O'Halloran Cian P, Agarwal Abhishek, Hawcutt Daniel B, Oni Louise, Moss James
Mersey and West Lancashire Teaching Hospitals NHS Trust, Prescot, UK.
NIHR Alder Hey Clinical Research Facility, Alder Hey Children's NHS Foundation Trust, Liverpool, UK.
Pediatr Res. 2025 Feb 22. doi: 10.1038/s41390-025-03943-z.
Information leaflets in research studies should be age-appropriate to be understood, however the formal readability of children's participant information leaflets (PILs) for research studies has not been assessed.
A single-centre cross-sectional study assessing paediatric PILs. Six readability tests were applied (Gunning Fog Index (GFI), Simple Measure of Gobbledygook (SMOG), Flesch Kincaid Grade Level (FKGL), Coleman-Liau Index (CLI), Automated Readability Index (ARI) and Flesch Reading Ease score (FRE). Results were compared between age groups, and whether the PIL was from either a commercially sponsored or investigator led study.
191 paediatric PILs were included. Age categories; <10 years (n = 65), ≤12 (n = 73), ≤15 (n = 73) and ≥16 (n = 61); were used for analysis. There were 39 commercial PILs and 226 non-commercial PILs. For the ≤10 and ≤12 age bands, all 6 median readability scores exceeded the target age group (thus hard to read, p < 0.005), and there was no difference in readability scores between these two age bands. Four scores from the readability tests were considered age-appropriate in the ≤15 year category, and all median scores were age-appropriate in the ≥16 years age groups. Readability scores for children's PILs were significantly higher in commercially sponsored versus non-commercial studies (P < 0.005).
Improvements are required to make children's PILs readable for the target audience, particularly in commercially sponsored research studies.
Paediatric participant information leaflets may not be readable in research studies, especially in younger age groups. PILs for children participating in commercially sponsored studies were less readable than non-commercial studies. Research teams writing PILs for a paediatric study need to consider the use of readability tools to ensure that the information they are providing is readable by the target audience.
研究中的信息手册应符合相应年龄阶段以便理解，但儿童研究参与者信息手册（PIL）的正式可读性尚未得到评估。
一项评估儿科PIL的单中心横断面研究。应用了六种可读性测试（冈宁雾度指数（GFI）、简化的繁冗度测量法（SMOG）、弗莱什-金凯德年级水平（FKGL）、科尔曼-廖指数（CLI）、自动可读性指数（ARI）和弗莱什阅读易读性得分（FRE））。对不同年龄组以及PIL是来自商业赞助研究还是研究者主导研究的结果进行了比较。
纳入了191份儿科PIL。年龄类别分为：<10岁（n = 65）、≤12岁（n = 73）、≤15岁（n = 73）和≥16岁（n = 6）；用于分析。有39份商业PIL和226份非商业PIL。对于≤10岁和≤12岁年龄组，所有6个中位数可读性得分均超过目标年龄组（因此难以阅读，p < 0.005），且这两个年龄组之间的可读性得分无差异。在≤15岁类别中，可读性测试的四个得分被认为符合年龄要求，在≥16岁年龄组中所有中位数得分均符合年龄要求。商业赞助研究中儿童PIL的可读性得分显著高于非商业研究（P < 0.005）。
需要改进以使儿童PIL对目标受众具有可读性，特别是在商业赞助的研究中。
儿科研究参与者信息手册在研究中可能不可读，尤其是在较年轻的年龄组中。参与商业赞助研究的儿童的PIL比非商业研究的可读性更低。为儿科研究撰写PIL的研究团队需要考虑使用可读性工具，以确保他们提供的信息对目标受众是可读的。
需注意，原文中“≥16 (n = 6)”可能有误，根据前文逻辑推测应为“≥16 (n = 61)”，译文已按此修正。
