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

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

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
Affiliations
Multicenter Study

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

Anne-Marie T Sweeney et al. BMJ Open. .

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.

Keywords: Asthma; Dermatology; Eczema; Gastroenterology; QUALITATIVE RESEARCH.

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Conflict of interest statement

Competing interests: A-MTS nil; SB: Grants from Sanofi Research and Development unrestrictive academic grant to UWE Bristol for this cross-condition validation study and Vifor Pharma: Independent academic grant to UWE Bristol to develop the Steroid PRO; SB is coinventor of the Steroid PRO (free for academic and clinical use), may in future receive occasional royalty payment related to commercial licences. JO nil; SES: Grants from Bristol Myers Squibb Foundation Robert A. Winn Diversity in Clinical Trials Career Development Awards (Payments to University of Pittsburgh), Rheumatology Research Foundation RISE Pilot Award (Payments to the University of Pittsburgh), AstraZeneca for Clinical trials, research support, GlaxoSmithKline for Clinical trials, research support. Consulting fees from Amgen (payments to the University of Pittsburgh) and Sanofi (payments to the University of Pittsburgh for research support). Payment or honoraria from Fresenius Kabi (payments to the University of Pittsburgh for research support). Participation in data monitoring committee for the MINT trial—University of Pittsburgh. Support for medical writing (no payment) from Genentech, Amgen and Sanofi. MS: National Heart, Lung, And Blood Institute of the National Institutes of Health under Award Numbers K23HL148527 (research support). PR: nil; CAS: nil; EA: nil; TC: nil; GO: nil; GD: nil; MN: Grants from Sanofi Research and Development unrestrictive academic grant to UWE Bristol for this cross-condition validation study and Vifor Pharma: Independent academic grant to UWE Bristol to develop the Steroid PRO; MN is coinventor of the Steroid PRO (free for academic and clinical use), may in future receive occasional royalty payment related to commercial licenses. JD: Grants from Sanofi Independent academic grant to UWE Bristol for this cross-condition validation study and Vifor Pharma: Independent academic grant to UWE Bristol to develop the Steroid PRO; JD is coinventor of the Steroid PRO (free for academic and clinical use), may in future receive occasional royalty payment related to commercial licenses. ED: nil; SLB: nil: RPR: nil; TP: nil SMG: Grants from Novartis (funding for investigator-initiated study-payments to institution), Arthritis Foundation (Payments to institution) and NIH (Payments to institution). Payments or honoraria for lectures to SMG from Yale, ACR, Florida Rheumatology Association, Japan College of Rheumatology. Payments to SMG from UBC for Data Monitoring Committee. CLH: Arthritis Australia Grant funding for institution for initial qualitative work for Steroid PRO performed in Australia. Leadership roles: Board, The Hospital Research Foundation (unpaid) and Aust NZ Vasculitis Society (unpaid). SLM: Grants from MRC Confidence in Concept scheme, 2021: lead applicant. Grant to develop early diagnosis methods for giant cell arteritis. Internal grant scheme administered by University of Leeds. This did not include any payment, benefits or salary support for me personally. Coapplicant on research grants with contribution to my salary: 2020: Vifor: development of a patient-reported outcome measure for glucocorticoid therapy (PI: Robson, University of the West of England; 2.5% FTE salary contribution for me), Coapplicant on research grants with contribution to my salary. 2020: Vifor: the glucocorticoid toxicity index in patients with vasculitis and polymyalgia rheumatica (PI: Luqmani, University of Oxford, 5% FTE salary contribution for me). Lead applicant on research grants with contribution to my salary 2021: STERLING-PMR: steroid-reducing options for relapsing PMR. 20% salary contribution to me. Consulting fees (payment to institution) from Roche/Chugai, Sanofi, AbbVie (2021-), AstraZeneca (2021-) and Pfizer (2021-). Honoraria or payment for lectures (all payments to institution) from Roche/Chugai Sept 2021: delivering a talk on giant cell arteritis at an educational day (non-promotional); Pfizer 2022: speaking in short educational videos (non-promotional, not related to Pfizer products.). UCB Oct-Nov 2022: payment to my institution (not to me personally) for speaking at Evolutions in Rheumatology (non-promotional, no mention of UCB products). Vifor April 2022: payment to my institution (not to me personally) for speaking at industry symposium at BSR2022 (non-promotional, no mention of Vifor products). Novartis 2022: payment to my institution (not to me personally) for delivering educational talk to Novartis staff. Support for registration to ACR Convergence 2021 (virtual attendance) from Pfizer. Participation on a Data Safety Monitoring Board or Advisory Board: 1. INCLUDE trial (non-commercially funded trial: CLAHRC and Haywood Foundation). 2017—Chair of trial steering committee. INCLUDE trial (ISRCTN12765345) was a pilot feasibility cluster trial of a package of care for patients with inflammatory rheumatic diseases in the community. 2. Non-commercial trial: GC-SheaLD, member of data monitoring committee 2018-2019. Member of data monitoring committee for phase 2 non-commercially funded trial GC-SheaLD (NCT03313297). Other financial or non-financial interests: (1) Investigator on industry sponsored clinical trials. Has acted as Site Principal Investigator and UK Chief Investigator on clinical trials (giant cell arteritis and polymyalgia rheumatica) for Sanofi. UK Chief Investigator for clinical trial in PMR for Sparrow (awaiting MHRA approval). (2) Infrastructure support from grant on which I am coapplicant UK Medical Research Council (MRC) TARGET Partnership Grant (MR/N011775/1/MRC_/Medical Research Council/UK). (3) Infrastructure support received includes data entry, database management and liaison with ethics committees. (4) Patron of PMRGCAuk. Patron of the patient charity PMRGCAuk. No formal role or contract; not a fiduciary or leadership role. I write a regular column for their Newswire newsletter. This is unpaid (voluntary) work. (5). Support from NIHR Leeds Biomedical Research Centre. JCR: Grants as PI from Sanofi Research and Development unrestrictive academic grant to UWE Bristol for this cross-condition validation study and Vifor Pharma: Independent academic grant to UWE Bristol to develop the Steroid PRO; JCR is coinventor of the Steroid PRO (free for academic and clinical use), may in future receive occasional royalty payment related to commercial licences and inventor translation reviews. Honorarium/payment for lectures and chairing sessions from Vifor Pharma in 2022 and 2023, and support to attend EULAR 2023 from Vifor Pharma. Support for medical writing from Vifor Pharma (no payment).

Figures

Figure 1
Figure 1. Assessment of the Steroid PRO by patients and clinicians in respiratory, dermatology, gastroenterology. (A) Patient assessment of relevance, (B) clinician assessment of relevance, (C) patient assessment of feasibility, (D) clinician assessment of feasibility.
See this image and copyright information in PMC

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