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Peer-Reviewed Publication
NEJM AI2025;2(9)September 1, 2025Journal Article

A Novel Playbook for Pragmatic Trial Operations to Monitor and Evaluate Ambient Artificial Intelligence in Clinical Practice.

Majid Afshar1,2,3,4, Felice Resnik1, Mary Ryan Baumann1,3,5, Josie Hintzke1, Kayla Lemmon1, Anne Gravel Sullivan1, Tina Shah6, Anthony Stordalen7, Michael Oberst7, Jason Dambach2,8, Leigh Ann Mrotek1, Mariah Quinn2, Kirsten Abramson2, Peter Kleinschmidt2, Tom Brazelton9, Heidi Twedt2,8, David Kunstman4,8, Graham Wills4,10, John Long8, Brian W Patterson3,4,10, Frank J Liao4,10, Stacy Rasmussen4, Elizabeth Burnside1, Cherodeep Goswami4, Joel E Gordon4,8
1Institute for Clinical and Translational Research, School of Medicine and Public Health, University of Wisconsin, Madison.
2Department of Medicine, School of Medicine and Public Health, University of Wisconsin, Madison.
3Department of Population Health Sciences, School of Medicine and Public Health, University of Wisconsin, Madison.
4University of Wisconsin Hospitals and Clinics, Madison.
5Department of Biostatistics and Medical Informatics, School of Medicine and Public Health, University of Wisconsin, Madison.
6Division of Pulmonary and Critical Care, Robert Wood Johnson / Barnabas Health System, Rutgers New Jersey Medical School, Newark, NJ.
7Abridge AI, Inc., Philadelphia.
8Department of Family and Community Health, School of Medicine and Public Health, University of Wisconsin, Madison.
9Department of Pediatrics, School of Medicine and Public Health, University of Wisconsin, Madison.
10BerbeeWalsh Department of Emergency Medicine, School of Medicine and Public Health, University of Wisconsin, Madison.

Abstract

BACKGROUND: Ambient artificial intelligence (AI) offers the potential to reduce documentation burden and improve efficiency through clinical note generation. Widespread adoption, however, remains limited due to challenges in electronic health record (EHR) integration, coding compliance, and real-world evaluation. This study introduces a framework and protocols to design, monitor, and deploy ambien…

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