Lung Screening: Efficacy versus Effectiveness

2011年，国家肺筛查试验（NLST）报告称， 低剂量CT（LDCT）筛查参与者的死亡率，而不是胸部X线。基于 在很大程度上，基于这些发现，LDCT肺部筛查现在是870万高风险患者的承保服务， 在美国的吸烟者和吸烟者。对于65岁以下的高危人群， 根据《平价医疗法案》，保险范围是强制性的;对于65岁及以上的人， 筛查费用由医疗保险支付。医疗保险仅在患者入组时才涵盖肺部筛查 在医疗保险和医疗补助服务中心批准的肺筛查登记处。的 美国放射学会肺癌筛查登记处（ACR-LCSR）是唯一一个 CMS目前批准的注册表。尽管大多数医学会都认可CT用于 肺癌筛查，美国家庭医生学会的结论是， 证据不足以推荐支持或反对肺部筛查，因为 这项计划并没有在社区推行。关切的是 肺筛查的传播集中在1）假阳性（FP）筛查的高率， 哪些参与者获得阳性筛查结果并需要额外的测试，但不 有肺癌，2）潜在的临床重要意义的相对较高的比率 在肺筛查时检测到的与肺癌无关的偶然发现（SIF），以及3） 这些FP和SIF异常的诊断评价的潜在危害。目前还不清楚 NLST中的FP和SIF比率是否会在社区实践中复制， 而不是临床试验。社区FP和SIF比率较高或效率低下 诊断评估可能导致癌症诊断延迟、过度检测、医源性 由于不必要的测试或肺部筛查的成本效益降低而导致的并发症 社区，而不是NLST对于拟议的研究，我们计划：1）比较 肺癌可疑异常的发生率和类型以及SIF的发生率和类型， ACR-LCSR社区登记数据与NLST相反，2）比较诊断 用于评估社区中这些异常的途径，而不是NLST，以及3） 使用决策树成本效益分析来比较社区肺部筛查与 NLST关于肺部和SIF异常率的成本-效果假设， 诊断途径;并确定每种类型的最具成本效益的诊断途径 异常这一信息对于确保减少肺癌的发病率至关重要。 NLST报告的死亡率是在社区环境中实现的。

In 2011, the National Lung Screening Trial (NLST) reported a 20% reduction in lung cancer mortality for participants screened with low-dose CT (LDCT) as opposed to chest X-ray. Based largely on these findings, LDCT lung screening is now a covered service for 8.7 million high-risk current and former smokers in the United States. For high-risk individuals younger than 65, insurance coverage is mandated under the Affordable Care Act; for those 65 and over screening is covered by Medicare. Medicare covers lung screening only if patients are enrolled in a Centers for Medicare and Medicaid Services-approved lung screening registry. The American College of Radiology Lung Cancer Screening Registry (ACR-LCSR) is the only registry currently approved by CMS. Although most medical societies have endorsed CT for lung cancer screening, the American Academy of Family Physicians concluded that the evidence was insufficient to recommend either for or against lung screening, as the results of the NLST had not been replicated in a community setting. Concerns regarding the dissemination of lung screening focus on 1) the high rate of false positive (FP) screens, for which participants receive a positive screening result and require additional testing, but do not have lung cancer, 2) the relatively high rate of potentially clinically important significant incidental findings (SIFs) detected at lung screening that are unrelated to lung cancer, and 3) potential harms from the diagnostic evaluation of these FP and SIF abnormalities. It is unclear whether the rate of FPs and SIFs seen in the NLST, will be replicated in community practice, as opposed to a clinical trial setting. Higher rates of FPs and SIFs in the community or inefficient diagnostic evaluation may result in delayed cancer diagnosis, excessive testing, iatrogenic complications due to unnecessary testing, or decreased cost-effectiveness of lung screening in the community, as opposed to the NLST. For the proposed research, we plan to: 1) compare the rate and type of abnormalities suspicious for lung cancer and the rate and type of SIFs in the ACR-LCSR community registry data as opposed to the NLST, 2) compare the diagnostic pathways used to assess these abnormalities in the community as opposed to the NLST, and 3) use a decision-tree cost-effectiveness analysis to compare community lung screening with NLST cost-effectiveness assumptions with respect to rates of lung and SIF abnormalities and diagnostic pathways; and to identify most cost-effective diagnostic pathways for each type of abnormality. This information is of vital importance to ensure that the reduction in lung cancer mortality reported by the NLST is achieved in the community setting.