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

Wang, X; Moullaali, TJ; Ouyang, M; Billot, L; Sandset, EC; Song, L; Delcourt, C; Hackett, ML; Watkins, CL; Robinson, TG; Yang, J; Lavados, PM; Brunser, A; Olavarría, VV; Muñoz-Venturelli, P; Arima, H; Middleton, S; Pontes-Neto, OM; Pandian, JD; Rogers, K; Anderson, CS

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

Wang, X Moullaali, TJ Ouyang, M Billot, L Sandset, EC Song, L Delcourt, C Hackett, ML Watkins, CL Robinson, TG Yang, J Lavados, PM Brunser, A Olavarría, VV Muñoz-Venturelli, P Arima, H Middleton, S Pontes-Neto, OM Pandian, JD Rogers, K

Anderson, CS

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Publisher:: S. Karger AG
Publication Type:: Journal Article
Citation:: Cerebrovasc Dis, 2021, 50, (1), pp. 78-87
Issue Date:: 2021

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Field	Value	Language
dc.contributor.author	Wang, X
dc.contributor.author	Moullaali, TJ
dc.contributor.author	Ouyang, M
dc.contributor.author	Billot, L
dc.contributor.author	Sandset, EC
dc.contributor.author	Song, L
dc.contributor.author	Delcourt, C
dc.contributor.author	Hackett, ML
dc.contributor.author	Watkins, CL
dc.contributor.author	Robinson, TG
dc.contributor.author	Yang, J
dc.contributor.author	Lavados, PM
dc.contributor.author	Brunser, A
dc.contributor.author	Olavarría, VV
dc.contributor.author	Muñoz-Venturelli, P
dc.contributor.author	Arima, H
dc.contributor.author	Middleton, S
dc.contributor.author	Pontes-Neto, OM
dc.contributor.author	Pandian, JD
dc.contributor.author	Rogers, K https://orcid.org/0000-0001-5497-4298
dc.contributor.author	Anderson, CS
dc.date.accessioned	2022-05-24T06:08:18Z
dc.date.available	2020-10-26
dc.date.available	2022-05-24T06:08:18Z
dc.date.issued	2021
dc.identifier.citation	Cerebrovasc Dis, 2021, 50, (1), pp. 78-87
dc.identifier.issn	1015-9770
dc.identifier.issn	1421-9786
dc.identifier.uri	http://hdl.handle.net/10453/157670
dc.description.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).
dc.format	Print-Electronic
dc.language	eng
dc.publisher	S. Karger AG
dc.relation.ispartof	Cerebrovasc Dis
dc.relation.isbasedon	10.1159/000512608
dc.rights	info:eu-repo/semantics/closedAccess
dc.subject	1103 Clinical Sciences, 1109 Neurosciences
dc.subject.classification	Neurology & Neurosurgery
dc.subject.mesh	Aged
dc.subject.mesh	Aged, 80 and over
dc.subject.mesh	Disability Evaluation
dc.subject.mesh	Disabled Persons
dc.subject.mesh	Female
dc.subject.mesh	Functional Status
dc.subject.mesh	Humans
dc.subject.mesh	Male
dc.subject.mesh	Middle Aged
dc.subject.mesh	Multicenter Studies as Topic
dc.subject.mesh	Patient Positioning
dc.subject.mesh	Patient Selection
dc.subject.mesh	Posture
dc.subject.mesh	Randomized Controlled Trials as Topic
dc.subject.mesh	Recovery of Function
dc.subject.mesh	Research Design
dc.subject.mesh	Stroke
dc.subject.mesh	Supine Position
dc.subject.mesh	Time Factors
dc.subject.mesh	Treatment Outcome
dc.subject.mesh	Humans
dc.subject.mesh	Disability Evaluation
dc.subject.mesh	Treatment Outcome
dc.subject.mesh	Recovery of Function
dc.subject.mesh	Posture
dc.subject.mesh	Supine Position
dc.subject.mesh	Research Design
dc.subject.mesh	Patient Selection
dc.subject.mesh	Time Factors
dc.subject.mesh	Aged
dc.subject.mesh	Aged, 80 and over
dc.subject.mesh	Middle Aged
dc.subject.mesh	Disabled Persons
dc.subject.mesh	Female
dc.subject.mesh	Male
dc.subject.mesh	Multicenter Studies as Topic
dc.subject.mesh	Randomized Controlled Trials as Topic
dc.subject.mesh	Stroke
dc.subject.mesh	Patient Positioning
dc.subject.mesh	Functional Status
dc.title	Influence of Including Patients with Premorbid Disability in Acute Stroke Trials: The HeadPoST Experience.
dc.type	Journal Article
utslib.citation.volume	50
utslib.location.activity	Switzerland
utslib.for	1103 Clinical Sciences
utslib.for	1109 Neurosciences
pubs.organisational-group	/University of Technology Sydney
pubs.organisational-group	/University of Technology Sydney/Faculty of Health
utslib.copyright.status	closed_access	*
dc.date.updated	2022-05-24T06:08:17Z
pubs.issue	1
pubs.publication-status	Published
pubs.volume	50
utslib.citation.issue	1

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).

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http://hdl.handle.net/10453/157670