Your browser doesn't support javascript.
loading
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 6.209
Filtrar
1.
Nat Commun ; 12(1): 352, 2021 01 13.
Artigo em Inglês | MEDLINE | ID: mdl-33441554

RESUMO

Several immunotherapy clinical trials in recurrent glioblastoma have reported long-term survival benefits in 10-20% of patients. Here we perform genomic analysis of tumor tissue from recurrent WHO grade IV glioblastoma patients acquired prior to immunotherapy intervention. We report that very low tumor mutation burden is associated with longer survival after recombinant polio virotherapy or after immune checkpoint blockade in recurrent glioblastoma patients. A relationship between tumor mutation burden and survival is not observed in cohorts of immunotherapy naïve newly diagnosed or recurrent glioblastoma patients. Transcriptomic analyses reveal an inverse relationship between tumor mutation burden and enrichment of inflammatory gene signatures in cohorts of recurrent, but not newly diagnosed glioblastoma tumors, implying that a relationship between tumor mutation burden and tumor-intrinsic inflammation evolves upon recurrence.


Assuntos
Neoplasias Encefálicas/terapia , Glioblastoma/terapia , Imunoterapia/métodos , Mutação , Terapia Viral Oncolítica/métodos , Biomarcadores Tumorais/genética , Neoplasias Encefálicas/genética , Neoplasias Encefálicas/patologia , Estudos de Coortes , Perfilação da Expressão Gênica/métodos , Regulação Neoplásica da Expressão Gênica , Genômica/métodos , Glioblastoma/genética , Glioblastoma/patologia , Humanos , Inflamação/genética , Recidiva Local de Neoplasia , Avaliação de Resultados em Cuidados de Saúde/métodos , Avaliação de Resultados em Cuidados de Saúde/estatística & dados numéricos , Modelos de Riscos Proporcionais , Análise de Sobrevida
2.
Am J Nurs ; 121(2): 68, 2021 02 01.
Artigo em Inglês | MEDLINE | ID: mdl-33497132

RESUMO

According to this study: Among survivors of in-hospital cardiac arrest, recurrent cardiac arrest is the strongest predictor of poor outcomes and is associated with fivefold lower survival chances.


Assuntos
Parada Cardíaca Extra-Hospitalar/mortalidade , Avaliação de Resultados em Cuidados de Saúde/estatística & dados numéricos , Recidiva , Estudos de Coortes , Humanos , Mortalidade/tendências , Estudos Retrospectivos , Análise de Sobrevida
4.
Lancet Child Adolesc Health ; 5(2): 103-112, 2021 02.
Artigo em Inglês | MEDLINE | ID: mdl-33333071

RESUMO

BACKGROUND: Disparities in outcomes of adult sepsis are well described by insurance status and race and ethnicity. There is a paucity of data looking at disparities in sepsis outcomes in children. We aimed to determine whether hospital outcomes in childhood severe sepsis were influenced by race or ethnicity and insurance status, a proxy for socioeconomic position. METHODS: This population-based, retrospective cohort study used data from the 2016 database release from the Healthcare Cost and Utilization Project Kids' Inpatient Database (KID). The 2016 KID included 3 117 413 discharges, accounting for 80% of national paediatric discharges from 4200 US hospitals across 47 states. Using multilevel logistic regression, clustered by hospital, we tested the association between race or ethnicity and insurance status and hospital mortality, adjusting for individual-level and hospital-level characteristics, in children with severe sepsis. The secondary outcome of length of hospital stay was examined through multilevel time to event (hospital discharge) regression, with death as a competing risk. FINDINGS: 12 297 children (aged 0-21 years) with severe sepsis with or without shock were admitted to 1253 hospitals in the 2016 KID dataset. 1265 (10·3%) of 12 297 patients did not have race or ethnicity data recorded, 15 (0·1%) were missing data on insurance, and 1324 (10·8%) were transferred out of hospital, resulting in a final cohort of 9816 children. Black children had higher odds of death than did White children (adjusted odds ratio [OR] 1·19, 95 % CI 1·02-1·38; p=0·028), driven by higher Black mortality in the south (1·30, 1·04-1·62; p=0·019) and west (1·58, 1·05-2·38; p=0·027) of the USA. We found evidence of longer hospital stays for Hispanic children (adjusted hazard ratio 0·94, 95% CI 0·88-1·00; p=0·049) and Black children (0·88, 0·82-0·94; p=0·0002), particularly Black neonates (0·53, 95% CI 0·36-0·77; p=0·0011). We observed no difference in survival between publicly and privately insured children; however, other insurance status (self-pay, no charge, and other) was associated with increased mortality (adjusted OR 1·30, 95% CI 1·04-1·61; p=0·021). INTERPRETATION: In this large, representative analysis of paediatric severe sepsis in the USA, we found evidence of outcome disparities by race or ethnicity and insurance status. Our findings suggest that there might be differential sepsis recognition, approaches to treatment, access to health-care services, and provider bias that contribute to poorer sepsis outcomes for racial and ethnic minority patients and those of lower socioeconomic position. Studies are warranted to investigate the mechanisms of poorer sepsis outcomes in Black and Hispanic children. FUNDING: None.


Assuntos
Cobertura do Seguro/estatística & dados numéricos , Seguro Saúde/estatística & dados numéricos , Tempo de Internação/estatística & dados numéricos , Sepse/etnologia , Sepse/mortalidade , Adolescente , Adulto , Criança , Pré-Escolar , Bases de Dados Factuais , Feminino , Disparidades em Assistência à Saúde , Mortalidade Hospitalar/etnologia , Humanos , Lactente , Recém-Nascido , Masculino , Avaliação de Resultados em Cuidados de Saúde/estatística & dados numéricos , Estudos Retrospectivos , Fatores Socioeconômicos , Estados Unidos , Adulto Jovem
5.
Femina ; 48(12): 739-746, 20201231. ilus, tab
Artigo em Português | LILACS-Express | LILACS | ID: biblio-1141184

RESUMO

Objetivo: Avaliar os desfechos obstétricos entre grávidas adolescentes e adultas. Métodos: Estudo do tipo transversal não randomizado entre gestantes adolescentes e grávidas adultas em uma maternidade pública de Marabá-Pará. Foram associados desfechos obstétricos entre os dois grupos estudados. Para a análise univariada, foi utilizada a distribuição de frequências relativa e absoluta, e para a análise bivariada, foi utilizado cálculo do risco relativo com intervalo de confiança de 95%. Na comparação das variáveis numéricas, foi o utilizado o teste de ANOVA 1. Resultados: Identificou-se uma relação estatisticamente relevante entre a gravidez na adolescência e o estado civil solteiro, menor escolaridade, realização de menos de seis consultas de pré-natal, parto vaginal, episiotomia, baixo peso do recém-nascido ao nascer e menor perímetro cefálico, quando comparadas com as adultas. Conclusão: A gravidez na adolescência se associa com piores desfechos obstétricos relacionados ao peso ao nascer, perímetro cefálico e realização de episiotomias, o que se associa a fatores como a condição emocional e financeira da mãe e com a baixa cobertura da saúde pública na região amazônica.(AU)


Objective: To evaluate obstetric outcomes among pregnant adolescents and adults. Methods: Non-randomized cross-sectional study among pregnant adolescent and adult pregnant women in a public maternity hospital in Marabá-Pará. Obstetric outcomes were associated between the two groups studied. For a univariate analysis a distribution of relative and absolute frequencies was used and for a bivariate analysis a calculation of relative risk with confidence interval of 95% was used. The ANOVA 1 test was used to compare numerical variables. Results: A statistically relevant association was identified between teenage pregnancy and single marital status, less education, less than six prenatal consultations, vaginal delivery, episiotomy, low birth weight at birth and smaller head circumference when compared to adults. Conclusion: Adolescent pregnancy is associated with worse obstetric outcomes related to birth weight, head circumference and episiotomies, which is associated with factors, such as the mother's emotional and financial condition, and the low public health coverage in the Amazon region.(AU)


Assuntos
Humanos , Feminino , Gravidez , Adolescente , Adulto , Gravidez na Adolescência , Gravidez , Avaliação de Resultados em Cuidados de Saúde/estatística & dados numéricos , Saúde Materna , Brasil/epidemiologia , Registros Médicos , Estudos Transversais , Fatores de Risco
6.
Medicine (Baltimore) ; 99(46): e22427, 2020 Nov 13.
Artigo em Inglês | MEDLINE | ID: mdl-33181640

RESUMO

There is paucity of data on the impact of surgical incision and analgesia on relevant outcomes.A retrospective STROBE-compliant cohort study was performed between July 2007 and August 2017 of patients undergoing lung transplantation. Gender, age, indication for lung transplantation, and the 3 types of surgical access (Thoracotomy (T), Sternotomy (S), and Clamshell (C)) were used, as well as 2 analgesic techniques: epidural and intravenous opioids. Outcome variables were: pain scores; postoperative hemorrhage in the first 24 hours, duration of mechanical ventilation, and length of stay at intensive care unit (ICU).Three hundred forty-one patients were identified. Thoracotomy was associated with higher pain scores than Sternotomy (OR 1.66, 95% CI: 1.01; 2.74, P: .045) and no differences were found between Clamshell and Sternotomy incision. The median blood loss was 800 mL [interquartile range (IQR): 500; 1238], thoracotomy patients had 500 mL [325; 818] (P < .001). Median durations of mechanical ventilation in Thoracotomy, Sternotomy, and Clamshell groups were 19 [11; 37] hours, 34 [IQR 16; 57.5] hours, and 27 [IQR 15; 50.5] hours respectively. Thoracotomy group were discharged earlier from ICU (P < .001).Thoracotomy access produces less postoperative hemorrhage, duration of mechanical ventilation, and lower length of stay in ICU, but higher pain scores and need for epidural analgesia.


Assuntos
Analgesia/normas , Transplante de Pulmão/métodos , Avaliação de Resultados em Cuidados de Saúde/estatística & dados numéricos , Esternotomia/efeitos adversos , Toracotomia/efeitos adversos , Administração Intravenosa/normas , Administração Intravenosa/estatística & dados numéricos , Adulto , Idoso , Analgesia/estatística & dados numéricos , Analgesia Epidural/normas , Analgesia Epidural/estatística & dados numéricos , Estudos de Coortes , Feminino , Humanos , Estimativa de Kaplan-Meier , Transplante de Pulmão/normas , Transplante de Pulmão/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Estudos Retrospectivos , Estatísticas não Paramétricas , Esternotomia/métodos , Esternotomia/estatística & dados numéricos , Toracotomia/métodos , Toracotomia/estatística & dados numéricos , Resultado do Tratamento
7.
BMC Fam Pract ; 21(1): 208, 2020 10 10.
Artigo em Inglês | MEDLINE | ID: mdl-33038926

RESUMO

BACKGROUND: To analyse the impact of the COVID-19 epidemic and the lockdown measures on the follow-up and control of chronic diseases in primary care. METHODS: Retrospective study in 288 primary care practices (PCP) of the Catalan Institute of Health. We analysed the results of 34 indicators of the Healthcare quality standard (EQA), comprising different types: treatment (4), follow-up (5), control (10), screening (7), vaccinations (4) and quaternary prevention (4). For each PCP, we calculated each indicator's percentage of change in February, March and April 2020 respective to the results of the previous month; and used the T-Student test for paired data to compare them with the percentage of change in the same month of the previous year. We defined indicators with a negative effect those with a greater negative change or a lesser positive change in 2020 in comparison to 2019; and indicators with a positive effect those with a greater positive change or a lesser negative change. RESULTS: We observed a negative effect on 85% of the EQA indicators in March and 68% in April. 90% of the control indicators had a negative effect, highlighting the control of LDL cholesterol with a reduction of - 2.69% (95%CI - 3.17% to - 2.23%) in March and - 3.41% (95%CI - 3.82% to - 3.01%) in April; and the control of blood pressure with a reduction of - 2.13% (95%CI - 2.34% to - 1.9%) and - 2.59% (95%CI - 2.8% to - 2.37%). The indicators with the greatest negative effect were those of screening, such as the indicator of diabetic foot screening with a negative effect of - 2.86% (95%CI - 3.33% to - 2.39%) and - 4.13% (95%CI - 4.55% to - 3.71%) in March and April, respectively. Only one vaccination indicator, adult Measles-Mumps-Rubella vaccine, had a negative effect in both months. Finally, among the indicators of quaternary prevention, we observed negative effects in March and April although in that case a lower inadequacy that means better clinical outcome. CONCLUSIONS: The COVID-19 epidemic and the lockdown measures have significantly reduced the results of the follow-up, control, screening and vaccination indicators for patients in primary care. On the other hand, the indicators for quaternary prevention have been strengthened and their results have improved.


Assuntos
Betacoronavirus , Infecções por Coronavirus/epidemiologia , Pneumonia Viral/epidemiologia , Atenção Primária à Saúde/organização & administração , Indicadores de Qualidade em Assistência à Saúde , Quarentena/estatística & dados numéricos , Adulto , Infecções por Coronavirus/prevenção & controle , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Avaliação de Resultados em Cuidados de Saúde/estatística & dados numéricos , Pandemias/prevenção & controle , Pneumonia Viral/prevenção & controle , Sistema de Registros , Estudos Retrospectivos , Espanha
8.
Lancet ; 396(10258): 1135-1159, 2020 10 17.
Artigo em Inglês | MEDLINE | ID: mdl-33069324

RESUMO

The Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2019 provides a rules-based synthesis of the available evidence on levels and trends in health outcomes, a diverse set of risk factors, and health system responses. GBD 2019 covered 204 countries and territories, as well as first administrative level disaggregations for 22 countries, from 1990 to 2019. Because GBD is highly standardised and comprehensive, spanning both fatal and non-fatal outcomes, and uses a mutually exclusive and collectively exhaustive list of hierarchical disease and injury causes, the study provides a powerful basis for detailed and broad insights on global health trends and emerging challenges. GBD 2019 incorporates data from 281 586 sources and provides more than 3·5 billion estimates of health outcome and health system measures of interest for global, national, and subnational policy dialogue. All GBD estimates are publicly available and adhere to the Guidelines on Accurate and Transparent Health Estimate Reporting. From this vast amount of information, five key insights that are important for health, social, and economic development strategies have been distilled. These insights are subject to the many limitations outlined in each of the component GBD capstone papers.


Assuntos
Assistência à Saúde/economia , Carga Global da Doença/economia , Saúde Global/tendências , Avaliação de Resultados em Cuidados de Saúde/estatística & dados numéricos , Coeficiente de Natalidade , Assistência à Saúde/estatística & dados numéricos , Feminino , Carga Global da Doença/tendências , Humanos , Masculino , Doenças não Transmissíveis/epidemiologia , Avaliação de Resultados em Cuidados de Saúde/tendências , Fatores de Risco , Fatores Socioeconômicos , Ferimentos e Lesões/epidemiologia
9.
Intern Emerg Med ; 15(8): 1457-1465, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-32960429

RESUMO

The correlation between myocardial injury and clinical outcome in COVID-19 patients is gaining attention in the literature. The aim of the present study was to evaluate the role of cardiac involvement and of respiratory failure in a cohort of COVID-19 patients hospitalized in an academic hospital in Lombardy, one of the most affected Italian (and worldwide) regions by the epidemic. The study included 405 consecutive patients with confirmed COVID-19 admitted to a medical ward from February 25th to March 31st, 2020. Follow-up of surviving patients ended either at hospital discharge or by July 30th, 2020. Myocardial injury was defined on the basis of the presence of blood levels of hs-TnI above the 99th percentile upper reference limit. Respiratory function was assessed as PaO2/FiO2 (P/F) ratio. The primary end-point was death for any cause. During hospitalization, 124 patients died. Death rate increased from 7.9% in patients with normal hs-TnI plasma levels and no cardiac comorbidity to 61.5% in patients with elevated hs-TnI and cardiac involvement (p < 0.001). At multivariable analysis, older age, P/F ratio < 200 (both p < 0.001) and hs-TnI plasma levels were independent predictors of death. However, it must be emphasized that the median values of hs-TnI were within normal range in non-survivors. Cardiac involvement at presentation was associated with poor prognosis in COVID-19 patients, but, even in a population of COVID-19 patients who did not require invasive ventilation at hospital admission, mortality was mainly driven by older age and respiratory failure.


Assuntos
Doenças Cardiovasculares/etiologia , Infecções por Coronavirus/complicações , Avaliação de Resultados em Cuidados de Saúde/normas , Pneumonia Viral/complicações , Centros de Atenção Terciária/estatística & dados numéricos , Idoso , Inibidores da Enzima Conversora de Angiotensina/uso terapêutico , Biomarcadores/análise , Biomarcadores/sangue , Doenças Cardiovasculares/epidemiologia , Infecções por Coronavirus/epidemiologia , Eletrocardiografia/métodos , Eletrocardiografia/estatística & dados numéricos , Feminino , Hospitalização/estatística & dados numéricos , Humanos , Itália/epidemiologia , Masculino , Pessoa de Meia-Idade , Avaliação de Resultados em Cuidados de Saúde/estatística & dados numéricos , Pandemias , Pneumonia Viral/epidemiologia , Reação em Cadeia da Polimerase/métodos , Centros de Atenção Terciária/organização & administração , Centros de Atenção Terciária/normas , Troponina I/análise , Troponina I/sangue
10.
Intern Emerg Med ; 15(8): 1415-1424, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-32772283

RESUMO

In this study, we aimed to assess the association between development of cardiac injury and short-term mortality as well as poor in-hospital outcomes in hospitalized patients with COVID-19. In this prospective, single-center study, we enrolled hospitalized patients with laboratory-confirmed COVID-19 and highly suspicious patients with compatible chest computed tomography features. Cardiac injury was defined as a rise of serum high sensitivity cardiac Troponin-I level above 99th percentile (men: > 26 ng/mL, women: > 11 ng/mL). A total of 386 hospitalized patients with COVID-19 were included. Cardiac injury was present among 115 (29.8%) of the study population. The development of cardiac injury was significantly associated with a higher in-hospital mortality rate compared to those with normal troponin levels (40.9% vs 11.1%, p value < 0.001). It was shown that patients with cardiac injury had a significantly lower survival rate after a median follow-up of 18 days from symptom onset (p log-rank < 0.001). It was further demonstrated in the multivariable analysis that cardiac injury could possibly increase the risk of short-term mortality in hospitalized patients with COVID-19 (HR = 1.811, p-value = 0.023). Additionally, preexisting cardiovascular disease, malignancy, blood oxygen saturation < 90%, leukocytosis, and lymphopenia at presentation were independently associated with a greater risk of developing cardiac injury. Development of cardiac injury in hospitalized patients with COVID-19 was significantly associated with higher rates of in-hospital mortality and poor in-hospital outcomes. Additionally, it was shown that development of cardiac injury was associated with a lower short-term survival rate compared to patients without myocardial damage and could independently increase the risk of short-term mortality by nearly two-fold.


Assuntos
Infecções por Coronavirus/complicações , Traumatismos Cardíacos/complicações , Hospitalização/estatística & dados numéricos , Avaliação de Resultados em Cuidados de Saúde/tendências , Pneumonia Viral/complicações , Adulto , Idoso , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/mortalidade , Feminino , Traumatismos Cardíacos/epidemiologia , Traumatismos Cardíacos/mortalidade , Hospitalização/tendências , Humanos , Irã (Geográfico)/epidemiologia , Masculino , Pessoa de Meia-Idade , Avaliação de Resultados em Cuidados de Saúde/estatística & dados numéricos , Pandemias/estatística & dados numéricos , Pneumonia Viral/epidemiologia , Pneumonia Viral/mortalidade , Modelos de Riscos Proporcionais , Estudos Prospectivos , Estatísticas não Paramétricas , Taxa de Sobrevida/tendências
11.
Medicine (Baltimore) ; 99(30): e21296, 2020 Jul 24.
Artigo em Inglês | MEDLINE | ID: mdl-32791713

RESUMO

Treatment of multidrug-resistant tuberculosis (MDR-TB) is challenging. More research is needed to understand treatment outcomes and associated factors.A retrospective cohort study was conducted to assess trends and predictors of treatment success among 398 MDR-TB and extensively drug resistant TB patients who started treatment in 2011 to 2015 in Hangzhou, China. Sociodemographic and clinical characteristic data were obtained from the national reporting database. Chi-square test for trend was used to evaluate changes in treatment success rates over the study years, and Cox regression analysis was used to identify predictors for poor treatment outcomes.The treatment success rate was 76% (301/398) for all participants, 77% (298/387) for MDR-TB cases and 27% (3/11) for extensively drug-resistant tuberculosis -TB cases. Treatment success increased significantly from 66% among patients who started treatment in 2011 to 85% in 2015 (P < .01). Of the 97 (24.4%) patients with unsuccessful treatment outcomes, 10 (2.5%) died, 64 (16.1%) failed treatment, and 23 (5.8%) were lost to follow-up. Patients who started treatment in 2013 to 2015 were less likely to have unsuccessful outcomes than those who started in 2011-2012 (adjusted odds ratio [AOR] 0.4, 95% confidence interval [CI] 0.3-0.6), patients ≥25 years were more likely to have unsuccessful outcomes than younger patients (AOR 1.6, 95% CI 1.3-2.1), and cases with kanamycin resistance was associated with three times the odds of having unsuccessful outcomes than kanamycin-susceptible cases (AOR 3.0, 95% CI 1.5-5.8).With proper case management of MDR-TB, patients can achieve a high treatment success rate. Hangzhou's program offers clinical evidence that can be used to inform MDR-TB programs elsewhere in China and abroad.


Assuntos
Antituberculosos/uso terapêutico , Tuberculose Extensivamente Resistente a Medicamentos/tratamento farmacológico , Avaliação de Resultados em Cuidados de Saúde/estatística & dados numéricos , Adulto , Idoso , China/epidemiologia , Tuberculose Extensivamente Resistente a Medicamentos/epidemiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Adulto Jovem
12.
BMC Med Res Methodol ; 20(1): 208, 2020 08 12.
Artigo em Inglês | MEDLINE | ID: mdl-32787782

RESUMO

BACKGROUND: The coronavirus pandemic (Covid-19) presents a variety of challenges for ongoing clinical trials, including an inevitably higher rate of missing outcome data, with new and non-standard reasons for missingness. International drug trial guidelines recommend trialists review plans for handling missing data in the conduct and statistical analysis, but clear recommendations are lacking. METHODS: We present a four-step strategy for handling missing outcome data in the analysis of randomised trials that are ongoing during a pandemic. We consider handling missing data arising due to (i) participant infection, (ii) treatment disruptions and (iii) loss to follow-up. We consider both settings where treatment effects for a 'pandemic-free world' and 'world including a pandemic' are of interest. RESULTS: In any trial, investigators should; (1) Clarify the treatment estimand of interest with respect to the occurrence of the pandemic; (2) Establish what data are missing for the chosen estimand; (3) Perform primary analysis under the most plausible missing data assumptions followed by; (4) Sensitivity analysis under alternative plausible assumptions. To obtain an estimate of the treatment effect in a 'pandemic-free world', participant data that are clinically affected by the pandemic (directly due to infection or indirectly via treatment disruptions) are not relevant and can be set to missing. For primary analysis, a missing-at-random assumption that conditions on all observed data that are expected to be associated with both the outcome and missingness may be most plausible. For the treatment effect in the 'world including a pandemic', all participant data is relevant and should be included in the analysis. For primary analysis, a missing-at-random assumption - potentially incorporating a pandemic time-period indicator and participant infection status - or a missing-not-at-random assumption with a poorer response may be most relevant, depending on the setting. In all scenarios, sensitivity analysis under credible missing-not-at-random assumptions should be used to evaluate the robustness of results. We highlight controlled multiple imputation as an accessible tool for conducting sensitivity analyses. CONCLUSIONS: Missing data problems will be exacerbated for trials active during the Covid-19 pandemic. This four-step strategy will facilitate clear thinking about the appropriate analysis for relevant questions of interest.


Assuntos
Avaliação de Resultados em Cuidados de Saúde/estatística & dados numéricos , Guias de Prática Clínica como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Projetos de Pesquisa/estatística & dados numéricos , Betacoronavirus/fisiologia , Comorbidade , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/terapia , Infecções por Coronavirus/virologia , Humanos , Avaliação de Resultados em Cuidados de Saúde/métodos , Pandemias , Pneumonia Viral/epidemiologia , Pneumonia Viral/terapia , Pneumonia Viral/virologia , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Reprodutibilidade dos Testes
14.
Health Qual Life Outcomes ; 18(1): 214, 2020 Jul 06.
Artigo em Inglês | MEDLINE | ID: mdl-32631444

RESUMO

BACKGROUND: People living with HIV experience burdensome multidimensional symptoms and concerns requiring person-centred care. Routine use of patient reported outcome measures can improve outcomes. There is no brief patient reported outcome measure (PROM) that currently reflects the breadth of concerns for people living with HIV. This study aimed to develop and cognitively test a brief novel patient reported outcome measure for use within routine adult HIV care- the "Positive Outcomes" HIV PROM. METHODS: Development followed the COSMIN taxonomy and guidance for relevance and comprehensiveness, and Rothrock guidance on development of valid patient reported outcome measures. The Positive Outcomes HIV PROM was developed by a steering group (people living with HIV, HIV professionals and health services researchers) using findings from a previously reported qualitative study of priority outcomes for people living with HIV. The prototype measure was cognitively tested with a purposive sample of people living with HIV. RESULTS: The Positive Outcomes HIV PROM consists of 23 questions (22 structured, and one open question) informed by the priorities of key stakeholders (n = 28 people living with HIV, n = 21 HIV professionals and n = 8 HIV commissioners) to ensure face and content validity, and refined through cognitive testing (n = 6 people living with HIV). Cognitive testing demonstrated high levels of acceptability and accessibility. CONCLUSIONS: The Positive Outcomes HIV PROM is the first brief patient reported outcome measure reflecting the diverse needs of people living with HIV designed specifically for use in the clinical setting to support patient assessment and care, and drive service quality improvement. It is derived from primary data on the priority outcomes for people living with HIV and is comprehensive and acceptable. Further psychometric testing is required to ensure reliability and responsiveness.


Assuntos
Fármacos Anti-HIV/uso terapêutico , Cognição/efeitos dos fármacos , Infecções por HIV/tratamento farmacológico , Avaliação de Resultados em Cuidados de Saúde/estatística & dados numéricos , Medidas de Resultados Relatados pelo Paciente , Assistência Centrada no Paciente/métodos , Qualidade de Vida/psicologia , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Psicometria/métodos , Pesquisa Qualitativa , Reprodutibilidade dos Testes
15.
Nat Commun ; 11(1): 3369, 2020 07 06.
Artigo em Inglês | MEDLINE | ID: mdl-32632153

RESUMO

Induced pluripotent stem cell (iPSC)-derived dopaminergic (DA) neurons are an expected source for cell-based therapies for Parkinson's disease (PD). The regulatory criteria for the clinical application of these therapies, however, have not been established. Here we show the results of our pre-clinical study, in which we evaluate the safety and efficacy of dopaminergic progenitors (DAPs) derived from a clinical-grade human iPSC line. We confirm the characteristics of DAPs by in vitro analyses. We also verify that the DAP population include no residual undifferentiated iPSCs or early neural stem cells and have no genetic aberration in cancer-related genes. Furthermore, in vivo studies using immunodeficient mice reveal no tumorigenicity or toxicity of the cells. When the DAPs are transplanted into the striatum of 6-OHDA-lesioned rats, the animals show behavioral improvement. Based on these results, we started a clinical trial to treat PD patients in 2018.


Assuntos
Neurônios Dopaminérgicos/citologia , Células-Tronco Pluripotentes Induzidas/citologia , Células-Tronco Neurais/transplante , Doença de Parkinson/terapia , Transplante de Células-Tronco/métodos , Animais , Diferenciação Celular/genética , Linhagem Celular , Modelos Animais de Doenças , Dopamina/metabolismo , Neurônios Dopaminérgicos/metabolismo , Humanos , Células-Tronco Pluripotentes Induzidas/metabolismo , Macaca fascicularis , Masculino , Camundongos Endogâmicos NOD , Camundongos Knockout , Camundongos SCID , Células-Tronco Neurais/citologia , Células-Tronco Neurais/metabolismo , Avaliação de Resultados em Cuidados de Saúde/métodos , Avaliação de Resultados em Cuidados de Saúde/estatística & dados numéricos , Ratos Nus , Transplante Heterólogo
16.
PLoS One ; 15(7): e0235485, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32639999

RESUMO

Evaluation studies of outcomes used in clinical research and their consistency are appearing more frequently in the literature, as a key part of the core outcome set (COS) development. Current guidance suggests such evaluation studies should use systematic review methodology as their default. We aimed to examine the methods used. We searched the Core Outcome Measures in Effectiveness Trials (COMET) database (up to May 2019) supplementing it with additional resources. We included evaluation studies of outcome consistency in clinical studies across health subjects and used a subset of A MeaSurement Tool to Assess systematic Reviews (AMSTAR) 2 (items 1-9) to assess their methods. Of 93 included evaluation studies of outcome consistency (90 full reports, three summaries), 91% (85/93) reported performing literature searches in at least one bibliographic database, and 79% (73/93) was labelled as a "systematic review". The evaluations varied in terms of satisfying AMSTAR 2 criteria, such that 81/93 (87%) had implemented PICO in the research question, whereas only 5/93 (6%) had included the exclusions list. None of the evaluation studies explained how inconsistency of outcomes was detected, however, 80/90 (88%) concluded inconsistency in individual outcomes (66%, 55/90) or outcome domains (20%, 18/90). Methods used in evaluation studies of outcome consistency in clinical studies differed considerably. Despite frequent being labelled as a "systematic review", adoption of systematic review methodology is selective. While the impact on COS development is unknown, authors of these studies should refrain from labelling them as "systematic review" and focus on ensuring that the methods used to generate the different outcomes and outcome domains are reported transparently.


Assuntos
Assistência à Saúde , Avaliação de Resultados em Cuidados de Saúde/estatística & dados numéricos , Publicações , Resultado do Tratamento , Bases de Dados Bibliográficas , Testes Diagnósticos de Rotina , Humanos
17.
PLoS One ; 15(7): e0236345, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32706800

RESUMO

Regulatory agencies around the world have been using flexible requirements for approval of new drugs, especially for cancer drugs. The US Food and Drug Administration (FDA) is mostly the first agency to approve new drugs worldwide, mainly due to the faster terms of the accelerated pathway and breakthrough therapy designation. Surrogate endpoints and preliminary data (e.g. single-arm and phase 2 studies) are used for these new approvals, however larger effect sizes are expected. We aim to compare FDA Accelerated vs Regular Pathway approvals and Breakthrough therapy designations (BTD) for lung cancer treatments between 2006 and 2018 regarding study design, sample size, outcome measures and effect size. We assessed the FDA database to collect data from studies that formed the basis of approvals of new drugs or indications for lung cancer spanning from 2006 to 2018. We found that accelerated pathway approvals are based on significantly more single-arm studies with small sample sizes and surrogate primary endpoints. However, effect size was not different between the pathways. A large proportion of studies used to support regular pathway approvals also showed these characteristics that are related to low quality and uncertain evidence. Compared to other approvals, BTD were more frequently based on single-arm studies. There was no significant difference in use of surrogate endpoints or sample size. 44% of BTD were based on studies demonstrating large effect sizes, proportionally more than approvals not receiving this designation. In conclusion, based on the indicators of evidence quality we extracted, criteria's for granting accelerated approval and breakthrough therapy designation seen not clear. Faster approvals are in the majority full of uncertainties which should be viewed with caution and the patient have to be communicated to allow shared decision making. Post-marketing validation is essential.


Assuntos
Antineoplásicos/uso terapêutico , Bases de Dados de Produtos Farmacêuticos/estatística & dados numéricos , Aprovação de Drogas/métodos , Neoplasias Pulmonares/tratamento farmacológico , United States Food and Drug Administration/estatística & dados numéricos , Humanos , Marketing , Avaliação de Resultados em Cuidados de Saúde/estatística & dados numéricos , Projetos de Pesquisa/estatística & dados numéricos , Tamanho da Amostra , Incerteza , Estados Unidos
18.
Med Care ; 58(7): 658-662, 2020 07.
Artigo em Inglês | MEDLINE | ID: mdl-32520839

RESUMO

BACKGROUND: Single-center comparative effectiveness studies evaluating outcomes that can occur posthospitalization may become biased if outcomes diagnosed at other facilities are not ascertained. Administrative datasets that link patients' records across facilities may improve outcome ascertainment. OBJECTIVE: To determine whether use of linked administrative data significantly augments thromboembolic outcome ascertainment. RESEARCH DESIGN: Retrospective cohort study. SUBJECTS: Patients with an acute isolated calf deep vein thrombosis (DVT) diagnosed at 1 Californian center during 2010-2013. MEASURES: Proximal DVT or pulmonary embolism (PE) within 180 days. We ascertained outcomes from linked California hospitalization, emergency department, and ambulatory surgery data and compared this information to outcomes previously identified from review of the center's medical records. RESULTS: Among 384 patients with an isolated calf DVT, 333 could be linked to longitudinal administrative data records. Ten patients had a possible proximal DVT or PE (4 more clearly so) from administrative data; all were unknown from medical record review. Eleven patients with known outcomes from medical record review had no outcome from administrative data. The adjusted odds ratio of proximal DVT or PE with therapeutic anticoagulation attenuated from 0.33 [95% confidence interval (CI), 0.12-0.87] using only medical record review to 0.64 (95% CI, 0.29-1.40) using both medical record review and possible outcomes from administrative data. Restricting the outcome to diagnoses clearly involving proximal DVT or PE, the adjusted odds ratio was 0.46 (95% CI, 0.19-1.10). CONCLUSIONS: Use of linked hospital administrative data augmented detection of outcomes but imperfect linkage, nonspecific diagnoses, and documentation/coding errors introduced uncertainty regarding the accuracy of outcome ascertainment.


Assuntos
Anticoagulantes/uso terapêutico , Organização e Administração/estatística & dados numéricos , Avaliação de Resultados em Cuidados de Saúde/normas , Tromboembolia Venosa/tratamento farmacológico , Adulto , Idoso , California , Estudos de Coortes , Bases de Dados Factuais/estatística & dados numéricos , Feminino , Humanos , Extremidade Inferior/irrigação sanguínea , Extremidade Inferior/fisiopatologia , Masculino , Pessoa de Meia-Idade , Razão de Chances , Avaliação de Resultados em Cuidados de Saúde/estatística & dados numéricos , Qualidade da Assistência à Saúde/normas , Qualidade da Assistência à Saúde/estatística & dados numéricos , Estudos Retrospectivos , Fatores de Risco , Tromboembolia Venosa/prevenção & controle
19.
PLoS One ; 15(6): e0234521, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32520977

RESUMO

OBJECTIVES: To examine the effect of weekend admission on short and long-term morbidity and mortality, for patients admitted to intensive care after suffering a cerebrovascular accident (stroke). DESIGN, SETTING, AND PARTICIPANTS: A hospital-wide, retrospective cohort study of 3,729 adult stroke patients admitted to the Beth Israel Deaconess Medical Centre (BIDMC) intensive care unit (ICU) between 2001 and 2012, using the Medical Information Mart for Intensive Care III (MIMIC-III) database. PRIMARY OUTCOME MEASURES: Primary outcome measures were ICU length-of-stay and mortality, hospital length-of-stay and mortality, proportions of patients discharged home after admission, and 6-month mortality. RESULTS: Overall, 23% of BIDMC ICU stroke admissions occurred over the weekend. Those admitted over the weekend were likelier to have suffered haemorrhagic stroke than those admitted during the week (60.6% vs 47.9%). Those admitted on the weekend were younger, and likelier to be male and unmarried, with similar ethnic representation. The OASIS severity of illness (32.5 vs. 32) and lowest day-one GCS (12.6 vs. 12.9) were similar between groups. Unadjusted ICU-mortality was significantly higher for patients admitted over the weekend (OR 1.32, CI 1.08-1.61), but when adjusted for type of stroke, became non-significant (OR 1.17, CI 0.95-1.44). In-hospital mortality was significantly higher for patients admitted to ICU over the weekend in both unadjusted (OR 1.45, CI 1.22-1.73) and adjusted (OR 1.31, CI 1.09-1.58) analyses. There was no significant difference in ICU or hospital length of stay. While patients admitted on the weekend appeared less likely to be discharged back to home and more at risk of 6-month mortality compared to weekday admissions, results were non-significant. CONCLUSIONS: The effect of weekend ICU-admission for stroke patients appears to be significant for in-hospital mortality. There were no significant differences in adjusted ICU-mortality, ICU or hospital length-of-stay, or longer-term morbidity and mortality measures.


Assuntos
Agendamento de Consultas , Cuidados Críticos/estatística & dados numéricos , Unidades de Terapia Intensiva/estatística & dados numéricos , Avaliação de Resultados em Cuidados de Saúde/estatística & dados numéricos , Admissão do Paciente/estatística & dados numéricos , Acidente Vascular Cerebral/terapia , Idoso , Idoso de 80 Anos ou mais , Feminino , Mortalidade Hospitalar , Humanos , Masculino , Pessoa de Meia-Idade , Acidente Vascular Cerebral/epidemiologia , Fatores de Tempo
20.
J Tradit Chin Med ; 40(3): 497-508, 2020 06.
Artigo em Inglês | MEDLINE | ID: mdl-32506865

RESUMO

The TCM protocol in the Diagnosis and Treatment Protocol for corona virus disease 2019 (COVID-19) (Trial Version 7) has been updated from previous versions. The protocol was formulated under the direct leadership of the National Administration of Traditional Chinese Medicine, based on the experience of a panel of experts, supported by evidence from fever clinics and from the outcomes of emergency (EM) observation rooms and inpatients throughout China (especially in Wuhan, Hubei Province) in combination with the latest scientific research results and data. The present interpretation of the TCM protocol is based on an overall understanding of the revised content, and aims to guide and standardize its clinical application to provide a reference for clinicians.


Assuntos
Betacoronavirus/efeitos dos fármacos , Infecções por Coronavirus , Medicamentos de Ervas Chinesas/uso terapêutico , Medicina Tradicional Chinesa/métodos , Pandemias , Pneumonia Viral , China , Protocolos Clínicos , Humanos , Avaliação de Resultados em Cuidados de Saúde/métodos , Avaliação de Resultados em Cuidados de Saúde/estatística & dados numéricos , Fitoterapia
SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA