Evaluating the role of expertise-based trial designs in trials of surgical interventions

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Randomised Controlled Trials (RCTs) have played a very important role in advancing health care by allowing accurate assessment of a new treatment by comparison with a standard treatment. The field of surgery has been slower to use RCTs than medicine in general. Different options for how to run such studies exist. Conventionally participating surgeons have been expected to perform both treatments under assessment. An alternative approach is to require a participating surgeon to perform the intervention they are most comfortable with. This has been called an expertise-based approach. This is attractive from a surgeon‘s perspective though such an approach does raise some scientific (such a study may need to be larger) and practical challenges (organising corresponding expertise surgeons to be available). The aim of this research is to evaluate the relative merit of the different approaches and specifically, in which circumstances is an expertise-based approach preferable from both a practical and scientific perspective.