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糖尿病指南制定的证据基础。

Evidence base in guideline generation in diabetes.

机构信息

Unit of Health Sciences and Education, University of Hamburg, Martin-Luther-King Platz 6, 20146, Hamburg, Germany.

出版信息

Diabetologia. 2013 Jun;56(6):1201-9. doi: 10.1007/s00125-013-2872-6. Epub 2013 Mar 9.

Abstract

During recent years much emphasis has been on the validity, reliability, reproducibility, clinical applicability, clarity, multidisciplinary process, scheduled review and documentation of clinical practice guidelines (CPGs). Still, CPGs show substantial variance in methodological quality. The present paper mainly focuses on two aspects that are particularly critical and contemporary from the perspective of evidence-based medicine: patient centredness and shared decision making, and conflict of interest. Sophisticated patient and consumer involvement at all stages of CPG development could be judged as being the gold standard. However, co-opting patients or consumer representatives and using other techniques of active patient involvement does not replace individual patient preferences in clinical decision-making processes. Current CPGs do not meet patient needs, since they do not provide concise, easy-to-read summaries of the benefits and risks of medicines together with more comprehensive scientific data as a prerequisite for informed or shared decision making. The vast majority of CPG panels have a financial conflict of interest (COI) and under-reporting is common. Not all organisations producing CPGs have set up COI policies, and existing policies vary widely. To solve the problem, CPG experts have recommended that methodologists without any important COI should lead the development process and have primary responsibility. There is a lot of room for other improvements through network transnational activities in the field of CPG development. Waste of time and resources should be avoided through sharing published and unpublished data identified, appraised and extracted for guideline development. The EASD could provide such a clearing house.

摘要

近年来,人们非常重视临床实践指南(CPG)的有效性、可靠性、可重复性、临床适用性、清晰度、多学科流程、预定审查和文件记录。尽管如此,CPG 在方法学质量上仍存在很大差异。本文主要关注循证医学视角下两个特别关键和现代的方面:以患者为中心和共同决策,以及利益冲突。在 CPG 开发的所有阶段,让患者和消费者参与其中并进行复杂的评估,可以被视为黄金标准。然而,招募患者或消费者代表并使用其他积极的患者参与技术并不能替代临床决策过程中患者的个人偏好。目前的 CPG 并不能满足患者的需求,因为它们没有提供简洁、易于阅读的药物益处和风险摘要,以及更全面的科学数据,作为知情或共同决策的前提。绝大多数 CPG 小组都存在财务利益冲突(COI),并且利益冲突的报告并不常见。并非所有制定 CPG 的组织都制定了 COI 政策,而且现有的政策差异很大。为了解决这个问题,CPG 专家建议没有任何重要 COI 的方法学家应该领导开发过程并承担主要责任。通过在 CPG 开发领域开展跨国网络活动,可以进行许多其他改进。通过共享已确定、评估和提取用于指南开发的已发表和未发表的数据,可以避免浪费时间和资源。EASD 可以提供这样一个信息交换中心。

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