NCT04153045

xrAI - Improving Quality and Efficiency in Chest Radiograph Interpretation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: 1QB Information Technologies Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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).

Conditions

• Pulmonary Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-02-12
• Primary completion: 2020-04-21
• Completion: 2020-04-21
• First posted: 2019-11-06
• Last updated: 2020-09-22

Locations

1 site across 1 country: Canada