Critical Appraisal of a Therapeutic Study quiz

Randomisation was performed in order to make groups equal at baseline?

The primary outcome was a composite outcome?

The clinical significance of the composite outcomes was similar?

Performing a per protocol analysis would have been preferable to the intention to treat analysis that occurred in the study?

The results of the study were described in terms of odds ratios.

‘Death or hemodynamic decompensation occurred in 13 of 506 patients (2.6%) in the tenecteplase group as compared with 28 of 499 (5.6%) in the placebo group (odds ratio, 0.44; 95% confidence interval, 0.23 to 0.87; P=0.02)

The fact that the 95% confidence intervals didn’t cross 1 means that this is an insignificant result?

‘Death or hemodynamic decompensation occurred in 13 of 506 patients (2.6%) in the tenecteplase group as compared with 28 of 499 (5.6%) in the placebo group (odds ratio, 0.44; 95% confidence interval, 0.23 to 0.87; P=0.02)

The p-value would be deemed statistically significant?

‘Death or hemodynamic decompensation occurred in 13 of 506 patients (2.6%) in the tenecteplase group as compared with 28 of 499 (5.6%) in the placebo group (odds ratio, 0.44; 95% confidence interval, 0.23 to 0.87; P=0.02)

The p-value indicates the magnitude of the therapeutic effect that tenecteplase holds?