在临床试验.gov上公开的泌尿瘤学试验摘要的可读性
Avi S Baskin1, Cameron J Britton1, Lan Ahn Galloway1
1Department of Urology, Vanderbilt University Medical Center, Nashville, Tennessee.
Urology practice
|June 16, 2025
概括
泌尿瘤学临床试验摘要复杂,需要先进的阅读技能. 在NIH之后,可读性得到了改善.
科学领域:
- 在瘤学瘤学.
- 临床试验 临床试验
- 卫生沟通健康沟通
背景情况:
- 临床试验简要摘要对于患者的理解至关重要.
- 评估这些摘要的可读性对于知情同意和参与至关重要.
- 泌尿瘤学试验是临床研究的一个重要领域.
研究的目的:
- 评估临床试验简要摘要的可读性,用于泌尿瘤学研究.
- 为了确定可读性如何根据癌症类型,出版年和研究赞助商而有所不同.
- 评估国家卫生研究院 (NIH) 简单语言指南对摘要可读性的影响.
主要方法:
- 分析了在clinicaltrials.gov.gov上注册的17175项泌尿瘤学试验.
- 计算表面指标 (单词数,句子长度,词汇量,缩写数) 和可读性得分 (弗莱什-金凯德分级,弗莱什阅读方便).
- 间断时间序列分析以评估2017年之前和之后的趋势 (NIH指南发布),并对研究赞助商 (政府,学术界,行业) 进行分类.
主要成果:
- 平均弗莱什-金凯德成绩水平 (FKGL) 为18.7,弗莱什阅读易度 (FRE) 为7.4.
- 从2000年至2016年,可读性下降了 (FKGL增加,FRE减少,P < .01),但在2017年之后有所改善 (FKGL减少,FRE增加,P < .01).
- 政府赞助的试验是最易读的 (FKGL 16.0),其次是学术 (FKGL 18.1) 和工业 (FKGL 19.1) (所有P < .01).
结论:
- 在ClinicalTrials.gov上的泌尿瘤学试验摘要仍然非常复杂,通常需要研究生水平的阅读能力.
- 在遵循NIH的简单语言指令后,可读性已有所改善.
- 需要进一步努力来提高临床试验描述的清晰度,以促进患者的理解和参与.
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