Smoking cessation counseling and treatment are critical corollaries to low-dose computed tomography (LDCT) screening, offering an opportunity to reduce smoking-related mortality. Although the Centers for Medicare and Medicaid Services (CMS) requires that smoking cessation interventions be delivered in conjunction with lung cancer screening for Medicare reimbursement of LDCT screening, neither the most effective interventions nor the best approach for implementing those interventions with demonstrated efficacy in this setting is known. This research policy statement identifies consensus prioritization of diverse stakeholders regarding three topics for research on smoking cessation interventions in the context of LDCT screening: (1) target population to study; (2) adaptation, development, and testing of potential interventions; and (3) implementation of interventions with demonstrated efficacy. In each of these three domains, we summarize the existing evidence; identify research gaps; and, on the basis of a formal process of consensus development, prioritize research questions. The fourth section presents our committee’s recommendations for standardized tools and measures to use in conducting this research. This statement offers a research agenda to inform investigators as well as governmental and nongovernmental funding agencies to generate high-priority, high-quality research surrounding integration of tobacco dependence treatment with LDCT screening.

Lung cancer is the leading cause of cancer death in the United States (1, 2). Over 90% of lung cancer deaths would be avoided if Americans never initiated cigarette smoking. Quitting smoking is the most effective intervention to reduce lung cancer mortality (3, 4); yet, approximately 36.5 million Americans continue to smoke cigarettes (2, 5). Current smokers between the ages of 55 and 64 years would gain 4 years of life expectancy from avoided lung cancer and other tobacco-related deaths if they quit smoking (6). Among current smokers, the number needed to intervene is as low as 77 because providing cessation interventions to 11 individuals leads to at least 1 additional successful quitter (7), and depending on age and sex, 1 early death from all tobacco-related causes can be avoided by helping as few as 7 individuals quit smoking, even among middle-aged and older adults (8). Despite the fact that nearly 70% of current smokers attempt to quit each year, only 1 to 6% of smokers are successful in quitting (9, 10).

The other intervention proven to reduce lung cancer mortality is annual LDCT screening of middle-aged and older smokers with a substantial history of tobacco use, which is associated with a gain of 0.04 years of life expectancy from avoided lung cancer deaths (11, 12). The number needed to screen is 320 to prevent 1 early lung cancer death (11, 12). In the NLST (National Lung Screening Trial), individuals in the LDCT screening arm who successfully quit smoking had the lowest rate of lung cancer deaths (13). Thus, providing smoking cessation treatment in conjunction with LDCT screening offers an opportunity to combine two interventions known to reduce smoking-related morbidity and mortality.

Recognizing the importance of helping adults quit smoking, the CMS requires that smoking cessation interventions be offered to receive Medicare reimbursement of LDCT screening. Similarly, multiple professional organizations and the U.S. Preventive Services Task Force recommend that smoking cessation interventions be delivered in conjunction with LDCT screening (14). Yet, neither the most effective interventions nor the best approach for implementing those interventions with demonstrated efficacy in this setting is known.

The National Institutes of Health (NIH); the National Academies of Science, Engineering, and Medicine; the Association for the Treatment of Tobacco Use and Dependence; and the Society for Research on Nicotine and Tobacco have all highlighted the need for research on optimal strategies to integrate smoking cessation interventions within LDCT screening programs (15–17). In this research statement, we discuss the methodology and development of a stakeholder-endorsed research priority agenda relating to tobacco dependence treatment in LDCT screening programs.

The committee chair (H.K.) and cochair (R.S.W.) convened a team with expertise in LDCT screening and/or tobacco dependence treatment (Table 1). The team included multiple stakeholders representing the perspectives of scientists conducting translational, clinical, cost-effectiveness, implementation science, and health services research; governmental and nongovernmental funding agencies; professional societies; clinicians (physicians, nurses, and health educators specializing in pulmonary medicine, thoracic surgery, and/or tobacco dependence treatment); and patients. To understand diverse contexts and strategies for implementing smoking cessation treatment within LDCT screening programs, we selected individuals representing various clinical settings, including academic centers, community hospitals, integrated health systems, and the Veterans Health Administration. Potential conflicts of interest were disclosed and managed in accordance with the policies and procedures of the American Thoracic Society (ATS).

Our committee met in person at the May 2016 ATS International Conference. Designated moderators led group discussions on four topics: the effect of screening on smoking cessation, interventions for smoking cessation in the LDCT screening setting (not including interventions at the policy level), implementation of smoking cessation interventions in the LDCT screening setting, and standardized tools and measures to conduct research on smoking cessation interventions in the setting of LDCT screening. For each of these topics, the moderator summarized the existing evidence (based on primary literature and recent systematic reviews) and identified critical gaps. Through discussion, the committee compiled several draft research questions in three areas: (1) target population to study; (2) adaptation, development, and testing of potential interventions; and (3) implementation of interventions with demonstrated efficacy. For the fourth topic, we discussed existing tools and measures to conduct high-quality research on smoking cessation and compiled lists of resources for investigators working in this area.

Following the in-person meeting, the chairs further refined the draft research questions to eliminate redundancy, with assistance from committee members. We then came to consensus through group discussion on 7 questions in each of the three topics (21 questions total) to be posed to a larger group of stakeholder representatives (Table 1) for prioritization through a subsequent online survey. We identified stakeholders with expertise in tobacco dependence treatment, inviting all members of the ATS Tobacco Action Committee as of August 1, 2016. We also identified stakeholders with expertise in LDCT screening by recruiting from among experts who participated in the July 2016 National Academies of Science, Engineering, and Medicine Workshop on Implementation of Lung Cancer Screening. Finally, stakeholders with expertise in both tobacco dependence treatment and LDCT screening were identified by chairs and committee members and invited to participate in the online survey. In total, 77 stakeholders, who included representatives from payers, government and nongovernment agencies, patient advocacy groups, funding agencies, academic hospitals, government hospitals, integrated health systems, and physician and nonphysician professional organizations, were invited to participate in the online survey. Including our committee members, a total of 43 participants (56%) participated in the online survey (Table 1). Each stakeholder was asked to rank topics from 1 (most important) to 7 (least important) in each of the three topic areas, with no ties between questions within a given topic area (i.e., each question had to be assigned a unique rank). The final prioritization of questions was generated hierarchically on the basis of average rank assigned (lowest to highest).

The chairs drafted the initial version of the manuscript of this document with assistance from committee members. The manuscript was circulated to the full committee and iteratively revised. The final document was approved by the ATS Board of Directors.

The results are organized into four sections designed to help scientists and funding agencies conduct and assess research related to integration of smoking cessation interventions with LDCT screening. The first three sections correspond to the three topics in which questions were prioritized: (1) target population to study; (2) adaptation, development, and testing of potential interventions; and (3) implementation of interventions with demonstrated efficacy. The fourth section presents our committee’s recommendations for standardized tools and measures to conduct this research.

Under the auspices of the ATS, our committee employed a formal process of consensus development to produce a national research agenda for smoking cessation interventions within LDCT screening programs in collaboration with a diverse set of stakeholders. A complete list of stakeholder-endorsed research priorities is available in Tables 2–4. Stakeholder preferences were strongest for the following questions within each domain:

Population: How do LDCT screening results (positive or negative test results) affect motivation to quit, and what is the resultant impact on the effectiveness of cessation?

In comments and discussions with voting members, researching how LDCT screening results affect motivation to quit, as well as the resultant impact on effectiveness of cessation, was prioritized within the population domain because it is likely to influence how screening providers communicate with patients about their results and provide messages about smoking cessation. Whereas the CMS highlights the importance of integrating smoking cessation counseling in the initial shared decision-making conversation about screening, the voting members highlighted that post-screening messaging and interventions related to smoking cessation may also be a critical priority.

Within the intervention domain, the topic of developing an evidence base for understanding how established interventions that have been demonstrated to be effective in other settings perform in the LDCT screening context was prioritized in part because screening providers are eager to ensure that the cessation interventions they provide are effective in this setting. Many voting members emphasized that providing the most effective care possible is a priority and should be guided as much as possible by research evidence. Within the implementation domain, stakeholders identified that a clear challenge to increasing smoking cessation within the LDCT screening setting is ensuring that evidence-based interventions are fully implemented. As highlighted by Park and colleagues, less than 10% of providers fully provided cessation services, in part because of limitations of clinician time and resources (25). To maximally reduce lung cancer mortality, it is critical to overcome barriers to referring high-risk smokers for both LDCT screening and tobacco dependence treatment and to support implementation of full-service LDCT screening programs capable of providing evidence-based tobacco dependence treatment.

Stakeholders were more consistent across rankings for the domains of intervention and implementation, in each case prioritizing one or two questions as clear priorities, whereas rankings were more widely dispersed across the questions within the population domain. Of note, multiple stakeholders contacted the chairs to comment on how difficult it was to rank these questions because they considered all of them important, and not all stakeholders ranked questions in all domains, which may similarly indicate difficulty in assigning relative priority to the questions. Nonetheless, each topic represents the consensus prioritization of diverse stakeholders and provides an agenda for research on smoking cessation interventions in the context of LDCT screening.

This research is urgently needed, as recognized by multiple organizations, including the NIH and the National Academies of Science, Engineering, and Medicine (17, 53). The NCI recently awarded six R01 grants to develop and test smoking cessation interventions for current smokers undergoing LDCT lung cancer screening (45, 53). The standardized measures and approaches outlined in this document provide scientists the tools with which to conduct high-quality studies using a variety of methods (explanatory trials, pragmatic trials, mixed methods, comparative effectiveness) to answer these questions and to assess mechanisms through which intervention effects may occur (mediators such as psychological characteristics, perceived lung cancer risk, self-efficacy/confidence to quit). This statement provides a road map for scientists and government and nongovernment funding agencies to use in generating high-priority, high-quality research to answer pressing questions surrounding integration of tobacco dependence treatment within LDCT screening screenings. We hope this statement will stimulate the research needed to provide answers to clinicians and administrators seeking to deliver effective smoking cessation interventions to smokers undergoing LDCT screening, thereby improving care and ultimately reducing lung cancer mortality.