Page 178 - DECISION-MAKING IN SEVERE TRAUMATIC BRAIN INJURY PATIENT OUTCOME, HOSPITAL COSTS, AND RESEARCH PRACTICE

Chapter 8
Substantial variation in informed consent policies was noted between regions in Europe. All centres in Northern and Eastern Europe reported prior proxy informed consent to be valid (100%), in contrast to centres in The Baltic States (75%), Southern Europe (45%), the United Kingdom (UK) (89%) and Western Europe (81%). Regarding Southern Europe, especially Italian centers (62%) reported proxy informed consent to be invalid. (See Suppl Table 4).
Acceptance of consent by an independent physician was lower (37%) and variable across European regions. (See Fig. 1 & Suppl Table 4) It was especially considered valid in Germany (100%), the UK (89%), and Spain (67%). None of the centers from The Netherlands, Italy and Norway reported this alternative to be valid, while other countries were inconsistent. (see Suppl Table 5)
The use of the deferred consent procedure was reported valid by most centers in most regions, except Eastern Europe. (see Suppl Table 4) When reported valid, it was mostly regulated by IRB approval (N=36) or by law (N=11). Of countries with ≥3 centres, all mentioned that the procedure was valid. (see Suppl Table 5)
PractIce
Overall practice
All participating centres (N=57) included 4498 patients. Most patients were admitted to the ICU stratum (N=2137;48%) followed by the Admission stratum (N=1517;34%) and the ER stratum (N=844;19%). Overall, patient informed consent (N=2497;56%) was the most frequently used type of consent, followed by proxy informed consent (N=1635;36%) and deferred consent (N=366;8%) The use of patient informed consent was lower for patients requiring ICU admission (N=426;20%) compared to patients requiring admission to the ward (N=1266;83%). (Table 2)
Table 2. Number of patients (%) and type of used informed consent procedure per stratum in the CENTER-TBI study.
Consent type | Stratum
Patient informed consent (N=2497, 56%)
Proxy informed consent (N=1635, 36%)
Deferred consent (N=366, 8%)
ER (N=844, 19%)
805 (95) 35 (4) 4 (0·5)
Admission (N=1517, 34%)
1266 (83) 223 (15) 28 (2)
ICU (N=2137, 48%)
426 (20) 1377 (64) 334 (16)
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