DATA MANAGEMENT AND BIOSTATISTICS

数据管理和生物统计学

• 批准号: 8318117
• 负责人: PATRICK JOHN FOX
• 金额: $ 9.4万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-01 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8318117
• 关键词: Behavioral; Biometry; Biostatistics Core; Classification; Clinical; Clinical Research; Cognitive; Collection; Complex; Confidentiality; Consult; Consultations; Data; Data Aggregation; Data Analyses; Data Collection; Data Quality; Data Set; Databases; Development; Diagnosis; Disease; Doctor of Philosophy; Emotions; Ensure; Foxes; Frontotemporal Dementia; Frontotemporal Lobar Degenerations; Genes; Genetic; Goals; Image; Life; Measurement; Methods; Neurologic; Patients; Pattern; Process; Research; Research Design; Research Personnel; Research Project Grants; Resolution; Secure; Symptoms; System; Techniques; Ubiquitin; Work; behavior measurement; brain behavior; data management; effective therapy; information classification; neuroimaging; normal aging; programs; quality assurance; sound; statistical service; tau Proteins; treatment strategy

The Data Management and Biostatistics Core (DMBC) will provide high quality data management services and statistical consulting to FTD PPG research projects and cores. The core will build upon the work that has been accomplished in the first five years and will continue to be directed by Patrick Fox, Ph.D., Co-Director of IHA. The three overarching aims for the renewal of this program project (i.e., the separation of FTLD and related disorders from AD and normal aging; the diagnosis of FTLD-tau related versus FTLD-ubiquitin cases during life; and a better understanding of brain-behavior correlates), require the integration of a wide variety of clinical, behavioral, neuroimaging, and genetics data in order to achieve the stated aims that would give rise to better methods for differentiating FTLD, CBD, PSP and AD during life. Developing accurate methods for clinically differentiating these disorders are essential for progress in implementing effective treatment strategies. Because of the inherent complexities in accurately differentiating among a collection of disorders with overlapping symptoms and in which patients may move fluidly from one to another during their lifetime, the identification of meaningful patterns in aggregated data obtained from subjects with clinically complex presentations requires the development and implementation of valid and reliable measurement and data collection strategies. These strategies must insure that: 1) the measurement of behavioral, cognitive, neurological, imaging and genetic informationuse scientifically and clinically sound techniques that result in a consistent classification of information (e.g.; inter-rater reliability); 2) that the observed phenomena are accurately recorded; 3) that the recorded measurements are accurately reflected in the data base; 4) that the data base is secure to avoid unauthorized changes; 5) that analytical data sets are accessible to investigators; and 6) that meaningful patterns in the data are identified using appropriate statisticalmethods. The goals of the DMBC are to provide accurate data and appropriate and timely statistical support to answer the scientific questions posed in the PPG. To this end, the DMBC will: 1) maintain a centralized FTD PPG clinical and research database, ensuring the integrity, availability, and confidentiality of all core and project data; 2)develop and maintain a comprehensive data quality assurance program to ensure the identification and resolution of data issues across the FTD PPG projects and cores; 3) develop and maintain appropriate data management processes to ensure the integration of databases from the Cores and Projects; 4) develop data reliability systems to ensure the accurate and consistent classification of observed phenomena among researchers; and 5) provide statistical consultation on research design and data analysis to all FTD PPG cores and projects.

数据管理和生物统计核心（DMBC）将提供高质量的数据管理服务 以及 FTD PPG 研究项目和核心的统计咨询。核心将建立在已经完成的工作的基础上 在前五年内已取得的成果，并将继续由联合主任帕特里克·福克斯博士指导 的IHA。该计划项目更新的三个总体目标（即 FTLD 和 AD 相关疾病和正常衰老； FTLD-tau 相关病例与 FTLD-泛素病例的诊断 一生中；以及更好地理解大脑行为的相关性），需要整合各种各样的 临床、行为、神经影像和遗传学数据，以实现既定目标 找到更好的方法来区分生活中的 FTLD、CBD、PSP 和 AD。开发准确的方法 临床上区分这些疾病对于实施有效治疗的进展至关重要 策略。由于准确区分一系列疾病的固有复杂性 具有重叠的症状，并且患者在其一生中可能会从一种症状转移到另一种症状， 从具有临床复杂性的受试者获得的汇总数据中识别有意义的模式 演示需要开发和实施有效且可靠的测量和数据 收集策略。这些策略必须确保：1）行为、认知、 神经学、影像学和遗传信息使用科学和临床合理的技术，导致 一致的信息分类（例如，评估者间的可靠性）； 2）观察到的现象是 准确记录； 3) 记录的测量结果准确地反映在数据库中； 4) 认为 数据库是安全的，可以避免未经授权的更改； 5) 可以访问分析数据集 调查员； 6) 使用适当的统计方法识别数据中有意义的模式。 DMBC 的目标是提供准确的数据和适当且及时的统计支持来回答 PPG 中提出的科学问题。为此，DMBC 将：1) 维护集中式 FTD PPG 临床和研究数据库，确保所有核心和项目的完整性、可用性和机密性 数据; 2）制定并维护全面的数据质量保证计划以确保识别 并解决 FTD PPG 项目和核心的数据问题； 3）开发并维护适当的 数据管理流程，以确保核心和项目数据库的集成； 4）开发 数据可靠性系统，确保观察到的现象的准确和一致的分类 研究人员； 5) 向所有 FTD PPG 提供研究设计和数据分析的统计咨询 核心和项目。