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[德国临床指南制定循证方法的方法学标准。科学界、自治机构与实践之间的共识]

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

作者信息

Helou A, Lorenz W, Ollenschläger G, Reinauer H, Schwartz F W

机构信息

Abteilung Epidemiologie, Sozialmedizin und Gesundheitssystemforschung, Medizinische Hochschule Hannover.

出版信息

Z Arztl Fortbild Qualitatssich. 2000 Jun;94(5):330-9.

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.

摘要

在过去几年里,临床指南制定的最合适方法一直是德国争议性辩论的主题。位于科隆的医学质量协会的德国指南信息中心提供了一个讨论平台,临床医生、方法学家、科学医学协会联合会以及企业自治机构(健康保险公司、医师协会和医院协会)在此就基于证据的指南制定的最重要方法达成了一致。人们普遍认为,在制定或修订临床实践指南时应遵循严格的方法标准,以确保科学质量和共识质量。该共识涉及以下几个方面:科学有效的指南:(1)基于对现有最佳证据的全面系统回顾;(2)从现有最佳证据中得出建议;(3)明确展示建议与证据的关联。通过(1)指南小组中所有相关利益攸关方的参与以及(2)正式共识制定方法的应用来确保共识质量。这种“基于证据的共识指南”被认为具有最高水平的科学和政治合法性。

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