Shawn M. Regis

Performance of ACR Lung-RADS in a Clinical CT Lung Screening Program

PURPOSE The aim of this study was to assess the effect of applying ACR Lung-RADS in a clinical CT lung screening program on the frequency of positive and false-negative findings. METHODS Consecutive, clinical CT lung screening examinations performed from January 2012 through May 2014 were retroactively reclassified using the new ACR Lung-RADS structured reporting system. All examinations had initially been interpreted by radiologists credentialed in structured CT lung screening reporting following the National Comprehensive Cancer Networks Clinical Practice Guidelines in Oncology: Lung Cancer Screening (version 1.2012), which incorporated positive thresholds modeled after those in the National Lung Screening Trial. The positive rate, number of false-negative findings, and positive predictive value were recalculated using the ACR Lung-RADS-specific positive solid/part-solid nodule diameter threshold of 6 mm and nonsolid (ground-glass) threshold of 2 cm. False negatives were defined as cases reclassified as benign under ACR Lung-RADS that were diagnosed with malignancies within 12 months of the baseline examination. RESULTS A total of 2,180 high-risk patients underwent baseline CT lung screening during the study interval; no clinical follow-up was available in 577 patients (26%). ACR Lung-RADS reduced the overall positive rate from 27.6% to 10.6%. No false negatives were present in the 152 patients with >12-month follow-up reclassified as benign. Applying ACR Lung-RADS increased the positive predictive value for diagnosed malignancy in 1,603 patients with follow-up from 6.9% to 17.3%. CONCLUSIONS The application of ACR Lung-RADS increased the positive predictive value in our CT lung screening cohort by a factor of 2.5, to 17.3%, without increasing the number of examinations with false-negative results.

Preliminary evaluation of a telephone-based smoking cessation intervention in the lung cancer screening setting: A randomized clinical trial

Incorporating effective smoking cessation interventions into lung cancer screening (LCS) programs will be essential to realizing the full benefit of screening. We conducted a pilot randomized trial to determine the feasibility and efficacy of a telephone-counseling (TC) smoking cessation intervention vs. usual care (UC) in the LCS setting. In collaboration with 3 geographically diverse LCS programs, we enrolled current smokers (61.5% participation rate) who were: registered to undergo LCS, 50-77 years old, and had a 20+ pack-year smoking history. Eligibility was not based on readiness to quit. Participants completed pre-LCS (T0) and post-LCS (T1) telephone assessments, were randomized to TC (N=46) vs. UC (N=46), and completed a final 3-month telephone assessment (T2). Both study arms received a list of evidence-based cessation resources. TC participants also received up to 6 brief counseling calls with a trained cessation counselor. Counseling calls incorporated motivational interviewing and utilized the screening result as a motivator for quitting. The outcome was biochemically verified 7-day point prevalence cessation at 3-months post-randomization. Participants (56.5% female) were 60.2 (SD=5.4) years old and reported 47.1 (SD=22.2) pack years; 30% were ready to stop smoking in the next 30 days. TC participants completed an average of 4.4 (SD=2.3) sessions. Using intent-to-treat analyses, biochemically verified quit rates were 17.4% (TC) vs. 4.3% (UC), p<.05. This study provides preliminary evidence that telephone-based cessation counseling is feasible and efficacious in the LCS setting. As millions of current smokers are now eligible for lung cancer screening, this setting represents an important opportunity to exert a large public health impact on cessation among smokers who are at very high risk for multiple tobacco-related diseases. If this evidence-based, brief, and scalable intervention is replicated, TC could help to improve the overall cost-effectiveness of LCS. TRIAL REGISTRATION NCT02267096, https://clinicaltrials.gov.

Low-dose computed tomography screening for lung cancer in a clinical setting: essential elements of a screening program.

The purpose of this article is to review clinical computed tomography (CT) lung screening program elements essential to safely and effectively manage the millions of Americans at high risk for lung cancer expected to enroll in lung cancer screening programs over the next 3 to 5 years. To optimize the potential net benefit of CT lung screening and facilitate medical audits benchmarked to national quality standards, radiologists should interpret these examinations using a validated structured reporting system such as Lung-RADS. Patient and physician educational outreach should be enacted to support an informed and shared decision-making process without creating barriers to screening access. Programs must integrate smoking cessation interventions to maximize the clinical efficacy and cost-effectiveness of screening. At an institutional level, budgets should account for the necessary expense of hiring and/or training qualified support staff and equipping them with information technology resources adequate to enroll and track patients accurately over decades of future screening evaluation. At a national level, planning should begin on ways to accommodate the upcoming increased demand for physician services in fields critical to the success of CT lung screening such as diagnostic radiology and thoracic surgery. Institutions with programs that follow these specifications will be well equipped to meet the significant oncoming demand for CT lung screening services and bestow clinical benefits on their patients equal to or beyond what was observed in the National Lung Screening Trial.

Surgical Outcomes in a Large, Clinical, Low-Dose Computed Tomographic Lung Cancer Screening Program

BACKGROUND Lung cancer screening with low-dose computed tomography is proven to reduce lung cancer mortality among high-risk patients. However, critics raise concern over the potential for unnecessary surgical procedures performed for benign disease as a result of screening. We reviewed our outcomes in a large clinical lung cancer screening program to assess the number of surgical procedures done for benign disease, as we believe this is an important quality metric. METHODS We retrospectively reviewed our surgical outcomes of consecutive patients who underwent low-dose computed tomography lung cancer screening from January 2012 through June 2014 using a prospectively collected database. All patients met the National Comprehensive Cancer Network lung cancer screening guidelines high-risk criteria. RESULTS There were 1,654 screened patients during the study interval with clinical follow-up at Lahey Hospital & Medical Center. Twenty-five of the 1,654 (1.5%) had surgery. Five of 25 had non-lung cancer diagnoses: 2 hamartomas, 2 necrotizing granulomas, and 1 breast cancer metastasis. The incidence of surgery for non-lung cancer diagnosis was 0.30% (5 of 1,654), and the incidence of surgery for benign disease was 0.24% (4 of 1,654). Twenty of 25 had lung cancer, 18 early stage and 2 late stage. There were no surgery-related deaths, and there was 1 major surgical complication (4%) at 30 days. CONCLUSIONS The incidence of surgical intervention for non-lung cancer diagnosis was low (0.30%) and is comparable to the rate reported in the National Lung Screening Trial (0.62%). Surgical intervention for benign disease was rare (0.24%) in our experience.

Automatic Lung-RADS™ classification with a natural language processing system

Background Our aim was to train a natural language processing (NLP) algorithm to capture imaging characteristics of lung nodules reported in a structured CT report and suggest the applicable Lung-RADS™ (LR) category. Methods Our study included structured, clinical reports of consecutive CT lung screening (CTLS) exams performed from 08/2014 to 08/2015 at an ACR accredited Lung Cancer Screening Center. All patients screened were at high-risk for lung cancer according to the NCCN Guidelines®. All exams were interpreted by one of three radiologists credentialed to read CTLS exams using LR using a standard reporting template. Training and test sets consisted of consecutive exams. Lung screening exams were divided into two groups: three training sets (500, 120, and 383 reports each) and one final evaluation set (498 reports). NLP algorithm results were compared with the gold standard of LR category assigned by the radiologist. Results The sensitivity/specificity of the NLP algorithm to correctly assign LR categories for suspicious nodules (LR 4) and positive nodules (LR 3/4) were 74.1%/98.6% and 75.0%/98.8% respectively. The majority of mismatches occurred in cases where pulmonary findings were present not currently addressed by LR. Misclassifications also resulted from the failure to identify exams as follow-up and the failure to completely characterize part-solid nodules. In a sub-group analysis among structured reports with standardized language, the sensitivity and specificity to detect LR 4 nodules were 87.0% and 99.5%, respectively. Conclusions An NLP system can accurately suggest the appropriate LR category from CTLS exam findings when standardized reporting is used.

Qualitative coronary artery calcium assessment on CT lung screening exam helps predict first cardiac events

Results A total of 1,513 individuals underwent CTLS. Downstream data, pre-test cardiac risk factors and CAC scores were available for 88.3% (1,336/1,513). The average length of follow-up was 2.64 (SD ±0.72) years. There were a total of 43 events, occurring in 1.55% (6/386) of patients with mild CAC, 3.24% (11/339) of patients with moderate CAC, and 8.90% (26/292) of patients with marked CAC. There were no events among patients with no reported CAC (0/319). Using multivariable logistic modeling, the increased odds of an initial cardiac event was 2.56 (95% CI, 1.76-3.92, P<0.001) for mild CAC, 6.57 (95% CI, 3.10-15.4, P<0.001) for moderate CAC, and 16.8 (95% CI, 5.46-60.3, P<0.001) for marked CAC, as compared to individuals with no CAC. Time to event analysis showed distinct differences among the four CAC categories (P<0.001). Conclusions Qualitative coronary artery calcification scoring of CTLS exams may provide a novel method to help select individuals at elevated risk for an initial cardiac event.

NCCN Guidelines as a Model of Extended Criteria for Lung Cancer Screening

Background: This review assessed the performance of patients in NCCN high-risk group 2 in a clinical CT lung screening (CTLS) program. Methods: We retrospectively reviewed screening results for all patients from our institution undergoing clinical CTLS from January 2012 through December 2016, with follow-up through June 2017. To qualify for screening, patients had to meet the NCCN Guidelines high-risk criteria for CTLS, have a physician order for screening, be asymptomatic, be lung cancer-free for 5 years, and have no known metastatic disease. We compared demographics and screening performance of NCCN high-risk groups 1 and 2 across >4 rounds of screening. Screening metrics assessed included rates of positive and suspicious examinations, significant incidental and infectious/inflammatory findings, false negatives, and cancer detection. We also compared cancer stage and histology detected in each NCCN high-risk group. Results: A total of 2,927 individuals underwent baseline screening, of which 698 (24%) were in NCCN group 2. On average, group 2 patients were younger (60.6 vs 63.1 years), smoked less (38.8 vs 50.8 pack-years), had quit longer (18.1 vs 6.3 years), and were more often former smokers (61.4% vs 44.2%). Positive and suspicious examination rates, false negatives, and rates of infectious/inflammatory findings were equivalent in groups 1 and 2 across all rounds of screening. An increased rate of cancer detection was observed in group 2 during the second annual (T2) screening round (2.7% vs 0.5%; P=.005), with no difference in the other screening rounds: baseline (T0; 2% vs 2.3%; P=.61), first annual (T1; 1.2% vs 1.7%; P=.41), and third annual and beyond (≥T3; 1.2% vs 1.1%; P=1.00). Conclusions: CTLS appears to be equally effective in both NCCN high-risk groups.

Adherence to Radiology Recommendations in a Clinical CT Lung Screening Program

BACKGROUND Assess patient adherence to radiologist recommendations in a clinical CT lung cancer screening program. METHODS Patients undergoing CT lung cancer screening between January 12, 2012, and June 12, 2013, were included in this institutional review board-approved retrospective review. Patients referred from outside our institution were excluded. All patients met National Comprehensive Cancer Network Guidelines Lung Cancer Screening high-risk criteria. Full-time program navigators used a CT lung screening program management system to schedule patient appointments, generate patient result notification letters detailing the radiologist follow-up recommendation, and track patient and referring physician notification of missed appointments at 30, 60, and 90 days. To be considered adherent, patients could be no more than 90 days past due for their next recommended examination as of September 12, 2014. Patients who died, were diagnosed with cancer, or otherwise became ineligible for screening were considered adherent. Adherence rates were assessed across multiple variables. RESULTS During the study interval, 1,162 high-risk patients were screened, and 261 of 1,162 (22.5%) outside referrals were excluded. Of the remaining 901 patients, 503 (55.8%) were male, 414 (45.9%) were active smokers, 377 (41.8%) were aged 65 to 73, and >95% were white. Of the 901 patients, 772 (85.7%) were adherent. Most common reasons for nonadherence were patient refusal of follow-up exam (66.7%), inability to successfully contact the patient (20.9%), and inability to obtain the follow-up order from the referring provider (7.8%); 23 of 901 (2.6%) were discharged for other reasons. CONCLUSIONS High rates of adherence to radiologist recommendations are achievable for in-network patients enrolled in a clinical CT lung screening program.