Construction of multi-source evidence body of evidence-based clinical practice guidelines for traditional Chinese medicine_Chinese Journal of Evidence-Based Medicine

Authors：

GAO Yicheng ^1,2,3 , LIU Zhihan ^1,2,3 , CAO Rui ^1,2,3 , FENG Yuting ^1,2,3 , CHAI Qianyun ^1,2,3 , LUO Minjing ^1,2,3 , XIA Ruyu ^1,2,3 ,  FEI Yutong ^1,2,3

1. Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing 100029, P. R. China;
2. Institute for Excellence in Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing 100029, P. R. China;
3. Beijing GRADE Center, Beijing University of Chinese Medicine, Beijing 100029, P. R. China;

Corresponding author：

FEI Yutong, Email: yutong_fei@163.com

Keywords：

Multi-source evidence body; Circumstances of evidence; Logic of evidence; Expert evidence; Evidence mapping; Clinical practice guideline

DOI：

10.7507/1672-2531.202302069

Video：

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Clinical practice guidelines will be incorporated in different evidence sources and evidence types, the research and exploration of multiple sources of evidence at China and foreign, this paper advocates the construction of both characteristics of multi-source evidence of traditional Chinese medicine, by combing 70 guide manuals, analyze the necessity and advantages of multi-source evidence construction, and further from the multi-source evidence source and evidence logic theory interpretation and application, in order to provide methodological references for the formulation of evidence-based clinical practice guidelines of traditional Chinese medicine.

Citation： GAO Yicheng, LIU Zhihan, CAO Rui, FENG Yuting, CHAI Qianyun, LUO Minjing, XIA Ruyu, FEI Yutong. Construction of multi-source evidence body of evidence-based clinical practice guidelines for traditional Chinese medicine. Chinese Journal of Evidence-Based Medicine, 2023, 23(6): 731-737. doi: 10.7507/1672-2531.202302069 Copy

1.	Institute of Medicine. Clinical practice guidelines we can trust. Washington (DC): National Academies Press (US), 2011.
2.	Sackett DL, Straus SE, Richardson WS, et al. How to practice and teach EBM (2nd edition). Edinburgh: Churchill Livingstone, 2000.
3.	Djulbegovic B, Hozo I, Li SA, et al. Certainty of evidence and intervention's benefits and harms are key determinants of guidelines' recommendations. J Clin Epidemiol, 2021, 136: 1-9.
4.	Minozzi S, Morgano GP, Scattoni ML, et al. GRADE notes 2: criteria for searching non-randomized or indirect evidence should be defined early in the guideline production process. J Clin Epidemiol, 2021, 139: 210-213.
5.	Monagle P, Cuello CA, Augustine C, et al. American society of hematology 2018 guidelines for management of venous thromboembolism: treatment of pediatric venous thromboembolism. Blood Adv, 2018, 2(22): 3292-3316.
6.	Ferreira JC, Patino CM. Choosing wisely between randomized controlled trials and observational designs in studies about interventions. J Bras Pneumol, 2016, 42(3): 165.
7.	廖星, 谢雁鸣, 王永炎, 等. 药品安全性证据分级分类探索研究—构建中药上市后安全性证据体. 中国中药杂志, 2015, 40(24): 4723-4727.
8.	卢姝亚, 赵思雅, 吴守媛, 等. 2019年期刊公开发表的中国临床实践指南文献调查与评价—证据质量和推荐强度. 协和医学杂志, 2022, 13(1): 130-137.
9.	杨楠, 陈耀龙. 2019年期刊公开发表的中国临床实践指南现状评价. 协和医学杂志, 2021, 12(3): 407-410.
10.	American Society of Clinical Oncology (ASCO). Methodology manual. 2021.
11.	Infectious Diseases Society of America. Handbook on clinical practice guideline development. 2021.
12.	Minds Guideline Center, Japan Council for Quality Health Care (2021). Minds handbook for clinical practice guideline development. 2021.
13.	U. S. Preventive Services Task Force. Procedure manual. 2021.
14.	National Institute for Health and Care Excellence (NICE). Developing NICE guidelines the manual. 2020.
15.	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. 中国研究型医院, 2020, 7(3): 93-97.
16.	胡琳莉, 黄国宁, 孙海翔, 等. CSRM指南共识的制定规范(2016). 生殖医学杂志, 2017, 26(4): 289-301.
17.	Neumann I, Schünemann HJ. Guideline groups should make recommendations even if the evidence is considered insufficient. CMAJ, 2020, 192(2): E23-E24.
18.	Robinson KA, Saldanha IJ, McKoy NA. Identification of research gaps from evidence-based guidelines: a pilot study in cystic fibrosis. Int J Technol Assess Health Care, 2011, 27(3): 247-252.
19.	Horton LG, Folger SG, Berry-Bibee E, et al. Research gaps from evidence-based contraception guidance: the US medical eligibility criteria for contraceptive use, 2016, and the US selected practice recommendations for contraceptive use, 2016. Contraception, 2016, 94(6): 582-589.
20.	Schünemann HJ, Mustafa R, Brozek J, et al. GRADE guidelines: 16. GRADE evidence to decision frameworks for tests in clinical practice and public health. J Clin Epidemiol, 2016, 76: 89-98.
21.	段碧芳, 刘建平. 中医人文特征与循证医学评价方法. 中医杂志, 2007, 48(4): 314-316.
22.	李焕芹, 邹忆怀, 姚钰宁, 等. 古籍循证在中医临床实践指南制订中的应用. 中国循证医学杂志, 2018, 18(2): 225-229.
23.	丁楠, 武晓冬, 赵楠琦, 等. 中医古籍文献分级和推荐体系的发展现状. 中华中医药杂志, 2021, 36(10): 6014-6017.
24.	张磊, 佟琳, 曾宪涛, 等. 中医古籍证据循证评价标准研究现状. 中国中医药图书情报杂志, 2021, 45(5): 66-69.
25.	占茂林, 张宇, 陈迪, 等. 中医传承模式及名老中医学术思想传承方法述评. 卫生职业教育, 2022, 40(4): 10-12.
26.	于河, 鲜馥阳, 费宇彤, 等. 开展真实世界名老中医经验传承病例系列研究方法要点. 中华中医药杂志, 2021, 36(8): 4451-4455.
27.	Legault K, Schunemann H, Hillis C, et al. McMaster RARE-Best practices clinical practice guideline on diagnosis and management of the catastrophic antiphospholipid syndrome. J Thromb Haemost, 2018, 16(8): 1656-1664.
28.	Pai M, Santesso N, Yeung CH, et al. Methodology for the development of the NHF-McMaster guideline on care models for haemophilia management. Haemophilia, 2016, 22(Suppl 3): 17-22.
29.	Nesrallah GE, Mustafa RA, MacRae J, et al. Canadian Society of Nephrology guidelines for the management of patients with ESRD treated with intensive hemodialysis. Am J Kidney Dis, 2013, 62(1): 187-198.
30.	Schünemann HJ, Zhang Y, Oxman AD, et al. Distinguishing opinion from evidence in guidelines. BMJ, 2019, 366: l4606.
31.	Mustafa RA, Garcia CAC, Bhatt M, et al. GRADE notes: how to use GRADE when there is "no" evidence. A case study of the expert evidence approach. J Clin Epidemiol, 2021, 137: 231-235.
32.	Scottish Intercollegiate Guidelines Network. A guideline developer's handbook. 2019.
33.	SUNY Downstate EBM Tutorial. Guide to research methods: the evidence pyramid. 2019.
34.	Rosenfeld RM, Shiffman RN, Robertson P, et al. Clinical practice guideline development manual, third edition: a quality-driven approach for translating evidence into action. Otolaryngol Head Neck Surg, 2013, 148(1 Suppl): S1-S55.
35.	American Academy of Neurology. Clinical practice guideline process manual. 2017.
36.	李楠, 金鑫瑶, 庞稳泰, 等. 2016—2019年中医药临床指南引文和证据类型分析. 中医杂志, 2021, 62(12): 1086-1091.
37.	姚亮. 中医药临床实践指南方法学质量研究. 兰州: 兰州大学, 2016.
38.	常文婧, 刘建平, 陈薇. 名老中医专家意见在中医药临床实践指南制订中的应用. 中国中西医结合杂志, 2022, 42(9): 1118-1123.
39.	刘辉, 兰慧, 赵思雅, 等. 2019年期刊公开发表的中国临床实践指南文献调查与评价—研究空白. 协和医学杂志, 2022, 13(3): 498-505.
40.	胡静, 王小语, 陈仲杰, 等. 基于《偏头痛针灸临床实践指南》国际标准研制探讨针灸治疗偏头痛随机对照试验存在问题. 中国针灸, 2022, 42(1): 91-95.
41.	夏如玉, 李迅, 王丽琼, 等. 随机对照试验在外科领域应用的指南对中医药循证实践和科研的启示. 中医杂志, 2017, 58(22): 1915-1919.

1. Institute of Medicine. Clinical practice guidelines we can trust. Washington (DC): National Academies Press (US), 2011.
2. Sackett DL, Straus SE, Richardson WS, et al. How to practice and teach EBM (2nd edition). Edinburgh: Churchill Livingstone, 2000.
3. Djulbegovic B, Hozo I, Li SA, et al. Certainty of evidence and intervention's benefits and harms are key determinants of guidelines' recommendations. J Clin Epidemiol, 2021, 136: 1-9.
4. Minozzi S, Morgano GP, Scattoni ML, et al. GRADE notes 2: criteria for searching non-randomized or indirect evidence should be defined early in the guideline production process. J Clin Epidemiol, 2021, 139: 210-213.
5. Monagle P, Cuello CA, Augustine C, et al. American society of hematology 2018 guidelines for management of venous thromboembolism: treatment of pediatric venous thromboembolism. Blood Adv, 2018, 2(22): 3292-3316.
6. Ferreira JC, Patino CM. Choosing wisely between randomized controlled trials and observational designs in studies about interventions. J Bras Pneumol, 2016, 42(3): 165.
7. 廖星, 谢雁鸣, 王永炎, 等. 药品安全性证据分级分类探索研究—构建中药上市后安全性证据体. 中国中药杂志, 2015, 40(24): 4723-4727.
8. 卢姝亚, 赵思雅, 吴守媛, 等. 2019年期刊公开发表的中国临床实践指南文献调查与评价—证据质量和推荐强度. 协和医学杂志, 2022, 13(1): 130-137.
9. 杨楠, 陈耀龙. 2019年期刊公开发表的中国临床实践指南现状评价. 协和医学杂志, 2021, 12(3): 407-410.
10. American Society of Clinical Oncology (ASCO). Methodology manual. 2021.
11. Infectious Diseases Society of America. Handbook on clinical practice guideline development. 2021.
12. Minds Guideline Center, Japan Council for Quality Health Care (2021). Minds handbook for clinical practice guideline development. 2021.
13. U. S. Preventive Services Task Force. Procedure manual. 2021.
14. National Institute for Health and Care Excellence (NICE). Developing NICE guidelines the manual. 2020.
15. 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. 中国研究型医院, 2020, 7(3): 93-97.
16. 胡琳莉, 黄国宁, 孙海翔, 等. CSRM指南共识的制定规范(2016). 生殖医学杂志, 2017, 26(4): 289-301.
17. Neumann I, Schünemann HJ. Guideline groups should make recommendations even if the evidence is considered insufficient. CMAJ, 2020, 192(2): E23-E24.
18. Robinson KA, Saldanha IJ, McKoy NA. Identification of research gaps from evidence-based guidelines: a pilot study in cystic fibrosis. Int J Technol Assess Health Care, 2011, 27(3): 247-252.
19. Horton LG, Folger SG, Berry-Bibee E, et al. Research gaps from evidence-based contraception guidance: the US medical eligibility criteria for contraceptive use, 2016, and the US selected practice recommendations for contraceptive use, 2016. Contraception, 2016, 94(6): 582-589.
20. Schünemann HJ, Mustafa R, Brozek J, et al. GRADE guidelines: 16. GRADE evidence to decision frameworks for tests in clinical practice and public health. J Clin Epidemiol, 2016, 76: 89-98.
21. 段碧芳, 刘建平. 中医人文特征与循证医学评价方法. 中医杂志, 2007, 48(4): 314-316.
22. 李焕芹, 邹忆怀, 姚钰宁, 等. 古籍循证在中医临床实践指南制订中的应用. 中国循证医学杂志, 2018, 18(2): 225-229.
23. 丁楠, 武晓冬, 赵楠琦, 等. 中医古籍文献分级和推荐体系的发展现状. 中华中医药杂志, 2021, 36(10): 6014-6017.
24. 张磊, 佟琳, 曾宪涛, 等. 中医古籍证据循证评价标准研究现状. 中国中医药图书情报杂志, 2021, 45(5): 66-69.
25. 占茂林, 张宇, 陈迪, 等. 中医传承模式及名老中医学术思想传承方法述评. 卫生职业教育, 2022, 40(4): 10-12.
26. 于河, 鲜馥阳, 费宇彤, 等. 开展真实世界名老中医经验传承病例系列研究方法要点. 中华中医药杂志, 2021, 36(8): 4451-4455.
27. Legault K, Schunemann H, Hillis C, et al. McMaster RARE-Best practices clinical practice guideline on diagnosis and management of the catastrophic antiphospholipid syndrome. J Thromb Haemost, 2018, 16(8): 1656-1664.
28. Pai M, Santesso N, Yeung CH, et al. Methodology for the development of the NHF-McMaster guideline on care models for haemophilia management. Haemophilia, 2016, 22(Suppl 3): 17-22.
29. Nesrallah GE, Mustafa RA, MacRae J, et al. Canadian Society of Nephrology guidelines for the management of patients with ESRD treated with intensive hemodialysis. Am J Kidney Dis, 2013, 62(1): 187-198.
30. Schünemann HJ, Zhang Y, Oxman AD, et al. Distinguishing opinion from evidence in guidelines. BMJ, 2019, 366: l4606.
31. Mustafa RA, Garcia CAC, Bhatt M, et al. GRADE notes: how to use GRADE when there is "no" evidence. A case study of the expert evidence approach. J Clin Epidemiol, 2021, 137: 231-235.
32. Scottish Intercollegiate Guidelines Network. A guideline developer's handbook. 2019.
33. SUNY Downstate EBM Tutorial. Guide to research methods: the evidence pyramid. 2019.
34. Rosenfeld RM, Shiffman RN, Robertson P, et al. Clinical practice guideline development manual, third edition: a quality-driven approach for translating evidence into action. Otolaryngol Head Neck Surg, 2013, 148(1 Suppl): S1-S55.
35. American Academy of Neurology. Clinical practice guideline process manual. 2017.
36. 李楠, 金鑫瑶, 庞稳泰, 等. 2016—2019年中医药临床指南引文和证据类型分析. 中医杂志, 2021, 62(12): 1086-1091.
37. 姚亮. 中医药临床实践指南方法学质量研究. 兰州: 兰州大学, 2016.
38. 常文婧, 刘建平, 陈薇. 名老中医专家意见在中医药临床实践指南制订中的应用. 中国中西医结合杂志, 2022, 42(9): 1118-1123.
39. 刘辉, 兰慧, 赵思雅, 等. 2019年期刊公开发表的中国临床实践指南文献调查与评价—研究空白. 协和医学杂志, 2022, 13(3): 498-505.
40. 胡静, 王小语, 陈仲杰, 等. 基于《偏头痛针灸临床实践指南》国际标准研制探讨针灸治疗偏头痛随机对照试验存在问题. 中国针灸, 2022, 42(1): 91-95.
41. 夏如玉, 李迅, 王丽琼, 等. 随机对照试验在外科领域应用的指南对中医药循证实践和科研的启示. 中医杂志, 2017, 58(22): 1915-1919.

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Construction of multi-source evidence body of evidence-based clinical practice guidelines for traditional Chinese medicine

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