ABSTRACT NUMBER: ESOC2026LB197 PLATFORM STUDY FOR INTRACEREBRAL HAEMORRHAGE (PLINTH): FEASIBILITY OF A PROPORTIONATE APPROACH TO CONSENT IN PLATFORM TRIAL RECRUITMENT

Abstract Background and aims Recruitment of people with spontaneous intracerebral haemorrhage (ICH) into clinical trials remains challenging. In this feasibility study, we aimed to evaluate the feasibility and acceptability of a proportionate consent process for a future platform trial for ICH. Methods We approached adults with incident ICH and sought verbal consent before written consent, using paper and multimedia materials and delivered face-to-face or by telephone, according to participant preference. Multimedia resources included a 3-minute narrated video about the study at verbal consent and a presentation with personalised information about the patient’s ICH and uncertainties about their care at written consent. We conducted semi-structured interviews on days 3 and 14 after written consent to explore acceptability and experiences of the consent process. Results Between October 2023 and June 2025, we approached 196 adults with ICH or their representatives. 168 (86%) provided verbal consent and 163 (83%) provided written consent (median age 72 years, 49% female, median ICH score 1 [IQR 0-2]). Most participants found giving verbal consent before written consent acceptable at both assessments (154/159, 97% and 149/152, 98%). Most (126/154, 82%) reported that the consent process supported their decision-making. Qualitative analysis dentified two preliminary themes: the multimedia materials were viewed as clear and educational; personalisation and dialogue increased relevance and value. Conclusions In this feasibility study, a proportionate consent process starting with verbal consent was acceptable to the vast majority of people with ICH or their representatives. Use of multimedia materials and flexible delivery methods may support recruitment of a broad and representative ICH population. Conflict of interest