DATA COORDINATING CENTER FOR NCICAS II

NCICAS II 数据协调中心

• 批准号: 2457864
• 负责人: HERMAN E. MITCHELL
• 金额: $ 145.72万
• 依托单位: RHO FEDERAL SYSTEMS DIVISION, INC.
• 依托单位国家: 美国
• 财政年份: 1996
• 资助国家: 美国
• 起止时间: 1996-08-01 至 2000-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2457864
• 关键词: asthma; behavioral /social science research tag; child (0-11); clinical research; clinical trials; cooperative study; health care cost /financing; health care model; human data; human subject; human therapy evaluation; information systems; middle childhood (6-11); patient care management; respiratory disorder chemotherapy; respiratory disorder epidemiology; urban poverty area

DESCRIPTION: (adapted from applicant's Abstract): This multi-site project will address the known, disproportionate burden of asthma morbidity among underserved inner-city children aged 4-12 years of age, with the following overall goals: (1) to design an appropriate asthma intervention (or set of interventions) acceptable to and feasible in the target population; (2) to design an evaluation strategy (trial) to adequately assess the cost-effectiveness of the intervention; and (3) to implement the intervention and randomized trial to determine cost-effectiveness. To achieve these goals, the investigators will be able to draw on the database and initial intervention experience of NCICAS I (trial still going on). This proposal describes the role of the DCC providing leadership and expertise in the following areas: (a) analyses of existing NCICAS I databases to guide development of the intervention strategy; (b) design of the evaluation (trial) including definition of subject eligibility, definition of intervention groups, identification of primary endpoints, randomization and power assessment; (c) central training of ASC staff in intervention and measurement and on-going monitoring to ensure standard implementation of common protocols across multiple sites; (d) on-going monitoring of all data acquisition to ensure high quality databases for analyses; and (e) primary analyses of trial outcomes, including integration of process measures and cost data to provide reliable assessments of cost-effectiveness. Appropriate ANOVA and ANCOVA models are proposed. In all of these activities, input will be solicited and coordinated from ASC investigators, program staff and consultants as required. As the DCC for the on-going NCICAS I, NERI is able to provide very fast start-up (the DCC staff are already in place and thoroughly familiar with the project); state-of-the-art distributed data management systems and randomization; full survey facilities for blinded subject follow-up using CATI; in-house expertise on measurement of cost-effectiveness; state-of-the-art expertise in the design and analysis of non-standard trials with innovative process measurement integration; and in-house medical expertise on pediatric health and asthma management.

描述：(改编自申请者摘要)：这个多站点项目 将解决已知的、不成比例的哮喘发病率负担 4-12岁的市中心儿童服务不足，有以下情况 总体目标：(1)设计适当的哮喘干预措施(或一套 干预措施)目标人群可以接受和可行；(2) 设计评估策略(试验)，以充分评估 干预措施的成本效益；及(3)落实 干预和随机试验以确定成本-效果。至 实现这些目标，调查人员将能够利用数据库 以及NCICAS I的初步干预经验(试验仍在进行中)。 本提案描述了DCC的作用，提供领导和 以下领域的专门知识：(A)对现有NCICAS I的分析 指导制定干预战略的数据库；(B)设计 评估(试验)包括受试者资格的定义， 干预组的定义、主要终点的识别、 随机化和权力评估；(C)对ASC工作人员进行集中培训 干预测量和持续监测，以确保标准 在多个地点执行共同协议；(D)持续 监控所有数据采集，以确保高质量的数据库 分析；和(E)对审判结果的初步分析，包括综合 过程措施和成本数据，以提供可靠的评估 成本效益。提出了合适的ANOVA和ANCOVA模型。在……里面 所有这些活动、意见都将征求和协调ASC 根据需要，调查人员、项目工作人员和顾问。 作为正在进行的NCICAS I的DCC，NERI能够非常快地提供 启动(DCC工作人员已经到位并完全熟悉 该项目)；最先进的分布式数据管理系统和 随机化；使用盲目受试者随访的完整调查设施 关于成本效益衡量的内部专门知识； 在非标准试验的设计和分析方面拥有最先进的专业知识 具有创新的流程测量集成；以及内部医疗 在儿科健康和哮喘管理方面的专业知识。