GRADEsystemet

GRADEsystemet, or the GRADE framework, is a structured approach used in developing clinical guidelines to assess the quality of evidence and the strength of recommendations. It provides a transparent, explicit method to judge how confident we can be in the effect estimates and in the guidance offered to clinicians and policymakers.

In GRADE, the quality of evidence is evaluated for each important outcome. Evidence from randomized trials starts as high quality and observational studies as low quality, then may be downgraded for limitations such as risk of bias, inconsistency, indirectness, imprecision, or publication bias. Conversely, certain factors—like a large or dose–response effect, or residual confounding that would reduce a demonstrated effect—can upgrade observational evidence.

The strength of recommendations is determined separately from the quality of evidence. Recommendations are categorized as strong or weak (sometimes labeled as conditional). This assessment considers the balance between desirable and undesirable effects, the overall certainty of the evidence, patient values and preferences, and resource use or feasibility.

A typical GRADE process includes framing questions in a PICO format, developing evidence profiles or Summary of Findings tables, and using the Evidence to Decision (EtD) framework to justify each recommendation. The framework is supported by tools and guidance, and has been adopted by many health organizations worldwide to promote consistency and transparency in guideline development.

Limitations of GRADE include its complexity and the need for training to apply it reliably. Nonetheless, it is widely regarded for improving clarity in how evidence informs recommendations.