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Technical and clinical validation of commercial automated volumetric MRI tools for dementia diagnosis—a systematic review
Neuroradiology ( IF 2.4 ) Pub Date : 2021-09-03 , DOI: 10.1007/s00234-021-02746-3
Hugh G Pemberton 1, 2, 3 , Lara A M Zaki 4 , Olivia Goodkin 1, 2 , Ravi K Das 5 , Rebecca M E Steketee 4 , Frederik Barkhof 1, 2, 6 , Meike W Vernooij 4, 7
Affiliation  

Developments in neuroradiological MRI analysis offer promise in enhancing objectivity and consistency in dementia diagnosis through the use of quantitative volumetric reporting tools (QReports). Translation into clinical settings should follow a structured framework of development, including technical and clinical validation steps. However, published technical and clinical validation of the available commercial/proprietary tools is not always easy to find and pathways for successful integration into the clinical workflow are varied. The quantitative neuroradiology initiative (QNI) framework highlights six necessary steps for the development, validation and integration of quantitative tools in the clinic. In this paper, we reviewed the published evidence regarding regulatory-approved QReports for use in the memory clinic and to what extent this evidence fulfils the steps of the QNI framework. We summarize unbiased technical details of available products in order to increase the transparency of evidence and present the range of reporting tools on the market. Our intention is to assist neuroradiologists in making informed decisions regarding the adoption of these methods in the clinic. For the 17 products identified, 11 companies have published some form of technical validation on their methods, but only 4 have published clinical validation of their QReports in a dementia population. Upon systematically reviewing the published evidence for regulatory-approved QReports in dementia, we concluded that there is a significant evidence gap in the literature regarding clinical validation, workflow integration and in-use evaluation of these tools in dementia MRI diagnosis.



中文翻译:


用于痴呆症诊断的商业自动化体积 MRI 工具的技术和临床验证——系统评价



神经放射学 MRI 分析的发展有望通过使用定量体积报告工具 (QReports) 来提高痴呆症诊断的客观性和一致性。转化为临床环境应遵循结构化的开发框架,包括技术和临床验证步骤。然而,已发布的可用商业/专有工具的技术和临床验证并不总是容易找到,并且成功集成到临床工作流程的途径也各不相同。定量神经放射学倡议 (QNI) 框架强调了临床定量工具的开发、验证和集成的六个必要步骤。在本文中,我们回顾了已发表的有关监管机构批准的用于记忆诊所的 QReports 的证据,以及这些证据在多大程度上满足 QNI 框架的步骤。我们总结了可用产品的公正技术细节,以提高证据的透明度并展示市场上的报告工具的范围。我们的目的是协助神经放射科医生就在临床中采用这些方法做出明智的决定。对于所确定的 17 种产品,有 11 家公司发布了对其方法的某种形式的技术验证,但只有 4 家公司发布了其 QReports 在痴呆人群中的临床验证。在系统地审查了监管机构批准的痴呆症 QReports 已发表的证据后,我们得出结论,在痴呆症 MRI 诊断中这些工具的临床验证、工作流程集成和使用中评估方面,文献中存在显着的证据差距。

更新日期:2021-09-04
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