Implementing lung cancer screening with low-dose computed tomography (CT) for high-risk persons poses logistic challenges and the data for the outcomes reported suggest more harm than benefit, according to a population-based Veterans Health Administration (VHA) study, the Lung Cancer Screening Demonstration Project.
Conducted in more than 2000 high-risk VHA patients aged 55 to 80 years, the study found lung cancer in 1.5% of patients, but around 60% of individuals who were screened were positive for the test, including 1 or more nodules that needed to be tracked. Incidental findings were further reported in around 40% of patients. Moreover, the logistics of setting up the project provided inordinate challenges even for a well-oiled machine such as the VHA, the researchers said.
The study is published online January 30 in JAMA Internal Medicine.
"During the process of setting up the project, we found that lung cancer screening is far more than just a scan," corresponding author Linda S. Kinsinger, MD, MPH, told Medscape Medical News. "It required developing new materials and ensuring collaboration and coordination between various clinical services and between clinical services and patients," she added.
Dr Kinsinger, now retired, was at the VHA National Center for Health Promotion and Disease Prevention in Durham, North Carolina, during the 3-year project.
This study "gives us the first carefully performed evaluation of a lung cancer screening program," write Rita F. Redberg, MD, MSc, and Patrick G. O'Malley, MD, MPH, in an accompanying editorial.
Dr Redberg is from the University of San Francisco, California, and is the editor of JAMA Internal Medicine. Dr O'Malley is from the Division of General Internal Medicine at the Uniformed Services University, Bethesda, Maryland, and is a deputy editor for the journal.
"We have to give the VHA credit for showing us the challenges faced in doing lung cancer screening correctly," Dr Redberg told Medscape Medical News.
"The findings of the VHA study and my own experience in reviewing the data indicates that LCS [lung cancer screening] is not the slam dunk we were told it would be," Dr Redberg said in an interview. "It is quite clear from this study that a substantial proportion of patients are harmed and many do not get the benefits," she added. "Indeed, we are learning more and more that early detection is not always better and that we detect things we do not need to worry about," Dr Redberg pointed out.
Resources Required for Implementation
Dr Kinsinger explained in an interview that the VHA project was not designed to replicate the National Lung Screening Trial, which was the basis of the 2013 US Preventive Services Task Force (USPSTF) recommendation.
Rather, a proactive population-based approach actively sought out all eligible individuals based on the USPSTF recommendation, she elaborated. Indeed, following VHA policy, this project was not deemed to be research but was "declared nonresearch clinical operations activities."
The project received funding for 3 years from the national VHA, which paid a full-time salary for a lung cancer screening coordinator in each of the eight participating facilities. The coordinator was responsible for educating primary care staff about the program. "Smaller facilities may not require a full-time coordinator," Dr Kinsinger conceded
The eight sites selected for this program had a dedicated staff — "strong support from facility leadership, clinical champions, and an onsite CT scanner, a radiologist, a multidisciplinary lung cancer program, and a tobacco cessation program," the researchers note.
Organizational efforts and processes included descriptions of leadership efforts, site activities, and local implementation processes used at each site. The efforts were documented in project notes, telephone calls and emails with site leaders and coordinators, and monthly site reports.
Project materials were developed for both patients and staff, including an implementation guide, which provided detailed guidance on a recommended approach to conduct the screening program, including resources, tools, and the evaluation plan.
Patient education materials and guidelines for nodule follow-up required revisions to improve clarity and utility, the researchers note.
Patient-level data were collected by using reminders, and medical electronic tools for gathering information not recorded with standardized codes were obtained from the VHA central data repository. A patient tracking system was also put in place for patients with suspicious findings, which required follow-up.
Dr Kinsinger explained that even with the VHA's highly esteemed electronic medical records, more detailed information about pack-years of smoking and years since quitting was not always captured.
Findings From the Demonstration Project
Across the eight sites, 4246 of 93,033 individuals were eligible for lung cancer screening using low-dose CT. They had a history of 30 or more pack-years of smoking, were current or former smokers (quit smoking <15 6="" a="" ago="" and="" cancer.="" did="" expectancy="" greater="" had="" have="" life="" months="" not="" of="" p="" than="" years="">
Of the 4246 individuals who were eligible for screening, just over half (57.7%) consented to screening.
In the paper, the researchers report results for 2106 individuals who completed lung cancer screening by June 2015. Follow-up was around 1 year.
Of the 2106 individuals who were screened, 1257 (59.7%) had a positive test result, including 1184 (56.2%) with one or more nodules that needed to be tracked. Most nodules were small (<5 and="" cm="" p="" solid.="">15>
Seventy-three patients (3.5%) had findings suspicious of lung cancer, and lung cancer was confirmed for 31 of these patients (1.5%) within a 330-day follow-up period. The average number of days from scan to diagnosis of lung cancer was 137 days (range, 5 - 330 days).
The rate of false-positive test results was 97.5% (1226 of 1257).
Incidental findings that might require follow-up were reported for 857 (40.7%) patients. The most common of these were emphysema, other pulmonary abnormalities, and coronary artery calcification.
Extrapolating from their study to the overall VHA population, the researchers estimate that 2,780,933 VHA patients would meet eligibility criteria for visits, age, and medical history; of these, around 900,000 VHA patients may be candidates for lung cancer screening using low-dose CT, based on their smoking history.
Accurately identifying these patients and discussing with them the benefits and harms of lung cancer screening will take significant effort for primary care teams, the study authors note.
While the study had its limitations and may not be generalizable to non-VHA healthcare systems and nonveterans, the study authors conclude: "The experience of the VHA, owing to its central organizational structure, may represent a best-case scenario, but even the VHA was challenged with implementing LCS [lung cancer screening]."
Arguments Against Population-Based Lung Cancer Screening
[We] found that implementing a comprehensive LCS program that followed recommendations to be challenging and complex, requiring new tools and patient care processes for staff as well as dedicated patient coordination," Dr Kinsinger and investigators write.
"Any healthcare system that is deciding on such an undertaking should go into it with their eyes wide open," Dr Kinsinger told Medscape Medical News.
The authors cite several drawbacks of a comprehensive lung cancer screening program, which included stressing the capacity of radiology services, increase in the workload of pulmonary services for nodules that needed follow-up, and the involvement of primary care in determining which incidental findings needed follow-up.
Quality assurance measures are also required for a successful screening program. In this study, the outcomes reported varied widely. The wide range of nodular findings (31% - 85%) may reflect differences in interpretation of participating radiologists. "Better standardization is required for consistency," Dr Kinsinger said. "Better guidelines for nodule follow-up are also needed," she added.
In their editorial, Dr Redberg and Dr O'Malley calculate that, based on the data reported, for every 1000 individuals who are screened, 10 will be diagnosed with early-stage lung cancer, 5 will be diagnosed with late-stage lung cancer, and 20 will undergo invasive procedures (bronchoscopy and thoracotomy) directly related to screening.
"It is very disturbing to know that more than 50% [550/1000] of patients will experience unnecessary alarm and repeat scans, with its associated irradiation," Dr Redberg told Medscape Medical News. "These are not good odds of benefit and this is likely the best data we'll get," she added.
Based on a separate report, also published online January 30, the editorialists point out that most lung cancer screening appears to be carried out in individuals who are not even eligible for such screening because they are low-risk individuals and never-smokers.
In April 2014, as a nonvoting member, Dr Redberg chaired the lung cancer screening discussion for Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) that recommended againstlow-dose CT for lung cancer screening. The reasons are highlighted in the editorial: harm from radiation if low-dose CT protocol was not followed, high rate of false-positives leading to potentially unnecessary invasive and risky procedures, high variability and low reproducibility of radiology readings for nodules, and higher morbidity and mortality from operative procedures.
Yet, in 2015, the Centers for Medicare & Medicaid Services (CMS) agreed to cover lung cancer screening for smokers aged 55 to 77 years.
The editorialists indicate that only robust economic and utility analyses can evaluate "[w]hether the benefits from this program outweigh the harms, and whether LCS is a wise investment of considerable resources required for screening and training."
The study authors point out that cost and budget effect analyses will be reported separately.
The study was funded by the Veterans Health Administration. Dr Kinsinger is retired and has disclosed no relevant financial relationships. The disclosures of other study authors are available in the publication. Dr Redberg served as chair of the MEDCAC panel for the Lung Cancer Screening discussion and is editor ofJAMA Internal Medicine, which published the study.
JAMA Intern Med. Published online January 30, 2017.5>