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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.

Parienti's second statistical comparison used data from our Figures 1 and 2 to do a simple difference-of-proportions test that showed a significant difference between the as-treated groups of patients who crossed over to repair and those who underwent repair as assigned. However, we . . . [Full Text of this Article]

Olga Jonasson, MD
ojonasson@ameritech.net
Department of Surgery
University of Illinois
Chicago

Robert J. Fitzgibbons, MD
Department of Surgery
Creighton University
Omaha, Neb

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