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GRADE Guidance: Using Thresholds for Judgments on Health Benefits and Harms in Decision Making (GRADE Guidance 42)
Wojtek Wiercioch1, Gian Paolo Morgano2, Thomas Piggott1
1Michael G. DeGroote Cochrane Canada & McMaster GRADE Centres, McMaster University, and Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada (W.W., T.P., R.N.).
Annals of Internal Medicine
|October 6, 2025
Summary
This study offers guidance on using decision thresholds (DTs) within the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. It provides methods to benchmark effect sizes for health decisions, enhancing transparency in evidence-to-decision frameworks.
Area of Science:
- Health technology assessment
- Clinical guideline development
- Evidence-based practice
Background:
- The Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework aids in making judgments about intervention effects.
- Benchmarking effect sizes using decision thresholds (DTs) can facilitate these judgments for health outcomes.
- Current GRADE usage requires clear methods for assessing the magnitude of health effects.
Purpose of the Study:
- To provide GRADE guidance on utilizing decision thresholds (DTs) for assessing the magnitude of desirable and undesirable health effects.
- To develop standardized approaches for incorporating DTs into Evidence-to-Decision (EtD) frameworks.
- To enhance transparency and consistency in health guideline and health technology assessment processes.
Main Methods:
- Iterative discussions and refinement within a GRADE project group, including in-person and online meetings.
- Development of guidance for using DTs in Evidence-to-Decision (EtD) frameworks, informed by practical examples and a randomized methodological study.
- Presentation of two main approaches for determining outcome-specific DTs: calculation-based and direct surveying of decision-makers.
Main Results:
- Guidance for using DTs in GRADE Evidence-to-Decision (EtD) frameworks has been developed.
- Two primary methods for determining DTs are presented: one based on empirical data and utility values, and another using direct input from decision-makers.
- The article demonstrates how these methods can be combined to enhance judgment transparency.
Conclusions:
- The proposed approaches for determining and using DTs offer transparency in GRADE Evidence-to-Decision (EtD) frameworks.
- These methods facilitate consistent judgments about the magnitude of intervention effects on health outcomes.
- The guidance supports more robust and reproducible health guideline and health technology assessments.
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