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.

在过去的十年中，许多探索性研究表明，与电视和电话两种方式的基于纸张的面对面（p-FTF）相比，远程神经认知评估（rNCA）的一致性很好。对老年阿尔茨海默病和相关痴呆症患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，降低接触COVID-19及其变体等传染性疾病的风险，快速获得护理，并最大限度地减少前往临床中心的旅行负担。目前，基于电视的rNCA是通过会议设备和服务实现的，“远程”审查员将患者的回答输入到纸质表格上。需要图形输入的测试会造成并发症。基于电话的rNCA可以实现家庭评估和纵向跟踪和跟踪，但同样依赖于基于纸张的数据捕获和相关的人工处理。