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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 <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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Statistical analysis plan for the Head Position in Stroke Trial (HeadPoST): An international cluster cross-over randomized trial
(2017)
Laurent Billot
;
Mark Woodward
;
Hisatomi Arima
;
Maree L Hackett
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MUÑOZ VENTURELLI, PAULA ANDREA
<jats:sec><jats:title>Background</jats:title><jats:p> There is evidence to indicate that the lying flat head position increases cerebral blood flow and oxygenation in patients with acute ischemic stroke, but how these physiological effects translate into clinical outcomes is uncertain. The Head Position in Stroke Trial aims to determine the comparative effectiveness of lying flat (0°) compared to sitting up (≥30°) head positioning, initiated within 24 h of hospital admission for patients with acute stroke. </jats:p></jats:sec><jats:sec><jats:title>Design</jats:title><jats:p> An international, pragmatic, cluster-randomized, crossover, open, blinded outcome assessed clinical trial. Each hospital with an established acute stroke unit (cluster) site was required to recruit up to 140 consecutive cases of acute stroke (one phase of head positioning before immediately crossing over to the other phase of head positioning), including both acute ischemic stroke and intracerebral hemorrhage, in each randomized head position as a ‘business as usual’ policy. </jats:p></jats:sec><jats:sec><jats:title>Objective</jats:title><jats:p> To outline in detail the predetermined statistical analysis plan for the study. </jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p> All accumulated data will be reviewed and formally assessed. Information regarding baseline characteristics of patients, their process of care and management will be outlined, and for each item, statistically relevant descriptive elements will be described. For the trial outcomes, the most appropriate statistical comparisons are described. </jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p> A statistical analysis plan was developed that is transparent, verifiable, and predetermined before completion of data collection. </jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p> We developed a predetermined statistical analysis plan for Head Position in Stroke Trial to avoid analysis bias arising from prior knowledge of the findings, in order to reliably quantify the benefits and harms of lying flat versus sitting up early after the onset of acute stroke. </jats:p></jats:sec><jats:sec><jats:title>Trial registration</jats:title><jats:p> ClinicalTrials.gov identifier NCT02162017; ANZCTR identifier ACTRN12614000483651 </jats:p></jats:sec>
10Scopus© Citations 3
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Blood pressure variability and outcome in acute ischemic and hemorrhagic stroke: a post hoc analysis of the HeadPoST study.
(2019)
Jatinder S. Minhas
;
Xia Wang
;
Pablo M. Lavados
;
Tom J. Moullaali
;
Hisatomi Arima
6Scopus© Citations 34
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Dysphagia screening and risks of pneumonia and adverse outcomes after acute stroke: An international multicenter study
(2020)
Menglu Ouyang
;
Elizabeth Boaden
;
Hisatomi Arima
;
Pablo M Lavados
;
Laurent Billot
Dysphagia is associated with aspiration pneumonia after stroke. Data are limited on the influences of dysphagia screen and assessment in clinical practice. </jats:p></jats:sec><jats:sec><jats:title>Aims</jats:title><jats:p> To determine associations between a “brief” screen and “detailed” assessment of dysphagia on clinical outcomes in acute stroke patients. </jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p> A prospective cohort study analyzed retrospectively using data from a multicenter, cluster cross-over, randomized controlled trial (Head Positioning in Acute Stroke Trial [HeadPoST]) from 114 hospitals in nine countries. HeadPoST included 11,093 acute stroke patients randomized to lying-flat or sitting-up head positioning. Herein, we report predefined secondary analyses of the association of dysphagia screening and assessment and clinical outcomes of pneumonia and death or disability (modified Rankin scale 3–6) at 90 days. </jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p> Overall, 8784 (79.2%) and 3917 (35.3%) patients were screened and assessed for dysphagia, respectively, but the frequency and timing for each varied widely across regions. Neither use of a screen nor an assessment for dysphagia was associated with the outcomes, but their results were compared to “screen-pass” patients, those who failed had higher risks of pneumonia (adjusted odds ratio [aOR] = 3.00, 95% confidence interval [CI] = 2.18–4.10) and death or disability (aOR = 1.66, 95% CI = 1.41–1.95). Similar results were evidence for the results of an assessment for dysphagia. Subsequent feeding restrictions were related to higher risk of pneumonia in patients failed dysphagia screen or assessment (aOR = 4.06, 95% CI = 1.72–9.54). </jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p> Failing a dysphagia screen is associated with increased risks of pneumonia and poor clinical outcome after acute stroke. Further studies concentrate on determining the effective subsequent feeding actions are needed to improve patient outcomes.
1Scopus© Citations 46

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