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Small pulmonary nodules are most often managed by surveillance imaging with computed tomography (CT) of the chest, but the optimal frequency and duration of surveillance are unknown. The Watch the Spot Trial is a multicenter, pragmatic, comparative-effectiveness trial with cluster randomization by hospital or health system that compares more- versus less-intensive strategies for active surveillance of small pulmonary nodules. The study plans to enroll approximately 35,200 patients with a small pulmonary nodule that is newly detected on chest CT imaging, either incidentally or by screening. Study protocols for more- and less-intensive surveillance were adapted from published guidelines. The primary outcome is the percentage of cancerous nodules that progress beyond American Joint Committee on Cancer seventh edition stage T1a. Secondary outcomes include patient-reported anxiety and emotional distress, nodule-related health care use, radiation exposure, and adherence with the assigned surveillance protocol. Distinctive aspects of the trial include: 1) the pragmatic integration of study procedures into existing clinical workflow; 2) the use of cluster randomization by hospital or health system; 3) the implementation and evaluation of a system-level intervention for protocol-based care; 4) the use of highly efficient, technology-enabled methods to identify and (passively) enroll participants; 5) reliance on data collected as part of routine clinical care, including data from electronic health records and state cancer registries; 6) linkage with state cancer registries for complete ascertainment of the primary study outcome; and 7) intensive engagement with a diverse group of patient and nonpatient stakeholders in the design and execution of the study.

Rationale: Radiologic pattern has been shown to predict survival in patients with fibrosing interstitial lung disease. The additional prognostic value of fibrosis extent by quantitative computed tomography (CT) is unknown. Objectives: We hypothesized that fibrosis extent provides information beyond visually assessed CT pattern that is useful for outcome prediction. Methods: We performed a retrospective analysis of chest CT, demographics, longitudinal pulmonary function, and transplantation-free survival among participants in the Pulmonary Fibrosis Foundation Patient Registry. CT pattern was classified visually according to the 2018 usual interstitial pneumonia criteria. Extent of fibrosis was objectively quantified using data-driven textural analysis. We used Kaplan-Meier plots and Cox proportional hazards and linear mixed-effects models to evaluate the relationships between CT-derived metrics and outcomes. Results: Visual assessment and quantitative analysis were performed on 979 enrollment CT scans. Linear mixed-effect modeling showed that greater baseline fibrosis extent was significantly associated with the annual rate of decline in forced vital capacity. In multivariable models that included CT pattern and fibrosis extent, quantitative fibrosis extent was strongly associated with transplantation-free survival independent of CT pattern (hazard ratio, 1.04; 95% confidence interval, 1.04--1.05; P,0.001; C statistic = 0.73). Conclusions: The extent of lung fibrosis by quantitative CT is a strong predictor of physiologic progression and survival, independent of visually assessed CT pattern. [ABSTRACT FROM AUTHOR]

Plain Language Summary Lung nodules are frequently detected on low‐dose computed tomography scans performed for lung cancer screening and incidentally detected on imaging performed for other reasons. There is wide variability in how lung nodules are managed by general practitioners and subspecialists, with high rates of guideline‐discordant care. This may be due in part to the level of evidence underlying current practice guideline recommendations (primarily based on findings from uncontrolled studies of diagnostic accuracy). The primary aims of lung nodule management are to minimize harms of diagnostic evaluations while expediting the evaluation, diagnosis, and treatment of lung cancer. Potentially useful tools such as lung cancer probability calculators, automated methods to identify patients with nodules in the electronic health record, and multidisciplinary team evaluation are often underused due to limited availability, accessibility, and/or provider knowledge. Finally, relatively little attention has been paid to identifying and reducing disparities among individuals with screening‐detected or incidentally detected lung nodules. This contribution to the American Cancer Society National Lung Cancer Roundtable Strategic Plan aims to identify and describe these knowledge gaps in lung nodule management and propose recommendations to advance clinical practice and research. Major themes that are addressed include improving the quality of evidence supporting lung nodule evaluation guidelines, strategically leveraging information technology, and placing emphasis on equitable approaches to nodule management. The recommendations outlined in this strategic plan, when carried out through interdisciplinary efforts with a focus on health equity, ultimately aim to improve early detection and reduce the morbidity and mortality of lung cancer. Lung nodules may be identified on chest scans of individuals who undergo lung cancer screening (screening‐detected nodules) or among patients for whom a scan was performed for another reason (incidental nodules). Although the vast majority of lung nodules are not lung cancer, it is important to have evidence‐based, standardized approaches to the evaluation and management of a lung nodule. The primary aims of lung nodule management are to diagnose lung cancer while it is still in an early stage and to avoid unnecessary procedures and other harms. Lung nodules may be identified on chest scans of individuals who undergo lung cancer screening (screening‐detected nodules) or among patients for whom a scan was performed for another reason (incidental nodules).Although the vast majority of lung nodules are not lung cancer, it is important to have evidence‐based, standardized approaches to the evaluation and management of a lung nodule.The primary aims of lung nodule management are to diagnose lung cancer while it is still in an early stage and to avoid unnecessary procedures and other harms. [ABSTRACT FROM AUTHOR]

Pulmonary nodules are managed on the basis of their size and morphologic characteristics. Radiologists are familiar with assessing nodule size by measuring diameter using manually deployed electronic calipers. Size may also be assessed with 3D volumetric measurements (referred to as volumetry) obtained with software. Nodule size and growth are more accurately assessed with volumetry than on the basis of diameter, and the evidence supporting clinical use of volumetry has expanded, driven by its use in lung cancer screening nodule management algorithms in Europe. The application of volumetry has the potential to reduce recommendations for imaging follow-up of indeterminate solid nodules without impacting cancer detection. Although changes in scanning conditions and volumetry software packages can lead to variation in volumetry results, ongoing technical advances have improved the reliability of calculated volumes. Volumetry is now the primary method for determining size of solid nodules in the European lung cancer screening position statement and British Thoracic Society recommendations. The purposes of this article are to review technical aspects, advantages, and limitations of volumetry and, by considering specific scenarios, to contextualize the use of volumetry with respect to its importance in morphologic evaluation, its role in predicting malignancy in risk models, and its practical impact on nodule management. Implementation challenges and areas requiring further evidence are also highlighted.

In 2014, the American College of Radiology (ACR) created Lung-RADS 1.0. The system was updated to Lung-RADS 1.1 in 2019, and further updates are anticipated as additional data become available. Lung-RADS provides a common lexicon and standardized nodule follow-up management paradigm for use when reporting lung cancer screening (LCS) low-dose CT (LDCT) chest examinations and serves as a quality assurance and outcome monitoring tool. The use of Lung-RADS is intended to improve LCS performance and lead to better patient outcomes. To date, the ACR's Lung Cancer Screening Registry is the only LCS registry approved by the Centers for Medicare & Medicaid Services and requires the use of Lung-RADS categories for reimbursement. Numerous challenges have emerged regarding the use of Lung-RADS in clinical practice, including the timing of return to LCS after planned follow-up diagnostic evaluation; potential substitution of interval diagnostic CT for future LDCT; role of volumetric analysis in assessing nodule size; assessment of nodule growth; assessment of cavitary, subpleural, and category 4X nodules; and variability in reporting of the S modifier. This article highlights the major updates between versions 1.0 and 1.1 of Lung-RADS, describes the system's ongoing challenges, and summarizes current evidence and recommendations.