Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04153045
Other study ID # xrAI ClinicalEvaluation Stage1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 12, 2020
Est. completion date April 21, 2020

Study information

Verified date September 2020
Source 1QB Information Technologies Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

xrAI (pronounced "X-ray") serves as a clinical assistance tool for trained clinical professionals who are interpreting chest radiographs. The tool is designed as a quality control and adjunct, limited, clinical decision support tool, and does not replace the role of clinical professionals. It highlights areas on chest radiographs for review by an interpreting clinician.

The objective of this study is to utilize machine learning and artificial intelligence algorithms (xrAI) to improve the quality and efficiency in the interpretation of chest radiographs by family doctors, nurse practitioners, emergency medicine physicians, internists, pulmonologists, and radiologists.

The hypothesis is that the addition of xrAI's analysis will reduce inter-observer variability in the interpretation of chest radiographs and increase participants' sensitivity, recall, and accuracy in pulmonary abnormality screening.


Description:

To investigate the effect of xrAI for clinicians that interpret chest radiographs as part of their daily responsibilities, the investigators have designed a randomized control trial.

The pulmonary abnormalities detected by xrAI and included in the definition of abnormal are as follows: any linear scar or fibrosis, atelectasis, consolidation, abscess or cavity, nodule, pleural effusion, severe cases of emphysema and COPD (mild cases with hyperinflation but not significant emphysema are not flagged), and pneumothorax.

To assess the causal effect of xrAI the investigators randomly assign 36 clinicians to either treatment (x-ray images processed by xrAI) or control (no xrAI processing) groups. Participants will only review images once. Each participant will perform 500 radiograph interpretations in total.

Participants in the control group will be asked to interpret the same 500 images without xrAI's analysis.

To increase the precision of the estimate and better investigate potential differences between clinical professionals, investigators block randomize the assignment of treatment or control group within each group of clinicians (family doctor, nurse practitioner, emergency medicine physician, internist, pulmonologist, radiologist). Within each group of clinicians, investigators will randomly assign half to treatment or control group. This randomized complete block design ensures that an equal number of each group of clinical professionals are represented in the treatment and control groups.

To analyse the effect of xrAI, the investigators will estimate the average treatment effect (ATE) for each subgroup by comparing the performance of the treatment and control groups using randomization-based inference (Green and Gerber, 2012).


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date April 21, 2020
Est. primary completion date April 21, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Family doctors currently practicing at a site within Saskatchewan Health Authority

- Nurse practitioners currently practicing at a site within Saskatchewan Health Authority

- Emergency medicine physicians currently practicing at a site within Saskatchewan Health Authority

- Internists currently practicing at a site within Saskatchewan Health Authority

- Pulmonologists currently practicing at a site within Saskatchewan Health Authority

- Radiologists currently practicing at a site within Saskatchewan Health Authority

Exclusion Criteria:

- Physicians not currently practicing at a site within Saskatchewan Health Authority.

- Physicians currently practicing at a site within Saskatchewan Health Authority as neither family doctors, nurse practitioners, emergency medicine physicians, internists, pulmonologists, nor radiologists.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Radiograph interpretation for pulmonary abnormalities
The pulmonary abnormalities detected by xrAI and included in the definition of abnormality are as follows: any linear scar or fibrosis, atelectasis, consolidation, abscess or cavity, nodule, pleural effusion, severe cases of emphysema and COPD (mild cases with hyperinflation but not significant emphysema are not flagged), pneumothorax. Participants in the treatment group will interpret 500 images presented alongside the results of xrAI's processing in a dark room and asked to categorize each image into one of the following categories: lungs are clear, at least one pulmonary abnormality is present, not sure. Participants in the control group will be asked to interpret the same 500 images as the treatment group but without xrAI's analysis.

Locations

Country Name City State
Canada 1QB Information Technologies Inc Vancouver British Columbia

Sponsors (2)

Lead Sponsor Collaborator
1QB Information Technologies Inc. Saskatchewan Health Authority - Regina Area

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of abnormalities identified divided by number of total of images analyzed (accuracy) Accuracy is defined as the ratio of the images where the physician's prediction matched the labels of the dataset.
Accuracy= (TP+FP) / (TP+FP+TN+FN)
TP (true positives) = cases interpreted as abnormal that are abnormal; FP (false positives) = cases wrongly interpreted to be abnormal; TN (true negatives) = cases correctly interpreted to be normal; FN (false negatives) = abnormal cases wrongly interpreted as normal.
Time needed to analyze 500 images. Participants will be asked to completed the exercise within 2 weeks.
Primary Number of true abnormalities identified divided by the total of abnormalities identified (precision) Precision is defined as the probability of a radiograph being abnormal if a physician makes the determination that it is abnormal.
Precision= TP / (TP+FP)
TP (true positives) = cases interpreted as abnormal that are abnormal; FP (false positives) = cases wrongly interpreted to be abnormal; TN (true negatives) = cases correctly interpreted to be normal; FN (false negatives) = abnormal cases wrongly interpreted as normal.
Time needed to analyze 500 images. Participants will be asked to completed the exercise within 2 weeks.
Primary Number of true abnormalities identified divided by the sum of true abnormalities identified and abnormalities missed (recall) Recall is defined as the probability of a physician catching an abnormality in an image if one exists (based on the labels of the dataset).
Recall= TP / (TP+FN)
TP (true positives) = cases interpreted as abnormal that are abnormal; FP (false positives) = cases wrongly interpreted to be abnormal; TN (true negatives) = cases correctly interpreted to be normal; FN (false negatives) = abnormal cases wrongly interpreted as normal.
Time needed to analyze 500 images. Participants will be asked to completed the exercise within 2 weeks.
Secondary Mean of physician accuracy (as defined in outcome 1) Investigators will calculate the mean of the accuracy of all participants in a group and the mean of the accuracy of all participants across all the groups. Time needed to analyze 500 images. Participants will be asked to completed the exercise within 2 weeks.
Secondary Mean of physician precision (as defined in outcome 2) Investigators will calculate the mean of the precision of all participants in a group and the mean of the precision of all participants across all the groups. Time needed to analyze 500 images. Participants will be asked to completed the exercise within 2 weeks.
Secondary Mean of physician recall (as defined in outcome 3) Investigators will calculate the mean of the recall of all participants in a group and the mean of the recall of all participants across all the groups. Time needed to analyze 500 images. Participants will be asked to completed the exercise within 2 weeks.
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03572335 - Systems Biology of Diffusion Impairment in Human Immunodeficiency Virus (HIV)
Recruiting NCT06088485 - The Effect of Bone Mineral Density in Patients With Adult Cystic Fibrosis
Terminated NCT03309358 - A Study of the Safety and Tolerability of Inhaled SNSP113 in Healthy Subjects and Subjects With Stable Cystic Fibrosis Phase 1
Active, not recruiting NCT02504697 - DECAMP-2: Screening of Patients With Early Stage Lung Cancer or at High Risk for Developing Lung Cancer
Completed NCT01443845 - Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS) Phase 4
Terminated NCT00524095 - Bronchiectasis in Chronic Obstructive Pulmonary Disease (COPD) Patients: Role of Prophylaxis Phase 2
Completed NCT00210249 - Development of an Evaluation Method of Elderly Condition in Patient Receiving Chemotherapy Treatment
Completed NCT00023114 - p450 Mediated Lung Toxicity N/A
Recruiting NCT06056882 - Simultaneous CLE Guided Crybiopsy in Patients With Pulmonary Nodules
Completed NCT03994848 - Incentive Spirometry Prehabilitation Study N/A
Completed NCT00366509 - Role of Helicobacter Pylori and Its Toxins in Lung and Digestive System Diseases
Withdrawn NCT05100160 - Gabapentin for the Reduction of Opiate Use Following Pulmonary Resection (GROUP Trial) Phase 3
Completed NCT03229473 - Fall Risk Assessment in COPD
Recruiting NCT04767074 - A Non-pharmacological Cough Control Therapy N/A
Not yet recruiting NCT03899298 - Safety and Clinical Outcomes With Amniotic and Umbilical Cord Tissue Therapy for Numerous Medical Conditions Phase 1
Completed NCT04996693 - On Dose Efficiency of Modern CT-scanners in Chest Scans N/A
Recruiting NCT04996173 - Cryospray Therapy Versus Standard of Care for Benign Airway Stenosis (CryoStasis) N/A
Completed NCT04601545 - The Virtual Reality Therapy as a Pulmonary Rehabilitation Supporting Method N/A
Recruiting NCT03937583 - Screening for Cancer in Patients With Unprovoked VTE Phase 4
Recruiting NCT02862418 - Imaging of Lungs With a New Type of Magnetic Resonance Imaging (MRI) Called UTE (Ultrashort Echo Time)