P092 Patients’ perceptions of glucocorticoid therapy impact on health-related quality of life during treatment for rheumatic diseases: international development of a treatment-specific patient-reported outcome measure (the Steroid PRO)
Authors: 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 , Goodman Susan , Hill Catherine , Robson Joanna C 
Published: April 2022

Abstract

Background/Aims
Glucocorticoids (GCs) are widely used to treat inflammatory rheumatic diseases. GCs carry a range of adverse effects of concern to patients and clinicians. The objective of this study was to explore the impact of GC therapy on health-related quality of life (HRQoL) during treatment for rheumatic diseases, as a basis for development of a patient-reported outcome measure (PROM) to be used in clinical trials and practice.

Methods
Patients from the UK, USA and Australia who were treated with GCs in the last two years for a rheumatic condition were invited to take part in semi-structured qualitative interviews. A steering committee of patient research partners, clinicians and methodologists devised an initial conceptual framework, which informed interview prompts and cues. Interviews identified physical and psychological symptoms and salient aspects of HRQoL in relation to treatment with GCs. Purposive sampling was used to include a range of demographic and disease features. The interview data were organised using NVivo, and inductive analysis identified initial themes and domains. Candidate questionnaire items were developed and refined using cognitive interviewing, linguistic assessment, and input from patient research partners.

Results
Sixty semi-structured qualitative interviews were conducted (UK n = 34, USA n = 10, Australia n = 16). Mean participant age was 58 years; 39 (66.1%) were female. Detailed demographic and GC use information is provided in Table 1.
The following initial domains were developed to identify key themes relating to treatment using GCs and their impact on HRQoL: benefits of steroids; physical symptoms; psychological symptoms; psychological impact of steroids; impact of steroids on participation and on relationships.
Forty-one candidate questionnaire items were developed from the individual themes. These were tested and refined by piloting with patient research partners, iterative rounds of cognitive interviews with patients with a range of rheumatic conditions from the UK, USA and Australia, and a linguistic translatability assessment, to define a draft questionnaire.

Conclusion
This international qualitative study underpins the development of candidate items for a treatment-specific PROM for patients with rheumatic diseases. The draft questionnaire is now ready for testing in an online large-scale survey to determine the final scale structure, possible item reduction, and measurement properties.

Disclosure
S. Bridgewater: None. M.A. Shepherd: None. J. Dawson: None. P. Richards: None. C. Silverthorne: None. M. Ndosi: None. C. Almeida: None. R.J. Black: None. J.T.L. Cheah: None. E. Dures: None. N. Ghosh: None. E.A. Hoon: None. S. Lyne: None. I. Navarro-Millan: None. D. Pearce-Fisher: None. C. Ruediger: None. J. Tieu: None. K. Yip: None. S. Mackie: None. S. Goodman: None. C. Hill: None. J.C. Robson: None.