P123 A novel self-referral enrolment pathway in a UK multicentre atopic dermatitis trial (BEACON trial): a single-site prospective observational study to assess feasibility and effectiveness

Abstract Recruiting clinical trial participants to time and target can be challenging. Innovative recruitment strategies, such as facilitating participant self-referral, can be beneficial. The BEACON trial is a national multicentre phase IV assessor-blinded randomized controlled trial comparing the effectiveness, tolerability and cost-effectiveness of ciclosporin, methotrexate and dupilumab in adults with moderate-to-severe eczema. The aim of this study was to describe the impact of self-referral at the sponsor (chief investigator) site in the first year of active recruitment. The BEACON trial opened in November 2023. Self-referral was promoted via the BEACON trial and National Eczema Society websites, social media channels and meetings. Interested participants registered their interest via the BEACON website, then were contacted by their nearest trial site. They were subsequently sent a seven-point questionnaire to assess key eligibility criteria and were contacted via telephone by a subinvestigator (with or without photos) once the questionnaires were completed. If deemed suitable they were invited in for formal screening. Data relating to the mechanism of referral and subsequent progress of all potential participants were prospectively collected and analysed. In total, 594 self-referrals have been received through the trial website, of which 127 were forwarded to the sponsor (chief investigator) site. All 127 referrals were contacted, of whom 66 (52%) were screened, 51 (40%) passed screening and 41 (32%) were randomized to study treatment (similar to internal hospital referrals: 46%, 38% and 32%). Among self-referrals, 61 (48%) did not proceed to screening due to disease severity (31%), being unreachable (25%), comorbidities (15%), prior medications (13%) or other reasons. Of the self-referrals screened (66), 15 (23%) did not pass screening. This was due to low disease severity (60%), change of mind (13%) or undisclosed comorbidities (27%). Of those participants who passed screening (51), 53% were of White ethnicity, 24% Asian, 14% mixed and 8% Black. Self-referral participants had an average Eczema Area and Severity Index score of 30.6 (range 19.8–39.1), including one patient with erythroderma. In conclusion, self-referral has proven to be an important, efficient and highly effective mechanism of recruitment into the BEACON trial. It has been as effective as the more traditional site-based identification and has helped increase accessibility and representation of underserved groups. The high level of interest and disease severity may in part reflect the ongoing access challenges within the National Health Service. These data demonstrate that enabling self-referral can significantly aid clinical trial recruitment.