Page 192 - DECISION-MAKING IN SEVERE TRAUMATIC BRAIN INJURY PATIENT OUTCOME, HOSPITAL COSTS, AND RESEARCH PRACTICE
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Chapter 9
outcome (modified Rankin Scale score 0–2). 29,30 The ULTRA-study included patients with decisional capacity without patient consent before intervention because delay in ultra-early administration of the study intervention could compromise its potential effect, and thereby invalidate trial design and trial outcome. Obtaining consent was even considered unethical because patients would have been exposed to unnecessary risk. 31 Several options to minimise time-to-consent have been suggested, ranging from information leaflets to the use of electronic consenting by telemedicine or smartphones.32–34 Nonetheless, many studies have described recruitment problems related to informed consent procedures.21,26,35 These problems are not limited to patients in acute care settings, but also occur when patients are exposed to continued and prolonged study activities.
To determine the approaches to informed consent procedures used by traumatic brain injury and ischaemic stroke researchers, we examined a representative sample of randomised controlled trials in emergency traumatic brain injury (n=70) and ischaemic stroke (N=76) literature (appendix pp 3–16; panel 2). Type of consent was reported in 61 (87%) of 70 randomised controlled trials on traumatic brain injury and in 71 (93%) of 76 randomised controlled trials on ischaemic stroke. Patient consent before medical intervention was mentioned to be the only consent option in 3 (5%) of 61 randomised controlled trials on traumatic brain injury and five (7%) of 71 randomised controlled trials on ischaemic stroke. In total, patient consent before intervention was reported to be an option in 15 (25%) of 61 randomised controlled trials on traumatic brain injury and 68 (96%) of 71 randomised controlled trials on ischaemic stroke (table; panel 3). Obtaining patient consent before intervention was often stated to be impossible because of the sustained brain injury (appendix pp 3, 16–17). In these cases, researchers resorted to three alternatives to patient informed consent before intervention: proxy informed consent before intervention, deferred consent, and exception from informed consent or waiver of consent.
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