Browsing by Author "Watkins, Caroline L."
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Item Influence of Including Patients with Premorbid Disability in Acute Stroke Trials: The HeadPoST Experience(2021) Wang, Xia; Moullaali, Tom J.; Ouyang, Menglu; Billot, Laurent; Sandset, Else Charlotte; Song, Lili; Delcourt, Candice; Hackett, Maree L.; Watkins, Caroline L.; Robinson, Thompson G.; Yang, Jie; Lavados, Pablo; Brunser, Alejandro; Muñoz Venturelli, Paula; Olavarría, Verónica; Arima, Hisatomi; Middleton, Sandy; Pontes-Neto, Octávio M.; Pandian, Jeyaraj Durai; Rogers; Rogers, Kris; Anderson, Craig S.Background: 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. Methods: 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. Results: 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; p < 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 p < 0.0001). There was no heterogeneity of the trial treatment effect by level of premorbid function. Conclusions: 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.Item Low blood pressure and adverse outcomes in acute stroke: HeadPoSTstudy explanations(2021) Muñoz Venturelli, Paula; Billota, Laurent; Wang, Xia; Ouyang, Menglu; Song, Lili; Arima, Hisatomi; Lavados, Pablo; Hackett, Maree L.; Olavarría, Verónica V.; Brunser, Alejandro; Middleton, Sandy; Pontes-Neto, Octavio M.; Lee, Tsong-Hai; Watkins, Caroline L.; Robinson, Thompson; Anderson, Craig S.Objective: As uncertainties exist over underlying causes, we aimed to define the characteristics and prognostic significance of low blood pressure (BP) early after the onset of acute stroke. Methods: Post hoc analyzes of the international Head Positioning in acute Stroke Trial (HeadPoST), a pragmatic cluster-crossover randomized trial of lying flat versus sitting up in stroke patients from nine countries during 2015-2016. Associations of baseline BP and death or dependency [modified Rankin scale (mRS) scores 3-6] and serious adverse events (SAEs) at 90 days were assessed in generalized linear mixed models with adjustment for multiple confounders. SBP and DBP was analysed as continuous measures fitted with a cubic spline, and as categorical measures with low (<10th percentile) and high (≥140 and ≥90 mmHg, respectively) levels compared with a normal range (≥10th percentile; 120-139 and 70-89 mmHg, respectively). Results: Among 11 083 patients (mean age 68 years, 39.9% women) with baseline BP values, 7.2 and 11.7% had low SBP (<120 mmHg) and DBP (<70 mmHg), respectively. Patients with low SBP were more likely to have preexisting cardiac and ischemic stroke and functional impairment, and to present earlier with more severe neurological impairment than other patients. Nonlinear 'J-shaped' relationships of BP and poor outcome were apparent: compared with normal SBP, those with low SBP had worse functional outcome (adjusted odds ratio 1.27, 95% confidence interval 1.02-1.58) and more SAEs, particularly cardiac events, with adjustment for potential confounders to minimize reverse causation. The findings were consistent for DBP and were stronger for ischemic rather than hemorrhagic stroke. Conclusion: The prognostic significance of low BP on poor outcomes in acute stroke was not explained by reverse causality from preexisting cardiovascular disease, and propensity towards greater neurological deficits and cardiac events. These findings provide support for the hypothesis that low BP exacerbates cardiac and cerebral ischemia in acute ischemic stroke.Item Oxygen desaturation and adverse outcomes in acute stroke: Secondary analysis of the HeadPoST study(2021) Ouyang, Menglu; Roffe, Christine; Billot, Laurent; Song, Lili; Wang, Xia; Muñoz Venturelli, Paula; Lavados, Pablo; Robinson, Thompson; Middleton, Sandy; Olavarría, Verónica V.; Watkins, Caroline L.; Lee, Tsong-Hai; Brunser, Alejandro M.; Pontes-Neto, Octavio M.; Hackett, Maree L.Objective: Uncertainty exists over the prognostic significance of low arterial oxygen saturation (SaO2) in acute stroke. We aimed to determine the strength of association of SaO2 and adverse outcomes among participants of the international Head Positioning in acute Stroke Trial (HeadPoST). Methods: Post-hoc analyzes of HeadPoST, a pragmatic cluster-crossover randomized trial of lying flat versus sitting up head positioning in 11,093 patients (age ≥18 years) with acute stroke at 114 hospitals in 9 countries during 2015–2016. Associations of the lowest recorded SaO2 level, as a continuous measure and as a cut-point for desaturation (SaO2 <93%), in the first 24 h and clinical outcomes of death or dependency (modified Rankin scale [mRS] scores 3–6) and any serious adverse event (SAE) at 90 days, were assessed in generalized linear mixed models adjusted for baseline and in-hospital management confounders. Results: There was an inverse J-shaped association between SaO2 and death or dependency, with a nadir for optimal outcome at 96–97%. Patients with SaO2 desaturation were older, and had greater neurological impairment, premorbid disability and cardiorespiratory disease. Desaturation was not clearly associated with death or dependency (adjusted odds ratio [aOR] 1.19, 95% confidence interval [CI] 0.95–1.48) but was with SAEs (aOR 1.34, 95% CI 1.07–1.68), without heterogeneity by head position, cardiac-respiratory comorbidity, or other pre-specified subgroups. Conclusions: Any change in SaO2 outside of 96–97% is associated with poorer outcome after acute stroke. Clinical trial registration: HeadPoST is registered at ClinicalTrials.gov (NCT02162017).Item Quantifying regional variations in components of acute stroke unit (ASU) care in the international HeadPoST study(2020) Ouyang, Menglu; Zhang, Yao; Wang, Xia; Song, Lili; Billot, Laurent; Robinson, Thompson; Lavados, Pablo; Arima, Hisatomi; Hackett, Maree L.; Olavarría, Verónica; Muñoz Venturelli, Paula; Middleton, Sandy; Watkins, Caroline L.; Pontes-Neto, Octavio M.; Lee, Tsong-Hai; Brunser, Alejandro; Anderson, Craig S.Objective: Access to acute stroke unit (ASU) care is known to vary worldwide. We aimed to quantify regional variations in the various components of ASU care. Method: Secondary analysis of the Head Positioning in acute Stroke Trial (HeadPoST), an international, multicentre, cluster crossover trial of head-up versus head-down positioning in 11,093 acute stroke patients at 114 hospitals in 9 countries. Patients characteristics and 11 standard components of processes of care were described according to ASU admission within and across four economically-defined regional groups (Australia/UK, China [includes Taiwan], India/Sri Lanka, and South America [Brazil/Chile/Colombia]). Variations in process of ASU care estimates were obtained in hierarchical mixed models, with adjustment for study design and potential patient- and hospital-level confounders. Results: Of 11,086 patients included in analyses, 59.7% (n = 6620) had an ASU admission. In China, India/Sri Lanka and South America, ASU patients were older, had greater neurological severity and more premorbid conditions than non-ASU patients. ASU patients were more likely to receive reperfusion therapy and multidisciplinary care within regions, but the components of care varied across regions. With Australia/UK as reference, patients in other regions had a lower probability of receiving reperfusion therapy, especially in India/Sri Lanka (adjusted odds ratio [aOR] 0.27, 95% confidence interval [CI] 0.12–0.63) and multidisciplinary care (mainly in formal dysphagia assessment, physiotherapy and occupational therapy). Conclusion: There is significant variation in the components of stroke care across economically-defined regions of the world. Ongoing efforts are required to reduce disparities and optimise health outcomes, especially in resource poor areas.