Health literacy predicts participant understanding of orally-presented informed consent information.
Health literacy predicts participant understanding of orally-presented informed consent information.
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DOI：
10.15761/crt.1000105
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发表时间：
2015
期刊：
影响因子：
--
通讯作者：
Waldrop-Valverde D
中科院分区：
文献类型：
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作者：
Ownby RL;Acevedo A;Goodman K;Caballero J;Waldrop-Valverde D
参与人类受试者研究的知情同意是临床研究的一个至关重要的方面，但研究表明，许多潜在的受试者不了解与其参与相关的信息。因此，更好地了解与参与者对研究相关信息的理解有关的因素是重要的。作为开发一种新的健康素养衡量标准的研究的一部分，参与者观看了一段50秒的视频，视频中有一位临床医生用他们喜欢的语言（西班牙语或英语）展示了知情同意信息。然后，他们回答了六个问题。在逐步复杂的回归模型中，我们评估了人口统计学变量，一般认知能力和健康素养与参与者回忆信息的关系。在一个只包括人口统计变量的模型中，西班牙语，黑人种族和年龄与表现较差有关。在一个包括一般认知能力和健康素养以及人口统计学影响的模型中，教育和健康素养与表现有关。考虑到潜在研究受试者的健康素养水平的知情同意干预措施可能会导致更好地了解与研究相关的信息，这些信息可以为他们参与研究的决定提供信息。
Informed consent for participation in studies with human subjects is a critically important aspect of clinical research, but research has shown that many potential subjects do not understand information relevant to their participation. A better understanding of factors related to participant understanding of study-related information is thus important. As part of a study to develop a new measure of health literacy, participants viewed a 50 second video in their preferred language (Spanish or English) of a clinician presenting informed consent information. They then responded to six questions about it. In progressively more complicated regression models, we evaluated the relation of demographic variables, general cognitive ability, and health literacy to participants’ recall of the information. In a model that only included demographic variables, Spanish language, black race and older age were associated with poorer performance. In a model that included the effects of general cognitive ability and health literacy as well as demographics, education and health literacy were related to performance. Informed consent interventions that take potential research subjects’ levels of health literacy into account may result in better understanding of research-related information that can inform their decision to participate.