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    Implementing Low-Intensity Thrombolysis Monitoring for Patients with Acute Ischemic Stroke in Latin America: Insights from the OPTIMISTmain Process Evaluation
    (S. Karger AG, 2025-12-18) ; ;
    Craig S. Anderson
    ;
    Carlos Delfino
    ;
    Marilaura Nuñez
    <jats:p>Introduction: The Optimal Post-rtPA-IV Monitoring in Ischemic Stroke Trial (OPTIMISTmain) was an international, pragmatic, stepped-wedge, cluster-randomized, non-inferiority trial designed to compare a low-intensity protocol to standard high-intensity monitoring in patients with mild-to-moderate acute ischemic stroke treated with thrombolysis. The results showed the safety, feasibility, and non-inferiority efficacy of the low-intensity monitoring protocol, supporting hospitals to consider adopting this approach in stroke care depending on local resources and circumstances. An embedded process evaluation was undertaken to explore factors influencing implementation and impact of the intervention in Latin America. Methods: A convergent mixed-methods design was used to combine quantitative data and qualitative interviews with implementers and patients (or family members) at participating hospitals in Chile and Mexico. Purposive sampling ensured that a diverse range of experiences and discourses were captured, and normalization process theory (NPT) guided the identification of factors facilitating or hindering the incorporation of low-intensity monitoring. The analysis focused on key implementation outcomes. Results: Low-intensity monitoring was widely accepted by clinicians who found it efficient, straightforward to implement, and potentially cost saving for hospital services. Patients and families expressed acceptance, emphasizing the protocol’s potential to support continuous improvements in healthcare. Implementation challenges included staff turnover across shifts and hospital units, reliance on external contractors, and resistance to changing established care routines. Factors enabling successful implementation included strong team communication, dedicated stroke units, and ongoing feedback. Overall, the intervention demonstrated high acceptability, adoption and appropriateness, fidelity (median of 17 assessments in both countries), and sustainability. Feasibility outcomes were more variable, reflecting organizational challenges at the healthcare system level, such as initial resistance of nursing teams and high workloads in emergency services. Conclusions: Implementation of a novel low-intensity monitoring protocol was well accepted by healthcare staff and offers potential benefits to patients with mild-to-moderate acute ischemic stroke admitted to hospitals in Latin America. Embedding a process evaluation into the main trial provided valuable insights into the challenges of implementing a complex intervention. A comprehensive understanding of the factors influencing organization change is critical to improving health outcomes.</jats:p>
      1
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    Intracerebral haemorrhage management practices and adherence to the INTERACT3 care bundle in Latin America: Results from an international survey
    (Elsevier BV, 2025-10)
    Julieta Rosales
    ;
    Leonardo Augusto Carbonera
    ;
    Ana Cláudia De Souza
    ;
    Eva Rocha
    ;
    Vanessa Cano-Nigenda
      2
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    STatin TReatment for COVID-19 to Optimise NeuroloGical recovERy (STRONGER): study protocol for a randomised, open label clinical trial in patients with persistent neurological symptoms after COVID-19 infection
    (BMJ, 2025-04)
    Carlos Delfino
    ;
    Cheryl Carcel
    ;
    Xiaolei Lin
    ;
    ;
    Sharon L Naismith
    <jats:sec> <jats:title>Introduction</jats:title> <jats:p>Increasing awareness of the high frequency, wide spectrum and disabling nature of symptoms that can persist following COVID-19 infection has prompted the investigation of management strategies. Our study aims to determine the effectiveness of atorvastatin on cognitive function, physical activity, mood, health-related quality of life and features of neurovascular impairment and neuroinflammation in adults with ongoing neurological symptoms after COVID-19 infection.</jats:p> </jats:sec> <jats:sec> <jats:title>Methods and analysis</jats:title> <jats:p>The STatin TReatment for COVID-19 to Optimise NeuroloGical recovERy study is an ongoing international, investigator-initiated and conducted, multicentre, prospective, randomised, open label, blinded endpoint trial with fixed time points for outcome assessments. A total of 410 participants with long covid neurological symptoms were planned to be randomly assigned to either the intervention group to receive 40 mg atorvastatin for 12 months or to a control group of no treatment, on top of usual care.</jats:p> </jats:sec> <jats:sec> <jats:title>Ethics and dissemination</jats:title> <jats:p>This study protocol was designed, implemented and reported, in accordance with the International Conference on Harmonisation guidelines for Good Clinical Practice, the National Health and Medical Research Council of Australia, the National Statement on Ethical Conduct in Human Research and with the ethical principles laid down in the World Medical Association Declaration of Helsinki. Central ethics committee approval was obtained from Sydney Local Health District Royal Prince Alfred Hospital Ethics (No: X21-0113 and 2021/ETH00777 10) in Australia. Site-specific ethics committee approvals were obtained elsewhere before any local study activities. All participants provided written informed consent.</jats:p> </jats:sec> <jats:sec> <jats:title>Trial registration number</jats:title> <jats:p>The study protocol is registered at Clinicaltrials.gov (<jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="clintrialgov" xlink:href="NCT04904536">NCT04904536</jats:ext-link>).</jats:p> </jats:sec>
      3
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    Patient centered outcomes in stroke: utility-weighted modified Rankin Scale results in a community-based study
    (Frontiers Media SA, 2025-03-21)
    Carlos Delfino
    ;
    Gabriel Cavada
    ;
    ; ;
    Background and aims</jats:title><jats:p>The transformation of modified Rankin Scale (mRS) scores based on the corresponding utilities of health-related quality of life questionnaires can facilitate the capture of Patient-Centered Outcomes (PCO) in stroke. We aimed to derive utility-weighted modified Rankin Scale (UW-mRS) values by mapping mRS functional status to EQ-5D-3L scores in a population-based cohort of stroke patients.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>The UW-mRS was obtained by analyzing the EQ5-D-3 L and mRS scores at 180 days after any stroke in the ÑANDU study, a large prospective community-based study in Chile. The mRS prediction was estimated using a linear regression adjusted by the EQ-5D-3L value. Generalized linear and binary logistic regression models were constructed to determine influencing factors of the UW-mRS, using STATA software (version 18.0).</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>We included 773 patients presenting with any stroke during 2015–2016: 48% were female, with a mean age of 71 years (SD 13.8), and 85% had an acute ischemic stroke (AIS). 82% of patients had a low socioeconomic status, 50% had less than 12 years of formal education, and only 32% lived in urban areas. UW-mRS values for mRS categories 0–6 at 180 days were 0.913, 0.694, 0.425, 0.249, −0.102, −0.347 and 0, respectively. Multivariable analysis identified age &amp;gt; 70 years (Coefficient <jats:italic>β</jats:italic> [β] -0.038 [Standard error SE 0.018], <jats:italic>p</jats:italic> = 0.032), prior mRS score 3–5 (<jats:italic>β</jats:italic> −0.556 [SE 0.197], <jats:italic>p</jats:italic> &amp;lt; 0.001), ischemic stroke (β −0.066 [SE 0.025], <jats:italic>p</jats:italic> = 0.010), and National Institutes of Health Stroke Scale (NIHSS) at admission&amp;gt;5 (<jats:italic>β</jats:italic> −0.015 [SE 0.002], <jats:italic>p</jats:italic> &amp;lt; 0.001) as significant predictors of worse UW-mRS scores (R<jats:sup>2</jats:sup> = 70%) in the overall group. Sex-disaggregated analysis showed that age &amp;gt; 70 years was a significant predictor in males (β −0.069 [SE 0.024], <jats:italic>p</jats:italic> = 0.006), while presenting an AIS had a greater impact on female’s worse UW-mRS score (β −0.087 [SE 0.033], <jats:italic>p</jats:italic> = 0.010).</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>These results present UW-mRS values derived from a population-based stroke study. Key determinants of health-related quality of life in post-stroke patients included age, prior disability, and stroke severity. Sex-disaggregated analysis revealed age being significant for males and AIS for females. Incorporating PCO as UW-mRS in stroke research can provide a more nuanced understanding of the impact of stroke on survivors, offering valuable insights for clinical decision-making and rehabilitation strategies across diverse healthcare contexts.<
    Scopus© Citations 1  6
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    Scopus© Citations 1  3
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    Post-COVID-19 condition: a sex-based analysis of clinical and laboratory trends
    <jats:sec><jats:title>Background and aim</jats:title><jats:p>Post-COVID-19 condition (PCC) encompasses long-lasting symptoms in individuals with COVID-19 and is estimated to affect between 31–67% of patients, with women being more commonly affected. No definitive biomarkers have emerged in the acute stage that can help predict the onset of PCC, therefore we aimed at describing sex-disaggregated data of PCC patients from a local cohort and explore potential acute predictors of PCC and neurologic PCC.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>A local cohort of consecutive patients admitted with COVID-19 diagnosis between June 2020 and July 2021 were registered, and clinical and laboratory data were recorded. Only those &amp;lt;65 years, discharged alive and followed up at 6 and 12 months after admission were considered in these analyses. Multivariable logistic regression analysis was performed to explore variables associated with PCC (STATA v 18.0).</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>From 130 patients in the cohort, 104 were contacted: 30% were women, median age of 42 years. At 6 months, 71 (68%) reported PCC symptoms. Women exhibited a higher prevalence of any PCC symptom (87 vs. 60%, <jats:italic>p</jats:italic> = 0.007), lower ferritin (<jats:italic>p</jats:italic> = 0.001) and procalcitonin (<jats:italic>p</jats:italic> = 0.021) and higher TNF levels (<jats:italic>p</jats:italic> = 0.042) in the acute phase compared to men. Being women was independently associated to 7.60 (95% CI 1.27–45.18, <jats:italic>p</jats:italic> = 0.026) higher risk for PCC. Moreover, women had lower return to normal activities 6 and 12 months.</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>Our findings highlight the lasting impact of COVID-19, particularly in young women, emphasising the need for tailored post-COVID care. The lower ferritin levels in women are an intriguing observation, warranting further research. The study argues for comprehensive strategies that address sex-specific challenges in recovery from COVID-19.</jats:p></jats:sec>
      9Scopus© Citations 3
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      8
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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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    A Chilean Experience of Telestroke in a COVID-19 Pandemic Year
    <jats:p>&lt;b&gt;&lt;i&gt;Background and Purpose:&lt;/i&gt;&lt;/b&gt; Telemedicine for stroke patients’ care (telestroke [TS]) has grown notably in recent decades and may offer advantages during health crisis. Hospital admissions related to stroke have decreased globally during the COVID-19 pandemic, but scarce information is available regarding the effect of COVID-19 in TS. Using a population-based TS registry, we investigated the impact of the first year of the COVID-19 pandemic throughout our TS network in Santiago, Chile. &lt;b&gt;&lt;i&gt;Methods:&lt;/i&gt;&lt;/b&gt; Stroke codes evaluated after the onset of COVID-19 restrictions in Chile (defined as March 15, 2020) were compared with those evaluated in 2019. We analyzed differences between number of stroke codes, thrombolysis rate, stroke severity, and time from the stroke onset to hospital admission. &lt;b&gt;&lt;i&gt;Results:&lt;/i&gt;&lt;/b&gt; We observed that the number of stroke codes and the number of patients undergoing reperfusion therapy did not change significantly (&lt;i&gt;p&lt;/i&gt; = 0.669 and 0.415, respectively). No differences were found with respect to the median time from the stroke onset to admission (&lt;i&gt;p&lt;/i&gt; = 0.581) or in National Institutes of Health Stroke Scale (NIHSS) scores (&lt;i&gt;p&lt;/i&gt; = 0.055). The decision-making-to-needle time was significantly shorter in the COVID-19 period (median 5 min [IQR 3–8], &lt;i&gt;p&lt;/i&gt; &amp;#x3c; 0.016), but no significant changes were found at the other times. &lt;b&gt;&lt;i&gt;Conclusions:&lt;/i&gt;&lt;/b&gt; This study demonstrates the potential of adapting TS to extreme situations such as the COVID-19 pandemic, as well as the importance of establishing networks that facilitate patient access to quality treatments. </jats:p>
    Scopus© Citations 7  1