Patient safety implications of wearing a face mask for prevention in the era of COVID-19 pandemic: a systematic review and consensus recommendations.

In the past, the use of face masks in western countries was essentially limited to occupational health. Now, because of the COVID-19 pandemic, mask-wearing has been recommended as a public health intervention. As potential side effects and some contraindications are emerging, we reviewed the literature to assess the impact of them in daily life on patient safety and to provide appropriate guidelines and recommendations. We performed a systematic review of studies investigating physiological impact, safety, and risk of masks in predefined categories of patients, which have been published in peer-reviewed journals with no time and language restrictions. Given the heterogeneity of studies, results were analyzed thematically. We used PRISMA guidelines to report our findings. Wearing a N95 respirator is more associated with worse side effects than wearing a surgical mask with the following complications: breathing difficulties (reduced FiO2, SpO2, PaO2 increased ETCO2, PaCO2), psychiatric symptoms (panic attacks, anxiety) and skin reactions. These complications are related to the duration of use and/or disease severity. Difficulties in communication is another issue to be considered especially with young children, older person and people with hearing impairments. Even if benefits of wearing face masks exceed the discomfort, it is recommended to take an "air break" after 1-2 h consecutively of mask-wearing. However, well-designed prospective studies are needed. The COVID-19 pandemic could represent a unique opportunity for collecting large amount of real-world data.

Is Inhaler Technique Adequately Assessed and Reported in Clinical Trials of Asthma and Chronic Obstructive Pulmonary Disease Therapy? A Systematic Review and Suggested Best Practice Checklist.

BACKGROUND: Inhaled medications are central to treating asthma and chronic obstructive pulmonary disease (COPD), yet critical inhaler technique errors are made by up to 90% of patients. In the clinical research setting, recruitment of subjects with poor inhaler technique may give a false impression of both the benefits and the necessity of add-on treatments such as biologic therapies. OBJECTIVE: To assess the frequency with which inhaler technique is assessed and reliably optimized before and during patient enrollment into randomized controlled trials (RCTs) addressing the efficacy of topical therapy, and the escalation of therapy for asthma and COPD. METHODS: Systematic searches were conducted of PubMed and Embase for RCTs published in the past 10 years involving patients with a diagnosis of asthma or COPD undergoing escalation of baseline inhaled therapy (stepping up, changing, adding, switching, increasing, etc) or the introduction of biologic agents. RESULTS: Searches highlighted 1,014 studies, 118 of which were eligible after the removal of duplicates as well as screening and full text review. Of these, only 14 (11.9%) included accessible information in the methods section or referred to such information in online supplements or protocols concerning assessment of participants' inhaler technique. We therefore developed the proposed Best Practice Inhaler Technique Assessment and Reporting Checklist. CONCLUSIONS: Our study identifies a concerning lack of checking and correcting inhaler technique, or at least reporting that this was undertaken, before enrollment in asthma and COPD RCTs, which may affect the conclusions drawn. Mandating the use of a standardized checklist in RCT protocols and ensuring all published RCTs report checking and correcting inhaler technique before enrollment are important next steps.

Bronchoscopy in Patients With Known or Suspected COVID-19: Results From the Global Pandemic SARS-CoV-2 Bronchoscopy Database (GPS-BD).

BACKGROUND: Amid the Coronavirus Disease 2019 (COVID-19) pandemic, the benefits and risks of bronchoscopy remain uncertain. This study was designed to characterize bronchoscopy-related practice patterns, diagnostic yields, and adverse events involving patients with known or suspected COVID-19. METHODS: An online survey tool retrospectively queried bronchoscopists about their experiences with patients with known or suspected COVID-19 between March 20 and August 20, 2020. Collected data comprised the Global Pandemic SARS-CoV-2 Bronchoscopy Database (GPS-BD). All bronchoscopists and patients were anonymous with no direct investigator-to-respondent contact. RESULTS: Bronchoscopy procedures involving 289 patients from 26 countries were analyzed. One-half of patients had known COVID-19. Most (82%) had at least 1 pre-existing comorbidity, 80% had at least 1 organ failure, 51% were critically ill, and 37% were intubated at the time of the procedure. Bronchoscopy was performed with diagnostic intent in 166 (57%) patients, yielding a diagnosis in 86 (52%). and management changes in 80 (48%). Bronchoscopy was performed with therapeutic intent in 71 (25%) patients, mostly for secretion clearance (87%). Complications attributed to bronchoscopy or significant clinical decline within 12 hours of the procedure occurred in 24 (8%) cases, with 1 death. CONCLUSION: Results from this international database provide a widely generalizable characterization of the benefits and risks of bronchoscopy in patients with known or suspected COVID-19. Bronchoscopy in this setting has reasonable clinical benefit, with diagnosis and/or management change resulting from about half of the diagnostic cases. However, it is not without risk, especially in patients with limited physiological reserve.

Training in interventional pulmonology: the European and US perspective.

As the breadth of interventional pulmonology continues to expand, training in this discipline gains further importance. Interventional pulmonology training in the USA and Europe has common roots and similar concepts; however, there are variations in its delivery. We discuss the similarities, differences, challenges and goals of interventional pulmonology training in both continents. Collaboration and exchange of experiences between the USA and Europe are fundamental to entering the new era of competency/mastery training to implement a multidimensional approach to procedure-related education.

Statistical approach to mediastinal staging in NSCLC with M.E.S.S.i.a. software.

The exclusion of pathological involvement of mediastinal lymph nodes in patients affected by NSCLC plays a central role in assessing  their prognosis and operability. Ceron et al. developed a software - called M.E.S.S.i.a (Mediastinal Evaluation with Statistical Support; instan approach) - that allows the calculation of the residual probability of lymph node involvement after a certain number of tests has been done, by integrating every test result with the pre-test prevalence. M.E.S.S.i.a. bridges a gap of current American College of Chest Physicians (ACCP) guidelines, providing probability values of mediastinal metastasis for a correct clinical decision. We conducted a preliminary retrospective study in a series of 108 patients affected by non small cell lung cancer (NSCLC). Pathological staging was compared to the probability of nodal involvement calculated by M.E.S.S.i.a. software. Forty-two out of 108 subjects (39%) had a calculated post-test probability <8%; none of these had proven N2/N3 metastasis at surgical staging (negative predictive value, NPV: 100%). In 12/41 cases M.E.S.S.i.a. was able to avoid invasive procedures. The remaining 66 (61%) patients did not reach the surgical threshold; among these, 11 displayed N2 positivity at pathological staging. Receiving operator curve (ROC) analysis produced an area under curve (AUC) value of  0.773 (p<0.001). These preliminary data show high accuracy of M.E.S.S.i.a. software in excluding N2/N3 lymph node involvement in NSCLC. We have therefore promoted a prospective multicenter study in order to to get a validation of the calculator at different levels of probability of lymph node involvement. The recruitable subjects are potentially operable NSCLC patients; the gold standard for detection of mediastinal disease is the surgical lymph node dissection.

Competence in operative bronchoscopy.

We describe the current knowledge and skills for the main techniques of operative bronchoscopy and their applications in the treatment of malignant and benign central airway disorders. Rigid bronchoscopy has a history of over 100 years. The use of rigid bronchoscopy was abandoned upon the introduction of the fiberoptic bronchoscope but has made a reappearance with the development of interventional pulmonology in the late nineteenth and early twentieth century. The advantages of rigid bronchoscopy include allowing simultaneous procedures, such as ablation, debulking and suctioning, without limiting ventilation but at the moment there are no standard approaches to perform the procedure. Rigid bronchoscopy also plays a vital role in stent placement, repositioning, maintenance and removal. An interventional pulmonology practice should only be developed when there is a locoregional unmet medical need and when a dedicated interventional pulmonology unit can be guaranteed. These departments should be available 7 days a week and should provide a fast and appropriate response to referrals in emergency cases. There is a clear need to define a competency-based training program for rigid bronchoscopy, including stent placement. An optimal, multimodality training program for bronchoscopy should include didactic lectures, web-based learning, case-based reviews and hands-on training.

Competence in bronchoscopic treatments in emphysema.

Bronchoscopic lung volume reduction (BLVR) has been proven to be effective in patients with severe emphysema. These techniques are divided into two groups: non-blocking devices that are independent of collateral ventilation and blocking devices that are dependent on collateral ventilation so the choice of the target lobe with inadequate scissors is crucial for the success of the treatment. Current evidences suggest that not all classes and phenotypes of emphysema will benefit from BLVR, and that each technique appears to provide a greater benefit to specific sub-groups of patients. Careful patient selection is imperative to prevent insertion in patients unlikely to gain clinical benefits as well as wasteful expenditure. The Chartis system represents the gold standard for measuring fissure integrity and is a direct measurement method. Indirect method is instead the TC study which, thanks to the development of software for quantitative analysis, allows us to obtain reliable measurements of regional density of parenchyma, airway thickness and scissor integrity. BLVR is a highly complex procedure: a first-level competence is a pre-requisite for admission to training. The practical training must be based on discussion of clinical cases and the insertion techniques of the different devices on plastic or animal models, or on cadavers. A specific course, offering final certification, has been developed on the use of Zephyr valves.

Competence in thoracic ultrasound.

Ultrasound examination is traditionally considered a safe and repeatable exam, but its use is highly operator-dependent. Because of this, lack of sufficient operator skills could lead to diagnostic errors and damage to patient safety related to unnecessary tests or interventional procedures. The indications for lung ultrasound include: diagnosis, quantification, and follow-up of different conditions for which acute respiratory failure or chest pain are the main clinical presentation. Clinicians should have theoretical and practical knowledge on: physics and technology of ultrasound, indications and methodology of ultrasound examination, normal thoracic anatomy identification by echography, and detection of signs of pleuro-pulmonary pathology. Consequently, according to international recommendations, core basic skills and minimum training recommendations for the practice of medical ultrasound and image acquisition are needed to ensure competence of clinicians using ultrasound.

Competence in bronchial thermoplasty.

Bronchial thermoplasty (BT) is an innovative non-pharmacological endoscopic treatment for patients with severe persistent asthma based on controlled heat release with a device called Alair™ Catheter (Boston Scientific, Natick, MA, USA). The Alair™ system is the first device that works by delivering radiofrequency or thermal energy to selectively reduce the amount of airway smooth muscle (ASM) in bronchi. Literature showed significant improvement in clinical outcomes such as symptom control, severe exacerbation rate, hospitalization, quality of life, and number of working or school days lost for asthma. Besides smooth muscle effects changes in inflammatory pattern after BT have been documented. Bronchial thermoplasty requires an experienced physician who had a proficiency training in bronchoscopy and had rigor, dexterity and a thorough knowledge of the airway anatomy. Furthermore, right selection of severe asthma patient is crucial in order to have best response after BT. This article reviews BT device description and how to perform the procedure. Criteria for right selection and management of patient before and after BT will be discussed.

Competence in pulmonary endoscopy emergencies.

In clinical practice, interventional pulmonologists face several situations which can lead to dramatic consequences especially regarding ventilation and require immediate intervention. We describe the main pathological conditions where an urgent bronchoscopy is crucial because they act through mechanisms such as airway obstructions or alteration of the anatomic integrity of the tracheobronchial tree. We point out the problems resulting from inhalation of foreign bodies, one of the most dramatic respiratory emergencies typical in childhood which needs not only the appropriate endoscopic equipment suitable for the age, but also great experience in the management of the possible related complications. Massive hemoptysis is then discussed in order to help to choose the right endoscope and to clarify the steps requested to face this dramatic event. Lastly, iatrogenic tracheal injuries are described, in spite of their low occurrence. The correct endoscopic assessment of the lesions enables to select the proper multidisciplinary therapeutic approach together with surgeons and anesthetists. Due to their peculiarities, emergencies do not allow classic training so it is difficult to estimate the procedure volume necessary to achieve an adequate endoscopic experience. We think, in this field, it is advisable to refer to numbers proposed for elections endoscopic procedures. For these reasons, we consider desirable the use of simulators and clinic case discussions during interventional pulmonologist's training.

Competence and training in interventional pulmonology.

Interventional pulmonology (IP) is experiencing a rapid evolution of new technologies. There is a need to develop structured training programs, organized in high volume expert centers in order to improve trainee education, and including the development of validated metrics for their competency assessment. Concerning teaching methods, a gradual progression from theory to practice, using new teaching techniques, including live sessions and low and high-fidelity simulation, flipped classroom models and problem-based learning (PBL) exercises would provide a training setting more suitable for our current need to improve skills and update professionals. Training programs should be learner-centered and competence-oriented, as well as being based on a spiral-shaped approach in which the same subject is addressed many times, from new and different perspectives of knowledge, ability, behavior and attitude, until the trainee has demonstrated a high degree of skill and professionalism. Furthermore there is a need to standardize the training programs as guide for physicians wishing to undertake a gradual and voluntary improvement of their own competencies, and assist those planning and organizing training programs in IP. The article includes a general part on core curriculum contents, innovative training methods and simulation, and introduces the following articles on the skills that the Interventional Pulmonologist must master in order to perform the different procedures. This monography should be considered a starting point that will evolve over time and results in better training for practitioners and better care for our patients. The task of establishing a trainee's competence to practice independently as an Interventional Pulmonologist remains the responsibility of the IP fellowship program director and faculty, who validate logbooks and assess competence for each procedure. These standards need to be reviewed and approved by national and International Scientific Societies and Healthcare Institutions with the aim to improve, disseminate and incorporate them in healthcare programs.

Competence in flexible bronchoscopy and basic biopsy technique.

Diagnostic bronchoscopy and tissue sampling techniques using forceps (endobronchial biopsy [EBB] and transbronchial biopsies [TBB]) or needle aspiration (transbronchial needle aspiration-TBNA), all performed with a flexible bronchoscope, are the basic elements of any interventional procedure. The flexible fibrobronchoscopy allows the visualization of the airways and is used both for diagnostic and therapeutic purposes. The working channel of both fibrobronchoscopes with optical fibers and videobronchoscopes, even if of relatively small diameter, allows the insertion of various diagnostic and therapeutic accessories. Fiber optic systems have been widely replaced by video cameras using a miniaturized charge-coupled device camera positioned at the end of the scope that provides electronic transmission of images to a monitor. The indications for both diagnostic and therapeutic fibrobronchoscopy derive from a correct evaluation of symptoms and objective signs of the patient and from the correct interpretation of imaging methods. Although bronchoscopy techniques keep evolving at a rapid pace, basic procedures such as bronchoalveolar lavage, transbronchial lung biopsy, and transbronchial needle aspiration still play a key role in pulmonary disease diagnostics, and therefore, these methods must still be part of the training of interventional pulmonologists. Trainees will acquire a thorough knowledge of thoracic anatomy and become skilled in the interpretation of thoracic imaging, after which they will be given a theoretical and practical training course on virtual reality simulators, on animal or cadaver models, the effectiveness of which has been fully demonstrated by scientific studies. Specific DOPS tests have been developed for a qualitative evaluation of procedures on simulators, on animal models and on the patient.

Competences in bronchoscopy for Intensive Care Unit, anesthesiology, thoracic surgery and lung transplantation.

Over the last decades, the use of flexible bronchoscopy has greatly increased in intensive care, anesthesia and thoracic surgery for diagnostic purpose, management of critical patients and to facilitate airway management for tracheal intubation, one lung ventilation and lung transplant management. The huge availability of endoscopic instruments and devices for airway management has amplified indications and possibilities for bronchoscopic procedures performed by intensive care physicians, anesthesiologist, endoscopists, and surgeons too. These practices need adequate technical skills that can be acquired only through defined learning pathways. This manuscript summarizes the indications and the competencies needed to perform bronchoscopic procedures in intensive care, anesthesia and thoracic surgery settings.

Competence in transbronchial cryobiopsy.

Over the last decade transbronchial lung cryobiopsy (TBLC) has proven to be an "innovative application" of an "old procedure" for the histologic diagnosis of diffuse interstitial lung diseases (DILDs). Thus, the technique of TBL cryobiopsy is now adopted for diagnostic purposes, transbronchially in peripheral airways to sample lung parenchyma, whereas this same technique was traditionally employed in the past for therapeutic purposes, essentially for the management of malignant obstruction of central airways. When patients with interstitial lung diseases (ILDs) need histopathological data in their diagnostic pathway, this bioptic approach could be a valid alternative to surgical lung biopsy, that is still the gold standard at the moment. TBL cryobiopsy has a good safety profile, its sensitivity and specificity appear good overall in idiopathic pulmonary fibrosis. In the last ten years, many papers have been published about this procedure defining modalities by which cryobiopsy should be performed. These studies have shown that TBL cryobiopsy is feasible, it allows to obtain larger lung parenchymal specimens (3 times larger than "classic" transbronchial biopsies), characterized by unaltered and artefact-free morphology, and it represents a safe and poorly invasive diagnostic tool for the histologic diagnosis of ILDs. The technical aspects are really important, and they still need a complete standardization. TBL cryobiopsy should be part of an equipment of the modern interventional pulmonologist, who should know indications and contraindications of this methodic and the technical aspects of the procedure. This is a complex procedure requiring to be performed by endoscopists working in specialized centers with specific knowledge of DILDs, and a multidisciplinary approach, which represent pre-requisites for admission to training in this procedure.

Competence in navigation and guided transbronchial biopsy for peripheral pulmonary lesions.

Options for non-surgical tissue diagnosis of the peripheral nodule include CT scan-guided TTNA, fluoroscopy-guided bronchoscopy, radial endobronchial ultrasound (EBUS), electromagnetic navigation bronchoscopy (ENB), and virtual bronchoscopy navigation (VBN). For physicians who choose to pursue non-surgical biopsy, the decision to perform CT scan-guided or ultrasound-guided TTNA, conventional bronchoscopy or bronchoscopy guided by EBUS, ENB, or VBN will depend on a number of factors. CT scan-guided TTNA is preferable for nodules located near the chest wall or for deeper lesions, provided that there is no need to go through the fissures and there is no surrounding emphysema. Ultrasound-guided TTNA requires contact between the lesion and the costal pleura. Bronchoscopic techniques are preferable for nodules ≥2 cm located near a patent bronchus, or in individuals at high risk for pneumothorax following TTNA. In most other situations, operator experience should guide the decision. Trainees must possess a perfect knowledge of anatomy and be fully competent in the interpretation of imaging (CT with contrast medium and PET) and have a thorough knowledge of navigation technology in all its complexities. Practical training can be performed on animal, cadaver or plastic models. In the last years, to improve diagnostic yield, navigational bronchoscopy has attracted significant attention.

Competence in endosonographic techniques.

Endobronchial ultrasound (EBUS) has revolutionized the field of bronchoscopy because it allows to observe peribronchial structures and distal peripheral lung lesions. The use of EBUS was first described by Hurte and Hanrath in 1992. EBUS technology exists in two forms: radial and convex transducer probes. The radial EBUS probe has a 20-MHZ (12-30 MHz available) rotating transducer that can be inserted together with or without a guide sheath through the working channel (2.0-2.8 mm) of a standard flexible bronchoscope. The transducer rotates and produces a 360-degree circular image around the central position of the probe. There are two types of radial EBUS probes: "peripheral" probes, used to identify parenchymal lung lesions, and "central" probes, with balloon sheaths, used for the assessment of airway walls and peribronchial lymph nodes.

Management of patients presenting with haemoptysis to a Tertiary Care Italian Emergency Department: the Florence Haemoptysis Score (FLHASc).

We analysed the clinical features and diagnostic workup of patients presenting with haemoptysis to an Italian teaching hospital to derive an easy-to-use clinical score to guide risk stratification and initial management in the emergency department (ED). We retrospectively reviewed clinical records of consecutive patients with haemoptysis over 1 year. A pre-specified set of variables, including demographic data, vital signs, type of expectorate (pure blood vs. blood-streaked sputum), comorbidities, and diagnostic tests and treatments was originally registered. The primary outcome was a composite of any of the following: death from any cause, invasive or non-invasive ventilation, Intensive Care Unit admission, blood transfusions or invasive haemostatic procedures. We investigated associations between the pre-specified clinical variables and the primary outcome using a logistic regression analysis. Finally, we derived a score (the Florence Haemoptysis Score, FLHASc) giving a proportional weight to each variable according to the Odds Ratios (OR). We included 197 patients with a median age of 60 years. The first radiological study was a plain chest X-ray in 128 patients (65%). For 33 (17%) patients, a chest computer tomography (CT scan) was the first radiological study. The most common diagnosis was lung malignancy (19% of cases). The diagnosis remained undetermined in one-third of patients. The primary outcome was met by 11.2% of the study population. Systolic blood pressure <100 mmHg (OR 9.7), a history of malignancy (OR 3), the expectoration of pure blood (OR 2.8), and more than 2 episodes of haemoptysis in the prior 24 h (OR 2.5) are found as independent predictors of the primary outcome. The FLHASc ranges from 0 to 6 with a prognostic accuracy of 78% (IC 95%, 68-88%). The primary outcome incidence is 2.4% (IC 95%, 0.2-8.2%) in patients with a FLHASc equal to zero (n = 85, 43%) versus 13.4% (IC 95% 7.8-21.1%) in patients with a FLHASc > 0 (p < 0.01). Among patients with a FLHASc equal to zero, a negative chest X-ray study identifies patients who may be safely discharged. Patients who presented to the ED with haemoptysis experience a heterogeneous management. We derive a simple clinical prognostic score that may rationalize their diagnostic workup.