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

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dc.contributor.authorOlavarria, Veronica
dc.contributor.authorArima, Hisatomi
dc.contributor.authorAnderson, Craig
dc.contributor.authorBrunser, Alejandro
dc.contributor.authorMuñoz Venturelli, Paula
dc.contributor.authorBillot, Laurent
dc.contributor.authorLavados, Pablo
dc.date.accessioned2017-08-17T13:18:29Z
dc.date.available2017-08-17T13:18:29Z
dc.date.issued2016
dc.description.abstractBackground 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.
dc.description.versionVersión Publicada
dc.format.extent5
dc.identifier.citationOlavarría VV, Arima H, Anderson CS, et al. Statistical analysis plan of the head position in acute ischemic stroke trial pilot (HEADPOST pilot). International Journal of Stroke. 2017;12(2):211-215. doi:10.1177/1747493016674955
dc.identifier.urihttp://hdl.handle.net/11447/1591
dc.identifier.urihttp://dx.doi.org/10.1177/1747493016674955
dc.language.isoen_US
dc.publisherSage Publications
dc.sourceInternational Journal of Stroke
dc.subjectCerebral blood flow velocity
dc.subjecthead position
dc.subjectischemic stroke
dc.subjectmiddle cerebral artery
dc.subjectpilot trial
dc.subjectstatistical analysis plan
dc.subjecttranscranial Doppler
dc.titleStatistical analysis plan of the head position in acute ischemic stroke trial pilot (HEADPOST pilot)
dc.typeArtículo

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