Biostatistics and Data Infrastructure core

The Biostatistics and Data Infrastructure Core (Data Core) will provide statistical expertise and data infrastructure for the Diabetes Prevention Program (DPP) Outcomes Study (DPPOS) Alzheimer’s disease (AD) and AD related dementias (ADRD) Project. The Data Core statisticians will play a significant role from the design to the

dissemination and close-out as we have done in DPP/DPPOS. The Data Core, led by Dr. Marinella Temprosa, will promote consistent analytical practices and definitions across the four projects, ancillary studies, and the manuscripts and presentations that emanate from the DPPOS AD/ADRD Project. In addition, the Data Core will

support the Administrative Core, Clinical Operations and Procedures Core (Clinical Core), Cognitive Assessment and Adjudication Core (Cognition Core), and Neuroimaging and Plasma Biomarkers Core (Biomarkers Core) in activities that require data management and statistical analyses. The Data Core will ensure the continuity of

DPP/DPPOS into the DPPOS AD/ADRD Project by overseeing all aspects of study design, power and sample sizes required to meet the proposed aims and determining analysis plans and performing data analyses. The Data Core will oversee the DPPOS AD/ADRD Project’s data collection and management, continue to ensure the

same high-quality, accurate, reliable, and data integrity as has been done for the past 25-years in DPP/DPPOS. Finally, the Data Core will implement a program to allow investigators inside and outside the DPPOS AD/ADRD Project study group to analyze data to answer questions beyond those proposed in the DPPOS AD/ADRD

Project as part of ancillary studies and manuscript proposals. The Data Core will achieve its goals through the following specific aims: (1) Provide statistical expertise for the four projects and activities of the other cores to promote scientific rigor in study design, study conduct, and the analyses and interpretation of data; (2) Provide

data and reporting infrastructure for all the projects and other cores. The data core will leverage MIDAS (Multi- modal Integrated Data Acquisition System), a web-based custom-built system developed at George Washington University which has been used since 2009 for DPPOS for data capture and adjudication and the study website

for reporting; (3) Maintain the central data warehouse and quality controls for all projects and other cores; (4) Disseminate data to facilitate ancillary studies, promote training in data analyses and for submission to the appropriate NIH repository, in collaboration with the Administrative Core. The Data Core will lead statistical and

data management activities in the DPPOS AD/ADRD Project. The Data Core will collaborate and integrate all with other cores and projects and develop synergies to elucidate the course of AD/ADRD in persons living with pre-diabetes and type 2 diabetes.