Data Management and Statistical Analysis Core (Core C)

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ABSTRACT The study of delirium, and its relationship to dementia and Alzheimer's Disease, presents distinct quantitative challenges, including elevated risk of participant attrition and confounding of associations via the influences of surgery and multimorbidity. The Data Management and Statistical Analysis (DMSA) Core (Core C) has been developed to address these challenges. The overall goal of the DMSA Core is to provide data management and biostatistical resources and expertise promoting best statistical and scientific practices within this Program Project. DMSA activities are directed toward the three mutually reinforcing Specific Aims: (1) to develop infrastructure for data capture and metadata management; (2) to develop and maintain secure data management infrastructure; and (3) to provide comprehensive statistical and data management support, including novel methods development, to each of the five projects. The DMSA's leadership has substantial expertise in observational studies, experimental design, longitudinal multivariate analysis, biomarker analysis, scale development, machine learning, and missing data, and is seasoned in the leadership of data science teams. Its skilled staff are substantially experienced in the acquisition and management of high quality data, as illustrated by the extremely successful data capture and completeness initiatives developed in the initial funding cycle. Core faculty maintain active and highly productive collaborative relationships with the SAGES investigators. Additionally, the DMSA provides key venues for collaboration, supervision and peer support of its faculty and personnel; maintenance of efficiency and productivity; and surety of quality control around data and analytic issues. The DMSA has embedded continuous innovation in its operations; examples of this innovation include novel scale development for cognitive and physical function; extended matching algorithms in case/control design, and the development of novel and integrated web-enabled data management and analysis tools, which enhance the reproducibility of scientific findings. The DMSA will provide the venue for efficient and cost effective information management and data analysis of the five projects proposed here; the feasibility of this ambitious effort is demonstrated by our success in the initial funding cycle and our well- developed research operations model. This Program Project has tremendous potential to advance the science of delirium, leading ultimately to the development of interventions targeting its incidence and sequelae. Ultimately, this Program Project holds tremendous potential to advance our understanding of delirium, and to develop more effective strategies for prevention and treatment of delirium and associated conditions and complications. The DMSA will play a critical role in its success.