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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.