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| Name | Class |
|---|---|
| Riverain Technologies | INDUSTRY |
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This is a study to determine whether or not a new type of software is, or is not, of benefit. The software, ClearRead Confirm, is designed to enhance the ability of radiologists to detect tubes, lines and wires that may be placed within a patients chest. These types of devices are commonly used for very sick patients in intensive care units and are also used following surgery and in the treatment of cancer. This study will test radiologist's detection of the tips of these devices comparing the results with standard chest radiographs and the the modified chest radiographs. The primary interest is in the time used to interpret the radiograph. We will determine if there is any change in accuracy of detection.
Primary hypothesis: the amount of time used for the interpretation of these radiographs will not change. (null hypothesis)
Secondary hypothesis: there will be no change in the accuracy of the detection of the tips of venous catheters and tubes transiting the esophagus. (null hypothesis)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard chest radiographs | The radiologists will be viewing two groups of chest images. The first group are standard chest radiographs. | ||
| Modified chest radiographs | This group of chest radiographs will be presented with the modified image. The modified image is intended to increase the visibility of tubes, lines and wires on chest radiographs |
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| Measure | Description | Time Frame |
|---|---|---|
| Time for Completion of Tasks | Time for completion of tasks of identifying the tips of tubes, lines, and wires. Outlying values are excluded from the calculation of the mean values and standard errors. Outlying values were defined as those more than three standard deviations from the mean time. | 8 hours |
| Accuracy in Detecting the Tips of Tubes, Lines, and Wires. | Measurement of accuracy in determining the location of the tips of nasogastric tubes (NG) (various types of nasogastric tubes combined) and of the tips of venous catheters (various types of venous catheters combined), compared to the determination of the expert panel. Measure is the distance from the median location determined by five experts in chest radiology. | 8 hours |
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| Measure | Description | Time Frame |
|---|---|---|
| Likert-Like | Following the viewing of the test radiographs, the radiologists were asked a series of questions of overall preference. On this scale, 1 indicates strong disagreement, 5 indicates strongly agree. Ten statements were used. Note that a low value for the standard image is equivalent to a high value for the modified image. | 10 minutes |
Inclusion Criteria:
Exclusion Criteria:
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There are two populations: the radiologists and the cases they will review. For cases, these are sequential cases selected by database search using defined search criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Matthew T Freedman, MD, MBA | Georgetown University | Principal Investigator |
| Shih-Chung Ben Lo, Ph.D. | Georgetown University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgetown University Medical Center, Suite 603, 2115 Wisconsin Ave | Washington D.C. | District of Columbia | 20007 | United States |
54 cases were used to train the radiologists on the use of the data recording computer and to make them familiar with the appearance of the processed chest radiographs. These cases were not used in the test of reader performance.
Ten Board Certified radiologists practicing in community (non-university) practice were recruited from the Washington, DC, - Baltimore, MD, Metropolitan region. Recruitment was by email and phone calls to prior participants in our studies and to other radiologists that they referred us to. Recruitment April, 2012 through September, 2012
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| ID | Title | Description |
|---|---|---|
| FG000 | Chest Radiographs | The radiologists will be viewing two groups of chest images. The first group are standard chest radiographs. The second group are the processed images. These radiographs were randomly placed into two groups. The radiologists were randomly placed in two groups. Each of these two groups interpreted half of the standard chest radiograph without processing and half with the special processing. The other group of radiologists interpreted the other half of the normal and the other half of the processed images. The radiologists reviewed each radiograph using one or the alternate presentation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Board Certified Radiologists
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| ID | Title | Description |
|---|---|---|
| BG000 | Radiologists | Board Certified Radiologists |
| Units | Counts |
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| 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 | Count of Participants |
| 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 | Time for Completion of Tasks | Time for completion of tasks of identifying the tips of tubes, lines, and wires. Outlying values are excluded from the calculation of the mean values and standard errors. Outlying values were defined as those more than three standard deviations from the mean time. | Each radiologist interpreted only half (158) chest radiographs. All of the radiographs were interpreted by a combination of the 10 radiologist participants. | Posted | Mean | Standard Error | seconds | 8 hours | chest radiographs | Participants |
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Injuries to radiologists during study. No systematic assessment was made of injuries to the radiologists.
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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 | Radiologists |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matthew T. Freedman | Georgetown University Medical Center | 4105429680 | MTFreedman@verizon.net |
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| Participants |
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| Sex/Gender, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Modified Chest Radiographs | This group of chest radiographs will be presented with the modified image. The modified image is intended to increase the visibility of tubes, lines and wires on chest radiographs. Each radiologist interpreted half the images as conventional images and half as processed images. |
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| Primary | Accuracy in Detecting the Tips of Tubes, Lines, and Wires. | Measurement of accuracy in determining the location of the tips of nasogastric tubes (NG) (various types of nasogastric tubes combined) and of the tips of venous catheters (various types of venous catheters combined), compared to the determination of the expert panel. Measure is the distance from the median location determined by five experts in chest radiology. | Posted | Mean | Standard Error | centimeters | 8 hours |
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| Other Pre-specified | Likert-Like | Following the viewing of the test radiographs, the radiologists were asked a series of questions of overall preference. On this scale, 1 indicates strong disagreement, 5 indicates strongly agree. Ten statements were used. Note that a low value for the standard image is equivalent to a high value for the modified image. | All 10 radiologist participants participated | Posted | Mean | Standard Deviation | units on a scale | 10 minutes |
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