TY - JOUR
T1 - 2024 Revision of the level of evidence grading system for ESC clinical practice guideline recommendations II
T2 - diagnostic tests and prediction models
AU - Di Angelantonio, Emanuele
AU - Pennells, Lisa
AU - Abdelhamid, Magdy
AU - Aboyans, Victor
AU - Asteggiano, Riccardo
AU - Čelutkienė, Jelena
AU - Grobbee, Diederick E
AU - Iung, Bernard
AU - Jüni, Peter
AU - McEvoy, John William
AU - Rakisheva, Amina
AU - Rossello, Xavier
AU - Visseren, Frank L J
AU - Baigent, Colin
AU - Prescott, Eva B
N1 - Publisher Copyright:
© 2025 The European Society of Cardiology. All rights reserved.
PY - 2025/5/21
Y1 - 2025/5/21
N2 - 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.
AB - 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.
U2 - 10.1093/eurheartj/ehaf016
DO - 10.1093/eurheartj/ehaf016
M3 - Article
C2 - 40116738
SN - 0195-668X
VL - 46
SP - 1895
EP - 1906
JO - European heart journal
JF - European heart journal
IS - 20
M1 - ehaf016
ER -