Methods for development of a core outcome set for clinical trials integrating traditional Chinese medicine and Western medicine

Journal of integrative medicine - Tập 19 - Trang 389-394 - 2021
Rui-jin Qiu1, Min Li2, Jia-yuan Hu3, Jing Chen4, Hong-cai Shang1
1Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700, China
2The Third Affiliated Hospital, Beijing University of Chinese Medicine, Beijing 100029, China
3Dermatology Department, Beijing Hospital of Traditional Chinese Medicine, Beijing 100010, China
4Department of Health Care, Baokang Hospital, Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China

Tài liệu tham khảo

Cheng, 2017, CONSORT extension for Chinese herbal medicine formulas 2017: recommendations, explanation, and elaboration, Ann Intern Med, 167, 112, 10.7326/M16-2977 Hao, 2015, Traditional Chinese medication for cardiovascular disease, Nat Rev Cardiol, 12, 115, 10.1038/nrcardio.2014.177 World Health Organization. WHO traditional medicine strategy 2014–2023. (2013-05-15) [2020–11–01]. https://www.who.int/publications/i/item/9789241506096. Chen, 2006, Situation of integrative medicine in China: results from a national survey in 2004, Chin J Integr Med, 12, 161, 10.1007/BF02836514 Qiu, 2019, Outcome reporting from clinical trials of non-valvular atrial fibrillation treated with traditional Chinese medicine or Western medicine: a systematic review, BMJ Open, 9, e028803, 10.1136/bmjopen-2018-028803 Williamson PR, Altman DG, Bagley H, Barnes KL, Blazeby JM, Brookes ST, et al. The COMET handbook: version 1.0. Trials 2017;18(Suppl 3):280. The COMET initiative. Core outcome measures in effectiveness trials. [2020-11-1]. https://www.comet-initiative.org/. Zhang, 2013, Clinical research of traditional Chinese medicine needs to develop its own system of core outcome sets, Evid Based Complement Alternat Med, 2013, 1 Xing, 2014, Approach to developing core outcome sets for clinical trials of traditional Chinese medicine, Zhonghua Zhong Yi Yao Za Zhi, 29, 1352 Yu, 2016, Establishment of core outcome sets in the trials of traditional Chinese medicine, Zhonghua Zhong Yi Yao Za Zhi, 31, 2526 Zhang, 2017, The construction of core outcome set of traditional Chinese medicine clinical trials (COS-TCM) and implementation specification of the Delphi method, Zhong Yi Za Zhi, 58, 20 Zhang, 2017, Core outcome set–standards for reporting: the COS-STAR statement, Zhongguo Xun Zheng Yi Xue Za Zhi, 17, 470 Zhang, 2018, Introduction of COS-STAD recommendations and its application in TCM, Zhongguo Xun Zheng Yi Xue Za Zhi, 18, 392 Qiu, 2019, The comparison of research and reporting guideline for core outcome sets and the significance for research in traditional Chinese medicine, Zhongguo Xun Zheng Yi Xue Za Zhi, 19, 1492 Qiu, 2017, Interpretation of the COMET handbook (version 1.0) and its insight for developing core outcome sets in clinical trials of traditional Chinese medicine, Zhongguo Xun Zheng Yi Xue Za Zhi, 17, 1482 Qiu, 2018, The approach of choosing outcome measurement instruments in clinical trials, Zhongguo Xun Zheng Yi Xue Za Zhi, 18, 238 Lam, 2019, ICD-11: impact on traditional Chinese medicine and world healthcare systems, Pharmaceut Med, 33, 373 Yang, 2010, Herbal interactions with anticancer drugs: mechanistic and clinical considerations, Curr Med Chem, 17, 1635, 10.2174/092986710791111279 Xiong X. Integrating traditional Chinese medicine into Western cardiovascular medicine: an evidence-based approach. Nat Rev Cardiol 2015;12(6):374. Kirkham, 2017, Core Outcome Set—STAndards for Development: the COS-STAD recommendations, PLoS Med, 14, e1002447, 10.1371/journal.pmed.1002447 Kirkham, 2019, Core Outcome Set—STAndardised Protocol Items: the COS-STAP Statement, Trials, 20, 116, 10.1186/s13063-019-3230-x Qiu, 2020, Core outcome set for clinical trials of COVID-19 based on traditional Chinese and Western medicine, Front Pharmacol, 11, 781, 10.3389/fphar.2020.00781 Chen, 2018, Meta-analysis on traditional Chinese medicine injection in the treatment of acute attack of bronchia, Zhong Yi Yao Lin Chuang Za Zhi, 30, 250 Cheng, 2018, Meta-analysis on clinical efficacy of Chinese herbal medicine in treatment of type 2 diabetes mellitus with dampness heat and spleen deficiency, Zhong Yi Yao Lin Chuang Za Zhi, 30, 264 Tang, 2018, A systematic review of the efficacy and safety of Chinese patent medicine in the treatment of coronary revascularization, Tianjin Zhong Yi Yao, 35, 20 Qiu, 2018, 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, 19, 541, 10.1186/s13063-018-2904-0 Qiu, 2019, Development of a core outcome set for myocardial infarction in clinical trials of traditional Chinese medicine: a study protocol, BMJ Open, 9, e032256, 10.1136/bmjopen-2019-032256 Zhang, 2018, Outcome measures of clinical trials of stable angina pectoris treated by Chinese medicine in 2005: literature research, Zhongguo Zhong Xi Yi Jie He Za Zhi, 38, 191 Zhang, 2003, Research on TCM syndrome nomenclature and classification: review and hypothesis, Beijing Zhong Yi Yao Da Xue Xue Bao, 26, 1 Zhu, 2008, Differentiation of pattern elements, Beijing: People’s Medical Publishing House Wang, 2006, The induction of syndrome factor and affecting target, Shandong Zhong Yi Yao Da Xue Xue Bao, 30, 6 Dodd, 2018, A taxonomy has been developed for outcomes in medical research to help improve knowledge discovery, J Clin Epidemiol, 96, 84, 10.1016/j.jclinepi.2017.12.020 Basch E, Reeve BB, Mitchell SA, Clauser SB, Minasian LM, Dueck AC, et al. Development of the National Cancer Institute’s patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE). J Natl Cancer Inst 2014;106(9): dju244. Guyatt, 2011, GRADE guidelines: 2. Framing the question and deciding on important outcomes, J Clin Epidemiol, 64, 395, 10.1016/j.jclinepi.2010.09.012 Hooft JV, Duffy JMN, Daly M, Williamson PR, Meher S, Thom E, et al. A core outcome set for evaluation of interventions to prevent preterm birth. Obstet Gynecol 2016;127(1):49–58. Prinsen, 2016, How to select outcome measurement instruments for outcomes included in a “Core Outcome Set”—a practical guideline, Trials, 17, 449, 10.1186/s13063-016-1555-2 Kirkham, 2016, Core Outcome Set—STAndards for Reporting: the COS-STAR statement, PLoS Med, 13, e1002148, 10.1371/journal.pmed.1002148 Davis, 2018, Choosing important health outcomes for comparative effectiveness research: an updated systematic review and involvement of low and middle income countries, PLoS ONE, 13, e0190695, 10.1371/journal.pone.0190695