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| Name | Class |
|---|---|
| Riverain Medical Group, Miamisburg, OH | UNKNOWN |
| BioStat Solutions, Inc., Mt. Airy, MD | INDUSTRY |
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A new software product takes two chest radiographs, aligns them, and then subtracts one image from the other. The resulting image represents an image showing any differences between them. The study is to determine whether radiologists using this new software perform better with it than when they do not use it.
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| Measure | Description | Time Frame |
|---|---|---|
| Localized Receiver Operating Characteristic (LROC) Comparison | The area under the LROC curve will be compared for the chest radiograph interpretations done without the new software and those done with the new software. Improvement will be demonstrated if the improvement with the new software is statistically significant at the p=<0.05. There were 422 cases in the total study. 20 of these were inserted as "noise" cases, not to be analyzed. Thus there were 402 cases to be analyzed. There were 120 cases with nodules and 282 without a nodule. LROC is a method for measuring the success or failure of a method where there is a tradeoff between the detection of lung nodules that are there (true positives) and the detection that the radiologist considers to be a nodule where no nodule is present (false positive). It yields a single number that done not have a unit of measurement. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and Specificity | Sensitivity and specificity will be measured. If the radiologists using the new software have higher sensitivity, statistically significant at the p=< 0.05, the use of the new software will be considered to have resulted in improvement. A decrease in specificity is expected. | 1 day |
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Inclusion Criteria:
For Radiologists: American Board of Radiology Certification and live within the Baltimore, MD-Washington, DC Metropolitan areas
For chest radiographs, evidence of the presence or absence of lung nodule confirmed by expert panel; adequate image quality
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Exclusion Criteria:
Radiologists who assisted by providing cases for review
For chest radiographs: poor image quality
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Radiologists in community practice of radiology chest radiographs of individuals with or without a lung nodule
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| Name | Affiliation | Role |
|---|---|---|
| Matthew T Freedman, MD, MBA | Georgetown University | Principal Investigator |
| S.-C. Ben Lo, PhD | Georgetown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ISIS Research Center, Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | United States |
discussion of project was done with each participant. Any questions were answered and signed consent was obtained. There were no dropouts of those recruited.
Recruited by email 15 radiologists practicing in the DC Metro area. Used prior subjects and those referred by prior research subjects.
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| ID | Title | Description |
|---|---|---|
| FG000 | Board Certified Radiologists | 15 Board Certified radiologists were recruited from non-University sites. Each served as subject and control is a crossover design |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Radiologists | Board Certified Radiologists working in the Washington, DC, Baltimore region |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Radiologists interpretations without use of tested software |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Localized Receiver Operating Characteristic (LROC) Comparison | The area under the LROC curve will be compared for the chest radiograph interpretations done without the new software and those done with the new software. Improvement will be demonstrated if the improvement with the new software is statistically significant at the p=<0.05. There were 422 cases in the total study. 20 of these were inserted as "noise" cases, not to be analyzed. Thus there were 402 cases to be analyzed. There were 120 cases with nodules and 282 without a nodule. LROC is a method for measuring the success or failure of a method where there is a tradeoff between the detection of lung nodules that are there (true positives) and the detection that the radiologist considers to be a nodule where no nodule is present (false positive). It yields a single number that done not have a unit of measurement. | All participants were included for calculation of A-LROC and Sensitivity-Specificity. All radiographs were interpreted both without and with software assistance | Posted | Mean | Standard Error | unitless | 1 day | responses on radiographs | Participants |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Board Certified Radiologists | 15 Board Certified radiologists were recruited from non-University sites. Each served as subject and control is a crossover design |
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The main limitation is that the experimental format for this study is similar to, but not identical to the clinical pattern of practice in that more data is recorded during the study than would normally be gathered in clinical practice
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matthew T. Freedman, MD | Georgetown University Medical Center | 4105429680 | freedmmt@georgetown.edu |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| False Positive Decisions of Radiologists |
This is a comparison of the radiologists working without and with the software. The false positive rate is the percentage of cases in which the radiologists identified a lesions/location suspected of being cancer at a location where cancer was not present. . A false positive represents a location selected on a chest image without cancer and, also, a mark on a chest image where cancer was present, but a different location, one without cancer, was marked.The radiologists could mark up to five locations on an image and had to provide a confidence rating for each. This analysis is of the single mark with the highest confidence level. |
| 1 day |
| Count of Participants |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Description |
|---|
| OG000 | Board Certified Radiologists Working Without Software | 15 Board Certified radiologists were recruited from non-University sites. Each served as subject and control is a crossover design |
| OG001 | Radiologists Working With Software | Each radiologist serves as own control, working without and with software. This is the arm working with software |
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| Secondary | Sensitivity and Specificity | Sensitivity and specificity will be measured. If the radiologists using the new software have higher sensitivity, statistically significant at the p=< 0.05, the use of the new software will be considered to have resulted in improvement. A decrease in specificity is expected. | Posted | Mean | Standard Error | Percentage of cases | 1 day |
|
|
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| Secondary | False Positive Decisions of Radiologists | This is a comparison of the radiologists working without and with the software. The false positive rate is the percentage of cases in which the radiologists identified a lesions/location suspected of being cancer at a location where cancer was not present. . A false positive represents a location selected on a chest image without cancer and, also, a mark on a chest image where cancer was present, but a different location, one without cancer, was marked.The radiologists could mark up to five locations on an image and had to provide a confidence rating for each. This analysis is of the single mark with the highest confidence level. | Posted | Mean | Standard Error | percentage of marks not on cancers | 1 day |
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| 0 |
| 15 |
| 0 |
| 15 |
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |