Statistical methods for randomised surgical trials

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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. There are number of features about surgery which make it more difficult to assess, and influence the planning stage of a trial, the day to day running, and also the analysis of the results. The surgeons undertaking the procedure may vary in both experience and inherent surgical ability. The availability of a surgical theatre and the surgical team are limited and therefore the surgery may be delayed. Surgery also differs is in the way that it is administered and a number of apparently valid variations of a particular procedure may be possible. Individually and collectively these issues have inhibited surgical RCTs. This work would look to address each of these issues from a statistical point of view and, by furthering our understanding, can facilitate the uptake and enhance the quality of RCTs in surgery. By doing so our knowledge of the best way to treat patients where surgery is an option will be enlarged.