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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.