Page 181 - DECISION-MAKING IN SEVERE TRAUMATIC BRAIN INJURY PATIENT OUTCOME, HOSPITAL COSTS, AND RESEARCH PRACTICE

Patients included using proxy informed consent (N (%))
122 (63) 90 (78) 54 (62) 279 (79) 154 (43) 94 (58) 154 (79) 260 (96) 1207
Deferred consent accepted in emergency research according to national legislation? [13]
Yes
Yes
Yes
Yes
Yes
Yes [29] Not mentioned Yes
Number of centers (%) accepting deferred consent in emergency research according to provider profiling
4 (100) 5 (100) 3 (75) 5 (63) 6 (86) 3 (100) 3 (100) 9 (100) 38
Patients included using deferred consent (N (%))
0 (0) 0 (0) 9 (10) 38 (11) 137 (38) 36 (22) 0 (0) 1 (0.4) 221
Informed consent in patients with an inability to provide consent
possible episode of an acute inability to provide informed consent. This assessment should ideally be recorded in the case report form to guarantee the validity of patient informed consent.
Alternatives for patient informed consent allowed the inclusion of 80% of ICU stratum
patients. Overall, proxy informed consent was the most frequently used alternative.
Although it was not always reported to be an accepted informed consent policy for 8 mentally incapacitated patients, it was an accepted procedure by all national laws.
Proxies usually prefer to be involved in decision-making, but proxy informed consent
has several important limitations.32 Several studies report substantial discrepancies
between patients and proxies and conclude that proxies are poor surrogate decision-
makers.7-9,33 In addition, proxies are not always present in emergency situations, or are
too overwhelmed by the stressful situation to provide valid proxy informed consent.34,35
Researchers and clinicians should be aware of the many factors that are important in
the process of informed consent.36
Fortunately, it was also possible to include patients by using deferred consent when it was impossible to obtain prior patient or proxy informed consent. A total of 45 centres (79%) from ten countries, according to national law, or 47 centres (82%), according to reported policies, were allowed to use this procedure. Nonetheless, only 15 centres (26%) actively (>2 inclusions) used it. There are multiple explanations for this discrepancy. First, the use of deferred consent might be accepted in national legislation, but local IRBs may not have authorised it for the CENTER-TBI study. Also, the use of deferred consent is not ethically neutral and the acceptance by IRBs, healthcare providers, patients and relatives
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