Long-term effects of flexible visitation in the intensive care unit on family members' mental health: 12-month results from a randomized clinical trial.

PURPOSE: The aim of this study was to assess the effects of flexible intensive care unit (ICU) visitation on the 1-year prevalence of post-traumatic stress, anxiety and depression symptoms among family members of critically ill patients. METHODS: This is a long-term outcome analysis of a cluster-crossover randomized clinical trial that evaluated a flexible visitation model in the ICU (12 h/day) compared to a restrictive visitation model (median 1.5 h/day) in 36 Brazilian ICUs. In this analysis, family members were assessed 12 months after patient discharge from the ICU for the following outcomes: post-traumatic stress symptoms measured by the Impact Event Scale-6 and anxiety and depression symptoms measured by the Hospital Anxiety and Depression Scale. RESULTS: A total of 519 family members were analyzed (288 in the flexible visitation group and 231 in the restrictive visitation group). Three-hundred sixty-nine (71.1%) were women, and the mean age was 46.6 years. Compared to family members in the restrictive visitation group, family members in the flexible visitation group had a significantly lower prevalence of post-traumatic stress symptoms (21% vs. 30.5%; adjusted prevalence ratio [aPR], 0.91; 95% confidence interval [CI] 0.85-0.98; p = 0.01). The prevalence of anxiety (28.9% vs. 33.2%; aPR 0.93; 95% CI 0.72-1.21; p = 0.59) and depression symptoms (19.2% vs. 25%; aPR, 0.78; 95% CI 0.60-1.02; p = 0.07) did not differ significantly between the groups. CONCLUSION: Flexible ICU visitation, compared to the restrictive visitation, was associated with a significant reduction in the 1-year prevalence of post-traumatic stress symptoms in family members.

Impact on pulmonary, cardiac, and renal function and long-term quality of life after hospitalization for acute respiratory distress syndrome due to COVID-19: Protocol of the Post-COVID Brazil 3 study.

RATIONALE: Evidence about long-term sequelae after hospitalization for acute respiratory distress syndrome due to COVID-19 is still scarce. PURPOSE: To evaluate changes in pulmonary, cardiac, and renal function and in quality of life after hospitalization for acute respiratory distress syndrome secondary to COVID-19. METHODS: This will be a multicenter case-control study of 220 participants. Eligible are patients who are hospitalized for acute respiratory distress syndrome due to COVID-19. In the control group, individuals with no history of hospitalization in the last 12 months or long-term symptoms of COVID-19 will be selected. All individuals will be subjected to pulmonary spirometry with a carbon monoxide diffusion test, chest tomography, cardiac and renal magnetic resonance imaging with gadolinium, ergospirometry, serum and urinary creatinine, total protein, and urinary microalbuminuria, in addition to quality-of-life questionnaires. Patients will be evaluated 12 months after hospital discharge, and controls will be evaluated within 90 days of inclusion in the study. For all the statistical analyses, p < 0.05 is the threshold for significance. RESULTS: The primary outcome of the study will be the pulmonary diffusing capacity for carbon monoxide measured after 12 months. The other parameters of pulmonary, cardiac, and renal function and quality of life are secondary outcomes. CONCLUSION: This study aims to determine the long-term sequelae of pulmonary, cardiac, and renal function and the quality of life of patients hospitalized for acute respiratory distress syndrome due to COVID-19 in the Brazilian population.

A Randomized, Open-Label, Non-inferiority Clinical Trial Assessing 7 Versus 14 Days of Antimicrobial Therapy for Severe Multidrug-Resistant Gram-Negative Bacterial Infections: The OPTIMISE Trial Protocol.

INTRODUCTION: Shorter courses of antimicrobials have been shown to be non-inferior to longer, "traditional" duration of therapies, including for some severe healthcare-associated infections, with a few exceptions. However, evidence is lacking regarding shorter regimes against severe infections by multidrug-resistant Gram-negative bacteria (MDR-GNB), which are often caused by distinct strains and commonly treated with second-line antimicrobials. In the duratiOn of theraPy in severe infecTIons by MultIdrug-reSistant gram-nEgative bacteria (OPTIMISE) trial, we aim to assess the non-inferiority of 7-day versus 14-day antimicrobial therapy in critically ill patients with severe infections caused by MDR-GNB. METHODS: This is a randomized, multicenter, open-label, parallel controlled trial to assess the non-inferiority of 7-day versus 14-day of adequate antimicrobial therapy for intensive care unit (ICU)-acquired severe infections by MDR-GNB. Adult patients with severe infections by MDR-GNB initiated after 48 h of ICU admission are screened for eligibility. Patients are eligible if they proved to be hemodynamically stable and without fever for at least 48 h on the 7th day of adequate antimicrobial therapy. After consenting, patients are 1:1 randomized to discontinue antimicrobial therapy on the 7th (± 1) day or to continue for a total of 14th (± 1) days. PLANNED OUTCOMES: The primary outcome is treatment failure, defined as death or relapse of infection within 28 days after randomization. Non-inferiority will be achieved if the upper edge of the two-tailed 95% confidence interval of the difference between the clinical failure rate in the 7-day and the 14-day group is not higher than 10%. CONCLUSION: The OPTIMISE trial is the first randomized controlled trial specifically designed to assess the duration of antimicrobial therapy in patients with severe infections by MDR-GNB. TRIAL REGISTRATION: ClinicalTrials.gov, NCT05210387. Registered on 27 January 2022. Seven Versus 14 Days of Antibiotic Therapy for Multidrug-resistant Gram-negative Bacilli Infections (OPTIMISE).

Impact on pulmonary, cardiac, and renal function and long-term quality of life after hospitalization for acute respiratory distress syndrome due to COVID-19: Protocol of the Post-COVID Brazil 3 study / Impacto nas funções pulmonar, cardíaca e renal e na qualidade de vida a longo prazo após internação por síndrome do desconforto respiratório agudo por COVID-19: protocolo do Estudo 3 Pós-COVID Brasil

ABSTRACT Rationale: Evidence about long-term sequelae after hospitalization for acute respiratory distress syndrome due to COVID-19 is still scarce. Purpose: To evaluate changes in pulmonary, cardiac, and renal function and in quality of life after hospitalization for acute respiratory distress syndrome secondary to COVID-19. Methods: This will be a multicenter case-control study of 220 participants. Eligible are patients who are hospitalized for acute respiratory distress syndrome due to COVID-19. In the control group, individuals with no history of hospitalization in the last 12 months or long-term symptoms of COVID-19 will be selected. All individuals will be subjected to pulmonary spirometry with a carbon monoxide diffusion test, chest tomography, cardiac and renal magnetic resonance imaging with gadolinium, ergospirometry, serum and urinary creatinine, total protein, and urinary microalbuminuria, in addition to quality-of-life questionnaires. Patients will be evaluated 12 months after hospital discharge, and controls will be evaluated within 90 days of inclusion in the study. For all the statistical analyses, p < 0.05 is the threshold for significance. Results: The primary outcome of the study will be the pulmonary diffusing capacity for carbon monoxide measured after 12 months. The other parameters of pulmonary, cardiac, and renal function and quality of life are secondary outcomes. Conclusion: This study aims to determine the long-term sequelae of pulmonary, cardiac, and renal function and the quality of life of patients hospitalized for acute respiratory distress syndrome due to COVID-19 in the Brazilian population.

RESUMO Fundamento: As evidências acerca das sequelas a longo prazo após internação por síndrome do desconforto respiratório agudo por COVID-19 ainda são escassas. Objetivo: Avaliar alterações nas funções pulmonar, cardíaca e renal e na qualidade de vida após internação por síndrome do desconforto respiratório agudo secundária à COVID-19. Métodos: Trata-se de estudo multicêntrico, caso-controle, incluindo 220 participantes. Os casos serão definidos como pacientes hospitalizados por síndrome do desconforto respiratório agudo devido à COVID-19. No Grupo Controle, serão selecionados indivíduos sem histórico de hospitalização nos últimos 12 meses ou sintomas a longo prazo de COVID-19. Todos os indivíduos serão submetidos à espirometria pulmonar com teste de difusão pelo monóxido de carbono, tomografia de tórax, ressonância magnética cardíaca e renal com gadolínio, ergoespirometria, creatinina sérica e urinária, proteínas totais e microalbuminúria urinária, além de questionários de qualidade de vida. Os casos serão avaliados 12 meses após a alta hospitalar e os controles, 90 dias após a inclusão no estudo. Para todas as análises estatísticas, será assumido como significativo o valor p < 0,05. Resultados: O desfecho primário do estudo foi definido com a capacidade de difusão pulmonar aferida para o monóxido de carbono a partir de 12 meses. Os demais parâmetros das funções pulmonar, cardíacas e renal e da qualidade de vida foram definidos como desfechos secundários. Conclusão: Este estudo visa determinar as sequelas a longo prazo nas funções pulmonar, cardíaca e renal e na qualidade de vida de pacientes internados por síndrome do desconforto respiratório agudo devido à COVID-19 na população brasileira.

Long-term Health-Related Quality of Life and Outcomes after Hospitalization for COVID-19 in Brazil: Post-COVID Brazil 1 Study Protocol. / Qualidade de Vida em Longo Prazo e Desfechos após Internação por COVID-19 no Brasil: Protocolo do Estudo Pós-COVID Brasil 1.

BACKGROUND: The long-term impact of hospitalization for COVID-19 on patients' physical, mental, and cognitive health still needs further assessment. OBJECTIVES: This study aims to evaluate factors associated with quality of life and cardiovascular and non-cardiovascular outcomes 12 months after hospitalization for COVID-19. METHODS: This prospective multicenter study intends to enroll 611 patients hospitalized due to COVID-19 (NCT05165979). Centralized telephone interviews are scheduled to occur at three, six, nine, and 12 months after hospital discharge. The primary endpoint is defined as the health-related quality-of-life utility score assessed by the EuroQol-5D-3L (EQ-5D-3L) questionnaire at 12 months. Secondary endpoints are defined as the EQ-5D-3L at three, six and nine months, return to work or education, persistent symptoms, new disabilities in instrumental activities of daily living, cognitive impairment, anxiety, depression, and post-traumatic stress symptoms, major cardiovascular events, rehospitalization, as well as all-cause mortality at 3, 6, 9, and 12 months after SARS-CoV-2 infection. A p-value <0.05 will be assumed as statistically significant for all analyses. RESULTS: The primary endpoint will be presented as the frequency of the EQ-5D-3L score 12 months after COVID-19 hospitalization. A sub-analysis to identify possible associations of independent variables with study outcomes will be presented. CONCLUSIONS: This study will determine the impact of COVID-19 on the quality of life and cardiovascular and non-cardiovascular outcomes of hospitalized patients 12 months after discharge providing insights to the public health system in Brazil.

FUNDAMENTO: O impacto em longo prazo da hospitalização por COVID-19 sobre a saúde física, mental e cognitiva dos pacientes requer mais investigação. OBJETIVOS: Este artigo visa avaliar os fatores associados com a qualidade de vida e desfechos cardiovasculares e não cardiovasculares 12 meses após a internação hospitalar por COVID-19. MÉTODOS: Este estudo multicêntrico prospectivo pretende incluir 611 pacientes internados por COVID-19 (NCT05165979). Entrevistas telefônicas centralizadas estão programadas para ocorrer em três, seis, nove e 12 meses após a alta hospitalar. O desfecho primário é definido como o escore de utilidade de qualidade de vida relacionada à saúde avaliada pelo questionário EuroQol-5D-3L (EQ-5D-3L) aos 12 meses. Desfechos secundários são definidos como o EQ-5D-3L aos três, seis e nove meses, retorno ao trabalho ou à escola, sintomas persistentes, novas incapacidades em atividades instrumentais diárias, déficit cognitivo, ansiedade, depressão, e sintomas de transtorno do estresse pós-traumático, eventos cardiovasculares maiores, reinternação, e mortalidade por todas as causas aos três, seis, nove e 12 meses após a infecção pelo SARS-CoV-2. Um valor de p<0,05 será considerado estatisticamente significativo para as análises. RESULTADOS: O desfecho primário será apresentado como frequência do escore EQ-5D-3L 12 meses após a internação por COVID-19. Uma subanálise para identificar possíveis associações das variáveis independentes com desfechos do estudo será apresentada. CONCLUSÃO: Este estudo determinará o impacto da COVID-19 sobre a qualidade de vida e de desfechos cardiovasculares e não cardiovasculares de pacientes internados 12 meses após a alta, e fornecerá novas informações ao sistema público de saúde no Brasil.

Effects of participation in interdisciplinary rounds in the intensive care unit on family satisfaction: A cross-sectional study.

OBJECTIVE: To investigate whether family participation in intensive care unit interdisciplinary bedside rounds affects family satisfaction. METHODS: A cross-sectional study was conducted at a 56-bed, adult, mixed intensive care unit of a tertiary hospital in Southern Brazil. From May to June 2019, family members of patients who stayed in the intensive care unit for at least 48 hours were invited to participate in the study at the time of patient discharge. The main exposure variable was participation in intensive care unit bedside rounds during the intensive care unit stay. Family satisfaction was assessed by using the Brazilian version of the Family Satisfaction in the Intensive Care Unit questionnaire. RESULTS: Of the 234 screened individuals, 118 were included. Eleven participants withdrew consent. A total of 107 individuals were assessed; 58 (54%) reported being present during bedside rounds, and 49 (46%) reported never being present. General satisfaction and satisfaction with the decision-making process were higher among families who were present during rounds than among families who were not (p = 0.01 and p = 0.007, respectively). CONCLUSION: The presence during interdisciplinary rounds was associated with improved general satisfaction and satisfaction with the decision-making aspect. This outcome indicates that efforts must be directed to conduct studies with more robust methodologies to confirm this association.

Association between acute disease severity and one-year quality of life among post-hospitalisation COVID-19 patients: Coalition VII prospective cohort study.

PURPOSE: To assess the association between acute disease severity and 1-year quality of life in patients discharged after hospitalisation due to coronavirus disease 2019 (COVID-19). METHODS: We conducted a prospective cohort study nested in 5 randomised clinical trials between March 2020 and March 2022 at 84 sites in Brazil. Adult post-hospitalisation COVID-19 patients were followed for 1 year. The primary outcome was the utility score of EuroQol five-dimension three-level (EQ-5D-3L). Secondary outcomes included all-cause mortality, major cardiovascular events, and new disabilities in instrumental activities of daily living. Adjusted generalised estimating equations were used to assess the association between outcomes and acute disease severity according to the highest level on a modified ordinal scale during hospital stay (2: no oxygen therapy; 3: oxygen by mask or nasal prongs; 4: high-flow nasal cannula oxygen therapy or non-invasive ventilation; 5: mechanical ventilation). RESULTS: 1508 COVID-19 survivors were enrolled. Primary outcome data were available for 1156 participants. At 1 year, compared with severity score 2, severity score 5 was associated with lower EQ-5D-3L utility scores (0.7 vs 0.84; adjusted difference, - 0.1 [95% CI - 0.15 to - 0.06]); and worse results for all-cause mortality (7.9% vs 1.2%; adjusted difference, 7.1% [95% CI 2.5%-11.8%]), major cardiovascular events (5.6% vs 2.3%; adjusted difference, 2.6% [95% CI 0.6%-4.6%]), and new disabilities (40.4% vs 23.5%; adjusted difference, 15.5% [95% CI 8.5%-22.5]). Severity scores 3 and 4 did not differ consistently from score 2. CONCLUSIONS: COVID-19 patients who needed mechanical ventilation during hospitalisation have lower 1-year quality of life than COVID-19 patients who did not need mechanical ventilation during hospitalisation.

Effects of participation in interdisciplinary rounds in the intensive care unit on family satisfaction: A cross-sectional study / Efeitos da participação em rodadas interdisciplinares em unidades de terapia intensiva na satisfação familiar: Um estudo transversal

ABSTRACT Objective: To investigate whether family participation in intensive care unit interdisciplinary bedside rounds affects family satisfaction. Methods: A cross-sectional study was conducted at a 56-bed, adult, mixed intensive care unit of a tertiary hospital in Southern Brazil. From May to June 2019, family members of patients who stayed in the intensive care unit for at least 48 hours were invited to participate in the study at the time of patient discharge. The main exposure variable was participation in intensive care unit bedside rounds during the intensive care unit stay. Family satisfaction was assessed by using the Brazilian version of the Family Satisfaction in the Intensive Care Unit questionnaire. Results: Of the 234 screened individuals, 118 were included. Eleven participants withdrew consent. A total of 107 individuals were assessed; 58 (54%) reported being present during bedside rounds, and 49 (46%) reported never being present. General satisfaction and satisfaction with the decision-making process were higher among families who were present during rounds than among families who were not (p = 0.01 and p = 0.007, respectively). Conclusion: The presence during interdisciplinary rounds was associated with improved general satisfaction and satisfaction with the decision-making aspect. This outcome indicates that efforts must be directed to conduct studies with more robust methodologies to confirm this association.

RESUMO Objetivo: Investigar se a participação da família em rodadas interdisciplinares à beira do leito da unidade de terapia intensiva afeta a satisfação familiar. Métodos: Foi realizado um estudo transversal em uma unidade de terapia intensiva adulto mista com 56 leitos de hospital terciário no Sul do Brasil. De maio a junho de 2019, os familiares de pacientes internados na unidade de terapia intensiva por, pelo menos, 48 horas foram convidados a participar do estudo no momento da alta do paciente. A principal variável de exposição foi a participação em rodadas à beira do leito na unidade de terapia intensiva durante a internação na unidade de terapia intensiva. A satisfação familiar foi avaliada por meio da versão brasileira do Family Satisfaction in the Intensive Care Unit. Resultados: Dos 234 indivíduos selecionados, 118 foram incluídos. Destes, 11 participantes retiraram o consentimento. Foram avaliados 107 indivíduos; 58 (54%) relataram estar presentes durante as rodadas à beira do leito, e 49 (46%) relataram nunca estar presentes. A satisfação geral e a satisfação com o processo de tomada de decisão foram maiores entre as famílias presentes durante as rodadas do que entre as famílias ausentes (p = 0,01 e p = 0,007, respectivamente). Conclusão: A presença durante as rodadas interdisciplinares foi associada à melhora da satisfação geral e satisfação em relação ao processo de tomada de decisão. Esse desfecho indica que, para confirmar essa associação, devem-se direcionar esforços para realizar estudos com metodologias mais robustas.

Qualidade de Vida em Longo Prazo e Desfechos após Internação por COVID-19 no Brasil: Protocolo do Estudo Pós-COVID Brasil 1 / Long-term Health-Related Quality of Life and Outcomes after Hospitalization for COVID-19 in Brazil: Post-COVID Brazil 1 Study Protocol

Resumo Fundamento O impacto em longo prazo da hospitalização por COVID-19 sobre a saúde física, mental e cognitiva dos pacientes requer mais investigação. Objetivos Este artigo visa avaliar os fatores associados com a qualidade de vida e desfechos cardiovasculares e não cardiovasculares 12 meses após a internação hospitalar por COVID-19. Métodos Este estudo multicêntrico prospectivo pretende incluir 611 pacientes internados por COVID-19 (NCT05165979). Entrevistas telefônicas centralizadas estão programadas para ocorrer em três, seis, nove e 12 meses após a alta hospitalar. O desfecho primário é definido como o escore de utilidade de qualidade de vida relacionada à saúde avaliada pelo questionário EuroQol-5D-3L (EQ-5D-3L) aos 12 meses. Desfechos secundários são definidos como o EQ-5D-3L aos três, seis e nove meses, retorno ao trabalho ou à escola, sintomas persistentes, novas incapacidades em atividades instrumentais diárias, déficit cognitivo, ansiedade, depressão, e sintomas de transtorno do estresse pós-traumático, eventos cardiovasculares maiores, reinternação, e mortalidade por todas as causas aos três, seis, nove e 12 meses após a infecção pelo SARS-CoV-2. Um valor de p<0,05 será considerado estatisticamente significativo para as análises. Resultados O desfecho primário será apresentado como frequência do escore EQ-5D-3L 12 meses após a internação por COVID-19. Uma subanálise para identificar possíveis associações das variáveis independentes com desfechos do estudo será apresentada. Conclusão Este estudo determinará o impacto da COVID-19 sobre a qualidade de vida e de desfechos cardiovasculares e não cardiovasculares de pacientes internados 12 meses após a alta, e fornecerá novas informações ao sistema público de saúde no Brasil.

Abstract Background The long-term impact of hospitalization for COVID-19 on patients' physical, mental, and cognitive health still needs further assessment. Objectives This study aims to evaluate factors associated with quality of life and cardiovascular and non-cardiovascular outcomes 12 months after hospitalization for COVID-19. Methods This prospective multicenter study intends to enroll 611 patients hospitalized due to COVID-19 (NCT05165979). Centralized telephone interviews are scheduled to occur at three, six, nine, and 12 months after hospital discharge. The primary endpoint is defined as the health-related quality-of-life utility score assessed by the EuroQol-5D-3L (EQ-5D-3L) questionnaire at 12 months. Secondary endpoints are defined as the EQ-5D-3L at three, six and nine months, return to work or education, persistent symptoms, new disabilities in instrumental activities of daily living, cognitive impairment, anxiety, depression, and post-traumatic stress symptoms, major cardiovascular events, rehospitalization, as well as all-cause mortality at 3, 6, 9, and 12 months after SARS-CoV-2 infection. A p-value <0.05 will be assumed as statistically significant for all analyses. Results The primary endpoint will be presented as the frequency of the EQ-5D-3L score 12 months after COVID-19 hospitalization. A sub-analysis to identify possible associations of independent variables with study outcomes will be presented. Conclusions This study will determine the impact of COVID-19 on the quality of life and cardiovascular and non-cardiovascular outcomes of hospitalized patients 12 months after discharge providing insights to the public health system in Brazil.

Factors Associated with Tobacco Cessation in Primary Health Care.

Introduction Cigarettes are the main cause of preventable death in the world, and primary health care services can contribute to the management of this habit. Objective To describe and analyze the factors associated with tobacco cessation in groups of smokers in primary health care. Methods The present is a cross-sectional study conducted in 12 primary health care units from July 2016 to May 2017. We investigated sociodemographic and health variables, as well as smoking characteristics and different interventions for tobacco cessation, with the outcome being studied and analyzed after the fourth group care session. Results We evaluated 329 smokers, of which 182 quit smoking after the fourth interview. Most of the individuals who quit smoking were women ( n = 121, 66.5%), with a monthly income of 2 to 5 minimum wages ( n = 88, 77.9%). After the multivariable analysis, we observed that tobacco cessation was significantly associated with depression (prevalence ratio [PR] = 1.11; 95% confidence interval [95%CI] = 1.02 to 1.22), as well as with belonging to the groups which used as approaches motivational interviewing (PR = 1.21; 95%CI = 1.13 to 2.01), patches (PR = 1.36; 95%CI = 1.24 to 1.48), and bupropion (PR = 1.16; 95%CI = 1.03 to 1.31). Conclusion Primary health care is the ideal site for the reduction of smoking rates, given that different technologies may be applicable and useful for tobacco cessation. The comprehensiveness and longitudinal care offered in primary care may provide opportunities for health professionals to understand which is the best technology for each health system user, thus contributing to personalized care.

O Teste de Caminhada de 6 Minutos prevê a melhora física em longo prazo de sobreviventes à unidade de terapia intensiva: um estudo de coorte prospectiva / The 6-Minute Walk Test predicts long-term physical improvement among intensive care unit survivors: a prospective cohort study

RESUMO Objetivo: Avaliar a capacidade do Teste de Caminhada de 6 Minutos para predizer a melhora do estado funcional físico em longo prazo de pacientes sobreviventes à unidade de terapia intensiva. Métodos: Foram avaliados, de forma prospectiva, entre fevereiro de 2017 e agosto de 2018, em um ambulatório pós-unidade de terapia intensiva, 32 sobreviventes à unidade de terapia intensiva. Foram inscritos consecutivamente os pacientes com permanência na unidade de terapia intensiva acima de 72 horas (para admissões emergenciais) ou acima de 120 horas (para admissões eletivas) que compareceram ao ambulatório pós-unidade de terapia intensiva 4 meses após receberem alta da unidade de terapia intensiva. A associação entre a distância percorrida no Teste de Caminhada de 6 Minutos realizado na avaliação inicial e a evolução do estado funcional físico foi avaliada durante 8 meses, com utilização do Índice de Barthel. Resultados: A distância média percorrida no Teste de Caminhada de 6 Minutos foi significantemente mais baixa nos sobreviventes à unidade de terapia intensiva do que na população geral (405m versus 557m; p < 0,001). A idade (β = -4,0; p < 0,001) e a fraqueza muscular (β = -99,7; p = 0,02) se associaram com a distância percorrida no Teste de Caminhada de 6 Minutos. A distância percorrida no Teste de Caminhada de 6 Minutos se associou com melhora do estado funcional físico no período de 8 meses de acompanhamento desses pacientes (razão de chance para cada 10m: 1,07; IC95% 1,01 - 1,16; p = 0,03). A área sob a curva Característica de Operação do Receptor para predição da melhora funcional física pelo Teste de Caminhada de 6 Minutos foi de 0,72 (IC95% 0,53 - 0,88). Conclusão: O Teste de Caminhada de 6 Minutos, realizado 4 meses após a alta da unidade de terapia intensiva, predisse com precisão moderada a melhora do estado funcional físico de sobreviventes à unidade de terapia intensiva.

ABSTRACT Objective: To evaluate the ability of the 6-Minute Walk Test to predict long-term physical functional status improvement among intensive care unit survivors. Methods: Thirty-two intensive care unit survivors were prospectively evaluated from February 2017 to August 2018 in a post-intensive care unit outpatient clinic in Brazil. Individuals with intensive care unit stays > 72 hours (emergency admissions) or > 120 hours (elective admissions) attending the post-intensive care unit clinic four months after intensive care unit discharge were consecutively enrolled. The association between the 6-Minute Walk Test distance at baseline and physical functional status was assessed over 8 months using the Barthel Index. Results: The mean 6-Minute Walk Test distance was significantly lower in intensive care unit survivors than in the general population (405m versus 557m; p < 0.001). Age (β = -4.0; p < 0.001) and muscle weakness (β = -99.7; p = 0.02) were associated with the 6-Minute Walk Test distance. A 6-Minute Walk Test distance was associated with improvement in physical functional status over the 8-month follow-up (odds ratio for each 10m of 1.07; 95%CI 1.01 - 1.16; p = 0.03). The area under the Receiver Operating Characteristic curve for the 6-Minute Walk Test prediction of physical functional status improvement was 0.72 (95%CI 0.53 - 0.88). Conclusion: The 6-Minute Walk Test performed 4 months after intensive care unit discharge predicted long-term physical functional status among intensive care unit survivors with moderate accuracy.

The Burden of Mental Illness Among Survivors of Critical Care-Risk Factors and Impact on Quality of Life: A Multicenter Prospective Cohort Study.

BACKGROUND: Survivors of critical care may demonstrate mental health disorders in the months after discharge. RESEARCH QUESTION: What are risk factors for mental health disorders after ICU discharge and is there an association between the burden of mental illness and health-related quality of life (HRQoL)? STUDY DESIGN AND METHODS: Multicenter prospective cohort study that included 579 adult ICU survivors with an ICU stay of > 72 h in 10 ICUs. RESULTS: The outcomes were anxiety and depression assessed by the Hospital Anxiety and Depression Scale, posttraumatic stress disorder (PTSD) assessed by the Impact Event Scale 6, and HRQoL assessed by the Short Form 12 version 2. The 6-month prevalences of any mental health disorder were 36.2% (the prevalences of anxiety, depression, and PTSD were 24.2%, 20.9%, and 15.4%, respectively). ICU survivors with mental health disorders showed worse HRQoL scores in both physical and mental dimensions than those without. The higher the number of psychiatric syndromes manifested, the worse the mental dimension of HRQoL. Age of < 65 years (P = .009), history of depression (P = .009), anxiety (P = .003) and depression (P = .02) symptoms at ICU discharge, physical dependence (P = .01), and decreased physical functional status (P = .04) at 6 months were associated with anxiety. History of depression (P = .001), depression symptoms at ICU discharge (P < .001), and decreased physical functional status at 6 months (P = .01) were associated with depression. Depression symptoms at ICU discharge (P = .01), physical dependence (P = .01), and decreased physical functional status (P = .02) at 6 months were associated with PTSD. INTERPRETATION: The network of potential risk factors for mental illness among patients discharged from an ICU is complex and involves multiple factors (age, premorbid mental health, acute emotional stress, and physical impairment after ICU stay). The negative impact of the burden of mental illness on HRQoL among critical care survivors is of concern.

The 6-Minute Walk Test predicts long-term physical improvement among intensive care unit survivors: a prospective cohort study. / O Teste de Caminhada de 6 Minutos prevê a melhora física em longo prazo de sobreviventes à unidade de terapia intensiva: um estudo de coorte prospectiva.

OBJECTIVE: To evaluate the ability of the 6-Minute Walk Test to predict long-term physical functional status improvement among intensive care unit survivors. METHODS: Thirty-two intensive care unit survivors were prospectively evaluated from February 2017 to August 2018 in a post-intensive care unit outpatient clinic in Brazil. Individuals with intensive care unit stays > 72 hours (emergency admissions) or > 120 hours (elective admissions) attending the post-intensive care unit clinic four months after intensive care unit discharge were consecutively enrolled. The association between the 6-Minute Walk Test distance at baseline and physical functional status was assessed over 8 months using the Barthel Index. RESULTS: The mean 6-Minute Walk Test distance was significantly lower in intensive care unit survivors than in the general population (405m versus 557m; p < 0.001). Age (ß = -4.0; p < 0.001) and muscle weakness (ß = -99.7; p = 0.02) were associated with the 6-Minute Walk Test distance. A 6-Minute Walk Test distance was associated with improvement in physical functional status over the 8-month follow-up (odds ratio for each 10m of 1.07; 95%CI 1.01 - 1.16; p = 0.03). The area under the Receiver Operating Characteristic curve for the 6-Minute Walk Test prediction of physical functional status improvement was 0.72 (95%CI 0.53 - 0.88). CONCLUSION: The 6-Minute Walk Test performed 4 months after intensive care unit discharge predicted long-term physical functional status among intensive care unit survivors with moderate accuracy.

OBJETIVO: Avaliar a capacidade do Teste de Caminhada de 6 Minutos para predizer a melhora do estado funcional físico em longo prazo de pacientes sobreviventes à unidade de terapia intensiva. MÉTODOS: Foram avaliados, de forma prospectiva, entre fevereiro de 2017 e agosto de 2018, em um ambulatório pós-unidade de terapia intensiva, 32 sobreviventes à unidade de terapia intensiva. Foram inscritos consecutivamente os pacientes com permanência na unidade de terapia intensiva acima de 72 horas (para admissões emergenciais) ou acima de 120 horas (para admissões eletivas) que compareceram ao ambulatório pós-unidade de terapia intensiva 4 meses após receberem alta da unidade de terapia intensiva. A associação entre a distância percorrida no Teste de Caminhada de 6 Minutos realizado na avaliação inicial e a evolução do estado funcional físico foi avaliada durante 8 meses, com utilização do Índice de Barthel. RESULTADOS: A distância média percorrida no Teste de Caminhada de 6 Minutos foi significantemente mais baixa nos sobreviventes à unidade de terapia intensiva do que na população geral (405m versus 557m; p < 0,001). A idade (ß = -4,0; p < 0,001) e a fraqueza muscular (ß = -99,7; p = 0,02) se associaram com a distância percorrida no Teste de Caminhada de 6 Minutos. A distância percorrida no Teste de Caminhada de 6 Minutos se associou com melhora do estado funcional físico no período de 8 meses de acompanhamento desses pacientes (razão de chance para cada 10m: 1,07; IC95% 1,01 - 1,16; p = 0,03). A área sob a curva Característica de Operação do Receptor para predição da melhora funcional física pelo Teste de Caminhada de 6 Minutos foi de 0,72 (IC95% 0,53 - 0,88). CONCLUSÃO: O Teste de Caminhada de 6 Minutos, realizado 4 meses após a alta da unidade de terapia intensiva, predisse com precisão moderada a melhora do estado funcional físico de sobreviventes à unidade de terapia intensiva.

Statistical analysis plan for a cluster-randomised trial assessing the effectiveness of implementation of a bedside evidence-based checklist for clinical management of brain-dead potential organ donors in intensive care units: DONORS (Donation Network to Optimise Organ Recovery Study).

BACKGROUND: The quality of clinical care of brain-dead potential organ donors may help reduce donor losses caused by irreversible or unreversed cardiac arrest and increase the number of organs donated. We sought to determine whether an evidence-based, goal-directed checklist for donor management in intensive care units (ICUs) can reduce donor losses to cardiac arrest. METHODS/DESIGN: The DONORS study is a multicentre, cluster-randomised controlled trial with a 1:1 allocation ratio designed to compare an intervention group (goal-directed checklist for brain-dead potential organ donor management) with a control group (standard ICU care). The primary outcome is loss of potential donors due to cardiac arrest. Secondary outcomes are the number of actual organ donors and the number of solid organs recovered per actual donor. Exploratory outcomes include the achievement of relevant clinical goals during the management of brain-dead potential organ donors. The present statistical analysis plan (SAP) describes all primary statistical procedures that will be used to evaluate the results and perform exploratory and sensitivity analyses of the trial. DISCUSSION: The SAP of the DONORS study aims to describe its analytic procedures, enhancing the transparency of the study. At the moment of SAP subsmission, 63 institutions have been randomised and were enrolling study participants. Thus, the analyses reported herein have been defined before the end of the study recruitment and database locking. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03179020. Registered on 7 June 2017.

Early and Late Mortality Following Discharge From the ICU: A Multicenter Prospective Cohort Study.

OBJECTIVES: To identify the frequency, causes, and risk factors of early and late mortality among general adult patients discharged from ICUs. DESIGN: Multicenter, prospective cohort study. SETTING: ICUs of 10 tertiary hospitals in Brazil. PATIENTS: One-thousand five-hundred fifty-four adult ICU survivors with an ICU stay greater than 72 hours for medical and emergency surgical admissions or greater than 120 hours for elective surgical admissions. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: The main outcomes were early (30 d) and late (31 to 365 d) mortality. Causes of death were extracted from death certificates and medical records. Twelve-month cumulative mortality was 28.2% (439 deaths). The frequency of early mortality was 7.9% (123 deaths), and the frequency of late mortality was 22.3% (316 deaths). Infections were the leading cause of death in both early (47.2%) and late (36.4%) periods. Multivariable analysis identified age greater than or equal to 65 years (hazard ratio, 1.65; p = 0.01), pre-ICU high comorbidity (hazard ratio, 1.59; p = 0.02), pre-ICU physical dependence (hazard ratio, 2.29; p < 0.001), risk of death at ICU admission (hazard ratio per 1% increase, 1.008; p = 0.03), ICU-acquired infections (hazard ratio, 2.25; p < 0.001), and ICU readmission (hazard ratio, 3.76; p < 0.001) as risk factors for early mortality. Age greater than or equal to 65 years (hazard ratio, 1.30; p = 0.03), pre-ICU high comorbidity (hazard ratio, 2.28; p < 0.001), pre-ICU physical dependence (hazard ratio, 2.00; p < 0.001), risk of death at ICU admission (hazard ratio per 1% increase, 1.010; p < 0.001), and ICU readmission (hazard ratios, 4.10, 4.17, and 1.82 for death between 31 and 60 days, 61 and 90 days, and greater than 90 days after ICU discharge, respectively; p < 0.001 for all comparisons) were associated with late mortality. CONCLUSIONS: Infections are the main cause of death after ICU discharge. Older age, pre-ICU comorbidities, pre-ICU physical dependence, severity of illness at ICU admission, and ICU readmission are associated with increased risk of early and late mortality, while ICU-acquired infections are associated with increased risk of early mortality.