18 research outputs found

    Optimal testing policies for diagnosing patients with intermediary probability of disease

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    This paper proposes a stochastic shortest path approach to find an optimal sequence of tests to confirm or discard a disease, for any prescribed optimality criterion. The idea is to select the best sequence in which to apply a series of available tests, with a view at reaching a diagnosis with minimum expenditure of resources. The proposed approach derives an optimal policy whereby the decision maker is provided with a test strategy for each a priori probability of disease, aiming to reach posterior probabilities that warrant either immediate treatment or a not-ill diagnosis

    Multicenter randomized trial of cell therapy in cardiopathies – MiHeart Study

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    BACKGROUND: Cardiovascular diseases are the major cause of death in the world. Current treatments have not been able to reverse this scenario, creating the need for the development of new therapies. Cell therapies have emerged as an alternative for cardiac diseases of distinct causes in experimental animal studies and more recently in clinical trials. METHOD/DESIGN: We have designed clinical trials to test for the efficacy of autologous bone marrow derived mononuclear cell therapies in four different cardiopathies: acute and chronic ischemic heart disease, and Chagasic and dilated cardiomyopathy. All trials are multicenter, randomized, double-blind and placebo controlled. In each trial 300 patients will be enrolled and receive optimized therapy for their specific condition. Additionally, half of the patients will receive the autologous bone marrow cells while the other half will receive placebo (saline with 5% autologous serum). For each trial there are specific inclusion and exclusion criteria and the method for cell delivery is intramyocardial for the chronic ischemic heart disease and intracoronary for all others. Primary endpoint for all studies will be the difference in ejection fraction (determined by Simpson's rule) six and twelve months after intervention in relation to the basal ejection fraction. The main hypothesis of this study is that the patients who receive the autologous bone-marrow stem cell implant will have after a 6 month follow-up a mean increase of 5% in absolute left ventricular ejection fraction in comparison with the control group. DISCUSSION: Many phase I clinical trials using cell therapy for cardiac diseases have already been performed. The few randomized studies have yielded conflicting results, rendering necessary larger well controlled trials to test for efficacy of cell therapies in cardiopathies. The trials registration numbers at the NIH registry are the following: Chagasic cardiomyopathy (NCT00349271), dilated cardiomyopathy (NCT00333827), acute myocardial infarction (NCT00350766) and Chronic Ischemic Heart Disease (NCT00362388)

    Multicenter double blind trial of autologous bone marrow mononuclear cell transplantation through intracoronary injection post acute myocardium infarction – MiHeart/AMI study

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    Background: Myocardial infarction remains as a major cause of mortality worldwide and a high rate of survivors develop heart failure as a sequel, resulting in a high morbidity and elevated expenditures for health system resources. We have designed a multicenter trial to test for the efficacy of autologous bone marrow (ABM) mononuclear cell (MC) transplantation in this subgroup of patients. The main hypothesis to be tested is that treated patients will have a significantly higher ejection fraction (EF) improvement after 6 months than controls. Methods: A sample of 300 patients admitted with ST elevation acute myocardial infarction (STEMI) and left ventricle (LV) systolic dysfunction, and submitted to successful mechanical or chemical recanalization of the infarct-related coronary artery will be selected for inclusion and randomized to either treated or control group in a double blind manner. The former group will receive 100 x 106 MC suspended in saline with 5% autologous serum in the culprit vessel, while the latter will receive placebo (saline with 5% autologous serum). Implications: Many phase I/II clinical trials using cell therapy for STEMI have been reported, demonstrating that cell transplantation is safe and may lead to better preserved LV function. Patients with high risk to develop systolic dysfunction have the potential to benefit more. Larger randomized, double blind and controlled trials to test for the efficacy of cell therapies in patients with high risk for developing heart failure are required.Brazilian Ministry of Science and Technology (MCT)/The Financing Agency for Studies and Projects (FINEP

    Global disparities in surgeons’ workloads, academic engagement and rest periods: the on-calL shIft fOr geNEral SurgeonS (LIONESS) study

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    : The workload of general surgeons is multifaceted, encompassing not only surgical procedures but also a myriad of other responsibilities. From April to May 2023, we conducted a CHERRIES-compliant internet-based survey analyzing clinical practice, academic engagement, and post-on-call rest. The questionnaire featured six sections with 35 questions. Statistical analysis used Chi-square tests, ANOVA, and logistic regression (SPSS® v. 28). The survey received a total of 1.046 responses (65.4%). Over 78.0% of responders came from Europe, 65.1% came from a general surgery unit; 92.8% of European and 87.5% of North American respondents were involved in research, compared to 71.7% in Africa. Europe led in publishing research studies (6.6 ± 8.6 yearly). Teaching involvement was high in North America (100%) and Africa (91.7%). Surgeons reported an average of 6.7 ± 4.9 on-call shifts per month, with European and North American surgeons experiencing 6.5 ± 4.9 and 7.8 ± 4.1 on-calls monthly, respectively. African surgeons had the highest on-call frequency (8.7 ± 6.1). Post-on-call, only 35.1% of respondents received a day off. Europeans were most likely (40%) to have a day off, while African surgeons were least likely (6.7%). On the adjusted multivariable analysis HDI (Human Development Index) (aOR 1.993) hospital capacity > 400 beds (aOR 2.423), working in a specialty surgery unit (aOR 2.087), and making the on-call in-house (aOR 5.446), significantly predicted the likelihood of having a day off after an on-call shift. Our study revealed critical insights into the disparities in workload, access to research, and professional opportunities for surgeons across different continents, underscored by the HDI

    Local Networks to Compete in the Global Era: The Italian SMEs Experience

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    O impacto da desnutrição na cardiomiopatia dilatada idiopática na infância

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    OBJETIVO: Determinar a importância da desnutrição como marcadora e preditora do óbito na cardiomiopatia dilatada idiopática na infância. MÉTODOS: Este é um estudo retrospectivo envolvendo 165 pacientes (setembro de 1979 a março de 2003). As variáveis analisadas foram sexo, idade e história de infecção viral nos últimos 3 meses, classe funcional da New York Heart Association (NYHA), percentil e desvio padrão do peso (índice z) e avaliação do estado nutricional. Foram realizadas 744 pesagens nos primeiros 72 meses e 93 no primeiro mês de evolução. Análise estatística: qui-quadrado, teste t de Student e análise de variância. Foram utilizados o valor alfa de 0,05 e o valor beta de 0,80. RESULTADOS: A idade no diagnóstico foi de 2,1±3,2 anos, com maior incidência nos menores de 2 anos (75,8%; IC95 = 68,5-82,1%) (p < 0,0001). A classe funcional III e IV foi observada em 81,2% (IC95 = 74,4-86,9%) (p < 0,0001), tendo todos os 40 óbitos ocorrido neste grupo (p = 0,0008). Na apresentação, a miocardite ocorreu em 39,4% (IC95 = 31,9-47,3%) (p = 0,0001). Houve forte associação entre miocardite e doença viral prévia (p = 0,0005) (RC = 3,15; IC95 = 1,55-6,44). A desnutrição na apresentação não influenciou o óbito (p = 0,10), porém a desnutrição evolutiva foi marcadora de óbito (p = 0,02) (RC = 3,21; IC95 = 1,04-9,95). Não houve diferença significativa no percentil de peso (p = 0,15) ou no índice z (p = 0,14) na apresentação. A média do percentil de peso e do índice z foram superiores nos sobreviventes (34,9+32,6 versus 8,6+16,0 e -0,62+1,43 versus -2,02+1,12) (p < 0,0001). A análise de variância demonstrou diferença significativa na evolução para o percentil de peso (p = 0,0417) e para o índice z (p = 0,0005) desde o primeiro mês de evolução. CONCLUSÃO: A avaliação do estado nutricional é de fácil execução, não implica ônus adicional e deve tornar-se rotina no seguimento do paciente com insuficiência cardíaca crônica

    O valor prognóstico da telerradiografia de tórax na cardiomiopatia dilatada idiopática na infância

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    OBJETIVOS: Analisar o valor prognóstico da cardiomegalia, da congestão pulmonar e do índice cardiotorácico como marcadores de óbito e sobrevida em crianças com cardiomiopatia dilatada. MÉTODOS: Estudo retrospectivo de 152 pacientes entre setembro de 1979 e março de 2003. Foram realizados 722 exames nos primeiros 72 meses e 100 nos primeiros 15 dias de evolução. Análise estatística: qui-quadrado, teste t de Student, análise de variância para medidas repetidas e método de Kaplan-Meier. Foram utilizados os valores alfa = 0,05 e beta = 0,80. RESULTADOS: Idade no diagnóstico de 2,2±3,2 anos. Incidência maior nos menores de 2 anos (76,3%; IC 95% = 68,7% a 82,8%) (p < 0,0001). Sexo (p = 0,07) e etnia (p = 0,11) não foram significantes, e a mortalidade não foi influenciada pela faixa etária (p = 0,73), sexo (p = 0,78) e etnia (p = 0,20). A maioria dos pacientes (84,2%; IC 95% = 77,4% a 89,6%) era grave, classe funcional III e IV (p < 0,0001), e todos os 43 óbitos ocorreram neste grupo (p = 0,0008). Cardiomegalia inicial foi observada em 94,1% (IC 95% = 89,1% a 97,2%) (p < 0,0001) e congestão pulmonar em 75,6% (IC 95% = 68,0% a 82,2%)(p < 0,0001), sendo mais freqüente na classe funcional III/IV (RC = 8,03; IC 95% = 2,85% a 23,1%)(p < 0,0001). A congestão pulmonar foi marcadora de óbito (RC = 3,16; IC 95 %= 1,06% a 10,07) (p = 0,0222), o mesmo não ocorrendo com a cardiomegalia (p = 0,1185). A sobrevida foi influenciada pela cardiomegalia (p = 0,0189) e pela congestão pulmonar (p = 0,0050). O índice cardiotorácico máximo e médio foram superiores no grupo óbito (0,749+0,053 versus 0,662+0,080) (p < 0,0001) e (0,716+0,059 versus 0,620+0,085) (p < 0,0001). A análise de variância demonstrou diminuição progressiva do índice cardiotorácico no grupo que sobreviveu (p < 0,0001). CONCLUSÃO: Em crianças com diagnóstico de cardiomiopatia dilatada Idiopática, a presença de congestão pulmonar no exame inicial e o aumento do índice cardiotorácico, são achados associados a menor sobrevida
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