Challenges in evaluating surgical innovation.


Research 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.

DOI: 10.1016/S0140-6736(09)61086-2
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@article{Ergina2009ChallengesIE, title={Challenges in evaluating surgical innovation.}, author={Patrick L Ergina and Jonathan A Cook and Jane M Blazeby and Isabelle Boutron and Pierre-Alain Clavien and Barnaby C Reeves and Christoph M Seiler and Douglas G Altman and Jeffrey K Aronson and Jeffrey S Barkun and W Bruce Campbell and Liane S Feldman and David R Flum and Paul Glasziou and Guy J Maddern and John C Marshall and Peter McCulloch and Jon Nicholl and Steven M Strasberg and Jonathan L Meakins and Deborah Ashby and Nick Black and John Bunker and Martin Burton and Marion Campbell and Kalipso Chalkidou and Iain Chalmers and Marc de Leval and Jon Deeks and Adrian Grant and Muir Gray and Roger Greenhalgh and Milos Jenicek and Sean Kehoe and Richard Lilford and Peter Littlejohns and Yoon Loke and Rajan Madhock and Kim McPherson and Peter Rothwell and Bill Summerskill and David Taggart and Parris Tekkis and Matthew Thompson and Tom Treasure and Ulrich Trohler and Jan Vandenbroucke}, journal={Lancet}, year={2009}, volume={374 9695}, pages={1097-104} }