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Table 1 Characteristics of the study population and baseline stroke severity as a function of informed consent status

From: Which factors influence the resort to surrogate consent in stroke trials, and what are the patient outcomes in this context?

  Informed consent  
  Direct (n = 167) Surrogate (n = 228) P value
Number of patients N = 167 N = 228  
Age, y, mean ± SD 63.5 ± 14.8 70.2 ± 14.1 <0.0001
Men 99 (59.3) 112 (49.1) 0.046
BMI, kg/m2, mean ± SD 26.6 ± 5.1 26.6 ± 5.0 0.96
Qualifying event    
Ischemic stroke 156 (93.4) 202 (88.6) 0.10
Brain haemorrhage 11 (6.6) 26 (11.4)  
Risk factors    
Hypertension 102 (61.1) 144 (63.2) 0.67
Diabetes 29 (17.4) 45 (19.7) 0.58
Hypercholesterolemia 70 (41.9) 111 (48.7) 0.18
Smokers 59 (35.3) 56 (24.6) 0.020
Heavy drinkers 27 (16.2) 37 (16.4) 0.96
Physical activity 101 (61.2) 94 (41.4) 0.0001
History of stroke 13 (7.8) 36 (15.9) 0.016
History of ischemic heart disease 25 (15.0) 57 (25.0) 0.015
Heart failure 8 (4.8) 35 (15.4) 0.0009
Peripheral arteriopathy 8 (4.8) 14 (6.2) 0.54
Stroke severity    
GCS score <15 6 (3.6) 90 (39.5) <0.0001
NIHSS score, median (IQR) 3 (1–5) 12 (6–19) <0.0001
NIHSS score >5 41 (24.6) 178 (78.1) <0.0001
Aphasia 31 (18.6) 119 (52.2) <0.0001
Cognitive impairment (IQCODE > 78) 58 (37.9) 107 (49.8) 0.024
  1. Values are quoted as the number (%), unless otherwise indicated.
  2. Abbreviations. BMI: body mass index, GCS: Glasgow Coma Scale, IQCODE: Informant Questionnaire on Cognitive Decline in the Elderly, IQR: interquartile range, NIHSS: National Institutes of Health Stroke Scale, SD: standard deviation.