Investigation and Evaluation of Chinese Clinical Practice Guidelines Published in Medical Journals in 2019:Methodological and Reporting Quality
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摘要:
目的 评价2019年期刊公开发表的中国临床实践指南的方法学质量和报告质量, 以了解我国指南的质量现状, 为未来指南制订提供改进方向和建议。 方法 采用AGREEⅡ和RIGHT工具分别评价指南的方法学质量和报告质量, 计算AGREE Ⅱ和RIGHT各领域及总体平均得分或平均报告率, 以60%作为合格阈值。 结果 共纳入符合要求的指南226篇。评价结果显示, 2019年期刊公开发表的中国临床实践指南AGREEⅡ平均得分为25.3%;各领域得分依次为: 范围和目的37.9%, 参与人员23.2%, 制订严谨性14.9%, 表达清晰性39.1%, 应用性14.6%, 编辑独立性22.5%。RIGHT平均报告率为33.9%, 各领域报告率依次为: 基本信息59.2%, 背景51.9%, 证据10.8%, 推荐意见31.5%, 评审与质控4.4%, 资助与利益冲突的声明和管理22.3%, 其他方面14.5%。12篇注册指南相较于未注册指南的AGREEⅡ平均得分高24.3%(48.3% 比24.0%), RIGHT平均报告率高21.2%(54.0% 比32.8%)。 结论 2019年期刊公开发表的中国临床实践指南的方法学质量和报告质量整体较低, 注册指南的整体得分高于未注册指南。 Abstract:Objective To evaluate the methodological and reporting quality of Chinese clinical practice guidelines published in medical journals in 2019, so as to understand their current quality and provide suggestions for the improvement of guideline development. Methods We used the AGREE Ⅱ tool and the RIGHT checkilist to assess the methodological and reporting quality of Chinese clinical practice guidelines respectively. The average score or average reporting rate was calculated for each domain and the overall. We used 60% as the qualified threshold. Results A total of 226 guidelines meeting the criteria were included. The average score of AGREE Ⅱ was 22.3%, and the scores of six domains were as follows: 37.9% (scope and purpose), 23.2% (stakeholder involvement), 14.9% (rigour of development), 39.1% (clarity of presentation), 14.6% (applicability), and 22.5%(editorial independence). The average reporting rate of RIGHT was 33.9%, and the reporting rates of seven domains were as follows: 59.2% (basic information), 51.9% (background), 10.8% (evidence), 31.5% (recommendation), 4.4% (review and quality assurance), 22.3%(funding and declaration and management of interests), and 14.5% (other information). Compared to unregistered guidelines, 12 registered guidelines had a 24.3% higher mean score (48.3% vs. 24.0%) in AGREE Ⅱ and a 21.2% higher mean reporting rate (54.0% vs. 32.8%) in RIGHT. Conclusions The overall methodological and reporting quality of Chinese clinical practice guidelines published in medical journals in 2019 were relatively low. Registered guidelines had higher overall scores than unregistered guidelines. -
Key words:
- clinical practice guidelines /
- methodological quality /
- reporting quality /
- evaluation
作者贡献:刘云兰、张静怡、史乾灵、杨楠、王子君、罗旭飞、任梦娟、荀杨芹、周奇、刘辉、吕萌负责指南的评价;刘云兰、张静怡负责统计数据并撰写文章;史乾灵、杨楠、王子君、罗旭飞、任梦娟、荀杨芹、周奇、刘辉、吕萌负责修改初稿;陈耀龙负责文章选题、结构设计、团队组建、数据核查及文章修订。利益冲突:所有作者均声明不存在利益冲突 -
表 1 2019年期刊公开发表的中国临床实践指南AGREEⅡ得分亚组分析(x±s, %)
分组 数量(篇) 范围和目的 参与人员 制订严谨性 表达清晰性 应用性 编辑独立性 平均得分 发表语种 中文 187 38.1±13.1 24.2±10.6 14.8±12.6 38.3±20.8 13.9±8.9 22.5±20.3 25.3±10.0 英文 39 37.1±12.5 17.4±14.2 15.3±14.0 42.7±18.8 17.8±7.0 22.2±22.4 25.4±11.2 注册状态 是 12 58.6±8.0 51.0±13.5 45.3±18.3 68.3±8.1 19.8±8.8 46.7±17.2 48.3±8.8 否 214 36.7±12.2 21.6±9.3 13.2±10.0 37.4±19.7 14.3±8.6 21.1±20.0 24.0±8.6 制订机构 卫生管理部门 20 30.8±11.1 10.2±9.6 6.8±2.5 21.5±10.6 16.9±8.6 12.5±17.9 16.4±5.3 学会/协会 161 38.0±12.7 24.5±10.8 15.5±12.6 41.0±20.4 15.1±8.9 25.0±20.7 26.5±10.1 医院 22 43.9±10.7 23.5±12.2 14.3±13.6 40.0±18.2 10.7±6.7 15.5±20.2 24.7±8.3 其他* 23 37.1±16.2 24.7±12.2 18.4±17.2 39.8±24.2 11.8±7.8 19.3±18.9 25.2±12.8 期刊收录情况# CSCD收录 114 41.1±11.7 25.0±11.0 14.9±12.2 41.5±20.6 13.4±8.4 21.5±20.8 26.2±10.0 非CSCD收录 73 33.3±13.8 23.4±10.1 14.6±13.3 33.3±20.2 14.6±9.7 24.1±19.5 23.9±9.9 SCI收录 34 35.7±12.1 14.5±11.7 13.6±12.8 40.0±18.6 17.7±7.1 20.0±22.7 23.6±10.3 非SCI收录 5 47.2±10.9 36.7±15.3 27.2±17.3 60.8±7.2 19.0±6.3 36.7±14.9 37.9±9.3 AGREEⅡ:指南研究与评价工具;*包括学校、科研机构和专家组;#中文期刊按照是否被CSCD收录进行分类,英文期刊按照是否被SCI收录进行分类;CSCD:中国科学引文数据库;SCI:科学引文索引 表 2 2019年期刊公开发表的中国临床实践指南RIGHT报告率亚组分析(x±s,%)
分组 数量(篇) 基本信息 背景 证据 推荐意见 评审与质控 资助与利益冲突 其他方面 平均报告率 发表语种 中文 187 60.8±14.1 54.5±16.2 11.2±18.9 30.5±23.0 3.5±13.8 21.8±19.5 11.8±20.0 34.2±11.0 英文 39 51.7±13.1 39.4±20.4 8.7±13.6 37.4±26.3 9.0±19.4 25.0±25.0 27.4±21.5 32.3±13.8 是否注册 是 12 52.8±13.9 64.6±18.3 45.0±24.3 71.4±14.9 16.7±24.6 58.3±22.2 22.2±21.7 54.0±12.2 否 214 59.6±14.3 51.2±17.7 8.9±15.7 29.2±22.1 3.7±14.0 20.3±18.5 14.0±21.0 32.8±10.4 制订机构 卫生管理部门 20 52.5±6.1 30.6±18.8 1.0±4.5 18.6±10.5 2.5±11.2 12.5±19.0 23.3±15.7 23.4±6.1 学会/协会 161 60.7±15.1 54.6±16.2 11.6±18.0 33.1±24.1 4.2±15.0 23.5±20.8 13.1±19.7 35.2±11.3 医院 22 58.3±13.4 50.6±18.7 10.0±21.2 29.9±21.1 9.1±19.7 22.7±18.8 16.7±22.4 33.5±10.2 其他* 23 54.4±12.2 52.6±15.9 14.7±22.0 35.3±29.5 2.6±11.5 22.4±20.2 14.0±32.0 34.4±14.1 期刊收录类型# CSCD收录 114 60.2±13.4 54.8±16.0 11.2±17.3 33.2±22.5 3.5±12.8 22.8±20.1 9.4±17.5 34.7±10.6 非CSCD收录 73 61.6±15.1 54.1±16.7 11.2±21.3 26.2±23.3 3.4±15.2 20.2±18.5 15.5±23.0 33.6±11.6 SCI收录 34 52.0±13.5 36.0±18.4 7.1±12.9 33.2±23.5 7.4±18.0 22.8±24.9 25.5±16.5 30.0±11.8 非SCI收录 5 50.0±11.8 62.5±19.8 20.0±14.1 65.7±29.6 20.0±27.4 40.0±22.4 40.0±43.5 48.0±17.5 RIGHT:卫生保健实践指南的报告条目;*同表 1;#同表 1;CSCD、SCI:同表 1 -
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