IDEAL framework for surgical innovation 1: the idea and development stages

Abstract

IDEAL is a framework for evaluations of surgical innovations, which follow a distinct development pathway differing from the approach developed for pharmacological interventions. Many pathway and evaluation challenges are shared by other interventional therapies, requiring individual therapist skills and customisation of treatment to the individual, partly through medical devices. This paper provides an overview of the IDEAL framework and recommendations, and focuses on the first two stages: idea and development. Surgical innovations comprise new techniques, modified strategies, or innovative instruments. The evidence base for many of these approaches—and therefore for much of current surgical practice—is vastly weaker than for most modern drug treatments. Randomised trials of surgical techniques (versus placebo surgery)1 were conducted within 10 years of the publication of the epochal streptomycin drug trial.2 Yet, despite rapid growth in recent years, the overall number of randomised controlled trials and systematic reviews in surgical innovations remains small compared with the number of studies evaluating drug treatments. Randomised trials have also been few in number and of poor quality in some other therapeutic specialities, where the success of the intervention depends on the skill and judgment of the individual operator.3 The IDEAL Collaboration was born out of a series of conferences between surgeons and methodologists at Balliol College, Oxford,4 5 6 which was convened to study why high quality trials in surgery were genuinely difficult to conduct, and what could be done to improve the evidence base for surgery. The conclusion was that innovation in surgery inevitably follows a pathway with important differences from that followed by pharmacological developments, and that a different approach to evaluation is therefore needed. It was noted that many non-surgical disciplines had similar problems with evaluation of such treatments (termed as “interventional therapies”), which rely on operator skill and tailoring of the …