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Background: Advanced diagnostic bronchoscopy targeting the lung periphery has developed at an accelerated pace over the last two decades, whereas evidence to support introduction of innovative technologies has been variable and deficient. A major gap relates to variable reporting of diagnostic yield, in addition to limited comparative studies. Objectives: To develop a research framework to standardize the evaluation of advanced diagnostic bronchoscopy techniques for peripheral lung lesions. Specifically, we aimed for consensus on a robust definition of diagnostic yield, and we propose potential study designs at various stages of technology development. Methods: Panel members were selected for their diverse expertise. Workgroup meetings were conducted in virtual or hybrid format. The cochairs subsequently developed summary statements, with voting proceeding according to a modified Delphi process. The statement was cosponsored by the American Thoracic Society and the American College of Chest Physicians. Results: Consensus was reached on 15 statements on the definition of diagnostic outcomes and study designs. A strict definition of diagnostic yield should be used, and studies should be reported according to the STARD (Standards for Reporting Diagnostic Accuracy Studies) guidelines. Clinical or radiographic follow-up may be incorporated into the reference standard definition but should not be used to calculate diagnostic yield from the procedural encounter. Methodologically robust comparative studies, with incorporation of patient-reported outcomes, are needed to adequately assess and validate minimally invasive diagnostic technologies targeting the lung periphery. Conclusions: This American Thoracic Society/American College of Chest Physicians statement aims to provide a research framework that allows greater standardization of device validation efforts through clearly defined diagnostic outcomes and robust study designs. High-quality studies, both industry and publicly funded, can support subsequent health economic analyses and guide implementation decisions in various healthcare settings. [ABSTRACT FROM AUTHOR]

Rationale: Strict adherence to procedural protocols and diagnostic definitions is critical to understand the efficacy of new technologies. Electromagnetic navigational bronchoscopy (ENB) for lung nodule biopsy has been used for decades without a solid understanding of its efficacy, but offers the opportunity for simultaneous tissue acquisition via electromagnetic navigational transthoracic biopsy (EMN-TTNA) and staging via endobronchial ultrasound (EBUS). Objective: To evaluate the diagnostic yield of EBUS, ENB, and EMN-TTNA during a single procedure using a strict a priori definition of diagnostic yield with central pathology adjudication. Methods: A prospective, single-arm trial was conducted at eight centers enrolling participants with pulmonary nodules (,3 cm; without computed tomography [CT]- and/or positron emission tomography-positive mediastinal lymph nodes) who underwent a staged procedure with same-day CT, EBUS, ENB, and EMNTTNA. The procedure was staged such that, when a diagnosis had been achieved via rapid on-site pathologic evaluation, the procedure was ended and subsequent biopsy modalities were not attempted. A study finding was diagnostic if an independent pathology core laboratory confirmed malignancy or a definitive benign finding. The primary endpoint was the diagnostic yield of the combination of CT, EBUS, ENB, and EMN-TTNA. Measurements and Main Results: A total of 160 participants at 8 centers with a mean nodule size of 1866mm were enrolled. The diagnostic yield of the combined procedure was 59% (94 of 160; 95% confidence interval [CI], 51-66%). Nodule regression was found on same-day CT in 2.5% of cases (4 of 160; 95% CI, 0.69-6.3%), and EBUS confirmed malignancy in 7.1% of cases (11 of 156; 95% CI, 3.6-12%). The yield of ENB alone was 49% (74 of 150; 95% CI, 41-58%), that of EMN-TTNA alone was 27% (8 of 30; 95% CI, 12-46%), and that of ENB plus EMN-TTNA was 53% (79 of 150; 95% CI, 44-61%). Complications included a pneumothorax rate of 10% and a 2% bleeding rate. When EMN-TTNA was performed, the pneumothorax rate was 30%. Conclusions: The diagnostic yield for ENB is 49%, which increases to 59% with the addition of same-day CT, EBUS, and EMN-TTNA, lower than in prior reports in the literature. The high complication rate and low diagnostic yield of EMN-TTNA does not support its routine use. Clinical trial registered with www.clinicaltrials.gov (NCT 03338049). [ABSTRACT FROM AUTHOR]

Importance: Current eligibility criteria for lung cancer (LC) screening are derived from randomised controlled trials and primarily based on age and smoking history. However, the individual benefits of screening are highly variable and potentially attenuated by co-morbidities such as advanced airflow limitation (AL).Objective: To examine the relationship between the presence and severity of AL and screening outcomes.Methods: This was a secondary analysis of 18 463 high-risk smokers, a substudy from the National Lung Screening Trial, who underwent pre-bronchodilator spirometry at baseline and median follow-up of 6.1 years. We used descriptive statistics and a competing risk proportional hazards model to examine differences in screening outcomes by chronic obstructive pulmonary disease severity group.Results: The risk of developing LC increased with worsening AL (effect size=0.34, p<0.0001), as did the risk of dying of LC (effect size=0.35, p<0.0001). While those with severe AL (Global Initiative for Obstructive Lung Disease, GOLD grade 3-4) had the highest risk of LC and the highest LC mortality, they also had fewer adenocarcinomas (effect size=-0.20, p=0.008) and a lower surgery rate (effect size=-0.16, p=0.014) despite comparable staging, and greater non-LC mortality relative to LC mortality (effect size=0.30, p<0.0001). In participants with no AL, screening with CT was associated with a significant reduction in LC deaths relative to chest X-ray (30.3%, 95% CI 4.5% to 49.2%, p<0.05). The clinically relevant but attenuated reduction in those with AL (18.5%, 95% CI -8.4% to 38.7%, p>0.05) could be attributed to GOLD 3-4, where no appreciable mortality reduction was observed.Conclusion: Despite a greater risk of LC, severe AL was not associated with any apparent reduction in LC mortality following screening. [ABSTRACT FROM AUTHOR]

Although the revised (2021) US Preventive Services Task Force recommendations for lung cancer screening offer the opportunity to save more lives and reduce disparities, National Lung Cancer Roundtable members share a cautionary message about the challenges ahead. To facilitate high‐quality care for diverse populations, a patient‐centered approach is needed that incorporates high‐quality shared decision‐making, improved access to care and navigation, and more streamlined systems of care. [ABSTRACT FROM AUTHOR]

Lung cancer screening (LCS) with low-dose CT (LDCT) imaging was recommended in 2013, making approximately 8 million Americans eligible for LCS. The demographic characteristics and outcomes of individuals screened in the United States have not been reported at the population level. What are the outcomes among people screened and entered in the American College of Radiology's Lung Cancer Screening Registry compared with those of trial participants? This was a cohort study of individuals undergoing baseline LDCT imaging for LCS between 2015 and 2019. Predictors of adherence to annual screening were computed. LDCT scan interpretations by Lung Imaging Reporting and Data System (Lung-RADS) score, cancer detection rates (CDRs), and stage at diagnosis were compared with National Lung Cancer Screening Trial data. Adherence was 22.3%, and predictors of poor adherence included current smoking status and Hispanic or Black race. On baseline screening, 83% of patients showed negative results and 17% showed positive screening results. The overall CDR was 0.56%. The percentage of people with cancer detected at baseline was higher in the positive Lung-RADS categories at 0.4% for Lung-RADS category 3, 2.6% for Lung-RADS category 4A, 11.1% for Lung-RADS category 4B, and 19.9% for Lung-RADS category 4X. The cancer stage distribution was similar to that observed in the National Lung Cancer Screening Trial, with 53.5% of patients receiving a diagnosis of stage I cancer and 14.3% with stage IV cancer. Underreporting into the registry may have occurred. This study revealed both the positive aspects of CT scan screening for lung cancer and the challenges that remain. Findings on CT imaging were correlated accurately with lung cancer detection using the Lung-RADS system. A significant stage shift toward early-stage lung cancer was present. Adherence to LCS was poor and likely contributes to the lower than expected cancer detection rate, all of which will impact the outcomes of patients undergoing screening for lung cancer. [Display omitted] [ABSTRACT FROM AUTHOR]

Advances in biomarker‐driven therapies for patients with nonsmall cell lung cancer (NSCLC) both provide opportunities to improve the treatment (and thus outcomes) for patients and pose new challenges for equitable care delivery. Over the last decade, the continuing development of new biomarker‐driven therapies and evolving indications for their use have intensified the importance of interdisciplinary communication and coordination for patients with or suspected to have lung cancer. Multidisciplinary teams are challenged with completing comprehensive and timely biomarker testing and navigating the constantly evolving evidence base for a complex and time‐sensitive disease. This guide provides context for the current state of comprehensive biomarker testing for NSCLC, reviews how biomarker testing integrates within the diagnostic continuum for patients, and illustrates best practices and common pitfalls that influence the success and timeliness of biomarker testing using a series of case scenarios. [ABSTRACT FROM AUTHOR]

Guided bronchoscopy is increasingly used to diagnose peripheral pulmonary lesions (PPLs). A meta-analysis published in 2012 demonstrated a pooled diagnostic yield of 70%; however, recent publications have documented yields as low as 40% and as high as 90%. Has the diagnostic yield of guided bronchoscopy in patients with PPLs improved over the past decade? A comprehensive search was performed of studies evaluating the diagnostic yield of differing bronchoscopic technologies used to reach PPLs. Study quality was assessed using the Quality assessment of diagnostic accuracy of studies (QUADAS-2) assessment tool. Number of lesions, type of technology used, overall diagnostic yield, and yield by size were extracted. Adverse events were recorded. Meta-analytic techniques were used to summarize findings across all studies. A total of 16,389 lesions from 126 studies were included. There was no significant difference in diagnostic yield prior to 2012 (39 studies; 3,052 lesions; yield 70.5%) vs after 2012 (87 studies; 13,535 lesions; yield 69.2%) (P >.05). Additionally, there was no significant difference in yield when comparing different technologies. Studies with low risk of overall bias had a lower diagnostic yield than those with high risk of bias (66% vs 71%, respectively; P =.018). Lesion size > 2 cm, presence of bronchus sign, and reports with a high prevalence of malignancy in the study population were associated with significantly higher diagnostic yield. Significant (P <.0001) between-study heterogeneity was also noted. Despite the reported advances in bronchoscopic technology to diagnose PPLs, the diagnostic yield of guided bronchoscopy has not improved. [Display omitted] [ABSTRACT FROM AUTHOR]

Lung cancer remains the leading cause of cancer-related mortality in the United States. The National Lung Screening Trial (NLST) demonstrated a 20% reduction in lung cancer mortality resulting from lung cancer screening (LCS) with an additive reduction from smoking abstinence. However, successful smoking cessation within LCS is variable. What patient and treatment factors are associated with attempts to quit smoking among those screened for lung cancer? In a secondary analysis of the American College of Radiology Imaging Network arm of the NLST, patient demographics, patient smoking behaviors, and tobacco treatment variables were stratified by patient smoking status. The Cox proportional hazards ratio was used to evaluate each variable's effect on attempting to quit smoking. Seven thousand three hundred sixty-nine patients were smoking actively at enrollment in the NLST. Of the patients who reported they were smoking, 73.4% did not receive any pharmacologic tobacco treatment. More patients who attempted to quit received pharmacologic tobacco treatment than those who continued to smoke: (nicotine replacement therapy [NRT], 18.0% vs 12.4% [ P <.01]; bupropion, 7.9% vs 6.9% [ P =.02]; both NRT and bupropion, 5.6% vs 3.9% [ P <.01]). Stable users were more likely to be women (47.8% vs 43.8%; P <.01), to be African American (8.2% vs 6.3%; P =.007), to be unmarried (43.2% vs 36.9% [ P <.01]), and to have less than a college education (47.7% vs 42.3%; P <.01). Patients with high dependence who received dual therapy with bupropion and NRT showed the highest likelihood of quit attempt (hazard ratio, 2.07; 95% CI, 1.75-2.44). In this analysis, only one-quarter of patients who underwent LCS and who smoked were treated with pharmacologic therapy, which is associated with increased likelihood of attempting to quit. Certain characteristics are associated with difficulty with attempting to quit smoking. Those with high nicotine dependence benefitted most from dual pharmacologic therapy. [Display omitted] [ABSTRACT FROM AUTHOR]

Background: Bronchoscopic lung biopsy is typically performed using transbronchial forceps. However, this method is limited by small sample size and presence of crush artifact. Cryobiopsy offers the potential to overcome these limitations with larger artifact-free samples but has not been widely adopted due to concerns over increased rates of bleeding and pneumothorax. A new, smaller 1.1-mm cryoprobe has been developed that operates in a similar fashion to forceps, though the safety profile of this cryoprobe has not yet been prospectively studied. Objective: The aim of this study was to investigate the safety of transbronchial biopsy using a novel 1.1-mm cryoprobe. Methods: This prospective, single-arm study enrolled patients referred for transbronchial biopsy. All procedures were performed using the 1.1-mm cryoprobe with oversheath. The primary outcome was the composite of significant complications related to the cryobiopsy procedure (bleeding Grade ≥3, pneumothorax Grade ≥2, and respiratory failure). Bleeding and pneumothorax were graded according to previously published scales. Results: Fifty participants from two academic medical centers underwent transbronchial cryobiopsy. Indications for biopsy included evaluation of lung transplant allograft (50%), diffuse lung disease (44%), and pulmonary parenchymal lesion (6%). There were two pneumothoraces (4%), neither of which required aspiration or chest tube placement. There were no Grade 3 or 4 bleeding events. Mild bleeding (Grade ≤2) was observed in 25 cases (50%). No complications occurred that met the a priori primary outcome of bleeding Grade ≥3, pneumothorax Grade ≥2, and respiratory failure. Conclusions: Transbronchial cryobiopsy using a 1.1-mm cryoprobe is feasible with an acceptable safety profile. [ABSTRACT FROM AUTHOR]

Background: Pharmacotherapies remain a central focus of successful tobacco control, but uptake remains very low. Objective: To estimate the cost effectiveness of a primary care nicotine replacement therapy (NRT) sampling intervention. Design: A Markov cohort simulation model was constructed to conduct cost-effectiveness analyses. Clinical trial results were used to initialize the Markov model. All other model parameters were derived from the literature. The study was conducted over a lifetime horizon, from the payers' budgetary perspective. Participants: Smokers with a primary care visit. Intervention: Medication sampling, which provided short, starter packets of NRT (nicotine patch and lozenge) to smokers in the primary care setting. Main Measures: Lifetime healthcare expenditures, quality-adjusted life years, and life years. Key Results: Medication sampling was the dominant strategy compared to standard care. Our intervention cost $75, yielding a discounted lifetime savings of $1065 in healthcare expenditures, and increased both discounted quality-adjusted life years and discounted life years by 0.01. One-way sensitivity analyses showed that medication sampling remained dominant in plausible ranges except when it failed to increase cessation relative to standard care. Probabilistic sensitivity analyses confirmed that medication sampling was dominant in 94.1% of the simulated cases, with an implementation cost of $74 (95% CI $73–$76) and discounted lifetime savings in health expenditures of $1061 (− $1106 to − $1,017), increasing quality-adjusted life years by 0.008 (0.0085–0.0093) and life years by 0.008 (0.0081–0.0089). Conclusion: Medication sampling, an easily implementable, scalable and low-cost intervention to encourage smoking cessation, is cost saving and improves quality of life. [ABSTRACT FROM AUTHOR]

Background: Lung cancer screening (LCS) with low-dose computed tomography (LDCT) was recommended by the U.S. Preventive Services Task Force (USPSTF) in 2013, making approximately 8 million Americans eligible for screening. The demographic characteristics and adherence of persons screened in the United States have not been reported at the population level.Objective: To define sociodemographic characteristics and adherence among persons screened and entered into the American College of Radiology's Lung Cancer Screening Registry (LCSR).Design: Cohort study.Setting: United States, 2015 to 2019.Participants: Persons receiving a baseline LDCT for LCS from 3625 facilities reporting to the LCSR.Measurements: Age, sex, and smoking status distributions (percentages) were computed among persons who were screened and among respondents in the 2015 National Health Interview Survey (NHIS) who were eligible for screening. The prevalence between the LCSR and the NHIS was compared with prevalence ratios (PRs) and 95% CIs. Adherence to annual screening was defined as having a follow-up test within 11 to 15 months of an initial LDCT.Results: Among 1 159 092 persons who were screened, 90.8% (n = 1 052 591) met the USPSTF eligibility criteria. Compared with adults from the NHIS who met the criteria (n = 1257), screening recipients in the LCSR were older (34.7% vs. 44.8% were aged 65 to 74 years; PR, 1.29 [95% CI, 1.20 to 1.39]), more likely to be female (41.8% vs. 48.1%; PR, 1.15 [CI, 1.08 to 1.23]), and more likely to currently smoke (52.3% vs. 61.4%; PR, 1.17 [CI, 1.11 to 1.23]). Only 22.3% had a repeated annual LDCT. If follow-up was extended to 24 months and more than 24 months, 34.3% and 40.3% were adherent, respectively.Limitations: Underreporting of LCS and missing data may skew demographic characteristics of persons reported to be screened. Underreporting of adherence may result in underestimates of follow-up.Conclusion: Approximately 91% of persons who had LCS met USPSTF eligibility criteria. In addition to continuing to target all eligible adults, men, those who formerly smoked, and younger eligible patients may be less likely to be screened. Adherence to annual follow-up screening was poor, potentially limiting screening effectiveness.Primary Funding Source: None. [ABSTRACT FROM AUTHOR]

Background: Pretreatment invasive nodal staging is paramount for appropriate treatment decisions in non-small cell lung cancer. Despite guidelines recommending when to perform staging, many studies suggest that invasive nodal staging is underused. Attitudes and barriers to guideline-recommended staging are unclear. The National Lung Cancer Roundtable initiated this study to better understand the factors associated with guideline-adherent nodal staging.Research Question: What are the knowledge gaps, attitudes, and beliefs of thoracic surgeons and pulmonologists about invasive nodal staging? What are the barriers to guideline-recommended staging?Study Design and Methods: A web-based survey of a random sample of pulmonologists and thoracic surgeons identified as members of American College of Chest Physicians (CHEST) was conducted in 2019. Survey domains included knowledge of invasive nodal staging guidelines, attitudes and beliefs toward implementation, and perceived barriers to guideline adherence.Results: Among 453 responding physicians, 29% were unaware that invasive nodal staging guidelines exist. Among the 320 physicians who knew guidelines exist, attitudes toward the guidelines were favorable, with 91% agreeing guidelines are generalizable and 90% agreeing that recommendations improved their staging and treatment decisions. Approximately 80% responded that guideline recommendations are based on satisfactory levels of scientific evidence, and 50% stated a lack of evidence linking adherence to guidelines to changes in management or better patient outcomes. Nearly 9 in 10 physicians reported at least one barrier to guideline adherence. The most common barriers included patient anxiety associated with treatment delays (62%), difficulty implementing guidelines into routine practice (52%), and time delays of additional testing (51%).Interpretation: Among physicians who responded to our survey, more than one-quarter were unaware of invasive nodal staging guidelines. Attitudes toward guideline recommendations were positive, although 20% reported insufficient evidence to support staging algorithms. Most physicians reported barriers to implementing guidelines. Multilevel interventions are likely needed to increase rates of guideline-recommended invasive nodal staging. [ABSTRACT FROM AUTHOR]

Background: Bronchial thermoplasty is a device-based treatment for subjects ≥ 18 years of age with severe asthma poorly controlled with inhaled corticosteroids and long-acting beta-agonists. The Post-FDA Approval Clinical Trial Evaluating Bronchial Thermoplasty in Severe Persistent Asthma (PAS2) study collected data on patients with severe asthma undergoing this procedure.Research Question: What are the 5-year efficacy and safety results in patients with severe asthma who have undergone bronchial thermoplasty?Study Design and Methods: This was a prospective, open-label, observational, multicenter study conducted in the United States and Canada. Subjects 18 to 65 years of age who were taking inhaled corticosteroids ≥ 1,000 μg/d (beclomethasone or equivalent) and long-acting beta-agonists ≥ 80 μg/d (salmeterol or equivalent) were included. Severe exacerbations, hospitalization, ED visits, and medication usage were evaluated for the 12 months prior to and at years 1 through 5 posttreatment. Spirometry was evaluated at baseline and at years 1 through 5 posttreatment.Results: A total of 284 subjects were enrolled at 27 centers; 227 subjects (80%) completed 5 years of follow-up. By year 5 posttreatment, the proportion of subjects with severe exacerbations, ED visits, and hospitalizations was 42.7%, 7.9%, and 4.8%, respectively, compared with 77.8%, 29.4%, and 16.1% in the 12 months prior to treatment. The proportion of subjects on maintenance oral corticosteroids decreased from 19.4% at baseline to 9.7% at 5 years. Analyses of subgroups based on baseline clinical and biomarker characteristics revealed a statistically significant clinical improvement among all subgroups.Interpretation: Five years after treatment, subjects experienced decreases in severe exacerbations, hospitalizations, ED visits, and corticosteroid exposure. All subgroups demonstrated clinically significant improvement, suggesting that bronchial thermoplasty improves asthma control in different asthma phenotypes.Clinical Trial Registration: ClinicalTrials.gov; No.: NCT01350336; URL: www.Clinicaltrials: gov. [ABSTRACT FROM AUTHOR]

Background: An ASCO taskforce comprised of representatives of oncology clinicians, the American Cancer Society National Lung Cancer Roundtable (NLCRT), LUNGevity, the GO2 Foundation for Lung Cancer, and the ROS1ders sought to: characterize U.S. oncologists' biomarker ordering and treatment practices for advanced non‐small‐cell lung cancer (NSCLC); ascertain barriers to biomarker testing; and understand the impact of delays on treatment decisions. Methods: We deployed a survey to 2374 ASCO members, targeting U.S. thoracic and general oncologists. Results: We analyzed 170 eligible responses. For non‐squamous NSCLC, 97% of respondents reported ordering tests for EGFR, ALK, ROS1, and BRAF. Testing for MET, RET, and NTRK was reported to be higher among academic versus community providers and higher among thoracic oncologists than generalists. Most respondents considered 1 (46%) or 2 weeks (52%) an acceptable turnaround time, yet 37% usually waited three or more weeks to receive results. Respondents who waited ≥3 weeks were more likely to defer treatment until results were reviewed (63%). Community and generalist respondents who waited ≥3 weeks were more likely to initiate non‐targeted treatment while awaiting results. Respondents <5 years out of training were more likely to cite their concerns about waiting for results as a reason for not ordering biomarker testing (42%, vs. 19% with ≥6 years of experience). Conclusions: Respondents reported high biomarker testing rates in patients with NSCLC. Treatment decisions were impacted by test turnaround time and associated with practice setting and physician specialization and experience. [ABSTRACT FROM AUTHOR]

Background: Targeted therapies for advanced non-small cell lung cancer (NSCLC) with oncogenic drivers have caused a paradigm shift in care. Biomarker testing is needed to assess eligibility for these therapies. Pulmonologists often perform bronchoscopy, providing tissue for both pathologic diagnosis and biomarker analysis. We performed this survey to define the existing knowledge and practices regarding the pulmonologists' role in biomarker testing for advanced NSCLC.Research Question: What is the current knowledge and practice of pulmonologists regarding biomarker testing and targeted therapies in advanced NSCLC?Study Design and Methods: This cross-sectional study was performed using an electronic survey of a random sample of 7,238 pulmonologists. Questions focused on diagnostic steps and biomarker analyses for NSCLC.Results: A total of 453 pulmonologists responded. Respondents vary by reported lung cancer patient volume, ranging from 51% evaluating one to four new cases per month to 19% evaluating > 10 cases per month. Interventional training, academic practice setting, and higher volume of endobronchial ultrasound with transbronchial needle aspiration (EBUS-TBNA) were associated with increased knowledge of practice guidelines for the number of recommended passes during EBUS-TBNA (P < .05). Academic pulmonologists more commonly performed or referred for EBUS-TBNA than community pulmonologists (96% and 83%, respectively; P < .0005). Higher testing rates were associated with interventional training, academic setting, and the presence of an institutional policy, whereas lower testing rates were associated with general pulmonologists, practice in community settings, and lack of a guiding institutional policy (P < .05).Interpretation: Substantial differences among pulmonologists' evaluation of advanced NSCLC, variation in knowledge of available biomarkers and the importance of targeted therapies, and differences in institutional coordination likely lead to underutilization of biomarker testing. Interventional training appears to drive improved knowledge and practice for biomarker testing more than practice setting. Improvements are needed in tissue acquisition and interdisciplinary coordination to ensure universal and comprehensive testing for eligible patients. [ABSTRACT FROM AUTHOR]

Rationale: Although lung cancer screening (LCS) with low-dose computed tomography (LDCT) is now recommended for those meeting standard risk factor-based eligibility criteria, the role of comorbidity in the uptake of LCS with LDCT in an older real-world U.S. population is not well established. Objectives: To examine the relationships between comorbidity, functional status, and LCS utilization in the United States. Methods: Using population-based data from the 2017-2019 Behavioral Risk Factor Surveillance System, we examined the association of comorbid conditions and functional limitations regarding activities of daily living with LCS utilization among participants that met the LCS criteria based on the U.S. Preventive Service Taskforce guidelines. We employed multivariable weighted logistic regression models to evaluate these associations, both overall and within subgroups defined by age (<65 yr vs. ⩾65 yr), sex, and smoking history. Results: Of 11,214 participants who met the eligibility criteria for LCS, 1,731 (16%) underwent LCS with LDCT. The majority were White (90%), male (55%), former smokers (52%), and living with at least one chronic comorbid condition (77%). More than 28% had three or more comorbid conditions, and approximately 40% of participants reported having some form of functional limitations. In the multivariable models, the likelihood of undergoing LCS with LDCT within the past year was positively associated with higher amount of comorbidity (⩾5 vs. 0: adjusted odds ratio, 2.34; 95% confidence interval [CI], 1.22-4.48) but not with functional limitations (⩾3 vs. 0: adjusted odds ratio, 1.00; 95% CI, 0.66-1.50). Conclusions: The presence of comorbid conditions is associated with a higher likelihood of undergoing LCS with LDCT. Because poor health status may diminish the benefits of screening, future research is needed to precisely characterize the health status of LCS-eligible individuals. [ABSTRACT FROM AUTHOR]

Background: Low-dose chest CT screening for lung cancer has become a standard of care in the United States, in large part because of the results of the National Lung Screening Trial (NLST). Additional evidence supporting the net benefit of low-dose chest CT screening for lung cancer, and increased experience in minimizing the potential harms, has accumulated since the prior iteration of these guidelines. Here, we update the evidence base for the benefit, harms, and implementation of low-dose chest CT screening. We use the updated evidence base to provide recommendations where the evidence allows, and statements based on experience and expert consensus where it does not.Methods: Approved panelists reviewed previously developed key questions using the Population, Intervention, Comparator, Outcome format to address the benefit and harms of low-dose CT screening, and key areas of program implementation. A systematic literature review was conducted using MEDLINE via PubMed, Embase, and the Cochrane Library on a quarterly basis since the time of the previous guideline publication. Reference lists from relevant retrievals were searched, and additional papers were added. Retrieved references were reviewed for relevance by two panel members. The quality of the evidence was assessed for each critical or important outcome of interest using the Grading of Recommendations, Assessment, Development, and Evaluation approach. Meta-analyses were performed when enough evidence was available. Important clinical questions were addressed based on the evidence developed from the systematic literature review. Graded recommendations and ungraded statements were drafted, voted on, and revised until consensus was reached.Results: The systematic literature review identified 75 additional studies that informed the response to the 12 key questions that were developed. Additional clinical questions were addressed resulting in seven graded recommendations and nine ungraded consensus statements.Conclusions: Evidence suggests that low-dose CT screening for lung cancer can result in a favorable balance of benefit and harms. The selection of screen-eligible individuals, the quality of imaging and image interpretation, the management of screen-detected findings, and the effectiveness of smoking cessation interventions can impact this balance. [ABSTRACT FROM AUTHOR]

Background: Low-dose chest CT screening for lung cancer has become a standard of care in the United States, in large part because of the results of the National Lung Screening Trial (NLST). Additional evidence supporting the net benefit of low-dose chest CT screening for lung cancer, and increased experience in minimizing the potential harms, has accumulated since the prior iteration of these guidelines. Here, we update the evidence base for the benefit, harms, and implementation of low-dose chest CT screening. We use the updated evidence base to provide recommendations where the evidence allows, and statements based on experience and expert consensus where it does not.Methods: Approved panelists reviewed previously developed key questions using the Population, Intervention, Comparator, Outcome format to address the benefit and harms of low-dose CT screening, and key areas of program implementation. A systematic literature review was conducted using MEDLINE via PubMed, Embase, and the Cochrane Library on a quarterly basis since the time of the previous guideline publication. Reference lists from relevant retrievals were searched, and additional papers were added. Retrieved references were reviewed for relevance by two panel members. The quality of the evidence was assessed for each critical or important outcome of interest using the Grading of Recommendations, Assessment, Development and Evaluation approach. Meta-analyses were performed where appropriate. Important clinical questions were addressed based on the evidence developed from the systematic literature review. Graded recommendations and ungraded statements were drafted, voted on, and revised until consensus was reached.Results: The systematic literature review identified 75 additional studies that informed the response to the 12 key questions that were developed. Additional clinical questions were addressed resulting in seven graded recommendations and nine ungraded consensus statements.Conclusions: Evidence suggests that low-dose CT screening for lung cancer can result in a favorable balance of benefit and harms. The selection of screen-eligible individuals, the quality of imaging and image interpretation, the management of screen-detected findings, and the effectiveness of smoking cessation interventions can impact this balance. [ABSTRACT FROM AUTHOR]

Background: Annual lung cancer screening (LCS) with low-dose chest computed tomography in older current and former smokers (ie, eligible adults) has been recommended since 2013. Uptake has been slow and variable across the United States. We estimated the LCS rate and growth at the national and state level between 2016 and 2018.Methods: The American College of Radiology's Lung Cancer Screening Registry was used to capture screening events. Population-based surveys, the US Census, and cancer registry data were used to estimate the number of eligible adults and lung cancer mortality (ie, burden). Lung cancer screening rates (SRs) in eligible adults and screening rate ratios with 95% confidence intervals (CI) were used to measure changes by state and year.Results: Nationally, the SR was steady between 2016 (3.3%, 95% CI = 3.3% to 3.7%) and 2017 (3.4%, 95% CI = 3.4% to 3.9%), increasing to 5.0% (95% CI = 5.0% to 5.7%) in 2018 (2018 vs 2016 SR ratio = 1.52, 95% CI = 1.51 to 1.62). In 2018, several southern states with a high lung-cancer burden (eg, Mississippi, West Virginia, and Arkansas) had relatively low SRs (<4%) among eligible adults, whereas several northeastern states with lower lung cancer burden (eg, Massachusetts, Vermont, and New Hampshire) had the highest SRs (12.8%-15.2%). The exception was Kentucky, which had the nation's highest lung cancer mortality rate and one of the highest SRs (13.7%).Conclusions: Fewer than 1 in 20 eligible adults received LCS nationally, and uptake varied widely across states. LCS rates were not aligned with lung cancer burden across states, except for Kentucky, which has supported comprehensive efforts to implement LCS. [ABSTRACT FROM AUTHOR]

Background: Lung cancer is a leading cause of cancer incidence and death in the United States. Risk factor-based guidelines and risk model-based strategies are used to identify patients who could benefit from low-dose chest CT (LDCT) screening. Few studies compare guidelines or models within the same cohort. We evaluate lung cancer screening performance of two risk factor-based guidelines (US Preventive Services Task Force 2014 recommendations [USPSTF-2014] and National Comprehensive Cancer Network Group 2 [NCCN-2]) and two risk model-based strategies, Prostate Lung Colorectal and Ovarian Cancer Screening (PLCOm2012) and the Bach model) in the same occupational cohort.Research Question: Which risk factor-based guideline or model-based strategy is most accurate in detecting lung cancers in a highly exposed occupational cohort?Study Design and Methods: Fire Department of City of New York (FDNY) rescue/recovery workers exposed to the September 11, 2001 attacks underwent LDCT lung cancer screening based on smoking history and age. The USPSTF-2014, NCCN-2, PLCOm2012 model, and Bach model were retrospectively applied to determine how many lung cancers were diagnosed using each approach.Results: Among the study population (N = 3,953), 930 underwent a baseline scan that met at least one risk factor or model-based LDCT screening strategy; 73% received annual follow-up scans. Among the 3,953, 63 lung cancers were diagnosed, of which 50 were detected by at least one LDCT screening strategy. The NCCN-2 guideline was the most sensitive (79.4%; 50/63). When compared with NCCN-2, stricter age and smoking criteria reduced sensitivity of the other guidelines/models (USPSTF-2014 [44%], PLCOm2012 [51%], and Bach[46%]). The 13 missed lung cancers were mainly attributable to smoking less and quitting longer than guideline/model eligibility criteria. False-positive rates were similar across all four guidelines/models.Interpretation: In this cohort, our findings support expanding eligibility for LDCT lung cancer screening by lowering smoking history from ≥30 to ≥20 pack-years and age from 55 years to 50 years old. Additional studies are needed to determine its generalizability to other occupational/environmental exposed cohorts. [ABSTRACT FROM AUTHOR]

Background: Lung cancer survivors need more options to improve quality of life (QoL). It is unclear to what extent patients with advanced stage disease are willing to participate in home-based physical activity (PA) and if these interventions improve QoL. The goal of our study was to determine interest in participating in our 3-month home-based walking regimen in patients with advanced stage lung cancer. We used a randomized design to evaluate for potential benefit in PA and patient-reported outcomes.Methods: We performed an open-label, 1:1 randomized trial in 40 patients with stage III/IV non-small cell lung cancer (NSCLC) evaluating enrollment rate, PA, QoL, dyspnea, depression, and biomarkers. Compared to usual care (UC), the intervention group (IG) received an accelerometer, in-person teaching session, and gain-framed text messages for 12 weeks.Results: We enrolled 56% (40/71) of eligible patients. Participants were on average 65 years and enrolled 1.9 years from diagnosis. Most patients were women (75%), and receiving treatment (85%) for stage IV (73%) adenocarcinoma (83%). A minority of patients were employed part-time or full time (38%). Both groups reported low baseline PA (IG mean 37 (Standard deviation (SD) 46) vs UC 59 (SD 56) minutes/week; p = 0.25). The IG increased PA more than UC (mean change IG + 123 (SD 212) vs UC + 35 (SD 103) minutes/week; p = 0.051)). Step count in the IG was not statistically different between baseline (4707 step/day), week 6 (5605; p = 0.16), and week 12 (4606 steps/day; p = 0.87). The intervention improved EORTC role functioning domain (17 points; p = 0.022) with borderline improvement in dyspnea (- 13 points; p = 0.051) compared to UC. In patients with two blood samples (25%), we observed a significant increase in soluble PD-1 (219.8 (SD 54.5) pg/mL; p < 0.001).Conclusions: Our pilot trial using a 3-month, home-based, mobile health intervention enrolled over half of eligible patients with stage III and IV NSCLC. The intervention increased PA, and may improve several aspects of QoL. We also identified potential biomarker changes relevant to lung cancer biology. Future research should use a larger sample to examine the effect of exercise on cancer biomarkers, which may mediate the association between PA and QoL.Clinical Trial Registration: Clinicaltrials.gov ( NCT03352245 ). [ABSTRACT FROM AUTHOR]

An integrated proteomic biomarker combining two plasma proteins (LG3BP and C163A) with five clinical/imaging factors (age, smoking status, nodule size, edge, and location) was previously shown to be potentially useful in nodule patients with a pretest probability of malignancy of 50% or less. The biomarker was more accurate than physician and risk calculator assessments.[4] Here we report the 2-year follow-up results of the PulmonAry NOdule Plasma proTeomIc Classifier (PANOPTIC) trial and an extended analysis to those with multiple pulmonary nodules. To the Editor: Pulmonary nodules pose a diagnostic dilemma for clinicians and patients.[1] Guidelines for nodule management emphasize assessment of pretest probability for malignancy (pCA) in determining next steps.[2] SP , sp [3] The goal for nodule management is to avoid diagnostic procedures in those with benign disease and expedite diagnosis and treatment in those with malignancy. [Extracted from the article]

Background: The diagnosis of peripheral pulmonary lesions (PPL) continues to present clinical challenges. Despite extensive experience with guided bronchoscopy, the diagnostic yield has not improved significantly. Robotic-assisted bronchoscopic platforms have been developed potentially to improve the diagnostic yield for PPL. Presently, limited data exist that evaluate the performance of robotic systems in live human subjects.Research Question: What is the safety and feasibility of robotic-assisted bronchoscopy in patients with PPLs?Study Design and Methods: This was a prospective, multicenter pilot and feasibility study that used a robotic bronchoscopic system with a mother-daughter configuration in patients with PPL 1 to 5 cm in size. The primary end points were successful lesion localization with the use of radial probe endobronchial ultrasound (R-EBUS) imaging and incidence of procedure related adverse events. Robotic bronchoscopy was performed in patients with the use of direct visualization, electromagnetic navigation, and fluoroscopy. After the use of R-EBUS imaging, transbronchial needle aspiration was performed. Rapid on-site evaluation (ROSE) was used on all cases. Transbronchial needle aspiration alone was sufficient when ROSE was diagnostic; when ROSE was not diagnostic, transbronchial biopsy was performed with the use of the robotic platform, followed by conventional guided bronchoscopic approaches at the discretion of the investigator.Results: Fifty-five patients were enrolled at five centers. One patient withdrew consent, which left 54 patients for data analysis. Median lesion size was 23 mm (interquartile range, 15 to 29 mm). R-EBUS images were available in 53 of 54 cases. Lesion localization was successful in 51 of 53 patients (96.2%). Pneumothorax was reported in two of 54 of the cases (3.7%); tube thoracostomy was required in one of the cases (1.9 %). No additional adverse events occurred.Interpretation: This is the first, prospective, multicenter study of robotic bronchoscopy in patients with PPLs. Successful lesion localization was achieved in 96.2% of cases, with an adverse event rate comparable with conventional bronchoscopic procedures. Additional large prospective studies are warranted to evaluate procedure characteristics, such as diagnostic yield.Clinical Trial Registration: ClinicalTrials.gov; No.: NCT03727425; URL: www.clinicaltrials.gov. [ABSTRACT FROM AUTHOR]

Background: Over decades, there have been several alterations to cigarettes, including the addition of filters and flavoring. However, lung cancer remains the leading cause of cancer-related death in the United States.Research Question: The aim of this study was to examine the association of type of cigarette on nicotine dependence in the setting of lung cancer screening.Study Design and Methods: This study is a secondary analysis of the American College of Radiology Imaging Network arm of the National Lung Screening Trial. Tobacco dependence was evaluated by using the Fagerstrӧm Test for Nicotine Dependence, the Heaviness of Smoking Index, and time to first cigarette. Clinical outcomes, including nicotine dependence and tobacco abstinence, were assessed with descriptive statistics and χ2 tests, stratified according to cigarette tar level, flavor, and filter. Logistic regression was used to study the influence of variables on smoking abstinence.Results: More than one-third of individuals presenting for lung cancer screening are highly addicted to nicotine and smoke within 5 min of waking up. Smokers of unfiltered cigarettes were more nicotine dependent compared with filtered cigarette smokers (OR, 1.32; P < .01). Although smokers of light/ultralight cigarettes had lower dependence (OR, 0.76, P < .0001), there was no difference in smoking abstinence compared with regular cigarette smokers. There was no difference in outcomes when comparing smokers of menthol vs unflavored cigarettes.Interpretation: In a screening population, the type of cigarette smoked is associated with different levels of dependence. Eliciting type of cigarette and time to first cigarette has the potential to allow for tailored tobacco treatment interventions within this context. [ABSTRACT FROM AUTHOR]

Background: Adherence to annual low-dose CT was 95% in the National Lung Screening Trial and must be replicated to achieve mortality benefit from screening.Research Question: How do we determine adherence rates within the Veterans Affairs Lung Cancer Screening Demonstration Project and identify factors predictive of adherence?Study Design and Methods: A secondary data analysis of the Lung Cancer Screening Demonstration Project that was conducted at eight Veterans Affairs medical centers was performed to determine adherence to follow up imaging and to determine factors predictive of adherence.Results: A total of 2,103 patients were screened. The adherence to screening from baseline scan (T0) to first follow-up scan (T1) was 82.2% and 65.2% from T1 to second follow-up scan (T2). Logistic regression modeling showed that presence of a nodule and the site of lung cancer screening were predictive of adherence. After three rounds of screening, 1,343 patients (64%) who underwent baseline screening underwent both subsequent annual low-dose CT scans; 225 patients (11%) had only one subsequent low-dose CT; 0.4% did not have a T1 scan but did have a T2 scan; 70 patients (3%) died, and 36 patients (1.7%) were diagnosed with lung cancer. There was significant variation in screening adherence across the eight sites, which ranged from 63% to 94% at T1 and 52% to 82% at T2 (P < .05).Interpretation: Despite a centralized program design with dedicated navigator and registry to assist with adherence to annual lung cancer screening, variations between sites suggest that active follow-up strategies are needed to optimize adherence. For the mortality benefit from lung cancer screening to be recognized, adherence to annual screening must achieve higher rates. [ABSTRACT FROM AUTHOR]

Computed tomography lung cancer screening reduces lung cancer mortality. However, screening is underutilized. This study assesses the extent to which providers discuss lung cancer screening with their patients, as a lack of discussion and counseling may serve as a potential cause of low utilization rates. Data from 1667 adults aged 55–80 years sampled in the 2017 Health Information National Trends Survey was utilized. A weighted multivariable logistic regression model was fit with past-year discussion about lung cancer screening with a provider as the outcome. The adjusted odds of discussion were higher for current cigarette smokers compared to non-cigarette smokers (adjusted odds ratio = 3.91; 95% confidence interval [CI], 1.75 to 8.74). Despite higher odds, the absolute prevalence was low with only 18% (95% CI, 11.8 to 24.2%) of current adult smokers reporting a past-year discussion. Knowledge of screening from trusted sources of medical information, such as doctors, can increase screening rates and may ultimately reduce lung cancer mortality. [ABSTRACT FROM AUTHOR]

Background: Bronchoscopy is commonly used to evaluate suspicious lung lesions. The yield is likely dependent on patient, radiographic, and bronchoscopic factors. Few studies have assessed these factors simultaneously while also including the preprocedure physician-assessed probability of cancer (pCA) when assessing yield.Methods: This study is a secondary data analysis from a prospective multicenter trial. Diagnostic yield of standard bronchoscopy with biopsy ± fluoroscopy, endobronchial ultrasound with transbronchial needle aspiration (EBUS-TBNA), electromagnetic navigation, and combination bronchoscopies was assessed. Definitions for diagnostic and nondiagnostic bronchoscopies were rigorously predefined. The association of diagnostic yield with individual variables was examined by using univariate and multivariate logistic regression analyses where appropriate.Results: A total of 687 patients were included from 28 sites. Overall diagnostic yield was 69%; 80% for EBUS, 55% for bronchoscopy with biopsy ± fluoroscopy, 57% for electromagnetic navigation, and 74% for combination procedures (P < .001). Patients with larger, central lesions with adenopathy were significantly more likely to undergo a diagnostic bronchoscopy. Patients with pCA < 10% and 10% to 60% had lower yields (44% and 42%, respectively), whereas pCA > 60% yielded a positive result in 77% (P < .001). In multivariate logistic regression, the use of EBUS-TBNA, larger sized lesions, and central location were significantly associated with a diagnostic bronchoscopy. Seventeen percent of those with a malignant diagnosis and 28% of those with a benign diagnosis required secondary procedures to establish a diagnosis.Conclusions: This study is the first to assess the yield of bronchoscopy according to physician-assessed pCA in a large, prospective multicenter trial. The yield of bronchoscopy varied greatly according to physician suspicion that cancer is present, the patients' clinical/radiographic features, and the type of procedure performed. Of the procedures performed, EBUS-TBNA was the most likely to provide a diagnosis. [ABSTRACT FROM AUTHOR]

Background: Bronchoscopy for the diagnosis of peripheral pulmonary lesions continues to present clinical challenges, despite increasing experience using newer guided techniques. Robotic bronchoscopic platforms have been developed to potentially improve diagnostic yields. Previous studies in cadaver models have demonstrated increased reach into the lung periphery using robotic systems compared to similarly sized conventional bronchoscopes, although the clinical impact of additional reach is unclear. Objectives: This study was performed to evaluate the performance of a robotic bronchoscopic system's ability to reach and access artificial tumor targets simulating peripheral nodules in human cadaveric lungs. Methods: Artificial tumor targets sized 10–30 mm in axial diameter were implanted into 8 human cadavers. CT scans were performed prior to procedures and all cadavers were intubated and mechanically ventilated. Electromagnetic navigation, radial probe endobronchial ultrasound, and fluoroscopy were used for all procedures. Robotic-assisted bronchoscopy was performed on each cadaver by an individual bronchoscopist to localize and biopsy peripheral lesions. Results: Sixty-seven nodules were evaluated in 8 cadavers. The mean nodule size was 20.4 mm. The overall diagnostic yield was 65/67 (97%) and there was no statistical difference in diagnostic yield for lesions <20 mm compared with lesions measuring 21–30 mm, the presence of a concentric or eccentric radial ultrasound image, or relative distance from the pleura. Conclusions: The robotic bronchoscopic system was successful at biopsying 97% of peripheral pulmonary lesions 10–30 mm in size in human cadavers. These findings support further exploration of this technology in prospective clinical trials in live human subjects. [ABSTRACT FROM AUTHOR]

Background: The ability to successfully perform a biopsy on pulmonary lesions by means of bronchoscopy varies widely due to anatomic and technological limitations. One major limitation is the lack of the ability to utilize real-time guidance during tissue sampling in the periphery. A novel system has been developed that enables real-time visualization and sampling of peripheral lesions by displaying an ultrasound image of the lesion and needle simultaneously. Methods: We performed a multicenter, prospective pilot in patients with peripheral pulmonary lesions undergoing a clinically indicated bronchoscopy. The purpose of this study was to demonstrate the feasibility of visualizing, accessing, and obtaining specimens adequate for the cytology of lung lesions when using a novel hybrid real-time ultrasound-guided fine-needle aspiration system for peripheral pulmonary lesions. Results: Twenty-three patients underwent bronchoscopic sampling of a peripheral pulmonary lesion with the study device. Mean lesion size was 3.6 (range 1.7–5.7) cm. Targeted lesions were located in all lobes of the lung. All lesions were successfully visualized and sampled under real-time visualization with specimens adequate for cytological evaluation. The needle was visualized in all lesions throughout targeting and sampling. There were no incidents of pneumothorax or moderate-to-severe bleeding. Conclusion: In this feasibility study, we report the first-in-human use of a continuous real-time endobronchial ultrasound guidance system to sample peripheral pulmonary lesions. Future generations of this device may improve usability and further studies are needed to determine the true diagnostic capabilities of this novel technique. [ABSTRACT FROM AUTHOR]

Background: There is discontent and turnover among faculty at US academic health centers because of the challenges in balancing clinical, research, teaching, and work–life responsibilities in the current healthcare environment. One potential strategy to improve faculty satisfaction and limit turnover is through faculty mentoring programs. Methods: A Mentor Leadership Council was formed to design and implement an institution-wide faculty mentoring program across all colleges at an academic health center. The authors conducted an experimental study of the impact of the mentoring program using pre-intervention (2011) and 6-year (2017) post-intervention faculty surveys that measured the long-term effectiveness of the program. Results: The percent of faculty who responded to the surveys was 45.9% (656/1428) in 2011 and 40.2% (706/1756) in 2017. For faculty below the rank of full professor, percent of faculty with a mentor (45.3% vs. 67.1%, P < 0.001), familiarity with promotion criteria (81.7% vs. 90.0%, P = 0.001), and satisfaction with department's support of career (75.6% vs. 84.7%, P = 0.002) improved. The percent of full professors serving as mentors also increased from 50.3% in 2011 to 68.0% in 2017 (P = 0.002). However, the percent of non-retiring faculty considering leaving the institution over the next 2 years increased from 18.8% in 2011 to 24.3% in 2017 (P = 0.02). Conclusions: Implementation of an institution-wide faculty mentoring program significantly improved metrics of career development and faculty satisfaction but was not associated with a reduction in the percent of faculty considering leaving the institution. This suggests the need for additional efforts to identify and limit factors driving faculty turnover. [ABSTRACT FROM AUTHOR]

Background: Shared decision-making is an essential element of low-dose CT (LDCT) screening for lung cancer. Understanding patient-level outcomes from the National Lung Screening Trial (NLST) is critical to effectively communicate risks and benefits of screening to patients.Methods: We performed a secondary analysis of data collected in the NLST. We determined outcomes of each LDCT scan performed in the NLST (downstream evaluation, complications, lung cancer diagnoses), and compared outcomes at the test level with outcomes calculated at the patient level for those randomized to LDCT screening. To assess the impact of COPD on patient outcomes, we compared outcomes among patients with and without COPD.Results: Of 75,138 LDCT scans, 14.2% led to a diagnostic study and 1.5% to an invasive procedure, with 0.3% of LDCT scans resulting in a procedure-related complication and 0.1% in a serious complication. Among 24,453 patients who underwent LDCT screening, 30.5% underwent a diagnostic study and 4.2% an invasive procedure, with 0.9% of screened patients experiencing a procedure-related complication and 0.3% a serious complication. Patients with COPD (defined by self-report) were more likely to need a diagnostic study (adjusted OR [aOR], 1.29; P < .01) and an invasive procedure (aOR, 1.41; P < .01) and more likely to experience a complication (aOR, 1.83; P < .01) and a serious complication (aOR, 1.78; P = .01). Patients with COPD also were more likely to be diagnosed with lung cancer (aOR, 1.43; P < .01).Conclusions: We provide important patient-level data from the NLST that can be used to guide shared decision-making. The risk-to-benefit ratio of screening may vary significantly in some patients, such as those with COPD, in whom both risks and benefits of screening may be increased. [ABSTRACT FROM AUTHOR]

Background and objective: Percutaneous lung biopsy for diagnostic sampling of peripheral lung nodules has been widely performed by interventional radiologists under computed tomography (CT) guidance. New technology allows pulmonologists to perform percutaneous lung biopsies using electromagnetic (EM) guided technology. With the adoption of this new technique, the safety, feasibility and diagnostic yield need to be explored. The goal of this study was to determine the safety, feasibility and diagnostic yield of EM‐guided percutaneous lung biopsy performed by pulmonologists. Methods: We conducted a retrospective, multicentre study of 129 EM‐guided percutaneous lung biopsies that occurred between November 2013 and March 2017. The study consisted of seven academic and three community medical centres. Results: The average age of participants was 65.6 years, BMI was 26.3 and 50.4% were females. The majority of lesions were in the right upper lobe (37.2%) and left upper lobe (31.8%). The mean size of the lesions was 27.31 mm and the average distance from the pleura was 13.2 mm. Practitioners averaged two fine‐needle aspirates and five core biopsies per procedure. There were 23 (17.8%) pneumothoraces, of which 16 (12.4%) received small‐bore chest tube placement. The diagnostic yield of percutaneous lung biopsy was 73.7%. When EM‐guided bronchoscopic sampling was also performed during the same procedural encounter, the overall diagnostic yield increased to 81.1%. Conclusion: In this large multicentred series, the use of EM guidance for percutaneous lung biopsies was safe and feasible, with acceptable diagnostic yield in the hands of pulmonologists. A prospective multicentre trial to validate these findings is currently underway (NCT03338049). [ABSTRACT FROM AUTHOR]

The National Lung Screening Trial (NLST) reported substantial reduction in lung cancer mortality among high-risk individuals screened annually with low-dose helical computed tomography (LDCT). As a result, the US Preventive Services Task Force issued a B recommendation for annual LDCT in high-risk individuals, which requires private insurers to cover it without cost-sharing. The Medicare program also covers LDCT for high-risk beneficiaries without cost-sharing. However, the NLST findings may not be generalizable to the community setting because of differences in patients, providers, and practices participating in the NLST. Thus, examining uptake of LDCT screening in community practice is critical, as is evaluating the immediate and downstream outcomes of screening, including false-positive scans, follow-up examinations and adverse events, costs, stage of disease at diagnosis, and survival. This commentary presents an overview of the landscape of the data resources currently available to evaluate the uptake, outcomes, and costs of LDCT screening in the United States. We describe the strengths and limitations of existing data sources, including administrative databases, surveys, and registries. Thereafter, we provide recommendations for improving the data infrastructure pertaining to three overarching research areas: receipt of guideline-consistent screening and follow-up, weighing benefits and harms of screening, and costs of screening. [ABSTRACT FROM AUTHOR]

Screening with low-dose CT scan has been shown to reduce mortality from lung cancer in those at risk based on age and smoking history. While lung cancer screening (LCS) is recommended by the United States Preventative Services Task Force and many professional societies, it has been recognized that the decision to be screened is complex due to a close balance of risk and benefit; therefore, shared decision-making is considered an essential component of effective LCS. The Centers for Medicare and Medicaid Services provides coverage for LCS following a mandated shared-decision making (SDM) visit. Here we review the concept of SDM, facilitators and barriers, evidence and knowledge gaps, and novel considerations for SDM within LCS. [ABSTRACT FROM AUTHOR]

Background: While the complexity of flexible bronchoscopy has increased, standard options for moderate sedation medications have not changed in three decades. There is a need to improve moderate sedation while maintaining safety. Remimazolam was developed to address shortcomings of current sedation strategies.Methods: A prospective, double-blind, randomized, multicenter, parallel group trial was performed at 30 US sites. The efficacy and safety of remimazolam for sedation during flexible bronchoscopy were compared with placebo and open-label midazolam.Results: The success rates were 80.6% in the remimazolam arm, 4.8% in the placebo arm (P < .0001), and 32.9% in the midazolam arm. Bronchoscopy was started sooner in the remimazolam arm (mean, 6.4 ± 5.82 min) compared with placebo (17.2 ± 4.15 min; P < .0001) and midazolam (16.3 ± 8.60 min). Time to full alertness after the end of bronchoscopy was significantly shorter in patients treated with remimazolam (median, 6.0 min; 95% CI, 5.2-7.1) compared with those treated with placebo (13.6 min; 95% CI, 8.1-24.0; P = .0001) and midazolam (12.0 min; 95% CI, 5.0-15.0). Remimazolam registered superior restoration of neuropsychiatric function compared with placebo and midazolam. Safety was comparable among all three arms, and 5.6% of the patients in the remimazolam group had serious treatment-emergent adverse events as compared with 6.8% in the placebo group.Conclusions: Remimazolam administered under the supervision of a pulmonologist was effective and safe for moderate sedation during flexible bronchoscopy. In an exploratory analysis, it demonstrated a shorter onset of action and faster neuropsychiatric recovery than midazolam. [ABSTRACT FROM AUTHOR]

Background: New technology has resulted in bronchoscopy being increasingly used for diagnosing pulmonary lesions. Reported yield from these procedures varies widely with few randomized clinical trials. This study compares the diagnostic yield of a thin bronchoscope and radial endobronchial ultrasound (R-EBUS) with standard bronchoscopy and fluoroscopy (SB-F) in lung lesions.Methods: Patients presenting for diagnostic bronchoscopic evaluation at five centers were randomized to undergo SB-F or R-EBUS with a thin bronchoscope (TB-EBUS). If SB-F was nondiagnostic, crossover to the TB-EBUS arm was allowed. Data on patient demographics, radiographic features, and final pathologic or radiographic follow-up were collected. Statistical comparisons were made by Fisher exact test, χ2 test, and Student t test. Bivariate and multivariate analyses were performed to determine predictors of diagnostic yield.Results: One hundred and ninety-seven patients were included in the final analyses. There was no difference in demographics, lesion size, or location between study arms. The average lesion size was 31.2 mm (SD, 10.8 mm). Bronchoscopy was diagnostic in 87 patients (44%). Although the diagnostic yield was higher in the TB-EBUS arm compared with the SB-F arm (49% vs 37%), this difference was not statistically significant (P = .11). Among those with nondiagnostic bronchoscopic findings in the standard arm, 87% (n = 46) crossed over to TB-EBUS, resulting in a diagnosis in seven additional patients (15% of 46).Conclusions: Bronchoscopy with or without a thin scope and R-EBUS had a poor diagnostic yield for pulmonary lesions. Future work should focus on improvements in technique and technology advances that ensure a higher likelihood of obtaining a diagnosis. [ABSTRACT FROM AUTHOR]