OBJECTIVES: To determine the feasibility of a randomised controlled trial of 'leave on' emollients for children with eczema.
DESIGN: Single-centre, pragmatic, 4-arm, observer-blinded, parallel, randomised feasibility trial.
SETTING: General practices in the UK.
PARTICIPANTS: Children with eczema aged 1 month to <5 years.
OUTCOME MEASURES: Primary outcome-proportion of parents who reported use of the allocated study emollient every day for the duration of follow-up (12 weeks). Other feasibility outcomes-participant recruitment and retention, data collection and completeness and blinding of observers to allocation.
INTERVENTIONS: Aveeno lotion, Diprobase cream, Doublebase gel, Hydromol ointment.
RESULTS: 197 children were recruited-107 by self-referral (mainly via practice mail-outs) and 90 by inconsultation (clinician consenting and randomising) pathways. Participants recruited inconsultation were younger, had more severe Patient-Oriented Eczema Measure scores and were more likely to withdraw than self-referrals. Parents of 20 (10%) of all the randomised participants reported using the allocated emollient daily for 84 days. The use of other non-study emollients was common. Completeness of data collected by parent-held daily diaries and at monthly study visits was good. Daily diaries were liked (81%) but mainly completed on paper rather than via electronic ('app') form. Major costs drivers were general practitioner consultations and eczema-related prescriptions. Observer unblinding was infrequent, and occurred at the baseline or first follow-up visit through accidental disclosure.
CONCLUSIONS: It is feasible in a primary care setting to recruit and randomise young children with eczema to emollients, follow them up and collect relevant trial data, while keeping observers blinded to their allocation. However, reported use of emollients (study and others) has design implications for future trials.
TRIAL REGISTRATION NUMBER: ISRCTN21828118/EudraCT2013-003001-26.
|Number of pages||9|
|Publication status||Published - 16 Nov 2016|
- BTC (Bristol Trials Centre)
- Centre for Surgical Research
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Professor Chris Metcalfe
- Bristol Medical School (PHS) - Professor of Medical Statistics
- Bristol Population Health Science Institute
- Centre for Academic Mental Health
Person: Academic , Member