Introduction and Aim of the Work: Numerous studies have shown contradictory data regarding sex differences in pre- and in-hospital delays of intravenous thrombolysis (IVT) for acute ischemic stroke (AIS). Our objective was to investigate these differences among Egyptian patients presenting with AIS. METHODS:This prospective, single-center, open-label cohort study was conducted from September 2022 to December 2023. Patients with IVT-eligible AIS, who did not receive IVT, were included in the study. Patients were recruited from the largest tertiary stroke center in the south of Egypt. All participants underwent a full neurological assessment including NIHSS, laboratory workup, and computed tomography or magnetic resonance imaging. The patients were subjected to a structured questionnaire designed to determine the parameters and time metrics associated with prehospital and in-hospital delays. RESULTS:A total of 897 patients, 41.8% of whom were females, were included in our study. General demographic characteristics were similar between both groups. A total of 70.9% of female patients and 65.1% of male patients arrived at stroke-ready hospital outside the therapeutic time window. Female patients experienced a significantly longer duration from symptom onset to hospital arrival (600 ± 618 min) compared to male patients (480 ± 438 min). Stroke misdiagnosis was nonsignificantly higher among the female group (58.9%). The time spent in the hospital did not significantly differ between males and females. CONCLUSION:The study results indicate a significant disparity in the management of female stroke patients in both prehospital and in-hospital settings, with the most pronounced delays occurring during prehospital care.
INTRODUCTION:Elevated blood pressure (BP) in acute hemorrhagic stroke has been associated with adverse clinical outcomes. Limited data from randomized controlled clinical trials (RCTs) indicate that early BP management, in the prehospital setting, may be safe and beneficial. We sought to evaluate the efficacy and safety of prehospital BP-lowering in acute hemorrhagic stroke when compared to usual care. PATIENTS AND METHODS:We conducted a systematic review and meta-analysis including available RCTs evaluating prehospital BP-lowering among acute hemorrhagic stroke patients. The pooled risk ratio (RR) of a 3-month good functional outcome, defined as modified-Rankin-Scale scores of 0-2 and all-cause 3-month mortality were the primary efficacy and safety outcomes, respectively. Secondary outcomes included the pooled RR of hematoma expansion (HE) and serious adverse events (SAEs). RESULTS:A total of four RCTs were included, comprising 642 patients treated with prehospital BP-lowering therapies and 617 patients receiving usual care. Prehospital BP-lowering was associated with similar rates of good functional outcome (RR: 1.07; 95% CI, 0.52-2.19) and all-cause mortality (RR: 0.90; 95% CI, 0.60-1.35) at 3 months, compared to usual care. The risk of SAEs (RR: 0.97; 95% CI, 0.74-1.26) and HE (RR: 1.05; 95% CI, 0.45-2.46) did not significantly differ between the two groups. Subgroup analyses revealed the superiority of the α-adrenoreceptor blocker urapidil compared to glyceryl trinitrate in terms of reducing SAE risk and HE. CONCLUSION:Our meta-analysis indicates that prehospital BP-lowering in acute hemorrhagic stroke does not improve functional outcome and survival. Future RCTs conducted in mobile stroke units, and exclusively focusing on patients with acute hemorrhagic stroke, are required.
INTRODUCTION:Endovascular therapy (EVT) has become an increasingly important part of acute stroke management. However, the lack of trained neurointerventionalists represents a key barrier in expanding availability of EVT in Europe. This project aimed to investigate the association between the number of neurointerventionalists and overall EVT rates. PATIENTS AND METHODS:A cross-sectional analysis was conducted using publicly available data from the Global Burden of Disease Report 2021 and the Stroke Action Plan for Europe (Stroke Service Tracker). Data on the number of neurointerventionalists across 35 European countries were surveyed through a structured survey distributed via the Resident and Research Fellow Section (RRFS) of the European Academy of Neurology (EAN). Correlation analyses were performed to estimate the association between neurointerventionalist density per served population, EVT rates and stroke-related mortality and morbidity. RESULTS:Survey response rate was 71% (25/35 countries). The proportion of acute ischaemic stroke patients treated with EVT ranged from 0.05% to 14.96% of people with ischaemic stroke, and the number of neurointerventionalists ranged from 9 to 137 per country and from 0.3 to 7.5 per million inhabitants. There was a positive correlation between the number of neurointerventionalists per population served and EVT rates (Spearman coefficient ρ = 0.507; 95% CI, 0.209-0.719). Greater availability of trained neurointerventionalists was moderately associated with lower national ischaemic-stroke mortality (ρ = -0.473; 95% CI, -0.746 to -0.065) and lower overall disability-adjusted life years (ρ = -0.444; 95% CI, -0.729 to -0.027). DISCUSSION AND CONCLUSION:The number of neurointerventionalists correlates positively with the annual volume of EVT across European countries; higher EVT rates were also associated with lower stroke-related mortality and disability; however, these associations are unadjusted for other important confounders and causality cannot be inferred. These data suggest an urgent need to increase neurointerventional capacity in Europe, for example, by expanding dedicated national training programmes and enhancing support from national and international professional societies.
Multiple sclerosis (MS) is a disease of the central nervous system, which is reflected in impaired transmission of impulses due to damage to the myelin layer. In addition to the visual evoked potentials, the vestibular evoked myogenic potentials (VEMPs) are increasingly considered for diagnosis. Due to a low signal-to-noise ratio, several hundred stimulus responses are usually averaged in order to determine the amplitude and latencies from these curves. However, this averaging procedure also filters out information that, if taken into account, could provide further insights into the course of the disease.16 young patients with MS and an EDSS score of 1.4 ± 0.6 were compared with 92 healthy subjects of the same age. Amplitude, latency, AR and five new parameters from the analysis were used as parameters from the tactile evoked oVEMPs.The total n10 amplitude and the n10 amplitude on the left side showed relevant differences though not reaching statistical significance. In contrast, the n10 amplitude on the right side and the LSD parameter were not significantly different. All n10 latencies and the AR as well as all parameters from the novelty analysis were significantly different.On the one hand, the present study confirms already known changes in the registration of oVEMPs in patients with MS compared to healthy subjects and, on the other hand, the new parameters have the potential to better describe the current state of the disease and to provide detailed information about the current state of myelination or the site of pathophysiological processes within the CNS.
This World Stroke Organization Scientific Statement highlights how sex and gender differences shape stroke risk, treatment, care, and research. Estrogen confers a relative protection before menopause, with risk increasing thereafter. Beyond shared cardiovascular determinants (hypertension, atrial fibrillation, and diabetes), women face sex-specific risks-hypertensive disorders of pregnancy, menopause, and hormone therapy, with clear implications for stroke prevention and management. Despite comparable efficacy of acute and secondary stroke therapies in women and men, women are less likely to receive timely acute treatment and often experience delays in recognition and access. The statement recommends gender-responsive prevention and care pathways; systematic consideration of pregnancy-related and menopausal factors; and public and professional education to improve stroke symptom recognition and purposeful inclusion of women across the research continuum. By integrating evidence from epidemiology, acute care, and secondary prevention, this statement provides clear and timely guidance for reducing inequities and shaping future research and policy to achieve equitable stroke care globally.
ZusammenfassungDie Multiple Sklerose ist eine Erkrankung des zentralen Nervensystems, die sich in der gestörten Reizweiterleitung durch Schädigung der Myelinschicht widerspiegelt. Neben den visuell evozierten Potenzialen sind es immer mehr auch die vestibulär evozierten myogenen Potenziale (VEMPs), die zur Befundung mitbetrachtet werden. Aufgrund eines geringen Signal-Rausch-Abstandes werden üblicherweise einige 100 Reizantworten gemittelt, um aus diesen Kurven Amplitudenhöhe und Latenzen zu bestimmen. Dieses Verfahren filtert jedoch Informationen aus der Messung heraus, welche weitere Erkenntnisse über den Krankheitszustand liefern könnten.16 junge Patienten mit MS und einem EDSS-Score von 1,4±0,6 wurden mit 92 gesunden Probanden gleichen Alters verglichen. Als Parameter wurden aus den taktil ausgelösten oVEMPs die n10-Amplitude, die n10-Latenz, das AR sowie 5 neue Parameter aus der neuen Analysemethode herangezogen.Die n10-Amplitude gesamt sowie die n10-Amplitude links waren grenzwertig signifikant unterschiedlich. Demgegenüber waren die n10-Amplitude rechts und der LSD-Parameter nicht signifikant unterschiedlich. Alle n10-Latenzen und das AR sowie alle Parameter aus der neuen Analyse waren signifikant unterschiedlich zwischen den Gruppen.Die vorliegende Studie bestätigt die zum einen schon bekannten Veränderungen in der Registrierung von oVEMPs bei Patienten mit MS gegenüber gesunden Probanden, und zum anderen haben die neuen Parameter das Potenzial, den aktuellen Krankheitszustand besser zu beschreiben und detaillierte Informationen über den aktuellen Zustand der Myelinisierung bzw. die Lokalisierung der pathophysiologischen Prozesse im ZNS zu geben.
BACKGROUND:Several studies have evaluated sex discrepancies in the prehospital management of patients with acute stroke. This systematic review and meta-analysis aims to summarize reported knowledge about sex differences in dispatch center and emergency medical service management. It proposes a roadmap of questions and the next necessary steps to ensure equitable prehospital stroke care. METHODS:We conducted a systematic review and meta-analysis, using a random-effects model with inverse weighting. PubMed, CINAHL, EMBASE, and EMCARE were searched for studies investigating sex differences in the prehospital management of patients with suspected and acute stroke. The main outcome was the relative risk (RR) for receiving a correct prehospital stroke diagnosis. Additional outcomes are related to prehospital management and time metrics. RESULTS:Sixteen studies were included, comprising 571 024 male patients and 622 764 female patients. No relevant risk of bias was detected. Female patients were less often correctly identified as stroke suspects than male patients (RR, 0.92 [95% CI, 0.89-0.96]; I2=73%). No differences were observed in the number receiving a dispatch code stroke (RR, 0.95 [95% CI, 0.88-1.02]; I2=96%), prenotification to hospital by emergency medical service (RR, 0.98 [95% CI, 0.96-1.00]; I2=92%), or conveyance to a stroke center (RR, 0.99 [95% CI, 0.79-1.24]; I2=82%). There was no difference in mean time from emergency call to hospital door (mean difference, 1.12 [95% CI, -0.64 to 2.89] minutes; I2=96%). No conclusion could be drawn for outcomes of on-site clinical management, emergency medical service-to-hospital team interaction, and most of the time metrics due to a lack of data. CONCLUSIONS:This analysis indicates sex differences in the prehospital recognition of acute stroke. However, significant heterogeneity and a lack of data for most steps of prehospital care also highlight the urgent need for high-quality studies to systematically investigate prehospital management disparity between female and male patients with suspected acute stroke. REGISTRATION:URL: https://crd.york.ac.uk/PROSPERO/; Unique identifier: CRD42023442997.
BACKGROUND:Cerebral microbleeds (CMBs) are markers of underlying hemorrhage-prone cerebral small vessel disease detected on MRI. They are associated with a heightened risk of stroke and cognitive decline. The prevalence of CMBs among Egyptian patients with ischemic stroke is not well studied. Our aim was to detect the prevalence of CMBs and associated risk factors among Egyptian patients with ischemic stroke. METHODS:A prospective, cross-sectional, single-center study of consecutive patients with ischemic stroke. Patients were recruited between January 2021 and January 2022 at the Assiut University Hospital in the south of Egypt. Patients with known bleeding diathesis were excluded. All participants underwent full neurological assessment, urgent laboratory investigations, and MRI with T2* sequence. RESULTS:The study included 404 patients, 191 (47.3%) of them were females. The mean age of the study population was 61 ± 1 years, and the mean NIHSS on admission was 12 ± 5. The prevalence of CMB was 26.5%, of whom 6.5% were young adults (age ≤45 years). CMBs were detected in 34.6% of patients with stroke caused by large artery atherosclerosis, 28.0% with small vessel disease stroke subtype, 25.2% with stroke of undetermined cause, and in 12.1% with cardioembolic stroke. History of AF, hypertension, dyslipidemia, Fazekas score >2, dual antiplatelet use, combined antiplatelet with anticoagulant treatment, and thrombolytic therapy remained independently associated with CMBs following multivariable regression analyses. CONCLUSION:The high number of identified CMBs needs to inform subsequent therapeutic management of these patients. We are unable to determine whether the association between CMBs and antithrombotic use is a causal relationship or rather confounded by indication for these treatments in our observational study. To understand more about the underlying cause of this finding, more studies are needed.
Patent foramen ovale (PFO) is frequently identified in young patients with cryptogenic ischaemic stroke. Potential stroke mechanisms include paradoxical embolism from a venous clot which traverses the PFO, in situ clot formation within the PFO, and atrial arrhythmias due to electrical signalling disruption. The purpose of this guideline is to provide recommendations for diagnosing, treating, and long-term managing patients with ischaemic stroke and PFO. Conversely, Transient Ischaemic Attack (TIA) was not considered an index event in this context because only one RCT involved TIA patients. However, this subgroup analysis showed no significant differences between TIA and stroke outcomes. The working group identified questions and outcomes, graded evidence, and developed recommendations following the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach and the European Stroke Organisation (ESO) standard operating procedure for guideline development. This document underwent peer-review by independent experts and members of the ESO Guideline Board and Executive Committee. The working group acknowledges the current evidentiary gap in delineating an unequivocal diagnostic algorithm for the detection of PFO. Although transoesophageal echocardiography is conventionally held as the most accurate diagnostic tool for PFO identification, its status as the ‘gold standard’ remains unsubstantiated by rigorously validated evidence. We found high-quality evidence to recommend PFO closure plus antiplatelet therapy in selected patients aged 18–60 years in whom no other evident cause of stroke is found but a PFO (i.e. PFO-associated stroke). The PASCAL classification system can be used to select such candidates for PFO closure. Patients with both a large right-to-left shunt and an atrial septal aneurysm benefit most from PFO closure. There is insufficient evidence to make an evidence-based recommendation on PFO closure in patients older than 60 and younger than 18 years. We found low quality evidence to suggest against PFO closure in patients with unlikely PFO-related stroke according to the PASCAL classification, except in specific scenarios (Expert Consensus). We suggest against long-term anticoagulation in patients with PFO-associated stroke unless anticoagulation is indicated for other medical reasons. Regarding the long-term AF monitoring after PFO closure, the working group concluded that there remains significant uncertainty regarding the risks and benefits associated with the use of long-term cardiac monitoring, such as implantable loop recorders. This document provides additional guidance, in the form of evidence-based recommendations or expert consensus statements, on diagnostic methods for PFO detection, and medical management after PFO closure.
Professor Klaus Fassbender is a distinguished neurologist from Germany, widely recognized for his groundbreaking contributions to the fields of neurology and neurodegenerative disease. His work has been pivotal in advancing our understanding of the pathophysiological mechanisms underlying neurodegenerative disorders, including Alzheimer's and Parkinson's disease, as well as in refining therapeutic strategies for their treatment. His studies in cerebrovascular disease have elucidated the complex molecular and cellular processes involved in ischemic and hemorrhagic stroke, leading to the development of novel therapeutic interventions, often bridging the gap between laboratory discoveries and their application in clinical settings. Professor Klaus Fassbender is "the father" of the mobile stroke unit (MSU). With the "time is brain" concept in mind, he proposed and developed the MSU concept for the first time, allowing prehospital stroke imaging, diagnosis, and treatment directly at the site of emergency. This concept reduced times between symptoms onset and treatment, resulting in an increased proportion of patients receiving treatment within "the golden hour" and leading to the improvement of functional outcomes at 90 days. Professor Fassbender's work has been instrumental in shaping contemporary approaches to diagnosing and managing stroke and neurodegenerative disease, making him a leading figure in modern neurology.
Inclusion of adaptive design features in a clinical trial provides preplanned flexibility to dynamically modify a trial during its conduct while preserving validity and integrity. Adaptive trials are needed to accelerate the conduct of more efficient, informative, and ethical clinical research in the field of neurology. Stroke is a natural candidate for adoption of these innovative approaches to trial design. This Research Methods in Neurology article is informed by a scoping review that identified 45 completed or ongoing adaptive clinical trials in stroke that were appraised: 15 trials had published results with or without a published protocol and 30 ongoing trials (14 trials had a published protocol, and 16 trials were registered only). Interventions spanned acute (n = 28), rehabilitation (n = 8), prevention (n = 8), and rehabilitation and prevention (n = 1). A subsample of these trials was selected to illustrate the utility of adaptive design features and discuss why each adaptive feature was incorporated in the design to best achieve the aim; whether each individual feature was used and whether it resulted in expected efficiencies; and any learnings during preparation, conduct, or reporting. We then discuss the operational, ethical, and regulatory considerations that warrant careful consideration during adaptive trial planning and reflect on the workforce readiness to deliver adaptive trials in practice. We conclude that adaptive trials can be designed, funded, conducted, and published for a wide range of research questions and offer future directions to support adoption of adaptive trial designs in stroke and neurologic research more broadly.
HomeStrokeVol. 55, No. 3Prehospital Stroke Detection in Women Is More Than Identifying LVOs Free AccessEditorialPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessEditorialPDF/EPUBPrehospital Stroke Detection in Women Is More Than Identifying LVOs Else Charlotte Sandset, Maren Ranhoff Hov and Silke Walter Else Charlotte SandsetElse Charlotte Sandset Correspondence to: Else Charlotte Sandset, MD, PhD, Department of Neurology, Oslo University Hospital, Norway. Email E-mail Address: [email protected] https://orcid.org/0000-0003-4312-4778 Department of Neurology, Oslo University Hospital, Norway (E.C.S., M.R.H.). The Norwegian Air Ambulance Foundation, Oslo, Norway (E.C.S., M.R.H.). Institute of Clinical Medicine, University of Oslo, Norway (E.C.S.). , Maren Ranhoff HovMaren Ranhoff Hov https://orcid.org/0000-0002-4465-8336 Department of Neurology, Oslo University Hospital, Norway (E.C.S., M.R.H.). The Norwegian Air Ambulance Foundation, Oslo, Norway (E.C.S., M.R.H.). Department of Health Science, Oslo Metropolitan University, Norway (M.R.H.). and Silke WalterSilke Walter https://orcid.org/0000-0002-1176-2911 Department of Neurology, Saarland University, Saarbrücken, Germany (S.W.). Originally published26 Feb 2024https://doi.org/10.1161/STROKEAHA.124.046407Stroke. 2024;55:555–557This article is a commentary on the followingSex Differences in Prehospital Identification of Large Vessel Occlusion in Patients With Suspected StrokeOptimal prehospital management with rapid identification of stroke suspects is crucial for rapid access to hyperacute stroke therapies and strongly influences clinical outcomes and mortality.1See related article, p 548Prehospital emergency medical service personnel only have limited diagnostic equipment to conclude the most time-sensitive diagnosis of an acute stroke. Recent studies show that up to 52% of acute strokes are missed2 and the identification of specific subtypes such as large vessel occlusion (LVO) stroke is even more challenging. Besides the well-established National Institutes of Health Stroke Scale, recently investigated in a prehospital clinical trial,3 multiple clinical scores exist to support emergency medical service personnel in quantifying and standardizing stroke symptoms into ordinal data results.4Information available on sex inequity in prehospital stroke care is growing5; however, no clinical scale has incorporated sex differences. In a recent Australian population–based cohort study with >200 000 confirmed patients with stroke, women, especially those younger than 70 years of age, were less likely than men to receive prehospital stroke care according to standard emergency medical service protocols.6 More insight into sex inequities in the hyperacute management of patients with stroke is needed, and, so far, only limited data are available, which analyze performance differences of prehospital scores in women and men.In this volume of Stroke, Ali et al7 have shown that there is no difference between men and women in the identification of patients with LVO using 8 stroke scales (Los Angeles Motor Scale, Rapid Arterial Occlusion Evaluation, Cincinnati Stroke Triage Assessment Tool, Cincinnati Prehospital Stroke Scale, Prehospital Acute Stroke Severity, Gaze-Face-Arm-Speech-Time, Conveniently Grasped Field Assessment Stroke Triage, and Face-Arm-Speech-Time Plus Severe Arm or Leg Motor Deficit) designed for use in the prehospital setting.They present pooled individual patient data from 2 prospective cohort studies, the LPSS (Leiden Prehospital Stroke Study) and the PRESTO (Prehospital Triage of Patients With Suspected Stroke), which were conducted in 4 ambulance regions in the southwest Netherlands between 2018 and 2019 and were both designed as prospective, multicenter, observational cohort studies. They included patients with prehospital suspected acute stroke within 6 hours after symptom onset. In both studies, ambulance paramedics documented 11 (LPSS) or 9 (PRESTO) clinical items for every patient on a mobile application, which were used to reconstruct 8 acute LVO scores. Overall, 2358 patients were analyzed, of whom 47% were women. A final diagnosis of LVO was found in 231 patients (100 women and 131 men). Of the 8 scales investigated, the Rapid Arterial Occlusion Evaluation score had the highest positive predictive value in both sexes (0.29 in women and 0.37 in men). There was a statistically significant difference between both sexes in the sensitivity of the Los Angeles Motor Scale score, which was higher in women than in men (0.76 versus 0.63; P=0.02).Independent of any acute LVO score or stroke subtype, only 64% of women compared with 74% of men had a correct diagnosis of stroke in the investigated cohorts, which is an alarming result potentially contributing to delays in treatment and consequently worse outcomes.The study has several limitations. The study population was limited to those patients presenting within 6 hours after symptom onset. While the patients included are those patients identified as suspected strokes by prehospital teams, there is no information about patients, who were not identified as suspected stroke candidates at the emergency site but who later had a confirmed stroke diagnosis (false negative). Because more women present with altered mental status, headache, reduced consciousness, generally reduced condition, or dizziness,8–13 this group could influence the performance of the scores dramatically. The Dutch health care system and stroke pathways are well established and optimized, which questions the generalizability of less elaborated systems.This analysis and the fact that these 8 scales perform without any relevant sex inequity is good and important to know. Still, the results warrant further optimization of hyperacute stroke care with the help of clinical scales, especially in the prehospital setting.First, these scales usually only collect basic neurological abnormalities and, hence, are superficial—and they need to be—to facilitate their implementation and attract users in difficult prehospital settings. Furthermore, although most scales are simplistic from a stroke expert perspective, in many countries due to the lack of human resources, prehospital teams comprise not only trained paramedics or emergency medical technicians but also untrained emergency assistants, who form independent ambulance crews and who might struggle identifying for example symptoms of agnosia for the Rapid Arterial Occlusion Evaluation scale or gaze deviation for the Cincinnati Stroke Triage Assessment Tool. Most clinical studies investigated the scales with teams of well-trained paramedics/emergency medical technicians or even emergency physicians.3,14–17Second, without increasing the knowledge about stroke of prehospital teams, all those patients with symptoms not captured by simplistic scales will always be disadvantaged and may miss out on adequate treatments. Ultimately, diagnostic identification of patients with stroke relies on the knowledge and competence of the prehospital teams involved.A Californian state-wide database analysis of >300 000 patients identified that the probability for women to get correctly identified as suspected patients with stroke in the prehospital setting was 26% lower than for men, and this was likely caused by the differences in clinical presentations.18 A systematic review and meta-analysis of 21 observational studies with nearly 7000 patients with stroke focused on the type of symptom as the most important factor for correct prehospital diagnosis. More than a quarter of all patients with stroke missed by the prehospital teams presented with symptoms not captured by simplistic prehospital stroke scales aimed at diagnosing LVO.2 Despite scales aiding our clinical judgment, competence and experience remain important factors in clinical decision-making. This is exemplified in a cohort study of 183 patients with suspected stroke, where accuracy for acute LVO detection by the clinical judgment of the emergency physician was higher than by Rapid Arterial Occlusion Evaluation and FAST-ED (Field Assessment Stroke Triage for Emergency Destination).19 The superiority of clinical judgment was also applied to the subgroup analysis of women versus men. These results, even if limited by the lack of real-life prehospital scenarios, clearly suggest the need and benefit of clinical expertise when working with patients with suspected acute stroke. Limiting prehospital stroke assessment to the simplistic scales for LVOs may result in fewer patients identified at the expense of women and may narrow down the possibilities that exist in the development of prehospital stroke competence. Currently, the most accurate prehospital stroke diagnosis can only be reached by using the concept of a mobile stroke unit, an ambulance equipped with a computed tomography scanner, a laboratory unit, telemedicine, and stroke expertise, either on board or connected remotely, but even if spreading, these ambulances will not reach all patients with suspected stroke.20–23There is a need for improving and standardizing training and competence of prehospital personnel in stroke recognition, including sex differences in symptom presentation. We need to harmonize pre- and in-hospital stroke educational programs and communication. Increased stroke knowledge of prehospital personnel is needed if we want to deploy the full potential of the already available hyperacute treatments and save our patients from disability.Disclosures Dr Sandset has received honoraria from Boston Scientific and Daiichi Sankyo unrelated to the present work. Dr Sandset is the past Secretary General of the European Stroke Organisation and a member of the Women Initiative for Stroke in Europe. Dr Walter is a member at large of the Executive Committee of the European Stroke Organisation and a board member of the Pre-Hospital Stroke Treatment Organisation. Dr Walter is a member of the Women Initiative for Stroke in Europe and is involved in prehospital stroke studies. Dr Hov is the principal investigator of the Paramedic Norwegian Acute Stroke Prehospital Project. Dr Sandset is the co-principal investigator of the Paramedic Norwegian Acute Stroke Prehospital Project.FootnotesFor Disclosures, see page 556.The opinions expressed in this article are not necessarily those of the editors or of the American Heart Association.Correspondence to: Else Charlotte Sandset, MD, PhD, Department of Neurology, Oslo University Hospital, Norway. Email else@sandset.netREFERENCES1. Magnusson C, Herlitz J, Sunnerhagen KS, Hansson PO, Andersson JO, Jood K. 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Effects of state-wide implementation of the Los Angeles Motor Scale for triage of stroke patients in clinical practice.Neurol Res Pract. 2021; 3:31. doi: 10.1186/s42466-021-00128-xCrossrefGoogle Scholar16. Duvekot MHC, Venema E, Rozeman AD, Moudrous W, Vermeij FH, Biekart M, Lingsma HF, Maasland L, Wijnhoud AD, Mulder L, et al. Comparison of eight prehospital stroke scales to detect intracranial large-vessel occlusion in suspected stroke (PRESTO): a prospective observational study.Lancet Neurol. 2021; 20:213–221. doi: 10.1016/S1474-4422(20)30439-7CrossrefGoogle Scholar17. Nguyen TTM, van den Wijngaard IR, Bosch J, van Belle E, van Zwet EW, Dofferhoff-Vermeulen T, Duijndam D, Koster GT, de Schryver E, Kloos LMH, et al. Comparison of prehospital scales for predicting large anterior vessel occlusion in the ambulance setting.JAMA Neurol. 2021; 78:157–164. doi: 10.1001/jamaneurol.2020.4418CrossrefMedlineGoogle Scholar18. Govindarajan P, Friedman BT, Delgadillo JQ, Ghilarducci D, Cook LJ, Grimes B, McCulloch CE, Johnston SC. Race and sex disparities in prehospital recognition of acute stroke.Acad Emerg Med. 2015; 22:264–272. doi: 10.1111/acem.12595CrossrefGoogle Scholar19. Schlemm E, Piepke M, Kessner SS, Meyer L, Cheng B, Gerloff C, Thomalla G. Clinical judgment vs triage scales for detecting large vessel occlusions in suspected acute stroke.JAMA Netw Open. 2023; 6:e2332894. doi: 10.1001/jamanetworkopen.2023.32894CrossrefGoogle Scholar20. Fassbender K, Merzou F, Lesmeister M, Walter S, Grunwald IQ, Ragoschke-Schumm A, Bertsch T, Grotta J. Impact of mobile stroke units.J Neurol Neurosurg Psychiatry. 2021; 92:815–822. doi: 10.1136/jnnp-2020-324005CrossrefGoogle Scholar21. Turc G, Hadziahmetovic M, Walter S, Churilov L, Larsen K, Grotta JC, Yamal JM, Bowry R, Katsanos AH, Zhao H, et al. Comparison of mobile stroke unit with usual care for acute ischemic stroke management: a systematic review and meta-analysis.JAMA Neurol. 2022; 79:281–290. doi: 10.1001/jamaneurol.2021.5321CrossrefGoogle Scholar22. Mackey J, Yamal JM, Parker SA, Silnes K, Rajan SS, Jacob AP, Wang M, Singh N, Jones WJ, Spokoyny I, et al; BEST-MSU Study Group. Golden hour treatment with tPA (tissue-type plasminogen activator) in the BEST-MSU study.Stroke. 2023; 54:415–425. doi: 10.1161/STROKEAHA.122.039821LinkGoogle Scholar23. Walter S, Audebert HJ, Katsanos AH, Larsen K, Sacco S, Steiner T, Turc G, Tsivgoulis G. European Stroke Organisation (ESO) guidelines on mobile stroke units for prehospital stroke management.Eur Stroke J. 2022; 7:XXVII–XXLIX. doi: 10.1177/23969873221079413CrossrefGoogle Scholar eLetters(0)eLetters should relate to an article recently published in the journal and are not a forum for providing unpublished data. Comments are reviewed for appropriate use of tone and language. Comments are not peer-reviewed. Acceptable comments are posted to the journal website only. Comments are not published in an issue and are not indexed in PubMed. Comments should be no longer than 500 words and will only be posted online. References are limited to 10. Authors of the article cited in the comment will be invited to reply, as appropriate.Comments and feedback on AHA/ASA Scientific Statements and Guidelines should be directed to the AHA/ASA Manuscript Oversight Committee via its Correspondence page.Sign In to Submit a Response to This Article Previous Back to top Next FiguresReferencesRelatedDetailsRelated articlesSex Differences in Prehospital Identification of Large Vessel Occlusion in Patients With Suspected StrokeMariam Ali, et al. Stroke. 2024;55:548-554 March 2024Vol 55, Issue 3 Advertisement Article InformationMetrics © 2024 American Heart Association, Inc.https://doi.org/10.1161/STROKEAHA.124.046407PMID: 38406857 Originally publishedFebruary 26, 2024 KeywordsEditorialscohort studieshumansstroketriagePDF download Advertisement SubjectsCerebrovascular Disease/Stroke
Inclusion of adaptive design features in a clinical trial provides preplanned flexibility to dynamically modify a trial during its conduct while preserving validity and integrity. Adaptive trials are needed to accelerate the conduct of more efficient, informative, and ethical clinical research in the field of neurology. Stroke is a natural candidate for adoption of these innovative approaches to trial design. This Research Methods in Neurology article is informed by a scoping review that identified 45 completed or ongoing adaptive clinical trials in stroke that were appraised: 15 trials had published results with or without a published protocol and 30 ongoing trials (14 trials had a published protocol, and 16 trials were registered only). Interventions spanned acute (n = 28), rehabilitation (n = 8), prevention (n = 8), and rehabilitation and prevention (n = 1). A subsample of these trials was selected to illustrate the utility of adaptive design features and discuss why each adaptive feature was incorporated in the design to best achieve the aim; whether each individual feature was used and whether it resulted in expected efficiencies; and any learnings during preparation, conduct, or reporting. We then discuss the operational, ethical, and regulatory considerations that warrant careful consideration during adaptive trial planning and reflect on the workforce readiness to deliver adaptive trials in practice. We conclude that adaptive trials can be designed, funded, conducted, and published for a wide range of research questions and offer future directions to support adoption of adaptive trial designs in stroke and neurologic research more broadly.
Cardioembolic stroke is a major cause of morbidity, with a high risk of recurrence, and anticoagulation represents the mainstay of secondary stroke prevention in most patients. The implementation of endovascular treatment in routine clinical practice complicates the decision to initiate anticoagulation, especially in patients with early hemorrhagic transformation who are considered at higher risk of hematoma expansion. Late hemorrhagic transformation in the days and weeks following stroke remains a potentially serious complication for which we still do not have any established clinical or radiological prediction tools. The optimal time to initiate therapy is challenging to define since delaying effective secondary prevention treatment exposes patients to the risk of recurrent embolism. Consequently, there is clinical equipoise to define and individualize the optimal timepoint to initiate anticoagulation combining the lowest risk of hemorrhagic transformation and ischemic recurrence in cardioembolic stroke patients. In this narrative review, we will highlight and critically outline recent observational and randomized relevant evidence in different subtypes of cardioembolic stroke with a special focus on anticoagulation initiation following endovascular treatment. We will refer mainly to the commonest cause of cardioembolism, non-valvular atrial fibrillation, and examine the possible risk and benefit of anticoagulation before, during, and shortly after the acute phase of stroke. Other indications of anticoagulation after ischemic stroke will be briefly discussed. We provide a synthesis of available data to help clinicians individualize the timing of initiation of oral anticoagulation based on the presence and extent of hemorrhagic transformation as well as stroke severity.
Introduction: Endovascular treatment for acute ischemic stroke patients with large vessel occlusion (LVO) has been established as a promising clinical intervention within a late time window of 6-24 h after symptom onset. Patients with slow progression, however, may still benefit from endovascular treatment beyond the 24-h time window (very late window). Aim: The aim of this study is to report insight into the potential clinical benefits of endovascular treatment for acute ischemic stroke beyond 24 h from symptom onset. Methods: A retrospective analysis was performed on consecutive patients undergoing endovascular treatment for acute anterior circulation LVO ischemic stroke beyond 24 h. Participants were recruited between July 2019 and November 2020. Patients were selected based on the DAWN/DEFUSE 3 criteria (Perfusion-RAPID, iSchemaView) and patients receiving treatment beyond 24 h were compared to a group of patients receiving endovascular treatment between 6 and 24 h after symptom onset. The primary outcome was the proportion of patients with functional independence at 90 days (modified Rankin Scale score of 0-2). The secondary outcomes were shift modified Rankin Scale (mRS) analysis and successful reperfusion was defined by thrombolysis in cerebral infarction (TICI) 2b-3 on the final procedure. Safety outcomes were symptomatic intracranial hemorrhage and death at the 90-day follow-up. Propensity score (PS)-matched analyses were employed to rectify the imbalanced baseline characteristics between the two groups. Results: A total of 166 patients were recruited with a median age of 63.0 (56.0-69.0) and 28.9% of all patients were females. Patients in the beyond 24-h group had a longer onset-to-groin time (median = 27.2 vs 14.3 h, p < 0.001) than those in the 6- to 24-h group. There were no statistically significant differences between the two groups in National Institutes of Health Stroke Scale (NIHSS) (median = 12.0 vs 15.0, p = 0.37), perfusion imaging characteristics (core: median = 11.0 vs 9.0 mL, p = 0.86; mismatch volume: median = 106.0 vs 96.0, p = 0.44; mismatch ratio = 6.46 vs 7.24, p = 0.91), and perfusion-to-groin time (median = 72.5 vs 76.0 min, p = 0.77). No significant differences were noted among patients between the two groups in the primary endpoint functional independence analysis (50.0% vs 46.6%, p = 0.77) and in the safety endpoint analysis: mortality (15.0% vs 11.0%, p = 0.71) or symptomatic hemorrhage (0% vs 3.42%, p > 0.999). In PS-matched analyses, there were no significant differences among patients between the two groups in functional independence (50.0% vs 54.8%, p = 0.74), mortality (16.7% vs 9.68%, p = 0.50), or symptomatic hemorrhage (0% vs 6.45%, p = 0.53). Conclusion: Endovascular treatment can be performed safely and effectively in LVO patients beyond 24 h from symptom onset when selected by target mismatch profile. The clinical outcome of these patients was comparable to those treated in the 6- to 24-h window. Larger studies are needed to confirm these findings.
BackgroundReducing pre- and in-hospital delays plays an important role in increasing the rate of intravenous thrombolysis (IVT) in patients with acute ischemic stroke. In Egypt, the IVT rate has increased steadily but is still far away from an ideal rate.AimThe study aimed to investigate the factors associated with pre- and in-hospital delays of IVT among patients with acute ischemic stroke coming from urban and rural communities.MethodsThis prospective, multicenter, observational cohort study was conducted from January 2018 to January 2019. Patients with acute ischemic stroke, who did not receive IVT, were included in the study. Patients were recruited from three large university stroke centers in Egypt, Assiut (south of Egypt), Tanta (north of Egypt), both serving urban and rural patients, and the University Hospital in Cairo (capital city), only serving an urban community. All participants underwent the National Institutes of Health Stroke Scale and full neurological assessment, urgent laboratory investigations, and computed tomography or magnetic resonance imaging to confirm the stroke diagnosis. The patients were subjected to a structured questionnaire that was designed to determine the parameters and time metrics for the pre- and in-hospital delays among patients from rural and urban regions.ResultsA total of 618 patients were included in the study, of which 364 patients (58.9%) lived in rural regions and 254 (41.1%) in urban regions. General demographic characteristics were similar between both groups. Approximately 73.3% of patients who arrived within the therapeutic time window were urban patients. The time from symptom onset till hospital arrival (onset to door time, ODT) was significantly longer among rural patients (738 ± 690 min) than urban patients (360 ± 342 min). Delayed onset to alarm time (OAT), initial misdiagnosis, and presentation to non-stroke-ready hospitals were the most common causes of pre-hospital delay and were significantly higher in rural patients. For patients arriving within the time window, the most common causes of in-hospital delays were prolonged laboratory investigations and imaging duration.ConclusionThe limited availability of stroke-ready hospitals in rural Egypt leads to delays in stroke management, with subsequent treatment inequality of rural patients with acute stroke.
HomeStrokeVol. 54, No. 2Women and Leadership in Stroke Clinical Trials: Time for a Call to Action Free AccessEditorialPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessEditorialPDF/EPUBWomen and Leadership in Stroke Clinical Trials: Time for a Call to Action Silke Walter, MD, Simona Sacco, MD and Else Charlotte Sandset, MD, PhD Silke WalterSilke Walter Correspondence to: Silke Walter, MD, Department of Neurology, Saarland University, Homburg, Germany. Email E-mail Address: [email protected] https://orcid.org/0000-0002-1176-2911 Department of Neurology, Saarland University, Homburg, Germany (S.W.). , Simona SaccoSimona Sacco https://orcid.org/0000-0003-0651-1939 Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, Italy (S.S.). and Else Charlotte SandsetElse Charlotte Sandset https://orcid.org/0000-0003-4312-4778 Department of Neurology, Oslo University Hospital, Norway (E.C.S.). The Norwegian Air Ambulance Foundation, Oslo, Norway (E.C.S.). Originally published27 Oct 2022https://doi.org/10.1161/STROKEAHA.122.041227Stroke. 2023;54:304–305This article is a commentary on the followingInvestigation on Gender Differences in Leadership of Stroke-Related Clinical TrialsOther version(s) of this articleYou are viewing the most recent version of this article. Previous versions: October 27, 2022: Ahead of Print See related article, p 295Awareness of sex inequalities in medicine and academic careers has mounted in recent years. Significantly fewer female medical doctors lead research projects, publish as first or last authors or are involved in committee, executive, or board work of medical societies or journals.1,2 Benefits of inclusivity are nowadays widely acknowledged and academic institutions, scientific societies, scientific journals, and industry are taking actions to mitigate these inequalities.3,4 But there is still a long way to go and if we look at the clinical trials area, we are stuck in groundhog day. Studies performed in several areas showed that women were highly underrepresented as principal investigators in clinical trials.5–7 We now know that stroke medicine is not exempt.8In this issue of Stroke, Rawlley et al8 have revealed that academic gender inequity is only the tip of the iceberg in stroke medicine. They present the results of their retrospective analysis with estimation of the sex gap in the field of stroke trials in North America. The authors analyzed clinical trials identified on the trial registration platform Clinicaltrials.gov, and on PubMed, for the years 2011 to 2020. Data were collected regarding sex of principle investigators and trial authors, medical backgrounds of trial leads being of medical doctor (MD) degree, or non-MDs, and trial setting in acute stroke (intervention within 24 hours after symptom onset) versus non-acute stroke medicine. Additionally, they acquired data from the Association of American Medical Colleges, and the Accreditation Council for Graduate Medical Education, for analysis of full-time neurology faculty appointments, and neurology residents and vascular neurology fellows in training. Overall 812 clinical trials registered on Clinicaltrials.gov and 110 trials published on PubMed were analysed. All results pointed towards the same direction: significantly more men than women were registered as principle investigators with the most striking difference in acute stroke trials (mean percentage: men 86.04% versus women 13.89%; P<0.01). Only in the group of non-MD degree holders, women were represented significantly more often, which likely is explained by their higher proportion in these professions. Independent from the trial setting in acute or non-acute stroke significantly more men than women were identified as first or last authors (mean percentage [SD]: first author: men 75.53% [12.53] versus women 24.46% [12.53]; P<0.001; last author: men 79.46% [13.80] versus women 20.53% [13.80]; P<0.001). No substantial change or trends for change in the number of female MD degree principle investigators, first or last authors could be observed in the last decade.The authors end with a most important analysis regarding the proportion of female MDs in vascular neurology fellowship programs. Their number is significantly lower than the proportion of women in neurology residency programs (mean percentage [SD] women in vascular neurology: 33.5% [6.83] versus women in neurology programs 42.5% [1.84]; P<0.05), which is an alarming result.The study has limitations. Search was limited to US based studies and may not be generalizable to other settings. No detailed information is available to understand differences between industry-sponsored and academic trials. Additionally, as clinical trials need several years to be completed it is possible that recent changes may pass as undetected in the present study.The numbers in the study by Rawlley et al8 deliver a clear message. We have failed in attracting and supporting young female medical doctors, not only in becoming clinical trialists and future academic leads, but first and foremost in specializing in stroke medicine. Clearly, this cannot be caused by a shortage of young potential. Women represent the majority of medical students in a multicenter analysis conducted in 4 European countries9 and also the Association of American Medical Colleges has described similar results in their annual report.10,11 However, only little attention is paid on where these prospering young, but female academics get lost on their way to developing their careers.The recent movement to embrace diversity and inclusion in the stroke community is bringing transformation in many areas, and while there is not a quick fix for the clinical trial gap, it is time to start acting now. Perpetuating the imbalance can have negative downstream impact on the stroke community and on future generations of women in stroke. We need female doctors in stroke medicine. Already now, the number of stroke specialists is dramatically lacking behind the number needed.12–14On the other hand, having women in clinical trial leadership roles can attract more women, who are in training and in their early careers to pursue stroke clinical research. There are many women in academic stroke medicine ready to lead clinical trials, and it is time to break the cultural values that have favored male predominance and give them a chance. Importantly, women should not be considered for clinical trial leadership solely if the trial is pertinent to a female patient population. Multiple stakeholders need to take responsibility in promoting inclusiveness as advocated in the cardiovascular area.15 There should be absolutely no reason to have a trial steering committee without a fair gender balance. This should be scrutinized by the sponsors and funding agencies. While giving opportunities to women who are already ready now to lead clinical trials, it is important to train the next generation of clinical trial leaders with structured programs to give them the needed competency. New generations of women should be trained not only to gain the competencies but also the confidence to serve as leaders. It is also important to provide women tools to help to navigate workplace challenges specific to women and to respond to cultural and gender assumptions. Additionally, active policies for establishing professional networks that may favor opportunities to lead clinical trials are important as well.To conclude, it is time to embrace policies that stop reinforcing gender inequalities in leading clinical trials to break the schemes that are at the basis of current figures. It will be of great interest to follow the gender gap in clinical trial leadership to understand how policies and actions are working.Article InformationDisclosures Dr Walter is the vice chair of the Women Initiative for Stroke in Europe and she is on the international advisory board of the Australian Stroke Alliance. Dr Sacco reports personal fees as speaker or advisor from Abbott, Allergan-Abbvie, AstraZeneca, Eli Lilly, Lundbeck, Novartis, NovoNordisk, Pfizer, Teva; research grants from Allergan, Novartis, Uriach. She is President elect of the European Stroke Organisation, second vice president of the European Headache Federation and a member of the Women Initiative for Stroke in Europe. Dr Sandset has received honoraria from Boston Scientific and Daiichi-Sankyo unrelated to the present work. She is the Sectretary General of the European Stroke Organisation and a member of the Women Initiative for Stroke in EuropeFootnotesThe opinions expressed in this article are not necessarily those of the editors or of the American Heart Association.For Disclosures, see page 305.Correspondence to: Silke Walter, MD, Department of Neurology, Saarland University, Homburg, Germany. Email silke.[email protected]euReferences1. Perez-Sanchez S, Madueno SE, Montaner J. Gender gap in the leadership of health institutions: the influence of hospital-level factors.Health Equity. 2021; 5:521–525. doi: 10.1089/heq.2021.0013CrossrefGoogle Scholar2. McDermott M, Gelb DJ, Wilson K, Pawloski M, Burke JF, Shelgikar AV, London ZN. Sex differences in academic rank and publication rate at top-ranked us neurology programs.JAMA Neurol. 2018; 75:956–961. doi: 10.1001/jamaneurol.2018.0275CrossrefGoogle Scholar3. Sandset EC, de Sousa DA, Christensen H, Cordonnier C, Fischer U, Katan M, Kremer C, Pavlovic A, Sprigg N, Bart van der Worp H, et al. Women in the European stroke organisation: one, two, many... - a top down and bottom up approach.Eur Stroke J. 2019; 4:247–253. doi: 10.1177/2396987319841979CrossrefGoogle Scholar4. The Lancet Gastroenterology H. Gender equality in medicine: change is coming.Lancet Gastroenterol Hepatol. 2019; 4:893. doi: 10.1016/S2468-1253(19)30351-6CrossrefGoogle Scholar5. Luong VTT, Ho C, Aedo-Lopez V, Segelov E. Gender profile of principal investigators in a large academic clinical trials group.Front Surg. 2022; 9:962120. doi: 10.3389/fsurg.2022.962120CrossrefGoogle Scholar6. Waldhorn I, Dekel A, Morozov A, Alon ES, Stave D, Tsrooya NB, Schlosser S, Markel G, Bomze D, Meirson T. Trends in women's leadership of oncology clinical trials.Front Oncol. 2022; 12:885275. doi: 10.3389/fonc.2022.885275CrossrefGoogle Scholar7. Muquith M, Pham T, Espinoza M, Hsiehchen D. Representation of investigators by gender among authors of phase 3 oncology trials worldwide.JAMA Netw Open. 2022; 5:e220031. doi: 10.1001/jamanetworkopen.2022.0031CrossrefGoogle Scholar8. Rawlley B, Marchina S, Cappucci SP, Gogia B, Wang J-Y, Stillman A, Kumar S. Investigation on gender differences in leadership of stroke-related clinical trials.Stroke. 2023; 54:295–303. doi: 10.1161/STROKEAHA.122.039173LinkGoogle Scholar9. Kuhlmann E, Ovseiko PV, Kurmeyer C, Gutierrez-Lobos K, Steinbock S, von Knorring M, Buchan AM, Brommels M. Closing the gender leadership gap: a multi-centre cross-country comparison of women in management and leadership in academic health centres in the European Union.Hum Resour Health. 2017; 15:2. doi: 10.1186/s12960-016-0175-yCrossrefGoogle Scholar10. AAMC. Fall Applicant, Matriculant, and Enrollment Data Tables.2021. Accessed September 11, 2022. https://www.aamc.org/media/57761/download?attachment.Google Scholar11. Snyder A, Xiang D, Smith A, Esswein S, Toubat O, Di Capua J, Kwan JM, Daye D. Gender disparities among medical students choosing to pursue careers in medical research: a secondary cross-sectional cohort analysis.BMC Med Educ. 2021; 21:591. doi: 10.1186/s12909-021-03004-zCrossrefGoogle Scholar12. Leira EC, Kaskie B, Froehler MT, Adams HP. The growing shortage of vascular neurologists in the era of health reform: planning is brain!Stroke. 2013; 44:822–827. doi: 10.1161/STROKEAHA.111.000466LinkGoogle Scholar13. Gulland A. RCP warns over shortage of stroke physicians.BMJ. 2016; 355:i6398. doi: 10.1136/bmj.i6398CrossrefGoogle Scholar14. Adams HP, Biller J. Future of subspecialty training in vascular neurology.Stroke. 2014; 45:3730–3733. doi: 10.1161/STROKEAHA.114.006318LinkGoogle Scholar15. Van Spall HGC, Lala A, Deering TF, Casadei B, Zannad F, Kaul P, Mehran R, Pearson GD, Shah MR, Gulati M, et al. Ending gender inequality in cardiovascular clinical trial leadership: JACC review topic of the week.J Am Coll Cardiol. 2021; 77:2960–2972. doi: 10.1016/j.jacc.2021.04.038CrossrefMedlineGoogle Scholar Previous Back to top Next FiguresReferencesRelatedDetailsRelated articlesInvestigation on Gender Differences in Leadership of Stroke-Related Clinical TrialsBharat Rawlley, et al. Stroke. 2023;54:295-303 February 2023Vol 54, Issue 2 Advertisement Article InformationMetrics © 2022 American Heart Association, Inc.https://doi.org/10.1161/STROKEAHA.122.041227PMID: 36300373 Originally publishedOctober 27, 2022 KeywordsstrokeEditorialsgenderleadershipgender equityPDF download Advertisement SubjectsHealth EquityHealth Services
IMPORTANCE:So far, uncertainty remains as to whether there is sufficient cumulative evidence that mobile stroke unit (MSU; specialized ambulance equipped with computed tomography scanner, point-of-care laboratory, and neurological expertise) use leads to better functional outcomes compared with usual care. OBJECTIVE:To determine with a systematic review and meta-analysis of the literature whether MSU use is associated with better functional outcomes in patients with acute ischemic stroke (AIS). DATA SOURCES:MEDLINE, Cochrane Library, and Embase from 1960 to 2021. STUDY SELECTION:Studies comparing MSU deployment and usual care for patients with suspected stroke were eligible for analysis, excluding case series and case-control studies. DATA EXTRACTION AND SYNTHESIS:Independent data extraction by 2 observers, following the PRISMA and MOOSE reporting guidelines. The risk of bias in each study was determined using the ROBINS-I and RoB2 tools. In the case of articles with partially overlapping study populations, unpublished disentangled results were obtained. Data were pooled in random-effects meta-analyses. MAIN OUTCOMES AND MEASURES:The primary outcome was excellent outcome as measured with the modified Rankin Scale (mRS; score of 0 to 1 at 90 days). RESULTS:Compared with usual care, MSU use was associated with excellent outcome (adjusted odds ratio [OR], 1.64; 95% CI, 1.27-2.13; P < .001; 5 studies; n = 3228), reduced disability over the full range of the mRS (adjusted common OR, 1.39; 95% CI, 1.14-1.70; P = .001; 3 studies; n = 1563), good outcome (mRS score of 0 to 2: crude OR, 1.25; 95% CI, 1.09-1.44; P = .001; 6 studies; n = 3266), shorter onset-to-intravenous thrombolysis (IVT) times (median reduction, 31 minutes [95% CI, 23-39]; P < .001; 13 studies; n = 3322), delivery of IVT (crude OR, 1.83; 95% CI, 1.58-2.12; P < .001; 7 studies; n = 4790), and IVT within 60 minutes of symptom onset (crude OR, 7.71; 95% CI, 4.17-14.25; P < .001; 8 studies; n = 3351). MSU use was not associated with an increased risk of all-cause mortality at 7 days or at 90 days or with higher proportions of symptomatic intracranial hemorrhage after IVT. CONCLUSIONS AND RELEVANCE:Compared with usual care, MSU use was associated with an approximately 65% increase in the odds of excellent outcome and a 30-minute reduction in onset-to-IVT times, without safety concerns. These results should help guideline writing committees and policy makers.
So far, uncertainty remains as to whether there is sufficient cumulative evidence that mobile stroke unit (MSU; specialized ambulance equipped with computed tomography scanner, point-of-care laboratory, and neurological expertise) use leads to better functional outcomes compared with usual care.To determine with a systematic review and meta-analysis of the literature whether MSU use is associated with better functional outcomes in patients with acute ischemic stroke (AIS).MEDLINE, Cochrane Library, and Embase from 1960 to 2021.Studies comparing MSU deployment and usual care for patients with suspected stroke were eligible for analysis, excluding case series and case-control studies.Independent data extraction by 2 observers, following the PRISMA and MOOSE reporting guidelines. The risk of bias in each study was determined using the ROBINS-I and RoB2 tools. In the case of articles with partially overlapping study populations, unpublished disentangled results were obtained. Data were pooled in random-effects meta-analyses.The primary outcome was excellent outcome as measured with the modified Rankin Scale (mRS; score of 0 to 1 at 90 days).Compared with usual care, MSU use was associated with excellent outcome (adjusted odds ratio [OR], 1.64; 95% CI, 1.27-2.13; P < .001; 5 studies; n = 3228), reduced disability over the full range of the mRS (adjusted common OR, 1.39; 95% CI, 1.14-1.70; P = .001; 3 studies; n = 1563), good outcome (mRS score of 0 to 2: crude OR, 1.25; 95% CI, 1.09-1.44; P = .001; 6 studies; n = 3266), shorter onset-to-intravenous thrombolysis (IVT) times (median reduction, 31 minutes [95% CI, 23-39]; P < .001; 13 studies; n = 3322), delivery of IVT (crude OR, 1.83; 95% CI, 1.58-2.12; P < .001; 7 studies; n = 4790), and IVT within 60 minutes of symptom onset (crude OR, 7.71; 95% CI, 4.17-14.25; P < .001; 8 studies; n = 3351). MSU use was not associated with an increased risk of all-cause mortality at 7 days or at 90 days or with higher proportions of symptomatic intracranial hemorrhage after IVT.Compared with usual care, MSU use was associated with an approximately 65% increase in the odds of excellent outcome and a 30-minute reduction in onset-to-IVT times, without safety concerns. These results should help guideline writing committees and policy makers.