P31 Trial design to improve inclusion of patients from ethnic minority backgrounds

Abstract

Abstract The ALPHA trial was a UK National Institute for Health and Care Research-funded, multicentre, prospective, adaptive, two-arm parallel group randomized controlled trial. Consenting participants with severe chronic hand eczema (CHE) were randomized on a 1 : 1 basis to receive either alitretinoin or immersion psoralen + ultraviolet A in conjunction with concomitant topical corticosteroids, emollients and patient education. Different skin types might respond differently to phototherapy due to different pigmentation, so it was important to recruit an ethnically diverse patient group. This was reflected in the design and analysis of the trial. ALPHA included a substudy where photographs were taken in a subgroup of randomly selected consenting participants and used as a disease-assessment quality-assurance check. Following a discussion with the Trial Steering Committee patient representative, a protocol amendment was implemented so that all consenting participants of an ethnic minority background would be selected for the substudy to assess any differences by skin type. The minimization algorithm was amended to incorporate the skin type as a minimization factor to ensure balance between the treatment groups in terms of skin colour and incorporated as a covariate in the primary analysis. ALPHA recruited 441 participants between October 2015 and June 2021, of which 49 (11.1%) were participants from ethnic minority background (13% was the national average in 2011, and 18% was the national average in 2021). In total, 95.2% (n = 373/392) of White participants and 92% (n = 45/49) of participants from ethnic minority backgrounds provided consent to have photographs taken as part of ALPHA. A total of 113 (30.3%) consenting White participants were selected for the photographic substudy, and 36 (80%) ethnic minority participants were selected. The presentation will report on the agreement between assessors in terms of photographs by skin type. Details of disagreement between photographs will be explored through the use of other disease-assessment measures that provide extra detail on the clinical symptoms that may not be visible on a photograph. Through increased awareness of the importance of different skin types, the trial was adapted to ensure ALPHA recruited a proportion of participants from ethnic minorities similar to the proportion of people from ethnic minority backgrounds in the UK. As a result, the trial was an example of adapting trial design to acknowledge the differences across ethnic groups, and to lead to improved research outcomes for patients from ethnic minority backgrounds. We will conclude the presentation with some practical recommendations for equality, diversity and inclusion in dermatological clinical trials.