Cross-condition validation of the Steroid PRO
Research type
Research Study
Full title
Cross-condition validation of the Patient Reported Outcome Measure for patients receiving glucocorticoids (the Steroid PRO)
IRAS ID
320303
Contact name
Joanna Clare Robson
Contact email
Sponsor organisation
University of the West of England, Bristol
Clinicaltrials.gov Identifier
2022 0050, Sponsor contract number
Duration of Study in the UK
1 years, 8 months, 31 days
Research summary
Testing a questionnaire about treatment with steroids for skin, lung or gastric conditions
Glucocorticoid drugs, also known as ‘steroids’, are used to treat a range of diseases. It is well-known that steroids can cause many unwanted side-effects. We are interested in measuring the impact of steroids on quality of life, from the patients’ perspective.
In the first part of this study, we interviewed people who are treated with steroids for a rheumatic condition. We asked them how taking steroids affects their everyday lives. From what they told us, we developed a questionnaire (the ‘Steroid PRO’) about the topics they identified as being most important.
Now we would like to test this questionnaire with people, aged 18 or over, who are taking steroids for other conditions. This could include people who have inflammation in the lungs, skin, or bowels. We will also ask for feedback from the medical teams who care for people who have these conditions.
The study involves a single interview with a researcher, either online or by telephone. People who want to take part will be given information about the study and asked to give written consent. Then they will be asked to talk about the wording of the questionnaire and how relevant it is to them.
This part of the study is funded by Sanofi Research and Development. The work is being carried out by independent researchers at the University of the West of England (UWE, Bristol). Participants will be recruited from hospitals in the UK, USA, and Australia.
We hope that the Steroid PRO questionnaire will be used in future research trials about steroid treatment and alternatives to steroids. The Steroid PRO questionnaire could also be used in clinics to improve communication between clinicians and patients.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
22/NE/0205
Date of REC Opinion
12 Oct 2022
REC opinion
Favourable Opinion