title: Home time is extended in patients with ischemic stroke who receive thrombolytic therapy: a validation study of home time as an outcome measure.
abstract: OBJECTIVE
  "Home time" (HT) refers to the number of days over the first 90 after stroke onset that a patient 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 acute stroke trials. We sought to validate HT and assess treatment responsiveness using independent data.
  
  
  METHODS
  We estimated HT in the Stroke Acute Ischemic NXY Treatment (SAINT) I neuroprotection trial. We compared outcomes between thrombolyzed (T) and nonthrombolyzed comparators (C) using HT and the modified Rankin Scale. For our primary analysis, we adjusted for baseline covariates that significantly influence HT 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 HT with baseline National Institutes of Health Stroke Scale and its components and with Day 90 modified Rankin Scale and Barthel Index.
  
  
  RESULTS
  SAINT I included 1699 patients from 23 countries, of whom 28.7% received alteplase. HT correlated with age, baseline severity, alteplase use, side of ischemic lesion, presence of diabetes, and country of patient enrollment (each P<0.05). We found an association between use of alteplase with better adjusted outcomes by either measure (OR for extended HT, 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). HT was significantly associated with baseline National Institutes of Health Stroke Scale and each component of the National Institutes of Health Stroke Scale except level of consciousness, dysarthria, and ataxia. HT was significantly associated with Day 90 modified Rankin Scale and Barthel Index.
  
  
  CONCLUSIONS
  HT is a responsive measure for use in multinational acute stroke trials. Its inclusion as a complementary outcome is reasonable. We propose treatment effects are adjusted for age, baseline National Institutes of Health Stroke Scale, side of stroke lesion, country of enrollment, and the presence of diabetes.
authors.affiliation: Acute Stroke Unit, University of Glasgow, University Department of Medicine and Therapeutics, Gardiner Institute, Western Infirmary & Faculty of Medicine, University of Glasgow, Glasgow, UK G11 6NT. 0808124@clinmed.gla.ac.uk
authors.forename: Nishant K
authors.initials: NK
authors.lastname: Mishra
authors.forename: Ashfaq
authors.initials: A
authors.lastname: Shuaib
authors.forename: Patrick
authors.initials: P
authors.lastname: Lyden
authors.forename: Hans-Christoph
authors.initials: HC
authors.lastname: Diener
authors.forename: James
authors.initials: J
authors.lastname: Grotta
authors.forename: Stephen
authors.initials: S
authors.lastname: Davis
authors.forename: Antoni
authors.initials: A
authors.lastname: Davalos
authors.forename: Tim
authors.initials: T
authors.lastname: Ashwood
authors.forename: Warren
authors.initials: W
authors.lastname: Wasiewski
authors.forename: Kennedy R
authors.initials: KR
authors.lastname: Lees
mesh_terms: D000368:Aged; D002545:Brain Ischemia / Q000188:drug therapy* / Q000401:mortality / Q000451:nursing; D015331:Cohort Studies; D005260:Female; D005343:Fibrinolytic Agents / Q000627:therapeutic use; D006699:Home Care Services; D006760:Hospitalization; D006801:Humans; D007902:Length of Stay / Q000639:trends; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care / Q000379:methods* / Q000639:trends; D020127:Recovery of Function / Q000187:drug effects / Q000502:physiology; D020521:Stroke / Q000188:drug therapy* / Q000401:mortality / Q000451:nursing; D015912:Thrombolytic Therapy / Q000379:methods*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D005343:Fibrinolytic Agents