Study on Outcome Indicators and Core Indicator Construction Ideas of Randomized Controlled Trials for Traditional Chinese Medicine in the Treatment of Cervicogenic Headache
Abstract: Objective: This study aims to analyze the current status of outcome indicators in randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) for cervicogenic headache (CEH), identify existing problems, and provide insights for the selection of clinical outcome indicators and the construction of a core outcome set. Methods:Eight domestic and international databases were searched by computer to collect RCT of TCM for CEH. After two rounds of literature screening and data extraction,the Risk of Bias (ROB) assessment tool developed by the Cochrane Collaboration was used to evaluate the risk of bias of the included literature, and statistical analysis was conducted on the outcome indicators. Results:A total of 47 RCTs were included,consisting of 46 Chinese articles and 1 English article,with a total sample size of 4 352 cases. The outcome indicators covered 5 categories and 69 types. The top 3 reporting rates were Visual Analogue Scale (VAS) (74.47%),cervical range of motion (ROM) (44.68%), and Diagnostic and Therapeutic Criteria for TCM Diseases and Syndromes (38.30%). Outcome indicators related to the clinical characteristics and pathogenesis of CEH had relatively high reporting rates,such as VAS score of pain,joint ROM indicators, quality of life indicators, and inflammatory factor indicators. Regarding the setting of outcome indicators, only 1 article clearly distinguished between primary and secondary outcome indicators. In terms of risk of bias, 26 articles did not mention the method of generating random grouping, and 43 articles did not mention the implementation of blinding. Conclusion: Although RCT of TCM for CEH has the advantage of focusing on clinical characteristics and pathogenesis in the selection and application of outcome indicators, there are problems such as unclear primary and secondary outcomes, insufficient application of random design and blinding, relatively few objective evaluation indicators, and lack of TCM-specific and economic indicators. It is recommended to establish a core outcome set in accordance with the Core Outcome Measures in Effectiveness Trials (COMET) initiative and clarify the construction path, including forming a candidate indicator pool, establishing a multidisciplinary expert group, conducting Delphi surveys, and holding consensus meetings. This will strengthen methodological design, increase objective and characteristic indicators,and enhance the value of TCM clinical research.