Defining ranges for certainty ratings of diagnostic accuracy

Hultcrantz M1, Langendam MW2, Leeflang M2, Lavergne V3, Ansari MT4, Mustafa RA5, Schünemann H6
1Swedish Agency for Health Technology Assessment and Assessment of Social Services; Karolinska Institutet, 2University of Amsterdam, 3University of Montreal, 4University of Ottawa, 5University of Missouri-Kansas City, 6McMaster University


The Grading of Recommendations Assessment, Development and Evaluation (GRADE) concept for certainty of evidence represents our confidence that the true effect lies above or below a threshold, or in a specified range. A clarification of how these concepts apply to certainty ratings of diagnostic test accuracy is needed. This is especially important as it relates to frequent lack of direct evidence assessing the effect of tests on patient-important outcomes.


To illustrate possible approaches for defining ranges when assessing the certainty of evidence for diagnostic test accuracy within a systematic review, health technology assessment, or clinical practice guideline.


After initial brainstorming with GRADE project group members, the investigators iteratively refined and clarified the approaches using input from workshops and discussions at GRADE Working Group meetings.


Ranges can be defined both for single test accuracy and for comparative accuracy of multiple tests. For systematics reviews and health technology assessments there are approaches for defining ranges that do not include value judgments about downstream health outcomes. Key challenges arise when clinical meaningful ranges should be set for sensitivity and specificity, in the context of a guideline. At the Colloquium, we will show how these challenges can be addressed using an example from a real-life systematic review illustrating a direct comparison between two test strategies.


The application of the approaches for defining ranges in test accuracy will provide a useful framework when assessing, presenting, and making decisions based on the certainty of evidence for diagnostic test accuracy.

Patient or healthcare consumer involvement:

No involvement at this early stage of methodological development.