Application of mixed methods research in individualized therapeutic evaluation of clinical trials of traditional Chinese medicine_Chinese Journal of Evidence-Based Medicine

Authors：

QIU Ruijin ¹ , ZHAO Chen ² , ZHONG Changming ¹ , HU Jiayuan ¹ , LI Min ³ , HUANG Ya ¹ , HAN Songjie ¹ , HE Tianmai ¹ , GUAN Manke ¹ ,  CHEN Jing ⁴ ,  SHANG Hongcai ¹

1. Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, P.R.China;
2. Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, P.R.China;
3. Beijing University of Chinese Medicine Third Affiliated Hospital, Beijing 100029, P.R.China;
4. Baokang Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300193, P.R.China;

Corresponding?author：

CHEN Jing, Email: cjshcsyc@126.com; SHANG Hongcai, Email: shanghongcai@foxmail.com

Keywords：

Traditional Chinese medicine; Therapeutic evaluation; Individualization; Mixed methods research

DOI：

10.7507/1672-2531.201911079

Video：

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The characteristics of traditional Chinese medicine (TCM) practice include treatment based on syndrome differentiation and holism, which determines it is difficult to reflect the individualized therapeutic evaluation and overall regulation of TCM through traditional randomized controlled trials, which is based on quantitative evaluation. The implementation of N-of-1 trials will provide opportunities for quantitative evaluation of individualized therapeutic evaluation of TCM. Using mixed methods research, such as exploratory sequence design, interpretive sequence design or convergent design can provide abundant data to individualized therapeutic evaluation of TCM in different aspects, which may reflect holism and humanities characteristics of TCM in individual level.

Citation： QIU Ruijin, ZHAO Chen, ZHONG Changming, HU Jiayuan, LI Min, HUANG Ya, HAN Songjie, HE Tianmai, GUAN Manke, CHEN Jing, SHANG Hongcai. Application of mixed methods research in individualized therapeutic evaluation of clinical trials of traditional Chinese medicine. Chinese Journal of Evidence-Based Medicine, 2020, 20(8): 973-978. doi: 10.7507/1672-2531.201911079 Copy

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2.	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.
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.	于亞南, 荊志偉, 劉駿, 等. 適應性治療臨床試驗設計與辨證論治療效評價的思考. 中國中醫基礎醫學雜志, 2012, 18(3): 316-318.
5.	邱瑞瑾, 陳靜, 雷翔, 等. 引入核心指標集概念構建中醫臨床療效模糊綜合評價方法. 中藥新藥與臨床藥理, 2018, 29(4): 528-534.
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7.	于丹丹, 廖星, 章軼立, 等. 混合方法研究及其在中醫藥領域應用的意義. 中醫雜志, 2019, 60(13): 1089-1094.
8.	Johnson RB, Onwuegbuzie AJ, Turner LA. Toward a definition of mixed methods research. J Mix Methods Res, 2007, 1: 112.
9.	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.
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12.	劉建平, 張玫, 楊閔, 等. 單病例隨機對照試驗設計在中醫藥研究中的應用. 中國中醫藥信息雜志, 2002, 9(6): 66-68.
13.	王輝, 陳靜, 商洪才, 等. 單病例隨機對照試驗設計在中醫藥臨床研究的探索與實踐. 中華中醫藥藥雜志, 2010, 25(11): 1823-1828.
14.	Guyatt G, Haynes B, Jaeschke R, et al. A introduction: The philosophy of evidence-based medicine. 2001. Available from: https://www.semanticscholar.org/paper/A-INTRODUCTION-%3A-THE-PHILOSOPHY-OF-EVIDENCE-BASED-Guyatt-Haynes/18736f55776de6ecf4c0b9ddff35ee52262c444d.
15.	邱瑞瑾, 張曉雨, 商洪才. 證候類中藥新藥臨床療效評價方法探索. 世界中醫藥, 2017, 12(6): 1230-1234.
16.	劉玉, 彭立生, 秦秀德, 等. 單病例隨機對照試驗在證候類中藥療效評價中的應用與思考. 中醫藥導報, 2017, 23(7): 11-12, 16.
17.	Charon R. Narrative medicine: honoring the stories of illness. New York: Oxford University Press, 2006.
18.	Charon R. The patient-physician relationship. Narrative medicine: a model for empathy, reflection, profession, and trust. JAMA, 2001, 286(15): 1897-1902.
19.	Fioretti C, Mazzocco K, Riva S, et al. Research studies on patients' illness experience using the narrative medicine approach: a systematic review. BMJ Open, 2016, 6(7): e011220.
20.	王一方, 郭莉萍. 我國廣義敘事醫學發展的文獻研究. 中國醫學倫理學, 2019, 32(2): 153-159.
21.	楊秋莉, 王永炎. 敘事醫學的平行病歷與中醫學的醫案醫話. 現代中醫臨床, 2015, 22(3): 1-4.
22.	王昊, 楊秋莉, 王子旭, 等. 關于中醫平行病歷書寫規范的建議. 現代中醫臨床, 2019, 26(3): 6-10.
23.	王永炎, 商洪才, 牟瑋, 等. 強化醫學人文理念, 直面新醫改學習敘事醫學. 現代中醫臨床, 2015, 22(1): 1-4.
24.	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.
25.	Guyatt GH, Haynes RB, Jaeschke RZ, et al. Users' Guides to the Medical Literature: XXV. Evidence-based medicine: principles for applying the Users' Guides to patient care. Evidence-Based Medicine Working Group. JAMA, 2000, 284(10): 1290-1296.

1. Shang H, Zhang J, Yao C, et al. Qi-shen-yi-qi dripping pills for the secondary prevention of myocardial infarction: a randomised clinical trial. Evid Based Complement Alternat Med, 2013, 2013(7329): 738391.
2. 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.
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. 于亞南, 荊志偉, 劉駿, 等. 適應性治療臨床試驗設計與辨證論治療效評價的思考. 中國中醫基礎醫學雜志, 2012, 18(3): 316-318.
5. 邱瑞瑾, 陳靜, 雷翔, 等. 引入核心指標集概念構建中醫臨床療效模糊綜合評價方法. 中藥新藥與臨床藥理, 2018, 29(4): 528-534.
6. 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.
7. 于丹丹, 廖星, 章軼立, 等. 混合方法研究及其在中醫藥領域應用的意義. 中醫雜志, 2019, 60(13): 1089-1094.
8. Johnson RB, Onwuegbuzie AJ, Turner LA. Toward a definition of mixed methods research. J Mix Methods Res, 2007, 1: 112.
9. 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.
10. Djulbegovic B, Guyatt GH. Progress in evidence-based medicine: a quarter century on. Lancet, 2017, 390(10092): 415-423.
11. 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.
12. 劉建平, 張玫, 楊閔, 等. 單病例隨機對照試驗設計在中醫藥研究中的應用. 中國中醫藥信息雜志, 2002, 9(6): 66-68.
13. 王輝, 陳靜, 商洪才, 等. 單病例隨機對照試驗設計在中醫藥臨床研究的探索與實踐. 中華中醫藥藥雜志, 2010, 25(11): 1823-1828.
14. Guyatt G, Haynes B, Jaeschke R, et al. A introduction: The philosophy of evidence-based medicine. 2001. Available from: https://www.semanticscholar.org/paper/A-INTRODUCTION-%3A-THE-PHILOSOPHY-OF-EVIDENCE-BASED-Guyatt-Haynes/18736f55776de6ecf4c0b9ddff35ee52262c444d.
15. 邱瑞瑾, 張曉雨, 商洪才. 證候類中藥新藥臨床療效評價方法探索. 世界中醫藥, 2017, 12(6): 1230-1234.
16. 劉玉, 彭立生, 秦秀德, 等. 單病例隨機對照試驗在證候類中藥療效評價中的應用與思考. 中醫藥導報, 2017, 23(7): 11-12, 16.
17. Charon R. Narrative medicine: honoring the stories of illness. New York: Oxford University Press, 2006.
18. Charon R. The patient-physician relationship. Narrative medicine: a model for empathy, reflection, profession, and trust. JAMA, 2001, 286(15): 1897-1902.
19. Fioretti C, Mazzocco K, Riva S, et al. Research studies on patients' illness experience using the narrative medicine approach: a systematic review. BMJ Open, 2016, 6(7): e011220.
20. 王一方, 郭莉萍. 我國廣義敘事醫學發展的文獻研究. 中國醫學倫理學, 2019, 32(2): 153-159.
21. 楊秋莉, 王永炎. 敘事醫學的平行病歷與中醫學的醫案醫話. 現代中醫臨床, 2015, 22(3): 1-4.
22. 王昊, 楊秋莉, 王子旭, 等. 關于中醫平行病歷書寫規范的建議. 現代中醫臨床, 2019, 26(3): 6-10.
23. 王永炎, 商洪才, 牟瑋, 等. 強化醫學人文理念, 直面新醫改學習敘事醫學. 現代中醫臨床, 2015, 22(1): 1-4.
24. 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.
25. Guyatt GH, Haynes RB, Jaeschke RZ, et al. Users' Guides to the Medical Literature: XXV. Evidence-based medicine: principles for applying the Users' Guides to patient care. Evidence-Based Medicine Working Group. JAMA, 2000, 284(10): 1290-1296.

Chinese Journal of Evidence-Based Medicine

Application of mixed methods research in individualized therapeutic evaluation of clinical trials of traditional Chinese medicine

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