Home time is extended in XXXX with ischemic stroke who receive thrombolytic therapy: a validation study of home time as an outcome measure.

@entity1 @entity64 @entity6 @entity2806 @entity1662 @entity1054 @entity2055 @entity4653
BACKGROUND AND PURPOSE: "Home time" ( @entity1054 ) refers to the number of days over the first 90 after @entity64 onset that a @entity1 spends residing in their own home or a relative's home versus any institutional care. It is an accessible and objective parameter, free from subjective bias, with potential as an outcome measure in @entity64 trials. We sought to validate @entity1054 and assess treatment responsiveness using independent data. METHODS: We estimated @entity1054 in the @entity64 Acute Ischemic NXY Treatment (SAINT) I neuroprotection trial. We compared outcomes between thrombolyzed (T) and nonthrombolyzed comparators (C) using @entity1054 and the modified Rankin Scale. For our primary analysis, we adjusted for baseline covariates that significantly influence @entity1054 and in sensitivity analyses considered all variables that differed between groups at baseline. We report ordinal logistic regression and analysis of covariance with 95% CIs. We describe the relationship of @entity1054 with baseline National Institutes of Health @entity64 Scale and its components and with Day 90 modified Rankin Scale and Barthel Index. RESULTS: SAINT I included 1699 @entity1 from 23 countries, of whom 28.7% received alteplase. @entity1054 correlated with age, baseline severity, alteplase use, side of @entity2806 , presence of @entity6 , and country of @entity1 enrollment (each P<0.05). We found an association between use of alteplase with better adjusted outcomes by either measure (OR for extended @entity1054 , 1.36; 95% CI, 1.08 to 1.72; P=0.009; analysis of covariance P=0.007 with a 5.5-day advantage; OR for more favorable modified Rankin Scale, 1.6; 95% CI, 1.28 to 2.00; P<0.0001; Cochran-Mantel-Haenszel P=0.046). @entity1054 was significantly associated with baseline National Institutes of Health @entity64 Scale and each component of the National Institutes of Health @entity64 Scale except level of @entity1662 , @entity4653 , and @entity2055 . @entity1054 was significantly associated with Day 90 modified Rankin Scale and Barthel Index. CONCLUSIONS: @entity1054 is a responsive measure for use in multinational @entity64 trials. Its inclusion as a complementary outcome is reasonable. We propose treatment effects are adjusted for age, baseline National Institutes of Health @entity64 Scale, side of @entity64 , country of enrollment, and the presence of @entity6 .
