Investigation and Evaluation of Chinese Clinical Practice Guidelines Published in Medical Journals in 2019: Analysis of the Evidence
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摘要:
目的 调查2019年期刊公开发表的中国临床实践指南推荐意见的证据引用现状,为合理利用研究证据支撑指南推荐意见提供参考。 方法 系统检索并筛选2019年期刊公开发表的中国临床实践指南,纳入有明确推荐意见、证据质量分级和相应分级说明的指南,提取指南推荐意见的引文信息并对其进行分析。 结果 共纳入指南31篇(中文29篇,英文2篇),包含568条推荐意见(平均每篇指南包含18条推荐意见)和3126篇引文,其中2541条引文作为证据在指南推荐意见说明中呈现(此类引文,下文简称“证据”)。平均每篇指南引用82篇证据,平均每条推荐意见引用4篇证据。证据来源位居前3位的国家依次为中国(28.8%)、美国(25.9%)和英国(7.0%)。发表于近5年的证据仅占比39.2%(995/2541)。证据文献类型主要为随机对照试验(26.9%),系统评价仅占比12.0%。 结论 2019年期刊公开发表的中国指南,存在未明确列出推荐意见及对支撑推荐意见的证据引用不全面、实效性差等问题。指南制订者应合理利用当前可得的研究证据,进一步提高我国临床实践指南的制订质量。 Abstract:Objective To investigate the current status of evidence of recommendations contained in Chinese clinical practice guidelines published in journals in 2019, so as to provide reference for the use of evidence for Chinese guidelines in the future. Methods We searched and analyzed information on Chinese guidelines published in 2019 with clear recommendations, grading of evidence quality and corresponding instructions of grading, as well as information on citations supporting the recommendations. Results A total of 31 guidelines (29 Chinese guidelines and 2 English guidelines) containing 568 recommendations and 3126 references were included. Each guideline included an average of 18 recommendations. Of these, 2541 references were presented as evidence in the statements of guideline recommendation(such references are referred to as "evidence" hereafter). The average number of evidence was 82 in each guideline and every recommendation has 4 pieces of evidence. The top three countries where the evidence was from were China (28.8%), the United States (25.9%), and the United Kingdom (7.0%). Only 39.2% (995/2541) of the evidence was published in the last 5 years. The most common type of evidence for guidelines was randomized controlled trials (26.9%). The citation of systematic reviews was only 12.0%. Conclusions Most of the Chinese guidelines published in 2019 did not have clear and unambiguous recommendations. Those guidelines with clear recommendations had incomplete and untimely evidence citations. Guideline developers should strengthen the rational use of currently available research evidence. -
Key words:
- clinical practice guideline /
- evidence /
- recommdation /
- systematic review
作者贡献:刘萧、杨楠负责数据提取、统计并撰写文章初稿;吴守媛、郭强强、刘辉、孙雅佳、王健健、王子君、史乾灵、赵思雅、李沁原负责数据提取;周奇、罗旭飞、吕萌负责初稿修改;陈耀龙、宋旭萍负责文章选题、结构设计、团队组建、数据核查及文章修订。利益冲突:无 -
表 1 31篇中国临床实践指南的引文和证据基本情况
序号 指南名称 推荐意见(条) 引文(篇) 证据(篇,%) 分级标准 1 2018 update of the APLAR recommendations for treatment of rheumatoid arthritis 66 175 112(64.0) 不清楚 2 中国脑出血诊治指南(2019) 34 106 96(90.6) 牛津分级修订 3 早产儿经鼻间歇正压通气临床应用指南(2019年版) 31 27 26(96.3) GRADE 4 骨质疏松症康复指南 26 76 58(76.3) GRADE修订 5 中国乙型肝炎病毒母婴传播防治指南(2019年版) 25 75 63(84.0) GRADE 6 骨科常见疼痛管理临床实践指南(2018版) 24 50 31(62.0) GRADE 7 中国心血管病风险评估和管理指南 23 123 104(84.6) GIN标准 8 绝经后骨质疏松症(骨痿)中医药诊疗指南(2019年版) 23 236 236(100) 不清楚 9 脑卒中水中运动治疗中国循证临床实践指南(2019版) 22 78 16(20.5) GRADE修订 10 直肠肛门日间手术临床实践指南(2019版) 22 140 113(80.7) 不清楚 11 生酮饮食治疗儿童癫痫性脑病循证指南 20 79 63(79.7) GRADE修订 12 肝胆管结石病微创手术治疗指南(2019版) 19 41 34(82.9) GRADE 13 奥马珠单抗治疗儿童过敏性哮喘的临床实践指南 17 45 40(88.9) GRADE 14 中国门静脉高压经颈静脉肝内门体分流术临床实践指南(2019版) 17 142 64(45.1) 不清楚 15 急性脊柱脊髓损伤围术期管理临床指南 16 88 72(81.8) GRADE修订 16 中国癌症症状管理实践指南——皮肤反应 15 46 14(30.4) GRADE 17 胆道闭锁诊断及治疗指南(2018版) 15 48 34(70.8) GRADE 18 中国癌症症状管理实践指南——厌食 15 48 28(58.3) GRADE 19 中国手术部位感染预防指南 13 226 214(94.7) 不清楚 20 子宫内膜异位症中西医结合诊治指南 13 55 29(52.7) GRADE 21 急性症状性骨质疏松性胸腰椎压缩骨折椎体强化术临床指南 13 82 76(92.7) GRADE修订 22 中国脑血管病一级预防指南2019 12 253 245(96.8) 不清楚 23 复杂性肝脏肿瘤三维可视化精准诊治指南(2019版) 11 32 24(75.0) GRADE 24 计算机辅助联合吲哚菁绿分子荧光影像技术在肝脏肿瘤诊断和手术导航中应用指南(2019版) 11 47 38(80.9) GRADE 25 丙型肝炎防治指南(2019年版) 11 93 75(80.6) 牛津分级 26 妊娠和产后甲状腺疾病诊治指南(第2版) 11 193 183(94.8) 不清楚 27 A Chinese practice guideline of the assisted reproductive technology strategies for women with advanced age 11 122 93(76.2) GRADE 28 中国非肌层浸润性膀胱癌治疗与监测循证临床实践指南(2018年标准版) 10 46 28(60.9) GRADE 29 中国消化内镜诊疗相关肠道准备指南(2019, 上海) 10 100 97(97.0) 牛津分级 30 一氧化氮吸入治疗在新生儿重症监护病房的应用指南(2019版) 5 72 65(90.3) GRADE 31 负压封闭引流技术腹部应用指南 4 182 170(93.4) 不清楚 GRADE:推荐意见分级评价、制订与评估;GIN:国际指南协作网;AAOS:美国骨科医师学会 表 2 2019年期刊公开发表的中国临床实践指南推荐意见的证据类型(n=2541)
证据类型 数量(篇,%) 随机对照试验 683(26.9) 队列研究 389(15.3) 病例报告/病例系列 318(12.5) 系统评价 306(12.0) 综述 218(8.6) 指南/共识 209(8.2) 横断面研究 99(3.9) 临床对照研究 92(3.6) 基础研究 40(1.6) 病例对照研究 39(1.5) 书籍 24(0.9) 单臂临床研究 17(0.7) 国家/机构文件 13(0.5) 诊断试验 7(0.3) 其他* 87(3.5) *包括评论、通信、方法学研究、经济学研究、模型研究等 -
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