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Fibrinolíticos , Ativador de Plasminogênio Tecidual , Humanos , Ativador de Plasminogênio Tecidual/uso terapêutico , Ativador de Plasminogênio Tecidual/administração & dosagem , Fibrinolíticos/uso terapêutico , Fibrinolíticos/administração & dosagem , AVC Isquêmico/tratamento farmacológico , Acidente Vascular Cerebral/tratamento farmacológico , Administração IntravenosaRESUMO
BACKGROUND: Despite the proven efficacy of telestroke in improving clinical outcomes by providing access to specialized expertise and allowing rapid expert hyperacute stroke management and decision-making, detailed operational evidence is scarce, especially for less developed or lower - income regions. AIM: We aimed to map the global telestroke landscape and characterize existing networks. METHODS: We employed a four-tiered approach to comprehensively identify telestroke networks, primarily involving engagement with national stroke experts, stroke societies, and international stroke authorities. A carefully designed questionnaire was then distributed to the leaders of all identified networks to assess these networks' structures, processes, and outcomes. RESULTS: We identified 254 telestroke networks distributed across 67 countries. High-income countries (HICs) concentrated 175 (69%) of the networks. No evidence of telestroke services was found in 58 (30%) countries. From the identified networks, 88 (34%) completed the survey, being 61 (71%) located in HICs. Network set-up was highly heterogenous, ranging from 17 (22%) networks with more than twenty affiliated hospitals, providing thousands of annual consultations using purpose-built highly specialized technology, to 11 (13%) networks with fewer than 120 consultations annually using generic videoconferencing equipment. Real-time video and image transfer was employed in 64 (75%) networks, while 62 (74%) conducting quality monitoring. Most networks established in the last three years were located in low- and middle-income countries (LMICs). CONCLUSIONS: This comprehensive global survey of telestroke networks found significant variation in network coverage, set-up, and technology use. Most services are in HICs, and few services are in LMICs, although an emerging trend of new networks in these regions marks a pivotal moment in global telestroke care. The wide variation in quality monitoring practices across networks, with many failing to report key performance metrics, underscores the urgent need for standardized, resource-appropriate quality assurance measures that can be adapted to diverse settings.
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Background: Although the incidence and case-fatality of subarachnoid haemorrhage (SAH) vary within countries, few countries have reported nationwide rates, especially for multi-ethnic populations. We assessed the nationwide incidence and case-fatality of SAH in New Zealand (NZ) and explored variations by sex, district, ethnicity and time. Methods: We used administrative health data from the national hospital discharge and cause-of-death collections to identify hospitalised and fatal non-hospitalised aneurysmal SAHs in NZ between 2001 and 2018. For validation, we compared these administrative data to those of two prospective Auckland Regional Community Stroke Studies. We subsequently estimated the incidence and case-fatality of SAH and calculated adjusted rate ratios (RR) with 95% confidence intervals to assess differences between sub-populations. Findings: Over 78,187,500 cumulative person-years, we identified 5371 SAHs (95% sensitivity and 85% positive predictive values) resulting in an annual age-standardised nationwide incidence of 8.2/100,000. In total, 2452 (46%) patients died within 30 days after SAH. Compared to European/others, Maori had greater incidence (RR = 2.23 (2.08-2.39)) and case-fatality (RR = 1.14 (1.06-1.22)), whereas SAH incidence was also greater in Pacific peoples (RR = 1.40 (1.24-1.59)) but lesser in Asians (RR = 0.79 (0.71-0.89)). By domicile, age-standardised SAH incidence varied between 6.3-11.5/100,000 person-years and case fatality between 40 and 57%. Between 2001 and 2018, the SAH incidence of NZ decreased by 34% and the case fatality by 12%. Interpretation: Since the incidence and case-fatality of SAH varies considerably between regions and ethnic groups, caution is advised when generalising findings from focused geographical locations for public health planning, especially in multi-ethnic populations. Funding: NZ Health Research Council.
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INTRODUCTION: The ARCOS-V study, an epidemiological study on stroke and transient ischaemic attack (TIA), faced the challenge of continuing data collection amidst the COVID-19 pandemic. This study aimed to describe the methodological changes and challenges encountered during the transition from paper-based methods to digital data collection for the ARCOS-V study and to provide insights into the potential of using digital tools to transform epidemiological research. METHODS: The study adapted to remote data collection using REDCap and Zoom, involving daily health record reviews, direct data entry by trained researchers, and remote follow-up assessments. The process was secured with encryption and role-based access controls. The transition period was analysed to evaluate the effectiveness and challenges of the new approach. RESULTS: The digital transition allowed for uninterrupted monitoring of stroke and TIA cases during lockdowns. Using REDCap and Zoom improved data reach, accuracy, and security. However, it also revealed issues such as the potential for systematic data entry errors and the need for robust security measures to protect sensitive health information. CONCLUSION: The ARCOS-V study's digital transformation exemplifies the resilience of epidemiological research in the face of a global crisis. The successful adaptation to digital data collection methods highlights the potential benefits of such tools, particularly as we enter a new age of artificial intelligence (AI).
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PURPOSE OF REVIEW: Recent stroke treatment advances have necessitated agile, broad-scale healthcare system redesign, to achieve optimal patient outcomes and access equity. Optimised hyperacute stroke care requires integrated pre-hospital, emergency department, stroke specialist, radiology, neurosurgical and endovascular neurointervention services, guided by a population-wide needs analysis. In this review, we survey system integration efforts, providing case studies, and identify common elements of successful initiatives. RECENT FINDINGS: Different regions and nations have evolved varied acute stroke systems depending on geography, population density and workforce. However, common facilitators to these solutions have included stroke unit care as a foundation, government-clinician synergy, pre-hospital pathway coordination, service centralisation, and stroke data guiding system improvement. Further technological advantages will minimize the geographical distance disadvantages and facilitate virtual expertise redistribution to remote areas. Continued treatment advances necessitate an integrated, adaptable, population-wide trans-disciplinary approach. A well-designed clinician-led and government-supported system can facilitate hyperacute care and scaffold future system enhancements.
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Acidente Vascular Cerebral , Fluxo de Trabalho , Humanos , Acidente Vascular Cerebral/terapia , Atenção à SaúdeRESUMO
AIM: Systolic blood pressure (SBP) >180mmHg following stroke thrombolysis has been associated with increased bleeding and poorer outcome. Aiming for the guideline SBP of <180mmHg often leads to SBP overshoot, as treatment is only triggered if this threshold is passed. We tested whether a lower target would result in fewer high SBP protocol violations. METHOD: This is a single-centre, sequential comparison of two blood pressure protocols. Between 2013 and 2017, the guideline-based post-thrombolysis SBP target of <180mmHg was compared with a new protocol aiming for 140-160mmHg. The primary outcome was rate of patients with SBPs >180mmHg. Secondary outcomes included rates of SBP <120 mmHg, antihypertensive infusion use, symptomatic intracerebral haemorrhage (sICH) and 3-month functional independence (modified Rankin Score [mRS] 0-2). Results were adjusted for age, baseline function and stroke severity using regression analysis. RESULTS: During the 23 months preceding and 18 months following the transition to the new protocol, 68 and 100 patients were thrombolysed respectively. Baseline characteristics were similar between groups. The odds of one or more SBPs >180mmHg trended lower in the intensive group (adjusted odds ratio [aOR] 0.61; 95% confidence interval [CI] 0.32-1.17; p=0.14). There was a higher rate of SBPs <120mmHg (aOR 3.09; 95% CI 1.49-6.40; p=0.002) in the intensive BP protocol group. sICH rate and 3-month mRS 0-2 were similar between groups. CONCLUSIONS: The more intensive post-thrombolysis BP protocol was associated with a significant increase in sub-optimally low BP events, with a non-significant trend toward fewer high BP protocol violations and unaffected patient outcomes.
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Anti-Hipertensivos , Pressão Sanguínea , Terapia Trombolítica , Humanos , Feminino , Masculino , Idoso , Terapia Trombolítica/métodos , Anti-Hipertensivos/uso terapêutico , Anti-Hipertensivos/administração & dosagem , Pressão Sanguínea/efeitos dos fármacos , Pessoa de Meia-Idade , Hipertensão/tratamento farmacológico , Acidente Vascular Cerebral/tratamento farmacológico , Idoso de 80 Anos ou mais , Resultado do Tratamento , Fibrinolíticos/uso terapêutico , Fibrinolíticos/administração & dosagem , AVC Isquêmico/tratamento farmacológico , Hemorragia Cerebral/tratamento farmacológicoRESUMO
The centennial anniversary of Hans Hinselmann's initial publication describing colposcopy is approaching. In the 100 years since the inventor's seminal paper, colposcopy has become indispensable in the diagnosis and management of cervical cancer. It remains central in diagnosing precancerous and cancerous cervical lesions and has dramatically reduced cervical cancer incidence and mortality since the mid-20th century.Previous descriptions of colposcopy's development in medical literature obscure the dark history of its earliest days, arising within the center of German Nazism. The pioneers of colposcopy benefited from the Nazi government's public health focus and exploited the environment fostered by the Nazi medical establishment. They made use of the apparatus of the Auschwitz concentration camp to position colposcopy for expanded postwar adoption, ultimately accomplishing Hinselmann's stated goal that colposcopy become a routine part of gynecologic examination and care. This historical exposition clarifies the Nazi past of colposcopy, highlights the important role that unethical treatment of victims of Auschwitz played in cementing this procedure within standard cervical cancer screening programs globally, and offers steps to reckon with this tragic legacy.
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Colposcopia , Neoplasias do Colo do Útero , História do Século XX , Colposcopia/história , Humanos , Feminino , Neoplasias do Colo do Útero/história , Neoplasias do Colo do Útero/diagnóstico , Alemanha , Detecção Precoce de Câncer/históriaRESUMO
INTRODUCTION: Dysphagia (i.e., disordered swallowing) is a consequence of stroke. Existing literature on the marginal cost of dysphagia after stroke is limited and ignores long-term impacts. Our aim was to determine the marginal 12-month cost attributable to dysphagia, including health-related quality of life (HRQoL) impacts, among patients hospitalised with stroke in New Zealand. METHODS: Secondary analysis of observational data from the REGIONS Care study, a national study from New Zealand of consecutively hospitalised patients with acute stroke between May 1, 2018, and October 30, 2018, including an outcome survey at 12 months among those who provided consent. Patients were identified as dysphagic if they received a swallow screen in hospital resulting in a speech language therapist review. Patients that required a nasogastric feeding tube in hospital were classified as "severe." Optimal linear propensity score matching was utilised to provide a group of patients to compare with stroke and dysphagia. All costs were converted to 2021NZD. RESULTS: Overall, of the 2,379 patients in the REGIONS cohort (51% male, median age: 78), 40% (944/2,379) were dysphagic (52% male, median age: 78), and 5% (111/2,379) were classified as severely dysphagic. Within 12 months of hospital discharge, dysphagia reduced HRQoL overall by 0.06 index points (95% CI: 0.028-0.100), and severe dysphagia by 0.12 index points (95% CI: 0.03-0.20). The estimated marginal 12-month cost attributable to stroke-related dysphagia was NZD 24,200 on average per patient. This estimate includes the additional hospitalisation costs (NZD 16,100), community rehabilitation services (NZD 570), hospital level aged residential care (NZD 4,030), and reduced HRQoL (NZD 3,470) over a 12-month period post-hospital discharge. The overall total marginal cost for those with severe dysphagia was NZD 34,000 per patient. CONCLUSION: We report cost estimates to 12 months from a national perspective on the additional costs and HRQoL outcomes of dysphagia for people hospitalised with stroke in New Zealand. Findings provide a novel contribution internationally since few prior studies have extended beyond the acute hospital phase of care. By quantifying the economic burden, we provide information to decision makers to improve dysphagia management strategies and ultimately enhance the overall HRQoL for people with stroke and dysphagia.
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The impacts of accumulating atmospheric greenhouse gases on the earth's climate are now well established. As a result, there have been increases in ambient temperatures and resultant higher frequency and duration of temperature extremes and other extreme weather events, which have been linked to a wide range of adverse health outcomes. This topical narrative review provides a summary of published evidence on the links between climate change and stroke. There is consistent evidence of associations between stroke incidence and mortality and increasing ambient temperature and air pollution. Associations have also been shown for changes in barometric pressure, wildfires, and desert dust and sandstorms, but current evidence is limited. Flooding and other extreme weather events appear to primarily cause service disruption, but more direct links to stroke may emerge. Synergies between dietary changes that reduce stroke risk and may also reduce carbon footprint are being explored. We also discuss the impact on vulnerable populations, proposed pathophysiologic mechanisms, mitigation strategies, and current research priorities. In conclusion, climate change increasingly impacts the stroke community, warranting elevated attention.
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Poluição do Ar , Gases de Efeito Estufa , Humanos , Mudança Climática , Poluição do Ar/efeitos adversos , Gases de Efeito Estufa/efeitos adversosRESUMO
BACKGROUND AND AIMS: Stroke is a leading cause of death in Aotearoa (New Zealand), and stroke reperfusion therapy is a key intervention. Sex differences in stroke care have previously been asserted internationally. This study assessed potential differences in stroke reperfusion rates and quality metrics by sex in Aotearoa (New Zealand). METHODS: This study used data from three overlapping sources. The National Stroke Reperfusion Register provided 4-year reperfusion data from 2018 to 2021 on all patients treated with reperfusion therapy (intravenous thrombolysis and thrombectomy), including time delays, treatment rates, mortality and complications. Linkage to Ministry of Health administrative and REGIONS Care study data provided an opportunity to control for confounders and explore potential mechanisms. T-test and Wilcoxon rank-sum analyses were used for continuous variables, while the chi-squared test and logistic regression were used for comparing dichotomous variables. RESULTS: Fewer women presented with ischaemic stroke (12 186 vs 13 120) and were 4.2 years older than men (median (interquartile range (IQR)) 79 (68-86) vs 73 (63-82) years). Women were overall less likely to receive reperfusion therapy (13.9% (1704) vs 15.8% (2084), P < 0.001) with an adjusted odds ratio of 0.83 (0.77-0.90), P < 0.001. The adjusted odds ratio for thrombolysis was lower for women (0.82 (0.76-0.89), P < 0.001), but lower rates of thrombectomy fell just short of statistical significance ((0.89 (0.79-1.00), P = 0.05). There were no significant differences in complications, delays or documented reasons for non-thrombolysis. CONCLUSIONS: Women were less likely to receive thrombolysis, even after adjusting for age and stroke severity. We found no definitive explanation for this disparity.
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Trombectomia , Terapia Trombolítica , Humanos , Nova Zelândia/epidemiologia , Feminino , Masculino , Idoso , Idoso de 80 Anos ou mais , Pessoa de Meia-Idade , Terapia Trombolítica/estatística & dados numéricos , Fatores Sexuais , Trombectomia/estatística & dados numéricos , Reperfusão/estatística & dados numéricos , Acidente Vascular Cerebral/terapia , Acidente Vascular Cerebral/epidemiologia , AVC Isquêmico/terapia , AVC Isquêmico/epidemiologia , Tempo para o Tratamento/estatística & dados numéricos , Sistema de RegistrosRESUMO
BACKGROUND: Disparities in the availability of reperfusion services for acute ischemic stroke are considerable globally and require urgent attention. Contemporary data on the availability of reperfusion services in different countries are used to provide the necessary evidence to prioritize where access to acute stroke treatment is needed. AIMS: To provide a snapshot of published literature on the provision of reperfusion services globally, including when facilitated by telemedicine or mobile stroke unit services. METHODS: We searched PubMed to identify original articles, published up to January 2023 for the most recent, representative, and relevant patient-level data for each country. Keywords included thrombolysis, endovascular thrombectomy and telemedicine. We also screened reference lists of review articles, citation history of articles, and the gray literature. The information is provided as a narrative summary. RESULTS: Of 11,222 potentially eligible articles retrieved, 148 were included for review following de-duplications and full-text review. Data were also obtained from national stroke clinical registry reports, Registry of Stroke Care Quality (RES-Q) and PRE-hospital Stroke Treatment Organization (PRESTO) repositories, and other national sources. Overall, we found evidence of the provision of intravenous thrombolysis services in 70 countries (63% high-income countries (HICs)) and endovascular thrombectomy services in 33 countries (68% HICs), corresponding to far less than half of the countries in the world. Recent data (from 2019 or later) were lacking for 35 of 67 countries with known year of data (52%). We found published data on 74 different stroke telemedicine programs (93% in HICs) and 14 active mobile stroke unit pre-hospital ambulance services (80% in HICs) around the world. CONCLUSION: Despite remarkable advancements in reperfusion therapies for stroke, it is evident from available patient-level data that their availability remains unevenly distributed globally. Contemporary published data on availability of reperfusion services remain scarce, even in HICs, thereby making it difficult to reliably ascertain current gaps in the provision of this vital acute stroke treatment around the world.
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AVC Isquêmico , Acidente Vascular Cerebral , Humanos , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/terapia , Trombectomia , Ambulâncias , ReperfusãoRESUMO
Background: Ordinalised vascular outcomes incorporating event severity are more informative than binary outcomes that just include event numbers. The TARDIS trial was the first vascular prevention study to use an ordinalised vascular outcome as its primary efficacy and safety measures and collected severity information for other vascular events. Methods: TARDIS was an international prospective randomised open-label blinded-endpoint trial assessing one month of intensive versus guideline antiplatelet therapy in patients with acute non-cardioembolic stroke or TIA. Vascular events and their severity were recorded up to final follow-up at 90 days post randomisation. For each outcome, statistical techniques compared ordinal/continuous (10 models) and dichotomous (5 models) analyses; results were then ranked with the smallest p-value being given the smallest rank. Outcomes were also assessed within the pre-defined subgroup of participants with mild stroke (NIHSS≤3), or TIA recruited within 24 h. Results: Ordinal versions of vascular event outcomes were created in 3096 participants for stroke, myocardial infarction, major cardiac events, bleeding events, serious adverse events and venous thromboembolism (VTE), with 32 outcomes being created overall (29 in the subgroup population due to the absence of VTE events). Overall, the tests run on ordinal outcomes tended to rank higher than tests performed on binary outcomes. 764 (24.7%) participants were recruited within 24 h of a mild stroke/TIA; again, tests run on ordinal outcomes ranked higher. Conclusions: In TARDIS, tests performed on ordinal vascular outcomes tended to attain a higher rank than those performed on binary outcomes. Trial registration: ISRCTN47823388.
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AIM: To describe atrial fibrillation (AF) patient characteristics and anticoagulation patterns in stroke patients in Aotearoa. METHODS: Reducing Ethnic and Geographic Inequities to Optimise New Zealand Stroke (REGIONS) Care study is a prospective, nation-wide observational study of consecutive adult stroke patients admitted to hospital between 1 May and 31 October 2018. AF and anticoagulation prescribing, intracerebral haemorrhage (ICH) and differences by Maori ethnicity and hospital location are described. RESULTS: Of 2,379 patients, 807 (34.3%) had a diagnosis of AF. AF patients were older than non-AF patients (mean 79.9 [SD 11] versus 72.5 [14.2], p<0.0001). AF was diagnosed before stroke in 666 patients (82.5%), of whom 442 (66.4%) were taking an anticoagulant. The most common documented reasons for non-anticoagulation were prior bleeding (20.5%), patient preference (18.1%), frailty, comorbidities/side effects (13.2%) and falls (6.8%). The ICH rate was similar for AF patients on versus not on an anticoagulant (adjusted odds ratio [aOR] 0.99, 95% confidence interval [CI] 0.55-1.80). Rates and reasons for oral anticoagulant non-prescribing were similar for Maori, non-Maori, urban and non-urban populations. CONCLUSIONS: Although anticoagulation prescribing in AF has improved, one third of stroke patients with known AF were not taking an anticoagulant prior to admission and the majority did not appear to have an absolute contraindication offering a multidisciplinary opportunity for improvement. There were no significant differences for Maori and non-urban populations in anticoagulant prescribing.
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Fibrilação Atrial , Acidente Vascular Cerebral , Adulto , Humanos , Fibrilação Atrial/complicações , Fibrilação Atrial/tratamento farmacológico , Fibrilação Atrial/epidemiologia , Estudos Prospectivos , Nova Zelândia/epidemiologia , Fatores de Risco , Acidente Vascular Cerebral/tratamento farmacológico , Acidente Vascular Cerebral/epidemiologia , Anticoagulantes/uso terapêutico , Administração OralRESUMO
Intensive antiplatelet therapy did not reduce recurrent stroke/transient ischaemic attack (TIA) events as compared with guideline treatment in the Triple Antiplatelets for Reducing Dependency after Ischaemic Stroke (TARDIS) trial, but did increase the frequency and severity of bleeding. In this pre-specified analysis, we investigated predictors of bleeding and the association of bleeding with outcome. TARDIS was an international prospective randomised open-label blinded-endpoint trial in participants with ischaemic stroke or TIA within 48 h of onset. Participants were randomised to 30 days of intensive antiplatelet therapy (aspirin, clopidogrel, dipyridamole) or guideline-based therapy (either clopidogrel alone or combined aspirin and dipyridamole). Bleeding was defined using the International Society on Thrombosis and Haemostasis five-level ordered categorical scale: fatal, major, moderate, minor, none. Of 3,096 participants, bleeding severity was: fatal 0.4%, major 1.5%, moderate 1.2%, minor 11.4%, none 85.5%. Major/fatal bleeding was increased with intensive as compared with guideline therapy: 39 vs. 17 participants, adjusted hazard ratio 2.21, 95% CI 1.24-3.93, p = 0.007. Bleeding events diverged between treatment groups in the 8-35 day period but not in the 0-7 or 36-90 day epochs. In multivariate analysis more, and more severe, bleeding events were seen with increasing age, female sex, pre-morbid dependency, increased time to randomisation, prior major bleed, prior antiplatelet therapy and in those randomised to triple vs guideline antiplatelet therapy. More severe bleeding was associated with worse clinical outcomes across multiple physical, emotional and quality of life domains.Trial registration ISRCTN47823388 .
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Isquemia Encefálica , Ataque Isquêmico Transitório , AVC Isquêmico , Acidente Vascular Cerebral , Feminino , Humanos , Inibidores da Agregação Plaquetária/efeitos adversos , Isquemia Encefálica/tratamento farmacológico , Ataque Isquêmico Transitório/tratamento farmacológico , Clopidogrel/uso terapêutico , Acidente Vascular Cerebral/tratamento farmacológico , Estudos Prospectivos , Qualidade de Vida , Aspirina/efeitos adversos , Hemorragia/tratamento farmacológico , Dipiridamol/uso terapêutico , Quimioterapia Combinada , AVC Isquêmico/tratamento farmacológico , Doença AgudaRESUMO
BACKGROUND: Accurate coded diagnostic data are important for epidemiological research of stroke. OBJECTIVE: To develop, implement and evaluate an online education program for improving clinical coding of stroke. METHOD: The Australia and New Zealand Stroke Coding Working Group co-developed an education program comprising eight modules: rationale for coding of stroke; understanding stroke; management of stroke; national coding standards; coding trees; good clinical documentation; coding practices; and scenarios. Clinical coders and health information managers participated in the 90-minute education program. Pre- and post-education surveys were administered to assess knowledge of stroke and coding, and to obtain feedback. Descriptive analyses were used for quantitative data, inductive thematic analysis for open-text responses, with all results triangulated. RESULTS: Of 615 participants, 404 (66%) completed both pre- and post-education assessments. Respondents had improved knowledge for 9/12 questions (p < 0.05), including knowledge of applicable coding standards, coding of intracerebral haemorrhage and the actions to take when coding stroke (all p < 0.001). Majority of respondents agreed that information was pitched at an appropriate level; education materials were well organised; presenters had adequate knowledge; and that they would recommend the session to colleagues. In qualitative evaluations, the education program was beneficial for newly trained clinical coders, or as a knowledge refresher, and respondents valued clinical information from a stroke neurologist. CONCLUSION: Our education program was associated with increased knowledge for clinical coding of stroke. To continue to address the quality of coded stroke data through improved stroke documentation, the next stage will be to adapt the educational program for clinicians.
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INTRODUCTION: The New Zealand (NZ) Central Region Stroke Network, serving 1.17 million catchment population, changed to tenecteplase for stroke thrombolysis in 2020 but was forced to revert to Alteplase in 2021 due to a sudden cessation of drug supply. We used this unique opportunity to assess for potential before and after temporal trend confounding. PATIENTS AND METHODS: In NZ all reperfused patients are entered prospectively into a national database for safety monitoring. We assessed Central Region patient outcomes and treatment metrics over three time periods: alteplase use (January 2018-January 2020); during switch to tenecteplase (February 2020-February 2021) and after reverting to alteplase (February 2021-December 2022) adjusting regression analyses for hospital, age, onset-to-needle, NIHSS, pre-morbid mRS and thrombectomy. RESULTS: Between January 2018 and December 2022, we treated 1121 patients with Alteplase and 286 with tenecteplase. Overall, patients treated with tenecteplase had greater odds of favorable outcome ordinal mRS [aOR = 1.43 (95% CI = 1.11-1.85)]; shorter door-to-needle (DTN) time [median 52 (IQR 47-83) vs 61 (45-84) minutes, p < 0.0001] and needle to groin (NTG) times [118 (74.5-218.5) vs 185 (118-255); p = 0.02)]. Symptomatic intracerebral hemorrhage (sICH) rate was lower in tenecteplase group [aOR 0.29 (0.09-0.95)]. Findings similarly favored tenecteplase when comparing tenecteplase to only the second alteplase phase. There was no inter-group difference when comparing the two alteplase phases. CONCLUSIONS: Our results suggest that previously reported benefits from tenecteplase in a real-world setting were not likely attributable to a temporal confounding.
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Isquemia Encefálica , Acidente Vascular Cerebral , Humanos , Tenecteplase/uso terapêutico , Ativador de Plasminogênio Tecidual/uso terapêutico , Fibrinolíticos/efeitos adversos , Isquemia Encefálica/induzido quimicamente , Acidente Vascular Cerebral/tratamento farmacológicoRESUMO
Importance: Symptomatic intracranial hemorrhage (sICH) is a serious complication of stroke thrombolytic therapy. Many stroke centers have adopted 0.25-mg/kg tenecteplase instead of alteplase for stroke thrombolysis based on evidence from randomized comparisons to alteplase as well as for its practical advantages. There have been no significant differences in symptomatic intracranial hemorrhage (sICH) reported from randomized clinical trials or published case series for the 0.25-mg/Kg dose. Objective: To assess the risk of sICH following ischemic stroke in patients treated with tenecteplase compared to those treated with alteplase. Design, Setting, and Participants: This was a retrospective observational study using data from the large multicenter international Comparative Effectiveness of Routine Tenecteplase vs Alteplase in Acute Ischemic Stroke (CERTAIN) collaboration comprising deidentified data on patients with ischemic stroke treated with intravenous thrombolysis. Data from more than 100 hospitals in New Zealand, Australia, and the US that used alteplase or tenecteplase for patients treated between July 1, 2018, and June 30, 2021, were included for analysis. Participating centers included a mix of nonthrombectomy- and thrombectomy-capacity comprehensive stroke centers. Standardized data were abstracted and harmonized from local or regional clinical registries. Consecutive patients with acute ischemic stroke who were considered eligible and received thrombolysis at the participating stroke registries during the study period were included. All 9238 patients who received thrombolysis were included in this retrospective analysis. Main Outcomes and Measures: sICH was defined as clinical worsening of at least 4 points on the National Institutes of Health Stroke Scale (NIHSS), attributed to parenchymal hematoma, subarachnoid, or intraventricular hemorrhage. Differences between tenecteplase and alteplase in the risk of sICH were assessed using logistic regression, adjusted for age, sex, NIHSS score, and thrombectomy. Results: Of the 9238 patients included in the analysis, the median (IQR) age was 71 (59-80) years, and 4449 patients (48%) were female. Tenecteplase was administered to 1925 patients. The tenecteplase group was older (median [IQR], 73 [61-81] years vs 70 [58-80] years; P < .001), more likely to be male (1034 of 7313 [54%] vs 3755 of 1925 [51%]; P < .01), had higher NIHSS scores (median [IQR], 9 [5-17] vs 7 [4-14]; P < .001), and more frequently underwent endovascular thrombectomy (38% vs 20%; P < .001). The proportion of patients with sICH was 1.8% for tenecteplase and 3.6% for alteplase (P < .001), with an adjusted odds ratio (aOR) of 0.42 (95% CI, 0.30-0.58; P < .01). Similar results were observed in both thrombectomy and nonthrombectomy subgroups. Conclusions and Relevance: In this large study, ischemic stroke treatment with 0.25-mg/kg tenecteplase was associated with lower odds of sICH than treatment with alteplase. The results provide evidence supporting the safety of tenecteplase for stroke thrombolysis in real-world clinical practice.