• Lancet · Sep 2009

    Evaluation and stages of surgical innovations.

    • Jeffrey S Barkun, Jeffrey K Aronson, Liane S Feldman, Guy J Maddern, Steven M Strasberg, Balliol Collaboration, Douglas G Altman, Jane M Blazeby, Isabell C Boutron, W Bruce Campbell, Pierre-Alain Clavien, Jonathan A Cook, Patrick L Ergina, David R Flum, Paul Glasziou, John C Marshall, Peter McCulloch, Jon Nicholl, Bournaby C Reeves, Christoph M Seiler, 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.
    • McGill University Health Centre, Montreal, QC, Canada. jeffrey.barkun@muhc.mcgill.ca
    • Lancet. 2009 Sep 26; 374 (9695): 1089-96.

    AbstractSurgical innovation is an important part of surgical practice. Its assessment is complex because of idiosyncrasies related to surgical practice, but necessary so that introduction and adoption of surgical innovations can derive from evidence-based principles rather than trial and error. A regulatory framework is also desirable to protect patients against the potential harms of any novel procedure. In this first of three Series papers on surgical innovation and evaluation, we propose a five-stage paradigm to describe the development of innovative surgical procedures.

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