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安全地将新技术引入泌尿外科实践。

Introducing new technology safely into urological practice.

机构信息

AZ Groeninge, P. Kennedylaan 5, 8500, Kortrijk, Belgium.

Guy's Hospital, Guy's and St Thomas' Trust (GSTT), London, UK.

出版信息

World J Urol. 2018 Apr;36(4):543-548. doi: 10.1007/s00345-018-2173-2. Epub 2018 Jan 11.

DOI:10.1007/s00345-018-2173-2
PMID:29327248
Abstract

PURPOSE

Surgical innovation is necessary to ensure continued improvement in patient care. However, several challenges unique to the surgical craft are encountered during the development and validation of such new technology. This article highlights some of these challenges and gives an overview of existing solutions.

METHODS

A Pubmed review was performed about the "introduction of new technology" to identify challenges. Cross-referencing was used to explore the possible solutions per challenge.

RESULTS

Several characteristics of the surgical craft itself limit our ability to establish randomised controlled trials and hence provide clear categorical evidence. Existing certification bodies for new technology often use unstructured regulations and allow fast-track bypassing systems. Consequently the IDEAL framework (innovation, development, exploration, assessment, long-term follow-up) proposes an objective scientific approach whilst defining stakeholder responsibilities. The selection of which new modality to implement is heavily influenced by third parties unrelated to the best patient outcomes and thus professional organisations can aid in this decision-making. Appropriate training of surgeons and their teams until proficiency is achieved is essential prior to credentialling. Finally long-term surveillance of outcomes in the form of registries is an increasing responsibility of the urological community to maintain our role in directing the adoption or rejection of these innovations.

CONCLUSION

Urological innovation is a dynamic and challenging process. Increasing efforts are identified within the urological community to render the process more reliable and transparent.

摘要

目的

为了确保患者护理的持续改善,外科创新是必要的。然而,在开发和验证新技术时,会遇到一些外科手术特有的独特挑战。本文重点介绍了其中的一些挑战,并概述了现有的解决方案。

方法

对“新技术的引入”进行 Pubmed 综述,以确定挑战。交叉引用用于探索每个挑战的可能解决方案。

结果

外科手术本身的几个特点限制了我们进行随机对照试验的能力,因此无法提供明确的分类证据。新技术的现有认证机构通常使用非结构化的规定,并允许快速通道绕过系统。因此,IDEAL 框架(创新、开发、探索、评估、长期随访)提出了一种客观的科学方法,同时定义了利益相关者的责任。选择实施哪种新方法在很大程度上受到与最佳患者结果无关的第三方的影响,因此专业组织可以帮助做出这一决策。在认证之前,对外科医生及其团队进行适当的培训,直到达到熟练程度,这是至关重要的。最后,以登记册形式对结果进行长期监测是泌尿外科界日益增加的责任,以保持我们在指导这些创新的采用或拒绝方面的作用。

结论

泌尿外科创新是一个充满活力和挑战的过程。在泌尿外科界内,已经确定了更多的努力,以使这一过程更加可靠和透明。

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