Page 194 - DECISION-MAKING IN SEVERE TRAUMATIC BRAIN INJURY PATIENT OUTCOME, HOSPITAL COSTS, AND RESEARCH PRACTICE

Chapter 9
Panel 3: Comparison of consent procedures in traumatic brain injury and ischaemic stroke literature
There are similarities and differences between the types of consent reported in traumatic brain injury and ischaemic stroke literature (appendix p 16).
First, the patient consent before intervention option was reported to be used less frequently in randomised controlled trials on traumatic brain injury (25%) than in randomised controlled trials on ischaemic stroke (96%; table). This difference does not necessarily mean that patient consent before intervention was impermissible when a participants’ consent capacity was intact, but could also mean that it was not considered applicable or relevant for the study population. The difference likely depends on patient and study characteristics and is probably related to a perceived continued ability to provide patient informed consent before intervention after ischaemic stroke in most patients, whereas traumatic brain injury generally has a greater effect on this ability. This might be especially true in the case of more severe traumatic brain injury, additional extracranial injury, and a need for intensive care unit admission.
Second, the reported possibility to use proxy informed consent before intervention was very high in both literature on traumatic brain injury (92%) and ischaemic stroke (88%), and the use of independent physician consent procedures was equally low (3·3% vs 2·8%).
Third, the use of deferred consent and exception from consent was higher in randomised controlled trials on traumatic brain injury (23%) than in those on ischaemic stroke (11%), probably for the same reasons as reported for patient informed consent before intervention differences. There seems to be an increase in randomised controlled trials allowing patient recruitment without patient informed consent before intervention or proxy informed consent before intervention; however, many studies did not use it as an alternative for patient informed consent or proxy informed consent before intervention.
Last, there were more missing descriptions of consent procedures in the literature on traumatic brain injury (13%) than on ischaemic stroke (6·6%), which is likely caused by the inclusion of more dated randomised controlled trials on traumatic brain injury. Nearly all newer studies included a description of informed consent procedures.
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