In a study reported in a research letter in JAMA Network Open, Zhao et al found that the rate of complications from invasive diagnostic procedures after low-dose computed tomography (CT) lung cancer screening in the community setting was lower than a prior estimate—but still higher than reported in the National Lung Screening Trial (NLST).
As related by the investigators, a previous analysis reported in 2019 indicated that complication rates of invasive diagnostic procedures for abnormal screening findings in the community setting were more than double those reported in the NLST. That analysis has been criticized on the basis that the findings may not have been truly representative of screening cohorts, because it included claims data predating insurance coverage of low-dose CT screening.
"The overall complication rate from this updated analysis remained 77% higher than that reported in the NLST. This higher rate observed among a screening cohort in community settings validates the concern of higher complication rates outside the NLST."— Zhao et al
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Study Details
The study used data from the IBM MarketScan Research Database (Commercial Claims and Encounters and Medicare Supplemental and Coordination of Benefits databases) to identify individuals who underwent low-dose CT screening between February 2015 and June 2017; those who underwent invasive diagnostic procedures within 6 months of low-dose CT; and those who experienced complications during the 3 months following such procedures.
All patients had to be enrolled in private health insurance (including Medicare supplemental insurance) for 6 months before and after low-dose CT. Invasive procedures were defined as cytology or needle biopsy, bronchoscopy, thoracic surgery, and other surgical procedures. A case-control analysis was performed with matching for age, sex, comorbidity score, state of residence, and quarter-year of low-dose CT screening.
Key Findings
Among 18,887 patients who underwent low-dose CT screening, 665 patients (3.5%) underwent invasive diagnostic procedures within 6 months after screening. A total of 591 matched pairs were included in case-control analysis.
The overall incremental complication rate for all invasive diagnostic procedures was 16.6% (95% confidence interval [CI] = 13.7%–19.9%). This rate was less than the 22.8% (95% CI = 22.6%–22.9%) rate reported in the previous analysis, but greater than the 9.4% (95% CI = 7.0%-12.3%) rate reported in the NLST.
The incremental complication rates were 38.5% (95% CI = 30.2%–47.4%) for thoracic surgery, 20.4% (95% CI = 14.2%–28.4%) for bronchoscopy, and 9.2% (95% CI = 6.2%–13.5%) for cytology or needle biopsy. According to severity, rates were 1.7% (95% CI = 0.9%–3.2%) for major, 9.3% (95% CI = 7.2%–12.0%) for intermediate, and 11.2% (95% CI = 8.8%–14.1%) for minor complications.
The investigators stated, “The overall complication rate from this updated analysis remained 77% higher than that reported in the NLST. This higher rate observed among a screening cohort in community settings validates the concern of higher complication rates outside the NLST. One limitation of this study was that we were not able to determine whether patients who had low-dose CT screening met the screening eligibility criteria because information on smoking pack-years and history was not available in claims data. As policymakers develop strategies to improve lung cancer screening rates in communities, our study highlights the importance of minimizing potential harms of screening by using shared decision-making and ensuring adherence to clinical guidelines for evaluation and management of screening-detected lung abnormalities.”
Ya-Chen Tina Shih, PhD, of the Department of Health Services Research, The University of Texas MD Anderson Cancer Center, is the corresponding author for the JAMA Network Open article.
Disclosure: The study was supported in part by a grant from the National Cancer Institute. For full disclosures of the study authors, visit jamanetwork.com.
