Core B: Biostatistics and Data Harmonization Shared Resource

核心B，生物统计学和数据协调共享资源

ABSTRACT – Core B, Biostatistics and Data Harmonization Shared Resource Strong biostatistical leadership and expertise are integral to achieving scientific integrity of research data and analytical results, and are indispensable for assuring confidence in the potential clinical or public health impact of research activities. The primary goal of Core B, the Biostatistics and Data Harmonization Shared Resource, is to oversee and guide all aspects of study design, data management and data analysis across all three P01 projects so the scientific aims of each project are addressed using standardized, high- quality datasets and the most appropriate statistical methods. We have a strong team of biostatisticians, programmer/analysts and investigators with extensive experience using the P01 data and population resources. Our resources include the California and Utah Cancer Registries linked to hospitalization, emergency and ambulatory surgery data; the University of North Carolina at Chapel Hill Cancer Information & Population Health Resource; the integrated healthcare systems of Kaiser Permanente Northern California and Southern California; and survey data on a population subset. The varying data sources present several challenges in cleaning, analysis and interpretation, including the potential for reverse causation and various forms of selection bias. Biostatistical consultation provided by the Core will ensure the appropriate application of approaches to determine the potential magnitude of such biases and methods to account for them. The specific aims of the Core are to: 1. Provide overall biostatistical leadership, consultation and support across all three P01 projects and Core C, the Survey Shared Resource; 2. Carry out cohort identification to meet the subject inclusion criteria for each aim of each project and for the survey described in Core C; 3. Harmonize and standardize variable definitions used across data sources and projects; 4. Construct and provide study analytic datasets that incorporate data from clinical and administration data sources, cancer registries, and patient surveys; 5. Oversee analyses using appropriate methods to achieve the aims of each project, including consideration of systematic biases, potential confounders, and sampling weights in the analysis of survey data. To carry out the objectives of this P01, centralized biostatistical expertise and services will ensure use of common concepts and data definitions throughout the P01. This Core will ensure that data are appropriate for the questions addressed, harmonized across source data systems to enhance comparability, and analyzed and interpreted with knowledge of strengths and limitations. This strategy will maximize the potential impact of P01 findings to inform and improve healthcare for adolescent and young adult cancer survivors.