Statistical analysis plan: Early mobilization by head-up tilt with stepping versus standard care after severe traumatic brain injury

Background: Early mobilization on a tilt table with stepping versus standard care may be beneficial for patients with severe brain injury, but data from randomized clinical trials are lacking. This detailed statistical analysis plan describes the analyses of data collected in a randomized clinical f...

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Autores principales:	Christian Gunge Riberholt, Christian Gluud, Janus Christian Jakobsen, Christian Ovesen, Jesper Mehlsen, Kirsten Møller
Formato:	article
Lenguaje:	EN
Publicado:	Elsevier 2021
Materias:	Statistical analysis plan Early mobilization Trial sequential analysis Traumatic brain injury Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/debf1deb755042baba4785c86bb93e2b
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spelling	oai:doaj.org-article:debf1deb755042baba4785c86bb93e2b2021-11-26T04:36:26ZStatistical analysis plan: Early mobilization by head-up tilt with stepping versus standard care after severe traumatic brain injury2451-865410.1016/j.conctc.2021.100856https://doaj.org/article/debf1deb755042baba4785c86bb93e2b2021-12-01T00:00:00Zhttp://www.sciencedirect.com/science/article/pii/S2451865421001563https://doaj.org/toc/2451-8654Background: Early mobilization on a tilt table with stepping versus standard care may be beneficial for patients with severe brain injury, but data from randomized clinical trials are lacking. This detailed statistical analysis plan describes the analyses of data collected in a randomized clinical feasibility trial for early mobilization by head-up tilt with stepping versus standard care after severe traumatic brain injury. Methods: Primary feasibility outcomes are the proportion of included participants who were randomized out of all screened patients; the proportion of participants allocated to the experimental intervention who received at least 60% of the planned exercise sessions; and safety outcomes such as adverse events and reactions and serious adverse events and reactions. Exploratory clinical outcomes are suspected unexpected serious adverse reactions; and functional outcomes as assessed by the Coma Recovery Scale-Revised at four weeks; Early Functional Ability Scale and Functional Independence Measure at three months. The description includes the statistical analysis plan, including the use of multiple imputations and Trial Sequential Analysis.Christian Gunge RiberholtChristian GluudJanus Christian JakobsenChristian OvesenJesper MehlsenKirsten MøllerElsevierarticleStatistical analysis planEarly mobilizationTrial sequential analysisTraumatic brain injuryMedicine (General)R5-920ENContemporary Clinical Trials Communications, Vol 24, Iss , Pp 100856- (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Statistical analysis plan Early mobilization Trial sequential analysis Traumatic brain injury Medicine (General) R5-920
spellingShingle	Statistical analysis plan Early mobilization Trial sequential analysis Traumatic brain injury Medicine (General) R5-920 Christian Gunge Riberholt Christian Gluud Janus Christian Jakobsen Christian Ovesen Jesper Mehlsen Kirsten Møller Statistical analysis plan: Early mobilization by head-up tilt with stepping versus standard care after severe traumatic brain injury
description	Background: Early mobilization on a tilt table with stepping versus standard care may be beneficial for patients with severe brain injury, but data from randomized clinical trials are lacking. This detailed statistical analysis plan describes the analyses of data collected in a randomized clinical feasibility trial for early mobilization by head-up tilt with stepping versus standard care after severe traumatic brain injury. Methods: Primary feasibility outcomes are the proportion of included participants who were randomized out of all screened patients; the proportion of participants allocated to the experimental intervention who received at least 60% of the planned exercise sessions; and safety outcomes such as adverse events and reactions and serious adverse events and reactions. Exploratory clinical outcomes are suspected unexpected serious adverse reactions; and functional outcomes as assessed by the Coma Recovery Scale-Revised at four weeks; Early Functional Ability Scale and Functional Independence Measure at three months. The description includes the statistical analysis plan, including the use of multiple imputations and Trial Sequential Analysis.
format	article
author	Christian Gunge Riberholt Christian Gluud Janus Christian Jakobsen Christian Ovesen Jesper Mehlsen Kirsten Møller
author_facet	Christian Gunge Riberholt Christian Gluud Janus Christian Jakobsen Christian Ovesen Jesper Mehlsen Kirsten Møller
author_sort	Christian Gunge Riberholt
title	Statistical analysis plan: Early mobilization by head-up tilt with stepping versus standard care after severe traumatic brain injury
title_short	Statistical analysis plan: Early mobilization by head-up tilt with stepping versus standard care after severe traumatic brain injury
title_full	Statistical analysis plan: Early mobilization by head-up tilt with stepping versus standard care after severe traumatic brain injury
title_fullStr	Statistical analysis plan: Early mobilization by head-up tilt with stepping versus standard care after severe traumatic brain injury
title_full_unstemmed	Statistical analysis plan: Early mobilization by head-up tilt with stepping versus standard care after severe traumatic brain injury
title_sort	statistical analysis plan: early mobilization by head-up tilt with stepping versus standard care after severe traumatic brain injury
publisher	Elsevier
publishDate	2021
url	https://doaj.org/article/debf1deb755042baba4785c86bb93e2b
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Statistical analysis plan: Early mobilization by head-up tilt with stepping versus standard care after severe traumatic brain injury

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