Goldstein Joshua N, Espinola Janice A, Fisher Jonathan, Pallin Daniel J, Camargo Carlos A
Int J Emerg Med. 2010 Nov 10;3(4):385-9. doi: 10.1007/s12245-010-0244-2.
Acute stroke is a leading cause of morbidity and mortality. Clinical trials in stroke are challenging because victims often do not have the capacity to provide informed consent, excluding those patients most likely to benefit from the research.
We evaluated patient willingness to participate in a hypothetical acute stroke trial using an exception from informed consent.
Consecutive patients presenting to four emergency departments (EDs) underwent structured interviews regarding a hypothetical stroke trial using an exception from informed consent.
Of 461 (72% of eligible) participants, 55% (95% CI, 50%-59%) were willing to be enrolled in the hypothetical study without giving informed consent. After multivariable analysis, independent predictors of willingness to enroll included Catholic religion (OR 1.57, 95% CI 1.17-2.10) and belief that current therapy offers a >50% chance of full recovery (OR 1.29, 95% CI 1.05-1.57). There was no difference between the proportion willing to enroll in a cardiac arrest study vs. a stroke study (55% vs. 55%, p = 0.83)
Fifty-five percent of ED patients would be willing to be enrolled in a stroke trial using exception from informed consent.
急性中风是发病和死亡的主要原因。中风的临床试验具有挑战性，因为患者往往没有能力提供知情同意，这就排除了那些最有可能从研究中受益的患者。
我们评估了患者使用知情同意豁免参与假设性急性中风试验的意愿。
连续到四个急诊科就诊的患者接受了关于使用知情同意豁免的假设性中风试验的结构化访谈。
在461名参与者（占 eligible 的72%）中，55%（95%可信区间，50%-59%）愿意在未提供知情同意的情况下参加假设性研究。多变量分析后，愿意入组的独立预测因素包括天主教信仰（比值比1.57，95%可信区间1.17-2.10）以及认为当前治疗有>50%的完全康复机会（比值比1.29，95%可信区间1.05-1.57）。愿意参加心脏骤停研究与中风研究的比例之间没有差异（55%对55%，p = 0.83）
55%的急诊科患者愿意参加使用知情同意豁免的中风试验。
