1.2. Limitations of GRADE
GRADE is used for systematic reviews, health technology assessments and clinical guidelines. The approach differs in principle somewhat for systematic reviews but this difference is not really relevant for KCE, as KCE does not in principle produces guidelines that do not go together with recommendations.
GRADE is not designed for the evaluations of public health interventions, and is not suitable not for Health System Research. Although some principles used in grade can be useful, there are too many unresolved questions. GRADE is in the first place designed for the evaluations of interventions, be such as drugs, surgical interventions or radiation therapy. Although GRADE also deals with diagnostics the approach is far from mature in this area and its usefulness is limited, we will explain the problems in more detail at the end of the document.
Recommendations that may be helpful but do not need grading are typically those in which it is sufficiently obvious that desirable effects outweigh undesirable effects that no direct evidence is available because no one would be foolish enough to conduct a study addressing the implicit clinical question. Typically, such recommendations are supported by a great deal of indirect evidence, but teasing out the nature of the indirect evidence would be challenging and a waste of time and energy. One way of recognizing such questions is that if one made the alternative explicit, it would be bizarre or laughable.
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