Elsevier

Surgery

Volume 118, Issue 3, September 1995, Pages 459-467
Surgery

Should we be performing more randomized controlled trials evaluating surgical operations?*

https://doi.org/10.1016/S0039-6060(05)80359-9Get rights and content

Background The objective of this study was, first, to determine what proportion of clinical treatmentevaluation questions involving surgical operations could be answered by a randomized controlled trial (RCT). Second, for those questions not amenable to a RCT, to determine the problems that potentially preclude the initiation of RCT in an ideal clinical research setting.

Methods A sample of treatment evaluation questions involving a surgical procedure was obtained by acomputerized search of the surgical literature. Problems precluding a RCT were defined. Their face validity and interobserver and intraobserver reliability were assessed. By use of these criteria, the sample questions were evaluated to determine whether a RCT could be performed and, if not, the predominant reasons precluding RCT of surgical procedures.

Results Only 38.8% of treatment evaluation questions could have been answered by a RCT in an ideal clinical research setting. Patient preference was the most common precluding problem encountered (40% of all problems). The principal precluding problem was patient preference in 23.1%, an uncommon condition in 24.2%, and lack of community (clinical) equipoise in 10%. Methodologic issues (1.2%) and surgical preference (2.3%) were infrequent precluding problems. Questions evaluating therapy for malignant disease, comparing surgical with nonsurgical therapies, and where survival was the primary outcome were more likely to have problems precluding RCT.

Conclusions In the ideal situation RCT can be performed to evaluate only 40% of treatment questionsinvolving surgical procedures. Patient preferences, uncommon conditions, and lack of surgical community equipoise appear to be the most common reasons precluding the performance of RCT of surgical operations.

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Supported in part by the Wigston Foundation, Toronto, Ethicon Canada Ltd., Samuel Lunenfeld Research Institute, Mount Sinai Hospital, Toronto, and Jenour Foundation, Australia.

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