GRADE guidelines: 21 part 2. Test accuracy: inconsistency, imprecision, publication bias, and other domains for rating the certainty of evidence and presenting it in evidence profiles and summary of findings tables

Holger J Schünemann¹, Reem A Mustafa², Jan Brozek³, Karen R Steingart⁴, Mariska Leeflang⁵, Mohammad Hassan Murad⁶, Patrick Bossuyt⁵, Paul Glasziou⁷, Roman Jaeschke³, Stefan Lange⁸, Joerg Meerpohl⁹, Miranda Langendam⁵, Monica Hultcrantz¹⁰, Gunn E Vist¹¹, Elie A Akl¹², Mark Helfand¹³, Nancy Santesso³, Lotty Hooft¹⁴, Rob Scholten¹⁴, Måns Rosen¹⁰, Anne Rutjes¹⁵, Mark Crowther³, Paola Muti¹⁶, Heike Raatz¹⁷, Mohammed T Ansari¹⁸, John Williams¹⁹, Regina Kunz²⁰, Jeff Harris²¹, Ingrid Arévalo Rodriguez²², Mikashmi Kohli²³, Gordon H Guyatt²⁴; GRADE Working Group

Affiliations

¹ 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.
² 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.
³ 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.
⁴ Department of Clinical Sciences, Liverpool School of Tropical Medicine, Pembroke Place, Liverpool L3 5QA, UK.
⁵ Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam University Medical Centers, Room J1b-214, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands.
⁶ Division of Preventive Medicine, Mayo Clinic, 200 1st ST. SW, Rochester, MN 55902, USA.
⁷ CREBP, Faculty Health Science & Medicine, Bond University, Gold Coast, Queensland 4229, Australia.
⁸ Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen/Institute for Quality and Efficiency in Health Care (IQWiG), Im Mediapark 8, 50670 Köln, Germany.
⁹ 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.
¹⁰ Swedish Agency for Health Technology Assessment and Assessment of Social Services (SBU), S:t Eriksgatan 117, SE-102 33 Stockholm, Sweden.
¹¹ Norwegian Knowledge Centre for the Health Services, PO Box 7004, St Olavs Plass, 0130 Oslo, Norway.
¹² Department of Internal Medicine, American University of Beirut, Riad-El-Solh Beirut, Beirut 1107 2020, Lebanon.
¹³ Oregon Evidence-Based Practice Center, Oregon Health & Science University, Portland VA Medical Center, Portland, OR, USA.
¹⁴ Cochrane Netherlands/Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, P.O. Box 85500, 3508 GA Utrecht, The Netherlands.
¹⁵ Clinical Trial Unit (CTU) Bern, Institute of Primary Health Care, Institute of Social and Preventive Medicine, University of Bern, Switzerland.
¹⁶ Department of Biomedical Science and Oral Health, University of Milan, Via Commenda 10, Milan, Italy.
¹⁷ University of Basel, Klingelbergstrasse 61, CH-4056 Basel, Switzerland; Kleijnen Systematic Reviews Ltd., 6 Escrick Business Park, Escrick, York YO19 6FD, UK.
¹⁸ Faculty of Medicine, School of Epidemiology and Public Health, Ottawa, Canada.
¹⁹ Duke University Medical Center and Durham Veterans Affairs Center for Health Services Research in Primary Care Durham, NC 27705, USA.
²⁰ Basel Institute of Clinical Epidemiology, University Hospital Basel, Hebelstrasse 10, Basel 4031, Switzerland.
²¹ Harris Associates, 386 Richardson Way, Mill Valley, CA 94941, USA.
²² Clinical Biostatistics Unit, Ramón y Cajal Hospital (IRYCIS), Madrid, Spain; Centro de investigación en Salud Pública y Epidemiología Clínica, Facultad de Ciencias de la Salud Eugenio Espejo, Universidad UTE, Quito, Ecuador.
²³ Department of Epidemiology, Biostatistics and Occupational Health, McGill University, 1650 Cedar Ave, Montreal, Quebec H3G 1A4, Canada.
²⁴ 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.

PMID: 32058069
DOI: 10.1016/j.jclinepi.2019.12.021

Free article

GRADE guidelines: 21 part 2. Test accuracy: inconsistency, imprecision, publication bias, and other domains for rating the certainty of evidence and presenting it in evidence profiles and summary of findings tables

Holger J Schünemann et al. J Clin Epidemiol. 2020 Jun.

Free article

. 2020 Jun:122:142-152.

doi: 10.1016/j.jclinepi.2019.12.021. Epub 2020 Feb 10.

Authors

Affiliations

¹ 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.
² 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.
³ 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.
⁴ Department of Clinical Sciences, Liverpool School of Tropical Medicine, Pembroke Place, Liverpool L3 5QA, UK.
⁵ Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam University Medical Centers, Room J1b-214, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands.
⁶ Division of Preventive Medicine, Mayo Clinic, 200 1st ST. SW, Rochester, MN 55902, USA.
⁷ CREBP, Faculty Health Science & Medicine, Bond University, Gold Coast, Queensland 4229, Australia.
⁸ Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen/Institute for Quality and Efficiency in Health Care (IQWiG), Im Mediapark 8, 50670 Köln, Germany.
⁹ 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.
¹⁰ Swedish Agency for Health Technology Assessment and Assessment of Social Services (SBU), S:t Eriksgatan 117, SE-102 33 Stockholm, Sweden.
¹¹ Norwegian Knowledge Centre for the Health Services, PO Box 7004, St Olavs Plass, 0130 Oslo, Norway.
¹² Department of Internal Medicine, American University of Beirut, Riad-El-Solh Beirut, Beirut 1107 2020, Lebanon.
¹³ Oregon Evidence-Based Practice Center, Oregon Health & Science University, Portland VA Medical Center, Portland, OR, USA.
¹⁴ Cochrane Netherlands/Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, P.O. Box 85500, 3508 GA Utrecht, The Netherlands.
¹⁵ Clinical Trial Unit (CTU) Bern, Institute of Primary Health Care, Institute of Social and Preventive Medicine, University of Bern, Switzerland.
¹⁶ Department of Biomedical Science and Oral Health, University of Milan, Via Commenda 10, Milan, Italy.
¹⁷ University of Basel, Klingelbergstrasse 61, CH-4056 Basel, Switzerland; Kleijnen Systematic Reviews Ltd., 6 Escrick Business Park, Escrick, York YO19 6FD, UK.
¹⁸ Faculty of Medicine, School of Epidemiology and Public Health, Ottawa, Canada.
¹⁹ Duke University Medical Center and Durham Veterans Affairs Center for Health Services Research in Primary Care Durham, NC 27705, USA.
²⁰ Basel Institute of Clinical Epidemiology, University Hospital Basel, Hebelstrasse 10, Basel 4031, Switzerland.
²¹ Harris Associates, 386 Richardson Way, Mill Valley, CA 94941, USA.
²² Clinical Biostatistics Unit, Ramón y Cajal Hospital (IRYCIS), Madrid, Spain; Centro de investigación en Salud Pública y Epidemiología Clínica, Facultad de Ciencias de la Salud Eugenio Espejo, Universidad UTE, Quito, Ecuador.
²³ Department of Epidemiology, Biostatistics and Occupational Health, McGill University, 1650 Cedar Ave, Montreal, Quebec H3G 1A4, Canada.
²⁴ 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.

PMID: 32058069
DOI: 10.1016/j.jclinepi.2019.12.021

Abstract

Objectives: This article provides updated GRADE guidance about how authors of systematic reviews and health technology assessments and guideline developers can rate 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) on the domains imprecision, inconsistency, publication bias, and other domains. It also provides guidance for how to present synthesized information in evidence profiles and summary of findings tables.

Study design and setting: We present guidance for rating certainty in TA in clinical and public health and review the presentation of results of a body of evidence regarding tests.

Results: Supplemented by practical examples, we describe how raters of the evidence can apply the GRADE domains inconsistency, imprecision, and publication bias to a body of evidence of TA studies.

Conclusion: Using GRADE in Cochrane and other reviews as well as World Health Organization and other guidelines helped refining the GRADE approach for rating the certainty of a body of evidence from TA studies. Although several of the GRADE domains (e.g., imprecision and magnitude of the association) require further methodological research to help operationalize them, judgments need to be made on the basis of what is known so far.

Keywords: Certainty of evidence; Diagnosis; Diagnostic accuracy; GRADE; Guidelines; HTA; Systematic reviews; Test accuracy; Tests.

PubMed Disclaimer

Publication types

Actions

MeSH terms

Actions
Actions
Actions
Actions
Actions
Actions
Actions

LinkOut - more resources

Full Text Sources

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

GRADE guidelines: 21 part 2. Test accuracy: inconsistency, imprecision, publication bias, and other domains for rating the certainty of evidence and presenting it in evidence profiles and summary of findings tables

Affiliations

GRADE guidelines: 21 part 2. Test accuracy: inconsistency, imprecision, publication bias, and other domains for rating the certainty of evidence and presenting it in evidence profiles and summary of findings tables

Authors

Affiliations

Abstract

Publication types

MeSH terms

LinkOut - more resources

Full Text Sources