TY - JOUR
T1 - Statistical analysis plan
T2 - Early mobilization by head-up tilt with stepping versus standard care after severe traumatic brain injury
AU - Riberholt, Christian Gunge
AU - Gluud, Christian
AU - Jakobsen, Janus Christian
AU - Ovesen, Christian
AU - Mehlsen, Jesper
AU - Møller, Kirsten
N1 - © 2021 The Authors.
PY - 2021/12
Y1 - 2021/12
N2 - 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.
AB - 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.
KW - Statistical analysis plan
KW - Early mobilization
KW - Trial sequential analysis
KW - Traumatic brain injury
U2 - 10.1016/j.conctc.2021.100856
DO - 10.1016/j.conctc.2021.100856
M3 - Protocol
C2 - 34877432
SN - 2451-8654
VL - 24
SP - 100856
JO - Contemporary Clinical Trials Communications
JF - Contemporary Clinical Trials Communications
ER -