Baker Arabella, Bonsu Natalie, Howells Laura, Muller Ingrid, Mitchell Eleanor J, Cowdell Fiona, Davies Firoza, Eddis-Finbow Mars, Montgomery Alan, Patel Devin, Putrym Goldie, Ridd Matthew J, Santer Miriam, Roberts Amanda, Thomas Kim S
Centre of Evidence Based Dermatology, School of Medicine, University of Nottingham, Nottingham, UK.
Faculty of Health Education and Life Sciences, Birmingham City University, Birmingham, UK.
Skin Health Dis. 2025 Apr 16;5(2):130-139. doi: 10.1093/skinhd/vzaf005. eCollection 2025 Apr.
Eczema is a prevalent, chronic, itchy skin condition that often persists into adulthood and significantly affects the quality of life of patients and their families. With no cure available at present, effective management is crucial. Although important patient priorities related to eczema self-management have been identified, they are rarely the focus of large, high-quality randomized controlled trials (RCTs).
To outline the methodology of using a citizen science approach to co-produce an online RCT on the frequency of bathing, to support the self-management of eczema.
The co-production of the trial with patients living with eczema involved research prioritization, intervention development and trial design, all carried out through a series of online meetings and surveys.
Co-producing the trial took 9 months, consisting of 13 online meetings (5 to prioritize the topic, 4 to develop the intervention and 4 to design the trial), requiring 39 h of time commitment from members of the public ( = 12) with a total spending of £5440 on reimbursements. A prioritization survey ( = 120) identified the most popular research question as how often to bath/shower, receiving 49% of votes. Following an iterative refinement among the co-production group members, the trial research question was formulated. The intervention development survey ( = 169) established current bathing practices and interest in participating in the trial. Survey results informed the development of study materials and influenced decisions related to trial design. The finalized study materials included key information about the target behaviour (weekly bathing or daily bathing), frequently asked questions and common concerns. The trial design co-production group determined the eligibility criteria, defined the intervention and comparator, selected the outcome measures, determined the study duration and developed the recruitment strategy. The Eczema Bathing Study opened to recruitment on 29 January 2024 and over 50% of the target sample size of 390 have been recruited within the first 2 months.
This paper provides a useful model for co-producing RCTs with members of the public. It describes the key stages of trial development (prioritization, intervention development, trial design) and contains information on the time and resources required to design trials using this approach.
湿疹是一种常见的慢性瘙痒性皮肤病，常持续至成年期，严重影响患者及其家人的生活质量。目前尚无治愈方法，有效管理至关重要。虽然已确定了与湿疹自我管理相关的重要患者优先事项，但它们很少成为大型高质量随机对照试验（RCT）的重点。
概述采用公民科学方法共同开展一项关于洗澡频率的在线随机对照试验的方法，以支持湿疹的自我管理。
与湿疹患者共同开展该试验涉及研究优先级确定、干预措施制定和试验设计，所有这些均通过一系列在线会议和调查进行。
共同开展该试验耗时9个月，包括13次在线会议（5次确定主题优先级、4次制定干预措施、4次设计试验），需要公众成员（n = 12）投入39小时的时间，报销费用总计5440英镑。一项优先级调查（n = 120）确定最受欢迎的研究问题是洗澡/淋浴的频率，获得49%的选票。在共同生产小组成员之间进行反复完善后，制定了试验研究问题。干预措施制定调查（n = 169）确定了当前的洗澡习惯以及参与试验的兴趣。调查结果为研究材料的开发提供了信息，并影响了与试验设计相关的决策。最终确定的研究材料包括关于目标行为（每周洗澡或每天洗澡）的关键信息、常见问题和普遍关注的问题。试验设计共同生产小组确定了纳入标准，定义了干预措施和对照，选择了结局指标，确定了研究持续时间并制定了招募策略。湿疹洗澡研究于2024年1月29日开始招募，在头两个月内已招募到目标样本量390人的50%以上。
本文为与公众共同开展随机对照试验提供了一个有用的模型。它描述了试验开发的关键阶段（优先级确定、干预措施开发、试验设计），并包含了使用这种方法设计试验所需的时间和资源信息。
