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. 針刺治療偏頭痛核心結局指標集的建立. 世界科學技術-中醫藥現代化, 2020, 22(1): 7-12.
9.	孫亞男, 何麗云, 雒琳, 等. 中醫藥治療慢性乙型肝炎臨床試驗的核心結局指標集研究. 中華中醫藥雜志, 2020, 35(9): 4684-4688.
10.	張明妍, 張俊華, 蔡慧姿, 等. 穩定型心絞痛中醫藥臨床試驗核心指標集研制. 針灸和草藥(英文), 2021, 1(1): 39-48.
11.	楊繼, 張垚, 張運嬌, 等. 基于主成分分析的中醫藥治療慢性心力衰竭臨床隨機對照試驗核心結局指標研究. 中西醫結合心腦血管病雜志, 2021, 19(15): 2496-2509,2515.
12.	謝倩文, 肖晶旻, 鄧雪儀, 等. 建立中醫藥治療缺血性卒中核心結局指標集的初步研究. 中醫雜志, 2022, 63(3): 220-228.
13.	邱瑞瑾. 中醫臨床研究核心指標集的方法構建. 北京: 北京中醫藥大學, 2018.
14.	邱瑞瑾, 孫楊, 韓松潔, 等. 非瓣膜性房顫中醫核心證候指標集的構建. 中國循證醫學雜志, 2021, 21(12): 1480-1488.
15.	萬穎. 慢性腰痛中醫臨床研究核心結局指標集的構建. 北京: 北京中醫藥大學, 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, 孫楊, 鐘長鳴, 等. 中醫核心證候指標集的構建思路. 中國循證醫學雜志, 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, B?hnke 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.	中華中醫藥學會. 中醫藥重大科學問題和工程技術難題. 中醫雜志, 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. 核心指標集研究方案的標準報告條目解讀及不同核心指標集研究報告指南對中醫藥領域研究的意義. 中國循證醫學雜志, 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, 鐘長鳴, 關曼柯, 等. 中西藥聯用臨床安全性評價應引入核心指標集. 中國循證醫學雜志, 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.	靳英輝, 韓斐, 王強, 等. 臨床實踐指南制定方法——指南范圍、主題及問題的確定. 中國循證心血管醫學雜志, 2018, 10(3): 257-261.
35.	李慧, 陳耀龍, 韋當, 等. 中醫(中西醫結合)臨床實踐指南制修訂方法—臨床問題的構建. 中華中醫藥雜志, 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. 針刺治療偏頭痛核心結局指標集的建立. 世界科學技術-中醫藥現代化, 2020, 22(1): 7-12.
9. 孫亞男, 何麗云, 雒琳, 等. 中醫藥治療慢性乙型肝炎臨床試驗的核心結局指標集研究. 中華中醫藥雜志, 2020, 35(9): 4684-4688.
10. 張明妍, 張俊華, 蔡慧姿, 等. 穩定型心絞痛中醫藥臨床試驗核心指標集研制. 針灸和草藥(英文), 2021, 1(1): 39-48.
11. 楊繼, 張垚, 張運嬌, 等. 基于主成分分析的中醫藥治療慢性心力衰竭臨床隨機對照試驗核心結局指標研究. 中西醫結合心腦血管病雜志, 2021, 19(15): 2496-2509,2515.
12. 謝倩文, 肖晶旻, 鄧雪儀, 等. 建立中醫藥治療缺血性卒中核心結局指標集的初步研究. 中醫雜志, 2022, 63(3): 220-228.
13. 邱瑞瑾. 中醫臨床研究核心指標集的方法構建. 北京: 北京中醫藥大學, 2018.
14. 邱瑞瑾, 孫楊, 韓松潔, 等. 非瓣膜性房顫中醫核心證候指標集的構建. 中國循證醫學雜志, 2021, 21(12): 1480-1488.
15. 萬穎. 慢性腰痛中醫臨床研究核心結局指標集的構建. 北京: 北京中醫藥大學, 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, 孫楊, 鐘長鳴, 等. 中醫核心證候指標集的構建思路. 中國循證醫學雜志, 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, B?hnke 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. 中華中醫藥學會. 中醫藥重大科學問題和工程技術難題. 中醫雜志, 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. 核心指標集研究方案的標準報告條目解讀及不同核心指標集研究報告指南對中醫藥領域研究的意義. 中國循證醫學雜志, 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, 鐘長鳴, 關曼柯, 等. 中西藥聯用臨床安全性評價應引入核心指標集. 中國循證醫學雜志, 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. 靳英輝, 韓斐, 王強, 等. 臨床實踐指南制定方法——指南范圍、主題及問題的確定. 中國循證心血管醫學雜志, 2018, 10(3): 257-261.
35. 李慧, 陳耀龍, 韋當, 等. 中醫(中西醫結合)臨床實踐指南制修訂方法—臨床問題的構建. 中華中醫藥雜志, 2016, 31(6): 2202-2205.

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