GRADE guidelines: 21 part 1. Study design, risk of bias, and indirectness in rating the certainty across a body of evidence for test accuracy.

Biomedical Research / standards Data Accuracy GRADE Approach / standards Guidelines as Topic Humans Publication Bias / statistics & numerical data Research Design / standards
Certainty of evidence Diagnosis Diagnostic accuracy GRADE Test accuracy Tests

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:
06 2020
Historique:
received: 27 07 2019
revised: 28 11 2019
accepted: 30 12 2019
pubmed: 16 2 2020
medline: 2 2 2021
entrez: 16 2 2020
Statut: ppublish

Résumé

This article provides updated GRADE guidance about how authors of systematic reviews and health technology assessments and guideline developers can assess the results and the certainty of evidence (also known as quality of the evidence or confidence in the estimates) of a body of evidence addressing test accuracy (TA). We present an overview of the GRADE approach and guidance for rating certainty in TA in clinical and public health and review the presentation of results of a body of evidence regarding tests. Part 1 of the two parts in this 21st guidance article about how to apply GRADE focuses on understanding study design issues in test accuracy, provide an overview of the domains, and describe risk of bias and indirectness specifically. Supplemented by practical examples, we describe how raters of the evidence using GRADE can evaluate study designs focusing on tests and how they apply the GRADE domains risk of bias and indirectness to a body of evidence of TA studies. Rating the certainty of a body of evidence using GRADE in Cochrane and other reviews and World Health Organization and other guidelines dealing with in TA studies helped refining our approach. The resulting guidance will help applying GRADE successfully for questions and recommendations focusing on tests.

Identifiants

DOI: 10.1016/j.jclinepi.2019.12.020 PMID: 32060007
pubmed: 32060007
pii: S0895-4356(19)30673-0
doi: 10.1016/j.jclinepi.2019.12.020
pii:
doi:

Types de publication

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

Langues

eng

Sous-ensembles de citation

IM

Pagination

129-141

Informations de copyright

Copyright © 2020 Elsevier Inc. All rights reserved.

Auteurs

Holger J Schünemann (HJ)

Department of Health Research Methods, Evidence, and Impact, McMaster GRADE Centre, McMaster University, 1280 Main Street West, Hamilton, Ontario L8S4K1, Canada; Department of Medicine, McMaster University, 1280 Main Street West, Hamilton, Ontario L8S4K1, Canada. Electronic address: schuneh@mcmaster.ca.

Reem A Mustafa (RA)

Department of Health Research Methods, Evidence, and Impact, McMaster GRADE Centre, McMaster University, 1280 Main Street West, Hamilton, Ontario L8S4K1, Canada; Department of Medicine, University of Kansas Medical Center, Kansas City, KS, USA.

Jan Brozek (J)

Department of Health Research Methods, Evidence, and Impact, McMaster GRADE Centre, McMaster University, 1280 Main Street West, Hamilton, Ontario L8S4K1, Canada; Department of Medicine, McMaster University, 1280 Main Street West, Hamilton, Ontario L8S4K1, Canada.

Karen R Steingart (KR)

Department of Clinical Sciences, Liverpool School of Tropical Medicine, Pembroke Place, Liverpool L3 5QA, UK.

Mariska Leeflang (M)

Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam University Medical Centers, Room J1b-214, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands.

Mohammad Hassan Murad (MH)

Division of Preventive Medicine, Mayo Clinic, 200 1st Street SW, Rochester, MN 55902, USA.

Patrick Bossuyt (P)

Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam University Medical Centers, Room J1b-214, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands.

Paul Glasziou (P)

CREBP, Faculty Health Science & Medicine, Bond University, Gold Coast QLD 4229, Australia.

Roman Jaeschke (R)

Department of Health Research Methods, Evidence, and Impact, McMaster GRADE Centre, McMaster University, 1280 Main Street West, Hamilton, Ontario L8S4K1, Canada; Department of Medicine, McMaster University, 1280 Main Street West, Hamilton, Ontario L8S4K1, Canada.

Stefan Lange (S)

Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, Institute for Quality and Efficiency in Health Care (IQWiG), Im Mediapark 8, 50670 Köln, Germany Cologne, Germany.

Joerg Meerpohl (J)

Institute for Evidence in Medicine, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany; Cochrane Germany, Cochrane Germany Foundation, Freiburg, Germany.

Miranda Langendam (M)

Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam University Medical Centers, Room J1b-214, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands.

Monica Hultcrantz (M)

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

Gunn E Vist (GE)

Norwegian Knowledge Centre for the Health Services, PO Box 7004, St Olavs Plass, 0130 Oslo, Norway.

Elie A Akl (EA)

Department of Internal Medicine, American University of Beirut, Riad-El-Solh Beirut, Beirut 1107 2020, Lebanon.

Mark Helfand (M)

Oregon Evidence-based Practice Center, Oregon Health & Science University, Portland VA Medical Center, Portland, OR, USA.

Nancy Santesso (N)

Department of Health Research Methods, Evidence, and Impact, McMaster GRADE Centre, McMaster University, 1280 Main Street West, Hamilton, Ontario L8S4K1, Canada; Department of Medicine, McMaster University, 1280 Main Street West, Hamilton, Ontario L8S4K1, Canada.

Lotty Hooft (L)

Cochrane Netherlands/Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, P.O. Box 85500, 3508 GA Utrecht, The Netherlands.

Rob Scholten (R)

Cochrane Netherlands/Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, P.O. Box 85500, 3508 GA Utrecht, The Netherlands.

Måns Rosen (M)

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

Anne Rutjes (A)

Clinical Trial Unit (CTU) Bern, Institute of Primary Health Care, University of Bern, Bern, Switzerland.

Mark Crowther (M)

Department of Health Research Methods, Evidence, and Impact, McMaster GRADE Centre, McMaster University, 1280 Main Street West, Hamilton, Ontario L8S4K1, Canada; Department of Medicine, McMaster University, 1280 Main Street West, Hamilton, Ontario L8S4K1, Canada.

Paola Muti (P)

Department of Oncology, McMaster University, 711 Concession Street, Hamilton, Ontario L8V1C3, Canada.

Heike Raatz (H)

University of Basel, Klingelbergstrasse 61, CH-4056 Basel, Switzerland; Kleijnen Systematic Reviews Ltd, 6 Escrick Business Park, Escrick, York YO19 6FD, UK.

Mohammed T Ansari (MT)

School of Epidemiology and Public Health, Faculty of Medicine, Ottawa, Canada.

John Williams (J)

Duke University Medical Center and Durham Veterans Affairs Center for Health Services Research in Primary Care Durham, NC 27705, USA.

Regina Kunz (R)

Basel Institute of Clinical Epidemiology, University Hospital Basel, Hebelstrasse 10, Basel 4031, Switzerland.

Jeff Harris (J)

Harris Associates, 386 Richardson Way, Mill Valley, CA 94941, USA.

Ingrid Arévalo Rodriguez (IA)

Clinical Biostatistics Unit, Hospital Universitario Ramón y Cajal, IRYCIS, CIBER of Epidemiology and Public Health, Madrid, Spain; Centro de investigación en Salud Pública y Epidemiología Clínica, Facultad de Ciencias de la Salud Eugenio Espejo, Universidad UTE, Quito, Ecuador.

Mikashmi Kohli (M)

Department of Epidemiology, Biostatistics and Occupational Health, McGill University, 1650 Cedar Avenue, Montreal, Quebec H3G 1A4, Canada.

Gordon H Guyatt (GH)

Department of Health Research Methods, Evidence, and Impact, McMaster GRADE Centre, McMaster University, 1280 Main Street West, Hamilton, Ontario L8S4K1, Canada; Department of Medicine, McMaster University, 1280 Main Street West, Hamilton, Ontario L8S4K1, Canada; Department of Medicine, University of Kansas Medical Center, Kansas City, KS, USA.

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