Effect of Patient Navigation on Completion of Lung Cancer Screening in Vulnerable Populations.

BACKGROUND: Although low-dose, CT-based lung cancer screening (LCS) can decrease lung cancer mortality in high-risk individuals, the process may be complex and pose challenges to patients, particularly those from minority underinsured and uninsured populations. We conducted a randomized controlled trial of telephone-based navigation for LCS within an integrated, urban, safety-net health care system. PATIENTS AND METHODS: Patients eligible for LCS were randomized (1:1) to usual care with or without navigation at Parkland Health in Dallas, Texas. The primary endpoint was completion of the first 3 consecutive steps in a patient's LCS process. We explored differences in completion of LCS steps between navigation and usual care groups, controlling for patient characteristics using the chi-square test. RESULTS: Patients (N=447) were randomized to either navigation (n=225) or usual care (n=222). Mean patient age was 62 years, 46% were female, and 69% were racial/ethnic minorities. There was no difference in completion of the first 3 steps of the LCS algorithm between arms (12% vs 9%, respectively; P=.30). For ordered LCS steps, completion rates were higher among patients who received navigation (86% vs 79%; P=.03). The primary reason for step noncompletion was lack of order placement. CONCLUSIONS: In this study, lack of order placement was a key reason for incomplete LCS steps. When orders were placed, patients who received navigation had higher rates of completion. Clinical team education and enhanced electronic health record processes to simplify order placement, coupled with patient navigation, may improve LCS in safety-net health care systems.

Shape-Sensing Robotic-Assisted Bronchoscopy with Concurrent use of Radial Endobronchial Ultrasound and Cone Beam Computed Tomography in the Evaluation of Pulmonary Lesions.

PURPOSE: Lung nodules are a common radiographic finding. Non-surgical biopsy is recommended in patients with moderate or high pretest probability for malignancy. Shape-sensing robotic-assisted bronchoscopy (ssRAB) combined with radial endobronchial ultrasound (r-EBUS) and cone beam computed tomography (CBCT) is a new approach to sample pulmonary lesions. Limited data are available regarding the diagnostic accuracy of combined ssRAB with r-EBUS and CBCT. METHODS: We conducted a retrospective analysis of the first 200 biopsy procedures of 209 lung lesions using ssRAB, r-EBUS, and CBCT at UT Southwestern Medical Center in Dallas, Texas. Outcomes were based on pathology interpretations of samples taken during ssRAB, clinical and radiographic follow-up, and/or additional sampling. RESULTS: The mean largest lesion dimension was 22.6 ± 13.3 mm with a median of 19 mm (range 7 to 73 mm). The prevalence of malignancy in our data was 64.1%. The diagnostic accuracy of ssRAB combined with advanced imaging was 91.4% (CI 86.7-94.8%). Sensitivity was 87.3% (CI 80.5-92.4%) with a specificity of 98.7% (CI 92.8-100%). The negative and positive predictive values were 81.3% and 99.2%. The rate of non-diagnostic sampling was 11% (23/209 samples). The only complication was pneumothorax in 1% (2/200 procedures), with 0.5% requiring a chest tube. CONCLUSION: Our results of the combined use of ssRAB with r-EBUS and CBCT to sample pulmonary lesions suggest a high diagnostic accuracy for malignant lesions with reasonably high sensitivity and negative predictive values. The procedure is safe with a low rate of complications.

Linear probe endobronchial ultrasound bronchoscopy with guided transbronchial needle aspiration (EBUS-TBNA) in the evaluation of mediastinal and hilar pathology: introducing the procedure to a teaching institution.

BACKGROUND: Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is an important tool in the diagnosis of mediastinal and hilar pathology. We describe our experience with EBUS-TBNA performed in a teaching institution primarily under conscious sedation. METHODS: Patients who underwent EBUS-TBNA were included in this retrospective review. We focused on the diagnostic yield of EBUS-TBNA in relationship to the nature of the mediastinal or hilar lesions (suspected malignancy vs. benign disease), incremental 25 procedures aliquots, lymph node (LN) station, LN size, and the number of needle aspirations per LN station. RESULTS: Of the 212 patients who underwent EBUS-TBNA, 200 patients had adequate follow-up information and were included in this analysis. The procedure was performed under conscious sedation in 97 % of patients and 133 patients (67 %) were suspected to have malignancy before the procedure. A total of 690 TBNAs were performed from 294 LN stations. The mean number of LN stations sampled per procedure was 1.47 ± 0.6. The mean number of TBNAs per LN station was 2.35 ± 0.91. The mean number of TBNAs per procedure was 3.45 ± 1.2. The overall sensitivity, specificity, negative predictive value (NPV), and diagnostic accuracy for all procedures were 87.41 % (CI 80.76-91.99), 100 % (CI 93.12-100), 75.36 % (CI 64.04-84.01), and 90.91 % (CI 85.92-94.25), respectively. The NPV increased significantly after the initial 25 procedures and remained high thereafter. EBUS-TBNA was more accurate (96.12 % (CI 91.25-98.33)) with higher NPV (90.74 % (CI 80.09-95.98)) in patients with suspected malignancy compared with patients with suspected benign disease (79.31 % (CI 67.23-87.75), 20 % (7.05-45.19)). Samples from relatively smaller LN (>5 to ≤20 mm) and from all analyzed LN stations were similarly accurate with high sensitivity and NPV. CONCLUSIONS: EBUS-TBNA allows safe real-time sampling of mediastinal and hilar lesions under conscious sedation with high diagnostic accuracy. The NPV is high and increased significantly after the initial 25-50 procedures. This is comparable to available surgical techniques, including mediastinoscopy, when malignancy is suspected. The NPV for specific benign disease remains low in our experience. The diagnostic yield is not affected by the LN station, size, or the number of passes per LN station.

Radiation dose of cone beam CT combined with shape sensing robotic assisted bronchoscopy for the evaluation of pulmonary lesions: an observational single center study.

Background: Shape sensing robotic-assisted bronchoscopy (ssRAB) combined with radial endobronchial ultrasound (r-EBUS) and cone beam computed tomography (CBCT) is a newer diagnostic modality for the evaluation of pulmonary lesions. There is limited data describing the radiation dose of CBCT combined with ssRAB. The purpose of this study was to describe the technical factors associated with the use of CBCT combined with ssRAB to biopsy pulmonary lesions. Methods: We conducted a single center, prospective observational study of patients undergoing ssRAB combined with fixed CBCT for the pulmonary lesion biopsy. We report our patient demographics, and pulmonary lesion and procedure characteristics. Results: A total of 241 ssRAB procedures were performed to biopsy 269 pulmonary lesions. The mean lesion size was measured in the following dimensions: anteroposterior (18.0±8.8 mm), transverse (17.2±10.5 mm), and craniocaudal (17.7±10.2 mm). A mean of 1.5±0.7 (median: 1, range: 1-4) CBCT spins were performed. The mean total fluoroscopy time (FT) was 5.6±2.9 minutes. The mean radiation dose of cumulative air kerma (CAK) was 63.5±46.7 mGy and the mean cumulative dose area product (DAP) was 22.6±16.0 Gy·cm2. Diagnostic yield calculated based on results at index bronchoscopy was 85.9%. There was a low rate of complications with 8 pneumothoraces (3.3%), 5 (2.1%) of which required chest tube placement. Conclusions: We describe the use of ssRAB combined with CBCT to biopsy pulmonary lesions as a safe diagnostic modality with relatively low radiation dose that is potentially comparable to other image guided sampling modalities. Bronchoscopists should be cognizant of the radiation use during the procedure for both patient and staff safety.

Life-threatening hemoptysis in patients with metastatic kidney cancer.

Hemoptysis is a complication of intrathoracic tumors, both primary and metastatic, and the risk may be increased by procedural interventions as well as Stereotactic Ablative Radiation (SAbR). The risk of hemoptysis with SAbR for lung cancer is well characterized, but there is a paucity of data about intrathoracic metastases. Here, we sought to evaluate the incidence of life-threatening/fatal hemoptysis (LTH) in patients with renal cell carcinoma (RCC) chest metastases with a focus on SAbR. We systematically evaluated patients with RCC at UT Southwestern Medical Center (UTSW) Kidney Cancer Program (KCP) from July 2005 to March 2020. We queried Kidney Cancer Explorer (KCE), a data portal with clinical, pathological, and experimental genomic data. Patients were included in the study based on mention of "hemoptysis" in clinical documentation, if they had a previous bronchoscopy, or had undergone SAbR to any site within the chest. Two hundred and thirty four patients met query criteria and their records were individually reviewed. We identified 10 patients who developed LTH. Of these, 4 had LTH as an immediate procedural complication whilst the remaining 6 had prior SAbR to ultra-central (UC; abutting the central bronchial tree) metastases. These 6 patients had a total of 10 lung lesions irradiated (UC, 8; central 1, peripheral 1), with a median total cumulative SAbR dose of 38 Gray (Gy/ lesion) (range: 25-50 Gy). Other risk factors included intrathoracic disease progression (n = 4, 67%), concurrent anticoagulant therapy (n = 1, 17%) and concurrent systemic therapy (n = 4, 67%). Median time to LTH from first SAbR was 26 months (range: 8-61 months). Considering that 130 patients received SAbR to a chest lesion during the study period, the overall incidence of LTH following SAbR was 4.6% (6/130). The patient population that received SAbR (n = 130) was at particularly high risk for complications, with 67 (52%) having two or more chest metastaes treated, and 29 (22%) receiving SAbR to three or more lesions. Overall, the risk of LTH following SAbR to a central or UC lesion was 10.5% (6/57). In conclusion, SAbR of RCC metastases located near the central bronchial tree may increase the risk of LTH.

Contribution of a Blood-Based Protein Biomarker Panel to the Classification of Indeterminate Pulmonary Nodules.

RATIONALE: The workup and longitudinal monitoring for subjects presenting with pulmonary nodules is a pressing clinical problem. A blood-based biomarker panel potentially has utility for identifying subjects at higher risk for harboring a malignant nodule for whom additional workup would be indicated or subjects at reduced risk for whom imaging-based follow-up would be indicated. OBJECTIVES: To assess whether a previously described four-protein biomarker panel, reported to improve assessment of lung cancer risk compared with a smoking-based lung cancer risk model, can provide discrimination between benign and malignant indeterminate pulmonary nodules. METHODS: A previously validated multiplex enzyme-linked immunoassay was performed on matched case and control samples from each cohort. MEASUREMENTS: The biomarker panel was tested in two case-control cohorts of patients presenting with indeterminate pulmonary nodules at the University of Pittsburgh Medical Center and the University of Texas Southwestern. MAIN RESULTS: In both cohorts, the biomarker panel resulted in improved prediction of lung cancer risk over a model on the basis of nodule size alone. Of particular note, the addition of the marker panel to nodule size greatly improved sensitivity at a high specificity in both cohorts. CONCLUSIONS: A four-marker biomarker panel, previously validated to improve lung cancer risk prediction, was found to also have utility in distinguishing benign from malignant indeterminate pulmonary nodules. Its performance in improving sensitivity at a high specificity indicates potential utility of the marker panel in assessing likelihood of malignancy in otherwise indeterminate nodules.

Patient navigation for lung cancer screening in an urban safety-net system: Protocol for a pragmatic randomized clinical trial.

The National Lung Screening Trial demonstrated improved lung cancer mortality with annual low-dose computed tomography (CT) screening, leading to lung cancer screening endorsement by the United States Preventive Services Task Force and coverage by the Centers for Medicare and Medicaid. Adherence to annual CT screens in that trial was 95%, which may not be representative of real-world, particularly medically underserved populations. This pragmatic trial will determine the effect of patient-focused, telephone-based patient navigation on adherence to CT-based lung cancer screening in an urban safety-net population. 340 adults who meet standard eligibility for lung cancer screening (age 55-77years, smoking history≥30 pack-years, quit within 15years if former smoker) are referred through an electronic medical record-based order by physicians in community- and hospital-based primary care settings within the Parkland Health and Hospital System in Dallas County, Texas. Eligible patients are randomized to usual care or patient navigation, which addresses adherence, patient-reported barriers, smoking cessation, and psycho-social concerns related to screening completion. Patients complete surveys and semi-structured interviews at baseline, 6-month, and 18-month follow-ups to assess attitudes toward screening. The primary endpoint of this pragmatic trial is adherence to three sequential, prospectively defined steps in the screening protocol. Secondary endpoints include self-reported tobacco use and other patient-reported outcomes. Results will provide real-world insight into the impact of patient navigation on adherence to CT-based lung cancer screening in a medically underserved population. This study was registered with the NIH ClinicalTrials.gov database (NCT02758054) on April 26, 2016.

Sleep behavior disorders in a large cohort of chinese (Taiwanese) patients maintained by long-term hemodialysis.

BACKGROUND: Disorders of sleep behavior and sleep-related breathing disorders are common in hemodialysis patients. Most such evidence is based on studies involving small numbers of patients. METHODS: We undertook a large multicenter analysis of sleep behavior in more than 700 Taiwanese patients on maintenance hemodialysis therapy for 6 months to 20-plus years by using self-administered questionnaires: the Pittsburgh Sleep Quality Index, Epworth Sleepiness Scale, and Berlin Questionnaire for risk for sleep apnea, validated for the general population. Patients also completed a questionnaire to assess symptoms related to restless legs and periodic limb movements (PLMs). Sleep behavior was analyzed in relation to demographic and dialysis-related parameters provided by the participating dialysis centers. RESULTS: Sleep disturbance was very common in this cohort, with problems of insomnia (66.6%) exceeding those related to daytime sleepiness (17.8%). Sleep disturbances were associated with restless legs syndrome (RLS)/PLM and a high risk for sleep apnea, determined by using the Berlin Questionnaire. Older age increased the odds of daytime sleepiness, but not insomnia. Lower dialysis dose (single-pool Kt/V) increased the likelihood of daytime sleepiness and was associated with greater rates for RLS/PLM and risk for sleep apnea. Use of antihypertensive medications (a probable surrogate for more severe hypertension) was associated strongly with high risk for sleep apnea. Smoking was associated with RLS/PLM and risk for sleep apnea, whereas consumption of stimulant beverages (coffee and tea) had contrary effects on RLS/PLM and risk for sleep apnea and were not implicated in measures of insomnia or daytime sleepiness. A greater likelihood of insomnia for greater hemoglobin levels and greater likelihood of daytime sleepiness for patients administered vitamin D analogues were not explained by the available data. CONCLUSION: Sleep disorders and sleep-related breathing disorders are common in hemodialysis patients. Greater attention in the care of dialysis patients needs to be directed to the diagnosis and management of sleep disorders.

Detecting medical device complications: lessons from an indwelling pleural catheter clinic.

Safety monitoring after implantation of medical devices is essential throughout a product's life cycle. A suspected increase in complications related to indwelling pleural catheters led to a 2-part cohort study. Part 1 investigated and corroborated the increase in rate of complications thought to be related to defective catheters. The inability of the standard clinical follow-up to detect such a rise in complication rates for more than 3 months and a 3-fold increase prompted the authors to develop a simple tool to monitor catheter complication rates. This tool, which combined quality control statistics (p-chart) and the existing billing software, was shown to be effective in part 2 of this study. Care center-level active safety assurance monitoring can be of great value because, unfortunately, an independent and impartial safety monitoring organization, which is essential for postmarketing surveillance of any medical device, is still not available.

Does pleural fluid appearance really matter? The relationship between fluid appearance and cytology, cell counts, and chemical laboratory measurements in pleural effusions of patients with cancer.

BACKGROUND: Previous reports have suggested that the appearance of pleural effusions (i.e., the presence or absence of blood) might help to establish the etiology of the effusions. This study explores the relationship between pleural fluid appearance and the results of chemical and cytological analyses in a group of patients with recurrent symptomatic pleural effusions and a diagnosis of cancer. METHODS: Medical records were reviewed from all 390 patients who were diagnosed with cancer, who underwent thoracentesis before placement of an intrapleural catheter (IPC) between April 2000 and January 2006. Adequate information for data analysis was available in 365 patients. The appearance of their pleural fluid was obtained from procedure notes dictated by the pulmonologists who had performed the thoracenteses. The patients were separated into 2 groups based on fluid appearance: non-bloody and bloody. Group differences in cytology interpretation were compared by using the chi square test. Cellular counts, chemical laboratory results, and survival after index procedure were compared by using the student's t test. RESULTS: Pleural fluid cytology was positive on 82.5% of the non-bloody effusions and on 82.4% of the bloody ones. The number of red blood cells (220.5 x 103/microL vs. 12.3 x 103/microL) and LDH values (1914 IU/dl vs. 863 IU/dl) were statistically higher in bloody pleural effusions. CONCLUSION: The presence or absence of blood in pleural effusions cannot predict their etiology in patients with cancer and recurrent symptomatic pleural effusions.

Familial spontaneous pneumothorax.

PURPOSE OF REVIEW: Over 10% of patients with primary spontaneous pneumothorax report a positive family history of the disease. While some cases can be attributed to rare inherited connective tissue diseases, several families with familial spontaneous pneumothorax have been described that do not show clinical evidence of these monogenic disorders. Until recently the molecular underpinning of this disease was unknown. RECENT FINDINGS: In the last 18 months, mutations in the gene encoding folliculin (FLCN) have been identified in individuals with familial spontaneous pneumothorax. Mutations in this gene were known previously to cause a rare skin disease, Birt-Hogg-Dubé syndrome, an autosomal dominantly inherited disease characterized by benign skin tumors, diverse types of renal cancer, pulmonary cysts, and spontaneous pneumothorax. Two animal models and studies of renal cancers support a tumor-suppressor function for folliculin. The presence of thin-walled cysts in basilar and subpleural locations of the lung is a feature of this disease. Most families display reduced penetrance of the pneumothorax phenotype. Several individuals with a family history of spontaneous pneumothorax have a mutation in the folliculin gene. SUMMARY: A significant fraction of families with familial spontaneous pneumothorax have mutations in the folliculin gene and should be considered a forme fruste of Birt-Hogg-Dubé syndrome.