Assume the odds ratio calculated from question 10.10 would be regarded as the smallest effect that was clinically or practically important. Then, using the 95% CI, calculated in 10.6, the odds ratio estimate for participants in the HAL group having a recurrence of a haemorrhoid at 12 months compared to participants in the RBL group, we can say the result of the trial is:

A. Statistically significant and potentially clinically important.

B. Statistically significant and not clinically important.

C. Statistically significant and clinically important.

D. Not statistically significant but potentially clinically important.

E. Not statistically significant and not clinically important.

Question 10.10

The sample size calculation for the trial was based on detecting a 15% absolute difference in the proportion of patients who experience a recurrence of a haemorrhoid at 12 months between the RBL and HAL treated groups (i.e. 30% rate in the control treated RBL patients versus a 15% rate in HAL treated patients). Express this difference as an odds ratio effect for recurrence of a haemorrhoid at 12 months between the HAL and RBL groups.

A. 0.26 B. 0.41 C. 0.85 D. 2.43 E. 3.86