Wei Chern Gavin Fong, Laura Howells, Ingrid Muller, Eleanor J Mitchell, Arabella Baker, Leila Thuma, Eleanor Harrison, Lucy Bradshaw, Yimin Jiang, Fiona Cowdel, Paul Leighton, Alan Montgomery, Jane Ravenscroft, Matthew J Ridd, Miriam Santer, Reiko J Tanaka, Nicholas Hilken, Richard Swinden, Richard Dooley, Carron Layfield, Clare Upton, Sophia Collins, Firoza Davies, Tracy Owen, Mars Eddis-Finbow, Devin Patel, Goldie Putrym, Hywel C Williams, Amanda Roberts, Kim S Thomas
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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.</p><p><strong>Methods: </strong>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. 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引用次数: 0
摘要
背景：湿疹（包括特应性湿疹、特应性皮炎）的优先设定伙伴关系已经确定，洗澡频率是患者感兴趣的一个关键领域。然而，目前还没有大规模、高质量的随机对照试验（RCTs）对此进行调查。快速湿疹试验项目是一个新颖的研究项目，旨在使用公民科学方法提供多个在线随机对照试验。这个项目涉及与公众合作，共同设计和开展研究，回答对他们重要的问题。通过这个项目进行的第一个试验是评估洗澡频率对湿疹的影响。方法：这是一项在线、双臂、平行组的优势随机对照试验，有内部试点阶段。在英国居住的年龄≥1岁的湿疹患者符合条件。排除标准是：患有其他类型湿疹的人，如静脉湿疹、手部湿疹和接触性湿疹；最近开始了新的湿疹治疗；参加另一项湿疹试验；患者定向湿疹测量(POEM)≤2；计划每周游泳两次以上；不能/不愿意改变洗澡的习惯。参与者按1:1的比例被分配到每周洗澡组（每周洗澡1或2次）或每天洗澡组（每周洗澡6次或更多），为期4周。主要终点是POEM，在4周内每周评估一次。次要结局包括皮肤特定生活质量、湿疹控制、瘙痒严重程度、常规湿疹治疗的使用、POEM改善≥3分的比例、湿疹的总体变化和安全性结局。参与者的样本也将被邀请参加一个半结构化的面试，讨论他们的经验。主要的比较分析将根据随机分配，而不考虑洗澡的实际频率。试验将按照CONSORT指南进行报告。该研究已于2023年11月10日获得伦敦-萨里研究伦理委员会（2 Redman Place, London, E20 1JQ, United Kingdom）的伦理批准（批准号：23/PR/0899）。试验注册：ISRCTN12016473, 22/11/2023, https://doi.org/10.1186/ISRCTN12016473。
The Eczema Bathing Study: Weekly versus daily bathing for people with eczema? Protocol of an online, randomised controlled trial.
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).
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