The investigators will conduct a prospective observational study in premenopausal women
visiting the gynaecological outpatient clinic for an ultrasonographic exam. Patients are
recruited when the diagnosis adenomyosis was made with transvaginal ultrasound (TVUS).
Diagnosis adenomyosis requires at least one direct US feature of adenomyosis (subendometrial
lines or buds, hyperechogenic islands or myometrial cysts). The sonographers obtain
two-dimensional (2D) images, a grey-scale video-clip, elastography and power-doppler and
micro-vascularity flow clips and images, and a three-dimensional (3D) uterine volume. The
investigators will evaluate the collected images, clips and 3D-volumes with different methods
to assess severity and test the feasibility and inter-observer agreement of these methods.
At the outpatient clinic, all real-time TVUS are assessed in a systematically manner by the
sonographers and the presence of MUSA (Morphological Uterus Sonographic Assessment) features
(subendometrial lines or buds, hyperechogenic islands or myometrial cysts, asymmetrical
myometrium, globular uterus, translesional vascularity, fan-shaped shadowing,
interrupted/irregular junctional zone) and an estimation of the affected myometrium, graded
in mild (<25% affected myometrium), moderate (25%-50% affected myometrium) or severe (>50%
affected myometrium) are reported. Clinical data, medical history, reason for visit, pain
score in numeric rating scale (NRS), pictorial blood assessment chart (PBAC) score, etc. is
collected.
Based on previous research and experience, four experts in gynaecological sonography select
multiple offline methods using 5D Viewer software, for the evaluation and quantification of
the severity of adenomyosis.
All the ultrasounds will be coded, so the assessors are blinded for patients demographics,
medical history, symptomatology and the assessment by the sonographers.
Two experienced gynaecologist and one resident in gynaecology will test these methods for
feasibility. Feasibility will be scored regarding technique, time and interpretation of MUSA
features. The selected feasible methods will be tested for inter-observer variation. Finally
a comparison of the severity evaluation by the assessors done with the new methods and the
results of the severity estimation at the outpatient clinic will be made.
The method(s) that obtained a good feasibility score and good inter-observer agreement will
consecutively be used in a follow-up study investigating the correlation with symptomatology,
e.g. pain (NRS) and PBAC score.
Additionally, a descriptive study using the elastography and micro-vascularity flow images
and clips will be performed.
The obtained data will be analysed to determine a total feasibility score, inter-observer
variation and inter-test agreement. Inter-observer variation was tested with Fleiss Kappa or
Intra Class Correlation Coefficient (ICC), depending on the data used. A kappa-coefficient of
0.41-0.60 or an ICC value of 05.-0.75 was set as moderate, κ0.51-0.80 or ICC 0.75-0.9 as good
and κ≥0.80 or ICC ≥0.9 as excellent agreement. A Jonckheere-Terpstra test was used to test
the trend of the new severity score and the estimated assessment of MUSA. Inter-test
agreement was calculated with Cohens weighted Kappa (κw). For the correlation with NRS and
PBAC intraclass correlation and Fleiss kappa were calculated and the mean severity outcomes
were correlated with NRS and PBAC.
All women will sign an informed consent.