Abstract
Self-reported tobacco pack-year history plays a large role in decisions about low-dose CT screening for lung cancer, yet is challenging to measure accurately. To what extent does random measurement error in pack-year information impact screening decisions and screening effectiveness? Retrospective cohort study of 10,449 patients with pack-year history documented at least twice between October 2013 and July 2017 across 8 academic Veterans Affairs sites. Outcome measures included (1) observed reliability of pack-year information based on all repeat measures for the study population and (2) each person's statistically "true" pack-year information based on best linear unbiased predictor from a multilevel linear random effects model. To examine how unreliability leads to misclassification of screening eligibility and inaccuracy in estimating lung cancer risk, we simulated pack-year observations for each person, first comparing simulated pack-year and lung cancer risk values with true values, then comparing outcomes when basing screening decisions on unreliable pack-year information vstrue information. Reliability of assessing pack-year information in routine practice varied across sites. Thus, we examined the clinical impact of two different levels of reliability, based on the range of intraclass correlation coefficients observed. Using a≥ 30-pack-year threshold led to a high rate of eligibility misclassifications (48.1%misclassified with higher reliability pack-year information and 60.7%misclassified with lower reliability information). However, using a lung cancer risk threshold leads to fewer misclassifications (47.3%-49.7%misclassified when using lower reliability pack-year information) and maintains screening effectiveness better when using unreliable pack-year information. Random error in real-world pack-year assessments leads to a substantial rate of misclassifying who should be offered CT screening if a≥ 30-pack-year criterion is used. However, using a lung cancer risk threshold mitigates the impact of unreliable pack-year information. Decision-makers concerned about the impact of unreliable pack-year information should consider using risk-based approaches to CT screening.
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