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Low-dose Computed Tomography Screening for Lung Cancer in a Clinical Setting: Essential Elements of a Screening Program

McKee, Brady J. MD; McKee, Andrea B. MD; Kitts, Andrea Borondy MS; Regis, Shawn M. PhD; Wald, Christoph MD, PhD, FACR

doi: 10.1097/RTI.0000000000000139
Symposium Review Articles

The purpose of this article is to review clinical computed tomography (CT) lung screening program elements essential to safely and effectively manage the millions of Americans at high risk for lung cancer expected to enroll in lung cancer screening programs over the next 3 to 5 years. To optimize the potential net benefit of CT lung screening and facilitate medical audits benchmarked to national quality standards, radiologists should interpret these examinations using a validated structured reporting system such as Lung-RADS. Patient and physician educational outreach should be enacted to support an informed and shared decision-making process without creating barriers to screening access. Programs must integrate smoking cessation interventions to maximize the clinical efficacy and cost-effectiveness of screening. At an institutional level, budgets should account for the necessary expense of hiring and/or training qualified support staff and equipping them with information technology resources adequate to enroll and track patients accurately over decades of future screening evaluation. At a national level, planning should begin on ways to accommodate the upcoming increased demand for physician services in fields critical to the success of CT lung screening such as diagnostic radiology and thoracic surgery. Institutions with programs that follow these specifications will be well equipped to meet the significant oncoming demand for CT lung screening services and bestow clinical benefits on their patients equal to or beyond what was observed in the National Lung Screening Trial.

Departments of *Radiology

Radiation Oncology, Lahey Hospital & Medical Center, Burlington, MA

Conflicts of Interest and Source of Funding: Payments for lectures (A.B.M., B.J.M.); Royalties: Lahey Hospital & Medical Center in partnership with Mevis Medical Solutions AG to develop a commercial CT lung screening radiologist credentialing software product (A.L.L.); Board Membership: Philips Radiology Medical Advice Network (C.W.); Expert Testimony: CRICO (C.W.); Grants: PI ACRIN 6690 National Liver Imaging Study (C.W.); and Patents: MIT Koch Institute #61/429,658 (C.W.).

Reprints: Brady J. McKee, MD, Department of Radiology, Lahey Hospital & Medical Center, Burlington, MA 01805 (e-mail: brady.j.mckee@lahey.org).

Lung cancer is the primary cause of cancer-related death in the United States, claiming nearly 450 lives every day.1 When diagnosed after symptoms occur, lung cancer typically is advanced, resulting in a discouragingly low 5-year survival rate of 16.8%, which has only marginally improved from the 1970s despite profound advances in therapeutic techniques during that time.1 Knowledge that lung cancer can be cured if caught early has driven a decades-long search for a suitable screening test.2 However, conclusive proof that lung cancer screening can reduce mortality remained elusive until publication of the landmark National Lung Screening Trial (NLST) in June 2011.3 The NLST reported that annual computed tomography (CT) lung screening reduces lung cancer–specific mortality by at least 20% in individuals at high risk for lung cancer.3,4 Before this publication, no professional society or governmental agency recommended lung cancer screening. Today, dozens of national societies and stakeholder groups, including the United States Preventive Services Task Force (USPSTF) and the Centers for Medicare & Medicaid Services (CMS), recommend CT lung screening for individuals at high risk for lung cancer.5–8 The December 2013 USPSTF level “B” recommendation and the November 2014 proposed CMS National Coverage Determination (NCD) will result in CT lung screening coverage with no copay for millions of high-risk Americans beginning in 2015.5,8,9

The medical community in general, and radiology departments in particular, now face the daunting task of safely and effectively performing millions of new CT scans each year with the tremendous upside potential of saving tens of thousands of lives.10 Suggested steps to start a decentralized CT lung screening program have been previously published.11 The focus of this present article is to review the supporting evidence and implementation of selected program elements key to conducting safe and effective CT lung screening including structured radiology reporting, informed (IDM) and shared decision making (SDM), and integrated smoking cessation. Using the Rescue Lung, Rescue Life (RLRL) program at Lahey Hospital & Medical Center (LHMC) as an example, we will review the day-to-day operations of a clinical CT lung screening program in its third year since inception. Finally, we will discuss prospective implications of steady-state CT lung screening in the United States at the national and individual institutional level and preparatory steps that can be taken today.

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CT LUNG SCREENING REPORTING AND DATA SYSTEM

BI-RADS Model

Overview

The value of structured reporting in imaging-based screening has been well established by long-term clinical use of the American College of Radiology (ACR) BI-RADS® system, successfully applied for decades to report and manage breast cancer screening findings.12 It was subsequently emulated by PI-RADS, C-RADS, LI-RADS, and HI-RADS for prostate, colon, liver, and head imaging, respectively.13 BI-RADS was the first practice management system developed for imaging and is considered to represent “…a quality assurance tool designed to standardize mammographic reading, reduce confusion in breast imaging interpretation and facilitate outcome monitoring.”14 In the months leading up to the official launch of their clinical CT lung screening program in January 2012, the RLRL team at LHMC followed the BI-RADS model and developed Lung-RADS, a structured reporting system to ensure uniform reporting, efficient communication, and accurate data tracking of CT lung screening findings.11,15 The original version of Lung-RADS, developed at LHMC, included a BI-RADS-like alphanumeric overall examination assessment score, a nodule lexicon, and a structured reporting format designed to overlay existing nodule follow-up algorithms such as the National Comprehensive Cancer Network (NCCN) Lung Cancer Screening Guidelines v1.2012.15–17 RLRL subsequently transferred control of Lung-RADS to the ACR, which released the current version, ACR Lung-RADS version 1.0, in April of 2014, summarized in Table 1.18

TABLE 1

TABLE 1

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Similarities

Many similarities exist between breast and lung screening. Both have approximately the same effective radiation dose per screening examination (∼0.7 mSv), the same baseline positive rates (∼10% with Lung-RADS), and the same 3 recommendation endpoints: annual imaging follow-up, interval imaging follow-up, and immediate call back/care escalation.6,18–22 The latter can take the form of alternative imaging modalities, consultation, and potentially invasive diagnostic and therapeutic procedures.11,18 Lung-RADS and BI-RADS are both decision-oriented reporting systems, linking imaging findings with standard guideline-based recommendations. Both constitute a shorthand language that the multidisciplinary care team members use to discuss the nature and downstream implications of imaging findings. Both facilitate quantification of screening imaging results and medical auditing designed to improve performance of radiologists, technologists, and the system as a whole. Lung-RADS replicates the BI-RADS overall assessment score and category descriptors and assigns into each category lung screening findings with a risk profile and follow-up recommendation which would be expected for a mammogram with the same score.18,19 For example, Lung-RADS 3 and BI-RADS 3 examinations both carry a risk for malignancy <5 times the pretest probability of disease.3,18,19,22 Aligning the overall examination assessment scores, risk profiles, and follow-up recommendations saves primary care providers (PCPs) and radiologists, already familiar with BI-RADS, the time and energy needed to learn an entirely new coding system, thus facilitating adoption.

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Differences—Incidental Findings

The presence of nontarget incidental findings sets CT lung screening apart from mammography. A standard 2-view mammogram does not image the entire breast; however, a CT lung screening examination images much more than the lungs.22 In the NLST, the overall rate of nontarget clinically significant incidental findings was 7.5% with a rate of 10.2% at prevalence (baseline) screening.3 Although there is no universally accepted definition of a “significant incidental finding,” in general, these findings require some form of clinical or imaging evaluation before the next scheduled lung screening examination.18,23 Concern for the presence of an extrapulmonary malignancy is an important, but not exclusive, reason to flag a finding as significant. CT lung screening can also reveal conditions such as cirrhosis or pancreatitis, which may require specific treatment and/or monitoring if previously unknown. Evaluation of all of these findings requires additional time and expense and may put patients at risk for complications if an invasive procedure is required for definitive treatment or diagnosis. Lung-RADS requires that the reading radiologist specifically code for significant incidental findings on each examination (Category S) to highlight the finding for the referring physician and facilitate auditing the resulting diagnostic workup.6,18

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Differences—Complications Related to Clinical Management of Positive Findings

The spectrum of complications associated with breast and lung screening interventions differ significantly. For breast biopsy, complications such as bleeding and infection are infrequent, usually easily managed, and rarely require hospitalization.24 Lung biopsy complications include those observed in breast biopsy as well as pulmonary bleeding, infection, and pneumothorax.25 These latter may occasionally require hospitalization and in very rare instances can be life-threatening. Six deaths were observed in the NLST population occurring within 60 days of interventions performed on patients with positive screening examinations who did not have cancer (false positives).3 Given the increased severity of these associated complications, lung screening interventions should be carefully directed toward patients with a likelihood for malignancy that is high enough to justify the elevated risks. Lung-RADS coding helps practices clearly segregate the 95% to 96% of patients who do not require evaluation for biopsy (Lung-RADS 3 or less) from the 4% to 5% of patients in whom biopsy may be a consideration (Lung-RADS 4).6,18,26 In addition, Lung-RADS requires a slightly higher pretest probability of malignancy (5% vs. 2% in mammography) before considering intervention.19 For the 2% to 5% risk group, a short interval follow-up low-dose chest CT in 6 months is recommended to identify the subset of patients for whom intervention may be appropriate.18 As a result, the positive predictive value (PPV) of a CT lung screening biopsy should exceed the mammography benchmark of 33%.6,14,19 In the first 24 months of screening, LHMC has observed a positive biopsy rate of nearly double the mammography benchmark at 67%.

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ACR Lung-RADS 1.0

Reducing False Positives

ACR Lung-RADS Version 1.0 incorporates a novel nodule follow-up algorithm that reduces the 26.6% false-positive rate of screening observed in the NLST to 10% or less without sacrificing the overall sensitivity of the examination to detect malignancy.6,18,26,27 Increasing the baseline screening positive size threshold for solid nodules from 4 to 6 mm and for nonsolid (ground-glass) nodules from 5 to 2 cm was instrumental in effecting this performance improvement.18,26 The decision to increase the solid nodule positive size threshold to 6 mm was based on the low PPV of solid nodules between 4 and 6 mm in the NLST (0.5%) and a 2013 International Early Lung Cancer Action Program (IELCAP) publication that reported no new false negatives and a positive rate of 10.2% when increasing the positive nodule size threshold from 5 to 6 mm.3,28 Retroactively applying the Lung-RADS positive nodule size thresholds to the NLST data reduced the positive rate to 13.7% at baseline screening and 5.9% for subsequent screenings.6 This increased the baseline NLST PPV to 6.9% and the PPV of subsequent screening to 10.9% versus the 3.8% overall PPV originally reported when using a 4 mm maximum dimension positive nodule size threshold.6,27 LHMC reported a similar positive rate of 10.5% and a PPV of 15.5% for pathology-proven malignancy when retroactively applying the current Lung-RADS positive nodule size thresholds to 1603 baseline screenings performed during the first 24 months of their program.26

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Managing Gaps

A Lung-RADS manual is pending release and will describe the Lung-RADS categories and modifiers in more detail with case examples. A nodule lexicon is likely to be included as part of the manual. Gaps currently not specifically addressed by Lung-RADS, which may be addressed by the manual, include guidance for findings suspicious for pulmonary infection or inflammation and for isolated, enlarged mediastinal lymph nodes reported to occur in 6% and 1% of screening examinations, respectively, at LHMC.18,20 Programs can expect to come across such findings and should establish internal protocols on how these will be handled within the Lung-RADS framework. For example, at LHMC, findings suspicious for infection or inflammation are designated as Lung-RADS 2 (Benign Appearing/Behaving) with a modifier “i” to allow separate tracking from the remaining large overall number of Lung-RADS 2 examinations (70% to 80% of all screening examinations).18,26 Should guidance on how to handle these types of findings be given in the Lung-RADS manual or in subsequent revisions of Lung-RADS, the modifier will allow easy identification of these cases for the purpose of retrospective review and medical audit.

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Use of Structured Lung CT Reporting Outside of the Screening Context

Lung-RADS is anchored around the question, “Is further evaluation warranted before the time of the next exam in 12 months?” The ACR Lung-RADS committee came to a consensus that any nodule (either nonsolid or solid) stable for at least 3 months would be safe to follow up with a repeat examination in 12 months.18 The Lung-RADS overall examination assessment score for nodules stable for >3 months is “Lung-RADS 2” or “benign appearing or behaving” to better reflect this approach.18 However, Lung-RADS recommendations should only be applied within a screening program in which participants are, by definition, asymptomatic and will be returning for subsequent examinations. The same approach cannot be taken with findings in emergency room patients or incidental pulmonary nodules in low-risk and moderate-risk patients who may never return for imaging evaluation. In these cases, and when a high-risk individual ages out or otherwise becomes ineligible for CT lung screening, other clinical lung imaging reporting guidelines, such as those from the Fleischner Society, should be considered in making future recommendations.29,30 Those qualified for CT lung screening but not interested in committing to a series of annual examinations or unwilling to return for follow-up examination to assess positive findings should not enroll in a screening program.

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Lung Screening Program Database

Enrollees in lung screening programs may undergo dozens of examinations over a period of decades. Helping ordering physicians keep track of these patients is one of the primary responsibilities of the program operational staff. The amount of data to record, even in small programs scanning <20 patients/wk, quickly becomes unmanageable by spreadsheet and requires a dedicated (relational) database. This database ideally should be able to access information stored in other electronic medical record systems, such as the radiology information system, to save time and eliminate errors in keeping current patient and MD contact numbers/addresses and patient-specific billing/insurance information. At a minimum, the database should alert staff when appointments are due or have been missed so that protocols to notify patients and the referring physicians can be enacted. However, a more comprehensive database solution that can accommodate information such as patient eligibility criteria, radiation dose, examination results, specific nodule details, incidental findings, and Lung-RADS scores can be used to automate patient notification letters, calculate operational quality metrics, and serve as a platform for research activities. At LHMC, significant information technology (IT) personnel time was spent originating a custom database specific for the lung screening program; dedicated commercial solutions continue to become available, which may help new programs avoid duplicating this effort.15

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Radiologist Credentialing

All radiologists regularly reading CT imaging of the chest should be capable of interpreting CT lung screening examinations with a modest investment in time to become familiar with current guidelines, recommendations, and dedicated structured reporting. The ACR has aggregated most of the needed information online at http://www.acr.org/Quality-Safety/Resources/Lung-Imaging-Resources.31 Prior experience with CT lung screening trials is helpful but not necessary.11 Programs providing CT lung screening services should consider establishing an internal credentialing process. This can help ensure that the radiologists interpreting the examinations have acquired the knowledge necessary to use the structured reporting system and that the radiology reports generated can be audited and used to derive quality metrics.6,32 Standardized templates and “macros” integrated into the radiology voice-recognition software, or dedicated CT lung screening reporting software, can help flatten the learning curve and ensure uniform reporting and guideline adherence.

At LHMC, the internal credentialing process requires that the radiologist-in-credentialing read a preselected list of publications about CT lung screening and review a series of lectures covering a variety of CT lung screening–specific topics including reporting with Lung-RADS. LHMC radiologists must achieve greater than an 80% score on a 50-question multiple-choice test derived from the lectures and publications. In addition, at least 100 screening cases are overread by a previously credentialed expert radiologist to ensure appropriate use of Lung-RADS and the LHMC structured reporting format. More cases are required if >90% accuracy is not demonstrated. All LHMC CT lung screening reports use a standard report template. The LHMC dictation system has a menu of preprogrammed macros available for the radiologist to insert into the report including nodule descriptions and Lung-RADS category-specific standard recommendations. LHMC radiologists must interpret at least 150 screening cases per year to maintain credentialing, similar to the yearly caseload required in mammography.22 LHMC residents who successfully complete the credentialing requirements receive attesting documentation. Currently, LHMC has 4 radiologists credentialed in CT lung screening, only 1 of whom concentrates predominantly on thoracic imaging. One radiologist is assigned to read CT lung screening examinations over half a day 3 times each week. This staffing level provides sufficient coverage to handle the current LHMC volume of 60 examinations per week and coverage during vacation weeks.20

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Lung Screening Program Quality Metrics

On September 26, 2014, 66 organizations, including the American Cancer Society, Lung Cancer Alliance, Society of Thoracic Surgeons, ACR, NCCN, American Thoracic Society, and American Lung Association, cosigned a letter to CMS in support of CT lung screening (Joint Societies Letter).6 The Joint Societies Letter endorses Lung-RADS and the IELCAP schema as validated CT lung screening structured reporting systems and proscribes specific CT lung screening quality metrics (Table 2).6 Per the Joint Societies Letter, programs that choose to use the IELCAP schema for CT lung screening reporting must have the ability to export their data using Lung-RADS, “…to a clinical quality registry for benchmarking and quality review.”6 As Lung-RADS was originally developed as a coding overlay for nodule follow-up algorithms, assigning a Lung-RADS overall examination assessment category to an IELCAP report should be a relatively straightforward process.15 For new CT lung screening sites, adopting either system is an option; however, choosing Lung-RADS would eliminate the extra work needed to convert radiology reports for upload to the ACR clinical quality registry after the fact. The clinical quality registry will juxtapose the individual institution’s quality metrics to expected benchmarks and aggregate results for all other participating institutions.6 This approach is designed to quickly identify ways to improve the overall safety and effectiveness of the screening process. Internally, the CT lung screening program oversight/steering committee should review program-wide and individual radiologist quality metrics at regular intervals.

TABLE 2

TABLE 2

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ACR Lung Screening Program Accreditation

In April 2014, the ACR initiated a CT lung screening center accreditation process. Interested programs must designate a supervising physician who can attest that the program elements and CT scanner protocols comply with the ACR requirements.33 Every scanner performing CT lung screening examinations must have an active ACR chest module accreditation, and CT lung screening protocols must be within exposure ranges specified by the ACR to insure low-dose radiation exposure to patients.33 The American Association of Physicists in Medicine Working Group on Standardization of CT Nomenclature recently released lung cancer screening protocols meeting the ACR requirements for multiple individual scanners across 6 manufacturers excerpted in Table 3.34 Other ACR requirements include an integrated smoking cessation referral mechanism, internal quality control process, and use of a structured reporting system such as Lung-RADS.33 The full ACR credentialing requirements are available at http://www.acr.org/Quality-Safety/Lung-Cancer-Screening-Center. Applying for accreditation is straightforward. Programs performing safe and effective CT lung screening should have no trouble fulfilling the requirements. As of October 2014, the ACR has designated 198 sites in the United States as accredited lung cancer screening centers.35

TABLE 3

TABLE 3

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IDM AND SDM

Overview

SDM

Many national organizations including the American Cancer Society, the American Lung Association, and the NCCN advocate that clinicians and patients engage in SDM when considering cancer screening.6,36,37 The definition of SDM varies and has been described generally as a “collaborative process that allows patients and providers to make health care decisions together, taking into account the best scientific evidence available, as well as the patient’s preferences and values.”38 Measures of SDM are listed in Table 4.39 The USPSTF suggests that SDM should be, “considered satisfactory when the patient has participated at a level at which he or she desires and feels comfortable.”39 Some, including the USPSTF, support a hierarchical approach to SDM, tailoring the extent of discussions on the basis of the evidence of net benefit of the intervention and other factors.39,40 More extensive exploration of individual patient values could be indicated when evidence of net benefit is small or weak such as in USPSTF “C” or “I” recommendations.39 USPSTF “A” and “B”–recommended services may also require varying levels of discussion. For example, patients and providers may need to allocate more time to consider newly recommended interventions, such as CT lung screening, wherein knowledge gaps about the risks, benefits, and alternatives are more common.39 All SDM interactions should be documented given the real medico-legal risk associated with delayed diagnosis of a potentially curable disease for which screening is recommended.39,41,42

TABLE 4

TABLE 4

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Barriers

Opportunities exist for improvement in day-to-day clinical use of SDM in the United States. In the Cancer Care Outcomes Research and Surveillance Study, 69% of patients with metastatic lung cancer and 81% with metastatic colorectal cancer surveyed did not understand that chemotherapy was unlikely to cure their disease.43 Whereas multiple factors likely contribute to misconceptions about treatment objectives, face-to-face encounters between patients and the oncologists prescribing the chemotherapy appear insufficient to satisfactorily inform patients. Barriers that contribute to inadequate IDM and SDM are listed below:

  • Physicians’ time constraint, shortening patient visits for economic reasons.
  • Physicians not conversant in all relevant data.
  • Varying guidelines among specialty physician groups, individual physicians, and patients.
  • Information from physicians being incomplete, not personally relevant, or understandable.
  • Information being delivered during time of extreme stress.44
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Decision Aids

The USPSTF recommends that clinicians consider decision aides and delivery systems that “offer balanced, unbiased, and evidence-based information, in addition to values clarification” to overcome these barriers and any other barriers specific to the recommended intervention.39 Examples include patient hotlines staffed by trained office personnel, web-based tools, written materials, and community/physician outreach.39 Collectively, these IDM interventions supplement the SDM patient-provider process. The term IDM collectively describes the overall process of information gathering, including SDM interventions and use of the IDM decision aids described above.39

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LHMC Example

Decentralization

LHMC developed a decentralized CT lung screening process specifically designed to cost-effectively overcome the barriers to IDM listed above without restricting access to screening.11,15 PCPs are preventive care experts best positioned to engage their patients in the SDM process about all screening decisions. To support their SDM process, LHMC requires an order from a provider before every examination.11,15 In addition, the screening program supplies patients and providers with decision aids in the form of written and verbal communications including telephone and e-mail access to knowledgeable program personnel at multiple time points before enrollment as described below.

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Physician Continuing Medical Education (CME)

LHMC conducted an extensive CME campaign for local physician groups at the time of program inception. In total, >50 face-to-face meetings between providers and CT lung screening content experts, both within and outside the health system, took place to prepare the provider base for their role in the SDM process. Physician-directed literature developed by the CT lung screening multidisciplinary steering committee is sent to every referring provider inquiring about patient eligibility. The literature includes facts about the NLST, program eligibility requirements, proven and theoretical risks of CT lung screening, mechanics of the CT screening process including how to order the examination, and descriptions of available smoking cessation resources.

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Patient Education

A multidisciplinary team, including primary care, developed a 4-page frequently asked question document (FAQ) written in layman’s terms, which detailed the following information:

  • Background information about lung cancer and lung screening.
  • Risks and benefits of lung screening.
  • Appropriate patient selection criteria.
  • Alternatives to lung screening.
  • Patient’s responsibility to pay for diagnostic studies or procedures.
  • What to expect during the examination and how often the test is performed.
  • Smoking cessation messaging and quit-line resources.
  • Method and timing of results communication.
  • What to expect after the examination.

The FAQ is made available in every LHMC provider’s office, online through the LHMC website, and by mail to every patient who calls to inquire or schedule an examination. Given the increasing number of adults accessing health information online, LHMC also has website education materials available to supplement the FAQ. These materials include a short video on CT lung screening and links to the FAQ document, physician-directed literature, background NLST information from the NCI, NCCN lung screening guidelines, a webinar on the CT lung screening program at LHMC, and contact information for the program navigator.

Community outreach revolving around small group meetings is also utilized as a decision aid. Presentations at regional councils on aging, veteran’s groups, military bases, professional firefighters association, semiprofessional baseball events, rotary clubs, chambers of commerce, health fairs, cancer walks, and lung advocacy events allow for community education in a neutral setting, outside the clinical office or hospital environment. Community education campaigns designed to raise awareness about the risks and benefits of screening in the patient’s home environment among family and friends support the IDM process by facilitating conversations with “trusted others.”45

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Measuring Outcomes

As has been suggested by the USPSTF, taking a systematic approach to SDM in CT lung screening program design can provide the foundation for research initiatives investigating patient-physician and patient-program screening interactions.39 Proposed outcome metrics to evaluate SDM models include patient-reported satisfaction and patient adherence to recommendations.39 The LHMC postexamination survey offered to all patients after baseline screening found a 98% overall likelihood to recommend screening to others. In addition, annual screening compliance at LHMC approaches 90%. These high levels of patient satisfaction and program compliance reflect the value of an approach of providing IDM interventions such as those detailed above to support the CT lung screening patient-provider SDM process.

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SMOKING CESSATION INTEGRATION

Overview

Approximately 50% of individuals at high-risk for lung cancer are active smokers and can benefit from smoking cessation.3,20 Many view CT lung screening as a teachable moment that can improve smoking cessation rates in this group.46,47 However, some express concern that CT lung screening may result in a “permission to smoke” phenomenon particularly among those with negative examination results, either reducing quit attempts and smoking cessation success or increasing relapse rates for recently quit smokers.47,48 As summarized below, evidence suggests that participation in a lung screening trial with integrated smoking cessation counseling does, in fact, lead to quit and abstinence rates superior to those observed in the general population even among those participants with negative examination results.48–52 In addition, positive examination results have been reported to directly correlate with increased rates of smoking cessation among trial participants.51,52 Both lung screening research trials and clinical CT lung screening programs create recurrent set time points for participants to engage with members of the health care staff for the express purpose of preventing lung cancer death. Promoting smoking cessation and/or abstinence in some form at each interaction likely contributed to the primary prevention successes observed in these trials. Capitalizing on these teachable moments to improve the cost and clinical effectiveness of screening should be a priority for all clinical programs.

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Overall Smoking Cessation Rates

A longitudinal study of 926 current and 594 former smokers in a lung cancer screening program at the Mayo Clinic reported smoking cessation rates of 14%, 22%, and 24% at the first, second, and third annual follow-up examinations, respectively.52 This compares favorably to the 5% to 7% annual smoking cessation rate in the general population.53 Ninety-eight percent of former smokers with >1 year of abstinence at the start of the study remained tobacco free at the third annual scan.52 Of former smokers who had quit 1 year or less at the start of the study, 71% remained tobacco free at the third annual scan comparing favorably with the general population abstinence rate of 7% in this group.52,54 The Dutch-Belgian lung cancer screening trial (NELSON) reported that 16.6% of 1284 male current smokers had quit smoking 2 years after trial enrollment compared with a general adult population quit rate of 3% to 7%.49 The Danish Lung Cancer Screening Trial (DLCST) also reported a relative increase in quit rates, with 11.9% of active smokers at baseline screening having quit at 1 year versus 4% for the general Danish population.50 The vast majority of screening examinations in these trials were negative, and similar rates of smoking cessation were observed among those assigned to CT lung screening and usual care in both the NELSON trial and the DLCST.50,55 These results and others argue against a “permission to smoke” phenomenon in the CT lung screening group.48

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Effect of a Positive Screening Result

Several studies, including the NLST, have reported higher smoking cessation rates in patients receiving positive screening examination results.51,52 In the 15,489 NLST participants who reported active smoking at the initial scan, the odds ratio for continued smoking versus a negative examination was 0.914 for a minor abnormality not suspicious for lung cancer, 0.811 for a major abnormality not associated with lung cancer, 0.785 for a finding suspicious for lung cancer stable from the previous scan, and 0.663 for a new or progressed finding suspicious for lung cancer.51 The previously described Mayo Clinic study showed positive correlation between the number of positive lung cancer screening results and smoking abstinence, with a 41.9% quit rate among baseline current smokers with 3 positive examinations versus 28.0% for 2 positive examinations, 24.2% for 1 positive examination, and 19.8% for those with no positive examinations.52

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Quit Readiness

Lung cancer screening program participation can increase the motivation to quit smoking.47 Of 134 ELCAP participants surveyed who were active smokers at program enrollment, 74% agreed that joining the screening program increased their motivation to quit smoking.47 Of those who quit smoking or decreased the amount they smoked, 87% said that undergoing a CT lung screening examination was the major influence in decreasing or eliminating their tobacco use.47 Participants cited discussing CT lung screening results with their physician as one reason for changes in smoking behavior.47

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Smoking Cessation Methods and Clinical CT Lung Screening

The USPSTF recommends that clinicians provide tobacco cessation interventions for those who actively use tobacco products and specifically details the importance of smoking cessation counseling in their CT lung cancer screening recommendation statement.5,56

“Smoking cessation is the most important intervention to prevent NSCLC. Advising smokers to stop smoking and preventing nonsmokers from being exposed to tobacco smoke are the most effective ways to decrease the morbidity and mortality associated with lung cancer. Current smokers should be informed of their continuing risk for lung cancer and offered cessation treatments. Screening with LDCT should be viewed as an adjunct to tobacco cessation interventions.”

In addition, offering smoking cessation interventions as part of annual lung screening is estimated to improve overall screening cost-effectiveness by 20% to 45%.57

It has been shown that interventions as brief as 3 minutes can increase cessation rates significantly.56 The US Public Health Service Clinical Practice Guidelines for Treating Tobacco Abuse and Dependence (Clinical Practice Guidelines) identifies 5 key steps to use every time a patient presents to a health care setting: (1) ask each patient about tobacco use; (2) advise patient to quit; (3) assess quit readiness; (4) assist with quitting; (5) arrange follow-up.58 CT lung screening programs should strive to integrate 1 or more of these steps into all lung cancer screening program-patient discussions with current and recently quit smokers taking into consideration practical limitations surrounding the venue of the patient interactions and the capabilities of the staff involved.6,7,32 Cessation interventions systematically performed by program staff at LHMC are described below. Additional strategies for how to perform each of the steps are provided in the Clinical Practice Guidelines and remain relevant for this venue.58

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Step 1—Ask Each Patient About Tobacco Use

Adding lung cancer screening to the menu of available preventive care options creates multiple new opportunities for providers to assess smoking status and promote tobacco cessation with their patients. Lung screening programs can assist providers by highlighting the various time points in the lung screening continuum ripe for cessation interventions during lung screening CME events and in provider-specific literature. Initial assessment for screening eligibility requires that providers document knowledge of the patient smoking status. Tobacco use can be reassessed when discussing examination results and must be reassessed when ordering follow-up examinations to ensure each patient remains qualified for screening.

Lung cancer screening programs can charge staff members interacting with the patient at the time of each examination to ask about current smoking status. No specific training in smoking cessation is required, but staff should be empowered to direct patients interested in cessation to available smoking cessation resources. At LHMC, CT scheduling staff use a scripted questionnaire to reconfirm high-risk qualifications including smoking status with every patient before scheduling the examination. In addition, LHMC CT technologists are required to ask and record each patient’s smoking status before every examination. These interactions are documented in the CT lung screening database and regularly reviewed by the supervising radiologist to assess technologist compliance. Reiterating the need to record smoking status at technologist staff meetings and providing technologists with written cues to inquire about smoking status on the CT workstations used to perform the examinations achieved >95% compliance rates across all shifts and sites performing screening at LHMC.

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Steps 2 and 3—Advise Patient to Quit, Assess Quit Readiness

The Clinical Practice Guidelines recommend that the advice to quit be clear, strong, and personalized. PCPs are best positioned to personalize this advice at various points throughout the lung screening continuum (enrollment, discussion of results, ordering follow-up examinations).58 The program can help by directing PCPs and patients to free online risk models that calculate an individual’s risk for lung cancer on the basis of their current smoking history and how risk, over time, will increase with continued smoking and decrease with smoking cessation.59,60 Alternatively, PCPs may choose to use data from the NLST to motivate patients, including the fact that 1 of every 100 patients in the NLST had lung cancer detected at baseline screening.3 Allowing patients to understand what constitutes high risk relative to their own tobacco use can serve as a powerful message to move them through the stages of quit readiness. The FAQ document sent to all patients scheduled for a screening examination at LHMC advises current smokers, in writing, that the most effective action they can take to avoid lung cancer is to quit smoking. It also congratulates those who have quit and encourages them to “keep up the good work.”

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Step 4–Assist With Quitting

For patients indicating they are ready to try quitting, the health care provider engaged in the lung cancer screening and smoking cessation discussion should either provide smoking cessation assistance or refer the patient to other qualified smoking cessation resources for help. After a CT lung screening order is received, LHMC program staff sends both the provider and patient literature detailing smoking cessation strategies and available cessation resources including the quit-line phone number, which directly accesses the free, on site Freedom from Smoking program. Written materials describing available resources to help with cessation should be available at all scanner locations for the CT technologists to give to patients who express a specific desire to pursue cessation during interaction with the technologist.

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Step 5—Arrange Follow-up

Follow-up is recommended after the quit date for those expressing a willingness to attempt cessation. The need for individuals enrolled in CT lung screening programs to return for annual examinations creates a structural opportunity for the patient’s PCP to conduct follow-up smoking cessation discussions. Details for what to discuss during the follow-up are provided in the Practical Clinical Guidelines.58

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Summary “Smoking Cessation”

By following the steps taken at LHMC to counsel patients on smoking cessation, over 2 annual rounds of screening, there should be at least 11 opportunities to engage in at least 1 of the 5 steps listed in the Clinical Practice Guidelines: (1) decision to pursue screening—PCP; (2) confirmation of qualification for screening—CT scheduling staff; (3) FAQ letter—program navigator; (4) baseline screening examination—CT technologist; (5) discussion of examination results—PCP; (6) baseline examination satisfaction questionnaire—program navigator; (7) ordering annual follow-up examination—PCP; (8) scheduling second annual screening examination—program navigator; (9) second annual screening—CT technologist; (10) discussion of second annual screening examination results—PCP; (11) second annual screening examination satisfaction questionnaire—program navigator.

Smoking cessation and abstinence rates in the LHMC program exceed those reported in the general population and are consistent with the rates reported in the clinical lung screening trials detailed above (McKee AB, in preparation). This supports the notion that elevated quit rates cannot be explained solely by a trial volunteer effect but instead may relate to integrating smoking cessation interventions at predetermined points in a CT lung screening program over a prolonged period of time. Whereas the methods to integrate smoking cessation counseling into a CT lung screening program may vary depending on the local resources available, the decision to integrate smoking cessation counseling should not.

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DAY-TO-DAY PROGRAM OPERATIONS

Overview

Since January 2012, LHMC has performed >4500 clinical CT lung screening examinations on >2500 unique patients at 2 screening locations on 4 different CT scanners. This section reviews the operational steps involved in the screening process at LHMC in chronological order, from enrollment to discharge, to highlight the roles of the various CT lung screening program staff and clarify when some of the program elements previously described are implemented.

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Screening and Eligibility

Most enrollees in the LHMC CT lung screening program are referred for screening after engaging in an IDM and SDM process with their PCP. If the patient and PCP together decide that screening is appropriate, the PCP will order the examination and refer the patient to contact the lung screening phone line (1-855-CT-CHEST) to confirm eligibility.11,15 During face-to-face meetings the provider will usually give an FAQ packet to the patient. The CT scheduling staff assesses eligibility by a scripted intake form and will schedule an appointment with the patient if they meet the high-risk criteria. Exclusion criteria include metastatic disease, a lung cancer diagnosis within the past 5 years, inability to breath-hold for 6 seconds, and symptoms suggesting an acute respiratory infection or concerning for malignancy.15 Patients are advised to discuss any acute symptoms with their PCP and defer screening for 12 weeks after symptom resolution. Any questions about eligibility are referred first to the program navigator and if necessary the supervising radiologist. Self-requesting patients, who contact the lung screening scheduling office without an MD order, will be assessed for eligibility. If qualified they can schedule a tentative appointment for screening but will be advised to discuss screening in detail with their PCP and further advised that if an order for screening is not received the appointment will be canceled.

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Entering New Patients

All intake information recorded by the CT schedulers is entered into the screening database. A copy of the intake form is scanned into PACS. A softcopy of these forms is therefore available for review by the reading radiologist at the time of examination interpretation as needed. All times and dates of contact with the patients and their PCPs are recorded in the database throughout the duration of program enrollment. Once a new medical record number is created, the database will automatically pull the patient’s demographic information (age, sex, address, etc.) from the radiology information system. The database will pull in the patient’s appointment date as well. The CT scheduling office, after the initial appointment is booked, sends an FAQ packet and smoking cessation resources written in layman’s terms to the patient.

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Instructions Before Examination

At the time of examination scheduling, and 48 hours before each examination, patients are given detailed instructions regarding what to expect on the day of their examination. Specifically, they are instructed by our program navigators to bring photo identification and not to wear any metal (zippers, buttons, etc.) over their chest to avoid the need to change for the examination. Patients are again reminded that they must be asymptomatic and that diagnostic testing required to evaluate any positive examination findings will be billed to the patient’s insurance in the customary manner. Patients are invited to ask any questions they may have about the screening process or any information included in the FAQ packet.

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Day of Appointment

The patient checks in at the CT office before their examination. Appointments are booked every 10 to 15 minutes, but only several minutes may be necessary if the patient does not need to change. The actual examination lasts <10 seconds during which the patient needs to breath-hold for <6 seconds. The CT technologist will perform the examination, record the patient’s current smoking status, and, if requested, provide smoking cessation resources. After the examination, the patient is told that they will be notified of the results within 2 weeks and are encouraged to contact the program if they do not hear anything in that time.

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Capturing Results

As previously described, all interpreting radiologists are internally credentialed and use Lung-RADS for examination interpretation. The screening database regularly queries the radiology information system for finalized reports. If a final report is identified, the database will notify the navigator. The Lung-RADS overall examination assessment score, nodule details, and follow-up recommendations are imported from the structured radiology report and used to generate a results letter, which is mailed to the patient. Finalized reports are sent to the ordering physician through the radiology information system. Additional data including radiation dose are recorded.11

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Patient Notification

Patients with negative or benign behaving/appearing findings (Lung-RADS 1 and 2) are sent a letter stating, in layman’s terms, that their examination showed no evidence of clinically active disease and gives a specific date in 12 months time when the patient should try to schedule the next screening. Patients with probably benign findings (Lung-RADS 3) receive a letter, also in layman’s terms, stating that their examination found 1 or more probably benign lung nodules, with a follow-up examination recommended in 6 months. Additional results letters are available for examinations demonstrating signs of infection, enlarged lymph nodes, significant incidental findings, and for patients who have aged out of the program. Currently, the database has a menu of 12 separate patient notification letters. The radiologist personally notifies the ordering physician of all suspicious findings (Lung-RADS 4) and recommends formal pulmonary consultation. The ordering physician will personally notify their patient of the result and arrange for consultation with a pulmonologist of their choosing. The interpreting radiologist will remind the ordering provider during that conversation that they are under no obligation to refer the patient to LHMC for the pulmonary consultation, or any other service, as a result of the patient participating in the LHMC lung screening program.

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Patient Contact After Appointment

Two weeks after sending the examination, the program navigator calls the patient to make sure they have been notified of the results. During the call the patient is given an opportunity to ask questions about the results of their examination or about the screening process in general. In addition, if the program already received a follow-up order from the PCP, the next appointment can be scheduled during this call. Before hanging up, the program navigator conducts a patient satisfaction survey and records the results in the database. The survey asks the patient to grade the level of concern the staff had for the patient’s comfort and asks the patient to provide feedback on multiple aspects of the screening process. All criticisms from patients and PCPs are reviewed by the supervising radiologist and presented at the program’s bimonthly steering committee meeting.11,15

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Suspicious Results and Significant Incidentals

All suspicious findings (Lung-RADS 4) are referred for formal pulmonary consultation and reviewed at the LHMC weekly multidisciplinary thoracic oncology clinic with thoracic surgery, pulmonary, diagnostic, and interventional radiology, radiation and medical oncology, and pathology in attendance.11,15 The program navigator performs periodic chart review for Lung-RADS 4 patients and maintains a record of all appointments. If the patient is diagnosed with lung cancer, the patient-level Lung-RADS status in the database is changed to “C,” and a date in 5 years is scheduled for the navigator to reassess the patient’s eligibility to return to annual CT lung screening.18,26 Potentially significant incidental findings (Lung-RADS Category S) are tracked in a similar manner with consistent periodic chart review and database status updates.18 All pathologic determinations of significant incidentals are recorded. LHMC has documented 1 extrapulmonary malignancy for every 4 lung cancers found to date exceeding the 1 in 7 rate reported in the COSMOS study.61

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Discharges

An individual enrolled in CT lung screening at LHMC may be discharged for several reasons. Anyone who informs the program staff or PCP that he or she no longer wishes to participate in the screening program will be discharged. The program will notify the PCP of the reason for discharge, if given, and will document the time and date of the request for discharge in the database. Reasons for discharge include moving out of the area, inability to obtain a follow-up order from their provider, and undergoing screening or treatment elsewhere. Patients who exceed the upper age limit of the program will also be discharged. They will be notified in the examination results letter of the discharge and told the program will contact them if the upper age limit for eligibility is increased. For patients who miss appointments, formal attempts by telephone and in writing will be made at 30, 60, and 90 days, with the PCP informed at 60 and 90 days. If, despite these efforts, no contact can be established with the patient, the patient will be discharged. The 90-day letter notifies the patient and PCP of the delinquency, documents all previous efforts to contact the patient, and states that the program will make no further efforts to contact the patient to reschedule the appointment. The letter also encourages the patient to contact the program at any time if they choose to reengage in the screening process.

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Research

There are many opportunities to integrate research initiatives into a CT lung screening program. After assessing eligibility, the LHMC CT schedulers ask all qualified patients if they would be interested in participating in a research study. Those with interest are informed that they will be contacted to discuss available research programs in more detail at a later date. Current patient-centric research protocols underway at LHMC include smoking cessation counseling through structured telephone interviews and several biomarkers studies.

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SCREENING VOLUME IMPLICATIONS

Overview

The Patient Protection and Affordable Care Act mandates that private insurers and health care exchanges provide coverage with no copay for all new screening services receiving a grade “A” or “B” recommendation by the USPSTF at the time of plan renewal.9 As a result, the December 2013 USPSTF “B” Recommendation supporting annual CT lung screening for heavy current and former smokers aged 55 to 80 will lead to no copay coverage for 5 to 6 million Americans in 2015.5,9,10 The November 2014 CMS proposal will cover an additional 3 to 4 million high-risk individuals.8,62 The Joint Societies Letter requests that CMS also provides coverage with evidence for an additional group of patients the Joint Societies consider to be a high risk: current and former smokers aged 50 to 80 years with greater than a 20 pack-year smoking history and 1 additional lung cancer risk factor not to include second-hand smoke exposure.6 Approximately 2 million additional Americans are estimated to meet these criteria.20

How many lives can be saved and how many resources will need to be dedicated to this effort will depend not only on the number of patients for whom insurance is available but also on the screening compliance rate and the quality of the screening services provided. It is worth reviewing current screening compliance rates with breast, cervical, and colorectal cancer screening to help generate estimates of long-term clinical needs for lung cancer screening. In addition, reviewing factors that affect compliance with other cancer screening recommendations can help inform how to best structure CT lung screening programs to maximize compliance and lives saved.

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Screening Compliance

Precedent: Breast, Colon, Cervix Cancer Compliance Rates

The Centers for Disease Control and Prevention used data from the National Health Interview Survey to assess the percentage of men and women up-to-date on screening for breast, cervix, and colorectal cancer between 2000 and 2010.63 In 2010, the highest compliance rate was reported in cervical cancer screening with 83.0% of women aged 21 to 65 years undergoing cervical cytology within the last 3 years as recommended by the USPSTF.63 Colorectal screening compliance for adults aged 50 to 75 years was 58.6% with similar rates reported in men (58.5%) and women (58.8%).63 For mammography, a compliance rate in between cervical and colorectal cancer was reported, with 72.4% of women aged 50 to 74 reported having had a mammogram in the last 2 years.63

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Factors Affecting Compliance

No significant age-related differences in breast screening compliance was observed in the National Health Interview Survey.63 Of note, uninsured women reported significantly lower compliance at 38.2%.64 Lack of a primary care physician and not having a physician recommendation for a mammogram were predictive of not getting a mammogram.64 Notably, smokers were less likely to get mammograms (odds ratio 0.7).64 Other factors predictive of having a mammogram included having health insurance, marital status, breast cancer knowledge, and a history of breast disease.64

A study assessing the impact of physician-patient communication on cancer screening reported that subjects who recalled their physician being very enthusiastic about recommending a mammogram and/or fecal occult blood test were significantly more likely to report having had the screening test.64 For mammography, 88.8% of those who described an enthusiastic physician discussion about screening reported a mammogram versus 79.7% for a low enthusiasm discussion and 65.6% for no discussion.65 Similarly for the fecal occult blood test, those recalling a high enthusiasm discussion had a 56.3% screening rate versus 46.2% for a low enthusiasm discussion and 12.4% for no discussion.65

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Lung Screening Compliance

CT lung screening differs from breast, colon, and cervix screening in that there is no need to disrobe (breast, colon, cervix), no medications (colon), and no physical contact or internal examination (breast, colon, cervix). The examination itself takes <10 seconds. It can be performed at times convenient for the patient, including evenings and weekends, as there is no need for a physician to be present. Given these advantages, a high compliance rate may be achievable; however, significant hurdles do exist.

The major barrier to CT lung screening today is the lack of widespread established insurance coverage, although this barrier should be removed during 2015. Until then, high-risk individuals must pay out-of-pocket on average $230 for the examination.66 Many other barriers, however, will persist into 2015 and beyond (Fig. 1). The increased severity of the complications associated with diagnostic interventions may dampen participation in CT lung screening versus mammography.24,25 The observation that smokers are less likely to engage in breast screening should negatively impact uptake given that a history of smoking is a CT lung screening eligibility requirement.64 PCPs have limited time available to learn about the current recommendations, and concerns over radiation exposure, patient anxiety, false positives, IDM, and incidental findings can paralyze providers from action.7 There are the societal challenges of competing funds, cost, and value in medicine, prejudice against current/former smokers, stigmatization perceived by current/former smokers, fear of encouraging smoking, and the current debate about screening in general.67,68 Whereas regular community outreach and CME campaigns will be needed to reduce these barriers, safe and well-run programs that save lives will be equally if not more important.11

FIGURE 1

FIGURE 1

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Demand for Screening Resources

Overview

Assuming insurance coverage is available for all USPSTF-defined high-risk individuals and a CT lung screening compliance rate similar to that of colon screening of 60%, approximately 5.4 million Americans will enroll in CT lung screening programs. What will the effect be of CT lung screening on lung cancer statistics overall if only 1.7% of the total US population (319,000,000) and only 6% of the estimated 90,000,000 American “ever smokers” enroll in CT lung screening programs?69,70 Up to 200,000 cases of smoking-related lung cancer are diagnosed annually.1,71 Assuming the 1% prevalence rate of cancer observed in the NLST, screening only 6% of ever smokers will detect 27% (54,000 of 200,000) of all smoking-related lung cancers.3 On the basis of the observation made by the NLST that 320 patients are required to be screened in order to avoid 1 lung cancer death, screening 5,400,000 high-risk smokers could save nearly 16,800 lives.3

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Radiology Resources

On the basis of the LHMC CT lung screening experience, a single full time employee radiologist should be able to review 7000 to 8000 examinations each year.15 Seven hundred new full-time radiology positions would be needed to interpret 5.4 million examinations assuming full-capacity radiologist utilization at present. In addition, around 500 CT technologist and 1000 technologist aide positions may need to be created, assuming 1 technologist and 2 technologist aides can perform 5 scans per hour, each hour of an 8 hour shift. The 4% of patients with suspicious lung screening findings will require approximately 200,000 formal consultations with pulmonologists, or other program designated specialists, able to make patient-specific recommendations on the appropriate downstream diagnostic pathways including positron emission tomography/CT, follow-up CT, biopsy, and surgery.6,18,20

With millions of new CT scans being performed, CT x-ray tube demand will rise. Tube life is variable and depends on a variety of factors. One study reported a mean life of 16.5 months, which would equate to roughly 10,000 scans based on the manufacturer’s warranty of 6000 scans/12 months.72 Institutions providing screening will have to increase budgets for CT tube purchasing, and tube manufacturers will have to increase production to avoid tube shortages and associated limitations on overall CT capacity. Assuming a 60% national compliance rate, 540 additional CT x-ray tubes would need to be replaced each year. At a replacement cost of $200,000 per tube this would theoretically require around $100 million each year beyond current expenditure levels nationally; however, for many institutions these costs may be covered under preexisting CT service contracts.

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Surgical Resources Required to Treat Newly Diagnosed Lung Cancers

In the absence of screening, 70% of the 220,000 cancers detected annually present with locally advanced or metastatic disease (stage 3 or 4), most of which are not considered to be eligible for surgery.1,73 With screening, assuming a 1% cancer detection rate, 54,000 cancers would be found in 5.4 million high-risk patients screened; however, 30% or fewer of these screen-detected cancers would be late stage.3,20,74 For the remaining 166,000 cases of cancer detected outside of screening, 70% or 116,200 will be late stage. Therefore, screening 6% of ever smokers should decrease the total percentage of late-stage cancers diagnosed from 70% (154,000/220,000) to 60% (132,400/220,000) and would increase the number of cases of operable early-stage disease by 33%.

A recent study from Canada simulating the impact of CT lung screening on operative caseload of thoracic surgeons appears to confirm this back-of-the-envelope assessment.75 The study modeled the increased number of operable cases resulting from the stage shift associated with CT lung screening as well as the future supply of thoracic surgeons in Canada, based on current staffing levels, average retirement age, and number of surgeons graduating from training programs. By 2030, the study predicts that CT lung screening will lead to an increase in operative cases of lung cancer (I, II, IIIA) per surgeon of 35% over current levels.75 To maintain caseloads at current levels from now through 2030, an additional 2 new thoracic surgery resident positions would need to be added each year, although an excess of thoracic surgeons after 2030 would result when cases of lung cancer are expected to fall.75 With a population roughly one tenth that of the United States, this model suggests the need to expand the number of graduating thoracic surgeons by up to 20 each year for the next 15 years to maintain current caseloads in the setting of nationwide CT lung screening.75

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High-risk Population Growth

The other major risk factor for lung cancer besides smoking is age. Age is rising on average for the population at high risk as a result of an aging baby boom generation. Currently, the average age at the time of lung cancer diagnosis is 70.1 By 2020 the number of Americans in the 70 to 74 age range is expected to increase 33% from 11 million to 14.7 million.76 In fact, lung cancer incidence is not expected to peak until 2030 as a result of the accumulated history of smoking in this population, increasing the importance of effective secondary prevention.75 To provide safe and effective screening in the face of this growing population at high risk, adequately trained physician and support staff will need to be available. Workforce planning, including expansion of a suitable mix of incremental residency and fellowship positions to make sure that workforce demand can be met needs to start now.

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Estimating Individual Program Volume

To estimate the number of CT lung screening examinations that could be expected at an individual institution in the steady state, the institution’s mammography volume can be used as a benchmark. There are approximately 60,000,000 women eligible for screening mammography in the United States.76 Assuming that CT lung screening can achieve 80% of the compliance rate of mammography (60% vs. 72%), an institution performing 40,000 screening mammograms per year, or screening 0.07% of all eligible women, could expect to perform 5000 CT lung screening examinations per year (80% of 0.07% of 9,000,000 at high risk) or approximately 100 CT lung screening examinations per week.63 Adding 100 CT scans per week to current caseloads would require the institution to plan to replace for an additional CT tube every other year.

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CONCLUSIONS

Starting a CT lung screening program may feel like an overwhelming task. It is true that considerable planning is required, particularly within the department of radiology; at the same time, radiologists are the natural leaders of such a program, as the vast majority of patients (∼96%) never leave the imaging realm as they are exclusively followed up with imaging. The opportunity to catch lung cancer early and cure patients makes this a worthwhile endeavor and is a tremendous opportunity for radiologists to visibly highlight their role as valuable local partners in clinical care. The good news is that, since the closure of the NLST in October 2010, there has never been a better time to build a program.77 Today there is broad support for CT lung screening in the medical community, including the USPSTF recommendation and proposed CMS NCD for annual screening in individuals at high risk.5–7 As a result of these recommendations, most people considered to be at high risk will have insurance coverage for screening with no copay in 2015.9 This will eliminate one of the major barriers to CT lung screening access and acceptance. Joint society practice guidelines for the performance and reporting of CT lung screening examinations have been published, and accreditation criteria have been established detailing the facility/site/personnel requirements and expected quality control measures.6,32,34 An ACR clinical practice registry to aggregate outcome data and periodically provide feedback for standard quality benchmarks to participating organizations is being developed.6 A structured reporting system specifically tailored for CT lung screening, ACR Lung-RADS, is available and widely endorsed by a diverse group of stakeholders.6,18 The ACR, LHMC, and the Lung Cancer Alliance have made available, by means of the internet, a wealth of information and tools designed to help start and manage CT lung screening programs.31,78,79 Industry has brought online commercially available databases and program management software to enroll patients, schedule appointments, record findings, report results, and calculate quality metrics. CT lung screening workstations with integrated databases, reporting tools, and image libraries may be available by the time this article is published. Technological advances in image reconstruction should help significantly reduce what is already a very low dose of radiation for scan acquisition.80 In fact the major challenge now is simply keeping up with the rapidly expanding volume of resources specifically designed to help start and manage a safe and effective CT lung screening program.

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Keywords:

computed tomography lung screening; Lung-RADS; low-dose computed tomography; Rescue Lung, Rescue Life

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