Randomised controlled trial of silk therapeutic garments for the management of atopic eczema in children: the CLOTHES trial

Kim S. Thomas (Lead / Corresponding author), Lucy E. Bradshaw, Tracey H. Sach, Fiona Cowdell, Jonathan M Batchelor, Sandra Lawton, Eleanor F. Harrison, Rachel H. Haines, Amina Ahmed, Taraneh Dean, Nigel P. Burrows, Ian Pollock, Hannah K. Buckley, Hywel C. Williams, Joanne Llewellyn, Clare Crang, Jane D. Grundy, Juliet Guiness, Andrew Gribbin, Eileen V. WakeEleanor J. Mitchell, Sara J. Brown, Alan A. Montgomery

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    Abstract

    Background: Atopic eczema (AE) is a chronic, itchy, inflammatory skin condition that affects the quality of life of children and their families. The role of specialist clothing in the management of AE is poorly understood.

    Objectives: To assess the effectiveness and cost-effectiveness of silk garments for the management of AE in children with moderate to severe disease.

    Design: Parallel-group, observer-blind, randomised controlled trial of 6 months' duration, followed by a 2-month observational period. A nested qualitative study evaluated the beliefs of trial participants, health-care professionals and health-care commissioners about the use of silk garments for AE.

    Setting: Secondary care and the community in five UK centres.

    Participants: Children aged 1-15 years with moderate or severe AE.

    Interventions: Participants were randomised (1 : 1 using online randomisation) to standard care or standard care plus 100% silk garments made from antimicrobially protected knitted sericin-free silk [DermaSilk(TM) (AlPreTec Srl, San Donà di Piave, Italy) or DreamSkin(TM) (DreamSkin Health Ltd, Hatfield, UK)]. Three sets of garments were supplied per participant, to be worn for up to 6 months (day and night). At 6 months the standard care group received the garments to use for the remaining 2-month observational period.

    Main outcome measures: Primary outcome - AE severity using the Eczema Area and Severity Index (EASI) assessed at 2, 4 and 6 months, by nurses blinded to treatment allocation. EASI scores were log-transformed for analysis. Secondary outcomes - patient-reported eczema symptoms (Patient Oriented Eczema Measure); global assessment of severity (Investigator Global Assessment); quality of life of the child (Atopic Dermatitis Quality of Life, Child Health Utility - 9 Dimensions), family (Dermatitis Family Impact Questionnaire) and main carer (EuroQoL-5 Dimensions-3 Levels); use of standard eczema treatments (e.g. emollients, topical corticosteroids); and cost-effectiveness. The acceptability and durability of the clothing, and adherence to wearing the garments, were assessed by parental/carer self-report. Safety outcomes - number of skin infections and hospitalisations for AE.

    Results: A total of 300 children were randomised (26 November 2013 to 5 May 2015): 42% female, 79% white, mean age 5 years. The primary analysis included 282 out of 300 (94%) children (n = 141 in each group). Garments were worn for at least 50% of the time by 82% of participants. Geometric mean EASI scores at baseline, 2, 4 and 6 months were 8.4, 6.6, 6.0, 5.4 for standard care and 9.2, 6.4, 5.8, 5.4 for silk clothing, respectively. There was no evidence of difference between the groups in EASI score averaged over all follow-up visits adjusted for baseline EASI score, age and centre (ratio of geometric means 0.95, 95% confidence interval 0.85 to 1.07; p = 0.43). This confidence interval is equivalent to a difference of -1.5 to 0.5 in the original EASI scale units. Skin infections occurred in 39 out of 141 (28%) and 36 out of 142 (25%) participants for standard care and silk clothing groups, respectively. The incremental cost per QALY of silk garments for children with moderate to severe eczema was £56,811 from a NHS perspective in the base case. Sensitivity analyses supported the finding that silk garments do not appear to be cost-effective within currently accepted thresholds.

    Limitations: Knowledge of treatment allocation may have affected behaviour and outcome reporting for some of the patient-reported outcomes.

    Conclusions: The addition of silk garments to standard AE care is unlikely to improve AE severity, or to be cost-effective compared with standard care alone, for children with moderate or severe AE. This trial adds to the evidence base to guide clinical decision-making.

    Future work: Non-pharmacological interventions for the management of AE remain a research priority among patients.

    Trial registration: Current Controlled Trials ISRCTN77261365.

    Original languageEnglish
    Pages (from-to)1-260
    Number of pages260
    JournalHealth Technology Assessment
    Volume21
    Issue number16
    DOIs
    Publication statusPublished - Apr 2017

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    Clothing
    Silk
    Atopic Dermatitis
    Eczema
    Randomized Controlled Trials
    Therapeutics
    Quality of Life
    Costs and Cost Analysis
    Skin
    Caregivers
    Cost-Benefit Analysis
    Sericins
    Emollients
    Confidence Intervals
    Delivery of Health Care
    Secondary Care
    Quality-Adjusted Life Years
    Dermatitis
    Standard of Care
    Child Care

    Cite this

    Thomas, K. S., Bradshaw, L. E., Sach, T. H., Cowdell, F., Batchelor, J. M., Lawton, S., ... Montgomery, A. A. (2017). Randomised controlled trial of silk therapeutic garments for the management of atopic eczema in children: the CLOTHES trial. Health Technology Assessment, 21(16), 1-260. https://doi.org/10.3310/hta21160
    Thomas, Kim S. ; Bradshaw, Lucy E. ; Sach, Tracey H. ; Cowdell, Fiona ; Batchelor, Jonathan M ; Lawton, Sandra ; Harrison, Eleanor F. ; Haines, Rachel H. ; Ahmed, Amina ; Dean, Taraneh ; Burrows, Nigel P. ; Pollock, Ian ; Buckley, Hannah K. ; Williams, Hywel C. ; Llewellyn, Joanne ; Crang, Clare ; Grundy, Jane D. ; Guiness, Juliet ; Gribbin, Andrew ; Wake, Eileen V. ; Mitchell, Eleanor J. ; Brown, Sara J. ; Montgomery, Alan A. / Randomised controlled trial of silk therapeutic garments for the management of atopic eczema in children : the CLOTHES trial. In: Health Technology Assessment. 2017 ; Vol. 21, No. 16. pp. 1-260.
    @article{173b02e26f924af6bf3c83e9d3bec869,
    title = "Randomised controlled trial of silk therapeutic garments for the management of atopic eczema in children: the CLOTHES trial",
    abstract = "Background: Atopic eczema (AE) is a chronic, itchy, inflammatory skin condition that affects the quality of life of children and their families. The role of specialist clothing in the management of AE is poorly understood.Objectives: To assess the effectiveness and cost-effectiveness of silk garments for the management of AE in children with moderate to severe disease.Design: Parallel-group, observer-blind, randomised controlled trial of 6 months' duration, followed by a 2-month observational period. A nested qualitative study evaluated the beliefs of trial participants, health-care professionals and health-care commissioners about the use of silk garments for AE.Setting: Secondary care and the community in five UK centres.Participants: Children aged 1-15 years with moderate or severe AE.Interventions: Participants were randomised (1 : 1 using online randomisation) to standard care or standard care plus 100{\%} silk garments made from antimicrobially protected knitted sericin-free silk [DermaSilk(TM) (AlPreTec Srl, San Don{\`a} di Piave, Italy) or DreamSkin(TM) (DreamSkin Health Ltd, Hatfield, UK)]. Three sets of garments were supplied per participant, to be worn for up to 6 months (day and night). At 6 months the standard care group received the garments to use for the remaining 2-month observational period.Main outcome measures: Primary outcome - AE severity using the Eczema Area and Severity Index (EASI) assessed at 2, 4 and 6 months, by nurses blinded to treatment allocation. EASI scores were log-transformed for analysis. Secondary outcomes - patient-reported eczema symptoms (Patient Oriented Eczema Measure); global assessment of severity (Investigator Global Assessment); quality of life of the child (Atopic Dermatitis Quality of Life, Child Health Utility - 9 Dimensions), family (Dermatitis Family Impact Questionnaire) and main carer (EuroQoL-5 Dimensions-3 Levels); use of standard eczema treatments (e.g. emollients, topical corticosteroids); and cost-effectiveness. The acceptability and durability of the clothing, and adherence to wearing the garments, were assessed by parental/carer self-report. Safety outcomes - number of skin infections and hospitalisations for AE.Results: A total of 300 children were randomised (26 November 2013 to 5 May 2015): 42{\%} female, 79{\%} white, mean age 5 years. The primary analysis included 282 out of 300 (94{\%}) children (n = 141 in each group). Garments were worn for at least 50{\%} of the time by 82{\%} of participants. Geometric mean EASI scores at baseline, 2, 4 and 6 months were 8.4, 6.6, 6.0, 5.4 for standard care and 9.2, 6.4, 5.8, 5.4 for silk clothing, respectively. There was no evidence of difference between the groups in EASI score averaged over all follow-up visits adjusted for baseline EASI score, age and centre (ratio of geometric means 0.95, 95{\%} confidence interval 0.85 to 1.07; p = 0.43). This confidence interval is equivalent to a difference of -1.5 to 0.5 in the original EASI scale units. Skin infections occurred in 39 out of 141 (28{\%}) and 36 out of 142 (25{\%}) participants for standard care and silk clothing groups, respectively. The incremental cost per QALY of silk garments for children with moderate to severe eczema was £56,811 from a NHS perspective in the base case. Sensitivity analyses supported the finding that silk garments do not appear to be cost-effective within currently accepted thresholds.Limitations: Knowledge of treatment allocation may have affected behaviour and outcome reporting for some of the patient-reported outcomes.Conclusions: The addition of silk garments to standard AE care is unlikely to improve AE severity, or to be cost-effective compared with standard care alone, for children with moderate or severe AE. This trial adds to the evidence base to guide clinical decision-making.Future work: Non-pharmacological interventions for the management of AE remain a research priority among patients.Trial registration: Current Controlled Trials ISRCTN77261365.",
    author = "Thomas, {Kim S.} and Bradshaw, {Lucy E.} and Sach, {Tracey H.} and Fiona Cowdell and Batchelor, {Jonathan M} and Sandra Lawton and Harrison, {Eleanor F.} and Haines, {Rachel H.} and Amina Ahmed and Taraneh Dean and Burrows, {Nigel P.} and Ian Pollock and Buckley, {Hannah K.} and Williams, {Hywel C.} and Joanne Llewellyn and Clare Crang and Grundy, {Jane D.} and Juliet Guiness and Andrew Gribbin and Wake, {Eileen V.} and Mitchell, {Eleanor J.} and Brown, {Sara J.} and Montgomery, {Alan A.}",
    note = "This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 16. See the NIHR Journals Library website for further project information.",
    year = "2017",
    month = "4",
    doi = "10.3310/hta21160",
    language = "English",
    volume = "21",
    pages = "1--260",
    journal = "Health Technology Assessment",
    issn = "1366-5278",
    publisher = "NIHR",
    number = "16",

    }

    Thomas, KS, Bradshaw, LE, Sach, TH, Cowdell, F, Batchelor, JM, Lawton, S, Harrison, EF, Haines, RH, Ahmed, A, Dean, T, Burrows, NP, Pollock, I, Buckley, HK, Williams, HC, Llewellyn, J, Crang, C, Grundy, JD, Guiness, J, Gribbin, A, Wake, EV, Mitchell, EJ, Brown, SJ & Montgomery, AA 2017, 'Randomised controlled trial of silk therapeutic garments for the management of atopic eczema in children: the CLOTHES trial', Health Technology Assessment, vol. 21, no. 16, pp. 1-260. https://doi.org/10.3310/hta21160

    Randomised controlled trial of silk therapeutic garments for the management of atopic eczema in children : the CLOTHES trial. / Thomas, Kim S. (Lead / Corresponding author); Bradshaw, Lucy E.; Sach, Tracey H.; Cowdell, Fiona; Batchelor, Jonathan M; Lawton, Sandra; Harrison, Eleanor F.; Haines, Rachel H.; Ahmed, Amina; Dean, Taraneh; Burrows, Nigel P.; Pollock, Ian; Buckley, Hannah K.; Williams, Hywel C.; Llewellyn, Joanne; Crang, Clare; Grundy, Jane D.; Guiness, Juliet; Gribbin, Andrew; Wake, Eileen V.; Mitchell, Eleanor J.; Brown, Sara J.; Montgomery, Alan A.

    In: Health Technology Assessment, Vol. 21, No. 16, 04.2017, p. 1-260.

    Research output: Contribution to journalArticle

    TY - JOUR

    T1 - Randomised controlled trial of silk therapeutic garments for the management of atopic eczema in children

    T2 - the CLOTHES trial

    AU - Thomas, Kim S.

    AU - Bradshaw, Lucy E.

    AU - Sach, Tracey H.

    AU - Cowdell, Fiona

    AU - Batchelor, Jonathan M

    AU - Lawton, Sandra

    AU - Harrison, Eleanor F.

    AU - Haines, Rachel H.

    AU - Ahmed, Amina

    AU - Dean, Taraneh

    AU - Burrows, Nigel P.

    AU - Pollock, Ian

    AU - Buckley, Hannah K.

    AU - Williams, Hywel C.

    AU - Llewellyn, Joanne

    AU - Crang, Clare

    AU - Grundy, Jane D.

    AU - Guiness, Juliet

    AU - Gribbin, Andrew

    AU - Wake, Eileen V.

    AU - Mitchell, Eleanor J.

    AU - Brown, Sara J.

    AU - Montgomery, Alan A.

    N1 - This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 16. See the NIHR Journals Library website for further project information.

    PY - 2017/4

    Y1 - 2017/4

    N2 - Background: Atopic eczema (AE) is a chronic, itchy, inflammatory skin condition that affects the quality of life of children and their families. The role of specialist clothing in the management of AE is poorly understood.Objectives: To assess the effectiveness and cost-effectiveness of silk garments for the management of AE in children with moderate to severe disease.Design: Parallel-group, observer-blind, randomised controlled trial of 6 months' duration, followed by a 2-month observational period. A nested qualitative study evaluated the beliefs of trial participants, health-care professionals and health-care commissioners about the use of silk garments for AE.Setting: Secondary care and the community in five UK centres.Participants: Children aged 1-15 years with moderate or severe AE.Interventions: Participants were randomised (1 : 1 using online randomisation) to standard care or standard care plus 100% silk garments made from antimicrobially protected knitted sericin-free silk [DermaSilk(TM) (AlPreTec Srl, San Donà di Piave, Italy) or DreamSkin(TM) (DreamSkin Health Ltd, Hatfield, UK)]. Three sets of garments were supplied per participant, to be worn for up to 6 months (day and night). At 6 months the standard care group received the garments to use for the remaining 2-month observational period.Main outcome measures: Primary outcome - AE severity using the Eczema Area and Severity Index (EASI) assessed at 2, 4 and 6 months, by nurses blinded to treatment allocation. EASI scores were log-transformed for analysis. Secondary outcomes - patient-reported eczema symptoms (Patient Oriented Eczema Measure); global assessment of severity (Investigator Global Assessment); quality of life of the child (Atopic Dermatitis Quality of Life, Child Health Utility - 9 Dimensions), family (Dermatitis Family Impact Questionnaire) and main carer (EuroQoL-5 Dimensions-3 Levels); use of standard eczema treatments (e.g. emollients, topical corticosteroids); and cost-effectiveness. The acceptability and durability of the clothing, and adherence to wearing the garments, were assessed by parental/carer self-report. Safety outcomes - number of skin infections and hospitalisations for AE.Results: A total of 300 children were randomised (26 November 2013 to 5 May 2015): 42% female, 79% white, mean age 5 years. The primary analysis included 282 out of 300 (94%) children (n = 141 in each group). Garments were worn for at least 50% of the time by 82% of participants. Geometric mean EASI scores at baseline, 2, 4 and 6 months were 8.4, 6.6, 6.0, 5.4 for standard care and 9.2, 6.4, 5.8, 5.4 for silk clothing, respectively. There was no evidence of difference between the groups in EASI score averaged over all follow-up visits adjusted for baseline EASI score, age and centre (ratio of geometric means 0.95, 95% confidence interval 0.85 to 1.07; p = 0.43). This confidence interval is equivalent to a difference of -1.5 to 0.5 in the original EASI scale units. Skin infections occurred in 39 out of 141 (28%) and 36 out of 142 (25%) participants for standard care and silk clothing groups, respectively. The incremental cost per QALY of silk garments for children with moderate to severe eczema was £56,811 from a NHS perspective in the base case. Sensitivity analyses supported the finding that silk garments do not appear to be cost-effective within currently accepted thresholds.Limitations: Knowledge of treatment allocation may have affected behaviour and outcome reporting for some of the patient-reported outcomes.Conclusions: The addition of silk garments to standard AE care is unlikely to improve AE severity, or to be cost-effective compared with standard care alone, for children with moderate or severe AE. This trial adds to the evidence base to guide clinical decision-making.Future work: Non-pharmacological interventions for the management of AE remain a research priority among patients.Trial registration: Current Controlled Trials ISRCTN77261365.

    AB - Background: Atopic eczema (AE) is a chronic, itchy, inflammatory skin condition that affects the quality of life of children and their families. The role of specialist clothing in the management of AE is poorly understood.Objectives: To assess the effectiveness and cost-effectiveness of silk garments for the management of AE in children with moderate to severe disease.Design: Parallel-group, observer-blind, randomised controlled trial of 6 months' duration, followed by a 2-month observational period. A nested qualitative study evaluated the beliefs of trial participants, health-care professionals and health-care commissioners about the use of silk garments for AE.Setting: Secondary care and the community in five UK centres.Participants: Children aged 1-15 years with moderate or severe AE.Interventions: Participants were randomised (1 : 1 using online randomisation) to standard care or standard care plus 100% silk garments made from antimicrobially protected knitted sericin-free silk [DermaSilk(TM) (AlPreTec Srl, San Donà di Piave, Italy) or DreamSkin(TM) (DreamSkin Health Ltd, Hatfield, UK)]. Three sets of garments were supplied per participant, to be worn for up to 6 months (day and night). At 6 months the standard care group received the garments to use for the remaining 2-month observational period.Main outcome measures: Primary outcome - AE severity using the Eczema Area and Severity Index (EASI) assessed at 2, 4 and 6 months, by nurses blinded to treatment allocation. EASI scores were log-transformed for analysis. Secondary outcomes - patient-reported eczema symptoms (Patient Oriented Eczema Measure); global assessment of severity (Investigator Global Assessment); quality of life of the child (Atopic Dermatitis Quality of Life, Child Health Utility - 9 Dimensions), family (Dermatitis Family Impact Questionnaire) and main carer (EuroQoL-5 Dimensions-3 Levels); use of standard eczema treatments (e.g. emollients, topical corticosteroids); and cost-effectiveness. The acceptability and durability of the clothing, and adherence to wearing the garments, were assessed by parental/carer self-report. Safety outcomes - number of skin infections and hospitalisations for AE.Results: A total of 300 children were randomised (26 November 2013 to 5 May 2015): 42% female, 79% white, mean age 5 years. The primary analysis included 282 out of 300 (94%) children (n = 141 in each group). Garments were worn for at least 50% of the time by 82% of participants. Geometric mean EASI scores at baseline, 2, 4 and 6 months were 8.4, 6.6, 6.0, 5.4 for standard care and 9.2, 6.4, 5.8, 5.4 for silk clothing, respectively. There was no evidence of difference between the groups in EASI score averaged over all follow-up visits adjusted for baseline EASI score, age and centre (ratio of geometric means 0.95, 95% confidence interval 0.85 to 1.07; p = 0.43). This confidence interval is equivalent to a difference of -1.5 to 0.5 in the original EASI scale units. Skin infections occurred in 39 out of 141 (28%) and 36 out of 142 (25%) participants for standard care and silk clothing groups, respectively. The incremental cost per QALY of silk garments for children with moderate to severe eczema was £56,811 from a NHS perspective in the base case. Sensitivity analyses supported the finding that silk garments do not appear to be cost-effective within currently accepted thresholds.Limitations: Knowledge of treatment allocation may have affected behaviour and outcome reporting for some of the patient-reported outcomes.Conclusions: The addition of silk garments to standard AE care is unlikely to improve AE severity, or to be cost-effective compared with standard care alone, for children with moderate or severe AE. This trial adds to the evidence base to guide clinical decision-making.Future work: Non-pharmacological interventions for the management of AE remain a research priority among patients.Trial registration: Current Controlled Trials ISRCTN77261365.

    U2 - 10.3310/hta21160

    DO - 10.3310/hta21160

    M3 - Article

    C2 - 28409557

    VL - 21

    SP - 1

    EP - 260

    JO - Health Technology Assessment

    JF - Health Technology Assessment

    SN - 1366-5278

    IS - 16

    ER -