Advance consent for participation in Acute Stroke Trials (ACTION): protocol for a feasibility study

Udoh, Ubong, Seeger, Rena, Dewar, Brian, Cummings, Emma, Gocan, Sophia, Nicholls, Stuart, Fedyk, Mark, Shepherd, Victoria ORCID: https://orcid.org/0000-0002-7687-0817, Perry, Jeff, Fahed, Robert, Ramsay, Tim, Brehaut, Jamie, Hill, Michael D, Poppe, Alexandre Y, Menon, Bijoy K, Swartz, Richard H, Dowlatshahi, Dar and Shamy, Michel 2024. Advance consent for participation in Acute Stroke Trials (ACTION): protocol for a feasibility study. Stroke and Vascular Neurology , 003029. 10.1136/svn-2023-003029

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Abstract

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.

Item Type:	Article
Date Type:	Published Online
Status:	In Press
Schools:	Medicine Centre for Trials Research (CNTRR)
Publisher:	BMJ Publishing Group
ISSN:	2059-8688
Date of First Compliant Deposit:	5 October 2024
Date of Acceptance:	21 June 2024
Last Modified:	07 Oct 2024 12:15
URI:	https://orca.cardiff.ac.uk/id/eprint/172619

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