Intention-to-treat and per-protocol analysis

Among the remaining 46 patients in the splint group and 50 in the cast group, we did not have any primary outcome data for 4 (3 splint, 1 cast) because they were lost to follow up for this outcome. We chose not to account for missing data beause it was such a small number of patients and unlikely to affect the outcome. However, Dr. [Pankaj B. Shah] raises a valid point. We conducted the analysis again, giving the missing cast patient the highest possible score of 100 and the three missing splint patients the lowest observed score in their group (73.28). The lower limit of 90% confidence interval was then -3.37 and the p value < 0.0001, thereby rejecting the null hypothesis that the splint is worse than the cast by more than 7 points. These results support the original findings in our article.