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
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References
- GRADE guidelines: 21 part 1. Study design, risk of bias and indirectness in rating the certainty across a body of evidence for test accuracy.J Clin Epidemiol. 2020; ([Epub ahead of print])https://doi.org/10.1016/j.jclinepi.2019.12.020
- World Health Organization Guidelines for treatment of cervical intraepithelial neoplasia 2-3 and screen-and-treat strategies to prevent cervical cancer.Int J Gynaecol Obstet. 2016; 132: 252-258
- World allergy organization (WAO) diagnosis and rationale for action against cow's milk allergy (DRACMA) guidelines.Pediatr Allergy Immunol. 2010; 21: 1-125
- GRADE Guidelines: 16. GRADE evidence to decision frameworks for tests in clinical practice and public health.J Clin Epidemiol. 2016; 76: 89-98
- GRADE guidelines: 22. The GRADE approach for tests and strategies-from test accuracy to patient-important outcomes and recommendations.J Clin Epidemiol. 2019; 111: 69-82
- Grading quality of evidence and strength of recommendations for diagnostic tests and strategies.BMJ. 2008; 336: 1106-1110
- Grading quality of evidence and strength of recommendations in clinical practice guidelines: Part 2 of 3. The GRADE approach to grading quality of evidence about diagnostic tests and strategies.Allergy. 2009; 64: 1109-1116
- Xpert((R)) MTB/RIF assay for extrapulmonary tuberculosis and rifampicin resistance.Cochrane Database Syst Rev. 2018; : CD012768
- Commercial serological tests for the diagnosis of active pulmonary and extrapulmonary tuberculosis: an updated systematic review and meta-analysis.PLoS Med. 2011; 8: e1001062
- Interferon-gamma release assays for active pulmonary tuberculosis diagnosis in adults in low- and middle-income countries: systematic review and meta-analysis.J Infect Dis. 2011; 204: S1120-S1129
- Diagnostic accuracy of pleural fluid NT-pro-BNP for pleural effusions of cardiac origin: a systematic review and meta-analysis.BMC Pulm Med. 2010; 10: 58
- Interpreting GRADE's levels of certainty or quality of the evidence: GRADE for statisticians, considering review information size or less emphasis on imprecision?.J Clin Epidemiol. 2016; 75: 6-15
- The performance of tests of publication bias and other sample size effects in systematic reviews of diagnostic test accuracy was assessed.J Clin Epidemiol. 2005; 58: 882-893
- Trim and fill: a simple funnel-plot-based method of testing and adjusting for publication bias in meta-analysis.Biometrics. 2000; 56: 455-463
- Testing for publication bias in diagnostic meta-analysis: a simulation study.Stat Med. 2014; 33: 3061-3077
- A non-inferiority test for diagnostic accuracy based on the paired partial areas under ROC curves.Stat Med. 2008; 27: 1762-1776
- Accuracy of magnetic resonance imaging in diagnosis of liver iron overload: a systematic review and meta-analysis.Clin Gastroenterol Hepatol. 2015; 13: 55-63 e5
- The diagnostic accuracy of fractional exhaled nitric oxide testing in asthma: a systematic review and meta-analyses.Mayo Clin Proc. 2018; 93: 191-198
- Can troponin I measurement predict short-term serious cardiac outcomes in patients presenting to the emergency department with possible acute coronary syndrome?.CJEM. 2004; 6: 22-30
- GRADE guidelines: 9. Rating up the quality of evidence.J Clin Epidemiol. 2011; 64: 1311-1316
- GRADE guidelines: 1. Introduction-GRADE evidence profiles and summary of findings tables.J Clin Epidemiol. 2011; 64: 383-394
- Decision-making about healthcare related tests and diagnostic strategies: user testing of GRADE evidence tables.PLoS One. 2015; 10: e0134553
- Defining ranges for certainty ratings of diagnostic accuracy: a GRADE concept paper.J Clin Epidemiol. 2020; 117: 138-148
- Application of GRADE: making evidence-based recommendations about diagnostic tests in clinical practice guidelines.Implement Sci. 2011; 6: 62
Article info
Publication history
Published online: February 10, 2020
Accepted:
December 30,
2019
Footnotes
Conflict of interest: The authors are members of the GRADE Working Group. ML is Co-convenor of Cochrane's Screening and Diagnostic Test Methods Group. As part of H.R.'s employment with Kleijnen Systematic Reviews Ltd. he has been working on projects for Bayer and Grunenthal.
Identification
Copyright
© 2020 Elsevier Inc. All rights reserved.
