[Systematic review and quality evaluation of core outcome sets in traditional Chinese medicine(2019-2024)].

Abstract

A core outcome set(COS) refers to the minimum set of outcomes that should be measured and reported in all clinical studies within a specific field. With the development of the COS for traditional Chinese medicine(COS-TCM), there has been a rapid increase in related publications, highlighting the need for a periodic secondary review. This study systematically reviewed and evaluated the quality of published COS-TCM research by comprehensively searching Chinese and English literature databases as well as specialized databases, using qualitative analysis and quality assessment methods. The objective is to synthesize the current state of research, identify common issues and methodological weaknesses, thereby supporting the high-quality advancement of the COS-TCM field. A total of 39 COS-TCM studies were included. It was found that existing studies generally employ sound methodologies. However, methodological improvements are needed in areas such as patient involvement, the development and publication of study protocols, the generation of a preliminary list of outcomes, and managing attrition in Delphi surveys. While the structural presentation is largely complete, reporting remains insufficient regarding the roles played by different stakeholder groups, detailed content of the consensus process, and the presentation of core outcomes. To improve future development, researchers could focus on both methodological application and reporting quality, and also address aspects such as research topic selection, stakeholder engagement, and the development of TCM-specific outcome and measurement instruments to better reflect the therapeutic characteristics and comparative advantages of TCM.