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A recent issue of the Lancet was focused on evaluation and innovation in surgery. The issue arose as a follow-up to an editorial published in the Lancet in 19961 in which the editor described surgical research as comic opera following the publication of a high-quality randomized controlled trial (RCT) that compared outcomes with laparoscopic cholecystectomy to those with mini-open cholecystectomy.
The journal issue included examples of RCTs in surgery, editorials, comments about academic surgery and proposals for globally applicable benchmarks in surgery. At its core were 3 articles2–4 focused on surgical innovation and evaluation with the goal of improving the quality of surgical evaluation. These articles arose from a series of meetings at Balliol College Oxford under the auspices of Dr. Jonathan Meakins, professor of surgery at Oxford and McGill Universities and former editor-in-chief of the Canadian Journal of Surgery. During the meetings, surgeons, methodologists and statisticians came together with the aim of developing a practical roadmap for improving clinical research in surgery. The 3 articles proposed a descriptive model delineating the stages of innovation, development, exploration, assessment and long-term study (the IDEAL model). 2–4
The first of the articles proposed a model to describe the development of innovative surgical procedures. The second article provided a summary of the challenges in evaluating surgical innovation and appropriately reinforces the central role of RCTs.
The third article outlined the IDEAL recommendations and lies at the heart of the proposal. The evaluation process is explicitly linked to the stage of development. Critical suggestions include protocol registration at a very early development phase, the importance of RCTs and alternatives to RCTs. The Balliol Colloquium then extended a call to regulators, funders, surgical societies and journal editors to take specific action to move toward the IDEAL.
How are Canadian surgeons to respond? The IDEAL model was developed within the confines of small group of leaders in the fields of surgery and evidence-based medicine. As a first step, the IDEAL model needs to be subjected to wider peer review and debate. The IDEAL model explicitly challenges surgical societies and surgical journals such as CJS to respond. Canadian surgical societies should debate the notion that innovative surgical procedures must be identified and subject to online registration of protocols and outcomes at the earliest stages. Surgical journal editors should consider whether more robust methods in the form of RCTs and nonrandomized studies can be promoted by insisting on the use of the CONSORT and STROBE guidelines. Or is it that what is really required is explicit regulatory change that mandates more robust evaluation before approval of surgical procedures and devices?
The report of the Balliol Colloquium in the Lancet marks an important moment in the history of surgical innovation and is strongly recommended to all in the surgical community. Are we prepared to respond to the call to the IDEAL?
Competing interests: None declared.