Abstract:
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.
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