Evidencebased Medicine An Overview

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Evidence-based Medicine An Overview
Sudigdo Sastroasmoro (sudigdo_s_at_yahoo.com) Medica
l Research Unit, Medical School University of
Indonesia
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• Younger staff IKA (1)
• Younger staff IKA (2)
• Senior staff IKA
• PPDS IKA
• PPDS IKA
• RSAB-HK
• SMF-RSCM
• Unud-Denpasar
• Undip-Semarang
• KPS/SPS IDAI Jakarta
• IKA Unair Surabaya
• Unibraw Malang
• USU Medan
• Unand Padang
• Unilam Banjarmasin
• Interntl Class, FMUI
• Unsri Palembang
• Raker IKA-Lido
• Raker Kolegium-Ancol

• 21. RSUD Bantul
• 22. PPDS IKA
• 23. International Class FMUI
• 24. Student Center FMUI
• 25. Iluni
• 26. Clin governance Fatmawati
• 27. HTA-Depkes
• 28. MMR-UGM
• 29. Mediva
• 30. Guidelines Cardiology
• 31. Alternative medicine
• 32. PHTDI Semarang
• 33. Foreign Health Manpower
• 34. Dermato-venereology RSCM
• 35. TIA Jakarta
• 36. PIT Peralmuni
• 37. PIT Ikabi
• 38. PIT PAPDI
• 39. Faculty of Dentistry UI

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EBM

• Started in early 90s by clinical epidemiologists
• 1992 only few articles on EBM
• 2000 gt1000 articles
• Indonesia started in 1997
• Workshops Yogya (2000)
  
  IKA FKUI (2000, 2001, etc)
• Group discussion on EBM / mailing list
• ltebm-f2000_at_yahoogroups.comgt
• (Moderator firmanda_at_cabi.net.idgt)

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EBM Clinical Epidemiology

• Fletcher Fletcher CE The application of
• epidemiologic principles in problems
  encountered in clinical medicine
• Sackett et al CE The basic science for
  clinical medicine
• Much resistance by experts
• EBM In principle no one disagree
• All major medical journals have adopted EBM
• Centers for EBM all over the world

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Previous practice
Problems with patients Dx, Rx, Px
6 yrs medical education
40-50 yrs medical practice
Consultant, colleagues Textbooks Handbooks Lecture
notes Clinical guidelines CME, seminars,
etc Journals
Usu. see only Results section, or even worse,
Abstract section
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What is Evidence-based Medicine?

• The conscientious, explicit, and judicious use
  of current best evidence in making decisions
  about the care of individual patients
• Pemanfaatan bukti mutakhir yang sahih dalam tata
  laksana pasien
• Integration of (1) physicians competence (2)
  valid evidence from studies (3) patients
  preference

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• Pros New paradigm in medicine
• Extraordinary innovations,
• only 2nd to Human Genome Project
  
• Cons New version of an old song
• Fair Nothing wrong with EBM, but
• Be careful in searching evidence
• Meta-analyses, clinical trials, and all study
  results should be critically appraised
• Keyword for EBM
• Methodological skill to judge the validity
• of study reports (Re. Andersen B
  Methodological errors in medical research, 1989)

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When doctors meet numbers .....
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There are two most difficult things to understand
woman
and ....
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Hierarchy of Lies
Statistics
Damn lies.....
Lies.....
(Mark Twain)
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A roadside merchant was asked how he could
sell rabbit sandwiches so cheap. "Well," he
explained, "I have to put some horse-meat in
too. But I mix them 5050. One horse, one
rabbit." (Darrel Huff, How to Lie with
Statistics)
A statistician can have his head in an oven and
his feet in ice, and he will say that on the
average he feels fine.
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Ways of Reaching The Truth

• Faith The seductive approach
• Trust me
• In my experience

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Ways of Reaching The Truth

• It makes sense logical
• The Inductive Approach
• Based on pathophysiology
• It ought to work
• These ought to, but dont
• External fetal monitoring
• Right heart catheterization

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Ways of Reaching The TruthA Medical Paradigm
Shift

• Evidence-Based Medicine
• The Deductive Approach
• Based on outcomes research
• Putting it all back together
• Demonstration that it does or doesnt work

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WHY EBM?

• 1. New evidence are continuously generated
• 2. We usually fail to get the new evidence
• 3. Our clinical performance deteriorates with
  time (the slippery slope)
• 4. Traditional CME does not improve clinical
• performance
• 5. EBM encourages self directed learning
  process which should overcome the above
  shortages

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Dean, Harvard Medical School to students

• We believe that 50 of what we are teaching to
  you now will prove to be false 5 years later the
  problem is that we do not know
• which 50

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100

Relative of remaining knowledge
2 4 6 8
10 12
Years after graduation
THE SLIPPERY SLOPE
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Steps in EBM practice

• Formulate clinical problems in answerable
  questions
• Search the best evidence use internet or other
  on-
• line database for current evidence
• 3. Critically appraise the evidence for
• Validity (was the study valid?)
• Importance (were the results clinically
  important?)
• Applicability (could we apply to our patient?)
• 4. Apply the evidence to patient
• 5. Evaluate our performance

VIA
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Main area
Diagnosis(Determination of disease or
problem) Treatment(Intervention necessary to
help the patient)Prognosis(Prediction of the
outcome of the disease)
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Others
Meta-analysisClinical guidelinesEconomic
analysis Clinical decision makingCost-effectiven
ess analysisQualitative research
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(I)Formulating clinical questions
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• A 3 year old boy with prolonged fever, skin rash,
  stomatitis, conjunctivitis, submandibular lymph
  node enlargement
• Good nutritional status
• Normal vital signs
• Increased BSR, increased pletelet count
• Dx suspected Kawasaki disease
• Consider aspirin, immunoglobulin

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Medical students(Background question)

• What is Kawasaki disease?
• What is the cause?
• What are symptoms signs?
• What is the treatment?
• Cardiac involvement?

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House officers(Foreground question)

• In a child with Kawasaki disease, will repeated
  echo examination necessary for early detection of
  cardiac involvement? (Dx)
• In a child with Kawasaki disease in acute phase,
  does administration of Intravenous immunoglobulin
  decrease the likelihood of developing coronary
  involvement? (Rx)
• In a child with Kawasaki disease without coronary
  involvement in acute stage, does administration
  of long-term aspirin reduce the possibility of
  delayed coronary involvement? (Px)

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Other example

• In neonates born to mothers with history of
  herpes simplex infection, does the administration
  of IVIG (intravenous immunoglobulin) reduce the
  possibility of neonatal herpes?

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Four elements of good clinical question PICO

• The Patient or Problem
• The Intervention
• Comparative intervention (if relevant)
• The Outcome

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Four elements of a well constructed clinical
question PICO
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IISearching the evidence
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Examples of on-line Journals / Databases

• http//bmj.com
• http//adc/bmjjournals.com
• MEDLINE/PubMed
• EMBASE
• MDConsult
• AAP Journal Club
• Cochrane Library

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Use keywords for searching

• Note
• Spelling (American / British), terminology
• Follow rigidly the instructions of each website
• Examples
• Host vs graft reaction AND management
• hemosiderosis AND thalassemia OR thalassaemia
• breast cancer OR Ca mammae AND immunoglobulin
  OR IVIG

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The Flora and Fauna of the Medical Jungle

• Original Research
• Academic Reviews
• Decision/Cost Analysis
• Medical Cookbooks (Practice Guidelines)
• Translation Journals
• CME
• Clinical Experience

• Experts
• Newsletters and Survey Services
• Pharmaceutical Representatives
• Computer sources
• Audiotapes
• Qualitative Research

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Original Research is at the center of our
information jungle
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IIIAppraising the evidenceVIA
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VIA

• VALIDITY In Methods section
• design, sample, sample size, eligibility
  criteria (inclusion, exclusion) sampling
  method, randomization method, intervention,
  measurements, methods of analysis, etc
• IMPORTANCE In Results section
• characteristics of subjects, drop out,
  analysis, p value, confidence intervals, etc
• APPLICABILITY In Discussion section our
  patients characteristics, local setting

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Example Critical appraisal for therapy

• Were the subjects randomized?
• Were all subjects received similar treatment?
• Were all relevant outcomes considered?
• Were all subjects randomized included in the
  analysis?
• Calculate CER, EER, RRR, ARR, and NNT
• Were study subjects similar to our patients in
  terms of prognostic factors?

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Hierarchy of evidence
Meta-analysis of RCT Large RCT Small
RCT Non-Randomized trials Observational
studies Case series / reports Anecdotes,
expert, consensus
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Implementation of EBM practiceHow to get
started

• 1. Teaching EBM in medical schools / PPDS
• Easier than to change the already existing
  attitude
• Most important
• May be included in formal curricula or
  integrated in
• existing activities ward rounds, on calls,
  case
• presentations, group discussions, journal
  clubs, etc
• 2. Workshop for teaching staff
• 3. Workshop for practitioners, incl. nurses

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Resistance to EBM teaching learning

• Rudimentary skill in critical appraisal /
• methodological skill
• Limited resources, esp. time factor
• Lack of high quality evidence
• Skepticism toward evidence-based practice
• Happy with current practice

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Development of EBM practice

• Passive diffusion model
• Active dissemination model
• Coordinated implementation model
• Patients community
• Health administrators
• Public policy makers
• Clinical policy makers

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Strategies for developing EBM practice

• Clinical guidelines
• Practice development leaders
• (! Environment)
• Development units
• Dissemination of good practice
• Networking
• Research summaries
• Action research

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Summing up ....
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Advantages of EBM

• Encourages reading habit
• Improves methodological skill (and willingness to
  do research?!)
• Encourages rational up to date management of
  patients
• Reduces intuition judgment in clinical
  practice, but not eliminates them
• Consistent with ethical and medico-legal aspects
  of patient management

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End result
self directed, life-long learning attitude for
high quality medical management
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Components of professionalism
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CME
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Conclusion

• EBM is nothing more than a
• framework of systematic use of
• current valid study results
• relevant to our patient

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• Evidence-based Cardiology
• Evidence-based Pediatrics
• Evidence-based Ob-Gyn
• Evidence-based Dentistry
• Evidence-based Nursing
• Evidence-based Health Policy
• Evidence-based Health Technology Assessment
• Evidence-based Decision Making
• Evidence-based Health Performance Indicators
• Evidence-based Clinical Audit
• Evidence-based Risk Management .
• Evidence-based Everything!!!

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Remember, however ...

• Medicine is the science of uncertainty
• and the art of probabilities

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A pediatrician has just read a meta-analysis
that asthmatic attack is more likely to develop
if a asthmatic baby is given egg white as
compared to yolk. One day a mother told the
pediatrician that her baby will wheeze
immediately if given egg yolk but no problem when
given egg white. The pediatrician responded No,
you are wrong. Valid level I evidence indicate
that white egg is far more allergenic than egg
yolk. From now on you have to give your baby the
yolk instead of the white.
Misused evidence