The Biostatistical Core (BC) will provide a shared resource for this program project. The BC will focus on database management, computer programming, experimental design, sampling, cost-effectiveness analysis, and statistical analysis for all projects. It will be responsible for working closely with the Survey Methods Core and individual projects to ensure that data linkage, quality, and security are maintained. For data not collected by the Survey Methods Core, the BC will data enter forms received from the projects, while paying close attention to quality control. Relational databases will be created and maintained for each project. Quality control checks on data and complete documentation of the database management system will be carried out. Statistical analysis plans have been developed for each project. Along with a description of the research design, outcome measures, and sample size, the proposed primary analyses of adherence to project-specific behavioral recommendations are also illustrated. Analyses of the Transtheoretical model and other core data items will compare responses obtained from them across the component projects. In addition details about analyzing changes over time within the CIS network are provided. Analysis for each project will be supervised by a designated senior biostatistician. Cost-effectiveness analysis (CEA) will be done for each of the projects. The broad policy relevance of CEA results are shown by project. Detailed tables outlining cost-measurement schemes for each of the projects are also illustrated. Given the common counseling protocol shared among the projects, CEA will also address the relative effectiveness of this protocol across projects. The BC will develop a Manual of Operations for each project and maintain communication with Project Leaders throughout the proposed program project. The BC will also collaborate with investigators in preparing project summary reports and research papers for publication.
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