[Methodological exploration of embedding qualitative and mixed methods research in acupuncture pilot trials from the...

Large randomized controlled trials evaluating the efficacy of acupuncture often face challenges of high heterogeneity in outcomes. The underlying reason is that acupuncture, as a complex intervention, is simplified to a single intervention, while pilot trials fail to effectively optimize trial designs. Based on the framework of complex interventions, this article proposes a paradigm shift for acupuncture pilot trials, transforming them from simple quantitative feasibility assessments into comprehensive platforms for systematically improving the maturity of population, intervention, comparison, and outcome (PICO) elements. This article systematically reviews the necessity of embedding qualitative research or mixed methods research within this paradigm and elucidates their key roles in identifying core issues, optimizing interventions, refining procedures, exploring mechanisms, and enhancing the interpretability of results. Furthermore, mixed methods design strategies and specific implementation pathways tailored to different objectives are proposed. Finally, the challenges of this paradigm in terms of cognitive acceptance, methodological integration, and resource requirements, as well as corresponding strategies, are critically analyzed. This article aims to provide theoretical foundations and practical guidance for establishing a more rigorous and highly interpretable methodological framework for acupuncture clinical trials.