Results of randomised controlled trials (RCTs) in surgery are frequently criticised because the quality assurance (QA) of surgical interventions is not considered, leading to potential performance bias and issues with generalisability. Whilst methods for surgical QA have been developed, it is unclear how to operationalise and report them in the context of pragmatic trials.
RCTs in surgery are notoriously difficult to design and conduct, due to numerous methodological and cultural challenges. A major methodological challenge is the risk of introducing performance bias. Surgeons may be more familiar with (or prefer) one intervention compared with another, and therefore deliver it and/or the associated peri-operative care to a different standard than that of the comparator. A potential way of reducing performance bias within surgical RCTs is to embed quality assurance QA processes for interventions within the trial, to provide reassurance about the standards of surgery and facilitate replication of successful interventions in practice
