A Qualitative Study Using Interviews With Patients Who Have Anti-neutrophil Cytoplasm Antibody (ANCA) Associated Vasculitis, to Develop a Patient Reported Outcome (PRO) Measure
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- This is a qualitative research study based on semi-quantitive exploratory patient interviews and therefore it is not appropriate to define only one outcome measure.
研究概览
简要总结
A qualitative study using interviews with patients who have antineutrophil cytoplasm antibody (ANCA) associated vasculitis, to develop a patient reported outcome (PRO)measure
详细描述
Patients with antineutrophil cytoplasmic antibody (ANCA) associated vasculitis (AAV) have inflammation in the small blood vessels leading to involvement in different body areas, e.g., the kidneys, lungs and skin. Untreated, the risk of death is over 80%; with current treatment, patients often suffer from ongoing disease activity, damage or treatment side effects which have a negative impact on quality of life. Because patients with AAV can have a wide range of disease features, the investigators hypothesise that general patient reported outcome (PROs) measurements, may not be specific enough to describe the full impact on quality of life.
The main objective of this project is to start from patients' experiences to develop a disease specific PRO for patients with AAV. Patients diagnosed with AAV will be recruited through clinics or inpatients at the Oxford University Hospitals (OUH) National Health Service (NHS) Trust, or, if the patients have previously consented to be contacted about future studies, through the Diagnostic and Classification of Vasculitis (DCVAS) or The Characterisation and Determinants of Quality of Life in ANCA Associated Vasculitis (VasQoL) study databases. After informed consent is obtained, individual patient interviews will be conducted; these will last for approximately one hour and will be recorded and transcribed. Themes will be independently extracted and amalgamated by the researchers. Approximately 25 patients with different types of ANCAassociated vasculitis and varying disease duration will be interviewed until saturation, i.e., no new substantive themes emerge. These themes will then evolve into individual candidate questionnaire items. Candidate items will be piloted on approximately 25 different patients with AAV using questionnaires and interviews, until no further comments arise, to produce a final set of candidate questionnaire items. The duration of the study 1.5 years.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is willing and able to give informed consent for participation in the study.
- •Male or female
- •Aged 18 years or above (no upper limit).
- •Diagnosed with granulomatosis with polyangiitis- Wegeners (GPA), Churg Strauss Syndrome (CSS) or microscopic polyangiitis (MPA)and fulfil either Chapel Hill consensus conference definitions or American College of Rheumatology (ACR) classification criteria.
排除标准
- •Unable or unwilling to give independent written informed consent
- •Significant communication barrier e.g., inability to speak English
- •Membership of the steering committee
结局指标
主要结局
This is a qualitative research study based on semi-quantitive exploratory patient interviews and therefore it is not appropriate to define only one outcome measure.
时间窗: No formal outcome measure therefore not applicable
The principle research objective: The investigators are going to interview patients with anti-neutrophil cytoplasm antibody associated vasculitis, to develop and pilot questionnaire items for a patient reported outcome measure specifically for their disease. The secondary research objective is to describe the impact of ANCA-associated vasculitis on the quality of life of patients attending the Oxford University Hospitals NHS Trust, based on individual anonymised interviews.
次要结局
未报告次要终点