TY - JOUR AU - Arima Hisatomi AU - Anderson Craig AU - Lavados P. AU - Munoz-Venturelli P. AU - Brunser A. AU - Olavarria V. AU - Billot Laurent AB -

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 h of onset of acute ischemic stroke involving the anterior circulation increases cerebral blood flow in the middle cerebral arteries, as measured by transcranial Doppler. The study will also assess the safety and feasibility of patients lying flat for >/=24 h. The trial was conducted in centers in three countries, with ability to perform early transcranial Doppler. 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 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 statistical analysis plan 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 statistical analysis plan for the HEADPOST Pilot study which is to be followed to avoid analysis bias arising from prior knowledge of the study findings. TRIAL REGISTRATION: The study is registered under HEADPOST-Pilot, ClinicalTrials.gov Identifier NCT01706094.

AD - Unidad de Neurologia Vascular, Servicio de Neurologia, Departamento de Medicina Interna, Clinica Alemana de Santiago, Facultad de Medicina Clinica Alemana Universidad del Desarrollo, Santiago, Chile volavarria@alemana.cl.
Department of Preventive Medicine and Public Health, Faculty of Medicine, Fukuoka University, Fukuoka, Japan The George Institute for Global Health, Sydney Medical School, University of Sydney, Sydney, NSW, Australia.
The George Institute for Global Health, Sydney Medical School, University of Sydney, Sydney, NSW, Australia Neurology Department, Royal Prince Alfred Hospital, Sydney, NSW, Australia.
Unidad de Neurologia Vascular, Servicio de Neurologia, Departamento de Medicina Interna, Clinica Alemana de Santiago, Facultad de Medicina Clinica Alemana Universidad del Desarrollo, Santiago, Chile.
Unidad de Neurologia Vascular, Servicio de Neurologia, Departamento de Medicina Interna, Clinica Alemana de Santiago, Facultad de Medicina Clinica Alemana Universidad del Desarrollo, Santiago, Chile The George Institute for Global Health, Sydney Medical School, University of Sydney, Sydney, NSW, Australia.
The George Institute for Global Health, Sydney Medical School, University of Sydney, Sydney, NSW, Australia.
Unidad de Neurologia Vascular, Servicio de Neurologia, Departamento de Medicina Interna, Clinica Alemana de Santiago, Facultad de Medicina Clinica Alemana Universidad del Desarrollo, Santiago, Chile Departamento de Ciencias Neurologicas, Facultad de Medicina, Universidad de Chile, Santiago, Chile. AN - 27742914 BT - International Journal of Stroke DP - NLM ET - 2016/10/16 LA - Eng LB - AUS
OCS
NMH
FY17 N1 - Olavarria, Veronica V
Arima, Hisatomi
Anderson, Craig S
Brunser, Alejandro
Munoz-Venturelli, Paula
Billot, Laurent
Lavados, Pablo M
HEADPOST Pilot Investigators
United States
Int J Stroke. 2016 Oct 14. pii: 1747493016674955. N2 -

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 h of onset of acute ischemic stroke involving the anterior circulation increases cerebral blood flow in the middle cerebral arteries, as measured by transcranial Doppler. The study will also assess the safety and feasibility of patients lying flat for >/=24 h. The trial was conducted in centers in three countries, with ability to perform early transcranial Doppler. 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 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 statistical analysis plan 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 statistical analysis plan for the HEADPOST Pilot study which is to be followed to avoid analysis bias arising from prior knowledge of the study findings. TRIAL REGISTRATION: The study is registered under HEADPOST-Pilot, ClinicalTrials.gov Identifier NCT01706094.

PY - 2016 SN - 1747-4949 (Electronic)
1747-4930 (Linking) T2 - International Journal of Stroke TI - Statistical analysis plan of the head position in acute ischemic stroke trial pilot (HEADPOST pilot) Y2 - FY17 ER -