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 th...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.展开更多
基金supported by CIHR SPOR Grant 2021(Application number 453176 Competition code 202010PJK)the New Frontiers in Research Fund(NFRF)2021 Innovative Approaches to Research in the Pandemic Context(Application ID 00379).
文摘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.
