Chapter 7: Grading a Body of Evidence on Diagnostic Tests
- Sonal SinghAffiliated withDepartment of Medicine, Johns Hopkins University School of MedicineDepartment of Epidemiology, Johns Hopkins University, Bloomberg School of Public Health Email author
- , Stephanie M. ChangAffiliated withCenter for Outcomes and Evidence, Agency for Healthcare Research and Quality
- , David B. MatcharAffiliated withDuke-NUS Medical SchoolDuke Center for Clinical Health Policy Research
- , Eric B. BassAffiliated withDepartment of Medicine, Johns Hopkins University School of MedicineDepartment of Epidemiology, Johns Hopkins University, Bloomberg School of Public Health
Grading the strength of a body of diagnostic test evidence involves challenges over and above those related to grading the evidence from health care intervention studies. This chapter identifies challenges and outlines principles for grading the body of evidence related to diagnostic test performance.
Diagnostic test evidence is challenging to grade because standard tools for grading evidence were designed for questions about treatment rather than diagnostic testing; and the clinical usefulness of a diagnostic test depends on multiple links in a chain of evidence connecting the performance of a test to changes in clinical outcomes.
Reviewers grading the strength of a body of evidence on diagnostic tests should consider the principle domains of risk of bias, directness, consistency, and precision, as well as publication bias, dose response association, plausible unmeasured confounders that would decrease an effect, and strength of association, similar to what is done to grade evidence on treatment interventions. Given that most evidence regarding the clinical value of diagnostic tests is indirect, an analytic framework must be developed to clarify the key questions, and strength of evidence for each link in that framework should be graded separately. However if reviewers choose to combine domains into a single grade of evidence, they should explain their rationale for a particular summary grade and the relevant domains that were weighed in assigning the summary grade.
KEY WORDSgrades diagnostic tests publication bias health care intervention
- Chapter 7: Grading a Body of Evidence on Diagnostic Tests
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Journal of General Internal Medicine
Volume 27, Issue 1 Supplement, pp 47-55
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- diagnostic tests
- publication bias
- health care intervention
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- Author Affiliations
- 1. Department of Medicine, Johns Hopkins University School of Medicine, 624 N Broadway, Rm 680 B, Baltimore, MD, 21205, USA
- 2. Department of Epidemiology, Johns Hopkins University, Bloomberg School of Public Health, Baltimore, MD, USA
- 3. Center for Outcomes and Evidence, Agency for Healthcare Research and Quality, Rockville, MD, USA
- 4. Duke-NUS Medical School, Singapore, Singapore
- 5. Duke Center for Clinical Health Policy Research, Durham, NC, USA