医护人员对儿童临床试验的认识、态度及关注点研究

Health care workers' cognition, attitude, and focus of clinical trials for children

目的获取医护人员对药物临床试验的认识、态度及关注点的基础数据,探讨如何提高儿童临床试验医护人员的参与度和依从性。方法在某三甲儿童综合医院,以科室为单位,随机抽取医生护士各3名,总抽样125位医护人员;调查内容涵盖临床试验基础知识、医护人员参与意愿及意愿的影响因素。结果医护人员对临床试验必要性与重要性的认识正确率为98.8%,临床试验风险与受益的正确率为82.1%,弱势群体的考虑为80.9%,知情同意为82.1%,隐私保护为90.9%,伦理委员会为95.9%,但在试验方案设计上,认识正确率仅51.2%;利他主义选择率在90.0%,98.4%选择试验操作困难为最主要的担心因素。结论医护人员对临床试验必要性与重要性、隐私保护、伦理委员会等方面认识较好,但对试验方案设计认识不足;利他主义和试验操作困难是医护人员的主要关注点。建议通过提高医护人员的认识、规范临床试验培训过程、加强医患沟通,促进儿童药物临床试验合理开展。

AIM To gain the data of health care workers＇ cognition, attitude and focus of clinical trials for children, and to explore the strategy of encouraging participation and compliance of health care workers.METHODS A questionnaire, which contained basic knowledge of clinical trials, willingness and potential factors, was randomly surveyed in one children＇s general hospital. Three doctors and three nurses were chosen from 125 health care workers, who came from each clinical department as the respondents. RESULTS The accuracy of health care workers＇ recognition on necessity and importance of clinical trials, risks and benefits,consideration of vulnerable groups, informed consent, privacy protection and ethic committee were 98.8%,82.1%, 80.9%, 82.1%, 90.9%, 95.9% respectively. However, only 51.2% made the right choice in protocol design. There was 90.0% of the health care workers chose altruism as the biggest motivation, and 98.4% took operational difficulties as the most worrisome factor. CONCLUSION Health care workers have a better understanding at the importance and necessity of clinical trials, privacy protection, ethic committee and so on,but have a weak understanding at designing protocols. Health care workers focus on altruism and the problems in trials＇ process mainly. In order to promote the rational development of clinical trials for children, health care workers＇ cognition should be improved, training process of clinical trials and the communication between doctor and patients should be strengthened.