Reporting guidelines in medical artificial intelligence: a systematic review and meta-analysis
Communications Medicine, vol. 4, pp. 71
Abstract
BACKGROUND: The field of Artificial Intelligence (AI) holds transformative potential in medicine. However, the lack of universal reporting guidelines poses challenges in ensuring the validity and reproducibility of published research studies in this field. METHODS: Based on a systematic review of academic publications and reporting standards demanded by both international consortia and regulatory stakeholders as well as leading journals in the fields of medicine and medical informatics, 26 reporting guidelines published between 2009 and 2023 were included in this analysis. Guidelines were stratified by breadth (general or specific to medical fields), underlying consensus quality, and target research phase (preclinical, translational, clinical) and subsequently analyzed regarding the overlap and variations in guideline items. RESULTS: AI reporting guidelines for medical research vary with respect to the quality of the underlying consensus process, breadth, and target research phase. Some guideline items such as reporting of study design and model performance recur across guidelines, whereas other items are specific to particular fields and research stages. CONCLUSIONS: Our analysis highlights the importance of reporting guidelines in clinical AI research and underscores the need for common standards that address the identified variations and gaps in current guidelines. Overall, this comprehensive overview could help researchers and public stakeholders reinforce quality standards for increased reliability, reproducibility, clinical validity, and public trust in AI research in healthcare. This could facilitate the safe, effective, and ethical translation of AI methods into clinical applications that will ultimately improve patient outcomes.
Authors 5
-
Technische Universität Dresden · Indiana University Indianapolis · Indiana University Melvin and Bren Simon Comprehensive Cancer Center · Indiana University School of Medicine · Else Kröner Fresenius Center for Digital Health · University Hospital Carl Gustav Carus · Purdue University West Lafayette
Affiliation as printed
Department of Biostatistics and Health Data Science, Richard M. Fairbanks School of Public Health, Indiana University, Indianapolis, IN, USA
Department of Visceral, Thoracic and Vascular Surgery, University Hospital and Faculty of Medicine Carl Gustav Carus, TUD Dresden University of Technology, Dresden, Germany
Else Kroener Fresenius Center for Digital Health, TUD Dresden University of Technology, Dresden, Germany
Indiana University Simon Comprehensive Cancer Center, Indiana University School of Medicine, Indianapolis, IN, USA
Regenstrief Center for Healthcare Engineering, Purdue University, West Lafayette, IN, USA
Weldon School of Biomedical Engineering, Purdue University, West Lafayette, IN, USA
-
Technische Universität Dresden · Else Kröner Fresenius Center for Digital Health
Affiliation as printed
Else Kroener Fresenius Center for Digital Health, TUD Dresden University of Technology, Dresden, Germany
-
Technische Universität Dresden · Else Kröner Fresenius Center for Digital Health
Affiliation as printed
Else Kroener Fresenius Center for Digital Health, TUD Dresden University of Technology, Dresden, Germany
-
Affiliation as printed
Department of Diagnostic and Interventional Radiology, University Hospital Aachen, Aachen, Germany
-
RWTH Aachen University · Universitätsklinikum Aachen · Heidelberg University · Technische Universität Dresden · University Hospital Heidelberg · Else Kröner Fresenius Center for Digital Health · University Hospital Carl Gustav Carus · National Center for Tumor Diseases
Affiliation as printed
Department of Medicine I, University Hospital Dresden, Dresden, Germany. jakob-nikolas.kather@alumni.dkfz.de
Department of Medicine III, University Hospital RWTH Aachen, Aachen, Germany. jakob-nikolas.kather@alumni.dkfz.de
Else Kroener Fresenius Center for Digital Health, TUD Dresden University of Technology, Dresden, Germany. jakob-nikolas.kather@alumni.dkfz.de
Medical Oncology, National Center for Tumor Diseases (NCT), University Hospital Heidelberg, Heidelberg, Germany. jakob-nikolas.kather@alumni.dkfz.de
Else Kroener Fresenius Center for Digital Health, TUD Dresden University of Technology, Dresden, Germany
Cited by 153 stored of 152
No patents citing this paper on Lens.org (checked 2026-10-06).