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The goal of screening is to detect a disease of serious consequence before it manifests clinical symptoms to improve the likelihood of a cure. What makes a screening program successful is balance —the outcome of a successful screening program is reduced deaths from a disease without causing substantial harm to the population being screened. The balance between benefit and harm from screening is different than diagnostic testing.
While diagnostic tests are used to evaluate individuals with symptoms or signs of a disease, we are testing asymptomatic individuals in screening. Only a minority of these individuals will benefit from screening, and the magnitude of the benefit and the most common harms are not equal. But implementation of screening through the development of high-quality programs can optimize this balance.
Two large controlled trials have shown that lung cancer screening with a low radiation dose chest computerized tomography (LDCT) scan reduces lung cancer mortality in a population at high risk for developing lung cancer.1,2 These, and other studies, have also informed us about the potential harms of screening. Most commonly, harm can occur during the performance of the screening test (e.g., radiation exposure) or from the management of screen-detected findings (e.g., biopsy or surgery for screen-detected benign lung nodules, overtreatment of cancer). Thoughtful planning of the components of a lung cancer screening program can maximize the benefit and minimize the harms.
There are 10 components of a high-quality screening program to consider:
Program structure: At the extremes, a program can be centralized or de-centralized. In a centralized program, individuals who are screen eligible are referred to the program and the program is responsible for their care. In a decentralized program, the care of individuals who are screen eligible is owned by the provider ordering the test. In between these extremes exists a hybrid option where the program elements are shared by the provider and the program. There is some evidence to suggest that the quality of centralized programs is highest, but all program structures can be successful if attention is paid to the remaining components.3
Who to enroll in a lung cancer screening program: Guidance from the United States Preventive Services Task Force (USPSTF) has contributed to policy from Centers for Medicare & Medicaid Services and other payors for who should be screened. Additional considerations at a program level include insuring equity in access to care and the selection of individuals who are otherwise well enough to tolerate the evaluation of screen detected findings and who would benefit from treatment of a screen detected early stage lung cancer.
How to identify and schedule screen eligible individuals: Uptake of lung cancer screening has been slow with many screen eligible individuals and providers either unaware of their eligibility or choosing not to be screened. Education of individuals and providers, ease of access to screening sites, the use of reminders and automated communication within electronic health records can help to increase uptake (Figure 1).
Shared-decision making: The fulcrum of the balance between benefit and harm shifts based on individual values. Successful shared decision making (SDM) integrates available evidence with patient values — often incorporating a tool such as a decision aid — to help an individual make a decision that is in line with their values. A screening program should plan for SDM either conducted by the central team or by supporting and sharing tools with ordering providers.
Perform and report the LDCT: A strong partnership with radiology is critical to high-quality screening. Monitoring the radiation dose delivered, the quality of the images produced, the accuracy of the image interpretation and the delivery of the interpretation through a structured radiology report are critical program elements.
Lung nodule evaluation: To expedite care of a screen detected lung cancer and minimize harms from the evaluation of benign lung nodules, each program should have experts in lung nodule evaluation and management algorithms for small solid, larger solid, and sub-solid lung nodules in place. A common approach is to use the LungRADS system in the structured reports to guide the frequency of monitoring lower risk lung nodules.4 Review of the management of higher risk lung nodules at a lung nodule tumor board may help to meet the goals outlined.
Non-lung nodule findings: LDCT images often uncover other findings in the chest, such as parenchymal lung disease, coronary artery calcification, aortic aneurysms, thyroid and adrenal nodules. These findings should be described in a standard fashion in a structured radiology report, and a screening program should develop an approach to supporting their management in partnership with specialists in these areas and in accordance with available guidelines.
Screening adherence: Adherence with annual screening and nodule follow-up has been reported to be quite low yet is critical to the success of a screening program. Systems should be put in place to allow for patient tracking and communication in order to maximize adherence.
Smoking cessation: Individuals who smoke should be offered smoking cessation guidance as part of the screening program, either delivered by program personnel, through referral to central resources or by supporting the referring provider.
Quality improvement: Quality indicators have been developed in relation to the selection of screen eligible individuals, the provision of smoking cessation guidance, adherence with annual screening and timely evaluation of lung nodules. Each program should be able to collect data that allows them to assess performance of these and other measures. This data should be tied to improvement projects. Program managers and population management software systems can be critical to these efforts.
Lung Cancer Screening at Cleveland Clinic
The Cleveland Clinic lung cancer screening program is a centralized program. Providers across the health system refer eligible individuals to one of the program’s providers at a local site. The program team engages each individual in a shared decision making visit that includes a review of eligibility, education about the benefit and harms of screening, use of a decision-aid, an overview of likely findings, the need for annual screening and smoking cessation counseling if needed. An LDCT is performed based on standardized protocols with radiation dose monitoring and tracking. Trained thoracic imaging radiologists interpret the LDCT and report the findings in a structured report. LungRADS is used as the basis for the report and the management of low-risk lung nodules.
Cleveland Clinic also has several systems in place to ensure that each case is reviewed carefully and that patients follow their care team’s recommendations. A multi-disciplinary lung nodule tumor board reviews the management of all concerning lung nodules. Adherence with follow-up and annual screening is tracked using a population management software program. Algorithms and partnerships have been developed for the management of non-lung nodule findings. The program developed objectives and tracks key results by attaching action plans to areas in need of improvement.
By designing a lung cancer screening program with attention to these 10 considerations, screening programs can achieve the goal of optimizing the benefit and minimizing the harms of lung cancer screening.