1/4 Collaboration to Advance Negative Symptom Assessment in Schizophrenia

描述（由申请人提供）：阴性症状是精神分裂症的明显临床特征，是该疾病特有的社区功能差和长期预后差的主要决定因素。然而，他们对现有的治疗只有最低限度的反应，对护理人员来说是一个沉重的负担。为了解决这一关键的未被满足的治疗需求，NIMH最近发起了一个共识发展会议，以确定研究重点，以刺激开发针对阴性症状的新疗法。在这一领域推进研究和开发新疗法的首要建议是开发“下一代”评估工具，解决现有措施的概念和方法问题。为了使该仪器得到广泛接受，会议与会者得出结论，必须遵循透明、严格的规模开发过程，使用大量、多样化和具有代表性的样本。作为nimh - matrix阴性症状工作组的成员，首席研究员与学术界、制药行业和政府机构的专家合作开发了一种新的工具——阴性症状评定量表（NSRS）。拟议的促进精神分裂症阴性症状评估的四站合作（CANSAS），包括马里兰大学、宾夕法尼亚大学、加州-洛杉矶大学和加州-伯克利大学，旨在实施NIMH倡议的建议，为期三年。这四个地点代表了正在进行的精神分裂症和阴性症状研究领域，具有开展拟议研究的必要基础设施和独特专业知识。研究1将评估300名精神分裂症门诊患者的β版NSRS的心理测量特性。结果将指导基于最先进的数据分析技术的数据驱动的工具改进，包括项目反应理论分析和项目水平因素分析，这将使我们能够确定NSRS项目评估潜在负面症状结构及其假定的子成分，测量的维度结构和性别不变性的程度。研究2将通过对160例精神分裂症患者修订后的NSRS进行验证性因子分析，评估心理测量学特性、重测信度和因子结构。还将评估关于精神分裂症的一系列其他临床和神经认知特征以及社会和情感功能测量的收敛/判别效度。CANSAS的多位点结构将允许在大量种族和临床不同的样本中对NSRS进行有效的评估，使我们能够迅速将量表的最终版本分发给进行临床试验和其他类型阴性症状研究的研究人员。公共卫生相关性：阴性症状是精神分裂症功能预后不良的主要决定因素，现有的治疗方法对这些症状大多无效。拟议的精神分裂症阴性症状评估推进合作（CANSAS）将执行最近NIMH共识发展会议的主要建议，以创建和验证一种新的评估工具——阴性症状评定量表，用于临床试验和其他类型的研究。这种最先进的仪器将在NIMH倡议中发挥核心作用，以刺激旨在减少与阴性症状相关的残疾的新治疗方法的发展。

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.