DATA COORDINATING CENTER FOR NCICAS II

NCICAS II 数据协调中心

• 批准号: 2887199
• 负责人: HERMAN E. MITCHELL
• 金额: $ 258.74万
• 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 2001-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2887199
• 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 disease /disorder therapy; 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：（改编自申请人的摘要）：该多站点项目 将解决已知的，不成比例的哮喘发病率的负担， 4-12岁得不到充分服务的市中心儿童， 总体目标：（1）设计适当的哮喘干预措施（或一套 干预措施）为目标人群所接受且可行;（2） 设计评价战略（试验），以充分评估 干预措施的成本效益;以及（3）实施 干预和随机试验，以确定成本效益。 到 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）。 本提案描述了发展协调委员会发挥领导作用的作用， （a）分析现有的第一个国家化学品评估和分析委员会 数据库，以指导制定干预战略;（B）设计 评价（试验），包括受试者合格性的定义， 定义干预组，确定主要终点， 随机化和把握度评估;（c）对ASC工作人员进行以下方面的集中培训 干预和测量以及持续监测，以确保标准 在多个地点实施共同协议;（d）正在进行 监控所有数据采集，以确保高质量的数据库， 分析;以及（e）试验结果的主要分析，包括整合 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 在所有这些活动中，将征求ASC的意见并进行协调 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能够提供非常快速的 启动（DCC工作人员已经到位，并完全熟悉 最先进的分布式数据管理系统， 随机化;使用盲态受试者随访的完整调查设施 CATI;关于成本效益衡量的内部专业知识; 非标准试验设计和分析方面的最先进专业知识 创新的过程测量集成;以及内部医疗 儿科健康和哮喘管理方面的专业知识。