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，国家肺部筛查试验(NLST)报告肺癌减少了20% 参与者的死亡率是通过低剂量CT(LDCT)进行筛查的，而不是胸部X光。基座 在很大程度上基于这些发现，LDCT肺部筛查现在是为870万高危人群提供的覆盖服务 美国现在和以前的吸烟者。对于65岁以下的高危人群， 保险范围是根据《平价医疗法案》规定的；适用于65岁及以上的人 筛查由联邦医疗保险覆盖。只有在患者参加了登记的情况下，医疗保险才会涵盖肺部筛查 在医疗保险和医疗补助服务中心批准的肺部筛查登记中。这个 美国放射学会肺癌筛查登记处(ACR-LCSR)是唯一 CMS目前批准的注册表。尽管大多数医学学会都支持CT治疗 在肺癌筛查中，美国家庭医生学会的结论是 没有足够的证据支持或反对肺部筛查，因为 NLST尚未在社区环境中复制。关注的是 传播肺部筛查的重点是1)假阳性(FP)筛查的高比率， 哪些参与者获得阳性筛查结果并需要进行额外测试，但不需要 有肺癌，2)较高的潜在临床重要意义 在肺部筛查中发现的与肺癌无关的偶然发现(SIF)，以及3) 对这些FP和SIF异常进行诊断评估的潜在危害。目前还不清楚 NLST中出现的FP和SIF比率是否会在社区实践中复制，如 反对临床试验环境。社区中FP和SIF的比率较高或效率低下 诊断评估可能会导致癌症诊断延迟、检测过多、医源性 不必要的检查引起的并发症，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 可疑肺癌的异常率和类型以及SIFs的比率和类型 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的途径，而不是NLST，以及3) 使用决策树成本-效果分析比较社区肺部筛查与 NLST关于肺和SIF异常率的成本效益假设 诊断途径；并确定每种类型的最经济有效的诊断途径 反常现象。这些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。