Clinical Ratings of Neurocognition (CRON)

神经认知临床评级 (CRON)

• 批准号: 7295706
• 负责人: JOSEPH VENTURA
• 金额: $ 20.25万
• 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 2010-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7295706
• 关键词: Academia; Activities of Daily Living; Attention; Awareness; Brain Diseases; Caregivers; Clinical; Clinical Research; Clinical Trials; Cognition; Cognitive; Cognitive deficits; Communities; Complement; Consensus; Data; Data Analyses; Dementia; Development; End Point; Family; Fostering; Functional disorder; Generations; Impaired cognition; Impairment; Industry; Interview; Life; Measures; Methods; Monitor; National Institute of Mental Health; Neurocognition; Neurocognitive; New Agents; Outcome; Participant; Patients; Phase; Process; Property; Proxy; Psychometrics; Range; Rate; Research; Research Personnel; Sampling; Schizophrenia; Severities; Structure; Symptoms; Syndrome; Testing; United States Food and Drug Administration; United States National Institutes of Health; Validity and Reliability; Work; base; clinically significant; cognitive function; concept; forging; functional disability; functional outcomes; impression; innovation; instrument; instrumentation; neurocognitive test; response; theories; tool; treatment trial

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）是治疗研究的主要焦点，因为它被认为是综合征的核心特征，与传统评定的症状相比，与功能结局更可靠相关。尽管它的中心地位，目前的概念，病理生理学和治疗，有没有公认的临床评级量表CIAS。这项研究将开发和评估一个新的量表的信度和效度：神经认知临床评分（CRON）。CRON将提供：（1）认知功能障碍的严重程度和变化的表面有效测量，这可能是监管部门批准靶向CIAS的药物所需的;（2）关于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;以及（3）为临床医生提供一种新的工具，可以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的临床医生将基于对患者和护理人员的访谈进行评级，对NIMH-MATRICS共识过程确定的对精神分裂症治疗研究重要的七个神经认知障碍领域进行采样。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过度包容的项目库，该项目库来自使用第一代工具，来自加州大学洛杉矶分校的精神分裂症认知临床总体印象和来自杜克的精神分裂症认知评定量表完成的210名精神分裂症患者的评估。第2阶段将部署CRON在一个独立的研究288名参与者，提供更详细的心理测量特性，初步证据的评分员和重测信度，并发和判别效度方面的标准化测试的神经认知功能，代理措施的功能能力，社区功能的措施，和症状与传统的评级量表测量。迫切需要拟议的发展来继续MATRICS倡议建立的势头，并促进监管机构对CIAS新疗法的接受和临床意识。