Duke Center for Health Informatics: Informatics Lessons for Pragmatic Trials in Older Adults: The PREVENTABLE Experience
Current guidelines do not address whether to initiate a statin in older adults for primary prevention of cardiovascular disease, and there are also questions about whether statins may help to preserve or benefit cognitive and physical function. The PRagmatic EValuation of evENTs And Benefits of Lipid-lowering in oldEr adults (PREVENTABLE) is a double-blind, placebo-controlled randomized pragmatic clinical trial funded by the National Institute on Aging and National Heart, Lung, and Blood Institute that began recruitment in September 2020. It will compare high-intensity statin therapy (atorvastatin 40 mg) with placebo in 20,000 community-dwelling adults aged ≥75 years without cardiovascular disease, disability, or dementia. Sites for the trial come from the National Patient-Centered Clinical Research Network (PCORnet), the Veterans Affairs system, and independent health systems. The goal of this talk is to review a number of the informatics challenges PREVENTABLE has faced to date, including the unique complexities of pragmatic research in older adults, needs for local adaptation of processes for recruitment and patient outreach, data harmonization and standardization, and the influence of pragmatic outcome ascertainment on plans for statistical monitoring.
Nick Pajewski, PhD, is an Associate Professor in the Department of Biostatistics and Data Science at Wake Forest University School of Medicine. At Wake Forest, Dr. Pajewski co-directs the Center for Health System Sciences, is the Director of Statistical Analytics for the Center for Health Care Innovation, and an Associate Director for the Center for Biomedical Informatics. Dr. Pajewski's background is in biostatistics, clinical trials, and clinical informatics. Much of his current research is in the context of large, multi-site randomized trials, typically focused on pharmacologic management of common chronic diseases in older adults. He is currently a member of the Data Coordinating Center and Steering Committee for the PRagmatic EValuation of evENTs And Benefits of Lipid-lowering in oldEr adults (PREVENTABLE) trial, and is the PI of the DCC for LEAP.
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Meeting number (access code) 920 0552 7024, Meeting password: 128631