建立中医药临床研究核心结局指标集

Establishment of core outcome sets in the trials of traditional Chinese medicine

中医药系统评价和Meta分析研究表明现有中医临床研究存在以下问题:选择疗效结局不公认,设计结局及其指标广泛且不统一,存在选择性报告偏倚的风险高,研究缺失数据多等。建立必须报告的、统一的、公认的、标准化的结局指标最小集合,即核心结局指标集(COS),不仅可以降低选择性报告偏倚,而且可以使相同干预措施的临床研究进行Meta分析或者不同干预措施的研究进行横向比较,方便临床医生选择更适合患者的治疗方法,文章将对COS的概念和研究方法进行描述。

Systematic reviews and meta-analysis of traditional Chinese medicine（TCM） showed many problems existed in TCM clinical trials, such as no accepted outcomes or indices applied for assessments, or no consensus among the varied outcomes or indices, or high risks of the selective reported bias or lots of missing data, etc. Core outcome sets（COSs）, identified as the minimum sets of outcomes that should be reported in all trial no matter primary or secondary outcomes, were established to solve the problems above. With COSs, different interventions with same outcomes from different trials could be compared, and the same interventions with different results from the same outcomes could be meta-analyzed. Besides, the report bias could be reduced and audited. Based on these evidences from comparisons and Meta-analyses, TCM practitioners could select the most suitable treatment for patients. This paper has reported and demonstrated the definitions and the study methods of COS.