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远程临床试验:虚拟现实方法的及时机会及其在神经病学中的潜在应用。

Remote clinical trials: A timely opportunity for a virtual reality approach and its potential application in neurology.

机构信息

Department of Diagnostics and Public Health, University of Verona, Verona, Italy.

Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.

出版信息

Br J Clin Pharmacol. 2021 Oct;87(10):3639-3642. doi: 10.1111/bcp.14922. Epub 2021 May 26.

DOI:10.1111/bcp.14922
PMID:34041779
Abstract

The COVID-19 pandemic boosted the expansion and development of new remote models of care and clinical research modalities. Health systems are going to implement telemedical innovations in the near future. Virtual clinical trials (VCT), also known as remote or decentralized ones, may profoundly change the way how clinical studies are conducted, for the benefit of patients with chronic and neurological diseases who are often fragile and may have limited access to traditional healthcare facilities. Despite significant progress, several limitations still need to be addressed to implement telemedicine technologies for VCT. The information and communication technology (ICT) devices (e.g., mobile apps and wearables) may be applied to VCTs but show some practical issues that may hamper the compliance with rigorous research criteria and protocols. We herewith discuss the advantages and disadvantages of virtual reality (VR) in combination with other ICT devices and solutions to improve the conduction of VCT in patients with neurological disorders. The so-called "digital divide," that is, the gap between people who can and those who cannot access high-speed and broadband internet connections, and issues related to VR, such as VR sickness, should be addressed to improve larger VCT participation to neurological patients.

摘要

COVID-19 大流行推动了新的远程医疗模式和临床研究模式的扩展和发展。医疗系统将在不久的将来实施远程医疗创新。虚拟临床试验(VCT),也称为远程或分散式临床试验,可能会深刻改变临床研究的进行方式,使患有慢性和神经系统疾病的患者受益,这些患者通常身体脆弱,可能难以获得传统的医疗保健设施。尽管取得了重大进展,但仍需要解决一些限制因素,才能将远程医疗技术应用于 VCT。信息和通信技术(ICT)设备(例如移动应用程序和可穿戴设备)可应用于 VCT,但存在一些实际问题,可能会妨碍严格的研究标准和方案的遵守。我们在此讨论虚拟现实(VR)与其他 ICT 设备和解决方案相结合在改善神经系统疾病患者 VCT 实施方面的优缺点。所谓的“数字鸿沟”,即能够和不能访问高速和宽带互联网连接的人之间的差距,以及与 VR 相关的问题,例如 VR 病,应加以解决,以提高更多神经系统疾病患者参与 VCT。

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