Evaluating the effect of weekly patient-reported symptom monitoring on trial outcomes: results of the Eczema Monitoring Online randomized controlled trial.

BACKGROUND: Patient-reported outcome measures (PROMs) are commonly used in eczema clinical trials. Several trials have used PROMs weekly for symptom monitoring. However, the increased frequency of patient-reported symptom monitoring may prompt participants to enhance the self-management of eczema and increase standard topical treatment use that can lead to improvements in outcomes over time. This is concerning as weekly symptom monitoring may constitute an unplanned intervention, which may mask small treatment effects and make it difficult to identify changes in the eczema resulting from the treatment under investigation. OBJECTIVES: To evaluate the effect of weekly patient-reported symptom monitoring on participants' outcomes and to inform the design of future eczema trials. METHODS: This was an online parallel-group nonblinded randomized controlled trial. Parents/carers of children with eczema and young people and adults with eczema were recruited online, excluding people scoring < 3 points on the Patient Oriented Eczema Measure (POEM), to avoid floor effects. Electronic PROMs were used for data collection. Participants were allocated using online randomization (1 : 1) to weekly POEM for 7 weeks (intervention) or no POEM during this period (control). The primary outcome was change in eczema severity based on POEM scores, assessed at baseline and week 8. Secondary outcomes included change in standard topical treatment use and data completeness at follow-up. Analyses were conducted according to randomized groups in those with complete data at week 8. RESULTS: A total of 296 participants were randomized from 14 September 2021 to 16 January 2022 (71% female, 77% white, mean age 26.7 years). The follow-up completion rate was 81.7% [n = 242; intervention group, n = 118/147 (80.3%); control group n = 124/149 (83.2%)]. After adjusting for baseline disease severity and age, eczema severity improved in the intervention group (mean difference in POEM score -1.64, 95% confidence interval -2.91 to -0.38; P = 0.01). No between-group differences were noted in the use of standard topical treatments and data completeness at follow-up. CONCLUSIONS: Weekly patient-reported symptom monitoring led to a small perceived improvement in eczema severity.

A practical guide to implementing a successful social media recruitment strategy: lessons from the Eczema Monitoring Online trial.

BACKGROUND: Participant recruitment into clinical trials remains challenging. The global increase in the number of social media users has accelerated the use of social media as a modality of recruitment, particularly during the COVID-19 pandemic when traditional recruitment methods were reduced. However, there is limited evidence on the performance of social media recruitment strategies into eczema clinical trials. METHODS: From September 2021 to January 2022, we recruited participants with eczema into an online randomised controlled trial using free advertising on Twitter, Facebook, Instagram and Reddit (unpaid methods), followed by paid Facebook advertisements (paid method). Unpaid methods were used periodically for 63 days, whilst the paid method for 16 days. Interested individuals who clicked on the advertisement link were directed to the study website, where they could sign up to participate. Consenting, randomisation and data collection occurred exclusively online, using a database management web platform. Evaluation of the social media recruitment methods was performed, including the number of expression of interests, enrolment yield, cost, baseline characteristics and retention. RESULTS: Our multi-platform based social media recruitment strategy resulted in 400 expressions of interests, leading to 296 participants. Unpaid methods accounted for 136 (45.9%) of participants, incurring no financial cost. Paid Facebook adverts reached 154,370 individuals, resulting in 123 (41.6%) trial participants for a total cost of £259.93 (£2.11 per participant) and other recruitment methods resulted in 37 (12.5%) enrolments. Paid advertisements predominantly attracted younger participants below the age of 20, whereas unpaid methods mainly drew in participants between 20-29 years of age. The social media platforms recruited an ethnically diverse participant population. Completion rate of follow-up was slightly higher for the paid method (n = 103, 83.7%) compared with the unpaid methods (n = 111, 81.6%). CONCLUSIONS: Unpaid social media posts recruited the most participants; however, it was time consuming for the researcher. Paid Facebook adverts rapidly recruited a large number of participants for a low cost and provided flexibility to target specific audiences. Our findings indicate that social media is an efficient tool that can potentially support recruitment to clinical trials. TRIAL REGISTRATION: ISRCTN45167024. Registered on 29 June 2021.

Content validity of the Recap of atopic eczema (RECAP) instrument in Dutch, English and German to measure eczema control in young people with atopic eczema: a cognitive interview study.

BACKGROUND: Recap of atopic eczema (RECAP) is a patient-reported outcome measure assessing eczema control. This instrument has been developed and validated in the UK. There are self-reported and proxy-reported versions in English, Dutch and German. However, it is unclear whether the self-reported version shows adequate content validity when completed by young people (8-16 years) in these languages. OBJECTIVES: To assess the content validity (comprehensibility, relevance and comprehensiveness) of the English, German and Dutch versions of the self-reported RECAP in young people with atopic eczema and to identify the most appropriate age cutoff for self-completion. METHODS: We conducted 23 semistructured cognitive interviews with young people aged 8-16 years, using the 'think-aloud' method. In Germany and the Netherlands, participants were recruited in dermatology clinics and in the UK through social media and existing mailing lists. Interviews were audio recorded, transcribed verbatim and analysed in the three languages, using a problem-focused coding manual. Transcripts were coded by two independent reviewers in each country. Themes were translated into English and compared across the three countries. RESULTS: Significant age-related comprehensibility issues with the last three items of the questionnaire occurred with young people aged 8-11 years, causing difficulties completing RECAP without help. However, older children had only minor problems and were able to complete the questionnaire by themselves. The self-reported version of RECAP has sufficient content validity for self-completion in young people aged 12 years and above. However, the German version with some translational adaptations may be appropriate for children from the age of 8 years. There may be some situations where the proxy version is needed for older children too. CONCLUSIONS: The self-reported version of RECAP is appropriate for use from the age of 12 years. The proxy version can be used in children younger than 12 years. Other measurement properties should be further investigated. What is already known about this topic? Recap of atopic eczema (RECAP) is an instrument recommended by the Harmonising Outcome Measures for Eczema initiative for the core outcome domain of long-term control of atopic eczema. Content validity of RECAP for self-completion by adults and of the proxy version has been assessed. What does this study add? In this study, content validity (comprehensibility, relevance and comprehensiveness) of the self-reported version of RECAP among young people (aged 8-16 years) with atopic eczema across the UK, Germany and the Netherlands is assessed. Based on these findings, key recommendations on how to measure eczema control in young people with atopic eczema are formulated. What are the clinical implications of this work? The Dutch, English and German self-completion versions of RECAP are recommended for use in adolescents from the age of 12 years. The proxy version could be used in children younger than 12 years or where children are cognitively or physically incapable of reporting their experience of eczema control. Caregivers should be encouraged to complete RECAP together with their child where possible.