The development and implementation of a low-cost mechanical ventilator in a low-middle-income country during the COVID-19 pandemic: The Unisabana-HERONS.

Background: The COVID-19 pandemic in Latin America generated the need to develop low-cost, fast-manufacturing mechanical ventilators. The Universidad de La Sabana and the Fundacion Neumologica Colombiana designed and manufactured the Unisabana-HERONS (USH) ventilator. Here, we present the preclinical and clinical study results to evaluate its effectiveness and safety characteristics in an animal model (Yorkshire Sow) and five patients with acute respiratory failure receiving mechanical ventilatory support for 24 h. Methods: The effectiveness and safety outcomes included maintaining arterial blood gases and pulse oximetry saturation (SpO2), respiratory pressures and volumes (during continuous monitoring) in the range of ARDS and lung-protective strategy goals, and the occurrence of barotrauma. A significance level of 0.05 was used for statistical tests. This clinical trial was registered on Clinicaltrials.gov (NCT04497623) and approved by the ethics committee. Results: Among patients treated with the Unisabana-HERONS, the most frequent causes of acute respiratory failure were pneumonia in 3/5 (60 %) and ARDS in 2/5 (40 %). During the treatment, the ventilatory parameters related to lung protection protocols were kept within the safety range, and vital signs and blood gas were stable. The percentage of time that the respiratory pressures or volumes were out of safety range were plateau pressure >30 cm H2O: 0.00 %; driving pressure >15 cm H2O: 0.06 %; mechanical power >15 J/min: 0.00 %; and Tidal volume >8 mL/kg: 0.00 %. There were no adverse events related to the ventilator. The usability questionnaire retrieved a median score for all items between 9 and 10 (best score: 10), indicating great ease of use. Conclusion: The Unisabana-HERONS ventilator effectively provided adequate gas exchange and maintained the ventilatory parameters in the range of lung protection strategies in humans and an animal model. Furthermore, it is straightforward to use and is a low-cost medical device.

Existing and Emerging Technologies for Therapeutic Monitoring of Lithium: A Scoping Review.

BACKGROUND/PURPOSE: Lithium is an effective psychoactive drug. It has a narrow therapeutic margin, with subtherapeutic levels or intoxication commonly occurring. Therapeutic drug monitoring (TDM) of lithium has several barriers. This scoping review aims to describe and analyze existing and emerging technologies for lithium TDM and to describe the lithium quantification parameters (precision, accuracy, detection limit) attributed to each technology. METHOD: PubMed, Scopus, Web of Science, and Google Scholar were searched. Studies that described lithium quantification and complied with PRISMA-ScR guidelines were included. Articles selection was conducted by 2 researchers. Good precision was defined if its relative standard deviation <3%; acceptable, from 3% to 5%; and low, >5%. Accuracy was considered good if the error <5%; acceptable, 5%1 to 0%; and low if it was >10%. RESULTS: Of the 2008 articles found, 22 met the inclusion criteria. Of these, 14 studies concerned laboratory devices, in which precision was found to be low in one third of cases, and half had good precision. Accuracy of one third was good, another third was low, and the remaining third did not report accuracy. The other 8 studies concerned portable devices, in which precision was low in more than 60% of the cases and good in 25% of the studies. Accuracy was low in 50% of the cases, and good in just over a third. Limits of detection included the therapeutic range of lithium in all studies. CONCLUSIONS: Among emerging technologies for lithium TDM, precision and accuracy remain a challenge, particularly for portable devices.

Risk factors for persistent tomographic abnormalities at 6 months of follow-up in a cohort of hospitalized patients with moderate and severe COVID-19 living at high altitude.

Introduction: After COVID-19, functional and tomographic lung alterations may occur, but there are no studies at high altitude where, due to lower barometric pressure, there are lower levels of arterial oxygen pressure and saturation in both normal subjects and patients with respiratory disease. In this study, we evaluated the computed tomographic (CT), clinical, and functional involvement at 3 and 6 months post-hospitalization in survivors with moderate-severe COVID-19, as well the risk factors associated with abnormal lung computed tomography (ALCT) at 6 months of follow-up. Materials and methods: Prospective cohort, after hospitalization for COVID-19, of patients older than 18 years residing at high altitude. Follow-up at 3 and 6 months with lung CT, spirometry, diffusing capacity of the lung for carbon monoxide (DLCO), six-minute walk test (6MWT), and oxygen saturation (SpO2). Comparisons between ALCT and normal lung computed tomography (NLCT) groups with X2 and Mann-Whitney U test, and paired test for changes between 3 and 6 months. A multivariate analysis was performed to evaluate the variables associated with ALCT at 6-month follow-up. Results: We included 158 patients, 22.2% hospitalized in intensive care unit (ICU), 92.4% with typical COVID CT scan (peripheral, bilateral, or multifocal ground glass, with or without consolidation or findings of organizing pneumonia), and median hospitalization of 7 days. At 6 months, 53 patients (33.5%) had ALCT. There were no differences between ALCT and NLCT groups in symptoms or comorbidities on admission. ALCT patients were older and more frequently men, smokers and hospitalized in ICU. At 3 months, ALCT patients had more frequently a reduced forced vital capacity (< 80%), and lower meters walked (6MWT) and SpO2. At 6 months, all patients improved lung function with no differences between groups, but there were more dyspnea and lower exercise SpO2 in ALCT group. The variables associated with ALCT at 6 months were age, sex, ICU stay, and typical CT scan. Conclusion: At 6-month follow-up, 33.5% of patients with moderate and severe COVID had ALCT. These patients had more dyspnea and lower SpO2 in exercise. Regardless of the persistence of tomographic abnormalities, lung function and 6MWT improved. We identified the variables associated with ALCT.

Learning curves and association of pathologist's performance with the diagnostic accuracy of linear endobronchial ultrasound transbronchial needle aspiration (EBUS-TBNA): a cohort study in a tertiary care reference centre.

OBJECTIVES: We aimed to assess the learning curves and the influence of the pathologist's performance on the endobronchial ultrasound transbronchial needle aspiration's (EBUS-TBNA's) diagnostic accuracy in a real-world study. DESIGN/SETTING: Cohort study conducted in a tertiary care university hospital (single centre) with patients referred for EBUS-TBNA. PARTICIPANTS/INTERVENTION: We initially evaluated 376 patients (673 lymph nodes), 368 (660 lymph nodes) of whom were recruited. The inclusion criterion was EBUS-TBNA indicated for the study of mediastinal or hilar lesions. The exclusion criteria were the absence of mediastinal and hilar lesions during EBUS confirmed by a normal mediastinum and hilum on chest CT (except in cases of mediastinal staging of cancer) and lost to follow-up. PRIMARY AND SECONDARY OUTCOME MEASURES: Diagnostic accuracy and related outcomes. METHODS: We included patients from a prospectively constructed database. We performed a logistic regression multivariate analysis to adjust for potential confounders of the association between pathologist performance and EBUS-TBNA accuracy. The Cumulative Summation (CUSUM) analysis was used to assess pathologists' performance and learning curves. RESULTS: Most indications for EBUS were suspicion of malignancy, including intrathoracic tumours (68.3%), extrathoracic tumours (9.8%) and cancer staging (7.0%). The patients' mean age was 63.7 years, and 71.5% were male. Overall EBUS-TBNA accuracy was 80.8%. In the multivariate logistic regression model, the factors independently associated with EBUS-TBNA accuracy included certain pathologists (ORs ranging from 0.16 to 0.41; p<0.017), a lymph node short-axis diameter <1 cm (OR: 0.36; 95% CI 0.21 to 0.62; p<0.001), and the aetiology of lymph node enlargement (ORs ranging from 7 to 37; p<0.001). CUSUM analysis revealed four different learning curve patterns, ranging from almost immediate learning to a prolonged learning phase, as well as a pattern consistent with performance attrition. CONCLUSIONS: Pathologists' proficiency conditioned EBUS-TBNA accuracy. This human factor is a potential source of error independent of factors conditioning tissue sample adequacy.

Pneumonia, Mortality, and Other Outcomes Associated with Unsafe Swallowing Detected via Fiberoptic Endoscopic Evaluation of Swallowing (FEES) in Patients with Functional Oropharyngeal Dysphagia: A Systematic Review and Meta-analysis.

The association between impairments in swallowing safety detected via fiberoptic endoscopic evaluation of swallowing (FEES) and dysphagia complications has been evaluated in small studies that have not allowed obtaining precise estimates of the presence of such an association. The objective of this study was to evaluate the risk of dysphagia complications associated with the detection of premature spillage, residue, penetration, and aspiration via FEES. A systematic review and meta-analysis of the literature were carried out. A search strategy was established using terms of controlled and free vocabulary (free text) in the PubMed, Lilacs, Embase, Medline, and Cochrane databases. The initial search in the databases identified 3545 articles, of which 321 were excluded due to duplication, 3224 were selected for review of titles and abstracts, 45 were selected for full-text review, 37 were excluded for not meeting the selection criteria, and 8 were included for the final analysis, with a total population of 1168 patients. Aspiration increased the risk of pneumonia (OR 2.97, 95% CI 1.52-5.80, P = 0.001). The number of studies that have evaluated the relationship of other FEES findings with dysphagia complications was limited (≤ 3). One study found a higher risk of mortality in patients with aspiration (OR 4.08, 95% CI 1.60-10.27, P = 0.003). Another study that evaluated the risk of mortality in a combined group of penetration and aspiration found no higher risk of mortality. Penetration, residue, and premature spillage were not found to be associated with an increased risk of pneumonia, mortality, or other outcomes. Aspiration demonstrated via FEES was associated with an increased risk of pneumonia and mortality. There is insufficient evidence for the capacity of premature spillage, penetration, and residue to predict dysphagia complications.

BASAN index (Body mass index, Age, Sex, Arterial hypertension and Neck circumference) predicts severe apnoea in adults living at high altitude.

OBJECTIVES: Obstructive sleep apnoea (OSA)/hypopnoea syndrome is associated with serious and major multiorgan morbidities, particularly in its most severe forms. However, no severe OSA screening instruments are available for high altitude residents that enable adequate identification and clinical prioritisation of such patients. We aimed at developing a severe OSA prediction tool based on the clinical characteristics and anthropometric measurements of a clinical referral cohort living at 2640 m.a.s.l. DESIGN: Cohort-nested cross-sectional study. SETTING: Sleep laboratory for standard polysomnography (PSG) in Colombia. PARTICIPANTS: A predictive model was generated from 8718 participants referred to the PSG laboratory. Results were subsequently validated in a second cohort of 1898 participants. PRIMARY OUTCOME: To identify clinical and anthropometric variables associated with severe OSA (>30 events/hour) and to include them in a binary logistic regression model. RESULTS: The significant variables that were retained with the presence of severe OSA included Body mass index (BMI), Age, Sex, Arterial hypertension and Neck circumference (BASAN). The area under the receiver operating characteristic curvefor the BASAN index was 0.69 (95% CI: 0.68 to 0.70) in the derivation cohort and 0.67 (95% CI: 0.65 to 0.69) in the validation cohort, whereby a BASAN index ≥2 had a sensitivity of 95% and a specificity of 17% to detect severe OSA. CONCLUSION: An objectively based approach to screen for the presence of severe OSA, the BASAN index, exhibits favourable sensitivity characteristics that should enable its operational use as a screening tool in a Hispanic population with a clinical suspicion of OSA and living at high altitude.

Bronchoscopist's perception of the quality of the single-use bronchoscope (Ambu aScope4™) in selected bronchoscopies: a multicenter study in 21 Spanish pulmonology services.

BACKGROUND: The disposable bronchoscope is an excellent alternative to face the problem of SARS-CoV-2 and other cross infections, but the bronchoscopist's perception of its quality has not been evaluated. METHODS: To evaluate the quality of the Ambu-aScope4 disposable bronchoscope, we carried out a cross-sectional study in 21 Spanish pulmonology services. We use a standardized questionnaire completed by the bronchoscopists at the end of each bronchoscopy. The variables were described with absolute and relative frequencies, measures of central tendency and dispersion depending on their nature. The existence of learning curves was evaluated by CUSUM analysis. RESULTS: The most frequent indications in 300 included bronchoscopies was bronchial aspiration in 69.3% and the median duration of these was 9.1 min. The route of entry was nasal in 47.2% and oral in 34.1%. The average score for ease of use, image, and aspiration quality was 80/100. All the planned techniques were performed in 94.9% and the bronchoscopist was satisfied in 96.6% of the bronchoscopies. They highlighted the portability and immediacy of the aScope4TM to start the procedure in 99.3%, the possibility of taking and storing images in 99.3%. The CUSUM analysis showed average scores > 70/100 from the first procedure and from the 9th procedure more than 80% of the scores exceeded the 80/100 score. CONCLUSIONS: The aScope4™ scored well for ease of use, imaging, and aspiration. We found a learning curve with excellent scores from the 9th procedure. Bronchoscopists highlighted its portability, immediacy of use and the possibility of taking and storing images.

Allergic Rhinitis and OSA in Children Residing at a High Altitude.

BACKGROUND: OSA affects 2% to 4 % of the pediatric population; allergic rhinitis (AR) has been identified as a risk factor in sleep-disordered breathing, but no studies evaluating such an association have been conducted in high-altitude environments. The goal of this study was to assess whether the severity of AR is associated with the severity of OSA in children undergoing polysomnography (PSG) in the high-altitude city of Bogotá, Colombia. METHODS: A cross-sectional observational study of children with AR was conducted. Severity of AR was evaluated by using the AR health-related quality of life questionnaire for children (ESPRINT-15) and the Allergic Rhinitis and its Impact on Asthma (ARIA) classification. Diagnosis and severity of OSA were established by using PSG. Potential associations between AR severity and OSA severity were assessed by using binary logistic regression and the Spearman correlation coefficient (ρ). RESULTS: A total of 99 children (mean age, 7.9 years; 45% female) were included; 53% had OSA. An ESPRINT-15 score was associated with severe OSA (OR, 2.0; 95% CI, 1.12-6.04; P = .01). Patients with moderate/severe persistent rhinitis according to ARIA exhibited a 10.1-fold greater risk of severe OSA (OR, 10.15; 95% CI, 1.15-89.0). Furthermore, the apnea-hypopnea index was associated with the ESPRINT-15 score (ρ = 0.215; P = .03) and with the ARIA severity scale (P = .04; ρ = 0.203). CONCLUSIONS: In symptomatic children with AR residing at a high altitude, increasing AR severity is associated with more severe OSA.

Frequency of emergency department visits and hospitalizations due to chronic obstructive pulmonary disease exacerbations in patients included in two models of care / Frecuencia de visitas al departamento de emergencias y hospitalizaciones debido a exacerbaciones de la enfermedad pulmonar obstructiva crónica en pacientes incluidos en dos modelos de atención

INTRODUCTION: Exacerbations of chronic obstructive pulmonary disease (COPD) have a huge impact on lung function, quality of life and mortality of patients. Emergency Department visits and hospitalizations due to exacerbations cause a significant economic burden on the health system. OBJECTIVE: To describe the differences in the number of emergency visits and hospitalizations due to exacerbations of COPD among patients included in two models of care of the same institution. MATERIALS AND METHODS: A historical cohort study in which COPD patients who are users of two models of care were included: COPD integrated care program (CICP) and general consultation of pulmonology (GCP). The first model, unlike the second one, offers additional educational activities, 24/7 telephone service, and priority consultations. The number of emergency visits and hospitalizations due to COPD exacerbations in patients who had completed at least one year of follow-up was evaluated. The multivariable Poisson regression model was used for calculating the incidence rate (IR) and the incidence rate ratio (IRR) with an adjustment for confounding factors. RESULTS: We included 316 COPD patients (166 from the CICP and 150 from the GCP). During the year of follow-up, the CICP patients had 50% fewer emergency visits and hospitalizations than patients from the GCP (IRR=0.50, 95%CI: 0.29-0.87, p=0.014). CONCLUSIONS: COPD patients in the CICP had fewer emergency visits and hospitalizations due to exacerbations. Prospective clinical studies are required to confirm the results and to evaluate the factors that contribute to the differences.

Introducción. Las exacerbaciones de la enfermedad pulmonar obstructiva crónica (EPOC) tienen un gran impacto en la función pulmonar, la calidad de vida y la mortalidad de los pacientes. Las visitas al Departamento de Emergencias y las hospitalizaciones debido a las exacerbaciones, causan una carga económica importante para el sistema de salud. Objetivo. Describir las diferencias en el número de visitas de emergencia y hospitalizaciones debidas a exacerbaciones de la EPOC, entre los pacientes incluidos en dos modelos de atención de la misma institución. Materiales y métodos. Se trata de un estudio de cohorte histórica en el que se incluyeron pacientes que son usuarios de dos modelos de atención: el programa de atención integrada de la EPOC (CICP) y la consulta general de neumología (PCG). El primer modelo, a diferencia del segundo, ofrece actividades educativas adicionales, servicio telefónico las 24 horas del día y consultas prioritarias. Se evaluó el número de visitas de emergencia y hospitalizaciones debido a exacerbaciones de la EPOC en pacientes que habían completado, al menos, un año de seguimiento. Se utilizó el modelo de regresión multivariable de Poisson para calcular la tasa de incidencia (IR) y la razón de tasas de incidencia (IRR), con un ajuste para factores de confusión. Resultados. Se incluyeron 316 pacientes con EPOC, 166 del CICP y 150 de la PCG. Durante el año de seguimiento, los pacientes en el CICP tuvieron 50 % menos visitas de emergencia y hospitalizaciones que los pacientes en la PCG (IRR=0,50; IC95% 0,29-0,87; p=0,014). Conclusiones. Los pacientes con EPOC en el CICP, tuvieron menos visitas de emergencia y hospitalizaciones debido a las exacerbaciones. Se requieren estudios clínicos prospectivos para confirmar los resultados y evaluar los factores que contribuyen a las diferencias.

Frequency of emergency department visits and hospitalizations due to chronic obstructive pulmonary disease exacerbations in patients included in two models of care / Frecuencia de visitas al departamento de emergencias y hospitalizaciones debido a exacerbaciones de la enfermedad pulmonar obstructiva crónica en pacientes incluidos en dos modelos de atención

Introduction: Exacerbations of chronic obstructive pulmonary disease (COPD) have a huge impact on lung function, quality of life and mortality of patients. Emergency Department visits and hospitalizations due to exacerbations cause a significant economic burden on the health system. Objective: To describe the differences in the number of emergency visits and hospitalizations due to exacerbations of COPD among patients included in two models of care of the same institution. Materials and methods: A historical cohort study in which COPD patients who are users of two models of care were included: COPD integrated care program (CICP) and general consultation of pulmonology (GCP). The first model, unlike the second one, offers additional educational activities, 24/7 telephone service, and priority consultations. The number of emergency visits and hospitalizations due to COPD exacerbations in patients who had completed at least one year of follow-up was evaluated. The multivariable Poisson regression model was used for calculating the incidence rate (IR) and the incidence rate ratio (IRR) with an adjustment for confounding factors. Results: We included 316 COPD patients (166 from the CICP and 150 from the GCP). During the year of follow-up, the CICP patients had 50% fewer emergency visits and hospitalizations than patients from the GCP (IRR=0.50, 95%CI: 0.29-0.87, p=0.014). Conclusions: COPD patients in the CICP had fewer emergency visits and hospitalizations due to exacerbations. Prospective clinical studies are required to confirm the results and to evaluate the factors that contribute to the differences.

Introducción. Las exacerbaciones de la enfermedad pulmonar obstructiva crónica (EPOC) tienen un gran impacto en la función pulmonar, la calidad de vida y la mortalidad de los pacientes. Las visitas al Departamento de Emergencias y las hospitalizaciones debido a las exacerbaciones, causan una carga económica importante para el sistema de salud. Objetivo. Describir las diferencias en el número de visitas de emergencia y hospitalizaciones debidas a exacerbaciones de la EPOC, entre los pacientes incluidos en dos modelos de atención de la misma institución. Materiales y métodos. Se trata de un estudio de cohorte histórica en el que se incluyeron pacientes que son usuarios de dos modelos de atención: el programa de atención integrada de la EPOC (CICP) y la consulta general de neumología (PCG). El primer modelo, a diferencia del segundo, ofrece actividades educativas adicionales, servicio telefónico las 24 horas del día y consultas prioritarias. Se evaluó el número de visitas de emergencia y hospitalizaciones debido a exacerbaciones de la EPOC en pacientes que habían completado, al menos, un año de seguimiento. Se utilizó el modelo de regresión multivariable de Poisson para calcular la tasa de incidencia (IR) y la razón de tasas de incidencia (IRR), con un ajuste para factores de confusión. Resultados. Se incluyeron 316 pacientes con EPOC, 166 del CICP y 150 de la PCG. Durante el año de seguimiento, los pacientes en el CICP tuvieron 50 % menos visitas de emergencia y hospitalizaciones que los pacientes en la PCG (IRR=0,50; IC95% 0,29-0,87; p=0,014). Conclusiones. Los pacientes con EPOC en el CICP, tuvieron menos visitas de emergencia y hospitalizaciones debido a las exacerbaciones. Se requieren estudios clínicos prospectivos para confirmar los resultados y evaluar los factores que contribuyen a las diferencias.

Obstructive sleep apnea and nocturnal hypoxemia are associated with an increased risk of lung cancer.

STUDY OBJECTIVES: To identify a link between sleep disordered breathing, nocturnal hypoxemia, and lung cancer. METHODS: We conducted a cross-sectional study of a combined cohort of 302 individuals derived from the sleep apnea in lung cancer study (SAIL; NCT02764866) investigating the prevalence of sleep apnea in lung cancer, and the sleep apnea in lung cancer screening study (SAILS; NCT02764866) investigating the prevalence of sleep apnea in a lung cancer screening program. All subjects had spirometry and a chest CT, underwent home sleep apnea testing (HSAT), and completed a sleep related questionnaire. Subjects from the SAIL study underwent HSAT prior to initiating oncologic therapy or surgery. Subjects with an apnea-hypopnea index (AHI) > 15 were compared with a control group of individuals with an AHI < 15. Propensity score, near neighbor matching, and logistic regression adjusted for potential confounders, were used in order to evaluate the association between sleep apnea, the AHI, oxygen desaturation indices and lung cancer. RESULTS: The prevalence of sleep apnea and lung cancer in the combined cohort was 42% and 21%, respectively. Lung cancer was 8% more prevalent in patients with an AHI >15. The difference was statistically significant when assessed by propensity score matching (p = 0.015) and nearest neighbor matching (p = 0.041). Binary logistic regression adjusted for potential confounders revealed a statistically significant association between AHI (p = 0.04), nocturnal hypoxemia, including time spent below 90% oxyhemoglobin saturation (T90%; p = 0.005), 3% oxygen desaturation index (ODI3; p = 0.02) and lung cancer. CONCLUSIONS: Sleep apnea and nocturnal hypoxemia are associated with an increased prevalence of lung cancer. CLINICAL TRIAL REGISTRATION: SAIL study (NCT02764866) and SAILS study (NCT02764866).

Real-time PCR assay for the diagnosis of pleural tuberculosis.

INTRODUCTION: The diagnosis of pleural tuberculosis requires an invasive and time-consuming reference method. Polymerase chain reaction (PCR) is rapid, but validation in pleural tuberculosis is still weak. OBJECTIVE: To establish the operating characteristics of real-time polymerase chain reaction (RT-PCR) hybridization probes for the diagnosis of pleural tuberculosis. METHODS: The validity of the RT-PCR hybridization probes was evaluated compared to a composite reference method by a cross-sectional study at the Hospital Universitario de la Samaritana. 40 adults with lymphocytic pleural effusion were included. Pleural tuberculosis was confirmed (in 9 patients) if the patient had at least one of three tests using the positive reference method: Ziehl-Neelsen or Mycobacterium tuberculosis culture in fluid or pleural tissue, or pleural biopsy with granulomas. Pleural tuberculosis was ruled out (in 31 patients) if all three tests were negative. The operating characteristics of the RT-PCR, using the Mid-P Exact Test, were determined using the OpenEpi 2.3 Software (2009). RESULTS: The RT-PCR hybridization probes showed a sensitivity of 66.7% (95% CI: 33.2%-90.7%) and a specificity of 93.5% (95% CI: 80.3%-98.9%). The PPV was 75.0% (95% CI: 38.8%-95.6%) and a NPV of 90.6% (95% CI: 76.6%-97.6%). Two false positives were found for the test, one with pleural mesothelioma and the other with chronic pleuritis with mesothelial hyperplasia. CONCLUSIONS: The RT-PCR hybridization probes had good specificity and acceptable sensitivity, but a negative value cannot rule out pleural tuberculosis.

INTRODUCCIÓN: El diagnóstico de tuberculosis pleural requiere un método de referencia invasivo y demorado. La reacción en cadena de la polimerasa es rápida, pero su validación en tuberculosis pleural aún es débil. OBJETIVO: Establecer las características operativas de la reacción en cadena de la polimerasa en tiempo real (RT-PCR) sondas de hibridación para el diagnóstico de tuberculosis pleural. MÉTODOS: Se evaluó la validez de la RT-PCR sondas de hibridación comparada con un método de referencia compuesto mediante un estudio transversal en el Hospital Universitario de la Samaritana. Se incluyeron 40 adultos con derrame pleural linfocitario. Tuberculosis pleural fue confirmada (en 9 pacientes) si el paciente tenía mínimo una de tres pruebas del método de referencia positiva: Ziehl-Neelsen o cultivo para Mycobacterium tuberculosis en líquido o tejido pleural, o biopsia pleural con granulomas; se descartó tuberculosis pleural (en 31 pacientes) si las tres pruebas eran negativas. Se determinaron las características operativas de la RT-PCR, mediante la Prueba Mid-P Exact, con el Software OpenEpi 2.3 (2009). RESULTADOS: La RT-PCR sondas de hibridación mostró una sensibilidad del 66.7% (IC 95%: 33.2%-90.7%) y una especificidad del 93.5% (IC 95%: 80.3%-98.9%). El VPP fue de 75.0% (IC 95%: 38.8%-95.6%) y un VPN de 90.6% (IC 95%: 76.6%-97.6%). Se encontraron dos falsos positivos para la prueba, uno con mesotelioma pleural y otro con pleuritis crónica con hiperplasia mesotelial. CONCLUSIONES: La RT-PCR sondas de hibridación tuvo una buena especificidad y una aceptable sensibilidad, pero un valor negativo no puede descartar tuberculosis pleural.

Accuracy and reliability of the sensory test performed using the laryngopharyngeal endoscopic esthesiometer and rangefinder in patients with suspected obstructive sleep apnoea hypopnoea: protocol for a prospective double-blinded, randomised, exploratory study.

INTRODUCTION: Patients with obstructive sleep apnoea hypopnoea syndrome (OSA) might have varying degrees of laryngopharyngeal mechanical hyposensitivity that might impair the brain's capacity to prevent airway collapse during sleep. However, this knowledge about sensory compromises in OSA comes from studies performed using methods with little evidence of their validity. Hence, the purpose of this study is to assess the reliability and accuracy of the measurement of laryngopharyngeal mechanosensitivity in patients with OSA using a recently developed laryngopharyngeal endoscopic esthesiometer and rangefinder (LPEER). METHODS AND ANALYSIS: The study will be prospective and double blinded, with a randomised crossover assignment of raters performing the sensory tests. Subjects will be recruited from patients with suspected OSA referred for baseline polysomnography to a university hospital sleep laboratory. Intra-rater and inter-rater reliability will be evaluated using the Bland-Altman's limits of agreement plot, the intraclass correlation coefficient, and the Pearson or Spearman correlation coefficient, depending on the distribution of the variables. Diagnostic accuracy will be evaluated plotting ROC curves using standard baseline polysomnography as a reference. The sensory threshold values ​​for patients with mild, moderate and severe OSA will be determined and compared using ANOVA or the Kruskal-Wallis test, depending on the distribution of the variables. The LPEER could be a new tool for evaluating and monitoring laryngopharyngeal sensory impairment in patients with OSA. If it is shown to be valid, it could help to increase our understanding of the pathophysiological mechanisms of this condition and potentially help in finding new therapeutic interventions for OSA. ETHICS AND DISSEMINATION: The protocol has been approved by the Institutional Review Board of Fundacion Neumologica Colombiana. The results will be disseminated through conference presentations and peer-reviewed publication. TRIAL REGISTRATION: This trial was registered at Clinical Trials Accuracy of the sensory test using the lLaryngopharyngeal endoscopic esthesiometer in obstructive sleep apnea. Protocol ID: 201611-22405. ClinicalTrials.gov ID: NCT03109171.

Diagnostic accuracy of nasal cannula versus microphone for detection of snoring.

OBJECTIVE: Snoring is a common reason for referral to a sleep unit. Although there are several instruments to measure snoring, there is no gold standard for this purpose. In this study, we determine the diagnostic accuracy of the cannula as compared with the microphone, which are the two most commonly used tools. STUDY DESIGN: We performed a cross-sectional study of 75 patients who underwent baseline home sleep apnea testing for any reason. METHODS: Snore intensity and percentage were assessed during Home sleep-apnea testing via nasal cannula and microphone in all patients. We performed a complete diagnostic accuracy analysis, assuming the microphone to be the reference instrument use in order to compare it with the cannula. RESULTS: The intra-class correlation coefficient between the cannula and microphone for the percentage of snoring was 0.25. The Bland Bland-Altman analysis to determine the agreement regarding the percentage of snoring showed a lower limit of -57.73 and an upper limit of 20.30. A linear regression analysis of the differences produced a negative slope of -0.86. The receiver operating characteristic curve for severe snoring using the cannula produced an area under the curve of 0.67 (P = 0.019). The cannula showed a sensitivity of 57.89 and a specificity of 73.21. CONCLUSION: The nasal cannula showed poor reliability and accuracy for measuring snoring. LEVEL OF EVIDENCE: 2b. Laryngoscope, 127:2886-2890, 2017.

Real-time PCR assay for the diagnosis of pleural tuberculosis / Reacción en cadena de la polimerasa en tiempo real para el diagnóstico de tuberculosis pleural

Abstract Introduction: The diagnosis of pleural tuberculosis requires an invasive and time-consuming reference method. Polymerase chain reaction (PCR) is rapid, but validation in pleural tuberculosis is still weak. Objective: To establish the operating characteristics of real-time polymerase chain reaction (RT-PCR) hybridization probes for the diagnosis of pleural tuberculosis. Methods: The validity of the RT-PCR hybridization probes was evaluated compared to a composite reference method by a cross-sectional study at the Hospital Universitario de la Samaritana. 40 adults with lymphocytic pleural effusion were included. Pleural tuberculosis was confirmed (in 9 patients) if the patient had at least one of three tests using the positive reference method: Ziehl-Neelsen or Mycobacterium tuberculosis culture in fluid or pleural tissue, or pleural biopsy with granulomas. Pleural tuberculosis was ruled out (in 31 patients) if all three tests were negative. The operating characteristics of the RT-PCR, using the Mid-P Exact Test, were determined using the OpenEpi 2.3 Software (2009). Results: The RT-PCR hybridization probes showed a sensitivity of 66.7% (95% CI: 33.2%-90.7%) and a specificity of 93.5% (95% CI: 80.3%-98.9%). The PPV was 75.0% (95% CI: 38.8%-95.6%) and a NPV of 90.6% (95% CI: 76.6%-97.6%). Two false positives were found for the test, one with pleural mesothelioma and the other with chronic pleuritis with mesothelial hyperplasia. Conclusions: The RT-PCR hybridization probes had good specificity and acceptable sensitivity, but a negative value cannot rule out pleural tuberculosis.

Resumen Introducción: El diagnóstico de tuberculosis pleural requiere un método de referencia invasivo y demorado. La reacción en cadena de la polimerasa es rápida, pero su validación en tuberculosis pleural aún es débil. Objetivo: Establecer las características operativas de la reacción en cadena de la polimerasa en tiempo real (RT-PCR) sondas de hibridación para el diagnóstico de tuberculosis pleural. Métodos: Se evaluó la validez de la RT-PCR sondas de hibridación comparada con un método de referencia compuesto mediante un estudio transversal en el Hospital Universitario de la Samaritana. Se incluyeron 40 adultos con derrame pleural linfocitario. Tuberculosis pleural fue confirmada (en 9 pacientes) si el paciente tenía mínimo una de tres pruebas del método de referencia positiva: Ziehl-Neelsen o cultivo para Mycobacterium tuberculosis en líquido o tejido pleural, o biopsia pleural con granulomas; se descartó tuberculosis pleural (en 31 pacientes) si las tres pruebas eran negativas. Se determinaron las características operativas de la RT-PCR, mediante la Prueba Mid-P Exact, con el Software OpenEpi 2.3 (2009). Resultados: La RT-PCR sondas de hibridación mostró una sensibilidad del 66.7% (IC 95%: 33.2%-90.7%) y una especificidad del 93.5% (IC 95%: 80.3%-98.9%). El VPP fue de 75.0% (IC 95%: 38.8%-95.6%) y un VPN de 90.6% (IC 95%: 76.6%-97.6%). Se encontraron dos falsos positivos para la prueba, uno con mesotelioma pleural y otro con pleuritis crónica con hiperplasia mesotelial. Conclusiones: La RT-PCR sondas de hibridación tuvo una buena especificidad y una aceptable sensibilidad, pero un valor negativo no puede descartar tuberculosis pleural.

Accuracy of endoscopic and videofluoroscopic evaluations of swallowing for oropharyngeal dysphagia.

OBJECTIVES: A systematic review and meta-analysis of the literature was conducted to compare the accuracy with which flexible endoscopic evaluation of swallowing (FEES) and videofluoroscopic swallowing study (VFSS) assessed oropharyngeal dysphagia in adults. DATA SOURCES: PubMed, Embase, and the Latin American and Caribbean Health Sciences Literature (LILACS) database. METHODS: A review of published studies was conducted in parallel by two groups of researchers. We evaluated the methodological quality, homogeneity, threshold effect, and publication bias. The results are presented as originally published, then with each test compared against the other as a reference and both compared against a composite reference standard, and then pooled using a random effects model. Software use consisted of Meta-DiSc and SPSS. RESULTS: The search yielded 5,697 articles. Fifty-two articles were reviewed in full text, and six articles were included in the meta-analysis. FEES showed greater sensitivity than VFSS for aspiration (0.88 vs. 0.77; P = .03), penetration (0.97 vs. 0.83; P = .0002), and laryngopharyngeal residues (0.97 vs. 0.80; P < .0001). Sensitivity to detect pharyngeal premature spillage was similar for both tests (VFSS: 0.80; FEES: 0.69; P = .28). The specificities of both tests were similar (range, 0.93-0.98). In the sensitivity analysis there were statistically significant differences between the tests regarding residues but only marginally significant differences regarding aspiration and penetration. CONCLUSIONS: FEES had a slight advantage over VFSS to detect aspiration, penetration, and residues. Prospective studies comparing both tests against an appropriate reference standard are needed to define which test has greater accuracy. LEVEL OF EVIDENCE: 2a Laryngoscope, 127:2002-2010, 2017.

Validation of the Spanish Version of the Eating Assessment Tool-10 (EAT-10spa) in Colombia. A Blinded Prospective Cohort Study.

Dysphagia might affect 12 % of the general population, and its complications include pneumonia, malnutrition, social isolation, and death. No validated Spanish symptom survey exists to quantify dysphagia symptoms among Latin Americans. Therefore, we performed a prospective cohort study in a tertiary care university hospital to validate the Spanish version of the 10-Item Eating-Assessment-Tool (EAT-10spa) for use in Colombia. After an interdisciplinary committee of five bilingual specialists evaluated the EAT-10spa (translated and validated in Spain) and deemed it appropriate for the Colombian culture, its feasibility, reliability, validity, sensitivity to change, and diagnostic capacity were evaluated. As a reference standard, we used the flexible endoscopic evaluation of swallowing with sensory testing and a standardized clinical evaluation. All assessments were blinded. In total, 133 subjects were included (52 % women, mean age 55 years) and completed the EAT-10spa (median completion time: 2 min [IQR 1-3 min]), 39 % of whom had an elementary-level education. Cronbach's α coefficient: 0.91; test-retest intra-class correlation coefficient: 0.94. The Spearman's correlation coefficient of the EAT-10spa with the 8-point penetration-aspiration scale was 0.54 (P < 0.001). The area under the receiver-operating-characteristic-curve (AUC-ROC) for dysphagia and aspiration were 0.79 (P < 0.001) and 0.81 (P < 0.001), respectively. The best cut-off points for dysphagia and aspiration were EAT-10spa ≥2 (sensitivity 93.6 %, specificity 36.4 %) and EAT-10spa ≥4 (sensitivity 94.3 %, specificity 49.5 %), respectively. A reduction in the EAT-10 ≥3 was the best cut-off point for a clinically significant improvement (AUC-ROC 0.83; P < 0.0001). The EAT-10spa showed excellent psychometric properties and discriminatory capacity for use in Colombia.

Escalas de calidad de vida y valoración de los síntomas en disfagia / Scales of quality of life and assessment of symptoms in dysphagia / Escalas de qualidade de vida e avaliação dos síntomas em disfagia

La disfagia es un síntoma que tiene repercusiones en la calidad de vida de cualquier individuo que la padezca. Asimismo puede asociarse a varias complicaciones respiratorias y nutricionales que van a impactar en los diferentes ámbitos psicosociales. Por esta razón se han establecido parámetros para evaluar la calidad de vida de los pacientes con este diagnóstico. Por otro lado es importante reconocer los síntomas que caracterizan la disfagia para que ésta sea detectada de manera oportuna por el personal de salud. Es por ello que también se han desarrollado escalas para este fin. Las escalas de calidad de vida y de evaluación de síntomas son instrumentos de evaluación importantes porque proporcionan información valiosa al médico tratante acerca de la percepción del estado de salud actual del paciente, los síntomas clave y los efectos de la intervención terapéutica. En este trabajo se describen las características y propiedades psicométricas de los instrumentos existentes para la evaluación de la calidad de vida y la valoración de los síntomas de los pacientes con disfagia.

Dysphagia it is a symptom with repercussions in life quality of any individual who suffer it. In the same way, it could be related to many respiratory and nutritional complications that will have an impact in different psychosocial aspects. For this reason it has been established parameters in order to evaluate the life quality of the patients with this condition. On the other hand, it is important to recognize the characteristic symptoms of dysphagia in order to be detected appropriately by the health community, for which reason has been also the development of scales. The life quality scales and the evaluation of symptoms are important instruments because provides valuable information to the doctor in charge about the perception of the current health condition of the patients, the key symptoms and the effects of a therapeutic intervention. In this paper we describe the characteristics and psychometric properties of the instruments available to the evaluation of life quality and the assessment of the symptoms of the patients with dysphagia.

A disfagia é um sintoma que tem repercussão na qualidade da vida de qualquer pessoa que sofra dela. Assim mesmo pode estar associada com algumas complicações respiratórias y nutricionais que impactaram nos diferentes âmbitos psicossociais. Por essa ração estabeleceram-se parâmetros para avaliar a qualidade de vida dos pacientes com esse diagnóstico. Por outro lado é importante reconhecer os sintomas que caracterizam a disfagia para que esta seja detectada de maneira oportuna pelo equipe de saúde. É por ele que também se tem desenvolvido escalas para isso. As escalas de qualidade de vida e de evacuação de sintomas são instrumentos de avaliação importantes por que dão informação valiosa ao médico encargado da percepção do estado de saúde do paciente, os sintomas chaves e os efeitos da intervenção terapêutica. Este paper descreve as características e propriedades psicométricas dos instrumentos para avaliação da qualidade da vida e valoração dos sintomas dos pacientes com disfagia.

Muerte, eutanasia y cuidados paliativos / Death, Euthanasia and Palliative Care

La persona humana posee, en potencia o en acto, una inteligencia capaz de realizar operaciones abstractas; una voluntad capaz de amar el bien, y una libertad que le permite determinar su manera de obrar (o de no obrar). Estas características, inherentes al ser de la persona humana, se derivan de la unidad sustancial que existe entre el alma espiritual y el cuerpo, y la dotan de una dignidad especial que debe reflejarse en la forma como afronta toda su existencia, y como es tratada y respetada por los demás.En efecto, la dignidad de la persona humana le confiere unos derechos y deberes entre los cuales se encuentra, de manera primordial, el respeto incondicionado a la vida humana inocente (tanto propia como ajena). Por este motivo, la muerte del ser humano y el periodo próximo a la misma requieren de un profundo respeto y de un tratamiento acorde con esa dignidad, que le permitan afrontar esta etapa con el máximo decoro e integridad.Mientras que la eutanasia representa una manera de afrontar la muerte que desconoce la inviolabilidad de la vida humana y, por tanto, atenta contra la dignidad de la persona, los cuidados paliativos hoy día cuentan con herramientas muy eficaces para aliviar el sufrimiento y acompañar al ser humano en esta crucial etapa de la vida en consonancia con la dignidad de la que está revestido.