Cumulative Incidence of False-Positive Test Results in Lung Cancer Screening A Randomized Trial
Cumulative Incidence of False-Positive Test Results in Lung Cancer Screening A Randomized Trial
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DOI：
10.7326/0003-4819-152-8-201004200-00007
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发表时间：
2010-04-20
影响因子：
39.2
通讯作者：
Kramer, Barnett S.
中科院分区：
文献类型：
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作者：
Croswell, Jennifer M.;Baker, Stuart G.;Kramer, Barnett S.
背景：肺癌筛查的直接面向消费者的宣传增加了，尤其是低剂量计算机断层扫描(CT)。然而，筛查使健康人面临潜在的危害，低剂量CT的累积假阳性率从未正式报告过。目的：量化参加一年或两年肺癌筛查的人至少得到1次假阳性结果的累积风险，以及不必要的诊断程序的发生率。设计：低剂量CT与胸片的随机对照试验。地点：正在进行的国家肺部筛查试验的可行性研究。患者：现任或既往吸烟者，年龄55~74岁，吸烟史30包或以上，无肺癌病史(n=3190)。干预：随机分配到低剂量CT或胸部X线片，基线和1次重复的年度筛查；最终筛查后1年的随访。结果：经Kaplan-Meier分析，1次筛查后1次或1次以上低剂量CT检查出现1次或1次以上假阳性的累积概率为21%(95%CI，19%~23%)，2次筛查后假阳性率为33%(CI，31%~35%)。8%~11%)和15%(CI，13%~16%)。共有7%的低剂量CT检查假阳性和4%的胸部摄影假阳性的参与者进行了侵入性检查。限制：筛查限制为2轮。第二次筛查后的随访时间限制为12个月。假阴性率可能被低估了。结论：仅仅两次年度检查后，肺癌筛查结果假阳性的风险很大，特别是对于低剂量CT。有必要对这些方法产生的经济、心理和身体负担进行进一步研究。
Background: Direct-to-consumer promotion of lung cancer screening has increased, especially low-dose computed tomography (CT). However, screening exposes healthy persons to potential harms, and cumulative false-positive rates for low-dose CT have never been formally reported.Objective: To quantify the cumulative risk that a person who participated in a 1- or 2-year lung cancer screening examination would receive at least 1 false-positive result, as well as rates of unnecessary diagnostic procedures.Design: Randomized, controlled trial of low-dose CT versus chest radiography. (ClinicalTrials.govregistration number: NCT00006382) Setting: Feasibility study for the ongoing National Lung Screening Trial.Patients: Current or former smokers, aged 55 to 74 years, with a smoking history of 30 pack-years or more and no history of lung cancer (n = 3190).Intervention: Random assignment to low-dose CT or chest radiography with baseline and 1 repeated annual screening; 1-year follow-up after the final screening. Randomization was centralized and stratified by age, sex, and study center.Measurements: False-positive screenings, defined as a positive screening with a completed negative work-up or 12 months or more of follow-up with no lung cancer diagnosis.Results: By using a Kaplan-Meier analysis, a person's cumulative probability of 1 or more false-positive low-dose CT examinations was 21% (95% CI, 19% to 23%) after 1 screening and 33% ( CI, 31% to 35%) after 2. The rates for chest radiography were 9% ( CI, 8% to 11%) and 15% ( CI, 13% to 16%), respectively. A total of 7% of participants with a false-positive low-dose CT examination and 4% with a false-positive chest radiography had a resulting invasive procedure.Limitations: Screening was limited to 2 rounds. Follow-up after the second screening was limited to 12 months. The false-negative rate is probably an underestimate.Conclusion: Risks for false-positive results on lung cancer screening tests are substantial after only 2 annual examinations, particularly for low-dose CT. Further study of resulting economic, psychosocial, and physical burdens of these methods is warranted.