Using Artificial Intelligence to Improve Tuberculosis Screening with Chest X-rays in Primary Healthcare Settings in China
Led by Xuelin Yang · Updated on 2025-12-31
22000
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Tuberculosis TB remains a major global health challenge with high rates of illness and death, making early and accessible detection critical. This research evaluates the impact of an artificial intelligence AI-assisted chest X-ray system JF CXR-1 in improving TB diagnosis speed and accuracy in primary care settings in Yichang City, China, which faces a high TB burden. The study aims to assess how integrating AI into the diagnosis process can enhance the overall TB care pathway and support public health goals.
The study is conducted in three stages first, retrospective imaging will be used to optimize and validate the AI-assisted systems accuracy. Second, a cluster randomized controlled trial will compare the AI-assisted chest X-ray screening to routine doctor analysis in township medical institutions, measuring diagnostic times and accuracy. Third, qualitative and quantitative methods will evaluate the feasibility and practicality of applying the AI screening approach in various community environments, aiming for wider adoption in primary healthcare.
Participants aged over 15 years with TB-related respiratory symptoms who have not been previously diagnosed with active pulmonary TB will undergo chest X-rays. Those in the intervention group will have their X-rays analyzed by the AI-assisted system alongside doctors, while the control group will have standard doctor-only reviews. Researchers will collect baseline data, follow diagnosis timing through the TB disease system, and assess diagnostic yield differences over six and twelve months. The study includes follow-up and monitoring to evaluate the AI systems impact on TB diagnosis and care efficiency.
CONDITIONS
Brief Title
Effectiveness of Computer-Aided Detection Chest X-Ray Screening for Improving Tuberculosis Diagnostic Yield in Chinese Primary Health Care Settings: Study Protocol for a Prospective Cluster Randomized Controlled Trial
Research Team
Y
Yang Xuelin
S
Su Xiaoyou Prof
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Receive medical treatment at primary healthcare hospitals in Yichang City, Hubei Province
Undergo chest X-ray examinations
Aged over 15 years
Have tuberculosis-related respiratory symptoms or signs
Not previously diagnosed with active pulmonary tuberculosis
Able to complete pathogen examinations and related follow-up inspections
You will not qualify if you...
Diagnosed with extrapulmonary tuberculosis or latent tuberculosis infection during the current visit
Chest X-ray image quality does not meet required standards
Unrecognized or unidentified participant information
Lost to follow-up or unable to complete the follow-up period
Experience sudden serious illness or choose to discontinue participation
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Ongoing during study period
Participants undergo chest X-ray examinations analyzed either by an artificial intelligence-assisted system with doctor review or by a regular doctor without AI assistance to identify potential signs of tuberculosis and decide if further tests are needed.
1 visit (in-person)
Long-term Monitoring
Duration - Up to 12 months after intervention starts
Participants are followed up to record the time of tuberculosis diagnosis as reported by the tuberculosis specific disease system.
Follow-up visits as needed
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SCREENING
Number of Arms
2
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Published Research Related To This Trial
Effectiveness of computer-aided detection chest X-ray screening for improving tuberculosis diagnostic yield in Chinese primary healthcare settings: study protocol for a prospective cluster randomised controlled trial.