Data Extraction:
Data were derived separately from all qualifying studies by the same two
scientists. A description of findings table was developed, which
included (a) research characteristics such as authors, year of
publication, study style, MRHIFU method, sample size, and follow-up
time; (b) Treatment parameters: NPV percent, patient eligibility
percentage, number of technological errors, use of bowel-interference
reduction methods, and sonication duration are all metrics to consider.
(c) primary outcome: reduction of fibroid-related symptoms, preferably
as measured by the validated disease-specific Uterine Fibroid Symptom
and Quality of Life Questionnaire (UFS-QoL); (d) secondary outcomes:
Health-Related Quality of Life (HRQL), as measured by the UFS-QoL
questionnaire, fibroid shrinkage as measured by follow-up MR imaging,
and the occurrence of any (serious) adverse events.
The outcomes analyzed were NPV%, defined by the formula: (non-perfused
volume/fibroid volume)*10025-27. Fibroid shrinkage is
defined as the reduction in the size of the uterine fibroids after
MR-HIFU. A higher transformed Symptom Severity Score (ISS) indicates
more significant symptom severity28. Health-related
quality of life concerning uterine fibroid comprises questions asked on
a five-point Likert scale, and the score is transformed in numeric from
0 to 10029. The patient who had to undergo a second
intervention after MRI-HIFU treatment for uterine fibroid related
problems was considered in reintervention percentage.
Skin burns, menstrual bleeding or unexplained discharge, cystitis,
urinary obstruction, constitutional complications, nerve injury, or
discomfort for more than seven days were all considered minor adverse
events. Patients that needed a second injection due to fibroid-related
symptoms were included in the re-intervention percentage (second
MR-HIFU, hysterectomy, myomectomy, or UAE).
Disagreements are settled by dialogue or consultation with a third
author. Several reports of a single clinical trial were available, the
most recent publication was used as the guide, and additional
information was gleaned from secondary journals. We tried to reach the
relevant authors by submitting an e-mail with a submission for
supplementary data if results were unavailable. A second e-mail was sent
if there was no response after seven days.