Abstract
We conducted a cross-sectional, multicenter study to compare the demographics, clinical characteristics, and lung cancer screening results among individuals eligible for lung cancer screening per 2013 vs 2021 US Preventive Services Task Force recommendations. Statistical tests are 2 sided, with P less than .05 considered statistically significant. Among 17 702 screened individuals (85.2% 2013 eligible, 14.8% 2021 newly eligible), a higher proportion of individuals screened per 2021 vs 2013 criteria were female (56.1% vs 48.1%, P < .001) and non-Hispanic Black (19.3% vs 13.4%, P < .001). The risk of developing and dying from lung cancer per 1000 people was statistically significantly higher among individuals eligible per 2013 vs 2021 criteria. A higher proportion of lung cancer screening exams had an increased suspicion of lung cancer in the 2013 vs 2021 criteria groups. Our data suggest that, as intended, updated 2021 US Preventive Services Task Force recommendations are leading to a higher proportion of lung cancer screening exams among non-Hispanic Black individuals and women.
In 2013, the US Preventive Services Task Force (USPSTF) first recommended annual lung cancer screening with low-dose computed tomography (CT) imaging for individuals aged 55 to 80 years who currently or formerly smoked (quit within 15 years) with at least a 30 pack-year smoking history (1). In April 2021, the USPSTF expanded lung cancer screening eligibility criteria to include individuals aged 50 to 80 years with at least a 20–pack-year smoking history (2). This change was based on a thorough evidence review and Cancer Intervention and Surveillance Monitoring Network modeling study, which found that the most efficient screening strategy started at age 50 years and included a 20 pack-year smoking history compared with prior 2013 eligibility criteria and also resulted in less disparity in screening eligibility by sex, race, and ethnicity (3,4). This change is expected to result in higher relative increases in lung cancer screening eligibility for women vs men as well as for non-Hispanic Black, Asian, and Hispanic populations vs non-Hispanic White populations (3,5,6). Since the 2021 update to the USPSTF lung cancer screening eligibility criteria, there have been limited data on the characteristics of individuals undergoing lung cancer screening and the impact of the updated eligibility criteria on low-dose CT imaging results. Hence, we compared the sociodemographic and clinical characteristics as well as radiologists’ Lung CT Screening Reporting & Data System (Lung-RADS) (7) assessment of baseline and subsequent lung cancer screening examinations using 2013 vs 2021 USPSTF-recommended eligibility criteria.
We included all lung cancer screening exams from January 2015 to September 2023 performed at 14 imaging facilities that participate in the North Carolina Lung Screening Registry. Briefly, the registry is funded by the National Cancer Institute to collect patient, radiologist, lung cancer screening exam, and follow-up data from community and academic imaging sites across North Carolina to evaluate the benefits and harms of lung cancer screening in real-world practice. For this study, we included low-dose CT lung cancer screening exams performed in individuals who currently or formerly smoked (quit within 15 years) and were aged 50 to 80 years with at least a 20–pack-year smoking history. We excluded exams with missing smoking information and those performed in individuals younger than 50 years or older than 80 years of age.
We made 2 sets of comparisons. In the first comparison, we categorized lung cancer screening exams into 2 groups. The first group included exams among individuals eligible according to the 2013 USPSTF criteria, defined as currently smoking or formerly smoking (quit within 15 years), with at least a 30–pack-year history, and aged 55 to 80 years (2013 Eligible). The second group included exams among individuals newly eligible according to the 2021 USPSTF criteria, defined as currently smoking or formerly smoking (quit within 15 years), with a 20– to 29–pack-year history, or who were aged 50 to 54 years and had undergone a lung cancer screening exam between April 1, 2021, and September 2023 (2021 Newly Eligible). In the second comparison, we categorized lung cancer screening into 2 groups that included the entire population screened under 2013 criteria until the introduction of the 2021 criteria on March 31, 2021 (2013 Entire) and the entire population screened under the 2021 criteria from April 1, 2021, onwards (2021 Entire).
For all individuals, we obtained sociodemographic and clinical characteristics from electronic health record systems. For race, “Other” is a designation in the electronic health record system. Using publicly available macro packages, we estimated the probability of developing lung cancer within 5 years if not undergoing screening (Lung Cancer Risk Assessment Tool model) and the probability of dying from lung cancer within 5 years if not undergoing screening (Lung Cancer Death Risk Assessment Tool model) (8). We extracted radiologist-reported Lung-RADS assessments from radiology reports.
We compared sociodemographic and clinical characteristics of individuals screened in each of the 2 groups using χ2 tests. We also compared the Lung-RADS distribution for baseline and subsequent exams between the 2 groups using χ2 tests. Statistical tests were 2 sided, and P less than .05 was considered statistically significant. This study was approved by the University of North Carolina at Chapel Hill institutional review board with a waiver of informed consent.
Among the 17 702 patients screened for lung cancer included in this study, 15 087 (85.2%) occurred among the 2013 Eligible and 2615 (14.8%) occurred among the 2021 Newly Eligible groups, whereas 39.4% occurred among 2013 Entire vs 60.6% among 2021 Entire (Table 1). Compared with the 2013 Eligible group, the 2021 Newly Eligible group had a higher proportion of exams among female participants (56.1% vs 48.1%), non-Hispanic Black individuals (19.3% vs 13.4%), individuals currently smoking (71.0% vs 52.0%), and individuals with a primary care clinician who ordered the lung cancer screening exam (69.2% vs 62.7%). In contrast, compared with the 2013 Eligible group, the 2021 Newly Eligible group had a lower proportion of exams among individuals with chronic obstructive pulmonary disease (43.7% vs 57.2%) and individuals with Medicare insurance (58.6% vs 67.7%). Similar patterns were observed comparing 2013 Entire and 2021 Entire. Most of those who were newly eligible per the 2021 criteria (83%) became eligible because of the reduction in pack-year smoking history. The risk of developing and dying from lung cancer per 1000 people was statistically significantly higher in the 2013 Eligible group vs the 2021 Newly Eligible group (median risk of developing lung cancer = 39.6 [interquartile tange (IQR) = 23.1-67.1] vs 19.0 [IQR=10.2-32.1]; risk of dying from lung cancer = 26.4 [IQR = 14.4-47.1] vs 10.7 [IQR = 5.5-20.1]), with similar results in the 2013 Entire vs 2021 Entire groups.
Table 1.
Comparison of sociodemographic characteristics among 17 702 lung cancer screening examinations per USPSTF using 2013 vs 2021 eligibility criteria
| Sociodemographic and clinical characteristics | Lung cancer screening among individuals eligible per 2013 criteria vs newly eligible per 2021 criteria |
Lung cancer screening among individuals eligible per 2013 criteria and screened through March 31, 2021 (2013 Entire) vs eligible per 2021 criteria and screened after March 31, 2021 (2021 Entire) |
|||||
|---|---|---|---|---|---|---|---|
| 2013 USPSTF Eligible | 2021 USPSTF Newly Eligible | 2013 Entire | 2021 Entire | ||||
| N = 15 087 | N = 2615 | P a | N = 6969 | N = 10 733 | P a | ||
| Age, No. (%), y | |||||||
| 50-54 | 0 | 560 (21.4) | <.001 | 0 | 560 (5.2) | <.001 | |
| 55-64 | 6867 (45.5) | 901 (34.5) | 3181 (45.6) | 4587 (42.7) | |||
| 65-74 | 7064 (46.8) | 984 (37.6) | 3301 (47.4) | 4747 (44.2) | |||
| 75-80 | 1156 (7.7) | 170 (6.5) | 487 (7.0) | 839 (7.8) | |||
| Median (IQR), y | 65 (61-70) | 63 (56-69) | <.001 | 65 (61-70) | 65 (60-70) | <.001 | |
| Sex, No. (%) | |||||||
| Male | 7823 (51.9) | 1147 (43.9) | <.001 | 3634 (52.2) | 5336 (49.7) | .002 | |
| Female | 7261 (48.1) | 1468 (56.1) | 3334 (47.9) | 5395 (50.3) | |||
| Missingb | 3 (0.02) | 0 | 1 (0.01) | 2 (0.02) | |||
| Race and ethnicity, No. (%) | |||||||
| Asian | 50 (0.3) | 17 (0.7) | <.001 | 17 (0.3) | 50 (0.5) | <.001 | |
| Black | 2016 (13.4) | 503 (19.3) | 880 (12.7) | 1639 (15.3) | |||
| Hispanic | 149 (1.0) | 32 (1.2) | 76 (1.1) | 105 (1.0) | |||
| American Indian or Alaska Native | 71 (0.5) | 19 (0.7) | 34 (0.5) | 56 (0.5) | |||
| White | 12 665 (84.2) | 2009 (77.0) | 5893 (85.0) | 8781 (82.0) | |||
| Otherb | 83 (0.6) | 28 (1.1) | 33 (0.5) | 78 (0.7) | |||
| Missingc | 53 (0.4) | 7 (0.3) | 36 (0.5) | 24 (0.2) | |||
| Year of lung cancer screening exam, No. (%) | |||||||
| Jan 2015-Mar 2021 | 6969 (46.2) | 0 | N/A | 6969 (100) | 0 | N/A | |
| Apr 2021-Dec 2023 | 8188 (53.8) | 2615 (100) | 0 | 10 733 (100) | |||
| Chronic obstructive pulmonary disease, No. (%) | |||||||
| Yes | 8320 (57.2) | 1092 (43.7) | <.001 | 4245 (62.0) | 5167 (50.7) | <.001 | |
| No | 6231 (42.8) | 1409 (56.3) | 2605 (38.0) | 5035 (49.4) | |||
| Missingc | 536 (3.6) | 114 (4.4) | 119 (1.7) | 531 (4.9) | |||
| Body mass index, No. (%) | |||||||
| Underweight or normal | 4619 (30.6) | 843 (32.2) | .10 | 2212 (31.7) | 3250 (30.3) | .04 | |
| Overweight or obese | 10 468 (69.4) | 1772 (67.8) | 4757 (68.3) | 7483 (69.7) | |||
| Median (IQR) | 28.3 (24.5-32.8) | 27.9 (24.0-32.3) | .001 | 28.2 (24.4-32.6) | 28.3 (24.4-32.8) | .001 | |
| Smoking pack-years, No. (%) | |||||||
| 20-29 | 0 | 2193 (83.9) | N/A | 0 | 2193 (20.4) | N/A | |
| ≥30 | 15 087 (100) | 422 (16.1) | 6969 (100) | 8540 (79.6) | |||
| Median (IQR) | 45.0 (37.5-59.0) | 24.0 (20.0-26.5) | <.001 | 45 (37.5-60) | 40 (30-51) | <.001 | |
| Smoking status, No. (%) | |||||||
| Current | 7852 (52.0) | 1857 (71.0) | <.001 | 3491 (50.1) | 6218 (57.9) | <.001 | |
| Former | 7235 (48.0) | 758 (29.0) | 3478 (49.9) | 4515 (42.1) | |||
| Time since quit, y | |||||||
| No. | 6787 | 708 | 3279 | 4216 | |||
| Median (IQR) | 4.4 (1.2-8.7) | 2.8 (0.7-6.9) | <.001 | 4.4 (1.2-8.9) | 4.0 (1.2-8.3) | .06 | |
| Insurance source, No. (%) | |||||||
| Private | 3320 (22.7) | 643 (25.9) | <.001 | 1737 (25.9) | 2226 (21.5) | <.001 | |
| Medicare | 9881 (67.7) | 1456 (58.6) | 4542 (67.6) | 6795 (65.6) | |||
| Medicaid | 722 (4.9) | 185 (7.5) | 291 (4.3) | 616 (5.9) | |||
| TRICARE | 123 (0.8) | 25 (1.0) | 64 (1.0) | 84 (0.8) | |||
| Managed care | 457 (3.1) | 143 (5.8) | 59 (0.9) | 541 (5.2) | |||
| Other | 83 (0.6) | 27 (1.1) | 24 (0.4) | 86 (0.8) | |||
| Uninsured (self-pay) | 15 (0.1) | 4 (0.2) | 1 (0.01) | 18 (0.2) | |||
| Missingc | 486 (3.2) | 132 (5.1) | 251 (3.6) | 367 (3.4) | |||
| Type of clinician who ordered lung cancer screening exam, No. (%) | |||||||
| Primary care | 9343 (62.7) | 1804 (69.2) | <.001 | 4024 (58.9) | 7123 (66.8) | <.001 | |
| Specialist (other) | 1071 (7.2) | 239 (9.2) | 539 (7.9) | 771 (7.2) | |||
| Specialist (pulmonologist) | 4472 (30.0) | 565 (21.7) | 2269 (33.2) | 2768 (26.0) | |||
| Urgent care | 5 (0.03) | 1 (0.04) | 3 (0.04) | 3 (0.03) | |||
| Missingc | 196 (1.3) | 6 (0.2) | 134 (1.9) | 68 (0.6) | |||
| Risk of developing lung cancer per 1000 People (Lung Cancer Risk Assessment Tool) | |||||||
| No. | 14 411 | 2585 | <.001 | 6454 | 10 542 | <.001 | |
| Median (IQR) | 39.6 (23.1-67.1) | 19.0 (10.2-32.1) | 43.5 (25.4-73.9) | 31.3 (17.9-54.9) | |||
| Risk of death from lung cancer per 1000 People (Lung Cancer Death Risk Assessment Tool) | |||||||
| No. | 14 411 | 2585 | <.001 | 6454 | 10542 | <.001 | |
| Median (IQR) | 26.4 (14.4-47.1) | 10.7 (5.5-20.1) | 29.4 (16.2-52.3) | 20.0 (10.6-37.3) | |||
P value for comparisons of categorical variables is for χ2 test and for comparisons of median is for Wilcoxon test. Where applicable, the Fisher exact test was performed; IQR = interquartile range; N/A = not applicable as these definitions are part of the new eligibility criteria; USPSTF = US Preventive Services Task Force.
“Other” is a designation in the patient’s electronic health record.
Missing and not reported are excluded from column percentage for known values.
Radiologists’ interpretation of the lung cancer screening exam per Lung-RADS scores indicated a higher proportion of exams with an increased suspicion for lung cancer in the 2013 Eligible vs 2021 Newly Eligible groups (Table 2). For example, on baseline lung cancer screening exams, radiologists reported Lung-RADS 3 (probably benign with 1%-2% likelihood of malignancy) among 8.4% of 2013 Eligible vs 7.6% of 2021 Newly Eligible individuals, Lung-RADS 4A (suspicious, with 5%-15% likelihood of malignancy) among 4.5% of 2013 Eligible vs 3.9% of 2021 Newly Eligible individuals, and Lung-RADS 4B or 4X (suspicious, with >15% likelihood of malignancy) among 3.2% of 2013 Eligible vs 2.5% of 2021 Newly Eligible individuals. A similar pattern was observed for subsequent lung cancer screening exams and in comparing the 2013 Entire and 2021 Entire groups.
Table 2.
Comparison of extracted Lung-RADS distribution among lung cancer screening exams based on USPSTF 2013 vs 2021 eligibility criteria, stratified by baseline and subsequent screening exams
| American College of Radiology Lung-RADS Assessment | Probability of malignancy, % | Lung cancer screening among individuals eligible per 2013 criteria vs newly eligible per 2021 criteria |
Lung cancer screening among individuals eligible per 2013 criteria and screened through March 31, 2021 (2013 Entire) vs eligible per 2021 criteria and screened after March 31, 2021 (2021 Entire) |
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|---|---|---|---|---|---|---|---|
| 2013 USPSTF Eligible, No. (%) | 2021 USPSTF Newly Eligible, No. (%) | P | 2013 Entire, No. (%) | 2021 Entire, No. (%) | P | ||
| Baseline lung cancer screening exam, No. | 8584 | 1693 | .002 | 4246 | 6031 | <.001 | |
| 0 (Incomplete) | N/A | 31 (0.4) | 13 (0.8) | 4 (0.1) | 40 (0.7) | ||
| 1 (Negative) | <1 | 2861 (33.5) | 560 (33.3) | 1587 (37.5) | 1834 (30.6) | ||
| 2 (Benign appearance or behavior) | <1 | 4277 (50.1) | 873 (52.0) | 1913 (45.2) | 3237 (54.0) | ||
| 3 (Probably benign) | 1-2 | 721 (8.4) | 127 (7.6) | 391 (9.2) | 457 (7.6) | ||
| 4A (Suspicious) | 5-15 | 382 (4.5) | 65 (3.9) | 196 (4.6) | 251 (4.2) | ||
| 4B or 4X (Highly suspicious) | >15 | 274 (3.2) | 42 (2.5) | 139 (3.3) | 177 (3.0) | ||
| Missing and not reporteda | N/A | 38 (0.4) | 13 (0.8) | 16 (0.4) | 35 (0.6) | ||
| Subsequent lung cancer screening exams, No. | 6503 | 922 | <.0001 | 2723 | 4702 | .001 | |
| 0 (Incomplete) | N/A | 21 (0.3) | 9 (1.0) | 2 (0.07) | 28 (0.6) | ||
| 1 (Negative) | <1 | 1805 (27.8) | 312 (33.8) | 821 (30.2) | 1296 (27.7) | ||
| 2 (Benign appearance or behavior) | <1 | 3985 (61.3) | 533 (57.8) | 1612 (59.4) | 2906 (62.1) | ||
| 3 (Probably benign) | 1-2 | 314 (4.8) | 29 (3.2) | 138 (5.1) | 205 (4.4) | ||
| 4A (Suspicious) | 5-15 | 216 (3.3) | 22 (2.4) | 95 (3.5) | 143 (3.1) | ||
| 4B or 4X (Highly suspicious) | >15 | 138 (2.1) | 11 (1.2) | 47 (1.7) | 102 (2.2) | ||
| Missing and not reporteda | N/A | 24 (0.4) | 6 (0.7) | 8 (0.3) | 22 (0.5) | ||
Missing and not reported are excluded from column percentage for known values. Lung-RADS = Lung CT Screening Reporting & Data System; USPSTF = US Preventive Services Task Force.
Since the USPSTF recommendations were updated to include individuals aged 50 to 54 years and people with a 20– to 29–pack-year smoking history in 2021, we found that a statistically significantly higher proportion of individuals screened were female vs male and non-Hispanic Black vs non-Hispanic White. The underlying risk of developing and dying from lung cancer was noticeably lower in people newly eligible under the 2021 criteria compared with individuals eligible under the 2013 criteria. This difference in risk can be attributed to several factors, including the younger age group, lower prevalence of chronic obstructive pulmonary disease, and a decreased cumulative smoking exposure measured in pack-years among the 2021 Eligible cohort. Further analysis of our findings highlighted higher Lung-RADS scores for individuals who met the 2013 eligibility criteria than for those who met the 2021 criteria. This finding aligns with our broader observation of an elevated risk of both developing and dying from lung cancer within the 2013 Eligible group.
Some of our findings are similar to a study of 815 individuals screened for lung cancer at an urban academic medical center in 2021 that found that individuals eligible according to the 2021 vs 2013 USPSTF criteria were more likely to be Black (54% vs 40%) or currently smoking (65% vs 55%) but were less likely to have chronic obstructive pulmonary disease (26% vs 41%) and had lower modified Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial lung cancer risk (3.27 vs 6.64) (9). In contrast to this prior study, we found a higher proportion of females screened under 2021 criteria vs 2013 criteria as well as differences in the radiologists’ assessments. Our study population was derived from 14 screening locations and included both academic and community sites, which accounts for some of the observed differences.
Our study has several limitations. Our study population is from North Carolina and thus may not be generalizable to the entire United States. Given the use of recent data, we do not have cancer follow-up information, but this gap will be addressed in future studies. It is possible that other factors may influence the observed changes in lung cancer screening patterns. Although Medicaid expansion in North Carolina did not occur until December 1, 2023, programs to increase access to health care in general and lung cancer screening specifically may have affected our study findings.
Updates to the 2021 USPSTF lung cancer screening eligibility criteria were in part aimed at increasing uptake in racial and ethnic minority populations and in women because of variability in the underlying risk of developing lung cancer based on lower smoking intensity. Our data suggest that updated 2021 USPSTF recommendations, as intended, are leading to a higher proportion of lung cancer screening exams being performed among non-Hispanic Black individuals and women. In addition, our data indicate that the newly eligible population is at lower risk of developing or dying from lung cancer, which may influence the net benefits of screening. Future research to evaluate the impact of the updated 2021 USPSTF criteria on lung cancer outcomes is needed.
Acknowledgements
We thank the North Carolina Lung Screening Registry sites and patients for their data contributions. The funding sources played no role in the design of the study; the collection, analysis, and interpretation of the data; the writing of the manuscript; or the decision to submit the manuscript for publication.
Contributor Information
Louise M Henderson, Department of Radiology, University of North Carolina, Chapel Hill, NC, USA; Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA.
Danielle D Durham, Department of Radiology, University of North Carolina, Chapel Hill, NC, USA.
James Gruden, Department of Radiology, University of North Carolina, Chapel Hill, NC, USA.
Michael Pritchard, Department of Radiology, University of North Carolina, Chapel Hill, NC, USA.
Lindsay Lane, Department of Radiology, University of North Carolina, Chapel Hill, NC, USA.
Jason Long, Department of Surgery, University of North Carolina, Chapel Hill, NC, USA.
Christina Bellinger, Department of Internal Medicine, Section on Pulmonary, Critical Care, Allergy and Immunology Diseases, Winston-Salem, NC, USA.
M Patricia Rivera, Department of Medicine, Division of Pulmonary and Critical Care Medicine, University of Rochester Medical Center, Rochester, NY, USA; Wilmot Cancer Institute, University of Rochester, Rochester, NY, USA.
Data availability
The data underlying this article cannot be shared due to prohibition against disclosures in existing data use agreements. Summary-level data will be shared on request to the corresponding author if permission is granted by parties who have signed data use agreements.
Author contributions
Louise M. Henderson, PhD (Conceptualization; Funding acquisition; Investigation; Methodology; Project administration; Supervision; Validation; Visualization; Writing—original draft; Writing—review & editing); Danielle Durham, PhD (Data curation; Formal analysis; Software; Supervision; Validation; Visualization; Writing—review & editing); James Gruden, MD (Writing—review & editing); Michael Pritchard, BS (Data curation; Software; Validation; Visualization; Writing—review & editing); Lindsay Lane, MPH (Project administration; Resources; Supervision; Writing—review & editing); Jason Long, MD, MPH (Writing—review & editing); Christina Bellinger, MD (Writing—review & editing); M. Patricia Rivera, MD (Conceptualization; Funding acquisition; Writing—original draft; Writing—review & editing).
Funding
This work was supported by the National Cancer Institute of the National Institutes of Health (R01CA212014 and R01CA251686) and the National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (UL1TR002489). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Conflicts of interest
The authors declare no conflict of interest.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
The data underlying this article cannot be shared due to prohibition against disclosures in existing data use agreements. Summary-level data will be shared on request to the corresponding author if permission is granted by parties who have signed data use agreements.