Evidence Based Medicine: st tat Sasa a efa st p

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Evidence Based Medicine (st?? ??tat????) S?µas?a
?a? efa?µ??? st?? ??????? p????

• Ofe??e?? ? µ? ß??pte?? (?pp????t??) s?µas?a t??
  ? ??? primum non nocere
• ?as???? a???? ?a? p?a?t??? s?µas?a t?? Evidence
  Based Medicine
• ???at?t?te? efa?µ???? st?? ??????? p???? µ?sa
  ap? 2 pa?ade??µata

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EBM - A. ??µa?a??d??
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EBM ???ß??µata a???????s?? t?? ?at?????
ß?ß?????af?a?

• ????? ß?ß?????af?a? e?d??? stat?st???
  a???????s? (p.?. ISS, PA catheter, multiple or
  logistic regression, ...)
• ?e???e?s? µ???µ?t?? ?a? d?at?p?s? µ?
  te?µ????µ???? ?p???se?? (p.?. TNF)
• Editorial JAMA 1992 267 411 Publication bias
  the triumph of hope over experience.

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??? S???t?s?µa s?µpe??sµata

• The TNF story by Beutler et al
• Cachectin is clearly only one of the mediators
  responsible for the numerous pathologic effects
  of lipopolysacharides
• J Exp. Med. 1985
• a single protein mediator (cachectin) is
  capable of inducing many of the deleterious
  effects of endotoxin Science 1987

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Evidence Based MedicineO??sµ?? t??p??
p??s????s?? e??? p??ß??µat??

• ability to access, summarize, and apply
• information from the literature to
• day-to-day clinical problems. Guyatt G, JAMA
  1993
• ?p??t?s? se 3 ßas??? e??t?µata
• 1. Are the results of a given study valid ?
• 2. What are the results ?
• 3. Will these (valid) results help me in
  caring for my patient ?

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Evidence Based Medicine ?a?ade??µata
p?a?t???? efa?µ???? ()

• E??t?µa - ?a??de??µa ?? 1
• ??e? te?µ?????e? ? e?e??et??? ? ? ß?apt???
  ep?d?as? t?? ???s?? ?a?et??a p?e?µ??????
• (se p???? s???e???µ??e? ?µ?de? as?e???)
• E??t?µa - ?a??de??µa ?? 2
• ??e? te?µ?????e? ? e?e??et??? ep?d?as? t??
  s?µp????µat???? pa?e?te????? d?at??f??
• st? ???s?µ?t?ta ? st?? eµf???s? ep?p?????

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Concepts in Emergency and Critical Care

• The effectiveness of Right Heart
  Catheterization in the Initial Care of
  Critically Ill Patients.
• Alfred F. Connors, ... Lee Goldman, ... W.A.
  Knaus for the S.U.P.P.O.R.T. Investigators
• JAMA 1996, 276 889-897

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Connors et al, JAMA 1996, 276 889-97

• ? ???s? t?? ?a?et??a ?? s?s?et??eta? µe a???s?
  ??st??? ?a? ???s?µ?t?ta?.
• ?e???? ap???s? t?? µe??t?? d??t?
• s?µa?t???? a???µ?? as?e???, s?µa?t??? ???µata,
  p??se?µ??? stat?st??? a????s?
• ?ditorial µe p??????µ??a s?µpe??sµata
• se pe???d? ?µfas?? st?? ??????? p???? t??
  cost/effectiveness evidence based medicine

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?e??t? t?? Connors et al 1996 S?µpe??sµata -
s????a e?e???t?? !!

• serious concerns about the role of RHC
• our findings should be confirmed
• the mechanisms by which RHC may harm patients
  should be explored (!!!)
• we must create an environment in which RHC can be
  performed
• sufficient uncertainty about RHC benefit gt
  need of a RCT

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Editorial, Dalen and Bone JAMA 1996
S?µpe??sµata

• Two possible ways of action
• undertake immediately an appropriately designed,
  multicenter, randomized, controlled clinical
  trial for the use of PAC or
• a moratorium to the use of flow-directed PA
  catheters

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Evidence Based Medicine ?a??de??µa 1????? p????
- p??? ??ßas? (outcome) - se p?????

• S???e???µ??? e??t?µa-pa??de??µa
• ??e? te?µ?????e? ? e?e??et??? ? ? ß?apt???
  ep?d?as? t?? ???s?? ?a?et??a p?e?µ??????
• (a???t??? ? ?et??? s?s??t?s? µe)
• ???s?µ?t?ta
• sto s????? t?? as?e??? t?? ??T
• se ?p??µ?de? as?e??? t?? ??T
• CCM Concensus Conference Dec. 1996

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EBM The 5 levels of evidence

• Quality control of the literature
• Level I large, randomized trials with clear-cut
  results, low risk of (a) or (b) error
• Level II small, randomized trials with uncertain
  results, moderate or high risk of (a) or (b)
  error
• Level III non randomized, contemporary controls
• Level IV non randomized with historical controls
  
• Level V case series, uncontrolled studies and
  expert opinion Sackett DL Chest 1989

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Evidence Based MedicineLevels of evidence gt
Grades of certainty

• Grading of evidence based on the literature
  Supported by
• Grade A at least two Level I investigations
• Grade B only one Level I investigation
• Grade C only Level II investigations
• Grade D at least one Level III investigation
• Grade E by Level IV or Level V evidence
• Sackett DL Chest 1989

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Evidence Based Medicine Consensus 1996 (I)
?e?t??s? ep?ß??s?? µe t? ???s? t?? ?a?et??a
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Evidence Based Medicine Consensus 1996 (I?)
?e?t??s? ep?ß??s?? µe t? ???s? t?? ?a?et??a
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Evidence Based Medicine ?a??de??µa 2????? p????
- p??? ??ßas? (outcome) - se p?????

• S???e???µ??? e??t?µa
• ??e? te?µ?????e? ? e?e??et??? ep?d?as? t??
• s?µp????µat???? pa?e?te????? d?at??f??
• st? ???s?µ?t?ta ?
• st?? eµf???s? ep?p?????
• se as?e?e?? t?? ??T

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Heyland DK et al 1999 ?eta-analysis
?ethods and results

• search strategy
• study selection criteria
• quality of primary studies
• data extraction
• prior hypotheses regarding sources of
  heterogeneity
• data analysis

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Mortality
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Complications
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?eta-analysis S????? s?µpe?asµ?t?? (?)

• ?e? ??e? te?µ?????e? ? e?e??et??? ep?d?as? t??
• s?µp????µat???? pa?e?te????? d?at??f??
• st? ???s?µ?t?ta ?
• st?? eµf???s? ep?p?????
• e?d??? ??a as?e?e?? t?? ??T,
• a??? p??a??? d?af???? se ?p??µ?de? ...

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?eta-analysis S????? s?µpe?asµ?t?? (?)

• ?p?d?as? t?? s?µp????µat???? pa?e?te?????
  d?at??f?? st? ???s?µ?t?ta
• t?s? µe??s?? se µe??te? ?at?te??? p???t?ta? ?a?
  µe??te? p?? ????a? lt 1989
• a???s? se as?e?e?? ??T - ?aµµ?a d??s? se
  ?e??????????? ßa???? p?s???te? as?e?e??
• ??? d?af??? se as?e?e?? µe ?p???e??a ? se ???s?
  ? µ? ??p?d???

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?eta-analysis S????? s?µpe?asµ?t?? (G)

• ?p?d?as? t?? s?µp????µat???? pa?e?te?????
  d?at??f?? st?? eµf???s? pa?e?e??e???
• µe??s? se µe??te? ?at?te??? p???t?ta? ?a?
  µe??te? lt 1989
• a???s? se as?e?e?? ??T ?a? µe??s? se
  ?e??????????? ßa???? p?s???te? as?e?e??
• µe??s? se as?e?e?? µe ?p???e??a ?a? se µe??te?
  ????? ??????s? ??p?d???

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Evidence Based MedicineS??????S???? ?? p??pe?
?a ?????µe

• ??at?p?s? s???e???µ???? e??t?µat??
• S?st?µat??? a?a??t?s? ß?ß?????af?a?
• E?t?µ?s?
• quality of evidence
• range of treatment effect
• importance of outcomes
• application in my patients with risk/benefit
  analysis
• Ap?fas? µe st????? ded?µ???? Level X

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Evidence Based Medicine and medical decision
making ?? µp????µe ?a ?????µe

• EBM Levels of evidence or certainty (to use
  for and not to replace medical decision making)
• YES or NO gt BW decisions based on clear-cut
  evidences
• In the real word medical decision making
• is based on shades of gray (D. Cook)
• S?µas?a t?? µet?f?as?? d?e???? ???? ?e?µ????µ???
  ?at???? ? ßas?sµ??? se te?µ???a ?a? ??? ßas?sµ???
  se ap?de??e?? (grades?)

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Evidence Based MedicineT? ?a µ?? ?????µe

• ?p?a??a e?? de? ?p?????? evidences
• ?a?? ???s? se cost / benefit analysis
• ?p?t?µ?s? d?af???? µeta?? as?e??? ()
• Yp?t?µ?s? t?? experience based medicine
• Decisions must be made by clinicians and not by
  reviewers, who combine experience, judgement and
  a thoughtful review of the literature. (EBM the
  wolf in sheeps clothing) Cassiere et al
  1998