Informed consent for research obtained during the intensive care unit stay

Table 1 Demographic, anamnestic characteristics and intensive care unit data of the two groups of patients

Characteristic	Complete recall	Incomplete recall	p
n	14	30
Demographic and educational data
Age, years (mean ± SD)	54 ± 22	54 ± 21	> 0.99^b
Male/female, n	9/5	19/11	0.95^c
Educational status
Up to junior high school, n (percentage)	6 (43)	11(37)	0.89^d
Intermediate (college), n (percentage)	6 (43)	16 (53)
Academic level or more, n (percentage)	1 (7)	1 (3)
Not available, n (percentage)	1 (7)	2 (7)
Daily alcohol intake, n (percentage)	1 (7)	8 (27)	0.23^c
ICU and hospital data
Admission diagnosis, n (percentage)			0.77^c
Abdominal surgery, n (percentage)	7 (50)	10 (33)
Cardiovascular surgery, n (percentage)	3 (21.5)	8 (27)
Trauma, n (percentage)	3 (21.5)	9 (30)
Other, n (percentage)	1 (7)	3 (10)
Emergency admission/elective admission, n	7/7	16/14	> 0.99^c
Admission SAPS II (mean ± SD)	16 ± 10	20 ± 9	0.24^b
Length of mechanical ventilation^a, hours (median (range))	0 (0–15)	0 (0–64)	0.47^e
Length of ICU stay, days (median (range))	3 (2–9)	4 (2–25)	0.43^e

ICU, intensive care unit; SAPS II, Simplified Acute Physiology Score second version. 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. ^aNone of the patients were intubated at the time of the informed consent procedure; ^bStudent's t test; ^cFisher's exact test; ^dχ² test; ^eMann–Whitney U test.

ISSN: 1364-8535