After serious concerns that some surgeons have failed to live up to expectations about the standards and quality of their research and practice—previously described as a "Comic Opera" (Lancet, 1996)—The Lancet this week publishes a landmark Series on the current state of surgical research, its problems, and proposed solution by the Balliol Collaboration. The Series forms part of the Lancet Surgery Special Issue.
Measuring the success of surgical interventions is just as important as measuring the effectiveness of drugs. Yet to date, surgical innovation has been poorly measured and regulated. To address the problems facing the field of surgery, the Balliol colloquia gathered surgeons and research experts from around the world, who met at Balliol College, Oxford, to consider how the quality of research in surgery could be improved.
Research in surgery has lagged behind other fields in medicine, due to a number of factors, including the complexity of designing high-quality research studies for surgical interventions. The second paper in the Series explores some of these problems, and is written by Dr Patrick Ergina, McGill University, Montreal, Canada, and colleagues. Surgeons can have preferences for one intervention over another, and might also be less tolerant of uncertainty about alternative treatments. Surgical interventions (unlike drug interventions) have several components that cannot be separated. Surgeons have a variety of experience, which interact with differences in patients, affecting the response to operations. The expectation that all surgeons should attain the ideal standard is not realistic. And how should outcomes be measured and by whom, and when? Lack of standardisation of surgical outcomes makes comparisons and reviews of existing literature even more difficult.
The experts propose a framework (IDEAL) to guide surgeons in evaluating new innovations in surgery, which is detailed in paper three of the Series—written by Peter McCulloch, Nuffield Department of Surgery, John Radcliffe Hospital, Oxford, & University of Oxford, UK, and colleagues. The aim of IDEAL is to identify beneficial innovations at an earlier stage and to subject new surgical procedures to evaluations that are as rigorous as those used to show efficacy in other branches of medicine. It provides guidelines on innovation, development, exploration, assessment, and long-term study (the steps which were set out and discussed in paper one, by Professor Jeffrey S Barkun, McGill University Health Centre, Montreal, Canada). The framework will form the basis of a discussion at the upcoming American College of Surgeons Meeting in Chicago, IL, USA, on Oct 11-15. McCulloch and colleagues conclude: "We believe surgical science can be greatly improved, and progress in surgical care and interventions will become safer, more efficient, and better."
A Comment which accompanies the Series is written by Dr Jonathan Meakins, of McGill University and the University of Oxford, who organised the Balliol Colloquia. He says: "The Collaboration, in its three reports in 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."
An accompanying Lancet Editorial says that the proportion of randomised controlled trials in surgery remains low and poor-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."
(Series 1) Professor Jeffrey S Barkun, McGill University Health Centre, E) jeffrey.barkun@muhc.mcgill.ca
(Series 2) Dr Patrick Ergina, McGill University, Montreal, Canada. T) +1 514 843 1463 E) patrick.ergina@muhc.mcgill.ca
(Series 3) Dr Peter McCulloch, Nuffield Department of Surgery, John Radcliffe Hospital, Oxford, & University of Oxford, UK. T) +44 (0)1865 740873 / +44 (0) 7786267510 E) peter.mcculloch@nds.ox.ac.uk
(Comment) Dr Jonathan Meakins, of McGill University, Montreal, Canada, and the University of Oxford, UK. T) +1-450-826-4467 E) jonathan.meakins@muhc.mcgill.ca
(Editorial) Lancet Press Office. T) +44 (0) 20 7424 4949 E) pressoffice@lancet.com
For all three Series papers, see: http://press.thelancet.com/surgseries.pdf
For Comment, and Editorial, see: http://press.thelancet.com/edcomsurgery.pdf
Journal
The Lancet