An observational study in Rheumatic Conditions, sponsored by University of the West of England. Not yet recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by University of the West of England · Observational
Three focus groups will be conducted with patients who have an inflammatory rheumatic condition and have been treated with steroids in the last three years to discuss the impact of steroids on their quality of life, the financial costs to them and costs to the NHS and social care. We will also ask people to give their thoughts on a general patient reported outcome (PRO) questionnaire (the EQ5D) and a steroid-specific questionnaire (the Steroid PRO).
Glucocorticoids, also known as steroids, are used in inflammatory rheumatic conditions such as rheumatoid arthritis, giant cell arteritis and lupus. They work quickly by controlling active inflammation and improving symptoms. Steroids do have adverse effects, including increased blood pressure, diabetes, infection and osteoporosis. They also impact peoples' mood, sleep and lead to weight gain.
Newer treatments are available, but they are usually more expensive than steroids. Economic evaluations weigh up different costs of treatment, including the costs of side effects. They are used to decide whether new treatments are 'cost-effective' enough for the NHS. At present, only some of the costs of steroids are considered, usually those directly related to healthcare. We would like to consider the broader costs to patients and society, and the impact on peoples' health-related quality of life.
This project will be overseen by a steering committee of clinicians, researchers, patient partners and charity representatives (including Vasculitis UK), health-economists, and PPIE experts. The project will include focus groups with people who have rheumatological conditions and have used steroids in the last three years. The focus groups will explore the full range of costs related to steroids. We will use open-ended questions and follow a framework used in economic evaluations. We will also ask people to give their thoughts on a general patient reported outcome (PRO) questionnaire (called the EQ5D) and a steroid-specific questionnaire (the Steroid PRO). One focus group will be held face to face in Leeds, and two will be held online so that people from across the UK can join. We will ask participants to consent to us recording and writing out the focus group data. The data will be anonymised for analysis by a researcher. We will submit the final report for publication. A lay summary will be circulated to participants and patient groups. This work will inform the next stages of our research to properly capture the full economic impact of steroids.
University of the West of England is the lead sponsor of 26 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients will be purposively sampled to include a spectrum of participants with a range of different inflammatory rheumatic conditions (including Rheumatoid Arthritis, Lupus, Giant Cell Arteritis) and demographics (including age, gender, ethnic group).
Exclusion Criteria:
Patients will be purposively sampled to include a spectrum of participants with a range of inflammatory rheumatic conditions and demographics.
Other: This is a qualitative focus group study therefore no interventions planned · Behavioral: This is a qualitative focus group study therefore no interventions planned
This is a qualitative focus group study therefore no interventions planned
This is a qualitative focus group study therefore no interventions planned
Steroid PRO
The Steroid PRO is a 15-item, valid and reliable scale for measuring the impact of glucocorticoid therapy in people with rheumatic diseases. The fifteen items are grouped into four domains (Social impact, Impact on Appearance, Psychological Impact and Treatment Concerns). The Steroid PRO responses options are presented across a 5-item Likert scale, with a numerical value attributed to the response: * Never (0) * Rarely (1) * Sometimes (2) * Often (3) * Always (4) Typically, each item or domain in the Steroid PRO is assigned a numerical value or score based on the response options provided. These scores may reflect the severity, frequency, or impact of symptoms, side effects, or other aspects of steroid therapy on the patient's well-being. The four subscales plus a total score can be used.
Time frame: Baseline (completed once during each focus group).
EQ-5D-5L
The EQ-5D-5L is a short questionnaire used to understand how a person's health affects their quality of life. The questionnaire asks people to rate themselves across 5 areas of daily life: mobility (moving around), self-care (washing, dressing), usual activities (work, study, housework), pain or discomfort, and anxiety or depression. Each area has 5 levels (1 = no problems, 5 = extreme problems). A respondent selects one level for each area, producing a 5 digit code (e.g., 12345). There is also a Visual Analogue Scale where respondents rate their overall health today with 0 = worst imaginable health and 100 = best imaginable health.
Time frame: Baseline (completed once during each focus group).
Plan to share: No — Not a clinical trial.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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University of the West of England