GRADE guidance 35: update on rating imprecision for assessing contextualized certainty of evidence and making decisions
Por:
Schunemann, HJ, Neumann, I, Hultcrantz, M, Brignardello-Petersen, R, Zeng, L, Murad, MH, Izcovich, A, Morgano, GP, Baldeh, T, Santesso, N, Cuello, CG, Mbuagbaw, L, Guyatt, G, Wiercioch, W, Piggott, T, De Beer, H, Vinceti, M, Mathioudakis, AG, Mayer, MG, Mustafa, R, Filippini, T, Iorio, A, Nieuwlaat, R, Marcucci, M, Coello, PA, Bonovas, S, Piovani, D, Tomlinson, G, Akl, EA
Publicada:
1 dic 2022
Ahead of Print:
1 dic 2022
Resumen:
Objectives: Grading of Recommendations Assessment, Development and Evaluation (GRADE) guidance to rate the certainty domain of imprecision is presently not fully operationalized for rating down by two levels and when different baseline risk or uncertainty in these risks are considered. In addition, there are scenarios in which lowering the certainty of evidence by three levels for imprecision is more appropriate than lowering it by two levels. In this article, we conceptualize and operationalize rating down for imprecision by one, two and three levels for imprecision using the contextualized GRADE approaches and making decisions. Methods: Through iterative discussions and refinement in online meetings and through email communication, we developed draft guid-ance to rating the certainty of evidence down by up to three levels based on examples. The lead authors revised the approach according to the feedback and the comments received during these meetings and developed GRADE guidance for how to apply it. We presented a sum-mary of the results to all attendees of the GRADE Working Group meeting for feedback in October 2021 (approximately 80 people) where the approach was formally approved. Results: This guidance provides GRADE's novel approach for the considerations about rating down for imprecision by one, two and three levels based on serious, very serious and extremely serious concerns. The approach includes identifying or defining thresholds for health outcomes that correspond to trivial or none, small, moderate or large effects and using them to rate imprecision. It facilitates the use of evidence to decision frameworks and also provides guidance for how to address imprecision about implausible large effects and trivial or no effects using the concept of the 'review information size' and for varying baseline risks. The approach is illustrated using prac-tical examples, an online calculator and graphical displays and can be applied to dichotomous and continuous outcomes. Conclusion: In this GRADE guidance article, we provide updated guidance for how to rate imprecision using the partially and fully contextualized GRADE approaches for making recommendations or decisions, considering alternate baseline risks and for both dichoto-mous and continuous outcomes. (c) 2022 Elsevier Inc. All rights reserved.
Filiaciones:
Schunemann, HJ:
Michael G DeGroote Cochrane Canada, World Hlth Org Collaborating Ctr Infect Dis Res M, Hamilton, ON, Canada
McMaster GRADE Ctr, Hamilton, ON, Canada
McMaster Univ, Hamilton, ON, Canada
McMaster Univ, Dept Hlth Res Methods Evidence & Impact, 1280 Main St West, Hamilton, ON L8S 4L8, Canada
McMaster Univ, Dept Med, 1280 Main St West, Hamilton, ON L8S 4L8, Canada
Humanitas Univ, Dept Biomed Sci, I-20072 Milan, Italy
Neumann, I:
McMaster Univ, Dept Hlth Res Methods Evidence & Impact, 1280 Main St West, Hamilton, ON L8S 4L8, Canada
Univ San Sebastian, Fac Med & Ciencia, Escuela Med, Santiago, Chile
Hultcrantz, M:
Swedish Agcy Hlth Technol Assessment & Assessment, S T Eriksgatan 117, S-10233 Stockholm, Sweden
Brignardello-Petersen, R:
McMaster Univ, Dept Hlth Res Methods Evidence & Impact, 1280 Main St West, Hamilton, ON L8S 4L8, Canada
Zeng, L:
McMaster Univ, Dept Hlth Res Methods Evidence & Impact, 1280 Main St West, Hamilton, ON L8S 4L8, Canada
Sichuan Univ, West China Univ Hosp 2, Evidence Based Pharm Ctr, Pharm Dept, 20,Sect 3,South Renmin Rd, Chengdu 610041, Peoples R China
Minist Educ, Key Lab Birth Defects & Related Dis Women & Child, 20,Sect 3,South Renmin Rd, Chengdu 610041, Peoples R China
Murad, MH:
Mayo Clin, Evidence Based Practice Ctr, 200 1st St SW, Rochester, MN 55905 USA
Izcovich, A:
German Hosp, Dept Internal Med, Buenos Aires, DF, Argentina
Morgano, GP:
McMaster Univ, Dept Hlth Res Methods Evidence & Impact, 1280 Main St West, Hamilton, ON L8S 4L8, Canada
Baldeh, T:
McMaster Univ, Dept Hlth Res Methods Evidence & Impact, 1280 Main St West, Hamilton, ON L8S 4L8, Canada
Santesso, N:
Michael G DeGroote Cochrane Canada, World Hlth Org Collaborating Ctr Infect Dis Res M, Hamilton, ON, Canada
McMaster GRADE Ctr, Hamilton, ON, Canada
McMaster Univ, Hamilton, ON, Canada
McMaster Univ, Dept Hlth Res Methods Evidence & Impact, 1280 Main St West, Hamilton, ON L8S 4L8, Canada
Cuello, CG:
Michael G DeGroote Cochrane Canada, World Hlth Org Collaborating Ctr Infect Dis Res M, Hamilton, ON, Canada
McMaster GRADE Ctr, Hamilton, ON, Canada
McMaster Univ, Hamilton, ON, Canada
McMaster Univ, Dept Hlth Res Methods Evidence & Impact, 1280 Main St West, Hamilton, ON L8S 4L8, Canada
Mbuagbaw, L:
Michael G DeGroote Cochrane Canada, World Hlth Org Collaborating Ctr Infect Dis Res M, Hamilton, ON, Canada
McMaster GRADE Ctr, Hamilton, ON, Canada
McMaster Univ, Hamilton, ON, Canada
McMaster Univ, Dept Hlth Res Methods Evidence & Impact, 1280 Main St West, Hamilton, ON L8S 4L8, Canada
Guyatt, G:
McMaster Univ, Dept Hlth Res Methods Evidence & Impact, 1280 Main St West, Hamilton, ON L8S 4L8, Canada
McMaster Univ, Dept Med, 1280 Main St West, Hamilton, ON L8S 4L8, Canada
Wiercioch, W:
Michael G DeGroote Cochrane Canada, World Hlth Org Collaborating Ctr Infect Dis Res M, Hamilton, ON, Canada
McMaster GRADE Ctr, Hamilton, ON, Canada
McMaster Univ, Hamilton, ON, Canada
McMaster Univ, Dept Hlth Res Methods Evidence & Impact, 1280 Main St West, Hamilton, ON L8S 4L8, Canada
Piggott, T:
Michael G DeGroote Cochrane Canada, World Hlth Org Collaborating Ctr Infect Dis Res M, Hamilton, ON, Canada
McMaster GRADE Ctr, Hamilton, ON, Canada
McMaster Univ, Hamilton, ON, Canada
McMaster Univ, Dept Hlth Res Methods Evidence & Impact, 1280 Main St West, Hamilton, ON L8S 4L8, Canada
De Beer, H:
Guide2Guidance, Utrecht, Netherlands
Vinceti, M:
Univ Modena & Reggio Emilia, Dept Biomed Metab & Neural Sci, Sect Publ Hlth, CREAGEN Environm Genet & Nutr Epidemiol Res Ctr, Modena, Italy
Mathioudakis, AG:
Univ Manchester, Sch Biol Sci, Div Immunol Immun Infect & Resp Med, Manchester, Lancs, England
Manchester Univ NHS Fdn Trust, Manchester Acad Hlth Sci Ctr, Wythenshawe Hosp, North West Lung Ctr, Manchester, Lancs, England
Mayer, MG:
EBSCO, EBSCO Clin Decis, 10 Estes St, Ipswich, MA 01938 USA
Cone Hlth, Triad Hospitalists, 1200 North Elm St, Greensboro, NC 27401 USA
Cone Hlth, Open Door Clin, 319 N Graham Hopedale Rd, Burlington, NC 27217 USA
Mustafa, R:
Univ Kansas, Med Ctr, Dept Internal Med, Div Nephrol & Hypertens, 3901 Rainbow Blvd,MS3002, Kansas City, KS 61160 USA
Filippini, T:
Univ Modena & Reggio Emilia, Dept Biomed Metab & Neural Sci, Sect Publ Hlth, CREAGEN Environm Genet & Nutr Epidemiol Res Ctr, Modena, Italy
Iorio, A:
McMaster Univ, Dept Hlth Res Methods Evidence & Impact, 1280 Main St West, Hamilton, ON L8S 4L8, Canada
McMaster Univ, Dept Med, 1280 Main St West, Hamilton, ON L8S 4L8, Canada
Nieuwlaat, R:
Michael G DeGroote Cochrane Canada, World Hlth Org Collaborating Ctr Infect Dis Res M, Hamilton, ON, Canada
McMaster GRADE Ctr, Hamilton, ON, Canada
McMaster Univ, Hamilton, ON, Canada
McMaster Univ, Dept Hlth Res Methods Evidence & Impact, 1280 Main St West, Hamilton, ON L8S 4L8, Canada
Marcucci, M:
McMaster Univ, Dept Hlth Res Methods Evidence & Impact, 1280 Main St West, Hamilton, ON L8S 4L8, Canada
McMaster Univ, Dept Med, 1280 Main St West, Hamilton, ON L8S 4L8, Canada
Coello, PA:
Inst Invest Biomed IIB St Pau, Ctr GRADE Barcelona, Barcelona, Spain
Bonovas, S:
Humanitas Univ, Dept Biomed Sci, I-20072 Milan, Italy
IRCCS Humanitas Res Hosp, I-20089 Milan, Italy
Piovani, D:
Humanitas Univ, Dept Biomed Sci, I-20072 Milan, Italy
IRCCS Humanitas Res Hosp, I-20089 Milan, Italy
Tomlinson, G:
Univ Toronto, Inst Hlth Policy Management & Evaluat, Toronto, ON, Canada
Univ Hlth Network, Biostat Res Unit, Toronto, ON, Canada
Akl, EA:
McMaster Univ, Dept Hlth Res Methods Evidence & Impact, 1280 Main St West, Hamilton, ON L8S 4L8, Canada
Amer Univ Beirut, Dept Internal Med, POB 11-0236, Beirut, Lebanon
Green Published, Bronze
|