[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.

Healing grief - an online self-help intervention programme for bereaved Chinese with prolonged grief: study protocol for a randomised controlled trial.

Background: In China, mental health services do not currently meet the needs of bereaved people with symptoms of prolonged grief disorder (PGD). Internet-based grief interventions may help fill this gap, but such programmes have not yet been developed or evaluated in China. The proposed study aims to investigate the effectiveness, acceptability, and feasibility of an online self-help intervention programme named Healing Grief for bereaved Chinese with prolonged grief, and to explore the psychological mechanisms of potential improvements.Methods: We designed a two-arm randomised controlled trial. At least 128 participants will be randomly assigned to either an Internet-based intervention group or a waitlist-control group. The Internet-based intervention will be developed based on the dual process model, integrating techniques of psychoeducation, behavioural activation, cognitive reappraisal, and meaning reconstruction, and will be delivered via expressive writing. The intervention comprises six modules, with two sessions in each module, and requires participants to complete two sessions per week and complete the intervention in 6 weeks. The primary outcomes include effectiveness, acceptability, and feasibility. The effectiveness will be assessed by measures of prolonged grief, posttraumatic stress, anxiety, and depressive symptoms. Acceptability and feasibility will be evaluated using survey and interview on user experience characteristics. Secondary outcomes include moderators and mediators, such as dual process coping, grief rumination, mindfulness, and continuing bond, to explore the psychological mechanisms of potential improvement. Assessments will take place at pre-intervention, post-intervention, and 3-month follow-up.Conclusion: The proposed study will determine the effectiveness, acceptability, and feasibility of the newly developed online self-help intervention for bereaved Chinese with prolonged grief and clarify how the intervention helps with symptom improvements. Such an intervention may play an important role in easing the imbalance between the delivery and receipt of bereavement psychological services in China.

In China, mental health services are not widely available for bereaved people.The proposed study will be the first one to develop and evaluate an Internet-based self-help grief intervention for bereaved Chinese with prolonged grief.The proposed study will determine whether and how the intervention helps to improve the mental health of bereaved Chinese with prolonged grief.

An effective insulin infusion protocol for severe traumatic brain injury patients: A retrospective observational study.

PURPOSE: Severe traumatic brain injury (sTBI) patients often experience stress hyperglycaemia, which can lead to negative outcomes. This study aims to introduce an effective insulin infusion protocol specifically designed for sTBI patients. METHODS: Data was collected from all sTBI patients during two periods: 1 October 2019 to 30 April 2020, and 1 June 2020 to 31 December 2020. In May 2020, a new insulin infusion protocol was implemented. Blood glucose management, infection, coagulation, and prognosis were compared in these two periods. RESULT: 195 patients were included, with 106 using the new protocol. The proportion of hyperglycaemia decreased from 40.04% to 26.91% (P<0.05), and the proportion of on-target blood glucose levels increased from 35.69% to 38.98% (P<0.05). Average blood glucose levels decreased from 9.98±2.79mmol/L to 8.96±2.82mmol/L (P<0.05). There was no substantial increase in hypoglycaemia, which remained controlled below 1%. The new protocol positively influenced glucose concentration and dispersion trends. There were no significant differences in catheter-related infections, antibiotic use, mechanical ventilation (MV) duration, length of stay in ICU, Glasgow Outcome Scale (GOS), or mortality. However, the conventional protocol group had a higher coagulation tendency (R-value of thromboelastography 4.80±1.35min vs. 5.52±1.87min, P<0.05), with no difference in deep vein thrombosis (DVT) incidence. CONCLUSION: Our findings suggest that a customized insulin infusion process for sTBI patients can effectively manage blood glucose. While there is no significant improvement in infection control or prognosis, it may have a positive impact on coagulation without affecting the occurrence of DVT.

Multidisciplinary treatment program for improvement in pain and disability associated with nonspecific chronic low back pain / Programa de tratamento multidisciplinar para melhora da dor e incapacidade associada a dor crônica lombar inespecífica

ABSTRACT BACKGROUND AND OBJECTIVES: Lumbar disorders, which contribute to significant workplace absenteeism and chronic disability, are associated with a considerable financial and social burden. Although a conservative approach provides satisfactory pain relief, biomechanical improvement and is associated with a low risk of adverse effects, there is lack of consensus in the literature regarding the best therapeutic strategy in such cases. METHODS: This retrospective longitudinal study used secondary data from the institutional medical records of patients who completed a multidisciplinary program for the treatment of low back pain between 2019 and 2021. Data regarding pain levels and motor skills were obtained from patients who completed the care program at a private hospital in Bento Gonçalves, RS. The following step-wise treatment algorithm was used: evaluation by a specialist physician for the etiological diagnosis of pain, pharmacological management and dry needling, followed by standard rehabilitation intervention performed by the physiotherapy team and exercises by the physical education team. The visual analogue scale (VAS) was used to measure pain at the start and at the completion of the intervention, and the Oswestry Disability Index (ODI) was used to measure motor skills at the start and at 6 and 12 months following the multiprofessional intervention for rehabilitation. RESULTS: A reduction in pain and motor disability in patients who completed all stages of the treatment program was observed. Pain by the VAS presented the following scores: baseline 7 [5-8] and after treatment 2 [0-4]; and the scores of the ODI were: at baseline 0.34 [0.26 - 0.40], at 6 months 0.16 [0.08 - 0.26] and after treatment 0.12 [0.04 - 0.21]. CONCLUSION: The treatment program reduced the pain and disability associated with low back pain and can serve as the basis for further studies carried out to confirm the effectiveness of this intervention.

RESUMO JUSTIFICATIVA E OBJETIVOS: As doenças lombares, que contribuem para um absenteísmo significativo no local de trabalho e para a incapacidade crônica, estão associadas a um encargo financeiro e social considerável. Embora a abordagem conservadora proporcione alívio satisfatório da dor, melhore a biomecânica e esteja associada a baixo risco de efeitos adversos, não há consenso na literatura sobre a melhor estratégia terapêutica nesses casos. MÉTODOS: Neste estudo longitudinal retrospectivo, foram utilizados dados secundários dos prontuários médicos institucionais de pacientes que completaram um programa multidisciplinar para tratamento de dor lombar entre 2019 e 2021. Dados sobre níveis de dor e habilidades motoras foram obtidos de pacientes que completaram o programa assistencial de um hospital privado de Bento Gonçalves, RS. Foi utilizado o seguinte tratamento passo a passo: avaliação por médico especialista para diagnóstico etiológico da dor, manejo farmacológico e agulhamento a seco, seguido de intervenção de reabilitação padrão realizada pela equipe de fisioterapia e exercícios pela equipe de educação física. A escala analógica visual (EAV) foi utilizada para medir a dor no início e após a conclusão da intervenção, e o Índice de Incapacidade de Oswestry (ODI) foi usado para medir as habilidades motoras no início e aos 6 e 12 meses após a intervenção multiprofissional para reabilitação. RESULTADOS: Observou-se redução na dor e na incapacidade motora em pacientes que completaram todas as etapas do programa de tratamento. A intensidade da dor medida pela EAV apresentou as seguintes pontuações: basal 7 [5-8] e após tratamento 2 [0-4]; enquanto o ODI apresentou as pontuações: basal 0,34 [0,26 - 0,40], até 6 meses 0,16 [0,08 - 0,26] e após o tratamento 0,12 [0,04 - 0,21]. CONCLUSÃO: O programa de tratamento reduziu a dor e a incapacidade associadas à dor lombar e pode servir de base para novos estudos realizados para confirmar a eficácia desta intervenção.

Protocolo de avaliação para apraxia de fala adquirida / Assessment protocol for acquired apraxia of speech

RESUMO Objetivo Elaborar um protocolo de avaliação do planejamento motor da fala com estímulos fonologicamente balanceados para o português brasileiro e que contemple todas as variáveis necessárias para este diagnóstico. Método Foram realizadas três etapas: Na primeira, construíram-se listas de palavras cujo critério principal foram os padrões silábicos e acentuais. Do levantamento realizado na Etapa 1, procedeu-se à seleção dos vocábulos que compuseram a primeira versão do protocolo na Etapa 2, reunidas em duas tarefas: de repetição e de Leitura em Voz Alta (LVA). Em seguida, investigou-se a ocorrência das palavras usando a base de dados do Corpus Brasileiro (PUC-SP) - Linguateca. Na etapa 3 realizou-se a análise estatística para verificar se as listas de repetição e de LVA estavam equilibradas quanto à ocorrência das palavras. Assim, as listas foram distribuídas em quartis e foram analisadas de forma descritiva e bivariada. O nível de significância utilizado foi de 5%. Resultados Após a realização de todas as etapas, foi possível obter as palavras que compuseram as listas das tarefas de repetição e de LVA. Finalmente, foram então acrescidas ao protocolo as demais tarefas consideradas essenciais para a avaliação da apraxia como as taxas diadococinéticas e a prancha para a emissão oral espontânea. Conclusão O protocolo desenvolvido contém as tarefas consideradas padrão para a avaliação da apraxia de fala pela literatura internacional, o que torna esse instrumento importante para o diagnóstico desse distúrbio em falantes do português brasileiro.

ABSTRACT Purpose To develop an assessment protocol for speech motor planning with phonologically balanced stimuli for Brazilian Portuguese, including all necessary variables for this diagnosis. Methods Three stages were carried out: In the first, word lists were built with the main criterion being syllabic and accentual patterns. From the survey conducted in Stage 1, the words that composed the first version of the protocol lists in Stage 2 were selected, and grouped into two fundamental tasks for diagnosing acquired apraxia of speech (AOS): repetition and Reading Aloud (RA). In Stage 3, the occurrence of words was investigated using the Brazilian Corpus (PUC-SP) - Linguateca database, and a statistical analysis was performed to verify if the repetition and RA lists were balanced in terms of the occurrences. Thus, the lists were distributed in quartiles and submitted to both descriptive and bivariate analyses. A significance level of 5% (p<0.05) was adopted. Results After completion of all stages, the words that composed the lists of the repetition and RA tasks were obtained. Finally, other tasks considered essential for the assessment of AOS, such as diadochokinetic rates and the board for spontaneous oral emission, were then added to the protocol. Conclusion The developed protocol contains the tasks considered standard for the assessment of AOS according to the international literature, which makes this instrument important for diagnosing this disorder in speakers of Brazilian Portuguese.

DPYD genotyping and 5-fluoropyrimidine toxicity: An overview of systematic reviews protocol. / [Artículo traducido] Genotipado del gen DPYD y toxicidad de las 5-fluoropirimidinas: protocolo de un resumen de revisiones sistemáticas.

INTRODUCTION: The increased risk of severe and life-threatening toxicity in patients with dihydropyridine dehydrogenase deficiency, under treatment with fluoropyrimidines, has been widely studied. An up-to-date overview of systematic reviews summarizing existing literature can add value by highlighting most relevant information and supports decision-making regarding treatment in dihydropyridine dehydrogenase deficient patients. The main objective of this overview is to identify published systematic reviews on the association between germline variations in the DPYD gene and fluoropyrimidine toxicity. METHODS AND ANALYSIS: This protocol was developed following the Preferred Reported Items for Systematic Review and Meta-analysis Protocols (PRISMA-P) checklist, and the overview of systematic reviews will be reported in accordance with the PRISMA statement. PubMed, Embase, Scopus and the Cochrane Library will be searched from inception to 2023. Systematic reviews irrespective of study designs that analyze the association between germline variations in the DPYD and fluoropyrimidine toxicity will be considered. Methodological quality will be assessed using AMSTAR2 checklist (Measurement Tool to Assess Systematic Reviews 2). Two independent investigators will perform the study selection, quality assessment and data collection. Discrepancies will be solved by a third investigator.

[Protocol of action in the dietary and nutritional approach in patients with dysphagia]. / Protocolo de actuación en el abordaje dietético y nutricional en pacientes con disfagia.

Introduction: Introduction: dysphagia is classified under "symptoms and signs involving the digestive system and abdomen" in the International Classification of Diseases (ICD-10, code R13). It is defined as obstruction in the region of the pharynx, sternum or xiphoid because of obstruction of the passage of food from the mouth to the stomach or cardia, and has become one of the most important causes affecting the adequate intake of energy and nutrients. An optimal dietary and nutritional approach plays a crucial role in the management of dysphagia. The main goal of such an approach is to ensure safe and sufficient nutrition to prevent malnutrition and complications associated with dysphagia. Objectives: to establish an action protocol for an effective dietary and nutritional approach in patients with dysphagia based on the existing scientific evidence. Methods: a review of the scientific literature on the dietary-nutritional approach to dysphagia was carried out. Results: the dietary and nutritional approach in patients with dysphagia requires a multidisciplinary and personalized approach and is essential to improve the quality of life of patients with dysphagia. Through the implementation of an evidence-based action protocol, it is possible to guarantee preventing aspiration and ensuring safe swallowing and modification of textures of different foods (thus promoting adequate intake of nutrients and fluids to avoid malnutrition and dehydration). Conclusion: adequate and protocolized management, from a dietary and nutritional point of view, can have a significant impact on the quality of life of patients, improving their well-being and preventing complications associated with this condition.

Introducción: Introducción: la disfagia se clasifica dentro de los "síntomas y signos que involucran el sistema digestivo y el abdomen" en la Clasificación Internacional de Enfermedades (CIE-10, código R13). Dicho síntoma produce en la región de la faringe, el esternón o el xifoides como resultado de la obstrucción del paso de alimentos de la boca al estómago o al cardias, y se ha convertido en una de las causas más importantes que afecta a la ingesta adecuada de energía y nutrientes. Un abordaje dietético y nutricional óptimo desempeña un papel crucial en el manejo de la disfagia. El objetivo principal de dicho abordaje es garantizar una alimentación segura y suficiente para prevenir la desnutrición y las complicaciones asociadas a la disfagia. Objetivos: establecer un protocolo de actuación para realizar, de forma eficaz, el abordaje dietético y nutricional en pacientes con disfagia en base a la evidencia científica existente. Métodos: se llevó a cabo una revisión de la literatura científica sobre el abordaje dietético-nutricional de la disfagia. Resultados: el abordaje dietético y nutricional en pacientes con disfagia requiere un enfoque multidisciplinar y personalizado, y es fundamental para mejorar la calidad de vida de los pacientes con disfagia. A través de la implementación del protocolo de actuación basado en la evidencia, se puede garantizar: prevenir la aspiración y asegurar una deglución segura y, modificación de texturas de los diferentes alimentos (promoviendo de esta forma la ingesta adecuada de nutrientes y líquidos para evitar la desnutrición y la deshidratación). Conclusión: un manejo adecuado y protocolizado, desde el punto de vista dietético y nutricional, puede llegar a tener un impacto significativo en la calidad de vida de los pacientes, mejorando su bienestar y previniendo complicaciones asociadas a esta condición.

Resumen ejecutivo de la actualización 2023 del consenso de actuación básica durante el ingreso hospitalario por insuficiencia cardiaca aguda / Executive summary of the 2023 update on the consensus regarding basic conduct during hospital admission for patients with acute heart failure

La insuficiencia cardiaca aguda (ICA) está asociada a una importante morbimortalidad, constituyendo la primera causa de hospitalización en mayores de 65 años en nuestro país. Las principales recomendaciones recogidas son: 1) al ingreso, se recomienda realizar una evaluación integral, considerando el tratamiento habitual y comorbilidades, ya que condicionan el pronóstico; 2) en las primeras horas de atención hospitalaria, el tratamiento descongestivo es prioritario, y se recomienda un abordaje terapéutico diurético precoz y escalonado en función de la respuesta; 3) durante la fase estable, se recomienda considerar el inicio y/o titulación del tratamiento con fármacos basados en la evidencia, es decir, sacubitrilo/valsartán o inhibidores de la enzima convertidora de angiotensina/antagonistas de los receptores de angiotensina II, betabloqueantes, antialdosterónicos e inhibidores SGLT2, y 4) en el momento del alta hospitalaria, es recomendable utilizar un listado —tipo check-list— para optimizar el manejo del paciente hospitalizado e identificar las opciones más eficientes para mantener la continuidad de cuidados tras el alta (AU)

Acute heart failure (AHF) is associated with significant morbidity and mortality and it stands as the primary cause of hospitalization for individuals over the age of 65 in Spain. This document outlines the main recommendations as follows: (1) upon admission, it is crucial to conduct a comprehensive assessment, taking into account the patient's standard treatment and comorbidities, as these factors determine the prognosis of the disease; (2) During the initial hours of hospital care, prioritizing decongestive treatment is essential. It is recommended to adopt an early staged diuretic therapeutic approach based on the patient's response; (3) In order to manage patients in the stable phase, it is advisable to consider initiating and/or adjusting evidence-based drug treatments such as sacubitril/valsartan or angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers, beta blockers, aldosterone antagonists, and SGLT2 inhibitors; (4) Upon hospital discharge, utilizing a checklist is recommended to optimize the patient's management and identify the most efficient options for ensuring continuity of care post-discharge (AU)

Dapagliflozin in patients with critical illness: rationale and design of the DEFENDER study / Dapagliflozina em pacientes com doença crítica: justificativa e desenho do estudo DEFENDER

ABSTRACT Background: Critical illness is a major ongoing health care burden worldwide and is associated with high mortality rates. Sodium-glucose cotransporter-2 inhibitors have consistently shown benefits in cardiovascular and renal outcomes. The effects of sodium-glucose cotransporter-2 inhibitors in acute illness have not been properly investigated. Methods: DEFENDER is an investigator-initiated, multicenter, randomized, open-label trial designed to evaluate the efficacy and safety of dapagliflozin in 500 adult participants with acute organ dysfunction who are hospitalized in the intensive care unit. Eligible participants will be randomized 1:1 to receive dapagliflozin 10mg plus standard of care for up to 14 days or standard of care alone. The primary outcome is a hierarchical composite of hospital mortality, initiation of kidney replacement therapy, and intensive care unit length of stay, up to 28 days. Safety will be strictly monitored throughout the study. Conclusion: DEFENDER is the first study designed to investigate the use of a sodium-glucose cotransporter-2 inhibitor in general intensive care unit patients with acute organ dysfunction. It will provide relevant information on the use of drugs of this promising class in critically ill patients. ClinicalTrials.gov registry: NCT05558098

RESUMO Antecedentes: A doença crítica é um importante ônus permanente da assistência médica em todo o mundo e está associada a altas taxas de mortalidade. Os inibidores do cotransportador de sódio-glicose do tipo 2 têm demonstrado consistentemente benefícios nos desfechos cardiovasculares e renais. Os efeitos dos inibidores do cotransportador de sódio-glicose do tipo 2 em doenças agudas ainda não foram devidamente investigados. Métodos: O DEFENDER é um estudo de iniciativa do investigador, multicêntrico, randomizado, aberto, desenhado para avaliar a eficácia e a segurança da dapagliflozina em 500 participantes adultos com disfunção orgânica aguda hospitalizados na unidade de terapia intensiva. Os participantes aptos serão randomizados 1:1 para receber 10mg de dapagliflozina e o tratamento padrão por até 14 dias ou apenas o tratamento padrão. O desfecho primário é um composto hierárquico de mortalidade hospitalar, início de terapia renal substitutiva e tempo de internação na unidade de terapia intensiva, até 28 dias. O monitoramento da segurança será rigoroso durante todo o estudo. Conclusão: O DEFENDER é o primeiro estudo desenvolvido para investigar o uso de um inibidor do cotransportador de sódio-glicose do tipo 2 em pacientes de unidade de terapia intensiva geral com disfunção orgânica aguda. O estudo fornecerá informações relevantes sobre o uso de medicamentos dessa classe promissora em pacientes críticos. Registro ClincalTrials.gov: NCT05558098

Impact of Telemedicine use on clinical care indicators of pediatric intensive care units: protocol for a cluster randomized clinical trial / Impacto do uso da Telemedicina nos indicadores clínicos assistenciais de unidades de terapia intensiva pediátricas: protocolo para um ensaio clínico randomizado em cluster

ABSTRACT The objective of this study is to present the protocol of a cluster randomized clinical trial to be conducted through the TeleICU project - Qualification of Intensive Care by Telemedicine. The study will consist of a cluster randomized clinical trial, open label, in pediatric intensive care units, with an allocation ratio of 1:1, to compare the intervention group (support of Telemedicine for patients admitted to the pediatric intensive care unit) with a control group (pediatric intensive care unit usual care). The study proposed to select 16 pediatric intensive care units, including 100 participants per site, with a total of 1,600 participants. The intervention group will receive telerounds from Monday to Friday and will have specialists and continuing education activities available. The primary outcome measure will be the length of stay in the pediatric intensive care unit, defined as the difference between the date of discharge of the participant and the date of admission to the intensive care unit. The secondary outcomes will be mortality rate, invasive mechanical ventilation-free days, days using antibiotics, days using vasoactive drugs and days using sedoanalgesia. This study will be conducted in accordance with Resolution 466/12 of the National Health Council, with approval by the Research Ethics Committee of the institutions involved. The present study has the potential to reproduce studies on Telemedicine in intensive care and may make important contributions to care in intensive care units in Brazil and other settings. If Telemedicine shows positive clinical care results compared to conventional treatment, more pediatric patients may benefit. ClinicalTrials.gov registry: NCT05260710

RESUMO O objetivo deste estudo será apresentar o protocolo de um ensaio clínico randomizado em cluster a ser realizado por meio do projeto TeleUTI - Qualificação da Assistência em Terapia Intensiva por Telemedicina. O estudo consistirá em um ensaio clínico randomizado por cluster, open label, em unidades de terapia intensiva pediátricas, com proporção de alocação de 1:1, com o intuito de comparar o grupo de intervenção (apoio da telemedicina para os pacientes internados na unidade de terapia intensiva pediátrica) com um grupo controle (cuidados habituais da unidade de terapia intensiva pediátrica). O estudo se propõe a selecionar 16 unidades de terapia intensiva pediátricas, incluindo 100 participantes por local, com o total de 1.600 participantes. O grupo intervenção receberá telerounds de segunda-feira a sexta-feira e terá à disposição especialistas e atividades de educação continuada. O desfecho primário a ser avaliado será o tempo de permanência nas unidades de terapia intensiva pediátricas, definido pela diferença entre a data de alta do participante com a data de admissão na unidade de terapia intensiva. Os desfechos secundários serão: taxa de mortalidade; dias livres de ventilação mecânica, dias de uso de antibióticos, dias de uso de drogas vasoativas e dias de uso de sedoanalgesia. Este estudo será conduzido em conformidade com a resolução 466/12 do Conselho Nacional de Saúde, com aprovação pelo Comitê de Ética em Pesquisa das instituições hospitalares envolvidas. O trabalho tem o potencial de reproduzir estudos sobre Telemedicina em cuidados intensivos, podendo trazer contribuições importantes ao atendimento em unidades de terapia intensiva no Brasil e em outras realidades. Se a Telemedicina mostrar resultados clínicos assistenciais positivos em relação ao tratamento convencional, mais pacientes pediátricos poderão ser beneficiados. Registro ClinicalTrials.gov: NCT05260710

Protocolo clínico e diretrizes terapêuticas do uso de "Cannabis" medicinal para epilepsia de difícil controle em pacientes infatojuvenis / Clinical protocol and therapeutic guidelines for the use of medicinal cannabis for difficult-to-control epilepsy in children and adolescents

Este documento apresenta Protocolo clínico e diretrizes terapêuticas do uso de "Cannabis" - Canabidiol (CBD) medicinal para epilepsia de difícil controle em pacientes infantojuvenis, no âmbito do Estado do Maranhão. O protocolo é o resultado do esforço coletivo da equipe técnica da Secretaria de Estado da Saúde do Maranhão, por meio da Secretaria Adjunta de Assistência à Saúde que contou, no processo de elaboração, com a consultoria técnica de profissionais especialistas com larga experiência e atuação na área assistencial de prestação do cuidado aos pacientes acometidos por epilepsia. As condutas aqui recomendadas são baseadas em evidências que têm motivado a regulamentação do uso clínico de extratos padronizados contendo canabidiol para tratamento de casos graves de epilepsia no Brasil e devem servir como orientação de conduta diagnóstica e terapêutica, sempre levando em conta os aspectos individuais de cada paciente.

Predictors of Mortality and Functional recovery after severe traumatic brain injury: protocol for a prospective cohort study

Introduction: traumatic brain injury is a global public health problem due to its severity and high rates of morbimortality worldwide. Identifying predictors associated with increased mortality and unfavorable functional outcomes after the traumatic brain injury event is crucial for minimizing morbidity and mortality rates. Therefore, this study aims to establish a protocol to investigate the predictors of mortality and functional recovery after severe traumatic brain injury in Brazil.Methods: The study will include all patients admitted for severe traumatic brain injury (Glasgow Coma Scale ≤ 8) at the State Hospital of Urgency and Emergency, which is the referral trauma hospital of Espirito Santo. The outcomes of interest are hospital mortality and functional recovery 24 months after hospital discharge. Subjects will be followed up at seventy-two hours, three months, six months, twelve months, and twenty-four months after the trauma. Morbidity will be determined by assessing: 1) the level of motor and cognitive disability, 2) functional impairment and quality of life, and 3) aspects of rehabilitation treatment. Additionally, the traumatic brain injury load, estimated by the years of life lost, will be calculated. Discussion: the results of this study will help identify variables that can predict morbidity and mortality, as well as diagnostic and therapeutic targets for patients with severe traumatic brain injury. Furthermore, the findings will have practical implications for: 1) the development of public policies, 2) investments in hospital infrastructure 3) understanding the socioeconomic impact of functional loss in the individuals.Study registration: the study received approval from the Ethics Committee of the Federal University of Espirito Santo under protocol number 4.222.002 on August 18, 2020.

Introdução: traumatismo cranioencefálico é um problema global de saúde pública devido à sua gravidade e altas taxas de morbimortalidade em todo o mundo. Identificar preditores associados ao aumento da mortalidade e desfechos funcionais desfavoráveis após o evento do traumatismo craniencefálico é primordial para minimizar as taxas de morbidade e mortalidade. Portanto, este estudo tem como objetivo estabelecer um protocolo para investigar os preditores de mortalidade e recuperação funcional após traumatismo cranioencefálico grave no Brasil. Métodos: este estudo tem como objetivo investigar os preditores de mortalidade e recuperação funcional em pacientes com traumatismo cranioencefálico, além de fornecer uma visão geral do traumatismo cranioencefálico no estado do Espírito Santo. O estudo abrangerá todos os pacientes internados por traumatismo cranioencefálico grave (Escala de Coma de Glasgow ≤ 8) no Hospital Estadual de Urgência e Emergência, o hospital de referência para traumas no Espírito Santo. Os desfechos de interesse incluem mortalidade hospitalar e recuperação funcional após 24 meses da alta hospitalar. Os participantes serão acompanhados em setenta e duas horas, três meses, seis meses, doze meses e vinte e quatro meses após o trauma. A morbidade será determinada pela avaliação de: 1) nível de incapacidade motora e cognitiva, 2) comprometimento funcional e qualidade de vida, e 3) aspectos do tratamento e reabilitação. Além disso, a carga de traumatismo cranioencefálico, estimada em anos de vida perdidos, será calculada. Discussão: os resultados deste estudo ajudarão a identificar variáveis que podem predizer a morbidade e a mortalidade após traumatismo cranioencefálico grave. Além disso, as descobertas terão implicações práticas para: 1) o desenvolvimento de políticas públicas, 2) investimentos em infraestrutura hospitalar e 3) compreensão do impacto socioeconômico da perda funcional nesses indivíduos. Registro do estudo: o estudo recebeu aprovação do Comitê de Ética da Universidade Federal do Espírito Santo sob o número de protocolo 4.222.002 em 18 de agosto de 2020

ANÁLISIS DE LOS ESTUDIOS DE FARMACOLOGÍA CLÍNICA DE ONCOLOGÍA AUTORIZADOS POR LA AGENCIA REGULATORIA NACIONAL EN ARGENTINA ENTRE 2018 Y 2022 / Analysis of oncology clinical pharmacology studies authorized by the national regulatory agency of Argentina between 2018 and 2022

El paradigma tradicional de la investigación clínica farmacológica comprende la realización de estudios de fase 1, 2 y 3. Sin embargo, el reciente avance de lo que se ha dado en llamar "medicina de precisión" ha impulsado el surgimiento de innovaciones en el diseño de ensayos clínicos, en especial en el área de la oncología. Este artículo tiene como propósito describir y caracterizar los estudios de farmacología clínica de oncología autorizados por la Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) durante el período comprendido entre agosto de 2018 y julio de 2022; analizar el estado de situación de los diseños de los ensayos clínicos en oncología, las fases de investigación, los productos en investigación y el sitio de localización tumoral en relación con el avance de la medicina de precisión y los diseños innovadores.

The traditional paradigm of pharmacological clinical research involves carrying out phase 1, 2, and 3 studies. However, the recent advance of what has been called "precision medicine" has promoted the emergence of innovations in the design of clinical trials, especially in the area of oncology. The purpose of this article is to describe and characterize oncology clinical pharmacology studies authorized by the National Administration of Drugs, Food and Medical Devices (ANMAT) during the period from August 2018 to July 2022, and analyze the status of the clinical trial designs, research phases, investigational products and tumor site locations concerning the advancement of precision medicine and innovative designs

Executive summary of the 2023 update on the consensus regarding basic conduct during hospital admission for patients with acute heart failure.

Acute heart failure (AHF) is associated with significant morbidity and mortality and it stands as the primary cause of hospitalization for individuals over the age of 65 in Spain. This document outlines the main recommendations as follows: (1) Upon admission, it is crucial to conduct a comprehensive assessment, taking into account the patient's standard treatment and comorbidities, as these factors determine the prognosis of the disease. (2) During the initial hours of hospital care, prioritizing decongestive treatment is essential. It is recommended to adopt an early staged diuretic therapeutic approach based on the patient's response. (3) In order to manage patients in the stable phase, it is advisable to consider initiating and/or adjusting evidence-based drug treatments such as sacubitril/valsartan or angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers, beta blockers, aldosterone antagonists, and SGLT2 inhibitors. (4) Upon hospital discharge, utilizing a checklist is recommended to optimize the patient's management and identify the most efficient options for ensuring continuity of care post-discharge.

Clases presenciales durante el COVID-19: implementación de protocolos de salud escolar / Face-to-face classes during COVID-19: implementation of school health protocols

Introducción: La apertura de las escuelas aumenta la probabilidad de un aumento de casos de COVID-19, y para prepararse para esto, las escuelas deben comenzar a crear varias listas de verificación, como se indica en el Decreto Conjunto de Cuatro Ministros sobre Directrices para Implementar el Aprendizaje Durante la Pandemia COVID-19. La apertura de escuelas seguras es posible siempre que se implemente suficiente planificación y mitigación, como mediante el uso de pautas de apertura de escuelas aceptables.Objetivo: El propósito de este estudio es examinar el cumplimiento de los protocolos de salud escolar durante el COVID-19 en West Java, Indonesia, así como las diferencias entre los participantes. Métodos: Se realizó un estudio transversal cuantitativo en una escuela primaria en West Java, Indonesia. Utilizando un instrumento estructurado, modificado de las Pautas para implementar el aprendizaje durante la pandemia de Covid-19 por los investigadores, que contiene características de la escuela, disponibilidad de infraestructura de saneamiento, instalaciones de higiene y salud, disponibilidad de comedores y Comportamiento de mantenimiento de protocolos de salud en las escuelas con 27 preguntas: 11 disponibilidad de instalaciones de saneamiento, higiene y salud, disponibilidad de comedores y Comportamiento de mantenimiento de protocolos de salud en las escuelas El estudio involucró a 347 personas de 29 escuelas primarias. Se utilizó el software SPSS y la prueba no paramétrica de Kruskal-Wallis para examinar las hipótesis del estudio. Resultado: La puntuación media en la subvariable disponibilidad de infraestructura de saneamiento, limpieza e instalaciones de salud fue alta (27,49/5,391). Las tres subvariables que se probaron fueron diferentes en función de la evaluación de los participantes, solo la subvariable disponibilidad de comedor no tuvo diferencia en el puntaje promedio entre los participantes, el valor de Sig = .255, que es más de 0.05. (AU)

Introduction: The opening of schools increases the likelihood of an increase in COVID-19 cases, and to prepare for this, schools must begin to create various checklists, as indicated in the Joint Decree of Four Ministers on Guidelines for Implementing Learning During the COVID-19 Pandemic. Safe school openings are possible provided sufficient planning and mitigation are implemented, such as through the use of acceptable school opening guidelines. Objective: The purpose of this study is to examine the compliance of school health protocols during COVID-19 in West Java, Indonesia, as well as the differences between participants.Methods: A quantitative cross-sectional study was conducted in an elementary school in West Jawa, Indonesia. Using a structured instrument, modified from Panduan Penyelenggaraan Pembelajaran di Masa Pandemi Covid-19 (Guidelines for Implementing Learning During the Covid-19 Pandemic) by the researchers, containing school characteristics, availability of sanitation infrastructure, hygiene and health facilities, canteen availability, and Behavior of maintaining health protocols in schools with 27 questions: 11 availability of sanitation, hygiene, and health facilities, canteen availability, and Behavior of maintaining health protocols in schools The study involved 347 individuals from 29 primary schools. SPSS software and the Kruskal-Wallis non-parametric test were used to examine the study hypotheses. Result: The mean score on sub-variable availability of sanitation infrastructure, cleanliness, and health facilities was high (27.49/5.391). The three sub-variables that were tested were different based on the participant's assessment, only the canteen availability sub-variable had no difference in the mean score between the participants, the value of Sig =.255, which is more than 0.05. (AU)

Estágio III - Enfermagem de cuidados de saúde à família em contexto de Unidade de Saúde Familiar / Stage III - Family health care nursing in the context of a Family Health Unit

Enquadramento: O Nascimento de um novo ser é considerado um acontecimento marcante que ocorre no seio de uma família. Esta é uma etapa importante do ciclo vital, caracterizado por sucessivas transformações psicossociais, desequilíbrios biofísicos, consolidação da relação entre membros da família e uma reorganização do relacionamento conjugal e familiar. As orientações emanadas pela Organização Mundial de Saúde (OMS) e pelo Ministério da Saúde (MS), reforçam a necessidade de fortalecer o cuidado pós-natal através da visita domiciliária. Esta após o nascimento é reconhecida como uma estratégia fundamental uma vez que fornece elementos efetivos dos cuidados ao Recém-Nascido (RN). Na visita domiciliária, promove-se a relação de proximidade entre equipa de saúde e família, contribuindo para a vigilância e promoção da saúde. Objetivo: analisar as competências comuns e especificas da enfermagem especializada na área da saúde familiar, adquiridas no âmbito do ensino clínico e mapear o conhecimento sobre intervenções protocoladas do enfermeiro de família para a visita domiciliária (VD) ao RN e Família. Metodologia: realizou uma análise critica-reflexiva sobre as competências adquiridas e desenvolvidas no ensino clínico e desenvolveu uma revisão sistemática de literatura. A pesquisa foi realizada em janeiro e fevereiro de 2022. Através da base de dados eletrónica do site da Ordem dos Enfermeiros, acesso reservado, EBSCOhot, selecionando a base de dados CINAHL e MEDLINE complete e através da base de dados da OE de acesso livre RCAP e Biblioteca Virtual em saúde, foram encontrados 32 resultados. Destes, 27 foram eliminados e 5 foram selecionados. O friso temporal em que incidiu o estudo decorreu de 2011 a 2021. Os resultados foram extraídos e sintetizados na forma de tabela e resumo narrativo. Resultados: O ensino clínico consolidou os conhecimentos científicos adquiridos ao longo da sua formação. Desenvolveu competências do enfermeiro especialista em enfermagem comunitária, na área da saúde familiar. Foram incluídos cinco estudos na RSL. No seguimento da RSL e de forma a recolher contributos para a construção de uma proposta de protocolo realizou um estudo descritivo, exploratório, recorrendo à metodologia descritiva. Neste estudo a amostra foi constituída por 13 enfermeiros de três unidades de saúde. Todos eles contribuíram com sugestões para a construção da proposta de protocolo e evidenciaram a sua importância. Conclusão: com base nos achados da RSL e no estudo realizado é apresentada uma proposta de protocolo para a visita domiciliária ao RN e família.

Background: The birth of a new being is considered a landmark event that occurs within a family. This is an important stage in the life cycle, characterized by successive psychosocial transformations, biophysical imbalances, consolidation of the relationship between family members and a reorganization of marital and family relationships. The guidelines issued by the World Health Organization (WHO) and the Ministry of Health (MS) reinforce the need to strengthen postnatal care through home visits. This after birth is recognized as a fundamental strategy as it provides effective elements of care for the Newborn (NB). During home visits, a close relationship is promoted between the healthcare team and the family, contributing to health surveillance and promotion. Objective: to analyze the common and specific skills of specialized nursing in the area of family health, acquired within the scope of clinical teaching and to map the knowledge about protocolized interventions of the family nurse for the home visit (HV) to the NB and Family. Methodology: carried out a critical-reflexive analysis of the skills acquired and developed in clinical teaching and developed a systematic literature review. The research was carried out in January and February 2022. Through the electronic database of the Order of Nurses website, access reserved, EBSCOhot, selecting the CINAHL and MEDLINE complete database and through the free access OE database RCAP and Virtual Health Library, 32 results were found. Of these, 27 were eliminated and 5 were selected. The period in which the study focused ran from 2011 to 2021. The results were extracted and synthesized in the form of a table and narrative summary. Results: Clinical teaching consolidated the scientific knowledge acquired throughout their training. Developed nursing specialist nurse skills community, in the area of family health. Five studies were included in the RSL. Following the RSL and in order to collect contributions for the construction of a protocol proposal, a descriptive, exploratory study was carried out, using descriptive methodology. In this study, the sample consisted of 13 nurses from three health units. They all contributed with suggestions for the construction of the protocol proposal and highlighted its importance. Conclusion: based on the RSL findings and the study carried out, a proposed protocol for home visits to the newborn and family.