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xrAI - Improving Quality and Efficiency in Chest Radiograph Interpretation

Primary Purpose

Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Radiograph interpretation for pulmonary abnormalities
Sponsored by
1QB Information Technologies Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pulmonary Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • 1QB Information Technologies Inc

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control

Treatment

Arm Description

Participants will review the 500 chest radiographs without the assistance of xrAI

Participants will review the 500 chest radiographs with the assistance of xrAI

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
November 4, 2019
Last Updated
September 18, 2020
Sponsor
1QB Information Technologies Inc.
Collaborators
Saskatchewan Health Authority - Regina Area
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1. Study Identification

Unique Protocol Identification Number
NCT04153045
Brief Title
xrAI - Improving Quality and Efficiency in Chest Radiograph Interpretation
Official Title
xrAI - Improving Quality and Efficiency in Chest Radiograph Interpretation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
February 12, 2020 (Actual)
Primary Completion Date
April 21, 2020 (Actual)
Study Completion Date
April 21, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
1QB Information Technologies Inc.
Collaborators
Saskatchewan Health Authority - Regina Area

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Participants will review the 500 chest radiographs without the assistance of xrAI
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Participants will review the 500 chest radiographs with the assistance of xrAI
Intervention Type
Device
Intervention Name(s)
Radiograph interpretation for pulmonary abnormalities
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of abnormalities identified divided by number of total of images analyzed (accuracy)
Description
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 Frame
Time needed to analyze 500 images. Participants will be asked to completed the exercise within 2 weeks.
Title
Number of true abnormalities identified divided by the total of abnormalities identified (precision)
Description
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 Frame
Time needed to analyze 500 images. Participants will be asked to completed the exercise within 2 weeks.
Title
Number of true abnormalities identified divided by the sum of true abnormalities identified and abnormalities missed (recall)
Description
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 Frame
Time needed to analyze 500 images. Participants will be asked to completed the exercise within 2 weeks.
Secondary Outcome Measure Information:
Title
Mean of physician accuracy (as defined in outcome 1)
Description
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 Frame
Time needed to analyze 500 images. Participants will be asked to completed the exercise within 2 weeks.
Title
Mean of physician precision (as defined in outcome 2)
Description
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 Frame
Time needed to analyze 500 images. Participants will be asked to completed the exercise within 2 weeks.
Title
Mean of physician recall (as defined in outcome 3)
Description
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 Frame
Time needed to analyze 500 images. Participants will be asked to completed the exercise within 2 weeks.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
1QB Information Technologies Inc
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6E 4B1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing 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.

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xrAI - Improving Quality and Efficiency in Chest Radiograph Interpretation

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