Uterine Fibroids Data Elements* | ||
Medical history | ||
General medical history | High blood pressure Diabetes Thyroid problems | Blood clots in legs or lungs Endometriosis Adenomyosis |
Menstrual cycle/flow | Are your periods regular (in timing and predictable within 5 days)? | Do you have a history of anemia related to your heavy periods or fibroids? If yes, did this anemia ever require A blood transfusion? Heaviness of flow |
Pregnancy history | Have you ever been pregnant? If yes, how many pregnancies have You had? For each pregnancy, outcome: | For each pregnancy, when did you Deliver? For each pregnancy, what type of Delivery did you have? |
Uterine fibroid history | Are you currently having any symptoms related to your fibroids? | If yes, select all fibroid-related Symptoms you are currently Experiencing |
Prior uterine fibroid procedures | How many prior procedures? Abdominal myomectomy (open surgery to remove the fibroids, abdominal incision) If yes, year of procedure Hysteroscopic myomectomy (telescope inside the uterus removing fibroids) If yes, year of procedure Laparoscopic or robotic myomectomy, (davinci robotic surgery) If yes, year of procedure Myomectomy, vaginal (open surgery to remove fibroids, vaginal incision) If yes, year of procedure Focused ultrasound (exablate; sonalleve) If yes, year of procedure | Endometrial ablation (any type; examples include: novasure impedance, her option, hydrotherm, microsulis (microwave), thermachoice balloon, resectoscope) If yes, year of procedure Radiofrequency ablation (acessa) (destroying the fibroid with heat from a needle that is inserted into the fibroid using a telescope inserted through a small abdominal incision) If yes, year of procedure Uterine arterial embolization/ uterine fibroid embolization (uae) (inserting particles to block fibroid blood vessels using a slender, flexible tube) If yes, year of procedure |
Current uterine fibroid therapies or supplements | Do you use hormonal birth control? If yes, what do you use it for: If yes, what type of hormonal birth Control? | Tranexamic acid (lysteda) Lupron Anti-inflammatory medication or nsaids (e.g., Ibuprofen, motrin, aleve, advil, anaprox, etc.) |
Imaging data | ||
Imaging data | Date of imaging Type of modality Fibroid location Fibroid sizes/measurement How many fibroids are visualized (e.g., Present or seen)? | How many fibroids are measured? Report all dimensions listed Adenomyosis? Endometriosis? Uterine lesion suspicious for malignancy? |
Procedure data | ||
Planned procedure | Planned procedure Was the planned procedure completed? | If no, was another uterine fibroid Procedure performed? |
All procedures | Procedure date Discharge date Primary surgeon Primary procedure performed Intraoperative adverse events (aes) If any aes, was ae device-related? | Ovarian pathology findings Uterine pathology findings Other operative findings Estimated blood loss (in cc/ml) Post-operative events Other procedures performed |
Hysterectomy | Surgical route Route for removal of uterus Uterine weight | Was morcellation used? If yes, was morcellation contained? If yes, what device was used to Morcellate and/or contain tissue? |
Abdominal myomectomy | Incision type # of excised fibroids | Cumulative weight of excised fibroids |
Hysteroscopic myomectomy | Cumulative weight of excised fibroids | # of excised fibroids |
Endometrial ablation | Type | |
Laparoscopic or robotic myomectomy | Was morcellation used? If yes, was morcellation contained? If yes, what device was used to Morcellate and/or contain tissue? | Cumulative weight of excised fibroids # of excised fibroids |
Uterine artery embolization | Uterine arteries embolized? | Ovarian arteries embolized? |
Magnetic resonance-guided focused ultrasound | Device # of treated fibroids | Injury to other structures diagnosed post-procedure |
Radiofrequency ablation via laparoscopy | # of fibroids visualized on ultrasound | # of treated fibroids |
Post-procedure data | ||
Post-procedure data | Treatment failure: did you have another fibroid procedure? Was cancer found during follow up? | If cancer was found, was it lms? Post-procedure adverse events |
Long-term follow-up data | ||
Long-term follow-up data | Treatment failure: did you have another fibroid procedure? Was cancer found during follow up? | If cancer found, was it lms? Post-procedure adverse events |
*These data elements may be entered by patients, by physicians, or through a hybrid approach based on available technology. Note: This table originally appeared in The Women’s Health Technologies Coordinated Registry Network (WHT-CRN) report.13 |