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
Background In ischaemic stroke,minor deficits(National Institutes of Health Stroke Scale(NIHSS)≤5)at presentation are common but often progress,leaving patients with significant disability.We compared the efficacy an...Background In ischaemic stroke,minor deficits(National Institutes of Health Stroke Scale(NIHSS)≤5)at presentation are common but often progress,leaving patients with significant disability.We compared the efficacy and safety of intravenous thrombolysis with tenecteplase versus alteplase in patients who had a minor stroke enrolled in the Alteplase Compared to Tenecteplase in Patients With Acute Ischemic Stroke(AcT)trial.Methods The AcT trial included individuals with ischaemic stroke,aged>18 years,who were eligible for standard-of-care intravenous thrombolysis.Participants were randomly assigned 1:1 to intravenous tenecteplase(0.25 mg/kg)or alteplase(0.9 mg/kg).Patients with minor deficits pre-thrombolysis were included in this post-hoc exploratory analysis.The primary efficacy outcome was the proportion of patients with a modified Rankin Score(mRS)of 0–1 at 90–120 days.Safety outcomes included mortality and symptomatic intracranial haemorrhage(sICH).Results Of the 378 patients enrolled in AcT with an NIHSS of≤5,the median age was 71 years,39.7%were women;194(51.3%)received tenecteplase and 184(48.7%)alteplase.The primary outcome(mRS score 0–1)occurred in 100 participants(51.8%)in the tenecteplase group and 86(47.5%)in the alteplase group(adjusted risk ratio(RR)1.14(95%CI 0.92 to 1.40)).There were no significant differences in the rates of sICH(2.9%in tenecteplase vs 3.3%in alteplase group,unadjusted RR 0.79(0.24 to 2.54))and death within 90 days(5.5%in tenecteplase vs 11%in alteplase group,adjusted HR 0.99(95%CI 0.96 to 1.02)).Conclusion In this post-hoc analysis of patients with minor stroke enrolled in the AcT trial,safety and efficacy outcomes with tenecteplase 0.25 mg/kg were not different from alteplase 0.9 mg/kg.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.
文摘Background In ischaemic stroke,minor deficits(National Institutes of Health Stroke Scale(NIHSS)≤5)at presentation are common but often progress,leaving patients with significant disability.We compared the efficacy and safety of intravenous thrombolysis with tenecteplase versus alteplase in patients who had a minor stroke enrolled in the Alteplase Compared to Tenecteplase in Patients With Acute Ischemic Stroke(AcT)trial.Methods The AcT trial included individuals with ischaemic stroke,aged>18 years,who were eligible for standard-of-care intravenous thrombolysis.Participants were randomly assigned 1:1 to intravenous tenecteplase(0.25 mg/kg)or alteplase(0.9 mg/kg).Patients with minor deficits pre-thrombolysis were included in this post-hoc exploratory analysis.The primary efficacy outcome was the proportion of patients with a modified Rankin Score(mRS)of 0–1 at 90–120 days.Safety outcomes included mortality and symptomatic intracranial haemorrhage(sICH).Results Of the 378 patients enrolled in AcT with an NIHSS of≤5,the median age was 71 years,39.7%were women;194(51.3%)received tenecteplase and 184(48.7%)alteplase.The primary outcome(mRS score 0–1)occurred in 100 participants(51.8%)in the tenecteplase group and 86(47.5%)in the alteplase group(adjusted risk ratio(RR)1.14(95%CI 0.92 to 1.40)).There were no significant differences in the rates of sICH(2.9%in tenecteplase vs 3.3%in alteplase group,unadjusted RR 0.79(0.24 to 2.54))and death within 90 days(5.5%in tenecteplase vs 11%in alteplase group,adjusted HR 0.99(95%CI 0.96 to 1.02)).Conclusion In this post-hoc analysis of patients with minor stroke enrolled in the AcT trial,safety and efficacy outcomes with tenecteplase 0.25 mg/kg were not different from alteplase 0.9 mg/kg.
