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 intervention to the patient (for example, cardiac catheterisation, endoscopic techniques, or physiotherapy).
The IDEAL Collaboration developed a framework for the stages in surgical innovation (idea, development, exploration, assessment, and long term study; tabletable)) and a set of recommendations on how evaluation should be conducted at each stage (box 1). The collaboration also proposed how the environment for surgical research could be improved by editors, regulators, funders, and professional societies. An open international collaborative group has been developed to explore these issues further.7 Recent concerns over hip resurfacing techniques8 and breast implants9 have raised serious questions about how medical devices are evaluated, and there has been considerable interest in applying the IDEAL framework to this problem, since many difficulties in evaluating device innovation mirror those in surgery innovation. In this series of three articles, we explain the problems and discuss proposed solutions put forward in the IDEAL recommendations, using current examples. This first article in the series focuses on the first two stages of the IDEAL framework: idea and development.
Box 1: Recommendations for studies in stages 1 (idea) and 2 (development)
- Mandatory registry for interventions thought to be first in man, with anonymous reporting option
- Protocols pre-registered on the above mandatory registry, for planned research programmes on a first-in-man intervention
- Development and use of agreed reporting standards and definitions for key outcomes and modifying factors
- Prospective development studies, with pre-published protocol and consecutive cases
- Publication of findings, including transparent reporting of changes in technique or device design and indication