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June 21, 2006

Repair of Inguinal Hernia vs Watchful Waiting—Reply

Author Affiliations

Letters Section Editor: Robert M. Golub, MD, Senior Editor.

JAMA. 2006;295(23):2724-2725. doi:10.1001/jama.295.23.2725-a

In Reply: Dr Parienti's suggestion that crossovers should be defined as failure of therapy would have biased the results. Crossovers from tension-free repair to watchful waiting can only occur within a limited time frame, while crossovers from watchful waiting to tension-free repair will accumulate as length of follow-up increases. In addition, the reasons for crossover differed between patients in the group assigned to operation (patient choice) and in the group assigned to watchful waiting (worsening of their condition and choice). We analyzed the data both by ITT and by as-treated to assess the impact of crossovers on the results, but ITT is the most statistically valid comparison.