Performance of the SHARPEN Score and the Charlson Comorbidity Index for In-Hospital and Post-Discharge Mortality Prediction in Infective Endocarditis. / Desempenho do Escore SHARPEN e do Índice de Comorbidade de Charlson para Predição de Mortalidade durante a Internação Hospitalar e após a Alta na Endocardite Infecciosa.

BACKGROUND: Central Illustration : Performance of the SHARPEN Score and the Charlson Comorbidity Index for In-Hospital and Post-Discharge Mortality Prediction in Infective Endocarditis. BACKGROUND: SHARPEN was the first dedicated score for in-hospital mortality prediction in infective endocarditis (IE) regardless of cardiac surgery. OBJECTIVES: To analyze the ability of the SHARPEN score to predict in-hospital and post-discharge mortality and compare it with that of the Charlson comorbidity index (CCI). METHODS: Retrospective cohort study including definite IE (Duke modified criteria) admissions from 2000 to 2016. The area under the ROC curve (AUC-ROC) was calculated to assess predictive ability. Kaplan-Meier curves and Cox regression was performed. P-value < 0.05 was considered statistically significant. RESULTS: We studied 179 hospital admissions. In-hospital mortality was 22.3%; 68 (38.0%) had cardiac surgery. Median (interquartile range, IQR) SHARPEN and CCI scores were 9(7-11) and 3(2-6), respectively. SHARPEN had better in-hospital mortality prediction than CCI in non-operated patients (AUC-ROC 0.77 vs. 0.62, p = 0.003); there was no difference in overall (p = 0.26) and in operated patients (p = 0.41). SHARPEN > 10 at admission was associated with decreased in-hospital survival in the overall (HR 3.87; p < 0.001), in non-operated (HR 3.46; p = 0.006) and operated (HR 6.86; p < 0.001) patients. CCI > 3 at admission was associated with worse in-hospital survival in the overall (HR 3.0; p = 0.002), and in operated patients (HR 5.57; p = 0.005), but not in non-operated patients (HR 2.13; p = 0.119). Post-discharge survival was worse in patients with SHARPEN > 10 (HR 3.11; p < 0.001) and CCI > 3 (HR 2.63; p < 0.001) at admission; however, there was no difference in predictive ability between these groups. CONCLUSION: SHARPEN was superior to CCI in predicting in-hospital mortality in non-operated patients. There was no difference between the scores regarding post-discharge mortality.

Long-Term Mortality and Health-Related Quality of Life After Continuous Versus Intermittent Renal Replacement Therapy in ICU Survivors: A Secondary Analysis of the Quality of Life After ICU Study.

Purpose: We assessed long-term outcomes in intensive care unit (ICU) survivors with acute kidney injury (AKI) submitted to intermittent or continuous renal replacement therapy (RRT) for comparisons between groups. Methods: The multicenter prospective cohort study included 195 adult ICU survivors with an ICU stay >72 h in 10 ICUs that had at least one episode of AKI treated with intermittent RRT (IRRT) or continuous RRT (CRRT) during ICU stay. The main outcomes were mortality and health-related quality of life (HRQoL). Hospital readmissions and physical dependence were also assessed. Results: Regarding RRT, 83 (42.6%) patients received IRRT and 112 (57.4%) received CRRT. Despite the similarity regarding sociodemographic characteristics, pre-ICU state of health and type of admission between groups, the risk of death (23.5% vs 42.7%; P < .001), the prevalence of sepsis (60.7%) and acute respiratory distress syndrome (17%) were higher at ICU admission among CRRT patients. The severity of critical illness was higher among CRRT patients, regarding the need for mechanical ventilation (75.0% vs 50.6%, P = .002) and vasopressors (91.1% vs 63.9%, P < .001). One year after ICU discharge, 67 of 195 ICU survivors died (34.4%) and, after adjustment for confounders, there were no significant differences in mortality when comparing IRRT and CRTT patients (34.9% vs 33.9%; P = .590), on HRQoL in both physical (41.9% vs 42.2%; P = .926) and mental dimensions (57.6% vs 56.6%; P = .340), and on the number of hospital readmissions and physical dependence. Conclusions: Our study suggests that among ICU survivors RRT modality (IRRT vs CRRT) in the ICU does not impact long-term outcomes after ICU discharge.

Lower quality of life in obese ICU survivors: a multicenter cohort study.

PURPOSE: To compare health-related quality of life (HRQoL) and functional status between obese, underweight, normal-weight, and overweight patients after three months post-intensive care unit (ICU) discharge. METHODS: Multicenter cohort study (10 Brazilian ICUs). 1600 ICU survivors (≥ 72 h in the ICU) were included.The main outcomes were HRQoL and functional status assessed three months after the ICU discharge. The secondary outcomes were mortality, hospital readmission, and ICU readmission during the same period. RESULTS: Obese patients (median 50.1; IQR 39.6-59.6) had lower HRQoL in the mental component than normal-weight patients (median 53; IQR 45.6-60.1) (p = 0.033). No differences were found between BMI categories regarding the physical component of HRQoL and the Barthel Index (p = 0.355 and 0.295, respectively). Regarding readmissions, 65.1 and 25.1% of patients were readmitted to the hospital and ICU, but there was no difference between the groups (p = 0.870 and 0.220, respectively). Obese patients died less frequently (11.8%) than underweight (30.9%) and normal-weight (19.3%) patients (p < 0.001). CONCLUSION: After three months of post-ICU discharge, obese patients had lower HRQoL in the mental component than normal-weight patients. However, obese patients died less than underweight and normal-weight patients.

Evidence-Based Checklist to Delay Cardiac Arrest in Brain-Dead Potential Organ Donors: The DONORS Cluster Randomized Clinical Trial.

Importance: The effectiveness of goal-directed care to reduce loss of brain-dead potential donors to cardiac arrest is unclear. Objective: To evaluate the effectiveness of an evidence-based, goal-directed checklist in the clinical management of brain-dead potential donors in the intensive care unit (ICU). Design, Setting, and Participants: The Donation Network to Optimize Organ Recovery Study (DONORS) was an open-label, parallel-group cluster randomized clinical trial in Brazil. Enrollment and follow-up were conducted from June 20, 2017, to November 30, 2019. Hospital ICUs that reported 10 or more brain deaths in the previous 2 years were included. Consecutive brain-dead potential donors in the ICU aged 14 to 90 years with a condition consistent with brain death after the first clinical examination were enrolled. Participants were randomized to either the intervention group or the control group. The intention-to-treat data analysis was conducted from June 15 to August 30, 2020. Interventions: Hospital staff in the intervention group were instructed to administer to brain-dead potential donors in the intervention group an evidence-based checklist with 13 clinical goals and 14 corresponding actions to guide care, every 6 hours, from study enrollment to organ retrieval. The control group provided or received usual care. Main Outcomes and Measures: The primary outcome was loss of brain-dead potential donors to cardiac arrest at the individual level. A prespecified sensitivity analysis assessed the effect of adherence to the checklist in the intervention group. Results: Among the 1771 brain-dead potential donors screened in 63 hospitals, 1535 were included. These patients included 673 males (59.2%) and had a median (IQR) age of 51 (36.3-62.0) years. The main cause of brain injury was stroke (877 [57.1%]), followed by trauma (485 [31.6%]). Of the 63 hospitals, 31 (49.2%) were assigned to the intervention group (743 [48.4%] brain-dead potential donors) and 32 (50.8%) to the control group (792 [51.6%] brain-dead potential donors). Seventy potential donors (9.4%) at intervention hospitals and 117 (14.8%) at control hospitals met the primary outcome (risk ratio [RR], 0.70; 95% CI, 0.46-1.08; P = .11). The primary outcome rate was lower in those with adherence higher than 79.0% than in the control group (5.3% vs 14.8%; RR, 0.41; 95% CI, 0.22-0.78; P = .006). Conclusions and Relevance: This cluster randomized clinical trial was inconclusive in determining whether the overall use of an evidence-based, goal-directed checklist reduced brain-dead potential donor loss to cardiac arrest. The findings suggest that use of such a checklist has limited effectiveness without adherence to the actions recommended in this checklist. Trial Registration: ClinicalTrials.gov Identifier: NCT03179020.

Desempenho do Escore SHARPEN e do Índice de Comorbidade de Charlson para Predição de Mortalidade durante a Internação Hospitalar e após a Alta na Endocardite Infecciosa / Performance of the SHARPEN Score and the Charlson Comorbidity Index for In-Hospital and Post-Discharge Mortality Prediction in Infective Endocarditis

Resumo Fundamento O SHARPEN foi o primeiro escore desenvolvido especificamente para a predição de mortalidade hospitalar em pacientes com endocardite infecciosa (EI), independentemente da realização de cirurgia cardíaca. Objetivos Analisar a capacidade do escore SHARPEN na predição de mortalidade hospitalar e mortalidade após a alta e compará-la à do Índice de Comorbidade de Charlson (ICC). Métodos Estudo retrospectivo do tipo coorte incluindo internações por EI (segundo os critérios de Duke modificados) entre 2000 e 2016. A área sob a curva ROC (AUC-ROC) foi calculada para avaliar a capacidade preditiva. Curvas de Kaplan-Meier e regressão de Cox foram realizadas. Um valor de p < 0,05 foi considerado estatisticamente significativo. Resultados Estudamos 179 internações hospitalares. A mortalidade hospitalar foi 22,3%; 68 (38,0%) foram submetidos à cirurgia cardíaca. Os escores SHARPEN e ICC (mediana e intervalo interquartil) foram, respectivamente, 9(7-11) e 3(2-6). O escore SHARPEN mostrou melhor predição de mortalidade hospitalar em comparação ao ICC nos pacientes não operados (AUC-ROC 0,77 vs. 0,62, p = 0,003); não foi observada diferença no grupo total (p=0,26) ou nos pacientes operados (p=0,41). Escore SHARPEN >10 na admissão foi associado a uma menor sobrevida hospitalar no grupo total (HR 3,87; p < 0,001), nos pacientes não operados (HR 3,46; p = 0,006) e de pacientes operados (HR 6,86; p < 0,001) patients. ICC > 3 na admissão foi associada a pior sobrevida hospitalar nos grupos total (HR 3,0; p = 0,002), de pacientes operados (HR 5,57; p = 0,005), mas não nos pacientes não operados (HR 2,13; p = 0,119). A sobrevida após a alta foi pior nos pacientes com SHARPEN > 10 (HR 3,11; p < 0,001) e ICC > 3 (HR 2,63; p < 0,001) na internação; contudo, não houve diferença na capacidade preditiva entre esses grupos. Conclusão O SHARPEN escore foi superior ao ICC na predição de mortalidade hospitalar nos pacientes não operados. Não houve diferença entre os escores quanto à mortalidade após a alta.

Abstract Background SHARPEN was the first dedicated score for in-hospital mortality prediction in infective endocarditis (IE) regardless of cardiac surgery. Objectives To analyze the ability of the SHARPEN score to predict in-hospital and post-discharge mortality and compare it with that of the Charlson comorbidity index (CCI). Methods Retrospective cohort study including definite IE (Duke modified criteria) admissions from 2000 to 2016. The area under the ROC curve (AUC-ROC) was calculated to assess predictive ability. Kaplan-Meier curves and Cox regression was performed. P-value < 0.05 was considered statistically significant. Results We studied 179 hospital admissions. In-hospital mortality was 22.3%; 68 (38.0%) had cardiac surgery. Median (interquartile range, IQR) SHARPEN and CCI scores were 9(7-11) and 3(2-6), respectively. SHARPEN had better in-hospital mortality prediction than CCI in non-operated patients (AUC-ROC 0.77 vs. 0.62, p = 0.003); there was no difference in overall (p = 0.26) and in operated patients (p = 0.41). SHARPEN > 10 at admission was associated with decreased in-hospital survival in the overall (HR 3.87; p < 0.001), in non-operated (HR 3.46; p = 0.006) and operated (HR 6.86; p < 0.001) patients. CCI > 3 at admission was associated with worse in-hospital survival in the overall (HR 3.0; p = 0.002), and in operated patients (HR 5.57; p = 0.005), but not in non-operated patients (HR 2.13; p = 0.119). Post-discharge survival was worse in patients with SHARPEN > 10 (HR 3.11; p < 0.001) and CCI > 3 (HR 2.63; p < 0.001) at admission; however, there was no difference in predictive ability between these groups. Conclusion SHARPEN was superior to CCI in predicting in-hospital mortality in non-operated patients. There was no difference between the scores regarding post-discharge mortality.

Impact of vertical positioning on lung aeration among mechanically ventilated intensive care unit patients: a randomized crossover clinical trial / Impacto do posicionamento vertical na aeração pulmonar em pacientes de unidades de terapia intensiva ventilados mecanicamente: um estudo clínico transversal randomizado

ABSTRACT Objective: To assess the impact of different vertical positions on lung aeration in patients receiving invasive mechanical ventilation. Methods: An open-label randomized crossover clinical trial was conducted between January and July 2020. Adults receiving invasive mechanical ventilation for > 24 hours and < 7 days with hemodynamic, respiratory and neurological stability were randomly assigned at a 1:1 ratio to the sitting position followed by passive orthostasis condition or the passive orthostasis followed by the sitting position condition. The primary outcome was lung aeration assessed using the lung ultrasound score (score ranges from 0 [better] to 36 [worse]). Results: A total of 186 subjects were screened; of these subjects, 19 were enrolled (57.8% male; mean age, 73.2 years). All participants were assigned to receive at least one verticalization protocol. Passive orthostasis resulted in mean lung ultrasound scores that did not differ significantly from the sitting position (11.0 versus 13.7; mean difference, -2.7; [95%CI -6.1 to 0.71; p = 0.11). Adverse events occurred in three subjects in the passive orthostasis group and in one in the sitting position group (p = 0.99). Conclusion: This analysis did not find significant differences in lung aeration between the sitting and passive orthostasis groups. A randomized crossover clinical trial assessing the impact of vertical positioning on lung aeration in patients receiving invasive mechanical ventilation is feasible. Unfortunately, the study was interrupted due to the need to treat COVID-19 patients. ClinicalTrials.gov registry: NCT04176445

RESUMO Objetivo: Avaliar o impacto de diferentes posicionamentos verticais na aeração pulmonar em pacientes em ventilação mecânica invasiva. Métodos: Trata-se de ensaio clínico aberto, randomizado e transversal, realizado entre janeiro e julho de 2020. Adultos em ventilação mecânica invasiva por mais de 24 horas e menos de 7 dias com estabilidade hemodinâmica, respiratória e neurológica foram distribuídos aleatoriamente em uma proporção de 1:1 à postura sentada seguida da condição de ortostatismo passivo ou o ortostatismo passivo seguido de postura sentada. O desfecho primário foi a aeração pulmonar avaliada pelo lung ultrasound score. O escore varia de zero (melhor) a 36 (pior). Resultados: Foram selecionados 186 indivíduos; destes, 19 foram incluídos (57,8% do sexo masculino; média idade de 73,2 anos). Todos os participantes foram selecionados para receber pelo menos um protocolo de verticalização. O ortostatismo passivo resultou em escores médios de aeração pulmonar por ultrassonografia que não diferiram significativamente da postura sentada (11,0 versus 13,7; diferença média, -2,7; IC95% -6,1 a 0,71; p = 0,11). Ocorreram eventos adversos em três indivíduos no grupo ortostatismo passivo e em um no grupo postura sentada (p = 0,99). Conclusão: Esta análise não encontrou diferenças significativas na aeração pulmonar entre os grupos ortostatismo passivo e postura sentada. É factível conduzir um estudo clínico transversal randomizado para avaliar o impacto do posicionamento vertical na aeração pulmonar em pacientes em ventilação mecânica invasiva. Infelizmente, o estudo foi interrompido devido à necessidade de tratar pacientes com COVID-19. Registro ClinicalTrials.gov: NCT04176445

Does an educational website improve psychological outcomes and satisfaction among family members of intensive care unit patients?

OBJECTIVE: To evaluate the impact of an educational website on satisfaction and symptoms of anxiety and depression among family members of critically ill adult patients. METHODS: We embedded an analysis of website access in a cohort study conducted in intensive care units with flexible visiting hours in Brazil. Family members were guided to access an educational website designed to help them understand the processes and emotions associated with an intensive care unit stay. Subjects were evaluated for baseline data within the first 48 hours following enrollment and outcome assessment at up to 7 days after patient discharge from the intensive care unit, death, or until the 30th day of the study. The main outcomes were satisfaction using the Critical Care Family Needs Inventory and the presence of anxiety and depression symptoms using the Hospital Anxiety and Depression Scale. RESULTS: A total of 532 family members were evaluated during the study period. Of these, 61 (11.5%) accessed the website. After adjustments, family members who accessed the website had significantly better mean Critical Care Family Needs Inventory scores (152.8 versus 145.2, p = 0.01) and a lower prevalence of probable clinical anxiety (prevalence ratio 0.35; 95%CI 0.14 - 0.89) than family members who did not access the website. There were no differences regarding symptoms of depression. CONCLUSION: Access to an educational website was associated with higher family satisfaction with care and a lower prevalence of clinical anxiety.

BNT162b2 mRNA COVID-19 against symptomatic Omicron infection following a mass vaccination campaign in southern Brazil: A prospective test-negative design study.

BACKGROUND: Evidence regarding effectiveness of BNT162b2 mRNA COVID-19 vaccine against Omicron in Latin America is limited. We estimated BNT162b2 effectiveness against symptomatic COVID-19 in Brazil when Omicron was predominant. METHODS: This prospective test-negative, case-control study was conducted in Toledo, Brazil, following a mass COVID-19 vaccination with BNT162b2. Patients were included if they were aged ≥12 years, sought care for acute respiratory symptoms in the public health system between November 3, 2021 and June 20, 2022, and were tested for SARS-CoV-2 using RT-PCR. In the primary analysis, we determined the effectiveness of two doses of BNT162b2 against symptomatic COVID-19. RESULTS: A total of 4,574 were enrolled; of these, 1,758 patients (586 cases and 1,172 controls) were included in the primary analysis. Mean age was 27.7 years, 53.8 % were women, and 90.1 % had a Charlson comorbidity index of zero. Omicron accounted for >97 % of all identified SARS-CoV-2 variants, with BA.1 and BA.2 accounting for 84.3 % and 12.6 %, respectively. Overall adjusted estimate of two-dose vaccine effectiveness against symptomatic COVID-19 was 46.7 % (95 %CI, 19.9 %-64.6 %) after a median time between the second dose and the beginning of COVID-19 symptoms of 94 days (IQR, 60-139 days). Effectiveness waned from 77.7 % at 7-29 days after receipt of a second dose to <30 % (non-significant) after ≥120 days. CONCLUSION: In a relatively young and healthy Brazilian population, two doses of BNT162b2 provided protection against symptomatic Omicron infection. However, this protection waned significantly over time, underscoring the need for boosting with variant-adapted vaccines in this population prior to waves of disease activity. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov number, NCT05052307 (https://clinicaltrials.gov/ct2/show/NCT05052307).

Reply to the letter "Understanding lactate and its clearance during extracorporeal membrane oxygenation for supporting refractory cardiogenic shock patients".

This is a reply to the letter titled "Understanding lactate and its clearance during extracorporeal membrane oxygenation for supporting refractory cardiogenic shock patients" by Eva Rully Kurniawati et al. In response to the concerns raised about our paper published in BMC Cardiovascular Disorders, titled "Association between serum lactate levels and mortality in patients with cardiogenic shock receiving mechanical circulatory support: a multicenter retrospective cohort study," we have addressed the confounding bias on the population included and the use of VA-ECMO and Impella CP. Furthermore, we have provided new data on the correlation of oxygen supply and lactate levels at admission of cardiogenic shock.

Does an educational website improve psychological outcomes and satisfaction among family members of intensive care unit patients? / Um portal educativo melhora os resultados psicológicos e a satisfação de familiares de pacientes em unidades de terapia intensiva?

ABSTRACT Objective: To evaluate the impact of an educational website on satisfaction and symptoms of anxiety and depression among family members of critically ill adult patients. Methods: We embedded an analysis of website access in a cohort study conducted in intensive care units with flexible visiting hours in Brazil. Family members were guided to access an educational website designed to help them understand the processes and emotions associated with an intensive care unit stay. Subjects were evaluated for baseline data within the first 48 hours following enrollment and outcome assessment at up to 7 days after patient discharge from the intensive care unit, death, or until the 30th day of the study. The main outcomes were satisfaction using the Critical Care Family Needs Inventory and the presence of anxiety and depression symptoms using the Hospital Anxiety and Depression Scale. Results: A total of 532 family members were evaluated during the study period. Of these, 61 (11.5%) accessed the website. After adjustments, family members who accessed the website had significantly better mean Critical Care Family Needs Inventory scores (152.8 versus 145.2, p = 0.01) and a lower prevalence of probable clinical anxiety (prevalence ratio 0.35; 95%CI 0.14 - 0.89) than family members who did not access the website. There were no differences regarding symptoms of depression. Conclusion: Access to an educational website was associated with higher family satisfaction with care and a lower prevalence of clinical anxiety.

RESUMO Objetivo: Avaliar o efeito de um portal educativo na satisfação e nos sintomas de ansiedade e depressão de familiares de pacientes adultos em estado crítico. Métodos: Inserimos uma análise de acesso a um portal num estudo de coorte realizado em unidades de terapia intensiva com horários de visita flexíveis no Brasil. Os familiares foram orientados a acessar um portal educativo concebido para os ajudá-los a compreender os processos e as emoções associados à internação em unidades de terapia intensiva. Os sujeitos foram avaliados quanto às informações basais nas primeiras 48 horas após a inclusão e quanto aos desfechos até 7 dias após a alta do paciente da unidade de terapia intensiva, morte ou até o 30º dia do estudo. Os principais desfechos foram a satisfação por meio do Inventário das Necessidades da Família em Cuidados Intensivos e a presença de sintomas de ansiedade e depressão utilizando a Escala Hospitalar de Ansiedade e Depressão. Resultados: Avaliaram-se 532 familiares durante o período do estudo. Destes, 61 (11,5%) acessaram o portal. Após ajustes, os familiares que acessaram o portal apresentaram médias significativamente melhores dos valores do Inventário de Necessidades da Família em Cuidados Intensivos (152,8 versus 145,2; p = 0,01) e menor prevalência de provável ansiedade clínica (razão de prevalência de 0,35; IC95% 0,14 - 0,89) do que familiares que não acessaram o portal. Não houve diferença em relação aos sintomas de depressão. Conclusão: O acesso a um portal educativo foi associado a maior satisfação familiar com os cuidados e menor prevalência de ansiedade clínica.

Impact of vertical positioning on lung aeration among mechanically ventilated intensive care unit patients: a randomized crossover clinical trial.

OBJECTIVE: To assess the impact of different vertical positions on lung aeration in patients receiving invasive mechanical ventilation. METHODS: An open-label randomized crossover clinical trial was conducted between January and July 2020. Adults receiving invasive mechanical ventilation for > 24 hours and < 7 days with hemodynamic, respiratory and neurological stability were randomly assigned at a 1:1 ratio to the sitting position followed by passive orthostasis condition or the passive orthostasis followed by the sitting position condition. The primary outcome was lung aeration assessed using the lung ultrasound score (score ranges from 0 [better] to 36 [worse]). RESULTS: A total of 186 subjects were screened; of these subjects, 19 were enrolled (57.8% male; mean age, 73.2 years). All participants were assigned to receive at least one verticalization protocol. Passive orthostasis resulted in mean lung ultrasound scores that did not differ significantly from the sitting position (11.0 versus 13.7; mean difference, -2.7; [95%CI -6.1 to 0.71; p = 0.11). Adverse events occurred in three subjects in the passive orthostasis group and in one in the sitting position group (p = 0.99). CONCLUSION: This analysis did not find significant differences in lung aeration between the sitting and passive orthostasis groups. A randomized crossover clinical trial assessing the impact of vertical positioning on lung aeration in patients receiving invasive mechanical ventilation is feasible. Unfortunately, the study was interrupted due to the need to treat COVID-19 patients.ClinicalTrials.gov registry: NCT04176445.

IMPACTO-MR: um estudo brasileiro de plataforma nacional para avaliar infecções e multirresistência em unidades de terapia intensiva / IMPACTO-MR: a Brazilian nationwide platform study to assess infections and multidrug resistance in intensive care units

RESUMO Objetivo: Descrever o IMPACTO-MR, um estudo brasileiro de plataforma nacional em unidades de terapia intensiva focado no impacto das infecções por bactérias multirresistentes relacionadas à assistência à saúde. Métodos: Descrevemos a plataforma IMPACTO-MR, seu desenvolvimento, critérios para seleção das unidades de terapia intensiva, caracterização da coleta de dados, objetivos e projetos de pesquisa futuros a serem realizados na plataforma. Resultados: Os dados principais foram coletados por meio do Epimed Monitor System® e consistiram em dados demográficos, dados de comorbidades, estado funcional, escores clínicos, diagnóstico de internação e diagnósticos secundários, dados laboratoriais, clínicos e microbiológicos e suporte de órgãos durante a internação na unidade de terapia intensiva, entre outros. De outubro de 2019 a dezembro de 2020, 33.983 pacientes de 51 unidades de terapia intensiva foram incluídos no banco de dados principal. Conclusão: A plataforma IMPACTO-MR é um banco de dados clínico brasileiro de unidades de terapia intensiva focado na pesquisa do impacto das infecções por bactérias multirresistentes relacionadas à assistência à saúde. Essa plataforma fornece dados para o desenvolvimento e pesquisa de unidades de terapia intensiva individuais e ensaios clínicos observacionais e prospectivos multicêntricos.

ABSTRACT Objective: To describe the IMPACTO-MR, a Brazilian nationwide intensive care unit platform study focused on the impact of health care-associated infections due to multidrug-resistant bacteria. Methods: We described the IMPACTO-MR platform, its development, criteria for intensive care unit selection, characterization of core data collection, objectives, and future research projects to be held within the platform. Results: The core data were collected using the Epimed Monitor System® and consisted of demographic data, comorbidity data, functional status, clinical scores, admission diagnosis and secondary diagnoses, laboratory, clinical, and microbiological data, and organ support during intensive care unit stay, among others. From October 2019 to December 2020, 33,983 patients from 51 intensive care units were included in the core database. Conclusion: The IMPACTO-MR platform is a nationwide Brazilian intensive care unit clinical database focused on researching the impact of health care-associated infections due to multidrug-resistant bacteria. This platform provides data for individual intensive care unit development and research and multicenter observational and prospective trials.

Retorno ao trabalho após a alta da unidade de terapia intensiva: uma coorte multicêntrica brasileira / Return to work after discharge from the intensive care unit: a Brazilian multicenter cohort

RESUMO Objetivo: Descrever a taxa e os fatores relacionados ao não retorno ao trabalho no terceiro mês pós-alta da unidade de terapia intensiva, além dos impactos do desemprego, da perda de renda e dos gastos com saúde para os sobreviventes. Métodos: Estudo de coorte prospectivo multicêntrico, que incluiu sobreviventes da doença aguda grave, hospitalizados entre 2015 e 2018, previamente empregados, que permaneceram mais de 72 horas internados na unidade de terapia intensiva. Os desfechos foram avaliados por entrevista telefônica no terceiro mês após a alta. Resultados: Dos 316 pacientes incluídos no estudo que trabalhavam previamente, 193 (61,1%) não retornaram ao trabalho nos 3 meses após a alta da unidade de terapia intensiva. Foram associados ao não retorno ao trabalho: baixo nível educacional (razão de prevalência de 1,39; IC95% 1,10 - 1,74; p = 0,006), vínculo empregatício prévio (razão de prevalência de 1,32; IC95% 1,10 - 1,58; p = 0,003), necessidade de ventilação mecânica (razão de prevalência de 1,20; IC95% 1,01 - 1,42; p = 0,04) e dependência física no terceiro mês pós-alta (razão de prevalência de 1,27; IC95% 1,08 - 1,48; p = 0,003). Os sobreviventes incapazes de retornar ao trabalho mais frequentemente apresentaram redução da renda familiar (49,7% versus 33,3%; p = 0,008) e aumento dos gastos em saúde (66,9% versus 48,3%; p = 0,002) quando comparados àqueles que retornaram ao trabalho no terceiro mês após a alta da unidade de terapia intensiva. Conclusão: Frequentemente, os sobreviventes de unidade de terapia intensiva não retornam ao trabalho até o terceiro mês pós-alta da unidade de terapia intensiva. Baixo nível educacional, trabalho formal, necessidade de suporte ventilatório e dependência física no terceiro mês pós-alta relacionaram-se ao não retorno ao trabalho. O não retorno ao trabalho também se relacionou com redução na renda familiar e aumento dos custos com saúde após a alta da unidade de terapia intensiva.

ABSTRACT Objective: To describe the rate and factors related to nonreturn to work in the third month after discharge from the intensive care unit and the impact of unemployment, loss of income and health care expenses for survivors. Methods: This was a prospective multicenter cohort study that included survivors of severe acute illness who were hospitalized between 2015 and 2018, previously employed, and who stayed more than 72 hours in the intensive care unit. Outcomes were assessed by telephone interview in the third month after discharge. Results: Of the 316 patients included in the study who had previously worked, 193 (61.1%) did not return to work within 3 months after discharge from the intensive care unit. The following factors were associated with nonreturn to work: low educational level (prevalence ratio 1.39; 95%CI 1.10 - 1.74; p = 0.006), previous employment relationship (prevalence ratio 1.32; 95%CI 1 10 - 1.58; p = 0.003), need for mechanical ventilation (prevalence ratio 1.20; 95%CI 1.01 - 1.42; p = 0.04) and physical dependence in the third month after discharge (prevalence ratio 1.27; 95%CI 1.08 - 1.48; p = 0.003). Survivors who were unable to return to work more often had reduced family income (49.7% versus 33.3%; p = 0.008) and increased health expenditures (66.9% versus 48.3%; p = 0.002). compared to those who returned to work in the third month after discharge from the intensive care unit. Conclusion: Intensive care unit survivors often do not return to work until the third month after discharge from the intensive care unit. Low educational level, formal job, need for ventilatory support and physical dependence in the third month after discharge were related to nonreturn to work. Failure to return to work was also associated with reduced family income and increased health care costs after discharge.

BNT162b2 against COVID-19 in Brazil using a test-negative design: Study protocol and statistical analysis plan.

INTRODUCTION: Real-world data on COVID-19 vaccine effectiveness are needed to validate evidence from randomized clinical trials. Accordingly, this study aims to evaluate, in a real-world setting in Brazil, the effectiveness of Pfizer-BioNTech BNT162b2 against symptomatic COVID-19 and COVID-19-related complications across diverse populations. MATERIALS AND METHODS: A test-negative case-control study with follow-up of cases is currently being conducted in Toledo, a city in southern Brazil, following a mass COVID-19 vaccination campaign with BNT162b2. The study is being conducted among patients aged 12 years or older seeking care in the public health system with acute respiratory symptoms and tested for SARS-CoV-2 on reverse transcription polymerase chain reaction (RT-PCR). Cases are RT-PCR positive and controls RT-PCR negative. Test-positive cases are prospectively followed through structured telephone interviews performed at 15 days post-enrollment, and at 1, 3, 6, 9 and 12 months. Baseline demographic, clinical, and vaccination data are being collected by means of structured interviews and medical registry records reviews at the time of enrollment. All RT-PCR-positive samples are screened for mutations to identify SARS-CoV-2 variants. ETHICS AND DISSEMINATION: The study protocol has been approved by the research ethics committee of all participant sites. Study findings will be disseminated through peer-reviewed publications and conference presentations. TRAIL REGISTRATION: Clinicatrials.gov: NCT05052307.

IMPACTO-MR: a Brazilian nationwide platform study to assess infections and multidrug resistance in intensive care units. / IMPACTO-MR: um estudo brasileiro de plataforma nacional para avaliar infecções e multirresistência em unidades de terapia intensiva.

OBJECTIVE: To describe the IMPACTO-MR, a Brazilian nationwide intensive care unit platform study focused on the impact of health care-associated infections due to multidrug-resistant bacteria. METHODS: We described the IMPACTO-MR platform, its development, criteria for intensive care unit selection, characterization of core data collection, objectives, and future research projects to be held within the platform. RESULTS: The core data were collected using the Epimed Monitor System® and consisted of demographic data, comorbidity data, functional status, clinical scores, admission diagnosis and secondary diagnoses, laboratory, clinical, and microbiological data, and organ support during intensive care unit stay, among others. From October 2019 to December 2020, 33,983 patients from 51 intensive care units were included in the core database. CONCLUSION: The IMPACTO-MR platform is a nationwide Brazilian intensive care unit clinical database focused on researching the impact of health care-associated infections due to multidrug-resistant bacteria. This platform provides data for individual intensive care unit development and research and multicenter observational and prospective trials.

OBJETIVO: Descrever o IMPACTO-MR, um estudo brasileiro de plataforma nacional em unidades de terapia intensiva focado no impacto das infecções por bactérias multirresistentes relacionadas à assistência à saúde. MÉTODOS: Descrevemos a plataforma IMPACTO-MR, seu desenvolvimento, critérios para seleção das unidades de terapia intensiva, caracterização da coleta de dados, objetivos e projetos de pesquisa futuros a serem realizados na plataforma. RESULTADOS: Os dados principais foram coletados por meio do Epimed Monitor System® e consistiram em dados demográficos, dados de comorbidades, estado funcional, escores clínicos, diagnóstico de internação e diagnósticos secundários, dados laboratoriais, clínicos e microbiológicos e suporte de órgãos durante a internação na unidade de terapia intensiva, entre outros. De outubro de 2019 a dezembro de 2020, 33.983 pacientes de 51 unidades de terapia intensiva foram incluídos no banco de dados principal. CONCLUSÃO: A plataforma IMPACTO-MR é um banco de dados clínico brasileiro de unidades de terapia intensiva focado na pesquisa do impacto das infecções por bactérias multirresistentes relacionadas à assistência à saúde. Essa plataforma fornece dados para o desenvolvimento e pesquisa de unidades de terapia intensiva individuais e ensaios clínicos observacionais e prospectivos multicêntricos.

Return to work after discharge from the intensive care unit: a Brazilian multicenter cohort. / Retorno ao trabalho após a alta da unidade de terapia intensiva: uma coorte multicêntrica brasileira.

OBJECTIVE: To describe the rate and factors related to nonreturn to work in the third month after discharge from the intensive care unit and the impact of unemployment, loss of income and health care expenses for survivors. METHODS: This was a prospective multicenter cohort study that included survivors of severe acute illness who were hospitalized between 2015 and 2018, previously employed, and who stayed more than 72 hours in the intensive care unit. Outcomes were assessed by telephone interview in the third month after discharge. RESULTS: Of the 316 patients included in the study who had previously worked, 193 (61.1%) did not return to work within 3 months after discharge from the intensive care unit. The following factors were associated with nonreturn to work: low educational level (prevalence ratio 1.39; 95%CI 1.10 - 1.74; p = 0.006), previous employment relationship (prevalence ratio 1.32; 95%CI 1 10 - 1.58; p = 0.003), need for mechanical ventilation (prevalence ratio 1.20; 95%CI 1.01 - 1.42; p = 0.04) and physical dependence in the third month after discharge (prevalence ratio 1.27; 95%CI 1.08 - 1.48; p = 0.003). Survivors who were unable to return to work more often had reduced family income (49.7% versus 33.3%; p = 0.008) and increased health expenditures (66.9% versus 48.3%; p = 0.002). compared to those who returned to work in the third month after discharge from the intensive care unit. CONCLUSION: Intensive care unit survivors often do not return to work until the third month after discharge from the intensive care unit. Low educational level, formal job, need for ventilatory support and physical dependence in the third month after discharge were related to nonreturn to work. Failure to return to work was also associated with reduced family income and increased health care costs after discharge.

OBJETIVO: Descrever a taxa e os fatores relacionados ao não retorno ao trabalho no terceiro mês pós-alta da unidade de terapia intensiva, além dos impactos do desemprego, da perda de renda e dos gastos com saúde para os sobreviventes. MÉTODOS: Estudo de coorte prospectivo multicêntrico, que incluiu sobreviventes da doença aguda grave, hospitalizados entre 2015 e 2018, previamente empregados, que permaneceram mais de 72 horas internados na unidade de terapia intensiva. Os desfechos foram avaliados por entrevista telefônica no terceiro mês após a alta. RESULTADOS: Dos 316 pacientes incluídos no estudo que trabalhavam previamente, 193 (61,1%) não retornaram ao trabalho nos 3 meses após a alta da unidade de terapia intensiva. Foram associados ao não retorno ao trabalho: baixo nível educacional (razão de prevalência de 1,39; IC95% 1,10 - 1,74; p = 0,006), vínculo empregatício prévio (razão de prevalência de 1,32; IC95% 1,10 - 1,58; p = 0,003), necessidade de ventilação mecânica (razão de prevalência de 1,20; IC95% 1,01 - 1,42; p = 0,04) e dependência física no terceiro mês pós-alta (razão de prevalência de 1,27; IC95% 1,08 - 1,48; p = 0,003). Os sobreviventes incapazes de retornar ao trabalho mais frequentemente apresentaram redução da renda familiar (49,7% versus 33,3%; p = 0,008) e aumento dos gastos em saúde (66,9% versus 48,3%; p = 0,002) quando comparados àqueles que retornaram ao trabalho no terceiro mês após a alta da unidade de terapia intensiva. CONCLUSÃO: Frequentemente, os sobreviventes de unidade de terapia intensiva não retornam ao trabalho até o terceiro mês pós-alta da unidade de terapia intensiva. Baixo nível educacional, trabalho formal, necessidade de suporte ventilatório e dependência física no terceiro mês pós-alta relacionaram-se ao não retorno ao trabalho. O não retorno ao trabalho também se relacionou com redução na renda familiar e aumento dos custos com saúde após a alta da unidade de terapia intensiva.

Convalescent plasma for COVID-19 in hospitalised patients: an open-label, randomised clinical trial.

BACKGROUND: The effects of convalescent plasma (CP) therapy in hospitalised patients with coronavirus disease 2019 (COVID-19) remain uncertain. This study investigates the effect of CP on clinical improvement in these patients. METHODS: This is an investigator-initiated, randomised, parallel arm, open-label, superiority clinical trial. Patients were randomly (1:1) assigned to two infusions of CP plus standard of care (SOC) or SOC alone. The primary outcome was the proportion of patients with clinical improvement 28 days after enrolment. RESULTS: A total of 160 (80 in each arm) patients (66.3% critically ill, 33.7% severely ill) completed the trial. The median (interquartile range (IQR)) age was 60.5 (48-68) years; 58.1% were male and the median (IQR) time from symptom onset to randomisation was 10 (8-12) days. Neutralising antibody titres >1:80 were present in 133 (83.1%) patients at baseline. The proportion of patients with clinical improvement on day 28 was 61.3% in the CP+SOC group and 65.0% in the SOC group (difference -3.7%, 95% CI -18.8-11.3%). The results were similar in the severe and critically ill subgroups. There was no significant difference between CP+SOC and SOC groups in pre-specified secondary outcomes, including 28-day mortality, days alive and free of respiratory support and duration of invasive ventilatory support. Inflammatory and other laboratory marker values on days 3, 7 and 14 were similar between groups. CONCLUSIONS: CP+SOC did not result in a higher proportion of clinical improvement on day 28 in hospitalised patients with COVID-19 compared to SOC alone.

Teaming-up nurses with ophthalmologists to expand the reach of eye care in a middle-income country: Validation of health data acquisition by nursing staff in a telemedicine strategy.

Telemedicine can be used to conduct ophthalmological assessment of patients, facilitating patient access to specialist care. Since the teleophthalmology models require data collection support from other health professionals, the purpose of our study was to assess agreement between the nursing technician and the ophthalmologist in acquisition of health parameters that can be used for remote analysis as part of a telemedicine strategy. A cross-sectional study was conducted with 140 patients referred to an ophthalmological telediagnosis center by primary healthcare doctors. The health parameters evaluated were visual acuity (VA), objective ophthalmic measures acquired by autorefraction, keratometry, and intraocular pressure (IOP). Bland-Altman plots were used to analyze agreement between the nursing technician and the ophthalmologist. The Bland-Altman analysis showed a mean bias equal to zero for the VA measurements [95%-LoA: -0.25-0.25], 0.01 [95%-LoA: -0.86-0.88] for spherical equivalent (M), -0.08 [95%-LoA: -1.1-0.95] for keratometry (K) and -0.23 [95%-LoA: -4.4-4.00] for IOP. The measures had a high linear correlation (R [95%CI]: 0.87 [0.82-0.91]; 0.97 [0.96-0.98]; 0.96 [0.95-0.97] and 0.88 [0.84-0.91] respectively). The results observed demonstrate that remote ophthalmological data collection by adequately trained health professionals is viable. This confirms the utility and safety of these solutions for scenarios in which access to ophthalmologists is limited.