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Evidence based medicine:

Pelayanan kesehatan dengan berdasar bukti-


bukti penelitian yang terbaik atau
mengintegrasikan bukti-bukti penelitian
terbaik dengan pengalaman klinik dan
keadaan atau kondisi tertentu pasien.
I. Are the results of the study valid?
II. What were the results?
III. Are these valid, important results
applicable to our patient?
Primary Guides:

Was the assignment of patients


to treatments randomized?

Was follow-up of patients


sufficiently long and complete?

Were patients analyzed in the


groups to which they were
randomized?
1. Apakah dilakukan randomisasi?

Mencegah risiko bias


Tiap subyek memiliki
Tujuan randomisasi kesempatan yang
sama
Balans karakteristik
subyek
Toast/coin
Table random
Random allocation
Cara randomisasi Simple random sampling
Cluster random
sampling
Multistage random
sampling
Randomized Randomisasi

Inclusion

Controlled Prosedur

Outcome

Intervensi
Clinical Trial
Vs. control group
Patient treatment A O
U
T
eligible C
Random O
M
E
treatment B
washe
Patient d
out

eligible
Treatment A Treatment B O
U
T
Random C
O
M
Treatment B Treatment A E
Menetapkan terapi yang
terbaik

Uncontrolled trial RCT

Tanpa pembanding Pembanding


Tanpa randomisasi Randomisasi
Tanpa blinding Blinding
Before-after Serial vs. parallel design
treatment
Secondary Guides:
Were patients, health workers, and
study personnel "blind" to treatment?
Were the groups similar at the start of
the trial?
Aside from the experimental
intervention, were the groups treated
equally?
Apakah perlakuan sama/seimbang?

Sama dalam hal


bentuk
rupa
warna
Obat/intervensi rasa
bau
konsistensi
cara
pemberian
What is the magnitude of the
treatment effect?
How precise was the estimate of the
treatment effect?
20 % group control (X)
15% group terapi (Y)
ARR (Absolute risk reduction ) : X-Y =
0,20-0,15 = 0,05
Relative risk : Y/X = 0,15/0,20 = 0,75
RRR (relative risk reduction ) =
1- (Y/X) x 100 = (1-0,75) x 100 = 25 %
. Apakah bermakna secara klinik/statistik?
Obat Rata-2 penurunan
p
tekanan darah

Antihipertensi A 14 mmHg
0.025
Mana yang harus
Antihipertensi B dipenuhi:
6 mmHg
Bermakna secara statistik ?
Atau
Bermakna secara klinik?
RRR = (|CER
CER :EER|/CER)
Control Event Rate (tanpa terapi dimaksud/plasebo)
EER : Experimental Event Rate (dengan terapi dimaksud)
CER (plasebo) 50%
EER (interferon) 39%
RRR (CER-EER/CER) ?
ARR (|CER-EER|) ?
NNT (1/ARR) ?
Event rate= progresivitas kecacatan dalam 33 bulan
CER = control event rate
EER = experimental event rate
RRR = relative risk reduction
ARR = absolute risk reduction
NNT = number needed to treat
CER (plasebo) 50%
EER (interferon) 39%

RRR (CER-EER/CER) (50% - 39%)/50% = 22%

ARR (|CER-EER|) 50% - 39% = 11 %

NNT (1/ARR) 1/11% = 9

Table 5.4 EBM-Sacket


95% Confidence
interval

Merokok Ca. pulmo

RR = 2,45; 95% CI (1,85:2,92)


RR = 1,85; 95% CI (0,95-2,25)
95% Confidence interval

Antibiotika profilaksi pada SC mencegah endometritis

RR untuk elective SC : 0.24 (95% CI: 0.11 -


0.48)
RR untuk non-elective SC : 0.30 (95% CI:
0.25 - 0.35)
1. Is our patient so different from those in the
study that its results cannot apply?
2. Is the treatment feasible in our setting?
3. What are our patients potential benefits and
harms from the therapy?
4. What are our patients values and
expectations for both the outcome we are
trying to prevent and the treatment we are
offering?