Center for Evidence-Based Medicine, Tianjin University of Traditional Chinese Medicine, 312 Anshanxi Road, Nankai District, Tianjin 300193, China.
Evid Based Complement Alternat Med. 2013;2013:202703. doi: 10.1155/2013/202703. Epub 2013 Nov 7.
Currently, quality issues concerning clinical research of traditional Chinese medicine (TCM) have come into the spotlight. It has been recognized that poorly-devised research methodology largely restricted the development of clinical research in TCM. The choice of appropriate outcome measurements is key to the success of clinical research; however, the current procedure for outcomes selection in clinical research of TCM is problematic due to the underdevelopment of clinical methodology. Under this circumstance, we propose the introduction to the concept of Core Outcome Set (COS) and discuss the feasibility of developing a COS system that caters for clinical studies in TCM, in the hope that the outcome evaluation system could be up to international standards.
目前，中药（TCM）临床研究的质量问题已经引起了关注。人们认识到，研究方法设计不当在很大程度上限制了 TCM 临床研究的发展。选择合适的结局测量是临床研究成功的关键；然而，由于临床方法学的发展不足，目前 TCM 临床研究中结局选择的程序存在问题。在这种情况下，我们提出引入核心结局集（COS）的概念，并探讨开发适合 TCM 临床研究的 COS 系统的可行性，希望使结局评估系统达到国际标准。
