Research status and progress of core outcome sets in the field of traditional Chinese medicine_Chinese Journal of Evidence-Based Medicine

Authors：

QIU Ruijin ^1,2 , WEI Xuxu ¹ , GUAN Zhiyue ¹ , HU Mingzhi ¹ , WANG Chunxia ³ , SHI Jiyan ³ , WAN Siqi ¹ , ZHANG Xinyi ¹ ,  SHANG Hongcai ¹

1. Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Dongzhimen Hospital, Beijing University of Traditional Chinese Medicine, Beijing 100029, P. R. China;
2. University of Liverpool, Liverpool, L693GL, UK;
3. Beijing University of Chinese Medicine, Beijing 100029, P. R. China;

Corresponding author：

SHANG Hongcai, Email: shanghongcai@foxmail.com

Keywords：

Core outcome set; Traditional Chinese medicine; Study progress

DOI：

10.7507/1672-2531.202209019

Video：

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Objectives With the increasing number of core outcome sets (COS) in traditional Chinese medicine (TCM), some problems gradually emerged, which may affect the popularization and application of COS. This paper analyzes the COS research status in the field of TCM based on registry and literature databases, so that researchers may pay attention to it. Methods Registry platforms and literature databases of Chinese and English were both searched from inception to June, 2022. Qualitative analysis was used to analyze the research status of COS. Results Seventy-two COS studies were identified from registry platforms, and the results showed some problems, such as uneven disease distribution, insufficient attention to TCM characteristics, unclear COS scope, and insufficient patient and public participation. Ninety-nine studies were identified from different databases, only 7.07% (7/99) of the studies were COS results, and few of them were cited by clinical trials and/or systematic reviews. Conclusion The authors proposed that standardizing the registration of COS in the field of TCM, improving the methodology of COS studies, expanding the application settings of COS, and strengthening the cooperation of different stakeholder groups are important to ameliorate sustainable development of COS.

Citation： QIU Ruijin, WEI Xuxu, GUAN Zhiyue, HU Mingzhi, WANG Chunxia, SHI Jiyan, WAN Siqi, ZHANG Xinyi, SHANG Hongcai. Research status and progress of core outcome sets in the field of traditional Chinese medicine. Chinese Journal of Evidence-Based Medicine, 2023, 23(2): 211-220. doi: 10.7507/1672-2531.202209019 Copy

1.	Li X, Zhang J, Huang J, et al. A multicenter, randomized, double-blind, parallel-group, placebo-controlled study of the effects of qili qiangxin capsules in patients with chronic heart failure. J Am Coll Cardiol, 2013, 62(12): 1065-1072.
2.	Song Y, Yao C, Yao Y, et al. XueBiJing injection versus placebo for critically ill patients with severe community-acquired pneumonia: a randomized controlled trial. Crit Care Med, 2019, 47(9): e735-e743.
3.	Wang C, Cao B, Liu QQ, et al. Oseltamivir compared with the Chinese traditional therapy maxingshigan-yinqiaosan in the treatment of H1N1 influenza: a randomized trial. Ann Intern Med, 2011, 155(4): 217-225.
4.	Zhang Y, Chen Y, Niu M, et al. Establishing a core outcome set for neurogenic bladder trials: study protocol for a scoping review and Delphi surveys. Trials, 2022, 23(1): 485.
5.	Gargon E, Gorst SL, Matvienko-Sikar K, et al. Choosing important health outcomes for comparative effectiveness research: 6th annual update to a systematic review of core outcome sets for research. PLoS One, 2021, 16(1): e0244878.
6.	Qiu RJ, Li M, Hu JY, et al. Methods for development of a core outcome set for clinical trials integrating traditional Chinese medicine and Western medicine. J Integr Med, 2021, 19(5): 389-394.
7.	Qiu R, Zhao C, Liang T, et al. Core outcome set for clinical trials of COVID-19 based on traditional Chinese and Western medicine. Front Pharmacol, 2020, 11: 781.
8.	李心怡, 石兆峰, 胡嘉元, 等. 针刺治疗偏头痛核心结局指标集的建立. 世界科学技术-中医药现代化, 2020, 22(1): 7-12.
9.	孙亚男, 何丽云, 雒琳, 等. 中医药治疗慢性乙型肝炎临床试验的核心结局指标集研究. 中华中医药杂志, 2020, 35(9): 4684-4688.
10.	张明妍, 张俊华, 蔡慧姿, 等. 稳定型心绞痛中医药临床试验核心指标集研制. 针灸和草药(英文), 2021, 1(1): 39-48.
11.	杨继, 张垚, 张运娇, 等. 基于主成分分析的中医药治疗慢性心力衰竭临床随机对照试验核心结局指标研究. 中西医结合心脑血管病杂志, 2021, 19(15): 2496-2509,2515.
12.	谢倩文, 肖晶旻, 邓雪仪, 等. 建立中医药治疗缺血性卒中核心结局指标集的初步研究. 中医杂志, 2022, 63(3): 220-228.
13.	邱瑞瑾. 中医临床研究核心指标集的方法构建. 北京: 北京中医药大学, 2018.
14.	邱瑞瑾, 孙杨, 韩松洁, 等. 非瓣膜性房颤中医核心证候指标集的构建. 中国循证医学杂志, 2021, 21(12): 1480-1488.
15.	万颖. 慢性腰痛中医临床研究核心结局指标集的构建. 北京: 北京中医药大学, 2021.
16.	Kirkham JJ, Davis K, Altman DG, et al. Core outcome set-STAndards for development: the COS-STAD recommendations. PLoS Med, 2017, 14(11): e1002447.
17.	邱瑞瑾, 孙杨, 钟长鸣, 等. 中医核心证候指标集的构建思路. 中国循证医学杂志, 2021, 21(11): 1353-1357.
18.	Xiong X. Integrating traditional Chinese medicine into Western cardiovascular medicine: an evidence-based approach. Nat Rev Cardiol, 2015, 12(6): 374.
19.	Evangelidis N, Tong A, Manns B, et al. Developing a set of core outcomes for trials in hemodialysis: an international Delphi survey. Am J Kidney Dis, 2017, 70(4): 464-475.
20.	van 't Hooft J, Duffy JMN, Daly M, et al. A core outcome set for evaluation of interventions to prevent preterm birth. Obstet Gynecol, 2016, 127(1): 49-58.
21.	Taylor J, Böhnke JR, Wright J, et al. A core outcome set for evaluating self-management interventions in people with comorbid diabetes and severe mental illness: study protocol for a modified Delphi study and systematic review. Trials, 2017, 18(1): 70.
22.	Morbey H, Harding AJE, Swarbrick C, et al. Involving people living with dementia in research: an accessible modified Delphi survey for core outcome set development. Trials, 2019, 20(1): 12.
23.	Reilly ST, Harding Aje, Morbey H, et al. What is important to people with dementia living at home? A set of core outcome items for use in the evaluation of non-pharmacological community-based health and social care interventions. Age and Ageing, 2020, 49: 664-671.
24.	中华中医药学会. 中医药重大科学问题和工程技术难题. 中医杂志, 2019, 60(12): 991-1000.
25.	Williamson PR, Altman DG, Bagley H, et al. The COMET handbook: version 1. 0. Trials, 2017, 18(Suppl 3): 280.
26.	邱瑞瑾, 胡嘉元, 李敏, 等. 核心指标集研究方案的标准报告条目解读及不同核心指标集研究报告指南对中医药领域研究的意义. 中国循证医学杂志, 2019, 19(12): 1492-1497.
27.	Boers M, Beaton DE, Shea BJ, et al. OMERACT Filter 2. 1:elaboration of the conceptual framework for outcome measurement in health intervention studies. J Rheumatol, 2019, 46(8): 1021-1027.
28.	Woodworth T, Furst DE, Alten R, et al. Standardizing assessment and reporting of adverse effects in rheumatology clinical trials II: the Rheumatology Common Toxicity Criteria v. 2. 0. J Rheumatol, 2007, 34(6): 1401-1414.
29.	Qiu R, Zhong C, Wan S, et al. Developing a core outcome set for assessing clinical safety outcomes of cardiovascular diseases in clinical trials of integrated traditional Chinese medicine and Western medicine: study protocol. Trials, 2022, 23(1): 239.
30.	邱瑞瑾, 钟长鸣, 关曼柯, 等. 中西药联用临床安全性评价应引入核心指标集. 中国循证医学杂志, 2020, 20(5): 511-514.
31.	Qiu R, Han S, Wei X, et al. Development of a core outcome set for the benefits and adverse events of acute heart failure in clinical trials of traditional Chinese medicine and Western medicine: a study protocol. Front Med (Lausanne), 2021, 8: 677068.
32.	Qiu R, Wan S, Guan Z, et al. The key elements and application of a master protocol in the development of the core outcome set. J Evid Based Med, 2022, 15(4): 320-327.
33.	Williamson PR, de Ávila Oliveira R, Clarke M, et al. Assessing the relevance and uptake of core outcome sets (an agreed minimum collection of outcomes to measure in research studies) in Cochrane systematic reviews: a review. BMJ Open, 2020, 10(9): e036562.
34.	靳英辉, 韩斐, 王强, 等. 临床实践指南制定方法——指南范围、主题及问题的确定. 中国循证心血管医学杂志, 2018, 10(3): 257-261.
35.	李慧, 陈耀龙, 韦当, 等. 中医(中西医结合)临床实践指南制修订方法—临床问题的构建. 中华中医药杂志, 2016, 31(6): 2202-2205.

1. Li X, Zhang J, Huang J, et al. A multicenter, randomized, double-blind, parallel-group, placebo-controlled study of the effects of qili qiangxin capsules in patients with chronic heart failure. J Am Coll Cardiol, 2013, 62(12): 1065-1072.
2. Song Y, Yao C, Yao Y, et al. XueBiJing injection versus placebo for critically ill patients with severe community-acquired pneumonia: a randomized controlled trial. Crit Care Med, 2019, 47(9): e735-e743.
3. Wang C, Cao B, Liu QQ, et al. Oseltamivir compared with the Chinese traditional therapy maxingshigan-yinqiaosan in the treatment of H1N1 influenza: a randomized trial. Ann Intern Med, 2011, 155(4): 217-225.
4. Zhang Y, Chen Y, Niu M, et al. Establishing a core outcome set for neurogenic bladder trials: study protocol for a scoping review and Delphi surveys. Trials, 2022, 23(1): 485.
5. Gargon E, Gorst SL, Matvienko-Sikar K, et al. Choosing important health outcomes for comparative effectiveness research: 6th annual update to a systematic review of core outcome sets for research. PLoS One, 2021, 16(1): e0244878.
6. Qiu RJ, Li M, Hu JY, et al. Methods for development of a core outcome set for clinical trials integrating traditional Chinese medicine and Western medicine. J Integr Med, 2021, 19(5): 389-394.
7. Qiu R, Zhao C, Liang T, et al. Core outcome set for clinical trials of COVID-19 based on traditional Chinese and Western medicine. Front Pharmacol, 2020, 11: 781.
8. 李心怡, 石兆峰, 胡嘉元, 等. 针刺治疗偏头痛核心结局指标集的建立. 世界科学技术-中医药现代化, 2020, 22(1): 7-12.
9. 孙亚男, 何丽云, 雒琳, 等. 中医药治疗慢性乙型肝炎临床试验的核心结局指标集研究. 中华中医药杂志, 2020, 35(9): 4684-4688.
10. 张明妍, 张俊华, 蔡慧姿, 等. 稳定型心绞痛中医药临床试验核心指标集研制. 针灸和草药(英文), 2021, 1(1): 39-48.
11. 杨继, 张垚, 张运娇, 等. 基于主成分分析的中医药治疗慢性心力衰竭临床随机对照试验核心结局指标研究. 中西医结合心脑血管病杂志, 2021, 19(15): 2496-2509,2515.
12. 谢倩文, 肖晶旻, 邓雪仪, 等. 建立中医药治疗缺血性卒中核心结局指标集的初步研究. 中医杂志, 2022, 63(3): 220-228.
13. 邱瑞瑾. 中医临床研究核心指标集的方法构建. 北京: 北京中医药大学, 2018.
14. 邱瑞瑾, 孙杨, 韩松洁, 等. 非瓣膜性房颤中医核心证候指标集的构建. 中国循证医学杂志, 2021, 21(12): 1480-1488.
15. 万颖. 慢性腰痛中医临床研究核心结局指标集的构建. 北京: 北京中医药大学, 2021.
16. Kirkham JJ, Davis K, Altman DG, et al. Core outcome set-STAndards for development: the COS-STAD recommendations. PLoS Med, 2017, 14(11): e1002447.
17. 邱瑞瑾, 孙杨, 钟长鸣, 等. 中医核心证候指标集的构建思路. 中国循证医学杂志, 2021, 21(11): 1353-1357.
18. Xiong X. Integrating traditional Chinese medicine into Western cardiovascular medicine: an evidence-based approach. Nat Rev Cardiol, 2015, 12(6): 374.
19. Evangelidis N, Tong A, Manns B, et al. Developing a set of core outcomes for trials in hemodialysis: an international Delphi survey. Am J Kidney Dis, 2017, 70(4): 464-475.
20. van 't Hooft J, Duffy JMN, Daly M, et al. A core outcome set for evaluation of interventions to prevent preterm birth. Obstet Gynecol, 2016, 127(1): 49-58.
21. Taylor J, Böhnke JR, Wright J, et al. A core outcome set for evaluating self-management interventions in people with comorbid diabetes and severe mental illness: study protocol for a modified Delphi study and systematic review. Trials, 2017, 18(1): 70.
22. Morbey H, Harding AJE, Swarbrick C, et al. Involving people living with dementia in research: an accessible modified Delphi survey for core outcome set development. Trials, 2019, 20(1): 12.
23. Reilly ST, Harding Aje, Morbey H, et al. What is important to people with dementia living at home? A set of core outcome items for use in the evaluation of non-pharmacological community-based health and social care interventions. Age and Ageing, 2020, 49: 664-671.
24. 中华中医药学会. 中医药重大科学问题和工程技术难题. 中医杂志, 2019, 60(12): 991-1000.
25. Williamson PR, Altman DG, Bagley H, et al. The COMET handbook: version 1. 0. Trials, 2017, 18(Suppl 3): 280.
26. 邱瑞瑾, 胡嘉元, 李敏, 等. 核心指标集研究方案的标准报告条目解读及不同核心指标集研究报告指南对中医药领域研究的意义. 中国循证医学杂志, 2019, 19(12): 1492-1497.
27. Boers M, Beaton DE, Shea BJ, et al. OMERACT Filter 2. 1:elaboration of the conceptual framework for outcome measurement in health intervention studies. J Rheumatol, 2019, 46(8): 1021-1027.
28. Woodworth T, Furst DE, Alten R, et al. Standardizing assessment and reporting of adverse effects in rheumatology clinical trials II: the Rheumatology Common Toxicity Criteria v. 2. 0. J Rheumatol, 2007, 34(6): 1401-1414.
29. Qiu R, Zhong C, Wan S, et al. Developing a core outcome set for assessing clinical safety outcomes of cardiovascular diseases in clinical trials of integrated traditional Chinese medicine and Western medicine: study protocol. Trials, 2022, 23(1): 239.
30. 邱瑞瑾, 钟长鸣, 关曼柯, 等. 中西药联用临床安全性评价应引入核心指标集. 中国循证医学杂志, 2020, 20(5): 511-514.
31. Qiu R, Han S, Wei X, et al. Development of a core outcome set for the benefits and adverse events of acute heart failure in clinical trials of traditional Chinese medicine and Western medicine: a study protocol. Front Med (Lausanne), 2021, 8: 677068.
32. Qiu R, Wan S, Guan Z, et al. The key elements and application of a master protocol in the development of the core outcome set. J Evid Based Med, 2022, 15(4): 320-327.
33. Williamson PR, de Ávila Oliveira R, Clarke M, et al. Assessing the relevance and uptake of core outcome sets (an agreed minimum collection of outcomes to measure in research studies) in Cochrane systematic reviews: a review. BMJ Open, 2020, 10(9): e036562.
34. 靳英辉, 韩斐, 王强, 等. 临床实践指南制定方法——指南范围、主题及问题的确定. 中国循证心血管医学杂志, 2018, 10(3): 257-261.
35. 李慧, 陈耀龙, 韦当, 等. 中医(中西医结合)临床实践指南制修订方法—临床问题的构建. 中华中医药杂志, 2016, 31(6): 2202-2205.

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