Applying GRADE for diagnosis revealed methodological challenges: an illustrative example for guideline developers.

Area of Science:

• Medical Diagnostics
• Evidence-Based Medicine
• Clinical Guideline Development

Background:

• The GRADE (Grading of Recommendations Assessment, Development and Evaluation) system is crucial for assessing evidence certainty in clinical practice.
• Applying GRADE for diagnostic test-treatment strategies requires evaluating multiple evidence components beyond just diagnostic accuracy.

Purpose of the Study:

• To identify challenges in applying GRADE for diagnosis when assessing the certainty of evidence for a complete test-treatment strategy.
• To propose solutions for overcoming these challenges in guideline development.

Main Methods:

• A case study was conducted using IgE testing for allergic rhinitis diagnosis.
• The GRADE framework was applied to evaluate the test-treatment strategy, including diagnostic accuracy, test burden, management effectiveness, natural disease course, and linked evidence.

Main Results:

• A significant lack of high-quality evidence was found for all evaluated elements of the test-treatment strategy.
• Specific evidence gaps were identified for test burden, natural disease course, and the link between test results and clinical management.
• Systematic review of all elements is time-consuming, exceeding the review of only test accuracy and management effectiveness.

Conclusions:

• Applying GRADE for diagnosis is challenging due to insufficient high-quality evidence and substantial time investment.
• Guideline panels should discuss and prioritize critical elements of the test-treatment strategy for systematic review.
• Utilizing gray literature and professional expertise for less critical elements can enhance efficiency.