Additional Up-Front Thoracic Ultrasound in the Workup of Patients with Unilateral Pleural Effusion: A Prospective Observational Pilot Study.

BACKGROUND: In patients with pleural effusion, specific ultrasound characteristics are associated with pleural malignancy. OBJECTIVES: This study aimed to evaluate the added value of an additional, up-front, systematic thoracic ultrasound (TUS) to standard imaging in patients with unilateral pleural effusion of unknown cause in a clinical setting. METHODS: In a prospective observational pilot study, patients referred for workup and thoracentesis of a unilateral pleural effusion received up-front TUS following a set protocol in addition to available imaging and US guiding the thoracentesis or diagnostic puncture. The primary outcome was the proportion of cases where systematic TUS changed the planned diagnostic workup. Follow-up took place 26 weeks after inclusion. RESULTS: From February to December 2020, 55 patients were included. Thirty-six (65%) patients had other chest imaging available before TUS. Twenty-one (38%) were diagnosed with malignant pleural effusion. Three patients (5%) had clinically relevant changes in the diagnostic workup after additional systematic TUS. CONCLUSIONS: Additional up-front, systematic TUS had limited clinically relevant effect on the planned diagnostic workup in patients with unilateral pleural effusion in a setting where chest CT scans often are available at referral.

Prediction of Time to Next Therapeutic Thoracentesis and Identification of Risk Factors of Rapid Pleural Fluid Recurrence: A Prospective Observational Study.

BACKGROUND: The value of pre-booked repeated thoracentesis in patients with recurrent pleural effusion is reliant on the estimation of time to next drainage. Identifying factors associated with rapid pleural fluid recurrence could be supportive. OBJECTIVE: We aimed to evaluate the ability of the patient and physician to predict the time to next therapeutic thoracentesis and to identify characteristics associated with rapid pleural fluid recurrence. METHOD: In a prospective, observational study, patients with recurrent unilateral pleural effusion and the physician were to predict the time to next symptom-guided therapeutic thoracentesis. Primary outcome was difference between days to actual thoracentesis and days predicted by the patient and the physician. Factors associated with pleural fluid recurrence within 60-day follow-up were assessed using Cox regression analysis. RESULTS: A total of 98 patients were included, 71% with malignant pleural effusion. Patients' and physicians' predictions numerically deviated by 6 days from the actual number of days to re-thoracentesis (IQR 2-12 and 2-13, respectively). On multivariate analyses, factors associated with increased hazard of pleural fluid recurrence included daily fluid production (HR 1.35 [1.16-1.59], p > 0.001) and large effusion size (HR 2.76 [1.23-6.19], p = 0.01). Septations were associated with decreased hazard (HR 0.48 [0.24-0.96], p = 0.04). CONCLUSION: Patients and physicians were equally unable to predict the time to next therapeutic thoracentesis. Daily fluid production and large effusion size were associated with increased risk of rapid pleural fluid recurrence, while septations were associated with a decreased risk. This may guide patients and physicians in when to expect a need for therapeutic thoracentesis.

Preparing for Reality: A Randomized Trial on Immersive Virtual Reality for Bronchoscopy Training.

BACKGROUND: Bronchoscopy is an essential procedure in the diagnosis and treatment of pulmonary diseases. However, the literature suggests that distractions affect the quality of bronchoscopy and affect inexperienced doctors more than experienced. OBJECTIVES: The objective of the study was as follows: does simulation-based bronchoscopy training with immersive virtual reality (iVR) improve the doctors' ability to handle distractions and thereby increase the quality, measured in procedure time, structured progression score, diagnostic completeness (%), and hand motor movements of a diagnostic bronchoscopy in a simulated scenario. Exploratory outcomes were heart rate variability and a cognitive load questionnaire (Surg-TLX). METHODS: Participants were randomized. The intervention group practiced in an iVR environment with a head-mounted display (HMD) while using the bronchoscopy simulator, while the control group trained without the HMD. Both groups were tested in the iVR environment using a scenario with distractions. RESULTS: 34 participants completed the trial. The intervention group scored significantly higher in diagnostic completeness (100 i.q.r. 100-100 vs. 94 i.q.r. 89-100, p value = 0.03) and structured progress (16 i.q.r. 15-18 vs. 12 i.q.r. 11-15, p value 0.03) but not in procedure time (367 s standard deviation [SD] 149 vs. 445 s SD 219, p value = 0.06) or hand motor movements (-1.02 i.q.r. -1.03-[-1.02] versus -0.98 i.q.r. -1.02-[-0.98], p value = 0.27). The control group had a tendency toward a lower heart rate variability (5.76 i.q.r. 3.77-9.06 vs. 4.12 i.q.r. 2.68-6.27, p = 0.25). There was no significant difference in total Surg-TLX points between the two groups. CONCLUSION: iVR simulation training increases the quality of diagnostic bronchoscopy in a simulated scenario with distractions compared with conventional simulation-based training.

Characterization of Lung Tumors that the Pulmonologist can Biopsy from the Esophagus with Endosonography (EUS-B-FNA).

BACKGROUND: According to guidelines, it is possible to biopsy lung tumors "immediately adjacent to the esophagus" with EUS-B-FNA. However, it is unknown what "immediately adjacent" exactly means. OBJECTIVE: to investigate the possibility of achieving EUS-B-FNA biopsies from a lung tumor depending on the distance from the esophagus and to establish the maximal allowable distance between the tumor and the esophagus. METHODS: In a prospective observational study, we included patients with a lung tumor located maximum 6 cm from the esophagus and indication of EUS-B-FNA from the tumor. The tumors were of different sizes. In a plot presenting the tumor size-distance relationship in cases with (biopsy) versus without (non-biopsy) successful EUS-B-FNA, a separation line representing the threshold between the groups were identified and a biopsy-index equation established. The maximal tumor-size corrected distance (TSCD) was calculated using the residuals to the separation line. RESULTS: In total, 70 patients were included. EUS-B-FNA from the lung tumor was possible in 46 patients. All tumors with a distance from the esophagus below 19 mm could be biopsied. The maximal allowable esophagus-tumor distance depended on tumor size. From the separation line, a biopsy-index equation was established with the sensitivity of 93.5%, a specificity of 100%, and total accuracy of 95.7%. The TSCD was 31 mm (sensitivity: 95.7%, specificity 75.0%, and accuracy: 88.6%). CONCLUSION: We established a biopsy-index equation to predict the achievability of a lung tumor using EUS-B-FNA depending on distance to esophagus and tumor size. A general maximal TSCD was 31 mm.

Automatic and Objective Assessment of Motor Skills Performance in Flexible Bronchoscopy.

BACKGROUND: Motor skills have been identified as a useful measure to evaluate competency in bronchoscopy. However, no automatic assessment system of motor skills with a clear pass/fail criterion in flexible bronchoscopy exists. OBJECTIVES: The objective of the study was to develop an objective and automatic measure of motor skills in bronchoscopy and set a pass/fail criterion. METHODS: Participants conducted 3 bronchoscopies each in a simulated setting. They were equipped with a Myo Armband that measured lower arm movements through an inertial measurement unit, and hand and finger motions through electromyography sensors. These measures were composed into an objective and automatic composite score of motor skills, the motor bronchoscopy skills score (MoBSS). RESULTS: Twelve novices, eleven intermediates, and ten expert bronchoscopy operators participated, resulting in 99 procedures available for assessment. MoBSS was correlated with a higher diagnostic completeness (Pearson's correlation, r = 0.43, p < 0.001) and a lower procedure time (Pearson's correlation, r = -0.90, p < 0.001). MoBSS was able to differentiate operator performance based on the experience level (one-way ANOVA, p < 0.001). Using the contrasting groups' method, a passing score of -0.08 MoBSS was defined that failed 30/36 (83%) novice, 5/33 (15%) intermediate, and 1/30 (3%) expert procedures. CONCLUSIONS: MoBSS can be used as an automatic and unbiased assessment tool for motor skills performance in flexible bronchoscopy. MoBSS has the potential to generate automatic feedback to help guide trainees toward expert performance.

Aspiration of Pericardial Effusion Performed with EUS-B-FNA in Suspected Lung Cancer.

Ultrasound-guided needle aspiration via the esophagus using the endobronchial endoscope (EUS-B-FNA) is increasingly being performed by the pulmonologist for the diagnosis of lung cancer, but we have little experience and data available in the literature especially with respect to staging of the disease. We present 2 cases of EUS-B-guided aspiration of malignant pericardial effusion performed in the same setting as bronchoscopy and endobronchial ultrasound. No complications were observed. We conclude that EUS-B-FNA may be safe and efficacious in the evaluation of pericardial effusion during lung cancer workup. Thus, EUS-B-FNA may save time in the diagnostic workup, improve cancer staging, and prevent transthoracic pericardiocentesis.

Simulation-Based Mastery Learning of Flexible Bronchoscopy: Deciding Factors for Completion.

BACKGROUND: Several studies have shown the beneficial effects of mastery learning of a simulation-based course, but not all trainees complete it. OBJECTIVES: The purpose of this study was to find deciding factors for the completion of a simulation-based mastery learning course with distributive practice in flexible bronchoscopy. METHODS: Seventy-seven trainees who signed up for the course were invited to a survey for deciding factors of completing the course. Sixty-two (81%) trainees answered the survey. RESULTS: Male trainees were more likely to complete the course. The most important factor for completion was clinical relevance, and the most important factor for not completing the course was being "too busy." CONCLUSION: Several deciding factors for completing the course were identified. Successful simulation-based mastery learning courses should be clinically relevant, and the trainees should be provided protected time to complete the training. The instructional design should also be adapted systematically for male and female trainees to achieve the necessary competencies.

Ensuring Basic Competence in Thoracentesis.

BACKGROUND: Trocar pigtail catheter thoracentesis (TPCT) is a common procedure often performed by junior physicians. Simulation-based training may effectively train physicians in the procedure prior to performing it on patients. An assessment tool with solid validity evidence is necessary to ensure sufficient procedural competence. OBJECTIVES: Our study objectives were (1) to collect evidence of validity for a newly developed pigtail catheter assessment tool (Thoracentesis Assessment Tool [ThorAT]) developed for the evaluation of TPCT performance and (2) to establish a pass/fail score for summative assessment. METHODS: We assessed the validity evidence for the ThorAT using the recommended framework for validity by Messick. Thirty-four participants completed two consecutive procedures and their performance was assessed by two blinded, independent raters using the ThorAT. We compared performance scores to test whether the assessment tool was able to discern between the two groups, and a pass/fail score was established. RESULTS: The assessment tool was able to discriminate between the two groups in terms of competence level. Experienced physicians received significantly higher test scores than novices in both the first and second procedure. A pass/fail score of 25.2 points was established, resulting in 4 (17%) passing novices and 1 (9%) failing experienced participant in the first procedure. In the second procedure 9 (39%) novices passed and 2 (18%) experienced participants failed. CONCLUSIONS: This study provides a tool for summative assessment of competence in TPCT. Strong validity evidence was gathered from five sources of evidence. A simulation-based training program using the ThorAT could ensure competence before performing thoracentesis on patients.

EUS-B-FNA for Diagnosing Liver and Celiac Metastases in Lung Cancer Patients.

BACKGROUND: In patients with suspected or proven lung cancer, assessment of regional nodal and distant metastases is key before treatment planning. By introducing the endobronchial ultrasound (EBUS)-guided scope into the esophagus and stomach (EUS-B), liver lesions and celiac nodes can be visualized. To date, the utility of EUS-B in diagnosing liver lesions and retroperitoneal lymph nodes is unknown. OBJECTIVES: To assess the feasibility, safety, and diagnostic yield of sampling of liver lesions and retroperitoneal nodes by EUS-B fine-needle aspiration (FNA) in a lung cancer staging setting. METHOD: Consecutive patients suspected of lung cancer in 2 Danish centers between 1 January 2015 and 31 December 2017 were included retrospectively when a lesion in the liver or a retroperitoneal lymph node was visualized and biopsied with EUS-B-FNA. RESULTS: 23 left liver lobe lesions and 19 retroperitoneal lymph nodes were sampled by EUS-B-FNA. Sensitivity and diagnostic yield of sampled liver lesions were 86 and 83%, respectively. In 19/23 patients, there was a cytopathological diagnosis of malignancy. Sensitivity and diagnostic yield from retroperitoneal lymph node samples were 83 and 63%, respectively. In 10/19 patients, the diagnosis was malignancy. No complications were observed. CONCLUSION: EUS-B-FNA enables safe sampling of left liver lobe lesions and retroperitoneal lymph nodes. EUS-B should be considered as a minimally invasive technique to provide tissue proof of distant metastases lung cancer patients.

Endoscopic Ultrasound with Bronchoscope-Guided Fine Needle Aspiration for the Diagnosis of Paraesophageally Located Lung Lesions.

BACKGROUND: Diagnosing centrally located lung tumors without endobronchial abnormalities and not located near the major airways is a diagnostic challenge. Tumors near or adjacent to the esophagus can be aspirated and detected with esophageal ultrasound (EUS) using gastrointestinal endoscopes. OBJECTIVE: To assess the feasibility and diagnostic yield of endoscopic ultrasound with bronchoscope-guided fine needle aspiration (EUS-B-FNA) in paraesophageally located lung tumors and its added value to bronchoscopy and endobronchial ultrasound (EBUS). METHODS: Retrospective, multicenter international study (from January 1, 2015 until January 1, 2018) of patients with suspected lung cancer, undergoing bronchoscopy, EBUS, and endoscopic ultrasound bronchoscopy (EUS-B) in one session by a single operator (pulmonologist), in whom the primary lung tumor was detected and aspirated by EUS-B. In the absence of malignancy following endoscopy, transthoracic ultrasound needle aspiration, clinical and radiological follow-up of at least 6 months was performed. The yield and sensitivity of EUS-B-FNA and its added value to bronchoscopy and EBUS was assessed. RESULTS: 58 patients were identified with the following diagnosis: non-small-cell lung cancer (n = 43), small-cell lung cancer (n = 6), mesothelioma (n = 2), metastasis (n = 1), nonmalignant (n = 6). The yield and sensitivity of EUS-B-FNA for detecting lung cancer was 90%. In 26 patients (45%), the intrapulmonary tumor was exclusively detected by EUS-B. Adding EUS-B to conventional bronchoscopy and EBUS increased the diagnostic yield for diagnosing lung cancer in para-esophageally located lung tumors from 51 to 91%. No EUS-B-related complications were observed. CONCLUSION: EUS-B-FNA is a feasible and safe technique for diagnosing centrally located intrapulmonary tumors that are located near or adjacent to the esophagus. EUS-B should be considered in the same endoscopy session following nondiagnostic bronchoscopy and EBUS.

The prevalence of ALK rearrangement in pulmonary adenocarcinomas in an unselected Caucasian population from a defined catchment area: impact of smoking.

AIMS: To assess the prevalence of EML4-ALK rearrangement gene measured by immunohistochemistry in an unselected population-based consecutive cohort of patients with adenocarcinoma of the lung (ACL), and the correlation with smoking history, thyroid transcription factor 1 (TTF1), gender and age. METHODS AND RESULTS: All patients diagnosed in the population of the greater Copenhagen area were included, irrespective of gender, age, smoking habits, stage or type of available diagnostic material. Tumours were stained with immunohistochemistry (clone 5A4). Immunohistochemistry-positive tumours were tested by fluorescence in-situ hybridization (FISH). During a 16-month period, 760 patients in the population were diagnosed with ACL. In 2.6% there was insufficient material for ALK testing (20 of 760). Eleven per cent of the remaining 740 ACL patients were never smokers, 43% were ex-smokers smokers and 46% were current smokers. Fourteen patients [1.9%, 95% confidence interval (CI) = 1.1-3.2] were ALK-positive by immunohistochemistry. Nine of 82 never-smokers (11%, 95% CI = 5.9-19.6) and five of 652 ex- or current smokers (0.8%, 95% CI = 0.4-2.1) were ALK-positive. Only two ALK-positive patients were found among 586 heavy smokers (> 15 pack-years) (0.3%, 95% CI = 0.09-1.2). Thirteen of the 14 immunohistochemistry-positive patients were FISH-positive. All ALK-positive tumours were TTF1-positive. The number needed to test (NNT) to identify one ALK positive patient was 9, 22 and 293 among never smokers, light and heavy smokers, respectively. CONCLUSIONS: Immunohistochemical analysis of ALK rearrangement was possible in 97.4% of patients. ALK rearrangement was found primarily in never smokers. NNT to identify one ALK-positive patient was 9, 22 and 293 among never smokers, light and heavy smokers, respectively.

Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration for Staging of Patients with Non-Small Cell Lung Cancer without Mediastinal Involvement at Positron Emission Tomography-Computed Tomography.

BACKGROUND: Staging of lung cancer is essential to the treatment, which is curative only in cases of localized disease. Previous studies have suggested that endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is unnecessary when positron emission tomography-computed tomography (PET-CT) shows no mediastinal involvement. OBJECTIVE: The aim of the study was to investigate how often EBUS-TBNA resulted in a clinically relevant upstaging in patients with lung cancer without mediastinal involvement at PET-CT. METHODS: A total of 981 consecutive patients from 2009 to 2014 were referred for preoperative EBUS-TBNA. We included 167 patients with lung cancer without involvement of the mediastinum at PET-CT (115 N0 and 52 N1). RESULTS: Of the 167 patients included, 10 (6.0%) were upstaged to N2 or N3 by EBUS-TBNA; 9 of these were originally classified as N1 at PET-CT. Therefore, 17.3% of the included N1 patients were upstaged to N2/N3 after EBUS-TBNA. This compares to only 0.9% of the N0 patients. After both EBUS-TBNA and PET-CT, 115 patients were operated, and 12 (10.4%) of these proved to be N2/N3. We calculated the sensitivity as 42.9%, the specificity as 99.0%, and the negative predictive value as 89.6%. CONCLUSIONS: The overall probability of a clinically relevant upstaging by EBUS-TBNA in patients judged as N0/N1 at PET-CT was 6.0%, compared to 0.9% in patients classified as N0 and 17.3% in patients classified as N1. The risk of overlooking N2/N3 disease after both PET-CT and EBUS-TBNA was 10.4%.

Esophageal Endosonography for the Diagnosis of Intrapulmonary Tumors: A Systematic Review and Meta-Analysis.

BACKGROUND: Biopsy-based diagnosis in patients with paraesophageal intrapulmonary tumors suspected of lung cancer is crucial for adequate treatment planning. OBJECTIVE: To evaluate the performance of transesophageal endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) in the diagnosis of intrapulmonary tumors located near or adjacent to the esophagus. METHODS: We performed a systematic review (PROSPERO, CRD42016033737) and searched MEDLINE, Embase, BIOSIS Previews, and Web of Science on September 22, 2016, without date or language restrictions. We included studies that evaluated the yield and/or sensitivity of EUS-FNA for diagnosing intrapulmonary tumors. Yield was defined as the number of patients in whom EUS-FNA made a biopsy-proven diagnosis (malignant or nonmalignant) relative to the total number of patients on whom EUS-FNA was performed. Sensitivity was defined as the number of patients in whom EUS-FNA made a biopsy-proven diagnosis of malignancy relative to the total number of patients in whom the tumor was found to be malignant. We performed a random-effects meta-analysis. RESULTS: Of 3,320 search results, 11 studies were included. Ten had a high risk of bias. The total number of patients was 313; the proportion of patients with malignancy ranged from 87 to 100% across these studies. The average yield was 0.90 (95% CI 0.82-0.95) and the average sensitivity was 0.92 (0.83-0.96). In the subgroup of prospective studies (n = 3), the average yield was 0.80 (0.56-0.93) and the average sensitivity was 0.83 (0.58-0.95). EUS-FNA-induced complications were reported for 5/256 patients (2.0%) for whom this information was available. CONCLUSIONS: Although the number of high-quality studies is limited, these findings suggest that EUS-FNA is safe and has a high yield for diagnosing intrapulmonary tumors.

Simulation-Based Training in Flexible Bronchoscopy and Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration (EBUS-TBNA): A Systematic Review.

BACKGROUND: The use of simulators in a training programme for technically challenging procedures has the advantages of lowering the risk of patient complications while helping the trainees with the initial part of their learning curve. OBJECTIVES: The aim of this study was to perform a systematic review of simulation-based training in flexible bronchoscopy and endobronchial ultrasound (EBUS). METHODS: We identified 1,006 publications in the PubMed database and included publications on flexible bronchoscopy below the carina and EBUS involving hands-on simulation-based training. Publications were excluded if they were written in languages other than English, if paediatric airways were involved or if they were not journal articles. The screening process was performed by 2 individuals, and a third reviewer made the final decision in case of disagreement. RESULTS: We included 30 publications. The studies included participants of varying experience and most commonly used a virtual reality simulator as a training modality. Assessment of the participants' skills was based on simulator metrics or on an assessment tool. Some studies included performance on patients for assessment of the operator after training on a simulator. CONCLUSIONS: Simulation-based training was demonstrated to be more efficient than the traditional apprenticeship model. Physical models and virtual reality simulators complement each other. Simulation-based education should be based on a mastery learning approach and structured as directed self-regulated learning in a distributed training programme.

Results of the Randomized Danish Lung Cancer Screening Trial with Focus on High-Risk Profiling.

RATIONALE: As of April 2015, participants in the Danish Lung Cancer Screening Trial had been followed for at least 5 years since their last screening. OBJECTIVES: Mortality, causes of death, and lung cancer findings are reported to explore the effect of computed tomography (CT) screening. METHODS: A total of 4,104 participants aged 50-70 years at the time of inclusion and with a minimum 20 pack-years of smoking were randomized to have five annual low-dose CT scans (study group) or no screening (control group). MEASUREMENTS AND MAIN RESULTS: Follow-up information regarding date and cause of death, lung cancer diagnosis, cancer stage, and histology was obtained from national registries. No differences between the two groups in lung cancer mortality (hazard ratio, 1.03; 95% confidence interval, 0.66-1.6; P = 0.888) or all-cause mortality (hazard ratio, 1.02; 95% confidence interval, 0.82-1.27; P = 0.867) were observed. More cancers were found in the screening group than in the no-screening group (100 vs. 53, respectively; P < 0.001), particularly adenocarcinomas (58 vs. 18, respectively; P < 0.001). More early-stage cancers (stages I and II, 54 vs. 10, respectively; P < 0.001) and stage IIIa cancers (15 vs. 3, respectively; P = 0.009) were found in the screening group than in the control group. Stage IV cancers were nonsignificantly more frequent in the control group than in the screening group (32 vs. 23, respectively; P = 0.278). For the highest-stage cancers (T4N3M1, 21 vs. 8, respectively; P = 0.025), this difference was statistically significant, indicating an absolute stage shift. Older participants, those with chronic obstructive pulmonary disease, and those with more than 35 pack-years of smoking had a significantly increased risk of death due to lung cancer, with nonsignificantly fewer deaths in the screening group. CONCLUSIONS: No statistically significant effects of CT screening on lung cancer mortality were found, but the results of post hoc high-risk subgroup analyses showed nonsignificant trends that seem to be in good agreement with the results of the National Lung Screening Trial. Clinical trial registered with www.clinicaltrials.gov (NCT00496977).

Endoscopic Ultrasound-Guided Liver Biopsy in the Hands of a Chest Physician.

Liver biopsy using transesophageal bronchoscopic ultrasound-guided fine needle aspiration (EUS-B-FNA) has never been described before and biopsies of infradiaphragmatic lesions using this technique are not considered to be standard. A patient suspected for primary lung cancer with multiple lesions in the liver was referred to our department. We conducted bronchoscopy and endobronchial ultrasound-guided (EBUS) biopsy from several enlarged mediastinal lymph nodes. Thereafter, we conducted EUS-B-FNA from a lesion in the left liver lobe. Pathology showed that the liver lesion represented a metastasis from a pulmonary adenocarcinoma. Bronchoscopy and EBUS samples were not able to establish diagnosis. We hereby demonstrated that a diagnostic EUS-B-FNA from a liver metastasis in a patient with lung cancer is possible. This underlines that chest physicians should not forget the esophagus when staging lung cancer.

Identifying Technical Procedures in Pulmonary Medicine That Should Be Integrated in a Simulation-Based Curriculum: A National General Needs Assessment.

BACKGROUND: Simulation training is a revolutionary addition to health care education. However, developing simulation-based training programs is often dictated by those simulators that are commercially available. Curriculum development requires deliberate planning and a standardized approach, including a 'general needs assessment'. OBJECTIVES: The aim of this study was to perform a national general needs assessment to identify technical procedures in pulmonary medicine that should be integrated in a simulation-based curriculum. METHODS: A three-round Delphi process was initiated among 62 key opinion leaders. Round 1 was an open-ended question to identify technical procedures pulmonologists should learn. Round 2 was a survey using a newly developed needs assessment formula to explore the frequency of procedures, number of operators, risk or discomfort when performed by an inexperienced doctor, and feasibility of simulation-based training. In round 3, results were reviewed and ranked according to priority. RESULTS: The response rates for the three rounds were 74, 63, and 60%, respectively. The Delphi process reduced the 30 procedures identified in round 1 to 11 prioritized technical procedures in round 3. These were: flexible bronchoscopy, pleurocentesis, endobronchial ultrasound, endoscopic ultrasound-guided fine-needle aspiration, noninvasive ventilation treatment, transthoracic biopsy of pleural or lung tumor, focused ultrasound scanning of the lungs, chest tube insertion, needle biopsy of visible lymph node/tumor of the skin, focused ultrasound scanning of the heart, and thoracoscopy. CONCLUSION: We performed a Delphi study using a needs assessment formula, which identified 11 technical procedures that are highly suitable for simulation-based training. Medical educators can use this list as a resource in planning simulation-based training programs for trainees in pulmonary medicine.

Simulator training for endobronchial ultrasound: a randomised controlled trial.

Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is very operator dependent and has a long learning curve. Simulation-based training might shorten the learning curve, and an assessment tool with solid validity evidence could ensure basic competency before unsupervised performance.A total of 16 respiratory physicians, without EBUS experience, were randomised to either virtual-reality simulator training or traditional apprenticeship training on patients, and then each physician performed EBUS-TBNA procedures on three patients. Three blinded, independent assessor assessed the video recordings of the procedures using a newly developed EBUS assessment tool (EBUSAT).The internal consistency was high (Cronbach's α=0.95); the generalisability coefficient was good (0.86), and the tool had discriminatory ability (p<0.001). Procedures performed by simulator-trained novices were rated higher than procedures performed by apprenticeship-trained novices: mean±sd are 24.2±7.9 points and 20.2±9.4 points, respectively; p=0.006. A pass/fail standard of 28.9 points was established using the contrasting groups method, resulting in 16 (67%) and 20 (83%) procedures performed by simulator-trained novices and apprenticeship-trained novices failing the test, respectively; p<0.001.The endobronchial ultrasound assessment tool could be used to provide reliable and valid assessment of competence in EBUS-TBNA, and act as an aid in certification. Virtual-reality simulator training was shown to be more effective than traditional apprenticeship training.

Combined endobronchial and esophageal endosonography for the diagnosis and staging of lung cancer: European Society of Gastrointestinal Endoscopy (ESGE) Guideline, in cooperation with the European Respiratory Society (ERS) and the European Society of Thoracic Surgeons (ESTS).

This is an official guideline of the European Society of Gastrointestinal Endoscopy (ESGE), produced in cooperation with the European Respiratory Society (ERS) and the European Society of Thoracic Surgeons (ESTS). It addresses the benefit and burden associated with combined endobronchial and esophageal mediastinal nodal staging of lung cancer. The Scottish Intercollegiate Guidelines Network (SIGN) approach was adopted to define the strength of recommendations and the quality of evidence.The article has been co-published with permission in the European Journal of Cardio-Thoracic Surgery and the European Respiratory Journal. Recommendations 1 For mediastinal nodal staging in patients with suspected or proven non-small-cell lung cancer (NSCLC) with abnormal mediastinal and/or hilar nodes at computed tomography (CT) and/or positron emission tomography (PET), endosonography is recommended over surgical staging as the initial procedure (Recommendation grade A). The combination of endobronchial ultrasound with real-time guided transbronchial needle aspiration (EBUS-TBNA) and endoscopic (esophageal) ultrasound with fine needle aspiration, with use of a gastrointestinal (EUS-FNA) or EBUS (EUS-B-FNA) scope, is preferred over either test alone (Recommendation grade C). If the combination of EBUS and EUS-(B) is not available, we suggest that EBUS alone is acceptable (Recommendation grade C).Subsequent surgical staging is recommended, when endosonography does not show malignant nodal involvement (Recommendation grade B). 2 For mediastinal nodal staging in patients with suspected or proven non-small-cell peripheral lung cancer without mediastinal involvement at CT or CT-PET, we suggest that EBUS-TBNA and/or EUS-(B)-FNA should be performed before therapy, provided that one or more of the following conditions is present: (i) enlarged or fluorodeoxyglucose (FDG)-PET-avid ipsilateral hilar nodes; (ii) primary tumor without FDG uptake; (iii) tumor size ≥ 3 cm (Fig. 3a - c) (Recommendation grade C). If endosonography does not show malignant nodal involvement, we suggest that mediastinoscopy is considered, especially in suspected N1 disease (Recommendation grade C).If PET is not available and CT does not reveal enlarged hilar or mediastinal lymph nodes, we suggest performance of EBUS-TBNA and/or EUS-(B)-FNA and/or surgical staging (Recommendation grade C). 3 In patients with suspected or proven < 3 cm peripheral NSCLC with normal mediastinal and hilar nodes at CT and/or PET, we suggest initiation of therapy without further mediastinal staging (Recommendation grade C). 4 For mediastinal staging in patients with centrally located suspected or proven NSCLC without mediastinal or hilar involvement at CT and/or CT-PET, we suggest performance of EBUS-TBNA, with or without EUS-(B)-FNA, in preference to surgical staging (Fig. 4) (Recommendation grade D). If endosonography does not show malignant nodal involvement, mediastinoscopy may be considered (Recommendation grade D). 5 For mediastinal nodal restaging following neoadjuvant therapy, EBUS-TBNA and/or EUS-(B)-FNA is suggested for detection of persistent nodal disease, but, if this is negative, subsequent surgical staging is indicated (Recommendation grade C). 6 A complete assessment of mediastinal and hilar nodal stations, and sampling of at least three different mediastinal nodal stations (4 R, 4 L, 7) (Fig. 1, Fig. 5) is suggested in patients with NSCLC and an abnormal mediastinum by CT or CT-PET (Recommendation grade D). 7 For diagnostic purposes, in patients with a centrally located lung tumor that is not visible at conventional bronchoscopy, endosonography is suggested, provided the tumor is located immediately adjacent to the larger airways (EBUS) or esophagus (EUS-(B)) (Recommendation grade D). 8 In patients with a left adrenal gland suspected for distant metastasis we suggest performance of endoscopic ultrasound fine needle aspiration (EUS-FNA) (Recommendation grade C), while the use of EUS-B with a transgastric approach is at present experimental (Recommendation grade D). 9 For optimal endosonographic staging of lung cancer, we suggest that individual endoscopists should be trained in both EBUS and EUS-B in order to perform complete endoscopic staging in one session (Recommendation grade D). 10 We suggest that new trainees in endosonography should follow a structured training curriculum consisting of simulation-based training followed by supervised practice on patients (Recommendation grade D). 11 We suggest that competency in EBUS-TBNA and EUS-(B)-FNA for staging lung cancer be assessed using available validated assessment tools (Recommendation Grade D).

Assessment of competence in simulated flexible bronchoscopy using motion analysis.

BACKGROUND: Flexible bronchoscopy should be performed with a correct posture and a straight scope to optimize bronchoscopy performance and at the same time minimize the risk of work-related injuries and endoscope damage. OBJECTIVES: We aimed to test whether an automatic motion analysis system could be used to explore if there is a correlation in scope movements and the operator's level of experience. Our hypothesis was that experienced bronchoscopists move less and keep the flexible scope straighter than less-experienced bronchoscopists while performing procedures. METHODS: Eleven novices, 9 intermediates and 9 experienced bronchoscopy operators performed 3 procedures each on a bronchoscopy simulator. The Microsoft Kinect system was used to automatically measure the total deviation of the scope from a perfectly straight, vertical line. RESULTS: The low-cost motion analysis system could measure the accumulated deviation of the scope precisely during the procedure. The deviations were greatest for the novices and smallest for the most experienced operators for all 3 procedures (p = 0.01, p = 0.01 and p = 0.04, respectively). The total deviation from the straight scope correlated negatively with the performance on the simulator (virtual-reality simulator score; p < 0.001). CONCLUSION: The motion analysis system could discriminate between different levels of experience. Automatic feedback on correct movements during self-directed training on simulators might help new bronchoscopists learn how to handle the bronchoscope like an expert.