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Full-Text Articles in Medicine and Health Sciences
Data And Safety Monitoring In Social Behavioral Intervention Trials: The Reach Ii Experience, Sara J. Czaja, Richard Schulz, Steven H. Belle, Louis D. Burgio, Nell Armstrong, Laura N. Gitlin, David W. Coon, Jennifer Martindale-Adams, Julie Klinger, Sidney M. Stahl
Data And Safety Monitoring In Social Behavioral Intervention Trials: The Reach Ii Experience, Sara J. Czaja, Richard Schulz, Steven H. Belle, Louis D. Burgio, Nell Armstrong, Laura N. Gitlin, David W. Coon, Jennifer Martindale-Adams, Julie Klinger, Sidney M. Stahl
Center for Applied Research on Aging and Health Research Papers
Background Psychosocial and behavioral interventions trials targeting a broad range of complex social and behavioral problems such as smoking, obesity and family caregiving have proliferated in the past 30 years. At the same time the use of Data and Safety Monitoring Boards (DSMBs) to monitor the progress and quality of intervention trials and the safety of study participants has increased substantially. Most of the existing literature and guidelines for safety monitoring and reporting of adverse events focuses on medical interventions. Consequently, there is little guidance for investigators conducting social and behavior trials.
Purpose This paper summarizes how issues associated with …