手术患者参与药物临床试验影响因素的调查问卷

A Questionnaire on Influencing Factors of Surgical Patients Participating in Drug Clinical Trials

目的:对即将手术的患者进行参与药物临床试验意愿的调查问卷,调查其参与或拒绝临床试验的影响因素,以便找出患者拒绝临床试验的因素,为药物临床试验工作的顺利开展提供指导。方法:参考已经过信效度检验的调查问卷,对某三甲医院的普外科、妇科、耳鼻喉科、泌尿外科、甲乳外科即将进行手术的患者进行现场问卷调查,发放问卷200份,已全部收回。结果:除了患者的年龄、文化程度、有无子女、家庭收入、医药费来源是影响患者参与药物临床试验的因素外,医院、医生的信任度,以及医生的建议,是否可以造福自己是患者参与药物临床试验的重要影响因素;患者对药物副作用的担心,他人的意见,对药物临床试验相关材料的阅读是患者拒绝临床试验的的重要影响因素;有29%的患者愿意参与临床试验,其中43.1%愿意为医学研究做贡献,有44.82%的患者在意临床试验是否可以造福自己,比如经济补贴,享受更多医疗检测等。有71%的患者拒绝参加药物临床试验,77.46%的患者拒绝参加的原因是担心药物的副作用和不良反应,45.07%的患者不参与的原因是对医院和医生不信任。结论:影响患者参与药物临床试验的因素包括患者的年龄,自身文化,有无子女,家庭收入,医药费来源,医院、医生的信任度,以及医生的建议,患者对药物副作用的担心,对药物临床试验相关材料的阅读。

Objective: To investigate the influencing factors of participating in drug clinical trials or refusing clinical trials for patients about to be operated, so as to find out the factors of patients refusing clinical trials and provide guidance for the development of drug clinical trials. Methods: With reference to the questionnaire that has been verified for reliability and validity, a field questionnaire survey was conducted among the patients who were about to undergo surgery in the department of general surgery, gynecology, ENT, urology, and nail and milk surgery of the Class A tertiary hospital. 200 questionnaires were distributed and all of them were recovered. Results: Patients’ age, education level, children or not, family income, sources of medical expenses, trust of hospitals and doctors, as well as doctors’ suggestions were important factors influencing patients’ participation in drug clinical trials. Patients’ concern about the side effects of drugs and the reading of relevant materials of drug clinical trials are important factors influencing patients’ rejection of clinical trials. 29% of patients are willing to participate in clinical trials, of which 43.1% are willing to contribute to medical research, and 44.82% care about whether clinical trials can benefit themselves, such as financial subsidies and more medical tests. 71% of the patients refused to participate in drug clinical trials, 77.46% of the patients refused to participate because they were worried about the side effects and adverse reactions of the drug, and 45.07% of the patients did not participate because they did not trust the hospital and doctors. Conclusions: The factors influencing patients’ participation in drug clinical trials include patients’ age, culture, children, family income, sources of medical expenses, trust of hospitals and doctors, as well as doctors’ recommendations, patients’ concern about drug side effects, and reading of related materials of drug clinical trials.