Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2021;50(1):78-87.
doi: 10.1159/000512608. Epub 2021 Jan 12.

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

Xia Wang  1   2 , Tom J Moullaali  3 , Menglu Ouyang  1 , Laurent Billot  1 , Else Charlotte Sandset  4   5 , Lili Song  6 , Candice Delcourt  1   7   8 , Maree L Hackett  1   9 , Caroline L Watkins  9 , Thompson G Robinson  10 , Jie Yang  2 , Pablo M Lavados  11 , Alejandro Brunser  11 , Verónica V Olavarría  11 , Paula Muñoz-Venturelli  11   9 , Hisatomi Arima  12 , Sandy Middleton  13 , Octávio M Pontes-Neto  14 , Jeyaraj Durai Pandian  15 , Kris Rogers  1 , Craig S Anderson  16   17   18   19
Affiliations
Randomized Controlled Trial

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

Xia Wang et al. Cerebrovasc Dis. 2021.

Abstract

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.

Clinical trial registration: HeadPoST is registered at http://www.ClinicalTrials.gov (NCT02162017).

Keywords: Acute stroke; Acute stroke trials; Clinical outcome.

PubMed Disclaimer

Publication types

Associated data