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A Novel Intelligent Scan Assistant System for Early Pregnancy Diagnosis by Ultrasound: Clinical Decision Support System Evaluation Study

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Abstract and Figures

Background: Early pregnancy ultrasound scans are usually performed by nonexpert examiners in obstetrics/gynecology (OB/GYN) emergency departments. Establishing the precise diagnosis of pregnancy location is key for appropriate management of early pregnancies, and experts are usually able to locate a pregnancy in the first scan. A decision-support system based on a semantic, expert-validated knowledge base may improve the diagnostic performance of nonexpert examiners for early pregnancy transvaginal ultrasound. Objective: This study aims to evaluate a novel Intelligent Scan Assistant System for early pregnancy ultrasound to diagnose the pregnancy location and determine the image quality. Methods: Two trainees performed virtual transvaginal ultrasound examinations of early pregnancy cases with and without the system. The ultrasound images and reports were blindly reviewed by two experts using scoring methods. A diagnosis of pregnancy location and ultrasound image quality were compared between scans performed with and without the system. Results: Each trainee performed a virtual vaginal examination for all 32 cases with and without use of the system. The analysis of the 128 resulting scans showed higher quality of the images (quality score: +23%; P<.001), less images per scan (4.6 vs 6.3 [without the CDSS]; P<.001), and higher confidence in reporting conclusions (trust score: +20%; P<.001) with use of the system. Further, use of the system cost an additional 8 minutes per scan. We observed a correct diagnosis of pregnancy location in 39 (61%) and 52 (81%) of 64 scans in the nonassisted mode and assisted mode, respectively. Additionally, an exact diagnosis (with precise ectopic location) was made in 30 (47%) and 49 (73%) of the 64 scans without and with use of the system, respectively. These differences in diagnostic performance (+20% for correct location diagnosis and +30% for exact diagnosis) were both statistically significant (P=.002 and P<.001, respectively). Conclusions: The Intelligent Scan Assistant System is based on an expert-validated knowledge base and demonstrates significant improvement in early pregnancy scanning, both in diagnostic performance (pregnancy location and precise diagnosis) and scan quality (selection of images, confidence, and image quality).
Original Paper
A Novel Intelligent Scan Assistant System for Early Pregnancy
Diagnosis by Ultrasound: Clinical Decision Support System
Evaluation Study
Ferdinand Dhombres1,2, MD, PhD; Paul Maurice1,2, MSc, MD; Lucie Guilbaud1, MSc, MD; Loriane Franchinard1,
MSc, MD; Barbara Dias1, MSc; Jean Charlet2,3, PhD; Eléonore Blondiaux4, MD, PhD; Babak Khoshnood5, MD, PhD;
Davor Jurkovic6, MD; Eric Jauniaux6, MD, PhD; Jean-Marie Jouannic1,2, MD, PhD
1Service de Médecine Fœtale, Sorbonne Université, Assistance Publique - Hôpitaux de Paris / Hôpitaux Universitaires Est Parisiens, Hôpital Armand
Trousseau, Paris, France
2Medical Informatics and Knowledge Engineering for eHealth Lab, INSERM, Paris, France
3Direction de la Recherche et de l'Innovation, Assistance Publique - Hôpitaux de Paris, Paris, France
4Service de Radiologie, Sorbonne Université, Assistance Publique - Hôpitaux de Paris / Hôpitaux Universitaires Est Parisiens, Hôpital Armand Trousseau,
Paris, France
5Obstetrical, Perinatal and Pediatric Epidemiology Research Team, Center for Biostatistics and Epidemiology, INSERM, Paris, France
6Gynaecology Diagnostic and Outpatient Treatment Unit, University College Hospital and Institute for Women's Health, University College London,
London, United Kingdom
Corresponding Author:
Ferdinand Dhombres, MD, PhD
Service de Médecine Fœtale
Sorbonne Université
Assistance Publique - Hôpitaux de Paris / Hôpitaux Universitaires Est Parisiens, Hôpital Armand Trousseau
26 avenue du Dr Arnold Netter
Paris, 75012
France
Phone: 33 622286740
Email: ferdinand.dhombres@inserm.fr
Abstract
Background: Early pregnancy ultrasound scans are usually performed by nonexpert examiners in obstetrics/gynecology
(OB/GYN) emergency departments. Establishing the precise diagnosis of pregnancy location is key for appropriate management
of early pregnancies, and experts are usually able to locate a pregnancy in the first scan. A decision-support system based on a
semantic, expert-validated knowledge base may improve the diagnostic performance of nonexpert examiners for early pregnancy
transvaginal ultrasound.
Objective: This study aims to evaluate a novel Intelligent Scan Assistant System for early pregnancy ultrasound to diagnose
the pregnancy location and determine the image quality.
Methods: Two trainees performed virtual transvaginal ultrasound examinations of early pregnancy cases with and without the
system. The ultrasound images and reports were blindly reviewed by two experts using scoring methods. A diagnosis of pregnancy
location and ultrasound image quality were compared between scans performed with and without the system.
Results: Each trainee performed a virtual vaginal examination for all 32 cases with and without use of the system. The analysis
of the 128 resulting scans showed higher quality of the images (quality score: +23%; P<.001), less images per scan (4.6 vs 6.3
[without the CDSS]; P<.001), and higher confidence in reporting conclusions (trust score: +20%; P<.001) with use of the system.
Further, use of the system cost an additional 8 minutes per scan. We observed a correct diagnosis of pregnancy location in 39
(61%) and 52 (81%) of 64 scans in the nonassisted mode and assisted mode, respectively. Additionally, an exact diagnosis (with
precise ectopic location) was made in 30 (47%) and 49 (73%) of the 64 scans without and with use of the system, respectively.
These differences in diagnostic performance (+20% for correct location diagnosis and +30% for exact diagnosis) were both
statistically significant (P=.002 and P<.001, respectively).
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Conclusions: The Intelligent Scan Assistant System is based on an expert-validated knowledge base and demonstrates significant
improvement in early pregnancy scanning, both in diagnostic performance (pregnancy location and precise diagnosis) and scan
quality (selection of images, confidence, and image quality).
(J Med Internet Res 2019;21(7):e14286) doi:10.2196/14286
KEYWORDS
decision support system; ontology; knowledge base; medical ultrasound; ectopic pregnancy
Introduction
Background
Ectopic pregnancy (EP) is defined by implantation of the
gestational sac outside the endometrial cavity and occurs in
1%-2% of all pregnancies [1]. EP accounts for approximately
3%-5% of pregnancy-related deaths in developed countries [2].
Around 95% of EPs implant in the fallopian tubes and 5%-7%
implant within the uterine wall but outside the uterine cavity.
Nontubal EPs are more difficult to diagnose than tubal EP and
are associated with a higher mortality and morbidity [3].
Delayed diagnosis is the main factor for EP associated with
maternal death [4] and affects the success rate of future
pregnancies [5]. Skilled ultrasound operators can diagnose an
EP at an early stage by transvaginal sonography (TVS), often
at the first examination [6]. However, less experienced operators
perform first-line screening for patients at risk of EP in most
emergency units; for them, this diagnosis remains difficult and
more than three examinations are often needed [7].
Prior Work
We have developed the first Intelligent Scan Assistant System
for early pregnancy TVS examination. This clinical decision
support system (CDSS) [8,9] is a computer program that
provides diagnosis assistance during TVS examination of
pregnancy of unknown location. During an ultrasound
examination and in real time, this system assists the operator
by suggesting ultrasound views to acquire and relevant signs
to look for; it also displays reference ultrasound images
demonstrating these relevant signs and views (from
expert-reviewed collections of early pregnancy cases). The
semantic design and features of this CDSS have been published
in the medical semantics informatics community [10]. One key
feature of this system is the personalized imaging protocol [11]:
The system guides the operator through a structured acquisition
of decisive ultrasound images to optimize the diagnostic
pathway. We deemed this system “intelligent” because these
personalized imaging protocols are not precalculated, but
dynamically derived by the system (by SPARQL queries on the
early pregnancy ontology of the knowledge base) from the
guided image analysis of the current case.
In a preliminary study, this novel system demonstrated efficient
support for a precise ultrasound image analysis, with a precision
of 83% for the identification of signs in a series of 208
retrospectively collected ultrasound images of various types of
ectopic pregnancies [10,11].
Study Goal
In this study, we aimed to assess the added value of this novel
CDSS for early pregnancy ultrasound. Our objective was to
evaluate the effect of using the CDSS during TVS on scan
quality and accuracy of the diagnosis of pregnancy location.
Methods
Clinical Decision Support System Evaluation Overview
Two obstetrics and gynecology (OB/GYN) trainees with basic
national training in ultrasound imaging (including early
pregnancy courses and simulation sessions) performed 32
ultrasound examinations in early pregnancy patients without
and with the CDSS. These were re-examinations of
prospectively collected 3D volumes from ultrasound data from
the gynecology emergency unit at a university hospital. At the
beginning of the study, the two trainees viewed a 2-minute video
presentation of the CDSS and had a 10-minute hands-on session
with the team who developed the CDSS. The TVS of early
pregnancy cases was performed using a simulation device with
and without the CDSS.
Ultrasound (Transvaginal) Simulator and 3D
Ultrasound Volume Collection
The simulation device was the interpolative model-based
ultrasound simulator ScanTrainer (MedaPhor, Wales, United
Kingdom) with a realistic haptic feedback transvaginal probe.
This ultrasound simulator produces 2D images generated from
3D vaginal ultrasound volumes, which had been acquired during
actual vaginal scans [12]. The complete virtual TVS platform
used for the study integrates the ultrasound simulator and the
CDSS with a dual screen setting (Figure 1). One screen displays
the usual information for scanning as a regular ultrasound
system. The other screen displays the CDSS interface for the
image analysis and scan assistance (Figure 2).
Thirty-two 3D vaginal ultrasound volumes for this study were
collected from patients during early pregnancy emergency
examinations in one university hospital center (Figure 3), using
an expert 3D ultrasound system (GE Healthcare Voluson E10/E8
with a RIC5-9-D vaginal probe, Cincinnati, OH). In our center,
the first ultrasound examinations are always performed by junior
OB/GYN examiners. In case of pregnancy of unknown locations
or EP, a second vaginal scan is performed by a senior OB/GYN
examiner. We collected 16 consecutive cases of pregnancy of
unknown locations and 16 consecutive cases of EP diagnosed
after the first ultrasound examination. For this study, three
additional 3D volume acquisitions were performed by the senior
OB/GYN examiner during the second TVS (acquisition field
of 180°/100°): one volume for the uterus and one adjacent
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volume for each adnexal region. In case of a suspected ruptured
EP, the volume acquisition was not performed, to avoid any
delay in performing the surgical procedure. Additionally, when
the diagnosis of intrauterine pregnancy was obvious (normal
pregnancy of 6 weeks of gestation or more) at the second
examination by the senior, no 3D volume was acquired. Rare
types of ectopic pregnancy (heterotopic pregnancy, interstitial
pregnancy, caesarean-section scar pregnancy, and cervical
pregnancy) were also excluded from this study. Thus, a
consecutive series of 32 sets of 3D vaginal ultrasound volumes
was collected, deidentified, and imported in the ultrasound
simulator. The final diagnoses of the 32 cases in this series were
intrauterine pregnancy (n=18) and tubal EP (n=14), all correctly
diagnosed by senior TVS experts and confirmed by pregnancy
outcomes.
Figure 1. Global view of the virtual vaginal ultrasound platform for evaluation of the Intelligent Scan Assistant System. The left monitor displays the
ultrasound simulator interface (ScanTrainer, MedaPhor, Wales, United Kingdom) and the right monitor displays the decision support system (Intelligent
Scan Assistant System).
Figure 2. Detailed view of the Intelligent Scan Assistant System (right monitor). The two main steps with the decision support system on the right
monitor are image analysis and scan assistance.
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Figure 3. Three-dimensional ultrasound volume acquisition flowchart. Selection of cases for the 3D ultrasound volume series used for the virtual
transvaginal scans (TVS) in this study. CDSS: clinical decision support system; EP: ectopic pregnancy; OB/GYN: obstetrics and gynecology; PUL:
pregnancy of unknown locations.
Clinical Decision Support System Evaluation Protocol
Virtual Ultrasound Examinations
The two trainees performing the virtual TVS were independent
of acquisition of 3D volumes, and they were unaware of the
medical report and final diagnosis. The clinical information
provided for the scans were identical for all cases and limited
to “moderate pelvic pain and positive pregnancy test.” The 32
scans were performed twice by each trainee without supervision
in a random order in a nonassisted mode (without the CDSS)
and 2 months later in assisted mode (with the CDSS). The
potential recall bias was also controlled by the 2-month interval
between the two TVS sessions. Additionally, it should be
mentioned that during these 2 months, the two trainee operators
did not receive any ultrasound training and did not have any
ultrasound scanning activity. In the nonassisted mode, the scans
were performed following the usual protocol for OB/GYN
emergency ultrasound in our center [13,14], using a standardized
reporting system. In the assisted mode, the scans were performed
following a personalized image analysis and acquisition protocol
suggested by the CDSS [10,11]. The personalized imaging
protocol and the CDSS workflow are presented in Figure 4.
Briefly, in step 1, the operator performs the scan and acquires
ultrasound images. In step 2, he/she follows the system guidance
for a precise analysis of these acquired images: He/she describes
the image with keywords for anatomical structures, ultrasound
signs, and technical elements (ultrasound route, mode, and
view). The keywords are displayed with text definitions and are
illustrated by expert-validated images. In step 3, if necessary,
the system suggests providing additional imaging elements
(ultrasound views, signs, and anatomical structures), thus
assisting the operator in establishing a comprehensive image
set in order to reach a precise diagnosis. This is a personal
imaging protocol that is automatically calculated by the system.
The personal imaging protocol is derived from computer-based
reasoning over the early pregnancy knowledge base. After step
3, the user may either follow the personal imaging protocol and
provide the additional requested elements or proceed to the final
report and finish the examination (step 4).
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Figure 4. Personalized imaging protocol and workflow of the Intelligent Scan Assistant System for ultrasound imaging.
Ultrasound Images and Report Scoring Methods
For each examination, we collected the images, reports, and
data on duration of the scans. Two senior experienced ultrasound
operators reviewed the images and reports of the virtual
examinations. During the review, they were blinded to the use
of the CDSS and the final diagnosis. They had the same minimal
clinical information for all cases as the two trainees: “moderate
pelvic pain and positive pregnancy test.
They scored the images according to the quality criteria for the
sagittal view of the uterus and the ovaries as per a previous
study [14]. The maximum quality score was 15 points (Textbox
1). They also performed a subjective scoring of the scans and
reports, reflecting their trust in the conclusion of the report
associated with the images. This level of trust was assessed with
a 5-level scale (Textbox 2).
Textbox 1. The image set quality was assessed using a score based on 15 items.
On the sagittal view of the uterus, the five quality criteria were as follows:
“uterine cervix visible” (1 point)
“uterine fundus visible” (1 point)
“endometrial midline echo visible” (1 point)
“endocervix visible” (1 point)
“uterus occupying more than half of the total image size” (1 point)
On each of the views of the ovaries, the 5×2 quality criteria were as follows:
“side stated” (1 point)
“follicle(s) visible” (1 point)
“iliac vein visible” (1 point)
“long axis of the ovary <30° with the horizontal line” (1 point)
“vary occupying more than a quarter of the total image size” (1 point)
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Textbox 2. The level of trust in the report was assessed using a 5-level scale.
Level 1: No trust in the final diagnosis (incorrect): The diagnosis is most likely incorrect, and the image set suggests another diagnosis.
Immediate supervisor examination is needed.
Level 2: No trust in the final diagnosis (low quality): The image set quality is insufficient and/or does not support the final diagnosis. Immediate
supervisor examination is needed.
Level 3: Moderate trust in the final diagnosis:Although the diagnosis might be correct, the image set quality is insufficient, and a supervisor
examination is needed.
Level 4: The image set quality could be improved; however, it is of sufficient quality to accurately support the final diagnosis. No supervisor
examination is needed.
Level 5 represents a total trustin the final diagnosis: The image set effectively supports the diagnosis, and no supervisor examination is needed.
Statistical Analysis
The reproducibility of the scoring methods for quality and trust
was assessed on a random sample of 20% of all scans (n=25)
and independently reviewed by both experts. We tested for the
differences in trust and quality scores. We also tested for the
differences between examination modes (assisted vs nonassisted
mode) in the diagnosis of location of pregnancy (ectopic OR
nonectopic) and in the final diagnosis precision (exact location
of the ectopic pregnancy, ie, “tubal pregnancy” explicitly stated
in the report conclusion). The gold standard for the diagnosis
was the final diagnosis in all cases, as reported in the senior
TVS report and confirmed by the pregnancy follow-up.
Statistical analysis was performed using R, version 3.3.1 (R
Foundation for Statistical Computing, Vienna, Austria) and
STATA, version 15 (StataCorp, College Station, TX). Paired t
tests were performed to compute the difference in continuous
variables (scan duration, image count, quality score, and trust
score). Exact McNemar tests were used to test for the differences
in categorical variables (presence of the three mandatory
ultrasound views, diagnosis of location, and final diagnosis
precision). We also calculated differences in the proportions of
outcomes, with 95% CIs, for assisted versus nonassisted modes.
Adjusted kappa coefficients (Cohen weighted kappa) for quality
scores and trust scores were computed to test for the
reproducibility of the scoring methods.
For all tests, a P value .05 was considered statistically
significant. Adjusted kappa values <0.6, between 0.6 and 0.8,
and >0.8 were considered to represent poor, moderate, and good
agreement, respectively.
Ethics Approval
The development of this CDSS for early pregnancy (including
expert-validated early pregnancy ultrasound images) and the
evaluation study (including collection and analysis of 3D
ultrasound volumes of early pregnancy) were both approved by
the French National College of the OB/GYN Institutional
Review Board (CNGOF Research Ethics Committee CEROG
#2015-GYN-1002 and #2016-GYN-0601, respectively).
Results
Virtual Scans and Scoring Method Reproducibility
Each trainee performed a virtual transvaginal examination for
all 32 cases with and without the system. The expert operators
reviewed the 128 resulting scans for quality of images and trust
in the reports. The experts’ agreement was tested on 25 scans.
The level of agreement was good, with kappa values of 0.86
(0.76-0.96) for objective quality scoring and 0.86 (0.70-1.0) for
subjective trust scoring.
Impact of the Clinical Decision Support System on
Image Quality
The scan quality differences are presented in Table 1. We found
that the average quality score for ultrasound images was 23%
higher when using the CDSS than with the nonassisted mode,
with an average value of 12.6 of 15 (P<.001). Additionally,
when using the CDSS, the number of images per scan was lower
than that with the nonassisted mode (4.6 vs 6.3, P<.001).
The average trust score was 20% higher when using the CDSS
than with the nonassisted mode, with an average value of 4.12
of 5 (P<.001).
Table 1. Differences in scan quality with (assisted mode) and without (nonassisted mode) the decision support system.a
P valueDifferenceNonassisted mode (64 scans)Assisted mode (64 scans)Scan quality parameter
<.001–1.69 (–27%)6.33 (2.07)4.64 (0.80)Image count in report, mean (SD)
<.001+8.3 (+129%)6.4 (3.3)14.7 (7.1)Scan duration (minutes), mean (SD)
<.001+2.3 (+23%)10.2 (1.90)12.5 (1.86)Quality score of image sets, mean (SD)
<.001+0.70 (+20%)3.42 (1.04)4.12 (0.83)Trust score of report, mean (SD)
aThe tests for difference were paired t tests.
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Impact of the Clinical Decision Support System on
Diagnosis of Pregnancy Location
The diagnosis differences are displayed in Table 2. We observed
a correct diagnosis of location in 39 (61%) and 52 (81%) of 64
scans in the nonassisted mode and assisted mode, respectively.
Additionally, the exact diagnosis was achieved in 30 (47%) and
49 (77%) scans in the nonassisted mode and assisted mode,
respectively. These differences (+20% for correct location
diagnosis and +30% for exact diagnosis) were both statistically
significant (P=.002 and P<.001, respectively).
Without the use of the CDSS, we recorded 8 false-negative
diagnoses of tubal EP (cases 44 and 23 for both trainees and
cases 50, 45, 33, and 1 for one trainee). With the CDSS, the
false-negative result for ectopic pregnancy was a scan of a tubal
pregnancy case (case 44 for one trainee). In the other seven
cases with false-negative diagnoses of EP, all relevant signs
associated with the final diagnosis (with reference images) were
presented to the trainee when using the CDSS. More precisely,
images exhibiting the key features of tubal pregnancy were
acquired following the personalized protocol of the CDSS and
correctly diagnosed. Additionally, the quality score, trust score,
and number of images per scan were significantly different
when using the CDSS as compared to not using the CDSS: 12.6
versus 10.2 (P=.01), 4.0 versus 3.0 (P=.02), and 4.7 versus 6.5
(P=.04), respectively. The scan duration was also significantly
different when using the CDSS as compared to not using the
CDSS (14.4 versus 7.6 min; P=.003).
Table 2. Differences in the diagnostic performance of trainees with (assisted mode) and without the decision support system (nonassisted mode).a
P valueDifference, % (95% CI)Difference, nNonassisted mode
(64 scans), n (%)
Assisted mode
(64 scans), n (%)
Diagnostic performance parameter
.002+20 (7-33)1339 (61)52 (81)Correct pregnancy location (ectopic/nonectopic)
<.001+30 (15-44)1930 (47)49 (77)Exact diagnosis (with precise ectopic location)
b
–10.9–78 (12.5)1 (1.6)False-negative of ectopic pregnancy
03 (4.7)3 (4.7)False-positive of ectopic pregnancy
aThe test for difference was exact McNemar test.
bNot available.
We observed 3 false-positive EP diagnoses in the assisted mode
and 3 other false-positive EP diagnoses in the nonassisted mode,
which were the 6 cases of intrauterine pregnancies.
Discussion
Principal Results
Our study demonstrated a significant improvement in early
pregnancy ultrasound examination, both in diagnostic
performance (pregnancy location and precise diagnosis) and
scan quality (selection of images, confidence, and image quality)
for OB/GYN trainees using the CDSS, when pregnancy of
unknown locations or EP was suspected.
Definitive diagnosis of ectopic pregnancy can be achieved by
TVS, but it relies on a precise analysis of ultrasound findings
[1,15-19]. However, in most emergency units, the initial TVS
is usually performed by trainees or sonographers with basic
expertise in OB/GYN scanning. The support of expert-validated
images in addition to the personalized protocol (intelligent
suggestions of ultrasound signs, views, and modes) are key
features of the CDSS, especially for improving the false-negative
diagnoses of EP. During the examination, it provides actionable
knowledge to less experienced operators, thus improving their
diagnostic capabilities in real time. Our results suggest that the
CDSS improves not only the diagnosis of early pregnancy
location, but also the diagnostic accuracy. The use of the CDSS
resulted in a better selection of images with higher quality. This
facilitates the review of the scans by the senior experts in our
department, as suggested by their higher trust scores.
Limitations
The main limitation of our study is that our evaluation relies on
virtual TVS. In a previous study, Infantes et al [20] showed that
offline analysis of 3D TVS static datasets has limitations in
terms of the diagnostic accuracy for EP [20]. However, their
study was not conducted with ultrasound simulation platforms
[12,21]. In our study, we chose the best simulation options for
realistic 2D ultrasound examinations. This led to a moderate
loss in image quality, but with this study design, the same patient
would have been scanned twice (with and without the CDSS)
and by each trainee (32 patients, 128 scans; 4 scans per patient),
thus specifically assessing the potential added value of the CDSS
itself. A key skill in ultrasound is to find the pathology and, in
the simulator, the trainees were presented with volumes that
contained all necessary information to make a diagnosis;
therefore, their scanning skills were not properly evaluated in
this study. However, even if the interpretation was easier, we
believe this was not a bias in favor of the CDSS. Interestingly,
the trainees complained about the lack of color Doppler imaging
(CDI) in the simulator, but only when they used the CDSS and,
in particular, for the cases of false-positive diagnoses of EP.
Better ultrasound imaging quality and access to the CDI mode
might change the performances of the CDSS. As the CDSS
includes a rich CDI semiology of EP, this change might even
be in favor of the CDSS. Palpation by a transvaginal probe often
provides critical information to make the correct diagnosis. This
cannot be done on current simulators, which is another limitation
of the study.
We observed an increase of 8 minutes in the scan duration.
Similar additional time costs were observed in a pilot study
when using standardized protocols with integrated software for
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the second trimester screening [22]. Consequently, we believe
that technical improvements, in particular, integration in the
ultrasound platform, could improve examination durations; in
our study, each image file was manually imported in the CDSS
during the TVS. Overall, an additional 8 minutes is a reasonable
cost for significant diagnostic improvements, and consequently,
for a reduction in the number of visits to diagnose the correct
location of the pregnancy.
Comparison With Prior Work
This CDSS is the first computer-based reasoning system in the
field of OB/GYN. In the current trend of new technical solutions
to improve ultrasound examinations, this CDSS has been
evaluated, offers novel intelligent scan assistance in real time,
is dynamically based on previous ultrasound findings, and has
salient reference images in backup. In contrast, only 58% of
CDSSs demonstrated improvements in the processes of care
[23].
Software-enforced standardized protocols for screening offer
interesting solutions for ultrasound scan improvement [22].
These systems implement static checklists to improve the
acquisition of standard image sets. Other tools automated the
2D images processing (eg, for caliper positioning) and the
3D/4D volume processing (eg, to derive 2D images of the fetal
brain and heart) [24-26]. Finally, online resources provide access
to collections of medical images, including ultrasound and
OB/GYN material [27-29].
Our choice of a CDSS based on ontology and semantic Web
technologies have several significant advantages. The ontology
is a model representing the medical knowledge involved in TVS
for early pregnancy. This model allows computer-based
reasoning and enables the personalized imaging protocol feature
of the CDSS. Of particular interest, this type of ontology-based
reasoning CDSS differs from current systems (eg, deep learning
and neural network systems) and does not integrate any
“black-box” component [9]: Every step of the calculation can
be audited and is readable by a human. More specifically, Figure
5 illustrates the effective support of the ontology to derive a
personalized imaging protocol. Every step of the protocol relies
on SPARQL queries to navigate through the graph of the
knowledge base (XML/RDF). This knowledge base is present
in a triplestore with semantic inference capabilities
(OWL/HermIT). Consequently, the result of every step of the
protocol is a set of resource description framework triple, with
labels (skos:prefLabel) that can be reviewed by medical experts.
When a sign is identified during the scan, in an echographic
view, the clinical reasoning principle is formalized as follows:
1. List all disorders suggested by the identified sign(s).
2. For all these disorders, list all associated sign(s).
3. For all these signs, list all required echographic view(s).
4. Provide support to the operator: ordered list of echographic
views required to look for relevant signs for differential
diagnosis.
The CDSS design implements international standards (RDF,
SPARQL, and OWL) with a generic strategy for medical
imaging. The CDSS was initially developed for early pregnancy
ultrasound. There is no technical obstacle to extending the
system to other areas of ultrasound imaging such as diagnosis
of placentation disorders or morphological ultrasound
examination of the fetus. Furthermore, it allows for a simple
curation process (eg, addition of new signs or new cases in the
collection) and does not require specific skills in informatics.
For example, when new ultrasound imaging features are
described in medical publications (eg, when fetal ultrasound
features of postnatal disorders are discovered, as it was recently
the case for the limited dorsal myeloschisis, which is a
well-known postnatal disorder [30]), updating the whole system
is easy. In contrast, updating usual expert systems would require
technical developments. Finally, semantic Web technologies
are designed to scale and support interoperability. The scaling
capability is the capability to handle a large amount of data and
is a prerequisite to cover the large domain of fetal abnormalities,
including ultrasound features, anatomical locations, adequate
ultrasound views, and nosology of fetal disorders. The
interoperability capability opens data integration with other
databases, in particular, genetic data repositories. This
interoperability is a possible way to establish correlations
between ultrasound phenotypes and genetic variants [31].
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Figure 5. Principles of clinical reasoning for the CDSS represented in the ontology for early pregnancy (epo). Step 1: Identification of "epo:sign_A",
using "epo:echographic_view_i". Step 2: Compute the list of disorders suggested by "epo:sign_A," "epo:disorder_1," and "epo:disorder_2". Step 3:
Compute the list of signs for the list of disorders: "epo:sign_B," "epo:sign_C," and "epo:sign_D". Step 4: Suggest a list of echographic views required
for the list of signs: "epo:echographic_view_j" and "epo:echographic_view_k". CDSS: clinical decision support system.
Conclusions
In the growing ecosystem of emerging new tools for medical
imaging assistance, the Intelligent Scan Assistant System is a
CDSS based on a semantic representation of expert knowledge,
consistent with a complementary solution that promotes
improvement of both scan quality and diagnostic accuracy. The
evaluation of the system on a simulation platform demonstrated
its added value for trainees in TVS. Consequently, the
implementation of this CDSS in routine care may reduce the
number of TVS examinations to the minimum number of TVSs
required to diagnose (or exclude) EP. These results await
confirmation by randomized control trials and further use in
different areas of OB/GYN imaging.
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Acknowledgments
We thank Dr Nicolas Perrot (Medical Imaging Center, Pyramides, Paris, France) for his help during the ultrasound volume
acquisition. The SATT-Lutech and Sorbonne University, Paris, France, supported and developed of the Intelligent Scan Assistant
System prototype, and the AP-HP founded the ultrasound simulation platform used in this study.
Conflicts of Interest
None declared.
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Abbreviations
CDI: color Doppler imaging
CDSS: clinical decision support system
EP: ectopic pregnancy
OB/GYN: obstetrics and gynecology
TVS: transvaginal sonography
Edited by G Eysenbach; submitted 05.04.19; peer-reviewed by S Sabarguna, S Sarbadhikari; comments to author 08.05.19; revised
version received 11.06.19; accepted 11.06.19; published 05.07.19.
Please cite as:
Dhombres F, Maurice P, Guilbaud L, Franchinard L, Dias B, Charlet J, Blondiaux E, Khoshnood B, Jurkovic D, Jauniaux E, Jouannic
JM
A Novel Intelligent Scan Assistant System for Early Pregnancy Diagnosis by Ultrasound: Clinical Decision Support System Evaluation
Study
J Med Internet Res 2019;21(7):e14286
URL: http://www.jmir.org/2019/7/e14286/
doi:10.2196/14286
PMID:
©Ferdinand Dhombres, Paul Maurice, Lucie Guilbaud, Loriane Franchinard, Barbara Dias, Jean Charlet, Eléonore Blondiaux,
Babak Khoshnood, Davor Jurkovic, Eric Jauniaux, Jean-Marie Jouannic. Originally published in the Journal of Medical Internet
Research (http://www.jmir.org), 05.07.2019. This is an open-access article distributed under the terms of the Creative Commons
Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction
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... Table 1 Publication year, disease, machine learning technology and expertise of the participants from the studies selected for the review. Year of publication Disease ML technology Expertise of participants Dhombres et al. [22] 2019 Pregnancy location Knowledge based ontology Obstetrics, gynecology Lundberg et al. [4] 2018 Hypoxaemia Gradient boosting Anaesthesiologist Steiner et al. [23] 2018 Breast cancer CNN Pathologist Lindsay et al. [1] 2018 Wrist fracture CNN Emergency medicine clinician Kaini et al. [24] 2020 Liver cancer CNN Pathologist Wu et al. [3] 2019 Gastric cancer CNN, RL Endoscopist Wang et al. [25] 2019 Colorectal cancer CNN Endoscopist Bien et al. [26] 2018 Knee injury CNN + Logistic regression Radiologist, Orthopedic surgeon Wijnberge et al. [5] 2020 Hypotension Logistic regression Anaesthesiologist Su et al. [27] 2019 Colorectal cancer CNN Endoscopist Zhou et al. [2] 2020 Rib fracture CNN Radiologist Tajmir et al. [28] 2019 Bone age assessment CNN Radiologist Sim et al. [29] 2019 Lung cancer CNN, commercial tool Radiologist Lee et al. [30] 2020 Thyroid cancer CNN Radiologist Kozuka et al. [31] 2020 Lung cancer CNN, commercial tool Radiologist Jang et al. [32] 2020 Lung cancer CNN, commercial tool Radiologist Cha et al [33] 2019 Muscle-invasive bladder cancer CNN Radiologist Cai et al. [34] 2019 Esophageal cancer CNN Endoscopist Sato et al. [35] 2021 Hip fractures CNN Clinician Yu et al. [36] 2019 Breast cancer GMM, Random forest Radiologist Choi et al. [37] 2021 Thoracic disease CNN Radiologist Choi et al. [38] 2022 Skull fracture CNN Radiologist Shang et al. [39] 2022 SARS-COV-2 CNN Radiologist Roller et al. [40] 2022 Graft failure Gradient boosting Physicians (internal medicine or nephrology) Wang et al. [41] 2022 Pancreatic cancer CNN Radiologist Yacoub et al. [42] 2022 Cardiac, pulmonary and musculoskeletal diseases CNN, commercial tool Radiologist ...
... These measures identify whether the ML-CDSS assisted participants to perform tasks more effectively. For example, the accuracy of diagnoses (e.g., early pregnancy, cancer diagnose, knee injury, wrist or rib fractures, bone age) was an often-used performance measure [22,24,26,[28][29][30]. Also, the performance measures of sensitivity and specificity [1,2,23,26,31,41,43,44] and AUC value (area under curve) [4,32,33,37,38,40,[43][44][45] were often used. ...
... These measures are related to examination time or the number of repetitions, detections or incidents. For example, studies [2,3,22,23,25,27,32,41,42,44] measured time to execute tasks (e.g., scan duration, review time, reaction time, reading time). Studies [3,5,22,25] measured the numbers of detections (e.g., number of polyps, number of unobserved sites), repetitions (e.g., number of scan images) and incidents (e.g., number of treatments or hypotensive events). ...
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... In 2019, a revamped CDSS leveraging both ontology and semantic web technologies emerged, ushering in dynamic, tailored imaging protocols. 85 This avant-garde CDSS, anchored in both AI and a meticulously validated knowledge repository, heralded transformative strides in early pregnancy ultrasound diagnostics. Empirical evidence attested to its efficacy, especially in amplifying the diagnostic acumen of nascent examiners, most prominently in ascertaining the exact locus of early pregnancies. ...
... Although existing predictive models and clinical decision support systems are widely used, there remains room for improvement F I G U R E 3 Development of pregnancy of unknown location (PUL) clinical decision support systems. [83][84][85] in PUL management. Even M4 and M6, the most recognized models in PUL management, show variable efficiency in different cohorts. ...
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... SUOG (Smart Ultrasound in Obstetrics and Gynecology) is a EU-funded decision support system for early pregnancy and fetal disorders based on semantic reasoning and ML. SUOG provides step by step guidance during prenatal scans and leverages a knowledge base with a dedicated ontology ( 46 ). The SUOG ontology (v 3.70i) contains fine-grained fetal ultrasound phenotype descriptions, of which 1358 are mapped under HPO classes or coded with HPO. ...
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Background Ectopic pregnancy is a frequent early complication of pregnancy associated with significant rates of morbidly and mortality. The positive diagnosis of this condition is established through transvaginal ultrasound scanning. The timing of diagnosis depends on the operator expertise in identifying the signs of ectopic pregnancy, which varies dramatically among medical staff with heterogeneous training. Developing decision support systems in this context is expected to improve the identification of these signs and subsequently improve the quality of care. In this article, we present a new knowledge base for ectopic pregnancy, and we demonstrate its use on the annotation of clinical images. ResultsThe knowledge base is supported by an application ontology, which provides the taxonomy, the vocabulary and definitions for 24 types and 81 signs of ectopic pregnancy, 484 anatomical structures and 32 technical elements for image acquisition. The knowledge base provides a sign-centric model of the domain, with the relations of signs to ectopic pregnancy types, anatomical structures and the technical elements. The evaluation of the ontology and knowledge base demonstrated a positive feedback from a panel of 17 medical users. Leveraging these semantic resources, we developed an application for the annotation of ultrasound images. Using this application, 6 operators achieved a precision of 0.83 for the identification of signs in 208 ultrasound images corresponding to 35 clinical cases of ectopic pregnancy. Conclusions We developed a new ectopic pregnancy knowledge base for the annotation of ultrasound images. The use of this knowledge base for the annotation of ultrasound images of ectopic pregnancy showed promising results from the perspective of clinical decision support system development. Other gynecological disorders and fetal anomalies may benefit from our approach.
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Introduction We have developed a new knowledge base intelligent system for obstetrics and gynecology ultrasound imaging, based on an ontology and a reference image collection. This study evaluates the new system to support accurate annotations of ultrasound images. We have used the early ultrasound diagnosis of ectopic pregnancies as a model clinical issue. Material and methods The ectopic pregnancy ontology was derived from medical texts (4260 ultrasound reports of ectopic pregnancy from a specialist center in the UK and 2795 Pubmed abstracts indexed with the MeSH term “Pregnancy, Ectopic”) and the reference image collection was built on a selection from 106 publications. We conducted a retrospective analysis of the signs in 35 scans of ectopic pregnancy by six observers using the new system. Results The resulting ectopic pregnancy ontology consisted of 1395 terms, and 80 images were collected for the reference collection. The observers used the knowledge base intelligent system to provide a total of 1486 sign annotations. The precision, recall and F-measure for the annotations were 0.83, 0.62 and 0.71, respectively. The global proportion of agreement was 40.35% 95% CI [38.64–42.05]. Discussion The ontology-based intelligent system provides accurate annotations of ultrasound images and suggests that it may benefit non-expert operators. The precision rate is appropriate for accurate input of a computer-based clinical decision support and could be used to support medical imaging diagnosis of complex conditions in obstetrics and gynecology.
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