TY - JOUR
T1 - GRADE guidelines 30: the GRADE approach to assessing the certainty of modeled evidence—An overview in the context of health decision-making
AU - Brozek, Jan L.
AU - Canelo-Aybar, Carlos
AU - Akl, Elie A.
AU - Bowen, James M.
AU - Bucher, John
AU - Chiu, Weihsueh A.
AU - Cronin, Mark
AU - Djulbegovic, Benjamin
AU - Falavigna, Maicon
AU - Guyatt, Gordon H.
AU - Gordon, Ami A.
AU - Hilton Boon, Michele
AU - Hutubessy, Raymond C. W.
AU - Joore, Manuela A.
AU - Katikireddi, Vittal
AU - LaKind, Judy
AU - Langendam, Miranda
AU - Manja, Veena
AU - Magnuson, Kristen
AU - Mathioudakis, Alexander G.
AU - Meerpohl, Joerg
AU - Mertz, Dominik
AU - Mezencev, Roman
AU - Morgan, Rebecca
AU - Morgano, Gian Paolo
AU - Mustafa, Reem
AU - O'Flaherty, Martin
AU - Patlewicz, Grace
AU - Riva, John J.
AU - Posso, Margarita
AU - Rooney, Andrew
AU - Schlosser, Paul M.
AU - Schwartz, Lisa
AU - Shemilt, Ian
AU - Tarride, Jean-Eric
AU - Thayer, Kristina A.
AU - Tsaioun, Katya
AU - Vale, Luke
AU - Wambaugh, John
AU - Wignall, Jessica
AU - Williams, Ashley
AU - Xie, Feng
AU - GRADE Working Group
AU - Zhang, Yuan
AU - Schünemann, Holger J.
N1 - Funding Information: A.R. was supported by the National Institutes of Health , National Institute of Environmental Health Sciences . Publisher Copyright: © 2020
PY - 2021/1
Y1 - 2021/1
N2 - Objectives: The objective of the study is to present the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) conceptual approach to the assessment of certainty of evidence from modeling studies (i.e., certainty associated with model outputs). Study Design and Setting: Expert consultations and an international multidisciplinary workshop informed development of a conceptual approach to assessing the certainty of evidence from models within the context of systematic reviews, health technology assessments, and health care decisions. The discussions also clarified selected concepts and terminology used in the GRADE approach and by the modeling community. Feedback from experts in a broad range of modeling and health care disciplines addressed the content validity of the approach. Results: Workshop participants agreed that the domains determining the certainty of evidence previously identified in the GRADE approach (risk of bias, indirectness, inconsistency, imprecision, reporting bias, magnitude of an effect, dose–response relation, and the direction of residual confounding) also apply when assessing the certainty of evidence from models. The assessment depends on the nature of model inputs and the model itself and on whether one is evaluating evidence from a single model or multiple models. We propose a framework for selecting the best available evidence from models: 1) developing de novo, a model specific to the situation of interest, 2) identifying an existing model, the outputs of which provide the highest certainty evidence for the situation of interest, either “off-the-shelf” or after adaptation, and 3) using outputs from multiple models. We also present a summary of preferred terminology to facilitate communication among modeling and health care disciplines. Conclusion: This conceptual GRADE approach provides a framework for using evidence from models in health decision-making and the assessment of certainty of evidence from a model or models. The GRADE Working Group and the modeling community are currently developing the detailed methods and related guidance for assessing specific domains determining the certainty of evidence from models across health care–related disciplines (e.g., therapeutic decision-making, toxicology, environmental health, and health economics).
AB - Objectives: The objective of the study is to present the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) conceptual approach to the assessment of certainty of evidence from modeling studies (i.e., certainty associated with model outputs). Study Design and Setting: Expert consultations and an international multidisciplinary workshop informed development of a conceptual approach to assessing the certainty of evidence from models within the context of systematic reviews, health technology assessments, and health care decisions. The discussions also clarified selected concepts and terminology used in the GRADE approach and by the modeling community. Feedback from experts in a broad range of modeling and health care disciplines addressed the content validity of the approach. Results: Workshop participants agreed that the domains determining the certainty of evidence previously identified in the GRADE approach (risk of bias, indirectness, inconsistency, imprecision, reporting bias, magnitude of an effect, dose–response relation, and the direction of residual confounding) also apply when assessing the certainty of evidence from models. The assessment depends on the nature of model inputs and the model itself and on whether one is evaluating evidence from a single model or multiple models. We propose a framework for selecting the best available evidence from models: 1) developing de novo, a model specific to the situation of interest, 2) identifying an existing model, the outputs of which provide the highest certainty evidence for the situation of interest, either “off-the-shelf” or after adaptation, and 3) using outputs from multiple models. We also present a summary of preferred terminology to facilitate communication among modeling and health care disciplines. Conclusion: This conceptual GRADE approach provides a framework for using evidence from models in health decision-making and the assessment of certainty of evidence from a model or models. The GRADE Working Group and the modeling community are currently developing the detailed methods and related guidance for assessing specific domains determining the certainty of evidence from models across health care–related disciplines (e.g., therapeutic decision-making, toxicology, environmental health, and health economics).
KW - Certainty of evidence
KW - GRADE
KW - Guidelines
KW - Health care Decision making
KW - Mathematical models
KW - Modelling studies
UR - http://www.scopus.com/inward/record.url?scp=85093682805&partnerID=8YFLogxK
U2 - https://doi.org/10.1016/j.jclinepi.2020.09.018
DO - https://doi.org/10.1016/j.jclinepi.2020.09.018
M3 - Article
C2 - 32980429
SN - 0895-4356
VL - 129
SP - 138
EP - 150
JO - Journal of Clinical Epidemiology
JF - Journal of Clinical Epidemiology
ER -