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.	于亚南, 荆志伟, 刘骏, 等. 适应性治疗临床试验设计与辨证论治疗效评价的思考. 中国中医基础医学杂志, 2012, 18(3): 316-318.
5.	邱瑞瑾, 陈静, 雷翔, 等. 引入核心指标集概念构建中医临床疗效模糊综合评价方法. 中药新药与临床药理, 2018, 29(4): 528-534.
6.	中华中医药学会. 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.
7.	于丹丹, 廖星, 章轶立, 等. 混合方法研究及其在中医药领域应用的意义. 中医杂志, 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, 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.
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12.	刘建平, 张玫, 杨闵, 等. 单病例随机对照试验设计在中医药研究中的应用. 中国中医药信息杂志, 2002, 9(6): 66-68.
13.	王辉, 陈静, 商洪才, 等. 单病例随机对照试验设计在中医药临床研究的探索与实践. 中华中医药药杂志, 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, 张晓雨, 商洪才. 证候类中药新药临床疗效评价方法探索. 世界中医药, 2017, 12(6): 1230-1234.
16.	刘玉, 彭立生, 秦秀德, 等. 单病例随机对照试验在证候类中药疗效评价中的应用与思考. 中医药导报, 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. 我国广义叙事医学发展的文献研究. 中国医学伦理学, 2019, 32(2): 153-159.
21.	杨秋莉, 王永炎. 叙事医学的平行病历与中医学的医案医话. 现代中医临床, 2015, 22(3): 1-4.
22.	王昊, 杨秋莉, 王子旭, 等. 关于中医平行病历书写规范的建议. 现代中医临床, 2019, 26(3): 6-10.
23.	王永炎, 商洪才, 牟玮, 等. 强化医学人文理念, 直面新医改学习叙事医学. 现代中医临床, 2015, 22(1): 1-4.
24.	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.
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. 于亚南, 荆志伟, 刘骏, 等. 适应性治疗临床试验设计与辨证论治疗效评价的思考. 中国中医基础医学杂志, 2012, 18(3): 316-318.
5. 邱瑞瑾, 陈静, 雷翔, 等. 引入核心指标集概念构建中医临床疗效模糊综合评价方法. 中药新药与临床药理, 2018, 29(4): 528-534.
6. 中华中医药学会. 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.
7. 于丹丹, 廖星, 章轶立, 等. 混合方法研究及其在中医药领域应用的意义. 中医杂志, 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, 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.
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. 刘建平, 张玫, 杨闵, 等. 单病例随机对照试验设计在中医药研究中的应用. 中国中医药信息杂志, 2002, 9(6): 66-68.
13. 王辉, 陈静, 商洪才, 等. 单病例随机对照试验设计在中医药临床研究的探索与实践. 中华中医药药杂志, 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, 张晓雨, 商洪才. 证候类中药新药临床疗效评价方法探索. 世界中医药, 2017, 12(6): 1230-1234.
16. 刘玉, 彭立生, 秦秀德, 等. 单病例随机对照试验在证候类中药疗效评价中的应用与思考. 中医药导报, 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. 我国广义叙事医学发展的文献研究. 中国医学伦理学, 2019, 32(2): 153-159.
21. 杨秋莉, 王永炎. 叙事医学的平行病历与中医学的医案医话. 现代中医临床, 2015, 22(3): 1-4.
22. 王昊, 杨秋莉, 王子旭, 等. 关于中医平行病历书写规范的建议. 现代中医临床, 2019, 26(3): 6-10.
23. 王永炎, 商洪才, 牟玮, 等. 强化医学人文理念, 直面新医改学习叙事医学. 现代中医临床, 2015, 22(1): 1-4.
24. 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.
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.

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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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