xrAI - Improving Quality and Efficiency in Chest Radiograph Interpretation by Radiologists

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 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.

Study Overview

• Status: Withdrawn
• Conditions: Pulmonary Disease
• Intervention / Treatment: Device: Radiograph interpretation for pulmonary abnormalities

Detailed Description

To investigate the effect of xrAI for radiologists 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 10 to 14 radiologists 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.

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

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Radiologist currently practicing at a Pureform Radiology clinic in Calgary, Canada.

Exclusion Criteria:

• Radiologists not currently practicing at a Pureform Radiology clinic in Calgary, Canada.
• Physicians currently practicing at a Pureform Radiology clinic in Calgary, Canada, but that are not radiologists by training.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control; Participants will review the 500 chest radiographs without the assistance of xrAI	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.
Experimental: Treatment; Participants will review the 500 chest radiographs with the assistance of xrAI	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean of radiologist accuracy (as defined in outcome 1)	Investigators will calculate the mean of the accuracy of all participants in each group.	Time needed to analyze 500 images. Participants will be asked to completed the exercise within 2 weeks.
Mean of radiologist precision (as defined in outcome 2)	Investigators will calculate the mean of the precision of all participants in each group.	Time needed to analyze 500 images. Participants will be asked to completed the exercise within 2 weeks.
Mean of radiologist recall (as defined in outcome 3)	Investigators will calculate the mean of the recall of all participants in each group.	Time needed to analyze 500 images. Participants will be asked to completed the exercise within 2 weeks.

Collaborators and Investigators

• Sponsor: 1QB Information Technologies Inc.

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2021
• Primary Completion (Anticipated): May 1, 2021
• Study Completion (Anticipated): May 1, 2021

Study Registration Dates

• First Submitted: January 6, 2020
• First Submitted That Met QC Criteria: January 6, 2020
• First Posted (Actual): January 9, 2020

Study Record Updates

• Last Update Posted (Actual): February 23, 2021
• Last Update Submitted That Met QC Criteria: February 21, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases
• Other Study ID Numbers: xrAI ClinicalEvaluation Rads

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: The results of this study will be shared though we have not yet decided the format (publication in a medical journal, conference, white paper) not the type of information that will be shared (individual anonymized participant data or outcomes of the study). We will update this section once the IPD sharing plan is confirmed.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No