Table 2.
Assessment Intervals | ||||
---|---|---|---|---|
Proposed Variables2 | Baseline Visit |
Follow-up visits: 1–2 weeks, 1 month, 3 month, 6 months, 9 months |
||
History | ||||
• Demographics | ||||
▪ DOB | ||||
▪ Gender | X | |||
▪ Race and ethnicity | ||||
• Date(s) of onset of Symptoms | ||||
▪ Fever | X | |||
▪ Rash | ||||
▪ Joint symptoms | ||||
• Pre-enrollment treatment history for SJIA |
X | |||
• Current Medications and doses |
X | X | ||
• Comorbid Diagnoses | X | |||
• Fever of sJIA in the past week | X | X | ||
• Rash of sJIA in the past week | X | X | ||
• Duration of morning stiffness | X | X | ||
• Serositis in the past week | X | X | ||
• Patient has MAS (impression of treating physician) |
X | X | ||
Patient reported outcomes and global assessments | ||||
• Pain | X | X | ||
• HRQOL | X | X | ||
• Physical function | X | X | ||
• Parent/patient global assessment of disease activity |
X | X | ||
• Physician global assessment of disease activity |
X | X | ||
Physical exam | ||||
• Height, weight, BMI | X | X | ||
• Rash | X | X | ||
• Active joint count | X | X | ||
• Lymphadenopathy | X | X | ||
• Hepatomegaly | X | X | ||
• Splenomegaly | X | X | ||
• Serositis | X | X | ||
Labs | ||||
• CBC (wbc, hemoglobin, platelet count) |
X | X | ||
• C-reactive protein | X | X | ||
• Erythrocyte sedimentation rate | X | X | ||
• Ferritin | X | X | ||
• LDH | X | X | ||
Treatment plan related items | ||||
• Serious adverse events or important medical event |
X | |||
• If plan discontinued, rationale | X | |||
• Number of IV steroid pulses, if Any |
X | |||
• Uveitis status at last eye exam | X |
Data is collected at baseline, 1–2 weeks, 1, 3, 6, 9 months. Data collection is encouraged at changes in treatment (even if it does not occur at a scheduled time point). Monthly phone follow-up recommended. Any additional visits in between these time points are at the discretion of the physician and data may or may not be collected.
Not included in table, malignancy and infection work-up, screen for tuberculosis at baseline (and then annually).