Sandy Middleton, Australian Catholic University
Caroline L. Watkins
Craig S. Anderson
Billot, L., Woodward, M., Arima, H., Hackett, M., Venturelli, P., Lavados, P., Brunser, A., Peng, B., Cui, L., Song, L., Heritier, S., Jan, S., Middleton, S., Olavarria, V., Lim, J., Robinson, T., Pontes-Neto, O., Watkins, C. L & Anderson, CS. (2017). Statistical analysis plan for the Head Position in Stroke Trial (HeadPoST): an international cluster cross-over randomised trial [accepted manuscript]. International Journal of Stroke,12(6), G. A. Donnan. 667-670. United Kingdom: Sage Publications Inc. Retrieved from https://doi.org/10.1177/1747493017701943
Background: Uncertainty exists over the optimum position for the head of a patient with acute stroke. 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, 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 70 consecutive cases of acute stroke, 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.
Open Access Journal Article