@article{4fb7b1144a1441018286cd1e1ebbe0ac,
title = "Effectiveness and cost-effectiveness of daily all-over-body application of emollient during the first year of life for preventing atopic eczema in high-risk children (The BEEP trial): Protocol for a randomised controlled trial",
abstract = "Background: Atopic eczema (AE) is a common skin problem that impairs quality of life and is associated with the development of other atopic diseases including asthma, food allergy and allergic rhinitis. AE treatment is a significant cost burden for health care providers. The purpose of the trial is to investigate whether daily application of emollients for the first year of life can prevent AE developing in high-risk infants (first-degree relative with asthma, AE or allergic rhinitis). Methods: This is a protocol for a pragmatic, two-arm, randomised controlled, multicentre trial. Up to 1400 term infants at high risk of developing AE will be recruited through the community, primary and secondary care in England. Participating families will be randomised in a 1:1 ratio to receive general infant skin-care advice, or general skin-care advice plus emollients with advice to apply daily to the infant for the first year of life. Families will not be blinded to treatment allocation. The primary outcome will be a blinded assessment of AE at 24months of age using the UK Working Party Diagnostic Criteria for Atopic Eczema. Secondary outcomes are other definitions of AE, time to AE onset, severity of AE (EASI and POEM), presence of other allergic diseases including food allergy, asthma and hay fever, allergic sensitisation, quality of life, cost-effectiveness and safety of the emollients. Subgroup analyses are planned for the primary outcome according to filaggrin genotype and the number of first-degree relatives with AE and other atopic diseases. Families will be followed up by online and postal questionnaire at 3, 6, 12 and 18months with a face-to-face visit at 24months. Long-term follow-up until 60months will be via annual questionnaires. Discussion: This trial will demonstrate whether skin-barrier enhancement through daily emollient for the first year of life can prevent AE from developing in high-risk infants. If effective, this simple and cheap intervention has the potential to result in significant cost savings for health care providers throughout the world by preventing AE and possibly other associated allergic diseases. Trial registration: ISRCTN registry; ID: ISRCTN21528841. Registered on 25 July 2014.",
keywords = "Atopic dermatitis, Barrier enhancement, Core outcomes, Eczema, Emollient, Filaggrin, Prevention, Protocol, Randomised controlled trial",
author = "Chalmers, {Joanne R.} and Haines, {Rachel H.} and Mitchell, {Eleanor J.} and Thomas, {Kim S.} and Brown, {Sara J.} and Matthew Ridd and Sandra Lawton and Simpson, {Eric L.} and Cork, {Michael J.} and Sach, {Tracey H.} and Bradshaw, {Lucy E.} and Montgomery, {Alan A.} and Boyle, {Robert J.} and Williams, {Hywel C.}",
note = "Funding Information: SJB has submitted a patent application (GB 1602011.7) relating to a mechanism for the gene EMSY in skin and has received honoraria for invited lectures at the American Academy of Asthma, Allergy and Immunology annual meetings. SL has received honorarium for educational activities from Thornton and Ross and Bayer. MJC has received fees for giving lectures and/or attending advisory boards and unrelated research funding from Almirall, Astellas Pharma, MSD, Johnson & Johnson and Stiefel-GSK who manufacture emollients. HCW became Director of the NIHR HTA Programme in October 2015. The other authors declare that they have no competing interests. Funding Information: The trial was developed with, and continues to be supported by, the UK Dermatology Clinical Trials Network (UK DCTN). The UK DCTN is grateful to the British Association of Dermatologists and the University of Nottingham for financial support of the Network. Additional nursing support is being been provided by the NIHR Clinical Research Networks. The trial is being managed through the Nottingham Clinical Trials Unit (NCTU) and sponsored by The University of Nottingham. Dr. Nicola Jay (Consultant Paediatrician Respiratory and Allergy, Sheffield Children{\textquoteright}s Hospital) and Dr. Michael Perkin (Consultant in Paediatric Allergy, St. George{\textquoteright}s, London) contributed significantly to developing the skin-prick testing and food challenge aspects of the trial. The Trial Management Group are: JRC, RHH, EJM, KST, SJB, MR, SL, ELS, MJC, THS, LEB, AAM, RJB, HCW, plus Sarah Walker (data coordinator NCTU) Jessica Haywood (data administrator NCTU), Louisa Gray (trial coordinator NCTU) and Andrew Jadowski (trial administrator NCTU). The independent members of the Trial Steering Committee are: Sarah Meredith, Chair, (Medical Research Council Clinical Trials Unit), Angela Crook (University College London), Paula Beattie (Royal Hospital for Sick Children, Glasgow), Kirsty Logan (patient representative, London). Michael Perkin (St. George{\textquoteright}s, London) was previously an independent member of the TSC. Additional NCTU staff involved in the trial: Keith Whitaker (IT programmer) Angela Pushpa-Rajah (trial manager Feb–Jul 2015), Sandip Stapleton (trial manager Sept 15–Jul 2016) and Margherita Carucci (trial coordinator Oct 14–Aug 15). Recruiting centres are: Nottingham University Hospitals NHS Trust: Professor Hywel C. Williams (PI), Susan Davies-Jones, Professor Jim Thornton; Portsmouth Hospitals NHS Trust: Dr. Bronwyn Hughes (PI), Andrew Gribbin, Sharon McCready, Zoe Garner, Amanda Hungate, Emma Glasspool, Rachel Watson, Ellie Jenkins; Harrogate and District NHS Foundation Trust: Dr. Alison Layton (PI), Louise Wills, Elizabeth Marshall, Joyce Guy, Christine Morgan; Sherwood Forest Hospitals NHS Foundation Trust: Dr. Michael Yanney (PI), Caroline Moulds, Lisa Foster, Yvette Girvan, Tunde Solebo, Victoria Moore, Andrea Palfreman; Burton Hospitals NHS Foundation Trust: Dr. Mansoor Ahmed (PI), Stephanie Boswell, Claire Prince, Jane Radford, Clare Mewies, Claire Backhouse, Elizabeth Kemp; Derby Hospitals NHS Foundation Trust: Dr. Adam Ferguson (PI), Elaine Coulborn, Melody McGregor, Coral Smith, Vanessa Unsworth, SallyAnn Bell, Jill Smith, Liane Hufton; University Hospitals of Leicester NHS Trust: Dr. Karen Harman (PI), Dr. Ingrid Helbling, Suzanne Foxon, Simal Patel; York Teaching Hospital NHS Foundation Trust: Dr. Calum Lyon (PI), Jill Green, Jessica Scott, Richard Furnival, Samantha Roche, Holly Alcock, Sian Sturdy; Sheffield Children{\textquoteright}s NHS Foundation Trust: Professor Michael Cork (PI) Heather Chisem, Hilary Rosser, Sarah Besley, Emma Steel, Sarah Senbeto, Pauline Bayliss, Carolyn Clark; Imperial College Healthcare NHS Trust: Dr. Robert Boyle (PI), Anna Bosanquet; Guy{\textquoteright}s and St Thomas{\textquoteright} NHS Foundation Trust: Dr. Carsten Flohr (PI), Annette Briley, Claire Singh, Rebecca Williams, Shelley Carter, Elodie Lawley; Bristol: Dr. Matthew Ridd (PI), Kingsley Powell, Lyn Liddiard. Primary Care recruitment sites: Francis Grove Surgery: Dr. Katherine Broad (PI), Nina Walters, Sarah Buttinger, Rachel Joy; Streatham Common Practice: Dr. Kirsty Rankin (PI), Dr. Ruth Danson, Ellen Trendell; Clapham Park Group Practice: Dr. Mydhili Chellappah (PI), Dr. Dina Saleh; Park Group Practice: Dr. Mita Patel (PI), Jayshireen Singh; SJB is supported by a Wellcome Trust Senior Research Fellowship in Clinical Science (106865/Z/15/Z). THS holds a Career Development Fellowship (NIHR-2014-07-006) supported by the National Institute for Health Research. Funding Information: This trial was funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme (project number 12/67/12). The food allergy and food sensitisation assessments are funded by external grants from Goldman Sachs Gives (no reference number) and the Sheffield Children{\textquoteright}s Hospital Research Fund (reference CA15008). Neither funder had any role in the trial design, the writing of this paper or decision to submit. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the HTA programme, THE NIHR, THE NHS or the Department of Health. Publisher Copyright: {\textcopyright} 2017 The Author(s).",
year = "2017",
month = jul,
day = "21",
doi = "10.1186/s13063-017-2031-3",
language = "English (US)",
volume = "18",
journal = "Trials",
issn = "1745-6215",
publisher = "BioMed Central",
number = "1",
}