中国中医科学院中医临床基础医学研究所,北京市东城区东直门内南小街16号,100700
13811839164@vip.126.com
收稿:2023-08-09,
修回:2023-09-26,
纸质出版:2024-01-02
移动端阅览
陈雅馨,梁宁,晏利姣等.中成药临床实践指南制定方法(二)——指南工作组的建立及利益冲突管理[J].中医杂志,2024,65(01):50-54.
CHEN Yaxin,LIANG Ning,YAN Lijiao,et al.Methodology for the Development of Clinical Practice Guidelines for Chinese Patent Medicine: 2.Establishment of Guideline Working Group and Management of Conflict of Interests[J].Journal of Traditional Chinese Medicine,2024,65(01):50-54.
陈雅馨,梁宁,晏利姣等.中成药临床实践指南制定方法(二)——指南工作组的建立及利益冲突管理[J].中医杂志,2024,65(01):50-54. DOI: 10.13288/j.11-2166/r.2024.01.010.
CHEN Yaxin,LIANG Ning,YAN Lijiao,et al.Methodology for the Development of Clinical Practice Guidelines for Chinese Patent Medicine: 2.Establishment of Guideline Working Group and Management of Conflict of Interests[J].Journal of Traditional Chinese Medicine,2024,65(01):50-54. DOI: 10.13288/j.11-2166/r.2024.01.010.
总结中成药临床实践指南工作组的建立及利益冲突管理的要点与方法,以期为中成药临床实践指南制定者提供参考。指南工作组的建立是制定中成药临床实践指南的第一步。结合中成药临床实践指南的特点,提出在建立指南工作组时需考虑多学科性、临床相关性、地域代表性3个关键要素。指南工作组可由指南指导委员会、指南临床专家组、系统评价组、指南秘书组和指南外部评审组构成。所有指南工作组成员需声明利益冲突,同时应对利益冲突管理流程进行详细介绍。
This paper summarized the key points and methods in terms of the establishment of the guideline working group and the management of conflict of interests, trying to provide reference for the development of clinical practice guidelines for Chinese patent medicine (CPM). The establishment of the working group is the first important step for developing CPM guidelines. Considering the characteristics of the clinical practice guidelines for CPM, this study suggests that the three key elements of ‘multidisciplinarity’, ‘clinical relevance’ and ‘geographical representativeness’ should be put focus on when forming the working group. The guideline advisory committee, clinical expert group, evidence systematic evaluation group, secretary group and the external review group should be established. All group members should clarify the conflict of interest, and the process and management method of the conflict of interest should be clearly reported.
朱峰 , 吕晓川 , 高峰 , 等 . 中成药不良反应的诱发原因及热点问题分析 [J]. 中国临床保健杂志 , 2018 , 21 ( 1 ): 127 - 130 .
冯佳佳 , 董子洵 , 史楠楠 , 等 . 制定/修订《中成药临床应用循证指南》的方法与程序 [J]. 中国研究型医院 , 2020 , 7 ( 3 ): 93 - 97 .
柴月 . 从利益冲突看医药产品推广行为之规制 [J]. 北京化工大学学报(社会科学版) , 2015 , 31 ( 2 ): 22 - 28 .
王郁 , 王丽颖 , 韩学杰 . 基于文献的中医临床实践指南共识法专家遴选指标研究 [J]. 中医药学报 , 2022 , 50 ( 5 ): 40 - 43 .
世界卫生组织 . 世界卫生组织指南制定手册 [M]. 杨克虎,主译. 兰州 : 兰州大学出版社 , 2013 : 9 - 30 .
周鹏翔 , 张相林 , 翟所迪 . 中国临床药学实践指南的制订:现状与发展 [J]. 中国循证医学杂志 , 2021 , 21 ( 9 ): 993 - 997 .
董斐 , 刘建平 . 从“经验”到“证据”:循证医学促进中医药传承创新发展 [J]. 南京中医药大学学报 , 2021 , 37 ( 5 ): 642 - 647 .
丁泓帆 , 杨楠 , 邓围 , 等 . WHO指南制定的基本原则和方法 [J]. 中国循证医学杂志 , 2016 , 16 ( 4 ): 471 - 477 .
孙广仁 , 郑洪新 . 中医基础理论 [M]. 北京 : 中国中医药出版社 , 2012 : 288 .
田金州 , 张伯礼 , 高学敏 , 等 . 制定中成药治疗优势病种临床应用指南的指导意见 [J]. 中国中西医结合杂志 , 2018 , 38 ( 1 ): 7 - 11 .
World Health Organization . WHO handbook for guideline development [M]. 2nd ed . Geneva : WHO Library , 2014 .
Kidney Disease : Improving Global Outcomes . KDIGO methods manual for guideline development [EB/OL].( 2022-12-21 )[ 2023-08-02 ]. https://kdigo.org/wp-content/uploads/2022/12/KDIGO-Methods-Manual-for-Guideline-Development_v1-3-copy-1.pdf.1 https://kdigo.org/wp-content/uploads/2022/12/KDIGO-Methods-Manual-for-Guideline-Development_v1-3-copy-1.pdf.1 .
Minds Guideline Center , Japan Council for Quality Health Care . Minds handbook for clinical practice guideline development 2014 [EB/OL].( 2015-01-18 )[ 2023-08-02 ]. http://minds4.jcqhc.or.jp/minds/guideline/pdf/MindsHB2014.pdf http://minds4.jcqhc.or.jp/minds/guideline/pdf/MindsHB2014.pdf .
The American Academy of Neurology . 2017 edition cli-nical practice guideline process manual [EB/OL].( 2017-06-17 )[ 2023-08-02 ]. https://www.aan.com /siteassets/home-page/policy-and-guidelines/guidelines/about-guidelines/17guidelineprocman_pg.pdf https://www.aan.com/siteassets/home-page/policy-and-guidelines/guidelines/about-guidelines/17guidelineprocman_pg.pdf .
Scottish Intercollegiate Guidelines Network . SIGN50: a guideline developer's handbook [EB/OL].( 2019-11-01 )[ 2023-10-02 ]. https://www.sign. ac.uk/media/2038/sign50_2019.pdf https://www.sign.ac.uk/media/2038/sign50_2019.pdf .
HOWELL M . KHA-CARI guidelines development manual [EB/OL].( 2015-02-01 )[ 2023-08-02 ]. https://www.cariguidelines.org/wp-content/uploads/2020/06/KHACARI_Guideline_development_-manual.pdf https://www.cariguidelines.org/wp-content/uploads/2020/06/KHACARI_Guideline_development_-manual.pdf .
British HIV Association . British HIV Association (BHIVA) guideline development manual [EB/OL].( 2011-09-13 )[ 2023-08-02 ]. https://www.bhiva.org/file/jgCacHqmux ZFL/GuidelineDevelopmentManual.pdf.4 https://www.bhiva.org/file/jgCacHqmuxZFL/GuidelineDevelopmentManual.pdf.4 .
赵明娟 , 靳英辉 , 张菁 , 等 . 临床实践指南制定方法:利益冲突的声明和管理 [J]. 中国循证心血管医学杂志 , 2018 , 10 ( 5 ): 513 - 517 .
0
浏览量
4
下载量
2
CSCD
关联资源
相关文章
相关作者
相关机构
京公网安备11010102007558号