Peer-Reviewed Publication
BMJ2026;395e100855.October 13, 2026Journal Article

Reporting completeness of clinical trials evaluating large language model interventions in medicine: systematic review.

David Chen1, Ayden Blayne1, Tony Ning1, Inaam Chattha1, Majid Afshar2, Jasmine Chiat Ling Ong3,4, Julian C Hong5,6,7, Nan Liu3,8,9,10,11, Leo Anthony Celi12,13,14, Karel G M Moons15, Gary S Collins16,17, Danielle S Bitterman18,19
1Division of Radiation Oncology, Department of Surgery, University of British Columbia, Vancouver, BC, Canada.
2Department of Medicine and Department of Biostatistics and Medical Informatics, University of Wisconsin, Madison, WI, USA.
3Duke-NUS AI + Medical Sciences Initiative, Duke-NUS Medical School, Singapore.
4Division of Pharmacy, Singapore General Hospital, Singapore.
5Department of Radiation Oncology, University of California, San Francisco, San Francisco, CA, USA.
6Bakar Computational Health Sciences Institute, University of California, San Francisco, San Francisco, CA, USA.
7UCSF UC Berkeley Joint Program in Computational Health, San Francisco, CA, USA.
8Centre for Biomedical Data Science, Duke-NUS Medical School, Singapore.
9Pre-hospital and Emergency Research Centre, Health Services Research and Population Health, Duke-NUS Medical School, Singapore.
10NUS Artificial Intelligence Institute, National University of Singapore, Singapore.
11Department of Biostatistics and Bioinformatics, Duke University, Durham, NC, USA.
12Division of Pulmonary, Critical Care and Sleep Medicine, Beth Israel Deaconess Medical Center, Boston, MA, USA.
13Laboratory for Computational Physiology, Massachusetts Institute of Technology, Cambridge, MA, USA.
14Department of Biostatistics, Harvard T H Chan School of Public Health, Boston, MA, USA.
15Julius Center for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht University, Utrecht, The Netherlands.
16Department of Applied Health Sciences, School of Health Sciences, College of Medicine and Health, University of Birmingham, Birmingham, UK.
17NIHR Biomedical Research Centre: Birmingham, Birmingham, University Hospitals Birmingham NHS Foundation Trust and University of Birmingham, Birmingham, UK.
18Artificial Intelligence in Medicine (AIM) Program, Mass General Brigham, Harvard Medical School, Boston, MA, USA dbitterman@bwh.harvard.edu.
19Department of Radiation Oncology, Brigham and Women's Hospital/Dana-Farber Cancer Institute, Boston, MA, USA.

Abstract

OBJECTIVE: To characterise the reporting completeness of clinical trials involving large language model (LLM) interventions using established reporting guidelines. DESIGN: Systematic review and meta-research analysis. DATA SOURCES: Bibliographic databases (Embase, Medline, and CENTRAL) were searched for trial reports and protocols, and trial registries (ClinicalTrials.gov and World Health Organi…

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