Clinical Validation of Machine Learning Triage of Chest Radiographs

Sponsor
Stanford University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05224479
Collaborator
Society of Thoracic Radiology (Other)
10
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3
3
3.3

Study Details

Study Description

Brief Summary

Artificial intelligence and machine learning have the potential to transform the practice of radiology, but real-world application of machine learning algorithms in clinical settings has been limited. An area in which machine learning could be applied to radiology is through the prioritization of unread studies in a radiologist's worklist. This project proposes a framework for integration and clinical validation of a machine learning algorithm that can accurately distinguish between normal and abnormal chest radiographs. Machine learning triage will be compared with traditional methods of study triage in a prospective controlled clinical trial. The investigators hypothesize that machine learning classification and prioritization of studies will result in quicker interpretation of abnormal studies. This has the potential to reduce time to initiation of appropriate clinical management in patients with critical findings. This project aims to provide a thoughtful and reproducible framework for bringing machine learning into clinical practice, potentially benefiting other areas of radiology and medicine more broadly.

Condition or Disease Intervention/Treatment Phase
  • Other: Traditional workflow triage
  • Other: Machine learning workflow triage
  • Other: Random workflow triage
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Radiologists will triage chest radiographs using traditional, machine learning, and random methods.Radiologists will triage chest radiographs using traditional, machine learning, and random methods.
Masking:
Single (Participant)
Masking Description:
Radiologists will be blinded when using machine learning and random triage methods.
Primary Purpose:
Diagnostic
Official Title:
Clinical Validation of Machine Learning Triage of Chest Radiographs
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Nov 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Traditional workflow triage

Radiologists follow standard triage of chest radiographs.

Other: Traditional workflow triage
Workflow triage is based on order location, STAT designation, and first-in-first-out status.

Other: Machine learning workflow triage
Workflow triage is based on the machine learning model's confidence of abnormality.

Other: Random workflow triage
Workflow triage is based on random order.

Active Comparator: Machine learning workflow triage

Radiologists follow machine learning triage of chest radiographs.

Other: Traditional workflow triage
Workflow triage is based on order location, STAT designation, and first-in-first-out status.

Other: Machine learning workflow triage
Workflow triage is based on the machine learning model's confidence of abnormality.

Other: Random workflow triage
Workflow triage is based on random order.

Sham Comparator: Random workflow triage

Radiologists follow randomly ordered triage of chest radiographs.

Other: Traditional workflow triage
Workflow triage is based on order location, STAT designation, and first-in-first-out status.

Other: Machine learning workflow triage
Workflow triage is based on the machine learning model's confidence of abnormality.

Other: Random workflow triage
Workflow triage is based on random order.

Outcome Measures

Primary Outcome Measures

  1. Turnaround time [up to 1 hour]

    Time from completion of radiograph to time that radiologist issues an assessment via preliminary or final report

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Radiologist at Stanford Hospital and Clinics
Exclusion Criteria:
  • None

Contacts and Locations

Locations

Site City State Country Postal Code
1 Stanford University Stanford California United States 94305

Sponsors and Collaborators

  • Stanford University
  • Society of Thoracic Radiology

Investigators

  • Principal Investigator: Emily Tsai, MD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Emily Tsai, Clinical Assistant Professor, Stanford University
ClinicalTrials.gov Identifier:
NCT05224479
Other Study ID Numbers:
  • 47832
First Posted:
Feb 4, 2022
Last Update Posted:
May 6, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of May 6, 2022