2. Guidelines
1. Where does judgement
come from?
2. The rise of the robot
physician
3. Guidelines for the politically
incorrect
4. The politics of guidelines
3. Life is short,
The Art [medicine] is long to learn,
Experience may be misleading,
And judgement is difficult
Hippocrates
4. Where does Judgement come from?
1. Tradition
2. Authority
3. Science
4. Analysis of the evidence
5. The personal factor
5.
6. Supportive Model
Based on a long-term personal relationship
between patient and physician
Palliation more important than intervention
The role of the physician was often to bear
witness:
7. Supportive Model
Based on a long-term personal relationship
between patient and physician
Palliation more important than intervention
The role of the physician was often to bear
witness:
“To cure sometimes, to relieve often, to
comfort always”
8. Where does Judgement come from?
1. Tradition
2. Authority
• Individual
• Collective
• Geographical
3. Science
4. Analysis of the Evidence
5. The personal factor
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. Where does Judgement come from?
1. Tradition
2. Authority
3. Science
• Experiment
• Population studies
• RCTs
4. Analysis of the Evidence
5. The personal factor
12. 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
13. … 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
14. Evidence-based medicine
Often used in the sense that “what I do is
evidence based; what other people do is not”
More accurately, it is a technique for making
best use of the information available, and for
replacing circumstantial (suggestive) evidence
with direct (experimental) evidence, generally
obtained through RCTs
15. Evidence-based medicine works well for
situations involving well-defined patient
groups, binary alternatives, and well
defined outcomes…
16. But…
You cannot make one good study out of 17 bad
studies
Even good information is only relevant in the
context (age group, inclusion criteria etc) in
which that information was obtained
17. The Evidence Gap…
“Evidence-based review … (must) … also be
supplemented by value judgments, where the
benefits of treatment are weighed against risks
and costs in a subjective fashion ...
We realise that others may have different
judgments …”
ADA/EASD Consensus, Diabetologia (2009) 52:17-30
18. Where does Judgement come from?
1. Tradition
2. Authority
3. Science
• Experiment
• Population studies
• RCTs
4. Analysis of the Evidence
5. The personal factor
19. Medical students are trained…
… to share the same knowledge base, and to think
and react the same way in the same situation
20. The stage beyond training …
To express yourself creatively through what you
do
To learn how to do better
To achieve mastery
21. Guidelines
1. Where does judgement come
from?
2. The rise of the robot
physician
3. Guidelines for the politically
incorrect
4. The politics of guidelines
23. 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 ill
More recently, a disease became something that
might turn into something that might make you ill
25. Doctor
Doctor
Public Professional
Patient
health Societies
“But I feel fine”
Big Pharma
26. Franklin D Roosevelt
(1882-1945)
Re-elected 1944
BP 200/100
Died of a massive brain
haemorrhage 6 months
later…
27. “The town that changed
America‟s heart”
“Has resulted in an average of four
extra years of life”
C Lenfant, Shattuck Lecture, 2003
28. “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
29. “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
37. 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
38. Guidelines
1. Where does judgement come
from?
2. The rise of the robot
physician
3. Guidelines for the
politically incorrect
4. The politics of guidelines
40. Guidelines: 5 politically incorrect
propositions
1. If you have a guideline, you don‟t have the evidence:
if you have the evidence, you don‟t need a guideline
2. Guidelines are an assertion of authority
3. Guidelines extend the boundaries of disease
4. Guidelines aspire to the point of therapeutic futility
5. Guidelines are least reliable in the evaluation of new
therapies
41. What is a guideline?
“A guideline is a statement by which to
determine a course of action. A guideline aims
to streamline particular processes according to
a set routine or sound practice.
By definition, following a guideline is never
mandatory. Guidelines are not binding and are
not enforced”.
http://www.va.gov/trm/TRMGlossaryPage.asp
42. Why Guidelines
are Issued:
1. The Angelic version
Guidelines help doctors to offer the best, safest
and most cost-effective treatment to their patients
They are issued as a service to humanity
43. 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
55. Guidelines Extend Disease
Examples:
Hypertension: “Prehypertension”
Diabetes: “Prediabetes”
Cardiology: The NSTEMI
Hepatology: Fatty liver to NAFLD
But the prize goes to:
Nephrology: Reduced GFR of ageing becomes CKD!
56. “All individuals with a Glomerular filtration rate (GFR) <60
mL/min/1.73 m2 for 3 months are classified as having
chronic kidney disease, irrespective of the presence or
absence of kidney damage..
NKF (2002). clinical practice guidelines for chronic kidney disease
57. See what
I mean?
Guidelines do not set out to reduce the
boundaries of disease
They set out to increase it
58. According to current guidelines ~95%
of the extreme elderly have a cardiovascular
risk factor that requires treatment…
59. According to current guidelines ~95%
of the extreme elderly have a cardiovascular
risk factor that requires treatment…
… because it might stop them growing old!
60. Guidelines: 5 politically incorrect
propositions
1. If you have a guideline, you don‟t have the evidence: if
you have the evidence, you don‟t need a guideline
2. Guidelines are an assertion of authority
3. Guidelines extend the boundaries of disease
4. Guidelines aspire to the point of therapeutic futility
5. Guidelines are least reliable in the evaluation of new
therapies
61. The Therapeutic
Imperative
By extending the boundaries of disease,
guidelines also extend the boundaries of
treatment…
62. The U-shaped curve
Risks of therapy Risks of disease
>risks of disease >risks of therapy
Therapeutic optimum
63. Guidelines define the therapeutic
maximum,
not the therapeutic optimum
Risks of therapy Risks of disease
>risks of disease >risks of therapy
Therapeutic optimum
64. The therapeutic optimum is a
one-person solution
Risks of therapy Risks of disease
>risks of disease >risks of therapy
Therapeutic optimum
65. Guidelines: 5 politically incorrect
propositions
1. If you have a guideline, you don‟t have the evidence:
if you have the evidence, you don‟t need a guideline
2. Guidelines are an assertion of authority
3. Guidelines extend the boundaries of disease
4. Guidelines aspire to the point of therapeutic futility
5. Guidelines are least reliable in the evaluation of
new therapies
66. Guidelines and new therapies
The global market for drugs for diabetes & lipids
was $70.8 billion in 2010*
In 2009, an adverse comment by the ASDA/EASD
Panel wrote 20% off the share price of GSK
Pharmaceutical money is the oxygen upon which
academic medicine depends
•IMS Health Midas, December 2010. http://www.imshealth.com/portal/site/ims
67. Conflicts of Interest
Professional society meetings depend upon
pharmaceutical support
The journals benefit from pharmaceutical support
Medical education benefits from pharmaceutical
support
Most of us benefit from pharmaceutical support
68. Data access and presentation
The trials are designed by the companies
The data are collected and analysed by the
companies
The companies decide if, where and how the data
are published
The companies support almost all the experts in a
given area directly or indirectly
69.
70. The Circuit
Pharma of Influence
Societies Experts
Guidelines Journals
71. The Circuit
Pharma of Influence
Societies Experts
Guidelines Journals
Health Audit
administrators reimbursement
72. What do clinicians want?
1. Access to the best available information
and analysis
2. Advice as to best use of this information
3. Common standards of care
4. Best use of resources
5. Better training of young physicians
73. Strengths of the current system
An insistence upon good quality information
The quest for better evidence
Use of clinical expertise in translation of evidence
into guidelines
Easy access to electronic sources of information
74. Weaknesses
Substitutes pseudo-certainty for uncertainty
Open to competing interests (societies, industry)
“One size fits all” recommendations
Easily misused by administrators
Converts individuals into statistics
Promotes the abdication of the clinician
75.
76. “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)
77. We are the people we treat.
We are defined by the way we look after them
