在弱势患者中采用改良的知情同意程序：一项描述性研究。
Use of a modified informed consent process among vulnerable patients: a descriptive study.
作者信息
Sudore Rebecca L, Landefeld C Seth, Williams Brie A, Barnes Deborah E, Lindquist Karla, Schillinger Dean
机构信息
Division of Geriatrics, San Francisco Veterans Administration Medical Center, University of California, San Francisco, CA 94121, USA.
出版信息
J Gen Intern Med. 2006 Aug;21(8):867-73. doi: 10.1111/j.1525-1497.2006.00535.x.
BACKGROUND
Little is known about patient characteristics associated with comprehension of consent information, and whether modifications to the consent process can promote understanding.
OBJECTIVE
To describe a modified research consent process, and determine whether literacy and demographic characteristics are associated with understanding consent information.
DESIGN
Descriptive study of a modified consent process: consent form (written at a sixth-grade level) read to participants, combined with 7 comprehension questions and targeted education, repeated until comprehension achieved (teach-to-goal).
PARTICIPANTS
Two hundred and four ethnically diverse subjects, aged > or = 50, consenting for a trial to improve the forms used for advance directives.
MEASUREMENTS
Number of passes through the consent process required to achieve complete comprehension. Literacy assessed in English and Spanish with the Short Form Test of Functional Health Literacy in Adults (scores 0 to 36).
RESULTS
Participants had a mean age of 61 years and 40% had limited literacy (s-TOHFLA<23). Only 28% of subjects answered all comprehension questions correctly on the first pass. After adjustment, lower literacy (P=.04) and being black (P=.03) were associated with requiring more passes through the consent process. Not speaking English as a primary language was associated with requiring more passes through the consent process in bivariate analyses (P<.01), but not in multivariable analyses (P>.05). After the second pass, most subjects (80%) answered all questions correctly. With a teach-to-goal strategy, 98% of participants who engaged in the consent process achieved complete comprehension.
CONCLUSIONS
Lower literacy and minority status are important determinants of understanding consent information. Using a modified consent process, little additional education was required to achieve complete comprehension, regardless of literacy or language barriers.
背景
关于与同意信息理解相关的患者特征，以及同意过程的修改是否能促进理解，我们所知甚少。
目的
描述一种修改后的研究同意过程，并确定读写能力和人口统计学特征是否与同意信息的理解相关。
设计
对修改后的同意过程进行描述性研究：向参与者宣读同意书（六年级水平的书面材料），并结合7个理解问题和针对性教育，重复进行直至理解（教到目标达成）。
参与者
204名年龄≥50岁、种族多样的受试者，他们同意参与一项旨在改进预先指示所用表格的试验。
测量指标
达到完全理解所需的同意过程通过次数。使用成人功能性健康素养简表（分数范围为0至36）对英语和西班牙语读写能力进行评估。
结果
参与者的平均年龄为61岁，40%的人读写能力有限（成人功能性健康素养简表得分<23）。只有28%的受试者在首次通过时正确回答了所有理解问题。调整后，较低的读写能力（P = 0.04）和黑人身份（P = 0.03）与需要更多次通过同意过程相关。在双变量分析中，不以英语为主要语言与需要更多次通过同意过程相关（P<0.01），但在多变量分析中并非如此（P>0.05）。在第二次通过后，大多数受试者（80%）正确回答了所有问题。采用教到目标的策略，参与同意过程的98%的参与者实现了完全理解。
结论
较低的读写能力和少数族裔身份是理解同意信息的重要决定因素。使用修改后的同意过程，无论读写能力或语言障碍如何，几乎不需要额外的教育就能实现完全理解。
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