Department of Medicine, Miller School of Medicine at the University of Miami, 1120 NW 14th St, Suite 971 (H-201), Miami, FL 33136, USA.
J Gen Intern Med. 2013 Jan;28(1):121-6. doi: 10.1007/s11606-012-2133-2. Epub 2012 Jul 11.
Inadequate health literacy may impair research subjects' ability to participate adequately in the informed consent (IC) process. Our aim is to evaluate the evidence supporting interventions, to improve comprehension of the IC process in low literacy subjects.
We performed a MEDLINE database search (1966 to November 2011) supplemented by manual searches of bibliographies of key relevant articles. We selected all studies in which a modification of the IC was tested to improve comprehension in low literacy populations. Study design, quality criteria, population, interventions and outcomes for each trial were extracted. The main outcome evaluated was comprehension, measured using a written test or verbal comprehension.
Our search strategy yielded 281 studies, of which only six met our eligibility criteria. The six studies included 1620 research participants. The studies predominantly included populations that were older (median age 61, range 48-64), ethnic minority, and with literacy level of 8th grade or below. Only one study had a randomized design. The specific intervention differed in each study. Two of the studies included the teach-back method or teach to goal method and achieved the highest level of comprehension. Two studies changed the readability level of the IC and resulted in the lowest comprehension among study subjects.
The evidence supporting interventions to improve the informed consent process in low literacy populations is extremely limited. Among the interventions evaluated, having a study team member spend more time talking one-on-one to study participants was the most effective strategy for improving informed consent understanding; however, this finding is based on the results of a single study.
健康素养不足可能会削弱研究对象充分参与知情同意（IC）过程的能力。我们的目的是评估支持干预措施的证据，以提高低文化程度受试者对 IC 过程的理解。
我们对 MEDLINE 数据库（1966 年至 2011 年 11 月）进行了检索，并对关键相关文章的参考文献进行了手动检索。我们选择了所有测试 IC 修订以提高低文化程度人群理解能力的研究。提取每个试验的研究设计、质量标准、人群、干预措施和结果。评估的主要结果是使用书面测试或口头理解来衡量的理解。
我们的搜索策略产生了 281 项研究，其中只有 6 项符合我们的入选标准。这 6 项研究包括 1620 名研究参与者。这些研究主要包括年龄较大的人群（中位数年龄为 61 岁，范围为 48-64 岁）、少数民族和 8 年级或以下的读写水平。只有一项研究采用随机设计。每项研究的具体干预措施都不同。两项研究包括回授法或目标教学法，达到了最高的理解水平。两项研究改变了 IC 的可读性水平，导致研究对象的理解程度最低。
支持改善低文化程度人群知情同意过程的干预措施的证据非常有限。在所评估的干预措施中，让研究团队成员花更多的时间与研究参与者一对一交谈是提高知情同意理解的最有效策略；然而，这一发现是基于一项研究的结果。
