Table I.
Overview of the core outcome sets for studies on uterus-sparing treatments of adenomyosis, structured into core domains.
| Category | Outcome |
|---|---|
| Pain | Cyclic pelvic pain |
| Dyschezia | |
| Dysmenorrhea | |
| Dyspareunia | |
| Non-cyclic, untriggered pelvic pain | |
| Pelvic bulk/pressure symptoms | |
| Radiating pain to lower back and/or extremities during menstruation | |
| Urinary system | Urinary frequency |
| Menstrual bleeding | Blood flow volume |
| Duration of bleeding | |
| Intermenstrual bleeding | |
| Frequency of bleeding/regularity of cycle | |
| Reproductive outcomes* | Infertility Core Outcome Set*: |
| Live, correctly sited (eutopic) pregnancy | |
| Pregnancy loss: | |
| Ectopic pregnancy | |
| Miscarriage | |
| Stillbirth | |
| Termination of pregnancy | |
| Live birth | |
| Gestational age at delivery | |
| Birthweight | |
| Neonatal mortality | |
| Major congenital anomaly | |
| Time to pregnancy leading to live birth | |
| Additional outcomes: | |
| Mode of Conception | |
| Postpartum Haemorrhage | |
| Abnormal placentation | |
| Haematology | Anaemia |
| Life impact | Health-related QOL |
| Sexual function (Including bleeding or pain during or after sexual activity) | |
| Delivery of care | Patient adherence to treatment |
| Patient satisfaction with treatment | |
| Symptom relief rate for most bothersome symptom | |
| Symptom recurrence for any symptom | |
| Symptom recurrence for most bothersome symptom | |
| Lesion size | |
| Uterus volume | |
| Discomfort During Procedure* | |
| Recovery Time* | |
| Need for repeated or other treatment (Need for re-intervention)* | |
| Length of hospital stay* | |
| Premature termination of procedure* | |
| Adverse outcomes | Adverse outcomes (including all harms, adverse reactions and side effects) |
| Infections* | |
| Unplanned/unscheduled bleeding on hormonal medication | |
| Reporting items | Endometriosis present |
| Fibroids present | |
| Chronic pelvic pain present | |
| Wish for future pregnancy | |
| Classification of adenomyosis | |
| Previous treatment for adenomyosis | |
| Recommended outcomes (not mandatory) | |
| Economy | Costs of treatment |
| How much the patient has to pay for a treatment (Patient costs) | |
| Value-for-money of treatment (Cost-utility analysis) | |
*
Outcome(s) applicable in certain study types only.