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Abstract

BACKGROUND Early pregnancy ultrasound scans are usually performed by non-expert examiners in OB/GYN emergency departments. Establishing the precise location diagnosis is key for appropriate management of early pregnancies, and experts are usually able to locate pregnancy at the first scan. A decision support system based on semantic expert-validated knowledge base may improve diagnosis performance of non-expert examiners, for early pregnancy transvaginal ultrasound. OBJECTIVE This study aims to evaluate a novel Intelligent Scan Assistant System for early pregnancy ultrasound on pregnancy location diagnosis and on image quality. METHODS Two trainees performed virtual transvaginal ultrasound examinations of early pregnancy cases without and with the system. The ultrasound images and reports were blindly reviewed by two experts using scoring methods. Pregnancy location diagnosis and ultrasound image quality was compared in scan performed without and with the system. RESULTS Each trainee performed a virtual vaginal examination for all 32 cases without and with the system. The analysis of the 128 resulting scans showed higher quality for the images (quality score +23%, p<0.001), less images per scan (4.6 vs. 6.3, p <0.001) and higher confidence in report conclusions (trust score +20%, p<.0001), when using the system. The use of the system cost an additional 8 minutes per scan. We observed a correct location diagnosis in 39/64 (61%) and 52/64 (81%) scans, in non-assisted mode and in assisted mode, respectively. Additionally, the exact diagnosis (with precise ectopic location) was achieved in 30/64 and 49/64 scans, without and with the system, respectively. These differences in diagnosis performance, +20% of correct location diagnosis and +30% in exact diagnosis were both statistically significant (p=0.002 and p<0.001, respectively). CONCLUSIONS The Intelligent Scan Assistant System based on an expert-validated knowledge base demonstrates significant improvement in early pregnancy scan both in diagnosis performance (pregnancy location and precise diagnosis) and in scan quality (selection of images, confidence and image quality). CLINICALTRIAL N/A
J Med Internet Res. 2019 Jul; 21(7): e14286.
Published online 2019 Jul 3. doi: 10.2196/14286: 10.2196/14286
PMCID: PMC6636237
PMID: 31271152
A Novel Intelligent Scan Assistant System for Early Pregnancy
Diagnosis by Ultrasound: Clinical Decision Support System
Evaluation Study
Monitoring Editor: Gunther Eysenbach
Reviewed by Subirosa Sabarguna and Suptendra Sarbadhikari
Ferdinand Dhombres, MD, PhD, Paul Maurice, MSc, MD, Lucie Guilbaud, MSc, MD, Loriane Franchinard, MSc,
MD, Barbara Dias, MSc, Jean Charlet, PhD, Eléonore Blondiaux, MD, PhD, Babak Khoshnood, MD, PhD,
Davor Jurkovic, MD, Eric Jauniaux, MD, PhD, and Jean-Marie Jouannic, MD, PhD
Service de Médecine Fœtale, Sorbonne Université, Assistance Publique - Hôpitaux de Paris / Hôpitaux Universitaires
Est Parisiens, Hôpital Armand Trousseau, Paris, France
Medical Informatics and Knowledge Engineering for eHealth Lab, INSERM, Paris, France
Direction de la Recherche et de l'Innovation, Assistance Publique - Hôpitaux de Paris, Paris, France
Service de Radiologie, Sorbonne Université, Assistance Publique - Hôpitaux de Paris / Hôpitaux Universitaires Est
Parisiens, Hôpital Armand Trousseau, Paris, France
Obstetrical, Perinatal and Pediatric Epidemiology Research Team, Center for Biostatistics and Epidemiology,
INSERM, Paris, France
Gynaecology Diagnostic and Outpatient Treatment Unit, University College Hospital and Institute for Women's Health,
University College London, London, United Kingdom
Ferdinand Dhombres, 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.
Corresponding author.
Corresponding Author: Ferdinand Dhombres ferdinand.dhombres@inserm.fr
Received 2019 Apr 5; Revisions requested 2019 May 8; Revised 2019 Jun 11; Accepted 2019 Jun 11.
Copyright ©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), 03.07.2019.
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 in any
medium, provided the original work, first published in the Journal of Medical Internet Research, is properly cited. The
complete bibliographic information, a link to the original publication on http://www.jmir.org/, as well as this copyright and
license information must be included.
Abstract
Background
1,21,2 1
1 1 2,3 4 5
6 6 1,2
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2
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5
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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).
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 volume for each adnexal region. In case of a
Virtual Ultrasound Examinations
Ultrasound Images and Report Scoring Methods
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.
Clinical Decision Support System Evaluation Protocol
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).
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).
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)
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 trust in 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).
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).
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 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].
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.
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.
Abbreviations
CDI color Doppler imaging
CDSS clinical decision support system
EP ectopic pregnancy
OB/GYN obstetrics and gynecology
TVS transvaginal sonography
Footnotes
Conflicts of Interest: None declared.
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Figures and Tables
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.
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.
Figure 4
Personalized imaging protocol and workflow of the Intelligent Scan Assistant System for ultrasound imaging.
Table 1
Differences in scan quality with (assisted mode) and without (nonassisted mode) the decision
support system.
Scan quality parameter Assisted mode (64 scans) Nonassisted mode (64 scans)
Image count in report, mean (SD) 4.64 (0.80) 6.33 (2.07)
Scan duration (minutes), mean (SD) 14.7 (7.1) 6.4 (3.3)
Quality score of image sets, mean (SD) 12.5 (1.86) 10.2 (1.90)
Trust score of report, mean (SD) 4.12 (0.83) 3.42 (1.04)
The tests for difference were paired t tests.
a
a
Table 2
Differences in the diagnostic performance of trainees with (assisted mode) and without the decision
support system (nonassisted mode).
Diagnostic performance parameter Assisted mode (64 scans), n (%) Nonassisted mode (64 scans), n (%)
Correct pregnancy location (ectopic/nonectopic) 52 (81) 39 (61)
Exact diagnosis (with precise ectopic location) 49 (77) 30 (47)
False-negative of ectopic pregnancy 1 (1.6) 8 (12.5)
False-positive of ectopic pregnancy 3 (4.7) 3 (4.7)
The test for difference was exact McNemar test.
Not available.
a
a
b
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.
Articles from Journal of Medical Internet Research are provided here courtesy of Gunther Eysenbach
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