Table 2.
Visit* | Enrollment visit | Response visit | Routine visit | Aortic screening visit | Withdrawal visit | |
---|---|---|---|---|---|---|
Study procedures | Time of visit (time from diagnosis) | Diagnosis | 2 Mo | 6th and every 12 Mo | 2 Y | |
Margin | + 5 years | +/−1 month | +/− 2 months | +/− 6 months | ||
Attendance data | X | X | X | X | ||
Eligibility and consent | X | |||||
Demography | X | |||||
Diagnostic characteristics, including disease stratification | X | (X) | (X) | X | X | |
Clinical evaluation | X | X | X | X | ||
Medicine and adverse events | X | X | X | X | ||
Complications | X | X | X | X | ||
Comorbidity | X | X | X | X | ||
PROMs | X | X | X | X | ||
Laboratory tests including biobank | X | X | X | X | ||
Angiography of aorta | X | |||||
Reason for withdrawal | X | |||||
Optional § | ||||||
Musculoskeletal ultrasound | X | X | X | |||
Vascular ultrasound | X | X | X | |||
[18F] FDG PET/CT | X | X | X | |||
TAB | X |
*Type of visit (enrollment, response, routine study, aortic screening, and withdrawal) is described in the section ‘Visits’. An enrollment visit is always performed together with a response or routine visit. Response visit is performed in incident patients after treatment initiation. Routine study visits will be performed as long as patients are followed in the rheumatology outpatient clinic. Withdrawal visit procedures will be performed in all cases where it is possible. Reason for withdrawal will always be obtained. §Imaging and/or TAB is performed at the physician’s discretion and on clinical indication. The type of imaging, e.g., diagnosis may vary depending on the patient and the study site. MO, months; Y, years; PROMs, patient-reported outcome measures; [18F] FDG PET/CT, 18F-FDG PET/CT, fluorine-18-fluorodeoxyglucose positron emission tomography with computed; TAB, temporal artery biopsy.