Dataset of the Eczema Monitoring Online randomised controlled trial

Abstract

The objectives of this study were to evaluate the effect of weekly patient-reported symptom monitoring on participants’ outcomes and to inform the design of future eczema trials on the optimum frequency of outcome assessments.

Electronic patient-reported outcome measures were used. All trial processes occurred online, including participant recruitment, eligibility screening, consent, randomisation and data collection through the Research Electronic Data Capture (REDCap©, Vanterbilt University), which is a secure web platform for managing trial data. Recruitment took place through internet-based methods, mainly social media. Individuals who clicked on the advert link were directed to the study website at www.emostudy.org2, which included study aims, eligibility criteria and full participant information. Individuals interested in taking part enrolled through the website. Upon providing informed consent electronically and completing eligibility checks, participants were randomised. After enrolment, participants received an automated welcome email explaining the frequency of data collection, according to their randomised allocation. Email reminders were sent after follow-up questionnaires were overdue by 5 days and 7 days and if still incomplete, a final text reminder with a weblink to the questionnaires was sent.