Applying Grading of Recommendations Assessment, Development and Evaluation (GRADE) to diagnostic tests was challenging but doable

Gowri Gopalakrishna; Reem A Mustafa; Clare Davenport; Rob J P M Scholten; Christopher Hyde; Jan Brozek; Holger J Schünemann; Patrick M M Bossuyt; Mariska M G Leeflang; Miranda W Langendam

doi:10.1016/j.jclinepi.2014.01.006

Applying Grading of Recommendations Assessment, Development and Evaluation (GRADE) to diagnostic tests was challenging but doable

J Clin Epidemiol. 2014 Jul;67(7):760-8. doi: 10.1016/j.jclinepi.2014.01.006. Epub 2014 Apr 13.

Affiliations

¹ Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Academic Medical Center, University of Amsterdam, PO Box 22700, 1100 DE Amsterdam, The Netherlands. Electronic address: g.gopalakrishna@amc.uva.nl.
² Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario L8N 3Z5, Canada; Department of Medicine, McMaster University, Hamilton, Ontario L8N 3Z5, Canada; School of Medicine, University of Missouri-Kansas City 5100 Rockhill Road, Kansas City, MO 64110, USA.
³ Department of Public Health, Epidemiology and Biostatistics, University of Birmingham, Edgbaston, Birmingham B15 2TT UK.
⁴ Dutch Cochrane Center, University Medical Center, Postbus 85500 3508 GA Utrecht, The Netherlands.
⁵ Institute of Health Research, University of Exeter Medical School, The Veysey Building Salmon Pool Lane, Exeter EX2 4SG UK.
⁶ Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario L8N 3Z5, Canada; Department of Medicine, McMaster University, Hamilton, Ontario L8N 3Z5, Canada.
⁷ Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Academic Medical Center, University of Amsterdam, PO Box 22700, 1100 DE Amsterdam, The Netherlands.

PMID: 24725643
DOI: 10.1016/j.jclinepi.2014.01.006

Abstract

Objectives: The Grading of Recommendations Assessment, Development and Evaluation (GRADE) Working Group developed an approach to assess the quality of evidence of diagnostic tests. Its use in Cochrane diagnostic test accuracy reviews is new. We applied this approach to three Cochrane reviews with the aim of better understanding the application of the GRADE criteria to such reviews.

Study design and setting: We selected reviews to achieve clinical and methodological diversities. At least three assessors independently assessed each review according to the GRADE criteria of risk of bias, indirectness, imprecision, inconsistency, and publication bias. Two teleconferences were held to share experiences.

Results: For the interpretation of the GRADE criteria, it made a difference whether assessors looked at the evidence from a patient-important outcome perspective or from a test accuracy standpoint. GRADE criteria such as inconsistency, imprecision, and publication bias were challenging to apply as was the assessment of comparative test accuracy reviews.

Conclusion: The perspective from which evidence is graded can influence judgments about quality. Guidance on application of GRADE to comparative test reviews and on the GRADE criteria of inconsistency, imprecision, and publication bias will facilitate the operationalization of GRADE for diagnostics.

Keywords: Cochrane diagnostic test accuracy systematic reviews; Diagnostic test accuracy; Diagnostics; GRADE; Medical tests; Systematic reviews.

MeSH terms

Diagnostic Tests, Routine / standards*
Evidence-Based Medicine / standards
Humans
Publication Bias
Review Literature as Topic