PRO Development for ANCA Associated Vasculitis
PRO Development for ANCA Associated Vasculitis
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.
Inclusion Criteria:

 -  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.

 Exclusion Criteria:

 -  Unable or unwilling to give independent written informed consent

 -  Significant communication barrier e.g., inability to speak English

 -  Membership of the steering committee