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No surgical innovation without evaluation : evolution and further development of the IDEAL Framework and Recommendations

Published on Feb 1, 2019in Annals of Surgery 9.48
· DOI :10.1097/SLA.0000000000002794
Allison Hirst13
Estimated H-index: 13
(University of Oxford),
Yiannis Philippou3
Estimated H-index: 3
(University of Oxford)
+ 14 AuthorsPeter McCulloch38
Estimated H-index: 38
(University of Oxford)
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Abstract
Objective: To update, clarify, and extend IDEAL concepts and recommendations. Background: New surgical procedures, devices, and other complex interventions need robust evaluation for safety, efficacy, and effectiveness. Unlike new medicines, there is no internationally agreed evaluation pathway for generating and analyzing data throughout the life cycle of surgical innovations. The IDEAL Framework and Recommendations were designed to provide this pathway and they have been used increasingly since their introduction in 2009. Based on a Delphi survey, expert workshop and major discussions during IDEAL conferences held in Oxford (2016) and New York (2017), this article updates and extends the IDEAL Recommendations, identifies areas for future research, and discusses the ethical problems faced by investigators at each IDEAL stage. Methods: The IDEAL Framework describes 5 stages of evolution for new surgical therapeutic interventions—Idea, Development, Exploration, Assessment, and Long-term Study. This comprehensive update proposes several modifications. First, a “Pre-IDEAL” stage describing preclinical studies has been added. Second we discuss potential adaptations to expand the scope of IDEAL (originally designed for surgical procedures) to accommodate therapeutic devices, through an IDEAL-D variant. Third, we explicitly recognise the value of comprehensive data collection through registries at all stages in the Framework and fourth, we examine the ethical issues that arise at each stage of IDEAL and underpin the recommendations. The Recommendations for each stage are reviewed, clarified and additional detail added. Conclusions: The intention of this article is to widen the practical use of IDEAL by clarifying the rationale for and practical details of the Recommendations. Additional research based on the experience of implementing these Recommendations is needed to further improve them.
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Sivesh K. Kamarajah (University of Newcastle), James Bundred1
Estimated H-index: 1
(University of Birmingham)
+ -3 AuthorsSteven White17
Estimated H-index: 17
(University of Newcastle)
Abstract Background Robotic pancreaticoduodenectomy (RPD) offers theoretical advantages to conventional laparoscopic surgery including improved instrument dexterity, 3D visualization and better ergonomics. This review aimed to determine if these theoretical advantages translate into improved patient outcomes comparing patients having either robotic pancreaticoduodenectomy or laparoscopic (LPD) equivalent. Method A systematic literature search was conducted for studies reporting minimally invasiv...
Theodoros Tsirlis (Freeman Hospital), Rohan Thakkar (Freeman Hospital)+ 4 AuthorsSteven White17
Estimated H-index: 17
(Freeman Hospital)
Published on Jul 10, 2019in Health Care Analysis 1.04
Giles Birchley6
Estimated H-index: 6
(UoB: University of Bristol),
Jonathan Ives18
Estimated H-index: 18
(UoB: University of Bristol)
+ 1 AuthorsJane M Blazeby55
Estimated H-index: 55
Published on Jul 18, 2019in British Journal of Surgery 5.59
Maurizio Bruno Nava11
Estimated H-index: 11
(University of Milan),
John R Benson19
Estimated H-index: 19
(ARU: Anglia Ruskin University)
+ 16 AuthorsJacek Jassem58
Estimated H-index: 58
(Gdańsk Medical University)
Published on Jun 11, 2019in Clinical Trials 2.26
Theodosios Bisdas2
Estimated H-index: 2
,
Patrick Bohan1
Estimated H-index: 1
+ 6 AuthorsVincent Riambau4
Estimated H-index: 4
BackgroundThe postmarket research goal is to assess “generalizability” or “external validity” to see if the early results of clinical trials with investigational devices are reproducible in everyda...
Published on Mar 25, 2019in American Journal of Bioethics 5.79
Giles Birchley6
Estimated H-index: 6
(UoB: University of Bristol),
Richard Huxtable11
Estimated H-index: 11
(UoB: University of Bristol)
+ 1 AuthorsJane M Blazeby55
Estimated H-index: 55
Published on Jun 3, 2019in American Journal of Bioethics 5.79
Jane Johnson7
Estimated H-index: 7
(USYD: University of Sydney),
Katrina Hutchison5
Estimated H-index: 5
(Macquarie University),
Wendy Rogers23
Estimated H-index: 23
(Macquarie University)
Published on Jun 1, 2019in BJUI 4.52
Michael Tradewell (UMN: University of Minnesota), Jacob A. Albersheim (UMN: University of Minnesota), Philipp Dahm40
Estimated H-index: 40
(UMN: University of Minnesota)
Thomas R.F. Steenbergen (Radboud University Nijmegen), Ingrid C.M. Geest (Radboud University Nijmegen)+ 2 AuthorsJurgen J. Fütterer39
Estimated H-index: 39
(Radboud University Nijmegen)