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

Bridgewater, Susan; Shepherd, Michael A.; Dawson, Jill; Richards, Pamela; Silverthorne, Christine; Ndosi, Mwidimi; Almeida, Celia; Black, Rachel J.; Cheah, Jonathan T.L.; Dures, Emma; Ghosh, Nilasha; Hoon, Elizabeth A.; Lyne, Suellen; Navarro-Millan, Iris; Pearce-Fisher, Diyu; Ruediger, Carlee; Tieu, Joanna; Yip, Kevin; Mackie, Sarah L.; Goodman, Susan; Hill, Catherine; Robson, Joanna C.

Abstract

OBJECTIVES: Glucocorticoids (GCs) ('steroids') are used to treat rheumatic diseases but adverse effects are common. We aimed to explore the impact of GC therapy on health-related quality of life (HRQoL), to inform the development of a treatment-specific patient-reported outcome measure (PROM) for use in clinical trials and practice. METHODS: Semi-structured qualitative interviews were conducted with patients from the UK, USA and Australia, treated for a rheumatic condition with GCs in the last 2 years. Purposive sampling was used to select participants with a range of demographic and disease features. An initial conceptual framework informed interview prompts and cues. Interviews elicited GC-related physical and psychological symptoms and salient aspects of HRQoL in relation to GC therapy. Interview data were analysed inductively to develop initial individual themes and domains. Candidate questionnaire items were developed and refined. RESULTS: Sixty semi-structured qualitative interviews were conducted (UK n = 34, USA n = 10, Australia n = 16). The mean age was 58 years; 39/60 were female; and 18 rheumatic diseases were represented. Some 126 individual themes were identified and organized into six domains: physical symptoms; psychological symptoms; psychological impact of steroids; impact of steroids on participation; impact of steroids on relationships; and benefits of steroids. Candidate questionnaire items were tested and refined by piloting with patient research partners, iterative rounds of cognitive interviews and linguistic translatability assessment, informing a draft questionnaire. CONCLUSION: We describe an international qualitative study to develop candidate items for a treatment-specific PROM for patients with rheumatic diseases. A future survey will enable the validation of a final version of the PROM.

• Journal Article Type: Article
• Acceptance Date: Feb 15, 2023
• Online Publication Date: Feb 25, 2023
• Publication Date: Nov 30, 2023
• Deposit Date: Mar 1, 2023
• Publicly Available Date: Nov 3, 2023
• Journal: Rheumatology
• Print ISSN: 1462-0324
• Electronic ISSN: 1462-0332
• Publisher: Oxford University Press (OUP)
• Peer Reviewed: Peer Reviewed
• Volume: 62
• Issue: 11
• Pages: 3565–3575
• DOI: https://doi.org/10.1093/rheumatology/kead081
• Keywords: rheumatic diseases, glucocorticoid steroids, quality of life, patient reported outcomes
• Public URL: https://uwe-repository.worktribe.com/output/10487388
• Publisher URL: https://academic.oup.com/rheumatology/advance-article-abstract/doi/10.1093/rheumatology/kead081/7058129?redirectedFrom=fulltext&login=false