Assessment Validation

评估验证

• 批准号: 10766041
• 负责人: JAMES P O'HALLORAN
• 金额: $ 26.6万
• 依托单位: NEUROCOMP SYSTEMS, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-30 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10766041
• 关键词: Address; Advisory Committees; Agreement; Alzheimer' s Disease; Alzheimer' s disease related dementia; Alzheimer' s disease test; Android; Architecture; Authorization documentation; Behavior assessment; COVID-19; Certification; Clinical; Clinical Trials; Clinical assessments; Communication; Data; Databases; Devices; Diagnosis; Disease; Distal; Elderly; Electronics; Evaluation; Exposure to; Goals; Health Services Accessibility; Home; Human; Hybrids; Impaired cognition; Infrastructure; Instruction; Internet; Language; Manuals; Modality; Monitor; Mus; Natural Language Processing; Neurocognitive; Operating System; Paper; Participant; Patients; Perception; Persons; Phase; Population; Portal System; Procedures; Process; Recommendation; Reference Standards; Reporting; Research; Risk Reduction; Sample Size; Sampling; Services; Site; Specific qualifier value; System; Technology Assessment; Telephone; Testing; Touch sensation; Trail Making Test; Training Activity; Travel; Underserved Population; Validation; Variant; Voice; authority; behavior test; clinical center; cognitive function; computerized; cost; dashboard; data management; design; digital; follow-up; indexing; instrument; mobile computing; neurocognitive test; next generation; nonEnglish language; patient response; peer; phase 1 testing; prototype; remote administration; remote assessment; research clinical testing; research study; response; software development; symposium; telephone based; usability; verbal; virtual

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.

过去十年的大量探索性研究表明，通过远程视频和电话方式对老年受试者样本进行研究，远程神经认知评估 (rNCA) 与纸质面对面 (p-FTF) 具有良好的一致性。阿尔茨海默病和相关痴呆症报告了类似的结果，rNCA 的理由包括满足服务不足人群的需求、降低接触 COVID-19 及其变种等传染病的风险、快速获得护理、目前，基于远程视频的 rNCA 是使用会议设备和服务来实施的，由“远程”检查员将患者的反应输入到纸质表格中，而基于电话的 rNCA 则可以实现家庭评估。纵向跟踪和跟进，但同样依赖于纸质数据采集和相关的手动处理。 提出了专门设计的远程检查者计算机化评估系统 (CARES)，该系统将基于企业级、下一代混合 REACT NATIVE (hRN) 架构实现统一的端到端 rNCA 评估和管理。参考标准神经认知和行为测试的计算机化版本广泛应用于 MCI 和阿尔茨海默病的临床识别和评估以及对照试验和基于电视视频的广泛研究，将通过远程“虚拟”进行。 “检查者”方法，使管理就像坐在患者或研究参与者旁边一样。在会议开始时和测试之间，远程检查者 (R-Ex) 和参与者将能够完全看到彼此并进行交谈。在参与者主办地点，系统将由一台 Windows 10-11 PC 和一台超薄 15.6 英寸触摸感应辅助显示器（例如 ViewSonic）组成。 TD1655）支持图形手写笔输入，可用于时钟绘图和轨迹制作等常用测试，旨在通过紧密集成 R-Ex 来适应老年人和有认知障碍的人，他们将能够 1) 控制鼠标和键盘。在站点的 PC 上输入响应，2) 控制会话节奏，3) 重复和补充数字化（人声）指令，4) 立即对响应进行评分（例如口头报告），以及 5) 暂停或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) 可操作性来实现，并且应用程序集成的 Web 连接将通过专有的点对点 WebRTC 通信层来实现。支持跨电视、电话和（计算机化）面对面方式以及跨操作系统（Windows、iOS、Android）的评估 在第一阶段，系统将在两个已建立的阿尔茨海默病中心进行评估，以估计并发有效性，在一组常用于评估阿尔茨海默病和相关痴呆症的神经认知测试中，CARES 计算机化版本与 p-FTF 版本的可靠性和可接受性代表了 rNCA 实施的根本性进步。