2024 Revision of the level of evidence grading system for ESC clinical practice guideline recommendations II: diagnostic tests and prediction models
Di Angelantonio E. Pennells L. Abdelhamid M. Aboyans V. Asteggiano R. Čelutkienė J. Grobbee D.E. Iung B. Jüni P. Mcevoy J.W. Rakisheva A. Rossello X. Visseren F.L.J. Baigent C. Prescott E.B.
21 May 2025Oxford University Press
European Heart Journal
2025#46Issue 201895 - 1906 pp.
The level of evidence (LOE) grading system for European Society of Cardiology (ESC) Clinical Practice Guidelines (CPG) classifies the quality of the evidence supporting a recommendation. However, the current taxonomy does not fully consider the optimal study design necessary to establish evidence for different types of recommendations in ESC guidelines. Therefore, two separate task forces of clinical and methodological experts were appointed by the CPG Committee, with the first tasked with updating the LOE grading system for therapy and prevention and the second responsible for developing a LOE grading system for diagnosis and prediction. This report from the second of these Task Forces develops a new system for diagnostic tests and prediction models which maintains the three-level grading structure to classify the quality of the evidence but introduces new definitions specific for diagnosis and prediction. For diagnostic tests, LOE A represents conclusive evidence of adequate diagnostic ability from at least two high-quality studies. Level of evidence B represents suggestive evidence from one high-quality or at least two moderate-quality studies. Level of evidence C represents preliminary evidence not classified as A or B, including evidence from less than two moderate-quality studies, or from expert consensus. For prediction models, LOE A represents conclusive evidence of adequate predictive ability from at least one high-quality derivation and two or more external validation studies of at least moderate quality. Level of evidence B represents suggestive evidence in one or more derivation studies and one or more external validation studies of at least moderate quality. Level of evidence C represents preliminary evidence not classified as A or B, including evidence from a derivation study of at least moderate quality, but with low quality or no external validation, or a derivation study of low quality.
Cardiovascular disease , Clinical Practice Guidelines , Diagnostic ability , Diagnostic tests , European Society of Cardiology , Evidence grading , Prediction models , Predictive ability , Study quality
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British Heart Foundation Cardiovascular Epidemiology Unit, Department of Public Health and Primary Care, University of Cambridge, Papworth Road, Cambridge Biomedical Campus, Cambridge, CB2 0BB, United Kingdom
Victor Phillip Dahdaleh Heart and Lung Research Institute, University of Cambridge, Papworth Road, Cambridge Biomedical Campus, Cambridge, CB2 0BB, United Kingdom
NIHR Blood and Transplant Research Unit in Donor Health and Behaviour, University of Cambridge, Cambridge, United Kingdom
BHF Centre of Research Excellence, School of Clinical Medicine, University of Cambridge, Addenbrookes Hospital, Cambridge, United Kingdom
Health Data Research UK Cambridge, University of Cambridge, Wellcome Genome Campus, Cambridge, United Kingdom
Health Data Science Centre, Human Technopole, V.le Rita Levi-Montalcini 1, Milan, 20157, Italy
Department of Cardiovascular Medicine, Faculty of Medicine, Kasr El Ainy, Cairo University, Cairo, Egypt
Department of Cardiology, Dupuytren University Hospital, Limoges, France
Faculty of Medicine, Insubria University, Varese, Laboratorio Analisi e Ricerca Clinica, Turin, Italy
Clinic of Cardiac and Vascular Diseases, Vilnius University, Vilnius, Lithuania
University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands
The Julius Center for Health Sciences and Primary Care, Utrecht, Netherlands
Hospital Bichat-Claude Bernard, Université de Paris, Paris, France
Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom
Department of Cardiology, University of Galway, School of Medicine, Galway, Ireland
National Institute for Prevention and Cardiovascular Health, Galway, Ireland
Cardiology Department, City Cardiology Center, Almaty, Kazakhstan
Cardiology Department, Hospital Universitari Son Espases, Health Research Institute of the Balearic Islands (IdiSBa), Palma de Mallorca, Spain
Facultad de Medicina, Universitat Illes Balears (UIB), Palma de Mallorca, Spain
Department of Vascular Medicine, University Medical Center Utrecht, Utrecht, Netherlands
Department of Cardiology, Bispebjerg University Hospital, Copenhagen, Denmark
British Heart Foundation Cardiovascular Epidemiology Unit
Victor Phillip Dahdaleh Heart and Lung Research Institute
NIHR Blood and Transplant Research Unit in Donor Health and Behaviour
BHF Centre of Research Excellence
Health Data Research UK Cambridge
Health Data Science Centre
Department of Cardiovascular Medicine
Department of Cardiology
Faculty of Medicine
Clinic of Cardiac and Vascular Diseases
University Medical Center Utrecht
The Julius Center for Health Sciences and Primary Care
Hospital Bichat-Claude Bernard
Clinical Trial Service Unit and Epidemiological Studies Unit
Department of Cardiology
National Institute for Prevention and Cardiovascular Health
Cardiology Department
Cardiology Department
Facultad de Medicina
Department of Vascular Medicine
Department of Cardiology
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