title: Applying Grading of Recommendations Assessment, Development and Evaluation (GRADE) to diagnostic tests was challenging but doable.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: 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.
authors.forename: Gowri
authors.initials: G
authors.lastname: Gopalakrishna
authors.affiliation: 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.
authors.forename: Reem A
authors.initials: RA
authors.lastname: Mustafa
authors.affiliation: Department of Public Health, Epidemiology and Biostatistics, University of Birmingham, Edgbaston, Birmingham B15 2TT UK.
authors.forename: Clare
authors.initials: C
authors.lastname: Davenport
authors.affiliation: Dutch Cochrane Center, University Medical Center, Postbus 85500 3508 GA Utrecht, The Netherlands.
authors.forename: Rob J P M
authors.initials: RJ
authors.lastname: Scholten
authors.affiliation: Institute of Health Research, University of Exeter Medical School, The Veysey Building Salmon Pool Lane, Exeter EX2 4SG UK.
authors.forename: Christopher
authors.initials: C
authors.lastname: Hyde
authors.affiliation: Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario L8N 3Z5, Canada; Department of Medicine, McMaster University, Hamilton, Ontario L8N 3Z5, Canada.
authors.forename: Jan
authors.initials: J
authors.lastname: Brozek
authors.affiliation: Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario L8N 3Z5, Canada; Department of Medicine, McMaster University, Hamilton, Ontario L8N 3Z5, Canada.
authors.forename: Holger J
authors.initials: HJ
authors.lastname: Schünemann
authors.affiliation: Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Academic Medical Center, University of Amsterdam, PO Box 22700, 1100 DE Amsterdam, The Netherlands.
authors.forename: Patrick M M
authors.initials: PM
authors.lastname: Bossuyt
authors.affiliation: Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Academic Medical Center, University of Amsterdam, PO Box 22700, 1100 DE Amsterdam, The Netherlands.
authors.forename: Mariska M G
authors.initials: MM
authors.lastname: Leeflang
authors.affiliation: Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Academic Medical Center, University of Amsterdam, PO Box 22700, 1100 DE Amsterdam, The Netherlands.
authors.forename: Miranda W
authors.initials: MW
authors.lastname: Langendam
mesh_terms: D003955:Diagnostic Tests, Routine / Q000592:standards*; D019317:Evidence-Based Medicine / Q000592:standards; D006801:Humans; D017594:Publication Bias; D012196:Review Literature as Topic
keywords: Cochrane diagnostic test accuracy systematic reviews; Diagnostic test accuracy; Diagnostics; GRADE; Medical tests; Systematic reviews