Core outcome set should be introduced to safety evaluation in clinical research of integrated traditional Chinese and western medicine_Chinese Journal of Evidence-Based Medicine

Authors：

QIU Ruijin ¹ , ZHONG Changming ¹ , GUAN Manke ¹ , HU Jiayuan ¹ , ZHAO Chen ² , CHEN Zhao ¹ , LI Min ³ , HAN Songjie ¹ , HE Tianmai ¹ , HUANG Ya 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：

Integrated traditional Chinese and western medicine; Safety; Clinical evaluation; Core outcome set

DOI：

10.7507/1672-2531.201911068

Video：

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Safeguarding patient’s safety is important in clinical research and practice. At present, there are many problems in the clinical safety evaluation of traditional Chinese medicine. For instance, combination of Chinese and western medicines provides difficulty for definite reflection of clinical safety of Chinese medicine, lack of reliability of reporting of symptomatic adverse events/reactions, as well as discrepancy in safety outcomes reporting in similar clinical studies. Based on the application of adverse events/reactions term sets and core outcomes sets in clinical trials of western medicine, it is proposed that the concept of core outcome sets should be introduced to the clinical safety evaluation of integrated Chinese and western medicines in order to improve the clinical safety evaluation.

Citation： QIU Ruijin, ZHONG Changming, GUAN Manke, HU Jiayuan, ZHAO Chen, CHEN Zhao, LI Min, HAN Songjie, HE Tianmai, HUANG Ya, CHEN Jing, SHANG Hongcai. Core outcome set should be introduced to safety evaluation in clinical research of integrated traditional Chinese and western medicine. Chinese Journal of Evidence-Based Medicine, 2020, 20(5): 511-514. doi: 10.7507/1672-2531.201911068 Copy

1.	董欣, 石悦. 中成药药品说明书的现状调查分析. 中国中医药信息杂志, 2015, 22(3): 117-120.
2.	姜俊杰, 谢雁鸣. 建立中药注射剂医院集中监测质量控制体系初探. 中国中药杂志, 2012, 37(18): 2689-2691.
3.	郑文科, 刘智, 雷翔, 等. 中成药上市后临床安全性评价研究模式的探索建立. 中国中药杂志, 2015, 40(18): 3693-3696.
4.	谢雁鸣, 廖星, 赵玉斌, 等. 中药上市后安全性医院集中监测技术规范(征求意见稿). 中国中药杂志, 2013, 38(18): 2919-2924.
5.	张俊华, 任经天, 胡镜清, 等. 中药注射剂临床安全性集中监测研究设计与实施专家共识. 中国中药杂志, 2017, 42(1): 6-9.
6.	Ioannidis JPA, Evans SJW, Tzsche PCG, 等. 更好地报告随机试验中的危害: CONSORT 声明扩展版. 中国循证医学杂志, 2006, 6(9): 682-689.
7.	吴泰相, 商洪才, 卞兆祥, 等. 中药不良反应/不良事件报告规范建议. 中国循证医学杂志, 2010, 10(2): 215-219.
8.	费宇彤, 杨红, 刘兆兰, 等. 药品不良反应个案报道的规范性报告. 中国药物警戒, 2010, 7(4): 206-208.
9.	李迅, 李昕雪, 刘智君, 等. 国内期刊中药临床试验安全性报告分析. 中国药物警戒, 2010, 7(1): 20-24.
10.	王连心, 谢雁鸣. 基于文献计量分析的参麦注射液临床安全性评估. 中国中药杂志, 2012, 37(18): 2779-2781.
11.	Chen KJ, Lu AP. Situation of integrative medicine in China: results from a national survey in 2004. Chin J Integr Med, 2006, 12(3): 161-165.
12.	Yang AK, He SM, Liu L, et al. Herbal interactions with anticancer drugs: mechanistic and clinical considerations. Curr Med Chem, 2010, 17(16): 1635-1678.
13.	Seruga B, Templeton AJ, Badillo FE, et al. Under-reporting of harm in clinical trials. Lancet Oncol, 2016, 17(5): e209-e219.
14.	NCI. Common Terminology Criteria for Adverse Events (CTCAE). Available at: https://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm#ctc_50.
15.	Woodworth T, Furst DE, Alten R, et al. Standardizing assessment and reporting of adverse effects in rheumatology clinical trials II: the Rheumatology Common Toxicity Criteria v.2.0. J Rheumatol, 2007, 34(6): 1401-1414.
16.	Basch E, Rogak LJ, Dueck AC. Methods for implementing and reporting patient-reported outcome (PRO) measures of symptomatic adverse events in cancer clinical trials. Clin Ther, 2016, 38(4): 821-830.
17.	Hagelstein V, Ortland I, Wilmer A, et al. Validation of the German patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE^TM). Ann Oncol, 2016, 27(12): 2294-2299.
18.	Kawaguchi T, Azuma K, Sano M, et al. The Japanese version of the National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE): psychometric validation and discordance between clinician and patient assessments of adverse events. J Patient Rep Outcomes, 2017, 2(1): 2.
19.	Williamson PR, Altman DG, Bagley H, et al. The COMET Handbook: version 1.0. Trials, 2017, 18(Suppl 3): 280.
20.	Coulman KD, Hopkins J, Brookes ST, et al. A core outcome set for the benefits and adverse events of bariatric and metabolic surgery: the BARIACT project. PLoS Med, 2016, 13(11): e1002187.
21.	Reeve BB, Mitchell SA, Dueck AC, et al. Recommended patient-reported core set of symptoms to measure in adult cancer treatment trials. J Natl Cancer Inst, 2014, 106(7): pii: dju129.
22.	Klokker L, Tugwell P, Furst DE, et al. Developing an OMERACT core outcome set for assessing safety components in rheumatology trials: the OMERACT safety working group. J Rheumatol, 2017, 44(12): 1916-1919.
23.	Gandhi TK. Safety lessons from the NIH clinical center. N Engl J Med, 2016, 375(18): 1705-1707.
24.	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.
25.	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.
26.	Li G, Zhou L, Ouyang W, et al. A core outcome set for clinical trials of Chinese medicine for hyperlipidemia: a study protocol for a systematic review and a Delphi survey. Trials, 2019, 20(1): 14.
27.	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.
28.	邱瑞瑾. 中医临床研究核心指标集的方法构建—以非瓣膜性房颤为例. 北京: 北京中医药大学, 2018.
29.	邱瑞瑾, 李敏, 胡嘉元, 等. 中成药上市后临床安全性评价核心数据集的构建方法探索. 世界科学技术-中医药现代化, 2018, 20(10): 1723-1728.

1. 董欣, 石悦. 中成药药品说明书的现状调查分析. 中国中医药信息杂志, 2015, 22(3): 117-120.
2. 姜俊杰, 谢雁鸣. 建立中药注射剂医院集中监测质量控制体系初探. 中国中药杂志, 2012, 37(18): 2689-2691.
3. 郑文科, 刘智, 雷翔, 等. 中成药上市后临床安全性评价研究模式的探索建立. 中国中药杂志, 2015, 40(18): 3693-3696.
4. 谢雁鸣, 廖星, 赵玉斌, 等. 中药上市后安全性医院集中监测技术规范(征求意见稿). 中国中药杂志, 2013, 38(18): 2919-2924.
5. 张俊华, 任经天, 胡镜清, 等. 中药注射剂临床安全性集中监测研究设计与实施专家共识. 中国中药杂志, 2017, 42(1): 6-9.
6. Ioannidis JPA, Evans SJW, Tzsche PCG, 等. 更好地报告随机试验中的危害: CONSORT 声明扩展版. 中国循证医学杂志, 2006, 6(9): 682-689.
7. 吴泰相, 商洪才, 卞兆祥, 等. 中药不良反应/不良事件报告规范建议. 中国循证医学杂志, 2010, 10(2): 215-219.
8. 费宇彤, 杨红, 刘兆兰, 等. 药品不良反应个案报道的规范性报告. 中国药物警戒, 2010, 7(4): 206-208.
9. 李迅, 李昕雪, 刘智君, 等. 国内期刊中药临床试验安全性报告分析. 中国药物警戒, 2010, 7(1): 20-24.
10. 王连心, 谢雁鸣. 基于文献计量分析的参麦注射液临床安全性评估. 中国中药杂志, 2012, 37(18): 2779-2781.
11. Chen KJ, Lu AP. Situation of integrative medicine in China: results from a national survey in 2004. Chin J Integr Med, 2006, 12(3): 161-165.
12. Yang AK, He SM, Liu L, et al. Herbal interactions with anticancer drugs: mechanistic and clinical considerations. Curr Med Chem, 2010, 17(16): 1635-1678.
13. Seruga B, Templeton AJ, Badillo FE, et al. Under-reporting of harm in clinical trials. Lancet Oncol, 2016, 17(5): e209-e219.
14. NCI. Common Terminology Criteria for Adverse Events (CTCAE). Available at: https://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm#ctc_50.
15. Woodworth T, Furst DE, Alten R, et al. Standardizing assessment and reporting of adverse effects in rheumatology clinical trials II: the Rheumatology Common Toxicity Criteria v.2.0. J Rheumatol, 2007, 34(6): 1401-1414.
16. Basch E, Rogak LJ, Dueck AC. Methods for implementing and reporting patient-reported outcome (PRO) measures of symptomatic adverse events in cancer clinical trials. Clin Ther, 2016, 38(4): 821-830.
17. Hagelstein V, Ortland I, Wilmer A, et al. Validation of the German patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE^TM). Ann Oncol, 2016, 27(12): 2294-2299.
18. Kawaguchi T, Azuma K, Sano M, et al. The Japanese version of the National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE): psychometric validation and discordance between clinician and patient assessments of adverse events. J Patient Rep Outcomes, 2017, 2(1): 2.
19. Williamson PR, Altman DG, Bagley H, et al. The COMET Handbook: version 1.0. Trials, 2017, 18(Suppl 3): 280.
20. Coulman KD, Hopkins J, Brookes ST, et al. A core outcome set for the benefits and adverse events of bariatric and metabolic surgery: the BARIACT project. PLoS Med, 2016, 13(11): e1002187.
21. Reeve BB, Mitchell SA, Dueck AC, et al. Recommended patient-reported core set of symptoms to measure in adult cancer treatment trials. J Natl Cancer Inst, 2014, 106(7): pii: dju129.
22. Klokker L, Tugwell P, Furst DE, et al. Developing an OMERACT core outcome set for assessing safety components in rheumatology trials: the OMERACT safety working group. J Rheumatol, 2017, 44(12): 1916-1919.
23. Gandhi TK. Safety lessons from the NIH clinical center. N Engl J Med, 2016, 375(18): 1705-1707.
24. 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.
25. 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.
26. Li G, Zhou L, Ouyang W, et al. A core outcome set for clinical trials of Chinese medicine for hyperlipidemia: a study protocol for a systematic review and a Delphi survey. Trials, 2019, 20(1): 14.
27. 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.
28. 邱瑞瑾. 中医临床研究核心指标集的方法构建—以非瓣膜性房颤为例. 北京: 北京中医药大学, 2018.
29. 邱瑞瑾, 李敏, 胡嘉元, 等. 中成药上市后临床安全性评价核心数据集的构建方法探索. 世界科学技术-中医药现代化, 2018, 20(10): 1723-1728.

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Core outcome set should be introduced to safety evaluation in clinical research of integrated traditional Chinese and western medicine

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