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

Video：

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Abstract Full text Figures/Tables Video References Cited by

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.	陳耀龍, 羅旭飛, 王吉耀, 等. 如何區分臨床實踐指南與專家共識. 協和醫學雜志, 2019, 10(4): 403-408.
3.	王吉耀. 用臨床實踐指南的評價標準指導指南的臨床應用. 上海醫學, 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.	陳耀龍, 楊克虎, 王小欽, 等. 中國制訂/修訂臨床診療指南的指導原則(2022版). 中華醫學雜志, 2022, 102(10): 697-703.
8.	呂愛平, 謝雁鳴, 韓學杰, 主編. 基于循證醫學的中醫臨床實踐指南編制方法與范例. 北京: 中國中醫藥出版社, 2013.
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11.	曾力楠, 李幼平, 張伶俐, 等. 國內外制訂臨床指南的指南的循證評價. 中國循證醫學雜志, 2016, 16(11): 1322-1330.
12.	靳英輝, 王丹琦, 李艷, 等. 臨床實踐指南制定方法—國內外臨床實踐指南制定手冊概要. 中國循證心血管醫學雜志, 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.	世界中醫藥學會聯合會. 中醫(中西醫結合)臨床實踐指南制修訂通則系列. 2018.
16.	Chen Y, Yang K, Maru?ic 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, 針灸臨床實踐指南制定及其評估規范.
19.	中華中醫藥學會. 循證中醫藥臨床實踐指南制訂的技術流程和規范. 2017.
20.	王小欽, 王吉耀. 循證臨床實踐指南的制定與實施. 北京: 人民衛生出版社, 2016.
21.	王環行. 循證臨床實踐指南的研發與評價. 北京: 中國協和醫科大學出版社, 2016.
22.	盧傳堅, 楊克虎. 中西醫結合診療指南制定手冊. 北京: 人民衛生出版社, 2016.
23.	中華醫學會肝病學分會, 中華醫學會感染病學分會. 關于臨床實踐指南制訂的規范. 中華肝臟病雜志, 2015, 23(12): 881-887.
24.	中華中醫藥學會. 中醫臨床診療指南編制通則. 北京: 中國中醫藥出版社, 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.	劉建平. 傳統醫學證據體的構成及證據分級的建議. 中國中西醫結合雜志, 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.	蔣朱明, 詹思延, 賈曉巍, 等. 制訂/修訂《臨床診療指南》的基本方法及程序. 中華醫學雜志, 2016, 96(4): 250-253.
29.	汪受傳, 陳爭光, 徐珊, 等. 建立循證中醫臨床實踐指南證據分級體系的構想. 世界科學技術-中醫藥現代化, 2013, 15(7): 1488-1492.
30.	李承羽, 趙晨, 陳耀龍, 等. 中醫藥臨床指南/共識中推薦意見分級標準的制訂. 中醫雜志, 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.	姚鈺寧, 曹克剛, 托托, 等. 基于專家問卷的中醫古籍證據分級及推薦方法的構建. 中醫雜志, 2021, 62(7): 572-576.

1. Institute of Medicine. Clinical practice guidelines we can trust. Washington, DC: The National Academies Press, 2011.
2. 陳耀龍, 羅旭飛, 王吉耀, 等. 如何區分臨床實踐指南與專家共識. 協和醫學雜志, 2019, 10(4): 403-408.
3. 王吉耀. 用臨床實踐指南的評價標準指導指南的臨床應用. 上海醫學, 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. 陳耀龍, 楊克虎, 王小欽, 等. 中國制訂/修訂臨床診療指南的指導原則(2022版). 中華醫學雜志, 2022, 102(10): 697-703.
8. 呂愛平, 謝雁鳴, 韓學杰, 主編. 基于循證醫學的中醫臨床實踐指南編制方法與范例. 北京: 中國中醫藥出版社, 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, 張伶俐, 等. 國內外制訂臨床指南的指南的循證評價. 中國循證醫學雜志, 2016, 16(11): 1322-1330.
12. 靳英輝, 王丹琦, 李艷, 等. 臨床實踐指南制定方法—國內外臨床實踐指南制定手冊概要. 中國循證心血管醫學雜志, 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. 世界中醫藥學會聯合會. 中醫(中西醫結合)臨床實踐指南制修訂通則系列. 2018.
16. Chen Y, Yang K, Maru?ic 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, 針灸臨床實踐指南制定及其評估規范.
19. 中華中醫藥學會. 循證中醫藥臨床實踐指南制訂的技術流程和規范. 2017.
20. 王小欽, 王吉耀. 循證臨床實踐指南的制定與實施. 北京: 人民衛生出版社, 2016.
21. 王環行. 循證臨床實踐指南的研發與評價. 北京: 中國協和醫科大學出版社, 2016.
22. 盧傳堅, 楊克虎. 中西醫結合診療指南制定手冊. 北京: 人民衛生出版社, 2016.
23. 中華醫學會肝病學分會, 中華醫學會感染病學分會. 關于臨床實踐指南制訂的規范. 中華肝臟病雜志, 2015, 23(12): 881-887.
24. 中華中醫藥學會. 中醫臨床診療指南編制通則. 北京: 中國中醫藥出版社, 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. 劉建平. 傳統醫學證據體的構成及證據分級的建議. 中國中西醫結合雜志, 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. 蔣朱明, 詹思延, 賈曉巍, 等. 制訂/修訂《臨床診療指南》的基本方法及程序. 中華醫學雜志, 2016, 96(4): 250-253.
29. 汪受傳, 陳爭光, 徐珊, 等. 建立循證中醫臨床實踐指南證據分級體系的構想. 世界科學技術-中醫藥現代化, 2013, 15(7): 1488-1492.
30. 李承羽, 趙晨, 陳耀龍, 等. 中醫藥臨床指南/共識中推薦意見分級標準的制訂. 中醫雜志, 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. 姚鈺寧, 曹克剛, 托托, 等. 基于專家問卷的中醫古籍證據分級及推薦方法的構建. 中醫雜志, 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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