中医药领域核心指标集研究现状及展望

Research status and progress of core outcome sets in the field of traditional Chinese medicine

目的 随着中医药领域核心指标集研究数量的增多,研究中存在的问题也逐渐凸显,甚至可能影响核心指标集的推广和应用。本研究基于研究注册平台和文献数据库检索对中医药领域核心指标集研究现状进行分析,希望能引起相关研究者重视。方法 计算机检索国内外核心指标集研究注册平台及中英文文献数据库中收录的中医药领域核心指标集研究,检索时限从建库至2022年6月,采用定性分析方法对中医药领域核心指标集研究现状进行梳理总结。结果 从核心指标集研究注册平台检索到72项注册的中医药领域核心指标集研究,这些研究存在疾病分布不均衡,中医特色指标关注不足,核心指标集适用范围不清晰,患者及公众参与力度不充分等问题。从文献数据库中检索到99篇中医药领域核心指标集文献,仅7.07%(7/99)篇为研究结果报告,且被临床研究和系统评价引用的较少。结论 未来研究者应从规范中医药领域核心指标集研究的注册,完善核心指标集研究的方法学,拓展核心指标集的应用场景,并加强不同利益相关群体合作等方面出发,以提高中医药领域核心指标集研究水平和应用。

Objectives With the increasing number of core outcome sets(COS) in traditional Chinese medicine(TCM), some problems gradually emerged, which may affect the popularization and application of COS. This paper analyzes the COS research status in the field of TCM based on registry and literature databases, so that researchers may pay attention to it. Methods Registry platforms and literature databases of Chinese and English were both searched from inception to June, 2022. Qualitative analysis was used to analyze the research status of COS. Results Seventy-two COS studies were identified from registry platforms, and the results showed some problems, such as uneven disease distribution, insufficient attention to TCM characteristics, unclear COS scope, and insufficient patient and public participation. Ninety-nine studies were identified from different databases, only 7.07%(7/99) of the studies were COS results, and few of them were cited by clinical trials and/or systematic reviews. Conclusion The authors proposed that standardizing the registration of COS in the field of TCM, improving the methodology of COS studies, expanding the application settings of COS, and strengthening the cooperation of different stakeholder groups are important to ameliorate sustainable development of COS.