Protocol for a Randomized Phase II Trial for Mesh Optimization by Autologous Plasma Coating in Prolapse Repair: IDEAL Stage 3

Gerullis, Holger; Barski, Dimitri; Georgas, Evangelos; Boros, Mihály; Ramon, Albert; Ecke, Thorsten; Selinski, Silvia; Luedders, Dörte; Kramer, Mario W.; Winter, Alexander; Wawroschek, Friedhelm; Otto, Thomas

doi:10.1007/s12325-017-0493-z

Cited by 4 publications

(4 citation statements)

References 47 publications

(48 reference statements)

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“…Of these, four described changes to one component of an invasive device (n=1) or robot (n=3). These were a modification to the coating of a vaginal implant device, 57 a new access port for use with a robot devices 58 59 and changing part of the procedure from open to robotic. 60 These were reported as IDEAL stage 1 (n=2), stage 2a (n=1) or stage 3 (n=1), respectively.…”

Section: Resultsmentioning

confidence: 99%

Examining the application of the IDEAL framework in the reporting and evaluation of innovative invasive procedures: secondary qualitative analysis of a systematic review

Richards,

Cousins,

Scroggie

et al. 2024

BMJ Open

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ObjectivesThe development of new surgical procedures is fundamental to advancing patient care. The Idea, Developments, Exploration, Assessment and Long-term (IDEAL) framework describes study designs for stages of innovation. It can be difficult to apply due to challenges in defining and identifying innovative procedures. This study examined how the IDEAL framework is operationalised in real-world settings; specifically, the types of innovations evaluated using the framework and how authors justify their choice of IDEAL study design.DesignSecondary qualitative analysis of a systematic review.Data sourcesCitation searches (Web of Science and Scopus) identified studies following the IDEAL framework and citing any of the ten key IDEAL/IDEAL_D papers.Eligibility criteriaStudies of invasive procedures/devices of any design citing any of the ten key IDEAL/IDEAL_D papers.Data extraction and synthesisAll relevant text was extracted. Three frameworks were developed, namely: (1) type of innovation under evaluation; (2) terminology used to describe stage of innovation and (3) reported rationale for IDEAL stage.Results48 articles were included. 19/48 described entirely new procedures, including those used for the first time in a different clinical context (n=15/48), reported as IDEAL stage 2a (n=8, 53%). Terminology describing stage of innovation was varied, inconsistent and ambiguous and was not defined. Authors justified their choice of IDEAL study design based on limitations in published evidence (n=36) and unknown feasibility and safety (n=32) outcomes.ConclusionIdentifying stage of innovation is crucial to inform appropriate study design and governance decisions. Authors’ rationale for choice of IDEAL stage related to the existing evidence base or lack of sufficient outcome data for procedures. Stage of innovation was poorly defined with inconsistent descriptions. Further work is needed to develop methods to identify innovation to inform practical application of the IDEAL framework. Defining the concept of innovation in terms of uncertainty, risk and degree of evidence may help to inform decision-making.

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Section: Resultsmentioning

confidence: 99%

Examining the application of the IDEAL framework in the reporting and evaluation of innovative invasive procedures: secondary qualitative analysis of a systematic review

Richards,

Cousins,

Scroggie

et al. 2024

BMJ Open

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Section: Resultsmentioning

confidence: 99%

“…Initial screening identified 62 of 136 records (45·6 per cent) for full‐text eligibility assessment. Finally, 48 relevant publications (42 study reports, 6 protocols) were included in the analysis 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 , 58 , 59 , 60 , 61 , 62 , 63 , 64 , 65 , 66 , 67 , 68 , 69 , 70 , 71 ( Fig . 1 ).…”

Section: Resultsmentioning

confidence: 99%

Outcome selection, measurement and reporting for new surgical procedures and devices: a systematic review of IDEAL/IDEAL-D studies to inform development of a core outcome set

et al. 2020

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Background: Outcome selection, measurement and reporting for the evaluation of new surgical procedures and devices is inconsistent and lacks standardization. A core outcome set may promote the safe and transparent evaluation of surgical innovations. This systematic review examined outcome selection, measurement and reporting in studies conducted within the IDEAL (Idea, Development, Exploration, Assessment and Long-term monitoring) framework to examine current practice and inform the development of a core outcome set for early-phase studies of surgical procedures/devices. Methods: Web of Science and Scopus citation searches were performed to identify author-reported IDEAL/IDEAL-D studies for any surgical procedure/device. Outcomes were extracted verbatim, including contextual information regarding outcome selection and measurement. Outcomes were categorized to inform a conceptual framework of outcome domains relevant to evaluating innovation. Results: Some 48 studies were identified. Outcome selection, measurement and reporting varied widely across studies in different IDEAL stages. From 1737 outcomes extracted, 22 domains specific to evaluating innovation were conceptualized under seven broad categories: procedure completion success/failure; modifications; unanticipated events; surgeons' experiences; patients' experiences; resource use specific to the innovative procedure/device; and other innovation-specific outcomes. Most innovation-specific outcomes were measured and reported in only a small number of studies. Conclusion: This review highlighted the need for guidance and standardization in outcome selection and reporting in the evaluation of new surgical procedures/devices. Novel outcome domains specific to innovation have been identified to establish a core outcome set for future evaluations of surgical innovations.

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“…Recently a first outcome of the registry with a randomized trial protocol, exploring a new mesh improvement for pelvic organ prolapse surgery, has been published [19]. The participating scientific societies and industrial manufacturers will expand and update the registry towards a multi-country or multi-continent presence (Fig.…”

Section: Discussionmentioning

confidence: 99%

Registry of implants for the reconstruction of pelvic floor in males and females: A feasibility case series

Barski

Gerullis

Ecke

et al. 2017

International Journal of Surgery

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h i g h l i g h t sA new web-based registry for the evaluation of implant assisted surgery for POP and SUI in males and females is presented. The presented case series show the feasibility of the registry with the need for indication based evaluation. The maximum score of cure was reached by 25e100% of patients depending on the indication. The preliminary results support the initiation of prospective registry according to IDEAL. a r t i c l e i n f o t r a c tIntroduction: Most aspects of implant-assisted reconstruction of pelvic floor in males and females are under debate and the research is not standardized. Registries are supposed to shed light to the indications, surgical techniques and material properties and to establish a standardized evaluation. Methods: A working group was formed to create an online platform for registration and outcome measurement of implant-assisted operations for pelvic organ prolapse (POP) and female and male stress urinary incontinence (SUI). 20 patients with modified mesh materials were evaluated over 23 months

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Protocol for a Randomized Phase II Trial for Mesh Optimization by Autologous Plasma Coating in Prolapse Repair: IDEAL Stage 3

Cited by 4 publications

References 47 publications

Examining the application of the IDEAL framework in the reporting and evaluation of innovative invasive procedures: secondary qualitative analysis of a systematic review

Examining the application of the IDEAL framework in the reporting and evaluation of innovative invasive procedures: secondary qualitative analysis of a systematic review

Outcome selection, measurement and reporting for new surgical procedures and devices: a systematic review of IDEAL/IDEAL-D studies to inform development of a core outcome set

Registry of implants for the reconstruction of pelvic floor in males and females: A feasibility case series

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