Design and conduct of clinical trials

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QUESTION 1 OF 2

Authors reported patient-reported outcomes in young patients treated with a fixation for isolated fractures of the hip. The primary outcome measures included the Oxford Hip Score (OHS). Authors reported a “significant difference in pre- and post-injury OHS (mean 9.8 point reduction (38 to -20; p < 0.001))”. The authors  performed statistical analysis using the independent-samples Kruskal-Wallis test and the Wilcoxon signed-rank test.
Which of the following is correct?

QUESTION ID: 1223

1. Box-plot would be an appropriate graph to display summary statistics.
2. Mean value is an appropriate measure of central tendency in this sample.
3. OHS was normally distributed in the sample.
4. The authors made distributional assumptions regarding the sample.
5. The significant difference in pre- and post-injury OHS suggests that the treatment method was clinically effective.
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QUESTION 2 OF 2

Researchers conducted a randomised trial to compare the efficacy of cast immobilisation vs symptomatic treatment for the management of avulsion fractures of the base of the fifth metatarsal. They stated “This is a non-inferiority study using a one-sided confidence interval for the difference between the two groups. At four weeks and six months, the symptomatic treatment proved non-inferior in terms of the primary outcome.”
Which of the following is correct?

QUESTION ID: 1224

1. P-value of 0.05 would be an appropriate margin of significant difference.
2. Since a one-sided confidence interval was used to assess difference, there was no need to assign a p-value to the tests.
3. Symptomatic treatment was equivalent in efficacy to cast immobilisation.
4. The authors were unable to reject the null hypothesis in this trial.
5. The study was likely to be free of confounding bias.
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