儿童临床试验民众认知度及参与度定性访谈研究:方法学特征分析

Public's Knowledge and Experiences Towards Pediatric Clinical Trials:Methodological Characteristics Analysis

目的 分析儿童临床试验民众认知度及参与度定性访谈研究的方法学特征,为我国开展儿童临床试验相关研究提供方法学参考。方法 计算机检索中国知网、万方数据知识服务平台、维普网、PubMed、Embase、APA PsycInfo、CINAHL和Web of Science数据库,获取自建库至2021年9月21日发表的所有采用定性访谈研究的儿童临床试验民众认知度与参与度相关文献。8名研究人员随机分为4组,2人一组经培训后使用Note Express(v 3.2)软件对文献进行预筛选和预提取,经一致性检验合格后再独立进行文献筛选、资料提取和方法学特征分析。对于重复纳入、无法判断及观点不一致的文献均下载全文,小组内筛选和记录排除原因,如有分歧则经组内讨论后由团队负责人决定。采用CASP定性研究评价工具进行质量评价,对提取资料进行归纳总结,采用Microsoft Excel 2020软件进行数据整理。结果 共纳入英文文献144篇,涉及137项研究,其中80.3%(110/137)的研究无或有轻微质量担忧;发表于2015—2021年的研究比例较高(54.7%,75/137);共23个国家发表了相关研究,其中以美国(37.2%,51/137)和英国(26.3%,36/137)最多;75.9%(104/137)的研究仅基于真实儿童临床试验;研究涉及最多的疾病类型为传染性疾病(28.9%,35/121)和肿瘤(22.3%,27/121);干预措施频次最高的是药物(38.6%,39/101)和疫苗(14.9%,15/101);招募方式多是医护人员在医院或诊所从临床试验受试者中招募访谈对象(43.0%,49/114);访谈对象主要是儿童的父母(79.6%,109/137);补偿方式多为代金券(46.7%,21/45);访谈内容多是父母对儿童临床试验的认知及态度(27.5%,78/284);多数研究采用半结构化访谈法(75.2%,103/137)和面对面访谈形式(88.3%,121/137);研究主要采用主题分析法(47.2%,51/108)和NVivo软件(77.6%,52/67)进行数据分析,并运用多人独立分析法(46.4%,52/112)和返回原始内容验证(77.8%,21/27)以确保数据可靠性及可信度。结论 针对患儿及其父母的半结构化访谈结合主题分析法是目前儿童临床试验认知度与参与度定性访谈研究的主要方法。疾病类型以及干预措施是该类研究设计和实施重点关注的临床特征。建议我国在进行访谈内容设计和确定招募策略时需特别关注依从性差或疗效不佳患儿及其父母的观点和体验,分析潜在受试患儿及其父母的认知、态度和经历,为后续优化试验方案和提升试验质量提供参考。

Objective This study aims to analyze the methodological characteristics of qualitative interview studies investigating the public's knowledge and experiences regarding pediatric clinical trials and to provide reference for the design and implementation of similar research in China.Methods We conducted a comprehensive search in CNKI,WanFang Data,Vip Network,PubMed,Embase,APA PsycInfo,CINAHL,and Web of Science databases.We identified all published qualitative interview studies that explored the public's knowledge and experiences related to children's participation in clinical trials up to September 21,2021.Eight researchers were divided into four groups,with two trained researchers in each group utilizing Note Express(v 3.2)software for pre-screening and data extraction.Literature screening,data extraction,and analysis were performed independently after consistency checks.Disagreements were resolved through team leader decisions after group discussion.The CASP Qualitative Checklist Tool was used to assess study quality,and the extracted data was summarized to develop a classification framework.Results A total of 144 English literature(137 studies)were included.The majority of the studies(80.3%,110/137)exhibited minimal or no quality concerns.Most studies(54.7%,75/137)were published from 2015 to 2021.Relevant studies were published in 23 countries,with the United States(37.2%,51/137)and the United Kingdom(26.3%,36/137)contributing the most.There were 75.9%(104/137)of studies focusing on actual pediatric clinical trials.The main diseases covered were infectious diseases(28.9%,35/121)and cancer(22.3%,27/121).Interventions in clinical trials predominantly involved drug therapy(38.6%,39/101)and vaccines(14.9%,15/101).Interviews were conducted by medical staff in hospitals or clinics,with participants mainly recruited from clinical trial subjects(43.0%,49/114).Most interviewees were parents(79.6%,109/137).Compensation was often provided in the form of vouchers(46.7%,21/45).The content of included studies largely centered on parents'perspectives and perceptions of pediatric clinical trial knowledge and processes(27.5%,78/284).Interviews were mainly performed as semi-structured interviews(75.2%,103/137)and face-to-face interviews(88.3%,121/137).Thematic analysis(47.2%,51/108)and NVivo software(77.6%,52/67)were commonly used for data analysis.Independent multi-person analysis(46.4%,52/112)and content verification(77.8%,21/27)were employed to ensure reliability and credibility.Conclusions Semi-structured in-depth interviews with parents and children using thematic analysis are a prominent research approach.Qualitative interview studies emphasize the clinical characteristics of diseases,including disease types and interventions.Specific attention should be given to perspectives and experiences of children and parents with poor adherence or clinical outcomes.Analyzing potential participants'knowledge,attitudes,and experiences can provide references for improving future trial design and quality.