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.
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.
Paul F. Pinsky, David S. Gierada, William Black, Reginald Munden, Hrudaya Nath, Denise Aberle, 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.
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