GRADE guidance 35: update on rating imprecision for assessing contextualized certainty of evidence and making decisions.

GRADE Guidelines Health technology assessment Imprecision Statistical significance Systematic reviews

Journal

Journal of clinical epidemiology
ISSN: 1878-5921
Titre abrégé: J Clin Epidemiol
Pays: United States
ID NLM: 8801383

Informations de publication

Date de publication:
10 2022
Historique:
received: 11 03 2022
revised: 21 07 2022
accepted: 25 07 2022
pubmed: 8 8 2022
medline: 17 12 2022
entrez: 7 8 2022
Statut: ppublish

Résumé

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. Through iterative discussions and refinement in online meetings and through email communication, we developed draft guidance to rating the certainty of evidence down by up to three levels based on examples.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 summary 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. 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 practical examples, an online calculator and graphical displays and can be applied to dichotomous and continuous outcomes. 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 dichotomous and continuous outcomes.

Identifiants

pubmed: 35934266
pii: S0895-4356(22)00188-3
doi: 10.1016/j.jclinepi.2022.07.015
pii:
doi:

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

225-242

Subventions

Organisme : Department of Health
Pays : United Kingdom

Informations de copyright

Copyright © 2022 Elsevier Inc. All rights reserved.

Auteurs

Holger J Schünemann (HJ)

World Health Organization Collaborating Center for Infectious Diseases, Research Methods and Recommendations, Michael G. DeGroote Cochrane Canada & McMaster GRADE Centres; McMaster University, Hamilton, Ontario, Canada; Department of Health Research Methods, Evidence and Impact, McMaster University, 1280 Main Street West, Hamilton, L8S 4L8, Ontario, Canada; Department of Medicine, McMaster University, 1280 Main Street West, Hamilton, L8S 4L8, Ontario, Canada; Department of Biomedical Sciences, Humanitas University, 20072 Pieve Emanuele, Milan, Italy. Electronic address: schuneh@mcmaster.ca.

Ignacio Neumann (I)

Department of Health Research Methods, Evidence and Impact, McMaster University, 1280 Main Street West, Hamilton, L8S 4L8, Ontario, Canada; Escuela de Medicina, Facultad de Medicina y Ciencia, Universidad San Sebastián, Sede, Santiago, Santiago, Chile.

Monica Hultcrantz (M)

Swedish Agency for Health Technology Assessment and Assessment of Social services (SBU), S:t Eriksgatan 117, Stockholm, 102 33, Sweden.

Romina Brignardello-Petersen (R)

Department of Health Research Methods, Evidence and Impact, McMaster University, 1280 Main Street West, Hamilton, L8S 4L8, Ontario, Canada.

Linan Zeng (L)

Department of Health Research Methods, Evidence and Impact, McMaster University, 1280 Main Street West, Hamilton, L8S 4L8, Ontario, Canada; Pharmacy Department/ Evidence-based Pharmacy Centre, West China Second University Hospital, Sichuan University and Key Laboratory of Birth Defects and Related Disease of Women and Children, Ministry of Education, No. 20, Section 3, South Renmin Road, Chengdu, 610041, China.

M Hassan Murad (MH)

Evidence-based Practice Center, Mayo Clinic, 200 1st Street. SW, Rochester, MN 55905, USA.

Ariel Izcovich (A)

Department of Internal Medicine, German Hospital, Buenos Aires, Argentina.

Gian Paolo Morgano (GP)

Department of Health Research Methods, Evidence and Impact, McMaster University, 1280 Main Street West, Hamilton, L8S 4L8, Ontario, Canada.

Tejan Baldeh (T)

Department of Health Research Methods, Evidence and Impact, McMaster University, 1280 Main Street West, Hamilton, L8S 4L8, Ontario, Canada.

Nancy Santesso (N)

World Health Organization Collaborating Center for Infectious Diseases, Research Methods and Recommendations, Michael G. DeGroote Cochrane Canada & McMaster GRADE Centres; McMaster University, Hamilton, Ontario, Canada; Department of Health Research Methods, Evidence and Impact, McMaster University, 1280 Main Street West, Hamilton, L8S 4L8, Ontario, Canada.

Carlos Garcia Cuello (CG)

World Health Organization Collaborating Center for Infectious Diseases, Research Methods and Recommendations, Michael G. DeGroote Cochrane Canada & McMaster GRADE Centres; McMaster University, Hamilton, Ontario, Canada; Department of Health Research Methods, Evidence and Impact, McMaster University, 1280 Main Street West, Hamilton, L8S 4L8, Ontario, Canada.

Lawrence Mbuagbaw (L)

World Health Organization Collaborating Center for Infectious Diseases, Research Methods and Recommendations, Michael G. DeGroote Cochrane Canada & McMaster GRADE Centres; McMaster University, Hamilton, Ontario, Canada; Department of Health Research Methods, Evidence and Impact, McMaster University, 1280 Main Street West, Hamilton, L8S 4L8, Ontario, Canada.

Gordon Guyatt (G)

Department of Health Research Methods, Evidence and Impact, McMaster University, 1280 Main Street West, Hamilton, L8S 4L8, Ontario, Canada; Department of Medicine, McMaster University, 1280 Main Street West, Hamilton, L8S 4L8, Ontario, Canada.

Wojtek Wiercioch (W)

World Health Organization Collaborating Center for Infectious Diseases, Research Methods and Recommendations, Michael G. DeGroote Cochrane Canada & McMaster GRADE Centres; McMaster University, Hamilton, Ontario, Canada; Department of Health Research Methods, Evidence and Impact, McMaster University, 1280 Main Street West, Hamilton, L8S 4L8, Ontario, Canada.

Thomas Piggott (T)

World Health Organization Collaborating Center for Infectious Diseases, Research Methods and Recommendations, Michael G. DeGroote Cochrane Canada & McMaster GRADE Centres; McMaster University, Hamilton, Ontario, Canada; Department of Health Research Methods, Evidence and Impact, McMaster University, 1280 Main Street West, Hamilton, L8S 4L8, Ontario, Canada.

Hans De Beer (H)

Guide2Guidance, Utrecht, The Netherlands.

Marco Vinceti (M)

CREAGEN-Environmental, Genetic and Nutritional Epidemiology Research Center, Section of Public Health, Department of Biomedical, Metabolic and Neural Sciences, University of Modena and Reggio Emilia, Modena, Italy.

Alexander G Mathioudakis (AG)

Division of Immunology, Immunity to Infection and Respiratory Medicine, School of Biological Sciences, The University of Manchester, & North West Lung Centre, Wythenshawe Hospital, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.

Martin G Mayer (MG)

EBSCO Clinical Decisions, EBSCO, 10 Estes StIpswich, MA 01938, USA; Triad Hospitalists, Cone Health, 1200 North Elm St, Greensboro, NC 27401, USA; Open Door Clinic, Cone Health, 319 N Graham Hopedale Rd, Burlington, NC 27217, USA.

Reem Mustafa (R)

Division of Nephrology and Hypertension, Department of Internal Medicine, University of Kansas Medical Centre, 3901 Rainbow Blvd, MS3002, Kansas City, KS 61160, USA.

Tommaso Filippini (T)

CREAGEN-Environmental, Genetic and Nutritional Epidemiology Research Center, Section of Public Health, Department of Biomedical, Metabolic and Neural Sciences, University of Modena and Reggio Emilia, Modena, Italy.

Alfonso Iorio (A)

Department of Health Research Methods, Evidence and Impact, McMaster University, 1280 Main Street West, Hamilton, L8S 4L8, Ontario, Canada; Department of Medicine, McMaster University, 1280 Main Street West, Hamilton, L8S 4L8, Ontario, Canada.

Robby Nieuwlaat (R)

World Health Organization Collaborating Center for Infectious Diseases, Research Methods and Recommendations, Michael G. DeGroote Cochrane Canada & McMaster GRADE Centres; McMaster University, Hamilton, Ontario, Canada; Department of Health Research Methods, Evidence and Impact, McMaster University, 1280 Main Street West, Hamilton, L8S 4L8, Ontario, Canada.

Maura Marcucci (M)

Department of Health Research Methods, Evidence and Impact, McMaster University, 1280 Main Street West, Hamilton, L8S 4L8, Ontario, Canada; Department of Medicine, McMaster University, 1280 Main Street West, Hamilton, L8S 4L8, Ontario, Canada.

Pablo Alonso Coello (PA)

Centro GRADE Barcelona, Instituto de Investigacion Biomedica (IIB Sant Pau), Barcelona, Spain.

Stefanos Bonovas (S)

Department of Biomedical Sciences, Humanitas University, 20072 Pieve Emanuele, Milan, Italy; IRCCS Humanitas Research Hospital, 20089 Rozzano, Milan, Italy.

Daniele Piovani (D)

Department of Biomedical Sciences, Humanitas University, 20072 Pieve Emanuele, Milan, Italy; IRCCS Humanitas Research Hospital, 20089 Rozzano, Milan, Italy.

George Tomlinson (G)

Institute of Health Policy, Management, and Evaluation, University of Toronto, Toronto, Ontario, Canada; Biostatistics Research Unit, University Health Network, Toronto, Ontario, Canada.

Elie A Akl (EA)

Department of Health Research Methods, Evidence and Impact, McMaster University, 1280 Main Street West, Hamilton, L8S 4L8, Ontario, Canada; Department of Internal Medicine, American University of Beirut, P.O.Box 11-0236, Beirut, Lebanon.

Articles similaires

[Redispensing of expensive oral anticancer medicines: a practical application].

Lisanne N van Merendonk, Kübra Akgöl, Bastiaan Nuijen
1.00
Humans Antineoplastic Agents Administration, Oral Drug Costs Counterfeit Drugs

Smoking Cessation and Incident Cardiovascular Disease.

Jun Hwan Cho, Seung Yong Shin, Hoseob Kim et al.
1.00
Humans Male Smoking Cessation Cardiovascular Diseases Female
Humans United States Aged Cross-Sectional Studies Medicare Part C
1.00
Humans Yoga Low Back Pain Female Male

Classifications MeSH