Benefícios, efeitos negativos e papel do profissional de enfermagem na cirurgia bariátrica

Objective: To describe evidence of the benefits, adverse effects, and the role of nursing professionals in bariatric surgery. Introduction: Obesity has reached concerning levels in Chile, posing a public health challenge. In this context, bariatric surgery emerges as a crucial intervention for patients with obesity who do not achieve results with conventional approaches. While notable benefits are evident in individuals opting for this surgical procedure, there are also risks and adverse effects on the physical, psychological, and social aspects. The initially positive relationship between bariatric surgery and quality of life can become unfavorable due to lack of adherence to postoperative recommendations. Nursing professionals play an important role in preparing and monitoring patients undergoing bariatric surgery, providing education and emotional support. Exhaustive pre- and postoperative assessment is crucial, with a significant contribution of these professionals in the comprehensive care of these patients. Conclusions: Bariatric surgery should not be considered as an isolated solution but as part of a multidisciplinary approach that includes lifestyle changes. It is essential to promote collaboration among healthcare professionals, highlighting the significant role of nursing professionals in improving the outcomes and quality of life of patients with obesity undergoing this intervention.Objetivo: Describir evidencias de los beneficios, efectos negativos y rol del profesional de enfermería en la cirugía bariátrica. Desarrollo: La obesidad ha alcanzado niveles preocupantes en Chile, siendo un desafío de salud pública. La cirugía bariátrica emerge como una intervención crucial para pacientes con obesidad que no obtienen resultados con enfoques convencionales. Aunque se evidencian beneficios notables en personas que optan por este procedimiento quirúrgico, también existen riesgos y efectos negativos en aspectos físicos, psicológicos y sociales. La relación inicialmente positiva entre la cirugía bariátrica y la calidad de vida puede volverse desfavorable debido a la falta de adherencia a recomendaciones postoperatorias. Los profesionales de enfermería juegan un importante rol en la preparación y seguimiento de los pacientes sometidos a cirugía bariátrica, proporcionando educación y apoyo emocional. La evaluación exhaustiva pre y postoperatoria es crucial, reconociendo la contribución de estos profesionales en el cuidado integral de estos pacientes. Conclusiones: La cirugía bariátrica no debe considerarse como una solución aislada, sino como parte de un enfoque multidisciplinario que incluya cambios en el estilo de vida. Es fundamental promover la colaboración entre profesionales de la salud, destacando el rol significativo de los profesionales de enfermería en mejorar los resultados y la calidad de vida de pacientes con obesidad sometidos a esta intervención.Objetivo: Descrever evidências dos benefícios, efeitos negativos e atuação do profissional de enfermagem na cirurgia bariátrica. Desenvolvimento: A obesidade atingiu níveis preocupantes no Chile, sendo um desafio de saúde pública. A cirurgia bariátrica está emergindo como uma intervenção crucial para pacientes com obesidade que não alcançam resultados com abordagens convencionais. Embora benefícios notáveis ​​sejam evidentes nas pessoas que optam por esse procedimento cirúrgico, também existem riscos e efeitos negativos nos aspectos físicos, psicológicos e sociais. A relação inicialmente positiva entre cirurgia bariátrica e qualidade de vida pode tornar-se desfavorável pela falta de adesão às recomendações pós-operatórias. Os profissionais de enfermagem desempenham papel importante no preparo e acompanhamento dos pacientes submetidos à cirurgia bariátrica, proporcionando educação e apoio emocional. A avaliação exaustiva pré e pós-operatória é fundamental, reconhecendo a contribuição desses profissionais no cuidado integral desses pacientes. Conclusões: A cirurgia bariátrica não deve ser considerada como uma solução isolada, mas sim como parte de uma abordagem multidisciplinar que inclui mudanças no estilo de vida. É fundamental promover a colaboração entre os profissionais de saúde, destacando o papel significativo dos profissionais de enfermagem na melhoria dos resultados e da qualidade de vida dos pacientes com obesidade submetidos a esta intervenção

Efficacy and safety of the CVnCoV SARS-CoV-2 mRNA vaccine candidate in ten countries in Europe and Latin America (HERALD): a randomised, observer-blinded, placebo-controlled, phase 2b/3 trial

Background: Additional safe and efficacious vaccines are needed to control the COVID-19 pandemic. We aimed to analyse the efficacy and safety of the CVnCoV SARS-CoV-2 mRNA vaccine candidate. Methods: HERALD is a randomised, observer-blinded, placebo-controlled, phase 2b/3 clinical trial conducted in 47 centres in ten countries in Europe and Latin America. By use of an interactive web response system and stratification by country and age group (18–60 years and ≥61 years), adults with no history of virologically confirmed COVID-19 were randomly assigned (1:1) to receive intramuscularly either two 0·6 mL doses of CVnCoV containing 12 μg of mRNA or two 0·6 mL doses of 0·9% NaCl (placebo) on days 1 and 29. The primary efficacy endpoint was the occurrence of a first episode of virologically confirmed symptomatic COVID-19 of any severity and caused by any strain from 15 days after the second dose. For the primary endpoint, the trial was considered successful if the lower limit of the CI was greater than 30%. Key secondary endpoints were the occurrence of a first episode of virologically confirmed moderate-to-severe COVID-19, severe COVID-19, and COVID-19 of any severity by age group. Primary safety outcomes were solicited local and systemic adverse events within 7 days after each dose and unsolicited adverse events within 28 days after each dose in phase 2b participants, and serious adverse events and adverse events of special interest up to 1 year after the second dose in phase 2b and phase 3 participants. Here, we report data up to June 18, 2021. The study is registered at ClinicalTrials.gov, NCT04652102, and EudraCT, 2020–003998–22, and is ongoing. Findings: Between Dec 11, 2020, and April 12, 2021, 39 680 participants were enrolled and randomly assigned to receive either CVnCoV (n=19 846) or placebo (n=19 834), of whom 19 783 received at least one dose of CVnCoV and 19 746 received at least one dose of placebo. After a mean observation period of 48·2 days (SE 0·2), 83 cases of COVID-19 occurred in the CVnCoV group (n=12 851) in 1735·29 person-years and 145 cases occurred in the placebo group (n=12 211) in 1569·87 person-years, resulting in an overall vaccine efficacy against symptomatic COVID-19 of 48·2% (95·826% CI 31·0–61·4; p=0·016). Vaccine efficacy against moderate-to-severe COVID-19 was 70·7% (95% CI 42·5–86·1; CVnCoV 12 cases in 1735·29 person-years, placebo 37 cases in 1569·87 person-years). In participants aged 18–60 years, vaccine efficacy against symptomatic disease was 52·5% (95% CI 36·2–64·8; CVnCoV 71 cases in 1591·47 person-years, placebo, 136 cases in 1449·23 person-years). Too few cases occurred in participants aged 61 years or older (CVnCoV 12, placebo nine) to allow meaningful assessment of vaccine efficacy. Solicited adverse events, which were mostly systemic, were more common in CVnCoV recipients (1933 [96·5%] of 2003) than in placebo recipients (1344 [67·9%] of 1978), with 542 (27·1%) CVnCoV recipients and 61 (3·1%) placebo recipients reporting grade 3 solicited adverse events. The most frequently reported local reaction after any dose in the CVnCoV group was injection-site pain (1678 [83·6%] of 2007), with 22 grade 3 reactions, and the most frequently reported systematic reactions were fatigue (1603 [80·0%] of 2003) and headache (1541 [76·9%] of 2003). 82 (0·4%) of 19 783 CVnCoV recipients reported 100 serious adverse events and 66 (0·3%) of 19 746 placebo recipients reported 76 serious adverse events. Eight serious adverse events in five CVnCoV recipients and two serious adverse events in two placebo recipients were considered vaccination-related. None of the fatal serious adverse events reported (eight in the CVnCoV group and six in the placebo group) were considered to be related to study vaccination. Adverse events of special interest were reported for 38 (0·2%) participants in the CVnCoV group and 31 (0·2%) participants in the placebo group. These events were considered to be related to the trial vaccine for 14 (<0·1%) participants in the CVnCoV group and for five (<0·1%) participants in the placebo group. Interpretation: CVnCoV was efficacious in the prevention of COVID-19 of any severity and had an acceptable safety profile. Taking into account the changing environment, including the emergence of SARS-CoV-2 variants, and timelines for further development, the decision has been made to cease activities on the CVnCoV candidate and to focus efforts on the development of next-generation vaccine candidates. Funding: German Federal Ministry of Education and Research and CureVac