南非开展的研究性医学临床试验知情同意书的可读性。

The readability of informed consent forms for research studies conducted in South Africa.

机构信息

Ezintsha, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.

出版信息

S Afr Med J. 2021 Feb 1;111(2):180-183. doi: 10.7196/SAMJ.2021.v111i2.14752.

DOI:10.7196/SAMJ.2021.v111i2.14752

PMID:33944731

Abstract

BACKGROUND

Informed consent forms (ICFs) are used to obtain consent from participants. However the complexity and comprehensiveness of these forms may not be appropriate. Readability can be quantified by formulas in Microsoft (MS) Word, such as the Flesch Reading Ease test. The South African (SA) ethics guidelines suggest that the MS Word Flesch-Kincaid Reading Grade score should be used to assess the complexity of ICFs and should be the equivalent of grade 8 level, or lower.

OBJECTIVES

To use readability formulas to determine whether current SA ICFs are appropriate for the general population.

METHODS

This was a descriptive study of a sample of English ICFs (solicited from our studies, as well as from local researchers) which received approval from local ethical review boards during the past 5 years, for prospective (≥6 months) drug studies that explored treatment and prevention of HIV, tuberculosis, diabetes or cardiovascular disease. ICFs were evaluated in MS Word for Flesch Reading Ease and Flesch-Kincaid Reading Grade, with the Simple Measure of Gobbledygook (SMOG) index calculated using www.readabilityformulas.com. Recommended targets for easy readability are above 60 for the Flesch Reading Ease score, and less than or equal to a grade 8 reading level for the Flesch-Kincaid Reading Grade and SMOG.

RESULTS

A total of 75 consent forms from 35 individual research studies conducted in SA over the last 5 years were included. The consent forms had been approved by six ethics committees across seven of the SA provinces. The median (interquartile range (IQR)) Flesch Reading Ease score was 55.8 (48.7 - 59.7) and 18 (25.0%) of the ICFs had easy or standard readability, while the median (IQR) Flesch-Kincaid Grade was 10.2 (8.8 - 11.4), with 23 (30.6%) at least a grade 8 level or lower. The median (IQR) SMOG index was 9.8 (9.0 - 11.1) and 4 (5.3%) scored below grade 8 level.

CONCLUSIONS

Two-thirds of the ICFs from this study fail to meet the SA readability standard, a result matched by using alternative readability formulas. Readability can be improved with simple techniques and by actively monitoring readability metrics.

摘要

背景

知情同意书（ICF）用于获得参与者的同意。然而，这些表格的复杂性和全面性可能并不合适。微软（MS）Word 中的公式可以量化可读性，例如弗莱什阅读容易度测试。南非（SA）伦理准则建议使用 MS Word Flesch-Kincaid 阅读等级评分来评估 ICF 的复杂性，并且应该相当于 8 年级水平或更低。

目的

使用可读性公式来确定当前的南非 ICF 是否适合普通人群。

方法

这是一项对过去 5 年来在我们的研究中以及当地研究人员那里征集的英语 ICF 样本的描述性研究，这些 ICF 已获得当地伦理审查委员会的批准，用于前瞻性（≥6 个月）药物研究，以探索 HIV、结核病、糖尿病或心血管疾病的治疗和预防。在 MS Word 中，对 Flesch 阅读容易度和 Flesch-Kincaid 阅读等级进行评估，并使用 www.readabilityformulas.com 计算 SMOG 指数。简单易懂的可读性目标是 Flesch 阅读容易度得分高于 60，Flesch-Kincaid 阅读等级和 SMOG 得分不超过 8 年级阅读水平。

结果

共纳入过去 5 年在南非进行的 35 项研究中的 75 份同意书。这些同意书已经得到了六个道德委员会的批准，这些委员会分布在南非七个省份。Flesch 阅读容易度评分的中位数（四分位距（IQR））为 55.8（48.7-59.7），18 份 ICF 具有简单或标准可读性，而 Flesch-Kincaid 等级的中位数（IQR）为 10.2（8.8-11.4），其中 23 份至少为 8 年级或更低。SMOG 指数的中位数（IQR）为 9.8（9.0-11.1），4 份（5.3%）的得分低于 8 年级水平。