Informed consent: the rate-limiting step in acute stroke trials.
Informed consent: the rate-limiting step in acute stroke trials.
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DOI：
10.3389/fneur.2011.00065
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发表时间：
2011
影响因子：
3.4
通讯作者：
Kasner SE
中科院分区：
文献类型：
--
作者：
Rose DZ;Kasner SE
成功实施脑梗塞、脑出血或蛛网膜下腔出血等神经血管急症的随机临床试验（RCT）极具挑战性。除了在患有急性神经功能缺损的人的许多模仿者中建立准确、超快速的诊断之外，还必须获得这一弱势患者群体的知情同意，他们可能无法表达自己的意愿，掌握自己情况的严重性，或提供完整的病史或检查。我们回顾了研究人员在提供已确定的和推定的卒中治疗时遇到的影响、障碍和因素，并重点关注知情同意，这是人类受试者最重要的研究保护因素，作为急性卒中随机对照试验入组的限速步骤。知情同意过程在中风文献中受到的关注相对较少，但对于患有急性认知、听觉、语言、运动或视觉障碍的中风患者尤其重要。代理人的同意可能无法准确反映患者的意愿。此外，对试验方法的混淆、安慰剂对照研究的负面意见以及患者或代理人的治疗误解可能会阻碍试验入组并需要进一步研究。知情同意例外提供了一个很少用于卒中随机对照试验的机会。最终，推进急性中风的知识基础和治疗范式至关重要，但自主性、仁慈（非渎职）和正义也必须仔细地融入任何精心设计的随机对照试验中。
Successful implementation of a randomized clinical trial (RCT) for neuro-vascular emergencies such as cerebral infarction, intracerebral hemorrhage, or subarachnoid hemorrhage is extraordinarily challenging. Besides establishing an accurate, hyper-expedited diagnosis among many mimics in a person with acute neurological deficits, informed consent must be obtained from this vulnerable group of patients who may be unable to convey their own wishes, grasp the gravity of their situation, or give a complete history or examination. We review the influences, barriers, and factors investigators encounter when providing established and putative stroke therapies, and focus on informed consent, the most important research protector of human subjects, as the rate-limiting step for enrollment into acute stroke RCTs. The informed consent process has received relatively little attention in the stroke literature, but is especially important for stroke victims with acute cognitive, aural, lingual, motor, or visual impairments. Consent by a surrogate may not accurately reflect the patient’s wishes. Further, confusion about trial methodology, negative opinions of placebo-controlled studies, and therapeutic misconception by patients or surrogates may impede trial enrollment and requires further study. Exception from informed consent offers an opportunity that is rarely if ever utilized for stroke RCTs. Ultimately, advancing the knowledge base and treatment paradigms for acute stroke is essential but autonomy, beneficence (non-malfeasance), and justice must also be carefully interwoven into any well-designed RCT.