家长和青少年对临床试验参与的看法:FUEL随机对照试验和开放式扩展研究
Linda M Lambert1, Felicia Trachtenberg2, Russell Gongwer2
1Division of Pediatric Cardiothoracic Surgery, University of Utah, Salt Lake City, UT, USA.
Cardiology in the young
|May 20, 2025
概括
家长和青少年参与者普遍对Fontan Udenafil运动纵向评估 (FUEL) 试验持积极看法. 积极的看法与研究团队和补偿有关,而负担和测试是缺点.
科学领域:
- 儿童心脏病学 儿童心脏病学
- 临床试验设计 临床试验设计
- 患者报告的结果
背景情况:
- 丹乌德纳菲尔运动纵向评估 (FUEL) 试验及其扩展旨在了解参与者的体验.
- 调查青少年和家长的看法对于改善未来临床研究参与至关重要.
研究的目的:
- 评估青少年和家长对FUEL试验及其开放式扩展的看法.
- 确定影响参与未来研究的因素.
主要方法:
- 一项经过验证的调查评估了参与者喜欢/不喜欢,研究团队的互动,研究负担和利益,使用5分利克特尺度.
- 回归模型确定了知觉的预测因素,开放式问题探索了研究经验的特定方面.
- 在两个时间点对青少年 (12-19岁) 和他们的父母进行了调查.
主要成果:
- 青少年 (1.35 ± 0.45) 和家长 (1.56 ± 0.38) 在T1.8对研究参与的看法总体上是积极的.
- 积极的主题包括帮助他人,积极的研究团队互动和补偿;负面的主题涉及研究负担和测试.
- 感知得分在T2仍然很高 (青少年:1.39 ± 0.51;父母:1.58 ± 0.37),母亲报告的感知略好于父亲.
结论:
- 青少年和家长对FUEL试验的看法基本上是积极的.
- 研究团队的参与和参与者的报酬对人们的看法产生了积极的影响.
- 减少研究负担和简化测试是未来参与研究的重要考虑因素.
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