Informed consent conversations and documents: A quantitative comparison
Informed consent conversations and documents: A quantitative comparison
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DOI：
10.1002/cncr.29759
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发表时间：
2016-02-01
期刊：
影响因子：
6.2
通讯作者：
Kodish, Eric D.
中科院分区：
文献类型：
--
作者：
Koyfman, Shlomo A.;Reddy, Chandana A.;Kodish, Eric D.
背景临床研究的知情同意包括两个组成部分：知情同意文件（ICD）和知情同意对话（ICC）。可读性软件已被用来帮助简化 ICD 的语言，但据作者所知，很少用于评估 ICC 期间使用的语言，这可能会影响知情同意的质量。当前的分析旨在确定转录的 ICC 的长度和阅读水平是否低于选定临床试验的相应 ICD，并评估研究者经验是否影响简单语言的使用和全面性。 方法当前的研究是一项前瞻性研究，当家庭被提供参加儿科 I 期肿瘤学试验时，在 6 个机构对 ICC 进行录音。将 ICC 的字数、Flesch-Kincaid 等级水平 (FKGL) 和 Flesch 阅读轻松评分 (FRES) 与相应的 ICD 进行比较，包括研究人员在 ICC 期间处理 8 个预先指定的关键同意要素的频率。 结果 确定了 69 个独特的医生/方案对。总体而言，ICC 包含的单词较少（4677 vs 6364 个单词；P=.0016），并且具有较低的 FKGL（6 vs 9.7；P.0001）和较高的 FRES（77.8 vs 56.7；P）
BACKGROUNDInformed consent for clinical research includes 2 components: informed consent documents (ICDs) and informed consent conversations (ICCs). Readability software has been used to help simplify the language of the ICD, but to the authors' knowledge is rarely used to assess the language used during the ICC, which may influence the quality of informed consent. The current analysis was performed to determine whether length and reading levels of transcribed ICCs are lower than their corresponding ICDs for selected clinical trials, and to assess whether investigator experience affected the use of simpler language and comprehensiveness.METHODSThe current study was a prospective study in which ICCs were audiorecorded at 6 institutions when families were offered participation in pediatric phase I oncology trials. Word count, Flesch-Kincaid Grade Level (FKGL), and Flesch Reading Ease score (FRES) of the ICCs were compared with corresponding ICDs, including the frequency with which investigators addressed 8 prespecified critical consent elements during the ICC.RESULTSSixty-nine unique physician/protocol pairs were identified. Overall, ICCs contained fewer words (4677 vs 6364 words; P=.0016) and had a lower FKGL (6 vs 9.7; P.0001) and a higher FRES (77.8 vs 56.7; P