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| Name | Class |
|---|---|
| VUNO Inc. | INDUSTRY |
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The goal of this observational study is to learn how well an artificial intelligence (AI)-based chest X-ray analysis software can incidentally detect interstitial lung disease (ILD), which appears as interstitial opacity, on chest X-rays taken for other reasons, and whether these AI-flagged findings represent true interstitial opacity.
The main question it aims to answer is: How often does an AI-flagged interstitial opacity correspond to true ILD?
This retrospective study uses existing records: researchers review each participant's follow-up computed tomography(CT), CT report, and final diagnosis to confirm true ILD and reticular opacity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AI interstitial opacity-positive | Patients whose index chest radiograph was flagged as interstitial opacity-positive by the AI software. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VUNO Med®-Chest X-ray™ | Device | VUNO Med®-Chest X-ray™ is artificial intelligence (AI)-based software that supports the detection and diagnosis of abnormal findings on chest radiographs. It automatically identifies abnormal findings and provides information on their type and location to aid clinical decision-making. |
| Measure | Description | Time Frame |
|---|---|---|
| Positive predictive value (PPV) of AI-detected interstitial opacity | Positive predictive value (PPV) of the AI flag for interstitial opacity is the proportion of AI interstitial-opacity-positive index radiographs confirmed as true positives by the radiologist reference standard (consensus review of the paired follow-up CT, CT report, follow-up diagnoses, and the index radiograph). PPV = true positives / all AI interstitial-opacity-positive cases. | From the index chest radiograph to the reference standard confirmation (the first follow-up CT after the index chest radiograph and/or final clinical diagnosis), up to 3.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of AI finding scores between true-positive and false-positive cases | The AI finding scores (e.g., interstitial opacity, consolidation, nodule, pleural effusion) were compared between interstitial-opacity true-positive and false-positive cases using the Mann-Whitney U test. Scores are summarized as the median (first-third quartile, Q1-Q3). | From the index chest radiograph to the reference standard confirmation (the first follow-up CT after the index chest radiograph and/or final clinical diagnosis), up to 3.5 years |
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Inclusion Criteria:
Exclusion Criteria:
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Adults aged ≥19 years attending the pulmonology and allergy clinics of Chung-Ang University Hospital (Seoul and Gwangmyeong, Republic of Korea) who underwent chest radiography between January 2022 and December 2024.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chung-Ang University Hospital | Seoul | Seoul | 06973 | South Korea |
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|
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011658 | Pulmonary Fibrosis |
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