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Concerns Related to Benefits and Harms of Real-World Shared Decision-Making for Lung Cancer Screening

Web Exclusives - Perspectives
James L. Mulshine, MD; David F. Yankelevitz, MD; Bruce Pyenson, FSA, MAAA
Dr Mulshine is Professor, Department of Internal Medicine, Rush Medical College, Rush University, Chicago, IL; Dr Yankelevitz is Professor of Radiology, Mount Sinai School of Medicine, New York, NY; Mr Pyenson is Adjunct Clinical Associate Professor, School of Global Public Health, New York University, and Principal, Milliman, New York, NY.

The US Preventive Services Task Force (USPSTF) has recently reaffirmed the benefit of lung cancer screening and has extended the eligibility to include additional at-risk individuals.1 In its final statement published on March 9, 2021, the USPSTF updated its recommendation to include annual screening for lung cancer with low-dose computed tomography (CT) in adults aged 50 to 80 years who have a 20 pack-year smoking history and who currently smoke or have quit smoking within the past 15 years.1

In that report, the USPSTF states that the harms associated with low-dose CT screening include false-positive results that lead to unnecessary tests and invasive procedures, incidental findings, short-term increases in distress resulting from indeterminate results, overdiagnosis, and radiation exposure.1 In light of these potential harms, the initial, 2015 Medicare coverage determination required a formal shared decision-making visit before screening.2

Although acceptance of new cancer screening services takes time, we believe that there is a general concern in the thoracic cancer community that the pace of lung cancer screening uptake is slower than expected,3,4 with, at most, 15% uptake. A critical obstacle to lung cancer screening often identified as a cause for this slow implementation is the unique Medicare obligation for the prescribing provider to conduct a formal shared decision-making visit with the patient.5

Other established cancer screenings are standard of practice, with no requirement for a shared decision-making visit, and a provider’s failure to recommend screening can increase their medical professional liability risk. The extra burden of the shared decision-making visit is especially troubling when issues associated with hesitancy about a public health measure are surfacing as a critical factor affecting equitable access to life-saving services.

In a recent JAMA editorial, Hoffman and colleagues dismissed shared decision-making as an implementation barrier, without objective evidence.6 This situation with shared decision-making is unfortunate, given the USPSTF recommendation that screening with thoracic CT should be expanded to include people at younger ages and with less smoking history,1 especially in light of the absence of evidence supporting the shared decision-­making process in this context.

Medicare does not require a shared decision-making visit for breast or colon cancer screenings. These screening modalities are offered to the general population based on age and sex.7 By contrast, lung cancer screening is recommended only for a smaller, higher-risk cohort of heavily tobacco-exposed individuals.1,2 With lung cancer screening, the risk for being diagnosed with cancer is higher than with breast or colon cancer screenings, and lung cancer is a more lethal cancer than these 2 cancers (or most other cancers),8 so that the benefit of life-years saved may also be greater. Ironically, breast and colon cancer screenings have much higher participation rates than the rates for lung cancer screenings.9

We now know that the long-term follow-up of the US National Lung Screening Trial has confirmed an objective mortality benefit with lung cancer screening and has demonstrated a very low overdiagnosis rate of 3% with such screening.10 This overdiagnosis rate is much lower than the more than 18% overdiagnosis rate that is generally cited in shared decision-making tools, and this factor was considered one of the most worrisome major potential harms of lung cancer screening.10,11 The nearly 1 in 5 overdiagnosis rate used in many shared decision-­making scripts may be a major negative factor relative to screening participation.12

The oddly cautious approach to lung cancer screening compared with other screenings appears in many reports. For example, the recent USPSTF statement on colorectal cancer screening does not mention radiation doses for CT colonography even though CT colonography typically involves higher radiation doses than lung cancer screening13; but radiation dose is part of most shared decision-making scripts for lung cancer screening. In addition, incidental findings (ie, radiographic findings that are discovered unintentionally during the CT evaluation) were cited as a harm of lung cancer screening, but were not noted to be problematic in the USPSTF comments on CT colonography, even though incidental findings frequently occur in both settings.13

Since 2002, when the National Cancer Institute launched its randomized screening study (the National Lung Cancer Screening Trial10) the potential harms associated with lung cancer screening, including the rate of false-positive diagnostic workups, overdiagnoses, and medical radiation dose exposure, have been reduced below the low levels in the trial through currently available screening management.14

Tobacco exposure leads to most lung cancers, even after successful cessation, so it continues to cut short the lives of countless individuals who have ever smoked. In a landmark 2006 decision, District Judge Gladys Kessler found that the major US tobacco companies had violated civil racketeering laws and engaged in a decades-long conspiracy to deceive the American public about the health effects of smoking and their marketing to children.15 The tobacco industry knowingly targeted children, blacks, and other vulnerable communities to use this lethal product.15

Lung cancer screening is a tool that can facilitate cure for people who would be diagnosed at an earlier-stage disease through screening. There is an ethical imperative to ensure that effective lung cancer screening is available, without hindrance to those who could benefit from it.

We struggle to imagine a shared decision-making process that would have accelerated or improved the current COVID-19 vaccination rates. If a prevention service is objectively validated, at-risk individuals should be provided information regarding the benefits and harms of that service, as we currently do with breast and colon cancer screenings, as well as with COVID-19 vaccinations. No public good is served by imposing a potentially significant implementation barrier uniquely on the lung cancer screening process.

Author Disclosure Statement

Dr Mulshine and Mr Pyenson have no conflicts of interest to report related to this perspective. Dr Yankelevitz has received financial compensation as an inventor of several patents and patent applications for evaluation of diseases of the chest, including measurement of nodules; he is a consultant for and co-owner of Accumetra, a private company developing tools to improve the quality of CT imaging; and is on the Advisory Board of Grail, which provides blood tests for cancer detection.

References

  1. US Preventive Services Task Force. Screening for lung cancer: US Preventive Services Task Force recommendation statement. JAMA. 2021;325:962-970.
  2. Centers for Medicare & Medicaid Services. Decision memo for screening for lung cancer with low dose computed tomography (CAG-00439N). February 5, 2015. www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=274. Accessed March 16, 2021.
  3. Raz DJ, Wu GX, Consunji M, et al. Perceptions and utilization of lung cancer screening among primary care physicians. J Thorac Oncol. 2016;11:1856-1862.
  4. Eberth JM, McDonnell KK, Sercy E, et al. A national survey of primary care physicians: perceptions and practices of low-dose CT lung cancer screening. Prev Med Rep. 2018;11:93-99.
  5. Fedewa SA, Kazerooni EA, Studts JL, et al. State variation in low-dose computed tomography scanning for lung cancer screening in the United States. J Natl Cancer Inst. 2020 Nov 12. Epub ahead of print.
  6. Hoffman RM, Reuland DS, Volk RJ. The Centers for Medicare & Medicaid Services requirement for shared decision-making for lung cancer screening. JAMA. 2021;325:933-934.
  7. Smith RA, Andrews K, Brooks D, et al. Cancer screening in the United States, 2016: a review of current American Cancer Society guidelines and current issues in cancer screening. CA Cancer J Clin. 2016;66:96-114.
  8. American Cancer Society. Key statistics for lung cancer. Updated January 12, 2021. www.cancer.org/cancer/lung-cancer/about/key-statistics.html. Accessed June 7, 2021.
  9. Sharma KP, Grosse SD, Maciosek MV, et al. Preventing breast, cervical, and colorectal cancer deaths: assessing the impact of increased screening. Prev Chronic Dis. 2020;17:E123.
  10. National Lung Screening Trial Research Team. Lung cancer incidence and mortality with extended follow-up in the National Lung Screening Trial. J Thorac Oncol. 2019;14:1732-1742.
  11. Patz EF Jr, Pinsky P, Gatsonis C, et al; for the NLST Overdiagnosis Manuscript Writing Team. Overdiagnosis in low-dose computed tomography screening for lung cancer. JAMA Intern Med. 2014;174:269-274. Erratum in: JAMA Intern Med. 2014;174:828.
  12. Agency for Healthcare Research and Quality. Is lung cancer screening right for me? March 2016. https://effectivehealthcare.ahrq.gov/decision-aids/lung-­cancer-screening/patient.html. Accessed June 8, 2021.
  13. US Preventive Services Task Force. Screening for colorectal cancer: US Preventive Services Task Force recommendation statement. JAMA. 2021;325:1965-1977.
  14. American Lung Association. What to expect from a lung cancer screening. Updated April 15, 2020. www.lung.org/lung-health-diseases/lung-disease-lookup/lung-cancer/saved-by-the-scan/resources/what-to-expect-from-lung-cancer-screening. Accessed June 8, 2021.
  15. Campaign for Tobacco-Free Kids. U.S. racketeering verdict: big tobacco guilty as charged. Updated May 2, 2018. www.tobaccofreekids.org/what-we-do/industry-watch/doj. Accessed June 8, 2021.
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Last modified: September 22, 2021
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