AB0834 DEVELOPMENT OF A CONCEPTUAL FRAMEWORK FOR A PATIENT REPORTED OUTCOME MEASURE TO CAPTURE PATIENTS’ PERCEPTIONS OF GLUCOCORTICOID THERAPY DURING TREATMENT FOR RHEUMATIC DISEASES
Authors: S. Bridgewater, J. Dawson, M. Ndosi, R. J. Black, J. T. L. Cheah, E. Dures, N. Ghosh, E. A. Hoon, I. Navarro-Millan, D. Pearce-Fisher, P. Richards, C. Ruediger, C. Silverthorne, J. Tieu, S. Mackie, S. Goodman, C. Hill, J. Robson
Journal: Annals of the Rheumatic Diseases (2021)

Background: Glucocorticoids (GCs) are a key treatment for the autoimmune rheumatic diseases; however, they produce numerous physical and psychological side effects. 1 The Outcome Measures in Rheumatology (OMERACT) Glucocorticoid Working Group have identified that there are no Patient Reported Outcome Measures (PROMs) for assessing the impact of systemic GC therapy across multiple rheumatic diseases from the patient’s perspective. 2,3 Objectives: The aim is to explore the impact of GCs on the symptoms and health-related quality of life of adults with rheumatic inflammatory diseases, to inform items for inclusion in a PROM. Key considerations will include patient perceptions of GC therapy at diagnosis and over the course of treatment, for use in future randomised controlled trials or in clinical practice. Methods: An international steering committee comprising researchers, rheumatology clinicians, methodologists and patient partners in the UK, Australia and USA developed an initial conceptual framework informed by a review of the literature. Semi-structured interviews were conducted in each country with patients who had an autoimmune rheumatic disease and had received GC therapy. The interviews explored salient aspects of health-related quality of life associated with being treated with GCs. Results: Interviews have been completed in three continents with patients who had a range of demographic features, rheumatological conditions and duration and dosage of GC therapy. Figure 1 shows the initial conceptual framework for developing the GC PROM (Steroid PRO). Figure 1. Conclusion: This conceptual framework will act as an evolving guide in the development of a PROM for assessing patients’ perspectives of systemic glucocorticoid therapy. Future work will include inductive analysis of qualitative transcripts to inform candidate questionnaire items, cognitive interviewing, linguistic translatability assessment, and an international validation survey to define the final PROM questionnaire and its measurement properties. References: [1]Cheah JTL, Robson JC, Black RJ, et al . The patient’s perspective of the adverse effects of glucocorticoid use: A systematic review of quantitative and qualitative studies. From an OMERACT working group. Semin Arthritis Rheum. 2020 Oct; 50 (5):996-1005. [2]Black RJ, Robson JC, Goodman SM, et al. A Patient-reported Outcome Measure for Effect of Glucocorticoid Therapy in Adults with Inflammatory Diseases Is Needed: Report from the OMERACT 2016 Special Interest Group. J Rheumatol. 2017; 44 (11):1754-8. [3]Cheah JTL, Black RJ, Robson JC, et al . Toward a Core Domain Set for Glucocorticoid Impact in Inflammatory Rheumatic Diseases: The OMERACT 2018 Glucocorticoid Impact Working Group. J Rheumatol. 2019; 46 (9):1179-1182. Disclosure of Interests: Susan Bridgewater Grant/research support from: Grant from Vifor Pharma for an independent investigator-led study to develop a PRO for steroids, Jill Dawson: None declared, Mwidimi Ndosi: None declared, Rachel J Black: None declared, Jonathan T.L. Cheah: None declared, Emma Dures: None declared, Nilasha Ghosh: None declared, Elizabeth A Hoon: None declared, Iris Navarro-Millan Consultant of: Received consultant fees from SOBI, Diyu Pearce-Fisher: None declared, Pamela Richards: None declared, Carlee Ruediger: None declared, Christine Silverthorne: None declared, Joanna Tieu Grant/research support from: Vifor Pharma, Sarah Mackie Consultant of: Consultancy on behalf of institution for Roche/Chugai, Sanofi, AbbVie and AstraZeneca, Grant/research support from: Educational grant from Roche to attend EULAR2019, Susan Goodman: None declared, Catherine Hill: None declared, Joanna Robson Speakers bureau: Vifor Pharma for educational webinar, Grant/research support from: Grant from Vifor Pharma for an independent investigator-led study to develop a PRO for steroids