Yang Shuang, Shih Ya-Chen Tina, Huo Jinhai, Mehta Hiren J, Wu Yonghui, Salloum Ramzi G, Alvarado Michelle, Zhang Dongyu, Braithwaite Dejana, Guo Yi, Bian Jiang
Department of Health Outcomes and Biomedical Informatics, College of Medicine, University of Florida, Gainesville, FL, United States.
Department of Health Services Research, University of Texas MD Anderson Cancer Center, Houston, TX, United States.
Lung Cancer. 2022 Mar;165:141-144. doi: 10.1016/j.lungcan.2021.12.020. Epub 2022 Jan 4.
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.
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.
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.
It is important to ensure adherence to clinical guidelines for nodule management and downstream work-up to minimize potential harms from screening.
尽管国家肺癌筛查试验(NLST)已证明低剂量计算机断层扫描(LDCT)对肺癌筛查有效,但在现实环境中,对于LDCT后侵入性诊断程序(IDP)的并发症发生率知之甚少。在本研究中,我们使用了来自大型临床研究网络的真实世界数据来估计LDCT后与IDP相关的并发症发生率。
利用2014年至2021年来自OneFlorida临床研究网络的电子健康记录和理赔数据,我们确定了在首次LDCT后的12个月内接受IDP(即细胞学或针吸活检、支气管镜检查、胸外科手术和其他手术)的病例个体。我们将每个病例与一名接受了LDCT但未进行任何IDP的对照个体进行匹配。我们计算了3个月的增量并发症发生率,即病例组和对照组之间按IDP和并发症严重程度划分的并发症发生率差异。
在7041名接受LDCT的个体中,301名(4.3%)在LDCT后的12个月内随后接受了IDP。总体3个月增量并发症发生率为16.6%(95%置信区间[CI]:9.9% - 23.1%),高于NLST报告的发生率(9.4%)。主要并发症的总体增量并发症发生率为5.6%(95% CI:1.9% - 9.6%),中度并发症为8.6%(95% CI:3.1% - 14.1%),轻度并发症为13.2%(95% CI:8.1% - 18.5%)。
确保遵守结节管理和下游检查的临床指南以尽量减少筛查带来的潜在危害非常重要。