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
Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, UK.
Nottingham Clinical Trials Unit, University of Nottingham, Queen's Medical Centre, Nottingham, UK.
Health Technol Assess. 2017 Apr;21(16):1-260. doi: 10.3310/hta21160.
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.
To assess the effectiveness and cost-effectiveness of silk garments for the management of AE in children with moderate to severe disease.
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.
Secondary care and the community in five UK centres.
Children aged 1-15 years with moderate or severe AE.
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 (AlPreTec Srl, San Donà di Piave, Italy) or DreamSkin (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.
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.
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 ( = 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; = 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.
Knowledge of treatment allocation may have affected behaviour and outcome reporting for some of the patient-reported outcomes.
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.
Non-pharmacological interventions for the management of AE remain a research priority among patients.
Current Controlled Trials ISRCTN77261365.
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 21, No. 16. See the NIHR Journals Library website for further project information.
特应性皮炎（AE）是一种慢性、瘙痒性炎症性皮肤病，会影响儿童及其家庭的生活质量。人们对专科服装在AE管理中的作用了解甚少。
评估丝绸服装对中重度AE患儿的疗效及成本效益。
为期6个月的平行组、观察者盲法随机对照试验，随后为2个月的观察期。一项嵌套的定性研究评估了试验参与者、医护人员和医疗保健专员对使用丝绸服装治疗AE的看法。
英国五个中心的二级医疗和社区。
年龄在1至15岁之间的中重度AE患儿。
参与者通过在线随机分组（1∶1）被随机分配至标准护理组或标准护理加100%由抗菌保护的无丝胶针织丝绸制成的丝绸服装组[DermaSilk（意大利圣多纳迪皮亚韦的AlPreTec Srl公司）或DreamSkin（英国哈特菲尔德的DreamSkin Health Ltd公司）]。每位参与者提供三套服装，可穿戴长达6个月（日夜均可）。6个月时，标准护理组收到服装用于剩余的2个月观察期。
主要结局——使用湿疹面积和严重程度指数（EASI）评估AE严重程度，由对治疗分配不知情的护士在2、4和6个月时进行评估。对EASI评分进行对数转换以进行分析。次要结局——患者报告的湿疹症状（患者导向性湿疹量表）；严重程度的整体评估（研究者整体评估）；儿童的生活质量（特应性皮炎生活质量，儿童健康效用-9维度）、家庭（皮炎家庭影响问卷）和主要照顾者（欧洲五维度健康量表-3水平）；标准湿疹治疗方法（如润肤剂、外用皮质类固醇）的使用情况；以及成本效益。通过父母/照顾者的自我报告评估服装的可接受性和耐用性，以及穿着服装的依从性。安全性结局——AE导致的皮肤感染次数和住院次数。
共有300名儿童被随机分组（2013年11月26日至2015年5月5日）：42%为女性，79%为白人，平均年龄5岁。主要分析纳入了300名儿童中的282名（94%）（每组141名）。82%的参与者至少50%的时间穿着服装。标准护理组在基线、2、4和6个月时的几何平均EASI评分分别为8.4、6.6、6.0、5.4，丝绸服装组分别为9.2、6.4、5.8、5.4。在根据基线EASI评分、年龄和中心进行调整后的所有随访中，两组的平均EASI评分没有差异的证据（几何均值比为0.95，95%置信区间为0.85至1.07；P = 0.43）。该置信区间相当于原始EASI量表单位中相差-1.5至0.5。标准护理组和丝绸服装组分别有141名参与者中的39名（28%）和142名参与者中的36名（25%）发生皮肤感染。从英国国家医疗服务体系（NHS）的角度来看，在基本情况下，中重度湿疹患儿使用丝绸服装每获得一个质量调整生命年（QALY）的增量成本为56,811英镑。敏感性分析支持了这一发现，即在目前公认的阈值范围内，丝绸服装似乎不具有成本效益。
对治疗分配的了解可能影响了一些患者报告结局的行为和结果报告。
对于中重度AE患儿，在标准AE护理中添加丝绸服装不太可能改善AE严重程度，与单独的标准护理相比也不具有成本效益。该试验增加了证据基础，以指导临床决策。
AE管理的非药物干预仍然是患者中的研究重点。
国际标准随机对照试验编号ISRCTN77261365。
该项目由英国国家卫生研究院（NIHR）卫生技术评估计划资助，将全文发表于《；第21卷，第16期》。有关进一步的项目信息，请参见NIHR期刊图书馆网站。
