Trial Outcomes & Findings for Reader Study to Demonstrate That Use of ClearRead Confirm is Superior to the Use Standard AP/PA X-ray Image (NCT NCT01655329)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

10 participants

Primary outcome timeframe

8 hours

Results posted on

2014-07-10

Participant Flow

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

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.

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Reader Study to Demonstrate That Use of ClearRead Confirm is Superior to the Use Standard AP/PA X-ray Image

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Radiologists n=10 Participants Board Certified Radiologists
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Sex/Gender, Customized female	3 participants n=93 Participants
Sex/Gender, Customized male	7 participants n=93 Participants
Region of Enrollment United States	10 participants n=93 Participants

PRIMARY outcome

Timeframe: 8 hours

Population: Each radiologist interpreted only half (158) chest radiographs. All of the radiographs were interpreted by a combination of the 10 radiologist participants.

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.

Outcome measures

Outcome measures
Measure	Standard Chest Radiographs n=334 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.	Modified Chest Radiographs n=334 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.	Venous Catheters Venous catheters easier to see on modified image	Cardiac Related Wires Cardiac related wires are easier to see on the standard image	Overall Image Quality Overall image quality is superior on the standard image	Image Quality Radioopaque Regions Image quality in the opaque image areas is superior on the confirm image	Confidence on Line Placement The modified image increased my confidence with respect to line placement	Need for Window/Level Manipulation The standard image required less window/level manipulation	Confidence on Tube Placement The confirm image increases my confidence with respect to tube placement.
Time for Completion of Tasks	27.68 seconds Standard Error 3.32 • Interval 21.04 to 34.24	22.90 seconds Standard Error 3.32 • Interval 16.34 to 29.46	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 8 hours

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.

Outcome measures

Outcome measures
Measure	Standard Chest Radiographs n=10 Participants 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.	Modified Chest Radiographs n=10 Participants 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.	Venous Catheters Venous catheters easier to see on modified image	Cardiac Related Wires Cardiac related wires are easier to see on the standard image	Overall Image Quality Overall image quality is superior on the standard image	Image Quality Radioopaque Regions Image quality in the opaque image areas is superior on the confirm image	Confidence on Line Placement The modified image increased my confidence with respect to line placement	Need for Window/Level Manipulation The standard image required less window/level manipulation	Confidence on Tube Placement The confirm image increases my confidence with respect to tube placement.
Accuracy in Detecting the Tips of Tubes, Lines, and Wires. Venous catheters distance in centimeters	3.49 centimeters Standard Error 0.52	3.14 centimeters Standard Error 0.52	—	—	—	—	—	—	—
Accuracy in Detecting the Tips of Tubes, Lines, and Wires. NG tubes distance in centimeters vs experts	3.62 centimeters Standard Error 0.79	3.96 centimeters Standard Error 0.78	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 10 minutes

Population: All 10 radiologist participants participated

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.

Outcome measures

Outcome measures
Measure	Standard Chest Radiographs n=10 Participants 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.	Modified Chest Radiographs n=10 Participants 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.	Venous Catheters n=10 Participants Venous catheters easier to see on modified image	Cardiac Related Wires n=10 Participants Cardiac related wires are easier to see on the standard image	Overall Image Quality n=10 Participants Overall image quality is superior on the standard image	Image Quality Radioopaque Regions n=10 Participants Image quality in the opaque image areas is superior on the confirm image	Confidence on Line Placement n=10 Participants The modified image increased my confidence with respect to line placement	Need for Window/Level Manipulation n=10 Participants The standard image required less window/level manipulation	Confidence on Tube Placement n=10 Participants The confirm image increases my confidence with respect to tube placement.
Likert-Like	3.9 units on a scale Standard Deviation 0.99	2.4 units on a scale Standard Deviation 0.97	4.5 units on a scale Standard Deviation 0.71	2.7 units on a scale Standard Deviation 1.34	2.5 units on a scale Standard Deviation 1.08	2.9 units on a scale Standard Deviation 1.29	4.1 units on a scale Standard Deviation 1.29	1.6 units on a scale Standard Deviation 1.26	4.4 units on a scale Standard Deviation 0.70

Adverse Events

Radiologists

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Matthew T. Freedman

Georgetown University Medical Center

Phone: 4105429680

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60