Abstract
Background
The lung cancer screening program at St Elizabeth Healthcare (Kentucky, USA) began in 2013. Over 33,000 low-dose computed tomography lung cancer screens have been performed. From 2015 through 2021, 2595 lung cancers were diagnosed systemwide. A Screening Program with Impactful Results from Early Detection, reviews that experience; 342 (13.2%) were diagnosed by screening and 2253 (86.8%) were non-screened. As a secondary objective, the non-screened cohort was queried to determine how many additional individuals could have been screened, identifying barriers and failures to meet eligibility.
Methods
Our QlikSense database extracted the lung cancer patients from the Cancer Patient Data and Management System, and identified and categorized them separately as screened or non-screened populations. Stage distribution was compared in screened and non-screened groups. Those meeting age criteria, with any smoking history, were further queried for screening eligibility, accessing the electronic medical record smoking history and audit trail, and determining if enough information was available to substantiate screening eligibility. The same methodology was applied to CMS 2015 and USPSTF 2021 criteria.
Results
The screened and non-screened patients were accounted for in a stage migration chart demonstrating clear shift to early stage among screened lung cancer patients. Additionally, analysis of non-screened individuals is presented.
Conclusion
Of the St Elizabeth Healthcare eligible patients attributed to primary care providers, 49.6% were screened in 2021. Despite this level of success, this study highlighted a sizeable pool of additional individuals that could have been screened. We are shifting focus to the non-screened pool of patients that meet eligibility, further enhancing the impact on our community.
Keywords
Introduction
The United States National Lung Screening Trial (NLST) demonstrated that lung cancer mortality can be reduced significantly using low-dose computed tomography (LDCT) screening as compared to chest X-ray in at-risk patients (aged 55–74, ≥ 30 pack-year smoking history, in currently smoking persons, or who have quit within the last 15 years). 1 These favorable results have been corroborated by similar relatively large prospective lung cancer screening (LCS) trials including the NELSON and MILD trials.2,3 Similar favorable data supporting LCS have been confirmed in other community-based reports.4,5 However, there is still low acceptance of LCS among providers and patients, with uptake of 5.7%–6.5% among patients who meet eligibility criteria.6–8
The relatively high prevalence of pulmonary nodules in the US general population, the fact that >95% of all pulmonary nodules are benign, and the fear that many patients with lung nodules might be subjected to excess tests and procedures with attendant morbidities, mortalities, and costs, have been major and legitimate concerns impeding the broader adoption of LCS.9,10 This is of particular concern in regions of the country with endemic histoplasmosis and coccidiomycosis as these fungi are, especially when small and in early evolution, associated with benign noncalcified nodules that can mimic primary lung cancer. 11 Kentucky consistently has the highest incidence and mortality of lung cancer in the US, as well as a high prevalence of histoplasmosis.12,13
As reported here, the aim of A Screening Program with Impactful Results from Early Detection (ASPIRED) was to review the LCS program (LCSP) at St Elizabeth Healthcare (SEHC) in the US state of Kentucky. Included are the steps we have taken to engineer a programmatic approach to manage pulmonary nodules, including our nodule review board (NRB) which reviews all Lung-RADS® category 4 nodules from our LCSP (see Appendix A, online supplemental material, for description of Lung-RADS v1.0), as well as the suspicious nodules that present through incidental and symptomatic channels. Our expectation is that our data and experience demonstrate that a well-coordinated, team-based, community hospital LCS program can safely and effectively reproduce the favorable results of the NLST. A secondary objective of ASPIRED was to evaluate the cohort of non-screened individuals to ascertain missed opportunities for patients who may have been screened with the existing electronic medical record (EMR) data, or query of the substance use audit trail, identifying individuals who may have met criteria had the smoking history been kept up properly, or had not been inadvertently changed. We did this for both Centers for Medicare & Medicaid Services (CMS) 2015 and the United States Preventive Services Task Force (USPSTF) 2021 criteria. Furthermore, we analyzed the non-screened individuals with lung cancer who did not meet USPSTF 2021 criteria, inclusive of before and after audits, and present the distribution of those individuals, relative to age, pack-years of smoking, and years since quitting smoking.
The US President's Cancer Panel and Moonshot initiative have placed an emphasis on increasing cancer screening uptake and closing the gaps in cancer screening, access, and follow-up care. Improving LCS rates in a manner more consistent with the trajectory patterns and penetrance of breast, cervical, and colon cancer screenings will contribute more favorably. 14 In an effort to promote this initiative, the National Lung Cancer Round Table hosted the inaugural Accelerating Uptake of LCS conference and workgroup (July 19–20, 2022). In Kentucky, late-stage lung cancer was stable from 2009 to 2014 but has shown an unprecedented drop of 19% in the 2014–2019 interval, twice the rate of decline in the United States. 15
Patients and methods
Patient data and setting
This retrospective analysis was under the approval of the SEHC Institutional Review Board; informed consent was not required as there was no research on human subjects in this retrospective review. Relevant data on patients who underwent LCS in the study period were collected from the EMR (EpicTM) and housed in a separate database. The study cohort includes all patients entering the LCS program for their baseline LDCT scan, from 1/1/15 to 12/31/21. Data from our LCSP was concurrently reported to the American College of Radiology (ACR) Registry.
During the study period, 20,564 lung cancer screens were performed on 10,916 unique patients. During this interval, the LCSP identified 342 lung cancers (3.1%). In the non-screened series, 2253 lung cancers were identified including cases of both symptomatic presentation and incidental discovery; these lung cancers were sourced through the Cancer Patient Data and Management System, as submitted to the Kentucky Cancer Registry.
SEHC, centered in Edgewood, Kentucky, is comprised of six hospitals with 1191 licensed hospital beds, multiple facilities, and two imaging centers. The affiliated provider group, St Elizabeth Physicians (SEPs), is comprised of 750 healthcare providers, including 188 primary care physicians, with 41 specialty and service lines, serving over 400,000 patients. Pertinent to the LCS program, SEHC employs 11 pulmonologists, 11 medical oncologists with 4 advanced practice registered nurses (APRNs), 4 radiation oncologists with 2 APRNs, 3 thoracic surgeons with 2 Certified Physician Assistants, and 10 pathologists. A private practice group of 33 board-certified radiologists (Radiology Associates of Northern Kentucky), a long-term partner with SEHC, supplied interpretations of all imaging. The radiologists and imaging sites meet the accreditation standards of the ACR and GO2 for Lung Cancer.
Lung cancer screening program
The SEHC LCSP began in 2013, pioneered by a radiologist, pulmonologist, and a part-time nurse navigator. Very few screens (n = 128) were done in the first 2 years, 2013–2014, and records were suboptimal; therefore, this early experience is excluded from our review. Entry criteria were initially as per NLST enrollment. In 2015, program eligibility was in accordance with CMS criteria (55–77 YO, ≥ 30 pack-year smoking history, and smoked within the last 15 years). Baseline LCS was ordered after a face-to-face shared-decision-making (SDM) encounter by the ordering provider, as per CMS guidelines; annual or follow-up screens were ordered by a physician or advanced practice provider, with SDM as an option. If insurance did not cover the exam, a technical/professional fee of $100 was charged.
Scan technique
A variety of computed tomographic (CT) scanners were utilized, including Toshiba (now Cannon Medical) 16, 40, and 64 slice, GE Medical 64 slice, Siemens Edge 128 slice, and Siemens Force 2 × 192 slice, used in single energy mode. GE scanners were obtained through acquisition of new facilities; our strategic vendor partner transitioned from Toshiba to Siemens in 2015. Iterative reconstruction was used, when available in 2013, and is currently used for all LDCTs. Standardized CT protocols were taken from NCCN Guidelines V1 2012, as well as the NLST, and verified with product specialists for Toshiba and Siemens. Target dose was less than 1.5 mSv and CT dose index vol. was less than 3.0 for patients with body mass index less than 30. All imaging sites, including the 11 CT scanners in this study, are ACR accredited.
Reporting
The initial screening program predated the ACR Lung-RADS system and utilized the Lahey Clinic Lung-RADS system. Follow-up recommendations were made per the American College of Chest Physicians Diagnosis and Management, third edition. 16 Nodules > 4–6 mm were followed at 12 months. A baseline nodule of ≥ 8 mm, or a growing nodule that was initially 5 mm or larger, was scored as suspicious and referred to a nodule clinic managed by pulmonologists prior to the creation of the NRB (see below). ACR Lung-RADS v1.0 replaced the original reporting system, and its use began in 2015. Since the program’s inception, comparison with prior exams was done when available. We adopted a ≥ 8 mm threshold for Lung-RADS category 4 nodules in 2015, as per ACR guidelines. After the formation of the NRB in July 2017, non-LCS radiology reports that detected incidental or symptomatic nodules ≥ 8 mm or masses were tagged “code lung management,” an annotation that directed reports to the LCS nurse navigator, who would queue them for presentation to the NRB.
All Lung-RADS category 4A, 4B, and 4X nodules were directed in like and designated low, intermediate, or high suspicion, with disposition conveyed to the ordering provider and patient by the nurse navigator.
Follow-up protocol and NRB
Patients with a normal or low-suspicion LDCT scan (Lung-RADS category 1 or 2) were sent letters notifying them of their results with a recommendation to continue with annual LDCT screening. All patients with a Lung-RADS category 3 result were sent a results letter and contacted via telephone by an LCS nurse navigator to review results and schedule short-interval follow-up CT scan. Patients with any incidental finding, with an S modifier, were also contacted via telephone by the nurse navigator.
The NRB, comprised of a radiologist, pulmonologist, thoracic surgeon, and nurse navigator(s), met weekly to collaborate and review all LCS-detected Lung-RADS category 4 nodules as well as incidental or symptomatic nodules ≥ 8 mm detected in the preceding week. The NRB made recommendations for either ongoing surveillance with follow-up imaging (in 3, 6, or 12 months), a referral to pulmonary, thoracic surgery, or medical oncology clinics, or recommendation to continue ongoing care by the present specialist. A subset of patients were referred to a multidisciplinary clinic comprised of pulmonary and thoracic surgery providers. NRB recommendations were placed in the EMR, and patients and ordering physicians were contacted by telephone up to three times; if no response was obtained, the patient was contacted by certified letter. All correspondence was copied to the patient's primary care provider (PCP) and/or ordering provider. The flow diagram for concerning lung nodules in our program is shown in Figure 1. During the study period, 1830 nodules were reviewed, with 40.8% sent for CT surveillance, 23.8% thoracic surgery and 23.3% pulmonary referral.

Nodule review board algorithm and process map.
Analysis of non-screened population
Of the 2253 non-screened lung cancer patients, we determined that 720 subjects (31.9%) met screening criteria as documented in discreet EMR fields (Table 1). These smoking history data were obtained by medical assistants, nurses, providers, or others, prior to enrollment, defining them as individuals that met screening criteria. Query of the smoking history audit trail further determined that an additional 294 (13.1%) non-screened patients would have met CMS screening criteria had the smoking history been more complete, maintained, and documented accurately in the discreet EMR fields. From the history available, 87 (3.9%) patients were undeterminable. In other words, 55.0% of the patients with lung cancer over the study interval did not meet CMS screening criteria, collectively accounting for 51.1% of the non-screened lung cancers that did not meet CMS screening criteria even after audit, and 3.9% for which eligibility could not be determined on review of the EMR smoking history.
Distribution of non-screened cohort respective of patients who could have qualified for screening, either with existing EMR data, or upon audit of substance use history.
EMR: electronic medical record; CMS: Centers for Medicare & Medicaid Services; USPSTF: United States Preventive Services Task Force.
Errors in the EMR smoking history, upon audit and review, included but were not limited to the following: 1) no start date or years of smoking; 2) patient marked as quitting smoking but no quit date entered; 3) patient reduced smoking and the discrete data field was erroneously reduced, often decreasing pack-years by 50% or more; 4) cigars were checked but not cigarettes making it difficult to ascertain whether pack-years were truly attributable to cigarettes; 5) cigarette smoking was noted but some or many of the essential details were omitted, preventing a determination of pack-years.
When the USPSTF 2021 criteria were applied to this same group of non-screened individuals, a net additional 278 (1014 per CMS vs. 1292 per USPSTF 2021) individuals qualified, a 27.4% improvement. This left 961 individuals (120, eligibility could not be determined + 841, did not meet screening criteria); that is, 42.7% of the non-screened lung cancer population not meeting USPSTF screening criteria. Table 2 analyzes the distribution of this group, independently looking at age, pack-years, and years since quit smoking.
Distribution of the non-screened cohort that did not meet USPSTF 2021 criteria on initial review of existing EMR data, and upon further query of substance use audit trail.
EMR: electronic medical record; USPSTF 2021: United States Preventive Services Task Force.
Statistics
Statistical analyses were performed using Minitab® 20.3. Mann Whitney tests were used to compare differences in median cancer stage across groups (e.g., LCS group vs. non-LCS group). Confidence intervals for proportions were employed as follow-up to assess the magnitude of any group-to-group differences.
Results
Patient demographics and categories
Table 3 depicts demographics
Demographics and lung-RADS score distribution.
Values are n (%). Median age was 67 for the non-screened and 69 for the screened cohorts.
aLung-RADS category 4 cases are broken out further as 4A, 4B, or 4X.
Program growth
During the study period, a total of 20,564 lung cancer screens were performed on 10,916 unique patients. Figure 2 shows the volume increase in screens over time during the study period.

Lung cancer screens by year.
Figure 3 depicts the evolution of baseline vs. annual LCS, illustrating the crossover in September 2019, when annual screens surpassed baseline LCS. Of note, the profound historical impact of the pandemic is demonstrated in April 2020.

Historical progression of baseline vs. annual screens. Data became available in January 2019. The arrow marks a historical intersection, when annual surpassed baseline lung cancer screens, in September 2019.
Stage migration
NLST demonstrated a statistically significant stage shift towards earlier stage of lung cancer at diagnosis in the screened population compared to the non-screened population, demonstrating a 20% reduction in lung cancer mortality. In our study, the LCSP (n = 342) shifted lung cancer stages significantly compared to the non-screened cohort (n = 2253): stages I, 54.7% (187) vs. 24.5% (553); II, 13.5% (46) vs. 8.3% (186); III, 18.4% (63) vs. 18.2% (411); and IV, 13.5% (46) vs. 49.0% (1103), (W = 198,313, p < 0.0001). Notably, 54.7% of all lung cancers discovered in the LCS cohort were in stage I, with 68.1% found collectively in the early stages, I and II.
Discussion
One purpose of our present study was to analyze our own institutional data, addressing both patient and provider barriers through education and presentation of our own program data. These barriers are further expanded and addressed in Appendix B (online supplemental material). Garnering the support of the family physicians, despite the lack of endorsement of their governing organization, was a key component of the success of the program. Demonstrating early and impactful results, similar to the NLST, for the screening program and having a PCP champion was integral to the buy-in of the PCPs and acceleration of the program. Improvements in the acquisition of the smoking history and efforts to minimize or negate the erroneous modification of the smoking history will prove worthwhile in capturing individuals at risk, making sure that those determined to be at risk do not get inadvertently removed from eligibility. This shortfall of the existing EMR, including multiple vendors, has been recognized across the nation. 17 As demonstrated in our smoking history audit analysis of the non-screened lung cancer cohort, 294 more individuals (13.1% of non-screened lung cancers) using CMS 2015 criteria, or 272 more (12.07%) using USPSTF 2021 criteria, could have qualified for screening had the smoking history been kept accurate and current. A longitudinal smoking history was implemented at SEHC in July 2023; it is our expectation that the accuracy and real-time maintenance of the smoking history will be greatly improved.
Kentucky consistently has the highest lung cancer incidence and mortality in the US, as well as some of the worst outcomes with respect to lung cancer survival.6,13 This is an ideal environment in which to promote LCS and demonstrate its effectiveness. The American Academy of Family Physicians did not endorse LCS prior to April 2021, and multiple reports have highlighted concerns that limited community hospital experience, risks, and costs outweigh potential benefits. 18 We add our experience to a growing body of evidence that LCS can be done effectively in a community setting, inside a structured team-based program, with ongoing progress and outcomes data monitoring.
We attribute the steady and consistent growth of our program to multiple impactful factors that occurred during the study period which led to increased awareness of LCS in our health system and region. These factors included but were not limited to: (1) Employment of a dedicated thoracic surgeon in 2016; (2) creation of the NRB in 2017, critical to garnering the buy-in and confidence of the ordering PCPs and referring specialists; (3) creation of a weekly dedicated thoracic oncology tumor board in 2017; (4) implementation of a Best Practice Alert within the EMR to alert providers if a patient met criteria for LCS in 2017; (5) employment of a full-time and dedicated LCS nurse navigator in 2018, who was instrumental in guiding patients and maintaining communication once a scan was completed; (6) naming a PCP champion as Director of the LCSP in November 2019; (7) an Annual Lung Cancer Symposium (2016–2022) geared primarily towards PCPs; (8) efforts to establish a sustainable process to reach out to patients that had an outstanding LCS order without a scheduled appointment; (9) administrative support and implementation of a team-based approach.
LCS uptake remains comparatively low in our system at 49.6% (CMS 2015) in 2021, compared with breast cancer (67.4%) and colorectal cancer screening (73.7%) uptake for this same year. Only 13.2% (n = 342) of the 2595 lung cancers diagnosed during the study period were detected through the LCSP (see Figure 4). Analysis of the non-screened population of lung cancers demonstrated that even upon audit of smoking history, the majority, or 55.0% (n = 1239 [2253–1014]) of the entire lung cancer cohort, over this 7-year period, would not have qualified for screening under the CMS 2015 criteria, used during this interval. Applying the expanded USPSTF 2021 criteria, an additional 300 individuals could have been added using the information at hand in the EMR, leaving 54.7% (n = 1233 [2253 − 1020]) not meeting criteria. Upon audit, another 272 subjects could have met the screening criteria. This greatly expanded the pool meeting screening criteria but still left 42.7% (n = 961 [2253 − 1292]) not meeting any present criteria recognized and covered by insurance. Other analyses have revealed similar assessments, or 46% not meeting USPSTF 2021 criteria. 19 Similarly, 36% of preventable lung cancer deaths in individuals with smoking history fall outside of the criteria. 20 These criteria, based solely on age and smoking history, fall shy of capturing the full burden of the population at risk for lung cancer. Using age alone, in our analysis, 3.5% of the non-screened lung cancers were below the USPSTF 50-year age limit, and 15.2% were above the 80-year threshold, raising the question of extending or removing the upper age limit.

Stage shift with lung cancer screening; analysis of 2595 lung cancers in St Elizabeth Healthcare (SEHC) over the 7-year interval, 2015–2021.
It is known that a plethora of risk factors aside from age and smoking history can contribute to lung cancer21–25 Recent interim analysis of the prospective International Lung Screening Trial demonstrated a 20% increase in lung cancers detected when the PLCOm2012 risk assessment model was compared to the USPSTF 2013 model. 26 When a four-panel blood-based protein biomarker panel was coupled with the PLCOm2012 (4MP + PLCOm2012), sensitivity improved by 9.9% and specificity by 6.9% compared with the USPSTF 2021 criteria, identifying 9.2% more lung cancer cases. 27
Our LCSP relies on a robust infrastructure centered on our NRB, which systematically and efficiently triages newly detected or newly concerning nodules and masses. Our system's programmatic approach, including the communication with and guidance of patients as well as the communication with ordering and referred providers by the nurse navigator(s), has been invaluable in attracting the buy-in and confidence of our ordering providers, alleviating some of the barriers inherent in LCS. It is our conviction that this also assures the most cost-effective, time-efficient, and lowest risk approach to patient care. We believe that our construct could serve as a useful paradigm for other programs looking to start or enhance their LCS efforts.
Supplemental Material
sj-docx-1-msc-10.1177_09691413231208160 - Supplemental material for Overcoming barriers to lung cancer screening using a systemwide approach with additional focus on the non-screened
Supplemental material, sj-docx-1-msc-10.1177_09691413231208160 for Overcoming barriers to lung cancer screening using a systemwide approach with additional focus on the non-screened by Michael R Gieske, Jessica Kerns, Gary M Schmitt, Goetz Kloecker, Irfan A Budhani, Joseph Nolan, Valerie A Williams, Deema Alkapalan, Katelyn Ferguson, Ryan Yadav and Royce F Calhoun in Journal of Medical Screening
Footnotes
Acknowledgments
The authors would like to thank Glen Turner, MD (retired pulmonologist) and Gary Schmitt, MD (practicing radiologist and co-author) for their vision in pioneering the LCS program at SEHC in 2013, with a part-time nurse navigator Joyce Jacobs, when the challenges of promoting and growing a lung cancer screening program were especially formidable. Also, we recognize Megan Lockwood, our first full-time nurse navigator. We thank Sara A. Browne, RN, and Jason Ellis for their significant contributions toward getting our initial reviews up and running, and extensive chart reviews. We thank Kathleen Murphy, RN for her contributions to the database. We thank Trish Boh for creating the NRB flow chart and assistance with the poster submitted to WCLC 2022, as well as Mary G. Barry, MD, Ellen F. Krasik, MD, PhD for their editorial assistance. The authors thank Amy Short, Quality Director Oncology Services, Andy Bramer, and our Clinical Research Institute for helping to bring the final manuscript to fruition. Finally, the authors thank St Elizabeth Healthcare for their unwavering support of this work (no other source of funding) and our patients for putting their trust in us.
Author contributions
Michael R. Gieske contriuted to conceptualization, validation, writing—original draft, review, and editing, methodology, data curation, visualization, project administration, revision. Jessica Kerns contributed to the conceptualization and Writing. Gary Schmitt contributed to the conceptualization, writing—original draft, review, and editing. Goetz Kloecker contributed to the conceptualization, writing—original draft, review, and editing. Irfan A Budhani contributed to the writing—original draft, review, and editing. Joseph Nolan contributed to the writing—original draft, review, and editing, formal analysis. Valerie A. Williams contributed to the writing—review, and editing. Deema Alkapalan contributed to the validation, writing—original draft, review, and editing. Katelyn Ferguson contributed to the data curation and investigation. Ryan Yadav contributed to the data curation, investigation. Royce F. Calhoun contributed to the conceptualization, writing—original draft, review, and editing.
Declaration of conflicting interests
The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Michael R. Gieske is a Consultant for the Lung Ambition Alliance and Subject Matter Expert for Association of Community Cancer Centers (ACCC) Rural Appalachian Lung Cancer Screening Initiative initiative (RALCSI). The remaining authors declared no potential conflicts of interest.
Funding
The authors received no financial support for the research, authorship, and/or publication of this article.
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References
Supplementary Material
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