To identify challenges in the application of GRADE for diagnosis when assessing the certainty of evidence in the test-treatment strategy (diagnostic accuracy, test burden, management effectiveness, natural course, linked evidence) in an illustrative example and to propose solutions to these challenges.
A case study in applying GRADE for diagnosis that looked at the added value of IgE for diagnosing allergic rhinitis.
Evaluation of the full test-treatment strategy showed a lack of (high-quality) evidence for all elements. In our example, we found a lack of evidence for test burden, natural course and link between test result and clinical management. Overall, systematically reviewing the evidence for all elements of a test-treatment strategy is more time-consuming than only considering test accuracy results and management effectiveness. To increase efficiency, the guideline panel could determine critical elements of the test-treatment strategy that need a systematic review of the evidence. For less critical elements, a guideline panel can rely on grey literature and professional expertise.
A lack of high-quality evidence and time investment if the full test-treatment strategy is assessed create challenges in applying GRADE for diagnosis. Discussion within guideline panels about critical elements that need to be reviewed might help.

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