Department of Medicine, University of Ottawa and The Ottawa Hospital, Ontario, Canada (H.F., D.D., M.S.).
Ottawa Hospital Research Institute, Ontario, Canada (H.F., B.D., D.D., M.S.).
Stroke. 2022 Jul;53(7):2420-2423. doi: 10.1161/STROKEAHA.122.038760. Epub 2022 May 23.
The AcT trial (Alteplase Compared to Tenecteplase) compares alteplase or tenecteplase for patients with acute ischemic stroke. All eligible patients are enrolled by deferral of consent. Although the use of deferral of consent in the AcT trial meets the requirements of Canadian policy, we sought to provide a more explicit and rigorous approach to the justification of deferral of consent organized around 3 questions. Ultimately, the approach we outline here could become the foundation for a general justification for deferral of consent.
AcT 试验（阿替普酶与替奈普酶比较）比较了急性缺血性脑卒中患者使用阿替普酶或替奈普酶的情况。所有符合条件的患者都通过延迟同意纳入研究。尽管 AcT 试验中使用延迟同意符合加拿大政策的要求，但我们试图围绕 3 个问题提供一种更明确和严格的方法来证明延迟同意的合理性。最终，我们在这里概述的方法可以成为延迟同意的一般理由的基础。
