Background: Low-radiation dose spiral computed tomography (LDCT) currently is being evaluated as a screening modality for lung carcinoma in a randomized trial. Although several diagnostic algorithms for the workup of positive LDCT screens have been proposed, to the authors' knowledge there is no widely accepted standard to date and there are few nationwide data concerning how such diagnostic workups are actually being performed outside a research protocol setting.
Methods: The Lung Screening Study (LSS) was a multicenter feasibility trial that randomized 1660 subjects to undergo LDCT and an equivalent number to undergo chest X-ray. Subjects with positive screens were referred to their own health care providers for diagnostic follow-up; LSS did not specify a diagnostic algorithm. LSS collected and abstracted medical records regarding procedures employed in the diagnostic workup of positive screens.
Results: Of the 522 subjects with a positive LDCT screen at baseline or at Year One, 12% underwent biopsy. Biopsy was less likely to be performed in subjects with 4-9-mm nodules (5%) than in subjects with nodules measuring 10+ mm (25%) or in subjects with no nodules but other suspicious findings (15%). Among 63% of the subjects who underwent chest CT on follow-up, the median time between screening and first follow-up chest CT was 82 days. Only a minority of subjects received diagnostic workups that were consistent with published algorithms.
Conclusions: The data from the current study represent the experience of subjects followed by their health care providers in five different U.S. metropolitan areas and one rural area. As such, they provide some indication of practices in the U.S. with regard to the diagnostic workup of patients with positive spiral CT screens.