Clinical trial NCT06314451: Cross-condition Validation of the Steroid PRO
Official title: Cross-condition Validation of the Patient Reported Outcome Measure for Patients Receiving Glucocorticoids (the Steroid PRO)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Inflammatory Disease
Immune System Disorder
Gastrointestinal Diseases
Dermatologic Disease
Respiratory Disease
Keywords: Glucocorticoids
Steroids
Health-related quality of life
Rheumatology
Respiratory
Gastroenterology
Dermatology
Pulmonology
Patient
Patient reported outcomes
Lead sponsor: University of the West of England
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
name: University of Pittsburgh
First posted: 2024-03-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: For each of the medical specialties (respiratory, gastroenterology, dermatology), 20 patients will be purposively sampled to include a spectrum of participants with a range of different diseases and demographics (age, gender, country) for each indication.

Key conditions will include inflammatory bowel disease (Ulcerative Colitis, Crohn's disease, Eosinophilic gastroenteritis), dermatological conditions (e.g subacute cutaneous lupus erythematosus (SCLE) systemic vasculitis, pemphigus, pemphigoid, atopic dermatitis), and respiratory conditions (asthma, COPD and interstitial lung disease).

Brief summary: Testing a questionnaire about treatment with steroids for skin, lung or gastric conditions

Detailed description: 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. The investigators are interested in measuring the impact of steroids on quality of life, from the patients' perspective.

In a previous part of this study, the investigators interviewed participants treated with steroids for a range of rheumatic conditions. The participants were asked how taking steroids affects their everyday lives. A patient questionnaire (the 'Steroid PRO') was then created focused on the topics identified as being most important to participants.

Now the investigators would like to test this questionnaire with new participants, aged 18 or over, who are taking steroids for other conditions. This could include participants who have inflammation in the lungs, skin, or bowels. The investigators will also ask for feedback from the medical teams who care for those who have these conditions.

The study involves a single interview with a researcher, either online or by telephone. Participants who want to take part will be given information about the study and asked to give written consent. Participants will be asked to talk about the wording of the questionnaire and how relevant and feasible 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 and USA.

The investigators 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.

Eligibility criteria: Inclusion Criteria:

* Aged ≥ 18 years old
* Diagnosed with an autoimmune or inflammatory respiratory, gastroenterology or dermatology condition
* Treatment with glucocorticoids with intravenous or oral glucocorticoids for an autoimmune or inflammatory condition within the previous year (or longer duration).
* Ability to give consent.

Exclusion Criteria:

* Aged \<18 years old
* No autoimmune or inflammatory respiratory, gastroenterology or dermatology diagnosis
* Not treated with glucocorticoids with intravenous or oral glucocorticoids for an autoimmune or inflammatory condition within the previous year (or longer duration)
* Unable to give consent

Primary outcomes:
measure: Steroid PRO
timeFrame: November 2022 - May 2024
Secondary outcomes:
Other outcomes:
Locations:
city: Bristol
country: United Kingdom
facility: University of the West of England
Study officials:
affiliation: University of the West of England
name: Joanna C Robson, FRCP PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bridgewater S, Shepherd MA, Dawson J, Richards P, Silverthorne C, Ndosi M, Almeida C, Black RJ, Cheah JTL, Dures E, Ghosh N, Hoon EA, Lyne S, Navarro-Millan I, Pearce-Fisher D, Ruediger C, Tieu J, Yip K, Mackie SL, Goodman S, Hill C, Robson JC. Measuring the impact of steroid therapy on health-related quality of life in patients with rheumatic diseases: international development of a glucocorticoid treatment-specific patient-reported outcome measure. Rheumatology (Oxford). 2023 Nov 2;62(11):3565-3575. doi: 10.1093/rheumatology/kead081.
citation: 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.