Impact of detailed informed consent on research subjects' participation: A prospective, randomized trial
Impact of detailed informed consent on research subjects' participation: A prospective, randomized trial
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DOI：
10.1016/j.jemermed.2007.06.026
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发表时间：
2008-04-01
影响因子：
1.5
通讯作者：
Marco, Catherine A.
中科院分区：
文献类型：
--
作者：
Marco, Catherine A.
本研究旨在根据入组前所需的知情同意水平和类型来衡量潜在研究受试者对调查研究设计的参与程度。在这项前瞻性随机试验中，300名合格的急诊科参与者被随机分为三组：口头同意（n = 100），有限的书面同意（n = 100），和详细的书面同意书，并签名（n = 100）。同意书与自我管理的患者满意度调查相关。主要结果是参与水平，其中参与被分类为完全、有限或拒绝。关于比例构建的95%置信区间（CI）用于评估三个同意组之间参与率的差异。在300名参与者中，没有发现年龄或性别组之间的人口统计学差异。与随机分配至口头同意组（85%;组间平均差异13%，95% CI 2%-24%）和有限书面同意组（84%;组间平均差异12%，95% CI 1%-23%）相比，随机分配至完成详细书面同意的受试者的完全参与率（72%）显著较低。随机分配至详细书面同意的受试者的拒绝率（23%）也显著高于有限书面同意组（12%;组间平均差异为-11%，95% CI为-21%至-1%）。所需知情同意的时间长度和类型影响了潜在研究受试者参与调查研究设计。要求签署详细书面知情同意书的参与者的参与率低于口头或有限书面同意的参与者。(C)2008年爱思唯尔公司
This study was undertaken to measure potential research subjects' participation in a survey research design, based on level and type of informed consent required before enrollment. In this prospective, randomized trial, 300 eligible Emergency Department participants were randomized to one of three groups: verbal consent (n = 100), limited written consent (n = 100), and detailed written consent with signature In = 100). The consent was related to a self-administered patient satisfaction survey. The primary outcome was level of participation, where participation was categorized as full, limited, or refusal. Ninety-five percent confidence intervals (CI) constructed about proportions were used to assess differences in participation rates between the three consent groups. Among 300 participants, no demographic differences were found between groups for age or gender. Participants who were randomized to complete the detailed written consent had a significantly lower rate of full participation (72%) when compared to those randomized to verbal consent (85%; mean difference between groups 13%, 95% CI 2% to 24%) and to those with limited written consent (84%; mean difference between groups 12%, 95% CI 1% to 23%). Participants randomized to detailed written consent also had a significantly higher refusal rate (23%) when compared to those in the limited written group (12%; mean difference between groups -11%, 95% CI -21% to -1%). The length and type of informed consent required affected potential research subject participation in a survey research design. Participants who were asked to sign a detailed written informed consent document had a lower rate of participation compared to those with verbal or limited written consent. (C) 2008 Elsevier Inc.