Centre for Health and Clinical Research, University of the West of England.
Bristol Royal Infirmary, University Hospitals and Weston Bristol NHS Foundation Trust, Bristol.
Rheumatology (Oxford). 2021 Oct 2;60(10):4671-4680. doi: 10.1093/rheumatology/keab076.
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.
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.
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.
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.
巨细胞动脉炎（GCA）是一种大血管血管炎（LVV），表现为头痛、下颌跛行、肌肉骨骼和视觉受累。目前的治疗方法是糖皮质激素和抗 IL-6 托珠单抗治疗难治性疾病。本研究的目的是探讨 GCA 及其治疗对患者健康相关生活质量（HRQoL）的影响，为开发用于临床试验和实践的特定疾病患者报告结局测量（PROM）提供信息。
来自英国和澳大利亚的经活检或影像学证实的 GCA 患者接受了访谈，以确定与 GCA 及其治疗相关的 HRQoL 的重要方面。有目的地进行了包括各种人口统计学和疾病特征（颅、LVV-GCA 和视觉受累）的抽样。归纳分析确定了重要的个体主题，然后确定了领域。候选问卷项目是从个体主题中开发出来的，通过试点、认知访谈和语言可翻译性评估进行了改进。
对来自英国（25 人）和澳大利亚（11 人）的 GCA 患者进行了 36 次访谈，直至达到饱和。平均年龄为 74 岁，23 人（63.9%）为女性，13 人（36.1%）有视力丧失，5 人（13.9%）有 LVV-GCA。五个领域内有 39 个个体主题：身体症状；日常生活活动和功能；参与；心理影响；自我意识和健康感知的影响。从个体主题中开发了 69 个候选项目；试点和改进后形成了 40 个项目的草案问卷。
这项国际定性研究为 GCA 的特定疾病 PROM 开发候选项目提供了依据。草案问卷现已准备好进行心理计量学测试。
