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.

INTRODUCTION: Tuberculosis (TB) remains a globally concerning infectious disease, and significant challenges persist in attaining the 2030 targets set by the WHO. With the rapid advancements in computer-aided detection (CAD) technology, CAD-assisted Chest X-Ray (CAD-CXR) has been applied in TB patients triaging, but the practical application value of the CAD-CXR system in real-world primary healthcare settings in China for TB prevention and control has not been fully elucidated. This protocol reports a design of a cluster randomised controlled trial (CRCT), which aims to evaluate the effectiveness and clinical pathway of CAD-CXR in enhancing TB diagnostic yield in primary healthcare settings, thereby contributing to global TB elimination strategies.

METHODS AND ANALYSIS: Scheduled for September 2025, this CRCT will recruit 22 townships in Yichang of Hubei Province, China. These townships will be randomly allocated at a 1:1 ratio to either the CAD-CXR system intervention group or the control group. In the intervention group, healthcare providers will use the CAD-CXR analysis system to assist in TB screening, whereas the control group will rely solely on conventional CXR interpretation by radiologists. The primary outcome of the study is the TB diagnostic yield; the secondary outcomes include diagnostic delay duration and the accuracy of the CAD-CXR system. These metrics will be comprehensively evaluated to assess the effectiveness of the CAD-CXR intervention. Findings from this study are anticipated to offer evidence-based recommendations regarding the optimal application scenarios and implementation pathways for CAD-CXR.

ETHICS AND DISSEMINATION: This study was approved by the Ethics Committee of the Peking Union Medical College (CAMS&PUMC-IEC-2025-044). Findings of this study will be disseminated through traditional academic pathways, including peer-reviewed publications and conference presentations.

TRIAL REGISTRATION NUMBER: NCT06963606.