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制定减药临床实践指南的研究方案:基于证据的GRADE方法和德尔菲共识法。

Study protocol for developing deprescribing clinical practice guidelines: evidence-based GRADE methodology and a Delphi consensus method.

作者信息

Quek Hui Wen, Page Amy, Lee Kenneth, Etherton-Beer Christopher

机构信息

Centre for Optimisation of Medicines, School of Allied Health, The University of Western Australia, 35 Stirling Hwy, Crawley, Western Australia, 6009, Australia.

Western Australian Centre for Health and Ageing, The University of Western Australia and Royal Perth Hospital, Perth, Australia.

出版信息

BMC Geriatr. 2025 Jul 19;25(1):538. doi: 10.1186/s12877-025-06202-2.

Abstract

BACKGROUND

Deprescribing has emerged as a strategy to reduce the use of potentially inappropriate medicines, particularly in older people. Evidence-based deprescribing clinical practice guidelines are a key enabler in integrating deprescribing into routine care. This protocol outlines the development of deprescribing clinical practice guidelines targeting many commonly prescribed medicines for older people, specifically focusing on applying the evidence-based Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology alongside a Delphi consensus-building process.

METHODS

The guideline development process follows the World Health Organisation Handbook for Guideline Development, Australian National Health and Medical Research Council Guideline Development Methodology, and the Appraisal of Guidelines for Research & Evaluation (AGREE) II Instrument with adaptations made to suit the guideline's purpose, available resources, and the urgent need for recommendations to support clinical decision-making. This project is developed by a multidisciplinary healthcare team, representatives from professional organisations, and patient or carer stakeholders. The development involves a two-part sequential approach: evidence-deriving using a structured GRADE methodology and consensus-building processes using a standardised Delphi approach. Firstly, a comprehensive systematic review and meta-analysis of the literature was conducted to identify evidence related to deprescribing in older people, with the evidence presented and certainty assessed using the GRADE framework. Where quality evidence is available, evidence-based recommendations will be formulated following the evidence-to-decision GRADE framework. For areas with insufficient quality evidence, consensus-based recommendations will be developed using a modified Delphi method. Additional good practice statements will be developed where necessary to facilitate the practical application of these recommendations.

DISCUSSION

Given the large scope of the currently proposed guidelines, the proposed approach discussed in this protocol is adapted based on several important considerations on the practical, operational, and resource issues. Given deprescribing is an emerging area and the limited availability of evidence for some drug classes, expert consensus and input from patient representatives offer a valuable alternative for recommendation development. The final guideline will provide clinicians with broad guidance for deprescribing common medicines used in older people that complement existing single-drug-class deprescribing guidelines and other treatment guidelines.

TRIAL REGISTRATION

Not applicable.

摘要

背景

减药已成为一种减少潜在不适当药物使用的策略,尤其是在老年人中。基于证据的减药临床实践指南是将减药纳入常规护理的关键推动因素。本方案概述了针对老年人多种常用药物的减药临床实践指南的制定,特别侧重于应用基于证据的推荐分级评估、制定和评价(GRADE)方法以及德尔菲共识建立过程。

方法

指南制定过程遵循世界卫生组织指南制定手册、澳大利亚国家卫生与医学研究委员会指南制定方法以及研究与评价指南评估(AGREE)II工具,并根据指南目的、可用资源以及支持临床决策的建议的迫切需求进行了调整。该项目由多学科医疗团队、专业组织代表以及患者或护理人员利益相关者共同开展。制定过程采用两部分的顺序方法:使用结构化GRADE方法获取证据以及使用标准化德尔菲方法进行共识建立过程。首先,对文献进行全面的系统评价和荟萃分析,以识别与老年人减药相关的证据,并使用GRADE框架呈现证据并评估其确定性。在有高质量证据的情况下,将遵循证据到决策的GRADE框架制定基于证据的建议。对于证据质量不足的领域,将使用改良的德尔菲方法制定基于共识的建议。必要时将制定额外的良好实践声明,以促进这些建议的实际应用。

讨论

鉴于当前拟议指南的范围广泛,本方案中讨论的拟议方法基于对实际、操作和资源问题的若干重要考虑进行了调整。鉴于减药是一个新兴领域,某些药物类别的证据有限,专家共识和患者代表的意见为建议制定提供了有价值的替代方案。最终指南将为临床医生提供关于老年人常用药物减药的广泛指导,补充现有的单药类别减药指南和其他治疗指南。

试验注册

不适用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5223/12275366/5edbdbb35a5d/12877_2025_6202_Fig1_HTML.jpg

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