Journal article
Statistical analysis plan for the Head Position in Stroke Trial (HeadPoST): an international cluster cross-over randomised trial
- 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 (HeadPoST) aims to determine the comparative effectiveness of lying flat (0°) compared to sitting up (≥30°) head positioning, initiated within 24 hours of hospital admission for patients with acute stroke.
Design
An international, pragmatic, cluster randomised, 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 ischaemic stroke and intracerebral haemorrhage, in each randomised head position as a ‘business as usual’ policy.
Objective
To outline in detail the predetermined statistical analysis plan (SAP) 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 SAP was developed that is transparent, verifiable, and predetermined before completion of data collection.
Conclusions
We developed a predetermined SAP for HeadPoST 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.
- Publication status:
- Published
- Peer review status:
- Peer reviewed
Actions
Access Document
- Files:
-
-
(Preview, Accepted manuscript, pdf, 99.7KB, Terms of use)
-
- Publisher copy:
- 10.1177/1747493017701943
Authors
- Funding agency for:
- Woodward, M
- Grant:
- G0601617
- Publisher:
- SAGE Publications
- Journal:
- International Journal of Stroke More from this journal
- Volume:
- 12
- Issue:
- 6
- Pages:
- 667-670
- Publication date:
- 2017-03-01
- Acceptance date:
- 2017-01-12
- DOI:
- EISSN:
-
1747-4949
- ISSN:
-
1747-4930
- Keywords:
- Pubs id:
-
pubs:675360
- UUID:
-
uuid:0b855661-012c-44b1-861b-c0bbff10a5ee
- Local pid:
-
pubs:675360
- Source identifiers:
-
675360
- Deposit date:
-
2017-02-02
- ARK identifier:
Terms of use
- Copyright holder:
- World Stroke Organization
- Copyright date:
- 2017
- Notes:
- Copyright © 2016 World Stroke Organization. This article has been accepted for publication in the International Journal of Stroke.
If you are the owner of this record, you can report an update to it here: Report update to this record