Advance Consent in Acute Stroke Trials: Survey of Canadian Stroke Physicians.

Advance consent presents a potential solution to the challenge of obtaining informed consent for participation in acute stroke trials. Clinicians in stroke prevention clinics are uniquely positioned to identify and seek consent from potential stroke trial participants. To assess the acceptability of advance consent to Canadian stroke clinic physicians, we performed an online survey. We obtained 58 respondents (response rate 35%): the vast majority (82%) expressed comfort with obtaining advance consent and 92% felt that doing so would not be a significant disruption to clinic workflow. These results support further study of advance consent for acute stroke trials.

Advance Consent in Acute Stroke Trials: Survey of Canadian Research Ethics Board Chairs.

Advance consent could allow individuals at high risk of stroke to provide consent before they might become eligible for enrollment in acute stroke trials. This survey explores the acceptability of this novel technique to Canadian Research Ethics Board (REB) chairs that review acute stroke trials. Responses from 15 REB chairs showed that majority of respondents expressed comfort approving studies that adopt advance consent. There was no clear preference for advance consent over deferral of consent, although respondents expressed significant concern with broad rather than trial-specific advance consent. These findings shed light on the acceptability of advance consent to Canadian ethics regulators.

Decreased Stroke Presentation Rates at a Comprehensive Stroke Center during COVID-19.

We reviewed stroke care delivery during the COVID-19 pandemic at our stroke center and provincial telestroke system. We counted referrals to our prevention clinic, code strokes, thrombolysis, endovascular thrombectomies, and activations of a provincial telestroke system from February to April of 2017-2020. In April 2020, there was 28% reduction in prevention clinic referrals, 32% reduction in code strokes, and 26% reduction in telestroke activations compared to prior years. Thrombolysis and endovascular thrombectomy rates remained constant. Fewer patients received stroke services across the spectrum from prevention, acute care to telestroke care in Ontario, Canada, during the COVID-19 pandemic.

Diagnosis of Transient Ischemic Attack: Sex-Specific Differences From a Retrospective Cohort Study.

BACKGROUND AND PURPOSE: Research suggests that women and men may present with different transient ischemic attack (TIA) and stroke symptoms. We aimed to explore symptoms and features associated with a definite TIA/stroke diagnosis and whether those associations differed by sex. METHODS: We completed a retrospective cohort study of patients referred to The Ottawa Hospital Stroke Prevention Clinic in 2015. Exploratory multinomial logistic regression was used to evaluate candidate variables associated with diagnosis and patient sex. Backwards elimination of the interaction terms with a significance level for staying in the model of 0.25 was used to arrive at a more parsimonious model. RESULTS: Based on 1770 complete patient records, sex-specific differences were noted in TIA/stroke diagnosis based on features such as duration of event, suddenness of symptom onset, unilateral sensory loss, and pain. CONCLUSIONS: This preliminary work identified sex-specific differences in the final diagnosis of TIA/stroke based on common presenting symptoms/features. More research is needed to understand if there are biases or sex-based differences in TIA/stroke manifestations and diagnosis.

Early vascular imaging and key system strategies expedite carotid revascularization after transient ischemic attack and stroke.

BACKGROUND: International guidelines recommend carotid revascularization within 14 days for patients with a symptomatic transient ischemic attack (TIA) or stroke event. However, significant delays in care persist, with only 9% of outpatients and 36% of inpatients in Ontario meeting this target. The study objective was to explore the influence of health system factors on carotid revascularization timelines. METHODS: We conducted a retrospective chart review of all symptomatic TIA/stroke patients undergoing carotid endarterectomy or stenting at The Ottawa Hospital (2015-2016). The primary outcome was time from TIA/stroke to carotid revascularization. Health system variables of interest included location and timing of patient presentation, timelines to vascular imaging, and same-day collaboration between key services such as emergency, neurology, and surgery. Descriptive statistics and univariate analysis were used to determine statistically significant differences between groups. RESULTS: A total of 228 records met the inclusion criteria. The median time from TIA/stroke to carotid revascularization was 10 days, with 58% of patients meeting the 14-day guideline. Prompt patient presentation to emergency demonstrated significantly shorter timelines to surgery (7 days; P < .001). Early vascular imaging was strongly correlated with early revascularization (4-5 days; P < .001). In addition, collaboration from two or more care services enhanced timelines to surgery ranging from 2.0 to 6.5 days (P < .001-.008). CONCLUSIONS: Early/emergency response to stroke symptoms was pivotal in achieving best practice recommendations for rapid carotid revascularization, emphasizing the need for ongoing public awareness. Emergency and ambulatory strategies to facilitate urgent vascular imaging, as well as mechanisms for same-day communication between teams require optimization to promote early revascularization.

Fast-Track Systems Improve Timely Carotid Endarterectomy in Stroke Prevention Outpatients.

BACKGROUND: For optimal stroke prevention, best practices guidelines recommend carotid endarterectomy (CEA) for symptomatic patients within two weeks; however, 2013 Ontario data indicated that only 9% of eligible patients from outpatient Stroke Prevention Clinics (SPCs) achieved this target. The goal of our study was to identify modifiable system factors that could enhance the quality and timeliness of care among patients needing urgent CEA. METHODS: We conducted a retrospective chart review of transient ischemic attack/stroke patients assessed in Champlain Local Health Integrated Network SPCs between 2011 and 2014 who subsequently underwent CEA. Descriptive statistics were used to define patient characteristics, timelines from symptom onset to CEA, and system factors that contributed to delays or improvements in care. Multivariate analysis was used to determine statistically significant variations between groups. RESULTS: Seventy-five records were eligible for study inclusion. Median time from initial symptoms to CEA was 31 days, with 21.3% of patients undergoing surgery within 2 weeks. Significant delays were common in patient presentation and assessment following symptom onset, wait times for vascular imaging and neurological assessment, and time from surgical assessment to CEA completion. Rapid testing and triage, coupled with collaborative initiatives among SPC, surgical, and radiology teams were associated with significantly improved timelines. CONCLUSIONS: Success factors for rapid CEA are multifaceted, including system changes that address public awareness of stroke and 911 response, improvements in vascular imaging access, and redesign of clinical services to promote collaboration and fast-tracking of care. Implementation of performance measures to monitor and guide clinical innovations is recommended.

Identifying sex-specific differences in the carotid revascularisation literature: findings from a scoping review.

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.

Rationalisations for women-only randomised controlled trials in conditions that affect both sexes: a scoping review protocol.

INTRODUCTION: Women have historically been under-represented in randomised controlled trials (RCTs), including many landmark RCTs that established standards of care. In light of this fact, some modern researchers are calling for replication of earlier landmark trials with women only. This approach is ethically concerning, in that it would require some enrolled women to be deprived of treatments that are currently considered standard of care. OBJECTIVE: In an attempt to better understand the justification of a women-only approach to designing clinical trials, this study looks to systematically categorise the number of women-only RCTs for conditions that affect both men and women and the reasons given within the medical and philosophical literatures to perform them. METHODOLOGY: This scoping review of the literature will search, screen and select articles based on predetermined inclusion/exclusion criteria, after which a grounded theory approach will be used to synthesise the data. It is expected that there will be a variety of reasons given for why a women-only trial may be justified. Electronic databases that will be searched include MEDLINE, EMBASE, Cochrane Database of Systematic Reviews, Cochrane Clinical Trials Register, Web of Science Proceedings, ClinicalTrials.gov, Philosopher's Index, Phil Papers, JSTOR, Periodicals Archive Online, Project MUSE and the National Reference Centre for Bioethics. SIGNIFICANCE: The scope of this study is to determine published rationales used to justify women-only randomised trials, both in the case of new trials and in the repetition of landmark trials. ETHICS AND DISSEMINATION: Research ethics board approval is not required for this study as there is no participant involvement. Results will be published as a stand-alone manuscript and will inform a larger project related to the ethics of a women-only RCT of carotid intervention for women with symptomatic high-grade carotid stenosis.

Cohort Study of Features Used by Experts to Diagnose Transient Ischemic Attack.

BACKGROUND AND PURPOSE: The diagnosis of transient ischemic attack (TIA) is largely dependent on a process of clinical decision-making that remains poorly characterized in the absence of a validated and accessible biomarker or imaging test. We performed a retrospective chart review to identify variables associated with a final neurologist diagnosis of TIA/stroke. METHODS: Records for all patients seen in The Ottawa Hospital's Stroke Prevention Clinic in 2015 were analyzed for patient and referral characteristics, features of the presenting neurological event, and final diagnosis by a stroke neurologist (classified as definite, possible, or definite not TIA/stroke). Multinomial logistic regression analysis with backward elimination was used to identify variables associated with the final diagnosis. RESULTS: Our inclusion criteria were met by 1894 patients. After backward elimination, 23 potentially important variables were identified, including monocular vision loss (odds ratio [OR]: 30.4, 95% confidence interval [CI]: 14.6-63.3), symptoms of sudden onset (OR: 28.3, 95% CI: 14.2-56.2), unilateral weakness affecting 2 or 3 of face, arm, or leg (OR: 17.7, 95% CI: 9.8-31.7), and homonymous hemianopia (OR: 16.6, 95% CI: 8.1-34.0). CONCLUSIONS: Accurate diagnosis of TIA is essential to initiating appropriate secondary stroke prevention therapies. A focus on elements of the patient history most commonly associated with a final diagnosis of TIA/stroke may help to identify patients in greatest need of urgent SPC assessment and allow for the provision of effective and efficient stroke prevention services.

Benefit of carotid revascularisation for women with symptomatic carotid stenosis: protocol for a systematic review.

INTRODUCTION: Carotid intervention in the form of endarterectomy or stenting is the current standard of care for the majority of patients with symptomatic high-grade carotid stenosis. However, some randomised controlled trials (RCT) have demonstrated that women benefited significantly less from intervention than men. It is unclear if this is a true phenomenon or a study sampling artefact, as women were severely under-represented in all RCTs of carotid revascularisation. A systematic review is needed to summarise the existing data and to answer the question of whether a women-only trial for symptomatic patients with ipsilateral carotid stenosis is scientifically necessary and ethically permissible. METHODS AND ANALYSIS: We will systematically search Medline, Embase, PubMed and the Cochrane libraries for all studies with data from RCTs that included women and compared either endarterectomy with stenting or revascularisation (by means of endarterectomy or stenting) with medical therapy in patients with symptomatic carotid stenosis. Search dates will be restricted to 1991-2018. Two reviewers will conduct screening search results, study selection, data extraction and quality assessment. We will include all studies reporting outcomes of interest. Planned subgroup analysis based on revascularisation technique, degree of stenosis and timing of intervention from the index event will be conducted with enough data. ETHICS AND DISSEMINATION: This research is exempt of ethics approval as no primary data will be collected. The results will be published in peer-reviewed journals and disseminated through national and international-level conferences and scientific meetings. The result of this comprehensive review will provide useful information on whether further RCTs are required to study a women-only population with symptomatic carotid disease. PROSPERO REGISTRATION NUMBER: CRD42019134967.

How do neurologists diagnose transient ischemic attack: A systematic review.

BACKGROUND: Identifying and treating patients with transient ischemic attack is an effective means of preventing stroke. However, making this diagnosis can be challenging, and over a third of patients referred to stroke prevention clinic are ultimately found to have alternate diagnoses. AIMS: We performed a systematic review to determine how neurologists diagnose transient ischemic attack. SUMMARY OF REVIEW: A systematic literature search was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines using MEDLINE, Embase, and the Cochrane Library databases. Publications eligible for inclusion were those that included information on the demographic or clinical features neurologists use to diagnose transient ischemic attacks or transient ischemic attack-mimics. Of 1666 citations, 210 abstracts were selected for full-text screening and 80 publications were ultimately deemed eligible for inclusion. Neurologists were more likely to diagnose transient ischemic attack based on clinical features including negative symptoms or speech deficits. Patients with positive symptoms, altered level of consciousness, or the presence of nonfocal symptoms such as confusion or amnesia were more likely to be diagnosed with transient ischemic attack-mimic. Neurologists commonly include mode of onset (i.e. sudden versus gradual), recurrence of attacks, and localizability of symptoms to a distinct vascular territory in the diagnostic decision-making process. Transient ischemic attack diagnosis was more commonly associated with advanced age, preexisting hypertension, atrial fibrillation, and other vascular risk factors. CONCLUSIONS: Neurologists rely on certain clinical and demographic features to distinguish transient ischemic attacks from mimics, which are not currently reflected in widely used risk scores. Clarifying how neurologists diagnose transient ischemic attack may help frontline clinicians to better select patients for referral to stroke prevention clinics.

Ontario regional stroke centres: survey of neurological nursing assessment practices with acute stroke patients.

A survey to explore which neurological stroke assessment scales were being used by nurses at all nine regional stroke centres (RSCs) in Ontario, and education strategies for implementation of the new scales was conducted in 2004. Findings revealed that nurses are moving away from reliance on the Glasgow Coma Scale (GCS) towards use of more standardized stroke severity scales to facilitate assessment, documentation, and care planning with acute stroke survivors. Scales used include the Canadian Neurological Scale and the National Institutes of Health Stroke Scale. Consistency in use between nurses was identified as an implementation challenge that was best addressed through integration of the scale into the process of care and documentation and bedside education.

A randomised controlled pilot study of standardised counselling and cost-free pharmacotherapy for smoking cessation among stroke and TIA patients.

Background Tobacco use is a major risk factor for recurrent stroke. The provision of cost-free quit smoking medications has been shown to be efficacious in increasing smoking abstinence in the general population. Objective The objective of this pilot study was to assess the feasibility and obtain preliminary data on the effectiveness of providing cost-free quit smoking pharmacotherapy and counselling to smokers identified in a stroke prevention clinic. Trial design Cluster randomised controlled trial. Methods All patients seen at the Ottawa Hospital Stroke Prevention Clinic who smoked more five or more cigarettes per day, were ready to quit smoking in the next 30 days, and were willing to use pharmacotherapy were invited to participate in the study. All participants were advised to quit smoking and treated using a standardised protocol including counselling and pharmacotherapy. Participants were randomly assigned to either a prescription only usual care group or an experimental group who received a 4-week supply of cost-free quit smoking medications and a prescription for medication renewal. All patients received follow-up counselling. The primary outcome was biochemically validated quit rates at 26 weeks. The research coordinator conducting outcome assessment was blind to group allocation. Results Of 219 smokers screened, 73 were eligible, 28 consented and were randomised, and 25 completed the 26-week follow-up assessment. All 28 patients randomised were included in the analysis. The biochemically validated 7-day point prevalence abstinence rate in the experimental group compared to the usual care group was 26.6% vs 15.4% (adjusted OR 2.00, 95% CI 0.33 to 13.26; p=0.20). Conclusions It would be feasible to definitively evaluate this intervention in a large multi-site trial. Trial registration number http://ClinicalTrials.gov # UOHI2010-1.

Neurological assessment by nurses using the National Institutes of Health Stroke Scale: implementation of best practice guidelines.

Assessment is an essential nursing skill that gathers clinical information to strengthen decisions about health interventions and priorities inpatient care delivery. Neurological assessment of the acute stroke survivor provides the cornerstone for early diagnosis, appropriate prognostic evaluation, and optimal management to obtain favourable patient outcomes. The nursing approach to neurological assessment has been enhanced in recent years through the development of new evidence-based assessment tools and the support of best practice guidelines. Based on gaps seen in clinical practice and current best practice guideline recommendations, neurological nurses from The Ottawa Hospital (TOH) identified the need to assess acute stroke survivors using a standardized neurological assessment tool. In 2004, a Registered Nurses of Ontario (RNAO) nursing advanced clinical practice fellowship provided the opportunity for the development of expertise in stroke assessment and establishment of recommendations for neurological nursing assessment at TOH. As a result, standards for nursing neurological assessment have been adopted at TOH using the National Institutes of Health Stroke Scale (NIHSS). This paper will review current evidence and best practice guidelines for neurological assessment. The significances of using the NIHSS for nurses in the context of the provision of acute stroke care will be presented. Knowledge transfer, application and evaluation of best practice guidelines (BPGs) in clinical nursing practice will also be discussed.