Computerized Alzheimer's Disease Clinical Interview System

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分割的评估组成部分。目前，在痴呆症临床试验和研究中收集的所有行为和精神病学数据中，大约95%是使用纸质表格记录的，这造成了许多根本性的低效和成本。尽管计算机化的实用程序可用于各种获取后组件，如登记、调度和跟踪，但所有这些都需要从纸质源文档进行手动转录，因此需要进行现场监控。目前还没有能够直接获取原始数据的综合系统，也没有任何针对阿尔茨海默病试验和研究的大量访谈和评定量表被计算机化。此外，面对面管理和多种形式的数据输入（例如书面文本、模拟比例尺、复选框）的集体人体工程学要求带来了难以解决的技术需求。该项目的目标是开发一个企业级系统，用于在阿尔茨海默病的临床试验和新疗法研究中全面实施基于访谈的行为和精神评估。计算机化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评估访谈中用全尺寸的“智能”电子表格取代纸质表格，实现即时电子捕获，从而消除后续容易出错的手动数据转录和传输步骤（例如，病例报告表格的创建和管理）和昂贵的现场数据处理。CADCIS将提供一套由AD/痴呆研究领域公认权威机构组成的指导委员会选择的已建立的评估工具的主集（包括所有现有方案的90%），该委员会包括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、报告和管理工具将大大简化多中心研究。综合评估培训模块将提供按需定位和认证的所有仪器在主集。集成的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阿尔茨海默病/痴呆症研究中心的多中心研究中得到确立。CADCIS将与计算机化痴呆评估系统（CEDAS）集成，该系统目前正在开发中（R43 AG026402-01），该系统包括广泛应用的认知评估工具，如老年痴呆症评估量表（ADAS）。CADCIS和CDAS将共同为AD和相关痴呆的综合计算机评估提供统一的解决方案。提出的发展将导致一种新型的高度集成的技术，用于阿尔茨海默病和相关痴呆研究的计算机临床评估。CADCIS将立即应用于新疗法的临床试验和研究环境中。拟议的发展将产生一种新型的高度集成技术，用于阿尔茨海默病和相关痴呆研究的计算机临床评估。CADCIS将立即应用于新疗法的临床试验和研究环境中。

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.