Linda M Lambert, Felicia Trachtenberg, Russell Gongwer, Thomas Giorgio, Olukayode Garuba, Sandra Mihelic, Kathleen Rathge, Martha Rolland, Cynthia Smith, Mary Stumpf, Stacy Woyciechowski, Frances Woodard, Jennifer S Yauck, Victoria L Pemberton
{"title":"父母和青少年对临床试验参与的看法：FUEL随机对照试验和开放标签扩展研究。","authors":"Linda M Lambert, Felicia Trachtenberg, Russell Gongwer, Thomas Giorgio, Olukayode Garuba, Sandra Mihelic, Kathleen Rathge, Martha Rolland, Cynthia Smith, Mary Stumpf, Stacy Woyciechowski, Frances Woodard, Jennifer S Yauck, Victoria L Pemberton","doi":"10.1017/S1047951125001702","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Adolescent and parental perceptions of the Fontan Udenafil Exercise Longitudinal Assessment Randomised Controlled Trial (FUEL) and its open-label extension were examined, to identify factors affecting future research participation.</p><p><strong>Methods: </strong>A validated survey was administered at two time points to adolescents (12-19 years) and their parents to assess likes/dislikes of study participation, research team, study burden and benefits. A 5-point Likert scale (strongly disagree [-2] to strongly agree [ + 2]) was used, and scores were averaged. Regression models explored potential predictors. Open-ended questions queried the most/least appealing aspects of participation and considerations for future research.</p><p><strong>Results: </strong>Among 250 FUEL participants at 14 centres, 179 adolescent and 183 parent surveys were completed at T1 (6 months after randomisation). Perceptions of research participation were generally positive: 1.35 ± 0.45 for adolescents; 1.56 ± 0.38 (<i>p</i> < 0.001) for parents. There were no significant differences between females vs. males. Themes from open-ended responses included liking to help others and themselves, liking the study team, and disliking study burden. Adolescents liked the compensation and disliked study-related testing. At T2 (end of open-label extension study), 121 adolescents and 114 parents responded. Perception scores remained high at 1.39 ± 0.51 for adolescents and 1.58 ± 0.37 for parents (<i>p</i> = 0.001). There were no significant gender differences in perceptions between adolescents, but mothers had slightly better perceptions than fathers (<i>p</i> = 0.004).</p><p><strong>Conclusions: </strong>Perceptions of research were positive and slightly better for parents. Study teams and compensation were key contributors to positive perceptions. Study burden and testing were viewed less favourably. Future studies should consider families' preferences and potential barriers to participation.</p>","PeriodicalId":9435,"journal":{"name":"Cardiology in the Young","volume":" ","pages":"1-7"},"PeriodicalIF":0.9000,"publicationDate":"2025-05-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Parental and adolescent perceptions of clinical trial participation: the FUEL randomised controlled trial and open-label extension study.\",\"authors\":\"Linda M Lambert, Felicia Trachtenberg, Russell Gongwer, Thomas Giorgio, Olukayode Garuba, Sandra Mihelic, Kathleen Rathge, Martha Rolland, Cynthia Smith, Mary Stumpf, Stacy Woyciechowski, Frances Woodard, Jennifer S Yauck, Victoria L Pemberton\",\"doi\":\"10.1017/S1047951125001702\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>Adolescent and parental perceptions of the Fontan Udenafil Exercise Longitudinal Assessment Randomised Controlled Trial (FUEL) and its open-label extension were examined, to identify factors affecting future research participation.</p><p><strong>Methods: </strong>A validated survey was administered at two time points to adolescents (12-19 years) and their parents to assess likes/dislikes of study participation, research team, study burden and benefits. A 5-point Likert scale (strongly disagree [-2] to strongly agree [ + 2]) was used, and scores were averaged. Regression models explored potential predictors. Open-ended questions queried the most/least appealing aspects of participation and considerations for future research.</p><p><strong>Results: </strong>Among 250 FUEL participants at 14 centres, 179 adolescent and 183 parent surveys were completed at T1 (6 months after randomisation). Perceptions of research participation were generally positive: 1.35 ± 0.45 for adolescents; 1.56 ± 0.38 (<i>p</i> < 0.001) for parents. There were no significant differences between females vs. males. Themes from open-ended responses included liking to help others and themselves, liking the study team, and disliking study burden. Adolescents liked the compensation and disliked study-related testing. At T2 (end of open-label extension study), 121 adolescents and 114 parents responded. Perception scores remained high at 1.39 ± 0.51 for adolescents and 1.58 ± 0.37 for parents (<i>p</i> = 0.001). There were no significant gender differences in perceptions between adolescents, but mothers had slightly better perceptions than fathers (<i>p</i> = 0.004).</p><p><strong>Conclusions: </strong>Perceptions of research were positive and slightly better for parents. Study teams and compensation were key contributors to positive perceptions. Study burden and testing were viewed less favourably. Future studies should consider families' preferences and potential barriers to participation.</p>\",\"PeriodicalId\":9435,\"journal\":{\"name\":\"Cardiology in the Young\",\"volume\":\" \",\"pages\":\"1-7\"},\"PeriodicalIF\":0.9000,\"publicationDate\":\"2025-05-21\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Cardiology in the Young\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1017/S1047951125001702\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"CARDIAC & CARDIOVASCULAR SYSTEMS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Cardiology in the Young","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1017/S1047951125001702","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
Parental and adolescent perceptions of clinical trial participation: the FUEL randomised controlled trial and open-label extension study.
Introduction: Adolescent and parental perceptions of the Fontan Udenafil Exercise Longitudinal Assessment Randomised Controlled Trial (FUEL) and its open-label extension were examined, to identify factors affecting future research participation.
Methods: A validated survey was administered at two time points to adolescents (12-19 years) and their parents to assess likes/dislikes of study participation, research team, study burden and benefits. A 5-point Likert scale (strongly disagree [-2] to strongly agree [ + 2]) was used, and scores were averaged. Regression models explored potential predictors. Open-ended questions queried the most/least appealing aspects of participation and considerations for future research.
Results: Among 250 FUEL participants at 14 centres, 179 adolescent and 183 parent surveys were completed at T1 (6 months after randomisation). Perceptions of research participation were generally positive: 1.35 ± 0.45 for adolescents; 1.56 ± 0.38 (p < 0.001) for parents. There were no significant differences between females vs. males. Themes from open-ended responses included liking to help others and themselves, liking the study team, and disliking study burden. Adolescents liked the compensation and disliked study-related testing. At T2 (end of open-label extension study), 121 adolescents and 114 parents responded. Perception scores remained high at 1.39 ± 0.51 for adolescents and 1.58 ± 0.37 for parents (p = 0.001). There were no significant gender differences in perceptions between adolescents, but mothers had slightly better perceptions than fathers (p = 0.004).
Conclusions: Perceptions of research were positive and slightly better for parents. Study teams and compensation were key contributors to positive perceptions. Study burden and testing were viewed less favourably. Future studies should consider families' preferences and potential barriers to participation.
期刊介绍：
Cardiology in the Young is devoted to cardiovascular issues affecting the young, and the older patient suffering the sequels of congenital heart disease, or other cardiac diseases acquired in childhood. The journal serves the interests of all professionals concerned with these topics. By design, the journal is international and multidisciplinary in its approach, and members of the editorial board take an active role in the its mission, helping to make it the essential journal in paediatric cardiology. All aspects of paediatric cardiology are covered within the journal. The content includes original articles, brief reports, editorials, reviews, and papers devoted to continuing professional development.
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