Evidence-Based Medicine (Ebm) : DR Gita Sekar Prihanti Mpdked
Evidence-Based Medicine (Ebm) : DR Gita Sekar Prihanti Mpdked
(EBM)
- Sackett, et al 2001
Decision making in medicine
Diagnosis
Treatment
Prevention
Prognosis
Etiology
Keterampilan Klinik
Keterampilan dan kemampuan menilai oleh
dokter yang didapat dari pengalaman dan
praktik klinik
Peningkatan keterampilan terlihat melalui
berbagai aspek, namun yang terutama adalah
semakin efektif dan efisien-nya kemampuan
menegakkan diagnosis, dan kemampuan dalam
mengidentifikasi dan mempertimbangkan nilai-
nilai, hak dan pendapat pasien dalam
pengambilan keputusan medis
Bukti Klinis
Penelitian yang relevan secara klinis, dapat berupa
penelitian ilmu-ilmu kedokteran dasar, tetapi terutama
dari riset-riset klinis yang berorientasi pasien
Berupa uji ketelitian (accuracy) dan ketepatan (precision)
sebuah metoda diagnosis (termasuk pemeriksaan fisik),
uji kekuatan suatu penanda prognosis, uji efektivitas dan
keamanan suatu terapi, tindakan rehabilitasi maupun
metoda pencegahan
Sebuah penemuan klinis dapat mengganti sebuah uji
metoda diagnosis maupun terapi yang telah diterima ke
metoda baru yang lebih kuat, tepat, efektif dan aman.
Mengapa perlu belajar &
mempraktikkan EBM?
Penelitian menemukan bahwa pasien
yang mendapatkan terapi yang berbasis
bukti memperoleh hasil yang lebih baik
dari yang tidak mendapat.
Merupakan cara up-date yang lebih
efisien dibanding metoda tradisional
(misal, berlangganan jurnal, ikut
seminar).
Perkembangan terakhir membuat EBM
lebih mungkin dipraktikkan.
So much evidence, so little time
Perkembangan
Strategi mencari dan menilai bukti yang
lebih efisien.
Ketersediaan jurnal-jurnal yang evidence-
based.
Dihasilkannya systematic review dan
ringkasan (summaries).
Sistem informasi yang memungkinkan
akses ke literatur dalam hitungan detik.
The flecainide story
Th e history of the use of the drug fl ecainide to treat
heart attacks in the United States in the 1980s is a
dramatic example of the gap between research and
clinical practice, and of the reliance on evidence of a
mechanism rather than an outcome. In 1979, the
developer of the defi brillator, Bernard Lown, pointed out
in an address to the American College of Cardiology that
one of the biggest causes of death was heart attack,
particularly among young and middle-aged men (20–64-
year-olds). People had a heart attack, developed
arrhythmia and died from the arrhythmia. He suggested
that a ‘safe and long-acting antiarrhythmic drug that
protects against ventricular fi brillation’ would save
millions of lives.
In response to this challenge, a paper was published in
the New England Journal of Medicine introducing a new
drug called fl ecainide — a local anesthetic derivative
that suppresses arrhythmia. The paper described a
study in which patients who had just had heart attacks
were randomly assigned to groups to receive either a
placebo or flecainide and were then switched from one
group to the other (a cross-over trial). The researchers
counted the number of premature ventricular
contractions (PVCs) as a measure of arrhythmias. The
patients on flecainide had fewer PVCs than the patients
on placebo. When the flecainide patients were ‘crossed
over’ to the placebo treatment, the PCs increased again.
Th e conclusion was straightforward: fl ecainide reduces
arrhythmias, arrhythmias cause heart attacks (the mechanism);
therefore, people who have had heart attacks should be given fl
ecainide. After the results were published, fl ecainide was approved
by the United States Food and Drug Administration and became
fairly standard treatment for heart attack in the United States
(although it did not catch on in Europe or Australia).
Almost immediately after the fi rst trials were complete,
however, other researchers had started gathering
information on the survival of the patients (the outcome)
instead of the PVC rate (the mechanism). Th is showed
that over the 18 months following treatment, more than
10% of people who were given flecainide died, which
was double the rate of deaths among a placebo group.
In other words, despite a perfectly good mechanism for
the usefulness of fl ecainide (it reduces arrhythmias), the
drug was clearly toxic and, overall, did more harm than
good.
Unfortunately, because the initial studies had been
widely published in medical texts, it was a long time
before doctors caught up with the subsequent data
showing poor outcomes, which did not attract as much
attention. Meanwhile, by 1989, about 200,000 people
were being treated with fl ecainide in the United States.
Based on the trial evidence, this would have caused tens
of thousands of additional heart attack deaths due to the
use of fl ecainide. Although there was published
information, doctors were systematically killing people
with fl ecainide because they did not know about the
good-quality outcome-based research.
What does the flecainide
example tell us?
In the flecainide example, the initial research was widely
disseminated because it was based on a traditional
mechanistic approach to medicine, and because it off
ered a ‘cure’. Th e subsequent outcomes research may
not have been widely disseminated because it was
counterintuitive and negative in terms of a potential
treatment. Doctors continued to prescribe fl ecainide
because they believed that it worked. Th ey did not know
that they needed to look for additional information.
Seorang ibu datang membawa anaknya
yang berumur 1,5 tahun dengan keluhan
pilek dan batuk sejak dua hari yang lalu.
Dahak keluar saat muntah, bening.
Pada pemeriksaan didapatkan suhu
37,9oC, FP 24x/menit, rongga hidung
hiperemis dan terdapat sekret encer dan
bening. Tenggorokan tidak hiperemis,
paru tidak ada kelainan.
Terapi?
Decongestan?
Antihistamin?
Antipiretik?
Edukasi?
The Antihistamine-decongestant combination
(ADC) was equivalent to placebo in providing
temporary relief of Upper Respiratory Infection
symptoms in preschool children. However, the
ADC did have significantly greater sedative
effects than did placebo.
Clemens CJ, Taylor JA, Almquist JR, Quinn HC, Mehta A,
Naylor GS.Is an antihistamine-decongestant combination
effective in temporarily relieving symptoms of the common
cold in preschool children? J Pediatr. 1997 Mar;130(3):463-6
FDA Experts Urge Ban on Cold
Medicines for Young Children
Critical question?
SPECIFIC KNOWLEDGE
TIPE
PERTANYA
AN GENERAL KNOWLEDGE
PENGALAMAN KLINIS
Using the question to guide
searching
Scenario - A 64 year old obese male who has tried many
ways to lose weight presents with a newspaper article about
“fat-blazer” – Chitosan. He asks for your advice.
Question
Population
Indicator (intervention, test, etc)
Comparator
Outcome
Using the question to guide
searching
Scenario - A 64 year old obese male who has tried many
ways to lose weight presents with a newspaper article about
“fat-blazer” – Chitosan. He asks for your advice.
Question
Population – in obese patients
Indicator (intervention, test, etc) – does chitosan
Comparator – compared to placebo
Outcome – decrease weight
1. Underline the key terms
2. Number the order of importance from 1-4
3. Think of alternate spellings, synonyms, & truncations
Using the question to guide
searching
Scenario - A 64 year old obese male who has tried many
ways to lose weight presents with a newspaper article about
“fat-blazer” – Chitosan. He asks for your advice.
Question 2
Population – obes* OR overweight
1
Indicator (intervention, test, etc) – does chitosan
Comparator – compared to placebo 4
Outcome – decrease weight OR kilogram* 3
1. Underline the key terms
2. Number the order of importance from 1-4
3. Think of alternate spellings, synonyms, & truncations
The “best” evidence depends on the
type of question
1. What are the phenomena/problems?
Observation (e.g., qualitative research)
2. What is frequency of the problem? (FREQUENCY)
Random (or consecutive) sample
3. Does this person have the problem? (DIAGNOSIS)
Random (or consecutive) sample with Gold Standard
4. Who will get the problem? (PROGNOSIS)
Follow-up of inception cohort
5. How can we alleviate the problem?
(INTERVENTION/THERAPY)
Randomised controlled trial
Interventions
Jean is a 55-year-old woman who quite
often crosses the Atlantic to visit her
elderly mother. She tends to get swollen
legs on these fl ights and is worried about
her risk of developing deep vein
thrombosis (DVT), because she has read
quite a bit about this in the newspapers
lately. She asks you if she should wear
elastic stockings on her next trip to reduce
her risk of this.
Aetiology and risk factors
George has come to your surgery to
discuss the possibility of getting a
vasectomy. He says he has heard
something about vasectomy causing an
increase in testicular cancer later in life.
You know that the risk of this is very low
but want to give him a more precise
answer.
Question:
‘In men, does having a vasectomy (compared with not having one),
increase the risk of getting testicular cancer in the future?’
Diagnosis
Julie is pregnant for the second time. She had her fi rst
baby when she was 33 and had amniocentesis to fi nd
out if the baby had Down syndrome. The test was
negative but it was not a good experience, because she
did not get the result until she was 18 weeks pregnant.
She is now 35 and 1 month pregnant, and asks if she
can have a test that would give her an earlier result. Th e
local hospital off ers serum biochemistry plus nuchal
translucency ultrasound screening as a fi rst trimester
test for Down syndrome. You wonder if this combination
of tests is as reliable as conventional amniocentesis.
Question:
‘For pregnant women, is nuchal translucency ultrasound
screening plus serum biochemistry testing in the fi rst
trimester as accurate (ie with equal or better sensitivity
and specifi city) as conventional amniocentesis for
diagnosing Down syndrome?’
Prognosis (prediction)
Childhood seizures are common and frightening for the
parents, and the decision to initiate prophylactic
treatment after a fi rst fi t is a difficult one. To help
parents make their decision, you need to explain the risk
of further occurrences following a single seizure of
unknown cause.
Question:
‘In children who have had one seizure of unknown cause
(either associated with a fever or not), what is the long-term
risk of further seizures?’
Frequency or rate
Mabel is a six-week-old baby at her
routine follow-up. She was born
prematurely at 35 weeks. Her parents ask
about her chances of developing hearing
problems, as friends of theirs had a
premature baby with deafness that was
detected late.
Phenomena
Mary is a mother who is concerned about her
three-year-old child. He has a fever. After you
have examined him, you conclude that he
probably has a viral infection. Mary asks, ‘But
what if he has a fever again during the night,
doctor?’ You want to understand her principal
underlying concerns so that you can reassure
her.
Question:
‘For mothers of children with a fever, what are the principal concerns?’
EBP Step 2: Mencari bukti terbaik
What study designs should you be looking for?
Where to search
PubMed : http://www.pubmed.gov
The Cochrane Library :
http://www.cochrane.org
Clinical Evidence :
http://www.clinicalevidence.com
Other useful places to search :
http://www.embase.com
The question guides the search
The Evidence Pyramid Clinical Decision-Making Tools
Connected to the Electronic Medical Record
Systems
overweight chitosan
Combining terms with
Boolean operators – OR
overweight obese
Boo-le-ans*
AND = both terms
OR = either term
NOT = not this term
(ADJacent, NEAR, … = AND + close)