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Author: search.filters.author.Laurent BillotSubject: search.filters.subject.stroke

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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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    Prognostic significance of early urinary catheterization after acute stroke: Secondary analyses of the international HeadPoST trial
    (2020)
    Menglu Ouyang
    ;
    Laurent Billot
    ;
    Lili Song
    ;
    Xia Wang
    ;
    Christine Roffe
    <jats:sec><jats:title>Background</jats:title><jats:p> An indwelling urinary catheter (IUC) is often inserted to manage bladder dysfunction, but its impact on prognosis is uncertain. We aimed to determine the association of IUC use on clinical outcomes after acute stroke in the international, multi-center, cluster crossover, Head Positioning in Acute Stroke Trial (HeadPoST). </jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p> Data were analyzed on HeadPoST participants (n = 11,093) randomly allocated to the lying-flat or sitting-up head position. Binomial, logistic regression, hierarchical mixed models were used to determine associations of early insertion of IUC within seven days post-randomization and outcomes of death or disability (defined as “poor outcome,” scores 3–6 on the modified Rankin scale) and any urinary tract infection at 90 days with adjustment of baseline and post-randomization management covariates. </jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p> Overall, 1167 (12%) patients had an IUC, but the frequency and duration of use varied widely across patients in different regions. IUC use was more frequent in older patients, and those with vascular comorbidity, greater initial neurological impairment (on the National Institutes of Health Stroke Scale), and intracerebral hemorrhage as the underlying stroke type. IUC use was independently associated with poor outcome (adjusted odds ratio (aOR): 1.40, 95% confidence interval (CI): 1.13–1.74), but not with urinary tract infection after adjustment for antibiotic treatment and stroke severity at hospital separation (aOR: 1.13, 95% CI: 0.59–2.18). The number exposed to IUC for poor outcome was 13. </jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p> IUC use is associated with a poor outcome after acute stroke. Further studies are required to inform appropriate use of IUC. </jats:p></jats:sec>
    Scopus© Citations 4  3
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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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    Impact of Evidence‐Based Stroke Care on Patient Outcomes: A Multilevel Analysis of an International Study
    (2019)
    MUÑOZ VENTURELLI, PAULA ANDREA  
    ;
    Xian Li
    ;
    Sandy Middleton
    ;
    Caroline Watkins
    ;
    LAVADOS GERMAIN, PABLO MANUEL  
    <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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    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
      1Scopus© Citations 6
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    Oxygen desaturation and adverse outcomes in acute stroke: Secondary analysis of the HeadPoST study
    (2021)
    Menglu Ouyang
    ;
    Christine Roffe
    ;
    Laurent Billot
    ;
    Lili Song
    ;
    Xia Wang
      1Scopus© Citations 2  1
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    Influence of Including Patients with Premorbid Disability in Acute Stroke Trials: The HeadPoST Experience
    (2021)
    Xia Wang
    ;
    Tom J. Moullaali
    ;
    Menglu Ouyang
    ;
    Laurent Billot
    ;
    Else Charlotte Sandset
    <jats:p>&lt;b&gt;&lt;i&gt;Background:&lt;/i&gt;&lt;/b&gt; Patients with premorbid functional impairment are generally excluded from acute stroke trials. We aimed to determine the impact of including such patients in the Head Positioning in acute Stroke Trial (HeadPoST) and early additional impairment on outcomes. &lt;b&gt;&lt;i&gt;Methods:&lt;/i&gt;&lt;/b&gt; Post hoc analyses of HeadPoST, an international, cluster-randomized crossover trial of lying-flat versus sitting-up head positioning in acute stroke. Associations of early additional impairment, defined as change in modified Rankin scale (mRS) scores from premorbid levels (estimated at baseline) to Day 7 (“early ΔmRS”), and poor outcome (mRS score 3–6) at Day 90 were determined with generalized linear mixed model. Heterogeneity of the trial treatment effect was tested according to premorbid mRS scores 0–1 versus 2–5. &lt;b&gt;&lt;i&gt;Results:&lt;/i&gt;&lt;/b&gt; Of 8,285 patients (38.9% female, mean age 68 ± 13 years) with complete data, there were 1,984 (23.9%) with premorbid functional impairment (mRS 2–5). A significant linear association was evident for early ∆mRS and poor outcome (per 1-point increase in ΔmRS, adjusted odds ratio 1.20, 95% confidence interval 1.14–1.27; &lt;i&gt;p&lt;/i&gt; &amp;#x3c; 0.0001). Patients with greater premorbid functional impairment were less likely to develop additional impairment, but their risk of poor 90-day outcome significantly increased with increasing (worse) premorbid mRS scores (linear trend &lt;i&gt;p&lt;/i&gt; &amp;#x3c; 0.0001). There was no heterogeneity of the trial treatment effect by level of premorbid function. &lt;b&gt;&lt;i&gt;Conclusions:&lt;/i&gt;&lt;/b&gt; Early poststroke functional impairment that exceeded premorbid levels was associated with worse 90-day outcome, and this association increased with greater premorbid functional impairment. Yet, including premorbid impaired patients in the HeadPoST did not materially affect the subsequent treatment effect. &lt;b&gt;&lt;i&gt;Clinical Trial Registration:&lt;/i&gt;&lt;/b&gt; HeadPoST is registered at http://www.ClinicalTrials.gov (NCT02162017). </jats:p>
      1Scopus© Citations 2
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    No benefit of flat head positioning in early moderate–severe acute ischaemic stroke: a HeadPoST study subgroup analysis
    (2020)
    BRUNSER, ALEJANDRO  
    ;
    Menglu Ouyang
    ;
    Hisatomi Arima
    ;
    Pablo M Lavados
    ;
    Thompson Robinson
    <jats:sec><jats:title>Background</jats:title><jats:p>Although the Head Positioning in acute Stroke Trial (HeadPoST) showed no effect of the flat head position (FP; vs sitting up head position (SUP)) on functional outcome, we hypothesised that it could still offer benefits if commenced early in those with acute ischaemic stroke (AIS) of at least moderate severity.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>Subgroup analysis of HeadPoST in participants with National Institutes of Health Stroke Scale (NIHSS) scores ≥7, ≥10 and ≥14, randomised to FP or SUP &lt;4.5 hours of AIS onset on functional outcomes defined by a shift in scores on the modified Rankin scale (mRS) and death/disability (mRS scores 3–6), and any cardiovascular serious adverse event. Logistic regression analyses were undertaken adjusted for study design and baseline risk factors.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>There was no significant differential treatment effect in patient subgroups defined by increasing baseline NIHSS scores: adjusted OR and 95% CI for ordinal shift and binary (3–6) mRS scores: for NIHSS ≥7 (n=867) 0.92 (0.67 to 1.25) and 0.74 (0.52 to 1.04); NIHSS ≥ 10 (n=606) 0.80 (0.58 to 1.10) and 0.77 (0.49 to 1.19); NIHSS ≥14 (n=378) 0.82 (0.54 to 1.24) and 1.22 (0.69 to 2.14).</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>Early FP had no significant effect in patients with moderate–severe AIS.</jats:p></jats:sec><jats:sec><jats:title>Trial registration number</jats:title><jats:p><jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="clintrialgov" xlink:href="NCT02162017">NCT02162017</jats:ext-link>.</jats:p></jats:sec>
    Scopus© Citations 3  1
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      17Scopus© Citations 29