Influence of Including Patients with Premorbid Disability in Acute Stroke Trials: The HeadPoST Experience

Journal
Cerebrovascular Diseases
ISSN
1015-9770
1421-9786
Date Issued
2021
Author(s)
Xia Wang
Tom J. Moullaali
Menglu Ouyang
Laurent Billot
Else Charlotte Sandset
Lili Song
Candice Delcourt
Maree L. Hackett
Caroline L. Watkins
Thompson G. Robinson
Jie Yang
Hisatomi Arima
Sandy Middleton
Octávio M. Pontes-Neto
Jeyaraj Durai Pandian
Kris Rogers
Craig S. Anderson
Type
Resource Types::text::journal::journal article
Scopus ID
2-s2.0-85099545711
WoS ID
WOS:000607702600001
DOI
URL
URL Institutional Repository
Abstract
<jats:p><b><i>Background:</i></b> 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. <b><i>Methods:</i></b> 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. <b><i>Results:</i></b> 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; <i>p</i> &#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 <i>p</i> &#x3c; 0.0001). There was no heterogeneity of the trial treatment effect by level of premorbid function. <b><i>Conclusions:</i></b> 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. <b><i>Clinical Trial Registration:</i></b> HeadPoST is registered at http://www.ClinicalTrials.gov (NCT02162017). </jats:p>
Cite this document
Wang, X., Moullaali, T. J., Ouyang, M., Billot, L., Sandset, E. C., Song, L., Delcourt, C., Hackett, M. L., Watkins, C. L., Robinson, T. G., Yang, J., Lavados, P. M., Brunser, A., Olavarría, V. V., Muñoz-Venturelli, P., Arima, H., Middleton, S., Pontes-Neto, O. M., Pandian, J. D., … Anderson, C. S. (2021). Influence of including patients with premorbid disability in acute stroke trials: The headpost experience. Cerebrovascular Diseases, 50(1), 78-87. https://doi.org/10.1159/000512608
Subjects
acute stroke

; 

acute stroke trials

; 

clinical outcome

; 

aged

; 

aged, 80 and over

; 

disability evaluation

; 

disabled persons

; 

female

; 

functional status

; 

humans

; 

male

; 

middle aged

; 

multicenter studies as topic

; 

patient positioning

; 

patient selection

; 

posture

; 

randomized controlled trials as topic

; 

recovery of function

; 

research design

; 

stroke

; 

supine position

; 

time factors

; 

treatment outcome

; 

acetylsalicylic acid

; 

alteplase

; 

heparin

; 

mannitol

; 

statin (protein)

; 

antibiotic therapy

; 

anticoagulant therapy

; 

antihypertensive therapy

; 

article

; 

atrial fibrillation

; 

brain hemorrhage

; 

brain ischemia

; 

cerebrovascular accident

; 

clinical trial

; 

controlled study

; 

coronary artery disease

; 

crossover procedure

; 

current smoker

; 

diabetes mellitus

; 

disability

; 

female

; 

heart failure

; 

human

; 

hypertension

; 

intensive care unit

; 

major clinical study

; 

male

; 

multicenter study

; 

national institutes of health stroke scale

; 

aged

; 

body position

; 

cerebrovascular accident

; 

convalescence

; 

disability

; 

disabled person

; 

functional status

; 

methodology

; 

middle aged

; 

multicenter study (topic)

; 

pathophysiology

; 

patient positioning

; 

patient selection

; 

randomized controlled trial (topic)

; 

supine position

; 

time factor

; 

treatment outcome

; 

very elderly