Table 4.
Suggested minimum data collection and assessment intervals to be used with treatment plans*
| Proposed variables | Baseline visit |
Follow up visits |
|---|---|---|
| History | ||
| Demographics | ||
| Date of birth | x | |
| Sex | x | |
| Race and ethnicity | x | |
| Clinical symptoms | ||
| Fever | x | x |
| Rash | x | x |
| Gastroenterological symptoms | x | x |
| Bone pain | x | x |
| Limitation of motor function$ | x | x |
| Pre-enrollment treatment history for CNO | x | |
| Family history of CNO-associated conditions# | x | |
| Past medical history/concurrently CNO-associated conditions# | x | x |
| Current medications and doses | x | x |
| Patient-reported outcomes and global assessments | ||
| Pain | x | x |
| Health-related quality of life | x | x |
| Physical function –CHAQ, PROMIS | x | x |
| Parent/patient global assessment of disease activity | x | x |
| Physician global assessment of disease activity | x | x |
| Physical examination | ||
| Height, weight | x | x |
| Clinically active CNO lesion count | x | x |
| Active joint counts | x | x |
| Enthesitis | x | x |
| Rash | x | x |
| Imaging findings | ||
| MRI (whole body preferred if available) | x | x |
| Bone scintigraphy if WB MRI is not available | x | |
| X ray if done | x | x |
| CT if done | x | x |
| DXA if done | x | x |
| Laboratory findings | ||
| CBC with differential | x | x |
| C-reactive protein | x | x |
| Erythrocyte sedimentation rate | x | x |
| Alkaline Phosphatase | x | |
| HLA-B27 | x | |
| Bone biopsy findings& | ||
| Bacterial, fungal and AFB culture | x | |
| Pathology | x | |
| Treatment plan–related items | ||
| Serious adverse events or important medical event | x | |
| If plan discontinued, rationale | x | |
| Number of glucocorticoid burst, if any | x |
Data are collected at baseline and at follow up visits every 2–3 months.
CNO: chronic nonbacterial osteomyelitis; MRI: magnetic resonance imaging; CT: computed tomography; DXA: dual energy X ray absorptiometry; CBC: complete blood cell count; HLA: human leukocyte antigen.
Prolonged school/daycare absences, limited use of upper limb, difficulty weight bearing, requiring crutches, bedridden from spinal/leg pain.
Psoriasis, inflammatory bowel disease, celiac disease, inflammatory arthritis, spondyloarthropathy
Needed when bone lesions do not follow typical distribution (clavicle or symmetrical lesions in long bones at metaphysis/epiphysis) in the absence of CNO-associated conditions.