• Patrick L Ergina, Jonathan A Cook, Jane M Blazeby, Isabelle Boutron, Pierre-Alain Clavien, Barnaby C Reeves, Christoph M Seiler, Balliol Collaboration, Douglas G Altman, Jeffrey K Aronson, Jeffrey S Barkun, W Bruce Campbell, Liane S Feldman, David R Flum, Paul Glasziou, Guy J Maddern, John C Marshall, Peter McCulloch, Jon Nicholl, Steven M Strasberg, Jonathan L Meakins, Deborah Ashby, Nick Black, John Bunker, Martin Burton, Marion Campbell, Kalipso Chalkidou, Iain Chalmers, Marc de Leval, Jon Deeks, Adrian Grant, Muir Gray, Roger Greenhalgh, Milos Jenicek, Sean Kehoe, Richard Lilford, Peter Littlejohns, Yoon Loke, Rajan Madhock, Kim McPherson, Peter Rothwell, Bill Summerskill, David Taggart, Parris Tekkis, Matthew Thompson, Tom Treasure, Ulrich Trohler, and Jan Vandenbroucke.
• Department of Surgery, McGill University Health Centre, Montreal, QC, Canada. patrick.ergina@muhc.mcgill.ca
• Lancet. 2009 Sep 26; 374 (9695): 1097-104.

AbstractResearch on surgical interventions is associated with several methodological and practical challenges of which few, if any, apply only to surgery. However, surgical evaluation is especially demanding because many of these challenges coincide. In this report, the second of three on surgical innovation and evaluation, we discuss obstacles related to the study design of randomised controlled trials and non-randomised studies assessing surgical interventions. We also describe the issues related to the nature of surgical procedures-for example, their complexity, surgeon-related factors, and the range of outcomes. Although difficult, surgical evaluation is achievable and necessary. Solutions tailored to surgical research and a framework for generating evidence on which to base surgical practice are essential.

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