The Eczema Bathing Study: Weekly versus daily bathing for people with eczema? Protocol of an online, randomised controlled trial [version 1; peer review: 1 approved, 2 approved with reservations]
Background A priority setting partnership for eczema (syn atopic eczema, atopic dermatitis) has identified that bathing frequency is a key area of patient interest. However, there are nolarge, high-quality randomised controlled trials (RCTs) investigating this. The Rapid Eczema Trials project is a n...
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2024-10-01
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| author | Paul Leighton Wei Chern Gavin Fong Ingrid Muller Laura Howells Arabella Baker Eleanor J Mitchell Eleanor Harrison Leila Thuma Yimin Jiang Lucy Bradshaw Alan Montgomery Fiona Cowdel Matthew J Ridd Jane Ravenscroft Reiko J Tanaka Miriam Santer Richard Swinden Nicholas Hilken Carron Layfield Richard Dooley Sophia Collins Clare Upton Tracy Owen Firoza Davies Devin Patel Mars Eddis-Finbow Hywel C Williams Goldie Putrym Kim S Thomas Amanda Roberts |
| author_facet | Paul Leighton Wei Chern Gavin Fong Ingrid Muller Laura Howells Arabella Baker Eleanor J Mitchell Eleanor Harrison Leila Thuma Yimin Jiang Lucy Bradshaw Alan Montgomery Fiona Cowdel Matthew J Ridd Jane Ravenscroft Reiko J Tanaka Miriam Santer Richard Swinden Nicholas Hilken Carron Layfield Richard Dooley Sophia Collins Clare Upton Tracy Owen Firoza Davies Devin Patel Mars Eddis-Finbow Hywel C Williams Goldie Putrym Kim S Thomas Amanda Roberts |
| author_sort | Paul Leighton |
| collection | DOAJ |
| description | Background A priority setting partnership for eczema (syn atopic eczema, atopic dermatitis) has identified that bathing frequency is a key area of patient interest. However, there are nolarge, high-quality randomised controlled trials (RCTs) investigating this. The Rapid Eczema Trials project is a novel programme of research that aims to deliver multiple online RCTs, using a citizen science approach. This project involves working with members of the public to co-design and conduct studies that answer questions of importance to them. The first trial to be conducted through this project is assessing the impact of bathing frequency on eczema. Methods This is an online, two-arm, parallel-group superiority RCT with internal pilot phase. People aged ≥1 year with eczemaliving in the United Kingdom are eligible. Exclusion criteria are: people with other types of eczema such as venous eczema, hand eczema and contact eczema; recently started a new eczema treatment; taking part in another eczema trial; Patient Oriented Eczema Measure (POEM) ≤2; planning to swim more than twice a week; unable/unwilling to change bathing practices. Participants are allocated 1:1 to either the weekly bathing group (bathe 1 or 2 times a week) or the daily bathing group (bathe 6 or more times a week) for 4 weeks. The primary outcome is POEM, assessed weekly over 4 weeks. Secondary outcomes include skin specific quality of life, eczema control, itch severity, use of usual eczema treatments, proportion who achieve an improvement in POEM of ≥3 points, global change in eczema and safety outcomes. A sample of participants will also be invited to a semi-structured interview to discuss their experience. The primary comparative analysis will be according to randomised allocation regardless of actual frequency of bathing. The trial will be reported in accordance with CONSORT guidelines. The study has received ethical approval by the London - Surrey Research Ethics Committee (2 Redman Place, London, E20 1JQ, United Kingdom) on 11/10/2023 ( approval number: 23/PR/0899). Trial registration ISRCTN12016473, 22/11/2023, https://doi.org/10.1186/ISRCTN12016473 |
| format | Article |
| id | doaj-art-6c6cc50c80414dd592f10a0cd4e7f1cc |
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| spelling | doaj-art-6c6cc50c80414dd592f10a0cd4e7f1cc2025-01-10T01:00:00ZengF1000 Research LtdNIHR Open Research2633-44022024-10-01414830The Eczema Bathing Study: Weekly versus daily bathing for people with eczema? Protocol of an online, randomised controlled trial [version 1; peer review: 1 approved, 2 approved with reservations]Paul Leighton0Wei Chern Gavin Fong1https://orcid.org/0000-0003-2546-156XIngrid Muller2Laura Howells3Arabella Baker4Eleanor J Mitchell5https://orcid.org/0000-0002-6998-4533Eleanor Harrison6Leila Thuma7https://orcid.org/0000-0002-3770-5800Yimin Jiang8Lucy Bradshaw9https://orcid.org/0000-0001-8382-6040Alan Montgomery10https://orcid.org/0000-0003-0450-1606Fiona Cowdel11https://orcid.org/0000-0002-9355-8059Matthew J Ridd12https://orcid.org/0000-0002-7954-8823Jane Ravenscroft13https://orcid.org/0000-0002-1609-7084Reiko J Tanaka14https://orcid.org/0000-0002-0769-9382Miriam Santer15Richard Swinden16Nicholas Hilken17Carron Layfield18Richard Dooley19Sophia Collins20Clare Upton21Tracy Owen22Firoza Davies23Devin Patel24Mars Eddis-Finbow25Hywel C Williams26Goldie Putrym27Kim S Thomas28Amanda Roberts29Centre of Evidence Based Dermatology, Lifespan and Population Health, University of Nottingham School of Medicine, Nottingham, England, UKCentre of Evidence Based Dermatology, Lifespan and Population Health, University of Nottingham School of Medicine, Nottingham, England, UKPrimary Care Research Centre, University of Southampton, Southampton, England, UKCentre of Evidence Based Dermatology, Lifespan and Population Health, University of Nottingham School of Medicine, Nottingham, England, UKCentre of Evidence Based Dermatology, Lifespan and Population Health, University of Nottingham School of Medicine, Nottingham, England, UKUniversity of Nottingham Nottingham Clinical Trials Unit, Nottingham, England, UKUniversity of Nottingham Nottingham Clinical Trials Unit, Nottingham, England, UKUniversity of Nottingham Nottingham Clinical Trials Unit, Nottingham, England, UKUniversity of Nottingham Nottingham Clinical Trials Unit, Nottingham, England, UKUniversity of Nottingham Nottingham Clinical Trials Unit, Nottingham, England, UKUniversity of Nottingham Nottingham Clinical Trials Unit, Nottingham, England, UKBirmingham City University Faculty of Health Education and Life Sciences, Birmingham, England, UKCentre for Applied Excellence in Skin & Allergy Research, University of Bristol Centre for Academic Primary Care, Bristol, England, UKCentre of Evidence Based Dermatology, Lifespan and Population Health, University of Nottingham School of Medicine, Nottingham, England, UKDepartment of Bioengineering, Imperial College London Faculty of Engineering, London, England, UKPrimary Care Research Centre, University of Southampton, Southampton, England, UKUniversity of Nottingham Nottingham Clinical Trials Unit, Nottingham, England, UKUniversity of Nottingham Nottingham Clinical Trials Unit, Nottingham, England, UKCentre of Evidence Based Dermatology, Lifespan and Population Health, University of Nottingham School of Medicine, Nottingham, England, UKUniversity of Nottingham Nottingham Clinical Trials Unit, Nottingham, England, UKCitizen Scientist contributor, England, UKUniversity of Nottingham Nottingham Clinical Trials Unit, Nottingham, England, UKCitizen Scientist contributor, England, UKCitizen Scientist contributor, England, UKCitizen Scientist contributor, England, UKCitizen Scientist contributor, England, UKCentre of Evidence Based Dermatology, Lifespan and Population Health, University of Nottingham School of Medicine, Nottingham, England, UKCitizen Scientist contributor, England, UKCentre of Evidence Based Dermatology, Lifespan and Population Health, University of Nottingham School of Medicine, Nottingham, England, UKCentre of Evidence Based Dermatology, Lifespan and Population Health, University of Nottingham School of Medicine, Nottingham, England, UKBackground A priority setting partnership for eczema (syn atopic eczema, atopic dermatitis) has identified that bathing frequency is a key area of patient interest. However, there are nolarge, high-quality randomised controlled trials (RCTs) investigating this. The Rapid Eczema Trials project is a novel programme of research that aims to deliver multiple online RCTs, using a citizen science approach. This project involves working with members of the public to co-design and conduct studies that answer questions of importance to them. The first trial to be conducted through this project is assessing the impact of bathing frequency on eczema. Methods This is an online, two-arm, parallel-group superiority RCT with internal pilot phase. People aged ≥1 year with eczemaliving in the United Kingdom are eligible. Exclusion criteria are: people with other types of eczema such as venous eczema, hand eczema and contact eczema; recently started a new eczema treatment; taking part in another eczema trial; Patient Oriented Eczema Measure (POEM) ≤2; planning to swim more than twice a week; unable/unwilling to change bathing practices. Participants are allocated 1:1 to either the weekly bathing group (bathe 1 or 2 times a week) or the daily bathing group (bathe 6 or more times a week) for 4 weeks. The primary outcome is POEM, assessed weekly over 4 weeks. Secondary outcomes include skin specific quality of life, eczema control, itch severity, use of usual eczema treatments, proportion who achieve an improvement in POEM of ≥3 points, global change in eczema and safety outcomes. A sample of participants will also be invited to a semi-structured interview to discuss their experience. The primary comparative analysis will be according to randomised allocation regardless of actual frequency of bathing. The trial will be reported in accordance with CONSORT guidelines. The study has received ethical approval by the London - Surrey Research Ethics Committee (2 Redman Place, London, E20 1JQ, United Kingdom) on 11/10/2023 ( approval number: 23/PR/0899). Trial registration ISRCTN12016473, 22/11/2023, https://doi.org/10.1186/ISRCTN12016473https://openresearch.nihr.ac.uk/articles/4-63/v1Atopic dermatitis Bath Eczema Evidence Personal care Randomised controlled trialeng |
| spellingShingle | Paul Leighton Wei Chern Gavin Fong Ingrid Muller Laura Howells Arabella Baker Eleanor J Mitchell Eleanor Harrison Leila Thuma Yimin Jiang Lucy Bradshaw Alan Montgomery Fiona Cowdel Matthew J Ridd Jane Ravenscroft Reiko J Tanaka Miriam Santer Richard Swinden Nicholas Hilken Carron Layfield Richard Dooley Sophia Collins Clare Upton Tracy Owen Firoza Davies Devin Patel Mars Eddis-Finbow Hywel C Williams Goldie Putrym Kim S Thomas Amanda Roberts The Eczema Bathing Study: Weekly versus daily bathing for people with eczema? Protocol of an online, randomised controlled trial [version 1; peer review: 1 approved, 2 approved with reservations] NIHR Open Research Atopic dermatitis Bath Eczema Evidence Personal care Randomised controlled trial eng |
| title | The Eczema Bathing Study: Weekly versus daily bathing for people with eczema? Protocol of an online, randomised controlled trial [version 1; peer review: 1 approved, 2 approved with reservations] |
| title_full | The Eczema Bathing Study: Weekly versus daily bathing for people with eczema? Protocol of an online, randomised controlled trial [version 1; peer review: 1 approved, 2 approved with reservations] |
| title_fullStr | The Eczema Bathing Study: Weekly versus daily bathing for people with eczema? Protocol of an online, randomised controlled trial [version 1; peer review: 1 approved, 2 approved with reservations] |
| title_full_unstemmed | The Eczema Bathing Study: Weekly versus daily bathing for people with eczema? Protocol of an online, randomised controlled trial [version 1; peer review: 1 approved, 2 approved with reservations] |
| title_short | The Eczema Bathing Study: Weekly versus daily bathing for people with eczema? Protocol of an online, randomised controlled trial [version 1; peer review: 1 approved, 2 approved with reservations] |
| title_sort | eczema bathing study weekly versus daily bathing for people with eczema protocol of an online randomised controlled trial version 1 peer review 1 approved 2 approved with reservations |
| topic | Atopic dermatitis Bath Eczema Evidence Personal care Randomised controlled trial eng |
| url | https://openresearch.nihr.ac.uk/articles/4-63/v1 |
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