Search

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., (© The Author(s) 2023. Published by Oxford University Press on behalf of the British Society for Rheumatology.)

Introduction: Glucocorticoids (GCs) remain widely used. However, the impact of GCs from the perspective of the patient, rather than of the clinician, remains relatively unexplored. Additionally, no general patient reported outcome measure has been developed to assess the effects of GCs across rheumatological conditions. The aim of this literature review was to identify the adverse effects of systemic GC use that are of importance to patients., Methods: OVID EMBASE, OVID MEDLINE, PsycINFO and CINAHL was searched relating to three concepts: GCs, the patient perspective and adverse effects. A meta-synthesis of the qualitative data was performed separately by two independent researchers before qualitative metasummary was utilized to quantitatively aggregate the findings (combining quantitative and qualitative results), including the derivation of frequency and intensity effect sizes to identify those outcomes most prominently featured across all reviewed articles., Results: The initial search retrieved 1,356 articles, of which 25 (18 quantitative, 7 qualitative) were deemed suitable for quality assessment and data extraction. Four major themes emerged amongst the 71 discrete outcomes: physical symptoms (44), psychological symptoms (18), effect on participation (6) and contextual factors (3)., Conclusions: Patients with a broad range of inflammatory diseases and demographic features describe key cross-cutting themes in relation to GCs and their impact on health-related quality of life. This work will inform the development of a core domain set for clinical trials involving GCs and a patient reported outcome to measure impact of GCs from the patient's perspective., (Copyright © 2020 Elsevier Inc. All rights reserved.)