Page 179 - DECISION-MAKING IN SEVERE TRAUMATIC BRAIN INJURY PATIENT OUTCOME, HOSPITAL COSTS, AND RESEARCH PRACTICE

Informed consent in patients with an inability to provide consent
Practice in ICU stratum
Proxy informed consent (N=1377;64%) was the most frequently used type of consent in the ICU, followed by patient informed consent (N=426;20%) and deferred consent (N=334;16%) (Table 3). Proxy informed consent was most frequently used in the UK (96%), Southern Europe (80%) and The Baltic States (76%), and less frequently in Northern (56%) and Western Europe (49%). In contrast, deferred consent was most frequently used in Northern (19%) and Western Europe (25%) but infrequently in the UK (0.3%) and the Baltic States (3%) (Table 3). Seven countries (41%) did not use deferred consent. Austria did not use proxy informed consent, but showed the highest number of deferred consents instead (65%). (see Suppl Table 6)
Table 3. Number of patients (%) and type of used informed consent procedures in the ICU stratum per region.
Answers | Regions
Patient informed consent Proxy informed consent Deferred consent
Sample Total (N=2137)
426 (20) 1377 (64) 334 (16)
Baltic States (N=33)
7 (21) 25 (76) 1 (3)
Eastern Europe (N=33)
11 (33) 20 (61) 2 (6)
Northern Europe (N=391)
97 (25) 219 (56) 75 (19)
Southern Europe (N=546)
75 (14) 433 (79) 38 (7)
United Kingdom (N=271)
10 (4) 260 (96) 1 (0·3)
Western Europe (N=863)
226 (26) 420 (49) 217 (25)
Comparison of policy and practice
Proxy informed consent and deferred consent procedures are accepted by national 8 legislation of all displayed countries.13,28,29 (Table 4) Some centers however reported
proxy or deferred consent procedures to be not accepted. In addition, there was
variation between accepted procedures and actually used informed consent
procedures. Italy for instance reported a low rate of proxy informed consent acceptance and a high enrolment rate using proxy informed consent.
When also including countries (≤3 centres) that could not be displayed, the use of deferred consent in emergency situations was allowed in 10 out of 17 countries. The procedure was not mentioned in national legislation in 6 countries. In the questionnaire, 47 (82%) of the participating centres reported that it was possible to include patients with an acute inability to provide informed consent by using deferred consent. In practice, only 15 centres from seven countries were responsible for 99% (N=330) of the deferred consent cases in the ICU.
177