The First General Consent Implementation in Swiss Traditional Chinese Medicine Practices. A Prospective One-Year Study

Summary Background Traditional Chinese Medicine (TCM) encompasses a wide range of treatments focused on diagnosing and managing illnesses, with increasing adoption in Western countries. TCM is often applied in isolated practices, therefore, rigorous research and real-world data collection remain challenging. The implementation of the General Consent (GC) facilitates this research, therefore, the aim was to investigate the acceptance rate of the GC during the first year of its implementation in TCM practices. Methods This prospective cohort study was conducted from 1 st January to 31 st December 2023 in five TCM practices located in Bad Zurzach, Baden, Lenzburg, Wil, and Zug in Switzerland. GC, together with other registration forms, were sent to patients prior to their appointments, collected during their first visit, and recorded by clinic secretaries. Logistic regression analysis was performed to investigate demographic factors influencing GC acceptance, considering variables such as age, sex, and practice location. Results The study recorded 1,095 patients who sought TCM treatments in 2023, of which 73.6% returned a valid GC document. Overall, the GC acceptance rate was 611/1,095 (55.8%); of those returning the GC, the acceptance rate was 611/806 (75.8%). The medianIQR age of patients was 5237,64 years and female patients were twice as likely to seek TCM treatments compared to male patients. Logistic regression analysis, odds ratio (95%CI), revealed no difference in GC acceptance rate with older age: 1.015 (0.996 to 1.034), p=0.115; female sex: 1.847 (0.588 to 5.804), p=0.294 and age*female sex: 0.983 (0.962 to 1.004), p=0.119. Significant differences in GC acceptance rates were observed across the five TCM practices. Conclusion The GC implementation in TCM practices was feasible, and the GC was well accepted by patients, independent of sex and age. The observed practice-related differences in GC acceptance require further investigation. More TCM practices should implement the GC to enable practice-based TCM research.