Film-screen versus digitized mammography: assessment of clinical equivalence.

OBJECTIVE: The purpose of this study was to determine whether diagnostic accuracy and callback rates using digitized film images are equivalent to those using film-screen mammograms. MATERIALS AND METHODS: Sixty sets of mammograms (four views per case) were digitized at a spatial resolution of 100 microm. The images were reviewed by seven mammographers. Five regions were evaluated in each breast. Each region was scored on a scale of 0 100% for suspicion of malignancy, and a receiver operating characteristic analysis was performed. Callback rates were calculated using a published lexicon scale. RESULTS: The observers' mean diagnostic accuracies using films and digitized images were 0.872 and 0.848, respectively. The upper 95% confidence boundary on the difference in accuracy was 0.066. The mean callback rate for normal, benign, and malignant areas using films versus digitized images was 0.048 versus 0.055, 0.498 versus 0.441, and 0.786 versus 0.737, respectively. The upper 95% confidence boundary for the absolute difference in callback rates was 0.037, 0.026, and 0.130 for normal, benign, and malignant areas, respectively. CONCLUSION: The diagnostic accuracies of the digitized images and films were similar; however, an increase in callback rates of 0.037 (i.e., upper 95% confidence boundary) for normal results and a reduction in the callback rates of 0.130 for malignant lesions is important. The use of digitized film images, at a spatial resolution of 100 microm, may compromise patient treatment in clinical practice.