Neurological Deficits in Stroke Patients that May Impede the Capacity to Provide Informed Consent for Endovascular Treatment Trials
Neurological Deficits in Stroke Patients that May Impede the Capacity to Provide Informed Consent for Endovascular Treatment Trials
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DOI：
10.1016/j.jstrokecerebrovasdis.2019.104447
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发表时间：
2019-12-01
影响因子：
2.5
通讯作者：
Dippel, Diederik W. J.
中科院分区：
文献类型：
--
作者：
Janssen, Paula M.;Chalos, Vicky;Dippel, Diederik W. J.
背景资料：我们评估了可能妨碍符合血管内治疗（EVT）条件的急性卒中患者提供参与试验同意书的能力的神经功能缺损的发生率。研究方法：我们使用了荷兰注册中心急性缺血性卒中血管内治疗的多中心随机对照试验的数据，这是一项前瞻性观察性队列研究。我们纳入了2014年3月至2016年6月期间接受EVT的1526例前部大血管闭塞患者。我们根据赫尔辛基宣言中所述的影响知情同意条件的神经系统症状评估参与试验的决策能力。我们制定了一个严格和温和的能力评估规则，使用2个不同的削减点的项目得分的美国国立卫生研究院卒中量表（NIHSS）。结果如下：应用严格和轻度规则，分别有1469例（96%）和1220例（80%）患者在入院时被认为不能决定参加试验，1077例（79%）和825例（60%）患者在入院后24-48小时被认为不能决定参加试验。基于严格规则提示丧失能力的预定义评分的最高频率是NIHSS项目“意识水平问题”（59%）、“最佳凝视”（68%）和“最佳语言”（58%）。被认为无能力的患者年龄较大（中位数为71岁对66岁，P = 0.043），NIHSS评分较高（中位数为16对8，P <0.001），左半球卒中的发生率（55%对28%，P <0.001）高于被认为有能力的患者。结论：在大多数有资格接受EVT的前循环卒中患者中，存在神经功能缺损，可能会妨碍提供参与试验的知情同意书的能力。
Background: We assessed the occurrence of neurological deficits that may impede the capacity to provide consent for trial participation in patients with an acute stroke, who are eligible for endovascular treatment (EVT). Methods: We used data from the Multicenter Randomized Controlled Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands Registry, a prospective observational cohort study. We included 1526 patients with an anterior large vessel occlusion, undergoing EVT between March 2014 and June 2016. We based our assessment of decision-making capacity for trial participation on neurological symptoms influencing conditions concerning informed consent as stated in the declaration of Helsinki. We formulated a strict and a mild capacity assessment rule, using 2 different cut points in item scores on the National Institutes of Health Stroke Scale (NIHSS). Results: Applying the strict and mild rule, respectively 1469 (96%) and 1220 (80%) patients deemed not capable of decision-making for trial participation on admission, and 1077 (79%) and 825 (60%) patients at 24-48 hours after admission. Highest frequencies of predefined scores suggesting incapacity based on the strict rule were on the NIHSS items "Level of Consciousness Questions" (59%), "Best Gaze" (68%), and "Best Language" (58%). Patients who were considered incapable were older (median 71 versus 66 years, P = .043), had higher NIHSS scores (median 16 versus 8, P < .001), and had more often left hemisphere strokes (55% versus 28%, P < .001) than patients who were presumably capable. Conclusions: In the majority of patients with an anterior circulation stroke who are eligible for EVT, neurological deficits are present that may impede the capacity to provide informed consent for trial participation.