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Evidence-Based
Medicine
(Bringing research evidence
into practice)
Sudigdo Sastroasmoro
Clinical Epidemiology and Evidence-based Medicine Unit
FMUI CMH, Jakarta
SS/EBM/IKA-UDIP-2010
Evidence-based Medicine
Medicine-based evidence
Pragmatic research
Outcome research
Related with
morbidity, mortality, quality of life
Morbidity
Mortality
QoL
Value
Patient
Satisfaction
Quality
=
Cost
Health
Status
Diagnosis
Patient with complaint

History
Physical
Simple test
Specific test: If the test (+) what is the probability
that the patient has the disease?
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: best
treatment?
Is drug X more effective than Y?
Focus on the clinical outcome, rather than
its explanation (biomolecular markers, etc)
Yes or no outcome most useful
Not in studies with idealized subjects
Px with DM are frequently have
hypercholesterolemia, obese, hypertension, etc
Prognosis
Usually in cohort studies
To inform 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)
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)
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
education
40-50 yrs
medical practice
Usu. see only Results section,

or even worse, Abstract
section
Problems with patients:

Dx, Rx, Px
Consultants,
colleagues
Textbooks
Handbooks
Lecture notes
Clinical guidelines
CME, seminars, etc
Journals
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
Antibiotics 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) physicians competence

(2) valid evidence from studies
(3) patients preference
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
100%
Years after graduation
THE SLIPPERY SLOPE

10
12
Our textbooks are

out-of-date
Fail to recommend Rx up to ten years after
its been shown to be efficacious.
Continue to recommend therapy up to ten
years after its been shown to be useless.
Steps in EBM practice

1. Formulate clinical problems in answerable questions
2. Search the best evidence: use internet or other online database for current evidence
3. Critically appraise the evidence for VIA
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
Main area
Diagnosis
(Determination of disease or problem)
Treatment
(Intervention necessary to help the patient)
Prognosis
(Prediction of the outcome of the disease)
(I)
Formulating clinical questions
A 2-year old boy 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
or recent developments.
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
Description The main

of patient intervention
or problem considered
B e
b r i e f
The
Outcome
alternative
expected
to compare
from this
with the
intervention?
intervention
a n d
s p e c i f i c
Do all clinical questions contain 4

elements of PICO?
No
The C implies in the question - PIO
Does temulawak increase appetite in
undernourished children?
Asking prevalence PO
How many percent of patients with TIA who
subsequently develop stroke?
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
Antiarrhythmic
Therapy
Antihypertens.
Therapy
Prostate
screening
POEM
Comment
Drug A PVC
On ECG
Drug A >
mortality
DOE & POEM

contradicts
Drug X BP
Drug X
mortality
PSA screening
detects prostate
Ca. early
? whether PSA
screening
mortality
POEM agrees
With DOE
DOE exists, but

POEM unknown
II
Searching the evidence
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 patients
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
Weight of
Scientific
Scrutiny
Meta-analysis of RCT
Level 1
Large RCT
Small RCT
Level 2
Non-Randomized trials
Observational studies
Level 3
Case series / reports

Anecdotes, expert, consensus Level 4
For complete description see www.cebm.net
Rec
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
Patient
With problem
The
EBM
Cycle
Apply
The
evidence
Appraise
The
evidence
Formulate
In answerable
question
Search the
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 (patients 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 professionalism, valid evidence, and patients 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

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Evidence-Based

Patient with complaint

: New paradigm in medicine

EBM & Clinical Epidemiology

Usu. see only Results section,

Problems with patients:

Integration of (1) physicians competence

Years after graduation

THE SLIPPERY SLOPE

Our textbooks are

Steps in EBM practice

A 2-year old boy presented with 6-day high

What is Kawasaki disease?

In women systemic lupus erythematosus, is

The Patient or Problem

Four elements of a well constructed clinical

Description The main

Do all clinical questions contain 4

Relevance: Type of Evidence

Comparing DOES and POEMs

DOE & POEM

DOE exists, but

Were the subjects randomized?

Case series / reports

Implementation of EBM practice:

Resistance to EBM teaching

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