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Appraising the uptake and use of the IDEAL Framework and Recommendations: A review of the literature

Published on Sep 1, 2018in International Journal of Surgery
· DOI :10.1016/j.ijsu.2018.07.008
Asha Khachane1
Estimated H-index: 1
(Maimonides Medical Center),
Yiannis Philippou3
Estimated H-index: 3
+ 1 AuthorsPeter McCulloch38
Estimated H-index: 38
Cite
Abstract
Abstract Introduction Evaluation of new surgical innovations is complex and variably regulated, and historically the quality of surgical studies has been criticized. The IDEAL (Idea, Development, Exploration, Assessment, Long-term monitoring) Framework was established to provide a pathway for evaluating surgical innovations at each stage of their development in order to produce high quality surgical research. Since the inception of IDEAL in 2009, there has been no assessment of its use. In this review, we look at the uptake and usage of IDEAL by examining the published literature. Methods We conducted a literature search to identify all of the publications that cited IDEAL and included only those papers that intentionally used IDEAL as part of the study methodology. We then characterized these publications by year of publication, specialty, and geographical location. We performed a critical appraisal of Stage 1, 2a, and 2b studies in order to assess the degree to which authors have correctly followed the Framework and Recommendations. Results We found 790 citations of IDEAL publications, and after abstract and full-text screening, 38 prospective studies for a surgical innovation that used IDEAL remained. We saw an overall increase in the uptake of IDEAL, with a predominance in urology and origin in the United Kingdom. The critical appraisal showed that although authors identified their project as using IDEAL, they often failed to include key IDEAL characteristics; this was especially true for the features unique to IDEAL Stages 2a and 2b. Conclusion It is evident from the large number of studies citing IDEAL that the importance and challenges of reporting surgical research is well recognized among researchers. There is growing enthusiasm for using IDEAL but the current level of understanding of the Recommendations is low. Clearer and more comprehensive explanation of the application of the IDEAL Framework and Recommendations is needed to guide surgical researchers undertaking IDEAL based studies of surgical innovations.
  • References (35)
  • Citations (2)
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References35
Newest
Published on Feb 1, 2019in Annals of Surgery 9.48
Allison Hirst13
Estimated H-index: 13
(University of Oxford),
Yiannis Philippou3
Estimated H-index: 3
(University of Oxford)
+ 14 AuthorsChristopher Pennell4
Estimated H-index: 4
(Maimonides Medical Center)
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 sinc...
Riaz A. Agha20
Estimated H-index: 20
(QVH: Queen Victoria Hospital),
Allison Hirst13
Estimated H-index: 13
+ 1 AuthorsPeter McCulloch38
Estimated H-index: 38
(University of Oxford)
Abstract Background New surgical procedures, devices and other complex interventions need robust evaluation for safety, efficacy and effectiveness. The IDEAL Framework and Recommendations lay out a pathway to achieve this and offer general guidance on how studies at each stage should be reported. However, researchers require some assistance in translating theory into practice. We will develop a set of reporting guidelines for each IDEAL stage where deemed necessary through Delphi consensus metho...
Published on Jan 1, 2018in The Lancet 59.10
Peter McCulloch38
Estimated H-index: 38
(University of Oxford),
Joshua Feinberg2
Estimated H-index: 2
+ 7 AuthorsChristopher Pennell4
Estimated H-index: 4
Summary The quality of clinical research in surgery has long attracted criticism. High-quality randomised trials have proved difficult to undertake in surgery, and many surgical treatments have therefore been adopted without adequate supporting evidence of efficacy and safety. This evidence deficit can adversely affect research funding and reimbursement decisions, lead to slow adoption of innovations, and permit widespread adoption of procedures that offer no benefit, or cause harm. Improvement ...
Published on Oct 1, 2017in Radiology 7.61
Alessandro Napoli28
Estimated H-index: 28
(Sapienza University of Rome),
Alberto Bazzocchi17
Estimated H-index: 17
+ 5 AuthorsCarlo Catalano45
Estimated H-index: 45
(Sapienza University of Rome)
The durable clinical efficacy and absence of adverse events associated with MR imaging–guided high-intensity focused ultrasound indicate the potential of this procedure to be part of a routine strategy for treatment of nonspinal osteoid osteoma in children and young adults.
Published on Oct 1, 2017in World Journal of Urology 2.76
A. Breda8
Estimated H-index: 8
(University of Barcelona),
Angelo Territo5
Estimated H-index: 5
(University of Barcelona)
+ 8 AuthorsAndrea Guttilla2
Estimated H-index: 2
(University of Barcelona)
Introduction Kidney transplantation (KT) is the preferred treatment for patients with end-stage renal disease (ESRD). To reduce the morbidity of the open surgery, a robotic-assisted approach has been recently introduced. Our aim is to evaluate surgical and functional results on 17 cases of robotic-assisted kidney transplantation (RAKT) performed at the same institution.
Published on Sep 1, 2017in European Urology 17.30
A. Villers10
Estimated H-index: 10
(Lille University of Science and Technology),
P. Puech12
Estimated H-index: 12
(Lille University of Science and Technology)
+ 8 AuthorsA. Ouzzane4
Estimated H-index: 4
(Lille University of Science and Technology)
Abstract Background Focal ablative therapy may be a suboptimal option for anterior prostate cancers (APCs) reaching the prostate apex due to concerns for thermal injury to the external sphincter. Objective To explore the technical feasibility of anterior partial prostatectomy (APP) for isolated APCs detected by magnetic resonance imaging (MRI), and to report short-term oncologic and functional outcomes. Design, setting, and participants Following institutional review board approval, over an 8-yr...
Published on Sep 1, 2017in The Lancet 59.10
André van der Merwe7
Estimated H-index: 7
(Stellenbosch University),
Frank R. Graewe7
Estimated H-index: 7
(Stellenbosch University)
+ 11 AuthorsTalal Al-Qaoud1
Estimated H-index: 1
(UWM: University of Wisconsin–Milwaukee)
Summary Introduction Ritual circumcision complicated by gangrene is a leading cause of penile loss in young men in South Africa. This deeply rooted cultural tradition is unlikely to be abolished. Conventional reconstructive techniques using free vascularised tissue flaps with penile implants are undesirable in this often socioeconomically challenged group because donor site morbidity can hinder manual labour and vigorous sexual activity might lead to penile implant extrusion. The psychosociologi...
Published on May 1, 2017in Surgery 3.48
Thilo Hackert34
Estimated H-index: 34
(Heidelberg University),
Ulla Klaiber7
Estimated H-index: 7
(Heidelberg University)
+ 10 AuthorsChristoph W. Michalski37
Estimated H-index: 37
(Heidelberg University)
Background Postoperative pancreatic fistula represents the most important complication after distal pancreatectomy. The aim of this study was to evaluate the use of a preoperative endoscopic injection of botulinum toxin into the sphincter of Oddi to prevent postoperative pancreatic fistula (German Clinical Trials Register number: DRKS00007885). Methods This was an investigator-initiated, prospective clinical phase I/II trial with an exploratory study design. We included patients who underwent pr...
Massimo Valerio13
Estimated H-index: 13
(UCL: University College London),
Taimur T. Shah7
Estimated H-index: 7
(UCL: University College London)
+ 4 AuthorsHashim U. Ahmed46
Estimated H-index: 46
(UCL: University College London)
Abstract Objectives The use of software-based magnetic resonance-transrectal ultrasound fusion to deliver focal therapy may increase the precision of treatment. This is a prospective development study assessing the feasibility of Magnetic resonance imaging-transrectal ultrasound (MRI-TRUS) fusion focal cryotherapy. Methods and materials Consecutive patients undergoing focal cryotherapy were included in an academic registry (December 2013–June 2014). MRI-TRUS fusion focal cryotherapy was offered ...
Published on Mar 1, 2017in The Journal of Urology 5.65
Massimo Valerio13
Estimated H-index: 13
(UCL: University College London),
Louise Dickinson14
Estimated H-index: 14
(UCL: University College London)
+ 6 AuthorsMark Emberton63
Estimated H-index: 63
(UCL: University College London)
Purpose: Irreversible electroporation has attractive attributes for focal ablation, namely nonthermal effect, precise demarcation of treatment and tissue selectivity. We report a prospective development study investigating focal irreversible electroporation.Materials and Methods: A total of 20 men with certain characteristics were recruited for study, including a visible index lesion on anterior magnetic resonance imaging that was concordant with transperineal targeted and template prostate mapp...