Abstract Number: Esoc2026a656 Acceptability of Deferred Consent Among Participants and Proxies of an Acute Neurosurgical Intervention Trial in Intracerebral Haemorrhage; A Dutch Ich Surgery Trial Substudy

Abstract Background and aims Obtaining valid informed consent is not always feasible in acute stroke trials. Although legal and ethical grounds for deferred consent in these situations exist, controversy remains on its proper use and acceptability, especially in trials with more invasive interventions. In this study, we assessed acceptability of deferred consent in an acute neurosurgical intervention trial in intracerebral haemorrhage. Methods We conducted a prospective telephone survey among participants of the Dutch ICH Surgery Trial (DIST; NCT05460793) or their proxies, whoever gave initial consent, using a piloted questionnaire. Primary outcome was the percentage of respondents that agreed with using deferred consent in DIST. Secondary outcomes included arguments for (dis)agreement, support for deferred consent in future trials, satisfaction with provided information, and views on proxy decision making. Results A total of 100 respondents were included (response rate 78%; baseline characteristics in Table 1). Of these, 88% (strongly) agreed with using deferred consent in DIST - mostly because of the need for urgent intervention (21%) and lack of decisional capacity (18%) - whereas 3% disagreed to some extent; the remaining 9% were indifferent or unable to answer. Most respondents (78%) felt sufficiently informed about DIST, but less than half about deferred consent (48%). There was strong agreement between participants and proxies (90%), and the majority of proxies (85%) felt capable of deciding on behalf of their relatives. Conclusions A large majority of respondents considered deferred consent acceptable. Deferred consent should be considered as alternative consent procedure in future acute trials in intracerebral haemorrhage, including those investigating neurosurgical interventions. Conflict of interest Nothing to disclose Table 1 - belongs to Conclusions