Stroke Division, Department of Neurology, University of South Florida, Tampa General Hospital Tampa, FL, USA.
Front Neurol. 2011 Oct 17;2:65. doi: 10.3389/fneur.2011.00065. eCollection 2011.
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.
成功实施神经血管急症（如脑梗死、脑出血或蛛网膜下腔出血）的随机临床试验（RCT）极具挑战性。除了在具有急性神经功能缺损的患者中准确、快速地诊断许多类似疾病外，还必须从可能无法表达自己意愿、无法理解病情严重性或无法提供完整病史或检查的这一脆弱群体中获得知情同意。我们回顾了研究者在提供已确立和推测的中风治疗方法时遇到的影响、障碍和因素，并重点关注知情同意，作为急性中风 RCT 入组的限速步骤，这是保护人类受试者的最重要研究保护措施。知情同意过程在中风文献中受到的关注相对较少，但对于急性认知、听觉、语言、运动或视觉障碍的中风患者尤为重要。代理人的同意可能无法准确反映患者的意愿。此外，患者或代理人对试验方法、对安慰剂对照研究的负面看法以及治疗误解的混淆可能会阻碍试验入组，需要进一步研究。知情同意豁免提供了一个机会，该机会很少在中风 RCT 中得到利用。最终，推进急性中风的知识库和治疗模式至关重要，但在任何精心设计的 RCT 中，自主性、善行（不渎职）和正义也必须精心交织在一起。
