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Nama : Zakiah NIM : 107101001778 Epidemiologi Gizi Critical Apparaisal CONTROLLED TRIAL OF SOTALOL FOR ONE YEAR AFTER

A. Descriptive of the evidence

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Exposure Outcome Study Design Study Population

Sotalol 320 mg and placebo Moratality rate because Acute Myocardial Infarction after intervention of sotalol and placebo. Clinical Trial All patiens between the ages of 30 and 69 years who had survive for five days after the onset of an Acute Myocardial Infarction. The mortality rates of 8,9% on placebo and


Main Result

7.3% on sotalol do not differ significanly ( rogrank test: X2 =1.1, p=0.3).

Internal Validity-concideration of non-causal explanation

Observation Bias

Multicentre double blind may prevent to occur Observation Bias. 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). RR sebesar 0.81 menunjukan



Chance variation(kebetulan)

hubunganyang tidak kuat, hal ini dapat diakibatkan oleh faktor kebetulan (chance).

Internal Validity-concideration of positive features of causation

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

setahun. Relative Risk sebesar 0.81 menujukkan 1 0 Strength of relationship bahwa hasil study tidak memiliki kekatan hubungan, karena lebih mendekati ke 1 ( 1 = tidak memiliki kekuatan hubungan). 78% of sotalol group and 4% of the placebo group had concentrations above 1.0 ug/ml 1 1 Dose-response (the level above which assays are reliable) and the result in the placebo group correspond to the propotion receiving sotalol openly. In most respecs, timolol, propanolol and Consistency sotalol are similar (beta adrenoceptor blocking drugs) . Specificity Sotalol and placebo are specified.

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D .

External validity- generalization of the result

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Applied to the eligible population Applied to the source population Applied to other relevant populations

91% (1331 patient) from1456 patients included and 125 patiens did not fully satisfy the trial protocol. Can be applied. Because the study used randomize method. 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.

Comparison of the results with other evidence

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Consistent with other evidence The result evidence suggest any specificity The results plausible biologically Coherency with the distribution of the exposure

Yes, Consistent with previous study about effect of beta adrenoceptor blocking drugs. Yes, Specific about the effect of beta adrenoceptor blocking drugs. Yes, Beta adrenoceptor blocking drugs ( included sotalol) can reduce mortality. Coherence with studies suggesting similar relationship.

and the outcome