Complication rates following invasive diagnostic procedures for lung abnormalities in the community setting were twice as high as those reported in the National Lung Screening Trial (NLST) in one of the first studies to attempt to examine the real-world costs and complications of screening for lung cancer.
The complication rate in the study among participants from the ages of 55 to 64 was 22.2%, compared with 9.8% in the NLST. The rate of complications was 23.8% among participants from the ages of 65 to 77, versus 8.5% in the NLST.
Associated downstream costs in the study, which was conducted by Ya-Chen Tina Shih, PhD, and colleagues at the University of Texas MD Anderson Cancer Center in Houston, ranged from $6,320 for minor complications of invasive diagnostic procedures, such as allergic reactions, to $56,845 for major complications, such as lung collapse.
The findings, appearing in JAMA Internal Medicine, reinforce the need for physicians to discuss the risks and benefits of lung cancer screening with eligible patients, said Shih.
Shared-decision making is a requirement of reimbursement for low-dose computed tomography lung cancer screening, which was mandated by the Centers for Medicare & Medicaid Services (CMS) beginning in 2015.
But evaluations of shared decision-making in the clinical setting — including one published simultaneously in the same journal indicated (see below) — suggest that real-world execution is far from optimal. Another recent analysis showed patient involvement in lung screening conversations to be minimal, with conversation times averaging less than a minute and discussions of potential harms associated with screening almost nonexistent.
“Shared decision-making is required for provider reimbursement, but we haven’t really known how it is being implemented,” Shih told MedPage Today. “From what we have been hearing, it appears it isn’t happening as frequently as we would like to see.”
Indeed, the new investigation of Medicare recipients undergoing lung cancer screening after the CMS mandate, also appearing in JAMA Internal Medicine, showed “remarkably low uptake of shared decision-making.”
Of just over 19,000 Medicare enrollees in the sample screened in 2016, just 1,719 (9%) had a separate shared decision-making physician’s visit on the day of screening or in the previous 3 months, according to James Goodwin, MD, and colleagues from the University of Texas Medical Branch at Galveston.
Characteristics associated with lower odds of shared decision-making before screening included:
- Black race: OR 0.76 vs white; 95% CI 0.59-0.97
- Female sex: OR 0.88; 95% CI 0.79-0.98
- Education: OR 0.81 for highest vs lowest quartile; 95% CI 0.68-0.96
Among recipients who did have a shared decision-making visit, 40% chose not to have lung cancer screening.
In the study by Shih and colleagues, the researchers said they had to use an indirect approach to estimate real-world costs and complications from lung cancer screening. The analysis of claims data from the MarketScan database from 2008 to 2015 did not include information of lung screening because the billing code for screening was not established until 2015, the investigators explained. So they looked for similar procedures associated with lung abnormalities reported in NLST.
The retrospective study included 174,702 people (62.6% of whom were female) from the ages of 55 to 77 who had invasive diagnostic procedures during the period, and a matched control group of 169,808 people (62.4% female) who did not have the procedures.
Among the main findings:
- The estimated complication rate was 22.2% (95% CI 21.7%-22.7%) among those in the younger age group and 23.8% (95% CI 23.0%-24.6%) among those in the Medicare group
- Complication rates were approximately twice as high as those reported in the NLST (9.8% and 8.5%, respectively)
- Mean incremental complication costs were $6,320 (95% CI $5,863-$6,777) for minor complications and $56,845 (95% CI $47,953-$65 737) for major complications
A significant study limitation cited by the researchers was the lack of direct data on people meeting lung screening eligibility criteria receiving screening for lung cancer, given that the study period predated CMS reimbursement for lung screening.
Shih said a clearer picture of lung screening complications will emerge in the next few years, as more direct screening data become available. But she added that results from the study, while tentative, should be included in shared decision-making discussions for lung cancer screening.
“Our study provides additional information, but it isn’t intended to scare people,” she emphasized. “The reality is that out of the screening population, less than 5% would have abnormal findings that would trigger an invasive procedure.”
But Rita Redberg, MD, editor of JAMA Internal Medicine, questioned the value of lung cancer screening in an Editor’s Note. Commenting on the findings by Goodwin’s group, Redberg wrote that the high percentage of patients who chose not to be screened after shared decision-making visits likely reflects “the high false-positive rate, high chance of incidental findings, and subsequent need for invasive procedures and small chance of benefit.”
“These data,” she said, “suggest that the current use of resources for lung cancer screening should be reexamined and efforts should be refocused on smoking cessation and smoking prevention to prevent lung cancer and improve health.”
The study by Shih and colleagues was funded by the University of Texas MD Anderson Cancer Center, the University of Florida Health Cancer Center, and the National Cancer Institute.
The study by Goodwin and colleagues was funded by the Cancer Prevention and Treatment Institute of Texas and the National Institutes of Health.