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Data at the time of informed consent and the attitude of the patients |
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| Parameter |
Complete recall |
Incomplete recall |
p |
|
|
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| 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 |
|
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. | |||
Chenaud et al. Critical Care 2006 10:R170 doi:10.1186/cc5120 |
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