No surgical innovation without evaluation: the IDEAL recommendations

McCulloch, Peter; Altman, Douglas G; Campbell, W Bruce; Flum, David R; Glasziou, Paul; Marshall, John C; Nicholl, Jon; Aronson, Jeffrey K; Barkun, Jeffrey S; Blazeby, Jane M; Boutron, Isabell C; Campbell, W Bruce; Clavien, Pierre-Alain; Cook, Jonathan A; Ergina, Patrick L; Feldman, Liane S; Flum, David R; Maddern, Guy J; Nicholl, Jon; Reeves, Bournaby C; ... (2009). No surgical innovation without evaluation: the IDEAL recommendations. Lancet, 374(9695), pp. 1105-12. London: Elsevier 10.1016/S0140-6736(09)61116-8

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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.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Pre-clinic Human Medicine > Institute of Social and Preventive Medicine

UniBE Contributor:

Tröhler, Ulrich

ISSN:

0140-6736

Publisher:

Elsevier

Language:

English

Submitter:

Factscience Import

Date Deposited:

04 Oct 2013 15:10

Last Modified:

25 Jun 2015 11:36

Publisher DOI:

10.1016/S0140-6736(09)61116-8

Web of Science ID:

000270370900033

BORIS DOI:

10.7892/boris.30634

URI:

https://boris.unibe.ch/id/eprint/30634 (FactScience: 194886)

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