Global differences in patient characteristics, case management and outcomes in intracerebral hemorrhage: the Factor Seven for Acute Hemorrhagic Stroke (FAST) trial.
BACKGROUND
The outcomes after stroke vary considerably between countries, yet the extent of the variation after intracerebral hemorrhage (ICH) remains unknown. This study examines differences in outcomes after ICH in a recent multinational trial, and explores the effect of differences in patient severity and case management for the variations observed.


METHODS
Factor Seven for Acute Hemorrhagic Stroke was a randomized, multinational, double-blind, placebo-controlled trial conducted between May 2005 and February 2007 at 122 sites in 22 countries. We investigated differences in baseline patient characteristics, case management and clinical outcomes across the 14 highest recruiting countries. Between-country differences in mortality and functional outcomes were examined using regression analysis while adjusting for differences in observed patient severity (case mix) and case management.


RESULTS
Eight hundred and one patients had complete data on baseline characteristics, case management and clinical outcomes and were recruited in a country that contributed >or=20 patients to the trial. Significant differences were observed between the countries in unadjusted mortality rates (p = 0.001) and functional outcomes (p = 0.001) at 90 days after ICH onset. When first adjusting for differences in case mix, and secondly differences in case management, the differences in outcomes remained significant, yet the variation between countries was reduced with each level of adjustment. Significant determinants of mortality were age, baseline ICH and intraventricular hemorrhage volume, baseline neurological deficit, smoking status, use of mechanical ventilation, total length of hospital stay, reduction in blood pressure between 1 and 20% during the first 24 h of admission and edema management. Poor functional outcomes were also determined by age, baseline ICH volume and baseline neurological deficit as well as neurosurgical procedures performed and sedation during the first 5 days of admission.


CONCLUSIONS
Significant global differences exist in the clinical outcomes after ICH, even after comprehensively adjusting for differences in case mix and case management. This is most likely due to unmeasured variation in case mix and case management. Similar research is encouraged in data sets of other multinational stroke trials to further investigate country-level and regional differences in clinical outcomes.
Christensen
Michael C
MC
Global Development, Novo Nordisk A/S, Bagsvaerd, Denmark. mcrc@novonordisk.com
Broderick
Joseph
J
Vincent
Catherine
C
Morris
Stephen
S
Steiner
Thorsten
T
D000367:Age Factors; D000368:Aged; D019090:Case Management; D002543:Cerebral Hemorrhage / Q000175:diagnosis* / Q000401:mortality / Q000628:therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007391:International Cooperation; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D011379:Prognosis; D016032:Randomized Controlled Trials as Topic; D012044:Regression Analysis; D012121:Respiration, Artificial; D012720:Severity of Illness Index; D012907:Smoking