01F. Introduction To EBM

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
Asialink for CE-EBM
(2007 – 2010)
 2 European countries
 Oxford, uk
 Utrecht, nl
 2 Asian countries
 Malaya Uni, my
 UI, id
 European Union, Euro 700,000
Evidence-based Medicine
versus
Opinion-based medicine
Experience-based medicine
Power-based medicine
Hope-based medicine
Logic-based medicine
Erratic-based medicine
Testimony-based medicine
Dr. Benjamin Spock:
Baby and Child Care
“I think it is preferable to accustom a baby to sleeping

on his stomach from the start of he is willing. He may
change later when he learns to turn over”.
Later evidence indicates that prone position is a

an significant risk factor for SIDS
(sudden infant death syndrome)
Evidence-based Medicine
Medicine-based evidence
Pragmatic research
Outcome research
Related with
morbidity, mortality, quality of life
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
Studies to be searched: Diagnostic tests
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
 Sudies to be searched: RCT
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)
 Studies: Cohorts, case controls
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)
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,

medical practice colleagues
Textbooks
Handbooks
Lecture notes
Usu. see only Results section, Clinical guidelines
or even worse, Abstract CME, seminars, etc
section 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
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
• physician‟s competence
• valid evidence from studies
• patient‟s preference
Why EBM?
Information overload
Keeping current with literature
Our clinical performance deteriorates with time (“the
slippery slope”)
Traditional CME does not improve clinical performance
EBM encourages self directed learning process which
should overcome the above shortages
100%
Relative $
% of
remaining
knowledge
2 4 6 8 10 12
Years after graduation
THE SLIPPERY SLOPE

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.
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 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 / Indicator
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
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
Comparing DOES and POEMs
Example DOE POEM Comment
Antiarrhythmic Drug A  PVC Drug A > DOE & POEM

On ECG mortality contradicts
Therapy
Drug X  POEM agrees

Antihypertens. Drug X  BP
mortality With DOE
Therapy
PSA screening ? whether PSA

Prostate DOE exists, but
detects prostate screening 
screening POEM unknown
Ca. early mortality
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 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
Scientific Meta-analysis of RCT Level 1
Scrutiny A
Large RCT
Small RCT Level 2
B
Non-Randomized trials
Observational studies Level 3
Case series / reports
C
Anecdotes, expert, consensus Level 4
For complete description see www.cebm.net
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’s
values
Valid Physician’s
evidence competence
Patient
With problem
The
Apply Formulate
The EBM In answerable
question
evidence Cycle
Appraise
The Search 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
EBM encourages clinical reasoning in the light of valid and
important evidence
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
Scientific vs. Real world Evidence
Scientific Real world
 Objective Can it work? Does it work?
 Purpose Regulatory approval Practice
 Design RCT Observational
 Setting/condition Ideal Real world
 Intervention Fixed Flexible
 Compliance High Low to high
 Internal validity High Variable
 External validity Low to medium High
 Duration Usually short Long
 Number of data Small to medium Big data
SS/EBM/IKA-UDIP-2010 http://medcommsnetworking.com/pres
Lesson learned
Dari studi penggunaan obat:
 Indikasi tidak tepat
 Persyaratan sering tidak terpenuhi # Audit
 Pemberian obat bervariasi # Verifikator
 Tulisan sulit dibaca
 Rekam medis tidak lengkap # Electronic MR
Dari pengalaman negara lain:
 Taiwan: Tidak melakukan HTA pada teknologi yang
tidak dijamin UHC negara-negara maju
 Untuk sementara kami akan melakukan hal yang sama
What is Evidence-Based
Medicine?
“Evidence-based medicine
is the integration of best
research evidence with
clinical expertise and
patient values”
Evidence-based …
Evidenve-based medicine
Evidence-based cardiology, pediatrics, neurology, etc etc
Evidence-based clinical practice guidelines
Evidence-based clinical audits
Evidence-based health technology assessment
Evidence-based community health development
Evidence-based health policy making
Evidence-based …… anything
“A 21st century clinician who cannot critically
read a study is as unprepared as one who
cannot take a blood pressure or examine the
cardiovascular system.”
BMJ 2008:337:704-705
Remember, however ......
Abscence of evidence is not

an evidence of absence
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

“I think it is preferable to accustom a baby to sleeping

Later evidence indicates that prone position is a

6 yrs medical Problems with patients:

40-50 yrs Consultants,

Years after graduation

THE SLIPPERY SLOPE

Fail to recommend Rx up to ten years after it‟s been

What is Kawasaki disease?

In a child with KD, would immunoglobulin treatment,

Experience with condition

In women with history of eclampsia, would

The Patient or Problem

The Intervention / Index / Indicator

Comparative intervention (if relevant)

Description The main The Outcome

POE: Patient-oriented evidence

DOE: Disease-oriented evidence

Example DOE POEM Comment

Antiarrhythmic Drug A  PVC Drug A > DOE & POEM

Drug X  POEM agrees

PSA screening ? whether PSA

EBM makes expensive medical care

EBM makes expensive medical care: cf

EBM cannot be implemented in developing countries

EBM is costly and time consuming

EBM ignores pathophysiology & reasoning

Abscence of evidence is not

Self directed, life-long learning attitude

EBM is nothing more than a

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