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xrAI - Improving Quality and Efficiency in Chest Radiograph Interpretation

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1QB Information Technologies

Status

Completed

Conditions

Pulmonary Disease

Treatments

Device: Radiograph interpretation for pulmonary abnormalities

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT04153045
xrAI ClinicalEvaluation Stage1

Details and patient eligibility

About

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.

Full 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).

Enrollment

28 patients

Sex

All

Volunteers

Accepts 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.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

28 participants in 2 patient groups, including a placebo group

Control
Placebo Comparator group
Description:
Participants will review the 500 chest radiographs without the assistance of xrAI
Treatment:
Device: Radiograph interpretation for pulmonary abnormalities
Treatment
Experimental group
Description:
Participants will review the 500 chest radiographs with the assistance of xrAI
Treatment:
Device: Radiograph interpretation for pulmonary abnormalities

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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