Co-producing a randomised controlled trial on the frequency of bathing in eczema: description of a citizen science approach

Arabella Baker* (Corresponding / Lead Author), Natalie Bonsu, Laura Howells, Ingrid Muller, Eleanor J Mitchell, Fiona Cowdell, Firoza Davies, Mars Eddis-Finbow, Alan Montgomery, Devin Patel, Goldie Putrym, Matthew J Ridd, Miriam Santer, Amanda Roberts, Kim S. Thomas (Corresponding / Lead Author)

*Corresponding author for this work

    Research output: Contribution to journalArticlepeer-review

    Abstract

    Background
    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 randomised controlled trials (RCTs).
    Objective
    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.
    Methods
    The co-production of the trial with patients living with eczema involved research prioritisation, intervention development and trial design, all carried out through a series of online meetings and surveys.
    Results
    Co-producing the trial took nine months, consisting of 13 online meetings (five to prioritise the topic, four to develop the intervention and four to design the trial), requiring 39 hours of time commitment from public members (n = 12) with a total spending of £5,440 on reimbursements. A prioritisation survey (n = 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 (n = 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 finalised 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 29th January 2024 and over 50% of the target sample size of 390 have been recruited within the first two months.
    Conclusions
    This paper provides a useful model for co-producing RCTs with members of the public. It describes the key stages of trial development (prioritisation, intervention development, trial design) and contains information on the time and resources required to design trials using this approach.

    WHAT DOES THIS STUDY ADD?
    •This study describes the methodology and practicalities of co-producing an RCT with patients that addresses topics that are important to them
    •It introduces an innovative approach of combining co-production and citizen science for more relevant and rapid trials
    •It promotes inclusivity by demonstrating the value of involving patients as active stakeholders throughout the research process

    Original languageEnglish
    JournalSkin Health and Disease
    Publication statusAccepted/In press (AAM) - 14 Jan 2025

    Keywords

    • Co-production
    • Patient and public involvement
    • Online survey
    • Randomised controlled trial

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