Table A2:
GRADE Evidence Profile for MRgHIFU Treatment of Uterine Fibroids
| Number of Studies (Initial Grade) | Risk of Bias | Inconsistency | Indirectness | Imprecision | Publication Bias | Upgrade Considerations | Quality |
|---|---|---|---|---|---|---|---|
| Technical success | |||||||
| 14 observational cohort studies (Low) | No serious limitations | No serious inconsistency | No serious limitations | No serious limitations | Unevaluated | (+1)a (dose-response) | Moderate |
| Safety (major adverse events) | |||||||
| 20 observational cohort studies (Low) | No serious limitations | No serious inconsistency | No serious limitations | No serious limitations | Unevaluated | (+1)b | Moderate |
| Symptom reduction (short term) | |||||||
| 12 observational cohort studies (Low) | Serious limitations (–1)c | No serious inconsistency | No serious limitations | No serious limitations | Unevaluated | (+2)d (large magnitude effect) | Moderate |
| Durability of symptom reduction (> 1 year) | |||||||
| 3 cohort studies (Low) | Serious limitations (–1)e | No serious inconsistency | No serious limitations | No serious limitations | Unevaluated | NA | Low |
| Fertility (pregnancy) | |||||||
| 5 cohort studies (Low) | Serious limitations (–1)e | Serious inconsistency (–1)e | Serious limitations (–1)e | Serious limitations (–1)e | Unevaluated | NA | Very low |
| Comparative effectiveness | |||||||
| Comparative studies with MRgHIFU are limited (no RCTs, few small selected groups) and insufficient for any meaningful comparisons between HIFU with different methods of guidance, other uterine-preserving options (UAE, myomectomy), or hysterectomy, other than comparisons of recovery trajectories which are related to the invasiveness of the treatment and their related protocols. | |||||||
Abbreviations: MRgHIFU, magnetic resonance–guided high-intensity focused ultrasound; NA, not available; RCT, randomized controlled trial; UAE, uterine artery embolization.
The degree of technical success is directly related to the ability to select appropriate patients, manage patients during the procedure, and utilize appropriate mitigation strategies.
Safety is directly related to adherence to the extensive technical safeguards, targeting, and real-time MR thermal monitoring.
Fibroid-related symptoms were evaluated by a validated disease-specific instrument at numerous institutes and in many countries, all consistently reporting statistically and clinically significant improvements over known control reference values.
The durability of symptom relief was only evaluated in a few studies and generally only for 2 or 3 years. There is convincing evidence that the symptom durability is dependent on the degree of initially induced thermal coagulative necrosis.
None of the cohort studies were designed to evaluate reproductive outcomes, and reproductive intent or history of the women was unknown.