COVID 19. Nuevos desafíos de en la Seguridad Hospitalaria y del Paciente / COVID 19. New challenges in hospital and patient safety

La gestión hospitalaria en el marco de la Pandemia planteó nuevos desafíos a los hospitales a partir de la Seguridad en la Atención de los pacientes y en particular de los Equipos de Salud. Para hablar de estos Nuevos Desafíos es pertinente comentar algunos Conceptos Básicos y partir de Viejos Desafíos y ver de qué manera los sistemas estaban preparados para recibir esta pandemia.

Applying systems thinking to identify enablers and challenges to scale-up interventions for hypertension and diabetes in low-income and middle-income countries: protocol for a longitudinal mixed-methods study.

INTRODUCTION: There is an urgent need to reduce the burden of non-communicable diseases (NCDs), particularly in low-and middle-income countries, where the greatest burden lies. Yet, there is little research concerning the specific issues involved in scaling up NCD interventions targeting low-resource settings. We propose to examine this gap in up to 27 collaborative projects, which were funded by the Global Alliance for Chronic Diseases (GACD) 2019 Scale Up Call, reflecting a total funding investment of approximately US$50 million. These projects represent diverse countries, contexts and adopt varied approaches and study designs to scale-up complex, evidence-based interventions to improve hypertension and diabetes outcomes. A systematic inquiry of these projects will provide necessary scientific insights into the enablers and challenges in the scale up of complex NCD interventions. METHODS AND ANALYSIS: We will apply systems thinking (a holistic approach to analyse the inter-relationship between constituent parts of scaleup interventions and the context in which the interventions are implemented) and adopt a longitudinal mixed-methods study design to explore the planning and early implementation phases of scale up projects. Data will be gathered at three time periods, namely, at planning (TP), initiation of implementation (T0) and 1-year postinitiation (T1). We will extract project-related data from secondary documents at TP and conduct multistakeholder qualitative interviews to gather data at T0 and T1. We will undertake descriptive statistical analysis of TP data and analyse T0 and T1 data using inductive thematic coding. The data extraction tool and interview guides were developed based on a literature review of scale-up frameworks. ETHICS AND DISSEMINATION: The current protocol was approved by the Monash University Human Research Ethics Committee (HREC number 23482). Informed consent will be obtained from all participants. The study findings will be disseminated through peer-reviewed publications and more broadly through the GACD network.

[Health working conditions and environment: conceptual model for remote and rural areas]. / Condiciones y medio ambiente de trabajo en salud: modelo conceptual para áreas remotas y rurales.

This report proposes a conceptual model on workplace environment and working conditions that integrates the available evidence to facilitate the design and evaluation of interventions aimed at improving the attraction, recruitment and retention of health personnel at the first level of care in rural and remote areas. Theoretical, empirical and testimonial evidence was consulted to support the model, and 15 frameworks disseminated in the last 20 years were synthesized. The article shows the diversity of perspectives and the complexity involved in establishing the dimensions to be considered in a proposal that is useful to apply to human resources for health policies.The proposed model includes four categories of components: factors of the external context, organizational factors, employment and work conditions, and individual factors. The boundaries between the components -as well as the weight and influence of each one- vary according to the interrelationship among them and the interaction with the environment, and thus its interpretation must be adapted to the context in which it is intended to be applied.Based on this conceptual model, the design and evaluation of interventions aimed at increasing the availability of health personnel -particularly at the primary care level in rural and remote areas of the Region of the Americas- should emerge from an interaction between health and employment policies, and the realities and expectations of workers and the communities.

[Factors and interventions that affect working conditions and environment to increase the attraction, recruitment and retention of human resources for health at the primary care level in rural, remote or underserved areas]. / Factores e intervenciones que inciden en las condiciones y medio ambiente de trabajo para incrementar la atracción, captación y retención de recursos humanos en salud en el primer nivel de atención de áreas rurales, remotas o desatendidas.

OBJECTIVE: To identify and systematize available empirical evidence on factors and interventions that affect working conditions and environment in order to increase the attraction, recruitment and retention of human resources for health at the primary care level in rural, remote or underserved areas. METHODS: Rapid review of reviews selected according to relevance, eligibility and inclusion criteria. The search was conducted on electronic and manual databases, including grey literature. AMSTAR I was used to assess the quality of systematic reviews and a thematic analysis for synthesis of the results. RESULTS: Sixteen reviews were included, one of which contained 14 reviews. Of the total, 20 reviews analyzed factors and 9 evaluated the effectiveness of interventions. The evidence on factors is abundant, but of limited quality. Individual, family and "previous exposure to a rural setting" factors were associated with higher recruitment; organizational and external context factors were important for human resource retention. Networking and professional support influenced recruitment and retention. Evidence on the effectiveness of interventions was limited, both in quantity and quality. The most frequently used intervention was incentives. CONCLUSIONS: Evidence on factors that are positively related to recruitment and retention of workers at the first level of care in rural, remote or underserved areas is sufficient and should be taken into account when designing interventions. Quality evidence on the effectiveness of interventions is scarce. More controlled studies with methodological rigor are needed, particularly in the Americas.

[Concerns and demands regarding COVID-19. Survey of health personnel]. / Preocupaciones y demandas frente a COVID-19. Encuesta al personal de salud.

The COVID-19 pandemic affected the organization of health services and had consequences for health teams, according to the pre-existing safety and working conditions. During the first week of April 2020, a cross sectional study was carried out with a qualitative-quantitative approach. The aim was to explore the conditions determining the organizational climate: leadership, communication, institutional resources, cohesion/conflict management, and training; and how these were perceived by health personnel to deal with the pandemic. A total of 5670 healthcare workers participated in an online survey and 50 were interviewed, from all subsectors of the Argentinean health system (public, private and union-health insurance); 72.9% were women, 51.4% were physicians, and the predominant age group was under 40 years. In the qualitative sample (interviews), 52% were men, 62% were physicians, and the average age was 44.8 years. The dimensions of the organizational climate were stratified and five independent predictors of perception of conditions were identified: age, gender, tasks performed, health system subsector, and jurisdiction. The condition most frequently perceived as inadequate were the inaccessibility of institutional resources and the access to personal protective equipment was a major concern. Claims included the need of institutional strategies to support healthcare workers and of a clear and uniform communication. In conclusion, at the time of the study, the health personnel perceived serious deficits in their organizations regarding the conditions necessary to confront COVID-19, with differences among subsectors of the health system.

La pandemia por COVID-19 afectó la organización de los servicios de salud y tuvo consecuencias en los equipos de salud, según las condiciones laborales y de bioseguridad pre-existentes en cada institución. Durante la primera semana de abril de 2020 se realizó un estudio de corte transversal. El objetivo fue indagar acerca de las condiciones que determinan el clima organizacional: liderazgo, comunicación, recursos institucionales, cohesión/gestión de conflictos y capacitación; y cómo éstas eran percibidas por el personal de salud para hacer frente a la pandemia. Se realizaron 5670 encuestas a trabajadores/as y 50 entrevistas a informantes clave de los tres subsectores del sistema de salud (público, privado y de seguridad social). En las encuestas, el 72.9% fueron mujeres, el 51.4% médicos/as y el grupo etario predominante fue el de menores de 40 años. El 47.8% de los/as participantes refirió pluriempleo. En las entrevistas, el 52% fueron varones, el 60% médicos/ as, la edad media 44.8 años. Se estratificaron las dimensiones y se identificaron predictores independientes de percepción: edad, género, tipo de tareas, subsector y jurisdicción. La dimensión percibida con mayor frecuencia como inadecuada fue la de recursos institucionales y la disponibilidad de equipos de protección personal fue identificada como una de las principales preocupaciones. Surgieron demandas de estrategias de contención para el personal de salud y de comunicación institucional clara y uniforme. En conclusión, al momento del estudio el personal de salud percibía serios déficits en sus organizaciones respecto de las condiciones necesarias para enfrentar la pandemia, con diferencias entre subsectores del sistema.

Preocupaciones y demandas frente a COVID-19: Encuesta al personal de salud / Concerns and demands regarding COVID-19. Survey of health personnel

La pandemia por COVID-19 afectó la organización de los servicios de salud y tuvo consecuencias en los equipos de salud, según las condiciones laborales y de bioseguridad pre-existentes en cada institución. Durante la primera semana de abril de 2020 se realizó un estudio de corte transversal. El objetivo fue indagar acerca de las condiciones que determinan el clima organizacional: liderazgo, comunicación, recursos institucionales, cohesión/gestión de conflictos y capacitación; y cómo éstas eran percibidas por el personal de salud para hacer frente a la pandemia. Se realizaron 5670 encuestas a trabajadores/as y 50 entrevistas a informantes clave de los tres subsectores del sistema de salud (público, privado y de seguridad social). En las encuestas, el 72.9% fueron mujeres, el 51.4% médicos/as y el grupo etario predominante fue el de menores de 40 años. El 47.8% de los/as participantes refirió pluriempleo. En las entrevistas, el 52% fueron varones, el 60% médicos/ as, la edad media 44.8 años. Se estratificaron las dimensiones y se identificaron predictores independientes de percepción: edad, género, tipo de tareas, subsector y jurisdicción. La dimensión percibida con mayor frecuencia como inadecuada fue la de recursos institucionales y la disponibilidad de equipos de protección personal fue identificada como una de las principales preocupaciones. Surgieron demandas de estrategias de contención para el personal de salud y de comunicación institucional clara y uniforme. En conclusión, al momento del estudio el personal de salud percibía serios déficits en sus organizaciones respecto de las condiciones necesarias para enfrentar la pandemia, con diferencias entre subsectores del sistema.

The COVID-19 pandemic affected the organization of health services and had consequences for health teams, according to the pre-existing safety and working conditions. During the first week of April 2020, a cross sectional study was carried out with a qualitative-quantitative approach. The aim was to explore the conditions determining the organizational climate: leadership, communication, institutional resources, cohesion/conflict management, and training; and how these were perceived by health personnel to deal with the pandemic. A total of 5670 healthcare workers participated in an online survey and 50 were interviewed, from all subsectors of the Argentinean health system (public, private and union-health insurance); 72.9% were women, 51.4% were physicians, and the predominant age group was under 40 years. In the qualitative sample (interviews), 52% were men, 62% were physicians, and the average age was 44.8 years. The dimensions of the organizational climate were stratified and five independent predictors of perception of conditions were identified: age, gender, tasks performed, health system subsector, and jurisdiction. The condition most frequently perceived as inadequate were the inaccessibility of institutional resources and the access to personal protective equipment was a major concern. Claims included the need of institutional strategies to support healthcare workers and of a clear and uniform communication. In conclusion, at the time of the study, the health personnel perceived serious deficits in their organizations regarding the conditions necessary to confront COVID-19, with differences among subsectors of the health system.

El cáncer como prioridad en la agenda sanitaria / Cancer as a priority on the health agenda

El cáncer concentra el 20% del total de defunciones en el país y representa la segunda causa de muerte. El objetivo de esta investigación operativa fue elaborar un análisis de situación con propuestas de mejora para incorporar al cáncer en la agenda política de los candidatos presidenciales. El estudio incluyó técnicas cualicuantitativas, el uso del Monitoreo de Resultados para un Sistema de Equidad (MoRES, "Monitoring Results for Equity System") para identificar brechas en relación a derechos vulnerados, mapeo de actores, uso de herramientas analíticas epidemiológicas y comunicacionales. Los resultados mostraron dos ejes programáticos para acercar propuestas a los distintos espacios políticos: incremento y optimización del financiamiento y la gestión de la enfermedad, por un lado, y, por el otro, incremento y optimización del financiamiento de los registros oncológicos a nivel provincial que permita mejorar la calidad de los datos. Todos tenemos responsabilidades sobre el monitoreo de las acciones y la implementación de la agenda de salud. Con la información disponible, Argentina está en condiciones de avanzar sobre la reducción en brechas de inequidades, pero hace falta que los portadores de derechos y de obligaciones se movilicen con visión y agenda compartida, un gran desafío que no es imposible de alcanzar. (AU)

Cancer represents the second cause of death, concentrating approximately 20% of the total deaths. The objective of this operational investigation was to elaborate a situation analysis with proposals for improvement to place cancer on the political agenda of presidential candidates. The study included qualitative and quantitative techniques, the use of MoRES ("Monitoring Results for Equity System") to identify inequality gaps in relation to violated rights, stakeholder mapping, the use of epidemiological and communicational analytical tools. The results of two programmatic axes to bring proposals to the different political spaces: improvements in financing and disease management, on the one hand, and, on the other, better financing and management of cancer registries at the provincial level that allowsimproving the quality of the data. We all have responsibilities on health agenda. With the available information, Argentina is in a position to move forward on the reduction of inequity and inequality gaps. An informed society, committed to health and aware of where priorities are, can contribute more and better to the formulation of a based rights health agenda. (AU)

Reducing Blindness from Retinopathy of Prematurity (ROP) in Argentina Through Collaboration, Advocacy and Policy Implementation.

Retinopathy of prematurity (ROP) is a largely avoidable cause of blindness in children worldwide, requiring high-quality neonatal care, early detection and treatment. In middle-income countries throughout Latin America, Eastern Europe and South Asia, there has been a rise in ROP blindness due to a combination of increased survival of preterm infants, resource-scarce medical environments and lack of policies, training and human resources. However, Argentina is an example of country where rates of ROP blindness have declined and ROP programmes have been successfully and effectively embedded within the health and legal system. The purpose of this study is to describe the activities and stakeholders, including Ministry of Health (MoH) and UNICEF, involved in the process, from recognition of an epidemic of ROP blindness to the development of national guidelines, policies and legislation for control. Using a retrospective mixed methods case study design, data on rates of severe ROP was collected from 13 neonatal intensive care units from 1999 to 2012, and on the proportion of children blind from ROP in nine blind schools in seven provinces. Legislative document review, focus group discussions and key informant interviews were conducted with neonatologists, ophthalmologists, neonatal nurses, parents, MoH officials, clinical societies, legislators and UNICEF officials in seven provinces. Results are presented combining the stages heuristic policy framework and Shiffman including: agenda setting, policy formulation, implementation and evaluation. By 2012, ROP had declined as a cause of blindness in children in schools for the blind as had rates of severe ROP needing treatment in the NICUs visited. Multiple factors played a role in reducing blindness from ROP in Argentina and successfully coordinating its control including national advocacy, leadership, legislation and international collaboration. Lessons learned in Argentina can potentially be scaled to other LMICs in Latin America and beyond with further context-specific research.

Maternidad Segura y Centrada en la Familia: la cultura organizacional de maternidades de la provincia de Buenos Aires / Safe and family-centered maternity hospitals: organizational culture of maternity hospitals in the province of Buenos Aires

Introducción. En 2010, se lanzó la iniciativa Maternidad Segura y Centrada en la Familia con el propósito de transformar las grandes maternidades públicas en espacios donde se implementaran prácticas seguras y se garantizaran los derechos de mujeres, recién nacidos y sus familias, lo que propuso un cambio de paradigma en la atención perinatal. El artículo reporta los hallazgos acerca de la cultura organizacional como insumo para la implementación de la iniciativa. Población y métodos. Se seleccionó una muestra no probabilística de 29 hospitales públicos de la provincia de Buenos Aires adheridos a la iniciativa. Durante 2011 y 2012, se aplicó una encuesta autoadministrada anónima a los integrantes de los servicios de Neonatología y Obstetricia, en la que se recogió información sobre tres dimensiones de la cultura organizational: clima organizational, prácticas seguras y facilitación para el cambio. Resultados. Se recolectaron 1828 encuestas; el 51% expresó la necesidad de mejorar la comunicación mediante más reuniones y el 60% evaluó positivamente algunos aspectos del liderazgo. La sobrecarga de trabajo fue reconocida como la principal causa de conflictos por el 60%. Aproximadamente, 25% expresó acuerdo y compromiso con la transformación de las maternidades en dirección a la iniciativa. La adhesión a las prácticas resultó dispar según cuáles fueran, aunque la mitad de los encuestados reportó que había razones legítimas para el cambio. Conclusiones. El diagnóstico de la cultura organizacional demostró que falta consolidar el compromiso con la iniciativa Maternidad Segura y Centrada en la Familia y que la evaluación del liderazgo no es integral. La sobrecarga de trabajo y las fallas de comunicación son las más importantes fuentes de conflicto.

Introduction. In 2010, the Safe and Family-Centered Maternity Hospitals initiative was launched in order to transform large public maternity centers into settings where safe practices are implemented and the rights of women, newborn infants and families are warranted. As a result, the paradigm of perinatal care was modified. This article reports on the findings of organizational culture as a component for the implementation of the initiative. Population and Methods. The sample was selected in a non-probabilistic way and was made up of 29 public hospitals located in the province of Buenos Aires that participated in the initiative. During 2011 and 2012, an anonymous, self-administered survey was completed by members of the Department of Neonatology and the Department of Obstetrics. The survey collected information on three dimensions of the organizational culture: organizational environment, safe practices, and facilitation of change. Results. A total of 1828 surveys were collected; 51% of survey respondents stated that there is a need to improve communicationby having more meetings, while 60% made a positive assessment of various aspects of leadership. Work overload was described as the main cause of conflicts by 60%. Approximately 25% agreed and showed commitment with the initiative of transforming maternity centers. Adherence to practices was dissimilar depending on the practice, but half of survey respondents reported that there were genuine reasons for change. Conclusions. The assessment of the organizational culture showed that commitment to the Safe and Family-Centered Maternity Hospitals initiative is yet to be consolidated, and the evaluation of leadership is not comprehensive. Work overload and communication failures are the main reasons for conflict.

[Safe and family-centered maternity hospitals: organizational culture of maternity hospitals in the province of Buenos Aires]. / Maternidad Segura y Centrada en la Familia: la cultura organizacional de maternidades de la provincia de Buenos Aires.

INTRODUCTION: In 2010, the Safe and Family-Centered Maternity Hospitals initiative was launched in order to transform large public maternity centers into settings where safe practices are implemented and the rights of women, newborn infants and families are warranted. As a result, the paradigm of perinatal care was modified. This article reports on the findings of organizational culture as a component for the implementation of the initiative. POPULATION AND METHODS: The sample was selected in a non-probabilistic way and was made up of 29 public hospitals located in the province of Buenos Aires that participated in the initiative. During 2011 and 2012, an anonymous, self-administered survey was completed by members of the Department of Neonatology and the Department of Obstetrics. The survey collected information on three dimensions of the organizational culture: organizational environment, safe practices, and facilitation of change. RESULTS: A total of 1828 surveys were collected; 51% of survey respondents stated that there is a need to improve communication by having more meetings, while 60% made a positive assessment of various aspects of leadership. Work overload was described as the main cause of conflicts by 60%. Approximately 25% agreed and showed commitment with the initiative of transforming maternity centers. Adherence to practices was dissimilar depending on the practice, but half of survey respondents reported that there were genuine reasons for change. CONCLUSIONS: The assessment of the organizational culture showed that commitment to the Safe and Family-Centered Maternity Hospitals initiative is yet to be consolidated, and the evaluation of leadership is not comprehensive. Work overload and communication failures are the main reasons for conflict.

Introducción. En 2010, se lanzó la iniciativa Maternidad Segura y Centrada en la Familia con el propósito de transformar las grandes maternidades públicas en espacios donde se implementaran prácticas seguras y se garantizaran los derechos de mujeres, recién nacidos y sus familias, lo que propuso un cambio de paradigma en la atención perinatal. El artículo reporta los hallazgos acerca de la cultura organizacional como insumo para la implementación de la iniciativa. Población y métodos.Se seleccionó una muestra no probabilística de 29 hospitales públicos de la provincia de Buenos Aires adheridos a la iniciativa. Durante 2011 y 2012, se aplicó una encuesta autoadministrada anónima a los integrantes de los servicios de Neonatología y Obstetricia, en la que se recogió información sobre tres dimensiones de la cultura organizacional: clima organizacional, prácticas seguras y facilitación para el cambio. Resultados. Se recolectaron 1828 encuestas; el 51% expresó la necesidad de mejorar la comunicación mediante más reuniones y el 60% evaluó positivamente algunos aspectos del liderazgo. La sobrecarga de trabajo fue reconocida como la principal causa de conflictos por el 60%. Aproximadamente, 25% expresó acuerdo y compromiso con la transformación de las maternidades en dirección a la iniciativa. La adhesión a las prácticas resultó dispar según cuáles fueran, aunque la mitad de los encuestados reportó que había razones legítimas para el cambio. Conclusiones. El diagnóstico de la cultura organizacional demostró que falta consolidar el compromiso con la iniciativa Maternidad Segura y Centrada en la Familia y que la evaluación del liderazgo no es integral. La sobrecarga de trabajo y las fallas de comunicación son las más importantes fuentes de conflicto.

Adherencia al tratamiento del paciente con fisura labio-palatina (FLAP) 2006 - 2013 / Adherence to treatment of patients with cleft lip palate (FLAP) 2006-2013

Las Fisuras Labio Palatinas son anomalías congénitas que consisten en una hendidura o separación en el labio superior. Se presentan, frecuentemente, acompañadas de paladar hendido. El presente trabajo tiene por objetivo estudiar la complejidad y grado de adherencia, estudiando el grado de abandono en la rehabilitación del paciente FLAP que concurre a instituciones o servicios adheridos a la Red de Servicios / Instituciones de la Argentina. De un total de 749 pacientes fueron contactados aquellos con más de 200 días de inasistencia al servicio en un total de 162 (21,6%), de los cuales 55 (11,4%) manifestó abandono de tratamiento. El 46,8% de los pacientes no cuentan con cobertura por obra social / prepaga o mutual. El 18,2% posee certificado de discapacidad. El 47,8% de los pacientes requieren entre 1 a 2 horas de traslado para su atención, y el 27,3% más de 2 horas, a lo que se debe sumar los tiempos de espera en las instituciones. Del análisis de las variables seleccionadas se podría estimar que la edad, severidad de la lesión, número de convivientes en el domicilio y ausencia de certificado de discapacidad podrían ser utilizados como indicadores de posible abandono en el tratamiento.

Cleft lip palate is a congenital anomaly consisting of a crack or separation in the upper lip. It is often accompanied by cleft palate. The aims of the study it is to analyze the complexity and degree of rehabilitation adhesion, by abandonment analysis, of the FLAP patient who attends institutions or services belonging to the network of services / institutions in Argentina. A total of 749 patients were contacted those with more than 200 days of absenteeism to the service in a total of 162 (21,6%), of which 55 (11,4%) said abandonment of treatment. 46,8% of patients do not have coverage for work social/insurance/mutual. 18,2% possesses a certificate of disability. 47,8% of patients require between 1-2 hours of transfer for your attention, and 27,3% more than 2 hours, what to add the waiting time at the institutions. Analysis of selected variables you could estimate that the age, severity of injury, number of cohabitants in the domicile and absence of disability certificate could be used as indicators of possible abandonment in the treatment.

Folic acid and folinic acid for reducing side effects in patients receiving methotrexate for rheumatoid arthritis.

OBJECTIVE: To perform a systematic review of the benefits and harms of folic acid and folinic acid in reducing the mucosal, gastrointestinal, hepatic, and hematologic side effects of methotrexate (MTX); and to assess whether folic or folinic acid supplementation has any effect on MTX benefit. METHODS: We searched the Cochrane Library, MEDLINE, EMBASE, and US National Institutes of Health clinical trials registry from inception to March 2012. We selected all double-blind, randomized, placebo-controlled clinical trials in which adult patients with rheumatoid arthritis (RA) were treated with MTX (dose ≤ 25 mg/week) concurrently with folate supplementation. We included only trials using low-dose folic or folinic acid (a starting dose of ≤ 7 mg weekly) because the high dose is no longer recommended or used. Data were extracted from the trials, and the trials were independently assessed for risk of bias using a predetermined set of criteria. RESULTS: Six trials with 624 patients were eligible for inclusion. Most studies had low or unclear risk of bias for key domains. The quality of the evidence was rated as "moderate" for each outcome as assessed by the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) working group, with the exception of hematologic side effects, which were rated as "low." There was no significant heterogeneity between trials, including where folic acid and folinic acid studies were pooled. For patients supplemented with any form of exogenous folate (either folic or folinic acid) while receiving MTX therapy for RA, a 26% relative (9% absolute) risk reduction was seen for the incidence of gastrointestinal side effects such as nausea, vomiting, or abdominal pain (RR 0.74, 95% CI 0.59 to 0.92; p = 0.008). Folic and folinic acid also appear to be protective against abnormal serum transaminase elevation caused by MTX, with a 76.9% relative (16% absolute) risk reduction (RR 0.23, 95% CI 0.15 to 0.34; p < 0.00001), as well as reducing patient withdrawal from MTX for any reason [60.8% relative (15.2% absolute) risk reduction, RR 0.39, 95% CI 0.28 to 0.53; p < 0.00001]. CONCLUSION: The results support a protective effect of supplementation with either folic or folinic acid for patients with RA during treatment with MTX. There was a clinically important significant reduction shown in the incidence of GI side effects and hepatic dysfunction (as measured by elevated serum transaminase levels), as well as a clinically important significant reduction in discontinuation of MTX treatment for any reason.

Folic acid and folinic acid for reducing side effects in patients receiving methotrexate for rheumatoid arthritis.

BACKGROUND: Methotrexate (MTX) is a disease modifying antirheumatic drug (DMARD) used as a first line agent for treating rheumatoid arthritis (RA). Pharmacologically, it is classified as an antimetabolite due to its antagonistic effect on folic acid metabolism. Many patients treated with MTX experience mucosal, gastrointestinal, hepatic or haematologic side effects. Supplementation with folic or folinic acid during treatment with MTX may ameliorate these side effects. OBJECTIVES: To identify trials of supplementation with folic acid or folinic acid during MTX therapy for rheumatoid arthritis and to assess the benefits and harms of folic acid and folinic acid (a) in reducing the mucosal, gastrointestinal (GI), hepatic and haematologic side effects of MTX, and (b) whether or not folic or folinic acid supplementation has any effect on MTX benefit. SEARCH METHODS: We originally performed MEDLINE searches, from January 1966 to June 1999. During the update of this review, we searched additional databases and used a sensitive search strategy designed to retrieve all trials on folic acid or folinic acid for rheumatoid arthritis from 1999 up to 2 March 2012. SELECTION CRITERIA: We selected all double-blind, randomised, placebo-controlled clinical trials (RCTs) in which adult patients with rheumatoid arthritis were treated with MTX (at a dose equal to or less than 25 mg/week) concurrently with folate supplementation. In this update of the review we only included trials using 'low dose' folic or folinic acid (a starting dose of ≤ 7 mg weekly). DATA COLLECTION AND ANALYSIS: Data were extracted from the trials, and the trials were independently assessed for risk of bias using a predetermined set of criteria. MAIN RESULTS: Six trials with 624 patients were eligible for inclusion. Most studies had low or unclear risk of bias for key domains. The quality of the evidence was rated as 'moderate' for each outcome as assessed by GRADE, with the exception of haematologic side effects which were rated as 'low'. There was no significant heterogeneity between trials, including where folic acid and folinic acid studies were pooled.For patients supplemented with any form of exogenous folate (either folic or folinic acid) whilst on MTX therapy for rheumatoid arthritis, a 26% relative (9% absolute) risk reduction was seen for the incidence of GI side effects such as nausea, vomiting or abdominal pain (RR 0.74, 95% CI 0.59 to 0.92; P = 0.008). Folic and folinic acid also appear to be protective against abnormal serum transaminase elevation caused by MTX, with a 76.9% relative (16% absolute) risk reduction (RR 0.23, 95% CI 0.15 to 0.34; P < 0.00001), as well as reducing patient withdrawal from MTX for any reason (60.8% relative (15.2% absolute) risk reduction, RR 0.39, 95% CI 0.28 to 0.53; P < 0.00001).We analysed the effect of folic or folinic acid on the incidence of stomatitis / mouth sores, and whilst showing a trend towards reduction in risk, the results were not statistically significant (RR 0.72, 95% CI 0.49 to 1.06)It was not possible to draw meaningful conclusions on the effect of folic or folinic acid on haematologic side effects of methotrexate due to small numbers of events and poor reporting of this outcome in included trials.It does not appear that supplementation with either folic or folinic acid has a statistically significant effect on the efficacy of MTX in treating RA (as measured by RA disease activity parameters such as tender and swollen joint counts, or physician's global assessment scores). AUTHORS' CONCLUSIONS: The results support a protective effect of supplementation with either folic or folinic acid for patients with rheumatoid arthritis during treatment with MTX.There was a significant reduction shown in the incidence of GI side effects, hepatic dysfunction (asmeasured by elevated serum transaminase levels) as well as a significant reduction in discontinuation of MTX treatment for any reason. A trend towards a reduction in stomatitis was demonstrated however this did not reach statistical significance.This updated review with its focus on lower doses of folic acid and folinic acid and updated assessment of risk of bias aimed to give a more precise and more clinically relevant estimate of the benefit of folate supplementation for patients with rheumatoid arthritis receiving methotrexate.

Major cardiovascular risk factors in Latin America: a comparison with the United States. The Latin American Consortium of Studies in Obesity (LASO).

BACKGROUND: Limited knowledge on the prevalence and distribution of risk factors impairs the planning and implementation of cardiovascular prevention programs in the Latin American and Caribbean (LAC) region. METHODS AND FINDINGS: Prevalence of hypertension, diabetes mellitus, abnormal lipoprotein levels, obesity, and smoking were estimated from individual-level patient data pooled from population-based surveys (1998-2007, n=31,009) from eight LAC countries and from a national survey of the United States (US) population (1999-2004) Age and gender specific prevalence were estimated and age-gender adjusted comparisons between both populations were conducted. Prevalence of diabetes mellitus, hypertension, and low high-density lipoprotein (HDL)-cholesterol in LAC were 5% (95% confidence interval [95% CI]: 3.4, 7.9), 20.2% (95% CI: 12.5, 31), and 53.3% (95% CI: 47, 63.4), respectively. Compared to LAC region's average, the prevalence of each risk factor tended to be lower in Peru and higher in Chile. LAC women had higher prevalence of obesity and low HDL-cholesterol than men. Obesity, hypercholesterolemia, and hypertriglyceridemia were more prevalent in the US population than in LAC population (31 vs. 16.1%, 16.8 vs. 8.9%, and 36.2 vs. 26.5%, respectively). However, the prevalence of low HDL-cholesterol was higher in LAC than in the US (53.3 vs. 33.7%). CONCLUSIONS: Major cardiovascular risk factors are highly prevalent in LAC region, in particular low HDL-cholesterol. In addition, marked differences do exist in this prevalence profile between LAC and the US. The observed patterns of obesity-related risk factors and their current and future impact on the burden of cardiovascular diseases remain to be explained.

Clinical trial regulation in Argentina: overview and analysis of regulatory framework, use of existing tools, and researchers' perspectives to identify potential barriers / Reglamentación de ensayos clínicos en la Argentina: panorama y anßlisis del marco normativo, uso de los instrumentos existentes y perspectivas de los investigadores para identificar posibles obstáculos

OBJECTIVE: To review and analyze the regulatory framework of clinical trial registration, use of existing tools (publicly accessible national/international registration databases), and users' perspectives to identify possible barriers to registration compliance by sponsors and researchers in Argentina. METHODS: Internationally registered trials recruiting patients in Argentina were found through clincialtrials.gov and the International Clinical Trial Registration Platform (ICTRP) and compared with publically available clinical trials registered through the National Administration of Drugs, Foods, and Medical Devices (ANMAT). A questionnaire addressing hypothesized attitudinal, knowledge-related, idiomatic, technical, economic, and regulatory barriers that could discourage or impede registration of clinical trials was developed, and semi-structured, in-depth interviews were conducted with a purposively selected sample of researchers (investigators, sponsors, and monitors) in Argentina. RESULTS: A response rate of 74.3 percent (n = 29) was achieved, and 27 interviews were ultimately used for analysis. Results suggested that the high proportion of foreign-sponsored or multinational trials (64.8 percent of all protocols approved by ANMAT from 1994-2006) may contribute to a communication gap between locally based investigators and foreign-based administrative officials. A lack of knowledge about available international registration tools and limited awareness of the importance of registration were also identified as limiting factors for local investigators and sponsors. CONCLUSIONS: To increase compliance and promote clinical trial registration in Argentina, national health authorities, sponsors, and local investigators could take the following steps: implement a grassroots educational campaign to improve clinical trial regulation, support local investigator-sponsor-initiated clinical trials, and/or encourage local and regional scientific...

OBJETIVO: Examinar y analizar el marco normativo del registro de ensayos clínicos, el uso de los instrumentos existentes (bases de datos de registro nacionales o internacionales de acceso público), y las perspectivas de los investigadores para determinar posibles obstßculos al cumplimiento del registro por los patrocinadores y los investigadores en la Argentina. MÉTODOS: Se realizó una búsqueda en el sitio web clinicaltrials.gov y en la Plataforma Internacional de Registro de Ensayos Clínicos (ICTRP) de los ensayos clínicos registrados en el ßmbito internacional que reclutan pacientes en la Argentina y los resultados se compararon con los ensayos clínicos incluidos en el registro de acceso público de la Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT). Se elaboró un cuestionario que abordaba los hipotéticos obstßculos relacionados con la actitud hacia el registro y el conocimiento de este, así como obstßculos idiomßticos, técnicos y económicos que podrían desalentar o dificultar el registro de los ensayos clínicos, y se llevaron a cabo entrevistas semiestructuradas exhaustivas en una muestra de investigadores seleccionada para este fin (investigadores clínicos, patrocinadores y monitores) en la Argentina. RESULTADOS: Se obtuvo una tasa de respuesta de 74,3 por ciento (n = 29) y finalmente se analizaron 27 entrevistas. Los resultados sugieren que la proporción elevada de ensayos clínicos con patrocinadores extranjeros o los ensayos multinacionales (64,8 por ciento de los protocolos aprobados por la ANMAT entre 1994 y el 2006) pueden contribuir a una deficiencia de comunicación entre los investigadores locales y los funcionarios administrativos ubicados en el extranjero. También se identificaron como factores limitantes para los investigadores y los patrocinadores locales la falta de conocimiento de los recursos internacionales disponibles para el registro y el escaso reconocimiento de la importancia del registro...