3/4 Collaboration to Advance Negative Symptom Assessment in Schizophrenia

3/4 合作推进精神分裂症阴性症状评估

• 批准号: 8021033
• 负责人: WILLIAM P. HORAN
• 金额: $ 27.75万
• 依托单位: BRENTWOOD BIOMEDICAL RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-03-01 至 2013-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8021033
• 关键词: Academia; Address; Adverse effects; Agreement; Antipsychotic Agents; Anxiety; Applications Grants; Area; Behavior; California; Caregiver Burden; Caregivers; Characteristics; Charge; Clinical; Clinical Trials; Cognition; Collaborations; Communities; Conduct Clinical Trials; Consensus; Consensus Development Conferences; Data; Data Analyses; Data Collection; Development; Disease; Distress; Drug Industry; Emotional; Ensure; Evaluation; Factor Analysis; Gender; Generations; Government Agencies; Gur; Health; Impairment; Industry; Interviewer; Lead; Los Angeles; Manuals; Maryland; Measurement; Measures; Methods; Modeling; Moods; Motivation; National Institute of Mental Health; Neurocognitive; Occupational; Outcome; Outpatients; Participant; Patient Self-Report; Patients; Pennsylvania; Pharmaceutical Preparations; Pharmacotherapy; Phase; Play; Positioning Attribute; Principal Investigator; Procedures; Process; Property; Psychology; Psychometrics; Recommendation; Recruitment Activity; Research; Research Infrastructure; Research Personnel; Research Priority; Role; Sampling; Schizoaffective Disorders; Schizophrenia; Severities; Sex Characteristics; Site; Social Functioning; Source; Structure; Symptoms; Techniques; Testing; Therapy Clinical Trials; Training; United States Food and Drug Administration; Universities; Validity and Reliability; Woman; Work; base; design; disability; emotional experience; functional outcomes; improved; instrument; meetings; member; men; method development; next generation; novel; programs; quality assurance; response; social; sound; success; symposium; theories; therapy development

DESCRIPTION (provided by applicant): Negative symptoms are distinct clinical features of schizophrenia that are major determinants of the poor community functioning and poor long-term outcome that characterize the disorder. However, they are only minimally responsive to available treatments and are a substantial burden for care-givers. To address this critical unmet treatment need, the NIMH recently sponsored a consensus development conference to identify research priorities to stimulate the development of novel treatments for negative symptoms. The number one recommendation for advancing research and moving towards new treatment development in this area was to develop a "next generation" assessment instrument that solves the conceptual and methodological problems of existing measures. For the instrument to achieve widespread acceptance, the conference participants concluded that it is essential to follow a transparent, rigorous scale development process using large, diverse, and representative samples. As members of the NIMH-MATRICS Negative Symptoms Workgroup, the Principal Investigators have collaborated with experts from academia, the pharmaceutical industry, and government agencies to develop a new instrument, the Negative Symptom Rating Scale (NSRS). The proposed four-site Collaboration to Advance Negative Symptom Assessment in Schizophrenia (CANSAS), including the Universities of Maryland, Pennsylvania, California-Los Angeles, and California-Berkeley, is designed to carry out the recommendations of this NIMH initiative over a three-year period. These four sites represent areas of ongoing research in schizophrenia and negative symptoms, with the necessary infrastructure and unique expertise to carry out the proposed studies. Study 1 will evaluate the psychometric properties of the beta version of the NSRS in 300 schizophrenia outpatients. Results will guide data-driven refinements of the instrument based on state-of-the-art data analytic techniques, including Item Response Theory analyses and item level factor analyses that will allow us to ascertain how well the NSRS items assesses the underlying negative symptom construct and its putative sub-components, the dimensional structure of the measure, and gender invariance. Study 2 will evaluate the psychometric properties, test-retest reliability, and factor structure via confirmatory factor analysis of the revised NSRS in160 patients with schizophrenia. Convergent/discriminant validity with respect to a range of other clinical and neurocognitive features of schizophrenia, as well as measures of social and emotional functioning will also be evaluated. The multi-site structure of the CANSAS will permit an efficient evaluation of the NSRS in large ethnically and clinically diverse samples, enabling us to rapidly disseminate a final version of the scale to researchers conducting clinical trials and other types of negative symptom research. PUBLIC HEALTH RELEVANCE: Negative symptoms are major determinants of poor functional outcome in schizophrenia and available treatments are largely ineffective for these symptoms. The proposed Collaboration to Advance Negative Symptom Assessment in Schizophrenia (CANSAS) will carry out the main recommendation of the recent NIMH Consensus Development Conference to create and validate a new assessment instrument, the Negative Symptom Rating Scale, for use in clinical trials and other types of research. This state-of-the art instrument will play a central role in the NIMH initiative to stimulate the development of new treatments aimed at reducing the disability associated with negative symptoms.

描述（由申请人提供）：负面症状是精神分裂症的不同临床特征，这些临床特征是社区功能较差的主要决定因素，而长期不良结果则是该疾病的特征。但是，它们仅对可用的治疗方法敏感，对护理人员来说是一个很大的负担。为了满足这种关键的未满足治疗需求，NIMH最近赞助了一项共识开发会议，以确定研究优先级，以刺激新的负面症状治疗方法的发展。在该领域进行研究并朝着新的治疗开发发展的第一条建议是开发一种“下一代”评估工具，以解决现有措施的概念和方法论问题。为了使工具获得广泛的接受，会议参与者得出的结论是，必须使用大型，多样化和代表性的样本遵循透明，严格的规模开发过程。作为NIMH摩托学负面症状工作组的成员，首席研究人员与学术界，制药行业和政府机构的专家合作开发了一种新工具，负面症状评级量表（NSRS）。提出的四个站点合作旨在提高精神分裂症（CANSAS）的负面症状评估，包括马里兰州，宾夕法尼亚州，加利福尼亚 - 洛杉矶安吉利斯和加利福尼亚 - 伯克利大学，旨在在三年期间内进行这项NIMH倡议的建议。这四个地点代表了精神分裂症和负面症状正在进行的研究领域，具有必要的基础设施和独特的专业知识来进行拟议的研究。研究1将评估300个精神分裂症门诊患者中NSR的β版本的心理测量特性。结果将基于最先进的数据分析技术指导仪器的数据驱动的改进，包括项目响应理论分析和项目级别因素分析，这将使我们能够确定NSRS项目评估潜在的负面症状结构及其假定的子组件，量度的尺寸结构，量度和性别无关。研究2将通过160例精神分裂症患者的NSRS进行验证性因素分析来评估心理测量特性，测试可靠性和因子结构。还将评估相对于精神分裂症的其他临床和神经认知特征的收敛性/判别有效性，以及社会和情感功能的度量。 CANSAS的多站点结构将允许对大型和临床上不同样本中的NSR进行有效评估，从而使我们能够迅速向进行临床试验和其他类型的负面症状研究的研究人员迅速传播量表的最终版本。公共卫生相关性：负面症状是精神分裂症功能不良的主要决定因素，而可用治疗方法在很大程度上对这些症状无效。拟议的合作促进精神分裂症（CANSA）的负面症状评估（CANSA）将进行最近的NIMH共识开发会议的主要建议，以创建和验证一种新的评估工具，负面症状评级量表，用于临床试验和其他类型的研究。这种最先进的工具将在NIMH倡议中发挥核心作用，以刺激旨在减少与负面症状相关的残疾的新疗法的发展。