Reaching beyond the review of research evidence : A qualitative study of decision-making during clinical guideline development

Background: The judgment and decision-making process during guideline development is central for producing high-quality clinical practice guidelines, but the topic is relatively underexplored in the guideline research literature. We studied the development process of national guidelines with a disease-prevention scope produced by the National board of Health and Welfare (NBHW) in Sweden. The NBHW formal guideline development model states that guideline recommendations should be based on four decision-criteria: research evidence; severity of the condition; cost-effectiveness; and ethical considerations. A group of health profession representatives is assigned the task of ranking condition–intervention pairs for guideline recommendations, taking into consideration the multiple decision criteria. The aim of this study was to investigate the decision-making process during the two-year development of national guidelines for methods of preventing disease. Methods: A qualitative longitudinal case study approach was used to investigate the decision-making process. Questionnaires, non-participant observations of nine two-day group meetings, and documents provided data for the analysis. Results: The guideline development model was adapted ad-hoc as the group encountered three main types of dilemmas: high quality evidence vs low adoptability of recommendation; insufficient evidence vs high urgency to act; and incoherence in vertical and horizontal judgments. Decision-criteria added by the group were ‘clinical knowledge and experience’, ‘potential guideline consequences’ and ‘needs of vulnerable groups’. Gender, professional status, and interpersonal skills were perceived to affect individuals’ relative influence on group discussions. Decision criteria changed over time in the group discussions. Conclusions: The study shows that guideline-development groups make compromises between rigour and pragmatism. The formal guideline-development model incorporated multiple aspects, but