From the Department of Medicine (M.C.S., D.D.), University of Ottawa, Ontario; The Ottawa Hospital (M.C.S., D.D.), Ontario; Ottawa Hospital Research Institute (M.C.S., B.D., D.D.), Ontario; Centre Hospitalier de L'Université de Montréal (Y.D., L.C.G.), Quebec; Department of Neurology (N.S.), University of Manitoba, Winnipeg; Department of Clinical Neurosciences (C.K., M.A.A., A.A., K.D.S., B.K.M., T.T.S.), University of Calgary, Alberta; Department of Neurology (B.H.B.), University of Alberta, Edmonton; McMaster University (L.C.), Hamilton, Ontario; Kelowna General Hospital (A.T.), British Columbia; and Sunnybrook Health Sciences Centre (R.H.S.), Toronto, Ontario, Canada.
Neurology. 2024 Nov 26;103(10):e209974. doi: 10.1212/WNL.0000000000209974. Epub 2024 Nov 7.
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.
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.
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 ( = 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%).
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.
近年来，研究人员一直在寻找解决获得急性中风试验参与知情同意的挑战。我们研究了 3 期阿替普酶与替奈普酶（AcT）试验中使用同意书延迟的相关结果。
作为我们方案的一部分，我们记录了同意书的方法、参与者退出、门到随机化时间和门到溶栓时间。来自 3 个地点的参与者被邀请完成一项关于 AcT 同意书和急性中风试验一般同意书的态度调查。
AcT 试验从加拿大 22 个中心招募了 1600 名参与者，其中 1537 名通过同意书延迟（96.0%）和 63 名（4.0%）通过前瞻性口头同意书后书面知情同意书招募。在通过同意书延迟招募的参与者中，95%（1454/1537）同意继续参与。无论同意书的方法如何，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）：同意书延迟组为 29 分钟（IQR 22-42），前瞻性同意组为 32 分钟（IQR 25-44）（ = 0.1602）。调查受访者强烈同意或非常同意在 AcT（86%）和任何急性中风试验中使用同意书延迟（76%）。
在 AcT 试验中，同意书延迟得到了参与者的广泛认可，这一点从较低的退出率和调查结果中可以看出。在 AcT 中使用同意书延迟的门到随机化时间较短，尽管在 1 个中心使用的前瞻性口头同意书系统仅略长。这些结果支持急性中风试验同意书创新的重要性。
