BACKGROUND AND OBJECTIVES In recent years, researchers have sought to address the challenges of obtaining informed consent for participation in acute stroke trials. We studied outcomes related to the use of deferral of consent in the phase 3 Alteplase Compared to Tenecteplase (AcT) trial. METHODS As part of our protocol, we captured methods of consent, participant withdrawals, door-to-randomization times, and door-to-needle times. Participants at 3 sites were invited to complete a survey of attitudes regarding consent for AcT and for acute stroke trials generally. RESULTS The AcT trial enrolled 1,600 participants from 22 centers across Canada of whom 1,537 were enrolled through deferral of consent (96.0%) and 63 (4.0%) were enrolled by prospective verbal consent followed by written informed consent. Of those enrolled by deferral of consent, 95% (1,454/1,537) consented to ongoing participation. Door-to-randomization times were similar regardless of method of consent, with an overall median of 30 minutes (interquartile range [IQR] 22-42): 29 minutes (IQR 22-42) in the deferral of consent group vs 32 minutes (IQR 25-44) in the prospective consent group (p = 0.1602). Survey respondents overwhelming agreed or strongly agreed with the use of deferral of consent in AcT (86%) and in any acute stroke trial (76%). DISCUSSION Deferral of consent was broadly acceptable to participants in the AcT trial as demonstrated by low rates of withdrawal and by survey results. Door-to-randomization times using deferral of consent in AcT were short, although a system of prospective verbal consent used at 1 center took only slightly longer. These results support the importance of innovation around consent for acute stroke trials.

中文翻译：

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与替奈普酶试验相比，阿替普酶试验中的同意相关结局。


背景和目标近年来，研究人员试图解决获得参与急性中风试验的知情同意的挑战。我们研究了 3 期阿替普酶与替奈普酶 （AcT） 试验中延迟同意相关的结局。方法 作为我们方案的一部分，我们捕获了同意方法、参与者退出、门到随机化时间和门到针时间。邀请 3 个地点的参与者完成一项关于同意 AcT 和一般急性中风试验的态度调查。结果： AcT 试验招募了来自加拿大 22 个中心的 1,600 名参与者，其中 1,537 名 （96.0%） 是通过延迟同意入组的，63 名 （4.0%） 是通过前瞻性口头同意和书面知情同意入组的。在通过延迟同意入组的人中，95% （1,454/1,537） 同意持续参与。无论采用何种同意方法，门到随机化时间都相似，总体中位数为 30 分钟（四分位距 [IQR] 22-42）：推迟同意组为 29 分钟 （IQR 22-42），而前瞻性同意组为 32 分钟 （IQR 25-44） （p = 0.1602）。调查受访者压倒性同意或强烈同意在 AcT （86%） 和任何急性卒中试验 （76%） 中使用延迟同意。讨论 推迟同意为 AcT 试验的参与者广泛接受，低退出率和调查结果证明了这一点。在 AcT 中使用延迟同意的门到随机化时间很短，尽管在 1 个中心使用的预期口头同意系统花费的时间仅稍长。这些结果支持了围绕急性卒中试验的同意进行创新的重要性。