Choice of moisturiser for eczema treatment (COMET)

feasibility study of a randomised controlled parallel group trial in children recruited from primary care

Matthew Ridd, Kirsty Garfield, Daisy Gaunt, Sandra Hollinghurst, Niamh Redmond, Kingsley Powell, Victoria Wilson, Richard Guy, Nicola Ball, Lindsay Shaw, Sarah Purdy, Chris Metcalfe

Research output: Contribution to journalArticle

12 Citations (Scopus)

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, observerblinded, 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 selfreferral (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.
Original languageEnglish
Article numbere012021
Number of pages9
JournalBMJ Open
Volume6
Issue number11
Publication statusPublished - 16 Nov 2016

Fingerprint

Emollients
Eczema
Feasibility Studies
Primary Health Care
Therapeutics
Referral and Consultation
Parents
Disclosure
Postal Service
Ointments
General Practice
General Practitioners
Prescriptions
Randomized Controlled Trials
Gels
Outcome Assessment (Health Care)
Costs and Cost Analysis

Cite this

Ridd, M., Garfield, K., Gaunt, D., Hollinghurst, S., Redmond, N., Powell, K., ... Metcalfe, C. (2016). Choice of moisturiser for eczema treatment (COMET): feasibility study of a randomised controlled parallel group trial in children recruited from primary care. BMJ Open, 6(11), [e012021].

Choice of moisturiser for eczema treatment (COMET) : feasibility study of a randomised controlled parallel group trial in children recruited from primary care. / Ridd, Matthew; Garfield, Kirsty; Gaunt, Daisy; Hollinghurst, Sandra; Redmond, Niamh; Powell, Kingsley ; Wilson, Victoria; Guy, Richard; Ball, Nicola; Shaw, Lindsay; Purdy, Sarah; Metcalfe, Chris.

In: BMJ Open, Vol. 6, No. 11, e012021, 16.11.2016.

Research output: Contribution to journalArticle

Ridd, M, Garfield, K, Gaunt, D, Hollinghurst, S, Redmond, N, Powell, K, Wilson, V, Guy, R, Ball, N, Shaw, L, Purdy, S & Metcalfe, C 2016, 'Choice of moisturiser for eczema treatment (COMET): feasibility study of a randomised controlled parallel group trial in children recruited from primary care', BMJ Open, vol. 6, no. 11, e012021.
Ridd, Matthew ; Garfield, Kirsty ; Gaunt, Daisy ; Hollinghurst, Sandra ; Redmond, Niamh ; Powell, Kingsley ; Wilson, Victoria ; Guy, Richard ; Ball, Nicola ; Shaw, Lindsay ; Purdy, Sarah ; Metcalfe, Chris. / Choice of moisturiser for eczema treatment (COMET) : feasibility study of a randomised controlled parallel group trial in children recruited from primary care. In: BMJ Open. 2016 ; Vol. 6, No. 11.
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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, observerblinded, 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 selfreferral (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.",
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T2 - feasibility study of a randomised controlled parallel group trial in children recruited from primary care

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AU - Garfield, Kirsty

AU - Gaunt, Daisy

AU - Hollinghurst, Sandra

AU - Redmond, Niamh

AU - Powell, Kingsley

AU - Wilson, Victoria

AU - Guy, Richard

AU - Ball, Nicola

AU - Shaw, Lindsay

AU - Purdy, Sarah

AU - Metcalfe, Chris

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N2 - Objectives: To determine the feasibility of a randomised controlled trial of ‘leave on’ emollients for children with eczema. Design: Single-centre, pragmatic, 4-arm, observerblinded, 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 selfreferral (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.

AB - Objectives: To determine the feasibility of a randomised controlled trial of ‘leave on’ emollients for children with eczema. Design: Single-centre, pragmatic, 4-arm, observerblinded, 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 selfreferral (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.

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UR - http://bmjopen.bmj.com/content/6/11/e012021.full

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