Acute stroke care

急性中风护理
  • 文章类型: Journal Article
    本文总结了血管神经病学领域的培训途径和职业机会。它强调了开创性的临床试验,这些试验改变了急性中风护理,并因此增加了对现成的血管神经病学专业知识的需求。本文强调需要在亚专科培训更多不同的医生,以及血管神经科医师在改善人口和地理领域的结果方面的作用。
    The article summarizes the training pathways and vocational opportunities within the field of vascular neurology. It highlights the groundbreaking clinical trials that transformed acute stroke care and the resultant increased demand for readily available vascular neurology expertise. The article emphasizes the need to train a larger number of diverse physicians in the subspecialty and the role of vascular neurologists in improving outcomes across demographic and geographic lines.
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  • 文章类型: Journal Article
    移动卒中单元(MSU)已被证明可以改善大都市和农村地区的院前卒中护理。由于地理原因,德国曼海姆市的社会和结构特征,已建立的MSU服务的概念不适用于曼海姆倡议。本分析的目的是确定最初建立本地MSU服务时需要考虑的主要决定因素。
    分析了2015年至2021年的局部中风统计数据,并计算了中风的昼夜节律分布和局部发病率。MSU患者人数和总项目成本估计为不同的操作模式,白天覆盖模型,人员配备配置,其中包括与医院的几种资源共享模式。对扩大的集水区进行了额外的病例数模拟。
    缺血性卒中患者症状发作的中位时间为下午1点。在工作日的10小时时间窗内,所有卒中患者中有54.3%入院。假设MSU能够覆盖53%的中风患者,MSU住院的缺血性卒中患者平均预期人数为0.64,每天10小时轮班,这可能会通过扩大MSU集水区来增加。MSU估计费用总额为每年815087欧元。TelenEurological评估将总成本降低了11.7%。
    该分析提供了在新型MSU计划的设计过程中需要解决的决定因素和考虑因素的框架,以便在中风护理改进与稀缺资源的可持续利用之间取得平衡。
    UNASSIGNED: Mobile stroke units (MSU) have been demonstrated to improve prehospital stroke care in metropolitan and rural regions. Due to geographical, social and structural idiosyncrasies of the German city of Mannheim, concepts of established MSU services are not directly applicable to the Mannheim initiative. The aim of the present analysis was to identify major determinants that need to be considered when initially setting up a local MSU service.
    UNASSIGNED: Local stroke statistics from 2015 to 2021 were analyzed and circadian distribution of strokes and local incidence rates were calculated. MSU patient numbers and total program costs were estimated for varying operating modes, daytime coverage models, staffing configurations which included several resource sharing models with the hospital. Additional case-number simulations for expanded catchment areas were performed.
    UNASSIGNED: Median time of symptom onset of ischemic stroke patients was 1:00 p.m. 54.3% of all stroke patients were admitted during a 10-h time window on weekdays. Assuming that MSU is able to reach 53% of stroke patients, the average expected number of ischemic stroke patients admitted to MSU would be 0.64 in a 10-h shift each day, which could potentially be increased by expanding the MSU catchment area. Total estimated MSU costs amounted to € 815,087 per annum. Teleneurological assessment reduced overall costs by 11.7%.
    UNASSIGNED: This analysis provides a framework of determinants and considerations to be addressed during the design process of a novel MSU program in order to balance stroke care improvements with the sustainable use of scarce resources.
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  • 文章类型: Journal Article
    背景:将静脉溶栓(IVT)用于缺血性卒中的治疗转化为临床实践仍然是一个挑战,尤其是在低收入和中等收入国家,其费率存在区域不一致。这项研究旨在确定影响马来西亚IVT提供及其比率变化的因素。
    方法:采用多重方法设计,在三家具有不同IVT率的公立医院中进行了一项多重案例研究,该研究支持针对慢性病的量身定制实施框架。在89个医疗服务提供者中进行了25次深入访谈和12个焦点小组讨论,以及对医院资源的调查和病历审查,以确定未接受IVT的原因。定性数据采用反思专题法进行分析,在用定量结果进行三角测量之前。
    结果:在确定的五个因素中,三个因素对整个医院的IVT变化有显著影响:1)通过高质量的卒中冠军领导,2)团队凝聚力,这需要团队动态及其程度的一致性,3)便利的工作过程,包括工作流程简化和对IVT的熟悉。在这些医院中被一致认为是障碍的另外两个因素包括患者因素,这些因素主要包括延迟就诊。和资源约束。约50.0-67.6%的缺血性卒中患者由于延迟就诊而错过了接受IVT的机会。
    结论:除了全球努力探索可持续措施以改善患者对中风的紧急反应之外,尝试改善为中风护理提供IVT的尝试还应考虑纳入针对卫生系统观点的干预措施,例如促进质量领导,团队凝聚力和工作流程优化。
    BACKGROUND: Translation into clinical practice for use of intravenous thrombolysis (IVT) for the management of ischemic stroke remains a challenge especially across low- and middle-income countries, with regional inconsistencies in its rate. This study aimed at identifying factors that influenced the provision of IVT and the variation in its rates in Malaysia.
    METHODS: A multiple case study underpinning the Tailored Implementation for Chronic Diseases framework was carried out in three public hospitals with differing rates of IVT using a multiple method design. Twenty-five in-depth interviews and 12 focus groups discussions were conducted among 89 healthcare providers, along with a survey on hospital resources and a medical records review to identify reasons for not receiving IVT. Qualitative data were analysed using reflective thematic method, before triangulated with quantitative findings.
    RESULTS: Of five factors identified, three factors that distinctively influenced the variation of IVT across the hospitals were: 1) leadership through quality stroke champions, 2) team cohesiveness which entailed team dynamics and its degree of alignment and, 3) facilitative work process which included workflow simplification and familiarity with IVT. Two other factors that were consistently identified as barriers in these hospitals included patient factors which largely encompassed delayed presentation, and resource constraints. About 50.0 - 67.6% of ischemic stroke patients missed the opportunity to receive IVT due to delayed presentation.
    CONCLUSIONS: In addition to the global effort to explore sustainable measures to improve patients\' emergency response for stroke, attempts to improve the provision of IVT for stroke care should also consider the inclusion of interventions targeting on health systems perspectives such as promoting quality leadership, team cohesiveness and workflow optimisation.
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  • 文章类型: Journal Article
    全球,大多数中风影响居住在中低收入国家(LMICs)的人,但在医疗资源有限的地区,将循证知识转化为临床实践仍然具有挑战性。作为南亚的LMIC,在尼泊尔,中风护理仍然是一个以前没有在全国范围内解决的医疗保健问题。尼泊尔中风项目(NSP)旨在改善尼泊尔三级医疗保健部门的急性中风护理。我们在此描述应用的方法,并分析18个月后NSP的障碍和促进者。
    NSP遵循四层战略:(1)通过在三级护理中心培训医疗保健专业人员来提高质量;(2)实施院内中风监测和质量监测系统;(3)提高公众对中风的认识;(4)与政治利益相关者合作,以促进中风护理的公共资助。我们进行了定性的,对观测数据进行迭代分析,以分析输出指标并确定最佳实践。
    采取了离线和在线举措来解决质量改进和公众意识问题。9家三级医院的1000多名医疗保健专业人员参加了由尼泊尔和国际中风专家举办的26次中风相关研讨会。每月组织网络研讨会,和聊天组建立了更好的网络和跨机构的案例共享。基于社交媒体的公众意识活动覆盖了300多万人。此外,现场活动和其他大众媒体运动已经开始。对于质量监控,引入了卒中护理质量注册(RES-Q).已经开始与利益攸关方(国家和国际)合作。
    我们确定了六项措施,可以支持在资源有限的情况下将三级护理中心发展为基本的中风中心。我们相信,我们的经验将有助于在LMICs将证据转化为实践的知识体系,虽然我们的结果的影响必须通过卒中治疗的过程指标来验证.
    UNASSIGNED: Globally, the majority of strokes affect people residing in lower- and lower-middle-income countries (LMICs), but translating evidence-based knowledge into clinical practice in regions with limited healthcare resources remains challenging. As an LMIC in South Asia, stroke care has remained a healthcare problem previously unaddressed at a national scale in Nepal. The Nepal Stroke Project (NSP) aims to improve acute stroke care in the tertiary healthcare sector of Nepal. We hereby describe the methods applied and analyze the barriers and facilitators of the NSP after 18 months.
    UNASSIGNED: The NSP follows a four-tier strategy: (1) quality improvement by training healthcare professionals in tertiary care centers; (2) implementation of in-hospital stroke surveillance and quality monitoring system; (3) raising public awareness of strokes; and (4) collaborating with political stakeholders to facilitate public funding for stroke care. We performed a qualitative, iterative analysis of observational data to analyze the output indicators and identify best practices.
    UNASSIGNED: Both offline and online initiatives were undertaken to address quality improvement and public awareness. More than 1,000 healthcare professionals across nine tertiary care hospitals attended 26 stroke-related workshops conducted by Nepalese and international stroke experts. Monthly webinars were organized, and chat groups were made for better networking and cross-institutional case sharing. Social media-based public awareness campaigns reached more than 3 million individuals. Moreover, live events and other mass media campaigns were instituted. For quality monitoring, the Registry of Stroke Care Quality (RES-Q) was introduced. Collaboration with stakeholders (both national and international) has been initiated.
    UNASSIGNED: We identified six actions that may support the development of tertiary care centers into essential stroke centers in a resource-limited setting. We believe that our experiences will contribute to the body of knowledge on translating evidence into practice in LMICs, although the impact of our results must be verified with process indicators of stroke care.
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  • 文章类型: Journal Article
    背景:尽管在急性中风护理方面取得了进展,急性卒中患者晚期就诊导致高死亡率和不良功能结局.这项研究确定了乌干达成年急性中风患者院前延误的患病率和相关因素。
    方法:在医院中,横断面研究,纳入到Mulago和Kiruddu国家转诊医院急诊科就诊的143例确诊急性卒中的研究参与者.使用面试官管理的问卷,关于社会人口统计学的细节,中风的发作,到达三级设施,收集卫生系统和临床因素。进行描述性统计和改良的Poisson回归分析以确定与院前延迟相关的因素。
    结果:在143名研究参与者中,近三分之二(79/146)患有缺血性卒中,三分之一(59/143)患有出血性卒中.平均年龄为59岁(SD16),51.7%的急性中风患者为男性。百分之九十一(130/143)在3小时后向紧急部队提出。大多数(124/143)报告说,在转诊到第三级设施之前访问了较低级别的设施。留在坎帕拉区外(PR:1.28(1.22-1.34),p<0.001),并使用租用或政府救护车运送到三级设施(PR:1.17(1.13-1.20),p<0.001)与院前延迟相关。
    结论:在乌干达公立三甲医院就诊的急性脑卒中患者中,院前延迟的发生率非常高。院前延误的原因应进一步定性探讨。减少院前延误的努力应包括改善中风患者的院前运输系统。
    BACKGROUND: Despite advancements in acute stroke care, acute stroke patients present late for care resulting in high mortality and poor functional outcomes. This study determined the prevalence of pre-hospital delay and associated factors among adult acute stroke patients in Uganda.
    METHODS: In a hospital based, cross-sectional study, one hundred and forty-three study participants with confirmed acute stroke presenting to the emergency units of Mulago and Kiruddu national referral hospitals were enrolled. Using an interviewer-administered questionnaire, details on sociodemographics, onset of stroke, arrival at the tertiary facility, health system and clinical factors were collected. Descriptive statistics and modified Poisson regression analyses were performed to determine factors associated with prehospital delay.
    RESULTS: Among the 143 study participants, nearly two-thirds (79/146) had ischemic stroke while a third (59/143) had haemorrhagic stroke. The mean age was 59 years (SD 16) and 51.7% of acute stroke patients were males. Ninety one percent (130/143) presented to the emergency unit after 3 hours. The majority (124/143) reported visiting lower-level facilities prior to referral to the tertiary facility. Staying outside Kampala district (PR: 1.28 (1.22-1.34), p < 0.001), and using hired or government ambulance for transport to tertiary facility (PR: 1.17 (1.13-1.20), p < 0.001) were associated with pre-hospital delay.
    CONCLUSIONS: Prevalence of pre-hospital delay among acute stroke patients presenting to public tertiary hospitals in Uganda is very high. The causes of pre hospital delay should be further explored qualitatively. Efforts to reduce prehospital delay should include improving pre-hospital transport systems for stroke patients.
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  • 文章类型: Journal Article
    先前的研究表明中风护理存在性别差异。女性患者的溶栓治疗率较低,OR低至0.57,结果较差。随着护理标准的更新和通过电话通话获得护理的改善,有可能减少或缓解这些差距。
    电话专家看到的急性中风咨询,从2021年1月1日至2021年4月30日,在203个设施(23个州)的急诊科的LLC医生是从TeleSpecialists™数据库中提取的。对这些遭遇进行了人口统计审查,中风时间指标,溶栓候选药物,病前改良的兰金评分,NIHSS得分,卒中危险因素,抗血栓使用,接受疑似中风的诊断,原因是没有溶栓治疗。治疗率,门到针(DTN)次数,冲程度量时间,并比较了女性和男性的治疗变量。
    包括18,783例患者(10,073例女性和8,710例男性)。在总数中,6.9%的女性接受了溶栓剂,而男性为7.9%(OR0.86,95%CI0.75-0.97,p=0.006)。男性的DTN中位数时间短于女性(38与41分钟,p<0.001)。男性患者更有可能被确诊为疑似中风,p<0.001。按年龄分析显示,只有十年有显著差异的溶栓治疗率为50-59,男性治疗增加,p=0.047。当使用卒中危险因素进行多变量logistic回归分析时,NIHSS得分,年龄,并接受疑似中风的诊断,女性的调整后比值比为0.9(95%CI0.8,1.01),p=0.064。
    虽然性别之间的治疗差异存在于数据中,并且在单变量分析中很明显,在多变量分析中没有看到显著差异,一旦中风危险因素,年龄,在电话设置中考虑了NIHSS评分和入院诊断。因此,两性之间溶栓率的差异可能反映了风险因素和症状学的差异,而不是医疗保健差异。
    UNASSIGNED: Previous studies have shown sex differences in stroke care. Female patients have both lower thrombolytic treatment rates with OR reported as low as 0.57 and worse outcomes. With updated standards of care and improved access to care through telestroke, there is potential to reduce or alleviate these disparities.
    UNASSIGNED: Acute stroke consultations seen by TeleSpecialists, LLC physicians in the emergency department in 203 facilities (23 states) from January 1, 2021 to April 30, 2021 were extracted from the Telecare by TeleSpecialists™ database. The encounters were reviewed for demographics, stroke time metrics, thrombolytics candidate, premorbid modified Rankin Score, NIHSS score, stroke risk factors, antithrombotic use, admitting diagnosis of suspected stroke, and reason not treated with thrombolytic. The treatment rates, door to needle (DTN) times, stroke metric times, and variables of treatment were compared for females and males.
    UNASSIGNED: There were 18,783 (10,073 female and 8,710 male) total patients included. Of the total, 6.9% of females received thrombolytics compared to 7.9% of males (OR 0.86, 95% CI 0.75-0.97, p = 0.006). Median DTN times were shorter for males than females (38 vs. 41 min, p < 0.001). Male patients were more likely to have an admitting diagnosis of suspected stroke, p < 0.001. Analysis by age showed the only decade with significant difference in thrombolytics treatment rate was 50-59 with increased treatment of males, p = 0.047. When multivariant logistic regression analysis was performed with stroke risk factors, NIHSS score, age, and admitting diagnosis of suspected stroke, the adjusted odds ratio for females was 0.9 (95% CI 0.8, 1.01), p = 0.064.
    UNASSIGNED: While treatment differences between sexes existed in the data and were apparent in univariate analysis, no significant difference was seen in multivariate analysis once stroke risk factors, age, NIHSS score and admitting diagnosis were taken into consideration in the telestroke setting. Differences in rates of thrombolysis between sexes may therefore be reflective of differences in risk factors and symptomatology rather than a healthcare disparity.
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  • 文章类型: Journal Article
    小儿中风是儿科死亡的十大原因之一。快速识别和治疗可以改善特定患者的预后,最近儿科血栓切除术的回顾性研究证明了这一点。我们建立了一个合作协议,涉及血管神经病学和儿科神经病学部门在我们的机构,以快速诊断和治疗小儿疑似中风。我们还前瞻性地收集数据,试图确定儿科患者急性卒中的预测因素。
    获得IRB批准,可根据住院医师笔记模板中的时间指标,前瞻性收集儿科规范卒中激活的临床数据。在可能的情况下,该协议强调磁共振成像而不是计算机断层扫描成像。我们用描述性统计分析了系统的性能。然后,我们进行了贝叶斯统计分析以搜索小儿中风的预测因子。
    在2.5年的研究期间,有40例儿科卒中,中位年龄为10.8岁。12例(30%)患者有中风,28例(70%)编码卒中患者被诊断为模拟卒中.从编码中风激活到完成成像确认或排除中风的中位时间为1小时。在贝叶斯分析中,精神状态改变,偏瘫,血管病变病史与卒中几率增加相关,尽管由于样本量小,可信的间隔很宽。
    一名学员制定并启动了儿科急性卒中方案,迅速实施了医院范围内的管理变革,从而快速诊断和分诊儿科卒中和疑似卒中。此更改不需要额外的人员或资源,我们鼓励其他医院和急诊科实施类似的系统。此外,在我们的贝叶斯统计分析中,偏瘫和精神状态改变是小儿急性卒中激活的卒中预测因素。然而,由于样本量小,可信的间隔很宽。进一步的多中心数据收集可以更明确地分析中风的预测因素,以及在紧急情况下为临床医生创建诊断工具的帮助。
    UNASSIGNED: Pediatric stroke is among the top 10 causes of death in pediatrics. Rapid recognition and treatment can improve outcomes in select patients, as evidenced by recent retrospective studies in pediatric thrombectomy. We established a collaborative protocol involving the vascular neurology and pediatric neurology division in our institution to rapidly diagnose and treat pediatric suspected stroke. We also prospectively collected data to attempt to identify predictors of acute stroke in pediatric patients.
    UNASSIGNED: IRB approval was obtained to prospectively collect clinical data on pediatric code stroke activations based on timing metrics in resident-physician note templates. The protocol emphasized magnetic resonance imaging over computed tomography imaging when possible. We analyzed performance of the system with descriptive statistics. We then performed a Bayesian statistical analysis to search for predictors of pediatric stroke.
    UNASSIGNED: There were 40 pediatric code strokes over the 2.5-year study period with a median age of 10.8 years old. 12 (30%) of patients had stroke, and 28 (70%) of code stroke patients were diagnosed with a stroke mimic. Median time from code stroke activation to completion of imaging confirming or ruling out stroke was 1 h. In the Bayesian analysis, altered mental status, hemiparesis, and vasculopathy history were associated with increased odds of stroke, though credible intervals were wide due to the small sample size.
    UNASSIGNED: A trainee developed and initiated pediatric acute stroke protocol quickly implemented a hospital wide change in management that led to rapid diagnosis and triage of pediatric stroke and suspected stroke. No additional personnel or resources were needed for this change, and we encourage other hospitals and emergency departments to implement similar systems. Additionally, hemiparesis and altered mental status were predictors of stroke for pediatric acute stroke activation in our Bayesian statistical analysis. However credible intervals were wide due to the small sample size. Further multicenter data collection could more definitively analyze predictors of stroke, as well as the help in the creation of diagnostic tools for clinicians in the emergency setting.
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  • 文章类型: Journal Article
    罗马尼亚是欧洲中风发病率最高的国家之一,也是死亡率最高的国家之一。由于可治疗原因导致的死亡率也很高,并且与欧盟最低的公共医疗支出有关。尽管如此,在过去的5年中,罗马尼亚在急性中风护理方面取得了重大成就,最显着的是国家溶栓率从0.8%提高到5.4%。众多的教育研讨会和与中风中心的持续沟通导致了一个坚实而活跃的中风网络。由于这个中风网络和ESO-EAST项目的共同努力,卒中护理质量明显提高。然而,罗马尼亚仍然面临许多问题:主要缺乏介入神经放射学专家,因此接受血栓切除术和颈动脉血运重建手术治疗的中风患者人数很少,神经康复中心数量少,全国缺乏神经科医师。
    Romania has one of the highest incidences of stroke and one of the highest mortality rates in Europe. The mortality rate due to treatable causes is also very high and is associated with the lowest public spending on healthcare in the European Union. Nonetheless, significant achievements in acute stroke care have been made in Romania in the last 5 years, most notably the increase of the national thrombolysis rate from 0.8% to 5.4%. Numerous educational workshops and constant communication with the stroke centers led to a solid and active stroke network. Due to the joint efforts of this stroke network and the ESO-EAST project, the quality of stroke care has significantly improved. However, Romania still faces many problems: a major lack of specialists in interventional neuroradiology and consequently a low number of stroke patients treated by thrombectomy and carotid revascularization procedures, a low number of neuro-rehabilitation centers and a country-wide lack of neurologists.
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  • 文章类型: Systematic Review
    背景全球有多种中风指南。综合这些并总结现有的中风指南对中风患者的管理建议,世界中风组织(WSO)指南委员会,在WSO的主持下,审查了可用的指导方针。他们确定了跨准则达成强烈一致的领域,和他们的全球覆盖。目的系统回顾2011年1月1日以来的卒中指南(不包括初级卒中预防和蛛网膜下腔出血)文献,评估质量(AGREEII),列出强烈推荐,并根据可用的中风护理判断适用性(最小,必要的,高级)。审查摘要搜索确定了15400个标题,检索到911条短信,由三个亚组审查的203份出版物(急性,二级预防,康复),以及从最新版本的相关指南中提取的建议。对于急性治疗,与脑出血相比,关于缺血性卒中的指南更多;建议针对院前,紧急情况,和急性医院护理。对于急性缺血性中风的再灌注治疗提出了强烈推荐。二级预防,强有力的建议包括建立病因诊断,高血压的管理,体重,糖尿病,脂质,生活方式的改变;和缺血性中风:心房颤动的管理,心脏瓣膜病,左心室和心房血栓,卵圆孔未闭,动脉粥样硬化性颅外大血管疾病,颅内动脉粥样硬化疾病,非心源性卒中的抗血栓药物。对于康复,强烈建议有组织的中风单元护理,多学科康复,任务特定培训,健身训练,以及针对卒中后损伤的特定干预措施。大多数建议来自高收入国家,大多数人没有考虑共病,资源影响和实施。患者和公众参与有限。结论该综述确定了许多领域的卒中护理存在强烈共识。然而,指南建议存在广泛的重复和冗余。未来的指导方针小组应考虑更紧密的合作以提高效率,包括更多在发展过程中有生活经验的人,考虑合并症,并就实施提出建议。
    There are multiple stroke guidelines globally. To synthesize these and summarize what existing stroke guidelines recommend about the management of people with stroke, the World Stroke Organization (WSO) Guideline committee, under the auspices of the WSO, reviewed available guidelines.
    To systematically review the literature to identify stroke guidelines (excluding primary stroke prevention and subarachnoid hemorrhage) since 1 January 2011, evaluate quality (The international Appraisal of Guidelines, Research and Evaluation (AGREE II)), tabulate strong recommendations, and judge applicability according to stroke care available (minimal, essential, advanced).
    Searches identified 15,400 titles; 911 texts were retrieved, 200 publications scrutinized by the three subgroups (acute, secondary prevention, rehabilitation), and recommendations extracted from most recent version of relevant guidelines. For acute treatment, there were more guidelines about ischemic stroke than intracerebral hemorrhage; recommendations addressed pre-hospital, emergency, and acute hospital care. Strong recommendations were made for reperfusion therapies for acute ischemic stroke. For secondary prevention, strong recommendations included establishing etiological diagnosis; management of hypertension, weight, diabetes, lipids, and lifestyle modification; and for ischemic stroke, management of atrial fibrillation, valvular heart disease, left ventricular and atrial thrombi, patent foramen ovale, atherosclerotic extracranial large vessel disease, intracranial atherosclerotic disease, and antithrombotics in non-cardioembolic stroke. For rehabilitation, there were strong recommendations for organized stroke unit care, multidisciplinary rehabilitation, task-specific training, fitness training, and specific interventions for post-stroke impairments. Most recommendations were from high-income countries, and most did not consider comorbidity, resource implications, and implementation. Patient and public involvement was limited.
    The review identified a number of areas of stroke care where there was strong consensus. However, there was extensive repetition and redundancy in guideline recommendations. Future guideline groups should consider closer collaboration to improve efficiency, include more people with lived experience in the development process, consider comorbidity, and advise on implementation.
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  • 文章类型: Journal Article
    目的:我们回顾了急性缺血性卒中(AIS)治疗阳性随机对照试验(RCT)的关键设计要素,并总结了其主要特征。
    方法:我们搜索了Medline,AIS治疗中阳性随机对照试验的Pubmed和Cochrane数据库。如果(1)试验采用随机对照设计,对端点(至少部分)进行盲化,(2)他们针对安慰剂(或在优势设计中的标准疗法之上)或批准的疗法进行了测试;(3)在试验终止和脱盲之前(如果在研究开始时需要)注册和/或发布了该方案;(4)在意向治疗分析中主要终点为阳性;(5)研究结果导致批准了研究产品和/或排名较高的建议。使用了一种局部方法,因此,研究结果被总结为叙述性综述.
    结果:17个阳性随机对照试验符合纳入标准。大多数试验包括少于1000名患者(n=15),具有高度选择性的纳入标准(n=16),使用改良的Rankin评分作为主要终点(n=15),并进行频率设计(n=16).试验往往是全国性的(n=12),由研究者发起并由公共资金执行(n=11)。
    结论:较小但有选择性的试验可用于确定特定卒中患者亚组的疗效。限制参与国家和中心的数量也可能是有利的,以避免中风管理和官僚负担的异质性。
    结论:本文描述的AIS治疗中阳性随机对照试验的关键特征可能有助于进一步设计研究具有潜在高效应大小的单一干预措施的试验。
    OBJECTIVE: We review key design elements of positive randomized controlled trials (RCTs) in acute ischemic stroke (AIS) treatment and summarize their main characteristics.
    METHODS: We searched Medline, Pubmed and Cochrane databases for positive RCTs in AIS treatment. Trials were included if (1) they had a randomized controlled design, with (at least partial) blinding for endpoints, (2) they tested against placebo (or on top of standard therapy in a superiority design) or against approved therapy; (3) the protocol was registered and/or published before trial termination and unblinding (if required at study commencement); (4) the primary endpoint was positive in the intention to treat analysis; and (5) the study findings led to approval of the investigational product and/or high ranked recommendations. A topical approach was used, therefore the findings were summarized as a narrative review.
    RESULTS: Seventeen positive RCTs met the inclusion criteria. The majority of trials included less than 1000 patients (n = 15), had highly selective inclusion criteria (n = 16), used the modified Rankin score as a primary endpoint (n = 15) and had a frequentist design (n = 16). Trials tended to be national (n = 12), investigator-initiated and performed with public funding (n = 11).
    CONCLUSIONS: Smaller but selective trials are useful to identify efficacy in a particular subgroup of stroke patients. It may also be of advantage to limit the number of participating countries and centers to avoid heterogeneity in stroke management and bureaucratic burden.
    CONCLUSIONS: The key characteristics of positive RCTs in AIS treatment described here may assist in the design of further trials investigating a single intervention with a potentially high effect size.
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