Computerized Alzheimer's Disease Clinical Interview System

描述(由申请人提供)：计算机化阿尔茨海默病临床面谈系统项目摘要和摘要广泛的行为和精神评估是痴呆症治疗开发和研究的一个不可或缺的评估组成部分。目前，在痴呆症临床试验和研究中收集的所有行为和精神数据中，约有95%是使用纸质表格记录的，这带来了许多根本的低效率和成本。尽管存在各种获取后组成部分的计算机化工具，如登记、日程安排和跟踪，但所有这些都需要从纸质来源文件中手动转录一段时间，因此需要进行现场监测。不存在实现直接获取主要数据的综合系统，也没有将AD试验和研究的众多访谈和评分表中的任何一个计算机化。此外，面对面管理和多种形式的数据输入(例如，书面文本、模拟天平、复选框)的集体人体工学要求提出了难以解决的技术要求。该项目的目标是开发一个企业级系统，以便在阿尔茨海默病新疗法的临床试验和研究中全面实施以面谈为基础的行为和精神评估。计算机化的阿尔茨海默病临床访谈系统(CADCIS)将利用平板电脑在面对面的临床访谈中用全尺寸的“智能”电子表格取代纸质表格，实现即时的电子捕获，从而消除随后的手动数据传输和传输(如创建和管理病例报告表格)和成本高昂的现场数据处理的错误步骤。CADCIS将提供由AD/痴呆症研究领域公认权威的指导委员会选择的一套主要评估工具(包括目前所有方案的90%)，这些权威包括NIMH赞助的CATIE-AD联盟的主任和NIA赞助的阿尔茨海默病合作研究(ADCS)的主要成员。先进的数据处理、报告和管理实用程序将大大简化多中心研究。综合评分员培训模块将为主集合中的所有仪器提供按需定向和认证。综合虚拟专用网络和无线技术将实现一系列自动数据传输和安全通信功能。该系统的技术实用性、可接受性和管理能力将在领先的AD/痴呆症研究中心的多中心研究中确定。CADCIS将与目前正在开发的计算机化痴呆症评估系统(CEDAS)(R43 AG026402-01)相结合，该系统包括广泛应用的认知评估工具，如阿尔茨海默病评估量表(ADAS)。同时，CADCIS和CDAS将为AD和相关痴呆的全面计算机化评估提供统一的解决方案。拟议的发展将导致一种新型的高度集成的技术，用于阿尔茨海默病的计算机化临床评估和相关的痴呆症研究。CADCIS将立即在新疗法的临床试验和研究环境中得到应用。NeuroComp系统公司(C)拟议中的开发将产生一种新型的高度集成技术，用于阿尔茨海默病的计算机化临床评估和相关的痴呆症研究。CADCIS将立即在新疗法的临床试验和研究环境中得到应用。

DESCRIPTION (provided by applicant): COMPUTERIZED ALZHEIMER'S DISEASE CLINICAL INTERVIEW SYSTEM Project Summary and Abstract Wide-ranging behavioral and psychiatric assessment is an integral evaluation component of dementia treatment development and research. At present, approximately 95% of all behavioral and psychiatric data collected in dementia clinical trials and research is recorded using paper forms, imposing numerous fundamental inefficiencies and costs. Although computerized utilities exist for various post-acquisition components such as enrollment, scheduling and tracking, all of these require a stage of manual transcription from paper source documents, creating the need for on-site monitoring. No integrated system exists that achieves direct capture of primary data, nor have any of the multitude of interviews and rating scales for AD trials and research been computerized. Moreover, the collective ergonomic requirements for face-to-face administration and multiple forms of data input (e.g. written text, analog scales, check boxes) impose formidable, unresolved technical demands. The project objective is to develop an enterprise class system for comprehensive computerized implementationof interview-based behavioraland psychiatric assessments in clinicaltrials andresearchof new treatments for Alzheimer's disease. The Computerized Alzheimer's Disease Clinical Interview System (CADCIS) will utilize tablet PCs to replace paper forms with full-size, "smart" electronic forms in face-to-face clinicalratinginterviews,achieving immediateelectronic capture, thus eliminating subsequent error-pronesteps of manualdatatranscription and transfer (e.g., CaseReport Form creation and management) and costlyon-site data processing. The CADCIS will provide a Master Set (inclusive of > 90% of all current protocols) of established evaluation instruments selected by a steering committee of recognized authorities in the field of AD/dementia research, including the Director of the NIMH-sponsored CATIE-AD consortium and leading members of the NIA-sponsored Alzheimer's Disease Cooperative Study (ADCS). Advanced data processing, reporting and management utilities will greatly simplify multicenter research. Integral rater training modules will provide on-demand orientation and certification for all instruments in the master set. Integrated virtual private network and wireless technologies will enable a range of automated data transfer and secure communication functions. The technical utility, acceptability and management capabilities of the system will be established in multicenter studies at leading AD/dementia research centers. The CADCIS will be integrated with a computerized dementia assessment system (CEDAS, currently under development (R43 AG026402-01) that includes widely-applied cognitive assessment instruments such as the Alzheimer's Disease Assessment Scale (ADAS). Conjunctively, the CADCIS and CDAS will provide a unified solution for comprehensive computerized assessment of AD and related dementias. The proposed development will result in a new type of highly integrated technology for computerized clinical evaluations of Alzheimer's disease and related dementia research. The CADCIS will find immediate application in clinical trials of new treatments as well as research settings. NeuroComp Systems, Inc. (c) The proposed development will result in a new type of highly integrated technology for computerized clinical evaluations of Alzheimer's disease and related dementia research. The CADCIS will find immediate application in clinical trials of new treatments as well as research settings.