Examining the readability of patient-informed consent forms

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Open Access Journal of Clinical Trials Pub Date : 2010-10-19 DOI:10.2147/OAJCT.S13608
Marli Terblanche, L. Burgess
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引用次数: 41

Abstract

Correspondence: Marli Terblanche Room 41, Department of Cardiology, 8th Floor, Tygerberg Hospital, Parow 7500, South Africa Tel +27 21 931 7825 Fax + 27 21 933 3597 Email marli@treadresearch.com Primary objective: To investigate the readability of informed consent forms (ICF) used at TREAD Research, a private clinical trial research unit located in Tygerberg Hospital. Secondary objective: To assess if there is a difference in readability between therapeutic areas, as well as a difference in readability over two time periods. Methods: The readability of 84 ICFs given to patients at TREAD Research between the years 2000 and 2009 was quantitatively assessed by means of the Flesch–Kincaid Reading Ease, Flesch–Kincaid Grade Level, and Gunning-Fog index. Results: The mean ± standard deviation (SD) Flesch–Kincaid Reading Ease score for the 84 ICFs was 46.60 ± 5.62 (range 33.2–65.6). The mean ± SD grade level was 12.13 ± 1.8 (range 8.3–14.9) using the Flesch–Kincaid formula and 13.96 ± 1.22 (range 10.3–16.6) using the Gunning-Fog index. Readability at grade level 8 was only found in 1.2% of all the ICFs assessed. No differences were found in readability between therapeutic areas or over the two time periods. Conclusions: The main finding is that these forms are too complex to be understood by average study participants and their families.
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检查患者知情同意书的可读性
通讯:Marli Terblanche,南非Parow 7500, Tygerberg医院8楼心脏病科41室电话+27 21 931 7825传真+27 21 933 3597电子邮件marli@treadresearch.com主要目的:调查知情同意书(ICF)在位于Tygerberg医院的私人临床试验研究单位TREAD Research中使用的可读性。次要目的:评估治疗区域之间的可读性是否存在差异,以及两个时间段的可读性差异。方法:采用Flesch-Kincaid Reading Ease、Flesch-Kincaid Grade Level和Gunning-Fog指数对2000 - 2009年在TREAD Research中给予患者的84份ICFs的可读性进行定量评价。结果:84例ICFs的Flesch-Kincaid Reading Ease评分均值±标准差(SD)为46.60±5.62(范围33.2 ~ 65.6)。使用Flesch-Kincaid公式的平均±SD等级水平为12.13±1.8(范围8.3-14.9),使用Gunning-Fog指数的平均±SD等级水平为13.96±1.22(范围10.3-16.6)。在所有被评估的ICFs中,只有1.2%的人具有8级的可读性。在治疗区域之间或在两个时间段内,没有发现可读性的差异。结论:主要发现是这些表格太复杂,一般的研究参与者和他们的家人无法理解。
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来源期刊
Open Access Journal of Clinical Trials
Open Access Journal of Clinical Trials MEDICINE, RESEARCH & EXPERIMENTAL-
CiteScore
3.90
自引率
0.00%
发文量
2
审稿时长
16 weeks
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