在研究研究中的儿科参与者信息传单的可读性
Cian P O'Halloran1, Abhishek Agarwal2,3, Daniel B Hawcutt2,3
1Mersey and West Lancashire Teaching Hospitals NHS Trust, Prescot, UK.
Pediatric research
|February 21, 2025
概括
参与者信息传单 (PILs) 对于研究中的儿童来说往往太难阅读,特别是对于年轻的年龄组和商业赞助的试验. 应该使用可读性工具来确保PIL与年龄相适应.
科学领域:
- 儿科研究 儿科研究
- 临床试验伦理学研究
- 卫生识字 卫生识字
背景情况:
- 参与者信息传单 (PILs) 对于研究中的知情同意至关重要.
- 确保PIL与年龄相适应,对于儿童的理解至关重要.
- 儿童PIL的可读性尚未得到正式评估.
研究的目的:
- 正式评估在研究中使用的儿童参与者信息传单 (PIL) 的可读性.
- 为了比较不同儿科年龄组的可读性.
- 为了评估商业赞助和研究人员领导的研究之间的可读性差异.
主要方法:
- 一个单中心的横截面研究分析了191个儿科PIL.
- 应用了六个标准化的可读性测试:枪击雾指数 (GFI),简单的测量Gobbledygook (SMOG),弗莱什金凯德等级水平 (FKGL),科尔曼-利乌指数 (CLI),自动可读性指数 (ARI) 和弗莱什阅读易度得分 (FRE).
- 结果按年龄类别 (<10, ≤12, ≤15, ≥16岁) 和研究赞助层分.
主要成果:
- 对于年龄≤10岁和≤12岁的儿童,所有可读性得分都表明PILs太难阅读 (p < 0.005).
- 对于老年人群来说,可读性有所改善,对于16岁以上的年龄组来说,分数是适合年龄的.
- 与非商业研究相比,商业赞助的PIL显示得分明显高 (可读性较低) (P < 0.005).
结论:
- 需要显著改进,以提高儿童PIL的可读性.
- 在商业赞助的儿科研究中,应特别注意PIL.
- 建议研究小组使用可读性评估工具,以确保PIL可供目标儿科受众使用.
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