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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 Healt
Mortality Satisfaction h
QoL Statu
s

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 90s 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
education patients:
Dx, Rx, Px

40-50 yrs Consultants,

medical colleagues
Textbooks
practice Handbooks
Lecture notes
Usu. see only Results section, Clinical guidelines
or even worse, Abstract CME, seminars, etc
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) physicians
competence (2) valid evidence from
studies (3) patients 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 its been shown to be
efficacious.
Continue to recommend therapy
up to ten years after its 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
1. Formulate practice
clinical problems in answerable
questions
2. Search the best evidence: use internet or
other on-
line database for current evidence VIA
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
 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 patientinterventionalternative expected
or problemconsidered 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
Antiarrhythmic Drug A PVC Drug A > DOE & POEM
Therapy On ECG mortality contradicts

Antihypertens.Drug X BP Drug X POEM agrees

Therapy mortality With DOE

PSA screening? whether PSA

Prostate detects prostatescreening
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
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 evidenceRec
Weight of
Meta-analysis of RCT Level 1
Scientific
Scrutiny
Large RCT A
Small RCT Level 2

Non-Randomized trials B
Level 3
Observational studies
Case series / reports C
Anecdotes, expert, Level 4
consensus
 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
 Physicians competence

Valid evidence Patients values

 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 (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 profess-
ionalism, 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
Terima Kasih