眼科 ›› 2025, Vol. 34 ›› Issue (3): 194-201.doi: 10.13281/j.cnki.issn.1004-4469.2025.03.004

• 论著 • 上一篇    下一篇

基于AGREE II的中国干眼临床指南及共识的质量评价研究

李逸粼 骆非1  王宁利1  胡健萍1,2   

  1. 1首都医科大学附属北京同仁医院 北京同仁眼科中心 眼科学与视觉科学北京市重点实验室,北京 100730;
    2中国医学科学院基础医学研究所 北京协和医学院基础学院 流行病与卫生统计学系,北京100005
  • 收稿日期:2025-04-08 出版日期:2025-05-25 发布日期:2025-05-25
  • 通讯作者: 胡健萍,Email:pucri_hujp@126.com

Quality assessment research of Chinese clinical guidelines and expert consensus on dry eye based on AGREE II

Li Yilin1, Luo Fei1, Wang Ningli1, Hu Jianping1,2   

  1. 1 Beijing Tongren Eye Center, Beijing Tongren Hospital, Capital Medical University; Beijing Key Laboratory of Ophthalmology and Visual Science, Beijing 100730, China; 2 Department of Epidemiology and Biostatistics, Institute of Basic Medical Sciences Chinese Academy of Medical Sciences; School of Basic Medicine Peking Union Medical College, Beijing 100005, China
  • Received:2025-04-08 Online:2025-05-25 Published:2025-05-25
  • Contact: Hu Jianping, Email: pucri_hujp@126.com

摘要: 目的 了解中国干眼临床指南及共识的质量现状,识别其制订的科学性、实用性和可信度,以推动干眼相关临床指导原则的质量提升,促进科学证据在临床实践中的有效应用。设计 横断面研究。研究对象 2020-2024年发表的12部中国干眼相关的临床指南/共识,其中1部为指南,11部为专家共识。方法 使用国际通用的临床指南质量评价工具AGREE II对其进行质量评价,采用极差法计算六个领域(范围和目的、表达清晰性、参与人员、开发的严谨性、应用性和编辑独立性)的标准化得分并进行汇总分析,使用组内相关系数(ICC)检验评估者的可靠性。主要指标 六个领域的标准化得分。结果 三位评估者对12部中国干眼临床指南/共识评价的ICC均>0.80,评价结果可靠。对12部干眼临床指南/共识的汇总分析显示,其在范围和目的(82.26%±4.06%)、清晰性(80.40%±5.44%)方面表现良好,但在参与人员(51.08%+8.44%)、严谨性[30.91%(26.39%,32.64%)]、应用性(57.99%±8.23%)和编辑独立性[47.22%(47.22%,47.22%)]方面有待提升。其中,严谨性领域得分较低,主要问题表现为未进行全面系统的证据检索、证据评价,推荐意见形成方法不透明等。结论 近年来,中国干眼临床指南/共识在范围和目的、清晰性方面表现良好,未来再制定类似指南/共识过程中应进一步重视方法学顶层设计,并确保过程严谨透明、报告规范、参与成员多样化,以进一步提升我国干眼指南的整体质量和临床实用性。(眼科,2025,34: 194-201)

关键词: 临床实践指南, 质量评价, 干眼

Abstract: Objective To assess the quality of Chinese clinical guidelines and consensus on dry eye, identifying their scientific basis, practicality, and credibility to enhance the quality of clinical guidelines related to dry eye and promote the effective application of scientific evidence in clinical practice. Design Cross-sectional study. Participants Twelve of the most recent Chinese clinical guidelines and consensus published between 2020 and 2024, including one guideline and eleven expert consensuses. Methods The quality of the guidelines was evaluated using the internationally recognized clinical guideline assessment tool, AGREE II. Standardized scores across six domains (Scope and Purpose, Clarity, Stakeholder Involvement, Rigor of Development Applicability, and Editorial Independence) were calculated using the range method and subsequently analyzed. The reliability of the evaluators was tested using the intraclass correlation coefficient (ICC). Main Outcomes Measures Standardized scores from the six domains. Results The ICC for the assessments by three evaluators of the twelve Chinese clinical guidelines and consensus was above 0.80, indicating reliable evaluation outcomes. Aggregate analysis revealed strong performance in the domains of Scope and Purpose (82.26%±4.06%) and Clarity (80.40%±5.44%). However, improvements were necessary in the domains of Stakeholder Involvement (51.08%±8.44%), Rigor of Development [30.91% (26.39%, 32.64%)], Applicability (57.99%±8.23%), and Editorial Independence [47.22% (47.22%, 47.22%)]. The lowest score was in the domain of Rigor of Development, primarily due to insufficient comprehensive and systematic evidence retrieval, lack of evidence evaluation, and non-transparent methods in forming recommendations. Conclusion Recently, Chinese clinical guidelines and consensus on dry eye have demonstrated strong performance in the domains of scope, purpose, and clarity. Moving forward, it is essential that the development of similar guidelines emphasizes rigorous methodological design, ensures transparency in the process, adheres to standardized reporting, and promotes diverse stakeholder involvement to enhance the overall quality and clinical applicability of dry eye guidelines in China. (Ophthalmol CHN, 2025, 34: 194-201)

Key words:  clinical practice guidelines, quality assessment, dry eye