Complex Intervention Frameworks for Acupuncture: Recommendations from a Scoping Review.

OBJECTIVE: To explore phase structures and evaluation components of existing complex intervention frameworks and to propose recommendations for future acupuncture frameworks. METHODS: Six databases and multiple sources of gray literature were searched. Literature on complex interventions, including guidelines, frameworks, models, methodological studies, consensus statements, policy documents, and web-based guidance, were included. A narrative synthesis was conducted to examine phase settings and inter-phase relationships. The included frameworks were further assessed for their applicability to acupuncture evaluation, and preliminary recommendations were developed. RESULTS: A total of 46 publications were included, identifying 21 eligible frameworks, which were further categorized into 14 framework series. The included frameworks were mainly characterized by 3 phases, including preparatory, intervention evaluation, and long-term evaluation. Two evaluation approaches were identified, clinical-effect-first and mechanistic-first. Two structural design logics, sequential linear and sequential iterative models, were observed. The most frequently addressed phase components were overall effect evaluation (n=10, 71.4%) and component evaluation (n=13, 92.9%), whereas long-term outcomes were rarely considered (n=3, 21.4%). Regarding applicability to acupuncture, 4 major aspects were identified: acupuncture theory integration, individualized treatment adjustment, long-term follow-up, and real-world heterogeneity. CONCLUSIONS: Existing frameworks vary substantially in phase structures and are not fully adapted to acupuncture. Potential considerations in future framework development include acupuncture theory and clinical experience, individualized intervention protocol, practitioner factors, acupuncture-specific outcomes, long-term follow-up and safety, and biomedical outcomes.