Ethnobotanical knowledge on non-conventional food plants and medicinal plants in Extractivist Reserve in the Brazilian Amazon / Conocimiento etnobotánico sobre plantas alimenticias no convencionales y plantas medicinales en una Reserva Extractivista en la Amazonía Brasileña

Information on the knowledge and ways of using food and medicinal plants by traditional populations, family farmers and Brazilian native population in the Amazon is essential to guarantee the food sovereignty of these groups. This study was conducted using semi-structured interviews applied to local respondents. A total of 269 species of both non-conventional food plants and medicinal plants were identified, distributed in 83 botanical families and 198 genera. The Arecaceae and Lamiaceae families had the highest species richness (11 and 7, respectively). The Shannon-Wiener (H') and Pielou (J') diversity indices were considered high (5.02 and 0.9, respectively) when compared to other ethnobotanical works. In the environment in which these families are found, these species become the only food and medicinal resources available.

La información sobre los saberes y formas de uso de las plantas alimenticias y medicinales por parte de las poblaciones tradicionales, agricultores familiares e indígenas brasileños en la Amazonía es fundamental para garantizar la soberanía alimentaria de estos grupos. Este estudio se realizó utilizando entrevistas semiestructuradas aplicadas a encuestados locales. Se identificaron un total de 269 especies tanto de plantas alimenticiasno convencionales como de plantas medicinales, distribuidas en 83 familias botánicas y 198 géneros. Las familias Arecaceae y Lamiaceae tuvieron la mayor riqueza de especies (11 y 7, respectivamente). Los índices de diversidad de Shannon-Wiener (H') y Pielou (J') fueron considerados altos (5,02 y 0,9, respectivamente) en comparación con otros trabajos etnobotánicos. En el ambiente en que se encuentran estas familias, estas especies se convierten en los únicos recursos alimenticios y medicinales disponibles.

Cultura de segurança em unidades de terapia intensiva na perspectiva da equipe multiprofissional: Estudo multicêntrico / Cultura de seguridad en unidades de terapia intensiva en la perspectiva del equipo multiprofesional: Estudio multicéntrico / Safety Culture in intensive care units from multiprofessional team perspective: A multicenter study

Resumo Introdução: A Cultura de Segurança do Paciente é considerada um importante componente estrutural dos serviços, que favorece a implantação de práticas seguras e a diminuição da ocorrência de eventos adversos. Objetivo: Identificar os fatores associados à cultura de segurança do paciente nas unidades de terapia intensiva adulto em hospitais de grande porte da região Sudeste do Brasil. Método: Estudo transversal do tipo survey e multicêntrico. Participaram 168 profissionais de saúde de quatro unidades (A, B, C e D) de terapia intensiva adulto. Foi utilizado o questionário "Hospital Survey on Patient Safety Culture". Considerou-se como variável dependente o nível de cultura de segurança do paciente e variáveis independentes aspectos sociodemográficos e laborais. Foram usadas estatísticas descritivas e para a análise dos fatores associados foi elaborado um modelo de regressão logística múltipla. Resultados: Identificou-se associação entre tipo de hospital com onze dimensões da cultura de segurança, quanto à função a categoria profissional médico, técnico de enfermagem e enfermeiro foram relacionadas com três dimensões; o gênero com duas dimensões e tempo de atuação no setor com uma dimensão. Conclusão: Evidenciou-se que o tipo de hospital, categoria profissional, tempo de atuação no setor e gênero foram associados às dimensões de cultura de segurança do paciente.

Resumen Introducción: La cultura de seguridad del paciente se considera un componente estructural importante de los servicios, que favorece la aplicación de prácticas seguras y la reducción de la aparición de acontecimientos adversos. Objetivo: Identificar los factores asociados a la cultura de seguridad del paciente en unidades de terapia intensiva adulto en hospitales de la región Sudeste del Brasil. Metodología: Estudio transversal de tipo encuesta y multicéntrico. Participaron 168 profesionales de salud de cuatro unidades (A, B, C y D) de terapia intensiva adulto. Se utilizó el cuestionario "Hospital Survey on Patient Safety Culture". Se consideró como variable dependiente el nivel de cultura de seguridad del paciente y variables independientes los aspectos sociodemográficos y laborales. Fueron usadas estadísticas descriptivas y, para analizar los factores asociados, fue elaborado un modelo de regresión logística múltiple. Resultados: Se identificó asociación entre tipo de hospital con once dimensiones de cultura de seguridad del paciente. En relación a la función, personal médico, técnicos de enfermería y personal de enfermería fueron asociados con tres dimensiones, el género con dos dimensiones y tiempo de actuación con una dimensión en el modelo de regresión. Conclusión: Se evidenció que el tipo de hospital, función, tiempo de actuación en el sector y género fueron asociados a las dimensiones de la cultura de seguridad del paciente.

Abstract Introduction: Patient safety culture is considered an important structural component of the services, which promotes the implementation of safe practices and the reduction of adverse events. Objective: To identify the factors associated with patient safety culture in adult intensive care units in large hospitals in Belo Horizonte. Method: Cross-sectional survey and multicenter study. A total of 168 health professionals from four units (A, B, C and D) of adult intensive care participated. The questionnaire "Hospital Survey on Patient Safety Culture" was used. The patient's level of safety culture was considered as a dependent variable, and sociodemographic and labor aspects were the independent variables. Descriptive statistics were used and a multiple logistic regression model was developed to analyze the associated factors. Results: An association was identified between the type of hospital and eleven dimensions of the safety culture. In terms of function, the doctors, nursing technicians, and nurse were related to three dimensions; gender with two dimensions, and time working in the sector with one dimension. Conclusion: It was evidenced that the type of hospital, function, time working in the sector, and gender were associated with the dimensions of patient safety culture.

[Ethics of care: Assessment of the ethical issues in the protocols or consensuses on mechanical restraint in force in Spain]. / Ética de los cuidados: valoración de los contenidos éticos en los protocolos o consensos de contención mecánica vigentes en España.

INTRODUCTION: Mechanical restraints are widely used in health care practice, despite the numerous ethical conflicts they raise. The aim of this study is to evaluate the ethical considerations contemplated in the current protocols on mechanical restraint in Spain. METHOD: Systematic review in PubMed, WOS and Scopus, Google and Google Scholar. An ad hoc list of 30 items was used to evaluate the ethical content of the protocols. The quality of guidelines was assessed with AGREE II. RESULTS: The need for informed consent (IC) is reflected in 72% of the documents, the IC model sheet is included in only 41% of them, the rest of the analyzed characteristics on IC are fulfilled in percentages between 6% (the document includes the need to reevaluate the indication for IC) and 31% (the document contemplates to whom it should be requested). More than 20 ethical contents are reflected in 31% of them and less than 10 in 19% of the guidelines. The quality of the guides, according to AGREE II, ranged from 27 to 116 points (maximum possible 161), with a mean score of 68.7. Only 9% of the documents were classified as high quality. Finally, the correlation between ethical content and quality measured with AGREE II was 0.75. CONCLUSIONS: The variability of ethical contents in guidelines on mechanical restraints is very high. The ethical requirements to be included in protocols, consensus or Clinical Practice Guidelines should be defined.

Long-term effectiveness and safety of tolvaptan in autosomal dominant polycystic kidney disease.

BACKGROUND AND OBJECTIVES: Evidence on the long-term use of tolvaptan in autosomal dominant polycystic kidney disease (ADPKD) is limited. The aim was to evaluate the tolvaptan effectiveness and safety in real clinical setting. MATERIAL AND METHODS: A single-center observational study (2016-2022) involving ADPKD patients treated with tolvaptan was conducted. Annual change in serum creatinine (sCr) and estimated glomerular filtration rate (eGFR) before and after treatment initiation were evaluated. Change in total kidney volume (TKV), blood pressure (BP) and urinary albuminuria at 12, 24 and 36 months after initiation were also determined. Adverse events (AEs) according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 were analyzed. RESULTS: A total of 22 patients were included. No significant differences pre- vs post tolvaptan treatment in annual rate of change in eGFR (-3.52ml/min/1.73m2 [-4.98%] vs -3.98ml/min/1.73m2 [-8.48%], p=0.121) and sCr (+0.06mg/dL [4.22%] vs +0.15mg/dL [7.77%], p=0.429) were observed. Tolvaptan improved urinary osmolality at 12 (p=0.019) and 24 months (p=0.008), but not at 36 months (p=0.11). There were no changes in TKV, BP control and urinary albuminuria at 12, 24 or 36 months. A worse response was shown in patients with rapid kidney function decline (p=0.042). A 36.4% of the patients developed grade III/IV AEs. A 22.7% discontinued treatment due to unacceptable toxicity. CONCLUSIONS: This study shows a modest benefit of tolvaptan in ADPKD patients, as well as safety concerns.

Implementation of a traceability system and safe manufacturing medications in a clean room. / Implantación de un sistema de trazabilidad y elaboración segura de medicamentos en la sala blanca.

OBJECTIVE: To describe the process of implementing a traceability and safe drug manufacturing system in the clean room of a Pharmacy Service to increase patient safety, in accordance with current legislation. METHODS: The process was carried out between September 2021 and July 2022. The software program integrated all the recommended stages of the manufacturing process outlined in the "Good Practices Guide for Medication Preparation in Pharmacy Services" (GBPP). The following sections were parameterized in the software program: personnel, facilities, equipment, starting materials, packaging materials, standardized work procedures, and quality controls. RESULTS: A total of 50 users, 4 elaboration areas and 113 equipments were included. 435 components were parameterized (195 raw materials and 240 pharmaceutical specialties), 54 packaging materials, 376 standardized work procedures (123 of them corresponding to sterile medicines and 253 to non-sterile medicines, of which 52 non-sterile were dangerous), in addition 17 were high risk, 327 medium risk, 32 low risk, and 13 quality controls. CONCLUSIONS: The computerization of the production process has allowed the implementation of a traceability and secure drug manufacturing system in a controlled environment in accordance with current legislation.

Caring to care: Nurturing ICU healthcare professionals' wellbeing for enhanced patient safety.

Healthcare professionals working in the Intensive Care Unit (ICU) care for patients suffering from a critical illness and their relatives. Working within a team of people with different personalities, competencies, and specialties, with constraints and demands might contribute to a working environment that is prone to conflicts and disagreements. This highlights that the ICU is a stressful place that can threaten healthcare professionals' wellbeing. This article aims to address the concept of wellbeing by describing how the stressful ICU work-environment threatens the wellbeing of health professionals and discussing how this situation jeopardizes patient safety. To promote wellbeing, it is imperative to explore actionable interventions such as improve communication skills, educational sessions on stress management, or mindfulness. Promoting ICU healthcare professionals' wellbeing through evidence-based strategies will not only increase their personal resilience but might contribute to a safer and more efficient patient care.

Estudio sobre las características de la información sanitaria en las conducciones entre centros penitenciario / Study of the characteristics of medical information in transfers between prisons

Introducción: La movilidad de la población penitenciaria precisa que la información transmitida en los traslados entre centros garantice una óptima continuidad asistencial. Objetivo: Valorar la calidad de la transmisión de información sanitaria cuando los internos son trasladados en conducción entre centros penitenciarios de todo el territorio español. Material y método: Estudio observacional, descriptivo y transversal, consistente en la revisión de historias clínicas de los internos que transitaron por el Centro Penitenciario (CP) Madrid III en un periodo de tres meses. Todas las variables medidas fueron cualitativas, expresadas en frecuencias absolutas y relativas. Resultados: Durante ese tiempo, 1.168 internos transitaron por el CP Madrid III. Solo 21 procedían de centros penitenciarios de Cataluña, País Vasco o Navarra, cuya historia clínica es diferente a la del resto del Estado, y solo el 57,14% aportaban algún tipo de información sanitaria. Del resto de internos, el 70,79% aportaba algún tipo de información: el 63,90% del total tenía medicación prescrita y el 5% metadona. De aquellos que tenían medicación, el 89,10% la tenían prescrita en la prescripción electrónica, siendo correcta en el 98% de los casos. Respecto a la metadona, solo el 75,44% lo tenía prescrito electrónicamente, siendo correcta en todos los casos. La fecha de la última dosis administrada solo se indicó en el 72,40% de los tratamientos. Discusión: Solo el 34,70% de las historias presentaban una calidad óptima en cuanto a la información transmitida, siendo en el 2,50% de los casos la información recibida deficiente. El uso de herramientas informáticas facilita la transmisión de la información, reduce la carga de trabajo y mejora la seguridad del paciente.(AU)

Introduction: The mobility of the prison population creates a need for information transmitted in transfers between centers that can guarantee optimal care continuity. Objective: To assess the quality of transmission of health information when inmates are transferred between prisons in Spain. Material and method: Observational, descriptive and cross-sectional study, consisting of a review of medical records of inmates who passed through Madrid III Prison in a three-month period. All measured variables were qualitative, and were expressed in absolute and relative frequencies. Results: 1,168 inmates passed through Madrid III Prison in this period. Only 21 came from prisons in Catalonia, the Basque Country or Navarre, where their medical records are different from those in the rest of Spain, and only 57.14% provided some type of health information. Of the remaining inmates, 70.79% provided some type of information: 63.90% of the total had prescriptions for medication and 5% were prescribed with methadone. Of those taking medication, 89.10% were prescribed it in electronic prescriptions, which were correct in 98% of the cases. For methadone, only 75.44% had electronic prescriptions,which were correct in all cases. The date of the last dose administered was only indicated in 72.40% of the treatments. Discussion: Only 34.70% of the records presented optimal quality in terms of the information transmitted, and in 2.50% of the cases the information received was deficient. The use of computerized tools facilitates the transmission of information, reduces the workload and improves patient safety.(AU)

Effectiveness and safety of injectable PCSK9 inhibitors in dyslipidaemias’ treatment and cardiovascular disease prevention: An overview of 86 systematic reviews and a network metaanalysis / Eficacia y seguridad de los inyectables inhibidores de la PCSK9 en el tratamiento de dislipidemias y la prevención de enfermedades cardiovasculares: una visión general de 86 revisiones sistemáticas y un metaanálisis en red

Objective Multiple systematic reviews (SR) have been performed on the effects of proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i), often providing conflicting findings. This overview and network meta-analysis (NMA) aimed to summarize SR findings on the efficacy and safety of PCSK9i and provide an updated NMA. Materials and methods MEDLINE (Pubmed), Scopus, Cochrane, Epistemonikos and Google Scholar were searched from inception to September 21, 2023 for SRs of randomized controlled trials (RCTs) and from January 1, 2020 to September 21, 2023 for additional RCTs. Double-independent study selection, data extraction and quality assessment were performed. Qualitative analysis was performed for SRs and a frequentist random-effects model NMA was performed for RCTs. Results Totally, 86 SRs and 76 RCTs were included. Alirocumab (77/86 [90%]) and evolocumab (73/86 [85%]) were mostly analyzed. Associations from SRs (35/42 [83%]) and the updated NMA indicated PCSK9i benefit on major adverse cardiovascular events (MACEs). Reductions were also noted for cerebrovascular events (47/66 [71%]), coronary revascularization (29/33 [88%]) and myocardial infarction (41/63 [65%]). Alirocumab was associated with reductions on all-cause mortality (RR=0.82, 95%CI [0.72,0.94]). Data on any CV event reduction were conflicting (7/16 [44%]). Inclisiran appeared effective only on MACEs (RR=0.76, 95%CI [0.61,0.94]). No reductions in heart failure were observed (0/16). No increases were identified between PCSK9i and any (0/35) or serious adverse events (0/52). However, PCSK9i were associated with injection-site reactions (20/28 [71%]). Conclusion PCSK9i appeared to be effective in CV outcomes and their clinical application was generally safe. (AU)

Objetivo Las revisiones sistemáticas (RS) sobre los efectos de los inhibidores de la proproteína convertasa subtilisina/kexina tipo 9 (PCSK9i), presentan resultados contradictorios. Esta revisión general y metaanálisis en red (MER) tiene como objetivo resumir los hallazgos sobre la eficacia y seguridad de los PCSK9i. Materiales y métodos Se realizaron búsquedas en MEDLINE (PubMed), Scopus, Cochrane, Epistemonikos y Google Scholar desde sus inicios hasta el 21 de septiembre de 2023 para las RS de ensayos controlados aleatorios (ECA) y desde el 1 de enero de 2020 hasta 21 de septiembre de 2023 para los ECA adicionales. La selección de estudios, extracción de datos y evaluación de calidad se llevaron a cabo de manera doble e independiente. Se realizó un análisis cualitativo de las SR y un modelo de efectos aleatorios frecuentistas MER para los ECA. Resultados En total, se incluyeron 86 SR y 76 RCT. Alirocumab (77/86 [90%]) y evolocumab (73/86 [85%]) fueron los más analizados. Se reconocieron beneficios de los PCSK9i en eventos cardiovasculares adversos mayores (ECVAM), reducción de eventos cerebrovasculares (47/66 [71%]), revascularización coronaria (29/33 [88%]) e infartos de miocardio (41/63 [65%]). Alirocumab redujo la mortalidad por todas las causas (RR: 0,82; IC del 95%: 0,72-0,94). Los resultados sobre la reducción de cualquier evento cardiovascular (CV) fueron contradictorios (7/16 [44%]). Inclisiran pareció ser efectivo solo en la reducción de ECVAM (RR: 0,76; IC del 95%: 0,61-0,94). No se observaron reducciones en insuficiencia cardíaca (0/16) o relación con eventos adversos serios (0/52). Sin embargo, se asociaron con reacciones en el lugar de la inyección (20/28 [71%]). (AU)

Perfil de seguridad de nirmatrelvir-ritonavir: evidencia de eventos adversos por interacciones farmacológicas / Safety profile of nirmatrelvir-ritonavir: Evidence of adverse events due to drug-drug interactions

Objetivo: evaluar el perfil de seguridad de nirmatrelvir-ritonavir (NMV-r) en la práctica clínica real y analizar la relevancia clínica de las interacciones farmacológicas en el desarrollo de eventos adversos. Material y métodos: estudio observacional, retrospectivo en el que se evaluaron los datos de seguridad de pacientes tratados con NMV-r entre abril y julio de 2022. Se recopilaron datos demográficos y analíticos antes de comenzar el tratamiento. La duración del seguimiento fue de 28 días y se evaluó el número reacciones adversas reportadas, así como si fueron manejadas de forma ambulatoria o precisaron de asistencia sanitaria especializada y la presencia de deterioro de la función renal y hepática. Se revisó el tratamiento concomitante, identificando interacciones farmacológicas teóricas (IFT) cuya gravedad fue definida mediante la clasificación Lexi-interact. Resultados: el estudio incluyó 146 pacientes, 82 (56,16 %) eran mujeres, cuya mediana de edad fue de 65 años (22-95). El número de IFT detectadas y mantenidas durante el tratamiento con NMV-r fue de 164, siendo el porcentaje de pacientes con al menos una interacción de 62,33%. La mediana de IFT por paciente fue de uno (0-5). En 18 pacientes (11,84%) se reportó al menos un evento adverso (EA). Once EA se relacionaron potencialmente con alguna IFT, 7 pacientes requirieron contacto con asistencia hospitalaria para el manejo del EA, 8 pacientes presentaron deterioro de la función renal y 2 de la función hepática a los 28 días. Los principales grupos de fármacos implicados en la aparición de algún EA fueron los anticoagulantes orales, así como los calcio-antagonistas. Conclusiones: nuestros resultados muestran un elevado número de IFT detectadas entre NMV-r y otros fármacos, aunque la frecuencia de EA asociados fue baja. Este estudio proporciona un mayor conocimiento de los fármacos implicados en dichas interacciones y su potencial relación con la aparición de EA.(AU)

Objective: The aim of the study was to evaluate the safety profile of nirmatrelvir-ritonavir (NMV-r) in real clinical practice and to analyze the clinical relevance of drug-drug interactions in the development of adverse events. Methods: Observational, retrospective study in which safety data of patients treated with NMV-r between April and July 2022 in an outpatient setting were evaluated. The duration of follow-up was 28 days and the number of adverse reactions reported, as well as whether they were managed on an outpatient basis or required health care, and the presence of renal and hepatic function impairment were assessed. Concomitant treatment was reviewed, identifying theoretical drug-drug interactions (TDDIs) whose severity was defined using the Lexi-interact classification. Results: The study included 146 patients, 82 (56,16%) were women, whose median age was 65 years (22-95). The number of TDDIs detected and maintained during treatment with NMV-r was 164, with the percentage of patients with at least one interaction being 62,33%. The median number of TDDIs per patient was 1 (0-5). At least 1 adverse event (AE) was reported in 18 patients (11,84%). Eleven AEs were potentially related to any TDDI. Seven patients required contact with hospital assistance for AE management. Eight patients had impaired renal function and 2 had impaired liver function at 28 days. The main groups of drugs implicated in the occurrence of an AE were oral anticoagulants and calcium antagonists. Conclusions: Our results show a high number of TDDIs detected were detected between NMV-r and other drugs. This study provides greater knowledge of the drugs involved in such interactions and their potential relationship with the occurrence of adverse events.(AU)

Safety profile of nirmatrelvir-ritonavir: Evidence of adverse events due to DDIs / Perfil de seguridad de nirmatrelvir-ritonavir: evidencia de eventos adversos por interacciones farmacológicas

Objetivo: evaluar el perfil de seguridad de nirmatrelvir-ritonavir (NMV-r) en la práctica clínica real y analizar la relevancia clínica de las interacciones farmacológicas en el desarrollo de eventos adversos. Material y métodos: estudio observacional, retrospectivo en el que se evaluaron los datos de seguridad de pacientes tratados con NMV-r entre abril y julio de 2022. Se recopilaron datos demográficos y analíticos antes de comenzar el tratamiento. La duración del seguimiento fue de 28 días y se evaluó el número reacciones adversas reportadas, así como si fueron manejadas de forma ambulatoria o precisaron de asistencia sanitaria especializada y la presencia de deterioro de la función renal y hepática. Se revisó el tratamiento concomitante, identificando interacciones farmacológicas teóricas (IFT) cuya gravedad fue definida mediante la clasificación Lexi-interact. Resultados: el estudio incluyó 146 pacientes, 82 (56,16 %) eran mujeres, cuya mediana de edad fue de 65 años (22-95). El número de IFT detectadas y mantenidas durante el tratamiento con NMV-r fue de 164, siendo el porcentaje de pacientes con al menos una interacción de 62,33%. La mediana de IFT por paciente fue de uno (0-5). En 18 pacientes (11,84%) se reportó al menos un evento adverso (EA). Once EA se relacionaron potencialmente con alguna IFT, 7 pacientes requirieron contacto con asistencia hospitalaria para el manejo del EA, 8 pacientes presentaron deterioro de la función renal y 2 de la función hepática a los 28 días. Los principales grupos de fármacos implicados en la aparición de algún EA fueron los anticoagulantes orales, así como los calcio-antagonistas. Conclusiones: nuestros resultados muestran un elevado número de IFT detectadas entre NMV-r y otros fármacos, aunque la frecuencia de EA asociados fue baja. Este estudio proporciona un mayor conocimiento de los fármacos implicados en dichas interacciones y su potencial relación con la aparición de EA.(AU)

Objective: The aim of the study was to evaluate the safety profile of nirmatrelvir-ritonavir (NMV-r) in real clinical practice and to analyze the clinical relevance of drug-drug interactions in the development of adverse events. Methods: Observational, retrospective study in which safety data of patients treated with NMV-r between April and July 2022 in an outpatient setting were evaluated. The duration of follow-up was 28 days and the number of adverse reactions reported, as well as whether they were managed on an outpatient basis or required health care, and the presence of renal and hepatic function impairment were assessed. Concomitant treatment was reviewed, identifying theoretical drug-drug interactions (TDDIs) whose severity was defined using the Lexi-interact classification. Results: The study included 146 patients, 82 (56,16%) were women, whose median age was 65 years (22-95). The number of TDDIs detected and maintained during treatment with NMV-r was 164, with the percentage of patients with at least one interaction being 62,33%. The median number of TDDIs per patient was 1 (0-5). At least 1 adverse event (AE) was reported in 18 patients (11,84%). Eleven AEs were potentially related to any TDDI. Seven patients required contact with hospital assistance for AE management. Eight patients had impaired renal function and 2 had impaired liver function at 28 days. The main groups of drugs implicated in the occurrence of an AE were oral anticoagulants and calcium antagonists. Conclusions: Our results show a high number of TDDIs detected were detected between NMV-r and other drugs. This study provides greater knowledge of the drugs involved in such interactions and their potential relationship with the occurrence of adverse events.(AU)

Validated medication deprescribing instruments for patients with palliative care needs: a systematic review / Instrumentos validados de desprescripción de medicamentos para los pacientes que reciben cuidados paliativos: una revisión sistemática

Objectives: Patients with life-limiting illnesses are prone to unnecessary polypharmacy. Deprescribing tools may contribute to minimizing negative outcomes. Thus, the aims of the study were to identify validated instruments for deprescribing inappropriate medications for patients with palliative care needs and to assess the impact on clinical, humanistic, and economic outcomes. Methods: A systematic review was conducted in LILACS, PUBMED, EMBASE, COCHRANE, and WEB OF SCIENCE databases (until May 2021). A manual search was performed in the references of enrolled articles. The screening, eligibility, extraction, and bias risk assessment were carried out by 2 independent researchers. Experimental and observational studies were eligible for inclusion. Results: Out of the 5791 studies retrieved, after excluding duplicates (n = 1050), conducting title/abstract screening (n = 4741), and full reading (n = 41), only 1 study met the inclusion criteria. In this included study, a randomized controlled trial was conducted, which showed a high level of bias risk overall. Adults 75 years or older (n = 130) with limited life expectancy and polypharmacy were allocated to 2 groups [intervention arm (deprescribing); and control arm (usual care)]. Deprescribing was performed with the aid of the STOPPFrail tool. The mean number of inappropriate medications and monthly medication costs were significantly lower in the intervention arm. No statistically significant differences were found in terms of unscheduled hospital presentations, falls, fractures, mortality, and quality of life. Conclusions: Despite the availability of several instruments to support deprescribing in patients with palliative care needs, only 1 of them has undergone validation and robust assessment for effectiveness in clinical practice. The STOPPFrail tool appears to reduce the number of inappropriate medications for older people with limited life expectancy (and probably palliative care needs)...(AU)

Objetivo: Los pacientes con enfermedades terminales son propensos a la polifarmacia innecesaria. Las herramientas de desprescripción pueden contribuir a minimizar los resultados negativos. Por lo tanto, los objetivos del estudio fueron identificar instrumentos validados para la desprescripción de medicamentos inapropiados en pacientes con necesidades de cuidados paliativos y evaluar el impacto en los resultados clínicos, humanísticos y económicos. Métodos: Se realizó una revisión sistemática en las bases de datos LILACS, PUBMED, EMBASE, COCHRANE y WEB OF SCIENCE (hasta mayo de 2021). Se realizó una búsqueda manual en las referencias de los artículos incluidos. La selección, elegibilidad, extracción y evaluación del riesgo de sesgo se llevaron a cabo por dos investigadores independientes. Se aceptó la inclusión de estudios observacionales y experimentales. Resultados: De los 5791 estudios recuperados, después de excluir duplicados (n = 1050), realizar la selección de títulos/resúmenes (n = 4741) y la lectura completa (n = 41), solo un estudio cumplió con los criterios de inclusión. En este estudio incluido, se realizó un ensayo controlado aleatorizado, que mostró un alto nivel de riesgo de sesgo en general. A los adultos de 75 años o más (n = 130) con esperanza de vida limitada y polifarmacia se les asignaron dos grupos [grupo de intervención (desprescripción) y grupo de control (atención habitual)]. Se realizó la desprescripción con la ayuda de la herramienta STOPPFrail. El número promedio de medicamentos inapropiados y los costos mensuales de los medicamentos fueron significativamente más bajos en el grupo de intervención. No se encontraron diferencias estadísticamente significativas en términos de presentaciones hospitalarias no programadas, caídas, fracturas, mortalidad y calidad de vida. Conclusiones: A pesar de la disponibilidad de varias herramientas para apoyar la deprescripción en pacientes con necesidades de cuidados paliativos...(AU)

Instrumentos validados de desprescripción de medicamentos para los pacientes que reciben cuidados paliativos: una revisión sistemática / Validated medication deprescribing instruments for patients with palliative care needs: a systematic review

Objectives: Patients with life-limiting illnesses are prone to unnecessary polypharmacy. Deprescribing tools may contribute to minimizing negative outcomes. Thus, the aims of the study were to identify validated instruments for deprescribing inappropriate medications for patients with palliative care needs and to assess the impact on clinical, humanistic, and economic outcomes. Methods: A systematic review was conducted in LILACS, PUBMED, EMBASE, COCHRANE, and WEB OF SCIENCE databases (until May 2021). A manual search was performed in the references of enrolled articles. The screening, eligibility, extraction, and bias risk assessment were carried out by 2 independent researchers. Experimental and observational studies were eligible for inclusion. Results: Out of the 5791 studies retrieved, after excluding duplicates (n = 1050), conducting title/abstract screening (n = 4741), and full reading (n = 41), only 1 study met the inclusion criteria. In this included study, a randomized controlled trial was conducted, which showed a high level of bias risk overall. Adults 75 years or older (n = 130) with limited life expectancy and polypharmacy were allocated to 2 groups [intervention arm (deprescribing); and control arm (usual care)]. Deprescribing was performed with the aid of the STOPPFrail tool. The mean number of inappropriate medications and monthly medication costs were significantly lower in the intervention arm. No statistically significant differences were found in terms of unscheduled hospital presentations, falls, fractures, mortality, and quality of life. Conclusions: Despite the availability of several instruments to support deprescribing in patients with palliative care needs, only 1 of them has undergone validation and robust assessment for effectiveness in clinical practice. The STOPPFrail tool appears to reduce the number of inappropriate medications for older people with limited life expectancy (and probably palliative care needs)...(AU)

Objetivo: Los pacientes con enfermedades terminales son propensos a la polifarmacia innecesaria. Las herramientas de desprescripción pueden contribuir a minimizar los resultados negativos. Por lo tanto, los objetivos del estudio fueron identificar instrumentos validados para la desprescripción de medicamentos inapropiados en pacientes con necesidades de cuidados paliativos y evaluar el impacto en los resultados clínicos, humanísticos y económicos. Métodos: Se realizó una revisión sistemática en las bases de datos LILACS, PUBMED, EMBASE, COCHRANE y WEB OF SCIENCE (hasta mayo de 2021). Se realizó una búsqueda manual en las referencias de los artículos incluidos. La selección, elegibilidad, extracción y evaluación del riesgo de sesgo se llevaron a cabo por dos investigadores independientes. Se aceptó la inclusión de estudios observacionales y experimentales. Resultados: De los 5791 estudios recuperados, después de excluir duplicados (n = 1050), realizar la selección de títulos/resúmenes (n = 4741) y la lectura completa (n = 41), solo un estudio cumplió con los criterios de inclusión. En este estudio incluido, se realizó un ensayo controlado aleatorizado, que mostró un alto nivel de riesgo de sesgo en general. A los adultos de 75 años o más (n = 130) con esperanza de vida limitada y polifarmacia se les asignaron dos grupos [grupo de intervención (desprescripción) y grupo de control (atención habitual)]. Se realizó la desprescripción con la ayuda de la herramienta STOPPFrail. El número promedio de medicamentos inapropiados y los costos mensuales de los medicamentos fueron significativamente más bajos en el grupo de intervención. No se encontraron diferencias estadísticamente significativas en términos de presentaciones hospitalarias no programadas, caídas, fracturas, mortalidad y calidad de vida. Conclusiones: A pesar de la disponibilidad de varias herramientas para apoyar la deprescripción en pacientes con necesidades de cuidados paliativos...(AU)

Papel del radiofarmacéutico clínico en la seguridad del paciente durante los estudios de perfusión miocárdica de esfuerzo con vasodilatadores / Role of the clinical radiopharmacist in patient safety during myocardial perfusion imaging with vasodilator stress agents

Objetivos: Evaluar el papel del radiofarmacéutico en un equipo multidisciplinar en la detección de contraindicaciones del regadenosón para su uso seguro en pacientes a los que se solicitó una SPECT de perfusión miocárdica. Métodos: Se estudió ambispectivamente su uso seguro en 1.905 pacientes (54,1% mujeres, edad media: 66,6±11,7 años, rango: 20-95años). Se registraron datos relativos al sexo, a la edad, al historial médico, a la medicación, a las alergias medicamentosas y a las contraindicaciones para el estrés farmacológico, así como las recomendaciones realizadas al médico nuclear responsable. Resultados: Las contraindicaciones detectadas y las correspondientes recomendaciones fueron las siguientes: riesgo de prolongación del intervalo QTc (7,5%): comprobación previa del intervalo QTc y monitorización del ECG; ictus o AIT previo (4,2%): evaluación de estenosis carotídea; alergia a salicilatos y/o sulfamidas (3,1%): empleo de [99mTc]Tc-MIBI; epilepsia o riesgo de convulsiones (2,4%): uso de adenosina o reconsiderar su indicación; tratamiento con corticosteroides sistémicos en EPOC severa (1,3%): reevaluar las condiciones del paciente; EPOC reagudizada (0,8%): posponer hasta la resolución del episodio agudo; asma grave (0,4%): no realizar la prueba; toma de metilxantinas (0,3%): evitar su consumo previo; otras (6,1%): evaluación de cada contraindicación. No se observaron contraindicaciones en el 73,6% de los pacientes. Se anularon el 2,9% de las peticiones debido a contraindicaciones absolutas. Conclusiones: Empleando una metodología de trabajo sistemática, el radiofarmacéutico detectó un elevado número de incidencias, presentando uno de cada cuatro pacientes alguna contraindicación clínica. Las recomendaciones emitidas fueron aceptadas por los médicos nucleares, que modificaron su enfoque, incrementando así la seguridad de estos pacientes.(AU)

Aim: To assess the radiopharmacist's role in a multidisciplinary team focused on the contraindications of regadenoson in order to ensure the safe use of pharmacologic vasodilator stress agents in patients undergoing SPECT-MPI. Methods: We ambispectively studied its safe use in 1905 patients (54.1% female, mean age: 66.6±11.7 years, range: 20-95years). Sex, age, medical history, medications, drug allergies, and contraindications for stress testing were registered together with recommendations for the nuclear physician in charge. Results: Detected contraindications and corresponding recommendations were as follows: risk factors for QTc interval prolongation 7.5% — measurement of QTc interval previously to test and monitor ECG; prior stroke or TIA 4.2% — consider carotid stenosis assessment; salicylates/sulfonamides allergy 3.1% — use 99mTc-sestamibi; epilepsy or risk factors for seizures 2.4% — use of adenosine or reconsider test indication; systemic corticosteroid therapy for severe COPD 1.3% — reassessment of patient's condition; acute exacerbation of COPD 0.8% — defer test until acute episode is over; severe asthma 0.4% — do not perform test; methylxanthine ingestion 0.3% — avoid consumption previously; other 6.1% — evaluation of other contraindications. No contraindications were detected in 73.6% of patients. The test was cancelled due to absolute contraindications in 2.9% of the requests. Conclusions: Working in a systematic way, the radiopharmacist was able to detect a high number of issues related to regadenoson, with one out of four patients presenting some clinical contraindication. The recommendations given by the radiopharmacist were well accepted by the nuclear physicians who changed their approach contributing to increase the safety of patients referred for MPI.(AU)

Is the sustainability of exposure to non-ionizing electromagnetic radiation possible? / ¿Es posible la sostenibilidad de la exposición a las radiaciones electromagnéticas no ionizantes?

Technological advances imply an increase in artificially generating sources of electromagnetic fields (EMF), therefore, resulting in a permanent exposure of people and the environment (electromagnetic pollution). Inconsistent results have been published considering the evaluated health effects. The purpose of this study was to review scientific literature on EMF to provide a global and retrospective perspective, on the association between human exposure to non-ionizing radiation (NIR, mainly radiofrequency-EMF) and health and environmental effects. Studies on the health effects of 5G radiation exposure have not yet been performed with sufficient statistical power, as the exposure time is still relatively short and also the latency and intensity of exposure to 5G. The safety standards only consider thermal effects, do not contemplate non-thermal effects. We consider relevant to communicate this knowledge to the general public to improve education in this field, and to healthcare professionals to prevent diseases that may result from RF-EMF exposures. (AU)

Los avances tecnológicos implican un aumento de las fuentes artificiales que generan campos electromagnéticos (CEM), esto se traduce en una exposición permanente de las personas y el medio ambiente (contaminación electromagnética) a CEM. Se han publicado resultados contradictorios en cuanto a los efectos evaluados sobre la salud. El propósito de este estudio fue revisar la literatura científica sobre CEM para proporcionar una perspectiva global y retrospectiva, sobre la asociación entre la exposición humana a la radiación no ionizante (RNI, principalmente CEM en el rango de las radiofrecuencias) y los efectos sobre la salud y el medio ambiente. Aún no se han realizado estudios sobre los efectos en la salud de la exposición a la radiación 5G con suficiente potencia estadística, ya que el tiempo de exposición es todavía relativamente corto, igual que ocurre con la latencia y la intensidad de la exposición a la 5G. Las normas de seguridad solo consideran los efectos térmicos, no contemplan los efectos no térmicos. Consideramos relevante comunicar el conocimiento actual sobre este tema tanto al público en general para mejorar la educación en este campo, como a los profesionales sanitarios para prevenir las enfermedades que puedan derivarse de las exposiciones a RF-EMF. (AU)

CLINICAL PROTOCOLS ADOPTED BY NURSES IN THE EXTRAVASATION OF ANTINEOPLASTIC DRUGS: AN INTEGRATIVE REVIEW / PROTOCOLOS CLÍNICOS ADOPTADOS POR ENFERMERÍA EN LA EXTRAVASACIÓN DE FÁRMACOS ANTINEOPLÁSICOS: UNA REVISIÓN INTEGRADORA / PROTOCOLOS CLÍNICOS ADOTADOS PELOS ENFERMEIROS NO EXTRAVASAMENTO DE ANTINEOPLÁSICOS: UMA REVISÃO INTEGRATIVA

Objective: To identify the patient safety measures and clinical protocols adopted by nurses in the case of antineoplastic extravasation. Methodology: The research approach was based on an integrative literature review that used the PICo strategy to structure the research question. Bibliographic surveys were carried out using the MEDLINE, Lilacs, BDENF, SciELO and PubMed databases using the following terms according to DeCS: "Clinical Protocols", " Extravasation of Therapeutic and Diagnostic Materials", "Oncology Nursing", "Patient Safety", "Antineoplastics". After applying the inclusion and exclusion criteria, 25 articles were selected, read in full, classified and organized according to the theme, and critically analyzed. Results: From the analysis of the studies, it was possible to delimit the main actions and knowledge of nurses in the management and guarantee of patient safety in the face of antineoplastic extravasation, as well as promising new managements in the prevention and treatment of this aggravation. Conclusion: Nurses' knowledge of specific measures for antineoplastic drug leakage is incipient, and there is a clear need for research to minimize the gaps in innovative knowledge in nursing practice with the aim of preventing extravasation.

Objetivo: Identificar las medidas de seguridad del paciente y los protocolos clínicos adoptados por el personal de enfermería en el caso de extravasación de antineoplásicos. Metodología: El abordaje de la investigación se basó en una revisión bibliográfica integradora que utilizó la estrategia PICo para estructurar la pregunta de investigación. Las pesquisas bibliográficas fueron realizadas en las bases de datos MEDLINE, Lilacs, BDENF, SciELO y PubMed, utilizando los siguientes términos de acuerdo con el DeCS: "Protocolos clínicos", " Extravasación de material terapéutico y de diagnóstico", "Enfermería oncológica", "Seguridad del paciente", "Antineoplásicos". Tras aplicar los criterios de inclusión y exclusión, se seleccionaron 25 artículos, que fueron leídos en su totalidad, clasificados y organizados según el tema, y analizados críticamente. Resultados: A partir del análisis de los estudios, fue posible delinear las principales acciones y conocimientos de las enfermeras en el manejo y garantía de la seguridad del paciente ante la extravasación de antineoplásicos, así como nuevos manejos promisorios en la prevención y tratamiento de este agravamiento. Conclusión: El conocimiento de las enfermeras sobre las medidas específicas para la fuga de fármacos antineoplásicos es incipiente, existiendo una clara necesidad de investigación para minimizar las lagunas de conocimiento innovador en la práctica enfermera con el objetivo de prevenir la extravasación.

Objetivo: Identificar quais são as medidas de segurança do paciente e protocolos clínicos adotados pelos enfermeiros no extravasamento de antineoplásicos. Metodologia: A abordagem da pesquisa se deu a partir de uma revisão integrativa da literatura que se utilizou da estratégia PICo para estruturar a questão de pesquisa. Foram realizados levantamentos bibliográficos utilizando as bases de dados MEDLINE, Lilacs, BDENF, SciELO e PubMed utilizando os termos segundo o DeCS: "Protocolos Clínicos", "Extravasamento de Materiais Terapêuticos e Diagnósticos", "Enfermagem Oncológica", "Segurança do paciente", "Antineoplásicos". Após a aplicação dos critérios de inclusão e exclusão, foram selecionados 25 artigos lidos na íntegra, classificados e organizados conforme a temática, e analisados criticamente. Resultados: A partir da análise dos estudos, foi possível delimitar as principais ações e conhecimentos dos enfermeiros no manejo e garantia da segurança do paciente diante do extravasamento de antineoplásicos, assim como novos manejos promissores na prevenção e tratamento deste agravo. Conclusão: Incipiente é o conhecimento dos enfermeiros sobre as medidas específicas diante do extravasamento de antineoplásicos, com evidente necessidade de pesquisas que minimizem as lacunas no conhecimento inovador na prática da enfermagem com desígnio de prevenir  o extravasamento.

How a single perioperative delirium case can make the difference.

This report describes how postoperative delirium in an elderly man during COVID-19 pandemic led to a serious event involving a central venous catheter. Delirium is a common cause of perioperative morbidity and mortality, and is characterised by an alteration in consciousness and perception and a reduced ability to focus, sustain or shift attention. The event was analysed by a multidisciplinary committee which developed a risk stratification delirium protocol in order to prevent similar events in the future.

Arbovirus - a threat to transfusion safety in Spain: a narrative review. / Arbovirus como amenaza para la seguridad transfusional en España: revisión narrativa.

Arboviruses represent a threat to transfusion safety for several reasons: the presence of vectors and the notification of autochthonous cases in our region, the recent increase in the number of cases transmitted through blood and/or blood component transfusion, the high prevalence rates of RNA of the main arboviruses in asymptomatic blood donors, and their ability to survive processing and storage in the different blood components. In an epidemic outbreak caused by an arbovirus in our region, transfusion centres can apply different measures: reactive measures, related to donor selection or arbovirus screening, and proactive measures, such as pathogen inactivation methods. The study of the epidemiology of the main arboviruses and understanding the effectiveness of the different measures that we can adopt are essential to ensure that our blood components remain safe.

Presence of metallic components in transdermal drug delivery systems and risk of skin burns. / [Artículo traducido] Presencia de partículas metálicas en parches transdérmicos de medicamentos y riesgo de quemaduras.

OBJECTIVE: Skin burns are associated with the presence of metallic components in transdermal drug delivery systems during Magnetic Resonance Imaging, cardioversion or defibrillation procedures. The aim of the study was to review the presence of metallic components in marketed products of transdermal drug delivery systems in Spain. METHOD: For each presentation, the summary of product characteristics was reviewed. If the information was not provided, manufacturers were contacted. RESULTS: We identified 59 marketed products of transdermal drug delivery systems of 12 different active substances. 59.3% of patches contained metallic components or their presence could not be ruled out. Information regarding the need to remove the patch was only included in 8 summaries of product characteristics (13.6%). A table was elaborated and included the following aspects: product, active substance, manufacturer, need to remove the patch before the exposure to magnetic or electric fields and references. CONCLUSION: More than a half of the patches at the time of the study contained metals or their absence could not be confirmed by the manufacturer. However, this information was only included in 13.6% of summaries of product characteristics.

[Occupational health policies in older workers: comparative analysis between Spain and Chile]. / Políticas en salud laboral en personas trabajadoras mayores: análisis comparativo entre España y Chile.

OBJECTIVE: To analyze and compare the current Spanish and Chilean regulations regarding occupational risk prevention, regarding the existence of specific indications that protect the occupational health and safety of people over 55 years of age. METHOD: Qualitative study in which a documentary content analysis was carried out using ATLAS/ti. The sample was 88 regulatory documents on occupational risk prevention for Spain and Chile. The guidance of the European Agency for Safety at Work (EU-OSHA) regarding age-critical risks was followed. RESULTS: In global terms, 21.9% of the total Spanish documents analyzed show the explicit presence of considerations on aging, while for Chile this occurs in 9%. Both countries mention indications regarding ergonomic risks and noise. Shift work and psychosocial risks are considered only in Spain, while extreme temperatures, vibrations and geographical altitude appear exclusively in Chilean regulations. Neither country refers to issues inherent to working women (care responsibilities, menopause). CONCLUSIONS: The Spanish regulations present a greater presence of indications on aging compared to the Chilean one. However, development in this area is insufficient in both countries. Chile and Spain have guides of recommendations, which are not mandatory, and their application is voluntary. This suggests that the prevention of occupational risks has a great pending challenge with people over 55 years of age.

Revisión sistemática de los ensayos clínicos sobre terapia antitrombótica con inhibidores del factor XI / Systematic review of clinical trials on the antithrombotic therapy with factor XI inhibitors

Antecedentes y objetivo La información proveniente de los ensayos clínicos fase 2 sugiere que los inhibidores del factor XI podrían mostrar un perfil de eficacia/seguridad más favorable que las terapias antitrombóticas actuales. El objetivo de esta revisión sistemática es analizar la evidencia disponible derivada de esos estudios. Métodos Se realizó una búsqueda bibliográfica en las bases de datos PubMed, Cochrane Library, Scopus y EMBASE, y en las plataformas de registro de ensayos clínicos Clinical Trials y Cochrane Central Register of Controlled Trials. Los resultados se publicaron según la declaración PRISMA. Resultados Se identificaron un total de 18 ensayos clínicos concluidos o en curso abordando múltiples escenarios, incluyendo fibrilación auricular, ictus, infarto de miocardio y tromboembolismo venoso. Se analizó la evidencia procedente de 8 estudios con resultados disponibles. En general, los estudios fase 2 con inhibidores del factor XI mostraron un perfil adecuado de eficacia y seguridad. El balance beneficio/riesgo fue más favorable en términos de reducción de tromboembolismo venoso en pacientes sometidos a artroplastia total de rodilla. Para esta indicación, los inhibidores del factor XI mostraron una reducción global del 50% en la tasa de complicaciones trombóticas y del 60% en la tasa de hemorragias comparado con enoxaparina. En los estudios de pacientes con fibrilación auricular, ictus e infarto de miocardio se observaron resultados más modestos. Conclusión Los inhibidores del Factor XI abren nuevas perspectivas en el tratamiento y la profilaxis antitrombótica. Los estudios fase 3 en curso permitirán definir los fármacos e indicaciones más idóneas. (AU)

Background and objective Data from phase 2 clinical trials suggest that factor XI inhibitors may exhibit a more favourable efficacy/safety profile than current antithrombotic therapies. This systematic review aims to analyze the available evidence derived from these studies. Methods A literature search in the PubMed, Cochrane Library, Scopus, EMBASE databases, and clinical trial registration platforms Clinical Trials and Cochrane Central Register of Controlled was conducted. The results were reported in accordance with the PRISMA statement. Results A total of 18 completed or ongoing clinical trials addressing multiple scenarios, including atrial fibrillation, stroke, myocardial infarction, and venous thromboembolism, were identified. Evidence from 8 studies with available results was analyzed. Overall, phase 2 studies with factor XI inhibitors demonstrated an acceptable efficacy and safety profile. The benefit-risk balance, in terms of reducing venous thromboembolism in patients undergoing total knee arthroplasty, was more favourable. For this scenario, factor XI inhibitors showed a 50% reduction in the overall rate of thrombotic complications and a 60% reduction in bleeding compared to enoxaparin. Modest results in studies involving patients with atrial fibrillation, stroke, and myocardial infarction were observed. Conclusions Factor XI inhibitors offer new prospects in antithrombotic treatment and prevention. Ongoing phase 3 studies will help define the most suitable drugs and indications. (AU)