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Introduction: We have recently reported the pilot use of a smartphone platform for electronic informed consenting (e-Consent) in acute stroke trials. We here report the feedback provided by legal authorized representatives (LAR) after consenting for a large vessel occlusion acute ischemic stroke (LVOS) randomized clinical trial. Methods: This is a single-center prospective study investigating the criticism of LAR after the use of e-Consent for a clinical trial of neuroprotectant in LVOS within 12 hours of last normal. REDCap (Research Electronic Data Capture) is a secure, Health Insurance Portability and Accountability Act compliant, web-based platform designed for research data capture that was used to create a survey project located on a static URL that can be remotely accessed (via smartphone browser). Regardless of the geographical position of the LAR, a standard link to the URL was sent via text message to the LAR and signed. A structured survey was applied to each LAR at least 12 hours after enrollment. Results: From February-August 2018, 33 patients were enrolled in the trial. Four LARs were unavailable, 3 expired before the questionnaire could be applied, and 1 refused to participate, leaving 25 patients for the primary analysis. Mean LAR age was 49±13 years, 68% were female, 44% black/48% white, 44% had high-school education or less. All LARs reported e-Consent to be “clear”. Eighty percent felt “ very confortable” in signing an e-Consent, 16% “somewhat” and 4% “not comfortable at all”. Four (16%) LARs would prefer paper consent. The overall experience was “excellent” in 64%, “good” in 28%, and “poor” in 8%. Seventy-two percent of surveys were done via phone and 28% in person. The patient’s median baseline and discharge NIHSS was 17[IQR 12-22] and 2[1-7], and 60% had discharge modified Rankin Scale 0-2. Male gender (75% vs 6%;p=0.04) and education level less than college (100% vs 0%);p=0.03 were associated with preference of paper over e-consent, while baseline and discharge NIHSS were not. Conclusion: e-Consent was overall very well perceived by LAR in a randomized clinical trial of LVOS. A small percentage of LAR, who were more commonly male and formally less educated, preferred paper consent.

Abstract: The coronavirus disease 2019 (COVID-19) pandemic has broad implications on stroke patient triage. Emergency medical services providers have to ensure timely transfer of patients while minimizing the risk of infectious exposure for themselves, their co-workers, and other patients. This statement paper provides a conceptual framework for acute stroke patient triage and transfer during the COVID-19 pandemic and similar healthcare emergencies in the future.

Background and Purpose: In September 2017, a new Hyperacute Stroke Unit (HASU) was opened in a metropolitan hospital with over 400 acute stroke admissions per year, offering endovascular clot retrieval (ECR) and IV thrombolysis; 185 ECR procedures completed in 2018. The HASU opening coincided with publication of the 2017 Australian Clinical Guidelines for Stroke Management. The Guidelines state stroke severity be assessed using a validated tool, such as the National Institute of Health Stroke Scale (NIHSS). A Quality Improvement workshop, March 2018, identified attendance of correct and reliable assessment for stroke severity as a service gap. Goal = Improve NIHSS completion on all stroke patients on presentation to hospital and 24hours post endovascular clot retrieval. This was to be achieved within 90 days of project implementation with the focus on nursing education; a new skill addition to the ward environment. Methods: Education workshops (August-September 18) were implemented with the goal of building knowledge, skills and confidence along with gaining NIHSS certification. All clinical and registered nurses were provided designated time to attend workshops. Workshops were also provided to Medical officers (January 2019) allocated to the Stroke team. Cognitive aids to assist with reducing variability in application of the NIHSS were created. These included NIHSS navigation aids to the electronic medical record, NIHSS app upload to mobile phones, paper based NIHSS assessment to assist the bedside nurses and ward round note templates with auto text for NIHSS completion. Data from three months pre and post implementation was collected and compared using the Australian Stroke Clinical Registry (AuSCR). All patients admitted with stroke were included in this analysis (Jan 18-April 19). Results: NIHSS completion on patient presentation increased by 12% (n=325). NIHSS completion at 24hrs for patients post ECR increased by 22% (n=163). 31 registered nurses trained; 8 medical officers trained. Conclusions: Targeted, multimodal strategies improved completion of NIHSS on presentation and particularly, 24hrs post ECR. Further implementation in the emergency department is required to gain improvements in NIHSS completion on presentation.

Introduction: Women have historically been underrepresented in RCTs of cardiovascular disease. We undertook a review of acute stroke RCTs to determine whether women were equitably represented and whether any sex disparity varied across geographic region. Methods: We searched for papers describing primary results of acute stroke RCTs published 2013-2018 in 9 major journals and abstracted the proportion of trial participants that were women (PPW). We then searched for incidence studies from the geographic regions in which trial enrollment took place and estimated the proportion of incident strokes occurring in women (PSW) in each region (i.e., North America, Europe, Asia Pacific, Multiple Regions). We quantified the representation of women using the enrollment disparity difference (EDD) calculated as the absolute difference between the two proportions (i.e., PSW - PPW). An EDD greater than 0 indicated a disparity in favor of men. We pooled EDDs from individual RCTs using random effects meta-analysis to estimate overall and region-specific disparities. Results: Among 60 trials the PPW ranged from 33.8% to 56.9% (median 44.7%). The overall pooled EDD was 0.07 (95% CI=0.06-0.08, Q p2 =85.8%) (Figure), indicating that 7% more men were included in the trials, relative to the underlying incidence. A statistically significant EDD existed in all regions; the magnitude was largest for RCTs with enrollment from Asia Pacific (EDD=0.11, 95% CI=0.10-0.13) and Multiple Regions (EDD=0.10, 95% CI=0.08-0.12) and smallest among North American and European trials (EDD 0.04 and 0.06, respectively). All region-specific summary estimates showed significant between study heterogeneity apart from Asia (Q p=0.102, I 2 =38.4%). Conclusions: Women were underrepresented globally in contemporary acute stroke RCTs; the magnitude of the disparity differed between regions. Future research should focus on trial eligibility criteria that may contribute to this disparity.

Background and Purpose— Delirium is associated with increased mortality, length of stay, and poor functional outcome following critical illness. The epidemiology of delirium in stroke is poorly described. We sought to collate evidence around occurrence (incidence or prevalence) of delirium in acute stroke. Methods— We searched multiple cross-disciplinary electronic databases using a prespecified search strategy, complemented by hand searching. Eligible studies described delirium in acute (first 6 weeks) stroke. We compared delirium occurrence using random-effects models to describe summary estimates. We assessed risk of bias using the Newcastle-Ottawa tool, incorporating this in sensitivity analyses. We performed subgroup analyses for delirium diagnostic method (confusion assessment method scoring, clinical diagnosis, other), duration and timing of delirium assessment (>1 or Results— Of 8822 titles, we included 32 papers (6718 participants) in the quantitative analysis. Summary estimate for occurrence of delirium was 25% (95% CI, 20%–30%; moderate quality evidence). Limiting to studies at low risk of bias (22 studies, 4422 participants), the occurrence rate was 23% (95% CI, 17%–28%). Subgroup summary estimates suggest that delirium occurrence may vary with assessment method: confusion assessment method, 21% (95% CI, 16%–27%); clinical diagnosis, 27% (95% CI, 19%–38%); other, 32% (95% CI, 22%–43%) but not with duration and timing of assessment. Meta-regression suggested decline in occurrence of delirium comparing historical to more recent studies (slope, 0.03 [SE, 0.004]; P Conclusions— Delirium is common, affecting 1 in 4 acute stroke patients. Reported rates of delirium may be dependent on assessment method. Our estimate of delirium occurrence could be used for audit, to plan intervention studies, and inform clinical practice. Clinical Trial Registration— URL: http://www.crd.york.ac.uk/PROSPERO/ . Unique identifier: CRD42015029251.

Introduction: At our institution, the pediatric stroke alert activations started in April 2011 to allow for rapid evaluation and imaging of children presenting within 48 hours with acute stroke symptoms. In a previously published paper, stroke alerts initiated in the pediatric emergency department confirmed strokes in 25% of children. The purpose of this study was to characterize pediatric stroke alerts in hospitalized children. Methods: Demographic and clinical information was obtained from a quality improvement database and medical records for patients (28 days -20 years) at a single institution. Stroke alerts were activated after hospital admission from April 2011 through December 2016. A stroke alert activation means that a neurology resident sees the patient within 15 minutes and MRI is acutely made available. All values were assessed with descriptive statistics. Results: There were 56 in-hospital stroke alerts (mean age 7.5 y, SD 6.1y, 52% male) over 5.75 years. Stroke was the final diagnosis for 25 (45%) children, 72% ischemic, 28% hemorrhage (Figure 1). Other diagnoses included other neurological urgencies including seizure (21%), posterior reversible encephalopathy syndrome (9%), transient ischemic attack (5%) and acute demyelinating encephalomyelitis (4%). Of 25 actual strokes, 68% were stroke alerts initiated by the pediatric ICU or pediatric cardiac ICU. Rapid imaging was completed in 91% of stroke alerts; MRI brain was the 1 st image in 55%. Nine of 25 children with stroke died (36%); 4 secondary to the stroke and the remainder were critically ill prior to stroke diagnosis. Conclusions: Pediatric in-hospital stroke alerts were confirmed stroke in 45% of children, while 38% were other neurological conditions requiring urgent neurologic evaluation. The high frequency of stroke and other serious illnesses in already hospitalized children demonstrates the importance of rapid evaluation via a pediatric stroke alert protocol when stroke is suspected.

Background: Patients who experience acute stroke often have complex discharge planning needs that impact transitions of care. The hectic acute care hospital environment is not always conducive to addressing these needs in a standardized fashion. Purpose: To improve communication among team members and identify potential post-acute needs early in the hospital stay. Ultimately we hoped to have a positive impact the readmission rate and the patient experience. Methods: We designed a structure for daily rounds, identifying who would attend, setting clear expectations, and having a consistent schedule. We piloted a paper based check list that would serve as a guide to the dialogue during daily rounds to ensure that the team addressed key issues in a step wise, standardized fashion. This process also included the patients and families and their goals of care. Results: Readmissions were reduced from 15.4% to 10.9%. HCAHPS scores improved, specifically "Discharge Information" from 70% to 94% and "Communication with Nurses" from 46% to 83%. Conclusions: For a patient population with complex discharge needs, transitions of care can be improved by implementing a daily rounding checklist. This could positively impact the readmission rate and the patient experience.

The manner in which information is presented can profoundly affect the interpretation of that information and, consequently, any action taken. As an illustrative example, let us assume that swimming pools across the country have to report the time it takes to rescue a child who is drowning. As a parent, would you be satisfied if the median time to rescue a drowning child was 30 seconds? Knowing that a lifeguard could reach your child in only half a minute may be comforting. However, this comfort likely would not last if you were then informed that the 90th percentile is 6 minutes, a time which is likely life-threatening. We argue here that acute ischemic stroke treatment faces a similar reporting issue and that we should be doing more to acknowledge and improve the 90th percentile for stroke patients. We recommend that investigators report interval times with the 90th percentile, in addition to median and interquartile range, in their primary results on paper and at presentation. In the long run, this change would allow us to focus on ensuring that the majority of patients are treated within an acceptable time frame, rather than only 50% of patients. Additionally, efforts tailored to improving the 90th percentile would result in improved systems of care and stroke outcomes. Based on data from recent endovascular trials, it is absolutely clear that when it comes to stroke treatment, time is brain.1–5 The longer the time from onset to reperfusion, the lower the likelihood of good outcome.6 The effect of time delay is even more pronounced when one considers onset to randomization times in endovascular trials.1–5 This is not because of physiological factors; rather, it is the result of these trials overtly selecting patients based on favorable imaging. In all of …

We thank the authors Ehrlich et al for their study, which is a valuable effort to look at the safety of computed tomographic angiography (CTA) in acute stroke patients in terms of renal function.1 Multiple previous papers have also found the use of contrast to be safe in triage of acute stroke patients, some even concluding that contrast could be injected even before waiting for serum creatinine levels.2 However, we would like to raise a few concerns about this study. Of the 289 patients included in the …

Background: Recent nursing initiatives encourage early mobilization of neurocritical care patients, but whether this intervention can be safely generalized to acute stroke is debatable. We performed a systematic review of findings from recent studies to provide direction for patient management and future research. Methods: An exhaustive literature search was performed in Medline, SCOPUS and the Cochrane Central Register of Controlled Trials to identify published clinical trial research using a very early mobility intervention (within 24 hours) in acute ischemic stroke patients. The primary efficacy outcome supporting the search was neurologic disability reduction or improved functional outcomes, and the primary safety outcome was neurologic deterioration. Studies were critically reviewed for inclusion by 3 separate investigators, findings were synthesized, and an overall recommendation for very early mobilization use in acute stroke was assigned according to GRADE criteria. Results: We initially identified 12 papers focused on early mobilization in acute stroke; of these, 6 observational studies were excluded, 1 study was excluded due to an ambiguous population, and 3 studies were excluded due to first initial mobilization out of bed occurring greater than 24 hours after admission. Two prospective randomized outcome blinded evaluation (PROBE) studies were retained, consisting of a total 2160 patients; ischemic stroke subtype was not disclosed in either study, limiting an understanding of the impact of very early mobilization on small versus large artery occlusion. Slower mobilization occurring beyond the first 24 hours was associated with higher rates of favorable outcome (mRS 0-2) at 90 days, whereas very early mobilization within the first 24 hours was associated with a number needed to harm of 25. Conclusions: In acute stroke, evidence supports a rested approach to care within the first 24 hours of hospitalization (GRADE: Strong recommendation, high quality of evidence). Similar to acute myocardial infarction, vascular insufficiency experienced in stroke likely warrants a more guarded approach to mobility. Additional studies exploring timing beyond 24 hours and dose of mobility interventions are warranted in discreet populations.

Objective: To observe the impact on stroke code time metrics after applying a “pit stop” model of bedside nursing for telestroke encounters. Background: Despite the recent push for target treatment times in acute stroke codes, no guidelines exist for optimizing practices specific to stroke care via telemedicine. Effective telestroke is dependent on efficient data gathering by remote staff, and lengthy metrics for real-world telestroke often preclude timely tPA treatment. By co-opting “pit stops” as inspiration, an optimized nursing workflow for telestroke can be created on the following principles: Identification of Shared Goals; Organized Urgency with the Removal of Gatekeepers; Multi-personnel, Non-Sequential Processes; Focus on Defined Staged Roles; and Empowered Engagement/Responsibility. Methods: The QCI-NASCAR protocol was implemented in Oct 2013, and data was collected prospectively on consecutive stroke code activations through Apr 2014 at St. Paul University Hospital (Dallas, TX), a telestroke spoke site. The nurse-driven protocol was reinforced by a paper checklist (i.e. “Driver Sheet”), which doubled as a data collection form. Timestamps were recorded in real time for: door time, MD at bedside, CT arrival, needle time, and/or code cancellation. The primary outcome was Door-to-CT (D2CT) times to reflect the portion of the stroke code most impacted by the nursing protocol. Results: Mean D2CT times were: all cases (n=152, 33.2 min), intervention-eligible cases (n=71, 27.0 min), and thrombolytic-eligible cases (n=57, 22.2 min). A trend for lower D2CT times and standard deviations was noted in comparing the first half of the data (n=76, 38.04 ± 58.1 min) to the second (n=77, 27.8 ± 19.1 min; p Conclusion: QCI-NASCAR demonstrates the feasibility of implementing a nursing-driven protocol for telestroke encounters. A larger, multi-institutional trial will demonstrate if such a protocol can significantly and reproducibly lower stroke code metrics to national guideline parameters.

Those of us in the stroke field have a big job ahead of us. When I started attending this meeting 20 years ago, most of the papers related to acute stroke therapy were laboratory related. Now, of course, we are in the era of clinical trials. But in designing clinical trials, we cannot forget the lessons that need to be learned from laboratory research. And it’s the job of the stroke neurologist to marry these 2 together, and that’s the main focus of what I’d like to talk about in the next few minutes. I’d like to make 4 key points. First, that stroke therapy is difficult. It’s a complex disease, and nobody said it would be easy. There are not going to be any magic bullets for stroke patients. Second, the most critical but ignored lesson from the laboratory is the importance of time. Third, it’s critical to change the role of neurologists in taking care of stroke patients, particularly because of the importance of time. Finally, I’d like to make a few comments about the direction of future stroke research. The bad news for acute stroke therapy is that as far as translating what we’ve done in the laboratory to clinical reality, stroke has been and always will be difficult to treat. We should expect small advances and many failures, and for every 1 positive clinical trial, we will probably have many negative ones; that’s just the nature of stroke disease. But substantial attenuation of damage is possible. I will try to show how the hopes of the laboratory have often been dashed by the reality of translation to human stroke by using an autobiographical approach. The basic principle that acute stroke is a treatable disease was demonstrated to me when I was a fellow at Massachusetts General …

Part I of this discussion of my 65 years since graduating from medical school covered my reasons for being in medicine at all, my explanation for the theatrical terms in the earlier para-scientific document, and finally the effect of World War II on my career.1 Part II will attempt to touch on the privileged life I led in the field of stroke prevention research. In its entirety it is designed as a story or tale about my 50 years in medical practice and does not follow the standard format of a scientific paper. Previously I alluded to the ongoing prejudicial custom of critical attempts to resist new ideas in scientific endeavor. I gave as examples the discordant behavior in Toronto that greeted the discovery of insulin and of less far-reaching consequence my own attempts to convince Canadian and American colleagues that there were 5 distinct causal mechanisms leading to syringomyelia. Surgeons in Cleveland and Boston were adamant that there was but one. Postmortem studies and now routine MR studies prove them wrong. My next contribution of a controversial nature was a description of a group of young patients with stroke whose causes we defined in a study with age and gender-matched controls as being due to emboli associated with mitral valve prolapse and to suggest that this was a clinically overlooked cause of cerebral ischemic events.2 Denials of variable vehemence appeared but the accumulating pathological and surgical data were quite incontrovertible. Ultimately in an Olmstead County prevalence study its occurrence as a cause of stroke was validated.3 Its prevalence is probably less than we suggested in our first report. The difference is probably explained by improvement in the conduct, interpretation and the delineation of newer stroke causes revealed by echocardiography. At times more than one potential cause …

To the Editor: We read with interest the recent paper by Castillo and colleagues evaluating the prognostic relevance of admission blood pressure (BP) values and describing a U-shaped effect in patients with acute ischemic stroke, as well as Boysen’s editorial comment on this issue.1,2 The study’s conclusion was that both high and low admission BP values are associated with poor prognosis regarding early neurological deterioration, infarct volume, and mortality at 3 months. After adjustment for the use of antihypertensive drugs and BP drop >20mm Hg, the authors found that the latter was the most important prognostic factor for poor outcome. Before accepting these important conclusions, we think that some comments are needed. We have also evaluated the prognostic value of admission BP values in an unselected collective of acute stroke patients. Our findings demonstrated that early and late mortality in patients with ischemic stroke as well as in patients with intracerebral hemorrhage followed a U-shaped pattern in relation to systolic and diastolic BP at admission.3 Low admission BP values were associated with heart failure and coronary artery disease, whereas high BP values were associated with history of hypertension and lacunar stroke. Death due to cardiovascular disease was significantly more frequent among patients with admission BP values beneath the U-point of 130 mm Hg, whereas death due to brain edema was significantly more frequent above this U-point.3 We also demonstrated by means of 24-hour BP monitoring that persisting elevated systolic 24-hour BP values during the acute phase of stroke are associated with subsequent brain edema formation in patients not receiving antihypertensive medication during the BP monitoring.4 Investigating the relationship …

Ensuring the reliability and validity of outcome measures used in clinical trials is essential to the success of the trial. The Trial of Org 10172 in Acute Stroke Treatment (TOAST) is a multicenter clinical trial that is recruiting patients with acute ischemic stroke seen at medical centers across the United States. This paper describes an approach to train physicians to use three clinical measures: the National Institutes of Health (NIH) Stroke Scale, a supplemental motor examination, and the Glasgow Outcome Scale. The program included education, certification, remediation when needed, monitoring, and reliability assessment. The goal was to ensure that interrater assessments were as equivalent to one another as possible. Of the first 95 clinicians who began the certification process, 75 passed during the first evaluation. Eighteen of the other physicians were able to complete the process after remediation. The intraclass correlations of both the NIH Stroke Scale and supplemental motor examination exceeded 0.95. The kappa values for the Glasgow Outcome Scale were 0.61 and 0.62 for the first and second ratings of the videotape, respectively. Our experience suggests that a program that includes educational and certification processes can be performed as part of the design of a multicenter clinical trial. The method of providing educational and testing videotapes to each site so that physicians can be trained and certified is an effective, inexpensive, and practical approach for enhancing and certifying the expertise of the large number of physicians involved in a multicenter study.

To the Editor: We read with interest the work of Missler et al1 and Buttner and colleagues2 and agree with both sets of researchers on the need for reliable, noninvasive markers of neuronal damage following acute stroke. Such markers may allow prognostication of future clinical outcome and may be useful in acute therapy trials as surrogate markers of efficacy. However, neither study cited our publication on serum S-100 protein levels in acute stroke,3 4 a study that examined 81 patients (68 with ischemic stroke and 13 with hemorrhagic stroke) within 48 hours of stroke ictus and compared them with 51 age-, race-, and gender-matched control subjects.3 As with both recent papers in Stroke , we found significantly higher serum S-100 protein levels in the stroke population than in the control group. Furthermore, the highest S-100 protein levels were seen in the hemorrhagic stroke group, and differentiation between the two stroke populations almost reached statistical significance. We also performed a temporal study (24, 48, 72, and 96 hours …

Previous surveys of stroke populations have offered only cursory information on language disturbance, and, conversely, few surveys of aphasic populations have dealth exclusively with stroke or with acute phenomena. This paper describes aphasia in 850 acute stroke patients consecutively registered by the Harlem Regional Stroke Program, of whom 177 (21%) were aphasic; of these, nine were of Broca's type, 24 were of Wernicke's type, 14 were of anomic, ten were conduction, seven were of "isolation" type, and 107 were "mixed." An unexpected finding was a significant over-representation of men among the nonfluent aphasics. During the following four to 12 weeks, 12% of fluent aphasics died, and 12% remained moderately or severely impaired; among survivors, aphasia improved in 74%, and in 44% it cleared completely. During the same period, 32% of nonfluent aphasics died, and 34% remained moderately or severely impaired; among survivors, aphasia improved in 52%, and in only 13% did it clear completely. In both fluent and nonfluent groups, hemiparesis and/or visual field cut were associated with poor prognosis.