Cast versus splint in children with minimally angulated fractures of the distal radius: a randomized controlled trial

We would like to thank you for your thoughtful comments and interest in our paper.

As you pointed out, 50 patients were initially randomized to each treatment arm. Due to diagnostic errors in 4 patients randomized to the splint, these patients had to be excluded immediately for safety reasons as these fractures required a different treatment strategy than a splint. There is some controversy with respect to post-randomization exclusion as some experts would advocate continuation of these patients in the trial and including them in the analysis, while others would agree that exclusion of patients that were enrolled in error is appropriate. We adopted the latter approach for this study as all errors in enrolment were related to diagnostic mistakes that were revealed within 24 hours of randomization.

For the remaining 46 patients in the splint group and 50 in the cast group, we did not have any primary outcome data on four of these patients (3 splint, 1 cast) as they were lost to follow up for this outcome. As you mentioned, there are methods to deal with missing data. In the original paper, we chose not to account for missing data, as it was such a small number of patients and unlikely to affect the outcome. However, you raise a valid point and 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 95% confidence interval is now -3.37, and the p-value is < 0.0001, thereby rejecting the null hypothesis that the splint is worse than the case by more than 7 points. Thus, these results support the findings reported on the original paper.

Please advise us if you have any additional questions, as we would be pleased to consider them.

Thank you,

Kathy Boutis Andrew Willan

Conflict of Interest:

None declared