| 摘要: |
| 目的:了解家长对儿童药物临床试验的认识和态度,为开展儿童药物临床试验提供参考。方法:选择2017 年1-8 月在上海交通大学医学院附属新华医院、复旦大学附属儿科医院、上海交通大学附属儿童医院、哈尔滨儿童医院住院患儿家长,自愿参加问卷调查,收集有效问卷468 份。重点调查内容为儿童药物临床试验目的、意义、必要性、现状以及家长顾虑等。结果:9.4%的家长了解儿童药物临床试验目的,不同学历家长的认识差异有统计学意义(P<0.05);71.6% 的家长认为儿童用药缺乏依据,66.2%家长认为有必要开展药物临床试验,不同学历家长的认识差异有统计学意义(P<0.05);17.9% 的家长认为临床试验管理比较规范,不同学历家长的认识差异无统计学意义(P>0.05);不需要及不知道药物临床试验需要医院伦理委员会审查的家长小学学历占比最高,分别为13.6% 和50.0%,不同学历家长对医院伦理委员会审查的认知差异有统计学意义( P<0.05);担忧孩子身体受伤害的家长占78.8%,担心药物副作用大的家长占69.0%,不同学历的家长对这两方面的认识差异均有统计学意义(P<0.05)。结论:大部分家长对儿童药物临床试验的认识存在偏差,针对不同学历的家长通过加强宣传、沟通,提高家长对儿童药物临床试验的正确认识,是顺利开展儿童药物临床试验的前提条件。 |
| 关键词: 药物临床试验 家长 儿童 认知状况 态度 |
| DOI：10.13407/j.cnki.jpp.1672-108X.2019.03.014 |
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| 基金项目: |
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| Survey of Parents'Cognitive Status and Attitude towards Clinical Trials of Drugs in Children |
| Li Lixia, Wang Xiaoyun, Li Fang, Yang Rui, Yang Yu, Lu Xiaotong |
| (Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai 200092, China) |
| Abstract: |
| Objective: To investigate parents'cognitive status and attitude towards clinical trials of drugs in children, so as to provide
basis for clinical trials of children's drugs. Methods: From Jan. to Aug. 2017, parents of hospitalized children from Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Fudan University Affiliated Pediatric Hospital, Shanghai Jiaotong University Children's Hospital and Harbin Children's Hospital were selected to participate into the questionnaire survey and 468 valid questionnaires were obtained. The key investigation contents were the purpose, significance, necessity, current status of the clinical trials of drugs in children, and concerns of parents. Results: Totally 9.4% of parents understood the purpose of clinical trials of drugs in children, and the differences of understanding of parents with different education backgrounds were statistically significant (P<0.05).The proportion of parents with primary school education who do not need or do not know that the clinical trials of drugs need to be reviewed by the hospital ethics committee was the highest, which was 13.6% and 50.0%, respectively. The cognitive difference of parents with different education backgrounds on the review by the hospital ethics committee was statistically significant (P <0.05).Parents who worried about their children's physical injury accounted for 78. 8%, and parents who worried about drug side effects accounted for 69.0%. Parents with different educational backgrounds had statistically significant differences in understanding of these two aspects (P<0.05). Conclusion: Most parents have a wrong understanding of clinical trials of drugs in children. For parents with different educational backgrounds, strengthening publicity, communication and improving parents'correct understanding of children's drug clinical trials are the preconditions for the smooth development of clinical trials of drugs in children. |
| Key words: drug clinical trials parents children cognitive status attitude |
