Influence of Including Patients with Premorbid Disability in Acute Stroke Trials: The HeadPoST Experience.
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
/ diagnosis
Supine Position
Time Factors
Treatment Outcome
Acute stroke
Acute stroke trials
Clinical outcome
Journal
Cerebrovascular diseases (Basel, Switzerland)
ISSN: 1421-9786
Titre abrégé: Cerebrovasc Dis
Pays: Switzerland
ID NLM: 9100851
Informations de publication
Date de publication:
2021
2021
Historique:
received:
13
07
2020
accepted:
26
10
2020
pubmed:
13
1
2021
medline:
6
8
2021
entrez:
12
1
2021
Statut:
ppublish
Résumé
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).
Sections du résumé
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).
Identifiants
pubmed: 33434907
pii: 000512608
doi: 10.1159/000512608
doi:
Banques de données
ClinicalTrials.gov
['NCT02162017']
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
78-87Informations de copyright
© 2021 S. Karger AG, Basel.