Objective

2

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

2

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

2

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

2

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.