The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Camperdown, New South Wales, Australia.
Department of Neurology, The First Affiliated Hospital of Chengdu Medical College, Chengdu, China.
Cerebrovasc Dis. 2021;50(1):78-87. doi: 10.1159/000512608. Epub 2021 Jan 12.
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.
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.
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.
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.
HeadPoST is registered at http://www.ClinicalTrials.gov (NCT02162017).
患有病前功能障碍的患者通常被排除在急性脑卒中试验之外。我们旨在确定在 Head Positioning in acute Stroke Trial (HeadPoST) 中纳入此类患者以及早期额外的功能障碍对结局的影响。
这是一项对 HeadPoST 的事后分析，HeadPoST 是一项国际、集群随机交叉试验，比较急性脑卒中患者仰卧位与坐位头位的效果。通过广义线性混合模型确定早期额外功能障碍（定义为从病前水平（估计在基线时）到第 7 天的改良 Rankin 量表（mRS）评分变化（“早期ΔmRS”）与第 90 天不良结局（mRS 评分 3-6）之间的关联。根据病前 mRS 评分 0-1 与 2-5 测试试验治疗效果的异质性。
在 8285 例（38.9%为女性，平均年龄 68±13 岁）完成数据的患者中，有 1984 例（23.9%）患有病前功能障碍（mRS 2-5）。早期ΔmRS 与不良结局之间存在显著的线性关联（ΔmRS 每增加 1 分，调整后的优势比为 1.20，95%置信区间为 1.14-1.27；p<0.0001）。病前功能障碍更严重的患者不太可能发生额外的功能障碍，但随着病前 mRS 评分的增加（恶化），其 90 天不良结局的风险显著增加（线性趋势 p<0.0001）。病前功能水平对试验治疗效果没有异质性。
超过病前水平的急性脑卒中后早期功能障碍与 90 天不良结局相关，且该关联随着病前功能障碍程度的增加而增加。然而，将病前功能受损的患者纳入 HeadPoST 并没有对随后的治疗效果产生实质性影响。
HeadPoST 在 http://www.ClinicalTrials.gov 注册（NCT02162017）。
