Abstract

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.2,3Objectives: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.

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