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.

Are the results of the study valid?What were the results?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 randomisasiMencegah risiko biasTiap subyek memiliki kesempatan yang samaBalans karakteristik subyekCara randomisasiToast/coinTable randomRandom allocationSimple random samplingCluster random samplingMultistage random sampling

RandomizedRandomisasiControlledInclusionProsedurOutcomeClinical TrialIntervensiVs. control group

Patienteligibletreatment Btreatment AOUTCOMERandom

eligiblePatientRandomTreatment ATreatment B

Menetapkan terapi yang terbaikPembandingRandomisasiBlindingSerial vs. parallel designTanpa pembandingTanpa randomisasiTanpa blindingBefore-after treatmentUncontrolled trialR 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 halbentukrupawarnarasabaukonsistensicara pemberianObat/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 = 0,05Relative risk : Y/X = 0,15/0,20 = 0,75RRR (relative risk reduction ) =1- (Y/X) x 100 = (1-0,75) x 100 = 25 %

6. Apakah bermakna secara klinik/statistik?Mana yang harus dipenuhi:Bermakna secara statistik ? AtauBermakna 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

RR = 2,45; 95% CI (1,85:2,92)RR = 1,85; 95% CI (0,95-2,25)Ca. pulmo95% Confidence intervalMerokok

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 endometritis95% Confidence interval

Is our patient so different from those in the study that its results cannot apply?Is the treatment feasible in our setting?What are our patients potential benefits and harms from the therapy?What are our patients values and expectations for both the outcome we are trying to prevent and the treatment we are offering?

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