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    Scopus© Citations 22  3
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    Predictive Accuracy of Clinicians Estimates of Death and Recovery after Acute Intracerebral Hemorrhage: Pre-Specified Analysis in INTERACT3 Study
    (2024)
    Menglu Ouyang
    ;
    Lu Ma
    ;
    Xiaoying Chen
    ;
    Xia Wang
    ;
    Laurent Billot
    <jats:p>Introduction: Accurately predicting a patient’s prognosis is an important component of decision-making in intracerebral hemorrhage (ICH). We aimed to determine clinicians’ ability to predict survival, functional recovery, and return to premorbid activities in patients with ICH. Methods: Pre-specified secondary analysis of the third intensive care bundle with blood pressure reduction in acute cerebral hemorrhage trial (INTERACT3), an international, multicenter, stepped-wedge cluster randomized controlled trial. Clinician perspectives on prognosis were collected at hospital admission and Day 7 (or before discharge). Prognosis questions were the likelihood of (i) survival at 48 h and 6 months, (ii) favorable functional outcome (recovery walking and self-care), and (iii) return to usual activities at 6 months. Clinician predictions were compared with actual outcomes. Results: Most clinician participants were from neurosurgery (75%) with a median of 8 working years (IQR 5–14) of experience. Of the 6,305 randomized patients who survived 48 h, 213 (3.4%) were predicted to die (positive predictive value [PPV] 0.99, 95% confidence interval [CI] 0.99–0.99). Of 5,435 patients who survived 6 months, 209 (3.8%) were predicted to die (PPV 0.93, 95% CI: 0.92–0.93). Predictions on the favorable functional outcome (PPV 0.54, 95% CI: 0.52–0.56) and satisfied ability to return to usual activities (PPV 0.50, 95% CI: 0.49–0.52) were poor. Prediction accuracy varied by working years and region of practice. Conclusions: In patients with ICH, clinician estimates of death are very good but conversely they are poor in predicting higher levels of functional recovery and activities. </jats:p>
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    Disparities in Stroke Incidence Over Time by Sex and Age in Latin America and the Caribbean Region 1997 to 2021: A Systematic Review and Meta‐Analysis
    <jats:sec sec-type="background" xml:lang="en"> <jats:title>Background</jats:title> <jats:p xml:lang="en">High‐income country studies show unfavorable trends in stroke incidence (SI) in younger populations. We aimed to estimate temporal change in SI disaggregated by age and sex in Latin America and the Caribbean region.</jats:p> </jats:sec> <jats:sec xml:lang="en"> <jats:title>Methods and Results</jats:title> <jats:p xml:lang="en"> A search strategy was used in MEDLINE, WOS, and LILACS databases from 1997 to 2021, including prospective population‐based observational studies with first‐ever stroke incidence in Latin America. Reports without data broken down by age and sex were excluded. Risk of bias was assessed with The Joanna Briggs Institute's guide. The main outcomes were incidence rate ratio and relative temporal trend ratio of SI, comparing time periods before 2010 with after 2010. Pooled relative temporal trend ratios considering only studies with 2 periods in the same population were calculated by random‐effects meta‐analysis. Meta‐regression analysis was used to evaluate incidence rate determinants. From 9242 records identified, 6 studies were selected including 4483 first‐ever stroke in 4 101 084 individuals. Crude incidence rate ratio in younger subjects (&lt;55 years) comparing before 2010:after 2010 periods showed an increase in SI in the past decade (incidence rate ratio, 1.37 [95% CI, 1.23–1.50]), in contrast to a decrease in older people during the same period (incidence rate ratio, 0.83 [95% CI, 0.76–0.89]). Overall relative temporal trend ratio (&lt;55:≥55 years) was 1.65 (95 CI%, 1.50–1.80), with higher increase in young women (pooled relative temporal trend ratio, 3.08 [95% CI, 1.18–4.97]; <jats:italic>P</jats:italic> for heterogeneity &lt;0.001). </jats:p> </jats:sec> <jats:sec xml:lang="en"> <jats:title>Conclusions</jats:title> <jats:p xml:lang="en">An unfavorable change in SI in young people, especially in women, was detected in population‐based studies in the past decade in Latin America and the Caribbean. Further investigation of the explanatory variables is required to ameliorate stroke prevention and inform local decision‐makers.</jats:p> </jats:sec> <jats:sec xml:lang="en"> <jats:title>Registration</jats:title> <jats:p xml:lang="en"> URL: <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="https://www.crd.york.ac.uk/prospero/">https://www.crd.york.ac.uk/prospero/</jats:ext-link> Identifier: CRD42022332563. </jats:p> </jats:sec>
      7Scopus© Citations 5
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    Scopus© Citations 12  1
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    INTEnsive care bundle with blood pressure reduction in acute cerebral hemorrhage trial (INTERACT3): study protocol for a pragmatic stepped-wedge cluster-randomized controlled trial
    (2021)
    Lili Song
    ;
    Xin Hu
    ;
    Lu Ma
    ;
    Xiaoying Chen
    ;
    Menglu Ouyang
    <jats:title>Abstract</jats:title><jats:sec> <jats:title>Background</jats:title> <jats:p>Early intensive blood pressure (BP) lowering remains the most promising treatment for acute intracerebral hemorrhage (ICH), despite discordant results between clinical trials and potential variation in the treatment effects by approach to control BP. As the third in a series of clinical trials on this topic, the INTEnsive care bundle with blood pressure Reduction in Acute Cerebral hemorrhage Trial (INTERACT3) aims to determine the effectiveness of a goal-directed care bundle protocol of early physiological control (intensive BP lowering, glycemic control, and pyrexia treatment) and reversal of anticoagulation, in acute ICH.</jats:p> </jats:sec><jats:sec> <jats:title>Methods</jats:title> <jats:p>INTERACT3 is a pragmatic, international, multicenter, stepped-wedge (4 phases/3 steps), cluster-randomized controlled trial to determine the effectiveness of a multifaceted care package in adult (age ≥ 18 years) patients (target 8360) with acute ICH (&lt; 6 h of onset) recruited from 110 hospitals (average of 19 consecutive patients per phase) in low- and middle-income countries. After a control phase, each hospital implements the intervention (intensive BP lowering, target systolic &lt; 140 mmHg; glucose control, target 6.1–7.8 mmol/L and 7.8–10.0 mmol/L in those without and with diabetes mellitus, respectively; anti-pyrexia treatment to target body temperature ≤ 37.5 °C; and reversal of anticoagulation, target international normalized ratio &lt; 1.5 within 1 h). Information will be obtained on demographic and baseline clinical characteristics, in-hospital management, and 7-day outcomes. Central trained blinded assessors will conduct telephone interviews to assess physical function and health-related quality of life at 6 months. The primary outcome is the modified Rankin scale (mRS) at 6 months analyzed using ordinal logistic regression. The sample size of 8360 subjects provides 90% power (<jats:italic>α</jats:italic> = 0.05) to detect a 5.6% absolute improvement (shift) in the primary outcome of the intervention versus control standard care, with various assumptions.</jats:p> </jats:sec><jats:sec> <jats:title>Discussion</jats:title> <jats:p>As the largest clinical trial in acute ICH, INTERACT3 is on schedule to provide an assessment of the effectiveness of a widely applicable goal-directed care bundle for a serious condition in which a clearly proven treatment has yet to be established.</jats:p> </jats:sec><jats:sec> <jats:title>Trial registration</jats:title> <jats:p><jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="http://clinicaltrials.gov">ClinicalTrials.gov</jats:ext-link> NCT03209258. Registered on 1 July 2017. Chinese Trial Registry ChiCTR-IOC-17011787. Registered on 28 June 2017</jats:p> </jats:sec>
    Scopus© Citations 15  1
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    Stroke in Latin America: Systematic review of incidence, prevalence, and case-fatality in 1997–2021
    (2023)
    Carlos Delfino Carvalho Pinheiro
    ;
    Marilaura Nuñez
    ;
    Claudia Asenjo-Lobos
    ;
    ;
    Amy Riviotta
    <jats:sec><jats:title>Background:</jats:title><jats:p> Stroke is a major global cause of death and disability. Most strokes occur in populations of low-middle-income country (LMIC); therefore, the subsequent disease burden is greater than in populations of high-income countries. Few epidemiological data exist for stroke in Latin America, composed primarily of LMIC. </jats:p></jats:sec><jats:sec><jats:title>Aims:</jats:title><jats:p> To determine epidemiological measures of incidence, prevalence, and 1-month case-fatality for stroke in Latin America/Caribbean (LAC) during 1997–2021. </jats:p></jats:sec><jats:sec><jats:title>Summary of review:</jats:title><jats:p> A structured search was conducted to identify relevant references from MEDLINE, WOS, and LILACS databases for prospective observational and cross-sectional studies in LAC populations from January 1997 to December 2021. A total of 9242 records were screened and 12 selected for analysis, seven incidence studies and five prevalence studies. Case-fatality was reported in six articles. Sub-group analysis by age, sex, and income countries was performed. A narrative synthesis of the findings was performed. Meta-analysis was performed using random-effect model to obtain pooled estimates with 95% confidence intervals (CIs). Studies quality was assessed according to the risk of bias criteria described in the Joanna Briggs Institute’s guide. The overall crude annual incidence rate of first-ever stroke in LAC was 119.0 (95% CI = 95.9–142.1)/100,000 people (with high heterogeneity between studies ( I<jats:sup>2</jats:sup> = 98.1%)). The overall crude prevalence was 3060 (95% CI: 95.9–142.1)/100,000 people (with high heterogeneity between studies ( I<jats:sup>2</jats:sup> = 98.8%)). The overall case-fatality at 1 month after the first stroke was 21.1% (95% CI = 18.6–23.7) ( I<jats:sup>2</jats:sup> = 49.40%). </jats:p></jats:sec><jats:sec><jats:title>Conclusion:</jats:title><jats:p> This review contributes to our understanding regarding the burden caused by stroke in LAC. More studies with comparable designs are needed to generate reliable data and should include both standardized criteria, such as the World Health Organization clinical criteria and updated standard methods of case assurance, data collection, and reporting. </jats:p></jats:sec>
    Scopus© Citations 11  9
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    Impact of Evidence‐Based Stroke Care on Patient Outcomes: A Multilevel Analysis of an International Study
    (2019) ;
    Xian Li
    ;
    Sandy Middleton
    ;
    Caroline Watkins
    ;
    <jats:sec xml:lang="en"> <jats:title>Background</jats:title> <jats:p xml:lang="en"> The uptake of proven stroke treatments varies widely. We aimed to determine the association of evidence‐based processes of care for acute ischemic stroke ( <jats:styled-content style="fixed-case">AIS</jats:styled-content> ) and clinical outcome of patients who participated in the HEADPOST (Head Positioning in Acute Stroke Trial), a multicenter cluster crossover trial of lying flat versus sitting up, head positioning in acute stroke. </jats:p> </jats:sec> <jats:sec xml:lang="en"> <jats:title>Methods and Results</jats:title> <jats:p xml:lang="en"> Use of 8 <jats:styled-content style="fixed-case">AIS</jats:styled-content> processes of care were considered: reperfusion therapy in eligible patients; acute stroke unit care; antihypertensive, antiplatelet, statin, and anticoagulation for atrial fibrillation; dysphagia assessment; and physiotherapist review. Hierarchical, mixed, logistic regression models were performed to determine associations with good outcome (modified Rankin Scale scores 0–2) at 90 days, adjusted for patient and hospital variables. Among 9485 patients with AIS, implementation of all processes of care in eligible patients, or “defect‐free” care, was associated with improved outcome (odds ratio, 1.40; 95% CI, 1.18–1.65) and better survival (odds ratio, 2.23; 95% <jats:styled-content style="fixed-case">CI</jats:styled-content> , 1.62–3.09). Defect‐free stroke care was also significantly associated with excellent outcome (modified Rankin Scale score 0–1) (odds ratio, 1.22; 95% <jats:styled-content style="fixed-case">CI</jats:styled-content> , 1.04–1.43). No hospital characteristic was independently predictive of outcome. Only 1445 (15%) of eligible patients with AIS received all processes of care, with significant regional variations in overall and individual rates. </jats:p> </jats:sec> <jats:sec xml:lang="en"> <jats:title>Conclusions</jats:title> <jats:p xml:lang="en"> Use of evidence‐based care is associated with improved clinical outcome in <jats:styled-content style="fixed-case">AIS</jats:styled-content> . Strategies are required to address regional variation in the use of proven <jats:styled-content style="fixed-case">AIS</jats:styled-content> treatments. </jats:p> </jats:sec> <jats:sec xml:lang="en"> <jats:title>Clinical Trial Registration</jats:title> <jats:p xml:lang="en"> <jats:styled-content style="fixed-case">URL</jats:styled-content> : <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="https://www.clinicaltrials.gov">https://www.clinicaltrials.gov</jats:ext-link> . Unique Identifier: <jats:styled-content style="fixed-case">NCT</jats:styled-content> 02162017. </jats:p> </jats:sec>
      1  8Scopus© Citations 21
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      9Scopus© Citations 16
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    Ethnicity and Other Determinants of Quality of Functional Outcome in Acute Ischemic Stroke
    (2020)
    Xiaoying Chen
    ;
    Xia Wang
    ;
    Candice Delcourt
    ;
    Jingwei Li
    ;
    Hisatomi Arima
    <jats:sec> <jats:title>Background and Purpose—</jats:title> <jats:p>Patient-centered outcomes are important. We aimed to determine predictors of health-related quality of life (HRQoL) and develop utility-weighted modified Rankin Scale (mRS) scores in thrombolyzed acute ischemic stroke patients from both arms of ENCHANTED (Enhanced Control of Hypertension and Thrombolysis Stroke Study).</jats:p> </jats:sec> <jats:sec> <jats:title>Methods—</jats:title> <jats:p>ENCHANTED was an international quasi-factorial clinical trial of different doses of intravenous alteplase and intensities of blood pressure control in acute ischemic stroke patients, with outcomes on the 5-Dimensional European Quality of Life Scale and mRS assessed at 90 days post-randomization. Logistic regression models were used to identify baseline predictors of poor HRQoL (≤mean 5-Dimensional European Quality of Life Scale utility scores). Ordinary least squares regression derived utility-weighted mRS scores.</jats:p> </jats:sec> <jats:sec> <jats:title>Results—</jats:title> <jats:p>In 4016 acute ischemic stroke patients with complete 5-Dimensional European Quality of Life Scale and mRS data, independent predictors of poor HRQoL were older age (odds ratio, 1.19 [95% CI, 1.12–1.27], per 10-year increase), non-Asian ethnicity (1.91 [1.61–2.27]), greater stroke severity on the National Institutes of Health Stroke Scale (1.11 [1.09–1.12]), diabetes mellitus (1.41 [1.18–1.69]), premorbid disability (mRS score 1 versus 0; 1.62 [1.33–1.97]), large vessel atheromatous pathogenesis (1.32 [1.12–1.54]), and proxy respondent (2.35 [2.01–2.74]). Sensitivity analyses indicate the ethnicity influence on HRQoL was driven by the high proportion of Chinese (62.9% of Asian) participants with better HRQoL compared with non-Chinese or other Asian groups. Derived utility values across mRS scores 0 to 5 were 0.977, 0.885, 0.748, 0.576, 0.194, and −0.174, respectively. Correlations between mRS and 5-Dimensional European Quality of Life Scale scores were stronger in Asians.</jats:p> </jats:sec> <jats:sec> <jats:title>Conclusions—</jats:title> <jats:p>HRQoL is worse after thrombolyzed acute ischemic stroke in the elderly, non-Asians, with greater initial severity, diabetes mellitus, premorbid disability, due to large vessel atheroma, and proxy assessment. The broader significance of better HRQoL in Asians is tempered by Chinese participants dominating analyses. From utility-weighted mRS scores indicating the greatest steps in mRS scores are between 5 and 3, treatments to avoid major disability provide the greatest benefits for patients.</jats:p> </jats:sec> <jats:sec> <jats:title>Registration—</jats:title> <jats:p> URL: <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="https://www.clinicaltrials.gov">https://www.clinicaltrials.gov</jats:ext-link> . Unique identifier: NCT01422616. </jats:p> </jats:sec>
      6Scopus© Citations 8
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    Quantifying regional variations in components of acute stroke unit (ASU) care in the international HeadPoST study
    (2020)
    Menglu Ouyang
    ;
    Yao Zhang
    ;
    Xia Wang
    ;
    Lili Song
    ;
    Laurent Billot
    Scopus© Citations 4  1