临床实践指南计划书的报告现状:系统性分析

Reporting Status of Clinical Practice Guideline Protocols:A Systematic Analysis

  • 摘要: 目的 系统分析近十年国内外公开发表的临床实践指南(下文简称指南")计划书核心要素报告现状,识别存在的问题,为今后指南计划书的规范撰写与发表提供依据。方法 检索近十年在中英文数据库公开发表的指南计划书,提取并分析其基本特征及注册信息、利益冲突管理、证据分级、制订流程与时间规划、传播与实施等内容;采用卡方检验探讨其不同特征与核心要素报告情况的关联。结果 共纳入94篇指南计划书,其中中文67篇(71.28%),英文27篇(28.72%)。82.98%的指南计划书进行了注册,92.55%报告了利益冲突管理,97.87%报告了证据检索,88.30%报告了证据分级,89.36%对传播与实施进行了说明。仅55.32%报告了制订流程,23.40%报告了时间规划。进一步分析显示,注册情况、证据检索、制订流程及时间规划的报告与发表年份相关,国内与国际指南在注册情况、利益冲突管理、制订流程、时间规划、传播与实施方面的报告情况存在差异,拟进行制订的指南在注册情况、制订流程及传播与实施方面的报告率高于拟进行更新/改编的指南。结论 当前指南计划书在方法学方面报告较为充分,但在制订流程与时间规划等方面仍存在不足。未来建议进一步推广指南计划书的发表及规范化报告,提升注册平台的国际认可度,强化制订流程与时间规划,提升指南制订的科学性与透明化。

     

    Abstract: Objective To systematically analyzed the reporting status of core elements in publicly available clinical practice guideline (hereafter referred to as "guideline") protocols published domestically and internationally over the past decade, identified existing problems, and provided evidence to inform the standardized writing and publication of future guideline protocols. Methods A systematic search was conducted in Chinese and English databases for clinical practice guideline protocols published during the past ten years. The basic characteristics and reporting of core elements-including registration information, conflict of interest management, evidence grading, development process and timeline planning, as well as dissemination and implementation-were extracted and analyzed. Chi-square tests were performed to explore associations between protocol characteristics and the reporting of core elements. Results A total of 94 guideline protocols were included, of which 67 were in Chinese (71.28%) and 27 were in English (28.72%). Overall, 82.98% of the guideline protocols were registered, 92.55% reported management of conflicts of interest, 97.87% reported evidence searching, 88.30% reported evidence grading, and 89.36% described dissemination and implementation strategies. However, only 55.32% reported the guideline development process, and merely 23.40% reported timeline planning. Further analysis indicated that the reporting of registration, evidence searching, development process, and timeline planning was associated with year of publication. Differences were observed between domestic and international guidelines in reporting registration, conflict of interest management, development process, time planning, and dissemination and implementation. Guidelines intended for development exhibited higher reporting rates for registration, development process, and dissemination and implementation compared to those planned for updating or adaptation. Conclusions Although current guideline protocols demonstrate relatively adequate reporting of methodological elements, deficiencies remain in development process and timeline planning. Future efforts should focus on promoting the publication and standardized reporting of guideline protocols, enhancing the international recognition of registration platforms, and strengthening the development process and timeline planning to advance the scientific rigor and transparency of guideline development.

     

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