Del Giudice Angela, Plaum Justin, Maloney Eileen, Kasner Scott E, Le Roux Peter D, Baren Jill M
Department of Neurology, University of Pennsylvania, Philadelphia, PA, USA.
Acad Emerg Med. 2009 Apr;16(4):309-15. doi: 10.1111/j.1553-2712.2009.00367.x. Epub 2009 Mar 6.
Aneurysmal subarachnoid hemorrhage (SAH) is a devastating disorder that still requires much clinical study. However, the decision to participate in a randomized clinical trial, particularly a neuroemergency trial, is a complex one. The purposes of this survey were to determine who would participate in a randomized clinical trial that intended to examine transfusion practices after SAH, to identify who could serve as potential proxy decision-makers, and to find which patient characteristics were associated with the decision to participate.
This was a cross-sectional study using a self-administered questionnaire, composed of a brief description of the proposed trial followed by questions about participation using a 5-point Likert scale. Information sought included potential decision-maker, demographic data, setting and reason for current health care access, and personal or family history of neurologic injury.
Nine-hundred five subjects were enrolled during emergency department (ED) visits, office visits, hospital admissions, or online, during a 1-month period: 63% were women and 46% were white. Nonneurologic problems were the leading reason (90%) for health care access, but 45% had a personal or family history of neurologic injury. Overall, 54% (95% confidence interval [CI] = 51% to 57%) of subjects stated they would definitely or probably consent to participate. No subject characteristics were associated with this decision: age (p = 0.28), sex (p = 0.16), race/ethnicity (p = 0.07), education (p = 0.44), religion (p = 0.42), clinical setting (p = 0.14), reason for visit (p = 0.58), and/or history of neurologic injury (p = 0.33). The vast majority (88%) identified a family member as the proxy decision-maker, again without differences among groups.
Greater than half of respondents stated they would participate in a proposed emergency treatment trial for SAH. Our survey suggests that the decision to participate is highly individualized, because no demographic, pathologic, historical, or access-related predictors of choice were found. Educational materials designed for this type of trial would need to be broad-based. Family members should be considered as proxy decision-makers where permitted by federal and local regulations.
动脉瘤性蛛网膜下腔出血（SAH）是一种严重的疾病，仍需要大量临床研究。然而，决定参与一项随机临床试验，尤其是一项神经急症试验，是一个复杂的决定。本调查的目的是确定谁会参与一项旨在研究SAH后输血实践的随机临床试验，确定谁可以作为潜在的代理决策者，并找出哪些患者特征与参与决定相关。
这是一项横断面研究，使用自填式问卷，问卷包括对拟议试验的简要描述，随后是关于参与情况的问题，采用5点李克特量表。所寻求的信息包括潜在决策者、人口统计学数据、当前医疗保健获取的环境和原因，以及个人或家族神经损伤史。
在1个月的时间里，共有905名受试者在急诊科就诊、门诊就诊、住院或通过网络参与：63%为女性，46%为白人。非神经系统问题是寻求医疗保健的主要原因（90%），但45%有个人或家族神经损伤史。总体而言，54%（95%置信区间[CI]=51%至57%）的受试者表示他们肯定或可能同意参与。没有受试者特征与该决定相关：年龄（p=0.28）、性别（p=0.16）、种族/民族（p=0.07）、教育程度（p=0.44）、宗教信仰（p=0.42）、临床环境（p=0.14）、就诊原因（p=0.58）和/或神经损伤史（p=0.33）。绝大多数（88%）将家庭成员确定为代理决策者，各群体之间同样没有差异。
超过一半的受访者表示他们会参与拟议的SAH急诊治疗试验。我们的调查表明，参与决定是高度个体化的，因为未发现人口统计学、病理学、病史或与获取相关的选择预测因素。为这类试验设计的教育材料需要具有广泛的基础。在联邦和地方法规允许的情况下，应将家庭成员视为代理决策者。
