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  • Choice of Moisturiser for Eczema Treatment (COMET): feasibility study of a randomised controlled parallel group trial in children recruited from primary care

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Dermatology
Research
Choice of Moisturiser for Eczema Treatment (COMET): feasibility study of a randomised controlled parallel group trial in children recruited from primary care
  1. Matthew J Ridd1,
  2. Kirsty Garfield2,
  3. Daisy M Gaunt2,
  4. Sandra Hollinghurst1,
  5. Niamh M Redmond1,
  6. Kingsley Powell1,
  7. Victoria Wilson1,
  8. Richard H Guy3,
  9. Nicola Ball1,
  10. Lindsay Shaw4,
  11. Sarah Purdy1,
  12. Chris Metcalfe2
  1. 1Centre for Academic Primary Care, School of Social and Community Medicine, University of Bristol, Bristol, UK
  2. 2Bristol Randomised Trials Collaboration, School of Social and Community Medicine, University of Bristol, Bristol, UK
  3. 3Department of Pharmacy and Pharmacology, University of Bath, Bath, UK
  4. 4Department of Dermatology, University Hospitals Bristol NHS Foundation Trust, Bristol, UK
  1. Correspondence to Dr Matthew J Ridd; m.ridd{at}bristol.ac.uk

Abstract

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.

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This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

https://doi.org/10.1136/bmjopen-2016-012021

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    Footnotes

    • Twitter Follow Matthew Ridd at @riddmj

    • Contributors MJR proposed the original study idea and its design, and NB, NMR, SH, SP, RHG and LS helped develop this idea and obtain funding for the project. Specific input provided by authors included: NB and LS on the choice and use of emollients in eczema and assessment of eczema severity; RHG on collection and interpretation of skin hydration data; DMG and CM on analysis, development of skin hydration model and reporting of main feasibility findings; SH and KG on analysis and reporting health economic data; KP and VW assisted with collation, cleaning and reporting of findings; NMR and SP input on study design and delivery; CM on trial methodology and conduct. MJR wrote the first draft and led on all subsequent revisions; NMR, KG, VW, SH, SP, KP, CM, DMG, NB, LS and RHG all commented on and contributed to revised versions of the manuscript. All authors have read and approved the final manuscript.

    • Funding The COMET study independent research funded by the National Institute for Health Research (Research for Patient Benefit Programme, PB-PG-0712-28056).

    • Disclaimer The views expressed in the publication are those of the author(s) and not necessarily those of the NHS, the National Institute for Health Research or the Department of Health.

    • Competing interests NB has been an employee of Galderma (UK) Ltd since May 2015.

    • Ethics approval Central Bristol Research Ethics Committee (REC reference: 13/SW/0297).

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement The research team will consider reasonable requests for sharing of patient level data. Requests should be made to MJR. Consent for data sharing was not obtained, but the presented data are anonymised and risk of identification is low.