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The goal of this observational study is to develop and validate artificial intelligence (AI)-driven models for improving the diagnosis of Primary Sjögren's Syndrome (PSS) using routine laboratory test data. The main question it aims to answer is:
Can AI-based algorithms accurately diagnose Primary Sjögren's Syndrome by analyzing laboratory test results, and do they outperform traditional diagnostic criteria in Chinese populations?
Researchers will retrospectively analyze anonymized clinical records and laboratory data (e.g., autoantibody levels, inflammatory markers) from patients with suspected or confirmed PSS across multiple medical centers in China. No new interventions will be administered, as the study utilizes existing historical data to train and validate the AI models. The performance of AI algorithms will be compared with current diagnostic standards (e.g., ACR/EULAR criteria) in terms of sensitivity, specificity, and clinical utility.
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| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic Accuracy of AI Models for Primary Sjögren's Syndrome (pSS) | The primary outcome measure is the comparative diagnostic accuracy of the AI-driven model versus the 2016 ACR/EULAR classification criteria for PSS. Accuracy will be quantified using sensitivity (true positive rate), specificity (true negative rate), and area under the receiver operating characteristic curve (AUC-ROC). The AI model's performance will be validated against a gold-standard clinician diagnosis based on comprehensive clinical, serological, and histological assessments. | Data Collection Period: January 1, 2013, to January 31, 2023 (retrospective analysis of historical records). Model Development and Validation: Completed within 12 months of data aggregation. |
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Inclusion Criteria:
Exclusion Criteria:
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This study includes patients with primary Sjögren's syndrome (pSS; diagnosed via 2016 ACR/EULAR or 2002 ACEG criteria: oral/ocular dryness, anti-SSA/Ro+, or positive biopsy) and controls (non-pSS autoimmune diseases or non-autoimmune sicca symptoms). Eligible participants were newly diagnosed at participating hospitals with complete lab data. Exclusions: pregnancy/breastfeeding, other autoimmune diseases, malignancies, severe infections, or missing lab records. Retrospective data spans multicenter clinical records, ensuring real-world validity.
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| Name | Affiliation | Role |
|---|---|---|
| Xinran Yuan, MD | Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University | Nanjing | Jiangsu | 210008 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41310216 | Derived | Liu S, Wu G, Pan M, Sun Q, Gao C, Long X, Tang C, Yuan X, Sun L. A multi-criterion feature integration framework for accurate diagnosis of Sjogren's disease using routine laboratory tests. NPJ Digit Med. 2025 Nov 27;8(1):729. doi: 10.1038/s41746-025-02110-2. |
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