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Table 2 Data at the time of informed consent and the attitude of the patients

From: Informed consent for research obtained during the intensive care unit stay

Parameter Complete recall Incomplete recall p
n 14 30  
Data at the time of informed consent    
   GCS (mean ± SD) 15 ± 0 15 ± 0 > 0.99a
   SOFA score (median (range)) 2 (1–5) 2.5 (0–9) 0.18b
   Temperature, °C (mean ± SD) 37.0 ± 0.5 37.2 ± 0.7 0.21a
   Glycemia, mmol/l (mean ± SD) 7 ± 2 7 ± 3 0.38a
   Creatinin, μmol/l (mean ± SD) 80 ±± 25 105 ± 78 0.24a
   Bilirubin, mmol/l (mean ± SD) 13 ± 6 15 ± 6 0.18a
Medications    
   24 hours before informed consent    
Morphine, n (percentage) 2 (14) 11 (37) 0.17c
Benzodiazepines, n (percentage) 1 (7) 5 (17) 0.65c
Vasopressors, n (percentage) 0 (0) 0 (0)  
   24 hours after informed consent    
Morphine, n (percentage) 8 (57) 18 (60) > 0.99c
Benzodiazepines, n (percentage) 1 (7) 3 (10) > 0.99c
'Attitude' of the patients    
   Read leaflet before consent, n (percentage) 11 (79) 17 (57) 0.20c
   Asked at least one question before consent, n (percentage) 8 (57) 6 (20) 0.03c
   Read or asked, n (percentage) 13 (93) 18 (60) 0.03c
   Read and asked, n (percentage) 6 (43) 5 (17) 0.13c
  1. GCS, Glasgow Coma Scale; SOFA, Sequential Organ Failure Assessment score. In the complete recall group, patients able to mention their clinical trial participation and the two clinical trial components; in the incomplete recall group, patients were unable to mention their clinical trial participation or one of the clinical trial components. aStudent's t test; bMann–Whitney U test;cFisher's exact test.