Analysis of the current situation of handbooks for Western medicine guideline and traditional Chinese medicine guideline development in China_Chinese Journal of Evidence-Based Medicine

Authors：

ZHANG Juanjuan ¹ , ZHOU Qi ² , WANG Zijun ² , WANG Ping ² , ZHAO Junxian ¹ , LI Bo ^3,4,5 , AN Guanghui ⁶ , GAO Hongyan ⁷ ,  WANG Xiaohui ¹ ,  CHEN Yaolong ^8,9,10,11

1. School of Public Health, Lanzhou University, Lanzhou 730000, P. R. China;
2. Evidence-based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou 730000, P. R. China;
3. Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing 100010, P. R. China;
4. Beijing Institute of Chinese Medicine, Beijing 100010, P. R. China;
5. Beijing Evidence-based Chinese Medicine Center, Beijing 100010, P. R. China;
6. School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, Shanghai 201203, P. R. China;
7. Institute of Science, Technology and Humanities, Shanghai University of Traditional Chinese Medicine, Shanghai 201203, P. R. China;
8. Institute of Health Data Science, Lanzhou University, Lanzhou 730000, P. R. China;
9. Research Unit of Evidence-Based Evaluation and Guidelines, Chinese Academy of Medical Sciences (2021RU017), School of Basic Medical Sciences, Lanzhou University, Lanzhou 730000, P. R. China;
10. WHO Collaborating Center for Guideline Implementation and Knowledge Translation, Lanzhou 730000, P. R. China;
11. Lanzhou University GRADE Center, Lanzhou 730000, P. R. China;

Corresponding author：

WANG Xiaohui, Email: wangxiaohui@lzu.edu.cn; CHEN Yaolong, Email: chevidence@lzu.edu.cn

Keywords：

Handbook for guideline development; Western medicine guideline; Traditional Chinese medicine guideline

DOI：

10.7507/1672-2531.202301053

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Objective To compare the similarities and differences in procedures between Western medicine (WM) and traditional Chinese medicine (TCM) guidelines. Methods We systematically searched China National Knowledge Infrastructure, WanFang Data, China Biology Medicine disc and PubMed from inception to May 17, 2022. Supplementary search of reputable medical institutions and organizations, as well as retrospective references were conducted and screened. We extracted and analyzed the basic information and guideline development procedure of the included handbooks. Results A total of 10 handbooks published from 2013 to 2022 were included, with four WM handbooks and six TCM handbooks. The median completeness of handbooks was 53.3%, with a maximum of 93.3% and a minimum of 43.3%. There are six handbooks with less than 60.0% completeness. The median reporting rate of the key steps was 65.0%, and the reporting rate of 5/8 of the key steps was more than 80.0%. Among the key reporting steps, role of funders, update methods, and conflict of interest management were reported at a low rate. Compared with WM handbooks, TCM handbooks reflected TCM characteristics in the procedure of topic selection, working groups, conflict of interest declaration and management, clinical questions, evidence, recommendations, report guideline, and external review. Conclusion The completeness and reporting rate of the key steps need to be improved. TCM characteristics need to be further integrated when developing TCM guideline handbooks. We highly recommend that guideline stakeholders actively participate in handbook development to promote the quality of handbooks.

Citation： ZHANG Juanjuan, ZHOU Qi, WANG Zijun, WANG Ping, ZHAO Junxian, LI Bo, AN Guanghui, GAO Hongyan, WANG Xiaohui, CHEN Yaolong. Analysis of the current situation of handbooks for Western medicine guideline and traditional Chinese medicine guideline development in China. Chinese Journal of Evidence-Based Medicine, 2023, 23(5): 575-582. doi: 10.7507/1672-2531.202301053 Copy

1.	Institute of Medicine. Clinical practice guidelines we can trust. Washington, DC: The National Academies Press, 2011.
2.	陈耀龙, 罗旭飞, 王吉耀, 等. 如何区分临床实践指南与专家共识. 协和医学杂志, 2019, 10(4): 403-408.
3.	王吉耀. 用临床实践指南的评价标准指导指南的临床应用. 上海医学, 2018, 41(6): 327-328.
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5.	National Institute for Health and Care Excellence. Developing nice guidelines the manual. 2017.
6.	Scottish Intercollegiate Guidelines Network. SIGN 50: a guideline developer’s handbook. SIGN, 2019.
7.	陈耀龙, 杨克虎, 王小钦, 等. 中国制订/修订临床诊疗指南的指导原则(2022版). 中华医学杂志, 2022, 102(10): 697-703.
8.	吕爱平, 谢雁鸣, 韩学杰, 主编. 基于循证医学的中医临床实践指南编制方法与范例. 北京: 中国中医药出版社, 2013.
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12.	靳英辉, 王丹琦, 李艳, 等. 临床实践指南制定方法—国内外临床实践指南制定手册概要. 中国循证心血管医学杂志, 2018, 10(1): 1-10.
13.	Ansari S, Rashidian A. Guidelines for guidelines: are they up to the task. A comparative assessment of clinical practice guideline development handbooks. PLoS One, 2012, 7(11): e49864.
14.	Schünemann HJ, Wiercioch W, Etxeandia I, et al. Guidelines 2. 0:systematic development of a comprehensive checklist for a successful guideline enterprise. CMAJ, 2014, 186(3): E123-E142.
15.	世界中医药学会联合会. 中医(中西医结合)临床实践指南制修订通则系列. 2018.
16.	Chen Y, Yang K, Marušic A, et al. A reporting tool for practice guidelines in health care: the RIGHT statement. Ann Intern Med, 2017, 166(2): 128-132.
17.	Brouwers MC, Kerkvliet K, Spithoff K, et al. The AGREE reporting checklist: a tool to improve reporting of clinical practice guidelines. BMJ, 2016, 352: i1152.
18.	GB/T 40972-2021, 针灸临床实践指南制定及其评估规范.
19.	中华中医药学会. 循证中医药临床实践指南制订的技术流程和规范. 2017.
20.	王小钦, 王吉耀. 循证临床实践指南的制定与实施. 北京: 人民卫生出版社, 2016.
21.	王环行. 循证临床实践指南的研发与评价. 北京: 中国协和医科大学出版社, 2016.
22.	卢传坚, 杨克虎. 中西医结合诊疗指南制定手册. 北京: 人民卫生出版社, 2016.
23.	中华医学会肝病学分会, 中华医学会感染病学分会. 关于临床实践指南制订的规范. 中华肝脏病杂志, 2015, 23(12): 881-887.
24.	中华中医药学会. 中医临床诊疗指南编制通则. 北京: 中国中医药出版社, 2015.
25.	Guyatt GH, Oxman AD, Vist GE, et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ, 2008, 336(7650): 924-926.
26.	刘建平. 传统医学证据体的构成及证据分级的建议. 中国中西医结合杂志, 2007, 27(12): 1061-1065.
27.	Zhou Q, Wang Z, Shi Q, et al. Clinical Epidemiology in China series. Paper 4:the reporting and methodological quality of Chinese clinical practice guidelines published between 2014 and 2018:a systematic review. J Clin Epidemiol, 2021, 140: 189-199.
28.	蒋朱明, 詹思延, 贾晓巍, 等. 制订/修订《临床诊疗指南》的基本方法及程序. 中华医学杂志, 2016, 96(4): 250-253.
29.	汪受传, 陈争光, 徐珊, 等. 建立循证中医临床实践指南证据分级体系的构想. 世界科学技术-中医药现代化, 2013, 15(7): 1488-1492.
30.	李承羽, 赵晨, 陈耀龙, 等. 中医药临床指南/共识中推荐意见分级标准的制订. 中医杂志, 2020, 61(6): 486-492.
31.	Xie R, Xia Y, Chen Y, et al. The RIGHT extension statement for traditional chinese medicine: development, recommendations, and explanation. Pharmacol Res, 2020, 160: 105178.
32.	Tang C, Duan Y, Zhang Y, et al. RIGHT for acupuncture: An extension of the RIGHT statement for clinical practice guidelines on acupuncture. J Clin Epidemiol, 2021, 139: 330-339.
33.	姚钰宁, 曹克刚, 托托, 等. 基于专家问卷的中医古籍证据分级及推荐方法的构建. 中医杂志, 2021, 62(7): 572-576.

1. Institute of Medicine. Clinical practice guidelines we can trust. Washington, DC: The National Academies Press, 2011.
2. 陈耀龙, 罗旭飞, 王吉耀, 等. 如何区分临床实践指南与专家共识. 协和医学杂志, 2019, 10(4): 403-408.
3. 王吉耀. 用临床实践指南的评价标准指导指南的临床应用. 上海医学, 2018, 41(6): 327-328.
4. World Health Organization. WHO handbook for guideline development (2nd edition). 2014.
5. National Institute for Health and Care Excellence. Developing nice guidelines the manual. 2017.
6. Scottish Intercollegiate Guidelines Network. SIGN 50: a guideline developer’s handbook. SIGN, 2019.
7. 陈耀龙, 杨克虎, 王小钦, 等. 中国制订/修订临床诊疗指南的指导原则(2022版). 中华医学杂志, 2022, 102(10): 697-703.
8. 吕爱平, 谢雁鸣, 韩学杰, 主编. 基于循证医学的中医临床实践指南编制方法与范例. 北京: 中国中医药出版社, 2013.
9. Turner T, Misso M, Harris C, et al. Development of evidence-based clinical practice guidelines (CPGs): comparing approaches. Implement Sci, 2008, 3: 45.
10. Schünemann HJ, Fretheim A, Oxman AD, et al. Improving the use of research evidence in guideline development: 1. Guidelines for guidelines. Health Res Policy Syst, 2006, 4: 13.
11. 曾力楠, 李幼平, 张伶俐, 等. 国内外制订临床指南的指南的循证评价. 中国循证医学杂志, 2016, 16(11): 1322-1330.
12. 靳英辉, 王丹琦, 李艳, 等. 临床实践指南制定方法—国内外临床实践指南制定手册概要. 中国循证心血管医学杂志, 2018, 10(1): 1-10.
13. Ansari S, Rashidian A. Guidelines for guidelines: are they up to the task. A comparative assessment of clinical practice guideline development handbooks. PLoS One, 2012, 7(11): e49864.
14. Schünemann HJ, Wiercioch W, Etxeandia I, et al. Guidelines 2. 0:systematic development of a comprehensive checklist for a successful guideline enterprise. CMAJ, 2014, 186(3): E123-E142.
15. 世界中医药学会联合会. 中医(中西医结合)临床实践指南制修订通则系列. 2018.
16. Chen Y, Yang K, Marušic A, et al. A reporting tool for practice guidelines in health care: the RIGHT statement. Ann Intern Med, 2017, 166(2): 128-132.
17. Brouwers MC, Kerkvliet K, Spithoff K, et al. The AGREE reporting checklist: a tool to improve reporting of clinical practice guidelines. BMJ, 2016, 352: i1152.
18. GB/T 40972-2021, 针灸临床实践指南制定及其评估规范.
19. 中华中医药学会. 循证中医药临床实践指南制订的技术流程和规范. 2017.
20. 王小钦, 王吉耀. 循证临床实践指南的制定与实施. 北京: 人民卫生出版社, 2016.
21. 王环行. 循证临床实践指南的研发与评价. 北京: 中国协和医科大学出版社, 2016.
22. 卢传坚, 杨克虎. 中西医结合诊疗指南制定手册. 北京: 人民卫生出版社, 2016.
23. 中华医学会肝病学分会, 中华医学会感染病学分会. 关于临床实践指南制订的规范. 中华肝脏病杂志, 2015, 23(12): 881-887.
24. 中华中医药学会. 中医临床诊疗指南编制通则. 北京: 中国中医药出版社, 2015.
25. Guyatt GH, Oxman AD, Vist GE, et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ, 2008, 336(7650): 924-926.
26. 刘建平. 传统医学证据体的构成及证据分级的建议. 中国中西医结合杂志, 2007, 27(12): 1061-1065.
27. Zhou Q, Wang Z, Shi Q, et al. Clinical Epidemiology in China series. Paper 4:the reporting and methodological quality of Chinese clinical practice guidelines published between 2014 and 2018:a systematic review. J Clin Epidemiol, 2021, 140: 189-199.
28. 蒋朱明, 詹思延, 贾晓巍, 等. 制订/修订《临床诊疗指南》的基本方法及程序. 中华医学杂志, 2016, 96(4): 250-253.
29. 汪受传, 陈争光, 徐珊, 等. 建立循证中医临床实践指南证据分级体系的构想. 世界科学技术-中医药现代化, 2013, 15(7): 1488-1492.
30. 李承羽, 赵晨, 陈耀龙, 等. 中医药临床指南/共识中推荐意见分级标准的制订. 中医杂志, 2020, 61(6): 486-492.
31. Xie R, Xia Y, Chen Y, et al. The RIGHT extension statement for traditional chinese medicine: development, recommendations, and explanation. Pharmacol Res, 2020, 160: 105178.
32. Tang C, Duan Y, Zhang Y, et al. RIGHT for acupuncture: An extension of the RIGHT statement for clinical practice guidelines on acupuncture. J Clin Epidemiol, 2021, 139: 330-339.
33. 姚钰宁, 曹克刚, 托托, 等. 基于专家问卷的中医古籍证据分级及推荐方法的构建. 中医杂志, 2021, 62(7): 572-576.

Chinese Journal of Evidence-Based Medicine

Analysis of the current situation of handbooks for Western medicine guideline and traditional Chinese medicine guideline development in China

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