Paul F. Pinsky, PhD; David S. Gierada, MD; William Black, MD; Reginald Munden, MD; Hrudaya Nath, MD; Denise Aberle, MD; Ella Kazerooni, MD
Grant Support: The NLST was supported by the following grants and contracts: U01-CA-80098, U01-CA-79778, N01-CN-25522, N01-CN-25511, N01-CN-25512, N01-CN-25513, N01-CN-25514, N01-CN-25515, N01-CN-25516, N01-CN-25518, N01-CN-25524, N01-CN-75022, N01-CN-25476, and N02-CN-63300.
Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M14-2108.
Reproducible Research Statement:Study protocol and statistical code: Available from Dr. Pinsky (e-mail, firstname.lastname@example.org). Data set: Available at https://biometry.nci.nih.gov/cdas.
Requests for Single Reprints: Paul F. Pinsky, PhD, National Cancer Institute, 9609 Medical Center Drive, Room 5E108, Bethesda, MD, 20892; e-mail, email@example.com.
Current Author Addresses: Dr. Pinsky: National Cancer Institute, 9609 Medical Center Drive, Room 5E108, Bethesda, MD 20892.
Dr. Gierada: Washington University School of Medicine, 510 South Kingshighway Boulevard, St. Louis, MO 63110.
Dr. Black: Department of Radiology, Geisel School of Medicine at Dartmouth, 1 Rope Ferry Road, Hanover, NH 03755.
Dr. Munden: 6565 Fannin Street, Houston, TX 77030.
Dr. Nath: University of Alabama at Birmingham School of Medicine, 1720 2nd Avenue South, Birmingham, AL 35294.
Dr. Aberle: Department of Radiologic Sciences, David Geffen School of Medicine at University of California, Los Angeles, 924 Westwood Boulevard, Los Angeles, CA 90024.
Dr. Kazerooni: Department of Radiology, University of Michigan, 1500 East Medical Center Drive, Ann Arbor, MI 48109.
Author Contributions: Conception and design: P.F. Pinsky, W. Black, R. Munden, D. Aberle, E. Kazerooni.
Analysis and interpretation of the data: P.F. Pinsky, D.S. Gierada, W. Black, R. Munden, H. Nath, E. Kazerooni.
Drafting of the article: P.F. Pinsky, H. Nath.
Critical revision of the article for important intellectual content: P.F. Pinsky, D.S. Gierada, W. Black, R. Munden, H. Nath, D. Aberle, E. Kazerooni.
Final approval of the article: P.F. Pinsky, D.S. Gierada, W. Black, R. Munden, H. Nath, D. Aberle, E. Kazerooni.
Provision of study materials or patients: R. Munden, D. Aberle, E. Kazerooni.
Statistical expertise: P.F. Pinsky.Collection and assembly of data: R. Munden, E. Kazerooni.
Pinsky PF, Gierada DS, Black W, Munden R, Nath H, Aberle D, et al. Performance of Lung-RADS in the National Lung Screening Trial: A Retrospective Assessment. Ann Intern Med. 2015;162:485-491. doi: 10.7326/M14-2086
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Published: Ann Intern Med. 2015;162(7):485-491.
Lung cancer screening with low-dose computed tomography (LDCT) has been recommended, based primarily on the results of the NLST (National Lung Screening Trial). The American College of Radiology recently released Lung-RADS, a classification system for LDCT lung cancer screening.
To retrospectively apply the Lung-RADS criteria to the NLST.
Secondary analysis of a group from a randomized trial.
33 U.S. screening centers.
Participants were randomly assigned to the LDCT group of the NLST, were aged 55 to 74 years, had at least a 30–pack-year history of smoking, and were current smokers or had quit within the past 15 years.
3 annual LDCT lung cancer screenings.
Lung-RADS classifications for LDCT screenings. Lung-RADS categories 1 to 2 constitute negative screening results, and categories 3 to 4 constitute positive results.
Of 26 722 LDCT group participants, 26 455 received a baseline screening; 48 671 screenings were done after baseline. At baseline, the false-positive result rate (1 minus the specificity rate) for Lung-RADS was 12.8% (95% CI, 12.4% to 13.2%) versus 26.6% (CI, 26.1% to 27.1%) for the NLST; after baseline, the false-positive result rate was 5.3% (CI, 5.1% to 5.5%) for Lung-RADS versus 21.8% (CI, 21.4% to 22.2%) for the NLST. Baseline sensitivity was 84.9% (CI, 80.8% to 89.0%) for Lung-RADS versus 93.5% (CI, 90.7% to 96.3%) for the NLST, and sensitivity after baseline was 78.6% (CI, 74.6% to 82.6%) for Lung-RADS versus 93.8% (CI, 91.4% to 96.1%) for the NLST.
Lung-RADS criteria were applied retrospectively.
Lung-RADS may substantially reduce the false-positive result rate; however, sensitivity is also decreased. The effect of using Lung-RADS criteria in clinical practice must be carefully studied.
National Institutes of Health.
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