Microscopic Polyangiitis Clinical Trial
Official title:
A Qualitative Study Using Interviews With Patients Who Have Anti-neutrophil Cytoplasm Antibody (ANCA) Associated Vasculitis, to Develop a Patient Reported Outcome (PRO) Measure
A qualitative study using interviews with patients who have antineutrophil cytoplasm antibody (ANCA) associated vasculitis, to develop a patient reported outcome (PRO)measure
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.
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Time Perspective: Prospective
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