Department of Health Services Research, Management and Policy, College of Public Health and Health Professions, University of Florida, Gainesville.
Department of Health Services Research, The University of Texas MD Anderson Cancer Center, Houston.
JAMA Intern Med. 2019 Mar 1;179(3):324-332. doi: 10.1001/jamainternmed.2018.6277.
The Centers for Medicare & Medicaid Services added lung cancer screening with low-dose computed tomography (LDCT) as a Medicare preventive service benefit in 2015 following findings from the National Lung Screening Trial (NLST) that showed a 16% reduction in lung cancer mortality associated with LDCT. A challenge in developing and promoting a national lung cancer screening program is the high false-positive rate of LDCT because abnormal findings from thoracic imaging often trigger subsequent invasive diagnostic procedures and could lead to postprocedural complications.
To determine the complication rates and downstream medical costs associated with invasive diagnostic procedures performed for identification of lung abnormalities in the community setting.
DESIGN, SETTING, AND PARTICIPANTS: A retrospective cohort study of non-protocol-driven community practices captured in MarketScan Commercial Claims & Encounters and Medicare supplemental databases was conducted. A nationally representative sample of 344 510 patients aged 55 to 77 years who underwent invasive diagnostic procedures between 2008 and 2013 was included.
One-year complication rates were calculated for 4 groups of invasive diagnostic procedures. The complication rates and costs were further stratified by age group.
Of the 344 510 individuals aged 55 to 77 years included in the study, 174 702 comprised the study group (109 363 [62.6%] women) and 169 808 served as the control group (106 007 [62.4%] women). The estimated complication rate was 22.2% (95% CI, 21.7%-22.7%) for individuals in the young age group and 23.8% (95% CI, 23.0%-24.6%) for those in the Medicare group; the rates were approximately twice as high as those reported in the NLST (9.8% and 8.5%, respectively). The mean incremental complication costs were $6320 (95% CI, $5863-$6777) for minor complications to $56 845 (95% CI, $47 953-$65 737) for major complications.
The rates of complications after invasive diagnostic procedures were higher than the rates reported in clinical trials. Physicians and patients should be aware of the potential risks of subsequent adverse events and their high downstream costs in the shared decision-making process.
2015 年，美国医疗保险和医疗补助服务中心（Centers for Medicare & Medicaid Services）将低剂量计算机断层扫描（LDCT）肺癌筛查作为医疗保险预防服务的一项福利，这是基于国家肺癌筛查试验（National Lung Screening Trial，NLST）的发现，该试验显示 LDCT 可使肺癌死亡率降低 16%。在开发和推广全国性肺癌筛查计划时面临的一个挑战是 LDCT 的高假阳性率，因为胸部成像的异常结果通常会引发后续的侵入性诊断程序，并可能导致术后并发症。
确定在社区环境中为识别肺部异常而进行的侵入性诊断程序相关的并发症发生率和下游医疗成本。
设计、地点和参与者：这是一项在 MarketScan 商业索赔和医疗保险补充数据库中捕获的非协议驱动的社区实践的回顾性队列研究。研究纳入了 2008 年至 2013 年间接受侵入性诊断程序的 344510 名年龄在 55 至 77 岁的具有全国代表性的患者。
计算了 4 组侵入性诊断程序的 1 年并发症发生率。根据年龄组进一步对并发症发生率和成本进行分层。
在纳入的 344510 名年龄在 55 至 77 岁的个体中，174702 人组成研究组（109363[62.6%]名女性），169808 人组成对照组（106007[62.4%]名女性）。年轻组的估计并发症发生率为 22.2%（95%CI，21.7%-22.7%），老年组为 23.8%（95%CI，23.0%-24.6%）；这些比率大约是 NLST 报告的两倍（分别为 9.8%和 8.5%）。轻度并发症的平均增量并发症成本为 6320 美元（95%CI，5863-6777 美元），而严重并发症的平均增量并发症成本为 56845 美元（95%CI，47953-65737 美元）。
侵入性诊断程序后的并发症发生率高于临床试验报告的发生率。在共同决策过程中，医生和患者应意识到潜在的不良事件风险及其高额的下游成本。
