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1.
Rev Bras Ter Intensiva ; 32(3): 444-457, 2020.
Artigo em Português, Inglês | MEDLINE | ID: mdl-33053036

RESUMO

The COVID-19 pandemic has brought concerns to managers, healthcare professionals, and the general population related to the potential mechanical ventilators' shortage for severely ill patients. In Brazil, there are several initiatives aimed at producing alternative ventilators to cover this gap. To assist the teams that work in these initiatives, we provide a discussion of some basic concepts on physiology and respiratory mechanics, commonly used mechanical ventilation terms, the differences between triggering and cycling, the basic ventilation modes and other relevant aspects, such as mechanisms of ventilator-induced lung injury, respiratory drive, airway heating and humidification, cross-contamination risks, and aerosol dissemination. After the prototype development phase, preclinical bench-tests and animal model trials are needed to determine the safety and performance of the ventilator, following the minimum technical requirements. Next, it is mandatory going through the regulatory procedures as required by the Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária - ANVISA). The manufacturing company should be appropriately registered by ANVISA, which also must be notified about the conduction of clinical trials, following the research protocol approval by the Research Ethics Committee. The registration requisition of the ventilator with ANVISA should include a dossier containing the information described in this paper, which is not intended to cover all related matters but to provide guidance on the required procedures.


Assuntos
Infecções por Coronavirus/terapia , Pneumonia Viral/terapia , Respiração Artificial/instrumentação , Ventiladores Mecânicos , Animais , Brasil/epidemiologia , Infecções por Coronavirus/epidemiologia , Desenho de Equipamento , Humanos , Pandemias , Pneumonia Viral/epidemiologia , Mecânica Respiratória , Lesão Pulmonar Induzida por Ventilação Mecânica/prevenção & controle
2.
Rev. bras. ter. intensiva ; 32(3): 444-457, jul.-set. 2020. tab, graf
Artigo em Português | LILACS-Express | LILACS | ID: biblio-1138512

RESUMO

RESUMO A pandemia por COVID-19 tem deixado os gestores, os profissionais de saúde e a população preocupados com a potencial escassez de ventiladores pulmonares para suporte de pacientes graves. No Brasil, há diversas iniciativas com o intuito de produzir ventiladores alternativos para ajudar a suprir essa demanda. Para auxiliar as equipes que atuam nessas iniciativas, são expostos alguns conceitos básicos sobre fisiologia e mecânica respiratória, os termos comumente utilizados no contexto da ventilação mecânica, as fases do ciclo ventilatório, as diferenças entre disparo e ciclagem, os modos ventilatórios básicos e outros aspectos relevantes, como mecanismos de lesão pulmonar induzida pela ventilação mecânica, pacientes com drive respiratório, necessidade de umidificação de vias aéreas, risco de contaminação cruzada e disseminação de aerossóis. Após a fase de desenvolvimento de protótipo, são necessários testes pré-clínicos de bancada e em modelos animais, a fim de determinar a segurança e o desempenho dos equipamentos, seguindo requisitos técnicos mínimos exigidos. Então, é imprescindível passar pelo processo regulatório exigido pela Agência Nacional de Vigilância Sanitária (ANVISA). A empresa responsável pela fabricação do equipamento deve estar regularizada junto à ANVISA, que também deve ser notificada da condução dos testes clínicos em humanos, seguindo protocolo de pesquisa aprovado pelo Comitê de Ética em Pesquisa. O registro do ventilador junto à ANVISA deve ser acompanhado de um dossiê, composto por documentos e informações detalhadas neste artigo, que não tem o propósito de esgotar o assunto, mas de nortear os procedimentos necessários.


ABSTRACT The COVID-19 pandemic has brought concerns to managers, healthcare professionals, and the general population related to the potential mechanical ventilators' shortage for severely ill patients. In Brazil, there are several initiatives aimed at producing alternative ventilators to cover this gap. To assist the teams that work in these initiatives, we provide a discussion of some basic concepts on physiology and respiratory mechanics, commonly used mechanical ventilation terms, the differences between triggering and cycling, the basic ventilation modes and other relevant aspects, such as mechanisms of ventilator-induced lung injury, respiratory drive, airway heating and humidification, cross-contamination risks, and aerosol dissemination. After the prototype development phase, preclinical bench-tests and animal model trials are needed to determine the safety and performance of the ventilator, following the minimum technical requirements. Next, it is mandatory going through the regulatory procedures as required by the Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária - ANVISA). The manufacturing company should be appropriately registered by ANVISA, which also must be notified about the conduction of clinical trials, following the research protocol approval by the Research Ethics Committee. The registration requisition of the ventilator with ANVISA should include a dossier containing the information described in this paper, which is not intended to cover all related matters but to provide guidance on the required procedures.

3.
Br J Anaesth ; 125(5): 779-801, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-32798067

RESUMO

BACKGROUND: Despite common use, the benefit of adding steroids to local anaesthetics (SLA) for chronic non-cancer pain (CNCP) injections is uncertain. We performed a systematic review and meta-analysis of English-language RCTs to assess the benefit and safety of adding steroids to local anaesthetics (LA) for CNCP. METHODS: We searched MEDLINE, EMBASE, and CENTRAL databases from inception to May 2019. Trial selection and data extraction were performed in duplicate. Outcomes were guided by the Initiative in Methods, Measurements, and Pain Assessment in Clinical Trials (IMMPACT) statement with pain improvement as the primary outcome and pooled using random effects model and reported as relative risks (RR) or mean differences (MD) with 95% confidence intervals (CIs). RESULTS: Among 5097 abstracts, 73 trials were eligible. Although SLA increased the rate of success (42 trials, 3592 patients; RR=1.14; 95% CI, 1.03-1.25; number needed to treat [NNT], 13), the effect size decreased by nearly 50% (NNT, 22) with the removal of two intrathecal injection studies. The differences in pain scores with SLA were not clinically meaningful (54 trials, 4416 patients, MD=0.44 units; 95% CI, 0.24-0.65). No differences were observed in other outcomes or adverse events. No subgroup effects were detected based on clinical categories. Meta-regression showed no significant association with steroid dose or length of follow-up and pain relief. CONCLUSIONS: Addition of cortico steroids to local anaesthetic has only small benefits and a potential for harm. Injection of local anaesthetic alone could be therapeutic, beyond being diagnostic. A shared decision based on patient preferences should be considered. If used, one must avoid high doses and series of steroid injections. CLINICAL TRIAL REGISTRATION: PROSPERO #: CRD42015020614.


Assuntos
Corticosteroides/uso terapêutico , Anestésicos Locais/uso terapêutico , Dor Crônica/tratamento farmacológico , Manejo da Dor/métodos , Corticosteroides/efeitos adversos , Anestésicos Locais/efeitos adversos , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento
4.
Curr Diabetes Rev ; 2020 08 10.
Artigo em Inglês | MEDLINE | ID: mdl-32778032

RESUMO

BACKGROUND: The management of type 2 diabetes mellitus (T2DM) requires a complex and organized care that includes patient lifestyle change. Additionally, emotional well-being is an important part of self-management, and it may impair the individual's adherence. Therefore, equipping them with the necessary coping and self-care techniques may be an important step in managing diabetes. OBJECTIVE: to evaluate the effect of interventions using established based-mindfulness protocols on glycemic control of individuals T2DM. METHODS: Data sources: Two electronic databases (PubMed and EMBASE) were searched from inception to December 2019. We limited our search to published studies in the English, Spanish and Portuguese language. STUDY SELECTION: Randomized clinical trials that assessed the effects of mindfulness in individuals with T2DM were selected. DATA EXTRACTION: Two authors independently assessed risk of bias and extracted data from the included trials. Data were pooled using inverse-variance random-effects meta-analyses. The quality of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. RESULTS: Four randomized trials were included. There were no differences in blood glucose change (mean difference between groups (MD) -0.73mg/dl; 95% CI, -10.49; 9.02; I2 =0%; very low quality of evidence) or glycated hemoglobin (MD 0.05%; 95%CI -0.22 to 0.32; I2 =29%; very low quality of evidence). CONCLUSIONS: Although the quality of current evidence is very low, our findings suggest that established protocols involving mindfulness has no effect on blood glucose or glycated hemoglobin in individuals with T2DM. Indeed, largescale trials are needed to evaluate the contribution of mindfulness on glycemic control in the clinical practice.

5.
Curr Probl Cardiol ; : 100429, 2019 Jun 29.
Artigo em Inglês | MEDLINE | ID: mdl-31326099

RESUMO

Myocardial injury after noncardiac surgery (MINS) includes patients with traditional myocardial infarction and those with ischemic myocardial injury after surgery. This study evaluated the prognostic value of MINS on major cardiovascular events and 30-day mortality, and determined independent preoperative predictors of MINS in patients after noncardiac surgery. This multicenter prospective cohort study was part of the VISION Study. The sample consisted of 2504 patients who underwent noncardiac surgery at 2 tertiary hospitals in Brazil between September 2008 and July 2012. Troponin Ts were measured 6-12 hours, and on days 1-3 after surgery. Cox regression analyses were performed to identify independent variables of major outcomes. A total of 314 (13%) patients were diagnosed with MINS, of which 26 (8%) died. Length-of-hospital stay of MINS patients was 3 times higher (18 ± 22 days vs 5.8 ± 11 days). In multivariate analysis, 30-day mortality was significantly higher among patients with MINS (hazard ratio [HR] 3.17 (95% confidence interval [CI] 1.56-6.41)), and major bleeding (HR 5.76 (95% CI 2.75-12.05)), sepsis (HR 5.08 (95% CI 2.25-11.46)), active cancer (HR 4.22 (95% CI 1.98-8.98)), and general surgery (HR 3.11 (95% CI 1.51-6.41)). Multivariable analysis indicated a higher chance of MINS in patients ≥75 years of age, history of diabetes mellitus, hypertension, heart failure, coronary disease, and end-stage renal failure. The incidence of MINS within 30 days after noncardiac surgery is related to higher mortality. Postoperative troponin monitoring in elder patients and with risk factors for atherosclerotic disease may help reduce postoperative cardiovascular events.

6.
Arq Bras Cardiol ; 112(3): 292-301, 2019 03.
Artigo em Inglês, Português | MEDLINE | ID: mdl-30916201

RESUMO

BACKGROUND: The choice of a mechanical (MP) or biological prosthesis (BP) for patients with valvular heart disease undergoing replacement is still not a consensus. OBJECTIVE: We aimed to determine the clinical outcomes of MP or BP placement in those patients. METHODS: We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) that compared biological prostheses and mechanical prostheses in patients with valvular heart diseases and assessed the outcomes. RCTs were searched in the MEDLINE, EMBASE, LILACS, CENTRAL, SCOPUS and Web of Science (from inception to November 2014) databases. Meta-analyses were performed using inverse variance with random effects models. The GRADE system was used to rate the quality of the evidence. A P-value lower than 0.05 was considered significant. RESULTS: A total of four RCTs were included in the meta-analyses (1,528 patients) with follow up ranging from 2 to 20 years. Three used old generation mechanical and biological prostheses, and one used contemporary prostheses. No significant difference in mortality was found between BP and MP patients (risk ratio (RR = 1.07; 95% CI 0.99-1.15). The risk of bleeding was significantly lower in BP patients than MP patients (RR = 0.64; 95% CI 0.52-0.78); however, reoperations were significantly more frequent in BP patients (RR = 3.60; 95% CI 2.44-5.32). There were no statistically significant differences between BP and MP patients with respect to systemic arterial embolisms and infective endocarditis (RR = 0.93; 95% CI 0.66-1.31, RR = 1.21; CI95% 0.78-1.88, respectively). Results in the trials with modern and old prostheses were similar. CONCLUSIONS: The mortality rate and the risk of thromboembolic events and endocarditis were similar between BP and MP patients. The risk of bleeding was approximately one third lower for BP patients than for MP patients, while the risk of reoperations was more than three times higher for BP patients.


Assuntos
Doenças das Valvas Cardíacas/cirurgia , Próteses Valvulares Cardíacas/normas , Bioprótese , Medicina Baseada em Evidências , Implante de Prótese de Valva Cardíaca/métodos , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Reoperação , Resultado do Tratamento
7.
Nutr Rev ; 77(6): 430-450, 2019 06 01.
Artigo em Inglês | MEDLINE | ID: mdl-30924853

RESUMO

CONTEXT: Recent evidence suggests that modulation of the gut microbiota may contribute to body weight control. OBJECTIVE: This systematic review aimed to assess the effects of oral supplementation with probiotics or synbiotics on body weight, body mass index (BMI), and waist circumference in overweight and obese adults (BMI ≥ 25 kg/m2). DATA SOURCES: Five electronic databases-PubMed, Embase, Cochrane Library/CENTRAL, LILACS, and Web of Science-were searched from inception to August 2017. No language restrictions were applied. STUDY SELECTION: Randomized and quasi-randomized parallel trials that assessed the effects of oral supplementation with probiotics or synbiotics vs any other intervention but bariatric surgery or fecal transplantation in overweight or obese adults were selected. DATA EXTRACTION: Three teams of 2 authors independently assessed risk of bias and extracted data from the included trials. Data were pooled using inverse-variance random-effects meta-analyses. The quality of evidence was assessed using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system. RESULTS: Nineteen randomized trials (28 publications, 1412 participants) were included. There were no differences in mean body weight change [mean difference (MD), -0.54 kg; 95%CI, -1.09 to 0.01; I2 = 0%; moderate quality of evidence) or mean BMI change (MD, -0.19 kg/m2; 95%CI, -0.43 to 0.04; I2 = 51%; low quality of evidence) between groups who received probiotics or synbiotics and control groups. Oral supplementation with probiotics or synbiotics reduced mean waist circumference compared with control (MD, -0.82 cm; 95%CI, -1.43 to -0.21; I2 = 46%; low quality of evidence). CONCLUSIONS: The findings suggest that oral supplementation with probiotics or synbiotics has a small effect to reduce waist circumference but no effect on body weight or BMI, although the quality of evidence is low to moderate. Therefore, the current evidence is not definitive. Large-scale trials are needed and may help to better inform clinical practice. SYSTEMATIC REVIEW REGISTRATION: PROSPERO registration number CRD42018075126.


Assuntos
Obesidade/tratamento farmacológico , Sobrepeso/tratamento farmacológico , Probióticos/administração & dosagem , Simbióticos/administração & dosagem , Administração Oral , Adulto , Idoso , Idoso de 80 Anos ou mais , Índice de Massa Corporal , Peso Corporal , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Probióticos/farmacologia , Ensaios Clínicos Controlados Aleatórios como Assunto , Circunferência da Cintura , Adulto Jovem
8.
Arq. bras. cardiol ; 112(3): 292-301, Mar. 2019. tab, graf
Artigo em Inglês | LILACS-Express | LILACS | ID: biblio-989329

RESUMO

Abstract Background: The choice of a mechanical (MP) or biological prosthesis (BP) for patients with valvular heart disease undergoing replacement is still not a consensus. Objective: We aimed to determine the clinical outcomes of MP or BP placement in those patients. Methods: We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) that compared biological prostheses and mechanical prostheses in patients with valvular heart diseases and assessed the outcomes. RCTs were searched in the MEDLINE, EMBASE, LILACS, CENTRAL, SCOPUS and Web of Science (from inception to November 2014) databases. Meta-analyses were performed using inverse variance with random effects models. The GRADE system was used to rate the quality of the evidence. A P-value lower than 0.05 was considered significant. Results: A total of four RCTs were included in the meta-analyses (1,528 patients) with follow up ranging from 2 to 20 years. Three used old generation mechanical and biological prostheses, and one used contemporary prostheses. No significant difference in mortality was found between BP and MP patients (risk ratio (RR = 1.07; 95% CI 0.99-1.15). The risk of bleeding was significantly lower in BP patients than MP patients (RR = 0.64; 95% CI 0.52-0.78); however, reoperations were significantly more frequent in BP patients (RR = 3.60; 95% CI 2.44-5.32). There were no statistically significant differences between BP and MP patients with respect to systemic arterial embolisms and infective endocarditis (RR = 0.93; 95% CI 0.66-1.31, RR = 1.21; CI95% 0.78-1.88, respectively). Results in the trials with modern and old prostheses were similar. Conclusions: The mortality rate and the risk of thromboembolic events and endocarditis were similar between BP and MP patients. The risk of bleeding was approximately one third lower for BP patients than for MP patients, while the risk of reoperations was more than three times higher for BP patients.


Resumo Fundamento: A escolha de próteses mecânicas ou biológicas para pacientes com doença de válvula cardíaca ainda não é um consenso. Objetivo: Determinar os desfechos clínicos de próteses mecânicas e biológicas nesses pacientes. Métodos: Conduzimos uma revisão sistemática e metanálise e estudos controlados randomizados (RCTs) que compararam próteses mecânicas e biológicas em pacientes com doenças de válvulas cardíaca, e avaliamos seus resultados. A busca por RCTs foi feita nas bases de dados MEDLINE, EMBASE, LILACS, CENTRAL, SCOPUS e Web of Science (do início a novembro de 2014). As metanálises foram realizadas usando variação inversa com modelos de efeitos aleatórios. Usamos o sistema GRADE para avaliar a qualidade da evidência. Um valor menor que 0,05 foi considerado significativo. Resultados: Um total de quatro RCTs foi incluído na metanálise (1528 pacientes) com acompanhamento de 2 a 20 anos. Em três estudos, foram utilizadas próteses mecânicas e biológicas mais antigas, e em um estudo próteses contemporâneas. Não foi observada diferença de mortalidade entre os pacientes que receberam próteses mecânicas e biológicas (risco relativo, RR = 1,07; IC95% 0,99-1,15). O risco de sangramento foi significativamente mais baixo nos pacientes que receberam próteses biológicas que naqueles com próteses mecânicas (RR = 0,64; IC95% 0,52-0,78). Contudo, as reoparações foram mais frequentes em pacientes com próteses biológicas (RR = 3,60; IC95% 2,44-5,32). Não houve diferenças estatisticamente significativas entre pacientes com próteses biológicas e mecânicas em relação à embolia arterial sistêmica e endocardite infecciosa (RR = 0,93; IC95% 0,66-1,31; RR = 1,21; IC95% 0,78-1,88, respectivamente). Resultados entre os estudos com próteses modernas e antigas foram similares. Conclusões: A taxa de mortalidade e o risco de eventos tromboembólicos e endocardite foram similares entre os pacientes que receberam próteses biológicas e mecânicas. O risco de sangramentos foi aproximadamente um terço menor nos pacientes com próteses biológicas que mecânicas, ao passo que o risco de reoperação foi mais que três vezes maior nos pacientes com próteses biológicas.

9.
Neural Plast ; 2018: 1638763, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-30050569

RESUMO

Background: Unilateral spatial neglect (USN) is the most frequent perceptual disorder after stroke. Noninvasive brain stimulation (NIBS) is a tool that has been used in the rehabilitation process to modify cortical excitability and improve perception and functional capacity. Objective: To assess the impact of NIBS on USN after stroke. Methods: An extensive search was conducted up to July 2016. Studies were selected if they were controlled and noncontrolled trials examining transcranial direct current stimulation (tDCS), repetitive transcranial magnetic stimulation (rTMS), and theta burst stimulation (TBS) in USN after stroke, with outcomes measured by standardized USN and functional tests. Results: Twelve RCTs (273 participants) and 4 non-RCTs (94 participants) proved eligible. We observed a benefit in overall USN measured by the line bisection test with NIBS in comparison to sham (SMD -2.35, 95% CI -3.72, -0.98; p = 0.0001); the rTMS yielded results that were consistent with the overall meta-analysis (SMD -2.82, 95% CI -3.66, -1.98; p = 0.09). The rTMS compared with sham also suggested a benefit in overall USN measured by Motor-Free Visual Perception Test at both 1 Hz (SMD 1.46, 95% CI 0.73, 2.20; p < 0.0001) and 10 Hz (SMD 1.19, 95% CI 0.48, 1.89; p = 0.54). There was also a benefit in overall USN measured by Albert's test and the line crossing test with 1 Hz rTMS compared to sham (SMD 2.04, 95% CI 1.14, 2.95; p < 0.0001). Conclusions: The results suggest a benefit of NIBS on overall USN, and we conclude that rTMS is more efficacious compared to sham for USN after stroke.


Assuntos
Transtornos da Percepção/terapia , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Reabilitação do Acidente Vascular Cerebral/métodos , Estimulação Transcraniana por Corrente Contínua/métodos , Estimulação Magnética Transcraniana/métodos , Humanos , Transtornos da Percepção/diagnóstico , Transtornos da Percepção/fisiopatologia
10.
Rev Bras Ter Intensiva ; 29(2): 142-153, 2017.
Artigo em Português, Inglês | MEDLINE | ID: mdl-28977255

RESUMO

BACKGROUND: The Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial (ART) is an international multicenter randomized pragmatic controlled trial with allocation concealment involving 120 intensive care units in Brazil, Argentina, Colombia, Italy, Poland, Portugal, Malaysia, Spain, and Uruguay. The primary objective of ART is to determine whether maximum stepwise alveolar recruitment associated with PEEP titration, adjusted according to the static compliance of the respiratory system (ART strategy), is able to increase 28-day survival in patients with acute respiratory distress syndrome compared to conventional treatment (ARDSNet strategy). OBJECTIVE: To describe the data management process and statistical analysis plan. METHODS: The statistical analysis plan was designed by the trial executive committee and reviewed and approved by the trial steering committee. We provide an overview of the trial design with a special focus on describing the primary (28-day survival) and secondary outcomes. We describe our data management process, data monitoring committee, interim analyses, and sample size calculation. We describe our planned statistical analyses for primary and secondary outcomes as well as pre-specified subgroup analyses. We also provide details for presenting results, including mock tables for baseline characteristics, adherence to the protocol and effect on clinical outcomes. CONCLUSION: According to best trial practice, we report our statistical analysis plan and data management plan prior to locking the database and beginning analyses. We anticipate that this document will prevent analysis bias and enhance the utility of the reported results. TRIAL REGISTRATION: ClinicalTrials.gov number, NCT01374022.


Assuntos
Respiração com Pressão Positiva/métodos , Alvéolos Pulmonares/metabolismo , /terapia , Interpretação Estatística de Dados , Humanos , Unidades de Terapia Intensiva , Projetos de Pesquisa , Taxa de Sobrevida , Resultado do Tratamento
11.
JAMA ; 318(14): 1335-1345, 2017 10 10.
Artigo em Inglês | MEDLINE | ID: mdl-28973363

RESUMO

Importance: The effects of recruitment maneuvers and positive end-expiratory pressure (PEEP) titration on clinical outcomes in patients with acute respiratory distress syndrome (ARDS) remain uncertain. Objective: To determine if lung recruitment associated with PEEP titration according to the best respiratory-system compliance decreases 28-day mortality of patients with moderate to severe ARDS compared with a conventional low-PEEP strategy. Design, Setting, and Participants: Multicenter, randomized trial conducted at 120 intensive care units (ICUs) from 9 countries from November 17, 2011, through April 25, 2017, enrolling adults with moderate to severe ARDS. Interventions: An experimental strategy with a lung recruitment maneuver and PEEP titration according to the best respiratory-system compliance (n = 501; experimental group) or a control strategy of low PEEP (n = 509). All patients received volume-assist control mode until weaning. Main Outcomes and Measures: The primary outcome was all-cause mortality until 28 days. Secondary outcomes were length of ICU and hospital stay; ventilator-free days through day 28; pneumothorax requiring drainage within 7 days; barotrauma within 7 days; and ICU, in-hospital, and 6-month mortality. Results: A total of 1010 patients (37.5% female; mean [SD] age, 50.9 [17.4] years) were enrolled and followed up. At 28 days, 277 of 501 patients (55.3%) in the experimental group and 251 of 509 patients (49.3%) in the control group had died (hazard ratio [HR], 1.20; 95% CI, 1.01 to 1.42; P = .041). Compared with the control group, the experimental group strategy increased 6-month mortality (65.3% vs 59.9%; HR, 1.18; 95% CI, 1.01 to 1.38; P = .04), decreased the number of mean ventilator-free days (5.3 vs 6.4; difference, -1.1; 95% CI, -2.1 to -0.1; P = .03), increased the risk of pneumothorax requiring drainage (3.2% vs 1.2%; difference, 2.0%; 95% CI, 0.0% to 4.0%; P = .03), and the risk of barotrauma (5.6% vs 1.6%; difference, 4.0%; 95% CI, 1.5% to 6.5%; P = .001). There were no significant differences in the length of ICU stay, length of hospital stay, ICU mortality, and in-hospital mortality. Conclusions and Relevance: In patients with moderate to severe ARDS, a strategy with lung recruitment and titrated PEEP compared with low PEEP increased 28-day all-cause mortality. These findings do not support the routine use of lung recruitment maneuver and PEEP titration in these patients. Trial Registration: clinicaltrials.gov Identifier: NCT01374022.


Assuntos
Respiração com Pressão Positiva/métodos , /terapia , Adulto , Idoso , Feminino , Humanos , Unidades de Terapia Intensiva , Masculino , Pessoa de Meia-Idade , Pneumotórax/etiologia , Respiração com Pressão Positiva/efeitos adversos , Volume de Ventilação Pulmonar , Falha de Tratamento
12.
Syst Rev ; 6(1): 116, 2017 06 19.
Artigo em Inglês | MEDLINE | ID: mdl-28629445

RESUMO

BACKGROUND: Preliminary evidence suggests statins may reduce major perioperative vascular events. However, evidence is limited to observational studies, underpowered trials, and non-comprehensive systematic reviews. This review aims to assess the effects of perioperative statin use on cardiovascular complications in patients submitted to non-cardiac surgery. METHODS: We will search MEDLINE/PubMed, EMBASE, LILACS, CENTRAL, Web of Science, and CINAHL for randomized controlled trials assessing the effects of perioperative statin use in adults undergoing non-cardiac surgery and reporting cardiovascular complications. For patients already using statins for hyperlipidemia, a preoperative loading dose of statin is required in the experimental group. We will place no language or publication restriction on our search. Teams of two reviewers will independently assess eligibility and risk of bias, and will extract data from the included trials. Our primary outcome is a combination of cardiovascular mortality or non-fatal myocardial infarction. We will also assess the following outcomes: individual components of the primary outcome, all-cause mortality, total myocardial infarction, elevated troponin in the first seven postoperative days, total stroke, total venous thromboembolism, postoperative atrial fibrillation, elevation of creatine phosphokinase or liver enzymes, and rates of myalgia or rhabdomyolysis. We will conduct meta-analyses using random-effects model and will use trial sequential analysis to establish monitoring boundaries to limit global type I error due to repetitive testing for our primary outcome. We will rate the quality of evidence using the GRADE system. DISCUSSION: The results of this systematic review may help to inform clinical practice and also the design of future large-scale randomized trials. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42016035987.


Assuntos
Inibidores de Hidroximetilglutaril-CoA Redutases , Infarto do Miocárdio/etiologia , Assistência Perioperatória/normas , Complicações Pós-Operatórias , Procedimentos Cirúrgicos Operatórios/efeitos adversos , Humanos , Inibidores de Hidroximetilglutaril-CoA Redutases/administração & dosagem , Inibidores de Hidroximetilglutaril-CoA Redutases/efeitos adversos , Mortalidade , Ensaios Clínicos Controlados Aleatórios como Assunto , Acidente Vascular Cerebral/etiologia , Revisões Sistemáticas como Assunto
13.
Rev. bras. ter. intensiva ; 29(2): 142-153, abr.-jun. 2017. tab, graf
Artigo em Português | LILACS | ID: biblio-899511

RESUMO

RESUMO Fundamentação: O estudo Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial (ART) é um ensaio clínico internacional, multicêntrico, randomizado, pragmático e controlado com ocultação da alocação que envolve 120 unidades de terapia intensiva no Brasil, Argentina, Colômbia, Espanha, Itália, Polônia, Portugal, Malásia e Uruguai, com o objetivo primário de determinar se o recrutamento alveolar gradual máximo associado com titulação da pressão positiva expiratória final, ajustada segundo a complacência estática do sistema respiratório (estratégia ART), é capaz de aumentar, quando comparada aos resultados do tratamento convencional (estratégia ARDSNet), a sobrevivência em 28 dias de pacientes com síndrome do desconforto respiratório agudo. Objetivo: Descrever o processo de gerenciamento dos dados e o plano de análise estatística em um ensaio clínico internacional. Métodos: O plano de análise estatística foi delineado pelo comitê executivo e revisado pelo comitê diretivo do ART. Foi oferecida uma visão geral do delineamento do estudo, com foco especial na descrição de desfechos primário (sobrevivência aos 28 dias) e secundários. Foram descritos o processo de gerenciamento dos dados, o comitê de monitoramento de dados, a análise interina e o cálculo do tamanho da amostra. Também foram registrados o plano de análise estatística para os desfechos primário e secundários, e os subgrupos de análise pré-especificados. Detalhes para apresentação dos resultados, inclusive modelos de tabelas para as características basais, adesão ao protocolo e efeito nos desfechos clínicos, foram fornecidos. Conclusão: Em acordo com as melhores práticas em ensaios clínicos, submetemos nossos planos de análise estatística e de gerenciamento de dados para publicação antes do fechamento da base de dados e início das análises. Antecipamos que este documento deve prevenir viés em análises e incrementar a utilidade dos resultados a serem relatados. Registro do estudo: Número no registro ClinicalTrials.gov NCT01374022.


ABSTRACT Background: The Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial (ART) is an international multicenter randomized pragmatic controlled trial with allocation concealment involving 120 intensive care units in Brazil, Argentina, Colombia, Italy, Poland, Portugal, Malaysia, Spain, and Uruguay. The primary objective of ART is to determine whether maximum stepwise alveolar recruitment associated with PEEP titration, adjusted according to the static compliance of the respiratory system (ART strategy), is able to increase 28-day survival in patients with acute respiratory distress syndrome compared to conventional treatment (ARDSNet strategy). Objective: To describe the data management process and statistical analysis plan. Methods: The statistical analysis plan was designed by the trial executive committee and reviewed and approved by the trial steering committee. We provide an overview of the trial design with a special focus on describing the primary (28-day survival) and secondary outcomes. We describe our data management process, data monitoring committee, interim analyses, and sample size calculation. We describe our planned statistical analyses for primary and secondary outcomes as well as pre-specified subgroup analyses. We also provide details for presenting results, including mock tables for baseline characteristics, adherence to the protocol and effect on clinical outcomes. Conclusion: According to best trial practice, we report our statistical analysis plan and data management plan prior to locking the database and beginning analyses. We anticipate that this document will prevent analysis bias and enhance the utility of the reported results. Trial registration: ClinicalTrials.gov number, NCT01374022.


Assuntos
Humanos , Alvéolos Pulmonares/metabolismo , Síndrome do Desconforto Respiratório do Adulto/terapia , Respiração com Pressão Positiva/métodos , Projetos de Pesquisa , Taxa de Sobrevida , Interpretação Estatística de Dados , Resultado do Tratamento , Unidades de Terapia Intensiva
14.
BMJ Open ; 7(2): e012680, 2017 02 23.
Artigo em Inglês | MEDLINE | ID: mdl-28235965

RESUMO

OBJECTIVE: A systematic review and meta-analysis to investigate the impact of electronic nicotine delivery systems (ENDS) and/or electronic non-nicotine delivery systems (ENNDS) versus no smoking cessation aid, or alternative smoking cessation aids, in cigarette smokers on long-term tobacco use. DATA SOURCES: Searches of MEDLINE, EMBASE, PsycInfo, CINAHL, CENTRAL and Web of Science up to December 2015. STUDY SELECTION: Randomised controlled trials (RCTs) and prospective cohort studies. DATA EXTRACTION: Three pairs of reviewers independently screened potentially eligible articles, extracted data from included studies on populations, interventions and outcomes and assessed their risk of bias. We used the Grading of Recommendations Assessment, Development and Evaluation approach to rate overall certainty of the evidence by outcome. DATA SYNTHESIS: Three randomised trials including 1007 participants and nine cohorts including 13 115 participants proved eligible. Results provided by only two RCTs suggest a possible increase in tobacco smoking cessation with ENDS in comparison with ENNDS (RR 2.03, 95% CI 0.94 to 4.38; p=0.07; I2=0%, risk difference (RD) 64/1000 over 6 to 12 months, low-certainty evidence). Results from cohort studies suggested a possible reduction in quit rates with use of ENDS compared with no use of ENDS (OR 0.74, 95% CI 0.55 to 1.00; p=0.051; I2=56%, very low certainty). CONCLUSIONS: There is very limited evidence regarding the impact of ENDS or ENNDS on tobacco smoking cessation, reduction or adverse effects: data from RCTs are of low certainty and observational studies of very low certainty. The limitations of the cohort studies led us to a rating of very low-certainty evidence from which no credible inferences can be drawn. Lack of usefulness with regard to address the question of e-cigarettes' efficacy on smoking reduction and cessation was largely due to poor reporting. This review underlines the need to conduct well-designed trials measuring biochemically validated outcomes and adverse effects.


Assuntos
Sistemas Eletrônicos de Liberação de Nicotina , Abandono do Hábito de Fumar/métodos , Fumar Tabaco/terapia , Terapia Comportamental , Humanos , Agonistas Nicotínicos/administração & dosagem , Ensaios Clínicos Controlados Aleatórios como Assunto , Dispositivos para o Abandono do Uso de Tabaco
15.
J Clin Epidemiol ; 84: 61-69, 2017 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-28063913

RESUMO

OBJECTIVES: To provide a perspective on the current practice of randomized clinical trials (RCTs) of diagnostic strategies focusing on patient-important outcomes. STUDY DESIGN AND SETTING: We conducted a comprehensive search of MEDLINE and included RCTs published in full-text reports that evaluated alternative diagnostic strategies. RESULTS: Of 56,912 unique citations, we sampled 7,500 and included 103 eligible RCTs, therefore suggesting that MEDLINE includes approximately 781 diagnostic RCTs. The 103 eligible trials reported on: mortality (n = 41; 39.8%); morbidities (n = 63; 61.2%); symptoms/quality of life/functional status (n = 14; 13.6%); and on composite end points (n = 10; 9.7%). Of the studies that reported statistically significant results (n = 12; 11.6%), we judged 7 (58.3%) as at low risk of bias with respect to missing outcome data and 4 (33.3%) as at low risk of bias regarding blinding. Of the 41 RCTs that reported on mortality, only one (2.4%) reported statistically significant results. Of 63 RCTs addressing morbidity outcomes, 11 (17.5%) reported statistically significant results, all of which reported relative effects of greater than 20%. CONCLUSION: RCTs of diagnostic tests are not uncommon, and sometimes suggest benefits on patient-important outcomes but often suffer from limitations in sample size and conduct.


Assuntos
Testes Diagnósticos de Rotina/estatística & dados numéricos , Avaliação de Resultados da Assistência ao Paciente , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Humanos , MEDLINE
17.
BMC Cardiovasc Disord ; 16: 121, 2016 06 02.
Artigo em Inglês | MEDLINE | ID: mdl-27255331

RESUMO

BACKGROUND: Trials of aspiration thrombectomy (AT) prior to primary percutaneous intervention (PCI) in patients with ST-segment elevation MI (STEMI) have shown apparently inconsistent results and therefore generated uncertainty and controversy. To summarize the effects of AT prior to PCI versus conventional PCI in STEMI patients. METHODS: Searches of MEDLINE, EMBASE and CENTRAL to June 2015 and review of reference lists of previous reviews. We included randomized controlled trials (RCTs) comparing AT prior to PCI with conventional PCI alone. Pairs of reviewers independently screened eligible articles; extracted data; and assessed risk of bias. We used the GRADE approach to rate overall certainty of the evidence. RESULTS: Among 73 potential articles identified, 20 trials including 21,660 patients were eligible; data were complete for 20,866 patients. Moderate-certainty evidence suggested a non statistically significant decrease in overall mortality (risk ratio (RR) 0.89, 95 % confidence interval, 0.78 to 1.01, risk difference (RD) 4/1,000 over 6 months), no impact on recurrent MI (RR 0.94, 95 % CI, 0.79 to 1.12) or major bleeding (RR 1.02, 95 % CI, 0.78 to 1.35), and an increase in stroke (RR 1.56, 95 % CI, 1.09 to 2.24, RD 3/1,000 over 6 months). CONCLUSIONS: Moderate certainty evidence suggests aspiration thrombectomy is associated with a possible small decrease in mortality (4 less deaths/1000 over 6 months) and a small increase in stroke (3 more strokes/1000 over 6 months). Because absolute effects are very small and closely balanced, thrombectomy prior to primary PCI should not be used as a routine strategy.


Assuntos
Trombose Coronária/terapia , Intervenção Coronária Percutânea , Infarto do Miocárdio com Supradesnível do Segmento ST/terapia , Trombectomia/métodos , Idoso , Distribuição de Qui-Quadrado , Trombose Coronária/diagnóstico por imagem , Trombose Coronária/mortalidade , Trombose Coronária/fisiopatologia , Feminino , Hemorragia/etiologia , Humanos , Masculino , Pessoa de Meia-Idade , Razão de Chances , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Recidiva , Medição de Risco , Fatores de Risco , Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico por imagem , Infarto do Miocárdio com Supradesnível do Segmento ST/mortalidade , Infarto do Miocárdio com Supradesnível do Segmento ST/fisiopatologia , Acidente Vascular Cerebral/etiologia , Trombectomia/efeitos adversos , Trombectomia/mortalidade , Fatores de Tempo , Resultado do Tratamento
18.
Syst Rev ; 5: 18, 2016 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-26831725

RESUMO

BACKGROUND: Steroids are often combined with local anesthetic (LA) and injected to reduce pain associated with various chronic non-cancer pain (CNCP) complaints. The biological rationale behind injection of a steroid solution is unclear, and it is uncertain whether the addition of steroids offers any additional benefits over injection of LA alone. We propose to conduct a systematic review and meta-analysis to summarize the evidence for using steroids and LA vs. LA alone in the treatment of CNCP. METHODS: An experienced librarian will perform a comprehensive search of EMBASE, MEDLINE, and the Cochrane Central Registry of Controlled Trials (CENTRAL) databases with search terms for clinical indications, LA, and steroid agents. We will review bibliographies of all relevant published reviews in the last 5 years for additional studies. Eligible trials will be published in English and randomly allocate patients with CNCP to treatment with steroid and LA injection therapy or injection with LA alone. We will use the guidelines published by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) to inform the outcomes that we collect and present. Teams of reviewers will independently and in duplicate assess trial eligibility, abstract data, and assess risk of bias among eligible trials. We will prioritize intention to treat analysis and, when possible, pool outcomes across trials using random effects models. We will report our findings as risk differences, weighted mean differences, or standardized mean differences for individual outcomes. Further, to ensure interpretability of our results, we will present risk differences and measures of relative effect for pain reduction based on anchor-based minimally important clinical differences. We will conduct a priori defined subgroup analyses and use the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system to evaluate the certainty of the evidence on an outcome-by-outcome basis. DISCUSSION: Our review will evaluate both the effectiveness and the adverse events associated with steroid plus LA vs. LA alone for CNCP, evaluate the quality of the evidence using the GRADE approach, and prioritize patient-important outcomes guided by IMMPACT recommendations. Our results will facilitate evidence-based management of patients with chronic non-cancer pain and identify key areas for future research. TRIAL REGISTRATION: PROSPERO CRD42015020614.


Assuntos
Corticosteroides , Anestésicos Locais , Dor Crônica/tratamento farmacológico , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Revisões Sistemáticas como Assunto
20.
Eur Heart J ; 37(2): 177-85, 2016 Jan 07.
Artigo em Inglês | MEDLINE | ID: mdl-26330424

RESUMO

AIMS: The aim of this study was to assess the effects of pre-operative statin therapy on cardiovascular events in the first 30-days after non-cardiac surgery. METHODS AND RESULTS: We conducted an international, prospective, cohort study of patients who were ≥45 years having in-patient non-cardiac surgery. We estimated the probability of receiving statins pre-operatively using a multivariable logistic model and conducted a propensity score analysis to correct for confounding. A total of 15 478 patients were recruited at 12 centres in eight countries from August 2007 to January 2011. The matched population consisted of 2845 patients (18.4%) treated with a statin and 4492 (29.0%) controls. The pre-operative use of statins was associated with lower risk of the primary outcome, a composite of all-cause mortality, myocardial injury after non-cardiac surgery (MINS), or stroke at 30 days [relative risk (RR), 0.83; 95% confidence interval (CI), 0.73-0.95; P = 0.007]. Statins were also associated with a significant lower risk of all-cause mortality (RR, 0.58; 95% CI, 0.40-0.83; P = 0.003), cardiovascular mortality (RR, 0.42; 95% CI, 0.23-0.76; P = 0.004), and MINS (RR, 0.86; 95% CI, 0.73-0.98; P = 0.02). There were no statistically significant differences in the risk of myocardial infarction or stroke. CONCLUSION: Among patients undergoing non-cardiac surgery, pre-operative statin therapy was independently associated with a lower risk of cardiovascular outcomes at 30 days. These results require confirmation in a large randomized trial. CLINICAL TRIAL REGISTRATION: Clinical Trials.gov NCT00512109.


Assuntos
Doenças Cardiovasculares/prevenção & controle , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Complicações Pós-Operatórias/prevenção & controle , Cuidados Pré-Operatórios/métodos , Adulto , Idoso , Doenças Cardiovasculares/mortalidade , Causas de Morte , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/mortalidade , Cuidados Pré-Operatórios/mortalidade , Estudos Prospectivos , Fatores de Risco , Resultado do Tratamento
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