Assessing the impact of steroids in children and young people
Research type
Research Study
Full title
Assessing the impact of glucocorticoids in children and young people with rheumatic conditions, patient reported outcomes measures (PROMS).
IRAS ID
352096
Contact name
Emily Barnes
Contact email
Sponsor organisation
University of the West of England
Duration of Study in the UK
1 years, 8 months, 31 days
Research summary
Background: Glucocorticoids (Steroids) are an effective treatment for those with Rheumatic conditions, reducing inflammation and damage to organs. However, they can also have a negative impact on one’s health related quality of life, such as increased weight, skin changes and delayed growth and puberty.
Aims: To capture the impact of steroids on children and young people (CYP) with rheumatic conditions.
Study 1:
Design: Qualitative focus groups to take place online (Zoom/Teams) and face to face (Bristol).
Recruitment: Children and young people aged 0-18 who have a clinical diagnosis of a rheumatological disease, who are currently taking steroids or have taken them within the last year. Recruitment will be through NHS paediatric and young adult rheumatology services, patient charities, support groups and social media.
Analysis: Focus groups will be audio recorded and transcribed. Content analysis will create themes and a long list of candidate questionnaire items to be tested in cognitive interviewing.Study 2:
Design: Cognitive Interviews in defined age groups (Parent Proxy for children under 8 years, 8-11, 12-14, 15-18). Online and face to face (Bristol).
Recruitment: Participants from study 1, and new participants will be given the opportunity to take part in this stage of the research. Recruitment will be through NHS paediatric and young adult rheumatology services, patient charities, support groups and social media.
Cognitive Interviews: In the cognitive interview process, patients are asked to say what they are thinking as they work through the questionnaire items—to think aloud and then they will be asked open ended semi structured interview questions about how they make sense of questionnaire items. Cognitive interviews will take up to 30 minutes.
Analysis: Interviews will be audio-recorded and transcribed. Candidate items will be amended and refined based on cognitive interview process and input from study team and patient partners. Cognitive interviews will be repeated in an iterative way until no new changes are required to create the final long list of candidate items ready for future large scale validation study.REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
25/YH/0122
Date of REC Opinion
18 Jun 2025
REC opinion
Favourable Opinion