[Analysis of influencing factors and evaluation methods for intervention fidelity in acupuncture clinical trials]
Lu Wang1, Xiaoyi Hu1, Weijuan Gang1
1Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing 100700, China.
Objective:
To systematically review and analyze the influencing factors and evaluation methods of intervention fidelity in acupuncture clinical trials, so as to provide a reference for constructing an evaluation framework of fidelity in acupuncture trials.
Methods:
A computerized search was conducted on the influencing factors and evaluation methods of intervention fidelity in acupuncture clinical trials across CNKI, Wanfang, VIP, SinoMed, PubMed, EMbase, Cochrane Library databases, spanned from inception to December 31, 2025; and supplemented by manual retrieval for the references of included articles. Influencing factors were categorized using the updated consolidated framework for implementation research (CFIR), while evaluation content of the fidelity was summarized in accordance with the items from the standards for reporting interventions in clinical trials of acupuncture (STRICTA).
Results:
A total of 143 articles were included. Factors influencing acupuncture intervention fidelity included 5 categories, named acupuncture-specific attributes, external factors, internal factors, individual characteristics, and implementation processes. The most common factors were perceived efficacy of acupuncture (16 articles, 11.19%), complexity of acupuncture (11 articles, 7.69%), doctor-patient communication (9 articles, 6.29%), acupuncturist competence (13 articles, 9.09%), patient's attitude toward acupuncture (13 articles, 9.09%), and convenience of receiving treatment (16 articles, 11.19%). Fidelity evaluation aimed at therapy assessment, with subjects as the main targets; and evaluation dimensions covered 4 categories (pre-intervention preparation, needling details, treatment protocol, and supportive measures), encompassing 21 items. Multiple evaluation approaches, tools, standards, and time points were applied; and the evaluation results were primarily based on quantitative analysis, with partial incorporation of qualitative analysis. Most trials reported only the aforementioned evaluation components.
Conclusion:
Key factors affecting acupuncture intervention fidelity include the acupuncture-specific attributes, doctor-patient communication, acupuncturist competence, patient attitudes, and treatment accessibility. Current fidelity evaluation methods in acupuncture trials are not unified and lack systematic assessment. In the future, a comprehensive and systematic fidelity evaluation methodology should be established to provide guidance for assessing the fidelity of acupuncture intervention.
