Randomized, controlled trials in surgery

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Abstract
PURPOSE: Although the randomized, controlled trial has gained preeminence as the criterion standard for evaluating pharmaceutical treatments, randomized controlled trials in surgery have been perceived as difficult to surmount. Furthermore, attitudes of surgeons toward randomized, controlled trials are not well understood. We determined the views of Australian surgeons about feasibility of and barriers to surgical randomized trials. METHODS: All members of the Section of Colon and Rectal Surgery of the Royal Australasian College of Surgeons (n=147) and all Australian colorectal subspecialist surgeons (n=72) were mailed a questionnaire that included questions about surgical randomized, controlled trials. RESULTS: A total of 195 surgeons responded (89 percent). Two-thirds (66.7 percent; 95 percent confidence interval 59.5-73.1) of respondents agreed that “Randomized controlled trials should be the study design of choice” to evaluate new surgical procedures. Only 19 percent (95 percent confidence interval 13.9-25.3) endorsed the statement that “too much emphasis is placed on results of randomized controlled trials.” Barriers to conducting surgical randomized, controlled trials identified by the majority included insufficient funding (74.4 percent; 95 percent confidence interval 67.5-80.2), a lack of support from the wider surgical community (55.9 percent; 95 percent confidence interval 48.6-62.9), and difficulties in convincing patients to accept random allocation to treatment (62.6 percent; 95 percent confidence interval 55.3-69.3). CONCLUSION: These results reveal positive attitudes among Australian surgeons toward randomized, controlled trials, although concerns about the feasibility of randomized, controlled trials have been reinforced.