Accuracy of soft-copy digital mammography versus that of screen-film mammography according to digital manufacturer: ACRIN DMIST retrospective multireader study.
OBJECTIVE
To retrospectively compare the accuracy for cancer diagnosis of digital mammography with soft-copy interpretation with that of screen-film mammography for each digital equipment manufacturer, by using results of biopsy and follow-up as the reference standard.


METHODS
The primary HIPAA-compliant Digital Mammographic Imaging Screening Trial (DMIST) was approved by the institutional review board of each study site, and informed consent was obtained. The approvals and consent included use of data for future HIPAA-compliant retrospective research. The American College of Radiology Imaging Network DMIST collected screening mammography studies performed by using both digital and screen-film mammography in 49 528 women (mean age, 54.6 years; range, 19-92 years). Digital mammography systems from four manufacturers (Fischer, Fuji, GE, and Hologic) were used. For each digital manufacturer, a cancer-enriched reader set of women screened with both digital and screen-film mammography in DMIST was constructed. Each reader set contained all cancer-containing studies known for each digital manufacturer at the time of reader set selection, together with a subset of negative and benign studies. For each reader set, six or 12 experienced radiologists attended two randomly ordered reading sessions 6 weeks apart. Each radiologist identified suspicious findings and rated suspicion of breast cancer in identified lesions by using a seven-point scale. Results were analyzed according to digital manufacturer by using areas under the receiver operating characteristic curve (AUCs), sensitivity, and specificity for soft-copy digital and screen-film mammography. Results for Hologic digital are not presented owing to the fact that few cancer cases were available. The implemented design provided 80% power to detect average AUC differences of 0.09, 0.08, and 0.06 for Fischer, Fuji, and GE, respectively.


RESULTS
No significant difference in AUC, sensitivity, or specificity was found between Fischer, Fuji, and GE soft-copy digital and screen-film mammography. Large reader variations occurred with each modality.


CONCLUSIONS
No statistically significant differences were found between soft-copy digital and screen-film mammography for Fischer, Fuji, and GE digital mammography equipment.
Hendrick
R Edward
RE
Lynn Sage Comprehensive Breast Ctr and Dept of Radiology, Feinberg School of Medicine, Northwestern Univ, Galter Pavilion, 13th Floor, 251 E Huron St, Chicago, IL 60611, USA. edward.hendrick@gmail.com
Cole
Elodia B
EB
Pisano
Etta D
ED
Acharyya
Suddhasatta
S
Marques
Helga
H
Cohen
Michael A
MA
Jong
Roberta A
RA
Mawdsley
Gordon E
GE
Kanal
Kalpana M
KM
D'Orsi
Carl J
CJ
Rebner
Murray
M
Gatsonis
Constantine
C
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D019540:Area Under Curve; D001943:Breast Neoplasms / Q000000981:diagnostic imaging*; D005260:Female; D006801:Humans; D008327:Mammography / Q000295:instrumentation; D008875:Middle Aged; D015588:Observer Variation; D011856:Radiographic Image Enhancement / Q000295:instrumentation; D012680:Sensitivity and Specificity; D014963:X-Ray Intensifying Screens