Influence Societies Experts Guidelines Journals Health Auditadministrators reimbursement
  70. 70. 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
  71. 71. 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
  72. 72. 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
  73. 73. “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)
  74. 74. We are the people we treat.We are defined by the way we look after them
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