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Table 2 Poor stroke outcomes 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

Surrogate

OR (95% CI)

P

OR (95% CI)*

P*

Day 8 outcomes

N = 166

N = 220

    

NIHSS >5†

25 (15.0)

117 (51.3)

5.99 (3.64-9.85)

<0.0001

5.81 (3.46-9.76)

<0.0001

Cognitive impairment (MMSE < 24) ‡

21 (12.6)

58 (25.4)

2.37 (1.37-4.10)

0.002

1.95 (1.11-3.44)

0.021

Poor outcome (mRS ≥ 3)

36 (21.7)

144 (65.5)

6.84 (4.31-10.86)

<0.0001

5.76 (3.57-9.28)

<0.0001

All-cause death

0 (0.0)

12 (5.5)

-

-

-

-

Day 90 outcomes

N = 161

N = 212

    

NIHSS >5†

10 (6.0)

44 (19.3)

3.75 (1.83-7.70)

0.0001

3.88 (1.85-8.15)

0.0003

Cognitive impairment (MMSE < 24) ‡

8 (4.8)

35 (15.4)

3.60 (1.63-7.99)

0.002

3.11 (1.38-7.01)

0.006

Poor outcome (mRS ≥ 3)

27 (16.8)

122 (57.6)

6.73 (4.10-11.04)

<0.0001

5.44 (3.24-9.12)

<0.0001

All-cause death

4 (2.5)

41 (19.3)

9.41 (3.30-26.87)

<0.0001

6.36 (2.18-18.58)

<0.0001

  1. Values are quoted as the number (%), unless otherwise indicated. *adjusted for the patient’s age, physical activity before stroke and history of heart failure.
  2. Abbreviations: MMSE: Mini Mental State Examination, mRS: modified Rankin score, NIHSS: National Institutes of Health Stroke Scale, OR: odds ratio, CI: confidence interval.