Critical Appraisal of a Therapeutic Study
Its now time to pull all the theory together and critically appraise a therapeutic study in the last of our podcasts.
In this podcast we review the PIETHO Study using a CASP; RCT checklist.
Again the paper is a free open access paper.
Have a read of the paper, run through the checklist, have a listen to the podcast and then to consolidate answer the questions below.
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Question 1 of 7
1. Question
Randomisation was performed in order to make groups equal at baseline?
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Question 2 of 7
2. Question
The primary outcome was a composite outcome?
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Question 3 of 7
3. Question
The clinical significance of the composite outcomes was similar?
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Question 4 of 7
4. Question
Performing a per protocol analysis would have been preferable to the intention to treat analysis that occurred in the study?
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Question 5 of 7
5. Question
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?
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Question 6 of 7
6. Question
'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?
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Question 7 of 7
7. Question
'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?
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