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

1. Odhiambo JA, Williams HC, Clayton TO, Robertson CF, Asher MI, ISAAC Phase Three Study Group. Global variations in prevalence of eczema symptoms in children from ISAAC Phase Three. J Allergy Clin Immunol. 2009;124(6):1251–8.e23. doi: 10.1016/j.jaci.2009.10.009 20004783

2. Lewis‐Jones S. Quality of life and childhood atopic dermatitis: the misery of living with childhood eczema. Int J Clin Pract. 2006;60(8):984–92. doi: 10.1111/j.1742-1241.2006.01047.x 16893440

3. Batchelor JM, Ridd MJ, Clarke T, Ahmed A, Cox M, Crowe S, et al. The Eczema Priority Setting Partnership: a collaboration between patients, carers, clinicians and researchers to identify and prioritize important research questions for the treatment of eczema. Br J Dermatol. 2013;168(3):577–82. doi: 10.1111/bjd.12040 22963149

4. National Eczema Society. Itching and scratching. London: National Eczema Society; 2016 [cited 2016 Mar 23]. http://www.eczema.org/itching-scratching.

5. Totté J, van der Feltz W, Hennekam M, van Belkum A, van Zuuren E, Pasmans S. Prevalence and odds of Staphylococcus aureus carriage in atopic dermatitis: a systematic review and meta-analysis. Br J Dermatol. 2016;175(4):687–95. doi: 10.1111/bjd.14566 26994362

6. Koller DY, Halmerbauer G, Bock A, Engstler G. Action of a silk fabric treated with AEGIS in children with atopic dermatitis: a 3-month trial. Pediatr Allergy Immunol. 2007;18(4):335–8. doi: 10.1111/j.1399-3038.2006.00511.x 17346297

7. Stinco G, Piccirillo F, Valent F. A randomized double-blind study to investigate the clinical efficacy of adding a non-migrating antimicrobial to a special silk fabric in the treatment of atopic dermatitis. Dermatology. 2008;217(3):191–5. doi: 10.1159/000141648 18583910

8. Fontanini C, Berti I, Monasta L, Longo G. DermaSilk in long-term control of infantile atopic dermatitis: a double blind randomized controlled trial. G Ital Dermatol Venereol. 2013;148(3):293–7. 23670066

9. Nankervis H, Thomas K, Delamere F, Barbarot S, Rogers N, Williams H. Scoping systematic review of treatments for eczema. Southampton (UK): NIHR Journals Library; 2016.

10. Harrison EF, Haines RH, Cowdell F, Sach TH, Dean T, Pollock I, et al. A multi-centre, parallel group superiority trial of silk therapeutic clothing compared to standard care for the management of eczema in children (CLOTHES Trial): study protocol for a randomised controlled trial. Trials. 2015;16(1):390.

11. Thomas KS, Bradshaw LE, Sach TH, Cowdell F, Batchelor JM, Lawton S, et al. Randomised controlled trial of silk therapeutic garments for the management of atopic eczema in children: the CLOTHES trial. Health Technol Assess. 2017;21. In press.

12. Williams H, Burney P, Hay R, Archer C, Shipley M, Hunter J, et al. The UK Working Party’s Diagnostic Criteria for Atopic Dermatitis. I. Derivation of a minimum set of discriminators for atopic dermatitis. Br J Dermatol. 1994;131(3):383–96. 7918015

13. Emerson RM, Charman CR, Williams HC. The Nottingham Eczema Severity Score: preliminary refinement of the Rajka and Langeland grading. Br J Dermatol. 2000;142:288–97. 10730763

14. National Institute for Health and Care Excellence. Management of atopic eczema in children from birth up to the age of 12 years. NICE clinical guideline 57. London: National Institute for Health and Care Excellence; 2007.

15. Schmitt J, Spuls P, Boers M, Thomas K, Chalmers J, Roekevisch E, et al. Towards global consensus on outcome measures for atopic eczema research: results of the HOME II meeting. Allergy. 2012;67(9):1111–7. doi: 10.1111/j.1398-9995.2012.02874.x 22844983

16. Chalmers JR, Simpson E, Apfelbacher CJ, Thomas KS, von Kobyletzki L, Schmitt J, et al. Report from the fourth international consensus meeting to harmonize core outcome measures for atopic eczema/dermatitis clinical trials (HOME initiative). Br J Dermatol. 2016;175(1):69–79. doi: 10.1111/bjd.14773 27436240

17. Barbier N, Paul C, Luger T, Allen R, De Prost Y, Papp K, et al. Validation of the Eczema Area and Severity Index for atopic dermatitis in a cohort of 1550 patients from the pimecrolimus cream 1% randomized controlled clinical trials programme. Br J Dermatol. 2004;150(1):96–102. 14746622

18. Schmitt J, Spuls PI, Thomas KS, Simpson E, Furue M, Deckert S, et al. The Harmonising Outcome Measures for Eczema (HOME) statement to assess clinical signs of atopic eczema in trials. J Allergy Clin Immunol. 2014;134(4):800–7. doi: 10.1016/j.jaci.2014.07.043 25282560

19. Futamura M, Leshem YA, Thomas KS, Nankervis H, Williams HC, Simpson EL. A systematic review of Investigator Global Assessment (IGA) in atopic dermatitis (AD) trials: many options, no standards. J Am Acad Dermatol. 2016;74(2):288–94. doi: 10.1016/j.jaad.2015.09.062 26685719

20. Charman C, Venn A, Williams H. The Patient-Oriented Eczema Measure: development and initial validation of a new tool for measuring atopic eczema severity from the patients’ perspective. Arch Dermatol. 2004;140(12):1513–9. doi: 10.1001/archderm.140.12.1513 15611432

21. Wolkerstorfer A, De Waard van der Spek F, Glazenburg E, Mulder P, Oranje A. Scoring the severity of atopic dermatitis: three item severity score as a rough system for daily practice and as a pre-screening tool for studies. Acta Derm Venereol. 1999;79:356–9. 10494710

22. Lawson V, Lewis-Jones S, Finlay A, Reid P, Owens R. The family impact of childhood atopic dermatitis: the dermatitis family impact questionnaire. Br J Dermatol. 1998;138:107–13. 9536231

23. Brooks R, Group E. EuroQol: the current state of play. Health Policy. 1996;37(1):53–72. 10158943

24. Stevens KJ, Brazier JE, McKenna SP, Doward LC, Cork MJ. The development of a preference-based measure of health in children with atopic dermatitis. Br J Dermatol. 2005;153(2):372–7. doi: 10.1111/j.1365-2133.2005.06736.x 16086752

25. Stevens K. Valuation of the Child Health Utility 9D Index. Pharmacoeconomics. 2012;30(8):729–47. doi: 10.2165/11599120-000000000-00000 22788262

26. Schram M, Spuls PI, Leeflang M, Lindeboom R, Bos J, Schmitt J. EASI, (objective) SCORAD and POEM for atopic eczema: responsiveness and minimal clinically important difference. Allergy. 2012;67(1):99–106. doi: 10.1111/j.1398-9995.2011.02719.x 21951293

27. Bland JM, Altman DG. Transformations, means, and confidence intervals. BMJ. 1996;312(7038):1079. 8616417

28. Bland JM, Altman DG. The use of transformation when comparing two means. BMJ. 1996;312(7039):1153. 8620137

29. Curtis L, Burns A. Unit costs of health and social care 2015. Canterbury: Personal Social Services Research Unit; 2015 [cited 2016 Apr 21]. http://www.pssru.ac.uk/project-pages/unit-costs/2015/.

30. Department of Health. NHS reference costs 2014 to 2015. London: Department of Health; 2015 [cited 2016 Apr 22]. https://www.gov.uk/government/publications/nhs-reference-costs-2014-to-2015.

31. Health and Social Care Information Centre. Prescription cost analysis, England—2015 London: Health and Social Care Information Centre; 2016 [cited 2016 Apr 8]. https://www.gov.uk/government/statistics/prescription-cost-analysis-england-2015.

32. Willan AR, Briggs AH, Hoch JS. Regression methods for covariate adjustment and subgroup analysis for non-censored cost-effectiveness data. Health Econ. 2004;13(5):461–75. doi: 10.1002/hec.843 15127426

33. Briggs AH, Wonderling DE, Mooney CZ. Pulling cost-effectiveness analysis up by its bootstraps: a non-parametric approach to confidence interval estimation. Health Econ. 1997;6(4):327–40. 9285227

34. Fenwick E, Claxton K, Sculpher M. Representing uncertainty: the role of cost-effectiveness acceptability curves. Health Econ. 2001;10(8):779–87. 11747057

35. National Health Service Business Services Authority. Preface: amendments to the Drug Tariff—March 2015. Newcastle upon Tyne: National Health Service Business Services Authority; 2015 [cited 2016 Dec 21]. http://www.nhsbsa.nhs.uk/PrescriptionServices/Documents/PPD%20Drug%20Tariff/March_2015.pdf.

36. Thomas KS, Dean T, O’Leary C, Sach TH, Koller K, Frost A, et al. A randomised controlled trial of ion-exchange water softeners for the treatment of eczema in children. PLoS Med. 2011;8(2):e1000395. doi: 10.1371/journal.pmed.1000395 21358807

37. NHS Digital. Prescription cost analysis, England—2014 [NS]. Leeds: NHS Digital; 2015 [cited 2016 Jun 9]. http://content.digital.nhs.uk/catalogue/PUB17274

38. Information Services Division Scotland. Prescription cost analysis for Scotland. Edinburgh: Information Services Division Scotland; 2010 [cited 2016 Jun 13]. http://www.isdscotlandarchive.scot.nhs.uk/isd/2241.html.

39. Welsh Government. Prescriptions dispensed in the community. Tables—prescription cost analysis: individual preparations, 2015. Cardiff: Welsh Government; 2016 [2016 Jun 9]. http://gov.wales/statistics-and-research/prescriptions-dispensed-community/?lang=en.

40. HSC Business Services Organisation. Pharmaceutical statistics: PCA 2015. Belfast: HSC Business Services Organisation; 2016 [cited 2016 Jun 9]. http://www.hscbusiness.hscni.net/services/1806.htm.