Large-scale stroke registries can provide critical insights into disease mechanisms, progression and healthcare needs, informing prevention and care. However, few collect detailed demographic, brain imaging, and comprehensive long-term follow-up data. To address this, we established the prospective Stroke Investigation Group in North And central London (SIGNAL) registry in 2017.

The SIGNAL registry included 3931 adults aged ≥18 years with confirmed acute stroke (cerebral ischaemia or intracerebral haemorrhage (ICH)) admitted to the University College London Hospital hyperacute stroke unit between January 2017 and 2020, drawn from an ethnically diverse North and Central London population (~1.6 million). Baseline data included demographic, clinical, brain imaging and next-of-kin information. Six month follow-up included measures of functional status and non-motor outcomes (anxiety, depression, fatigue, sleep, pain, language, continence, social participation, cognition) via face-to-face, telephone or postal follow-up methods.

The mean age of individuals included in the SIGNAL registry was 72.1 years, and 1806 (45.9%) were female. The ethnic distribution comprised 2365 (60%) white, 649 (16.5%) black and 511 (13%) Asian. Stroke diagnoses included 3371 (85.8%) with cerebral ischaemia and 560 (14.2%) with ICH. On admission, 2240 individuals (57.0%) had a National Institutes of Health Stroke Scale score >4, indicating moderate stroke severity. At hospital discharge, the median functional outcome, measured by the modified Rankin Scale, was 3 (IQR 1–4), indicating moderate disability. At 6 months, functional outcomes measured with mRS were available for 3755 individuals (95.6%) with a median score of 1 (IQR=0–3) and non-motor outcomes were available for 3080 individuals (92.3%). The most prevalent adverse non-motor outcomes were fatigue 1756 (57%), reduced social participation 1694 (55%) and sleep disturbance 1663 (54%).

Further analyses of SIGNAL registry data will investigating associations between stroke mechanisms, subtypes and neuroimaging features and 6-month functional status, non-motor outcomes and cognitive impairment. Longer term follow-up of survivors for ~10 years is also planned.

Perioperative randomised controlled trials (RCTs) in liver transplantation are relatively infrequent. RCTs performed in this complex patient population need to be robustly conducted to maximise patient benefit and graft utility given the scarcity of donor organs. Recruitment challenges can compromise RCTs and studies in this population face unique challenges due to recipient illness severity, their comorbidities, demographics and the geographical constraints of specialist transplant centres. Emergency presentation and after-hours admission may further limit patients’ capacity or readiness to consider trial participation. This Study Within a Trial (SWAT) specifically explored motivators and barriers to recruitment in patients awaiting liver transplantation.

An observational mixed-methods ‘Study within a Trial’, nested within a feasibility RCT.

This study was dual centred at two Tertiary National Health Service Hospitals; The Royal Free Hospital, a liver transplant centre in North London and University Hospital Birmingham, a liver transplant centre in Birmingham.

Adults who were eligible for liver transplantation and recruitment into the associated RCT were eligible for inclusion into the SWAT.

Completion of an 18-question validated written questionnaire which explored motivation for accepting or declining participation in the RCT.

Through completion of the questionnaire, participants shared their perspectives on the RCT and their rationale for consenting or declining participation. Responses were analysed, providing feedback to the Trial Management Group (TMG) to refine recruitment strategies for future trials. An additional component, comprising interviews and audio recordings of recruitment consultations, was planned if the RCT recruitment rates fell below prespecified thresholds or concerns were raised by the RCT TMG, neither of which occurred.

84 completed questionnaires were received. Motivators included patients believing that the trial will benefit others, interest in helping with research, perception that benefits outweigh risks and belief that it offered the best treatment. Barriers included concerns about randomisation, feeling overburdened and a perception of lack of support from family or friends.

This is the first study exploring recruitment to a perioperative RCT involving patients undergoing liver transplantation. Key motivators were altruism and perceived safety, while barriers included concerns about randomisation and lack of family support. Future focus during recruitment should be on neutral patient-centred consultations, adequate information sharing, fostering of patient trust, improved explanation of randomisation and engagement of the patient’s support network.

NCT04941911 (Health Research Authority) and SWAT 152 (the Study With A Trial Database).