Search

Background: In some acute care trials, immediate informed consent is not possible, but deferred consent is often considered problematic. We investigated the opinions of patients, proxies, and physicians about deferred consent in an acute stroke trial to gain insight into its acceptability and effects., Methods: Paper-based surveys were sent to patients who were randomly assigned in the Ultra-early Tranexamic Acid After Subarachnoid Hemorrhage (ULTRA) trial between 2015 and 2018 in two tertiary referral centers and to physicians of centers who agreed or declined to participate. The primary outcome measure was the proportion of respondents who agreed with deferral of consent in the ULTRA trial. Secondary outcomes included respondents' preferred consent procedure for the ULTRA trial, the effect of deferred consent on trust in physicians and scientific research, and the willingness to participate in future research., Results: Eighty-nine of 135 (66%) patients or proxies and 20 of 30 (67%) physicians completed the survey. Of these, 82 of 89 (92%) patients or proxies and 14 of 20 (70%) physicians agreed with deferral of consent in the ULTRA trial. When asked for their preferred consent procedure for the ULTRA trial, 31 of 89 (35%) patients or proxies indicated deferred consent, 15 of 89 (17%) preferred immediate informed consent, and 32 of 89 (36%) had no preference. None of the patients' or proxies' trust in physicians or scientific research had decreased because of the deferred consent procedure. Willingness to participate in future studies remained the same or increased in 84 of 89 (94%) patients or proxies., Conclusions: A large majority of the surveyed patients and proxies and a somewhat smaller majority of the surveyed physicians agreed with deferred consent in the ULTRA trial. Deferred consent may enable acute care trials in an acceptable manner without decreasing trust in medicine. Future research should investigate factors facilitating the responsible use of deferred consent, such as in-depth interviews, to study the minority of participants who agreed with deferred consent but still preferred immediate informed consent., (© 2021. The Author(s).)

Background: We assessed the occurrence of neurological deficits that may impede the capacity to provide consent for trial participation in patients with an acute stroke, who are eligible for endovascular treatment (EVT)., Methods: We used data from the Multicenter Randomized Controlled Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands Registry, a prospective observational cohort study. We included 1526 patients with an anterior large vessel occlusion, undergoing EVT between March 2014 and June 2016. We based our assessment of decision-making capacity for trial participation on neurological symptoms influencing conditions concerning informed consent as stated in the declaration of Helsinki. We formulated a strict and a mild capacity assessment rule, using 2 different cut points in item scores on the National Institutes of Health Stroke Scale (NIHSS)., Results: Applying the strict and mild rule, respectively 1469 (96%) and 1220 (80%) patients deemed not capable of decision-making for trial participation on admission, and 1077 (79%) and 825 (60%) patients at 24-48 hours after admission. Highest frequencies of predefined scores suggesting incapacity based on the strict rule were on the NIHSS items "Level of Consciousness Questions" (59%), "Best Gaze" (68%), and "Best Language" (58%). Patients who were considered incapable were older (median 71 versus 66 years, P = .043), had higher NIHSS scores (median 16 versus 8, P < .001), and had more often left hemisphere strokes (55% versus 28%, P < .001) than patients who were presumably capable., Conclusions: In the majority of patients with an anterior circulation stroke who are eligible for EVT, neurological deficits are present that may impede the capacity to provide informed consent for trial participation., (Copyright © 2019 Elsevier Inc. All rights reserved.)