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揭示可读性挑战:对临床试验中的同意文件可访问性的广泛分析
Adrian H Zai1, Jamie M Faro1, Jeroan Allison1
1Department of Population and Quantitative Health Science, University of Massachusetts Chan Medical School, Worcester, MA, USA.
美国临床试验中的知情同意表 (ICF) 经常超过推的读数水平. 虽然可读性正在改善,但大多数ICF仍然复杂,影响参与者的理解和道德同意.
科学领域:
- 临床研究伦理学
- 卫生识字 卫生识字
- 监管合规性 监管合规性
背景情况:
- 知情同意表格 (ICF) 对于临床试验参与者的理解至关重要.
- 现有的ICF可读性标准经常没有得到满足.
- 在机构审查委员会 (IRB) 的建议和ICF实际的识字水平之间存在差距.
研究的目的:
- 评估来自clinicaltrials.gov.gov的5000多个美国ICF的可读性.
- 评估识字水平,并确定从2005年到2024年的ICF可读性趋势.
主要方法:
- 从clinicaltrials.gov.gov获得的5,239个美国ICF的分析.
- 应用可读性指标,包括Flesch阅读易度和Flesch-Kincaid等级水平.
- 在18年期间 (2005-2024) 检查可读性趋势.
主要成果:
- 对于ICF的平均Flesch-Kincaid等级水平为10.99,超过了推的八年级水平.
- 分析的ICF中,有91%的文字高于推的八年级阅读水平.
- 观察到一个积极的趋势,最近的研究越来越少超过10年级的阅读水平.
结论:
- 建议和实际ICF可读性之间仍然存在很大的差距.
- 需要持续努力,以简化ICFs的不同教育背景.
- 提高ICF的理解对于伦理临床试验的进行和参与者的参与至关重要.
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