Readability standards for informed-consent forms as compared with actual readability
Readability standards for informed-consent forms as compared with actual readability
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DOI：
10.1056/nejmsa021212
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发表时间：
2003-02-20
影响因子：
158.5
通讯作者：
Brancati, FL
中科院分区：
文献类型：
--
作者：
Paasche-Orlow, MK;Taylor, HA;Brancati, FL
背景：机构审查委员会（IRB）负责保护识字有限的潜在研究受试者，但可能在发布不可读的知情同意书方面发挥无意的作用。我们假设，由IRB提供的知情同意书的形式福尔斯短的IRB自己的可读性标准和可读性的影响水平的研究活动，当地识字率，和联邦supervison.METHODS：为了测试这些假设，我们进行了一项横断面研究，连接数据从几个公共使用的来源。共有114个美国医学院的网站接受了IRB可读性标准和知情同意书模板的调查。实际可读性是用Flesch-Kincaid量表来衡量的，该量表根据阅读和理解英语文本所需的最低年级水平（范围，0至12）来评分。研究活动的水平，当地识字率，和联邦监督的数据从组织Websites.RESULTS：由IRB提供的文本的平均可读性得分为10.6（95%的置信区间，10.3至10.8）的Flesch-Kincaid量表。在61个网站（54%）中发现的具体可读性标准从5年级阅读水平到10年级阅读水平不等。由IRB提供的样本文本可读性的平均Flesch-Kincaid评分超过了规定标准2.8个等级（95%置信区间，2.4至3.2; P
BACKGROUND:Institutional review boards (IRBs) are charged with safeguarding potential research subjects with limited literacy but may have an inadvertent role in promulgating unreadable consent forms. We hypothesized that text provided by IRBs in informed-consent forms falls short of the IRBs' own readability standards and that readability is influenced by the level of research activity, local literacy rates, and federal oversight.METHODS:To test these hypotheses, we conducted a cross-sectional study linking data from several public-use sources. A total of 114 Web sites of U.S. medical schools were surveyed for IRB readability standards and informed-consent-form templates. Actual readability was measured with the Flesch-Kincaid scale, which assigns a score on the basis of the minimal grade level required to read and understand English text (range, 0 to 12). Data on the level of research activity, local literacy rates, and federal oversight were obtained from organizational Web sites.RESULTS:The average readability score for text provided by IRBs was 10.6 (95 percent confidence interval, 10.3 to 10.8) on the Flesch-Kincaid scale. Specific readability standards, found on 61 Web sites (54 percent), ranged from a 5th-grade reading level to a 10th-grade reading level. The mean Flesch-Kincaid scores for the readability of sample text provided by IRBs exceeded the stated standard by 2.8 grade levels (95 percent confidence interval, 2.4 to 3.2; P