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

Primary Purpose

Pulmonary Disease

Status
Withdrawn
Phase
Not Applicable
Locations
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:

  • 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.

Sites / Locations

    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 radiologist accuracy (as defined in outcome 1)
    Investigators will calculate the mean of the accuracy of all participants in each group.
    Mean of radiologist precision (as defined in outcome 2)
    Investigators will calculate the mean of the precision of all participants in each group.
    Mean of radiologist recall (as defined in outcome 3)
    Investigators will calculate the mean of the recall of all participants in each group.

    Full Information

    First Posted
    January 6, 2020
    Last Updated
    February 21, 2021
    Sponsor
    1QB Information Technologies Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04221100
    Brief Title
    xrAI - Improving Quality and Efficiency in Chest Radiograph Interpretation by Radiologists
    Official Title
    xrAI - Improving Quality and Efficiency in Chest Radiograph Interpretation by Radiologists
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Not enough participants enrolled in the study
    Study Start Date
    March 2021 (Anticipated)
    Primary Completion Date
    May 2021 (Anticipated)
    Study Completion Date
    May 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    1QB Information Technologies Inc.

    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 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 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).

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

    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.

    Learn more about this trial

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

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