Tangudu Vivek, Afrin Kahkashan, Reddy Sandy, Deutz Nicolaas E P, Woltering Steven, Bukkapatnam Satish T S
Department of Industrial & Systems Engineering, Texas A&M University, 101 Bizzell St, College Station, TX, 77843, USA.
Department of Biomedical Engineering, Texas A&M University, College Station, TX, 77843, USA.
Sleep Breath. 2021 Jun;25(2):737-748. doi: 10.1007/s11325-020-02171-5. Epub 2020 Aug 31.
In recent years, point-of-care (POC) devices, especially smart wearables, have been introduced to provide a cost-effective, comfortable, and accessible alternative to polysomnography (PSG)-the current gold standard-for the monitoring, screening, and diagnosis of obstructive sleep apnea (OSA). Thorough validation and human subject testing are essential steps in the translation of these device technologies to the market. However, every device development group tests their device in their own way. No standard guidelines exist for assessing the performance of these POC devices. The purpose of this paper is to critically distill the key aspects of the various protocols reported in the literature and present a protocol that unifies the best practices for testing wearable and other POC devices for OSA.
A limited review and graphical descriptive analytics of literature-including journal articles, web sources, and clinical manuscripts by authoritative agencies in sleep medicine-are performed to glean the testing and validation methods employed for POC devices, specifically for OSA.
The analysis suggests that the extent of heterogeneity of the demographics, the performance metrics, subject survey, hypotheses, and statistical analyses need to be carefully considered in a systematic protocol for testing POC devices for OSA.
We provide a systematic method and list specific recommendations to extensively assess various performance criteria for human subject testing of POC devices. A rating scale of 1-3 is provided to encourage studies to put a focus on addressing the key elements of a testing protocol.
近年来，即时检测（POC）设备，尤其是智能可穿戴设备，已被引入，为阻塞性睡眠呼吸暂停（OSA）的监测、筛查和诊断提供一种经济高效、舒适且易于使用的替代当前金标准——多导睡眠图（PSG）的方法。全面的验证和人体试验是将这些设备技术推向市场的关键步骤。然而，每个设备开发团队都以自己的方式测试其设备。目前尚无评估这些POC设备性能的标准指南。本文的目的是批判性地提炼文献中报道的各种方案的关键方面，并提出一种统一测试可穿戴设备和其他用于OSA的POC设备最佳实践的方案。
对文献进行有限回顾和图形描述性分析，文献包括睡眠医学权威机构的期刊文章、网络资源和临床手稿，以收集用于POC设备，特别是用于OSA的测试和验证方法。
分析表明，在用于测试OSA的POC设备的系统方案中，需要仔细考虑人口统计学、性能指标、受试者调查、假设和统计分析的异质性程度。
我们提供了一种系统方法，并列出了具体建议，以广泛评估POC设备人体试验的各种性能标准。提供了一个1 - 3的评分量表，以鼓励研究关注测试方案的关键要素。
