Objective: To explore the influence of patients' participation in and completing the acupuncture clinical trials through a cross-sectional survey. In addition, we explored potential factors involved in improving patient's compliance to treatment, thus enhancing the quality of acupuncture clinical studies.
Methods: A survey was conducted at outpatient department of acupuncture and metabolic diseases in two hospitals in Beijing. The semi-structured questionnaire was designed based on literature review and Delphi methods. It contains 15 questions related to patients' experience and attitude. SPSS 22.0 was used for analyses. OR and 95% CI were used for dichotomous outcomes. Logistic regression analysis (LRA) and multi-LRA were used to explore the factors influencing patients' participation or completion and the relationship between demographic characteristics and potential factors.
Results: A survey was conducted from April to September 2016. Five hundred patients were consecutively sampled to fill semi-structured questionnaires regardless of their types of disease. The participants (75.2% were female) were in the age range of 15-85 years and all of them completed the survey. The effect and safety of acupuncture therapy were considered to be the deciding factors by 92% and 96% of the respondents, respectively. Only 40 of the surveyed participants (8.0%) had previously participated in the clinical trials. The LRA showed they paid more attention to treatment regimen (frequency and session of treatment) when deciding whether or not to participate in the trials (OR 1.54, 95% CI 1.02-2.34). Multivariate LRA showed that elder people considered cost (OR 1.36, 95% CI 1.09-1.70) to be an important factor, while the participants having medical insurance (OR 1.45, 95% CI -0.20-0.93) thought informed consent was important. Meanwhile, participants with higher education preferred regular follow-up (OR 1.16, 95% CI 0.02-0.28).
Conclusion: After providing adequate information regarding the potential benefits and harms of the acupuncture treatment, completion of the treatment within the specific time regimen was found to be the most important factor affecting patient's compliance. Other factors, such as cost and regular follow-up, should also be given special consideration.
Keywords: acupuncture; clinical trials; cross-sectional study; patient compliance.