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• W2029284540 abstract "The response to the trial of minimally invasive versus open oesophagectomy1Biere SSAY van Berge Henegouwen MI Maas KW et al.Minimally invasive oesophagectomy for patients with oesophageal cancer: a multicentre, open-label, randomised controlled trial.Lancet. 2012; 379: 1887-1892Summary Full Text Full Text PDF PubMed Scopus (1132) Google Scholar shows how surgeons often react to trials and don't believe randomised data. The letters identify individual pre­operative,2Spengler CM Verges S Walder B Minimally invasive versus open oesophagectomy for oesophageal cancer.Lancet. 2012; 380: 885Summary Full Text Full Text PDF PubMed Scopus (4) Google Scholar perioperative,3Swisher S Ajani J Correa A et al.Minimally invasive versus open oesophagectomy for oesophageal cancer.Lancet. 2012; 380: 883Summary Full Text Full Text PDF PubMed Scopus (5) Google Scholar, 4Mariette C Robb WB Minimally invasive versus open oesophagectomy for oesophageal cancer.Lancet. 2012; 380: 883Summary Full Text Full Text PDF PubMed Scopus (10) Google Scholar and post­operative4Mariette C Robb WB Minimally invasive versus open oesophagectomy for oesophageal cancer.Lancet. 2012; 380: 883Summary Full Text Full Text PDF PubMed Scopus (10) Google Scholar, 5Parotto M Valenza F Ori C et al.Minimally invasive versus open oesophagectomy for oesophageal cancer.Lancet. 2012; 380: 884Summary Full Text Full Text PDF PubMed Google Scholar components of surgery and argue that had components been different or more tightly controlled, trial outcomes would be altered. For example, various correspondents suggest that lower rates of respiratory infection might have been achieved by use of alternative strategies for preoperative preparation,5Parotto M Valenza F Ori C et al.Minimally invasive versus open oesophagectomy for oesophageal cancer.Lancet. 2012; 380: 884Summary Full Text Full Text PDF PubMed Google Scholar patient positioning,4Mariette C Robb WB Minimally invasive versus open oesophagectomy for oesophageal cancer.Lancet. 2012; 380: 883Summary Full Text Full Text PDF PubMed Scopus (10) Google Scholar ventilator settings,5Parotto M Valenza F Ori C et al.Minimally invasive versus open oesophagectomy for oesophageal cancer.Lancet. 2012; 380: 884Summary Full Text Full Text PDF PubMed Google Scholar anaesthetic agents,5Parotto M Valenza F Ori C et al.Minimally invasive versus open oesophagectomy for oesophageal cancer.Lancet. 2012; 380: 884Summary Full Text Full Text PDF PubMed Google Scholar or postoperative care.3Swisher S Ajani J Correa A et al.Minimally invasive versus open oesophagectomy for oesophageal cancer.Lancet. 2012; 380: 883Summary Full Text Full Text PDF PubMed Scopus (5) Google Scholar This approach, however, does not consider how intervention components can be dependent on or independent of each other, nor how delivery of surgical interventions is inevitably heterogeneous between different surgeons working in different hospitals and health-care systems. Ergina and colleagues6Ergina PL Cook JA Blazeby JM et al.Challenges in evaluating surgical innovation.Lancet. 2009; 374: 1097-1104Summary Full Text Full Text PDF PubMed Scopus (453) Google Scholar have therefore proposed that interventions in multi­centre pragmatic surgical trials be regarded as “complex interventions” and that the design and conduct of randomised controlled trials (RCTs) in surgery should account for this complexity. The UK Medical Research Council has published guidance7Medical Research CouncilComplex interventions guidance.http://www.mrc.ac.uk/Utilities/Documentrecord/index.htm?d=MRC004871Google Scholar on assessing complex interventions in health care, recommending that feasibility work is done to model the intervention (and outcomes) so that the intervention can be manualised and delivered according to the manual in the main trial. Although methods for developing and manualising surgical interventions in pragmatic trials are not available, we propose that the feasibility work could define intervention key components, describe boundaries for intervention delivery, and inform manual development. Manuals could also specify minimum mandatory or prohibited components to allow a pragmatic approach. A multicentre pragmatic trial is therefore still needed to consider the key components of minimally invasive oesophagectomy and how it should be delivered. Trial design will require dedicated feasibility work to establish critical intervention components, including which elements of pre­operative, perioperative, and post­operative care need to be mandated in the main trial. Also, the main trial needs to measure and report fidelity to the intervention protocol. In the UK, we are doing a Randomised feasibility study of Open and Minimally Invasive Oesophagectomy (ROMIO), which aims to achieve this. We expect that information gained during this feasibility study will inform the design and efficient and timely conduct of a methodologically robust main RCT with a trial manual to inform delivery of the intervention both during and after the trial, to convince surgeons that a fair comparison has been made. We are all members of the ROMIO group. CM is the principal investigator of the ROMIO study. The ROMIO trial is funded by the UK Health Technology Assessment Programme." @default.
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• W2029284540 date "2013-01-01" @default.
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• W2029284540 title "Understanding surgical interventions in RCTs: the need for better methodology" @default.
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• W2029284540 doi "https://doi.org/10.1016/s0140-6736(13)60015-x" @default.
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