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Matthew J Swanson,1,2 Colin L Uyeki,1 Sarah R Yoder,1 Sanket S Dhruva,3 Jennifer E Miller,4 Joseph S Ross4– 6 1Frank H. Netter MD School of Medicine, Quinnipiac University, North Haven, CT, USA; 2Leonard N. Stern School of Business, New York University, New York, NY, USA; 3Department of Medicine, University of California, San Francisco School of Medicine, San Francisco, CA, USA; 4Department of Medicine, Yale School of Medicine, New Haven, CT, USA; 5Department of Health Policy and Management, Yale School of Public Health, New Haven, CT, USA; 6Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT, USACorrespondence: Matthew J Swanson, Frank H. Netter MD School of Medicine, Quinnipiac University, 370 Bassett Road, North Haven, CT, 06473-1908, USA, Email Matthew.Swanson@stern.nyu.eduBackground: Representation of diverse study populations in pivotal clinical trials for medical devices and subgroup analyses for demographic groups to explore differences in safety and effectiveness are essential to understanding the benefits and risks in diverse populations. The US Food and Drug Administration (FDA) has taken many steps to improve transparency and subgroup analyses over the past decade, but there has not been a recent evaluation of demographic reporting and subgroup analyses.Methods: We reviewed all FDA Premarket Approvals for high-risk cardiovascular devices from 2014 to 2022, focusing on pivotal studies supporting device approval. We abstracted detailed demographic data about the age, sex, race, ethnicity, and socioeconomic position of study participants. We also assessed the presence and results of subgroup analyses to understand the safety and effectiveness of devices across trial populations.Results: Analysis of 92 pivotal studies revealed that age and sex were reported in 96.7% of the studies, while race and ethnicity were reported in 71.7% and 58.7%, respectively. However, only 7.9% of studies explicitly detailed the participation of older adults (≥ 65 years) and no studies ... |