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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Software diagnosis | Software diagnosis with gold standard of 3 specialist physicians' interpretation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chang Gung Pleural Effusion Detection Software | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity | The rate of test results that correctly indicate the presence. | baseline |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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This is a retrospective study, and the data comes from the Chang Gung Medical Research Database(CGRD) which was an database form 6 hospitals of Chang Gung Memorial hospital. According to inclusion and exclusion criteria, Chest X-ray data from the database during 2018.01.01~2020.12.31 was collected.
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| Name | Affiliation | Role |
|---|---|---|
| Chang-Fu Kuo, MD/Ph.D | Associate Professor and Director Division of Rheumatology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung memorial hospital | Taoyuan City | 333 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36044215 | Background | Ahn JS, Ebrahimian S, McDermott S, Lee S, Naccarato L, Di Capua JF, Wu MY, Zhang EW, Muse V, Miller B, Sabzalipour F, Bizzo BC, Dreyer KJ, Kaviani P, Digumarthy SR, Kalra MK. Association of Artificial Intelligence-Aided Chest Radiograph Interpretation With Reader Performance and Efficiency. JAMA Netw Open. 2022 Aug 1;5(8):e2229289. doi: 10.1001/jamanetworkopen.2022.29289. | |
| 3203523 |
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| ID | Term |
|---|---|
| D010996 | Pleural Effusion |
| ID | Term |
|---|---|
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
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| baseline |
| Background |
| Lachin JM. Properties of simple randomization in clinical trials. Control Clin Trials. 1988 Dec;9(4):312-26. doi: 10.1016/0197-2456(88)90046-3. |
| 21772732 | Background | Suresh K. An overview of randomization techniques: An unbiased assessment of outcome in clinical research. J Hum Reprod Sci. 2011 Jan;4(1):8-11. doi: 10.4103/0974-1208.82352. |
| 30929415 | Background | Lim CY, In J. Randomization in clinical studies. Korean J Anesthesiol. 2019 Jun;72(3):221-232. doi: 10.4097/kja.19049. Epub 2019 Apr 1. |