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The investigators plan to conduct a multicenter, prospective, randomized controlled trial to systematically evaluate the incremental value of pathology-based artificial intelligence (AI) models in a pan-disease diagnostic workflow. The study will primarily compare interpretation using an AI-assisted platform with conventional independent slide reading in terms of diagnostic accuracy (e.g., AUC), reading efficiency (e.g., diagnostic time), diagnostic report quality, diagnostic confidence (Likert scale), and pathologists' satisfaction with the AI model. Investigators will also assess superiority among less experienced (junior) pathologists and non-inferiority among more experienced (senior) pathologists. Successful completion of this project will provide high-level prospective evidence to support standardized deployment, quality control, and broader implementation of pathology AI in clinical practice. This trial may also evaluate the potential benefits and risks of using AI tools in medical research.
In this study, investigators plan to enroll 60 pathologists with varying levels of experience and 2,000 patients requiring pathological diagnosis, with whole-slide images (WSIs) collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AI-assisted group | Experimental | Pathologists in this group are required to use the AI pathology diagnostic model to assist their diagnoses. The AI pathology model will provide a predicted result for each case. |
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| Independent Diagnosis Group (Control Group) | Placebo Comparator | In this group, pathologists will independently diagnose each case based on their own clinical experience, and will record both their time to diagnosis and their diagnostic confidence. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AI model | Other | Doctors in this group are required to use the AI model to assist their diagnoses. The AI pathology model will provide a predicted result for each case. |
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| Measure | Description | Time Frame |
|---|---|---|
| Area under ROC curve (AUC) | Area under the curve | Assessments will be conducted within one week after the pathologists' diagnoses |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic time per case | Time required for the pathologist to complete the diagnosis of each case in the AI-assisted diagnosis group compared with the independent diagnosis group. Diagnostic time is defined as the duration (in minutes/seconds) from initiating case review to finalizing and submitting the diagnostic report in the study system. | Measured immediately after the pathologists' diagnosis |
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Pathologists:
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Patients:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhengyu Zhang | Contact | 13837365993 | zzyusmu@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Li Liang | Nanfang Hospital, Southern Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital Affiliated to AMU SOUTHWEST HOSPITAL | Chongqing | Chongqing Municipality | China |
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| Control | Other | Pathologists will independently diagnose each case based on their own clinical experience, and will record both their time to diagnosis and their diagnostic confidence. |
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| Pathologists' diagnostic confidence | Self-reported diagnostic confidence of pathologists for each case in the AI-assisted diagnosis group compared with the independent diagnosis group. Diagnostic confidence will be rated by the reporting pathologist on a [10]-point Likert scale (e.g., 1 = very uncertain to 10 = very confident) immediately after completing the diagnosis. Higher scores indicate greater diagnostic confidence. | At the time of diagnosis for each case. |
| Nanfang Hospital, Southern Medical University | Guangzhou | Guangdong | China 510515 | China |
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| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | China |
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