Considered judgement in evidence-based guideline development.

BACKGROUND Clinical practice guidelines should be based on the best available evidence. However, this evidence is often incomplete, controversial, or lacking. Other considerations beyond the evidence are therefore needed to be able to formulate specific and applicable recommendations for clinical practice. OBJECTIVE The aim of this study is to obtain consensus among experts about a set of domains and items covering the most relevant 'other considerations' to formulate recommendations in evidence-based guideline development. METHODS An initial list of 10 domains and 49 items for a systematic and considered judgement of scientific evidence was generated from the literature. A panel of Dutch experts in guideline development tested this list using a two-round Delphi consensus technique. Each expert was asked to independently score the relevance of the items on a 4-point Likert scale, ranging from 'very important' to 'not important'. The final list consisted of items that were included by at least 60% consensus. RESULTS Twenty-eight experts participated in the first Delphi round and 21 of them in the second round. High scoring domains were 'clinical relevance', 'safety', and 'availability of resources'. There was consensus about the relevance of 37 items. The domain 'conflicts of interest by industry' was excluded because of lack of consensus. CONCLUSION This is the first formal consensus approach towards structuring the considered judgement process in formulating recommendations in clinical guidelines. The final list of items can be used to facilitate the process of guideline development. The next step is to test the practical usefulness and applicability of this list in guideline development.