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
Objective No systematic review of the literature has dedicated itself to looking at the management of symptomatic carotid stenosis in female patients.In this scoping review,we aimed to identify all randomised controll...Objective No systematic review of the literature has dedicated itself to looking at the management of symptomatic carotid stenosis in female patients.In this scoping review,we aimed to identify all randomised controlled trials(RCTs)that reported sex-specific outcomes for patients who underwent carotid revascularisation,and determine whether sufficient information is reported within these studies to assess short-term and long-term outcomes in female patients.Design,setting and participants We systematically searched Medline,Embase,Pubmed and Cochrane libraries for RCTs published between 1991 and 2020 that included female patients and compared either endarterectomy with stenting,or any revascularisation(endarterectomy or stenting)with medical therapy in patients with symptomatic high-grade(>50%)carotid stenosis.Results From 1537 references examined,27 eligible studies were identified.Sex-specific outcomes were reported in 13 studies.Baseline patient characteristics of enrolled female patients were reported in 2 of those 13 studies.Common outcomes reported included stroke and death,however,there was significant heterogeneity in the reporting of both periprocedural and long-term outcomes.Sex-specific differences relating to the degree of stenosis and time from index event to treatment are largely limited to studies comparing endarterectomy to medical therapy.Adverse events were not reported by sex.Conclusions Only half of the previously published RCTs and systematic reviews report sex-specific outcomes.Detailed analyses on the results of carotid artery intervention for female patients with symptomatic stenosis are limited.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Objective No systematic review of the literature has dedicated itself to looking at the management of symptomatic carotid stenosis in female patients.In this scoping review,we aimed to identify all randomised controlled trials(RCTs)that reported sex-specific outcomes for patients who underwent carotid revascularisation,and determine whether sufficient information is reported within these studies to assess short-term and long-term outcomes in female patients.Design,setting and participants We systematically searched Medline,Embase,Pubmed and Cochrane libraries for RCTs published between 1991 and 2020 that included female patients and compared either endarterectomy with stenting,or any revascularisation(endarterectomy or stenting)with medical therapy in patients with symptomatic high-grade(>50%)carotid stenosis.Results From 1537 references examined,27 eligible studies were identified.Sex-specific outcomes were reported in 13 studies.Baseline patient characteristics of enrolled female patients were reported in 2 of those 13 studies.Common outcomes reported included stroke and death,however,there was significant heterogeneity in the reporting of both periprocedural and long-term outcomes.Sex-specific differences relating to the degree of stenosis and time from index event to treatment are largely limited to studies comparing endarterectomy to medical therapy.Adverse events were not reported by sex.Conclusions Only half of the previously published RCTs and systematic reviews report sex-specific outcomes.Detailed analyses on the results of carotid artery intervention for female patients with symptomatic stenosis are limited.
