International expert consensus on endpoints for full-thickness laparoendoscopic colonic excision.

作者: Andrew C. Currie , Ronan Cahill , Conor P. Delaney , Omar D. Faiz , Robin H. Kennedy

DOI: 10.1007/S00464-015-4362-Z

关键词:

摘要: Full-thickness laparoendoscopic excision has been reported for complex endoscopically unresectable colonic polyps. However, the endpoints used in these studies vary significantly and therefore making definitive conclusions regarding novel procedure would be improved if a common data set were adopted. This study sought to define most appropriate that should measured research on full-thickness of A Web-based Delphi Questionnaire was developed using systematic literature review endpoints. Outcomes grouped into general, complication, technical histopathology International specialists laparoscopic surgery, endoscopy transanal endoscopic microsurgery invited participate. The questionnaire required prioritization outcomes 5-point Likert scale. Respondents then sent second containing feedback scores from round 1 asked re-prioritize based received identify final core outcome set. total 33 (75 % response rate) participants 11 countries completed 28 proposed endpoints, all round. Eight rated important stakeholders within four domains—reoperation (general); anastomotic leak, mortality (complications); secure closure site, macroscopic completeness (technical); presence cancer, clearance resected margins en bloc specimen production (histopathology). provisional consensus minimum number feasible clinically meaningful measures use Widespread adoption will allow better reporting technique more efficient development clinical practice.

参考文章(9)
A. Brigic, A. Southgate, P. Sibbons, S. K. Clark, C. Fraser, R. H. Kennedy, Full-thickness laparoendoscopic colonic excision in an experimental model British Journal of Surgery. ,vol. 100, pp. 1649- 1654 ,(2013) , 10.1002/BJS.9298
M. B. Leon, N. Piazza, E. Nikolsky, E. H. Blackstone, D. E. Cutlip, A. P. Kappetein, M. W. Krucoff, M. Mack, R. Mehran, C. Miller, M.-a. Morel, J. Petersen, J. J. Popma, J. J. M. Takkenberg, A. Vahanian, G.-A. van Es, P. Vranckx, J. G. Webb, S. Windecker, P. W. Serruys, Standardized endpoint definitions for transcatheter aortic valve implantation clinical trials: a consensus report from the Valve Academic Research Consortium European Heart Journal. ,vol. 32, pp. 205- 217 ,(2011) , 10.1093/EURHEARTJ/EHQ406
Natalie S. Blencowe, Angus G. K. McNair, Christopher R. Davis, Sara T. Brookes, Jane M. Blazeby, Standards of outcome reporting in surgical oncology: a case study in esophageal cancer. Annals of Surgical Oncology. ,vol. 19, pp. 4012- 4018 ,(2012) , 10.1245/S10434-012-2497-X
Bradford R. Hirsch, Robert M. Califf, Steven K. Cheng, Asba Tasneem, John Horton, Karen Chiswell, Kevin A. Schulman, David M. Dilts, Amy P. Abernethy, Characteristics of oncology clinical trials: insights from a systematic analysis of ClinicalTrials.gov. JAMA Internal Medicine. ,vol. 173, pp. 972- 979 ,(2013) , 10.1001/JAMAINTERNMED.2013.627
R. N. Whistance, R. O. Forsythe, A. G. K. McNair, S. T. Brookes, K. N. L. Avery, A. M. Pullyblank, P. A. Sylvester, D. G. Jayne, J. E. Jones, J. Brown, M. G. Coleman, S. J. Dutton, R. Hackett, R. Huxtable, R. H. Kennedy, D. Morton, A. Oliver, A. Russell, M. G. Thomas, J. M. Blazeby, , A systematic review of outcome reporting in colorectal cancer surgery. Colorectal Disease. ,vol. 15, ,(2013) , 10.1111/CODI.12378
Paula R Williamson, Douglas G Altman, Jane M Blazeby, Mike Clarke, Declan Devane, Elizabeth Gargon, Peter Tugwell, Developing core outcome sets for clinical trials: issues to consider. Trials. ,vol. 13, pp. 132- 132 ,(2012) , 10.1186/1745-6215-13-132
A. Currie, A. Brigic, N. S. Blencowe, S. Potter, O. D. Faiz, R. H. Kennedy, J. M. Blazeby, Systematic review of surgical innovation reporting in laparoendoscopic colonic polyp resection. British Journal of Surgery. ,vol. 102, ,(2015) , 10.1002/BJS.9675
Jamie J Kirkham, Elizabeth Gargon, Mike Clarke, Paula R Williamson, Can a core outcome set improve the quality of systematic reviews? – a survey of the Co-ordinating Editors of Cochrane review groups Trials. ,vol. 14, pp. 21- 21 ,(2013) , 10.1186/1745-6215-14-21
A Fink, J Kosecoff, M Chassin, R H Brook, Consensus methods: characteristics and guidelines for use. American Journal of Public Health. ,vol. 74, pp. 979- 983 ,(1984) , 10.2105/AJPH.74.9.979