scholarly journals Statistical analysis plan for the Head Position in Stroke Trial (HeadPoST): An international cluster cross-over randomized trial

2017 ◽  
Vol 12 (6) ◽  
pp. 667-670 ◽  
Author(s):  
Laurent Billot ◽  
Mark Woodward ◽  
Hisatomi Arima ◽  
Maree L Hackett ◽  
Paula Muñoz Venturelli ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Statistical Analysis ◽  
Acute Stroke ◽  
Acute Ischemic Stroke ◽  
Statistical Analysis Plan ◽  
Head Position ◽  
Process Of Care ◽  
Head Positioning ◽  
Cluster Randomized ◽  
Stroke Trial

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. Trial registration ClinicalTrials.gov identifier NCT02162017; ANZCTR identifier ACTRN12614000483651

Statistical analysis plan of the head position in acute ischemic stroke trial pilot (HEADPOST pilot)

2016 ◽  
Vol 12 (2) ◽  
pp. 211-215
Author(s):  
Verónica V Olavarría ◽  
Hisatomi Arima ◽  
Craig S Anderson ◽  
Alejandro Brunser ◽  
Paula Muñoz-Venturelli ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Statistical Analysis ◽  
Pilot Study ◽  
Acute Ischemic Stroke ◽  
Transcranial Doppler ◽  
Controlled Trial ◽  
Statistical Analysis Plan ◽  
Head Position ◽  
Process Of Care ◽  
Anterior Circulation

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.

Negative Interaction of Aspirin and Streptokinase in Acute Ischemic Stroke: Further Analysis of the Multicenter Acute Stroke Trial-Italy

2000 ◽  
Vol 10 (1) ◽  
pp. 61-64 ◽  
Author(s):  
Alfonso Ciccone ◽  
Cristina Motto ◽  
Elisabetta Aritzu ◽  
Alessandra Piana ◽  
Livia Candelise
Keyword(s):  
Ischemic Stroke ◽  
Acute Stroke ◽  
Acute Ischemic Stroke ◽  
Negative Interaction ◽  
Stroke Trial

scholarly journals B.01 Predictors of dysphagia screening after acute ischemic stroke: Who gets tested?

2016 ◽  
Vol 43 (S2) ◽  
pp. S9-S9
Author(s):  
RA Joundi ◽  
R Martino ◽  
G Saposnik ◽  
J Fang ◽  
V Giannakeas ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Acute Stroke ◽  
Acute Ischemic Stroke ◽  
Odds Ratio ◽  
Stroke Unit ◽  
Adjusted Odds Ratio ◽  
Process Of Care ◽  
Stroke Registry ◽  
Multivariable Regression ◽  
Mild Stroke

Background: Dysphagia is a devastating complication of stroke and can lead to malnutrition, immobility, aspiration pneumonia, and death. Guidelines advocate screening all patients with acute stroke for swallowing impairment. However, previous research suggests only 60% are screened, and it is unclear what factors contribute to receiving dysphagia screening. Methods: We used the Ontario Stroke Registry to identify patients who were admitted to Regional Stroke Centres from 2010-2013. We used multivariable regression to identify predictors of receiving a dysphagia screen within 72 hours. Results: Among 7172 patients with acute ischemic stroke, 1705 patients (23.8%) did not undergo screening. Factors increasing the odds of being tested were: Stroke unit admission (adjusted odds ratio aOR 6.5), presenting with speech deficits (aOR 1.9) or weakness (aOR 1.5), or receiving thrombolysis (aOR 1.9). Seizure (aOR 0.49) and mild stroke (aOR 0.59 vs moderate stroke) decreased the odds of being tested. Among those with mild strokes who received a swallowing screen, 33% failed. *All p<0.0001. Conclusions: Patients with mild stroke are at risk of not being screened for dysphagia, despite a significant fail rate among those tested. This may expose untested patients to a higher risk of complications from dysphagia, and suggests a gap in process of care that should be addressed.

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