No surgical innovation without evaluation: the IDEAL recommendations

Peter McCulloch, Douglas G Altman, W Bruce Campbell, David R Flum, Paul Glasziou, John C Marshall, Jon Nicholl, Jeffrey K Aronson, Jeffrey S Barkun, Jane M Blazeby, Isabell C Boutron, Steven Bruce Campbell, Pierre-Alain Clavien, Jonathan Cook, Patrick L Ergina, Liane S Feldman, David R Flum, Guy J Maddern, Jon Nicholl, Bournaby C ReevesChristoph M Seiler, 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, Patrick L Ergina, Adrian Grant, Muir Gray, Roger Greenhalgh, Milos Jenicek, Sean Kehoe, Richard Lilford, Peter Littlejohns, Yoon Loke, Rajan Madhock, Donald McPherson, Jonathan Meakins, Peter Rothwell, Bill Summerskill, David Taggart, Parris Tekkis, Mandy Thompson, Tom Treasure, Balliol Collaboration

Research output: Contribution to journalArticle

810 Citations (Scopus)

Abstract

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.
Original languageEnglish
Pages (from-to)1105-1112
Number of pages8
JournalThe Lancet
Volume374
Issue number9695
DOIs
Publication statusPublished - 26 Sep 2009

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Keywords

  • biomedical research
  • clinical trials as topic
  • editorial policies
  • evaluation studies as topic
  • humans
  • randomized controlled trials as topic
  • research design
  • research support as topic
  • surgical procedures, operative
  • treatment outcome

Cite this

McCulloch, P., Altman, D. G., Campbell, W. B., Flum, D. R., Glasziou, P., Marshall, J. C., ... Balliol Collaboration (2009). No surgical innovation without evaluation: the IDEAL recommendations. The Lancet, 374(9695), 1105-1112. https://doi.org/10.1016/S0140-6736(09)61116-8

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, Steven Bruce; Clavien, Pierre-Alain; Cook, Jonathan; Ergina, Patrick L; Feldman, Liane S; Flum, David R; Maddern, Guy J; Nicholl, Jon; Reeves, Bournaby C; Seiler, Christoph M; Strasberg, Steven M; Meakins, Jonathan L; Ashby, Deborah; Black, Nick; Bunker, John; Burton, Martin; Campbell, Marion; Chalkidou, Kalipso; Chalmers, Iain; de Leval, Marc; Deeks, Jon; Ergina, Patrick L; Grant, Adrian; Gray, Muir; Greenhalgh, Roger; Jenicek, Milos; Kehoe, Sean; Lilford, Richard; Littlejohns, Peter; Loke, Yoon; Madhock, Rajan; McPherson, Donald ; Meakins, Jonathan; Rothwell, Peter; Summerskill, Bill; Taggart, David; Tekkis, Parris; Thompson, Mandy; Treasure, Tom; Balliol Collaboration.

In: The Lancet, Vol. 374, No. 9695, 26.09.2009, p. 1105-1112.

Research output: Contribution to journalArticle

McCulloch, P, Altman, DG, Campbell, WB, Flum, DR, Glasziou, P, Marshall, JC, Nicholl, J, Aronson, JK, Barkun, JS, Blazeby, JM, Boutron, IC, Campbell, SB, Clavien, P-A, Cook, J, Ergina, PL, Feldman, LS, Flum, DR, Maddern, GJ, Nicholl, J, Reeves, BC, Seiler, CM, Strasberg, SM, Meakins, JL, Ashby, D, Black, N, Bunker, J, Burton, M, Campbell, M, Chalkidou, K, Chalmers, I, de Leval, M, Deeks, J, Ergina, PL, Grant, A, Gray, M, Greenhalgh, R, Jenicek, M, Kehoe, S, Lilford, R, Littlejohns, P, Loke, Y, Madhock, R, McPherson, D, Meakins, J, Rothwell, P, Summerskill, B, Taggart, D, Tekkis, P, Thompson, M, Treasure, T & Balliol Collaboration 2009, 'No surgical innovation without evaluation: the IDEAL recommendations', The Lancet, vol. 374, no. 9695, pp. 1105-1112. https://doi.org/10.1016/S0140-6736(09)61116-8
McCulloch P, Altman DG, Campbell WB, Flum DR, Glasziou P, Marshall JC et al. No surgical innovation without evaluation: the IDEAL recommendations. The Lancet. 2009 Sep 26;374(9695):1105-1112. https://doi.org/10.1016/S0140-6736(09)61116-8
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, Steven Bruce ; Clavien, Pierre-Alain ; Cook, Jonathan ; Ergina, Patrick L ; Feldman, Liane S ; Flum, David R ; Maddern, Guy J ; Nicholl, Jon ; Reeves, Bournaby C ; Seiler, Christoph M ; Strasberg, Steven M ; Meakins, Jonathan L ; Ashby, Deborah ; Black, Nick ; Bunker, John ; Burton, Martin ; Campbell, Marion ; Chalkidou, Kalipso ; Chalmers, Iain ; de Leval, Marc ; Deeks, Jon ; Ergina, Patrick L ; Grant, Adrian ; Gray, Muir ; Greenhalgh, Roger ; Jenicek, Milos ; Kehoe, Sean ; Lilford, Richard ; Littlejohns, Peter ; Loke, Yoon ; Madhock, Rajan ; McPherson, Donald ; Meakins, Jonathan ; Rothwell, Peter ; Summerskill, Bill ; Taggart, David ; Tekkis, Parris ; Thompson, Mandy ; Treasure, Tom ; Balliol Collaboration. / No surgical innovation without evaluation : the IDEAL recommendations. In: The Lancet. 2009 ; Vol. 374, No. 9695. pp. 1105-1112.
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KW - clinical trials as topic

KW - editorial policies

KW - evaluation studies as topic

KW - humans

KW - randomized controlled trials as topic

KW - research design

KW - research support as topic

KW - surgical procedures, operative

KW - treatment outcome

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