Clinical trial NCT04221100: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Pulmonary Disease
Lead sponsor: 1QB Information Technologies Inc.
Sponsor class: INDUSTRY
First posted: 2020-01-09
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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).

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.

Primary outcomes:
measure: Number of abnormalities identified divided by number of total of images analyzed (accuracy)
timeFrame: Time needed to analyze 500 images. Participants will be asked to completed the exercise within 2 weeks.
measure: Number of true abnormalities identified divided by the total of abnormalities identified (precision)
timeFrame: Time needed to analyze 500 images. Participants will be asked to completed the exercise within 2 weeks.
measure: Number of true abnormalities identified divided by the sum of true abnormalities identified and abnormalities missed (recall)
timeFrame: Time needed to analyze 500 images. Participants will be asked to completed the exercise within 2 weeks.
Secondary outcomes:
measure: Mean of radiologist accuracy (as defined in outcome 1)
timeFrame: Time needed to analyze 500 images. Participants will be asked to completed the exercise within 2 weeks.
measure: Mean of radiologist precision (as defined in outcome 2)
timeFrame: Time needed to analyze 500 images. Participants will be asked to completed the exercise within 2 weeks.
measure: Mean of radiologist recall (as defined in outcome 3)
timeFrame: Time needed to analyze 500 images. Participants will be asked to completed the exercise within 2 weeks.
Other outcomes:
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