Abstract
Randomised evaluations of surgical interventions are rare; some interventions have been widely adopted without rigorous evaluation. Unlike other medical areas, the randomised controlled trial (RCT) design has not become the default study design for the evaluation of surgical interventions. Surgical trials are difficult to successfully undertake and pose particular practical and methodological challenges. However, RCTs have played a role in the assessment of surgical innovations and there is scope and need for greater use. This article will consider the design, conduct and analysis of an RCT of a surgical intervention. The issues will be reviewed under three headings: the timing of the evaluation, defining the research question and trial design issues. Recommendations on the conduct of future surgical RCTs are made. Collaboration between research and surgical communities is needed to address the distinct issues raised by the assessment of surgical interventions and enable the conduct of appropriate and well-designed trials.
Highlights
The promotion of randomised controlled trials (RCTs) to evaluate surgical interventions was once colourfully suggested to be the 'fifth horseman of an apocalyptical surgical fundamentalism' [1]
While the value of the RCT design has been more readily accepted by others, it has not become the default study design for the evaluation of new surgical interventions [2,3,4]
It should be noted that some authors use a wider definition of surgical trials [3] which includes trials in a surgical context, where surgery is involved but is not one of the interventions under evaluation, for example a placebo-controlled trial of ibuprofen for pain and disability relief after hip replacement surgery [5]
Summary
The promotion of randomised controlled trials (RCTs) to evaluate surgical interventions was once colourfully suggested to be the 'fifth horseman of an apocalyptical surgical fundamentalism' [1]. While the surgical community can be in equipoise, individual surgeons may have strong preferences In light of these concerns, the use of expertisebased randomised trials has been proposed as an alternative design, where participants are randomised to surgeons with expertise in the allocated intervention [25,39]. An expertise-based trial may not necessarily produce a result generalisable to the whole surgical community, due to the make up of the participating surgeons and centres. Blinding is not commonly undertaken in surgical trials [59] This is probably partly due to the standard care pathway, where patients commonly return to the surgeon who performed their surgery for re-assessment. Where allocated interventions are performed by different clinicians, as in an expertise-based trial or medical versus surgical trials, randomisation will need to be earlier. Exclusions threaten the value of randomisation, and reasons should be specified prior to commencement of randomisation [68]
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