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Evidence-Based Medicine
(”Bringing research evidence into practice”)

Sudigdo Sastroasmoro
(s_sudigdo@yahoo.com)
Fakultas Kedokteran Universitas Indonesia
Evidence-based Medicine
• Opinion-based medicine
• Experience-based medicine
• Power-based medicine
• Hope-based medicine
• Logic-based medicine
• Erratic-based medicine
Evidence-based Medicine
• Medicine-based evidence
• Pragmatic research
• Outcome research

Related with morbidity, mortality, & quality of life


Morbidity Patient Health
Mortality Satisfaction Status
QoL

Quality
Value =
Cost
Diagnosis
• Patient with complaint
• History
• Physical
• Simple test
• Specific test
Yes or no answer
Predictive value is the most important
The spectrum of the presentations must
resemble that in practice
Treatment
• Patient with certain diagnosis
• Does drug X more effective than Y?
• Focus on the outcome, rather than its
explanation (biomolecular markers)
• Yes or no outcome most useful
Prognosis
• Usually in cohort studies
• To inform the patient about the fate of the
patient
• Absolute risk is more important than relative
risk
– Absolute: Your risk of having second stroke in 1 year is
30%
– Relative: Your risk of having second stroke in 1 year is 2
times than in non-smokers (RR = 2)
EBM
• Started in early 90’s by clinical
epidemiologists
• 1992 : only few articles on EBM
• 2000 : >1000 articles
• Indonesia : started in 1997
• Workshops : Yogya (2000)
IKA FKUI (2000, 2001, etc)
• Group discussion on EBM / mailing list:
<ebm-f2000@yahoogroups.com>
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
Previous Practice
6 yrs medical Problems with patients:
education Dx, Rx, Px

40-50 yrs Consultants, colleagues


medical practice Textbooks
Handbooks
Lecture notes
Clinical guidelines
Usu. see only Results section, CME, seminars, etc
or even worse, Abstract section Journals
Previous Practice

• Trust me
• In my experience ….
• Logically
• Textbook, handbook, capita selecta
The results….
“Opinion-based medicine”
• Steroid inj. in prematures to prevent RDS
• Routine episiotomy
• Routine circumcision
• Antibitotics for flu-like syndrome
• Use of immunomodulators
• “Skin test” before antibiotic injection
• Routine chest X-ray for pre-op preparation
• CT scan after minor head trauma
• etc ……
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) physician’s competence
(2) valid evidence from studies
(3) patient’s preference
• 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: Methodo-logical errors in
medical research, 1989)
100%
THE SLIPPERY SLOPE
Relative $
% of
remaining
knowledge

2 4 6 8 10 12

Years after graduation


WHY EBM?
1. Information overload
2. Keeping current with literature
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
Our textbooks are
out-of-date
• Fail to recommend Rx up to ten years
after it’s been shown to be efficacious.
• Continue to recommend therapy up to
ten years after it’s been shown to be
useless.
The Inevitable Consequence

• On average, the clinically-important


knowledge of physicians
deteriorates rapidly after we
complete our training.
Steps in EBM practice
1. Formulate clinical problems in answerable questions
2. 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?)
VIA
 Importance (were the results clinically
important?)
 Applicability (could we apply to our patient?)
4. Apply the evidence to patient
5. Evaluate our performance
Main Area
Diagnosis
(Determination of disease or problem)

Treatment
(Intervention necessary to help the patient)

Prognosis
(Prediction of the outcome of the disease)
• A 2-year old boy diagnosed presented with 6-
day high fever, conjunctival injection without
secretion, skin rash> blood test shows
leukocytosis, high ESR, CRP +++. He was
suspected to have Kawasaki disease. The
pediatrician is aware of the use of
immunoglobulin to prevent coronary
involvement, but uncertain about the dosage.
Medical students:
(Background question)

• What is Kawasaki disease?


• What is the etiology?
• How it is diagnosed?
• What is the treatment of choice?
• Complications?
House Officers
(Foreground Question)

• In a child with KD, would


immunoglobulin treatment, compared
with no immunoglobulin, reduce the
chance to develop coronary
complication?
Foreground
questions

Background
questions

Experience with condition


Other Examples
• In women with history of eclampsia, would
administration of low-dose aspirin during pregnancy
prevent eclampsia? (Prevention)
• In young women with solitary thyroid nodule, can
USG, compared with biopsy, differentiate between
benign from malignant? (Diagnosis)
• In women systemic lupus erythematosus, is
history of congestive heart failure, compared with
no heart failure, worsen the prognosis? (Prognosis)
Four elements of
good clinical question: PICO

• The Patient or Problem


• The Intervention / Index
• Comparative intervention (if
relevant)
• The Outcome
Four elements of a well constructed
clinical question: PICO
P I C O

Description The main The Outcome


of patient intervention alternative expected
or problem considered to compare from this
with the intervention?
intervention

B e b r i e f a n d s p e c i f i c
Relevance: Type of Evidence

• POE: Patient-oriented evidence


–mortality, morbidity, quality of life
• DOE: Disease-oriented evidence
–pathophysiology, pharmacology,
etiology
POEM

• Patient-Oriented
• Evidence
Comparing DOES and POEMs

Example DOE POEM Comment

E DOE & POEM


Antiarrhythmic Drug A  PVC Drug A >
Therapy On ECG mortality contradicts

Antihypertens. Drug X  BP Drug X  POEM agrees


Therapy mortality With DOE

PSA screening ? whether PSA


Prostate detects prostate screening 
screening Ca. early mortality
III
Appraising the evidence:
VIA
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
patient’s characteristics, local setting
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?
Hierarchy of evidence Rec
Weight of
Meta-analysis of RCT Level 1
Scientific
Scrutiny Large RCT A
Small RCT Level 2

Non-Randomized trials B
Observational studies Level 3

Case series / reports C


Anecdotes, expert, consensus Level 4
Implementation of EBM practice:
How 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
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
Physician’s competence

Patient’s values
Valid evidence
Patient
With problem

Apply Formulate
The evidence In answerable
question

Critically
Appraise Search the
The evidence evidence
Criticism to EBM
• EBM makes expensive medical care
• EBM cannot be implemented in developing
countries
• EBM is costly and time consuming
• EBM ignore pathophysiology & reasoning
• EBM ignore experience and clinical judgment
• EB-guidelines etc interfere with professional
autonomy
Criticism to EBM
EBM makes expensive medical care
Cf:
– Routine antibiotics for ARTI & diarrhea
– Liberal indication for C-section
– Unnecessary sophisticated procedures
/ exams
– Unnecessary / harmful treatment:
steroid for recurrent cough
Criticism to EBM

EBM cannot be implemented in developing


countries
• By definition EBM is implemented if it is
implementable (patient’s preference and
local condition) – for the benefit of the
patients and the community
Criticism to EBM

EBM is costly and time consuming


• EBM does requires facilities at the cost
of quality medical care!
• Cost benefit ratio should be assessed in
individual and community levels
Criticism to EBM
EBM ignores pathophysiology &
reasoning
• EBM encourages clinical reasoning in the
light of valid and important evidence
• Pathophysiology and reasoning should be
seen as hypothesis and should end-up in
empirical evidence
Criticism to EBM
EBM ignore experience and clinical judgment
• Personal experience and clinical judgment
are by no means can be eliminated
• EBM encourage detailed and systematic
documentation of experience and judgment
• Subjective experience should be, whenever
possible, translated into more objective
measures
Criticism to EBM
EB-guidelines interfere with professional
autonomy
– Professional conduct (competence, altruism,
openness, collegiality, ethics) is encouraged in EBM
– Every physician should develop their own practice
attitude based on his/her profess-ionalism, valid
evidence, and patient’s values
– Development of clinical guidelines and other
standards of care should be seen as a guide and
implemented according to clinical setting
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
End Result

Self directed, life-long learning attitude


for high quality patient care
Conclusion
• EBM is nothing more than a
• framework of systematic use of
• current valid study results
• relevant to our patient