BMJ Open. 2025 Feb 5;15(2):e089225.doi: 10.1136/bmjopen-2024-089225.

Anne-Marie T Sweeney ^1 2, Susan Bridgewater ^1 2, Jen Orme ^1 2, Sebastian E Sattui ³, Michelle Sharp ⁴, Pamela Richards ¹, Christine A Silverthorne ^1 2, Elizabeth Arthurs ⁵, Tom Creed ⁵, Genevieve Osborne ⁶, Giles Dunhill ⁶, Jill Dawson ⁷, Emma Dures ^1 8, Shaney L Barratt ⁹, Richard P Ramonell ¹⁰, Timothy Patton ¹¹, Susan M Goodman ¹², Catherine L Hill ^13 14, Sarah L Mackie ^15 16, Mwidimi Ndosi ^1 2, Joanna C Robson ^17 2

Author information

¹University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK.

²Center for Health and Clinical Research, University of the West of England, Bristol, UK.

³University of Pittsburgh, Pittsburgh, Pennsylvania, USA.

⁴Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.

⁵Gastroenterology Department, University Hospitals Bristol and Weston NHS Trust, Bristol, UK.

⁶Dermatology Department, University Hospitals Bristol and Weston NHS Trust, Bristol, UK.

⁷Nuffield Department of Population Health, University of Oxford, Oxford, UK.

⁸University of the West of England, Bristol, UK.

⁹North Bristol NHS Foundation Trust, Bristol, UK.

¹⁰Division of Pulmonary Allergy Critical Care and Sleep Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.

¹¹Department of Dermatology, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.

¹²Weill Cornell Medicine, New York City, New York, USA.

¹³The University of Adelaide, Adelaide, South Australia, Australia.

¹⁴Department of Rheumatology, The Queen Elizabeth Hospital, Woodville South, South Australia, Australia.

¹⁵Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, UK.

¹⁶Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.

¹⁷University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK Jo.Robson@uwe.ac.uk.

Abstract

Objectives: The Steroid PRO is a treatment-specific patient-reported outcome questionnaire which measures the impact of glucocorticoids on health-related quality of life. It has 15 items grouped into 4 domains (Social impact, Impact on Appearance, Psychological Impact and Treatment Concerns). Initially developed and validated in rheumatic diseases, the Steroid PRO demonstrates potential for broader application in patients with other inflammatory conditions. The objective of this study was to assess face validity, content validity and feasibility of the Steroid PRO in (1) patients treated with glucocorticoids for inflammatory respiratory, dermatological and gastroenterological conditions and (2) clinicians working within these specialties in the UK and USA.

Design: Qualitative study with semistructured cognitive interview methods.

Setting: Online or face-to-face interviews with participants from seven departments across three secondary care hospitals in the UK and USA.

Participants: Inclusion criteria: (1) Adult patients with inflammatory respiratory, gastroenterological and dermatological conditions treated with glucocorticoids and (2) healthcare professionals (HCPs) working in respiratory, dermatology and gastroenterology departments in the UK and USA.

Results: Purposive sampling to ensure a range of patient and HCP participants. A total of 42 patient participants were recruited, from respiratory/pulmonology (n=14, 33.3%), dermatology (n=13, 31.0%) and gastroenterology (n=15, 35.8%) medical departments; 32 in the UK and 10 from the USA. Mean age 48.2 years (range 22-71) and 19 (45.2%) were female. Patient participants had a range of inflammatory lung, skin and bowel conditions, with a spectrum of demographics and patterns of glucocorticoid use. 14 HCPs participated from the UK (9) and USA (5). Face validity: 97% (30/31) patients and 100% (14/14) HCPs reported the Steroid PRO was 'relevant or very relevant' to them and their disease.

Feasibility: 97% (30/31) patients and 100% (14/14) HCPs reported the Steroid PRO was 'easy or very easy to complete'. Patients reported that the four domains of the Steroid PRO had relevance to them and that it was validating to see their concerns represented: 'It's obvious you guys know what you're talking about-these are my issues. It's very validating when you realise it's not just you. These problems are real and they matter.… These are not questions my doctor asks me about. Doctors never ask about psychosocial aspects. It would be really great if they used this' (female patient with asthma). Patients and clinicians felt the Steroid PRO would be suitable for use in clinical practice within their specialties and would aid in understanding of the impact of glucocorticoids.

Conclusions: The Steroid PRO demonstrated face validity and content validity for assessing the impact of glucocorticoids in patients with inflammatory respiratory, gastroenterological and dermatological conditions. Additionally, the feasibility of using the Steroid PRO with both patients and HCPs has been established. Future work should include quantitative testing of the Steroid PRO as an outcome measure within clinical trials in these conditions.

Trial registration number: NCT06314451.