Validity of Pleural Effusion Detection Software

Study Overview
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Brief Summary
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The Chang Gung Pleural Effusion Detection Software is a medical software that can automatically detect whether there is a pleural effusion in Chest X-Ray. The purpose of this study is to verify whether the Chang Gung Pleural Effusion Detection Software can correctly identify patients with pleural effusion in Chest X-Ray. The results of the software analysis will be used for the performance of the software on the primary and secondary outcomes.

Detailed Description
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This clinical trial is a retrospective study. DICOM images of de-identified Chest X-Ray were collected from 6 hospitals of Chang Gung Memorial Hospital from January 1, 2018 to December 31, 2020. After confirming that the Chest X-Ray that meet the inclusion and exclusion criteria are correct, 282 samples will be sampled for this test, including 141 images with pleural effusion and 141 images without pleural effusion. The image must be in DICOM format. Then, 3 specialists physicians interpret 282 samples whether there were pleural effusion, and the result was the standard of this study (Reference standard). After determining the reference standard of each Chest X-Ray, the 282 samples were input into the Chang Gung Pleural Effusion Detection Software, and analyzed by the primary and secondary outcomes.

Official Title
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A Study to Evaluate Accuracy and Validity of Chang Gung Pleural Effusion Detection Software Compared With Reference by Qualified Physicians

Conditions
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Pleural Effusion

Intervention / Treatment
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* Device: Chang Gung Pleural Effusion Detection Software


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The case were over 20 years old and under 100 years old. DICOM format. Brand model of Canon. DICOM resolution length range (700-3400 pixels), width range (490-3600 pixels). poster-anterior view(PA-view) of chest X-ray Exclusion Criteria: The chest X-ray contains items that affect interpretation, such as chest tubes, endotracheal tubes, and heart rhythm regulators, but does not include patches and circuits used in electrocardiograms. The chest X-ray that are difficult to interpret due to poor image quality.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Software diagnosis<br>Software diagnosis with gold standard of 3 specialist physicians' interpretation. | Device: Chang Gung Pleural Effusion Detection Software<br>* The Chang Gung Pleural Effusion Detection Software is an independent software as a medical device, which inputs digital Chest X-Ray to automatically detect whether there is a pleural effusion. The inferred results output by this software can assist clinicians or professional medical personnel to identify whether a patient has pleural effusion. This product is only used to analyze the digitized Chest X-Ray DICOM of patients over 20 years old and under 100 years old.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity | The rate of test results that correctly indicate the presence. | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specificity | The rate of test results that correctly indicate the absence. | baseline | 
| Area Under the receiver operating characteristic Curve | A graphical plot that illustrates the diagnostic ability of a binary classifier system as its discrimination threshold is varied. | baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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artificial intelligence