[Methodological standards of the evidence-based approach of clinical guidelines development in Germany. Consensus between the scientific community, self-governed bodies and practice]

Abstract

The most appropriate method of clinical guidelines development has been the subject of controversial debates in Germany during the last few years. The German Guidelines Clearinghouse at the Society for Quality in Medicine (Cologne) provided a discussion forum where clinicians, methodologists, the Association of the Scientific Medical Societies, and the corporate self-governed bodies (the health insurances, physicians' associations, and the hospital associations) agreed on the most important methods of an evidence-based approach for guidelines development. It was generally agreed that rigorous methodological standards should be followed to ensure both the scientific quality and the consensus quality in the development or revision of clinical practice guidelines. The agreement draws on the following topics: Scientifically valid guidelines: (1) are based on a comprehensive and systematic review of the best available evidence, (2) derive the recommendations from the best available evidence, and (3) demonstrate explicitly how the recommendations are linked to the evidence. The quality of consensus is ensured through (1) the participation of all relevant stakeholders in the guideline panel and (2) the application of formal consensus development methods. This type of an "evidence-based consensus guideline" is assumed to possess the highest level of scientific and political legitimacy.