Letters Section Editor: Robert M. Golub, MD, Senior Editor.
To the Editor: Dr Fitzgibbons and colleagues1 conducted a randomized controlled trial comparing watchful waiting vs immediate repair of inguinal hernia. The authors reported similar primary outcomes in both groups and concluded that delaying surgical repair is safe.
Data can be analyzed in many ways. To maintain the effect of randomization and thus group comparability, the authors appropriately used an intent-to-treat (ITT) approach. However, assuming that crossing-over equals failure in the ITT analysis would result in immediate repair having a superior primary outcome of pain-limiting activities (50/317 [15.8%] vs 97/336 [28.9%], P<.001 by 2-sided Fisher exact test).
Parienti J. Repair of Inguinal Hernia vs Watchful Waiting. JAMA. 2006;295(23):2724-2725. doi:10.1001/jama.295.23.2724-a