Outcomes associated with significant incidental findings in lung cancer screening

项目摘要/摘要： 2011年，国家肺部筛查试验(NLST)报告肺癌减少了20% 低剂量CT筛查的参与者死亡率和全因死亡率降低6% (LDCT)，而不是胸部X光(CXR)。主要基于这些发现，肺部筛查 现在，美国有870万符合NLST标准的人可以使用LDCT 资格标准。对于65岁以下的高风险个人，保险范围是强制的 根据《平价医疗法案》；对于65岁及以上的人，医疗保险涵盖筛查。这个 在LDCT肺筛查期间成像的身体区域不仅包括肺，而且 异常常见于其他器官。与肺癌无关的发现， 但具有潜在的临床重要性，通常被称为重大偶发事件 调查结果(SIF)。在NLST中，10%的参与者在第一次筛查时检测到SIF 在两个发病筛查中，平均各为6%。尽管众所周知，SIF是 与卫生保健利用率的增加相关，目前尚不清楚是否检测到这些 异常对患者的健康是有益的，也是有害的。SIF可能被证明是有益的，如果它们 代表潜在的恶性疾病，如癌症，早期干预 改善结果。然而，如果SIF代表良性条件，那么它们可能被证明是有害的，例如 如肝囊肿，其工作会给患者带来额外的发病率、费用或精神压力。 与SIF相关的结果可能会因SIF所在器官的不同而不同 都被发现了。NLST中SIF的发现可能在一定程度上解释了所有原因的差异 报告的死亡率发生在LDCT和CXR之间。这个项目的目标是了解 LDCT肺筛查中发现SIF的发病率和死亡率。 关于SIF以及短期和长期成果的信息可在NLST数据中获得，以及 提供了一个独特的机会来确定与LDCT相关的发病率和死亡率- 检测到SIF。我们建议使用NLST数据来确定SIF检测是否 与NLST的LDCT臂相比，降低了全原因死亡率 CXR臂。我们还计划确定那些最有可能导致癌症检测的SIF，以及那些 SIFS最常与医源性并发症有关。这项研究的结果将提供 可用于制定实践指南的证据，这些指南可应用于 管理LDCT检测到的SIF，以最大限度地提高成本效益和健康效益 肺癌筛查计划，并将潜在的危害降至最低。

Project Summary/Abstract: In 2011, the National Lung Screening Trial (NLST) reported a 20% reduction in lung cancer mortality and a 6% reduction in all-cause mortality for participants screened with Low Dose CT (LDCT) as opposed to chest X-ray (CXR). Based largely on these findings, lung screening using LDCT is now available to 8.7 million people in the United States who meet the NLST eligibility criteria. For high-risk individuals younger than 65, insurance coverage is mandated under the Affordable Care Act; for those 65 and older screening is covered by Medicare. The area of the body imaged during LDCT lung screening encompasses more than the lung, and abnormalities are often visualized in other organs. Findings that are unrelated to lung cancer, but which are of potential clinical importance, are commonly referred to as significant incidental findings (SIFs). In the NLST, SIFs were detected in 10% of participants at the first screen and an average of 6% at each of the two incidence screens. Although SIFs are known to be associated with increased health care utilization, it remains unclear whether detection of these abnormalities is beneficial or detrimental to patient health. SIFs may prove beneficial if they represent potentially malignant conditions, such as cancers, for which early intervention improves outcomes. However, SIFs may prove harmful if they represent benign conditions, such as liver cysts, whose work-up causes additional morbidity, costs, or mental duress for patients. The outcomes associated with SIFs are likely to differ depending on the organ in which the SIF is discovered. The discovery of SIFs in the NLST may, in part, explain the difference in all-cause mortality reported between the LDCT and CXR arms. The goal of this project is to understand the morbidity and mortality associated with detection of a SIF on LDCT lung screening. Information on SIFs and short- and long-term outcomes is available in the NLST data, and offers a unique opportunity to determine the morbidity and mortality associated with LDCT- detected SIFs. We propose to use the NLST data to determine whether SIF detection was associated with reduced all-cause mortality in the LDCT arm of the NLST, compared with the CXR arm. We also plan to identify those SIFs most likely to lead to cancer detection, and those SIFs most often associated with iatrogenic complications. Findings from this study will provide evidence that may be used to develop practice guidelines that can be applied to the management of LDCT-detected SIFs to maximize the cost-effectiveness and health benefits of lung cancer screening programs and to minimize the potential harms.