Like drugs, surgical innovations must be evaluated through trials

Like drugs, surgical innovations must be evaluated through trials

This week The Lancet publishes a landmark series on the current state of surgical research and its problems. The series is part of The Lancet Surgery Special Issue. There is serious concern that some surgeons have failed to live up to expectations about the standards and quality of their research and practice. The Balliol Collaboration proposes a solution.

Evaluating the achievements of surgical interventions is as essential as measuring the effectiveness of drugs. Up until now, surgical innovation has been weakly measured and regulated. In order to tackle the various problems in the field of surgery, the Balliol colloquia gathered surgeons and research experts from around the world. They met at the Balliol College, in Oxford, to explore how the quality of research in surgery could be improved.

Due to a number of factors, research in surgery has lagged behind other fields in medicine. This is in part because of the complexity of designing high-quality research studies for surgical interventions. The second paper in the series studies some of these problems. It is the work of Dr Patrick Ergina, McGill University, Montreal, Canada, and colleagues. It explains that surgeons can prefer one intervention over another. They might as well be less lenient about the uncertainty about alternative treatments. Unlike drug interventions, surgical interventions have several components that cannot be separated. Surgeons have a diversity of experiences, which work together with differences in patients. This affects the response to operations. The expectation that all surgeons should achieve the ideal standard is not rational. It is difficult to determine how outcomes should be measured, when and by whom. The lack of standardisation of surgical outcomes makes it even more complicated to make comparisons and reviews of existing literature.

A framework (IDEAL) is recommended by the experts. Its purpose is to guide surgeons in evaluating new innovations in surgery. It is detailed in the third paper of the series and is the work of Peter McCulloch, Nuffield Department of Surgery, John Radcliffe Hospital, Oxford, & University of Oxford, UK, and colleagues. The goal of IDEAL is to classify beneficial innovations at an earlier stage and to review new surgical procedures through evaluations that are as rigorous as those used to demonstrate efficacy in other branches of medicine. It provides guidelines on innovation, development, exploration, assessment, and long-term study.The steps are outlined and reviewed in the first paper, by Professor Jeffrey S Barkun, McGill University Health Centre, Montreal, Canada. The structure will be the central subject of debate at the upcoming American College of Surgeons Meeting in Chicago, IL, USA, (Oct 11-15). McCulloch and colleagues write in conclusion: "We believe surgical science can be greatly improved, and progress in surgical care and interventions will become safer, more efficient, and better."

A additional comment to the series is The Lancet today, has outlined the stages of innovation, the difficulties that present in the surgical setting, but most importantly, an approach to the timing of assessment, which will allow innovation to be appropriately appraised. This process will in turn allow society and regulatory bodies to properly assess the value of a surgery in the care of our patients."

A supplementary Lancet editorial states that the proportion of randomised controlled trials in surgery remains low. Moreover, inferior quality research continues without benefit to patients or surgeons. It concludes: "Surgery contributes substantially to improved health and wellbeing throughout the world. To do so efficiently and reliably requires that decisions about surgery are informed by high-quality outcome data. The methodological framework to guide such research within the complexities of surgery is available. Any alternative approach is less than IDEAL."

"Surgical Innovation and Evaluation 1"

"Evaluation and stages of surgical innovations"

Jeffrey S Barkun, Jeffrey K Aronson, Liane S Feldman, Guy J Maddern, Steven M Strasberg, for the Balliol Collaboration

Lancet 2009; 374: 1089-96

"Surgical research: the reality and the IDEAL"

Jonathan L Meakins

The Lancet

ABSORB III clinical trial at Baptist South (Video Medical And Professional 2020).

Section Issues On Medicine: Medical practice