Patient perceptions of health-related quality of life in giant cell arteritis: international development of a disease-specific patient-reported outcome measure

• Published in: Rheumatology (Oxford, England) England), 2021-10, Vol.60 (10), p.4671-4680
• Main Authors: Robson, Joanna C, Almeida, Celia, Dawson, Jill, Bromhead, Alison, Dures, Emma, Guly, Catherine, Hoon, Elizabeth, Mackie, Sarah, Ndosi, Mwidimi, Pauling, John, Hill, Catherine
• Format: Article
• Language: English
• Subjects: Aged; Antibodies, Monoclonal, Humanized - therapeutic use; Australia; Clinical Science; Cost of Illness; Diagnostic Self Evaluation; Female; Functional Status; Giant Cell Arteritis - drug therapy; Giant Cell Arteritis - psychology; Glucocorticoids - therapeutic use; Humans; Male; Patient Reported Outcome Measures; Qualitative Research; Quality of Life - psychology; Self Concept; Social Participation - psychology; United Kingdom
• ISSN: 1462-0324; 1462-0332
• DOI: 10.1093/rheumatology/keab076

Abstract Objectives GCA is a large vessel vasculitis (LVV) presenting with headache, jaw claudication, musculoskeletal and visual involvement. Current treatment is glucocorticoids and anti-IL-6 tocilizumab in refractory disease. The objective of this study was to explore the impact of GCA and its treatment on people’s health-related quality of life (HRQoL), to inform the development of a disease-specific patient-reported outcome measure (PROM) for use in clinical trials and practice. Methods Participants from the UK and Australia, with biopsy- or imaging-confirmed GCA, were interviewed to identify salient aspects of HRQoL in relation to GCA and its treatment. Purposive sampling included a range of demographic and disease features (cranial, LVV-GCA and visual involvement). Inductive analysis identified individual themes of importance, then domains. Candidate questionnaire items were developed from the individual themes, refined by piloting, cognitive interviews and a linguistic translatability assessment. Results Thirty-six interviews were conducted to saturation with participants with GCA from the UK (25) and Australia (11). Mean age was 74 years, 23 (63.9%) were female, 13 (36.1%) had visual loss and 5 (13.9%) had LVV-GCA. Thirty-nine individual themes within five domains were identified: physical symptoms; activity of daily living and function; participation; psychological impact; and impact on sense of self and perception of health. Sixty-nine candidate items were developed from individual themes; piloting and refinement resulted in a 40-item draft questionnaire. Conclusion This international qualitative study underpins the development of candidate items for a disease-specific PROM for GCA. The draft questionnaire is now ready for psychometric testing.