Clinical trial NCT04153045: xrAI - Improving Quality and Efficiency in Chest Radiograph Interpretation
Official title: xrAI - Improving Quality and Efficiency in Chest Radiograph Interpretation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease
Lead sponsor: 1QB Information Technologies Inc.
Sponsor class: INDUSTRY
Collaborators: name: Saskatchewan Health Authority - Regina Area
First posted: 2019-11-06
Enrollment: 28
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 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).

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.

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 physician 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 physician 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 physician 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:
Locations:
city: Vancouver
country: Canada
facility: 1QB Information Technologies Inc
state: British Columbia
Study officials:
References: