Evaluation of the effect of symptom monitoring with patient-reported outcome measures on clinical outcomes in eczema: an online, parallel-group randomised controlled trial - the EMO trial protocol.

BACKGROUND AND AIMS: Online questionnaires completed by participants are often used in eczema clinical trials to capture the views of participants about their eczema. This allows researchers to measure the effectiveness of different treatments. Findings of some eczema RCTs showed an improvement in eczema severity scores in both groups in the absence of an intervention effect. This could have occurred as a result of general trial effects or might have been due to the impact of completing questionnaires regularly (known as monitoring) that might caused a change in the way people manage their eczema. This is a concern within clinical trials because completing regular questionnaires may make it harder to identify changes in the eczema resulting from the treatments being tested. Currently, there is a lack of understanding around the impact of regular monitoring of disease activity on trial outcomes in eczema and further research is needed. This methodological trial is designed to investigate whether completing questionnaires is an effective intervention in improving eczema severity. The overall aim of this study is to inform the design of future eczema randomised controlled trials on whether regular monitoring of eczema symptoms affects patient-reported outcomes.

ETHICAL APPROVAL: Favourable ethics opinion to conduct this study was given by the Faculty of Medicine and Health Science Research Ethics Committee, University of Nottingham (Ref. number: 239- 0421).

TRIAL REGISTRATION: The EMO trial has been prospectively registered on the ISRCTN registry on 29th June 2021 (ISRCTN45167024).