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, 石悅. 中成藥藥品說明書的現狀調查分析. 中國中醫藥信息雜志, 2015, 22(3): 117-120.
2.	姜俊杰, 謝雁鳴. 建立中藥注射劑醫院集中監測質量控制體系初探. 中國中藥雜志, 2012, 37(18): 2689-2691.
3.	鄭文科, 劉智, 雷翔, 等. 中成藥上市后臨床安全性評價研究模式的探索建立. 中國中藥雜志, 2015, 40(18): 3693-3696.
4.	謝雁鳴, 廖星, 趙玉斌, 等. 中藥上市后安全性醫院集中監測技術規范(征求意見稿). 中國中藥雜志, 2013, 38(18): 2919-2924.
5.	張俊華, 任經天, 胡鏡清, 等. 中藥注射劑臨床安全性集中監測研究設計與實施專家共識. 中國中藥雜志, 2017, 42(1): 6-9.
6.	Ioannidis JPA, Evans SJW, Tzsche PCG, 等. 更好地報告隨機試驗中的危害: CONSORT 聲明擴展版. 中國循證醫學雜志, 2006, 6(9): 682-689.
7.	吳泰相, 商洪才, 卞兆祥, 等. 中藥不良反應/不良事件報告規范建議. 中國循證醫學雜志, 2010, 10(2): 215-219.
8.	費宇彤, 楊紅, 劉兆蘭, 等. 藥品不良反應個案報道的規范性報告. 中國藥物警戒, 2010, 7(4): 206-208.
9.	李迅, 李昕雪, 劉智君, 等. 國內期刊中藥臨床試驗安全性報告分析. 中國藥物警戒, 2010, 7(1): 20-24.
10.	王連心, 謝雁鳴. 基于文獻計量分析的參麥注射液臨床安全性評估. 中國中藥雜志, 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. 中醫臨床研究核心指標集的方法構建—以非瓣膜性房顫為例. 北京: 北京中醫藥大學, 2018.
29.	邱瑞瑾, 李敏, 胡嘉元, 等. 中成藥上市后臨床安全性評價核心數據集的構建方法探索. 世界科學技術-中醫藥現代化, 2018, 20(10): 1723-1728.

1. 董欣, 石悅. 中成藥藥品說明書的現狀調查分析. 中國中醫藥信息雜志, 2015, 22(3): 117-120.
2. 姜俊杰, 謝雁鳴. 建立中藥注射劑醫院集中監測質量控制體系初探. 中國中藥雜志, 2012, 37(18): 2689-2691.
3. 鄭文科, 劉智, 雷翔, 等. 中成藥上市后臨床安全性評價研究模式的探索建立. 中國中藥雜志, 2015, 40(18): 3693-3696.
4. 謝雁鳴, 廖星, 趙玉斌, 等. 中藥上市后安全性醫院集中監測技術規范(征求意見稿). 中國中藥雜志, 2013, 38(18): 2919-2924.
5. 張俊華, 任經天, 胡鏡清, 等. 中藥注射劑臨床安全性集中監測研究設計與實施專家共識. 中國中藥雜志, 2017, 42(1): 6-9.
6. Ioannidis JPA, Evans SJW, Tzsche PCG, 等. 更好地報告隨機試驗中的危害: CONSORT 聲明擴展版. 中國循證醫學雜志, 2006, 6(9): 682-689.
7. 吳泰相, 商洪才, 卞兆祥, 等. 中藥不良反應/不良事件報告規范建議. 中國循證醫學雜志, 2010, 10(2): 215-219.
8. 費宇彤, 楊紅, 劉兆蘭, 等. 藥品不良反應個案報道的規范性報告. 中國藥物警戒, 2010, 7(4): 206-208.
9. 李迅, 李昕雪, 劉智君, 等. 國內期刊中藥臨床試驗安全性報告分析. 中國藥物警戒, 2010, 7(1): 20-24.
10. 王連心, 謝雁鳴. 基于文獻計量分析的參麥注射液臨床安全性評估. 中國中藥雜志, 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. 中醫臨床研究核心指標集的方法構建—以非瓣膜性房顫為例. 北京: 北京中醫藥大學, 2018.
29. 邱瑞瑾, 李敏, 胡嘉元, 等. 中成藥上市后臨床安全性評價核心數據集的構建方法探索. 世界科學技術-中醫藥現代化, 2018, 20(10): 1723-1728.

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