%0 Journal Article %1 McCulloch2009 %A McCulloch, Peter %A Altman, Douglas G %A Campbell, W Bruce %A Flum, David R %A Glasziou, Paul %A Marshall, John C %A Nicholl, Jon %A Aronson, Jeffrey K %A Barkun, Jeffrey S %A Blazeby, Jane M %A Boutron, Isabell C %A Clavien, Pierre-Alain %A Cook, Jonathan A %A Ergina, Patrick L %A Feldman, Liane S %A Maddern, Guy J %A Reeves, Bournaby C %A Seiler, Christoph M %A Strasberg, Steven M %A Meakins, Jonathan L %A Ashby, Deborah %A Black, Nick %A Bunker, John %A Burton, Martin %A Campbell, Marion %A Chalkidou, Kalipso %A Chalmers, Iain %A de Leval, Marc %A Deeks, Jon %A Grant, Adrian %A Gray, Muir %A Greenhalgh, Roger %A Jenicek, Milos %A Kehoe, Sean %A Lilford, Richard %A Littlejohns, Peter %A Loke, Yoon %A Madhock, Rajan %A McPherson, Kim %A Meakins, Jonathan %A Rothwell, Peter %A Summerskill, Bill %A Taggart, David %A Tekkis, Parris %A Thompson, Matthew %A Treasure, Tom %A Trohler, Ulrich %A Vandenbroucke, Jan %D 2009 %J Lancet %K BiomedicalResearch ClinicalTrialsasTopic EditorialPolicies EvaluationStudiesasTopic Humans Operative Operative:standards ResearchDesign ResearchSupportasTopic SurgicalProcedures TreatmentOutcome RCT %N 9695 %P 1105-12 %R 10.1016/S0140-6736(09)61116-8 %T No surgical innovation without evaluation: the IDEAL recommendations. %U http://www.ncbi.nlm.nih.gov/pubmed/19782876 %V 374 %X 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. %@ 1474-547X

@article{McCulloch2009, 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.}, added-at = {2023-02-03T11:44:35.000+0100}, author = {McCulloch, Peter and Altman, Douglas G and Campbell, W Bruce and Flum, David R and Glasziou, Paul and Marshall, John C and Nicholl, Jon and Aronson, Jeffrey K and Barkun, Jeffrey S and Blazeby, Jane M and Boutron, Isabell C and Clavien, Pierre-Alain and Cook, Jonathan A and Ergina, Patrick L and Feldman, Liane S and Maddern, Guy J and Reeves, Bournaby C and Seiler, Christoph M and Strasberg, Steven M and Meakins, Jonathan L and Ashby, Deborah and Black, Nick and Bunker, John and Burton, Martin and Campbell, Marion and Chalkidou, Kalipso and Chalmers, Iain and de Leval, Marc and Deeks, Jon and Grant, Adrian and Gray, Muir and Greenhalgh, Roger and Jenicek, Milos and Kehoe, Sean and Lilford, Richard and Littlejohns, Peter and Loke, Yoon and Madhock, Rajan and McPherson, Kim and Meakins, Jonathan and Rothwell, Peter and Summerskill, Bill and Taggart, David and Tekkis, Parris and Thompson, Matthew and Treasure, Tom and Trohler, Ulrich and Vandenbroucke, Jan}, biburl = {https://www.bibsonomy.org/bibtex/22ae004b90f8fc3db6581be9e5cca18ac/jepcastel}, city = {Nuffield Department of Surgery, University of Oxford, Oxford, UK. peter.mcculloch@nds.ox.ac.uk}, doi = {10.1016/S0140-6736(09)61116-8}, interhash = {3962ca5ea727ec5847829cb9cbd4075b}, intrahash = {2ae004b90f8fc3db6581be9e5cca18ac}, isbn = {1474-547X}, issn = {1474-547X}, journal = {Lancet}, keywords = {BiomedicalResearch ClinicalTrialsasTopic EditorialPolicies EvaluationStudiesasTopic Humans Operative Operative:standards ResearchDesign ResearchSupportasTopic SurgicalProcedures TreatmentOutcome RCT}, month = {9}, note = {5332<br/>JID: 2985213R; ppublish;<br/>Tipus d'estudis; Cirurgia}, number = 9695, pages = {1105-12}, pmid = {19782876}, timestamp = {2023-05-04T08:59:38.000+0200}, title = {No surgical innovation without evaluation: the IDEAL recommendations.}, url = {http://www.ncbi.nlm.nih.gov/pubmed/19782876}, volume = 374, year = 2009 }