TABLE 2.
Comparing Options for Management: Patient-centered Results for Uterine Fibroids (COMPARE-UF) data collection summary
| Interval | Data source | Domains |
|---|---|---|
| Baselinea | Patient | Demographic information |
| Medical history | ||
| Uterine fibroid procedure history | ||
| Current medical therapies | ||
| Menstrual and fibroid history | ||
| Reproductive history | ||
| Health-related quality of life scales | ||
| Uterine fibroid symptom—quality of life (fibroid-specific outcomes) | ||
| Euro quality of life-5D (general health outcomes) | ||
| Patient health questionnaire-2 (depression) | ||
| Menopause rating scale | ||
| Imaging | Radiology report (within 12 mo before procedure) | Date of imaging |
| Central data abstraction | Type of imaging | |
| Fibroid description/measurement | ||
| Uterine description/measurement | ||
| Ovaries description | ||
| Suspicious findings | ||
| Procedure | Operative note | Date of procedure |
| Pathology note | Discharge date | |
| Discharge summary | Type of procedure | |
| Central data | Primary surgeon | |
| Abstraction | Procedural details | |
| Complications | ||
| Procedural findings | ||
| Short-term follow-up evaluation (6–8 wk after procedure) | Patient | 4 Health-related quality of life scales |
| Complications | ||
| Rehospitalization | ||
| Return to work | ||
| Annual follow-up evaluation (date of consent as anchor) | Patient | 4 Health-related quality of life scales |
| Interim uterine fibroid procedures and therapies | ||
| Menopausal status | ||
| Pregnancy outcomes |
a
If medical and procedural history data are missing, the local site coordinator will complete with the data from medical record.