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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.