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?

Tujuan randomisasi• Mencegah risiko bias• Tiap subyek memiliki

kesempatan yang sama

• Balans karakteristik subyek

Cara randomisasi

• Toast/coin• Table random• Random allocation• Simple random sampling• Cluster random

sampling• Multistage random

sampling

Randomized Randomisasi

Controlled

Inclusion

Prosedur

Outcome

Clinical TrialIntervensi

Vs. control group

PatientPatient

eligibleeligible

treatment Btreatment B

treatment Atreatment A OUTCOME

RandomRandom

washewashedd

outout

eligibleeligible

PatientPatient

RandomRandom

Treatment BTreatment B

Treatment ATreatment A

OUTCOME

Treatment ATreatment A

Treatment BTreatment B

Menetapkan terapi yang terbaik

PembandingRandomisasiBlindingSerial vs. parallel design

Tanpa pembandingTanpa randomisasiTanpa blindingBefore-after treatment

Uncontrolled trial R C T

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• rasa• bau• konsistensi• cara

pemberian

Obat/intervensi

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 %

6. Apakah bermakna secara klinik/statistik?Obat Rata-2 penurunan p

tekanan darah

Antihipertensi A 14 mmHg0.025Antihipertensi B 6 mmHgMana yang harus dipenuhi:

• Bermakna secara statistik ? Atau

• Bermakna secara klinik?

RRR = (|CER – EER|/CER)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 bulanCER = control event rateEER = experimental event rateRRR = relative risk reductionARR = absolute risk reductionNNT = number needed to treat

CER (plasebo) 50%EER (interferon) 39%

Table 5.4 EBM-Sacket

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

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

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

RR = 2,45; 95% CI (1,85:2,92) RR = 1,85; 95% CI (0,95-2,25)

Ca. pulmo

95% Confidence interval

Merokok

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)

Antibiotika profilaksi pada SC mencegah endometritis

95% Confidence interval

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 patient’s potential benefits and

harms from the therapy?4. What are our patient’s values and

expectations for both the outcome we are trying to prevent and the treatment we are offering?