8~18岁儿童对临床研究认知的调查  

A survey of knowledge regarding pediatric clinical trial among children at 8-18 years of age

作　　者：潘薇薇[1] 倪韶青[2] 李春梅[2] 漆林艳[2] 梁建凤[3] 申屠建中[4] Pan Weiwei;Ni Shaoqing;Li Chunmei;Qi Linyan;Liang Jianfeng;Shentu Jianzhong(Pharmacy Department of Children′s Hospital,Zhejiang University School of Medicine,Hangzhou 310052,China;Office of Clinical Research Institution of Children′s Hospital,Zhejiang University School of Medicine,Hangzhou 310052,China;Statistics and Analysis Department of Children′s Hospital,Zhejiang University School of Medicine,Hangzhou 310052,China;Department of Clinical Research Centre of the First Affiliated Hospital,Zhejiang University School of Medicine,Hangzhou 310009,China)

机构地区：[1]浙江大学医学院附属儿童医院药剂科,杭州310052 [2]浙江大学医学院附属儿童医院临床试验机构管理办公室,杭州310052 [3]浙江大学医学院附属儿童医院统计室,杭州310052 [4]浙江大学医学院附属第一医院临床药学研究中心,杭州310009

出　　处：《中华儿科杂志》2019年第11期876-881,共6页Chinese Journal of Pediatrics

基　　金：国家自然科学基金(81573516);国家科技重大专项(2013ZX09303003);浙江省基础公益研究计划(LGF19H310004)。

摘　　要：目的了解8~18岁儿童对儿科临床研究的认知程度,为该人群的科普宣教提供依据。方法设计调查问卷于2016年1月至2017年1月通过微信问卷网及现场调查相结合的方式进行调查研究,按照不同发育情况,把接受问卷调查的儿童分为8~10岁、11~13岁、14~15岁、16~18岁组,分析儿童对临床研究认知的情况。结果发放问卷1329份,回收问卷1233份,有效回收率92.8%。药物临床研究的总体知晓率为32.8%(405/1233)。22.9%(282/1233)的人认为,临床研究是拿人做小白鼠。选择自己应该决定是否参加临床研究的占44.6%(550/1233),选择父母或监护人决定的占74.2%(915/1233),选医生决定的占36.8%(454/1233)。当自己想要参加研究,而父母或监护人不同意时,选择放弃的占33.9%(418/1233)。当自己不想参加研究,而父母或监护人觉得应该参加时,选择放弃的占51.3%(632/1233),选择说服父母或监护人的占28.8%(355/1233)。对于参加临床研究的担忧,选择是否会增加额外的不舒服或痛苦的占68.1%(840/1233)。问到怎样可以减少担忧时,选择医生或护士对我很关心的总体比率为58.0%(715/1233)。对于怎样可以鼓励参加研究,选择知道其他小伙伴也跟我一样参加临床研究及知道参加研究后情况的分别占55.6%(686/1233)和49.3%(608/1233)。结论8~18岁儿童对临床研究的认知不高,需要针对该人群开展临床研究科学认知的宣教,需要采取措施真正关心参与研究的儿童。Objective To investigate the knowledge regarding clinical research among children at 8-18 years of age.The survey results will form the basis for developing public education program for this population.Methods The survey was conducted among children at 8-18 years of age using WeChat and spot investigation between January 2016 and January 2017.According to different developmental stages,the survey population was divided into four groups:age 8-10,11-13,14-15 and 16-18 years.The level of knowledge regarding clinical research was analyzed.Results Totally 1329 questionnaires were issued and 1233 effective questionnaires were returned with a recovery rate of 92.8%.The overall awareness rate regarding clinical research was 32.8%(405/1233).It revealed that 282(22.9%)individuals thought that clinical research was to treat people like experimental rats.When asked"who have the final decision on research participation",the percentages of those who chose oneself,parents or guardian and doctor were 44.6%(550/1233),74.2%(915/1233)and 36.8%(454/1233)respectively.When asked"If you want to participate a study,but your parents or guardian do not agree,what would you do?",33.9%(418/1233)of individuals will"give up".As to"If you do not want to participate a study,but your parents or guardian think you should,what would you do?",51.3%(632/1233)chose"listen to parents"and 28.8%(355/1233)chose"refuse the suggestions of parents or guardian".As to"what are your greatest concerns of participating an investigation?",68.1%(840/1233)chose"worry about added pain or discomfort".but 58.0%(715/1233)thought if"doctors and nurses take good care of me"their"concerns will reduce"or"feel better to participate in the research?".55.6%(686/1233)and 49.3%(608/1233)individuals responded that they will"participate in an research?"when they"know that other people also participate the research"and when they"know the details regarding what will happen after the enrollment".Conclusions The knowledge level of clinical research among children aged 8-18 years were

关 键 词：儿童 认知 问卷调查 临床研究 

分 类 号：R47[医药卫生—护理学]