Keeping up with technological innovation: the moral imperative for pragmatic clinical trials in interventional pulmonology.

The advances in minimally invasive lung cancer diagnostics of the last decade have transformed patient care but have also raised important concerns about the regulatory processes used to approve new devices and the best way to generate data to support their use. Disruptive technologies, such as robotic bronchoscopy, have been widely adopted by interventional pulmonologists in the absence of robust data demonstrating improved patient outcomes. Comparative research is needed to inform patient care, but traditional methods of conducting clinical trials in which research teams operate separately from clinical teams are ill-suited to testing the safety and effectiveness of technologies being introduced on the market at unprecedented speed.

Conflicts of Interest in Bronchoscopy Research: Is Self-Reporting Sufficient?

Background: Robotic assisted bronchoscopy has been enthusiastically adopted in the United States and has transformed the treatment of patients with indeterminate pulmonary nodules. Unprecedented industry investments in research, development, and marketing have profoundly affected the bronchoscopy landscape, leading to concerns that conflicts of interest could influence the validity of bronchoscopy studies. Disclosures of conflicts of interest in research are predicated on open and transparent self-reporting.

The Lung Cancer Prediction Model "Stress Test": Assessment of Models' Performance in a High-Risk Prospective Pulmonary Nodule Cohort.

Background: Pulmonary nodules represent a growing health care burden because of delayed diagnosis of malignant lesions and overtesting for benign processes. Clinical prediction models were developed to inform physician assessment of pretest probability of nodule malignancy but have not been validated in a high-risk cohort of nodules for which biopsy was ultimately performed.

Research Question: Do guideline-recommended prediction models sufficiently discriminate between benign and malignant nodules when applied to cases referred for biopsy by navigational bronchoscopy?

Study Design And Methods: We assembled a prospective cohort of 322 indeterminate pulmonary nodules in 282 patients referred to a tertiary medical center for diagnostic navigational bronchoscopy between 2017 and 2019.

Robotic versus Electromagnetic bronchoscopy for pulmonary LesIon AssessmeNT: the RELIANT pragmatic randomized trial.

Background: Robotic-assisted bronchoscopy has recently emerged as an alternative to electromagnetic navigational bronchoscopy for the evaluation of peripheral pulmonary lesions. While robotic-assisted bronchoscopy is proposed to have several advantages, such as an easier learning curve, it is unclear if it has comparable diagnostic utility as electromagnetic navigational bronchoscopy.

Methods: Robotic versus Electromagnetic bronchoscopy for pulmonary LesIon AssessmeNT (RELIANT) is an investigator-initiated, single-center, open label, noninferiority, cluster randomized controlled trial conducted in two operating rooms at Vanderbilt University Medical Center.

Diagnostic Yield vs Diagnostic Accuracy for Peripheral Lung Biopsy Evaluation: Evidence Supporting a Future Pragmatic End Point.

Background: Diagnostic yield and accuracy endpoints have been used inconsistently in the evaluation of advanced diagnostic bronchoscopy devices and techniques, limiting between-study comparisons. In addition, diagnostic accuracy can be adjudicated only after prolonged clinical follow-up, which delays reporting on the performance of novel devices.

Research Question: Will a conservative diagnostic yield definition result in few false-negative initial results to closely approximate diagnostic accuracy and represent a useful outcome for future studies of diagnostic utility?

Methods: Commonly used definitions of diagnostic yield were applied to a prospective data set of consecutive peripheral pulmonary lesions sampled by navigational bronchoscopy from 2017 to 2019.

Assessing the clinical utility of biomarkers using the intervention probability curve (IPC).

Background: Assessing the clinical utility of biomarkers is a critical step before clinical implementation. The reclassification of patients across clinically relevant subgroups is considered one of the best methods to estimate clinical utility. However, there are important limitations with this methodology.

Update on Biomarkers for the Stratification of Indeterminate Pulmonary Nodules.

Lung cancer is the leading cause of cancer-related deaths. Early detection and diagnosis are critical, as survival decreases with advanced stages. Approximately 1.

Shape-Sensing Robotic-Assisted Bronchoscopy vs Digital Tomosynthesis-Corrected Electromagnetic Navigation Bronchoscopy: A Comparative Cohort Study of Diagnostic Performance.

Background: Electromagnetic navigational bronchoscopy has been the dominant bronchoscopic technology for targeting small peripheral lesions and now includes digital tomosynthesis-electromagnetic navigational bronchoscopy (DT-ENB), allowing near-real-time intraprocedural nodule visualization. Shape-sensing robotic-assisted bronchoscopy (ssRAB), with improved catheter stability and articulation recently became available. Although the diagnostic performance of these two methods seems higher than that of legacy systems, data remain limited.

18F-FSPG PET imaging for the evaluation of indeterminate pulmonary nodules.

Background: 18F-fluorodeoxyglucose (FDG) PET/CT is recommended for evaluation of intermediate-risk indeterminate pulmonary nodules (IPNs). While highly sensitive, the specificity of FDG remains suboptimal for differentiating malignant from benign nodules, particularly in areas where fungal lung diseases are prevalent. Thus, a cancer-specific imaging probe is greatly needed.

Risk stratification of indeterminate pulmonary nodules.

Purpose Of Review: Lung cancer remains the leading cause of cancer-related death in the United States, with poor overall 5-year survival. Early detection and diagnosis are key to survival as demonstrated in lung cancer screening trials. However, with increasing implementation of screening guidelines and use of computed tomography, there has been a sharp rise in the incidence of indeterminate pulmonary nodules (IPNs).

Idiomarina fontislapidosi sp. nov. and Idiomarina ramblicola sp. nov., isolated from inland hypersaline habitats in Spain.

Two bacterial strains, F23T and R22T, have been isolated from hypersaline habitats in Málaga (S. Spain) and Murcia (E. Spain).

Garcin syndrome resulting from a giant cell tumor of the skull base in a child.

Garcin syndrome is characterized by a progressive ipsilateral involvement of cranial nerves, culminating in paralysis of all or at least seven of them, without sensory or motor long-tract disturbance, with no intracranial hypertension, and with osteoclastic involvement in the skull base on radiographic computed tomography. Giant cell tumor is a primary bone tumor rarely affecting the skull base. An 8-year-old female presented with a 3-month history of increasingly worsening right otalgia, tinnitus, hearing loss, right facial numbness, and diplopia.

Salivary characteristics of diabetic children.

Salivary components may suffer variations that can be detected by chemical determinations. The aim of this work was to determine physical and biochemical characteristics of the saliva of a group of diabetic children compared to those of a control group. Relation to oral health indices was also determined.