Definition of a Positive Test Result in Computed Tomography Screening for Lung Cancer A Cohort Study
Definition of a Positive Test Result in Computed Tomography Screening for Lung Cancer A Cohort Study
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DOI：
10.7326/0003-4819-158-4-201302190-00004
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发表时间：
2013-02-19
影响因子：
39.2
通讯作者：
Smith, James P.
中科院分区：
文献类型：
--
作者：
Henschke, Claudia I.;Yip, Rowena;Smith, James P.
背景：低剂量计算机断层扫描筛查肺癌可降低高危人群的死亡率，但“假阳性”结果可能导致不必要的评估和随之而来的风险。确定阳性结果的替代阈值对阳性结果和癌症诊断率的影响尚不清楚。目的：通过使用更严格的阈值来评估基线轮筛查中阳性结果的频率和潜在的诊断延迟。设计：前瞻性队列研究。背景：多机构国际早期肺癌行动计划。患者：2006年至2010年期间进行基线计算机断层扫描的21,136名参与者。测量方法：实性和半实性肺结节的频率，以及使用当前（5mm）和更严格的结节直径阈值诊断肺癌的比率。结果：根据目前阳性结果的定义（任何实质、实性或半实性、非钙化结节>= 5.0 mm），基线轮阳性结果的频率为16%（3396/21 136）。当选择阈值为6.0、7.0、8.0和9.0 mm时，阳性结果的频率分别为10.2% （95% CI， 9.8%至10.6%）、7.1% （CI， 6.7%至7.4%）、5.1% （CI， 4.8%至5.4%）和4.0% （CI， 3.7%至4.2%）。使用这些替代定义将分别减少36%、56%、68%和75%的工作量。同时，对于0%、5.0% （CI， 1.1%至9.0%）、5.9% （CI， 1.7至10.1%）和6.7% （CI， 2.2%至11.2%）的癌症病例，肺癌诊断最多延迟9个月。局限性：这是一项回顾性分析，因此不能确定诊断延迟是否会改变结果。结论：这些发现表明，在肺癌计算机断层扫描的基线轮中，使用7或8毫米的阈值来确定阳性结果应该进行前瞻性评估，以确定减少进一步检查的益处是否超过由此导致的诊断延迟。
Background: Low-dose computed tomography screening for lung cancer can reduce mortality among high-risk persons, but "false-positive" findings may result in unnecessary evaluations with attendant risks. The effect of alternative thresholds for defining a positive result on the rates of positive results and cancer diagnoses is unknown.Objective: To assess the frequency of positive results and potential delays in diagnosis in the baseline round of screening by using more restrictive thresholds.Design: Prospective cohort study.Setting: Multi-institutional International Early Lung Cancer Action Program.Patients: 21 136 participants with baseline computed tomography performed between 2006 and 2010.Measurements: The frequency of solid and part-solid pulmonary nodules and the rate of lung cancer diagnosis by using current (5 mm) and more restrictive thresholds of nodule diameter.Results: The frequency of positive results in the baseline round by using the current definition of positive result (any parenchymal, solid or part-solid, noncalcified nodule >= 5.0 mm) was 16% (3396/21 136). When alternative threshold values of 6.0, 7.0, 8.0 and 9.0 mm were used, the frequencies of positive results were 10.2% (95% CI, 9.8% to 10.6%), 7.1% (CI, 6.7% to 7.4%), 5.1% (CI, 4.8% to 5.4%), and 4.0% (CI, 3.7% to 4.2%), respectively. Use of these alternative definitions would have reduced the work-up by 36%, 56%, 68%, and 75%, respectively. Concomitantly, lung cancer diagnostics would have been delayed by at most 9 months for 0%, 5.0% (CI, 1.1% to 9.0%), 5.9% (CI, 1.7 to 10.1%), and 6.7% (CI, 2.2% to 11.2%) of the cases of cancer, respectively.Limitation: This was a retrospective analysis and thus whether delays in diagnosis would have altered outcomes cannot be determined.Conclusion: These findings suggest that using a threshold of 7 or 8 mm to define positive results in the baseline round of computed tomography screening for lung cancer should be prospectively evaluated to determine whether the benefits of decreasing further work-up outweigh the consequent delay in diagnosis in some patients.