IDEAL framework for surgical innovation 3: randomised controlled trials in the assessment stage and evaluations in the long term study stage

The complexity of surgical procedures oft en poses challenges for conducting a rigorous and comprehensive evaluation. This paper considers the fi nal two IDEAL stages of surgical innovation. Surgical randomised controlled trials are oft en challenging to undertake and require careful consideration of the intervention defi nition, who should deliver it, and the impact of surgeon and patient preferences. In the long term study stage, better monitoring of surgical procedures is needed, along with improved surveillance of devices. Introduction The IDEAL framework describes the stages through which interventional therapy innovation normally passes: idea, development, exploration, assessment, and long term follow-up (also known as stages 1, 2a, 2b, 3, and 4, respectively). This paper focuses on the stages of assessment (specifi cally in relation to randomised trials) and long term follow-up. By the assessment stage, a new intervention will have shown early promise and be used increasingly by the surgical community; however, the intervention's relative benefi t compared with alternative approaches will be uncertain. At the long term follow-up stage, a surgical intervention will need further assessment owing to technical refi nements or to related devices or procedures being brought onto the market. Surgical procedures are conducted with an almost infinite set of subtle variations: surgeon training, team exper