Understanding the Use of Optimal Formatting and Plain Language When Presenting Key Information in Clinical Trials.

IF 1.7 4区 哲学 Q2 ETHICS
Erin D Solomon, Jessica Mozersky, Matthew P Wroblewski, Kari Baldwin, Meredith V Parsons, Melody Goodman, James M DuBois
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引用次数: 9

Abstract

Recent revisions to the Common Rule require that consent documents begin with a focused presentation of the study's key information that is organized to facilitate understanding. We surveyed 1,284 researchers working with older adults or individuals with Alzheimer's disease, supplemented with 60 qualitative interviews, to understand current use and barriers to using evidence-based formatting and plain language in key information. Researchers reported using formatting in 42% of their key information sections, and plain language in 63% of their key information sections. Perceived barriers included lack of knowledge, Institutional Review Board, other members of their team, and the burden associated with implementation. Education and training are required to increase adoption of the practices.

Abstract Image

了解在临床试验中使用最佳格式和简单的语言来呈现关键信息。
最近对《共同规则》的修订要求同意书文件从重点介绍研究的关键信息开始,这些信息的组织有助于理解。我们调查了1284名研究老年人或阿尔茨海默病患者的研究人员,并辅以60次定性访谈,以了解目前在关键信息中使用循证格式和简明语言的情况和障碍。研究人员报告称,42%的关键信息部分使用了格式,63%的关键信息章节使用了简明语言。感知到的障碍包括缺乏知识、机构审查委员会、其团队的其他成员以及与实施相关的负担。需要进行教育和培训,以增加对这些做法的采用。
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来源期刊
CiteScore
3.50
自引率
7.70%
发文量
30
审稿时长
>12 weeks
期刊介绍: The Journal of Empirical Research on Human Research Ethics (JERHRE) is the only journal in the field of human research ethics dedicated exclusively to empirical research. Empirical knowledge translates ethical principles into procedures appropriate to specific cultures, contexts, and research topics. The journal''s distinguished editorial and advisory board brings a range of expertise and international perspective to provide high-quality double-blind peer-reviewed original articles.
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