Assessment Validation

过去十年的大量探索性研究表明，远程神经认知评估(RNCA)与纸质面对面(p-FTF)的远程神经认知评估(RNCA)在远程视频和电话模式下的一致性都很好。对患有阿尔茨海默病和相关痴呆症的老年受试者样本的研究报告了类似的结果。RNCA的基本原理包括满足服务不足人群的需求，降低暴露于新冠肺炎和变种等感染性疾病的风险，快速获得护理，以及将前往临床中心的旅行负担降至最低。目前，基于电视的RNCA是使用会议设备和服务实现的，由“远程”审查员将患者的答复输入到纸质表格上。需要图形输入的测试会带来复杂的问题。基于电话的rNCA能够在家中进行评估和纵向跟踪和跟踪，但同样依赖于基于纸面的数据捕获和相关的人工处理。 提出了一种专门设计的远程考试计算机化评估系统(CARE)，该系统将基于企业级、下一代混合反应原生(HRN)体系结构实现统一的端到端rNCA评估和管理。CARE将托管参考标准神经认知和行为测试的计算机版本，这些测试广泛应用于MCI和阿尔茨海默病的临床识别和评估，并用于对照试验和广泛的研究。基于远程视频的评估将通过远程“虚拟检查员”方法进行，使管理就像坐在患者或研究参与者旁边一样。在会话开始和测试之间，远程主考员(R-Ex)和参与者将能够在全屏模式下看到对方并进行对话，从而建立和保持融洽的关系。在参与者托管现场，该系统将包括一台Windows 10-11 PC和一台超薄15.6英寸触摸式辅助显示器(例如，ViewSonic TD1655)，使其能够以图形触笔输入常用的测试，如钟表绘制和轨迹绘制。CARE的设计目的是为了满足老年人和有认知障碍的人的需要，通过将R-Ex紧密结合在一起，R-Ex将能够1)控制站点PC上的鼠标和键盘，输入响应，2)控制会话速度，3)重复和补充数字化(人类语音)指令，4)立即评分响应(例如，口头报告)，以及5)暂停或终止测试。这些功能将通过集成的、特定于应用程序的远程桌面控制(RDC)操作和屏幕共享来实现。应用程序集成的Web连接将由专有的对等WebRTC通信层实施。多平台CARE将支持跨电话、电话和(计算机化)面对面模式以及跨操作系统(Windows、iOS、Android)的评估。在第一阶段，该系统将在两个已建立的阿尔茨海默氏症中心进行评估，以评估CARE计算机化版本与p-FTF版本在一套神经认知测试中的同时有效性、可靠性和可接受性，这些测试通常用于评估阿尔茨海默病和相关痴呆。CARE代表着在运作rNCA方面的根本性进展。

Numerous exploratory research studies over the past decade have demonstrated good to excellent agreement of remote neurocognitive assessment (rNCA) compared to paper-based Face-to-Face (p-FTF) by both televideo and telephonic modalities. Studies in samples of elderly subjects with Alzheimer’s disease and related dementias reported similar results. Rationale for rNCA include addressing the needs of underserved populations, reducing risk of exposure to infective disorders such as COVID-19 and variants, rapid care access, and minimizing travel burden to clinical centers. Currently, televideo-based rNCA is implemented using conferencing devices and services with a “remote” examiner entering patient responses onto paper forms. Tests requiring graphical entry pose complications. Telephonically-based rNCA enables in-home assessment and longitudinal tracking and follow up but is similarly dependent on paper-based data capture and associated manual processing. A purpose-designed Computerized Assessment by Remote Examiner System (CARES) is proposed that will enable unified, end-to-end rNCA assessment and management based on an enterprise-level, next-generation hybrid REACT NATIVE (hRN) architecture. CARES will host computerized versions of reference standard neurocognitive and behavioral tests widely applied in the clinical identification and assessment of MCI and Alzheimer’s disease and for controlled trials and wide-ranging research. Televideo-based assessments will be performed by a remote “Virtual Examiner” approach, enabling administration as if seated adjacent to a patient or research participant. At the start of a session and between tests, a Remote Examiner (R-Ex) and a participant will be able to see and converse with each other in full screen mode, establishing and maintaining rapport. At a participant-hosting site, the system will be comprised of a Windows 10-11 PC and an ultrathin 15.6” touch-sensitive secondary monitor (e.g., ViewSonic TD1655) enabling graphical stylus entry for commonly applied tests such as Clock Drawing and Trail Making. CARES has been designed to accommodate the elderly and those with cognitive impairments by closely integrating the R-Ex who will be able to 1) control the mouse and keyboard on the site’s PC, entering responses, 2) control session pace, 3) repeat and supplement digitized (human voice) instructions, and 4) immediately score responses (e.g., verbal report), and 5) pause or terminate a test. These capabilities will be enabled by integrated, application-specific Remote Desktop Control (RDC) operability and screen sharing. Application-integrated web connectivity will be implemented by a proprietary peer-to-peer WebRTC communication layer. The multiplatform CARES will support assessment across televideo, telephonic, and (computerized) in-person modalities and across operating systems (Windows, iOS, Android). In Phase I, the system will be evaluated at two established Alzheimer’s centers to estimate concurrent validity, reliability, and acceptability of CARES computerized versions vs. p-FTF versions in a set of neurocognitive tests commonly applied in the evaluation of Alzheimer’s disease and related dementias. CARES represents a fundamental advance in operationalizing rNCA.