33 research outputs found

    Sistemas de saúde comparados : risco moral e teoria da agência nos países Estados Unidos, Canadá e Reino Unido

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    Ao longo da segunda metade do século passado, foi observado um significativo aumento no gasto destinado à saúde como porcentagem da renda nacional. Ao mesmo tempo, a literatura a respeito da Economia da Saúde relata certas características a respeito do mercado em questão, diferenciando-o do restante da economia. Dentre essas diferenças, há os casos de risco moral e problema principal-agente. Com base nisso, o estudo de como tornar os sistemas nacionais de saúde mais eficientes é de suma importância. O objetivo desse trabalho é analisar as reformas institucionais que tiveram como foco o combate aos problemas de mercado supracitados realizadas por três diferentes países (Estados Unidos, Canadá e Reino Unido). Como método, é realizada uma revisão da literatura para compreender a estrutura funcional desses três sitemas de saúde, e os temas de risco moral e problema principal-agente. Após, são analisadas as mudanças institucionais ocorridas durante a segunda metade do século XX e início do século XXI, em especial àquelas realizadas com intuito de combater os problemas de mercado em questão. A conclusão resultante da realização do estudo foi de que, há sim diferenças em certos casos nos mecanismos adotados pelos países para combater o risco moral e a teoria da agência, dependendo da estrutura do sistema de saúde ser essencialmente pública ou privada. Entretanto, certas medidas foram adotadas pelos três países analisados independentemente dessa estrutura e, assim, fazem com que, de certa forma, haja um movimento de convergência institucional entre os diferentes sistemas de saúde em questão. Dessa forma, espera-se que o presente estudo possa servir como guia para formadores de políticas públicas na missão de tornar os sistemas de saúde nacionais mais eficientes.During the second half of the last century, a significant rise in the share of spent destinated to health as a percentage of the total national income was observed. At the same time, current literature regarding Health Economics describes certain characteristics about this market that diferentiates it from the rest of the economy. Among them, there are the cases of moral hazard and principal-agent problem. With that in mind, the study of how to make health systems more efficient is of great value. The aim of this particular study is to analyze the institutional reforms adopted by three different countries (United States, Canada and United Kingdom) that had the goal of dealing with the above mentioned market problems. As method, a review of the literature is done, with the focus of understanding both the structure of this three health systems and the topics of moral hazard and agency theory relative to Health Economics. Then, the institutional changes adopted by these countries during the second half of the XX and begining of XXI centuries, with a focus directed to the ones that aimed to fight those two market problems, are analyzed. It was possible to conclude, after the study, that there are differences in certain cases in the mecanisms adopted by these countries to deal with moral hazard and principal-angent problem, depending on the structure of the health system being mainly public or private. However, it was seen that there are some changes that were adopted by this three different countries, independently of its market structure. As so, the hypotesis that there is a certain convergence in the modern health systems is broght to debate. As a conclusion, it is expected that this works can be used as a tool to public policy makers in the mission of building efficient national health systems

    Hyperoxemia and excess oxygen use in early acute respiratory distress syndrome : Insights from the LUNG SAFE study

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    Publisher Copyright: © 2020 The Author(s). Copyright: Copyright 2020 Elsevier B.V., All rights reserved.Background: Concerns exist regarding the prevalence and impact of unnecessary oxygen use in patients with acute respiratory distress syndrome (ARDS). We examined this issue in patients with ARDS enrolled in the Large observational study to UNderstand the Global impact of Severe Acute respiratory FailurE (LUNG SAFE) study. Methods: In this secondary analysis of the LUNG SAFE study, we wished to determine the prevalence and the outcomes associated with hyperoxemia on day 1, sustained hyperoxemia, and excessive oxygen use in patients with early ARDS. Patients who fulfilled criteria of ARDS on day 1 and day 2 of acute hypoxemic respiratory failure were categorized based on the presence of hyperoxemia (PaO2 > 100 mmHg) on day 1, sustained (i.e., present on day 1 and day 2) hyperoxemia, or excessive oxygen use (FIO2 ≥ 0.60 during hyperoxemia). Results: Of 2005 patients that met the inclusion criteria, 131 (6.5%) were hypoxemic (PaO2 < 55 mmHg), 607 (30%) had hyperoxemia on day 1, and 250 (12%) had sustained hyperoxemia. Excess FIO2 use occurred in 400 (66%) out of 607 patients with hyperoxemia. Excess FIO2 use decreased from day 1 to day 2 of ARDS, with most hyperoxemic patients on day 2 receiving relatively low FIO2. Multivariate analyses found no independent relationship between day 1 hyperoxemia, sustained hyperoxemia, or excess FIO2 use and adverse clinical outcomes. Mortality was 42% in patients with excess FIO2 use, compared to 39% in a propensity-matched sample of normoxemic (PaO2 55-100 mmHg) patients (P = 0.47). Conclusions: Hyperoxemia and excess oxygen use are both prevalent in early ARDS but are most often non-sustained. No relationship was found between hyperoxemia or excessive oxygen use and patient outcome in this cohort. Trial registration: LUNG-SAFE is registered with ClinicalTrials.gov, NCT02010073publishersversionPeer reviewe

    Rationale, study design, and analysis plan of the Alveolar Recruitment for ARDS Trial (ART): Study protocol for a randomized controlled trial

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    Background: Acute respiratory distress syndrome (ARDS) is associated with high in-hospital mortality. Alveolar recruitment followed by ventilation at optimal titrated PEEP may reduce ventilator-induced lung injury and improve oxygenation in patients with ARDS, but the effects on mortality and other clinical outcomes remain unknown. This article reports the rationale, study design, and analysis plan of the Alveolar Recruitment for ARDS Trial (ART). Methods/Design: ART is a pragmatic, multicenter, randomized (concealed), controlled trial, which aims to determine if maximum stepwise alveolar recruitment associated with PEEP titration is able to increase 28-day survival in patients with ARDS compared to conventional treatment (ARDSNet strategy). We will enroll adult patients with ARDS of less than 72 h duration. The intervention group will receive an alveolar recruitment maneuver, with stepwise increases of PEEP achieving 45 cmH(2)O and peak pressure of 60 cmH2O, followed by ventilation with optimal PEEP titrated according to the static compliance of the respiratory system. In the control group, mechanical ventilation will follow a conventional protocol (ARDSNet). In both groups, we will use controlled volume mode with low tidal volumes (4 to 6 mL/kg of predicted body weight) and targeting plateau pressure &lt;= 30 cmH2O. The primary outcome is 28-day survival, and the secondary outcomes are: length of ICU stay; length of hospital stay; pneumothorax requiring chest tube during first 7 days; barotrauma during first 7 days; mechanical ventilation-free days from days 1 to 28; ICU, in-hospital, and 6-month survival. ART is an event-guided trial planned to last until 520 events (deaths within 28 days) are observed. These events allow detection of a hazard ratio of 0.75, with 90% power and two-tailed type I error of 5%. All analysis will follow the intention-to-treat principle. Discussion: If the ART strategy with maximum recruitment and PEEP titration improves 28-day survival, this will represent a notable advance to the care of ARDS patients. Conversely, if the ART strategy is similar or inferior to the current evidence-based strategy (ARDSNet), this should also change current practice as many institutions routinely employ recruitment maneuvers and set PEEP levels according to some titration method.Hospital do Coracao (HCor) as part of the Program 'Hospitais de Excelencia a Servico do SUS (PROADI-SUS)'Brazilian Ministry of Healt

    Sistemas de saúde comparados : risco moral e teoria da agência nos países Estados Unidos, Canadá e Reino Unido

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    Ao longo da segunda metade do século passado, foi observado um significativo aumento no gasto destinado à saúde como porcentagem da renda nacional. Ao mesmo tempo, a literatura a respeito da Economia da Saúde relata certas características a respeito do mercado em questão, diferenciando-o do restante da economia. Dentre essas diferenças, há os casos de risco moral e problema principal-agente. Com base nisso, o estudo de como tornar os sistemas nacionais de saúde mais eficientes é de suma importância. O objetivo desse trabalho é analisar as reformas institucionais que tiveram como foco o combate aos problemas de mercado supracitados realizadas por três diferentes países (Estados Unidos, Canadá e Reino Unido). Como método, é realizada uma revisão da literatura para compreender a estrutura funcional desses três sitemas de saúde, e os temas de risco moral e problema principal-agente. Após, são analisadas as mudanças institucionais ocorridas durante a segunda metade do século XX e início do século XXI, em especial àquelas realizadas com intuito de combater os problemas de mercado em questão. A conclusão resultante da realização do estudo foi de que, há sim diferenças em certos casos nos mecanismos adotados pelos países para combater o risco moral e a teoria da agência, dependendo da estrutura do sistema de saúde ser essencialmente pública ou privada. Entretanto, certas medidas foram adotadas pelos três países analisados independentemente dessa estrutura e, assim, fazem com que, de certa forma, haja um movimento de convergência institucional entre os diferentes sistemas de saúde em questão. Dessa forma, espera-se que o presente estudo possa servir como guia para formadores de políticas públicas na missão de tornar os sistemas de saúde nacionais mais eficientes.During the second half of the last century, a significant rise in the share of spent destinated to health as a percentage of the total national income was observed. At the same time, current literature regarding Health Economics describes certain characteristics about this market that diferentiates it from the rest of the economy. Among them, there are the cases of moral hazard and principal-agent problem. With that in mind, the study of how to make health systems more efficient is of great value. The aim of this particular study is to analyze the institutional reforms adopted by three different countries (United States, Canada and United Kingdom) that had the goal of dealing with the above mentioned market problems. As method, a review of the literature is done, with the focus of understanding both the structure of this three health systems and the topics of moral hazard and agency theory relative to Health Economics. Then, the institutional changes adopted by these countries during the second half of the XX and begining of XXI centuries, with a focus directed to the ones that aimed to fight those two market problems, are analyzed. It was possible to conclude, after the study, that there are differences in certain cases in the mecanisms adopted by these countries to deal with moral hazard and principal-angent problem, depending on the structure of the health system being mainly public or private. However, it was seen that there are some changes that were adopted by this three different countries, independently of its market structure. As so, the hypotesis that there is a certain convergence in the modern health systems is broght to debate. As a conclusion, it is expected that this works can be used as a tool to public policy makers in the mission of building efficient national health systems

    Statistical analysis plan for a cluster-randomized crossover trial comparing the effectiveness and safety of a flexible family visitation model for delirium prevention in adult intensive care units (the ICU Visits Study)

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    Abstract Background Most adult intensive care units (ICUs) worldwide adopt restrictive family visitation models (RFVMs). However, evidence, mostly from non-randomized studies, suggests that flexible adult ICU visiting hours are safe policies that can result in benefits such as prevention of delirium and increase in satisfaction with care. Accordingly, the ICU Visits Study was designed to compare the effectiveness and safety of a flexible family visitation model (FFVM) vs. an RFVM on delirium prevention among ICU patients, and also to analyze its potential effects on family members and ICU professionals. Methods/design The ICU Visits Study is a cluster-randomized crossover trial which compares an FFVM (12 consecutive ICU visiting hours per day) with an RFVM (< 4.5 ICU visiting hours per day) in 40 Brazilian adult ICUs. Participant ICUs are randomly assigned to either an FFVM or RFVM in a 1:1 ratio. After enrollment and follow-up of 25 patients, each ICU is crossed over to the other visitation model, until 25 more patients per site are enrolled and followed. The primary outcome is the cumulative incidence of delirium measured by the Confusion Assessment Method for the ICU. Secondary and tertiary outcomes include relevant measures of effectiveness and safety of ICU visiting policies among patients, family members, and ICU professionals. Herein, we describe all primary statistical procedures that will be used to evaluate the results and perform exploratory and sensitivity analyses of this study. This pre-specified statistical analysis plan was written and submitted without knowledge of the study data. Discussion This a priori statistical analysis plan aims to enhance the transparency of our study, facilitating unbiased analyses of ICU visit study data, and provide guidance for statistical analysis for groups conducting studies in the same field. Trial registration ClinicalTrials.gov, NCT02932358. Registered on 11 October 2016

    Immunocompromised patients with acute respiratory distress syndrome: Secondary analysis of the LUNG SAFE database

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    Background: The aim of this study was to describe data on epidemiology, ventilatory management, and outcome of acute respiratory distress syndrome (ARDS) in immunocompromised patients. Methods: We performed a post hoc analysis on the cohort of immunocompromised patients enrolled in the Large Observational Study to Understand the Global Impact of Severe Acute Respiratory Failure (LUNG SAFE) study. The LUNG SAFE study was an international, prospective study including hypoxemic patients in 459 ICUs from 50 countries across 5 continents. Results: Of 2813 patients with ARDS, 584 (20.8%) were immunocompromised, 38.9% of whom had an unspecified cause. Pneumonia, nonpulmonary sepsis, and noncardiogenic shock were their most common risk factors for ARDS. Hospital mortality was higher in immunocompromised than in immunocompetent patients (52.4% vs 36.2%; p &lt; 0.0001), despite similar severity of ARDS. Decisions regarding limiting life-sustaining measures were significantly more frequent in immunocompromised patients (27.1% vs 18.6%; p &lt; 0.0001). Use of noninvasive ventilation (NIV) as first-line treatment was higher in immunocompromised patients (20.9% vs 15.9%; p = 0.0048), and immunodeficiency remained independently associated with the use of NIV after adjustment for confounders. Forty-eight percent of the patients treated with NIV were intubated, and their mortality was not different from that of the patients invasively ventilated ab initio. Conclusions: Immunosuppression is frequent in patients with ARDS, and infections are the main risk factors for ARDS in these immunocompromised patients. Their management differs from that of immunocompetent patients, particularly the greater use of NIV as first-line ventilation strategy. Compared with immunocompetent subjects, they have higher mortality regardless of ARDS severity as well as a higher frequency of limitation of life-sustaining measures. Nonetheless, nearly half of these patients survive to hospital discharge. Trial registration: ClinicalTrials.gov, NCT02010073. Registered on 12 December 2013

    Effect of flexible family visitation on delirium among patients in the Intensive Care Unit: the ICU visits randomized clinical trial

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    Fernando Augusto Bozza. Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Documento produzido em parceria ou por autor vinculado à Fiocruz, mas não consta a informação no documento.Intensive Care Unit, Hospital Moinhos de Vento (HMV), Porto Alegre, Rio Grande do Sul, Brazil (Rosa, D. B. da Silva, Eugênio, Haack, Medeiros, Tonietto, Teixeira); Research Projects Office, HMV, Porto Alegre, Rio Grande do Sul, Brazil (Rosa, Falavigna, D. B. da Silva, Sganzerla, Santos, Kochhann, de Moura, Eugênio, Haack, Barbosa, Robinson, Schneider, de Oliveira, Jeffman, Medeiros, Hammes); Brazilian Research in Intensive Care Network (BRICNet), São Paulo, São Paulo (Rosa, Cavalcanti, Machado, Azevedo, Salluh, Nobre, Bozza, Teixeira); HCor Research Institute, São Paulo, São Paulo, Brazil (Cavalcanti); Department of Anesthesiology, Pain and Intensive Care, Universidade Federal de São Paulo (UNIFESP), São Paulo, São Paulo, Brazil (Machado); Intensive Care Unit, Hospital Sírio-Libanês, São Paulo, São Paulo, Brazil (Azevedo); Department of Critical Care, Instituto D’Or de Pesquisa e Ensino, Rio de Janeiro, Rio de Janeiro, Brazil (Salluh, Mesquita, Bozza); Intensive Care Unit, Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, Rio Grande do Sul, Brazil (Pellegrini, Moraes); Intensive Care Unit, Hospital Santa Cruz, Santa Cruz do Sul, Rio Grande do Sul, Brazil (Foernges); Intensive Care Unit, Hospital Santa Rita, Porto Alegre, Rio Grande do Sul, Brazil (Torelly); Intensive Care Unit, Hospital Universitário do Oeste do Paraná, Cascavel, Paraná, Brazil (Ayres, Duarte); Intensive Care Unit, Hospital do Câncer de Cascavel, Cascavel, Paraná, Brazil (Duarte); Intensive Care Unit, Hospital das Clínicas, Faculdade de Medicina de Ribeirão Preto, Ribeirão Preto, São Paulo, Brazil (Lovato); Intensive Care Unit, Santa Casa de Misericórdia de Feira de Santana, Feira de Santana, Bahia, Brazil (Sampaio); Intensive Care Unit, Hospital Geral Clériston Andrade, Feira de Santana, Bahia, Brazil (de Oliveira Júnior); Intensive Care Unit, Santa Casa de Misericórdia de São João Del Rei, São João Del Rei, Minas Gerais, Brazil (Paranhos); Intensive Care Unit, Hospital Regional Doutor Deoclécio Marques de Lucena, Parnamirim, Rio Grande do Norte, Brazil (Dantas, de Brito); Intensive Care Unit, Fundação Hospital Adriano Jorge, Manaus, Amazonas, Brazil (Paulo); Intensive Care Unit, Hospital Agamenon Magalhães, Recife, Pernambuco, Brazil (Gallindo); Intensive Care Unit, Hospital da Cidade, Passo Fundo, Rio Grande do Sul, Brazil (Pilau); Intensive Care Unit, Hospital Mãe de Deus, Porto Alegre, Rio Grande do Sul, Brazil (Valentim); Intensive Care Unit, Hospital de Urgências de Goiânia, Goiânia, Goiânia, Brazil (Meira Teles); Intensive Care Unit, Hospital das Clínicas, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, Minas Gerais, Brazil (Nobre); Intensive Care Unit, Pavilhão Pereira Filho, Porto Alegre, Rio Grande do Sul, Brazil (Birriel); Intensive Care Unit, Hospital Regional do Baixo Amazonas, Santarém, Pará, Brazil (Corrêa e Castro); Intensive Care Unit, Hospital Nossa Senhora da Conceição, Porto Alegre, Rio Grande do Sul, Brazil (Specht); School of Medicine, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, Rio Grande do Sul, Brazil (N. B. da Silva); Department of Public Health Sciences, Medical University of South Carolina, Charleston (Korte); Unit of Pediatric Anesthesia and Intensive Care, Ospedale dei Bambini—ASST Spedali Civili, Brescia, Italy (Giannini); Oswaldo Cruz Foundation (FIOCRUZ), Rio de Janeiro, Rio de Janeiro, Brazil (Bozza).Submitted by Janaína Nascimento ([email protected]) on 2019-09-11T14:37:38Z No. of bitstreams: 1 ve_Rosa_Regis_etal_INI_2019.pdf: 616825 bytes, checksum: 2aae5be305137324e272a08cc32e9270 (MD5)Approved for entry into archive by Janaína Nascimento ([email protected]) on 2019-09-11T14:52:11Z (GMT) No. of bitstreams: 1 ve_Rosa_Regis_etal_INI_2019.pdf: 616825 bytes, checksum: 2aae5be305137324e272a08cc32e9270 (MD5)Made available in DSpace on 2019-09-11T14:52:11Z (GMT). No. of bitstreams: 1 ve_Rosa_Regis_etal_INI_2019.pdf: 616825 bytes, checksum: 2aae5be305137324e272a08cc32e9270 (MD5) Previous issue date: 2019Múltipla - Ver em Notas.IMPORTANCE: The effects of intensive care unit (ICU) visiting hours remain uncertain. OBJECTIVE: To determine whether a flexible family visitation policy in the ICU reduces the incidence of delirium. DESIGN, SETTING AND PARTICIPANTS: Cluster-crossover randomized clinical trial involving patients, family members, and clinicians from 36 adult ICUs with restricted visiting hours (<4.5 hours per day) in Brazil. Participants were recruited from April 2017 to June 2018, with follow-up until July 2018. INTERVENTIONS: Flexible visitation (up to 12 hours per day) supported by family education (n = 837 patients, 652 family members, and 435 clinicians) or usual restricted visitation (median, 1.5 hours per day; n = 848 patients, 643 family members, and 391 clinicians). Nineteen ICUs started with flexible visitation, and 17 started with restricted visitation. MAIN OUTCOMES AND MEASURES: Primary outcome was incidence of delirium during ICU stay, assessed using the CAM-ICU. Secondary outcomes included ICU-acquired infections for patients; symptoms of anxiety and depression assessed using the HADS (range, 0 [best] to 21 [worst]) for family members; and burnout for ICU staff (Maslach Burnout Inventory). RESULTS: Among 1685 patients, 1295 family members, and 826 clinicians enrolled, 1685 patients (100%) (mean age, 58.5 years; 47.2% women), 1060 family members (81.8%) (mean age, 45.2 years; 70.3% women), and 737 clinicians (89.2%) (mean age, 35.5 years; 72.9% women) completed the trial. The mean daily duration of visits was significantly higher with flexible visitation (4.8 vs 1.4 hours; adjusted difference, 3.4 hours [95% CI, 2.8 to 3.9]; P < .001). The incidence of delirium during ICU stay was not significantly different between flexible and restricted visitation (18.9% vs 20.1%; adjusted difference, −1.7% [95% CI, −6.1% to 2.7%]; P = .44). Among 9 prespecified secondary outcomes, 6 did not differ significantly between flexible and restricted visitation, including ICU-acquired infections (3.7% vs 4.5%; adjusted difference, −0.8% [95% CI, −2.1% to 1.0%]; P = .38) and staff burnout (22.0% vs 24.8%; adjusted difference, −3.8% [95% CI, −4.8% to 12.5%]; P = .36). For family members, median anxiety (6.0 vs 7.0; adjusted difference, −1.6 [95% CI, −2.3 to −0.9]; P < .001) and depression scores (4.0 vs 5.0; adjusted difference, −1.2 [95% CI, −2.0 to −0.4]; P = .003) were significantly better with flexible visitation. CONCLUSIONS AND RELEVANCE: Among patients in the ICU, a flexible family visitation policy, vs standard restricted visiting hours, did not significantly reduce the incidence of delirium
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