Departments of Biomedical Data Science and Radiology, Stanford University, Stanford, CA, USA.
Department of Radiology, Stanford University, Stanford, CA, USA.
JNCI Cancer Spectr. 2021 Oct 6;5(6). doi: 10.1093/jncics/pkab081. eCollection 2021 Dec.
The Lung Computed Tomography Screening Reporting and Data System (Lung-RADS) reduces the false-positive rate of lung cancer screening but introduces prolonged periods of uncertainty for indeterminate findings. We assess the cost-effectiveness of a screening program that assesses indeterminate findings earlier via a hypothetical diagnostic biomarker introduced in place of Lung-RADS 3 and 4A guidelines.
We evaluated the performance of the US Preventive Services Task Force (USPSTF) recommendations on lung cancer screening with and without a hypothetical noninvasive diagnostic biomarker using a validated microsimulation model. The diagnostic biomarker assesses the malignancy of indeterminate nodules, replacing Lung-RADS 3 and 4A guidelines, and is characterized by a varying sensitivity profile that depends on nodules' size, specificity, and cost. We tested the robustness of our findings through univariate sensitivity analyses.
A lung cancer screening program per the USPSTF guidelines that incorporates a diagnostic biomarker with at least medium sensitivity profile and 90% specificity, that costs $250 or less, is cost-effective with an incremental cost-effectiveness ratio lower than $100 000 per quality-adjusted life year, and improves lung cancer-specific mortality reduction while requiring fewer screening exams than the USPSTF guidelines with Lung-RADS. A screening program with a biomarker costing $750 or more is not cost-effective. The health benefits accrued and costs associated with the screening program are sensitive to the disutility of indeterminate findings and specificity of the biomarker, respectively.
Lung cancer screening that incorporates a diagnostic biomarker, in place of Lung-RADS 3 and 4A guidelines, could improve the cost-effectiveness of the screening program and warrants further investigation.
肺部计算机断层扫描筛查报告和数据系统(Lung-RADS)降低了肺癌筛查的假阳性率,但为不确定结果带来了更长时间的不确定性。我们评估了一种筛查方案的成本效益,该方案通过在 Lung-RADS 3 和 4A 指南中引入假设的诊断生物标志物更早地评估不确定发现。
我们使用经过验证的微观模拟模型评估了美国预防服务工作组(USPSTF)关于肺癌筛查的建议是否使用和不使用假设的非侵入性诊断生物标志物。该诊断生物标志物评估不确定结节的恶性程度,取代 Lung-RADS 3 和 4A 指南,并具有取决于结节大小、特异性和成本的不同敏感性特征。我们通过单变量敏感性分析测试了我们发现的稳健性。
根据 USPSTF 指南进行的肺癌筛查计划,如果纳入具有至少中等敏感性特征和 90%特异性、成本为 250 美元或以下的诊断生物标志物,其增量成本效益比低于每质量调整生命年 100000 美元,则具有成本效益,并可降低肺癌特异性死亡率,同时比 Lung-RADS 下的 USPSTF 指南需要更少的筛查检查。成本为 750 美元或更高的生物标志物筛查计划则不具有成本效益。筛查计划的健康收益和相关成本分别对不确定发现的不适度和生物标志物的特异性敏感。
用诊断生物标志物替代 Lung-RADS 3 和 4A 指南的肺癌筛查可能会提高筛查计划的成本效益,值得进一步研究。