Standards for clinical trials for treating TB.

BACKGROUND: The value, speed of completion and robustness of the evidence generated by TB treatment trials could be improved by implementing standards for best practice.METHODS: A global panel of experts participated in a Delphi process, using a 7-point Likert scale to score and revise draft standards until consensus was reached.RESULTS: Eleven standards were defined: Standard 1, high quality data on TB regimens are essential to inform clinical and programmatic management; Standard 2, the research questions addressed by TB trials should be relevant to affected communities, who should be included in all trial stages; Standard 3, trials should make every effort to be as inclusive as possible; Standard 4, the most efficient trial designs should be considered to improve the evidence base as quickly and cost effectively as possible, without compromising quality; Standard 5, trial governance should be in line with accepted good clinical practice; Standard 6, trials should investigate and report strategies that promote optimal engagement in care; Standard 7, where possible, TB trials should include pharmacokinetic and pharmacodynamic components; Standard 8, outcomes should include frequency of disease recurrence and post-treatment sequelae; Standard 9, TB trials should aim to harmonise key outcomes and data structures across studies; Standard 10, TB trials should include biobanking; Standard 11, treatment trials should invest in capacity strengthening of local trial and TB programme staff.CONCLUSION: These standards should improve the efficiency and effectiveness of evidence generation, as well as the translation of research into policy and practice.

Evaluating newly approved drugs in combination regimens for multidrug-resistant tuberculosis with fluoroquinolone resistance (endTB-Q): study protocol for a multi-country randomized controlled trial.

BACKGROUND: Treatment for fluoroquinolone-resistant multidrug-resistant/rifampicin-resistant tuberculosis (pre-XDR TB) often lasts longer than treatment for less resistant strains, yields worse efficacy results, and causes substantial toxicity. The newer anti-tuberculosis drugs, bedaquiline and delamanid, and repurposed drugs clofazimine and linezolid, show great promise for combination in shorter, less-toxic, and effective regimens. To date, there has been no randomized, internally and concurrently controlled trial of a shorter, all-oral regimen comprising these newer and repurposed drugs sufficiently powered to produce results for pre-XDR TB patients. METHODS: endTB-Q is a phase III, multi-country, randomized, controlled, parallel, open-label clinical trial evaluating the efficacy and safety of a treatment strategy for patients with pre-XDR TB. Study participants are randomized 2:1 to experimental or control arms, respectively. The experimental arm contains bedaquiline, linezolid, clofazimine, and delamanid. The control comprises the contemporaneous WHO standard of care for pre-XDR TB. Experimental arm duration is determined by a composite of smear microscopy and chest radiographic imaging at baseline and re-evaluated at 6 months using sputum culture results: participants with less extensive disease receive 6 months and participants with more extensive disease receive 9 months of treatment. Randomization is stratified by country and by participant extent-of-TB-disease phenotype defined according to screening/baseline characteristics. Study participation lasts up to 104 weeks post randomization. The primary objective is to assess whether the efficacy of experimental regimens at 73 weeks is non-inferior to that of the control. A sample size of 324 participants across 2 arms affords at least 80% power to show the non-inferiority, with a one-sided alpha of 0.025 and a non-inferiority margin of 12%, against the control in both modified intention-to-treat and per-protocol populations. DISCUSSION: This internally controlled study of shortened treatment for pre-XDR TB will provide urgently needed data and evidence for clinical and policy decision-making around the treatment of pre-XDR TB with a four-drug, all-oral, shortened regimen. TRIAL REGISTRATION: ClinicalTrials.Gov NCT03896685. Registered on 1 April 2018; the record was last updated for study protocol version 4.3 on 17 March 2023.

Update of the PANCCO clinical practice guidelines for the treatment of ulcerative colitis in the adult population.

Ulcerative colitis (US) is a chronic disease of unknown etiology. It is incurable and its clinical course is intermittent, characterized by periods of remission and relapse. The prevalence and incidence of the disease has been increasing worldwide. The update presented herein includes the participation of healthcare professionals, decision-makers, and a representative of the patients, all of whom declared their conflicts of interest. Answerable clinical questions were formulated, and the outcomes were graded. The information search was conducted on the Medline/PubMed, Embase, Epistemonikos, and LILACS databases, and covered grey literature sources, as well. The search was updated on November 30, 2020, with no restrictions regarding date or language. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) classification system was implemented to establish the strength of the recommendation and quality of evidence. A formal consensus was developed, based on the RAND/UCLA methodology and the document was peer reviewed. The short version of the Clinical Practice Guidelines for the Treatment of Ulcerative Colitis in the Adult Population is presented herein, together with the supporting evidence and respective recommendations. In mild-to-moderate UC, budesonide MMX is an option when treatment with 5-ASA fails, and before using systemic steroids. In moderate-to-severe UC, infliximab, adalimumab, vedolizumab, ustekinumab, and tofacitinib can be used as first-line therapy. If there is anti-TNF therapy failure, ustekinumab and tofacitinib provide the best results. In patients with antibiotic-refractory pouchitis, anti-TNFs are the treatment of choice.

Epidemiology and characteristics of ischaemic stroke in young adults in Aragon.

INTRODUCTION: Stroke affects around 15 million people per year, with 10%-15% occurring in individuals under 50 years old (stroke in young adults). The prevalence of different vascular risk factors and healthcare strategies for stroke management vary worldwide, making the epidemiology and specific characteristics of stroke in each region an important area of research. This study aimed to determine the prevalence of different vascular risk factors and the aetiology and characteristics of ischaemic stroke in young adults in the autonomous community of Aragon, Spain. METHODS: A cross-sectional, multi-centre study was conducted by the neurology departments of all hospitals in the Aragonese Health Service. We identified all patients aged between 18 and 50 years who were admitted to any of these hospitals with a diagnosis of ischaemic stroke or TIA between January 2005 and December 2015. Data were collected on demographic variables, vascular risk factors, and type of stroke, among other variables. RESULTS: During the study period, 786 patients between 18 and 50 years old were admitted with a diagnosis of ischaemic stroke or TIA to any hospital of Aragon, at a mean annual rate of 12.3 per 100 000 population. The median age was 45 years (IQR: 40-48 years). The most prevalent vascular risk factor was tobacco use, in 404 patients (51.4%). The majority of strokes were of undetermined cause (36.2%), followed by other causes (26.5%). The median NIHSS score was 3.5 (IQR: 2.0-7.0). In total, 211 patients (26.8%) presented TIA. Fifty-nine per cent of the patients admitted with a diagnosis of ischaemic stroke (10.3%) were treated with fibrinolysis. CONCLUSIONS: Ischaemic stroke in young adults is not uncommon in Aragon, and is of undetermined aetiology in a considerable number of cases; it is therefore necessary to implement measures to improve study of the condition, to reduce its incidence, and to prevent its recurrence.

Evaluating newly approved drugs for multidrug-resistant tuberculosis (endTB): study protocol for an adaptive, multi-country randomized controlled trial.

BACKGROUND: Treatment of multidrug- and rifampin-resistant tuberculosis (MDR/RR-TB) is expensive, labour-intensive, and associated with substantial adverse events and poor outcomes. While most MDR/RR-TB patients do not receive treatment, many who do are treated for 18 months or more. A shorter all-oral regimen is currently recommended for only a sub-set of MDR/RR-TB. Its use is only conditionally recommended because of very low-quality evidence underpinning the recommendation. Novel combinations of newer and repurposed drugs bring hope in the fight against MDR/RR-TB, but their use has not been optimized in all-oral, shorter regimens. This has greatly limited their impact on the burden of disease. There is, therefore, dire need for high-quality evidence on the performance of new, shortened, injectable-sparing regimens for MDR-TB which can be adapted to individual patients and different settings. METHODS: endTB is a phase III, pragmatic, multi-country, adaptive, randomized, controlled, parallel, open-label clinical trial evaluating the efficacy and safety of shorter treatment regimens containing new drugs for patients with fluoroquinolone-susceptible, rifampin-resistant tuberculosis. Study participants are randomized to either the control arm, based on the current standard of care for MDR/RR-TB, or to one of five 39-week multi-drug regimens containing newly approved and repurposed drugs. Study participation in all arms lasts at least 73 and up to 104 weeks post-randomization. Randomization is response-adapted using interim Bayesian analysis of efficacy endpoints. The primary objective is to assess whether the efficacy of experimental regimens at 73 weeks is non-inferior to that of the control. A sample size of 750 patients across 6 arms affords at least 80% power to detect the non-inferiority of at least 1 (and up to 3) experimental regimens, with a one-sided alpha of 0.025 and a non-inferiority margin of 12%, against the control in both modified intention-to-treat and per protocol populations. DISCUSSION: The lack of a safe and effective regimen that can be used in all patients is a major obstacle to delivering appropriate treatment to all patients with active MDR/RR-TB. Identifying multiple shorter, safe, and effective regimens has the potential to greatly reduce the burden of this deadly disease worldwide. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT02754765. Registered on 28 April 2016; the record was last updated for study protocol version 3.3, on 27 August 2019.

Digital microscopic image application (DMIA), an automatic method for particle size distribution analysis in waste activated sludge.

An important physical property in environmental samples is particle size distribution. Several processes exist to measure particle diameter, including change in electrical resistance, blocking of light, the fractionation of field flow and laser diffraction (these being the most commonly used). However, their use requires expensive and complex equipment. Therefore, a digital microscopic imaging application (DMIA) method was developed adapting the algorithms used in the helminth egg automatic detector software coupled with a neural network (NN) and Bayesian algorithms. This allowed the determination of particle size distribution in samples of waste activated sludge (WAS), recirculated sludge (RCS), and pre-treated sludge (PTS). The recirculation and electro-oxidation pre-treatment processes showed an effect in increasing the degree of solubilization, decreasing particle size and breakage factor with ranges between 44.29%, and 31.89%. Together with a final NN calibration process, it was possible to compare results. For example, the 90th percentile of equivalent diameter value obtained by the DMIA with the corresponding result for the laser diffraction method. DMIA values: 228.76 µm (WAS), 111.18 µm (RCS), and 84.45 µm (PTS). DMIA processing has advantages in terms of reducing complexity, cost and time, and offers an alternative to the laser diffraction method.

Helminth Egg Automatic Detector (HEAD): Improvements in development for digital identification and quantification of helminth eggs and their application online.

Helminths are parasitic worms that constitute a major public health problem. Conventional analytical techniques to evaluate helminth eggs in environmental samples rely on different steps, namely sedimentation, filtration, centrifugation, and flotation, to separate the eggs from a variety of particles and concentrate them in a pellet for direct observation under an optical microscope. To improve this process, a new approach was implemented in which various image processing algorithms were developed and implemented by a Helminth Egg Automatic Detector (HEAD). This allowed identification and quantification of pathogenic helminth eggs of global medical importance and it was found to be useful for relatively clean wastewater samples. After the initial version, two improvements were developed: first, a texture verification process that reduced the number of false positive results; and second, the establishment of the optimal thresholds (morphology and texture) for each helminth egg species. This second implementation, which was found to improve on the results of the former, was developed with the objective of using free software as a platform for the system. This does not require the purchase of a license, unlike the previous version that required a Mathworks® license to run. After an internal statistical verification of the system was carried out, trials in internationally recognized microbiology laboratories were performed with the aim of reinforcing software training and developing a web-based system able to receive images and perform the analysis throughout a web service. Once completed, these improvements represented a useful and cheap tool that could be used by environmental monitoring facilities and laboratories throughout the world; this tool is capable of identifying and quantifying different species of helminth eggs in otherwise difficult environmental samples: wastewater, soil, biosolids, excreta, and sludge, with a sensitivity and specificity for the TensorFlow (TF) model in the web service values of 96.82% and 97.96% respectively. Additionally, in the case of Ascaris, it may even differentiate between fertile and non-fertile eggs.

The fourth national anti-tuberculosis drug resistance survey in Peru.

BACKGROUND: Peru has one of the highest burdens of multidrug-resistant tuberculosis (MDR-TB), but universal drug susceptibility testing (DST) has not yet been achieved.OBJECTIVE: To estimate the proportion of drug resistance among smear-positive TB patients in Peru.DESIGN: From September 2014 to March 2015, we performed a national drug resistance survey of patients aged ≥15 years; TB was diagnosed based on sputum smear positivity. We performed DST at the National Reference Laboratory of the Peruvian National Institute of Health, Lima, Peru, using the proportion method in Middlebrook 7H10 agar for four first-line drugs and six second-line drugs, and the Wayne method for pyrazinamide.RESULTS: Of the 1908 new and 272 previously treated patients included in the analysis, 638 (29.3%) patients had resistance to at least one first-line drug. MDR-TB was diagnosed in 7.3% of new and 16.2% of previously treated patients (P < 0.001). There were five (0.2%) patients with extensively drug-resistant TB.CONCLUSION: MDR-TB has increased to 7.3% in new patients from 5.3% in the previous survey, indicating that resistance to anti-tuberculosis drugs is increasing in Peru. Ongoing community transmission of resistant strains highlights an urgent need for early diagnosis, optimised treatment and effective contact tracing of MDR-TB patients.

Epidemiology and characteristics of ischaemic stroke in young adults in Aragon. / Epidemiología y características del ictus isquémico en el adulto joven en Aragón.

INTRODUCTION: Stroke affects around 15 million people per year, with 10%-15% occurring in individuals under 50 years old (stroke in young adults). The prevalence of different vascular risk factors and healthcare strategies for stroke management vary worldwide, making the epidemiology and specific characteristics of stroke in each region an important area of research. This study aimed to determine the prevalence of different vascular risk factors and the aetiology and characteristics of ischaemic stroke in young adults in the autonomous community of Aragon, Spain. METHODS: A cross-sectional, multi-centre study was conducted by the neurology departments of all hospitals in the Aragonese Health Service. We identified all patients aged between 18 and 50 years who were admitted to any of these hospitals with a diagnosis of ischaemic stroke or TIA between January 2005 and December 2015. Data were collected on demographic variables, vascular risk factors, and type of stroke, among other variables. RESULTS: During the study period, 786 patients between 18 and 50 years old were admitted with a diagnosis of ischaemic stroke or TIA to any hospital of Aragon, at a mean annual rate of 12.3 per 100 000 population. The median age was 45 years (IQR: 40-48 years). The most prevalent vascular risk factor was tobacco use, in 404 patients (51.4%). The majority of strokes were of undetermined cause (36.2%), followed by other causes (26.5%). The median NIHSS score was 3.5 (IQR: 2.0-7.0). In total, 211 patients (26.8%) presented TIA. Fifty-nine per cent of the patients admitted with a diagnosis of ischaemic stroke (10.3%) were treated with fibrinolysis. CONCLUSIONS: Ischaemic stroke in young adults is not uncommon in Aragon, and is of undetermined aetiology in a considerable number of cases; it is therefore necessary to implement measures to improve study of the condition, to reduce its incidence, and to prevent its recurrence.

Quick incubation process to determine inactivation of Ascaris and Toxocara eggs.

Helminth eggs are among the most important biological contaminants in environmental engineering. They pose a significant health risk associated with poor sanitation, the use of contaminated water for irrigation, and the disposal of excreta or sludge to land. Helminths are parasitic worms transmitted to humans via their eggs, which is the infective stage of their life cycle. They are therefore relevant to public health and environmental fields due to their low infectious dose, their persistence in the environment (up to several years), and their high resistance to conventional disinfection processes. The evaluation of the efficiency of any process of inactivation, through the determination of the viability of these parasites, is fundamental, but the traditional incubation technique requires 20 days to determine both the viability and the infectivity of nematode eggs. However, the present study found that, using an inactivation process at a temperature of 60 °C for 1 hour and incubation at 28 °C and 34 °C, the absence of division of the nucleus of eggs of species from two genera, Ascaris lumbricoides and Toxocara canis, showed them to be inactivated following only 48 hours of incubation. Similar inactivation results were observed using an automatic system as long as the eggs were inactivated. The minimum time required to evaluate the inactivation of nematode eggs through the incubation technique was 48 hours.

[Signs predicting early growth of intracerebral haemorrhage in computer tomography without enhancement and mortality]. / Signos predictores de crecimiento precoz de la hemorragia intracerebral en la tomografia computarizada sin contraste y mortalidad.

INTRODUCTION: Intracerebral haemorrhage is associated with high morbidity and mortality, and an increase in its volume in the early phases entails a poorer prognosis. The blend sign, the heterogeneous density, the irregular morphology and a fluid level in the haematoma are related to an early growth of the haematoma. AIM: To determine whether these four characteristics are associated with greater mortality at 7, 30 and 90 days of the occurrence of the intracerebral haemorrhage. PATIENTS AND METHODS: A retrospective cohort study that included all the patients attended in our hospital between 2010 and 2015 for spontaneous intracerebral haemorrhage with a computed tomography brain scan performed in the first six hours following the onset of symptoms. RESULTS: Of the 158 patients included in the sample, 23 (14.6%) presented blend sign; 39 (24.7%), heterogeneity; 53 (33.5%), irregularity; and 33 (20.9%), fluid level. In the bivariate analysis, only heterogeneity and irregularity were associated with increased mortality at 7, 30 and 90 days. In the multivariate logistic regression analysis, previous treatment with an antiplatelet drug, a score on the Glasgow Coma Scale below 13 and irregularity were associated with higher mortality in the first seven days. CONCLUSION: The study shows an association between irregularity of the haematoma and mortality in the first seven days. Irregularity would allow identification of patients with a more unfavourable prognosis; in these cases, strict surveillance, especially of factors related to the growth of the haematoma, could improve their prognosis.

TITLE: Signos predictores de crecimiento precoz de la hemorragia intracerebral en la tomografia computarizada sin contraste y mortalidad.Introduccion. La hemorragia intracerebral esta asociada a una elevada morbimortalidad y su aumento de volumen en fases iniciales conlleva un peor pronostico. El signo de la mezcla, la densidad heterogenea, la morfologia irregular y un nivel liquido en el hematoma se relacionan con un crecimiento precoz del hematoma. Objetivo. Determinar si esas cuatro caracteristicas se asocian a una mayor mortalidad a los 7, 30 y 90 dias de ocurrida la hemorragia intracerebral. Pacientes y metodos. Estudio de cohortes retrospectivo que incluyo a todos los pacientes atendidos en nuestro hospital, entre 2010 y 2015, por una hemorragia intracerebral espontanea con tomografia computarizada cerebral realizada en las primeras seis horas tras el inicio de los sintomas. Resultados. De los 158 pacientes incluidos, 23 (14,6%) presentaban signo de la mezcla, 39 (24,7%) heterogeneidad, 53 (33,5%) irregularidad y 33 (20,9%) nivel liquido. En el analisis bivariante, solo la heterogeneidad y la irregularidad se asociaron a mayor mortalidad a los 7, 30 y 90 dias. En el analisis por regresion logistica multivariante, el tratamiento previo con antiagregante plaquetario, una puntuacion en la escala de coma de Glasgow menor de 13 y la irregularidad se asociaron a una mayor mortalidad en los siete primeros dias. Conclusion. El estudio muestra asociacion entre la irregularidad del hematoma y la mortalidad en los siete primeros dias. La irregularidad permitiria identificar a pacientes con peor pronostico, en los que una vigilancia estricta, especialmente de factores relacionados con el crecimiento del hematoma, podria mejorar su pronostico.

Patrones culturales de cuidado familiar al adulto mayor en condición de discapacidad y pobreza / Cultural patterns of family care for the elderly in conditions of disability and poverty

Objetivo: describir los patrones de cuidado familiar con adultos mayores en condición de discapacidad y pobreza de tres grupos culturalmente diversos en Colombia. Metodología: estudio cualitativo de análisis de datos secundarios basado en 35 documentos recopilados entre el 2007 al 2016. El material fue organizado en el programa N-Vivo. El análisis siguió las cuatro fases propuestas por Leininger. Resultados principales: el patrón cultural "Cuidar entre sufrimiento, generosidad y agradecimiento" evidencia el intenso sufrimiento del cuidador por "verlo así" a la situación del adulto mayor por los tres grupos colombianos, la tensión emocional para el cuidador y el sistema de creencias que moviliza el cuidador para ofrecer cuidado, la constante tensión emocional para evitarle complicaciones en un entorno de exiguos recursos, así como, la gratitud del adulto mayor. Conclusión: el patrón familiar de los tres grupos en Colombia está determinado por el significado atribuido a la situación del adulto mayor y los valores, expectativas y sentimientos de obligación y reciprocidad que mueven a dar y recibir el cuidado. Sin embargo, el contexto de desprotección social debe ser considerado en la atención a éste tipo de población

Objective: to describe the patterns of family care with the elderly in the condition of disability and poverty of three culturally diverse groups in Colombia. Methodology: qualitative study of secondary data analysis based on 35 collected documents from 2017 to 2016. The material was organized in the N-Vivo program. The analysis followed the four phases proposed by Leininger. Main results: the cultural pattern "Caring between suffering, generosity and gratitude" shows the intense suffering of the caregiver by "seeing it like this" in the situation of the older adult by the three Colombian groups, the emotional tension for the caregiver and the belief system that mobilizes the caregiver to provide care, constant emotional tension to avoid complications in an environment of meager resources, as well as the gratitude of the elderly. Main conclusion: the family pattern of the three groups in Colombia is determined by the meaning attributed to the situation of the elderly and the values, expectations and feelings of obligation and reciprocity that move to give and receive care. However, the context of social unprotectedness must be considered in the attention to this type of population

Efecto programa de apoyo social: percepción de cuidadoras familiares de personas mayores afrocolombianas en Guapi, Cauca / Effect of a social support program: perception of family caregivers of afrocolombian elderly, Guapi ­ Cauca / Efeito programa de apoio social: percepção de cuidadoras familiares de pessoas maiores afrocolombianas em Guapi, Cauca

Introducción: En la actualidad temas como la vejez, discapacidad y poblaciones vulnerables son relevantes y demandan programas de apoyo social. Objetivo: Describir el efecto de un programa de apoyo social para cuidadoras familiares de personas mayores afrocolombianas con discapacidad en Guapi-Cauca. Metodología: Cuantitativa de tipo cuasi-experimental, sin grupo control, con preprueba y posprueba. Muestra intencional de 50 cuidadoras familiares afrocolombianas. El programa de apoyo social, culturalmente congruente, fue aplicado por la enfermera investigadora y dos lideresas de la comunidad. Información recolectada con cuestionario MOS-Apoyo social, procesado y analizado con métodos descriptivos y prueba de rango signado de Wilcoxon. Consideró aspectos éticos. Resultados: En su mayoría las mujeres cumplen el rol de cuidadoras familiares (95%) especialmente las hijas (49%), que dedican más de 8 horas al cuidado del familiar (35%), las personas mayores presentan dependencia severa (60%), moderada (36%) y leve (4%). Predominan familias nucleares con personas mayores (66%) y extensa modificada (34%). El programa indicó efectos estadísticamente significativos de apoyo social global y por dimensiones a las cuidadoras familiares (Valor-p < 0,001). Conclusión: El programa de apoyo social abordado desde la perspectiva cultural es una oportunidad para cocrear diversidad terapéutica con mediación entre saberes populares y profesionales y mostró efectos estadísticamente significativos sobre el apoyo social global (Valor-p < 0,001) y por dimensiones en las cuidadoras familiares (Valor-p < 0,001).

Currently, issues as elderly, disability, and vulnerable population are relevant and demand social support programs. Objective: To describe the effect of a social support program for family caregivers of afro Colombian disabled elderly in Guapi, Cauca. Methodology: Quantitative, quasi-experimental design, without control group, with pretest and post-test. Intentional sample of 50 afro Colombian family caregivers. The social support program, culturally congruent, was applied by the nurse researcher and two community leaders. The information was collected with MOS Questionnaire-Social support, and processed and analyzed with descriptive methods and Wilcoxon signed rank test. Ethical aspects were considered. Results: For the most part, women fulfill the role of family caregivers (95%), especially daughters (49%), who dedicate more than 8 hours to family (35%) caring for the relative. The elderly present severe dependency (60%), moderate dependency (36%) or mild dependency (4%). Nuclear families with elderly (66%) and extended modified families (34%) predominate. The program revealed statistically significant effects of global social support and by dimensions to family caregivers (value -p < 0,001). Conclusions: The social support program tackled from the cultural perspective is an opportunity to co-create therapeutic diversity with mediation between popular and professional knowledge, and showed statistically significant effects over global social support (Value-p < 0,001) and by dimensions in family caregivers (Value-p < 0,001).

Introdução: Na atualidade temas como a velhice, deficientes e povoados vulneráveis são relevantes e demandam programas de apoio social. Objetivo: Descrever o efeito de um programa de apoio social para cuidadoras familiares de pessoas maiores afros colombianos com deficiência em Guapi-Cauca. Metodologia: Quantitativa de tipo quase-experimental, sem grupo controle, com pré-teste e pós-teste. Amostragem intencional de 50 cuidadoras familiares afros colombianas. O programa de apoio social, culturalmente congruente, foi aplicado pela enfermeira pesquisadora e dos lideres da comunidade. Informação coletada com questionário MOS- Apoio social, processado e analisado com métodos descritivos e prova de rango atribuído de Wilcoxon. Considerou aspectos éticos. Resultados: Em sua maioria as mulheres cumprem rol de cuidadoras familiares (95%) especialmente as filhas (49%), que dedicam mais de 8 horas ao cuidado dum familiar (35%), as pessoas maiores apresentam dependência severa (60%), moderada (36%) e leve (4%). Predominam famílias nucleares com pessoas maiores (66%) e extensas modificadas (34%). O programa indicou efeitos estatisticamente significativos de apoio social global e por dimensões ás cuidadoras familiares (Valor-p < 0,001). Conclusão: O programa de apoio social abordado desde a perspectiva cultural é uma oportunidade para criar diversidade terapêutica com mediação entre conhecimentos populares e profissionais e amostrou efeitos estatisticamente significativos sobre o apoio social global (Valor-p < 0,001) e por dimensões nas cuidadoras familiares (Valor-p < 0,001).

Prevalence of pyrazinamide resistance and Wayne assay performance analysis in a tuberculosis cohort in Lima, Peru.

BACKGROUND: Multidrug-resistant tuberculosis (MDR-TB) regimens often contain pyrazinamide (PZA) even if susceptibility to the drug has not been confirmed. This gap is due to the limited availability and reliability of PZA susceptibility testing. OBJECTIVES: To estimate the prevalence of PZA resistance using the Wayne assay among TB patients in Lima, Peru, to describe characteristics associated with PZA resistance and to compare the performance of Wayne with that of BACTEC™ MGIT™ 960. METHODS: PZA susceptibility using the Wayne assay was tested in patients diagnosed with culture-positive pulmonary TB from September 2009 to August 2012. Factors associated with PZA resistance were evaluated. We compared the performance of the Wayne assay to that of MGIT 960 in a convenience sample. RESULTS: The prevalence of PZA resistance was 6.6% (95%CI 5.8-7.5) among 3277 patients, and 47.7% (95%CI 42.7-52.6) among a subset of 405 MDR-TB patients. In multivariable analysis, MDR-TB (OR 86.0, 95%CI 54.0-136.9) and Latin American-Mediterranean lineage (OR 3.40, 95%CI 2.33-4.96) were associated with PZA resistance. The Wayne assay was in agreement with MGIT 960 in 83.9% of samples (κ 0.66, 95%CI 0.56-0.76). CONCLUSION: PZA resistance was detected using the Wayne assay in nearly half of MDR-TB patients in Lima. This test can inform the selection and composition of regimens, especially those dependent on additional resistance.

Empoderamiento de líderes comunitarias afrocolombianas desde la Atención Primaria de Salud / Empowerment of Afro-Colombian community leaders from Primary Health Care

Resumen Objetivo: Describir los resultados cualitativos del programa de Atención Primaria de Salud (APS) Centro de Desarrollo Humano Comunitario adaptado a la cultura, para el empoderamiento de líderes comunitarias afrocolombianas en Guapi, Colombia. Metodología: Estudio cualitativo, con observación participante registrada en diarios de campo. El análisis se realizó de forma inductiva interpretando el programa de APS Centro de Desarrollo Humano Comunitario, en Guapi, Colombia. Participaron 30 líderes comunitarias afrocolombianas. Resultados: Del estudio emergieron las siguientes tres categorías: Mayor espiritualidad y competencia cultural; Estabilidad y control con participación en microempresas; y Crecimiento en la toma de decisiones en equipo. Conclusiones: El programa de APS permite contribuir al empoderamiento de líderes comunitarias afrocolombianas, promoviendo el control y la participación social en virtud del autoconocimiento, la organización, la colaboración comunitaria, el trabajo intersectorial y la gestión de proyectos en crecimiento. Estos factores son claves para, mediante el progreso socioeconómico, mejorar la salud y el desarrollo integral de la comunidad.

Resumo Objetivo: Descrever resultados qualitativos do programa de Atenção Primária à Saúde (APS) Centro de Desarrollo Humano Comunitario adaptado à cultura para o empoderamento de líderes comunitárias afro-colombianas em Guapi, Colômbia. Metodologia: Estudo qualitativo, com observação participante registrada em diários de campo. A análise se fez de forma indutiva interpretando o programa APS Centro de Desarrollo Humano Comunitario, em Guapi, Colômbia. Trinta líderes comunitárias afro-colombianas participaram do estudo. Resultados: No estudo surgiram as seguintes três categorias: Maior espiritualidade e competência cultural; Estabilidade e controle com a participação nas microempresas e Crescimento na tomada de decisões em equipe. Conclusão: O programa do APS contribui com o empoderamento de líderes comunitárias afro-colombianas, promovendo o controle e a participação social através do autoconhecimento, organização, colaboração comunitária, o trabalho intersetorial e a gestão de projetos em crescimento. Esses fatores são fundamentais para, mediante o progresso socioeconômico, melhorar a saúde e o desenvolvimento integral da comunidade.

Abstract Objective: To describe qualitative results of a culture-oriented Primary Health Care (PHC) Centro de Desarrollo Humano Comunitario program for the empowerment of Afro-Colombian community leaders in Guapi, Colombia. Methodology: Qualitative study with participant observation recorded in field diaries. The analysis was performed inductively interpreting the aps Community Human Development Center program in Guapi, Colombia. Participated 30 Afro-Colombian community leaders. Results: From the study three categories emerged as follows: Greater spirituality and cultural competence; Stability and control with micro-enterprises participation; and Growth in decisions-making as a team. Conclusions: The PHC program contributes to the empowerment of Afro-Colombian community leaders, promoting control and social participation according to self-knowledge, organization, community engagement, intersectoral work, and expanding project management. These are key factors for improving, by means of socio-economic progress, health and the integral development of the community.

Pharmacokinetic Evidence from the HIRIF Trial To Support Increased Doses of Rifampin for Tuberculosis.

Rifamycins exhibit concentration-dependent killing of Mycobacterium tuberculosis; higher exposures potentially induce better outcomes. We randomized 180 tuberculosis patients in Peru to receive rifampin at 10, 15, or 20 mg/kg/day. A total of 168 had noncompartmental pharmacokinetic analyses; 67% were sampled twice, and 33% were sampled six times. The doses administered were well tolerated. The median area under the concentration-time curve from 0 to 6 h (interquartile range) was 24.9 (17.6 to 32.1), 43.1 (30.3 to 57.5), or 55.5 (35.7 to 73.2) h · µg/ml. The median maximum drug concentration in serum in the experimental arms reached the target of 8 µg/ml. Continued investigation of higher rifampin doses is warranted. (This study has been registered at ClinicalTrials.gov under registration no. NCT01408914.).

Efecto de un programa de atención primaria en salud sobre la funcionalidad familiar desde abuelos y nietos, Guapi - Cauca / Effect of a program of primary health attention on family functionality from grandparents and grandchildren in the municipality of Guapi - Cauca

Objetivo: Determinar el efecto en la funcionalidad familiar de un programa de Atención Primaria en Salud desde abuelos y nietos, en Guapi-Cauca. Materiales y métodos: Estudio cuasi experimental sin grupo control. Participaron 50 familias afrocolombianas. El programa fue construido con la comunidad, con acciones de cuidado adaptadas culturalmente y en entornos saludables. Información recolectada con la Escala de Efectividad del Funcionamiento Familiar (ASF-E 20), procesada y analizada con métodos descriptivos y prueba de rango signado de Wilcoxon. Resultados: El programa de APS obtuvo un efecto estadísticamente significativo en la funcionalidad de las familias desde los nietos (Valor-p < 0,001) y abuelos (Valor-p 0.004). Conclusiones: El programa de APS con estrategia de entornos saludables y cuidados culturalmente congruentes, tiene un efecto en la efectividad de la funcionalidad familiar en los abuelos y nietos de las familias afrocolombianas del Municipio de Guapi Cauca. Favoreció la funcionalidad familiar acciones de promoción de la salud a través de alianzas estratégicas y oportunidades en el desarrollo individual y colectivo de niños y abuelos.

Objective: To determine the effect of a Primary Health Attention program on family functionality from grandparents and grandchildren in the municipality of Guapi in the department of Cauca. Materials and methods: A quasi-experimental study without control group was performed where 50 Afro-Colombian families participated. The program was built with the community by using culturally adapted care actions and healthy environments. The information was collected with the scale of Effectiveness of Family Functioning (ASF-20), and it was processed and analyzed with descriptive methods and range test signed of Wilcoxon. Results: The PHC program obtained a statistically significant effect on the functionality of families from grandchildren (Value-p <0,001) and grandparents (Value-p <0,004). Conclusions: The PHC program with strategy of healthy environments and culturally congruent care has effect over effectiveness of family functionality in grandparents and grandchildren in Afro-Colombian families in the municipality of Guapi, Cauca. It favored family functionality actions for the promotion of health through strategic alliances and opportunities for individual and collective development of children and grandparents.

Cuidadores familiares campesinos: depresión, tiempo de cuidado y dependencia / Peasant family caregivers: depression, time for care and dependence / Cuidadores familiares camponeses: depresão, tempo de cuidado e dependência

OBJETIVO: Establecer la asociación de la depresión de cuidadores familiares campesinos con el tiempo de cuidado y la dependencia de la persona anciana cuidada. MATERIALES Y MÉTODO: Estudio de tipo transversal con alcance correlacional. La muestra intencional fue de 50 cuidadores. Fueron aplicados: una encuesta sociodemográfica, la escala de Yesavage para medir la depresión, el Índice de Barthel (IB) para medir el grado de dependencia funcional. RESULTADOS: El cuidado es principalmente de mujeres (76%) y por lo general son hijos/hijas (40%), otros parientes (36%) o esposas/esposos (22%); mayores de 60 años (50%), casados (40%) y solteros (30%); de nivel socioeconómico bajo (94%) y bajo nivel educativo (66%); el 84 por ciento viven solos (as) con el familiar que cuidan; 64% han estado a cargo de su familiar durante más de ocho años y el 18% por ciento ha cuidado a su pariente durante un período de 4 a 8 años. Se encontró asociación significativa entre depresión del cuidador y el grado de dependencia (p =0,019). No se encontró asociación significativa entre la depresión y el tiempo como cuidador (p = 0,867). CONCLUSIONES: La severidad de la dependencia podría ser predictor de la depresión moderada o severa. Sin embargo, aspectos culturales pueden influir en la experiencia y construcción de significados del rol de cuidador y tener efectos en los resultados de la depresión según el tiempo como cuidador

OBJETIVE: To stablish the connection between peasant family caregivers depression and the time of care and dependence of the elderly taken care of. MATERIALS AND METHOD: Cross-sectional study with correlational scope. The intended sample was of 50 caregivers. Socio-demographic survey, Yesavage Geriatric Depression Scale, and the Barthel Index (BI) to measure the grade of functional dependency were applied. RESULTS: Care comes mainly from women (76%) and generally they are sons/daughters (40%), other relatives (36%) or spouses (22%); they are adults over 60 years old (50%), married (40%) and single (30%), from low socioeconomic level (94%) and low educational level (66%); 84 percent live alone with the relative they take care of and they have been in charge of their relative for more than eight years (64%); 18 % have been taking care of their relative for a period of 4 to 8 years. Significant connection between depression of caregiver and the degree of dependence (p =0.019) was found. No significant association between depression and time as a caregiver (p = 0.867) was found. CONCLUSIONS: The severity of dependence could be predictor of moderate to severe depression. Nevertheless, cultural aspects could affect the experience and construction of meaning of the role of care giver and have effects in the results of depression depending on the time as a care giver

OBJETIVO: Estabelecer a associação da depressão de cuidadores familiares camponeses com o tempo de cuidado e a dependência da pessoa anciã cuidada. MATERIAIS E MÉTODO: Estudo de tipo transversal com alcance correlacional. A amostra intencional foi de 50 cuidadores. Foram aplicados: uma enquete sócio-demográfica, a escada de Yesavage para medir a depressão, o Índice de Barthel (IB) para medir o grau de dependência funcional. RESULTADOS: O cuidado é principalmente de mulheres (76%) e pelo geral são filhos/filhas (40%), outros parentes (36%) o esposas/esposos (22%); maiores de 60 anos (50%), casados (40%) e solteiros (30%); de nível socioeconômico baixo (94%) e baixo nível educativo (66%); o 84 por cento moram sós (as) com o familiar quem cuidam; 64% Tem estado a cargo de sua familiar durante mais de oito anos e o 18% por cento tem cuidado a seu parente durante um período de 4 a 8 anos. Encontrou se associação significativa entre depressão do cuidador e o grau de dependência (p =0,019). Não se achou associação significativa entre a depressão o tempo como cuidador (p = 0,867). CONCLUSÕEs: A severidade da dependência poderia ser preditor da depressão moderada ou severa. Porem, aspetos culturais podem influir na experiência e construção de significados do rol de cuidador e ter efeitos nos resultados da depressão segundo o tempo como cuidador