Context: Encouraged by direct-to-consumer marketing, smokers and their physicians are contemplating lung cancer screening with a promising but unproven imaging procedure, helical computed tomography (CT). Objective: To estimate the potential benefits, harms, and cost-effectiveness of lung cancer screening with helical CT in various efficacy scenarios. Design, Setting, and Population: Using a computer-simulated model, we compared annual helical CT screening to no screening for hypothetical cohorts of 100 000 current, quitting, and former heavy smokers, aged 60 years, of whom 55% were men. We simulated efficacy by changing the clinical stage distribution of lung cancers so that the screened group would have fewer advanced-stage cancers and more localized-stage cancers than the nonscreened group (ie, a stage shift). Our model incorporated known biases in screening programs such as lead time, length, and overdiagnosis bias. Main Outcome Measures: We measured the benefits of screening by comparing the absolute and relative difference in lung cancer-specific deaths. We measured harms by the number of false-positive invasive tests or surgeries per 100 000 and incremental cost-effectiveness in US dollars per quality-adjusted life-year (QALY) gained. Results: Over a 20-year period, assuming a 50% stage shift, the current heavy smoker cohort had 553 fewer lung cancer deaths (13% lung cancer-specific mortality reduction) and 1186 false-positive invasive procedures per 100 000 persons. The incremental cost-effectiveness for current smokers was $116 300 per QALY gained. For quitting and former smokers, the incremental cost-effectiveness was $558 600 and $2 322 700 per QALY gained, respectively. Other than the degree of stage shift, the most influential parameters were adherence to screening, degree of length or overdiagnosis bias in the first year of screening, quality of life of persons with screen-detected localized lung cancers, cost of helical CT, and anxiety about indeterminate nodule diagnoses. In 1-way sensitivity analyses, none of these parameters was sufficient to make screening highly cost-effective for any of the cohorts. In multiway sensitivity analyses, a program screening current smokers was $42 500 per QALY gained if extremely favorable estimates were used for all of the influential parameters simultaneously. Conclusion: Even if efficacy is eventually proven, screening must overcome multiple additional barriers to be highly cost-effective. Given the current uncertainty of benefits, the harms from invasive testing, and the high costs associated with screening, direct-to-consumer marketing of helical CT is not advisable.
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