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

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2.	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.
3.	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.
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, 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.
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.	陳千吉, 陳紅, 張英, 等. 基于中國腰痛患者Oswestry功能障礙指數測量性能證據的COSMIN系統評價. 中國康復醫學雜志, 2022, 37(1): 79-83.
22.	邱瑞瑾, 孫楊, 胡嘉元, 等. 臨床研究中選擇結局指標測量工具的方法. 中國循證醫學雜志, 2018, 18(2): 238-243.
23.	于長禾, 張英, 萬穎, 等. 基于結局指標重要性和中醫藥代表性構建中醫臨床療效評價指標體系. 中華中醫藥雜志, 2021, 36(3): 1238-1243.
24.	邱瑞瑾, 魏旭煦, 關之玥, 等. 中醫藥領域核心指標集研究現狀及展望. 中國循證醫學雜志, 2023, 23(2): 211-220.
25.	商洪才, 李幼平, 張伯禮, 等. 中醫藥臨床療效個體化評價方法初探—循證目標成就量表法的提出. 中國循證醫學雜志, 2007, 7(7): 537-541.
26.	石兆峰, 趙晨, 胡嘉元, 等. 構建中醫個體化長時程療效評價方法. 中國循證醫學雜志, 2020, 20(12): 1373-1378.
27.	雷黃偉, 吳清杰, 陳子文, 等. 中醫藥臨床療效循證評價的現狀與對策研究. 中華中醫藥雜志, 2020, 35(4): 1637-1641.
28.	高蕊. 符合中醫特色臨床評價體系的構建與思考. 中國新藥雜志, 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, 劉衛紅, 張會娜, 等. “病證結合”多主要終點評價法在中醫藥臨床研究中的應用. 世界中醫藥, 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. 中醫臨床個性化療效評價內涵解析及體系構建研究. 福州: 福建中醫藥大學, 2018.
34.	邱瑞瑾, 商洪才. 中醫臨床研究核心結局指標中的敘事元素. 中醫雜志, 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. 中藥治療糖尿病腎臟疾病隨機對照試驗結局指標的現狀分析. 中國實驗方劑學雜志, 2023, 13: 1-12.

1. 鄭文科, 鄢丹, 張曉朦, 等. 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.
2. 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.
3. 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.
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, 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.
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. 陳千吉, 陳紅, 張英, 等. 基于中國腰痛患者Oswestry功能障礙指數測量性能證據的COSMIN系統評價. 中國康復醫學雜志, 2022, 37(1): 79-83.
22. 邱瑞瑾, 孫楊, 胡嘉元, 等. 臨床研究中選擇結局指標測量工具的方法. 中國循證醫學雜志, 2018, 18(2): 238-243.
23. 于長禾, 張英, 萬穎, 等. 基于結局指標重要性和中醫藥代表性構建中醫臨床療效評價指標體系. 中華中醫藥雜志, 2021, 36(3): 1238-1243.
24. 邱瑞瑾, 魏旭煦, 關之玥, 等. 中醫藥領域核心指標集研究現狀及展望. 中國循證醫學雜志, 2023, 23(2): 211-220.
25. 商洪才, 李幼平, 張伯禮, 等. 中醫藥臨床療效個體化評價方法初探—循證目標成就量表法的提出. 中國循證醫學雜志, 2007, 7(7): 537-541.
26. 石兆峰, 趙晨, 胡嘉元, 等. 構建中醫個體化長時程療效評價方法. 中國循證醫學雜志, 2020, 20(12): 1373-1378.
27. 雷黃偉, 吳清杰, 陳子文, 等. 中醫藥臨床療效循證評價的現狀與對策研究. 中華中醫藥雜志, 2020, 35(4): 1637-1641.
28. 高蕊. 符合中醫特色臨床評價體系的構建與思考. 中國新藥雜志, 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, 劉衛紅, 張會娜, 等. “病證結合”多主要終點評價法在中醫藥臨床研究中的應用. 世界中醫藥, 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. 中醫臨床個性化療效評價內涵解析及體系構建研究. 福州: 福建中醫藥大學, 2018.
34. 邱瑞瑾, 商洪才. 中醫臨床研究核心結局指標中的敘事元素. 中醫雜志, 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. 中藥治療糖尿病腎臟疾病隨機對照試驗結局指標的現狀分析. 中國實驗方劑學雜志, 2023, 13: 1-12.

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