[Implementation strategies and optimization paths of process evaluation in acupuncture clinical trials]

The root cause of the lagging evidence level in clinical trials of acupuncture lies in the complex system characteristics of acupuncture intervention. Process evaluation can solve the above difficulties through systematically monitoring the implemention of fidelity, verifying causal mechanism, analyzing situational factors and other approaches. In view of the complexity of operation, this study proposes a framework for process evaluation, i.e., constructing "fidelity index" can enable quantitative measurement of differences in technical schools, and can develop "total stimulus dose" to standardize intervention dosage; using "capability matrix" can model the dynamic interaction between clinicians and patients, so as to cope with the uncertainty, and applying "therapeutic alliance scale" to capture the variation of human factors; for background effect visualization, a "resource heatmap" can be created to integrate macro-variables such as medical insurance policy coverage and cultural acceptance; and using the "latent category growth model" can identify heterogeneous trajectories and establish a closed loop of monitoring, optimization and feedback in terms of dynamic tracking of efficacy. By the fidelity index, capability matrix, resource heatmap, and dynamic trajectory model, this framework can transform the abstract complexity into the intervention target, which can significantly improve the validity and extensibility of the experiment. Process evaluation can drive the leap from empirical inheritance to evidence-based medicine in acupuncture research, which will not only provide methodological support for the modernization of traditional medicine, but also can enhance the internationalization trend of acupuncture by optimizing localization adaptation strategies and policy evidence transformation paths.