Cross-condition Validation of the Steroid PRO

NCT06314451 | Recruiting

• 1 other identifier: HAS.22.11.035
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Outcome Measures

Primary Outcomes (1)

• Steroid PRO

  Validated outcome measure to capture the impact of treatment with glucocorticoids on health related quality of life (Bridgewater ARD 2023). 15 item questionnaire, 4 domains (Impact on Appearance, Psychological Impact, Social impact and Treatment Concerns). Steroid PRO is the full title of the outcome measure. A PRO is a patient reported outcome. Higher scores equal greater impact on health related quality of life. Raw scores: minimum possible score 0, maximum 45.

  November 2022 - May 2024

Study Arms (2)

Patients with respiratory, gastroenterology and dermatology inflammatory conditions

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. Sample size will also be led by the point at which no further issues are emerging during the cognitive interview process.

Other: Cognitive Interview

Clinicians and researchers skilled in inflammatory diseases

Clinician researchers from each country (UK, USA) will be purposively sampled to include a spectrum of participants with a range of clinical experience and demographics (age, gender, country). Sample size will also be led by the point at which no further issues are emerging during the cognitive interview process.

Other: Cognitive Interview

Interventions

Cognitive Interview OTHER

The study involves a single cognitive interview with a researcher, either online, by telephone, or face-to-face. 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. Cognitive interviewing is recognized as a significant part of developing questionnaires for patient reported outcome measures (PROMs). The cognitive interviewing process used in PROM development will be adapted in this study to test the Steroid PRO in new disease populations. Cognitive interviewing will be carried out using pragmatic, light-touch interviews, underpinned by think aloud techniques and clean language principles.

Clinicians and researchers skilled in inflammatory diseases; Patients with respiratory, gastroenterology and dermatology inflammatory conditions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of the West of England: lead
• Johns Hopkins University: collaborator
• University of Pittsburgh: collaborator

Study Sites (1)

University of the West of England

Bristol, BS2 8HW, United Kingdom

RECRUITING

Related Publications (3)

• 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.

  PMID: 36840642 BACKGROUND

• 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.

  PMID: 37949468 BACKGROUND

• Sweeney AT, Bridgewater S, Orme J, Sattui SE, Sharp M, Richards P, Silverthorne CA, Arthurs E, Creed T, Osborne G, Dunhill G, Dawson J, Dures E, Barratt SL, Ramonell RP, Patton T, Goodman SM, Hill CL, Mackie SL, Ndosi M, Robson JC. Impact of glucocorticoids on patients' quality of life: a qualitative study assessing face validity and feasibility of the Steroid PRO in patients with inflammatory gastroenterology, respiratory and dermatology conditions. BMJ Open. 2025 Feb 5;15(2):e089225. doi: 10.1136/bmjopen-2024-089225.

  PMID: 39909511 DERIVED

MeSH Terms

Conditions

Immune System Diseases; Gastrointestinal Diseases; Skin Diseases; Respiration Disorders

Condition Hierarchy (Ancestors)

Digestive System Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Diseases

Study Officials

• Joanna C Robson, FRCP PhD

  University of the West of England

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joanna C Robson, FRCP PhD

CONTACT

0117 3427418; jo.robson@uwe.ac.uk

Leigh Taylor

CONTACT

0117 328 1170; leigh.taylor@uwe.ac.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: March 18, 2024
• Study Start: June 1, 2022
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)