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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

RecruitingNAAges 15 Years - anyAllXuelin Yang
NCT06963606 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The global incidence rate and mortality of tuberculosis (TB) pose a challenge to achieving the goals set out in the tuberculosis eradication strategy and the SDGs by 2030. At present, timely and accessible early detection methods for tuberculosis are still a major obstacle. In this context, the emergence of artificial intelligence (AI), especially the AI-assisted chest X-ray (CXR) in the field of diagnostic imaging, has proved the potential to significantly improve the speed and accuracy of tuberculosis diagnosis. However, the extent to which these technologies can affect the broader tuberculosis care cascade, especially by reducing the diagnostic time in the population level, has not yet been explored. The proposed project plans to use the certified AI-assisted CXR system (JF CXR-1) for tuberculosis screening, which aims not only to integrate AI into the diagnosis process, but also to c

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📋 Eligibility rules (as published)
Eligibility criteria Inclusion criteria Participants must receive medical treatment at the primary healthcare hospitals in Yichang City, Hubei Province, and underwent chest X-ray examinations. The participants have to meet the following criteria: 1. \>15 years old. 2. Appearance of tuberculosis-related respiratory symptoms or signs. 3. Individuals not previous diagnosed with active pulmonary tuberculosis. 4. Capable of completing pathogen examinations and subsequent related inspections. Exclusion criteria Those who meet any of the below criteria will be excluded: 1. Diagnosed with extrapulmonary tuberculosis or latent tuberculosis infection during the current visit. 2. The quality of Chest X-ray images did not meet the standard requirements. 3. Unrecognized identity information participants. Withdrawal Criteria 1. Participants who are lost to follow-up or who do not complete the follow-up period. 2. Participants who experience a sudden and serious illness or choose not to continue participating in the study.
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What it tests

  • Artificial intelligence-assisted chest X-ray in TB screening
  • Routine doctors analyze the process of chest X-rays
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Where

1 site
Township Health-care settings in Yichang City
Yichang, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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