Silk garments plus standard care compared with standard care for treating eczema in children: a randomised controlled, observer blind, pragmatic trial (CLOTHES Trial)

Background The role of clothing in the management of eczema (syn. atopic dermatitis, atopic eczema) is poorly understood. This trial evaluated the effectiveness and cost-effectiveness of silk garments (in addition to standard care) for the management of eczema in children with moderate to severe...

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Main Authors:	Thomas, Kim S., Bradshaw, Lucy E., Sach, Tracey H., Batchelor, Jonathan M., Lawton, Sandra, Harrison, Eleanor F., Haines, Rachel H., Ahmed, Amina, Williams, Hywel C., Dean, Taraneh, Burrows, Nigel P., Pollock, Ian, Llewellyn, Joanne, Crang, Clare, Grundy, Jane D., Guiness, Juliet, Gribbin, Andrew, Mitchell, Eleanor J., Cowdell, Fiona, Brown, Sara J., Montgomery, Alan A.
Format:	Article
Language:	English
Published:	Public Library of Science 2017
Online Access:	http://eprints.nottingham.ac.uk/41097/ http://eprints.nottingham.ac.uk/41097/ http://eprints.nottingham.ac.uk/41097/ http://eprints.nottingham.ac.uk/41097/8/journal.pmed.1002280.pdf

id	nottingham-41097
recordtype	eprints
spelling	nottingham-410972018-01-23T15:00:18Z http://eprints.nottingham.ac.uk/41097/ Silk garments plus standard care compared with standard care for treating eczema in children: a randomised controlled, observer blind, pragmatic trial (CLOTHES Trial) Thomas, Kim S. Bradshaw, Lucy E. Sach, Tracey H. Batchelor, Jonathan M. Lawton, Sandra Harrison, Eleanor F. Haines, Rachel H. Ahmed, Amina Williams, Hywel C. Dean, Taraneh Burrows, Nigel P. Pollock, Ian Llewellyn, Joanne Crang, Clare Grundy, Jane D. Guiness, Juliet Gribbin, Andrew Mitchell, Eleanor J. Cowdell, Fiona Brown, Sara J. Montgomery, Alan A. Background The role of clothing in the management of eczema (syn. atopic dermatitis, atopic eczema) is poorly understood. This trial evaluated the effectiveness and cost-effectiveness of silk garments (in addition to standard care) for the management of eczema in children with moderate to severe disease. Methods and findings This was a parallel group randomised controlled, observer-blind trial. Children aged 1 to 15 years with moderate to severe eczema were recruited from secondary care and the community in five UK centres. Participants were allocated using on-line randomisation (1:1) to standard care, or standard care plus silk garments; stratified by age and recruiting centre. Silk garments were worn for 6 months. Primary outcome (eczema severity) was assessed at baseline, 2, 4 and 6 months, by nurses blinded to treatment allocation using the Eczema Area and Severity Index (EASI), which was log-transformed for analysis (intention-to-treat analysis). Safety outcome: number of skin infections. Three hundred children were randomised (26th Nov 2013 to 5th May 2015): 42% girls, 79% white, mean age 5 years. Primary analysis included 282/300 (94%) children (n = 141 in each group). The garments were worn more often at night than in the day (median of 81% of nights (25th to 75th centile 57% to 96%) and 34% of days (25th to 75th centile 10% to 76%)). Geometric mean EASI scores at baseline, 2, 4 and 6 months were 9·2, 6·4, 5·8, 5·4 for silk clothing and 8·4, 6·6, 6·0, 5·4 for standard care. There was no evidence of any difference between the groups in EASI score averaged over all follow up visits adjusted for baseline EASI score, age and centre (adjusted ratio of geometric means: 0·95, 95% CI 0·85 to 1·07). This confidence interval is equivalent to a difference of -1·5 to 0·5 in the original EASI scale units which is not clinically important. Skin infections occurred in 36/142 (25%) and 39/141 (28%) for silk clothing and standard care respectively. Even if the small observed treatment effect was genuine, the incremental cost per QALY was £56,881 in the base case analysis from an NHS perspective, suggesting that silk garments are unlikely to be cost-effective within currently accepted thresholds. Main limitations: whilst minimising detection bias, use of an objective primary outcome may have underestimated treatment effects. Conclusions Silk clothing is unlikely to provide additional benefit over standard care in children with moderate to severe eczema. Public Library of Science 2017-04-11 Article PeerReviewed application/pdf en cc_by http://eprints.nottingham.ac.uk/41097/8/journal.pmed.1002280.pdf Thomas, Kim S. and Bradshaw, Lucy E. and Sach, Tracey H. and Batchelor, Jonathan M. and Lawton, Sandra and Harrison, Eleanor F. and Haines, Rachel H. and Ahmed, Amina and Williams, Hywel C. and Dean, Taraneh and Burrows, Nigel P. and Pollock, Ian and Llewellyn, Joanne and Crang, Clare and Grundy, Jane D. and Guiness, Juliet and Gribbin, Andrew and Mitchell, Eleanor J. and Cowdell, Fiona and Brown, Sara J. and Montgomery, Alan A. (2017) Silk garments plus standard care compared with standard care for treating eczema in children: a randomised controlled, observer blind, pragmatic trial (CLOTHES Trial). PLoS Medicine, 14 (4). e1002280/1-e1002280/23. ISSN 1549-1277 http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1002280 doi:10.1371/journal.pmed.1002280 doi:10.1371/journal.pmed.1002280
repository_type	Digital Repository
institution_category	Local University
institution	University of Nottingham Malaysia Campus
building	Nottingham Research Data Repository
collection	Online Access
language	English
description	Background The role of clothing in the management of eczema (syn. atopic dermatitis, atopic eczema) is poorly understood. This trial evaluated the effectiveness and cost-effectiveness of silk garments (in addition to standard care) for the management of eczema in children with moderate to severe disease. Methods and findings This was a parallel group randomised controlled, observer-blind trial. Children aged 1 to 15 years with moderate to severe eczema were recruited from secondary care and the community in five UK centres. Participants were allocated using on-line randomisation (1:1) to standard care, or standard care plus silk garments; stratified by age and recruiting centre. Silk garments were worn for 6 months. Primary outcome (eczema severity) was assessed at baseline, 2, 4 and 6 months, by nurses blinded to treatment allocation using the Eczema Area and Severity Index (EASI), which was log-transformed for analysis (intention-to-treat analysis). Safety outcome: number of skin infections. Three hundred children were randomised (26th Nov 2013 to 5th May 2015): 42% girls, 79% white, mean age 5 years. Primary analysis included 282/300 (94%) children (n = 141 in each group). The garments were worn more often at night than in the day (median of 81% of nights (25th to 75th centile 57% to 96%) and 34% of days (25th to 75th centile 10% to 76%)). Geometric mean EASI scores at baseline, 2, 4 and 6 months were 9·2, 6·4, 5·8, 5·4 for silk clothing and 8·4, 6·6, 6·0, 5·4 for standard care. There was no evidence of any difference between the groups in EASI score averaged over all follow up visits adjusted for baseline EASI score, age and centre (adjusted ratio of geometric means: 0·95, 95% CI 0·85 to 1·07). This confidence interval is equivalent to a difference of -1·5 to 0·5 in the original EASI scale units which is not clinically important. Skin infections occurred in 36/142 (25%) and 39/141 (28%) for silk clothing and standard care respectively. Even if the small observed treatment effect was genuine, the incremental cost per QALY was £56,881 in the base case analysis from an NHS perspective, suggesting that silk garments are unlikely to be cost-effective within currently accepted thresholds. Main limitations: whilst minimising detection bias, use of an objective primary outcome may have underestimated treatment effects. Conclusions Silk clothing is unlikely to provide additional benefit over standard care in children with moderate to severe eczema.
format	Article
author	Thomas, Kim S. Bradshaw, Lucy E. Sach, Tracey H. Batchelor, Jonathan M. Lawton, Sandra Harrison, Eleanor F. Haines, Rachel H. Ahmed, Amina Williams, Hywel C. Dean, Taraneh Burrows, Nigel P. Pollock, Ian Llewellyn, Joanne Crang, Clare Grundy, Jane D. Guiness, Juliet Gribbin, Andrew Mitchell, Eleanor J. Cowdell, Fiona Brown, Sara J. Montgomery, Alan A.
spellingShingle	Thomas, Kim S. Bradshaw, Lucy E. Sach, Tracey H. Batchelor, Jonathan M. Lawton, Sandra Harrison, Eleanor F. Haines, Rachel H. Ahmed, Amina Williams, Hywel C. Dean, Taraneh Burrows, Nigel P. Pollock, Ian Llewellyn, Joanne Crang, Clare Grundy, Jane D. Guiness, Juliet Gribbin, Andrew Mitchell, Eleanor J. Cowdell, Fiona Brown, Sara J. Montgomery, Alan A. Silk garments plus standard care compared with standard care for treating eczema in children: a randomised controlled, observer blind, pragmatic trial (CLOTHES Trial)
author_facet	Thomas, Kim S. Bradshaw, Lucy E. Sach, Tracey H. Batchelor, Jonathan M. Lawton, Sandra Harrison, Eleanor F. Haines, Rachel H. Ahmed, Amina Williams, Hywel C. Dean, Taraneh Burrows, Nigel P. Pollock, Ian Llewellyn, Joanne Crang, Clare Grundy, Jane D. Guiness, Juliet Gribbin, Andrew Mitchell, Eleanor J. Cowdell, Fiona Brown, Sara J. Montgomery, Alan A.
author_sort	Thomas, Kim S.
title	Silk garments plus standard care compared with standard care for treating eczema in children: a randomised controlled, observer blind, pragmatic trial (CLOTHES Trial)
title_short	Silk garments plus standard care compared with standard care for treating eczema in children: a randomised controlled, observer blind, pragmatic trial (CLOTHES Trial)
title_full	Silk garments plus standard care compared with standard care for treating eczema in children: a randomised controlled, observer blind, pragmatic trial (CLOTHES Trial)
title_fullStr	Silk garments plus standard care compared with standard care for treating eczema in children: a randomised controlled, observer blind, pragmatic trial (CLOTHES Trial)
title_full_unstemmed	Silk garments plus standard care compared with standard care for treating eczema in children: a randomised controlled, observer blind, pragmatic trial (CLOTHES Trial)
title_sort	silk garments plus standard care compared with standard care for treating eczema in children: a randomised controlled, observer blind, pragmatic trial (clothes trial)
publisher	Public Library of Science
publishDate	2017
url	http://eprints.nottingham.ac.uk/41097/ http://eprints.nottingham.ac.uk/41097/ http://eprints.nottingham.ac.uk/41097/ http://eprints.nottingham.ac.uk/41097/8/journal.pmed.1002280.pdf
first_indexed	2018-09-06T13:10:43Z
last_indexed	2018-09-06T13:10:43Z
_version_	1610863810426437632

Silk garments plus standard care compared with standard care for treating eczema in children: a randomised controlled, observer blind, pragmatic trial (CLOTHES Trial)

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