Outcome set | Category | Details | Timing | Data source |
1. Mortality | Longitudinal outcomes | Date of death | Tracked throughout | Administrative |
2. Pulmonary function | Clinical monitoring |
| Every 3–6 months (depending on severity of sarcoidosis) | Clinical |
3. Soluble interleukin-2 receptor (sIL-2R) change as an activity biomarker | Clinical monitoring |
| Every visit to the clinic | Clinical |
4. Weight gain | Clinical monitoring | Weight (kg) measured at each pulmonary function test | Every visit to the clinic | Clinical |
5. Quality of life; physical functioning | Patient-reported health status | King’s Sarcoidosis Questionnaire40 and the Fatigue Assessment Scale37 | Every 6 months | Patient reported |
6. Osteoporosis | Clinical monitoring | Diagnosis T-score 1=Normal >–1.0 2=Osteopenia <–1.0, >–2.5 3=Osteoporosis <–2.5 4=Severe osteoporosis <–2.5 plus fragility fractures 5=Not indicated Based on WHO Osteoporosis Classification 52 | Monitor throughout treating the patient | Clinical |
7. Clinical outcome status41 | Longitudinal outcomes | 1=Resolved never treated 2=Resolved, no therapy >1 year 3=Minimal disease never treated 4=Minimal disease no therapy >1 year 5=Persistent no current therapy, never treated 6=Persistent no current therapy, no therapy >1 year 7=Persistent-current therapy, asymptomatic 8=Persistent-current therapy, symptomatic 9=Persistent-current therapy, worsening prior year 99=Unknown | After 2 years and/or 5 years | Clinician evaluation/administrative |