Best Emollients for Eczema (BEE): Pragmatic, primary care, multi-centre, individually randomised superiority trial of four emollients in children with eczema, with internal pilot and nested qualitative study

DESIGN: Pragmatic, parallel, individually randomised superiority trial of four types of emollient with internal pilot and nested qualitative study SETTING: Primary care (GP surgeries) in England (East Midlands, Wessex and West of England) POPULATION: Children 6 months to 12 years old with eczema (POEM>2); willing to be randomised to and use allocated emollient as sole leave on treatment for 16 weeks; no known sensitivity to study emollient; carer able to give consent and complete outcome measures HEALTH TECHNOLOGIES: Lotion, Cream, Gel, Ointment OUTCOMES: Primary: carer-reported eczema symptoms (POEM, measured weekly for 16 weeks). Secondary: eczema signs (EASI, by blinded assessor), quality of life (condition-specific – ADQoL, generic – CHU-9D main carer and EQ-5D-5L; and Dermatitis Family Impact, DFI), use of study emollient/other eczema treatments, satisfaction with emollient and adverse effects. Data collected via online or paper questionnaires and GP electronic medical record (EMR) review at 12 months. ANALYSIS: Linear mixed models for differences in weekly POEM scores, adjusting for baseline values. SAMPLE SIZE: 520 (130 per group) to detect a difference of 3.0 in POEM scores between any two groups (b=0.90) assuming POEM SD 5.5 and 20% loss to follow-up. To account for multiple testing, a=0.0083 (a=0.05/6 pairwise comparisons equivalent). QUALITATIVE STUDY: Semi-structured interviews. Initial round with ~20 participants (including participants who stop using emollient), within first 4 weeks, with focus on emollient acceptability and perceived effectiveness. Further interviews with ~40 participants after 16 weeks will focus on experiences of emollient use and decision making around future use. Thematic analysis using constant comparative method. Audio-recording of ~60 recruitment consultations during internal pilot, to ensure robust consent procedures. CURRENT & PLANNED CARE PATHWAYS: All participants will use allocated study emollient as only leave on treatment for 16 weeks. Participants can change after this – maximising recruitment/retention but allowing collection of data on behaviour relating to preferences. PROJECT TIMETABLE: Months -6 to 0 - set-up & approvals; 1 to 6 - staff recruitment & training; participant recruitment and interviews (5 to 24); participant follow-up (9 to 28); 17 to 36 - EMR review; 28 to 40 - data cleaning, analysis & reporting. Based on feasibility study: 3 centres, ~7 participants recruited (and followed-up) per month per centre from 75 practices. Internal pilot (first 9 months of recruitment) with clear stop/go criteria based on recruitment & retention. TEAM EXPERTISE: Experienced team with established working relationships, comprising: clinical academics (primary care and dermatology); primary care researchers; trialists; medical statistician; health economist; qualitative researchers; PPI and knowledge mobilisation members.