RT Journal Article
SR Electronic
T1 Advance Consent for participation in Acute Stroke Trials (ACTION): protocol for a feasibility study
JF Stroke and Vascular Neurology
JO Stroke Vasc Neurol
FD BMJ Publishing Group Ltd
SP svn-2023-003029
DO 10.1136/svn-2023-003029
A1 Udoh, Ubong
A1 Seeger, Rena
A1 Dewar, Brian
A1 Cummings, Emma
A1 Gocan, Sophia
A1 Nicholls, Stuart
A1 Fedyk, Mark
A1 Shepherd, Victoria
A1 Perry, Jeff
A1 Fahed, Robert
A1 Ramsay, Tim
A1 Brehaut, Jamie
A1 Hill, Michael D
A1 Poppe, Alexandre Y
A1 Menon, Bijoy K
A1 Swartz, Richard H
A1 Dowlatshahi, Dar
A1 Shamy, Michel
YR 2024
UL http://svn.bmj.com/content/early/2024/10/02/svn-2023-003029.abstract
AB Introduction 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.Methods and design 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.Conclusion This study will test the feasibility of enrolling patients at risk of stroke into acute stroke trials using advance consent.Data sharing not applicable as no datasets generated and/or analysed for this study.