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BACKGROUND: Xpert MTB/RIF Ultra (Ultra) is an automated molecular test for the detection of Mycobacterium tuberculosis in sputum. We compared the sensitivity of Ultra to that of mycobacterial growth indicator tube (MGIT) liquid culture, considered the most sensitive assay in routine clinical use. METHODS: In this prospective, multicentre, cross-sectional diagnostic accuracy study, we used a non-inferiority design to assess whether the sensitivity of a single Ultra test was non-inferior to that of a single liquid culture for detection of M tuberculosis in sputum. We enrolled adults (age ≥18 years) with pulmonary tuberculosis symptoms in 11 countries and each adult provided three sputum specimens with a minimum volume of 2 mL over 2 days. Ultra was done directly on sputum 1, and Ultra and MGIT liquid culture were done on resuspended pellet from sputum 2. Results of MGIT and solid media cultures done on sputum 3 were considered the reference standard. The pre-defined non-inferiority margin was 5·0%. FINDINGS: Between Feb 18, 2016, and Dec 4, 2019, we enrolled 2906 participants. 2600 (89%) participants were analysed, including 639 (25%) of 2600 who were positive for tuberculosis by the reference standard. Of the 2357 included in the non-inferiority analysis, 877 (37%) were HIV-positive and 984 (42%) were female. Sensitivity of Ultra performed directly on sputum 1 was non-inferior to that of sputum 2 MGIT culture (MGIT 91·1% vs Ultra 91·9%; difference -0·8 percentage points; 95% CI -2·8 to 1·1). Sensitivity of Ultra performed on sputum 2 pellet was also non-inferior to that of sputum 2 MGIT (MGIT 91·1% vs Ultra 91·9%; difference -0·8 percentage points; -2·7 to 1·0). INTERPRETATION: For the detection of M tuberculosis in sputum from adults with respiratory symptoms, there was no difference in sensitivity of a single Ultra test to that of a single MGIT culture. Highly sensitive, rapid molecular approaches for M tuberculosis detection, combined with advances in genotypic methods for drug resistance detection, have potential to replace culture. FUNDING: US National Institute of Allergy and Infectious Diseases.
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Mycobacterium tuberculosis , Esputo , Tuberculosis Pulmonar , Humanos , Mycobacterium tuberculosis/aislamiento & purificación , Mycobacterium tuberculosis/genética , Mycobacterium tuberculosis/crecimiento & desarrollo , Esputo/microbiología , Adulto , Femenino , Masculino , Estudios Transversales , Estudios Prospectivos , Persona de Mediana Edad , Tuberculosis Pulmonar/diagnóstico , Tuberculosis Pulmonar/microbiología , Sensibilidad y Especificidad , Técnicas de Diagnóstico Molecular/métodos , Técnicas de Diagnóstico Molecular/normas , Adulto Joven , AncianoRESUMEN
Background: The NOVA Tuberculosis Total Antibody Rapid Test is a commercially available lateral flow serological assay that is intended to be used as an aid in the diagnosis of tuberculosis. We conducted a study to estimate diagnostic accuracy of this assay for diagnosis of active pulmonary tuberculosis disease and for detection of M. tuberculosis infection. Methods: This study used existing frozen plasma specimens that had been obtained previously from consenting HIV-negative adults in Cambodia, South Africa, and Vietnam whose tuberculosis status was rigorously characterized using sputum mycobacterial cultures and blood interferon gamma release assay. The investigational assay was performed in a single laboratory by laboratory staff specifically trained to conduct the assays according to the manufacturer's procedures. In addition, intensity of the test band was subjectively assessed. Results: Plasma specimens from 150 participants were tested. All testing attempts yielded a determinate result of either positive or negative. For diagnosis of active pulmonary tuberculosis disease, test sensitivity and specificity were 40.0 % (20/50, 95 % confidence interval [CI] 27.6 % to 53.8 %) and 85.0 % (95 % CI 76.7 % to 90.7 %), respectively. For detection of M. tuberculosis infection, test sensitivity and specificity were 28.0 % (95 % CI 20.5 % to 37.2 %) and 86.0 % (95 % CI 73.8 % to 93.0 %), respectively. Among the 35 positive tests, no statistically significant band intensity trend was found across participant groups (p = 0.17). Conclusion: Study findings do not support a role for the NOVA Tuberculosis Test in current tuberculosis diagnostic algorithms.
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We present a case of a 32-year-old female presenting with shortness of breath and increasing oxygen requirements. Further imaging discovered a large mass extending circumferentially into the pericardium, cardiac wall, and chambers, involving the anterior and middle mediastinum. Direct tissue biopsy of the mass for a diagnosis was unsafe. Therefore, advanced flow cytometric analysis for tumor marker expression of the malignant effusion was used to differentiate the mass as a vascular sarcoma, consistent with cardiac angiosarcoma. Additionally, cytometric analysis for programmed cell death protein 1 (PD1), programmed death-ligand 1 (PDL1), and cytotoxic T-lymphocyte-associated antigen 4 (CTLA4) was also performed; a study seldom investigated for angiosarcomas but may have advantages over immunohistochemical analysis.
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Heart failure with recovered ejection fraction (HFrecEF) involves those who have previously had reduced cardiac function that has subsequently improved. However, there is not a single definition of this phenomenon and recovery of cardiac function in terms of left ventricular ejection fraction (LVEF) itself does not necessarily correlate with remission from the detrimental physiology of heart failure (HF) and its consequences. There is also the question of the utility of defibrillators in these patients, and whether they should be replaced at the time of battery depletion. To address this, several studies have shown specific predictors of ensuing LVEF recovery, including patient demographics, co-morbidities, and medication use, as well as predictors of ventricular arrhythmias (VA) following LVEF recovery. Recent studies have also shown novel imaging parameters that may aid in predicting which patients would have a higher risk of these arrhythmias. Additional data describe a small, yet appreciable risk of VA, in addition to appropriate shocks as well. In this review, we describe predictors of LVEF recovery, carefully analyse and characterize the continued risk for VA and appropriate shocks following LVEF recovery, and explore additional novel modalities that may aid in decision-making.
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Insuficiencia Cardíaca , Función Ventricular Izquierda , Arritmias Cardíacas , Desfibriladores , Insuficiencia Cardíaca/terapia , Humanos , Volumen Sistólico/fisiología , Función Ventricular Izquierda/fisiologíaRESUMEN
BACKGROUND: Point-of-care cardiac ultrasound (cardiac POCUS) has potential to become a useful tool for improving cardiovascular care in Tanzania. We conducted a pilot program to train clinicians at peripheral health centers to obtain and interpret focused cardiac POCUS examinations using a hand-held portable device. METHODS: Over a 5-day period, didactic and experiential methods were used to train clinicians to conduct a pre-specified scanning protocol and recognize key pathologies. Pre- and post-training knowledge and post-training image acquisition competency were assessed. In their usual clinical practices, trainees then scanned patients with cardiovascular signs/symptoms, recorded a pre-specified set of images for each scan, and documented their interpretation as to presence or absence of key pathologies on a case report form. A cardiologist subsequently reviewed all images, graded them for image quality, and then documented their interpretation of key pathologies in a blinded fashion; the cardiologist interpretation was considered the gold standard. RESULTS: 8 trainees (6 Clinical Officers, 1 Assistant Medical Officer, and 1 Medical Doctor) initiated and completed the training. Trainees subsequently performed a total of 429 cardiac POCUS examinations in their clinical practices over a 9 week period. Stratified by trainee, the median percent of images that were of sufficient quality to be interpretable was 76.7% (range 18.0-94.2%). For five of eight trainees, 75% or more of images were interpretable. For detection of pre-specified key pathologies, kappa statistics for agreement between trainee and cardiologist ranged from - 0.03 (no agreement) for detection of pericardial effusion to 0.42 (moderate agreement) for detection of tricuspid valve regurgitation. Mean kappa values across the key pathologies varied by trainee from 0 (no agreement) to 0.32 (fair agreement). CONCLUSIONS: The 5-day training program was sufficient to train most clinicians to obtain basic cardiac images but not to accurately interpret them. Proficiency in image interpretation may require a more intensive training program.
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Ecocardiografía , Educación Médica Continua , Cardiopatías/diagnóstico por imagen , Capacitación en Servicio , Pruebas en el Punto de Atención , Adulto , Competencia Clínica , Estudios de Factibilidad , Femenino , Humanos , Aprendizaje , Masculino , Persona de Mediana Edad , Variaciones Dependientes del Observador , Valor Predictivo de las Pruebas , Evaluación de Programas y Proyectos de Salud , Reproducibilidad de los Resultados , TanzaníaRESUMEN
BACKGROUND: Patient-provider communication is critical for engaging and retaining people living with HIV in care, especially among medically case-managed patients in need of service coordination and adherence support. Expanding patient-provider communication channels to include mobile health modalities, such as text messaging and video calling, has the potential to facilitate communication and ultimately improve clinical outcomes. However, the implementation of these communication modalities in clinical settings has not been well characterized. OBJECTIVE: The purpose of this study is to understand patient and provider perspectives on the acceptability of and preferences for using text messaging and video calling as a means of communication; perceived factors relevant to adoption, appropriateness, and feasibility; and organizational perspectives on implementation within an HIV clinic in South Carolina. METHODS: We conducted 26 semistructured in-depth interviews among patients receiving case management services (n=12) and clinic providers (n=14) using interview guides and content analysis informed by the Proctor taxonomy of implementation outcomes and the Consolidated Framework for Implementation Research. Participants were purposefully sampled to obtain maximum variation in terms of age and gender for patients and clinic roles for providers. The data were analyzed using quantitative and qualitative content analyses. RESULTS: Most patients (11/12, 92%) and providers (12/14, 86%) agreed that they should have the capacity to text message and/or video call each other. Although consensus was not reached, most preferred using a secure messaging app rather than standard text messaging because of the enhanced security features. Perceived benefits to adoption included the added convenience of text messaging, and potential barriers included the cost and access of smartphone-based technology for patients. From an organizational perspective, some providers were concerned that offering text messaging could lead to unreasonable expectations of instant access and increased workload. CONCLUSIONS: Patients and providers perceived text messaging and video calling as acceptable, appropriate, and feasible and felt that these expanded modes of communication could help meet patients' needs while being safe and not excessively burdensome. Although patients and providers mostly agreed on implementation barriers and facilitators, several differences emerged. Taking both perspectives into account when using implementation frameworks is critical for expanding mobile health-based communication, especially as implementation requires active participation from providers and patients.
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BACKGROUND: Hepatitis C virus (HCV) infection is under-recognized among US adults and children. Prenatal HCV screening may help close the diagnosis gap among women while also identifying at-risk infants. Current surveillance efforts for maternal HCV rely primarily on birth certificate data. We sought a more accurate assessment of HCV prevalence among pregnant women in Ohio by combining existing public health surveillance data. METHODS: Vital Statistics (VS) birth certificate data and Ohio Disease Reporting System (ODRS) HCV case data, both available through the Ohio Department of Health, were linked to determine rates of past or present HCV infection among women giving birth from 2012 to 2015 in Ohio, overall and by county. Among women with available test results, the proportion with present HCV infection indicated by detectable viraemia during pregnancy was calculated. RESULTS: Birth certificate data identified 4695 deliveries to women with past/present HCV infection during the study period. Linkage to ODRS revealed an additional 1778 deliveries to women with past/present infection, including 355 with confirmed viraemia during pregnancy. The prevalence of past/present HCV among pregnant women in Ohio rose from 0.82% in 2012 to 1.54% in 2015. CONCLUSIONS: Maternal HCV infection is under-recognized and increasing in prevalence. Current case identification processes are inadequate in pregnancy, even among women with prior positive HCV testing. Alternative approaches, including enhanced risk factor-based screening or universal prenatal screening in high prevalence settings, are needed to improve rates of HCV recognition among reproductive-aged women and newborns at risk of vertical transmission.