8/3/2019 Critical Apparaisal Controlled Trial of Sotalol for One Year After Myocardial Infarction

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Nama : ZakiahNIM : 107101001778Epidemiologi Gizi

Critical Apparaisal CONTROLLED TRIAL OF SOTALOL FOR ONEYEAR AFTER MYOCARDIAL INFARCTION

A. Descriptive of the evidence

1 Exposure Sotalol 320 mg and placebo

2 Outcome

Moratality rate because Acute Myocardial

Infarction after intervention of sotalol and

placebo.

3 Study Design Clinical Trial

4 Study PopulationAll patiens between the ages of 30 and 69years who had survive for five days after the

onset of an Acute Myocardial Infarction.

5 Main Result

The mortality rates of 8,9% on placebo and

7.3% on sotalol do not differ significanly

( rogrank test: X2 =1.1, p=0.3).B. Internal Validity-concideration of non-causal explanation

6 Observation BiasMulticentre double blind may prevent to

occur Observation Bias.

7 Confounding

Sex, Clinacal History, Therapy before infart,

risk factors during acure phase previous,

other arrhytmias in acute stage, site infarct.

But in this study the confounding are only

sex, previous angina and Left Bundle

Branch Block (LBBB).

8 Chance variation(kebetulan)

RR sebesar 0.81 menunjukan

hubunganyang tidak kuat, hal ini dapat

diakibatkan oleh faktor kebetulan (chance).

C. Internal Validity-concideration of positive features of causation

9 Time relationship Ada, karena pemberian intervensi

dilakukan setelah 5-14 hari tejadinya Acute

Myocardial Infarction (ditentukan oleh

peneliti) yang dimulai sejak 1 Jan 1978

sampai 31 Ags 1980. Setiap diikuti selama

8/3/2019 Critical Apparaisal Controlled Trial of Sotalol for One Year After Myocardial Infarction

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setahun.

1

0Strength of relationship

Relative Risk sebesar 0.81 menujukkan

bahwa hasil study tidak memiliki kekatan

hubungan, karena lebih mendekati ke 1 ( 1

= tidak memiliki kekuatan hubungan).

1

1Dose-response

78% of sotalol group and 4% of the placebo

group had concentrations above 1.0 ug/ml

(the level above which assays are reliable)

and the result in the placebo group

correspond to the propotion receiving

sotalol openly.1

2Consistency

In most respecs, timolol, propanolol and

sotalol are similar (beta adrenoceptor

blocking drugs) .1

3Specificity Sotalol and placebo are specified.

D

.External validity- generalization of the result

14

Applied to the eligiblepopulation

91% (1331 patient) from1456 patients

included and 125 patiens did not fully

satisfy the trial protocol.1

5

Applied to the source

population

Can be applied. Because the study used

randomize method.

1

6

Applied to other relevant

populations

Can be applied, because the study not only

take part in a region but its taken from the

other region. So it can be applied to other

population abroadly.E. Comparison of the results with other evidence

1

7

Consistent with other

evidence

Yes, Consistent with previous study about

effect of beta adrenoceptor blocking drugs.1

8

The result evidence suggest

any specificity

Yes, Specific about the effect of beta

adrenoceptor blocking drugs.1

9

The results plausible

biologically

Yes, Beta adrenoceptor blocking drugs

( included sotalol) can reduce mortality.2

0

Coherency with the

distribution of the exposure

Coherence with studies suggesting similar

relationship.

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and the outcome