Robson Joanna C, Dawson Jill, Cronholm Peter F, Milman Nataliya, Kellom Katherine S, Ashdown Susan, Easley Ebony, Farrar John T, Gebhart Don, Lanier Georgia, McAlear Carol A, Peck Jacqueline, Luqmani Raashid A, Shea Judy A, Tomasson Gunnar, Merkel Peter A
Department of Rheumatology, Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK.
School of Clinical Sciences, University of Bristol, Bristol, UK.
Patient Relat Outcome Meas. 2018 Jan 4;9:17-34. doi: 10.2147/PROM.S144992. eCollection 2018.
The antineutrophil cytoplasmic antibody (ANCA)-associated vasculitides (AAVs) are multisystem diseases of the small blood vessels. Patients experience irreversible damage and psychological effects from AAV and its treatment. An international collaboration was created to investigate the impact of AAV on health-related quality of life (HRQoL), and develop a disease-specific patient-reported outcome measure to assess outcomes of importance to patients.
Patients with AAV from the UK, USA, and Canada were interviewed to identify salient aspects of HRQoL affected by AAV. The study was overseen by a steering committee including four patient research partners. Purposive sampling of interviewees ensured representation of a range of disease manifestations and demographics. Inductive analysis was used to identify themes of importance to patients; these were further confirmed by a free-listing exercise in the US. Individual themes were recast into candidate items, which were scrutinized by patients, piloted through cognitive interviews and received a linguistic and translatability evaluation.
Fifty interviews, conducted to saturation, with patients from the UK, USA, and Canada, identified 55 individual themes of interest within seven broad domains: general health perceptions, impact on function, psychological perceptions, social perceptions, social contact, social role, and symptoms. Individual themes were constructed into >100 candidate questionnaire items, which were then reduced and refined to 35 candidate items.
This is the largest international qualitative analysis of HRQoL in AAV to date, and the results have underpinned the development of 35 candidate items for a disease-specific, patient-reported outcome questionnaire.
抗中性粒细胞胞浆抗体（ANCA）相关血管炎（AAV）是累及小血管的多系统疾病。AAV及其治疗会给患者带来不可逆的损害和心理影响。为此开展了一项国际合作，以研究AAV对健康相关生活质量（HRQoL）的影响，并制定一项针对该疾病的患者报告结局指标，以评估对患者重要的结局。
对来自英国、美国和加拿大的AAV患者进行访谈，以确定受AAV影响的HRQoL的显著方面。该研究由一个指导委员会监督，其中包括四名患者研究伙伴。对受访者进行目的抽样，以确保涵盖一系列疾病表现和人口统计学特征。采用归纳分析法确定对患者重要的主题；这些主题在美国通过自由列举练习得到进一步确认。将各个主题重新编写为候选条目，由患者进行审查，通过认知访谈进行试点，并接受语言和可翻译性评估。
对来自英国、美国和加拿大的患者进行了50次访谈，直至饱和，确定了七个广泛领域内的55个感兴趣的个体主题：总体健康认知、对功能的影响、心理认知、社会认知、社会接触、社会角色和症状。将个体主题构建为100多个候选问卷条目，然后缩减并提炼为35个候选条目。
这是迄今为止对AAV患者HRQoL进行的最大规模的国际定性分析结果，为针对该疾病的患者报告结局问卷的35个候选条目的制定提供了依据。
