Page 180 - DECISION-MAKING IN SEVERE TRAUMATIC BRAIN INJURY PATIENT OUTCOME, HOSPITAL COSTS, AND RESEARCH PRACTICE

Chapter 8
Table 4. Comparison of observed practice, national legislation and reported policy regarding informed consent procedures in the CENTER-TBI ICU stratum.
Country (N)
Belgium (N=4) France (N=5) Germany (N=4) Italy (N=8) Netherlands (N=7) Norway (N=3) Spain (N=3)
UK (N=9) Total
DISCUSSION
Patients included using patient informed consent (N (%))
71 (37) 25 (22) 24 (28) 34 (10) 68 (19) 33 (20) 41 (21) 10 (4) 306
Proxy informed consent procedures accepted according to national legislation? [13]
Yes Yes Yes Yes Yes Yes [28] Yes
Yes
Number of centers (%) accepting proxy informed consent according to provider profiling
4 (100) 5 (100) 2 (50) 3 (37) 6 (86) 3 (100) 2 (67) 8 (89) 33
Patient informed consent alternatives like proxy informed consent, deferred consent and independent physician consent were widely used in the CENTER-TBI study and were essential to include ICU admitted TBI patients with an acute inability to provide informed consent. Alternatives to patient informed consent are essential in TBI research. Only 20% of ICU patients provided patient informed consent. This study found substantial between and within-country variation in reported accepted informed consent policies and actually used informed consent procedures. Variation could be caused by several reasons and could indicate that either clear national or European legislation is unavailable or that knowledge of such legislation may be inconsistent amongst clinicians and researchers.
The number of patient informed consent (N=2497; 56%) observed in the CENTER- TBI core study was higher than expected. This was partly due to the large number of patients in the ER and Admission strata (>95% with mild TBI) that were able to provide informed consent (87%). In addition, many patients in the ICU stratum had mild TBI (36%).27 This could explain the high number of patient informed consents (20%) in the ICU, but it is also possible that study personnel wrongly considered a patient to have the ability to provide patient informed consent. The CENTER-TBI study did not use or document any assessment of a patients’ ability to provide informed consent. Although assessment methods are available and used in some studies, they have important limitations.30,31 It is important that researchers formally assess the ability to provide informed consent in all patients when possible. Especially in patients with a
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