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

Zhonghua Er Ke Za Zhi. 2019 Nov 2;57(11):876-881. doi: 10.3760/cma.j.issn.0578-1310.2019.11.012.
[Article in Chinese]

Abstract

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 1 329 questionnaires were issued and 1 233 effective questionnaires were returned with a recovery rate of 92.8%. The overall awareness rate regarding clinical research was 32.8% (405/1 233) . 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% (550/1 233), 74.2% (915/1 233) and 36.8% (454/1 233) respectively. When asked "If you want to participate a study, but your parents or guardian do not agree, what would you do?", 33.9% (418/1 233) 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% (632/1 233) chose "listen to parents" and 28.8% (355/1 233) chose "refuse the suggestions of parents or guardian". As to "what are your greatest concerns of participating an investigation?" , 68.1% (840/1 233) chose "worry about added pain or discomfort". but 58.0% (715/1 233) thought if "doctors and nurses take good care of me" their "concerns will reduce" or "feel better to participate in the research?". 55.6% (686/1 233) and 49.3% (608/1 233) 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 not high. It is very necessary to promote the public education of clinical research for this population and also very necessary to address their concern regarding the research.

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1 329份,回收问卷1 233份,有效回收率92.8%。药物临床研究的总体知晓率为32.8%(405/1 233)。22.9%(282/1 233)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%(550/1 233),选择父母或监护人决定的占74.2%(915/1 233),选医生决定的占36.8%(454/1 233)。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%(418/1 233)。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%(632/1 233),选择说服父母或监护人的占28.8%(355/1 233)。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%(840/1 233)。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%(715/1 233)。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%(686/1 233)和49.3%(608/1 233)。 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。.

Keywords: Child; Clinical research; Cognition; Questionnaires.

MeSH terms

  • Adolescent
  • Anxiety
  • Child
  • Clinical Trials as Topic*
  • Female
  • Health Knowledge, Attitudes, Practice*
  • Humans
  • Male
  • Surveys and Questionnaires