Safety monitoring in the U.S. study to Protect Brain Health Through Lifestyle Intervention to Reduce Risk (US POINTER): Prevention (nonpharmacological) / Multidomain. (7th December 2020)

• Record Type: Journal Article
• Authors: Williams, Benjamin J; Felton, Deborah M; Nichols, John E; Espeland, Mark A; Baker, Laura D
• Is Part Of: Alzheimer's & dementia. Volume 16(2020)Supplement 10
• Page Start: n/a
• Page End: n/a
• Publication Date: 2020-12-07
• Subjects: Alzheimer's disease -- Periodicals; Alzheimer Disease -- Periodicals; Dementia -- Periodicals; Démence; Maladie d'Alzheimer; Périodique électronique (Descripteur de forme); Ressource Internet (Descripteur de forme); 616.83
• DOI: 10.1002/alz.043678
• Languages: English
• ISSNs: 1552-5260

Abstract

Abstract: Background: US POINTER is a multisite randomized clinical trial funded by the Alzheimer's Association. It is designed to evaluate whether different lifestyle interventions (exercise, nutrition, and cognitive and social stimulation) protect cognitive function over a 2‐year period in approximately 2000 older adults. Method: We have designed a web‐based safety tracking system (STS) that meets the complexity of this trial that involves oversight of participants as they carry out the interventions by community partners at 5 trial sites. Result: In US POINTER, participants interact with community interventionists as well as research clinic staff and clinicians. All personnel are charged with documenting potential safety events. We designed the STS to allow timely and accurate collection of safety data by study personnel regardless of their role in the study or the location of their contact with the participant. This ensures that safety data are complete. Health events entered by interventionists and clinical trial staff are reviewed by local site clinicians to determine if the event meets criteria for an adverse event (AE). If so, the clinician then determines the expectedness, relatedness, and risk of harm of the AE. These determinations are captured on the STS. Safety reporting is then reviewed and adjudicated by the central Safety Manager and the trial Safety Officer and, if needed, by the Safety Committee. The STS facilitates these processes and ensures the accuracy and consistency of safety data reporting throughout the trial. Importantly, the trial design requires that study personnel, Safety Manager, Safety Officer, and the Data Coordinating Center remain masked or unmasked as to study interventions and outcomes. The STS was designed so that access to the STS is restricted by study role in order to maintain the intervention assignment mask. These attributes of the STS help to maintain the rigor and integrity of the trial. Conclusion: The innovation of the POINTER STS is that it allows for reporting of AEs obtained during any point of contact between the participant, community partners and study personnel, and allows for a multi‐level review of safety events in a centralized, efficient and timely manner thus ensuring participant's ongoing safety throughout the trial.