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Statistical analysis plan for the Head Position in Stroke Trial (HeadPoST) : An international cluster cross-over randomised trial
Billot, Laurent Woodward, Mark Arima, Hisatomi Hackett, Maree Muñoz Venturelli, Paula Lavados, Pablo M. Brunser, Alejandro Peng, Bin Cui, Liying Song, Lily
Billot, Laurent
Woodward, Mark
Arima, Hisatomi
Hackett, Maree
Muñoz Venturelli, Paula
Lavados, Pablo M.
Brunser, Alejandro
Peng, Bin
Cui, Liying
Song, Lily
Author
Billot, Laurent
Woodward, Mark
Arima, Hisatomi
Hackett, Maree
Muñoz Venturelli, Paula
Lavados, Pablo M.
Brunser, Alejandro
Peng, Bin
Cui, Liying
Song, Lily
Heritier, Stephane
Jan, Stephen
Middleton, Sandy
Olavarría, Verónica V.
Lim, Joyce
Robinson, Thompson
Pontes-Neto, Octavio
Watkins, Caroline L.
Anderson, Craig S.
Woodward, Mark
Arima, Hisatomi
Hackett, Maree
Muñoz Venturelli, Paula
Lavados, Pablo M.
Brunser, Alejandro
Peng, Bin
Cui, Liying
Song, Lily
Heritier, Stephane
Jan, Stephen
Middleton, Sandy
Olavarría, Verónica V.
Lim, Joyce
Robinson, Thompson
Pontes-Neto, Octavio
Watkins, Caroline L.
Anderson, Craig S.
Abstract
Background
There is evidence to indicate that the lying flat head position increases cerebral blood flow and oxygenation in patients with acute ischemic stroke, but how these physiological effects translate into clinical outcomes is uncertain. The Head Position in Stroke Trial aims to determine the comparative effectiveness of lying flat (0°) compared to sitting up (≥30°) head positioning, initiated within 24 h of hospital admission for patients with acute stroke.
Design
An international, pragmatic, cluster-randomized, crossover, open, blinded outcome assessed clinical trial. Each hospital with an established acute stroke unit (cluster) site was required to recruit up to 140 consecutive cases of acute stroke (one phase of head positioning before immediately crossing over to the other phase of head positioning), including both acute ischemic stroke and intracerebral hemorrhage, in each randomized head position as a ‘business as usual’ policy.
Objective
To outline in detail the predetermined statistical analysis plan for the study.
Methods
All accumulated data will be reviewed and formally assessed. Information regarding baseline characteristics of patients, their process of care and management will be outlined, and for each item, statistically relevant descriptive elements will be described. For the trial outcomes, the most appropriate statistical comparisons are described.
Results
A statistical analysis plan was developed that is transparent, verifiable, and predetermined before completion of data collection.
Conclusions
We developed a predetermined statistical analysis plan for Head Position in Stroke Trial to avoid analysis bias arising from prior knowledge of the findings, in order to reliably quantify the benefits and harms of lying flat versus sitting up early after the onset of acute stroke.
Keywords
stroke, ischemic stroke, clinical trial, head position, treatment, nursing care
Date
2017
Type
Journal article
Journal
International Journal of Stroke
Book
Volume
12
Issue
6
Page Range
667-670
Article Number
ACU Department
Nursing Research Institute
Faculty of Health Sciences
Faculty of Health Sciences
Collections
Relation URI
Source URL
Event URL
Open Access Status
Published as green open access
License
File Access
Controlled
Open
Open