Trial Outcomes & Findings for Reader Study of DeltaView™ Chest Radiograph Software (NCT NCT01261507)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

15 participants

Primary outcome timeframe

1 day

Results posted on

2015-12-01

Participant Flow

Recruited by email 15 radiologists practicing in the DC Metro area. Used prior subjects and those referred by prior research subjects.

discussion of project was done with each participant. Any questions were answered and signed consent was obtained. There were no dropouts of those recruited.

Participant milestones

Participant milestones
Measure	Board Certified Radiologists 15 Board Certified radiologists were recruited from non-University sites. Each served as subject and control is a crossover design
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Reader Study of DeltaView™ Chest Radiograph Software

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Radiologists n=15 Participants Board Certified Radiologists working in the Washington, DC, Baltimore region
Age, Categorical >=65 years	0 Participants n=93 Participants
Sex: Female, Male Female	5 Participants n=93 Participants
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=93 Participants
Sex: Female, Male Male	10 Participants n=93 Participants
Region of Enrollment United States	15 participants n=93 Participants

PRIMARY outcome

Timeframe: 1 day

Population: All participants were included for calculation of A-LROC and Sensitivity-Specificity. All radiographs were interpreted both without and with software assistance

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.

Outcome measures

Outcome measures
Measure	Board Certified Radiologists Working Without Software n=402 responses on radiographs 15 Board Certified radiologists were recruited from non-University sites. Each served as subject and control is a crossover design	Radiologists Working With Software n=402 responses on radiographs Each radiologist serves as own control, working without and with software. This is the arm working with software
Localized Receiver Operating Characteristic (LROC) Comparison	0.477 unitless Standard Error 0.037	0.536 unitless Standard Error 0.037

SECONDARY outcome

Timeframe: 1 day

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.

Outcome measures

Outcome measures
Measure	Board Certified Radiologists Working Without Software n=15 Participants 15 Board Certified radiologists were recruited from non-University sites. Each served as subject and control is a crossover design	Radiologists Working With Software n=15 Participants Each radiologist serves as own control, working without and with software. This is the arm working with software
Sensitivity and Specificity Sensitivity: correct detection of cancer	43.8 Percentage of cases Standard Error 0.36 • Interval 0.092 to -0.033	50.1 Percentage of cases Standard Error 0.36 • Interval 0.092 to -0.033
Sensitivity and Specificity Specificity: cancer free cases correctly identifie	94.1 Percentage of cases Standard Error 0.12	92.6 Percentage of cases Standard Error 0.12

SECONDARY outcome

Timeframe: 1 day

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.

Outcome measures

Outcome measures
Measure	Board Certified Radiologists Working Without Software n=15 Participants 15 Board Certified radiologists were recruited from non-University sites. Each served as subject and control is a crossover design	Radiologists Working With Software n=15 Participants Each radiologist serves as own control, working without and with software. This is the arm working with software
False Positive Decisions of Radiologists	9.7 percentage of marks not on cancers Standard Error 1.9	11.2 percentage of marks not on cancers Standard Error 1.9

Adverse Events

Board Certified 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, MD

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: LTE60