Recently a growth in the number of radiology studies across multiple modalities has been
observed alongside the modest increase in staffing levels. This carries higher risks of
increased workload and efficiency losses. The integration of computer vision-based
services into URIS will improve the radiologists' productivity and job performance.
Existing prerequisites for conducting the study:
1. Increasing the number of preventive and diagnostic radiological studies entails the
growing workload for radiologists and increased risk of interpretation errors, which
in turn leads to the decrease in quality of medical care.
2. When a radiologist opens a worklist of studies, in the absence of special notes,
he/she writes a report in the random order, not being able to select from the list
the studies that require the most attention and prompt response (studies with
pathological findings), which increases the time of diagnosis.
3. The absence of the structured pre-filled template of report leads to the increase in
time for preparing reports.
4. A radiologist has to spend considerable time evaluating the dynamics of pathological
changes, which also increases the time to prepare a report as well as the risk of
error.
5. Interpretation of preventive studies requires double reading, which is implemented
inefficiently due to the staff shortage.
Study objectives:
1. Study the diagnostic accuracy of the Services in accordance with the methodological
guidelines No. 43 "Clinical trials of software based on intelligent technologies
(diagnostic radiology)" (recommended by the Expert Council on Science of the Moscow
Healthcare Department, Protocol No. 8 of June 25, 2019).
2. Audit the studies conducted with Services application in order to determine the
number of interpretation errors, and compare it with the audit result without their
application (hypothesis 1).
3. Conduct timekeeping to estimate time for preparing a report and the total number of
evaluated studies with and without using the Services (hypothesis 2,3).
4. Conduct a survey of radiologists who use the Services in their work, in order to
determine their opinion about the implementation of innovative technologies in the
diagnostic process.
METHODOLOGY. 1. The Experiment is carried out by the Moscow Healthcare Department in accordance with
Regulation No. 43 of January 24, 2020 "On approval of the procedure and conditions
for conducting the Experiment on the use of innovative computer vision technologies
for analysis of medical images and further application in Moscow healthcare system".
2. The experiment is conducted on the next types of studies:
1)Detection of CT signs consistent with COVID-19 (coronavirus) lung involvement (Chest
CT); 2) Emphysema extent (Chest CT); 3) Detection of CT signs consistent with malignant
neoplasm in the lungs (Chest CT); 4) Detection of LDCT signs consistent with malignant
neoplasm in the lungs (Chest LDCT); 5) Detection and localization of compression
vertebral fractures with a degree of vertebral body deformity of over 25% according to
the Genant semi-quantitative scale, grades 2-3 (Chest CT); 6) Detection of free pleural
fluid (effusion) (Chest CT); 7) Detection of enlarged intrathoracic lymph nodes
(lymphadenopathy) (Chest CT); 8) Detection of bronchiectasis (Chest CT); 9) Detection of
CT signs consistent with pulmonary tuberculosis (Chest CT); 10) Coronary calcium score
(Chest CT/ LDCT); 11) Paricardial fat volume (Chest CT); 12) Dilation of ascending and
descending thoracic aortas (Chest CT/ LDCT); 13) Dilation of the pulmonary trunk (Chest
CT/ LDCT); 14) Detection of sarcoidosis (Chest CT); 15) Detection of signs consistent
with the impairment of lung airness (Chest CT); 16) Detection of signs consistent with
the focal lesions in the chest bones (Chest CT); 17) Detection of CT signs consistent
with rib fracture (Chest CT); 18) Detection of signs of urolithiasis (Abdominal CT); 19)
Detection of signs consistent with the focal lesions in the skeleton bones (Abdominal
CT); 20) Detection of liver lesions (Abdominal CT); 21) Detection of CT signs consistent
with gallbladder stones (Abdominal CT); 22) Detection of CT signs consistent with renal
lesions (Abdominal CT); 23) Measuring the abdominal aorta dilation (Abdominal CT); 24)
Detection of adrenal lesions (Abdominal/Chest CT); 25) Detection and localization of
compression vertebral fractures with a degree of vertebral body deformity of over 25%
according to the Genant semi-quantitative scale, grades 2-3 (Abdominal CT); 26)
Automation of routine liver measurements (dimensions, liver density, choledochus
diameter, portal vein diameter) (Abdominal CT); 27) Automation of routine kidney
measurements (kidney size, pelvicalyceal system size) (Abdominal CT); 28) Automation of
routine measurements of spleen and pancreas (size, density of the spleen and pancreas)
(Abdominal CT); 29) Detection of acute ischemic stroke and its ASPECTS score (Head CT);
30) Detection of hemorrhage and its automatic volume calculation in ml or cm³ (Head CT);
31) Automation of routine measurements (ventriculometry, displacement of median
structures, measurement of the craniovertebral junction) (Head CT); 32) Detection and
localization of (at least 7) signs consistent with the priority disease (Chest XR); 33)
Detection of signs (at least one) consistent with bone fracture (MSS XR); 34) Detection
of radiologic signs (at least one) consistent with arthrosis of the joints (MSS XR); 35)
Detection of radiological signs (at least one) consistent with deforming arthrosis of the
hip (MSS XR); 36) Detection of radiological signs (at least one) consistent with the
fracture of the shoulder joint bones (MSS XR); 37) Detection of radiological signs (at
least one) consistent with the fracture of the hip joint bones (MSS XR) 38) Detection of
radiological signs (at least one) consistent with the fracture of the ankle joint bones
(MSS XR).
39) Detection of reduced pneumatization / opacity of the paranasal sinuses (Head XR) 40)
Detection of signs (at least one) consistent with transverse flat foot (MSS XR) 41)
Detection of signs (at least one) consistent with the longitudinal flat foot in the
lateral plane (MSS XR); 42) Detection of the signs of osteoporosis: detection and
localization of compression vertebral fractures with a degree of height loss of over
25% as well as the radio density measurements of vertebral bodies (Spine XR); 43)
Detection of signs consistent with osteochondrosis in the frontal and/or sagittal
plane (Spine XR); 44) Detection of signs consistent with scoliosis in the frontal
plane (Spine XR); 45) Detection of signs consistent with spondylolisthesis in the
sagittal plane (Spine XR); 46) Detection and localization of findings consistent
with breast cancer (MMG); 47) Detection of multiple sclerosis (Brain MRI); 48)
Detection and localization of intracranial neoplasms (extracerebral, intracerebral)
(Brain MRI); 49) Automation of routine measurements (ventriculometry, displacement
of median structures, measurement of the craniovertebral junction, changes in white
matter, intracranial measurements) (Brain MRI); 50) Detection of signs consistent
with the focal lesions in the cervical spinal cord (Cervical spine MRI); 51)
Detection and localization of MRI signs (at least one) consistent with degenerative
changes in the cervical discs on sagittal and axial T2-WI (Cervical spine MRI); 52)
Detection and localization of MRI signs (at least one) consistent with degenerative
changes in the thoracic discs on sagittal and axial T2-WI (Thoracic spine MRI); 53)
Detection of signs consistent with the focal lesions in the thoracic spinal cord
(Thoracic spine MRI); 54) Detection and localization of MRI signs (at least one)
consistent with degenerative changes in the lumbosacral discs on sagittal and axial
T2-WI (Lumbosacral spine MRI); 55) Detection of signs consistent with the focal
lesions in the lumbosacral spinal cord (Lumbosacral spine MRI); 56) Detecting signs
consistent with the areas of cartilage breakdown (chondromalacia) along the
articular surfaces of the knee and the patellofemoral joint (Knee joint MRI); 57)
Automated routine measurements of the prostate gland (dimensions) (Lesser pelvis
MRI); 58) Automated routine measurements of the uterus (corpus and cervix: position,
dimensions, displacements) (Lesser pelvis MRI).
3. For each Service during the Experiment, a certain number of studies is provided for
processing based on their type:
1. CT/LDCT
XR
MMG
MRI
4. A methodology for including services in the Experiment has been developed. For each
Service, the participation process in the Experiment consists of the following
stages:
1. selection;
2. the preparatory stage;
3. the main stage;
4. the final stage.
During the Experiment, a radiologist will routinely be able to:
- - work on a sorted list of patients (triage);
- work with images processed by the Service;
- work with a pre-filled template of the radiological report on each study;
- evaluate the work of the Service according to the developed questionnaire.
During
the Experiment, a patient will receive the individual plan of the follow-up support.
It includes preventive examinations or observation as well as treatment by a
specialist.
Systematization and final analysis of the Experiment results is carried out within three
months from the completion date of the last Service participation in the Experiment.
Based on the results of the Experiment, recommendations can be prepared on the
possibility to register certain services as a medical device (software).
