Lung Screening: Efficacy versus Effectiveness

肺部筛查：功效与效果

• 批准号: 10165656
• 负责人: Ilana F Gareen
• 金额: $ 50.95万
• 依托单位: BROWN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-01-01 至 2023-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10165656
• 关键词: Academy; Address; Advisory Committees; Affordable Care Act; American; American College of Radiology; Clinical; Clinical Trials; Communities; Community Practice; Cost Effectiveness Analysis; Data; Decision Analysis; Decision Trees; Detection; Diagnosis; Diagnostic; Diagnostic tests; Diffusion; Effectiveness; Enrollment; Ensure; Evaluation; Family Physicians; Goals; Guidelines; Iatrogenesis; Incidental Findings; Individual; Insurance Carriers; Insurance Coverage; Lead; Lung; Lung CAT Scan; Lung nodule; Malignant Neoplasms; Malignant neoplasm of lung; Medical; Medical Societies; Medicare; National Comprehensive Cancer Network; Nodule; Participant; Pathway interactions; Patients; Policy Maker; Preventive service; Privatization; Protocols documentation; Quality-Adjusted Life Years; Recommendation; Registries; Reporting; Research; Risk; Screening Result; Screening for cancer; Services; Testing; Thoracic Radiography; Time; Translating; United States; United States Centers for Medicare and Medicaid Services; base; cancer diagnosis; community setting; comparative cost effectiveness; comparative efficacy; cost; cost effective; cost effectiveness; data registry; former smoker; health care service utilization; high risk; improved; low dose computed tomography; lung cancer screening; meetings; mortality; older patient; participant enrollment; patient screening; radiologist; screening; tv watching

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.

2011年，国家肺筛查试验（NLST）报告肺癌降低了20％ 用低剂量CT（LDCT）筛选的参与者的死亡率与胸部X射线相反。基于 在这些发现上，LDCT肺部筛查现在是870万高风险的服务。 美国现任和前吸烟者。对于65岁以下的高危个人 根据《平价医疗法案》规定了保险范围；对于65岁及以上的 筛查由Medicare涵盖。医疗保险涵盖肺部筛查，仅当患者入学时 在医疗保险和医疗补助服务批准的肺部筛查中心中。这 美国放射学院肺癌筛查注册中心（ACR-LCSR）是唯一的 目前由CMS批准的注册表。尽管大多数医学社会都认可了CT 肺癌筛查，美国家庭医师学会得出的结论是 证据不足以推荐或反对肺部筛查，作为结果 NLST在社区环境中没有被复制。对 将肺部筛查的焦点传播到1）较高的假阳性（FP）屏幕的速率 哪些参与者将获得积极的筛选结果，需要进行其他测试，但不 患有肺癌，2）相对较高的潜在临床重要意义率 肺部筛查中检测到的偶然发现（SIF）与肺癌无关，3） 对这些FP和SIF异常的诊断评估造成的潜在危害。目前尚不清楚 是否在NLST中看到的FPS和SIF的速率将在社区实践中复制为 反对临床试验环境。社区中FPS和SIF的率较高或效率低下 诊断评估可能导致癌症诊断延迟，过度测试，医源性 由于不必要的测试引起的并发症，或肺部筛查的成本效益降低 社区，而不是NLST。对于拟议的研究，我们计划：1）比较 异常的率和类型可疑肺癌和SIF的速率和类型 ACR-LCSR社区注册表数据与NLST相反，2）比较诊断 用于评估社区中这些异常而不是NLST的途径，3） 使用决策树成本效益分析将社区肺筛查与 关于肺部和SIF异常率的NLST成本效益假设 诊断途径；并确定每种类型的最具成本效益的诊断途径 紊乱 etc。该信息对于确保肺癌的减少至关重要 NLST报告的死亡率是在社区环境中实现的。