Abstract
INTRODUCTION: Although the National Lung Screening Trial (NLST) has proven low-dose computed tomography (LDCT) is effective for lung cancer screening, little is known about complication rates from invasive diagnostic procedures (IDPs) after LDCT in real-world settings. In this study, we used the real-world data from a large clinical research network to estimate the complication rates associated with IDPs after LDCT. METHODS: Using 2014-2021 electronic health records and claims data from the OneFlorida clinical research network, we identified case individuals who underwent an IDP (i.e., cytology or needle biopsy, bronchoscopy, thoracic surgery, and other surgery) within 12 months of their first LDCT. We matched each case with one control individual who underwent an LDCT but without any IDPs. We calculated 3-month incremental complication rates as the difference in the complication rate between the case and control groups by IDP and complication severity. RESULTS: Among 7,041 individuals who underwent an LDCT, 301 (4.3%) subsequently had an IDP within 12 months following the LDCT. The overall 3-month incremental complication rate was 16.6% (95% confidence interval [CI]: 9.9% - 23.1%), higher than that reported in the NLST (9.4%). The overall incremental complication rate was 5.6% (95% CI: 1.9% - 9.6%) for major, 8.6% (95% CI: 3.1% - 14.1%) for intermediate, and 13.2% (95% CI: 8.1% - 18.5%) for minor complications. CONCLUSIONS: It is important to ensure adherence to clinical guidelines for nodule management and downstream work-up to minimize potential harms from screening.