| dc.description | Background: The HEADPOST Pilot is a proof of concept, open, prospective, multicenter,
international, cluster randomized, phase IIb controlled trial, with masked outcome
assessment. The trial will test if lying flat head position initiated in patients within 12
hours of onset of acute ischemic stroke involving the anterior circulation increases
cerebral blood flow in the middle cerebral arteries, as measured by transcranial Doppler
For Review Only (TCD).
The study will also assess the safety and feasibility of patients lying flat for ≥ 24
hours. The trial was conducted in centres in 3 countries, with ability to perform early
TCD. A feature of this trial was that patients were randomized to a certain position
according to the month of admission to hospital.
Objective: To outline in detail the predetermined statistical analysis plan (SAP) for
HEADPOST Pilot study.
Methods: All data collected by participating researchers will be reviewed and formally
assessed. Information pertaining to the baseline characteristics of patients, their process
of care, and the delivery of treatments will be classified, and for each item, appropriate
descriptive statistical analyses are planned with comparisons made between randomized
groups. For the outcomes, statistical comparisons to be made between groups are planned and described.
Results: This SAP was developed for the analysis of the results of the HEADPOST Pilot
study to be transparent, available, verifiable, and predetermined before data lock.
Conclusions: We have developed a SAP for the HEADPOST Pilot study which is to be
followed to avoid analysis bias arising from prior knowledge of the study findings. | |
