Measuring the impact of steroid therapy on health-related quality of life in patients with rheumatic diseases: international development of a glucocorticoid treatment-specific patient-reported outcome measure

Susan Bridgewater; Michael A Shepherd; Jill Dawson; Pamela Richards; Christine Silverthorne; Mwidimi Ndosi; Celia Almeida; Rachel J Black; Jonathan T L Cheah; Emma Dures; Nilasha Ghosh; Elizabeth A Hoon; Suellen Lyne; Iris Navarro-Millan; Diyu Pearce-Fisher; Carlee Ruediger; Joanna Tieu; Kevin Yip; Sarah L Mackie; Susan Goodman; Catherine Hill; Joanna C Robson

doi:10.1093/rheumatology/kead081

Measuring the impact of steroid therapy on health-related quality of life in patients with rheumatic diseases: international development of a glucocorticoid treatment-specific patient-reported outcome measure

Rheumatology (Oxford). 2023 Nov 2;62(11):3565-3575. doi: 10.1093/rheumatology/kead081.

Authors

Susan Bridgewater^{1

2}, Michael A Shepherd^{1

2}, Jill Dawson³, Pamela Richards², Christine Silverthorne^{1

2}, Mwidimi Ndosi^{1

2}, Celia Almeida^{1

2}, Rachel J Black^{4

5

6}, Jonathan T L Cheah⁷, Emma Dures^{1

2}, Nilasha Ghosh⁸, Elizabeth A Hoon^{9

10}, Suellen Lyne^{4

6}, Iris Navarro-Millan^{7

11}, Diyu Pearce-Fisher⁸, Carlee Ruediger⁶, Joanna Tieu^{6

12}, Kevin Yip⁸, Sarah L Mackie^{13

14}, Susan Goodman⁸, Catherine Hill^{4

5

6}, Joanna C Robson^{1

2}

Affiliations

¹ Faculty of Health and Applied Sciences, School of Health and Social Wellbeing, University of the West of England-UWE Bristol, Bristol, UK.
² Academic Rheumatology Department, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK.
³ Department of Population Health (HSRU), University of Oxford, Oxford, UK.
⁴ Discipline of Medicine, The University of Adelaide, Adelaide, Australia.
⁵ Rheumatology Department, Royal Adelaide Hospital, Adelaide, Australia.
⁶ Department of Rheumatology, The Queen Elizabeth Hospital, Adelaide, Australia.
⁷ Department of Medicine, Division of Rheumatology, University of Massachusetts Medical School, Worcester, MA, USA.
⁸ Division of Rheumatology, Hospital for Special Surgery, Weill Cornell Medicine, New York, NY, USA.
⁹ Discipline of General Practice, The University of Adelaide, Adelaide, Australia.
¹⁰ School of Public Health, The University of Adelaide, Adelaide, Australia.
¹¹ Division of General Internal Medicine, Weill Cornell Medicine, New York, NY, USA.
¹² Rheumatology Unit, Lyell McEwin Hospital, Adelaide, Australia.
¹³ Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.
¹⁴ NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, UK.

Abstract

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.

Keywords: glucocorticoid steroids; patient-reported outcomes; quality of life; rheumatic diseases.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Female
Glucocorticoids / therapeutic use
Humans
Male
Middle Aged
Patient Reported Outcome Measures
Quality of Life*
Rheumatic Diseases* / chemically induced
Rheumatic Diseases* / drug therapy
Steroids
Surveys and Questionnaires

Substances

Glucocorticoids
Steroids