A scoping review of the core outcome set research in traditional Chinese medicine_Chinese Journal of Evidence-Based Medicine

Authors：

QIU Xingying ¹ , TANG Qi ¹ , CAO Wencong ¹ , LIU Bingqing ¹ ,  WEN Zehuai ^2,3,4 ,  LI Geng ^2,3

1. The Second Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou 510405, P. R. China;
2. State Key Laboratory of Dampness Syndrome of Chinese Medicine, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510120, P. R. China;
3. Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510120, P. R. China;
4. Science and Technology Innovation Center, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510405, P. R. China;

Corresponding author：

WEN Zehuai, Email: wenzh@gzucm.edu.cn; LI Geng, Email: ligeng@gzucm.edu.cn

Keywords：

Traditional Chinese medicine; Core outcome set; Scoping review

DOI：

10.7507/1672-2531.202306122

Video：

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Objective To summarize the current studies of the core outcome set of traditional Chinese medicine (COS-TCM) and analyze their possible problems. Methods The CNKI, WanFang Data, VIP, PubMed, Web of Science, Embase, and Cochrane Library databases were electronically searched to collect studies from inception to April 18, 2023. The relevant characteristics of the included studies were extracted, and the development steps, stakeholders, and outcomes of COS-TCM were analyzed. Results A total of 28 COS-TCM studies were included. Two studies, only published systematic reviews without providing more information, were excluded from the analysis. Among the 26 studies for analysis, 25 studies (96.15%) used a mixture of methods to develop COS-TCM. Clinicians (n=25) were the most common participants, followed by methodologists and patients. Fifteen studies (57.69%) reported measures to help patients better participate. Twelve consensus definitions were found in the included studies, of which 14 studies' consensus definitions were divided into three levels:"consensus in", "consensus out", and "no consensus". Among the 14 studies that reported the final COS-TCM results, only 4 studies recommended Chinese medicine characteristic outcomes. For the measurement of outcomes, 14 studies (53.85%) made plans for the selection of tools. Conclusion The current COS-TCM research has made some progress, and the common developing methods are roughly the same as those nationally used. However, there are still some problems, such as inadequate and low-transparency reports, lack of TCM characteristic outcomes, and so on. We suggest that future COS-TCM studies should refer to COS-STAP, COS-STAR, COS-STAD, and other international standards as well as emphasize the advantages of TCM during development and reporting so that it can improve the transparency of developing methods, research quality, and the proportion of TCM characteristics of the final COS.

Citation： QIU Xingying, TANG Qi, CAO Wencong, LIU Bingqing, WEN Zehuai, LI Geng. A scoping review of the core outcome set research in traditional Chinese medicine. Chinese Journal of Evidence-Based Medicine, 2023, 23(12): 1419-1427. doi: 10.7507/1672-2531.202306122 Copy

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2.	赵琼, 张俊龙, 窦志芳. 中医疗效评价的现状分析与解决思路探析. 中华中医药杂志, 2023, 38(2): 772-774.
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6.	COMET Initiative. Core outcome set for stable angina pectoris in traditional Chinese medicine (COS-SAP-TCM).
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8.	邱瑞瑾, 魏旭煦, 关之玥, 等. 中医药领域核心指标集研究现状及展望. 中国循证医学杂志, 2023, 23(2): 211-220.
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1. 符宇, 邵明义, 赵瑞霞, 等. 基于中医证据的中医临床疗效评价方法探讨. 中医杂志, 2020, 61(13): 1124-1129.
2. 赵琼, 张俊龙, 窦志芳. 中医疗效评价的现状分析与解决思路探析. 中华中医药杂志, 2023, 38(2): 772-774.
3. 代欣玥, 訾明杰, 杨巧宁, 等. 基于文献的中医药临床研究结局指标现状分析及思考. 中医杂志, 2022, 63(12): 1122-1127.
4. Williamson PR, Altman DG, Blazeby JM, et al. Developing core outcome sets for clinical trials: issues to consider. Trials, 2012, 13: 132.
5. 邢冬梅, 张俊华, 张伯礼. 中医临床研究核心结局指标集形成路径. 中华中医药杂志, 2014, 29(5): 1352-1355.
6. COMET Initiative. Core outcome set for stable angina pectoris in traditional Chinese medicine (COS-SAP-TCM).
7. Zhang L, Zhang J, Chen J, et al. Clinical research of traditional Chinese medicine needs to develop its own system of core outcome sets. Evid Based Complement Alternat Med, 2013, 2013: 202703.
8. 邱瑞瑾, 魏旭煦, 关之玥, 等. 中医药领域核心指标集研究现状及展望. 中国循证医学杂志, 2023, 23(2): 211-220.
9. 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.
10. 卞薇, 陈慧, 宋国敏, 等. 概况性评价简介. 中国循证医学杂志, 2017, 17(4): 488-493.
11. 孙亚男, 于长禾, 杨洋, 等. 基于系统评价与专家共识建立中医治疗乙肝的核心结局指标集: 方案. 沈阳: 世界中联伦理审查委员会第四届学术年会暨世界中联临床疗效评价专业委员会第八届学术年会, 2014.
12. 李凯, 张俊华, 蔡慧姿, 等. 中药注射剂治疗非小细胞肺癌临床试验结局指标文献研究. 天津中医药, 2021, 38(2): 209-212.
13. 王子衿, 孙伟伟, 张颖思, 等. 中医药治疗子宫内膜异位症随机对照试验结局指标与测量工具的现状分析. 中国中药杂志, 2023, 48(16): 4521-4528.
14. 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.
15. 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.
16. 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.
17. Jin X, Pang B, Zhang J, et al. Core outcome set for clinical trials on coronavirus disease 2019 (COS-COVID). Engineering (Beijing), 2020, 6(10): 1147-1152.
18. 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.
19. 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.
20. 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.
21. Qiu R, Zhong C, Han S, et al. Development of a core outcome set for myocardial infarction in clinical trials of traditional Chinese medicine: a study protocol. BMJ Open, 2019, 9(12): e032256.
22. Zhang M, Zhang J, Chua H, et al. Core outcome set for stable angina pectoris in traditional Chinese medicine (COS-SAP-TCM). Acupunct Herb Med, 2021, 1(1): 39-48.
23. 白杨, 宏亚丽, 陈波, 等. 针灸治疗粘连性肩关节囊炎临床研究核心结局指标集的构建方法. 中国针灸, 2023, 43(6): 701-705.
24. 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.
25. 嵇鑫陈. 中医药治疗重症肌无力的临床研究核心指标集构建研究. 长春: 长春中医药大学, 2022.
26. 秦懿囡, 徐天宇, 李泽鑫, 等. 初步构建针刺治疗特发性面神经麻痹核心结局指标集. 世界科学技术-中医药现代化, 2023, 25(3): 1069-1077.
27. 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.
28. 李凯. 中医药治疗肺癌核心指标集研究. 天津: 天津中医药大学, 2021.
29. Sheng X, Chen C, Ji Z, et al. Development of a core outcome set on traditional Chinese medicine and Western medicine for rheumatic heart disease: a study protocol. BMJ Open, 2022, 12(11): e062497.
30. Zhang T, Li X, Zhao L, et al. Development of a core outcome set in the clinical trials of traditional Chinese medicine for stroke: a study protocol. Front Med (Lausanne), 2022, 9: 753138.
31. Zhang M, Chua HZ, Zhang J, et al. Developing a core outcome set on traditional Chinese medicine (COS-TCM) for chronic heart failure (CHF): a study protocol. BMJ Open, 2021, 11(7): e047148.
32. Dai XY, Zi MJ, Liu CX, et al. Development of a core outcome set in the clinical trials of traditional Chinese medicine for diabetic foot: a study protocol. Front Med (Lausanne), 2022, 9: 1025833.
33. Niu B, Zhang M, Chua HZ, et al. Treatment of chronic pulmonary heart disease with traditional Chinese medicine: a protocol for the development of a core outcome set (COS-TCM-CPHD). Evid Based Complement Alternat Med, 2021, 2021: 5559883.
34. Li G, Han R, Lin M, et al. Developing a core outcome set for clinical trials of Chinese medicine for hyperlipidemia. Front Pharmacol, 2022, 13: 847101.
35. Qiu R, Li M, Zhang X, et al. Development of a core outcome set (COS) and selecting outcome measurement instruments (OMIs) for non-valvular atrial fibrillation in traditional Chinese medicine clinical trials: study protocol. Trials, 2018, 19(1): 541.
36. Liu M, Gao Y, Yuan Y, et al. Sjogren's syndrome in clinical trials of traditional Chinese medicine: protocol for the development of a core outcome set. Trials, 2021, 22(1): 233.
37. Jia M, Lu Y, Liang X, et al. Development of a core outcome set for hypertensive intracerebral hemorrhage in clinical trials of traditional Chinese medicine: a study protocol. Trials, 2022, 23(1): 871.
38. Dodd S, Clarke M, Becker L, et al. A taxonomy has been developed for outcomes in medical research to help improve knowledge discovery. J Clin Epidemiol, 2018, 96: 84-92, 96-84.
39. Basch E, Reeve BB, Mitchell SA, et al. Development of the National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE). J Natl Cancer Inst, 2014, 106(9): dju244.
40. 张明妍, 张俊华, 张伯礼, 等. 中医药临床试验核心指标集研制技术规范. 中华中医药杂志, 2021, 36(2): 924-928.
41. Williamson PR, Altman DG, Bagley H, et al. The COMET handbook: version 1. 0. Trials, 2017, 18(Suppl 3): 280.
42. 代欣玥. 中医药治疗糖尿病足临床研究核心指标集指标域构建研究. 北京: 中国中医科学院, 2021.
43. 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.
44. Gargon E, Crew R, Burnside G, et al. Higher number of items associated with significantly lower response rates in COS Delphi surveys. J Clin Epidemiol, 2019, 108: 108-120.
45. Hall DA, Smith H, Heffernan E, et al. Recruiting and retaining participants in e-Delphi surveys for core outcome set development: Evaluating the COMiT'ID study. PLoS One, 2018, 13(7): e0201378.
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Chinese Journal of Evidence-Based Medicine

A scoping review of the core outcome set research in traditional Chinese medicine

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