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Investigation and Evaluation of Chinese Clinical Practice Guidelines Published in Medical Journals in 2019:Funding and Conflicts of Interest
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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中资助与利益冲突报告情况，为我国指南的资助与利益冲突规范化管理提供参考。 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，对资助与利益冲突相关信息进行提取、统计和分析。 结果 共纳入指南226篇，其中报告资助和利益冲突的指南分别为68篇(30.1%)和120篇(53.1%)，二者同时报告的指南仅41篇(18.1%)；接受资助的指南涉及170项资金，主要为国家级(82项，48.2%)和省部级(52项，30.6%)基金项目；仅5篇(2.2%)指南报告了资金支持在指南制订过程中的用途。报告利益冲突的指南为120篇，其中102篇(85.0%)仅描述为“无利益冲突”，报告利益冲突收集、评估和管理方法的指南不足10%，且无获取相关信息的公开途径。 结论 2019年期刊公开发表的中国临床实践指南资助与利益冲突报告率较低，报告内容不充分，相关文件无法公开获取。未来我国指南制订者应加强对资助和利益冲突领域的声明与管理。同时，管理者和研究者应积极完善相关政策，研发相应的报告规范。 Abstract:Objective To analyze the situation of funding and conflicts of interest of Chinese clinical practice guidelines published in medical journals in 2019, so as to provide reference for the standardized management of funding and conflicts of interest in Chinese guidelines. Methods We systematically searched four electronic databases and additional sources for Chinese guidelines published in medical journals from January 1 to December 31, 2019. After screening, two researchers independently extracted data on funding and conflicts of interest and cross checked. We analyzed data by using EndNote X9, Microsoft Excel 2019 and SPSS 25.0 software. Results We finally included 226 guidelines, of which, 187 were published in Chinese and 39 in English. There were 68 (30.1%) and 120 (53.1%) guidelines that reported funding and conflicts of interest, respectively, and only 41 (18.1%) that reported on both. There were 64 (28.3%) guidelines reported to have received funding, involving 170 projects, which were mainly at the national level (82, 48.2%) and ministerial and provincial-level (52, 30.6%). Only 5 (2.2%) guidelines reported the role of the funder in the stages of the development process. Among the 120 guidelines that reported conflicts of interest, 102 (85.0%) simply described "no conflicts of interest", while there were less than 10% of guidelines that reported the methods of collection, assessment and management for conflicts of interest, and there was no public access available to such information. Conclusions There is a lack of effective management of funding and conflicts of interest in the Chinese guidelines published in medical journals in 2019, which is reflected in the low reporting rate, insufficient reporting contents and unavailable materials provided by the guideline developers. We suggest that guideline developers in the future should pay more attention to the field of guideline funding and conflicts of interest. Guidelines managers and researchers should actively improve management policies, and develop relevant reporting standards. -
Key words:
- clinical practice guideline /
- funding /
- conflicts of interest
作者贡献：史乾灵、王子君负责数据提取、统计并撰写文章初稿；马艳芳、王健健、刘辉、罗旭飞、杨楠、吕萌、刘云兰、荀杨芹负责初稿修订；陈耀龙、关泉林负责文章选题、结构设计、团队组建、数据核查及文章修订。利益冲突：无史乾灵、王子君对本文同等贡献 -
表 1 2019年中国临床实践指南的资助来源、具体项目及数量(n=170)
资助来源 具体项目 数量[n(%)] 国家 82(48.2) 国家自然科学基金委员会 国家自然科学基金 35(20.6) 中华人民共和国科学技术部 国家重点研发计划、国家科技重大专项等 24(14.1) 国家中医药管理局 国家中医药管理局项目 6(3.5) 中华人民共和国教育部 - 5(2.9) 国家卫生健康委员会 - 3(1.8) 其他a - 9(5.3) 省/市/特别行政区 52(30.6) 北京市 首都卫生发展科研专项、北京市自然科学基金等 18(10.6) 上海市 上海市卫生健康委员会科研项目等 10(5.9) 广东省 广东省自然科学基金等 7(4.2) 其他b - 17(10.0) 商业机构c - 17(10.0) 高校/研究机构 中国医学科学院医学与健康科技创新工程项目等 8(4.7) 学会/协会 - 8(4.7) 医院 - 1(0.6) 基金会 - 1(0.6) 其他d - 1(0.6) 自筹 未报告 未报告 a无法对具体机构进行分类；b包括云南省4项、江苏省3项、甘肃省3项、四川省2项、福建省2项、辽宁省1项、湖北省1项和香港特别行政区1项；c17家商业机构(15家药企和2家其他商业实体)共同资助《中国高血压防治指南2018年修订版》；d中文科技期刊精品建设计划项目；-：具体项目较多，不一一呈现 
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表 2 2019年中国临床实践指南的资助领域及各领域资金项目平均数量(n=170)
资助领域 资金项目数量[n(%)] 指南数量[n(%)] 资金项目平均数量(n) 循环系统疾病 30(17.6) 7(11.5) 4.3 肌肉骨骼系统疾病/结缔组织病 25(14.7) 9(14.8) 2.8 肿瘤 22(12.9) 9(14.8) 2.4 呼吸系统疾病 18(10.6) 8(13.1) 2.3 某些感染性疾病/寄生虫病 16(9.4) 7(11.5) 2.3 皮肤疾病 15(8.8) 4(6.6) 3.8 泌尿生殖系统疾病 10(5.9) 3(4.9) 3.3 内分泌、营养或代谢性疾病 9(5.3) 1(1.6) 9.0 神经系统疾病 9(5.3) 5(8.2) 1.8 消化系统疾病 9(5.3) 5(8.2) 1.8 精神、行为或神经发育障碍 5(2.9) 1(1.6) 5.0 传统医学病证-模块1 1(0.6) 1(1.6) 1.0 起源于围生期的某些情况 1(0.6) 1(1.6) 1.0
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表 3 2019年中国临床实践指南的利益冲突报告情况(n=120)
分类 指南数量[n(%)] 利益冲突表述形式 明确报告不存在利益冲突 118(98.3) 无利益冲突 102(85.0) 不存在与本指南相关的利益冲突 5(4.2) 不存在与本指南直接相关的利益冲突 3(2.5) 不存在与本指南推荐意见相关的利益冲突 2(1.7) 制订过程与任何单位、个人无经济利益关系 1(0.8) 指南编写过程中均无涉及任何经济或非经济利益冲突 1(0.8) 未发现与指南制订有关的严重利益冲突 1(0.8) 商业机构资助了修订工作会议，但不参与或影响指南学术内容及证据评估，指南保持独立性 1(0.8) 指南内容与相关产品的生产和销售厂商无经济利益关系 1(0.8) 本指南与任何商业机构均无直接或间接的利益关系 1(0.8) 未明确报告是否存在利益冲突 2(1.7) 利益冲突报告者表述形式 所有作者 86(71.7) 指南工作组成员 8(6.7) 指南专家组成员 5(4.2) 指南专家组成员及患者代表 2(1.7) 指南所有成员 2(1.7) 临床问题遴选调研对象、指南制订委员会成员、指南证据合成与评价成员 1(0.8) 指南工作组成员及共识专家 1(0.8) 指南小组成员 1(0.8) 编写组所有成员 1(0.8) 未报告 13(10.8) 利益冲突的收集方法 签署利益冲突声明 5(4.2) 填写利益声明表 7(5.8) 未报告 108(90.0) 利益冲突的评估方法 由指南制订学会秘书处进行核查 2(1.7) 秘书处收集后提交至指南指导委员会进行监督和评估 1(0.8) 未报告 117(97.5) 利益冲突的管理方法 如存在利益冲突，指导委员会将确定其严重性，决定最终结果 1(0.8) 未报告 119(99.2)
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