Udoh Ubong, Seeger Rena, Dewar Brian, Cummings Emma, Gocan Sophia, Nicholls Stuart, Fedyk Mark, Shepherd Victoria, Perry Jeff, Fahed Robert, Ramsay Tim, Brehaut Jamie, Hill Michael D, Poppe Alexandre Y, Menon Bijoy K, Swartz Richard H, Dowlatshahi Dar, Shamy Michel
Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.
Stroke Vasc Neurol. 2024 Oct 2. doi: 10.1136/svn-2023-003029.
Obtaining informed consent for research from patients in medical emergencies remains a challenge, particularly in acute stroke care as treatment must be administered quickly and patients often arrive in the hospital in a state of incapacitation. Adaptations to standard consenting approaches-such as the use of surrogate consent or deferral of consent-have significant limitations. This feasibility study aims to test a new consenting approach in acute stroke care that we call advance consent. Advance consent has the potential to render emergency trial enrolment faster, fairer and more transparent, leading to more generalisable results.
We will conduct a five-part study at The Ottawa Hospital, a quaternary care stroke centre: (1) administering questionnaires in the Ottawa Hospital Stroke Prevention Clinic that will examine patients' perspectives on research participation and advance consent; (2) inviting participants to consent in advance to any or both currently enrolling acute stroke trials; (3) tracking patient enrolment into these trials over 1 year; (4) administering a follow up questionnaire to participants at 1 year and (5) administering a questionnaire to participating hospital staff in order to interrogate their experiences with advance consent. Outcomes include but are not limited to eligibility rate, recruitment rate, withdrawal rate and the proportion of patients whose advance consent results in trial enrolment.
This study will test the feasibility of enrolling patients at risk of stroke into acute stroke trials using advance consent.
在医疗紧急情况下从患者处获得研究知情同意仍然是一项挑战，尤其是在急性中风护理中，因为治疗必须迅速进行，而且患者通常在丧失行为能力的状态下入院。对标准同意方法的调整——例如使用替代同意或延迟同意——有很大局限性。这项可行性研究旨在测试一种我们称为预先同意的急性中风护理新同意方法。预先同意有可能使紧急试验入组更快、更公平、更透明，从而产生更具普遍性的结果。
我们将在渥太华医院（一家四级护理中风中心）开展一项分为五个部分的研究：（1）在渥太华医院中风预防诊所发放问卷，调查患者对研究参与和预先同意的看法；（2）邀请参与者预先同意参与任何一项或两项正在招募患者的急性中风试验；（3）在1年时间内跟踪这些试验的患者入组情况；（4）在1年后向参与者发放一份随访问卷；（5）向参与研究的医院工作人员发放一份问卷，以了解他们在预先同意方面的经验。结果包括但不限于符合条件率、招募率、退出率以及预先同意导致试验入组的患者比例。
本研究将测试使用预先同意将有中风风险的患者纳入急性中风试验的可行性。
