Key issues and solutions in the selection of core outcomes in clinical efficacy evaluation for traditional Chinese medicine_Chinese Journal of Evidence-Based Medicine

Authors：

QIU Ruijin ^1,2 , GUAN Zhiyue ¹ , ZHANG Xinyi ¹ , CHEN Zhuo ¹ , WANG Wenhui ³ ,  SHANG Hongcai ^1,3

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. Hunan University of Traditional Chinese Medicine, Changsha 410208, P. R. China;

Corresponding author：

SHANG Hongcai, Email: shanghongcai@126.com

Keywords：

Efficacy evaluation; Outcomes; Evidence; Humanistic value; Methodology

DOI：

10.7507/1672-2531.202307055

Video：

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There are many problems in the selection of outcomes in clinical trials of traditional Chinese medicine (TCM), such as insufficient research on the applicability of outcomes, insufficient research of individualized outcomes for syndrome differentiation and treatment, incomplete selection methods for overall/comprehensive evaluation outcomes, lack of evidence in the importance of outcomes for researchers, and insufficient reflection of the humanistic value of outcomes. Although the core outcome sets (COS) may help clinical trialists to select outcomes to a certain extent, the COS has not been widely used at present, and the judgment of the importance of the outcomes in the COS is mainly based on the personal experience of the participants. The lack of methodology will also lead to multiple COS in the same disease area. The authors believe that it is necessary to improve the methodology of outcomes research, especially in the development of COS. Developing evidence and humanistic values framework may be a potential way to help researchers select core outcomes in clinical efficacy evaluation of TCM.

Citation： QIU Ruijin, GUAN Zhiyue, ZHANG Xinyi, CHEN Zhuo, WANG Wenhui, SHANG Hongcai. Key issues and solutions in the selection of core outcomes in clinical efficacy evaluation for traditional Chinese medicine. Chinese Journal of Evidence-Based Medicine, 2024, 24(4): 466-471. doi: 10.7507/1672-2531.202307055 Copy

1.	郑文科, 鄢丹, 张晓朦, 等. 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.
2.	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.
3.	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.
4.	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.
5.	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.
6.	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.
7.	Qiu R, Hu J, Huang Y, et al. Outcome reporting from clinical trials of non-valvular atrial fibrillation treated with traditional Chinese medicine or Western medicine: a systematic review. BMJ Open, 2019, 9(8): e028803.
8.	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.
9.	Bellucci C, Hughes K, Toomey E, et al. A survey of knowledge, perceptions and use of core outcome sets among clinical trialists. Trials, 2021, 22(1): 937.
10.	Hughes KL, Williamson PR, Young B. In-depth qualitative interviews identified barriers and facilitators that influenced chief investigators' use of core outcome sets in randomised controlled trials. J Clin Epidemiol, 2022, 144: 111-120.
11.	Williamson PR, Altman DG, Bagley H, et al. The COMET handbook: version 1. 0. Trials, 2017, 18(Suppl 3): 280.
12.	Cai K, Fuller A, Zhang Y, et al. Towards development of core domain sets for short term and long term studies of calcium pyrophosphate crystal deposition (CPPD) disease: a framework paper by the OMERACT CPPD working group. Semin Arthritis Rheum, 2021, 51(4): 946-950.
13.	Ma C, Panaccione R, Fedorak RN, et al. Development of a core outcome set for clinical trials in inflammatory bowel disease: study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey. BMJ Open, 2017, 7(6): e016146.
14.	Kim AH, Roberts C, Feagan BG, et al. Developing a standard set of patient-centred outcomes for inflammatory bowel disease-an international, cross-disciplinary consensus. J Crohns Colitis, 2018, 12(4): 408-418.
15.	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.
16.	Guyatt GH, Oxman AD, Kunz R, et al. GRADE guidelines: 2. Framing the question and deciding on important outcomes. J Clin Epidemiol, 2011, 64(4): 395-400.
17.	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.
18.	Iwashyna TJ, McPeake J. Choosing outcomes for clinical trials: a pragmatic perspective. Curr Opin Crit Care, 2018, 24(5): 428-433.
19.	Prinsen CA, Vohra S, Rose MR, et al. How to select outcome measurement instruments for outcomes included in a "Core Outcome Set" - a practical guideline. Trials, 2016, 17(1): 449.
20.	Biggane AM, Brading L, Ravaud P, et al. Survey indicated that core outcome set development is increasingly including patients, being conducted internationally and using Delphi surveys. Trials, 2018, 19(1): 113.
21.	陈千吉, 陈红, 张英, 等. 基于中国腰痛患者Oswestry功能障碍指数测量性能证据的COSMIN系统评价. 中国康复医学杂志, 2022, 37(1): 79-83.
22.	邱瑞瑾, 孙杨, 胡嘉元, 等. 临床研究中选择结局指标测量工具的方法. 中国循证医学杂志, 2018, 18(2): 238-243.
23.	于长禾, 张英, 万颖, 等. 基于结局指标重要性和中医药代表性构建中医临床疗效评价指标体系. 中华中医药杂志, 2021, 36(3): 1238-1243.
24.	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.
25.	商洪才, 李幼平, 张伯礼, 等. 中医药临床疗效个体化评价方法初探—循证目标成就量表法的提出. 中国循证医学杂志, 2007, 7(7): 537-541.
26.	石兆峰, 赵晨, 胡嘉元, 等. 构建中医个体化长时程疗效评价方法. 中国循证医学杂志, 2020, 20(12): 1373-1378.
27.	雷黄伟, 吴清杰, 陈子文, 等. 中医药临床疗效循证评价的现状与对策研究. 中华中医药杂志, 2020, 35(4): 1637-1641.
28.	高蕊. 符合中医特色临床评价体系的构建与思考. 中国新药杂志, 2021, 30(9): 780-783.
29.	Jacobse J, Ten Voorde W, Tandon A, et al. Comprehensive evaluation of microneedle-based intradermal adalimumab delivery vs. subcutaneous administration: results of a randomized controlled clinical trial. Br J Clin Pharmacol, 2021, 87(8): 3162-3176.
30.	Zichi C, Paratore C, Gargiulo P, et al. Adoption of multiple primary endpoints in phase III trials of systemic treatments in patients with advanced solid tumours: a systematic review. Eur J Cancer, 2021, 149: 49-60.
31.	胡晶, 刘卫红, 张会娜, 等. “病证结合”多主要终点评价法在中医药临床研究中的应用. 世界中医药, 2017, 12(6): 1214-1217.
32.	Wells GA, Tugwell P, Tomasson G, et al. Composite outcomes at OMERACT: multi-outcome domains and composite outcome domains. Semin Arthritis Rheum, 2021, 51(6): 1370-1377.
33.	王洋. 中医临床个性化疗效评价内涵解析及体系构建研究. 福州: 福建中医药大学, 2018.
34.	邱瑞瑾, 商洪才. 中医临床研究核心结局指标中的叙事元素. 中医杂志, 2020, 61(17): 1512-1515.
35.	Feng S, Chen L, Tian G, et al. Validity and reliability of patient section of evidence-based medical records about doctor-patient building through integrated therapy of traditional Chinese and Western medicine (DPEBMR-P) in patients with gastrointestinal diseases. Ann Transl Med, 2019, 7(6): 121.
36.	王一帆, 王希茜, 申世雨, 等. 中药治疗糖尿病肾脏疾病随机对照试验结局指标的现状分析. 中国实验方剂学杂志, 2023, 13: 1-12.

1. 郑文科, 鄢丹, 张晓朦, 等. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. Qiu R, Hu J, Huang Y, et al. Outcome reporting from clinical trials of non-valvular atrial fibrillation treated with traditional Chinese medicine or Western medicine: a systematic review. BMJ Open, 2019, 9(8): e028803.
8. 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.
9. Bellucci C, Hughes K, Toomey E, et al. A survey of knowledge, perceptions and use of core outcome sets among clinical trialists. Trials, 2021, 22(1): 937.
10. Hughes KL, Williamson PR, Young B. In-depth qualitative interviews identified barriers and facilitators that influenced chief investigators' use of core outcome sets in randomised controlled trials. J Clin Epidemiol, 2022, 144: 111-120.
11. Williamson PR, Altman DG, Bagley H, et al. The COMET handbook: version 1. 0. Trials, 2017, 18(Suppl 3): 280.
12. Cai K, Fuller A, Zhang Y, et al. Towards development of core domain sets for short term and long term studies of calcium pyrophosphate crystal deposition (CPPD) disease: a framework paper by the OMERACT CPPD working group. Semin Arthritis Rheum, 2021, 51(4): 946-950.
13. Ma C, Panaccione R, Fedorak RN, et al. Development of a core outcome set for clinical trials in inflammatory bowel disease: study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey. BMJ Open, 2017, 7(6): e016146.
14. Kim AH, Roberts C, Feagan BG, et al. Developing a standard set of patient-centred outcomes for inflammatory bowel disease-an international, cross-disciplinary consensus. J Crohns Colitis, 2018, 12(4): 408-418.
15. 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.
16. Guyatt GH, Oxman AD, Kunz R, et al. GRADE guidelines: 2. Framing the question and deciding on important outcomes. J Clin Epidemiol, 2011, 64(4): 395-400.
17. 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.
18. Iwashyna TJ, McPeake J. Choosing outcomes for clinical trials: a pragmatic perspective. Curr Opin Crit Care, 2018, 24(5): 428-433.
19. Prinsen CA, Vohra S, Rose MR, et al. How to select outcome measurement instruments for outcomes included in a "Core Outcome Set" - a practical guideline. Trials, 2016, 17(1): 449.
20. Biggane AM, Brading L, Ravaud P, et al. Survey indicated that core outcome set development is increasingly including patients, being conducted internationally and using Delphi surveys. Trials, 2018, 19(1): 113.
21. 陈千吉, 陈红, 张英, 等. 基于中国腰痛患者Oswestry功能障碍指数测量性能证据的COSMIN系统评价. 中国康复医学杂志, 2022, 37(1): 79-83.
22. 邱瑞瑾, 孙杨, 胡嘉元, 等. 临床研究中选择结局指标测量工具的方法. 中国循证医学杂志, 2018, 18(2): 238-243.
23. 于长禾, 张英, 万颖, 等. 基于结局指标重要性和中医药代表性构建中医临床疗效评价指标体系. 中华中医药杂志, 2021, 36(3): 1238-1243.
24. 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.
25. 商洪才, 李幼平, 张伯礼, 等. 中医药临床疗效个体化评价方法初探—循证目标成就量表法的提出. 中国循证医学杂志, 2007, 7(7): 537-541.
26. 石兆峰, 赵晨, 胡嘉元, 等. 构建中医个体化长时程疗效评价方法. 中国循证医学杂志, 2020, 20(12): 1373-1378.
27. 雷黄伟, 吴清杰, 陈子文, 等. 中医药临床疗效循证评价的现状与对策研究. 中华中医药杂志, 2020, 35(4): 1637-1641.
28. 高蕊. 符合中医特色临床评价体系的构建与思考. 中国新药杂志, 2021, 30(9): 780-783.
29. Jacobse J, Ten Voorde W, Tandon A, et al. Comprehensive evaluation of microneedle-based intradermal adalimumab delivery vs. subcutaneous administration: results of a randomized controlled clinical trial. Br J Clin Pharmacol, 2021, 87(8): 3162-3176.
30. Zichi C, Paratore C, Gargiulo P, et al. Adoption of multiple primary endpoints in phase III trials of systemic treatments in patients with advanced solid tumours: a systematic review. Eur J Cancer, 2021, 149: 49-60.
31. 胡晶, 刘卫红, 张会娜, 等. “病证结合”多主要终点评价法在中医药临床研究中的应用. 世界中医药, 2017, 12(6): 1214-1217.
32. Wells GA, Tugwell P, Tomasson G, et al. Composite outcomes at OMERACT: multi-outcome domains and composite outcome domains. Semin Arthritis Rheum, 2021, 51(6): 1370-1377.
33. 王洋. 中医临床个性化疗效评价内涵解析及体系构建研究. 福州: 福建中医药大学, 2018.
34. 邱瑞瑾, 商洪才. 中医临床研究核心结局指标中的叙事元素. 中医杂志, 2020, 61(17): 1512-1515.
35. Feng S, Chen L, Tian G, et al. Validity and reliability of patient section of evidence-based medical records about doctor-patient building through integrated therapy of traditional Chinese and Western medicine (DPEBMR-P) in patients with gastrointestinal diseases. Ann Transl Med, 2019, 7(6): 121.
36. 王一帆, 王希茜, 申世雨, 等. 中药治疗糖尿病肾脏疾病随机对照试验结局指标的现状分析. 中国实验方剂学杂志, 2023, 13: 1-12.

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