Rheumatic ConditionsHEISTNCT07863245
Health Economic Impact of Steroids
An observational study of Rheumatic Conditions, run by University of the West of England at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatic Conditions
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Sep 2026to 30 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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).
Who may be able to join
- People who have an inflammatory rheumatic condition.
- People who are aged 18 years or older.
- Have the capacity to give informed consent.
- Have a good understanding of spoken and written English to be able to understand the participant information sheet, consent form and demographic form, and to participate in the focus group.
- Received treatment with intravenous or oral glucocorticoids for an inflammatory rheumatic condition within the previous three years.
Who cannot join
- People who do not have an inflammatory rheumatic condition.
- People who are less than 18 years of age.
- Do not have the capacity to give informed consent.
- Have insufficient understanding of spoken and written English be able to understand the participant information sheet, consent form and demographic form, and to participate in the focus group.
- Either have never taken steroids or not taken steroids within the last three years as part of the treatment plan for their rheumatological condition.
- Membership of the steering committee.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Christine A Silverthorne contact
United Kingdom1 site
University of the West of England / Bristol Royal Infirmary
Bristol, BS2 8HW
About this study
Official title: Health Economic Impact of Steroids: Exploration and Measurement of the Impact of Glucocorticoids in Patients With Inflammatory Rheumatic Conditions
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).
Read the detailed description
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.
- Conditions
- Rheumatic Conditions
- Being tested
- This is a qualitative focus group study therefore no interventions planned
- Keywords
- Glucocorticoids, Steroids, Rheumatology, Patient, Health-related quality of life, Health economic impact
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is a qualitative focus group study therefore no interventions plannedOther
This is a qualitative focus group study therefore no interventions planned
This is a qualitative focus group study therefore no interventions plannedBehavioural
This is a qualitative focus group study therefore no interventions planned
| Study group | Role | What they receive |
|---|---|---|
| Patients with inflammatory rheumatic conditions. | Patients will be purposively sampled to include a spectrum of participants with a range of inflammatory rheumatic conditions and demographics. Receives: Other: This is a qualitative focus group study therefore no interventions planned; Behavioral: This is a qualitative focus group study therefore no interventions planned |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (completed once during each focus group).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start15 Sep 2026 (estimated)
- Primary completion15 Feb 2027 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatic ConditionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of the West of England
- Sponsor type
- University, hospital or other
- Collaborators
- UK Musculoskeletal Translational Research Collaboration (MSK TRC), University of Leeds
- Responsible party
- Sponsor
- Investigators
- Joanna C Robson, Principal investigator, University of the West of England
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07863245
- Sponsor's protocol ID
- UWE PIMS Number 14724554
- Other IDs
- 137073
- Acronym
- HEIST
- Status last verified
- Oct 2026
- First submitted
- 17 Sep 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not a clinical trial.
Publications
Bridgewater S, Ndosi M, Dawson J, Richards P, Silverthorne C, Dures E, Goodman SM, Hill C, Mackie SL, Robson JC. Validation of a new glucocorticoid-specific Patient-Reported Outcome Questionnaire (the Steroid PRO). Ann Rheum Dis. 2024 Feb 15;83(3):394-400. doi: 10.1136/ard-2023-224946.
PubMed 37949468
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Economic Impact of Steroids: Exploration and Measurement of the Impact of Glucocorticoids in Patients With Inflammatory Rheumatic Conditions
- ClinicalTrials.gov ID
- NCT07863245
- Acronym / sponsor ID
- HEIST / UWE PIMS Number 14724554
- Conditions
- Rheumatic Conditions
- Keywords
- Glucocorticoids, Steroids, Rheumatology, Patient, Health-related quality of life, Health economic impact
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of the West of EnglandUniversity, hospital or other
- Collaborators
- UK Musculoskeletal Translational Research Collaboration (MSK TRC), University of Leeds
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 15 Feb 2027 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 7 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with inflammatory rheumatic conditions. | – | Other: This is a qualitative focus group study therefore no interventions planned, Behavioral: This is a qualitative focus group study therefore no interventions plannedPatients will be purposively sampled to include a spectrum of participants with a range of inflammatory rheumatic conditions and demographics. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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).
Key inclusion criteria (5 listed)
- People who have an inflammatory rheumatic condition.
- People who are aged 18 years or older.
- Have the capacity to give informed consent.
- Have a good understanding of spoken and written English to be able to understand the participant information sheet, consent form and demographic form, and to participate in the focus group.
- Received treatment with intravenous or oral glucocorticoids for an inflammatory rheumatic condition within the previous three years.
Key exclusion criteria (6 listed)
- People who do not have an inflammatory rheumatic condition.
- People who are less than 18 years of age.
- Do not have the capacity to give informed consent.
- Have insufficient understanding of spoken and written English be able to understand the participant information sheet, consent form and demographic form, and to participate in the focus group.
- Either have never taken steroids or not taken steroids within the last three years as part of the treatment plan for their rheumatological condition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This is a qualitative focus group study therefore no interventions plannedThis is a qualitative focus group study therefore no interventions planned | Other | Patients with inflammatory rheumatic conditions. |
| This is a qualitative focus group study therefore no interventions plannedThis is a qualitative focus group study therefore no interventions planned | Behavioural | Patients with inflammatory rheumatic conditions. |
Primary outcome
Steroid PRO
Time frame: Baseline (completed once during each focus group).
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.
EQ-5D-5L
Time frame: Baseline (completed once during each focus group).
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Background: PubMed 37949468Bridgewater S, Ndosi M, Dawson J, Richards P, Silverthorne C, Dures E, Goodman SM, Hill C, Mackie SL, Robson JC. Validation of a new glucocorticoid-specific Patient-Reported Outcome Questionnaire (the Steroid PRO). Ann Rheum Dis. 2024 Feb 15;83(3):394-400. doi: 10.1136/ard-2023-224946.
- Individual participant dataSharing planned: No. Not a clinical trial.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christine A Silverthorne contact
Joanna C Robson principal investigator
University of the West of England
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatic Conditions, run by University of the West of England at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joanna C Robson (0044117-342-7418, jo.robson@uwe.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Steroid PRO (time frame: Baseline (completed once during each focus group).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07863245, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.