Investing in New Technology in Pulmonary Medicine–Navigating the Tortuous Path to Success.

The introduction of new technologies offer the promise to advance medicine. This occurs alongside improved efforts to control costs of healthcare by hospital administrators, Center for Medicare and Medicaid Services’ (CMS) pivot to value programs, and commercial payers’ efforts to reduce reimbursement. These trends present a challenge for the pulmonologist, among others, who must navigate increasingly complex and highly scrutinized evaluation processes used to secure new technologies. Healthcare providers are turning toward value assessments, while simultaneously tasked with a mission of offering state-of-the art technologies and services. Pulmonologists desiring new technologies are thus faced with increased scrutiny in their evaluation of costs and clinical data to support investments. Consideration of this scrutiny and further evidence to temper the evaluation will improve the likelihood of adoption and patient access to clinically-impactful technology. The identification of this evidence may provide – to both administrators and pulmonary clinicians – a comprehensive view of the clinical and economic benefits of such technologies. It is imperative that all parties involved in the decision process work collaboratively to deploy value-added and clinically-impactful technologies. While a physician group might invest in such new technologies, the capital required often leads such decisions to a larger organization such as a hospital, healthcare system, or privately owned entity. This article aims to provide a framework for pulmonary clinicians to better understand the processes that purchasers use to evaluate new technologies, the pressures that influence their consideration, and what resources may be leveraged towards success

Video Endoscopy for Laser Photoresection in Tracheobronchial Pathology: Some Considerations After 9 Years Experience With 2105 Treatments

Between 1984 and 1993 we performed 2105 laser treatments in 1210 patients: 52% of treatments were done for malignant pathology, 45% for benign tracheal stenoses and 3% were in a miscellaneous group. The procedure was carried out with a rigid bronchoscope under general anaesthesia. In patients with malignant tumors, it is a good palliative treatment—safe, well tolerated and with immediate results; it can be repeated as many times as needed with and is well accepted by the patient. In patients without tumors, this method avoids emergency tracheotomies. The long term results are now under evaluation

Endoscopic Management of Obstruction due to an Acquired Bronchial Web

Bronchial webs are thin, membrane-like diaphragms that may obstruct the airway. Several congenital cases have been reported. Though rare, the true incidence of these lesions is probably underestimated because many of them are unrecognized. The case of a 71-year-old woman with an acquired bronchial web causing right main stem bronchus obstruction that went unrecognized for 47 years post-trauma is reported. The lesion was successfully treated using rigid bronchoscopy with laser therapy, balloon dilation and stent placement. This is the first reported case of an acquired bronchial web formation. It is also the first reported case that was successfully treated with this technique

Lung cancer screening: assessment of health literacy and readability of online educational resources

Abstract Background Lung cancer screening can reduce mortality but can be a complex, multi-step process. Poor health literacy is associated with unfavorable outcomes and decreased use of preventative services, so it is important to address barriers to care through efficient and practical education. The readability of lung cancer screening materials for patients is unknown and may not be at the recommended 6th grade reading level set by the American Medical Association. Our goals were to: (1) measure the health literacy of a lung cancer screening population from an urban academic medical center, and (2) examine the readability of online educational materials for lung cancer screening. Methods We performed a retrospective cross sectional study at a single urban academic center. Health literacy was assessed using three validated screening questions. To assess the readability of educational materials, we performed a Google search using the phrase, “What is lung cancer screening?” and the Flesch-Kincaid Grade Level (FKGL) formula was used to estimate the grade level required to understand the text. Results There were 404 patients who underwent lung cancer screening during the study period. The prevalence of inadequate/marginal health literacy was 26.7–38.0%. Fifty websites were reviewed and four were excluded from analysis because they were intended for medical providers. The mean FKGL for the 46 websites combined was 10.6 ± 2.2. Conclusions Low health literacy was common and is likely a barrier to appropriate education for lung cancer screening. The current online educational materials regarding lung cancer screening are written above the recommended reading level set by the American Medical Association

Concomitant weekly docetaxel, cisplatin and radiation therapy in locally advanced non-small cell lung cancer: a dose finding study

The optimal dose of weekly docetaxel in combination with cisplatin and concomitant thoracic radiation therapy (XRT) in patients with locally advanced non-small cell lung cancer (NSCLC) is not well defined. The purpose of this study was to define the maximal tolerated dose (MTD) of docetaxel in this combination. Eligible patients had unresectable stage IIIA or IIIB NSCLC without pleural effusion. Treatment consisted of cisplatin 25 mg/m 2 plus docetaxel weekly and concomitant standard XRT for a total of 60 Gy at 200 cGy/fraction/day 5 times weekly for 6 weeks. The starting dose of docetaxel in the first cohort was 15 mg/m 2/week. This dose was escalated by 5 mg/m 2 per cohort of 3 patients. No intrapatient dose escalation was allowed. The doses of cisplatin and XRT were not escalated. A total of 23 patients were enrolled, and 19 patients were evaluable for analysis. The first cohort (docetaxel 15 mg/m 2/week) completed treatment without any Grade 3 or 4 toxicities. The second cohort (docetaxel 20 mg/m 2/week) was expanded to 6 patients because of Grade 3 cough observed in 1 patient. One of 5 patients experienced Grade 3 esophagitis at the docetaxel 25 mg/m 2/week dose level. Dose limiting toxicity consisting of Grade 3 esophagitis was reached in 4 of 5 patients receiving docetaxel at 30 mg/m 2/week. This study determined the MTD of weekly docetaxel to be 25 mg/m 2 when combined with cisplatin 25 mg/m 2 and radiation therapy for locally advanced NSCLC. Further evaluation of this regimen in a phase II trial is underway

Design of the Endobronchial Valve for Emphysema Palliation Trial (VENT): a non-surgical method of lung volume reduction

Abstract Background Lung volume reduction surgery is effective at improving lung function, quality of life, and mortality in carefully selected individuals with advanced emphysema. Recently, less invasive bronchoscopic approaches have been designed to utilize these principles while avoiding the associated perioperative risks. The Endobronchial Valve for Emphysema PalliatioN Trial (VENT) posits that occlusion of a single pulmonary lobe through bronchoscopically placed Zephyr® endobronchial valves will effect significant improvements in lung function and exercise tolerance with an acceptable risk profile in advanced emphysema. Methods The trial design posted on Clinical trials.gov, on August 10, 2005 proposed an enrollment of 270 subjects. Inclusion criteria included: diagnosis of emphysema with forced expiratory volume in one second (FEV1) 100%; residual volume > 150% predicted), and heterogeneous emphysema defined using a quantitative chest computed tomography algorithm. Following standardized pulmonary rehabilitation, patients were randomized 2:1 to receive unilateral lobar placement of endobronchial valves plus optimal medical management or optimal medical management alone. The co-primary endpoint was the mean percent change in FEV1 and six minute walk distance at 180 days. Secondary end-points included mean percent change in St. George's Respiratory Questionnaire score and the mean absolute changes in the maximal work load measured by cycle ergometry, dyspnea (mMRC) score, and total oxygen use per day. Per patient response rates in clinically significant improvement/maintenance of FEV1 and six minute walk distance and technical success rates of valve placement were recorded. Apriori response predictors based on quantitative CT and lung physiology were defined. Conclusion If endobronchial valves improve FEV1 and health status with an acceptable safety profile in advanced emphysema, they would offer a novel intervention for this progressive and debilitating disease. Trial Registration ClinicalTrials.gov: NCT00129584</p