Critical Appraisal

Artikel terapi
Oleh
dr. Evi Nurhayatun,SpPD, MKes

Five steps in EBM

1. Formulate an answerable question
2. Track down the best evidence
3. Critically appraise the evidence for:

Relevance
Validity
Importancy
Applicability

4. Integrate with clinical expertise and patient

values
5. Evaluate our effectiveness and efficiency

keep a record; improve the process

A. Validity
Randomization
Blinding
Equal treatment between groups
Sample size
All relevant outcome considered
Sufficient follow up

METHODS

B. Importance
Y

RESULTS

B. Importance
Control Event Rate: risiko untuk

mengalami bad outcome/hasil pada

kelompok kontrol = d/(c+d)
Experimental Event Rate: risiko
untuk mengalami bad outcome/hasil
pada kelompok perlakuan = b/(a+b)

Importance
Y

40

10

50

30

20

50

CER= control event rate = 20/50=0.4

EER= experiment event rate = 10/50=0.2
RRR = relative risk reduction = (CER-EER)/CER = (0.4-0.2)/0.4 = 50%

B. Importance
Relative Risk Reduction: beda risiko

relatif untuk mengalami bad

outcome/hasil antara kelompok
perlakuan dan kelompok kontrol =
(CER-EER)/CER
- Penurunan risiko terjadinya bad
outcome pada kelompok perlakuan
dibanding kel kontrol
- Makin besar RRR, makin besar efek
terapi

B. Importance
Absolute Risk Reduction: beda risiko

absolut untuk mengalami bad

outcome/hasil antara kelompok
perlakuan & kelompok kontrol = CEREER
- Berapa persen risiko bad outcome yang
bisa dikurangi
- 0% ARR 100%
- Makin besar ARR, makin besar efek
terapi

Importance
USA, 1960s:

Newspapers: the risk of suffering from deep vein

thrombosis in OC users was 2 times compared to
that in non OC users! (This is a RRR)
Closer examination:
The risk for DVT in non-OC : 1/100,000 personyear
The risk for DVT ini OC
: 2/100,000 personyear
Thus: to have 1 additional bad outcome, one has to
treat 100,000 women for 1 year

Importance
Y

40

10

50

30

20

50

CER= control event rate = 20/50=0.4

EER= experiment event rate = 10/50=0.2
ARR = absolute risk reduction = (CER-EER) = 0.4-0.2 = 0.2
NNT = 1/ARR = 1/0.2 = 5

Importance
NNT = number needed to treat
= jumlah pasien yang perlu diberi terapi
untuk mencegah 1 bad outcome
= jumlah pasien yang perlu diberi terapi
untuk mendapatkan 1 tambahan
good outcome
= 1/ARR
Makin besar NNT, makin TIDAK
efektif terapi
- NNT = 1-4 efektif

C. Applicability
Your own patient(s):

(educated guess) determine f, i.e, a

factor reflecting how much severe
are your patients compared to the
average of the important prognostic
factors of the study subjects
Your NNT = f x NNT

Applicability
Determine PEER = patient expected

event rate (event rate of your patient

if he/she is not treated with the drug
under consideration)
Then:

Your NNT = PEER/(PEER-EER)

THERAPY WORKSHEET
V: Are the results of this trial valid?
o
o
o
o
o

Was the assignment randomized?& concealed?

Intention to treat?
Blinding?
Equal treatment aside from experimental Rx?
Groups similar at the start of trial?

I: Are the results important?

o CER, EER, RRR, ARR, NNT

A: Can you apply this valid & important

evidence?

o Is your patient similar to the patient?

o How great the benefit?
o Other aspects

Example.
Formulate answerable question!
In a pregnant woman with high risk

of preterm delivery, is weekly

administered of antenatal
corticosteroid better than single one?

PICO
P: a pregnant woman with high risk of
preterm delivery
I: weekly courses of antenatal steroid
C: a single course of antenatal steroid
O: reduce morbidity

SEARCH THE EVIDENCE.

Pubmed clinical query

Appraisal the study

Use therapy worksheet

V: Are the results of this trial valid?

Was the assignment randomized?& concealed?

Intention to treat?
Blinding?
Equal treatment aside from experimental Rx?
Groups similar at the start of trial?

o
o
o
o

I: Are the results important?

CER, EER, RRR, ARR, NNT

A: Can you apply this valid & important

evidence?

Is your patient similar to the patient?

How great the benefit?
Other aspects

o
o

Validity
Are the results of this trial
valid?
Was
the assignment

randomized?
concealed?

 Intention to

treat?

 Blinding?

 Equal treatment aside from

experimental Rx?

 Groups similar

at the start of
trial?

Importance:

Are the results important?

CER, EER, RRR, ARR, NNT

Importance:

Are the results important?

CER, EER, RRR, ARR, NNT

78.5% 22.5% 100%

72.0% 28.0% 100%

Importance:

Are the results important?

CER, EER, RRR, ARR, NNT

CER= control event rate = 28/100=0.28

78.5% 22.5% 100%

EER= experiment event rate =

22.5/100=0.225

72.0% 28.0% 100%

ARR = absolute risk reduction = (CEREER) = 0.280-0.225 = 0.055

NNT = 1/ARR = 1/0.055 = 18

Applicability..
Your NNT = f x NNT
f=1
Our NNT = 18

TELAAH KRITIS
(Critical Appraisal)

28

VALIDITY
1. Apakah pemberian terapi pada pasien dilakukan dengan

randomisasi ? Dan apakah randomisasi disegel ? Ya

2. Apakah dilakukan masking ? Ya

29

VALIDITY
3.

Apakah kelompok yang diperbandingkan setara pada

awal percobaaan ? Ya

30

VALIDITY
4. Apakah semua pasien yang masuk dalam penelitian
diperhitungkan dalam simpulan analisis sesuai dengan alokasi
awalnya ? Tidak, walaupun hasil per protocol ~ Intention to
treat

METOD
E

31

VALIDITY
5. Apakah kedua kelompok dirawat secara sepadan, diluar
perbedaan pemberian terapi ? Ya
6. Apakah kedua kelompok yang diteliti mirip ? Ya

32

IMPORTANT
KELOMPOK
( Cr Cl 30 49
ml/min)

SEMBUH

TIDAK /
komplikasi
(per tahun)

Obat baru
(rivaroxaban)

1440

34

Kontrol (wafarin)

1435

41

CER: control event rate resiko menjadi bad outcome pada

klompok kontrol = 2,78 %
EER: Experimental event rate resiko menjadi bad outcome
pada kelompok experimental = 2,30 %
RRR (relative risk reduction) = 17,27 %
ARR berapa persen resiko bad otcome bisa dikurangi 0,48
NNT jumlah pasien yang perlu diterapi untuk cegah 1 bad
outcome = 2 (efektif)

33

APPLICABLE
1. Apakah pasien kita mirip dengan subyek

penelitian ? Ya, namun pembagian derajat

insufisensi renal tidak sama

2. Apakah terapi baru tersebut tersedia, terjangkau

dan dapat diterima pasien ? Tidak

- Rivaroxaban masuk dalam ASKES dengan
diagnosa tertentu, tetapi tidak masuk Jamkesmas
- Harga rivaroxaban cukup mahal dan kurang
terjangkau untuk terapi jangka panjang
- Follow up pasien secara rutine diperlukan untuk
mengontrol efek samping
34

TELAAH KRITIS
(Critical Appraisal)
Contoh 3

35

Patients with chronic obstructive

pulmonary disease received tiotropium
5 g once daily via Respimat Soft
Inhaler for 6 weeks

measure physical function at week 6

measure physical function at baseline

Improvement of Physical function

Validity

Importancy

www.themegallery.com

Applicability

www.themegallery.com

Conclusion
less valid

the study in
this jurnal
Applicable

Important