Study of the Diagnostic Delay of Tuberculosis in Spain / Estudio del retraso diagnóstico de la tuberculosis en España

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Evaluación del Programa Integrado de Investigación en Tuberculosis promovido por la sociedad española de Neumología y Cirugía Torácica tras 11 años de funcionamiento / Evaluation of the Integrated Tuberculosis Research Program Sponsored by the Spanish Society of Pulmonology and Thoracic Surgery: 11 Years on

OBJETIVO: El objetivo del estudio fue conocer la tendencia de las variables relacionadas con la tuberculosis (TB) en España a partir del registro del Programa Integrado de Investigación en Tuberculosis (PII-TB) de la Sociedad Española de Neumología y Cirugía Torácica (SEPAR) y evaluar el PII-TB mediante indicadores relacionados con sus objetivos científicos. MÉTODO: Estudio transversal multicéntrico de base poblacional de casos nuevos de TB registrados prospectivamente por el PII-TB entre 2006 y 2016. La tendencia temporal de variables cuantitativas se realizó mediante un modelo de regresión lineal y las cualitativas mediante la prueba de χ2 de tendencia lineal. RESULTADOS: Se analizaron 6.892 casos de TB con una mediana anual de 531. La tendencia general fue significativamente decreciente en mujeres, inmigrantes, privados de libertad y en tratados inicialmente con 3 fármacos. Se incrementaron significativamente la tendencia de grupos de 40 -50 años y > 50 años, primera atención por especialista de zona, hospitalización, retraso diagnóstico, localización diseminada y extrapulmonar única, cultivo (+), realización de antibiogramas, resistencia a fármacos, tratamiento directamente observado, prolongación del tratamiento y muerte por otra causa. Los objetivos científicos del PII-TB que incrementaron significativamente fueron las publicaciones alcanzando un máximo de 8 en 2016 y con un factor de impacto total de 49,664, y también mejoraron los proyectos iniciados anualmente, presentaciones en congresos y las tesis o tesinas. CONCLUSIONES: El PII-TB proporciona información relevante sobre la TB y sus factores asociados en España. Se ha formado un amplio equipo de investigadores y se han detectado aspectos científicos positivos y otros mejorables

OBJECTIVE: The objective of the study was to determine the trend of variables related to tuberculosis (TB) from the Integrated Tuberculosis Research Program (PII-TB) registry of the Spanish Society of Pulmonology and Thoracic Surgery (SEPAR), and to evaluate the PII-TB according to indicators related to its scientific objectives. METHOD: Cross-sectional, population-based, multicenter study of new TB cases prospectively registered in the PII-TB between 2006 and 2016. The time trend of quantitative variables was calculated using a lineal regression model, and qualitative variables using the χy test for lineal trend. RESULTS: A total of 6,892 cases with an annual median of 531 were analyzed. Overall, a significant downward trend was observed in women, immigrants, prisoners, and patients initially treated with 3 drugs. Significant upward trends were observed in patients aged 40-50 and > 50 years, first visit conducted by a specialist, hospitalization, diagnostic delay, disseminated disease and single extrapulmonary location, culture (+), sensitivity testing performed, drug resistance, directly observed treatment, prolonged treatment, and death from another cause. The scientific objectives of the PII-TB that showed a significant upward trend were publications, which reached a maximum of 8 in 2016 with a total impact factor of 49,664, numbers of projects initiated annually, presentations at conferences, and theses. CONCLUSIONS: PII-TB provides relevant information on TB and its associated factors in Spain. A large team of researchers has been created; some scientific aspects of the registry were positive, while others could have been improved

Evaluation of the Integrated Tuberculosis Research Program Sponsored by the Spanish Society of Pulmonology and Thoracic Surgery: 11 Years on. / Evaluación del Programa Integrado de Investigación en Tuberculosis promovido por la sociedad española de Neumología y Cirugía Torácica tras 11 años de funcionamiento.

OBJECTIVE: The objective of the study was to determine the trend of variables related to tuberculosis (TB) from the Integrated Tuberculosis Research Program (PII-TB) registry of the Spanish Society of Pulmonology and Thoracic Surgery (SEPAR), and to evaluate the PII-TB according to indicators related to its scientific objectives. METHOD: Cross-sectional, population-based, multicenter study of new TB cases prospectively registered in the PII-TB between 2006 and 2016. The time trend of quantitative variables was calculated using a lineal regression model, and qualitative variables using the χy test for lineal trend. RESULTS: A total of 6,892 cases with an annual median of 531 were analyzed. Overall, a significant downward trend was observed in women, immigrants, prisoners, and patients initially treated with 3 drugs. Significant upward trends were observed in patients aged 40-50 and > 50 years, first visit conducted by a specialist, hospitalization, diagnostic delay, disseminated disease and single extrapulmonary location, culture(+), sensitivity testing performed, drug resistance, directly observed treatment, prolonged treatment, and death from another cause. The scientific objectives of the PII-TB that showed a significant upward trend were publications, which reached a maximum of 8 in 2016 with a total impact factor of 49,664, numbers of projects initiated annually, presentations at conferences, and theses. CONCLUSIONS: PII-TB provides relevant information on TB and its associated factors in Spain. A large team of researchers has been created; some scientific aspects of the registry were positive, while others could have been improved.

Safety and efficacy of the C-Tb skin test to diagnose Mycobacterium tuberculosis infection, compared with an interferon γ release assay and the tuberculin skin test: a phase 3, double-blind, randomised, controlled trial.

BACKGROUND: Targeted screening and treatment of Mycobacterium tuberculosis infection substantially reduces the risk of developing active tuberculosis. C-Tb (Statens Serum Institute, Copenhagen, Denmark) is a novel specific skin test based on ESAT-6 and CFP10 antigens. We investigated the safety and diagnostic potential of C-Tb compared with established tests in the contact-tracing setting. METHODS: Negative controls, close contacts, occasional contacts, and patients with active pulmonary tuberculosis were enrolled at 13 centres in Spain. We compared C-Tb with the QuantiFERON-TB Gold In-Tube ([QFT] Qiagen, Hilden, Germany) interferon γ release assay (IGRA) and the purified protein derivative (PPD) RT 23 tuberculin skin test ([TST] Statens Serum Institute). All participants older than 5 years were tested with QFT. Some participants in the negative control group received C-Tb without the TST to test for potential interactions between C-Tb and PPD RT 23. The rest were randomly assigned in blocks of ten and tested with both C-Tb and TST, with five in each block receiving injection of C-Tb in the right arm and the TST in the left arm and five vice versa. The primary and safety analyses were done in all participants randomly assigned to a group who received any test. This trial is registered with ClinicalTrials.gov, number NCT01631266, and with EudraCT, number 2011-005617-36. FINDINGS: From July 24, 2012, to Oct 2, 2014, 979 participants were enrolled, of whom 263 were negative controls, 299 were occasional contacts, 316 were close contacts, and 101 were patients with tuberculosis. 970 (99%) participants completed the trial. Induration sizes were similar for C-Tb and TST, but TST positivity was affected by BCG vaccination status. We found a strong positive trend towards C-Tb test positivity with increasing risk of infection, from 3% in negative controls to 16% in occasional contacts, to 43% in close contacts. C-Tb and QFT results were concordant in 785 (94%) of 834 participants aged 5 years and older, and results did not differ significantly between exposure groups. The safety profile of C-Tb was similar to that for the TST. INTERPRETATION: C-Tb delivered IGRA-like results in a field-friendly format. Being unaffected by BCG vaccination status, the C-Tb skin test might provide more accurate treatment guidance in settings where the TST is commonly used. FUNDING: Statens Serum Institut.

Costes de la tuberculosis en España: factores relacionados / Tuberculosis costs in Spain and related factors

Objetivo. Analizar los costes directos e indirectos derivados del diagnóstico y tratamiento de la tuberculosis (TB) y sus factores asociados. Pacientes y métodos. Estudio prospectivo de pacientes diagnosticados de TB entre septiembre de 2014 y septiembre de 2015. Se calcularon los costes directos (estancias hospitalarias, consultas, estudios diagnósticos y tratamiento), e indirectos (absentismo laboral y pérdida de productividad, estudio de contactos y medidas rehabilitadoras). Los costes se compararon atendiendo a las variables: edad, sexo, país de origen, ingreso hospitalario, pruebas diagnósticas, tratamiento, resistencia farmacológica, tratamiento directamente observado (TDO) y días de baja laboral. Se compararon proporciones mediante Chi cuadrado y las variables significativas se incluyeron en un modelo de regresión logística calculándose las odds ratio (OR) y sus correspondientes intervalos de confianza del 95% (IC). Resultados. Fueron incluidos 319 pacientes con una edad media de 56,72 ± 20,79 €. El coste medio fue de 10.262,62 ± 14.961,66 €, y aumentaba significativamente en relación con el ingreso hospitalario, el uso de la PCR, la realización de baciloscopia y cultivo, antibiograma, tomografía axial computarizada de tórax, biopsia pleural, tratamiento de más de 9 meses, TDO y baja laboral. En el análisis multivariante mantenían asociación independiente: ingreso hospitalario (OR = 96,8; IC: 29-472,3), antibiograma (OR = 4,34; IC: 1,71-12,1), tomografía axial computarizada de tórax (OR = 2,25; IC: 1,08-4,77), TDO (OR = 20,76; IC: 4,11-148) y baja laboral (OR = 26,9; IC: 8,51-122). Conclusión. La Tuberculosis acarrea un gasto sanitario significativo. Medidas dirigidas a mejorar el control de la enfermedad y disminuir los ingresos hospitalarios serían importantes para reducirlo

Objective. To analyze the direct and indirect costs of diagnosis and management of tuberculosis (TB) and associated factors. Patients and methods. Prospective study of patients diagnosed with TB between September 2014 and September 2015. We calculated direct (hospital stays, visits, diagnostic tests, and treatment) and indirect (sick leave and loss of productivity, contact tracing, and rehabilitation) costs. The following cost-related variables were compared: age, gender, country of origin, hospital stays, diagnostic testing, sensitivity testing, treatment, resistance, directed observed therapy (DOT), and days of sick leave. Proportions were compared using the chi-squared test and significant variables were included in a logistic regression analysis to calculate odds ratio (OR) and corresponding 95% confidence intervals. Results. 319 patients were included with a mean age of 56.72 ± 20.79 years. The average cost was €10,262.62 ± 14,961.66, which increased significantly when associated with hospital admission, polymerase chain reaction, sputum smears and cultures, sensitvity testing, chest computed tomography, pleural biopsy, drug treatment longer than nine months, DOT and sick leave. In the multivariate analysis, hospitalization (OR = 96.8; CI 29-472), sensitivity testing (OR = 4.34; CI 1.71-12.1), chest CT (OR = 2.25; CI 1.08-4.77), DOT (OR = 20.76; CI 4.11-148) and sick leave (OR = 26,9; CI 8,51-122) showed an independent association with cost. Conclusion. Tuberculosis gives rise to significant health spending. In order to reduce these costs, more control of transmission, and fewer hospital admissions would be required

Factors associated with smoking among tuberculosis patients in Spain.

BACKGROUND: To determine the prevalence of smoking and analyze associated factors in a cohort of patients diagnosed with tuberculosis (TB) in Spain between 2006 and 2013. METHODS: Multicenter, cross-sectional, descriptive, observational study using a national database of TB patients, using logistic regression to calculate odds ratios (OR) and confidence intervals (CI). RESULTS: We analyzed 5,846 cases (62 % men, mean age 39 years, 33 % foreigners). 23.4 % were alcohol abuser, 1.3 % were injected drug users (IDU), 4.6 % were co-infected with HIV, and 7.5 % had a history of TB treatment. 6.6 % and 0.8 % showed resistance to one and multiple drugs, respectively. The predominant clinical presentation was pulmonary (71 %) with a cavitary radiological pattern in 32.8 % of cases. 82 % of cases were confirmed microbiologically, and 54 % were smear-positive microscopy. 2,300 (39.3 %) patients were smokers. The following factors were associated with smoking: male sex (OR = 2.26;CI:1.97;2.60), Spanish origin (OR = 2.79;CI:2.40-3.24), alcoholism (OR = 2.85;CI:2.46;3.31), IDU (OR = 2.78;CI:1.48;5.52), homelessness (OR = 1.99;CI:1.14-3.57), pulmonary TB (OR = 1.61;CI:1.16;2.24), cavitary radiological pattern (OR = 1.99;CI:1.43;2.79) and a smear-positive microscopy at the time of diagnosis (OR = 1.39;CI:1.14;1.17). CONCLUSIONS: The prevalence of smoking among TB patients is high. Smokers with TB have a distinct sociodemographic, clinical, radiological and microbiological profile to non-smokers.

Sumario ejecutivo de la guía de práctica clínica sobre el uso de las pruebas de liberación de interferón-gamma para el diagnóstico de infección tuberculosa / Executive Summary of the Guidelines for the Use of interferon-gamma Release Assays in the Diagnosis of Tuberculosis Infection

El uso de las pruebas de liberación de interferón-gamma para el diagnóstico de la infección tuberculosa está muy generalizado en España. Sin embargo, no se ha alcanzado un consenso respecto a su aplicación en situaciones clínicas específicas. Con el fin de redactar una guía de empleo en la práctica clínica, un grupo de expertos que incluyó a especialistas en enfermedades infecciosas, enfermedades respiratorias, microbiología, pediatría y medicina preventiva, junto con un experto en metodología, efectuaron una búsqueda sistemática en la literatura, sintetizaron los resultados, calificaron la calidad de las evidencias y formularon recomendaciones de acuerdo con la metodología Grading of Recommendations of Assessment Development and Evaluations. Este documento es una guía basada en la evidencia para el empleo de las pruebas de liberación de interferón-gamma en el diagnóstico de la infección tuberculosa en pacientes en riesgo de padecer tuberculosis o en los que se sospeche enfermedad activa. La guía será aplicable tanto en atención primaria y especializada como en salud pública

Interferon-gamma release assays are widely used for the diagnosis of tuberculosis infection in Spain. However, there is no consensus on their application in specific clinical scenarios. To develop a guide-line for their use, a panel of experts comprising specialists in infectious diseases, respiratory diseases, microbiology, pediatrics and preventive medicine, together with a methodologist, conducted a systematic literature search, summarized the findings, rated the quality of the evidence, and formulated recommendations following the Grading of Recommendations of Assessment Development and Evaluations methodology. This document provides evidence-based guidance on the use of interferon-gamma release assays for the diagnosis of tuberculosis infection in patients at risk of tuberculosis or suspected of having active disease. The guidelines will be applicable to specialist and primary care, and public health

Executive Summary of the Guidelines for the Use of interferon-gamma Release Assays in the Diagnosis of Tuberculosis Infection. / Sumario ejecutivo de la guía de práctica clínica sobre el uso de las pruebas de liberación de interferón-gamma para el diagnóstico de infección tuberculosa.

Interferon-gamma release assays are widely used for the diagnosis of tuberculosis infection in Spain. However, there is no consensus on their application in specific clinical scenarios. To develop a guide-line for their use, a panel of experts comprising specialists in infectious diseases, respiratory diseases, microbiology, pediatrics and preventive medicine, together with a methodologist, conducted a systematic literature search, summarized the findings, rated the quality of the evidence, and formulated recommendations following the Grading of Recommendations of Assessment Development and Evaluations methodology. This document provides evidence-based guidance on the use of interferon-gamma release assays for the diagnosis of tuberculosis infection in patients at risk of tuberculosis or suspected of having active disease. The guidelines will be applicable to specialist and primary care, and public health.

Tuberculosis Costs in Spain and Related Factors. / Costes de la tuberculosis en España: factores relacionados.

OBJECTIVE: To analyze the direct and indirect costs of diagnosis and management of tuberculosis (TB) and associated factors. PATIENTS AND METHODS: Prospective study of patients diagnosed with TB between September 2014 and September 2015. We calculated direct (hospital stays, visits, diagnostic tests, and treatment) and indirect (sick leave and loss of productivity, contact tracing, and rehabilitation) costs. The following cost-related variables were compared: age, gender, country of origin, hospital stays, diagnostic testing, sensitivity testing, treatment, resistance, directed observed therapy (DOT), and days of sick leave. Proportions were compared using the chi-squared test and significant variables were included in a logistic regression analysis to calculate odds ratio (OR) and corresponding 95% confidence intervals. RESULTS: 319 patients were included with a mean age of 56.72±20.79 years. The average cost was €10,262.62±14,961.66, which increased significantly when associated with hospital admission, polymerase chain reaction, sputum smears and cultures, sensitvity testing, chest computed tomography, pleural biopsy, drug treatment longer than nine months, DOT and sick leave. In the multivariate analysis, hospitalization (OR=96.8; CI 29-472), sensitivity testing (OR=4.34; CI 1.71-12.1), chest CT (OR= 2.25; CI 1.08-4.77), DOT (OR=20.76; CI 4.11-148) and sick leave (OR=26,9; CI 8,51-122) showed an independent association with cost. CONCLUSION: Tuberculosis gives rise to significant health spending. In order to reduce these costs, more control of transmission, and fewer hospital admissions would be required.

Executive summary of the guidelines for the use of interferon-gamma release assays in the diagnosis of tuberculosis infection / Sumario Ejecutivo de la Guía de Práctica Clínica sobre el uso de las pruebas de liberación de interferón-gamma para el diagnóstico de infección tuberculosa

Interferon-gamma release assays are widely used for the diagnosis of tuberculosis infection in Spain. However, there is no consensus on their application in specific clinical scenarios. To develop a guideline for their use, a panel of experts comprising specialists in infectious diseases, respiratory diseases, microbiology, pediatrics and preventive medicine, together with a methodologist, conducted a systematic literature search, summarized the findings, rated the quality of the evidence, and formulated recommendations following the GRADE (Grading of Recommendations of Assessment Development and Evaluations) methodology. This document provides evidence-based guidance on the use of interferon-gamma release assays for the diagnosis of tuberculosis infection in patients at the risk of tuberculosis or suspected of having active disease. The guidelines will be applicable to specialist and primary care, and public health

Las técnicas de detección in vitro de interferón-gamma (IGRA, del inglés interferon-gamma release assays), están ampliamente implantadas para el diagnóstico de infección tuberculosa en España. Sin embargo, no hay consenso sobre su aplicación en diferentes escenarios clínicos. Para desarrollar una guía de práctica clínica sobre su uso, un grupo de trabajo compuesto por especialistas en enfermedades infecciosas, neumología, microbiología, pediatría y medicina preventiva, junto con un metodólogo, llevaron a cabo una búsqueda sistemática de la literatura, sintetizaron la evidencia y gradaron su calidad, y formularon las recomendaciones siguiendo el método GRADE (Grading of Recommendations of Assessment Development and Evaluations). Este documento proporciona una guía basada en la evidencia para el uso de los IGRA para el diagnóstico de infección tuberculosa en pacientes en riesgo de tuberculosis o con sospecha de enfermedad activa. Esta guía es aplicable en la atención especializada y primaria, y salud pública

Executive summary of the guidelines for the use of interferon-γ release assays in the diagnosis of tuberculosis infection.

Interferon-gamma release assays are widely used for the diagnosis of tuberculosis infection in Spain. However, there is no consensus on their application in specific clinical scenarios. To develop a guideline for their use, a panel of experts comprising specialists in infectious diseases, respiratory diseases, microbiology, pediatrics and preventive medicine, together with a methodologist, conducted a systematic literature search, summarized the findings, rated the quality of the evidence, and formulated recommendations following the GRADE (Grading of Recommendations of Assessment Development and Evaluations) methodology. This document provides evidence-based guidance on the use of interferon-gamma release assays for the diagnosis of tuberculosis infection in patients at the risk of tuberculosis or suspected of having active disease. The guidelines will be applicable to specialist and primary care, and public health.

Factors associated with unreported tuberculosis cases in Spanish hospitals.

BACKGROUND: Under-reporting of tuberculosis (TB) cases complicates disease control, hinders contact tracing and alters the accuracy of epidemiological data, including disease burden. The objective of the present study is to evaluate the proportion of unreported TB cases in Spanish healthcare facilities and to identify the associated factors. METHODS: A multi-center retrospective study design was employed. The study included TB cases diagnosed in 16 facilities during 2011-2012. These cases were compared to those reported to the corresponding public health departments. Demographic, microbiological and clinical data were analyzed to determine the factors associated with unreported cases. Associated factors were analyzed on a bivariate level using the x(2) test and on a multivariate level using a logistic regression. Odds ratios (OR) and 95 % confidence intervals (CI) were calculated. RESULTS: Of the 592 TB cases included in the study, 85 (14.4 %) were not reported. The percentage of unreported cases per healthcare center ranged from 0-45.2 %. The following variables were associated to under-reporting at a multivariate level: smear-negative TB (OR = 1.87; CI:1.07-3.28), extrapulmonary disease (OR = 2.07; CI:1.05-4.09) and retired patients (OR = 3.04; CI:1.29-7.18). A nurse case manager was present in all of the centers with 100 % reporting. The percentage of reported cases among the smear-positive cases was 9.4 % and 19.4 % (p = 0.001) among the rest of the study population. Smear-positive TB was no associated to under-reporting. CONCLUSIONS: It is important that TB Control Programs encourage thorough case reporting to improve disease control, contact tracing and accuracy of epidemiological data. The help from a TB nurse case manager could improve the rate of under-reporting.

Resistencia a fármacos antituberculosos de primera línea en Españna durante 2010-2011. Estudio RETUBES / Resistance to First-Line Antituberculosis Drugs in Spain, 2010-2011. RETUBES Study

Introducción: La magnitud de la resistencia actual a fármacos antituberculosos en España es desconocida. El objetivo del estudio es describir la resistencia a fármacos antituberculosos de primera línea y determinar sus factores asociados. Métodos: Estudio prospectivo multicéntrico de pacientes tuberculosos adultos con aislamiento de Mycobacterium tuberculosis y antibiograma de fármacos de primera línea en 32 hospitales y un centro extrahospitalario del sistema sanitario nacional durante los años 2010 y 2011. Resultados: Se estudió a 519 pacientes, 342 españoles y 177 (34,1%) extranjeros, 48 de ellos (9,2%) con resistencia a cualquier fármaco, de los que 35 (6,7%) eran resistentes a isoniacida. Hubo 10 casos multirresistentes (1,9%) y ninguno extremadamente resistente. Se detectó resistencia inicial a isoniacida en 28 de los 487 (5,7%) pacientes sin antecedentes de tratamiento antituberculoso previo, afectando más a los extranjeros (p < 0,01), y resistencia adquirida en 7 (22,6%) casos previamente tratados. La multirresistencia fue inicial en 6 casos (1,2%) y adquirida en otros 4 (12,9%). Los factores asociados a tener resistencia inicial a isoniacida fueron ser inmigrante y la convivencia en grupo (OR = 2,3; IC del 95%, 0,98- 5,67, y OR = 2,2; IC del 95%, 1,05-7,07, respectivamente). El factor asociado a la existencia de resistencia adquirida a isoniacida fue la edad inferior a 50 años (p = 0,03). Conclusiones: La tasa de resistencia inicial a isoniacida es superior a la estimada, probablemente debida al aumento de la inmigración durante los últimos años, lo que aconseja su vigilancia nacional sistemática. Los individuos inmigrantes y los que conviven en grupo tienen mayor riesgo de tener resistencia a isoniacida

Introduction: The magnitude of current resistance to antituberculosis drugs in Spain is unknown. The objective of this study is to describe resistance to first-line antituberculosis drugs and determine the associated factors. Methods: Prospective multicenter study of adult tuberculosis patients with positive Mycobacterium tuberculosis culture and antibiogram including first-line drugs in 32 hospitals and one out-patient center of the Spanish Health System between 2010 and 2011. Results: A total of 519 patients, 342 Spanish nationals and 177 (34.1%) foreigners were studied. Drug resistance was found in 48 (9.2%), of which 35 (6.7%) were isoniazid-resistant. There were 10 (1.9%) multiresistant cases and no strain was extremely resistant. Initial isoniazid resistance was detected in 28 of the 487 (5.7%) antituberulosis-naïve patients, most of whom were foreigners (P<.01). Acquired resistance was seen in 7 (22.6%) previously treated cases. Multiresistance was initial in 6 cases (1.2%) and acquired in another 4 (12.9%). Factors associated with initial isoniazid resistance were immigrant status and group cohabitation OR = 2.3; 95%CI: .98-5.67 and OR = 2.2; 95%CI: 1.05-7.07 respectively). The factor associated with acquired resistance to isoniazid was age below 50 years (P=.03). Conclusions: The rate of initial isoniazid resistance is greater than estimated, probably due to the increase in immigration during recent years, suggesting that systematic national monitoring is required. Immigrants and those who cohabit in groups have a higher risk of isoniazid resistance

Resistance to first-line antituberculosis drugs in Spain, 2010-2011. RETUBES Study.

INTRODUCTION: The magnitude of current resistance to antituberculosis drugs in Spain is unknown. The objective of this study is to describe resistance to first-line antituberculosis drugs and determine the associated factors. METHODS: Prospective multicenter study of adult tuberculosis patients with positive Mycobacterium tuberculosis culture and antibiogram including first-line drugs in 32 hospitals and one out-patient center of the Spanish Health System between 2010 and 2011. RESULTS: A total of 519 patients, 342 Spanish nationals and 177 (34.1%) foreigners were studied. Drug resistance was found in 48 (9.2%), of which 35 (6.7%) were isoniazid-resistant. There were 10 (1.9%) multiresistant cases and no strain was extremely resistant. Initial isoniazid resistance was detected in 28 of the 487 (5.7%) antituberulosis-naïve patients, most of whom were foreigners (P<.01). Acquired resistance was seen in 7 (22.6%) previously treated cases. Multiresistance was initial in 6 cases (1.2%) and acquired in another 4 (12.9%). Factors associated with initial isoniazid resistance were immigrant status and group cohabitation OR=2.3; 95%CI: .98-5.67 and OR=2.2; 95%CI: 1.05-7.07 respectively). The factor associated with acquired resistance to isoniazid was age below 50 years (P=.03). CONCLUSIONS: The rate of initial isoniazid resistance is greater than estimated, probably due to the increase in immigration during recent years, suggesting that systematic national monitoring is required. Immigrants and those who cohabit in groups have a higher risk of isoniazid resistance.

A predictive scoring instrument for tuberculosis lost to follow-up outcome.

BACKGROUND: Adherence to tuberculosis (TB) treatment is troublesome, due to long therapy duration, quick therapeutic response which allows the patient to disregard about the rest of their treatment and the lack of motivation on behalf of the patient for improved. The objective of this study was to develop and validate a scoring system to predict the probability of lost to follow-up outcome in TB patients as a way to identify patients suitable for directly observed treatments (DOT) and other interventions to improve adherence. METHODS: Two prospective cohorts, were used to develop and validate a logistic regression model. A scoring system was constructed, based on the coefficients of factors associated with a lost to follow-up outcome. The probability of lost to follow-up outcome associated with each score was calculated. Predictions in both cohorts were tested using receiver operating characteristic curves (ROC). RESULTS: The best model to predict lost to follow-up outcome included the following characteristics: immigration (1 point value), living alone (1 point) or in an institution (2 points), previous anti-TB treatment (2 points), poor patient understanding (2 points), intravenous drugs use (IDU) (4 points) or unknown IDU status (1 point). Scores of 0, 1, 2, 3, 4 and 5 points were associated with a lost to follow-up probability of 2,2% 5,4% 9,9%, 16,4%, 15%, and 28%, respectively. The ROC curve for the validation group demonstrated a good fit (AUC: 0,67 [95% CI; 0,65-0,70]). CONCLUSION: This model has a good capacity to predict a lost to follow-up outcome. Its use could help TB Programs to determine which patients are good candidates for DOT and other strategies to improve TB treatment adherence.