Clinical Ratings of Neurocognition (CRON)

神经认知临床评级 (CRON)

• 批准号: 7148946
• 负责人: JOSEPH VENTURA
• 金额: $ 17.38万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-30 至 2008-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7148946
• 关键词: clinical research; cognition disorders; data collection methodology /evaluation; data quality /integrity; diagnosis design /evaluation; human subject; human therapy evaluation; interview; mental disorder chemotherapy; mental disorder diagnosis; patient oriented research; psychometrics; schizophrenia

DESCRIPTION (provided by applicant): Cognitive impairment associated with schizophrenia (CIAS) is a major focus of treatment research because it is acknowledged as a core feature of the syndrome that is more reliably associated with functional outcomes than traditionally rated symptoms. Despite its centrality to current concepts of pathophysiology and treatment, there are no accepted clinical rating scales for CIAS. The proposed research will develop and assess reliability and validity of a new scale: Clinical Ratings of Neurocognition (CRON). CRON will provide: (1) face-valid measures of severity and change of cognitive dysfunction that will likely be needed for regulatory approval of agents targeting CIAS; (2) important information about real-world cognitive functioning and its relations to activities of daily living, complementing standardized cognitive tests; and (3) a new tool for clinicians that will enhance their sensitivity to cognitive deficits in schizophrenia, and increase their attention to features of the illness more relevant to long-term outcome and functional disability. Clinicians using CRON will base their ratings on interviews of patients and caregivers, sampling the seven domains of neurocognitive impairment important for schizophrenia treatment research as determined by the NIMH- MATRICS consensus process. Modern psychometric methods will be used to maximize CRON's sensitivity to cognitive impairment and change over the range most likely to be targeted in treatment trials. Phase 1 of the proposed research develops a beta version of CRON, using Classical Test Theory and Item Response Theory methods to refine an over-inclusive item-bank derived from assessments completed in 210 people with schizophrenia using first-generation instruments, the Clinical Global Impression of Cognition in Schizophrenia from UCLA, and the Schizophrenia Cognition Rating Scale from Duke. Phase 2 will deploy CRON in an independent study of 288 participants, to provide more detailed assessment of psychometric properties, preliminary evidence of inter-rater and test-retest reliability, and concurrent and discriminant validity with respect to standardized tests of neurocognitive function, proxy measures of functional capacity, measures of community function, and symptoms measured with traditional rating scales. The proposed developments are urgently needed to continue the momentum established by the MATRICS initiative, and facilitate regulatory acceptance and clinical awareness of new treatments for CIAS.

描述（由申请人提供）：与精神分裂症相关的认知障碍（CIAS）是治疗研究的一个主要焦点，因为它被认为是该综合征的核心特征，与传统评估的症状相比，与功能结果的相关性更可靠。尽管 CIAS 在当前的病理生理学和治疗概念中占据核心地位，但目前还没有公认的 CIAS 临床评级量表。拟议的研究将开发和评估新量表的可靠性和有效性：神经认知临床评级（CRON）。 CRON 将提供：(1) 认知功能障碍严重程度和变化的表面有效测量，这可能是监管部门批准针对 CIAS 的药物所需要的； (2) 有关现实世界认知功能及其与日常生活活动关系的重要信息，补充标准化认知测试； (3) 为临床医生提供的一种新工具，将提高他们对精神分裂症认知缺陷的敏感性，并增加他们对与长期结果和功能障碍更相关的疾病特征的关注。使用 CRON 的临床医生将根据对患者和护理人员的访谈进行评级，对由 NIMH-MATRICS 共识流程确定的对精神分裂症治疗研究很重要的七个神经认知障碍领域进行抽样。现代心理测量方法将用于最大限度地提高 CRON 对认知障碍的敏感性，并在治疗试验中最有可能针对的范围内进行改变。拟议研究的第一阶段开发了 CRON 的测试版，使用经典测试理论和项目反应理论方法来完善一个包含过多内容的项目库，该项目库源自使用第一代仪器“临床总体印象”对 210 名精神分裂症患者完成的评估加州大学洛杉矶分校的精神分裂症认知量表和杜克大学的精神分裂症认知评定量表。第二阶段将在一项 288 名参与者的独立研究中部署 CRON，以提供更详细的心理测量特性评估、评估者间和重测可靠性的初步证据，以及神经认知功能标准化测试、代理测量的并发和判别有效性功能能力、社区功能的测量以及用传统评级量表测量的症状。迫切需要拟议的发展来继续 MATRICS 倡议所建立的势头，并促进监管机构对 CIAS 新疗法的接受和临床认识。