No surgical innovation without evaluation: the IDEAL recommendations.


Surgery and other invasive therapies are complex interventions, the assessment of which is challenged by factors that depend on operator, team, and setting, such as learning curves, quality variations, and perception of equipoise. We propose recommendations for the assessment of surgery based on a five-stage description of the surgical development process. We also encourage the widespread use of prospective databases and registries. Reports of new techniques should be registered as a professional duty, anonymously if necessary when outcomes are adverse. Case series studies should be replaced by prospective development studies for early technical modifications and by prospective research databases for later pre-trial evaluation. Protocols for these studies should be registered publicly. Statistical process control techniques can be useful in both early and late assessment. Randomised trials should be used whenever possible to investigate efficacy, but adequate pre-trial data are essential to allow power calculations, clarify the definition and indications of the intervention, and develop quality measures. Difficulties in doing randomised clinical trials should be addressed by measures to evaluate learning curves and alleviate equipoise problems. Alternative prospective designs, such as interrupted time series studies, should be used when randomised trials are not feasible. Established procedures should be monitored with prospective databases to analyse outcome variations and to identify late and rare events. Achievement of improved design, conduct, and reporting of surgical research will need concerted action by editors, funders of health care and research, regulatory bodies, and professional societies.

DOI: 10.1016/S0140-6736(09)61116-8
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@article{McCulloch2009NoSI, title={No surgical innovation without evaluation: the IDEAL recommendations.}, author={Peter McCulloch and Douglas G Altman and W Bruce Campbell and David R Flum and Paul Glasziou and John C Marshall and Jon Nicholl and Jeffrey K Aronson and Jeffrey S Barkun and Jane M Blazeby and Isabell C Boutron and Pierre-Alain Clavien and Jonathan A Cook and Patrick L Ergina and Liane S Feldman and Guy J Maddern and Bournaby C Reeves and Christoph M Seiler 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 Jonathan Meakins 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={1105-12} }