揭开可读性难题的面纱:广泛分析临床试验中同意书的可读性。

IF 2.1 Q3 MEDICINE, RESEARCH & EXPERIMENTAL
Journal of Clinical and Translational Science Pub Date : 2024-09-16 eCollection Date: 2024-01-01 DOI:10.1017/cts.2024.595
Adrian H Zai, Jamie M Faro, Jeroan Allison
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引用次数: 0

摘要

背景:临床研究试验依赖知情同意书(ICF)向潜在参与者解释研究的方方面面。尽管我们努力确保 ICF 的可读性,但对其复杂性和参与者理解能力的担忧依然存在。机构审查委员会(IRB)的标准与 ICF 的实际可读性水平之间存在明显差距,ICF 的可读性往往超过了建议的八年级阅读水平。本研究评估了来自美国 ClinicalTrials.gov 的五千多份 ICF 的可读性,以评估其识字水平:我们使用可读性指标,如 Flesch 阅读轻松度、Flesch-Kincaid 等级、Gunning Fog 指数和难词百分比,对 ClinicalTrials.gov 中的 5,239 份美国 ICF 进行了分析。我们研究了 2005 年至 2024 年期间启动的各项研究的可读性水平趋势:结果:大多数 ICF 超过了建议的八年级阅读水平,平均 Flesch-Kincaid 等级为 10.99。虽然 91% 的国际功能、残疾和健康分类的写作水平高于 8 年级水平,但可读性明显提高,近年来超过 10 年级阅读水平的研究较少:结论:本研究揭示了建议的可读性水平与实际 ICF 之间的差异,凸显了简化的必要性。尽管近年来有改进的趋势,但仍有必要继续努力,确保不同教育背景的参与者都能理解 ICF,加强同意过程的道德完整性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Unveiling readability challenges: An extensive analysis of consent document accessibility in clinical trials.

Background: Clinical research trials rely on informed consent forms (ICFs) to explain all aspects of the study to potential participants. Despite efforts to ensure the readability of ICFs, concerns about their complexity and participant understanding persist. There is a noted gap between Institutional Review Board (IRB) standards and the actual readability levels of ICFs, which often exceed the recommended 8th-grade reading level. This study evaluates the readability of over five thousand ICFs from ClinicalTrials.gov in the USA to assess their literacy levels.

Methods: We analyzed 5,239 US-based ICFs from ClinicalTrials.gov using readability metrics such as the Flesch Reading Ease, Flesch-Kincaid Grade Level, Gunning Fog Index, and the percentage of difficult words. We examined trends in readability levels across studies initiated from 2005 to 2024.

Results: Most ICFs exceeded the recommended 8th-grade reading level, with an average Flesch-Kincaid Grade Level of 10.99. While 91% of the ICFs were written above the 8th-grade level, there was an observable improvement in readability, with fewer studies exceeding a 10th-grade reading level in recent years.

Conclusions: The study reveals a discrepancy between the recommended readability levels and actual ICFs, highlighting a need for simplification. Despite a trend toward improvement in more recent years, ongoing efforts are necessary to ensure ICFs are comprehensible to participants of varied educational backgrounds, reinforcing the ethical integrity of the consent process.

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来源期刊
Journal of Clinical and Translational Science
Journal of Clinical and Translational Science MEDICINE, RESEARCH & EXPERIMENTAL-
CiteScore
2.80
自引率
26.90%
发文量
437
审稿时长
18 weeks
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