Document is current

Article History

Received: 8 July 2024

Accepted: 14 March 2025

First Online: 23 March 2025

Competing interests

: E.S.S. reported receiving grants from the US Food and Drug Administration to support projects within the Yale University–Mayo Clinic Center of Excellence in Regulatory Science and Innovation and from the Patient Centered Outcomes Research Institute; the National Heart, Lung, and Blood Institute; the Centers for Disease Control and Prevention; the National Institute of Biomedical Imaging and Bioengineering; and the National Institute on Minority Health and Health Disparities, all for work unrelated to this study. S.L. reported receiving funding through an early career fellowship from the Gulf Research Program of the National Academies of Sciences, Engineering, and Medicine. Y.L. reported receiving grants from the Sentara Research Foundation; the National Heart, Lung, and Blood Institute, National Institutes of Health; and the Patient-Centered Outcomes Research Institute outside of the submitted work. X.M. consulted for Bristol Myers Squibb outside the submitted work. J.S.R. reported grants from the Agency for Healthcare Research and Quality (AHRQ, R01HS022882) during the conduct of the study; grants from the US Food and Drug Administration, Johnson & Johnson, Medical Devices Innovation Consortium, grants from the National Institutes of Health/National Heart, Lung, and Blood Institute (NIH/NHLBI), and Arnold Ventures outside the submitted work; and serving as an expert witness at the request of Relator’s attorneys, the Greene Law Firm, in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen Inc that was settled September 2022. H.M.K. received personal fees from Element Science, Identifeye, and F-Prime; is a co-founder of Hugo Health, Refactor Health, and ENSIGHT-AI; was the editor of Journal Watch and is a section editor of UpToDate; and is associated with contracts, through Yale New Haven Hospital, from the US Centers for Medicare & Medicaid Services and through Yale University from Janssen, Johnson & Johnson Consumer, and Pfizer. K.C. has received grant funding from the Health Effects Institute and the National Heart, Lung, and Blood Institute. No other disclosures were reported. The remaining authors declare no competing interests.