ZHANG Mingyan, LI Kai, CAI Huizi, et al. Overview of the Development of Core Outcome Set for Clinical Trials and Related Key Issues in the Field of Traditional Chinese Medicine[J]. Journal of Traditional Chinese Medicine2021, 62(2): 108-113.
ZHANG Mingyan, LI Kai, CAI Huizi, et al. Overview of the Development of Core Outcome Set for Clinical Trials and Related Key Issues in the Field of Traditional Chinese Medicine[J]. Journal of Traditional Chinese Medicine2021, 62(2): 108-113.DOI: 10.13288/j.11-2166/r.2021.02.005.
It is of great significance to select the appropriate outcomes when evaluating the effect of an intervention. The core outcome set(COS) is an agreed and standardized minimum set of outcomes that should be reported in all clinical trials of the same disease
which is key to standardize the use of outcomes. This paper reviewed the background and development history of COS and revealed the importance of COS researches. Based on the actual use experience
the characteristics and limitations of two registry platforms(COMET database and Chicos webpage) were also introduced
and the rational selection and use of different databases and platforms were analyzed. Currently
the COS method is not yet comprehensive. And regarding the particularity of traditional Chinese medicine(TCM)
there are certain problems to be solved in developing COS for TCM
including the standardization of original outcomes
the overlapping of outcome categories
the implementation difficulty to widely seek the international consensus
and the inadequacy of the reflection of TCM characteristics. It is expected to provide references for various stakeholders in developing COS for clinical trials.