Surgical innovation

Broekman, Marike L. D.; Carrière, Michelle E.; Bredenoord, Annelien L.

doi:10.1097/md.0000000000003790

Cited by 52 publications

(23 citation statements)

References 62 publications

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“…The information crucial to informed consent should include the innovative nature of the procedure, evidence to support it, and the surgeon’s experience with it [11]. …”

Section: Ethical Justification For Formal Oversightmentioning

confidence: 99%

“…[11]. Care should be taken to avoid tendencies, including implicit rationing that excludes certain patients, which may exploit vulnerable patients [16, 17].…”

Section: Ethical Justification For Formal Oversightmentioning

confidence: 99%

“…Human factors, on the other hand, benefit from a more multidisciplinary approach that recognizes the legal and cultural contexts behind these ethical principles. These have been expounded in the previous literature and are briefly summarized to motivate discussion for novel oversight mechanisms [ 11 ].…”

Section: Ethical Justification For Formal Oversightmentioning

confidence: 99%

“…Informed consent standards mandate that it is the responsibility of the surgeon to ensure that the patient understands the pertinent information necessary to make a choice about whether to proceed with a procedure. The information crucial to informed consent should include the innovative nature of the procedure, evidence to support it, and the surgeon’s experience with it [ 11 ].…”

Section: Ethical Justification For Formal Oversightmentioning

confidence: 99%

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Oversight in Surgical Innovation: A Response to Ethical Challenges

et al. 2018

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BackgroundSurgical innovation has advanced outcomes in the field, but carries inherent risk for surgeons and patients alike. Oversight mechanisms exist to support surgeon-innovators through difficulties associated with the innovation process.MethodsA literature review of ethical risks and oversight mechanisms was conducted.ResultsOversight mechanisms range from the historical concept of surgical exceptionalism to departmental, hospital, and centralized committees. These fragmentary and non-standardized oversight mechanisms leave surgeon-innovators and patients open to significant risk of breaching the ethical principles at the core of surgical practice. A systematized approach that mitigates these risks while maintaining the independence and dignity of the surgical profession is necessary. We propose an oversight framework that incorporates multiple structures tailored toward the ethical risk introduced by different forms of innovation.DiscussionWe summarize ethical risks and current regulatory structures, and we then use these findings to outline an oversight framework that may be applied to surgical practice.

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“…The information crucial to informed consent should include the innovative nature of the procedure, evidence to support it, and the surgeon’s experience with it [11]. …”

Section: Ethical Justification For Formal Oversightmentioning

confidence: 99%

“…[11]. Care should be taken to avoid tendencies, including implicit rationing that excludes certain patients, which may exploit vulnerable patients [16, 17].…”

Section: Ethical Justification For Formal Oversightmentioning

confidence: 99%

Section: Ethical Justification For Formal Oversightmentioning

confidence: 99%

Section: Ethical Justification For Formal Oversightmentioning

confidence: 99%

See 2 more Smart Citations

Oversight in Surgical Innovation: A Response to Ethical Challenges

et al. 2018

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“…In neurosurgical disease, low incidence and high burden may further hinder systematic evaluation of any new technique. Regardless of these difficulties, it is vital that new technologies and procedures undergo a strategic and ethical clinical introduction [ 9 ].…”

Section: Introductionmentioning

confidence: 99%

Innovation in neurosurgery: less than IDEAL? A systematic review

et al. 2017

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BackgroundSurgical innovation is different from the introduction of novel pharmaceuticals. To help address this, in 2009 the IDEAL Collaboration (Idea, Development, Exploration, Assessment, Long-term follow-up) introduced the five-stage framework for surgical innovation. To evaluate the framework feasibility for novel neurosurgical procedure introduction, two innovative surgical procedures were examined: the endoscopic endonasal approach for skull base meningiomas (EEMS) and the WovenEndobridge (WEB device) for endovascular treatment of intracranial aneurysms.MethodsThe published literature on EEMS and WEB devices was systematically reviewed. Identified studies were classified according to the IDEAL framework stage. Next, studies were evaluated for possible categorization according to the IDEAL framework.ResultsFive hundred seventy-six papers describing EEMS were identified of which 26 papers were included. No prospective studies were identified, and no studies reported on ethical approval or patient informed consent for the innovative procedure. Therefore, no clinical studies could be categorized according to the IDEAL Framework. For WEB devices, 6229 articles were screened of which 21 were included. In contrast to EEMS, two studies were categorized as 2a and two as 2b.ConclusionThe results of this systematic review demonstrate that both EEMS and WEB devices were not introduced according to the (later developed in the case of EEMS) IDEAL framework. Elements of the framework such as informed consent, ethical approval, and rigorous outcomes reporting are important and could serve to improve the quality of neurosurgical research. Alternative study designs and the use of big data could be useful modifications of the IDEAL framework for innovation in neurosurgery.Electronic supplementary materialThe online version of this article (doi:10.1007/s00701-017-3280-3) contains supplementary material, which is available to authorized users.

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Informed consent within a learning health system: A scoping review

Cumyn

Barton

Dault

et al. 2019

Learning Health Systems

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Introduction: A major consideration for the implementation of a learning health system (LHS) is consent from participants to the use of their data for research purposes.The main objective of this paper was to identify in the literature which types of consent have been proposed for participation in research observational activities in a LHS. We were particularly interested in understanding which approaches were seen as most feasible and acceptable and in which context, in order to inform the development of a Quebec-based LHS.Methods: Using a scoping review methodology, we searched scientific and legal databases as well as the gray literature using specific terms. Full-text articles were reviewed independently by two authors on the basis of the following concepts:(a) LHS and (b) approach to consent. The selected papers were imported in NVivo software for analysis in the light of a conceptual framework that distinguishes various, largely independent dimensions of consent.Results: A total of 93 publications were analysed for this review. Several studies reach opposing conclusions concerning the best approach to consent within a LHS.However, in the light of the conceptual framework we developed, we found that many of these results are distorted by the conflation between various characteristics of consent. Thus, when these characteristics are distinguished, the results mainly suggest the prime importance of the communication process, by contrast to the scope of consent or the kind of action required by participants (opt-in/opt-out). We identified two models of consent that were especially relevant for our purpose: metaconsent and dynamic consent.Conclusions: Our review shows the importance of distinguishing carefully the various features of the consent process. It also suggests that the metaconsent model is a valuable model within a LHS, as it addresses many of the issues raised with regards

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Surgical innovation

Abstract: Supplemental Digital Content is available in the text

Cited by 52 publications

References 62 publications

Oversight in Surgical Innovation: A Response to Ethical Challenges

Oversight in Surgical Innovation: A Response to Ethical Challenges

Innovation in neurosurgery: less than IDEAL? A systematic review

Informed consent within a learning health system: A scoping review

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