Writing recommendations is one of the most important steps in developing a clinical guideline. (NICE, 2009) According to the GRADE system, a recommendation is depending on several factors: not only the level of evidence, but also the balance between harm and benefit, the patients’ values and preferences, and the cost of the intervention. These factors allow allocating a level of strength to the recommendation which has to be translated in the formulation of the recommendation.
In specific situations, the available literature provides no evidence, or that conflicting or poor evidence that it is not possible to draw clear conclusions. In these cases, several solutions exist: no recommendation, recommendation without grading, recommendation with low strength or an “only in research” recommendation (see Figure 1). The choice between these solutions is not easy.
This part of the process note aims to provide guidance and tips to formulate clinical recommendations with consistency. It is based on documents from other guideline developers as NICE, SIGN, IKNL, from the GRADE literature and a discussion between KCE experts involved in GCP or in data analysis. It is intended to be used by all experts (intern and extern) involved in the development of clinical guidelines.
Figure - Situations after the literature search