Computerized Antipsychotic Evaluation System

描述（由申请人提供）：广泛的神经认知评估是候选抗精神病药物对照临床试验的一个组成部分。然而，人工管理大型神经认知测试电池效率低下，容易出错，并且不满足跨多个站点的标准化需求。该项目的目标是开发一种先进的、广谱的计算机化神经认知评估系统，该系统将为各种方案的综合管理和管理提供一个单一的、统一的平台，足以满足至少75%的对照临床试验和相关研究应用的要求。计算机化抗精神病药物评估系统（CAES）将引入前所未有的内容、功能和效用集成。优点包括：(a)通过标准化的多媒体管理提高数据质量；(b)对所有考试的考官进行全面的多媒体培训；(c)自动化项目报告和文件编制；(d)患者自动跟踪和调度；(e)自动遵守协议；(f)减少审查员的要求和错误；(g) CRFs的自动生成和跟踪；(h)自动电子数据库转移和(i)相应降低成本。计算机平台是唯一适合评估受损科目，因为它的交互式，双显示和控制架构，集成了一个人类考官，能够精确控制任何考试的每一步管理过程。考官可以实时对口头报告和公开的行为表现进行评分，这是当前一代单显示系统所不具备的重要功能。CAES双监视器架构将在先进的认知评估平台（ACAP）硬件设备上实现，提供全面的电子患者反应捕获并赋予可移植性。为了确保评估工具集的相关性，以及在临床试验中应用的系统功能，开发将由精神分裂症研究领域公认权威的指导委员会指导，包括nimh赞助的CATIE（临床抗精神病药物试验干预有效性）联盟的成员。CAES测试工具和审查员培训模块（ETM）的技术效用、并发有效性和可接受性将在多中心研究中确定。

DESCRIPTION (provided by applicant): Wide-ranging neurocognitive assessment is an integral component of controlled clinical trials of candidate antipsychotic treatments. However, manual administration of large neurocognitive test batteries is inefficient, error prone, and does not meet the needs for standardization across multiple sites. The project objective is to develop an advanced, wide spectrum computerized neurocognitive assessment system that will provide a single, unified platform for comprehensive administration and management of various protocols, sufficient to meet the requirements of a minimum of 75% of controlled clinical trials as well as related research applications. The computerized antipsychotic evaluation system (CAES) will introduce an unprecedented range of content, functionality and utility integration. Advantages include: (a) increased data quality through standardized, multimedia-based administration; (b) integral multimedia-based examiner training for all tests; (c) automated project reporting and documentation; (d) automated patient tracking and scheduling; (e) automated protocol compliance; (f) reduced examiner requirements and errors; (g) automatic generation and tracking of CRFs; (h) automated electronic database transfer and (i) correspondingly reduced costs. The computer platform is uniquely suited to assessment of impaired subjects due to its interactive, dual-display and control architecture that integrates a human examiner, enabling precise control of every step of the administration process for any test. An examiner can score verbal report and overt behavioral performance in real time, an important capability not available in the current generation of single-display systems. The CAES dual-monitor architecture will be implemented on an advanced cognitive assessment platform (ACAP) hardware device, providing comprehensive electronic patient response capture and conferring portability. To ensure relevance of the assessment instrument set, as well as system functions for application in clinical trials, development will be guided by a steering committee of recognized authorities in the field of schizophrenia research, including members of the NIMH-sponsored CATIE (Clinical Antipsychotic Trials in Intervention Effectiveness) consortium. The technical utility, concurrent validity and acceptability of the CAES test instruments and examiner training module (ETM) will be determined in a multicenter study.