TY - JOUR
T1 - Definition of a positive test result in computed tomography screening for lung cancer
T2 - a cohort study
AU - International Early Lung Cancer Action Program Investigators
AU - Henschke, Claudia I
AU - Yip, Rowena
AU - Yankelevitz, David F
AU - Smith, James P
AU - Shaham, Dorith
PY - 2013/2/19
Y1 - 2013/2/19
N2 - BACKGROUND: 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.OBJECTIVE: To assess the frequency of positive results and potential delays in diagnosis in the baseline round of screening by using more restrictive thresholds.DESIGN: Prospective cohort study.SETTING: Multi-institutional International Early Lung Cancer Action Program.PATIENTS: 21 136 participants with baseline computed tomography performed between 2006 and 2010.MEASUREMENTS: 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.RESULTS: 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.LIMITATION: This was a retrospective analysis and thus whether delays in diagnosis would have altered outcomes cannot be determined.CONCLUSION: 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.
AB - BACKGROUND: 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.OBJECTIVE: To assess the frequency of positive results and potential delays in diagnosis in the baseline round of screening by using more restrictive thresholds.DESIGN: Prospective cohort study.SETTING: Multi-institutional International Early Lung Cancer Action Program.PATIENTS: 21 136 participants with baseline computed tomography performed between 2006 and 2010.MEASUREMENTS: 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.RESULTS: 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.LIMITATION: This was a retrospective analysis and thus whether delays in diagnosis would have altered outcomes cannot be determined.CONCLUSION: 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.
KW - Delayed Diagnosis
KW - Humans
KW - Lung Neoplasms/diagnostic imaging
KW - Mass Screening/methods
KW - Radiation Dosage
KW - Retrospective Studies
KW - Tomography, X-Ray Computed/methods
UR - http://www.scopus.com/inward/record.url?scp=84874385423&partnerID=8YFLogxK
U2 - 10.7326/0003-4819-158-4-201302190-00004
DO - 10.7326/0003-4819-158-4-201302190-00004
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C2 - 23420233
SN - 0003-4819
VL - 158
SP - 246
EP - 252
JO - Annals of Internal Medicine
JF - Annals of Internal Medicine
IS - 4
ER -
