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Validation of the simplified modified Rankin scale for stroke trials: Experience from the ENCHANTED alteplase-dose arm
(2020)
Xiaoying Chen
;
Jingwei Li
;
Craig S Anderson
;
Richard I Lindley
;
Maree L Hackett
<jats:sec><jats:title>Background and aims</jats:title><jats:p> The structured, simplified modified Rankin scale questionnaire (smRSq) may increase reliability over the interrogative approach to scoring the modified Rankin scale (mRS) in acute stroke research and practice. During the conduct of the alteplase-dose arm of the international ENhanced Control of Hypertension ANd Thrombolysis StrokE stuDy (ENCHANTED), we had an opportunity to compare each of these approaches to outcome measurement. </jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p> Baseline demographic data were recorded together with the National Institutes of Health Stroke Scale (NIHSS). Follow-up measures obtained at 90 days included mRS, smRSq, and the 5-Dimension European Quality of life scale (EQ-5D). Agreements between smRSq and mRS were assessed with the Kappa statistic. Multiple logistic regression was used to identify baseline predictors of Day 90 smRSq and mRS scores. Treatment effects, based on Day 90 smRSq/mRS scores, were tested in logistic and ordinal logistic regression models. </jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p> SmRSq and mRS scores had good agreement (weighted Kappa 0.79, 95% confidence interval (CI) 0.78–0.81), while variables of age, atrial fibrillation, diabetes mellitus, pre-morbid mRS (1 vs. 0), baseline NIHSS scores, and imaging signs of cerebral ischemia, similarly predicted their scores. Odds ratios for death or disability, and ordinal shift, 90-day mRS scores using smRSq were 1.05 (95% CI 0.91–1.20; one-sided P = 0.23 for non-inferiority) and 0.98 (95% CI 0.87–1.11; P = 0.02 for non-inferiority), similar to those using mRS. </jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p> This study demonstrates the utility of the smRSq in a large, ethnically diverse clinical trial population. Scoring of the smRSq shows adequate agreement with the standard mRS, thus confirming it is a reliable, valid, and useful alternative measure of functional status after acute ischemic stroke. </jats:p></jats:sec><jats:sec><jats:title>Clinical Trial registration</jats:title><jats:p> URL: http://www.clinicaltrials.gov . Unique identifier: NCT01422616. </jats:p></jats:sec>
Scopus© Citations 9 7
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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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Sex differences in treatment, radiological features and outcome after intracerebral haemorrhage: Pooled analysis of Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage trials 1 and 2
(2020)
Else Charlotte Sandset
;
Xia Wang
;
Cheryl Carcel
;
Shoichiro Sato
;
Candice Delcourt
<jats:sec><jats:title>Introduction</jats:title><jats:p> Reports vary on how sex influences the management and outcome from acute intracerebral haemorrhage. We aimed to quantify sex disparities in clinical characteristics, management, including response to blood pressure lowering treatment, and outcomes in patients with acute intracerebral haemorrhage, through interrogation of two large clinical trial databases. </jats:p></jats:sec><jats:sec><jats:title>Patients and Methods</jats:title><jats:p> Post-hoc pooled analysis of the Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage trials 1 and 2, where patients with a hypertensive response (systolic, 150–220 mmHg) after spontaneous intracerebral haemorrhage (<6 h) were randomised to intensive (target <140 mmHg <1 h) or guideline-recommended (<180 mmHg) blood pressure lowering treatment. The interaction of sex on early haematoma growth (24 h), death or major disability (modified Rankin scale scores 3–6 at 90 days), and effect of randomised treatment were determined in multivariable logistic regression models adjusted for baseline confounding variables. </jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p> In 3233 participants, 1191 (37%) were women who were significantly older, had higher baseline National Institutes of Health Stroke Scale scores and smaller haematoma volumes compared to men. Men had higher three-month mortality (odds ratio 1.48, 95% confidence interval 1.10–2.00); however, there was no difference between women and men in the combined endpoint of death or major disability. There were no significant sex differences on mean haematoma growth or effect of randomised blood pressure lowering treatment. </jats:p></jats:sec><jats:sec><jats:title>Discussion</jats:title><jats:p> Men included in the Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage trials had more comorbidities, larger baseline haematoma volumes and higher mortality after adjustment for age, as compared with women. </jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p> Men included in the Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage trials had a greater odds of dying after intracerebral haemorrhage than women, which could not be readily explained by differing casemix or patterns of blood pressure management. </jats:p></jats:sec><jats:sec><jats:title>Clinical trial registration</jats:title><jats:p> The Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage trials studies are registered with ClinicalTrials.gov (NCT00226096 and NCT00716079). </jats:p></jats:sec>
Scopus© Citations 15 30
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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
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Self-reported Snoring Patterns Predict Stroke Events in High-Risk Patients With OSA
(2020)
Jingwei Li
;
R. Doug McEvoy
;
Danni Zheng
;
Kelly A. Loffler
;
Xia Wang
Scopus© Citations 25 2
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Infratentorial Intracerebral Hemorrhage Relation of Location to Outcome
(2019)
Ruiqi Chen
;
Xia Wang
;
Craig S. Anderson
;
Thompson Robinson
;
LAVADOS GERMAIN, PABLO MANUEL
<jats:sec> <jats:title>Background and Purpose—</jats:title> <jats:p>Infratentorial intracerebral hemorrhage (ICH) has a poor outcome but is rarely analyzed by cerebellar versus brain stem location. We evaluated this relationship and clinical outcomes among participants of the INTERACT 1 and 2 (Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trials).</jats:p> </jats:sec> <jats:sec> <jats:title>Methods—</jats:title> <jats:p>Participants with brain stem and cerebellar ICH were compared. Logistic regression models were used to compare outcomes of death or major disability and quality of life.</jats:p> </jats:sec> <jats:sec> <jats:title>Results—</jats:title> <jats:p>Of 195 included patients, 92 (47%) and 103 (53%) had brain stem and cerebellar ICH, respectively. Patients with brain stem ICH were younger (mean [SD] age, 59±13 versus 70±11 years), less female (28.3% versus 50.5%), with higher admission National Institutes of Health Stroke Scale scores (median [interquartile range], 6 [4–10) versus 3 [2–8]), less prior ICH (3% versus 17%), smaller ICH volumes (1.6 mL [1.0–2.8 mL] versus 5.1 mL [2.6–10.7 mL]), and less intraventricular extension (3% versus 39%) than those with cerebellar ICH. Brain stem ICH had higher mortality (odds ratio, 37.1; 95% CI, 1.99–692.27) and worse scores in the European Quality of Life Scale (EQ-5D) pain domain (odds ratio, 3.36; 95% CI, 1.38–8.20).</jats:p> </jats:sec> <jats:sec> <jats:title>Conclusions—</jats:title> <jats:p>Cerebellar and brain stem ICH differ in their clinical characteristics and prognosis, with the latter being associated with higher case fatality and worse EQ-5D scores in the pain domain.</jats:p> </jats:sec> <jats:sec> <jats:title>Clinical Trial 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 identifiers: NCT00226096 and NCT00716079. </jats:p> </jats:sec>
10Scopus© Citations 35
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Applicability of ENCHANTED trial results to current acute ischemic stroke patients eligible for intravenous thrombolysis in England and Wales: Comparison with the Sentinel Stroke National Audit Programme registry
(2019)
Thompson G Robinson
;
Benjamin D Bray
;
Lizz Paley
;
Nikola Sprigg
;
Xia Wang
<jats:sec><jats:title>Background</jats:title><jats:p> Randomized controlled trials provide high-level evidence, but the necessity to include selected patients may limit the generalisability of their results. </jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p> Comparisons were made of baseline and outcome data between patients with acute ischemic stroke (AIS) recruited into the alteplase-dose arm of the international, multi-center, Enhanced Control of Hypertension and Thrombolysis Stroke study (ENCHANTED) in the United Kingdom (UK), and alteplase-treated AIS patients registered in the UK Sentinel Stroke National Audit Programme (SSNAP) registry, over the study period June 2012 to October 2015. </jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p> There were 770 AIS patients (41.2% female; mean age 72 years) included in ENCHANTED at sites in England and Wales, which was 19.5% of alteplase-treated AIS patients registered in the SSNAP registry. Trial participants were significantly older, had lower baseline neurological severity, less likely Asian, and had more premorbid symptoms, hypertension and atrial fibrillation. Although ENCHANTED participants had higher rates of symptomatic intracerebral hemorrhage than those in SSNAP, there were no differences in onset-to-treatment time, levels of disability (assessed by the modified Rankin scale) at hospital discharge, and mortality over 90 days between groups. </jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p> Despite the high level of participation, equipoise over the dose of alteplase among UK clinician investigators favored the inclusion of older, frailer, milder AIS patients in the ENCHANTED trial. </jats:p></jats:sec><jats:sec><jats:title>Clinical trial registration</jats:title><jats:p> Clinical Trial Registration-URL: http://www.clinicaltrials.gov . Unique identifier: NCT01422616 </jats:p></jats:sec>
5Scopus© Citations 1
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Sex differences in treatment and outcome after stroke Pooled analysis including 19,000 participants
(2019)
Cheryl Carcel
;
Xia Wang
;
Else Charlotte Sandset
;
Candice Delcourt
;
Hisatomi Arima
<jats:sec><jats:title>Objective</jats:title><jats:p>To explore the sex differences in outcomes and management after stroke using a large sample with high-quality international trial data.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>Individual participant data were obtained from 5 acute stroke randomized controlled trials. Data were obtained on demographics, medication use, in-hospital treatment, and functional outcome. Study-specific crude and adjusted models were used to estimate sex differences in outcomes and management, and then pooled using random-effects meta-analysis.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>There were 19,652 participants, of whom 7,721 (40%) were women. After multivariable adjustments, women with ischemic stroke had higher survival at 3–6 months (odds ratio [OR] 0.82, 95% confidence interval [CI] 0.70–0.97), higher likelihood of disability (OR 1.20, 95% CI 1.06–1.36), and worse quality of life (weighted mean difference −0.07, 95% CI −0.09 to 0.04). For management, women were more likely to be admitted to an acute stroke unit (OR 1.17, 95% CI 1.01–1.34), but less likely to be intubated (OR 0.58, 95% CI 0.36–0.93), treated for fever (OR 0.82, 95% CI 0.70–0.95), or admitted to an intensive care unit (OR 0.83, 95% CI 0.74–0.93). For preadmission medications, women had higher odds of being prescribed antihypertensive agents (OR 1.22, 95% CI 1.13–1.31) and lower odds of being prescribed antiplatelets (OR 0.86, 95% CI 0.79–0.93), glucose-lowering agents (OR 0.86, 95% CI 0.78–0.94), or lipid-lowering agents (OR 0.85, 95% CI 0.77–0.94).</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>This analysis suggests that women who had ischemic stroke had better survival but were also more disabled and had poorer quality of life. Variations in hospital and out-of-hospital management may partly explain the disparities.</jats:p></jats:sec>
1Scopus© Citations 115 2
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Sleep duration and risk of cardiovascular events: The SAVE study
(2020)
Jingwei Li
;
Danni Zheng
;
Kelly A Loffler
;
Xia Wang
;
R Doug McEvoy
<jats:sec><jats:title>Background and aim</jats:title><jats:p> Controversy exists regarding cardiovascular risk in relation to sleep duration. We determined sleep duration and major recurrent cardiovascular event associations in patients with obstructive sleep apnoea and established cardiovascular disease. </jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p> Secondary analyses of the international, multicenter, Sleep Apnea Cardiovascular Endpoints trial. Sleep duration was estimated from overnight home oximetry (ApneaLink monitor) used for obstructive sleep apnoea diagnosis. Cox proportional hazards models were used to determine associations of categorized sleep duration (<6 h, 6–8 h (reference), and >8 h) and major cardiovascular outcomes: primary composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and any hospitalization for unstable angina, heart failure, or transient ischemic attack; secondary composite of cardiac and cerebral (stroke/transient ischemic attack) events. </jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p> Oximetry-derived sleep duration estimates were available in 2687 participants (mean 61.2 years, 80.9% males) who experienced a total of 436 cardiovascular events over a mean follow-up of 3.7 years. Compared to the reference category, sleep duration was not associated with risk of the primary composite cardiovascular outcome (adjusted hazard ratio (HR) 1.00, 95% confidence interval 0.76–1.33, and HR 1.22, 95% confidence interval 0.98–1.52, for sleep duration <6 and >8 h, respectively). However, long sleep was associated with increased cerebral events (HR 1.67, 95% confidence interval 1.17–2.39; P = 0.005) and stroke alone (HR 1.79, 95% confidence interval 1.22–2.63; P = 0.003). </jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p> Long sleep duration is associated with an increased risk of stroke but not cardiac events in obstructive sleep apnoea patients with existing cardiovascular disease. </jats:p></jats:sec><jats:sec><jats:title>Clinical trial registration</jats:title><jats:p> The trial is registered at ClinicalTrials.gov (NCT00738179). </jats:p></jats:sec>
8Scopus© Citations 27

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