Assessing Compliance and Satisfaction Among Participants in Clinical Trials on Traditional Chinese Medicine

Abstract

Shuang Xiao,1 Anthony Androulakis,2 William D Skelton,3 Irene L Quan,4 Jinlian Cheng,1 Yan Wang,1 Xueqi Zhu,1 Haiqun Zhang5 1Office of Drug Clinical Trial Institution, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, People’s Republic of China; 2School of Public Health, University of South Carolina, Columbia, SC, USA; 3D.AC, The Acupuncture Clinic, Columbia, SC, USA; 4Northwestern University Feinberg School of Medicine, Chicago, IL, USA; 5Trauma Orthopaedics, Beijing Fengsheng Special Hospital of Traditional Medical Traumatology and Orthopaedics, Beijing, People’s Republic of ChinaCorrespondence: Jinlian Cheng, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, 23 Art Museum Back Street, Dongcheng District, Beijing, People’s Republic of China, Tel [phone], Email [email protected]: The aim of this study is to assess the willingness, motivation, satisfaction levels, and expectations of participants engaged in clinical trials, while also exploring factors that influence compliance from the participants’ standpoint. Furthermore, this research aims to enhance the understanding of all stakeholders involved in clinical trials about the needs of participants and to offer evidence-based and pragmatic recommendations for effectively managing clinical trial participants.Methods: An electronic questionnaire covers various aspects of Traditional Chinese Medicine (TCM) clinical trials. The distribution of the electronic questionnaire was facilitated through WeChat groups, WeChat Moments, and individual interactions. Count data was expressed in terms of frequency (or rate), and subsequent analysis was conducted utilizing the standard chi-squared test. A p value≤ 0.05 was considered significant. By drawing a Pareto chart, the priority of factors influencing participants’ willingness to participate in clinical trials was systematically assessed.Results: 88 participants answered the questionnaire. A decline in education level corresponded to a decreasing comprehension of participants’ grasp of “clinical trial” and “clinical trial participant” (p< 0.05). The primary reason for participants’ reservations about joining clinical trials stems from their inadequate comprehension of clinical trial details. The key factors contributing to participants’ reluctance to engage in clinical trials encompass aspects of trial design, the operational procedures, insufficient understanding of clinical trial particulars, concerns about potential harm to their bodies and opposition from family members. Importantly, these areas of participants’ hesitation and unwillingness to partake in clinical trials mirror the factors participants’ dissatisfaction contributing to.Conclusion: We found four factors significantly influencing participants’ willingness to engage and their overall satisfaction: the participant’s profile, trial design, trial institution setup, and the qualifications of the researchers. Derived from these critical factors, this paper presents a series of constructive measures.Keywords: clinical trial, traditional Chinese medicine, compliance, satisfaction, participants

Keywords

• clinical trial
• traditional chinese medicine
• compliance
• satisfaction
• participants