DATA COORDINATING CENTER FOR NCICAS II

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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.