End Points and Statistical Analyses in a Trial of Transfascial Fixation for Open Retromuscular Ventral Hernia Repairs—Reply

Abstract

COMMENT & RESPONSEIn Reply We thank the authors for their insightful comments on our trial. 1 The correct reference for our decision to use the pragmatic hernia recurrence definition is reference 13 in our article. 2 We believe that hernia recurrence was the appropriate primary outcome and that the definition, while complex, is accurate. Unfortunately, in hernia surgery, there is no unified definition of a recurrent hernia, and it is quite challenging to define. Because it can involve the patient, radiograph, and surgeons' perceptions, which may not always align, it is paramount to clearly define how hernia recurrences are being measured and the weight of each of these opinions on determining whether there is a true recurrence.Based on the modified Delphi process performed in our previous randomized clinical trial, the consensus was that a blinded computed tomography (CT) scan would hold the highest weight and the patient perception of a bulge the lowest weight. As such, if a patient had all 3 modalities, then the CT would trump any other finding. If only the patient perspective was available, a bulge would be considered a recurrence until proven otherwise. While acknowledging that this definition is cumbersome and occasionally difficult to interpret, we highlight that it is the most comprehensive definition. This allows the reader to clearly interpret how these decisions are being made and the weight of each modality.The authors bring up an interesting point as to allowing patients to respond with an "I don't know" answer when determining if transfascial sutures were placed. Unfortunately, we did not include that interpretation but highlight our great efforts to maintain blinding of the examiner and the patients with the placement of sham transfascial incisions in the control arm. Furthermore, we agree that the terms single blind and double blind can be misleading and believe it is most appropriate to clearly state who was blinded and how we maintained blinding. As such, the patients and assessors were blinded, but for obvious reasons, the surgeons could not be blinded and thus were not involved in the postoperative assessment of the patients for key outcomes.