Claudia I. Henschke, PhD, MD; Rowena Yip, MPH; David F. Yankelevitz, MD; James P. Smith, MD; for the International Early Lung Cancer Action Program Investigators*
* For a list of members of the International Early Lung Cancer Action Program, see the Appendix.
Grant Support: In part by the Flight Attendant Medical Research Institute, the American Legacy Foundation, Department of Energy (DE-FG02-96SF21260), Israel Cancer Association, The Rogers Family Fund, Yad-Hanadiv Foundation, Jacob and Malka Goldfarb Charitable Foundation, Auen/Berger Foundation, Princess Margaret Foundation, Berger Foundation, Mills Peninsula Hospital Foundation, Columbia University Medical Center, Mount Sinai Medical Center, Weill Medical College of Cornell University, Cornell University, New York Presbyterian Hospital, Swedish Hospital, Christiana Care Helen F. Graham Cancer Center, Holy Cross Hospital, Eisenhower Hospital, Jackson Memorial Hospital Health System, and Evanston Northwestern Healthcare.
Potential Conflicts of Interest: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M11-2154.
Reproducible Research Statement: Study protocol: Available at www.ielcap.org/professionals/docs/ielcap.pdf. Statistical code and data set: Not available.
Requests for Single Reprints: Claudia I. Henschke, PhD, MD, Department of Radiology, Mount Sinai School of Medicine, 1 Gustave L. Levy Place, New York, NY 10029; e-mail, Claudia.Henschke@mountsinai.org.
Current Author Addresses: Drs. Henschke and Yankelevitz: Department of Radiology, Mount Sinai School of Medicine, 1 Gustave L. Levy Place, New York, NY 10029.
Ms. Yip: Early Lung and Cardiac Action Program, Department of Radiology, Mount Sinai Medical Center, 1 Gustave L. Levy Place, Box 1234, New York, NY 10029.
Dr. Smith: Weill Cornell Medical College, 1300 York Avenue, New York, NY 10065.
Author Contributions: Conception and design: C.I. Henschke, J.P. Smith, D. Yankelevitz.
Analysis and interpretation of the data: C.I. Henschke, R. Yip, D.F. Yankelevitz, J.P. Smith.
Drafting of the article: C.I. Henschke, J.P. Smith, D.F. Yankelevitz.
Critical revision of the article for important intellectual content: C.I. Henschke, R. Yip, J.P. Smith, D.F. Yankelevitz.
Final approval of the article: C.I. Henschke, R. Yip, J.P. Smith, D. F. Yankelevitz.
Provision of study materials or patients: C.I. Henschke.
Statistical expertise: C.I. Henschke, R. Yip.
Obtaining of funding: C.I. Henschke, D.F. Yankelevitz.
Administrative, technical, or logistic support: C.I. Henschke.
Collection and assembly of data: C.I. Henschke, R. Yip.
Henschke CI, Yip R, Yankelevitz DF, Smith JP, . Definition of a Positive Test Result in Computed Tomography Screening for Lung Cancer: A Cohort Study. Ann Intern Med. 2013;158:246-252. doi: 10.7326/0003-4819-158-4-201302190-00004
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Published: Ann Intern Med. 2013;158(4):246-252.
Low-dose computed tomography screening for lung cancer can reduce mortality among high-risk persons, but “false-positive” findings may result in unnecessary evaluations with attendant risks. The effect of alternative thresholds for defining a positive result on the rates of positive results and cancer diagnoses is unknown.
To assess the frequency of positive results and potential delays in diagnosis in the baseline round of screening by using more restrictive thresholds.
Prospective cohort study.
Multi-institutional International Early Lung Cancer Action Program.
21 136 participants with baseline computed tomography performed between 2006 and 2010.
The frequency of solid and part-solid pulmonary nodules and the rate of lung cancer diagnosis by using current (5 mm) and more restrictive thresholds of nodule diameter.
The frequency of positive results in the baseline round by using the current definition of positive result (any parenchymal, solid or part-solid, noncalcified nodule ≥5.0 mm) was 16% (3396/21 136). When alternative threshold values of 6.0, 7.0, 8.0 and 9.0 mm were used, the frequencies of positive results were 10.2% (95% CI, 9.8% to 10.6%), 7.1% (CI, 6.7% to 7.4%), 5.1% (CI, 4.8% to 5.4%), and 4.0% (CI, 3.7% to 4.2%), respectively. Use of these alternative definitions would have reduced the work-up by 36%, 56%, 68%, and 75%, respectively. Concomitantly, lung cancer diagnostics would have been delayed by at most 9 months for 0%, 5.0% (CI, 1.1% to 9.0%), 5.9% (CI, 1.7 to 10.1%), and 6.7% (CI, 2.2% to 11.2%) of the cases of cancer, respectively.
This was a retrospective analysis and thus whether delays in diagnosis would have altered outcomes cannot be determined.
These findings suggest that using a threshold of 7 or 8 mm to define positive results in the baseline round of computed tomography screening for lung cancer should be prospectively evaluated to determine whether the benefits of decreasing further work-up outweigh the consequent delay in diagnosis in some patients.
The Flight Attendant Medical Research Institute and the American Legacy Foundation.
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Hematology/Oncology, Pulmonary/Critical Care, Lung Cancer, Cancer Screening/Prevention, Prevention/Screening.
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