Educational interventions in pharmacovigilance to improve the knowledge, attitude and the report of adverse drug reactions in healthcare professionals: Systematic Review and Meta-analysis.

OBJECTIVES: Underreporting of adverse drug reactions (ADRs) limits and delays the detection of signs. The aim of this systematic review with meta-analyses was to synthesize the evidence of educational interventions (EIs) efficacy in health professionals to increase ADR reporting, attitudes, and knowledge of pharmacovigilance. EVIDENCE ACQUISITION: A systematic literature review was carried out to identify randomized clinical trials evaluating the efficacy of EI in pharmacovigilance in health professionals to improve ADR reports, knowledge, and attitude toward pharmacovigilance. ADR reports were pooled by calculating Odds Ratio (OR) with a 95% confidence interval (95%CI), while pharmacovigilance knowledge and attitude were pooled by calculating a mean difference (MD) with 95%CI. In addition, the subanalysis was performed by EI type. Meta-analysis was performed with RevMan 5.4 software. PROSPERO registry CRD42021254270. RESULTS: Eight hundred seventy-five articles were identified as potentially relevant, and 11 were included in the systematic review. Metanalysis showed that EI increased ADR reporting in comparison with control group (OR = 4.74, [95%CI, 2.46 to 9.12], I2 = 93%, 5 studies). In subgroup analysis, the workshops (OR = 6.26, [95%CI, 4.03 to 9.73], I2 = 57%, 3 studies) increased ADR reporting more than telephone-based interventions (OR = 2.59, [95%CI, 0.77 to 8.73], I2 = 29%, 2 studies) or combined interventions (OR = 5.14, [95%CI, 0.97 to 27.26], I2 = 93%, 3 studies). No difference was observed in pharmacovigilance knowledge. However, the subanalysis revealed that workshops increase pharmacovigilance knowledge (SMD = 1.85 [95%CI, 1.44 to 2.27], 1 study). Only one study evaluated ADR reporting attitude among participants and showed a positive effect after the intervention. CONCLUSION: EI improves ADR reports and increases pharmacovigilance knowledge. Workshops are the most effective EI to increase ADR reporting.

Psychometric properties of a Spanish translation of the Functionality Appreciation Scale (FAS) in adults from Colombia.

The 7-item Functionality Appreciation Scale (FAS) measures the extent of an individual's appreciation of their body for what it can do and is capable of doing. Although the FAS has been widely used in diverse linguistic contexts, it has not been previously translated into Spanish. Here, we examined the psychometric properties of a novel Spanish translation of the FAS in Colombian adults. A total of 1420 university students from Colombia (804 women, 616 men) completed the FAS, as well as additional validated measures. Exploratory and confirmatory factor analyses in separate subsamples supported a unidimensional model of FAS scores. The FAS evidenced scalar invariance across gender identity, with men having significantly higher FAS scores than women (Cohen's d = 0.18). FAS scores were also found to have adequate composite reliability, as well as adequate convergent (significant associations with body appreciation, appearance evaluation, and eating disorder psychopathology) and concurrent validity (significant associations with self-esteem, life satisfaction, and gratitude). Functionality appreciation incrementally predicted life satisfaction in women, but not in men. Overall, these results suggest that the Spanish FAS is a psychometrically valid and reliable tool for the assessment of functionality appreciation in university-aged populations from Colombia.

Plantas medicinales que se expende en mercado de Barranca para aliviar las afecciones respiratorias

Muchos años han pasado hasta hoy, donde las plantas medicinales juegan un papel importante en tratamiento de muchas enfermedades y aún falta investigar más sobre sus propiedades. Objetivo. Determinar la relación que hay entre consumo de plantas medicinales y alivio de enfermedades respiratorias de trabajadores del mercado el Milagro. Materiales y métodos. Se basó en estudio descriptivo con enfoque cuantitativo, prospectivo y observacional, se enfocó en edades de 20 a 60 años, ambos sexos quienes participaron voluntariamente. Se tomó datos desde junio hasta setiembre del 2021 de muestra de 60 trabajadores. Se recolectaron datos de dimensiones del consumo de plantas medicinales y relación entre plantas y alivio de enfermedades respiratorias por semana, luego se promedió por mes de allí se procesaron mediante estadísticas básicas y correlación. Resultados. Se pudo determinar que consumieron plantas medicinales como eucalipto, escorzonera y huamanripa para afecciones respiratorias en agosto con 3% y setiembre con 5% eucalipto para COVID-19; consumieron hierbas medicinales como eucalipto, escorzonera y huamanripa como infusiones destacó agosto con 7%; consumieron hierbas medicinales para enfermedades respiratorias destacó julio con 25% y setiembre con 64 % para COVID-19; consumieron hierbas para aliviar síntomas del coronavirus sobresalió setiembre con 80% y correlación entre consumo de hierbas y alivio de síntomas de COVID-19 obtuvo r = 0.8946. Conclusiones. Se pudo establecer que existe una alta relación entre consumo de plantas medicinales y alivio de síntomas este virus y afecciones respiratorias; por lo tanto, los consumos de hierbas en muchos casos conjuntamente con terapia médica mejoraron las dolencias de estas enfermedades.

Many years have passed until today, where medicinal plants play an important role in the treatment of many diseases and there is still a lack of research on their properties. Objective. To determine the relationship between the consumption of medicinal plants and the relief of respiratory diseases in workers of the El Milagro market. Materials and methods. It was based on a descriptive study with a quantitative, prospective and observational approach, focused on ages from 20 to 60 years, both sexes, who participated voluntarily. Data were collected from June to September 2021 from a sample of 60 workers. Data were collected on the dimensions of consumption of medicinal plants and the relationship between plants and relief of respiratory diseases per week, then averaged by month and processed by basic statistics and correlation. Results. It was determined that they consumed medicinal plants such as eucalyptus, scorzonera and huamanripa for respiratory diseases in August with 3% and September with 5 % eucalyptus for COVID-19; they consumed medicinal herbs such as eucalyptus, scorzonera and huamanripa as infusions in August with 7%; consumed medicinal herbs for respiratory diseases, July stood out with 25% and September with 64% for COVID-19; consumed herbs to alleviate symptoms of coronavirus, September stood out with 80% and correlation between consumption of herbs and relief of COVID-19 symptoms obtained r = 0. 8946. Conclusions. It was possible to establish that there is a high relationship between consumption of medicinal plants and relief of symptoms of this virus and respiratory diseases; therefore, the consumption of herbs in many cases together with medical therapy improved the ailments of these diseases.

Muitos anos se passaram até hoje, onde as plantas medicinais desempenham um papel importante no tratamento de muitas doenças e ainda são necessárias mais pesquisas sobre suas propriedades. Objetivo. Determinar a relação entre o consumo de plantas medicinais e o alívio de doenças respiratórias em trabalhadores do mercado El Milagro. Materiais e métodos. Este foi um estudo descritivo com uma abordagem quantitativa, prospectiva e observacional, com foco em trabalhadores com idade entre 20 e 60 anos, de ambos os sexos, que participaram voluntariamente. Os dados foram coletados de junho a setembro de 2021 de uma amostra de 60 trabalhadores. Os dados foram coletados sobre as dimensões do consumo de plantas medicinais e a relação entre as plantas e o alívio de doenças respiratórias por semana, depois calculados em média por mês e processados usando estatísticas básicas e correlação. Resultados. Foi determinado que eles consumiram plantas medicinais como eucalipto, scorzonera e huamanripa para doenças respiratórias em agosto com 3% e setembro com 5%, eucalipto para COVID-19; eles consumiram ervas medicinais como eucalipto, scorzonera e huamanripa como infusões em agosto com 7%; consumiram ervas medicinais para doenças respiratórias em julho com 25% e setembro com 64% para COVID-19; consumiram ervas para aliviar os sintomas do coronavírus, setembro se destacou com 80% e a correlação entre o consumo de ervas e o alívio dos sintomas da COVID-19 obteve r = 0. 8946. Conclusões. Foi possível estabelecer que existe uma alta correlação entre o consumo de plantas medicinais e o alívio dos sintomas desse vírus e das doenças respiratórias; portanto, o consumo de ervas em muitos casos, em conjunto com a terapia médica, melhorou os males dessas doenças.

Alemtuzumab in relapsed immune severe aplastic anemia: Long-term results of a phase II study.

Immune severe aplastic anemia (SAA) is characterized by pancytopenia and immune-mediated bone marrow destruction. SAA may be treated with hematopoietic stem cell transplantation (HSCT) or immunosuppressive therapy (IST). However, 30% of patients treated with IST relapse. We previously reported a clinical trial of alemtuzumab in which more than half of 25 relapsed SAA patients (56%) responded hematologically. Here, we present long-term results of a total of 42 patients. Participants with SAA who had previously completed antithymocyte globulin (ATG)-based IST, but had relapsed, were enrolled on this study. Alemtuzumab was administered intravenously (IV) (n = 28) or subcutaneously (SC) (n = 14). The primary endpoint was hematologic response at 6 months. Secondary endpoints included relapse, clonal evolution, and survival. This trial was registered at clinicaltrials.gov (NCT00195624). Patients were enrolled over 9 years, with median follow-up of 6 years. Median age was 32 years, with 57% being female. At 6 months, 18 patients (43%) achieved response; 15 (54%) of those who received IV compared with 3 (21%) who received SC therapy. Six patients (14%) had durable long-term response without need for subsequent AA-directed therapy or HSCT at last follow-up. Nine patients had clonal evolution, with high-risk evolution occurring in 6. Overall survival was 67% at median follow-up of 6 years. Prolonged iatrogenic immunosuppression was observed as long as 2 years after alemtuzumab administration. Alemtuzumab induces responses in relapsed SAA, some of which are durable long-term. However, immunosuppression can persist for years, requiring long-term monitoring.

Inclusão da atenção à saúde masculina de caminhoneiros a partir do Cartão de Saúde do Caminhoneiro e da Caminhoneira na Atenção Primária à Saúde / Inclusion of male health care for truck drivers from the Truck Driver and Truck Driver Health Card in Primary Health Care / Inclusión de la atención médica masculina para conductores de camiones de la Tarjeta de Salud de Camioneros y Camioneros en la Atención Primaria de Salud

Objetivo: identificar o avanço da implantação do Cartão de Saúde do Caminhoneiro e da Caminhoneira na Atenção Primária à Saúde desses profissionais. Método: estudo descritivo exploratório, por meio de entrevistas estruturadas. O público-alvo foram os profissionais de saúde das unidades de saúde localizadas próximas ao Pontos de Parada e Descanso certificados pelo o Ministério da Infraestrutura e caminhoneiros do sexo masculino presentes nestes mesmos Pontos. Resultados: 50% dos responderam que em sua rota de trabalho já tiveram alguma necessidade de atendimento de saúde, porém 100% responderam que não foram atendidos com o CSCC. 58% dos profissionais de saúde entrevistados não tiveram capacitação sobre PNAISH, 75% responderam que desconhecem a política e 83% a Nota Técnica n° 08/2020. Na avaliação de 25% (n=3) dos profissionais de saúde, o CSCC facilitou o acesso a busca de atendimento na Atenção Primária pelos caminhoneiros. Foram considerados dificuldades ou obstáculos para a implementação do CSCC: a questão de desconhecimento do CSCC por parte da equipe(75%), a falta de capacitação(83%) e a baixa procura dos profissionais caminhoneiros(58%). Conclusão: esta pesquisa resultou em uma proposta de Projeto Piloto de implementação ao acesso à Atenção Primária à Saúde com a prática do Cartão de Saúde do Caminhoneiro e da Caminhoneira

Objective: to identify the progress of the implementation of the Trucker's and Trucker's Health Card in the Primary Health Care of these professionals. Method: exploratory descriptive study, through structured interviews. The target audience was the health professionals of the health units located near the Stop and Rest Points certified by the Ministry of Infrastructure and male truck drivers present in these same Points. Results: 50% of the respondents answered that in their work route they had already had some need for health care, but 100% answered that they were not attended with the CSCC. 58% of the health professionals interviewed did not have training on PNAISH, 75% answered that they are unaware of the policy and 83% the Technical Note No. 08/2020. In the evaluation of 25% (n=3) of the health professionals, the CSCC facilitated the access to seek care in Primary Care by truck drivers. The following were considered difficulties or obstacles to the implementation of the CSCC: the issue of lack of knowledge of the CSCC by the team (75%), the lack of training (83%) and the low demand of professional truck drivers (58%). Conclusion: this research resulted in a proposal for a Pilot Project to implement access to Primary Health Care with the practice of the Trucker's and Trucker's Health Card.

Objetivo: identificar los avances de la implementación de la Tarjeta de Salud del Camionero y Camionero en la Atención Primaria de Salud de estos profesionales. Método: estudio descriptivo exploratorio, a través de entrevistas estructuradas. El público objetivo fueron los profesionales de la salud de las unidades de salud ubicadas cerca de los Puntos de Parada y Descanso certificados por el Ministerio de Infraestructura y los conductores de camiones varones presentes en estos mismos Puntos. Resultados: 50% de los encuestados respondieron que en su ruta de trabajo ya habían tenido alguna necesidad de atención médica, pero 100% respondieron que no fueron atendidos con el CSCC. El 58% de los profesionales de la salud entrevistados no tenía capacitación sobre PNAISH, el 75% respondió que desconoce la política y el 83% la Nota Técnica Nº 08/2020. En la evaluación de 25% (n=3) de los profesionales de salud, el CSCC facilitó el acceso a buscar atención en Atención Primaria por parte de camioneros. Se consideraron dificultades u obstáculos para la implementación del CSCC: el problema de la falta de conocimiento del CSCC por parte del equipo (75%), la falta de capacitación (83%) y la baja demanda de conductores de camiones profesionales (58%). Conclusión: esta investigación resultó en una propuesta de Proyecto Piloto para implementar el acceso a la Atención Primaria de Salud con la práctica de la Tarjeta de Salud del Camionero y Camionero.

Clinical outcomes and immune responses to SARS-CoV-2 vaccination in severe aplastic anaemia.

Patients with severe aplastic anaemia (SAA) are often not vaccinated against viruses due to concerns of ineffective protective antibody response and potential for pathogenic global immune system activation, leading to relapse. We evaluated the impact of COVID-19 vaccination on haematological indices and disease status and characterized the humoural and cellular responses to vaccination in 50 SAA patients, who were previously treated with immunosuppressive therapy (IST). There was no significant difference in haemoglobin (p = 0.52), platelet count (p = 0.67), absolute lymphocyte (p = 0.42) and neutrophil (p = 0.98) counts prior to and after completion of vaccination series. Relapse after vaccination, defined as a progressive decline in counts requiring treatment, occurred in three patients (6%). Humoural response was detectable in 90% (28/31) of cases by reduction in an in-vitro Angiotensin II Converting Enzyme (ACE2) binding and neutralization assay, even in patients receiving ciclosporin (10/11, 90.1%). Comparison of spike-specific T-cell responses in 27 SAA patients and 10 control subjects revealed qualitatively similar CD4+ Th1-dominant responses to vaccination. There was no difference in CD4+ (p = 0.77) or CD8+ (p = 0.74) T-cell responses between patients on or off ciclosporin therapy at the time of vaccination. Our data highlight appropriate humoural and cellular responses in SAA previously treated with IST and true relapse after vaccination is rare.

Predictors of clonal evolution and myeloid neoplasia following immunosuppressive therapy in severe aplastic anemia.

Predictors, genetic characteristics, and long-term outcomes of patients with SAA who clonally evolved after immunosuppressive therapy (IST) were assessed. SAA patients were treated with IST from 1989-2020. Clonal evolution was categorized as "high-risk" (overt myeloid neoplasm [meeting WHO criteria for dysplasia, MPN or acute leukemia] or isolated chromosome-7 abnormality/complex karyotype without dysplasia or overt myeloid neoplasia) or "low-risk" (non-7 or non-complex chromosome abnormalities without morphological evidence of dysplasia or myeloid neoplasia). Univariate and multivariate analysis using Fine-Gray competing risk regression model determined predictors. Long-term outcomes included relapse, overall survival (OS) and hematopoietic stem cell transplant (HSCT). Somatic mutations in myeloid cancer genes were assessed in evolvers and in 407 patients 6 months after IST. Of 663 SAA patients, 95 developed clonal evolution. Pre-treatment age >48 years and ANC > 0.87 × 109/L were strong predictors of high-risk evolution. OS was 37% in high-risk clonal evolution by 5 years compared to 94% in low-risk. High-risk patients who underwent HSCT had improved OS. Eltrombopag did not increase high-risk evolution. Splicing factors and RUNX1 somatic variants were detected exclusively at high-risk evolution; DNMT3A, BCOR/L1 and ASXL1 were present in both. RUNX1, splicing factors and ASXL1 somatic mutations detected at 6 months after IST predicted high-risk evolution.

Danger appraisal and pathogen-avoidance mechanisms in stigma towards severe mental illness: the mediating role of affective responses.

BACKGROUND: Stereotypes of dangerousness are common predictors of stigmatising attitudes towards Severe Mental Illness (SMI). However less is known about pathogen avoidance mechanisms underlying stigma towards SMI, specially in samples of non-industrialised societies of Latin America and the Caribbean. The primary aim of this study was to examine pathogen-disgust sensitivity and danger appraisal mechanisms in responses of stigma towards SMI. METHODS: Cross-sectional design with convenience sampling. Using an online survey, volunteers at the Universidad del Norte in Colombia (N = 271) provided their sociodemographic data and completed the Three-Domain Disgust Scale (TDDS). Participants were randomised to different descriptions of someone with SMI that varied in terms of aggressiveness (with and without danger) and causes of the SMI. Then, following the attribution questionnaire (AQ-27), respondents reported affective and discriminatory responses to the person in the description. RESULTS: Increased disgust sensitivity to pathogen stimuli resulted in stronger reports of anger (ß = .14; p = .03), and fear (ß = 0.27; p < 0.001). The relationship between disgust sensitivity and discriminatory responses was indirectly mediated by fear towards SMI (Bootstrapped CI =-.04,-.009). Dangerousness attributions in the description of SMI predicted stronger feelings of anger (ß = .23; p = 0.001) and fear (ß = .40; p < .001), as well increased support for coercion-segregation of SMI (ß = .34; p = 0.04), but less intentions to help (ß = -.26; p = 0.003). The relationship between dangerousness and support for coercion was mediated by fear (Bootstrapped CI = .72, 1.37) and anger (Bootstrapped CI = .06, .44), whereas pity (Bootstrapped CI = .03, .38) and fear (Bootstrapped CI = -1.39, -.69) mediated responses of support for coercion-segregation of SMI. Attributions about causes and personal responsibility were not significantly linked to stigma towards SMI (p > 0.05). CONCLUSIONS: Findings suggested that pathogen avoidance and danger appraisal systems interplay in the generation of discriminatory behaviour towards SMI. Anti-stigma programs and policy makers would benefit from introducing strategies that challenge stereotypes of dangerousness and unpredictability by promoting positive contact with people with SMI.

Estudio de familia vulnerable de zona rural peruana aplicando el proceso de enfermería / Study of a vulnerable family in a Peruvian rural area applying the nursing process / Estudo de uma família vulnerável em uma área rural peruana aplicando o processo de enfermagem

Se realizó un estudio de caso, en una familia vulnerable de una zona rural. La información se recolectó utilizando como técnicas de la observación, la entrevista, el análisis documental; y de instrumento el formato de valoración de los once Patrones Funcionales de Gordon, mediante visitas domiciliarias; ejecutado de abril a junio del 2021. Se solicitó permiso a la familia previa autorización y consentimiento informado, respetándose la confidencialidad de los datos. Se brindó cuidado enfermero a una familia vulnerable aplicando las etapas del proceso de atención de enfermería, utilizando las taxonomías Diagnostico Enfermeros: Definiciones y Clasificación, Calificación de los Resultados de Enfermería, Clasificación de las Intervenciones de Enfermería. Los diagnósticos priorizados fueron: Mantenimiento ineficaz de la salud relacionado con recursos insuficientes e/p conocimiento insuficiente sobre prácticas básicas de salud; obesidad relacionada con conocimientos insuficientes sobre los factores modificables evidenciado por índice de masa corporal de 34,5 y perímetro abdominal de 1,50 m. de la madre. El último diagnóstico fue: estreñimiento relacionado con cambios en el patrón intestinal manifestado por ingesta insuficiente de fibras, de líquido y falta de ejercicio. La aplicación del plan de cuidados estandarizados en una familia vulnerable en tiempos de pandemia, permitió el abordaje holístico de los problemas identificados, que posibilitó establecer tres diagnósticos, ejecutar las intervenciones, para pasar de una puntuación diana de dos a cuatro, que evidencian la efectividad en el logro de los resultados esperados.

A case study was carried out in a vulnerable family in a rural area. The information was collected using as techniques of observation, interview, documentary analysis; and as an instrument, the evaluation format of the 11 Gordon Functional Patterns, through home visits; executed from April to June 2021. Permission was requested from the family with prior authorization and informed consent, respecting the confidentiality of the data. Nursing care was provided to a vulnerable family applying the stages of the nursing care process, using the Taxonomies of Nursing Diagnosis: Definitions and Classification, Qualification of Nursing Results, Classification of Nursing Interventions. The prioritized diagnoses were: Ineffective health maintenance related to insufficient resources and / or insufficient knowledge about basic health practices; obesity related to insufficient knowledge about modifiable factors evidenced by body mass index of 34.5 and abdominal circumference of 1.50 m. of the mother. The last diagnosis was: constipation related to changes in the intestinal pattern manifested by insufficient fiber and fluid intake and lack of exercise. The application of the standardized care plan in a vulnerable family in times of pandemic, allowed a holistic approach to the problems identified, which made it possible to establish three diagnoses, execute the interventions, to go from a target score of two to four, which show the effectiveness in achieving the expected results.

Foi realizado um estudo de caso em uma família vulnerável em uma área rural. As informações foram coletadas por meio de observação, entrevista, análise documental e o formulário de avaliação dos onze Padrões Funcionais de Gordon como instrumento, por meio de visitas domiciliares; realizadas de abril a junho de 2021. A permissão foi solicitada à família com autorização prévia e consentimento informado, respeitando a confidencialidade dos dados. O atendimento de enfermagem foi prestado a uma família vulnerável aplicando as etapas do processo de atendimento de enfermagem, utilizando as taxonomias Diagnóstico de Enfermagem: Definições e Classificação, Classificação de Resultados de Enfermagem, Classificação de Intervenções de Enfermagem. Os diagnósticos priorizados foram: manutenção ineficaz da saúde relacionada à insuficiência de recursos e/ou conhecimento insuficiente das práticas básicas de saúde; obesidade relacionada ao conhecimento insuficiente dos fatores modificáveis como evidenciado pelo índice de massa corporal da mãe de 34,5 e circunferência abdominal de 1,50 m. O último diagnóstico foi constipação. O último diagnóstico foi constipação relacionada a mudanças no padrão intestinal manifestadas por ingestão insuficiente de fibras, ingestão de líquidos e falta de exercício. A aplicação do plano de atendimento padronizado em uma família vulnerável em tempos de pandemia permitiu uma abordagem holística dos problemas identificados, o que possibilitou estabelecer três diagnósticos, implementar as intervenções e passar de uma pontuação alvo de dois para quatro, demonstrando a eficácia na obtenção dos resultados esperados.

Incidence, severity, and preventability of adverse events during the induction of patients with acute lymphoblastic leukemia in a tertiary care pediatric hospital in Mexico.

Healthcare-associated adverse events represent a heavy burden of symptoms for pediatric oncology patients. Their description allows knowing the safety and quality of the care processes in countries with limited resources. This study aimed to describe the incidence, types, severity, and preventability of adverse events occurring in pediatric patients with acute lymphoblastic leukemia during the induction phase in a tertiary care pediatric hospital in Mexico. This study analyzed a cohort based on medical records of between 2015 and 2017. Initially, information on patients and adverse events was collected; subsequently, two pediatric oncologist reviewers independently classified adverse events, severity and preventability. Agreement between reviewers was evaluated. Adverse events incidence rates were estimated by type, severity, and preventability. One-hundred and eighty-one pediatric patients pediatric patients with acute lymphoblastic leukemia were studied. An overall adverse events rate of 51.8 per 1000 patient-days was estimated, involving 81.2% of patients during induction. Most adverse events were severe or higher (52.6%). Infectious processes were the most common severe or higher adverse event (30.5%). The presence of adverse events caused 80.2% of hospital readmissions. Of the adverse events, 10.5% were considered preventable and 53.6% could be ameliorable in severity. Improving the safety and quality of the care processes of children with acute lymphoblastic leukemia is possible, and this should contribute to the mitigation and prevention of adverse events associated morbidity and mortality during the remission induction phase.

Long-term outcomes in patients with severe aplastic anemia treated with immunosuppression and eltrombopag: a phase 2 study.

Patients with severe aplastic anemia (SAA) are either treated with bone marrow transplant (BMT) or immunosuppression (IST) depending on their age, comorbidities, and available donors. In 2017, our phase 2 trial reported improved hematologic responses with the addition of eltrombopag (EPAG) to standard IST for SAA when compared with a historical cohort treated with IST alone. However, the rates and characteristics of long-term complications, relapse, and clonal evolution, previously described in patients treated with IST alone, are not yet known with this new regimen, IST and EPAG. Patients were accrued from 2012 to 2020, with a total of 178 subjects included in this secondary endpoint analysis. With double the sample size and a much longer median follow-up (4 years) since the original publication in 2017, we report a cumulative relapse rate of 39% in responding patients who received cyclosporine (CSA) maintenance and clonal evolution of 15% in all treated patients at 4 years. Relapse occurred at distinct timepoints: after CSA dose reduction and EPAG discontinuation at 6 months, and after 2 years when CSA was discontinued. Most relapsed patients were retreated with therapeutic doses of CSA +/- EPAG, and two-thirds responded. Clonal evolution to a myeloid malignancy or chromosome 7 abnormality (high-risk) was noted in 5.7% of patients and conferred a poorer overall survival. Neither relapse nor high-risk evolution occurred at a higher rate than was observed in a historical comparator cohort, but the median time to both events was earlier in IST and EPAG treated patients. This trial was registered at www.clinicaltrials.gov as #NCT01623167.

Comportamiento de la mortalidad por COVID-19 en profesionales de enfermería de América Latina / Behavior of COVID-19 mortality in nursing professionals in Latin America / Comportamento de mortalidade dos enfermeiros da COVID-19 na América Latina

Los enfermeros han estado al frente de la crisis causada por la COVID-19 lo que puso de manifiesto las oportunidades del sistema sanitario y la necesidad del cuidado de este gremio profesional. La finalidad del presente estudio fue analizar el comportamiento de la mortalidad por COVID-19 en profesionales de enfermería de América Latina. Se fundamentó en una revisión sistemática de la literatura, donde se hizo seguimiento de la declaración PRISMA en las bases de datos SCIELO, EMBASE, MEDLINE, PsycoINFO y SCOPUS. Los resultados de la búsqueda y aplicación de los criterios de inclusión y exclusión permitieron la selección de 25 trabajos que fueron sintetizados en una matriz que promulgó el análisis de contenido por año, país del recurso y aportes sustanciales de la revisión. Se percibió el efecto del comportamiento del profesional de enfermería en un marco de bienestar en emergencia y frágil a consecuencia del COVID-19.

Nurses have been at the forefront of the crisis caused by COVID-19, which highlighted the opportunities of the health system and the need for the care of this professional guild. The purpose of this study was to analyze the behavior of COVID-19 mortality in nursing professionals in Latin America. It was based on a systematic review of the literature, where the PRISMA statement was followed up in the SCIELO, EMBASE, MEDLINE, PsycoINFO and SCOPUS databases. The results of the search and application of the inclusion and exclusion criteria allowed the selection of 25 papers that were synthesized in a matrix that promulgated the content analysis by year, country of the resource and substantial contributions of the review. The effect of nursing professional behavior in an emergency and fragile wellness setting as a result of COVID-19 was perceived.

Os enfermeiros têm estado na vanguarda da crise da COVID-19, destacando as oportunidades para o sistema de saúde e a necessidade de cuidados de enfermagem. O objetivo deste estudo foi analisar o comportamento da mortalidade dos enfermeiros da COVID-19 na América Latina. Foi baseado em uma revisão sistemática da literatura, onde a declaração PRISMA foi rastreada nas bases de dados SCIELO, EMBASE, MEDLINE, PsycoINFO e SCOPUS. Os resultados da busca e aplicação dos critérios de inclusão e exclusão permitiram a seleção de 25 trabalhos que foram sintetizados em uma matriz que promulgou a análise de conteúdo por ano, país do recurso e contribuições substanciais da revisão. O efeito do comportamento profissional de enfermagem em um ambiente de emergência e bem-estar frágil como resultado da COVID-19 foi percebido.

Teletrabajo en el contexto Covid-19 y su impacto en la salud de docentes universitarios / Teleworking in the context of Covid-19 and its impact on the health of university teachers / Teletrabalho no contexto da Covid-19 e seu impacto na saúde de professores universitários

El teletrabajo es una modalidad de trabajo impulsado en época del contexto Covid-19. Implica la ejecución de labores desde un lugar diferente a la organización haciendo uso de las tecnologías de la información, con ello el estado protege y garantiza el derecho laboral, pero a la vez, constituye una fuente de riesgos para la salud. OBJETIVO. Evaluar los riesgos laborales del teletrabajo en el marco de la emergencia sanitaria Covid-19 en docentes de una universidad pública y privada. METERIAL Y METODOS. Investigación básica de diseño no experimental de tipo descriptivo - comparativo. Se realizó en una muestra de 277 docentes de la Universidad Nacional Santiago Antúnez de Mayolo y Universidad San Ignacio de Loyola del Perú. Los datos se recolectaron a través de un Cuestionario de Riesgos Laborales del Teletrabajo aplicado vía online y tuvo 34 ítems. El instrumento evaluó: riesgos musculoesqueléticos, riesgos psicosociales, fatiga visual y riesgos locativos. RESULTADOS. 48,2% (54) docentes que realizaron teletrabajo en universidades públicas y 44,2% (73) de los docentes de universidades privadas presentaron algún riesgo laboral (riesgo musculoesquelético, riesgo psicosocial, riesgo locativo o riesgo visual). El 37,9% (105) presentaron riesgos laborales músculo esquelético, 22,4% (62) riesgo locativo, 19,5% (54) riesgo laboral psicosocial y 8,7% (24) riesgo visual. CONCLUSIONES. No existe una diferencia significativa de riesgos laborales entre docentes procedentes de universidad pública y privada durante el desarrollo del teletrabajo en el marco de la emergencia sanitaria por Covid-19.

Teleworking is a work modality promoted during the Covid-19 context. It implies the execution of work from a place other than the organization making use of information technologies, with this the state protects and guarantees labor law, but at the same time, constitutes a source of health risks. OBJECTIVE. To evaluate the occupational risks of teleworking in the framework of the Covid-19 health emergency in teachers of a public and private university. MATERIAL AND METHODS. Basic research of non-experimental descriptive-comparative design. It was carried out in a sample of 277 teachers from the Santiago Antúnez de Mayolo National University and the San Ignacio de Loyola University of Peru. The data was collected through a Telework Occupational Risks Questionnaire applied online and had 34 items. The instrument evaluated: musculoskeletal risks, psychosocial risks, visual fatigue and locative risks. RESULTS. 48.2% (54) teachers who teleworked in public universities and 44.2% (73) of teachers from private universities presented some occupational risk (musculoskeletal risk, psychosocial risk, locative risk or visual risk). 37.9% (105) presented musculoskeletal occupational risks, 22.4% (62) locative risk, 19.5% (54) psychosocial occupational risk and 8.7% (24) visual risk. CONCLUSIONS. There is no significant difference in occupational risks between teachers from public and private universities during the development of telework in the framework of the health emergency caused by Covid-19.

O teletrabalho é uma modalidade de trabalho promovida no contexto da Covid-19. Implica a execução do trabalho a partir de um local distinto da organização que faz uso das tecnologias de informação, com isso o Estado protege e garante o direito do trabalho, mas ao mesmo tempo constitui uma fonte de riscos para a saúde. OBJETIVO. Avaliar os riscos ocupacionais do teletrabalho no âmbito da emergência sanitária Covid-19 em docentes de uma universidade pública e privada. MATERIAL E METODOS. Pesquisa básica de delineamento descritivo-comparativo não experimental. Foi realizado em uma amostra de 277 professores da Universidade Nacional Santiago Antúnez de Mayolo e da Universidade San Ignacio de Loyola do Peru. Os dados foram coletados por meio de um Questionário de Riscos Ocupacionais de Teletrabalho aplicado online e continha 34 itens. O instrumento avaliou: riscos musculoesqueléticos, riscos psicossociais, fadiga visual e riscos locativos. RESULTADOS. 48,2% (54) professores que faziam teletrabalho em universidades públicas e 44,2% (73) dos professores de universidades privadas apresentaram algum risco ocupacional (risco musculoesquelético, risco psicossocial, risco locativo ou risco visual). 37,9% (105) apresentavam risco ocupacional musculoesquelético, 22,4% (62) risco locativo, 19,5% (54) risco ocupacional psicossocial e 8,7% (24) risco visual. CONCLUSÕ. Não existe diferença significativa nos riscos ocupacionais entre docentes de universidades públicas e privadas durante o desenvolvimento do teletrabalho no quadro da emergência sanitária provocada por Covid-9.

Prevalence and types of drug interactions in hospitalized pediatric patients in Mexico City.

OBJECTIVE: Drug-drug interactions may modify the therapeutic effect or the safety profile of the medicines used in pediatric populations.  Although interest on potential drug interactions in these age groups has  increased, information on clinically relevant drug-drug interactions is still  scarce. The aim of this study was to explore the prevalence and  characteristics of potential and clinically relevant drug-drug interactions  among pediatric patients hospitalized in two pediatric hospitals of Mexico  City. METHOD: A cross-sectional study was conducted on patient records in critical, oncological, burns and other non-critical services by a pediatric resident physician at both hospitals. Micromedex® was used as a source of potential drug-drug interactions data. Subsequently, each  interaction's prevalence, severity and evidence level were estimated.  Additionally, drug-drug interaction causality with regard to diverse clinical  outcomes of hospitalized patients was determined through the Drug  Interaction Probability Scale. The clinical consequences of each interaction  were classified by severity. RESULTS: The observed prevalence of one or more potential drug-drug interactions in hospitalized patients was 61.3% (52.2-70.4%), whilst  the prevalence of real drug-drug interactions was 3.6% (0.1-7.1%). Of  potential drug-drug interactions, 60.5% were considered major and only  5.1% contraindicated. These were generally more common in intensive  care and burn units. The main pharmacological agents involved in  potential drug-drug interactions were opioids analgesics and anti-infective  and neurologic agents. Four clinically relevant drug-drug interactions  required a regimen change and another prompted an extension of the  patient's hospital stay. CONCLUSIONS: Potential drug-drug interactions were common in the pediatric patients studied, whereas the frequency of real drug-drug  interactions was low. However, some drug-drug interactions required  medical actions in addition to routine monitoring. More information is  needed on real drug-drug interactions as those related to failed efficacy  might be underestimated.

Objetivo: Las interacciones fármaco-fármaco pueden modificar el efecto terapéutico o la seguridad de los medicamentos usados en  poblaciones pediátricas. Aunque el interés sobre interacciones potenciales  en estos grupos etarios viene incrementando, aún es escasa la información sobre interacciones fármaco-fármaco que se manifiestan clínicamente en el paciente (reales). El propósito de este estudio fue explorar la prevalencia y características de las interacciones fármaco-fármaco potenciales y reales  en pacientes ingresados en dos hospitales pediátricos de la Ciudad de  México.Método: Se llevó a cabo un estudio transversal en expedientes de  pacientes atendidos en servicios críticos, oncológicos, de quemados y otros no críticos por un médico residente de pediatría en ambos hospitales. Se  usó Micromedex® como fuente de datos de interacciones potenciales,  luego se estimó su prevalencia por paciente, gravedad y nivel de  evidencia. Adicionalmente, se determinó la causalidad de las interacciones  fármaco-fármaco con diversos desenlaces clínicos de los pacientes  hospitalizados mediante la Drug Interaction Probability Scale, y finalmente  se clasificaron por gravedad.Resultados: La prevalencia observada de pacientes hospitalizados con  una o más interacciones fármaco-fármaco potenciales fue del 61,3% (52,5­70,4%), mientras que la prevalencia de interacciones  fármaco-fármaco reales fue del 3,6% (0,1-7,1%). Entre las interacciones  potenciales, el 60,5% se consideraron importantes y sólo el 5,1%  contraindicadas. En general, las interacciones fármaco-fármaco potenciales fueron más comunes en los servicios de cuidados intensivos y de  quemados. Los principales grupos farmacológicos involucrados en  interacciones potenciales fueron agentes analgésicos opioides, antibióticos  y neurológicos. Cuatro interacciones reales requirieron modificación de la  farmacoterapia y una prolongó la estancia hospitalaria.Conclusiones: Las interacciones potenciales fueron comunes en los pacientes pediátricos estudiados, mientras que la frecuencia de  interacciones reales fue baja; sin embargo, sus consecuencias requirieron  acciones médicas adicionales a la monitorización habitual. Se requiere más información sobre las interacciones reales, aquellas referidas a faltas de  eficacia podrían estar subestimadas.

HLA associations, somatic loss of HLA expression, and clinical outcomes in immune aplastic anemia.

Immune aplastic anemia (AA) features somatic loss of HLA class I allele expression on bone marrow cells, consistent with a mechanism of escape from T-cell-mediated destruction of hematopoietic stem and progenitor cells. The clinical significance of HLA abnormalities has not been well characterized. We examined the somatic loss of HLA class I alleles and correlated HLA loss and mutation-associated HLA genotypes with clinical presentation and outcomes after immunosuppressive therapy in 544 AA patients. HLA class I allele loss was detected in 92 (22%) of the 412 patients tested, in whom there were 393 somatic HLA gene mutations and 40 instances of loss of heterozygosity. Most frequently affected was HLA-B*14:02, followed by HLA-A*02:01, HLA-B*40:02, HLA-B*08:01, and HLA-B*07:02. HLA-B*14:02, HLA-B*40:02, and HLA-B*07:02 were also overrepresented in AA. High-risk clonal evolution was correlated with HLA loss, HLA-B*14:02 genotype, and older age, which yielded a valid prediction model. In 2 patients, we traced monosomy 7 clonal evolution from preexisting clones harboring somatic mutations in HLA-A*02:01 and HLA-B*40:02. Loss of HLA-B*40:02 correlated with higher blood counts. HLA-B*07:02 and HLA-B*40:01 genotypes and their loss correlated with late-onset of AA. Our results suggest the presence of specific immune mechanisms of molecular pathogenesis with clinical implications. HLA genotyping and screening for HLA loss may be of value in the management of immune AA. This study was registered at clinicaltrials.gov as NCT00001964, NCT00061360, NCT00195624, NCT00260689, NCT00944749, NCT01193283, and NCT01623167.

Prevalencia y tipos de interacciones farmacológicas en pacientes pediátricos hospitalizados en la Ciudad de México / Prevalence and types of drug interactions in hospitalized pediatric patients in Mexico City

Objetivo: Las interacciones fármaco-fármaco pueden modificar el efectoterapéutico o la seguridad de los medicamentos usados en poblacionespediátricas. Aunque el interés sobre interacciones potenciales en estos grupos etarios viene incrementando, aún es escasa la información sobre interacciones fármaco-fármaco que se manifiestan clínicamente en el paciente(reales). El propósito de este estudio fue explorar la prevalencia y características de las interacciones fármaco-fármaco potenciales y reales en pacientes ingresados en dos hospitales pediátricos de la Ciudad de México.Método: Se llevó a cabo un estudio transversal en expedientes de pacientes atendidos en servicios críticos, oncológicos, de quemados y otros nocríticos por un médico residente de pediatría en ambos hospitales. Se usóMicromedex® como fuente de datos de interacciones potenciales, luego seestimó su prevalencia por paciente, gravedad y nivel de evidencia. Adicionalmente, se determinó la causalidad de las interacciones fármaco-fármacocon diversos desenlaces clínicos de los pacientes hospitalizados mediante laDrug Interaction Probability Scale, y finalmente se clasificaron por gravedad.Resultados: La prevalencia observada de pacientes hospitalizadoscon una o más interacciones fármaco-fármaco potenciales fue del 61,3%(52,5-70,4%), mientras que la prevalencia de interacciones fármaco-fármacoreales fue del 3,6% (0,1-7,1%). Entre las interacciones potenciales, el 60,5%se consideraron importantes y sólo el 5,1% contraindicadas. (AU)

Objective: Drug-drug interactions may modify the therapeutic effect orthe safety profile of the medicines used in pediatric populations. Althoughinterest on potential drug interactions in these age groups has increased,information on clinically relevant drug-drug interactions is still scarce. Theaim of this study was to explore the prevalence and characteristics ofpotential and clinically relevant drug-drug interactions among pediatricpatients hospitalized in two pediatric hospitals of Mexico City.Method: A cross-sectional study was conducted on patient records incritical, oncological, burns and other non-critical services by a pediatricresident physician at both hospitals. Micromedex® was used as a sourceof potential drug-drug interactions data. Subsequently, each interaction’sprevalence, severity and evidence level were estimated. Additionally,drug-drug interaction causality with regard to diverse clinical outcomes ofhospitalized patients was determined through the Drug Interaction Probability Scale. The clinical consequences of each interaction were classifiedby severity.Results: The observed prevalence of one or more potential drug-druginteractions in hospitalized patients was 61.3% (52.2-70.4%), whilst theprevalence of real drug-drug interactions was 3.6% (0.1-7.1%). Of potential drug-drug interactions, 60.5% were considered major and only 5.1%contraindicated. (AU)

Eltrombopag added to immunosuppression for children with treatment-naïve severe aplastic anaemia.

Acquired severe aplastic anaemia (SAA) has an immune pathogenesis, and immunosuppressive therapy (IST) with anti-thymocyte globulin and cyclosporine is effective therapy. Eltrombopag (EPAG) added to standard IST was associated with higher overall and complete response rates in patients with treatment-naïve SAA compared to a historical IST cohort. We performed a paediatric subgroup analysis of this trial including all patients aged <18 years who received EPAG plus standard IST (n = 40 patients) compared to a historical cohort (n = 87) who received IST alone. Response, relapse, clonal evolution, event-free survival (EFS), and overall survival were assessed. There was no significant difference in either the overall response rate (ORR) or complete response rate at 6 months (ORR 70% in EPAG group, 72% in historical group, P = 0·78). Adults (≥18 years) had a significantly improved ORR of 82% with EPAG compared to 58% historically (P < 0·001). Younger children had lower response rates than did adolescents. The trend towards relapse was higher and EFS significantly lower in children who received EPAG compared to IST alone. Addition of EPAG added to standard IST did not improve outcomes in children with treatment-naïve SAA. EPAG in the paediatric population should not automatically be considered standard of care. Registration: clinicaltrials.gov (NCT01623167).

Descriptive study of adverse drug reactions in a tertiary care pediatric hospital in México from 2014 to 2017.

INTRODUCTION: In Pediatrics, adverse drug reactions (ADRs) affect morbidity and mortality. In Mexico, the characteristics of ADRs and suspect drugs have not been described in hospitalized children. OBJECTIVE: To estimate the frequency of ADRs and describe them, as well as suspect drugs, in a tertiary care pediatric hospital in Mexico. METHODS: A total of 1,649 Hospital Infantil de Mexico Federico Gómez ADR reports were analyzed. Completeness of the information was assessed, and ADRs severity and seriousness were assigned based on NOM-220-SSA1-2012, with causality being established according to the Naranjo algorithm. ADRs were classified with WHO Adverse Drug Reaction Terminology (WHO-ART). The drugs involved in ADRs were categorized according to the Anatomical Therapeutic Chemical (ATC) classification. Descriptive analysis was performed using the SPSS 20 statistical package. RESULTS: Of all the reports, 5.8% lacked sufficient information for the analysis (grade 0). ADRs frequency ranged from 2.12% to 8.07%. ADRs occurred most commonly in children (56.9%), in the female gender (52%), in subjects with normal BMI Z-score (46.6%) and malnutrition (35.3%), diagnosed with neoplasms (72.2%) and in the Emergency Department (70.0%). ADRs were severe in 14.4% of cases, in 81.0% they were serious and 2.1% were classified as definite. Most common serious ADR was febrile neutropenia (44.5%). The 0.7% of patients recovering with sequelae; 1.1% died (with the medication being associated) and 70.3% were admitted to the hospital as a result of an ADR. Antineoplastic and immunomodulating agents were more commonly associated with serious ADRs. CONCLUSION: ADRs affected morbidity and mortality, which is why strengthening pharmacovigilance programs in Mexican pediatric hospitals is necessary.