Faculty of Health and Applied Sciences, School of Health and Social Wellbeing, University of the West of England-UWE Bristol, Bristol, UK.
Academic Rheumatology Department, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK.
Rheumatology (Oxford). 2023 Nov 2;62(11):3565-3575. doi: 10.1093/rheumatology/kead081.
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.
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.
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.
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.
糖皮质激素（GCs）（“类固醇”）用于治疗风湿性疾病，但常见不良反应。我们旨在探讨 GC 治疗对健康相关生活质量（HRQoL）的影响，为开发一种用于临床试验和实践的特定于治疗的患者报告结局测量（PROM）提供信息。
对过去 2 年内接受 GCs 治疗风湿性疾病的英国、美国和澳大利亚患者进行了半结构化定性访谈。采用目的抽样选择具有一系列人口统计学和疾病特征的参与者。初始概念框架为访谈提示和线索提供了信息。访谈引出了与 GC 相关的身体和心理症状，以及与 GC 治疗相关的 HRQoL 的重要方面。通过归纳分析访谈数据，开发了初始的个体主题和领域。开发和完善了候选问卷项目。
进行了 60 次半结构化定性访谈（英国 n=34，美国 n=10，澳大利亚 n=16）。平均年龄为 58 岁；39/60 名女性；代表了 18 种风湿性疾病。确定并组织成六个领域的 126 个个体主题：身体症状；心理症状；类固醇的心理影响；类固醇对参与的影响；类固醇对人际关系的影响；和类固醇的好处。通过与患者研究伙伴一起进行试点、迭代认知访谈和语言可翻译性评估，对候选问卷项目进行了测试和完善，为问卷草案提供了信息。
我们描述了一项国际定性研究，以开发用于风湿性疾病患者的特定于治疗的 PROM 的候选项目。未来的调查将使 PROM 的最终版本得以验证。
