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

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 randomized controlled trials (RCTs).

Objectives: 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 prioritization, intervention development and trial design, all carried out through a series of online meetings and surveys.

Results: 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 (n = 12) with a total spending of £5440 on reimbursements. A prioritization 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 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.

Conclusions: 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.