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Original Investigation
January 14, 2019

Complication Rates and Downstream Medical Costs Associated With Invasive Diagnostic Procedures for Lung Abnormalities in the Community Setting

Author Affiliations
  • 1Department of Health Services Research, Management and Policy, College of Public Health and Health Professions, University of Florida, Gainesville
  • 2Department of Health Services Research, The University of Texas MD Anderson Cancer Center, Houston
  • 3Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston
JAMA Intern Med. 2019;179(3):324-332. doi:10.1001/jamainternmed.2018.6277
Key Points

Question  What are the complication rates and downstream medical costs associated with invasive diagnostic procedures for lung abnormalities in the community setting?

Findings  In this cohort study of 344 510 patients in national databases, the estimated complication rate was 22.2% for individuals in the younger age group (55-64 years) and 23.8% for those in the Medicare group (65-77 years). The complication costs varied by patient age and complication type, ranging from $6320 to $56 845.

Meaning  Shared decision-making communications between physicians and patients on lung cancer screening should include a discussion on the risks of subsequent adverse events and downstream costs associated with invasive diagnostic procedures.


Importance  The Centers for Medicare & Medicaid Services added lung cancer screening with low-dose computed tomography (LDCT) as a Medicare preventive service benefit in 2015 following findings from the National Lung Screening Trial (NLST) that showed a 16% reduction in lung cancer mortality associated with LDCT. A challenge in developing and promoting a national lung cancer screening program is the high false-positive rate of LDCT because abnormal findings from thoracic imaging often trigger subsequent invasive diagnostic procedures and could lead to postprocedural complications.

Objective  To determine the complication rates and downstream medical costs associated with invasive diagnostic procedures performed for identification of lung abnormalities in the community setting.

Design, Setting, and Participants  A retrospective cohort study of non–protocol-driven community practices captured in MarketScan Commercial Claims & Encounters and Medicare supplemental databases was conducted. A nationally representative sample of 344 510 patients aged 55 to 77 years who underwent invasive diagnostic procedures between 2008 and 2013 was included.

Main Outcomes and Measures  One-year complication rates were calculated for 4 groups of invasive diagnostic procedures. The complication rates and costs were further stratified by age group.

Results  Of the 344 510 individuals aged 55 to 77 years included in the study, 174 702 comprised the study group (109 363 [62.6%] women) and 169 808 served as the control group (106 007 [62.4%] women). The estimated complication rate was 22.2% (95% CI, 21.7%-22.7%) for individuals in the young age group and 23.8% (95% CI, 23.0%-24.6%) for those in the Medicare group; the rates were approximately twice as high as those reported in the NLST (9.8% and 8.5%, respectively). The mean incremental complication costs were $6320 (95% CI, $5863-$6777) for minor complications to $56 845 (95% CI, $47 953-$65 737) for major complications.

Conclusions and Relevance  The rates of complications after invasive diagnostic procedures were higher than the rates reported in clinical trials. Physicians and patients should be aware of the potential risks of subsequent adverse events and their high downstream costs in the shared decision-making process.

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    1 Comment for this article
    Comparing apples with watermelons
    Frederic Grannis, Cliical Professor of Surg | City of Hope National Medical Center
    A recent article in JAMA Internal Medicine from Ya-Chen Tina Shih, PhD, from the University of Texas, draws highly questionable conclusions from a study comparing two widely disparate groups of patients and concludes that risks described to patients in CT screening shared-decision making should be more than doubled. This is very wrong.
    A few facts are necessary to consider.
    First, less than two percent of those at high risk of lung cancer (LC) are currently screened in the U.S. Hence, only fewer than one in 50 of the patients in their study group were screen participants. Screened patients
    are asymptomatic and in generally good health. Neither is the case with their study group of patients with symptomatic clinical illness . It is accordingly not surprising to find higher complications in their group.
    Do the authors seriously expect anyone to believe their assertion that the complication rate after bronchoscopy is 36%?
    In addition, the NLST is also a poor control group. Because NLST did not employ a diagnostic algorithm, far too many unnecessary procedures were done, with higher expense and complications. In properly conducted CT screening, following IELCAP or NCCN guidelines, testing for non-malignant nodules detected by screening is much lower, as are cost and morbidity.
    The correct conclusion is that CT screening, conducted properly, is very safe and cost effective and that is what patients should be told in shared decision making. They should also be told that LC detected by CT screening experience 10-year survival in more than 80% of cases.
    Finally, we should get rid of the requirement for shared decision making in lung cancer. No other cancer screening carries this burden. The requirement for primary care providers to spend a considerable amount of time combined with grossly inaccurate available decision aids combine to drive down the rate of uptake of LC screening with consequent failure to save many lives.
    CONFLICT OF INTEREST: IELCAP research with paid accomodations and travel to research meetings. Paid testimony in medical monitoring llawsuits against Philip Morris Corp.