Characterization of US Food and Drug Administration Class I Recalls from 2018 to 2022 for Moderate- and High-Risk Medical Devices: A Cross-Sectional Study

Autor: Mooghali M, Ross JS, Kadakia KT, Dhruva SS

Publikováno v: Medical Devices: Evidence and Research, Vol Volume 16, Pp 111-122 (2023)

Maryam Mooghali,1,2 Joseph S Ross,1– 4 Kushal T Kadakia,5 Sanket S Dhruva6,7 1Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA; 2Yale Collaboration for Regulatory Rigor, Integrity, and Transparency (CRRIT), Yale School o

Externí odkaz: https://doaj.org/article/aedfbaa848d14c2797cf97116bd4cd58

Class I Recalls of Cardiovascular Devices Between 2013 and 2022 : A Cross-Sectional Analysis.

Autor: See C; Department of Medicine, University of California, San Francisco, San Francisco, California (C.S.)., Mooghali M; Section of General Medicine, Department of Medicine, Yale School of Medicine, New Haven, Connecticut (M.M.)., Dhruva SS; Philip R. Lee Institute for Health Policy Studies, University of California, San Francisco, and Section of Cardiology, Department of Medicine, San Francisco Veterans Affairs Medical Center, San Francisco, California (S.S.D.)., Ross JS; Section of General Medicine, Department of Medicine, Yale School of Medicine, and Department of Health Policy and Management, Yale School of Public Health, New Haven, Connecticut (J.S.R.)., Krumholz HM; Department of Health Policy and Management, Yale School of Public Health; Center for Outcomes Research and Evaluation, Yale New Haven Hospital; and Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut (H.M.K.)., Kadakia KT; Harvard Medical School, Boston, Massachusetts (K.T.K.).

Publikováno v: Annals of internal medicine [Ann Intern Med] 2024 Nov; Vol. 177 (11), pp. 1499-1508. Date of Electronic Publication: 2024 Sep 17.

Trustworthy and ethical AI-enabled cardiovascular care: a rapid review.

Autor: Mooghali M; Section of General Internal Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA. maryam.mooghali@yale.edu.; Yale Center for Outcomes Research and Evaluation (CORE), 195 Church Street, New Haven, CT, 06510, USA. maryam.mooghali@yale.edu., Stroud AM; Biomedical Ethics Research Program, Mayo Clinic, Rochester, MN, USA., Yoo DW; School of Information, Kent State University, Kent, OH, USA., Barry BA; Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN, USA.; Division of Health Care Delivery Research, Mayo Clinic, Rochester, MN, USA., Grimshaw AA; Harvey Cushing/John Hay Whitney Medical Library, Yale University, New Haven, CT, USA., Ross JS; Section of General Internal Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA.; Department of Health Policy and Management, Yale School of Public Health, New Haven, CT, USA., Zhu X; Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN, USA., Miller JE; Section of General Internal Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA.

Publikováno v: BMC medical informatics and decision making [BMC Med Inform Decis Mak] 2024 Sep 04; Vol. 24 (1), pp. 247. Date of Electronic Publication: 2024 Sep 04.

Associations Between Surrogate Markers and Clinical Outcomes for Nononcologic Chronic Disease Treatments.

Autor: Wallach JD; Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, Georgia.; Collaboration for Regulatory Rigor, Integrity, and Transparency, Yale School of Medicine, New Haven, Connecticut., Yoon S; Collaboration for Regulatory Rigor, Integrity, and Transparency, Yale School of Medicine, New Haven, Connecticut.; Department of Internal Medicine, Massachusetts General Hospital, Harvard Medical School, Boston., Doernberg H; Collaboration for Regulatory Rigor, Integrity, and Transparency, Yale School of Medicine, New Haven, Connecticut.; Department of Internal Medicine, Massachusetts General Hospital, Harvard Medical School, Boston., Glick LR; Department of Internal Medicine, Massachusetts General Hospital, Harvard Medical School, Boston., Ciani O; Center for Research on Health and Social Care Management, SDA Bocconi School of Management, Milan, Italy., Taylor RS; MRC/CSO Social and Public Health Sciences Unit, School of Health & Wellbeing, University of Glasgow, Glasgow, Scotland, United Kingdom.; Robertson Centre for Biostatistics, School of Health & Wellbeing, University of Glasgow, Glasgow, Scotland, United Kingdom., Mooghali M; Collaboration for Regulatory Rigor, Integrity, and Transparency, Yale School of Medicine, New Haven, Connecticut.; Section of General Internal Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut., Ramachandran R; Collaboration for Regulatory Rigor, Integrity, and Transparency, Yale School of Medicine, New Haven, Connecticut.; Section of General Internal Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.; Yale National Clinicians Scholars Program, Yale School of Medicine, New Haven, Connecticut., Ross JS; Collaboration for Regulatory Rigor, Integrity, and Transparency, Yale School of Medicine, New Haven, Connecticut.; Section of General Internal Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.; Yale National Clinicians Scholars Program, Yale School of Medicine, New Haven, Connecticut.; Department of Health Policy and Management, Yale School of Public Health, Yale-New Haven Health System, New Haven, Connecticut.; Center for Outcomes Research and Evaluation, Yale-New Haven Health System, New Haven, Connecticut.

Publikováno v: JAMA [JAMA] 2024 May 21; Vol. 331 (19), pp. 1646-1654.

Characterization of accelerated approval status, trial endpoints and results, and recommendations in guidelines for oncology drug treatments from the National Comprehensive Cancer Network: cross sectional study.

Autor: Mooghali M; Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA.; Yale Collaboration for Regulatory Rigor, Integrity, and Transparency, Yale School of Medicine, New Haven, CT, USA., Mitchell AP; Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA., Skydel JJ; Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA., Ross JS; Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA.; Yale Collaboration for Regulatory Rigor, Integrity, and Transparency, Yale School of Medicine, New Haven, CT, USA.; Department of Health Policy and Management, Yale School of Public Health; and Center for Outcomes Research and Evaluation, Yale New Haven Health System, New Haven, CT, USA., Wallach JD; Department of Epidemiology, Rollins School of Public Health, Atlanta, GA, USA., Ramachandran R; Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA.; Yale Collaboration for Regulatory Rigor, Integrity, and Transparency, Yale School of Medicine, New Haven, CT, USA.

Publikováno v: BMJ medicine [BMJ Med] 2024 Apr 05; Vol. 3 (1), pp. e000802. Date of Electronic Publication: 2024 Apr 05 (Print Publication: 2024).