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

Summary

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 critically assess its impact on the overall tuberculosis care cascade. The selected location for this project is Yichang City in western Hubei Province, China, which is facing a high TB burden. The city has established a strong city-wide health big data platform ten years ago, providing the basis for this project. The project will first optimize the AI-assisted CXR system through retrospective imaging to validate the accuracy of case screening (Stage Ⅰ). Secondly, the project will shift its focus to the real world, where cluster randomized controlled trials will be conducted in primary-care settings (Stage Ⅱ). In this stage, the effectiveness of the AI-assisted CXR system in reducing the diagnostic time of TB cases will be evaluated by comparing with those settings without using the tool. In stage Ⅲ, the qualitative and quantitative methods will be used to evaluate the generalization, practicality, and feasibility of extending the screening strategy in various community environments. If the AI-assisted screening strategy is proven accurate, effective, and sustainable, it may pave the way for its widespread adoption in primary healthcare institutions and other grassroots areas in China. This can not only improve the timeliness of tuberculosis diagnosis, but also help to allocate medical resources more effectively and significantly reduce tuberculosis-related incidence and mortality, bringing positive changes to global public health. In addition, the results of the project can also provide information for policy decisions and guide the formulation of strategies to prioritize the integration of AI into health care, which can not only fight against tuberculosis but also a series of other diseases.

Conditions

• Tuberculosis (TB)

Interventions

DIAGNOSTIC_TEST

Artificial intelligence-assisted chest X-ray in TB screening

After the completion of the chest DR Examination, the chest X-ray was analyzed by the artificial intelligence-assisted system (JF CXR-1) to identify the potential signs of tuberculosis. Meanwhile, the doctor analyzed the results of the chest X-ray. After the analysis results were confirmed, the initial judgment results of the doctor and the analysis results of the artificial intelligence-assisted system were recorded, and the reading results of the artificial intelligence-assisted system were fed back to the doctor. Review the doctor's comprehensive analysis results of the artificial intelligence-assisted system, make a final judgment on the chest X-ray results, and determine whether further relevant examinations (such as etiological examination, CT examination, etc.) are needed. Record the doctor's judgment results. Follow up and record the time of diagnosis reported by the tuberculosis specific disease system.

OTHER

Routine doctors analyze the process of chest X-rays

After the chest DR Examination is completed, a regular doctor reviews the films without using an artificial intelligence-assisted system. Once the results of the regular doctor's review are confirmed, a final judgment is made on whether further related examinations (such as etiological tests, CT scans, etc.) are needed, and the doctor's judgment is recorded. Follow up and record the time of diagnosis reported by the tuberculosis specific disease system

Sponsors & Collaborators

• China Medical Board (CMB)

  collaborator UNKNOWN

• Yichang Center for Disease Control and Prevention, China

  collaborator UNKNOWN

• JF Intelligent Healthcare Medical Technology Co

  collaborator UNKNOWN

• Xuelin Yang

  lead OTHER

Principal Investigators

• Wang Ye Prof · chool of Population Medicine and Public Health, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

15 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-09-01

Primary Completion

2027-12-31

Completion

2027-12-31

Countries

• China

Study Locations