Page 175 - DECISION-MAKING IN SEVERE TRAUMATIC BRAIN INJURY PATIENT OUTCOME, HOSPITAL COSTS, AND RESEARCH PRACTICE

Informed consent in patients with an inability to provide consent
use of informed consent procedures in general and not specifically for the CENTER-TBI study. The question mentioning the ‘deferred consent/waiver of consent’ alternatives was used to assess the possibility of study start without prior informed consent in emergency research and was named deferred consent in this article. Answers explicitly represent a general consensus at the centres, rather than an individuals’ preference, in an attempt to capture the actual policy of all study centres. Responses were collected and stored by using a secure online database (QuesGen Systems Incorporated, Burlingame, CA, USA).23 Detailed information on the provider profiling questionnaires has been published previously.24 An additional analysis of national regulations that were applicable at the time of study was performed and compared with the results of the questionnaire and actual observed informed consent procedures.13
Practice: CENTER-TBI Core study
The CENTER-TBI Core study (clinicaltrials.gov NCT02210221; RRID: SCR_015582) was
conducted between December 2014 and December 2017.25 Enrolment criteria were a
clinical diagnosis of TBI, indication for CT-scanning, and presentation to study centre
within 24h of injury. Approval from an IRB or any other appropriate ethics review body
was obtained by all centres and informed consent procedures followed local and
national requirements. On enrolment, patients were differentiated by care pathway:
ER stratum (discharged from emergency room), Admission stratum (hospital ward), 8 and ICU stratum (admission to the intensive care unit (ICU)). For this study, informed
consent practice was pragmatically observed in the ICU stratum (N=2137) of CENTER- TBI, since we focussed on patients with an acute inability to provide informed consent. The presence of the inability to provide informed consent was very unlikely in patients from the ER and Admission stratum because nearly all sustained mild TBI and provided informed consent themselves.
Clinical data included details on the type and time of informed consent and were collected and de-identified using a web-based electronic case report form (QuesGen) and stored on a secure database, hosted by the International Neuroinformatics Coordinating Facility (INCF; www.incf.org) in Stockholm, Sweden.26
Analyses
Data (Version 1·0, released: 01/11/2018) was extracted via the custom-made data access tool Neurobot (http://neurobot.incf.org), developed by INCF. Descriptive statistics were used to obtain frequencies and percentages. For analysis of potential differences
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