Your browser doesn't support javascript.
loading
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 35.266
Filtrar
1.
Bull Math Biol ; 83(8): 89, 2021 07 03.
Artigo em Inglês | MEDLINE | ID: mdl-34216281

RESUMO

This work presents a model-agnostic evaluation of four different models that estimate a disease's basic reproduction number. The evaluation presented is twofold: first, the theory behind each of the models is reviewed and compared; then, each model is tested with eight impartial simulations. All scenarios were constructed in an experimental framework that allows each model to fulfill its assumptions and hence, obtain unbiased results for each case. Among these models is the one proposed by Thompson et al. (Epidemics 29:100356, 2019), i.e., a Bayesian estimation method well established in epidemiological practice. The other three models include a novel state-space method and two simulation-based approaches based on a Poisson infection process. The advantages and flaws of each model are discussed from both theoretical and practical standpoints. Finally, we present the evolution of Covid-19 outbreak in Colombia as a case study for computing the basic reproduction number with each one of the reviewed methods.


Assuntos
Número Básico de Reprodução/estatística & dados numéricos , COVID-19/epidemiologia , COVID-19/transmissão , Pandemias/estatística & dados numéricos , SARS-CoV-2 , Teorema de Bayes , Colômbia/epidemiologia , Simulação por Computador , Intervalos de Confiança , Epidemias/estatística & dados numéricos , Humanos , Conceitos Matemáticos , Modelos Biológicos , Modelos Estatísticos , Distribuição de Poisson
2.
Cochrane Database Syst Rev ; 5: CD013540, 2021 05 05.
Artigo em Inglês | MEDLINE | ID: mdl-34097766

RESUMO

BACKGROUND: Medications with anticholinergic properties are commonly prescribed to older adults. The cumulative anticholinergic effect of all the medications a person takes is referred to as the 'anticholinergic burden' because of its potential to cause adverse effects. It is possible that high anticholinergic burden may be a risk factor for development of cognitive decline or dementia. There are various scales available to measure anticholinergic burden but agreement between them is often poor. OBJECTIVES: To assess whether anticholinergic burden, as defined at the level of each individual scale, is a prognostic factor for future cognitive decline or dementia in cognitively unimpaired older adults. SEARCH METHODS: We searched the following databases from inception to 24 March 2021: MEDLINE (OvidSP), Embase (OvidSP), PsycINFO (OvidSP), CINAHL (EBSCOhost), and ISI Web of Science Core Collection (ISI Web of Science). SELECTION CRITERIA: We included prospective and retrospective longitudinal cohort and case-control observational studies with a minimum of one year' follow-up that examined the association between an anticholinergic burden measurement scale and future cognitive decline or dementia in cognitively unimpaired older adults. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed studies for inclusion, and undertook data extraction, assessment of risk of bias, and GRADE assessment. We extracted odds ratios (OR) and hazard ratios, with 95% confidence intervals (CI), and linear data on the association between anticholinergic burden and cognitive decline or dementia. We intended to pool each metric separately; however, only OR-based data were suitable for pooling via a random-effects meta-analysis. We initially established adjusted and unadjusted pooled rates for each available anticholinergic scale; then, as an exploratory analysis, established pooled rates on the prespecified association across scales. We examined variability based on severity of anticholinergic burden. MAIN RESULTS: We identified 25 studies that met our inclusion criteria (968,428 older adults). Twenty studies were conducted in the community care setting, two in primary care clinics, and three in secondary care settings. Eight studies (320,906 participants) provided suitable data for meta-analysis. The Anticholinergic Cognitive Burden scale (ACB scale) was the only scale with sufficient data for 'scale-based' meta-analysis. Unadjusted ORs suggested an increased risk for cognitive decline or dementia in older adults with an anticholinergic burden (OR 1.47, 95% CI 1.09 to 1.96) and adjusted ORs similarly suggested an increased risk for anticholinergic burden, defined according to the ACB scale (OR 2.63, 95% CI 1.09 to 6.29). Exploratory analysis combining adjusted ORs across available scales supported these results (OR 2.16, 95% CI 1.38 to 3.38), and there was evidence of variability in risk based on severity of anticholinergic burden (ACB scale 1: OR 2.18, 95% CI 1.11 to 4.29; ACB scale 2: OR 2.71, 95% CI 2.01 to 3.56; ACB scale 3: OR 3.27, 95% CI 1.41 to 7.61); however, overall GRADE evaluation of certainty of the evidence was low. AUTHORS' CONCLUSIONS: There is low-certainty evidence that older adults without cognitive impairment who take medications with anticholinergic effects may be at increased risk of cognitive decline or dementia.


Assuntos
Antagonistas Colinérgicos/efeitos adversos , Disfunção Cognitiva/induzido quimicamente , Demência/induzido quimicamente , Idoso , Idoso de 80 Anos ou mais , Análise de Variância , Viés , Antagonistas Colinérgicos/farmacologia , Intervalos de Confiança , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Observacionais como Assunto , Razão de Chances , Prognóstico , Síndrome , Resultado do Tratamento
3.
Cochrane Database Syst Rev ; 5: CD013029, 2021 05 06.
Artigo em Inglês | MEDLINE | ID: mdl-34097768

RESUMO

BACKGROUND: Age-related macular degeneration (AMD) is one of the leading causes of blindness in high-income countries. The majority of cases of AMD are of the non-exudative type. Experts have proposed photobiomodulation (PBM) therapy as a non-invasive procedure to restore mitochondrial function, upregulate cytoprotective factors and prevent apoptotic cell death in retinal tissue affected by AMD. OBJECTIVES: To assess the effectiveness and safety of PBM compared to standard care, no treatment or sham treatment for people with non-exudative AMD. SEARCH METHODS: We searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register) (Issue 5, 2020), Ovid MEDLINE, Embase, ISRCTN, ClinicalTrials.gov and the WHO ICTRP to 11 May 2020 with no language restrictions. SELECTION CRITERIA: The review included randomised controlled trials (RCTs) on participants receiving any type of PBM therapy for non-exudative AMD compared to standard care, sham treatment or no treatment. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. We considered the following outcome measures at 12 months: best-corrected visual acuity (BCVA) ; contrast sensitivity; near vision; low luminance density score; reading speed; vision-related quality of life score; and adverse events such as progression of AMD and conversion to exudative AMD. We graded the certainty of the evidence using GRADE. MAIN RESULTS: We included two published RCTs from single centres in the UK and Canada, which recruited 60 participants (60 eyes) and 30 participants (46 eyes) respectively. Participants in these trials were people with non-exudative AMD with Age-Related Eye Disease Study (AREDS) categories 2 to 4. One study compared single wavelength PBM with no treatment. This study was at risk of performance bias because the study was not masked, and there was attrition bias. One study compared multi-wavelength PBM with sham treatment and conflicts of interest were reported by study investigators. We also identified three eligible ongoing RCTs from searching the clinical trials database. When comparing PBM with sham treatment or no treatment for non-exudative AMD, there was no evidence of any meaningful clinical difference in BCVA at 12 months (mean difference (MD) 0.02 logMAR, 95% confidence interval (CI) -0.02 to 0.05; 2 RCTs, 90 eyes; low-certainty evidence). One study comparing multi-wavelength PBM with sham treatment showed an improvement in contrast sensitivity at Level E (18 cycles/degree) at 12 months (MD 0.29 LogCS, 95% CI 0.23 to 0.35; 1 RCT, 46 eyes; low-certainty evidence). Visual function and health-related quality of life scores were comparable between single wavelength PBM and no treatment groups at 12 months (VFQ-48 score MD 0.43, 95% CI -0.17 to 1.03; P = 0.16; 1 RCT, 47 eyes; low-certainty evidence). When comparing PBM with sham treatment or no treatment for non-exudative AMD, there was no evidence of any meaningful clinical difference in conversion to exudative AMD (risk ratio (RR) 0.97, 95% CI 0.17 to 5.44; 2 RCTs, 96 eyes; very low-certainty evidence) at 12 months. There was inconclusive evidence that single wavelength PBM prevents the progression of AMD (RR 0.79, 95% CI 0.41 to 1.53; P = 0.48; 1 RCT, 50 eyes; low-certainty evidence). Disease progression was defined as the development of advanced AMD or significant increase in drusen volume. No included study reported near vision, low luminance vision or reading speed outcomes. AUTHORS' CONCLUSIONS: Currently there remains uncertainty whether PBM treatment is beneficial in slowing progression of non-exudative macular degeneration. There is a need for further well-designed controlled trials assessing dosimetry, powered for both effectiveness and safety outcomes. Consideration should be given to the adoption of agreed clinical outcome measures and patient-based outcome measures for AMD.


Assuntos
Terapia com Luz de Baixa Intensidade/métodos , Degeneração Macular/radioterapia , Viés , Intervalos de Confiança , Sensibilidades de Contraste , Progressão da Doença , Humanos , Terapia com Luz de Baixa Intensidade/efeitos adversos , Avaliação de Resultados em Cuidados de Saúde , Placebos , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento , Acuidade Visual
4.
Cochrane Database Syst Rev ; 5: CD012972, 2021 05 06.
Artigo em Inglês | MEDLINE | ID: mdl-34097769

RESUMO

BACKGROUND: The World Health Organization (WHO) recommends Xpert MTB/RIF in place of smear microscopy to diagnose tuberculosis (TB), and many countries have adopted it into their diagnostic algorithms. However, it is not clear whether the greater accuracy of the test translates into improved health outcomes. OBJECTIVES: To assess the impact of Xpert MTB/RIF on patient outcomes in people being investigated for tuberculosis. SEARCH METHODS: We searched the following databases, without language restriction, from 2007 to 24 July 2020: Cochrane Infectious Disease Group (CIDG) Specialized Register; CENTRAL; MEDLINE OVID; Embase OVID; CINAHL EBSCO; LILACS BIREME; Science Citation Index Expanded (Web of Science), Social Sciences citation index (Web of Science), and Conference Proceedings Citation Index - Social Science & Humanities (Web of Science). We also searched the WHO International Clinical Trials Registry Platform, ClinicalTrials.gov, and the Pan African Clinical Trials Registry for ongoing trials. SELECTION CRITERIA: We included individual- and cluster-randomized trials, and before-after studies, in participants being investigated for tuberculosis. We analysed the randomized and non-randomized studies separately.  DATA COLLECTION AND ANALYSIS: For each study, two review authors independently extracted data, using a piloted data extraction tool. We assessed the risk of bias using Cochrane and Effective Practice and Organisation of Care (EPOC) tools. We used random effects meta-analysis to allow for heterogeneity between studies in setting and design.  The certainty of the  evidence in the randomized trials was assessed by GRADE. MAIN RESULTS: We included 12 studies: eight were randomized controlled trials (RCTs), and four were before-and-after studies. Most included RCTs had a low risk of bias in most domains of the Cochrane 'Risk of bias' tool. There was inconclusive evidence of an effect of Xpert MTB/RIF on all-cause mortality, both overall (risk ratio (RR) 0.89, 95% confidence interval (CI) 0.75 to 1.05; 5 RCTs, 9932 participants, moderate-certainty evidence), and restricted to studies with six-month follow-up (RR 0.98, 95% CI 0.78 to 1.22; 3 RCTs, 8143 participants; moderate-certainty evidence). There was probably a reduction in mortality in participants known to be infected with HIV (odds ratio (OR) 0.80, 95% CI 0.67 to 0.96; 5 RCTs, 5855 participants; moderate-certainty evidence). It is uncertain whether Xpert MTB/RIF has no or a modest effect on the proportion of participants starting tuberculosis treatment who had a successful treatment outcome (OR) 1.10, 95% CI 0.96 to 1.26; 3RCTs, 4802 participants; moderate-certainty evidence). There was also inconclusive evidence of an effect on the  proportion of participants who were treated for tuberculosis (RR 1.10, 95% CI 0.98 to 1.23; 5 RCTs, 8793 participants; moderate-certainty evidence). The proportion of participants treated for tuberculosis who had bacteriological confirmation was probably higher in the Xpert MTB/RIF group (RR 1.44, 95% CI 1.29 to 1.61; 6 RCTs, 2068 participants; moderate-certainty evidence). The proportion of participants with bacteriological confirmation who were lost to follow-up pre-treatment was probably reduced (RR 0.59, 95% CI 0.41 to 0.85; 3 RCTs, 1217 participants; moderate-certainty evidence). AUTHORS' CONCLUSIONS: We were unable to confidently rule in or rule out the effect on all-cause mortality of using Xpert MTB/RIF rather than smear microscopy. Xpert MTB/RIF probably reduces mortality among participants known to be infected with HIV. We are uncertain whether Xpert MTB/RIF has a modest effect or not on the proportion treated or, among those treated, on the proportion with a successful outcome. It probably does not have a substantial effect on these outcomes. Xpert MTB/RIF probably increases both the proportion of treated participants who had bacteriological confirmation, and the proportion with a laboratory-confirmed diagnosis who were treated. These findings may inform decisions about uptake alongside evidence on cost-effectiveness and implementation.


Assuntos
Antibióticos Antituberculose/farmacologia , Mycobacterium tuberculosis/efeitos dos fármacos , Mycobacterium tuberculosis/isolamento & purificação , Reação em Cadeia da Polimerase em Tempo Real/métodos , Rifampina/farmacologia , Tuberculose Pulmonar/diagnóstico , Viés , Intervalos de Confiança , Estudos Controlados Antes e Depois , Farmacorresistência Bacteriana , Infecções por HIV/mortalidade , Humanos , Mycobacterium tuberculosis/genética , Técnicas de Amplificação de Ácido Nucleico/métodos , Razão de Chances , Ensaios Clínicos Controlados Aleatórios como Assunto , Kit de Reagentes para Diagnóstico , Tuberculose Pulmonar/tratamento farmacológico , Tuberculose Pulmonar/microbiologia , Tuberculose Pulmonar/mortalidade
5.
N Engl J Med ; 385(1): 11-22, 2021 07 01.
Artigo em Inglês | MEDLINE | ID: mdl-34133854

RESUMO

BACKGROUND: Evidence is urgently needed to support treatment decisions for children with multisystem inflammatory syndrome (MIS-C) associated with severe acute respiratory syndrome coronavirus 2. METHODS: We performed an international observational cohort study of clinical and outcome data regarding suspected MIS-C that had been uploaded by physicians onto a Web-based database. We used inverse-probability weighting and generalized linear models to evaluate intravenous immune globulin (IVIG) as a reference, as compared with IVIG plus glucocorticoids and glucocorticoids alone. There were two primary outcomes: the first was a composite of inotropic support or mechanical ventilation by day 2 or later or death; the second was a reduction in disease severity on an ordinal scale by day 2. Secondary outcomes included treatment escalation and the time until a reduction in organ failure and inflammation. RESULTS: Data were available regarding the course of treatment for 614 children from 32 countries from June 2020 through February 2021; 490 met the World Health Organization criteria for MIS-C. Of the 614 children with suspected MIS-C, 246 received primary treatment with IVIG alone, 208 with IVIG plus glucocorticoids, and 99 with glucocorticoids alone; 22 children received other treatment combinations, including biologic agents, and 39 received no immunomodulatory therapy. Receipt of inotropic or ventilatory support or death occurred in 56 patients who received IVIG plus glucocorticoids (adjusted odds ratio for the comparison with IVIG alone, 0.77; 95% confidence interval [CI], 0.33 to 1.82) and in 17 patients who received glucocorticoids alone (adjusted odds ratio, 0.54; 95% CI, 0.22 to 1.33). The adjusted odds ratios for a reduction in disease severity were similar in the two groups, as compared with IVIG alone (0.90 for IVIG plus glucocorticoids and 0.93 for glucocorticoids alone). The time until a reduction in disease severity was similar in the three groups. CONCLUSIONS: We found no evidence that recovery from MIS-C differed after primary treatment with IVIG alone, IVIG plus glucocorticoids, or glucocorticoids alone, although significant differences may emerge as more data accrue. (Funded by the European Union's Horizon 2020 Program and others; BATS ISRCTN number, ISRCTN69546370.).


Assuntos
COVID-19/tratamento farmacológico , Glucocorticoides/uso terapêutico , Imunoglobulinas Intravenosas/uso terapêutico , Síndrome de Resposta Inflamatória Sistêmica/tratamento farmacológico , Adolescente , Anticorpos Antivirais , COVID-19/imunologia , COVID-19/mortalidade , COVID-19/terapia , Criança , Pré-Escolar , Estudos de Coortes , Intervalos de Confiança , Quimioterapia Combinada , Feminino , Hospitalização , Humanos , Imunomodulação , Masculino , Pontuação de Propensão , Análise de Regressão , Respiração Artificial , SARS-CoV-2/imunologia , Síndrome de Resposta Inflamatória Sistêmica/imunologia , Síndrome de Resposta Inflamatória Sistêmica/mortalidade , Síndrome de Resposta Inflamatória Sistêmica/terapia , Resultado do Tratamento
6.
Infez Med ; 29(2): 181-190, 2021 Jun 01.
Artigo em Inglês | MEDLINE | ID: mdl-34061782

RESUMO

In recent years, and now especially with the arrival of the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), there has been increased interest in understanding the role of bats in the dynamics of transmission and origin of this pandemic agent. To date, no systematic reviews have been published on this topic. This systematic review aimed to summarize and highlight the frequency of bat infections reported in currently available observational studies for coronavirus. The purpose of this study was also to examine the differences between the pool prevalence by technique and country. We performed a systematic literature review with meta-analysis, using three databases to assess coronavirus (CoV) infection in bats and its diagnosis by serological and molecular tests. We carried out random-effects model meta-analysis to calculate the pooled prevalence and 95% confidence interval (95% CI). In all, 824 articles were retrieved (1960-2021). After screening by abstract/title, 43 articles were selected for full-text assessment. Of these, 33 were finally included for qualitative and quantitative analyses. From the total of studies, the pool prevalence by RT-PCR (n=14,295 bats) for CoV was 9.8% (95% CI 8.7-10.9%); Italy reported the highest pooled prevalence (44.9%, 95% CI 31.6-58.1%), followed by the Philippines (29.6%). Regarding the ELISA, the pool prevalence for coronavirus from 15 studies, including 359 bats, was 30.2% (95% CI 14.7-45.6%). The results for coronaviruses with the MIF were significantly lower, 2.6% (95% CI 1.5-3.7%). A considerable proportion of infected bats tested positive, particularly by molecular tests. This essential condition highlights the relevance of bats and the need for future studies to detail their role as potential reservoirs of SARS-CoV-2. In this meta-analysis, bats were positive in almost 10% by RT-PCR, suggesting their relevance and the need to understand their potential participation in maintaining wild zoonotic transmission.


Assuntos
COVID-19/veterinária , Quirópteros/virologia , Reservatórios de Doenças/virologia , SARS-CoV-2 , Animais , Viés , COVID-19/epidemiologia , COVID-19/virologia , Intervalos de Confiança , Estudos Observacionais como Assunto , Prevalência , Estudos Soroepidemiológicos
7.
JAMA ; 325(22): 2262-2272, 2021 06 08.
Artigo em Inglês | MEDLINE | ID: mdl-34077499

RESUMO

Importance: Continuous glucose monitoring (CGM) has been shown to be beneficial for adults with type 2 diabetes using intensive insulin therapy, but its use in type 2 diabetes treated with basal insulin without prandial insulin has not been well studied. Objective: To determine the effectiveness of CGM in adults with type 2 diabetes treated with basal insulin without prandial insulin in primary care practices. Design, Setting, and Participants: This randomized clinical trial was conducted at 15 centers in the US (enrollment from July 30, 2018, to October 30, 2019; follow-up completed July 7, 2020) and included adults with type 2 diabetes receiving their diabetes care from a primary care clinician and treated with 1 or 2 daily injections of long- or intermediate-acting basal insulin without prandial insulin, with or without noninsulin glucose-lowering medications. Interventions: Random assignment 2:1 to CGM (n = 116) or traditional blood glucose meter (BGM) monitoring (n = 59). Main Outcomes and Measures: The primary outcome was hemoglobin A1c (HbA1c) level at 8 months. Key secondary outcomes were CGM-measured time in target glucose range of 70 to 180 mg/dL, time with glucose level at greater than 250 mg/dL, and mean glucose level at 8 months. Results: Among 175 randomized participants (mean [SD] age, 57 [9] years; 88 women [50%]; 92 racial/ethnic minority individuals [53%]; mean [SD] baseline HbA1c level, 9.1% [0.9%]), 165 (94%) completed the trial. Mean HbA1c level decreased from 9.1% at baseline to 8.0% at 8 months in the CGM group and from 9.0% to 8.4% in the BGM group (adjusted difference, -0.4% [95% CI, -0.8% to -0.1%]; P = .02). In the CGM group, compared with the BGM group, the mean percentage of CGM-measured time in the target glucose range of 70 to 180 mg/dL was 59% vs 43% (adjusted difference, 15% [95% CI, 8% to 23%]; P < .001), the mean percentage of time at greater than 250 mg/dL was 11% vs 27% (adjusted difference, -16% [95% CI, -21% to -11%]; P < .001), and the means of the mean glucose values were 179 mg/dL vs 206 mg/dL (adjusted difference, -26 mg/dL [95% CI, -41 to -12]; P < .001). Severe hypoglycemic events occurred in 1 participant (1%) in the CGM group and in 1 (2%) in the BGM group. Conclusions and Relevance: Among adults with poorly controlled type 2 diabetes treated with basal insulin without prandial insulin, continuous glucose monitoring, as compared with blood glucose meter monitoring, resulted in significantly lower HbA1c levels at 8 months. Trial Registration: ClinicalTrials.gov Identifier: NCT03566693.


Assuntos
Glicemia/análise , Diabetes Mellitus Tipo 2/tratamento farmacológico , Controle Glicêmico/métodos , Hipoglicemiantes/uso terapêutico , Insulina/uso terapêutico , Idoso , Intervalos de Confiança , Diabetes Mellitus Tipo 2/sangue , Feminino , Hemoglobina A Glicada/análise , Humanos , Masculino , Pessoa de Meia-Idade , Satisfação do Paciente , Período Pós-Prandial , Tamanho da Amostra , Fatores de Tempo , Resultado do Tratamento
8.
JAMA ; 325(22): 2273-2284, 2021 06 08.
Artigo em Inglês | MEDLINE | ID: mdl-34077502

RESUMO

Importance: Continuous glucose monitoring (CGM) is recommended for patients with type 1 diabetes; observational evidence for CGM in patients with insulin-treated type 2 diabetes is lacking. Objective: To estimate clinical outcomes of real-time CGM initiation. Design, Setting, and Participants: Exploratory retrospective cohort study of changes in outcomes associated with real-time CGM initiation, estimated using a difference-in-differences analysis. A total of 41 753 participants with insulin-treated diabetes (5673 type 1; 36 080 type 2) receiving care from a Northern California integrated health care delivery system (2014-2019), being treated with insulin, self-monitoring their blood glucose levels, and having no prior CGM use were included. Exposures: Initiation vs noninitiation of real-time CGM (reference group). Main Outcomes and Measures: Ten end points measured during the 12 months before and 12 months after baseline: hemoglobin A1c (HbA1c); hypoglycemia (emergency department or hospital utilization); hyperglycemia (emergency department or hospital utilization); HbA1c levels lower than 7%, lower than 8%, and higher than 9%; 1 emergency department encounter or more for any reason; 1 hospitalization or more for any reason; and number of outpatient visits and telephone visits. Results: The real-time CGM initiators included 3806 patients (mean age, 42.4 years [SD, 19.9 years]; 51% female; 91% type 1, 9% type 2); the noninitiators included 37 947 patients (mean age, 63.4 years [SD, 13.4 years]; 49% female; 6% type 1, 94% type 2). The prebaseline mean HbA1c was lower among real-time CGM initiators than among noninitiators, but real-time CGM initiators had higher prebaseline rates of hypoglycemia and hyperglycemia. Mean HbA1c declined among real-time CGM initiators from 8.17% to 7.76% and from 8.28% to 8.19% among noninitiators (adjusted difference-in-differences estimate, -0.40%; 95% CI, -0.48% to -0.32%; P < .001). Hypoglycemia rates declined among real-time CGM initiators from 5.1% to 3.0% and increased among noninitiators from 1.9% to 2.3% (difference-in-differences estimate, -2.7%; 95% CI, -4.4% to -1.1%; P = .001). There were also statistically significant differences in the adjusted net changes in the proportion of patients with HbA1c lower than 7% (adjusted difference-in-differences estimate, 9.6%; 95% CI, 7.1% to 12.2%; P < .001), lower than 8% (adjusted difference-in-differences estimate, 13.1%; 95% CI, 10.2% to 16.1%; P < .001), and higher than 9% (adjusted difference-in-differences estimate, -7.1%; 95% CI, -9.5% to -4.6%; P < .001) and in the number of outpatient visits (adjusted difference-in-differences estimate, -0.4; 95% CI, -0.6 to -0.2; P < .001) and telephone visits (adjusted difference-in-differences estimate, 1.1; 95% CI, 0.8 to 1.4; P < .001). Initiation of real-time CGM was not associated with statistically significant changes in rates of hyperglycemia, emergency department visits for any reason, or hospitalizations for any reason. Conclusions and Relevance: In this retrospective cohort study, insulin-treated patients with diabetes selected by physicians for real-time continuous glucose monitoring compared with noninitiators had significant improvements in hemoglobin A1c and reductions in emergency department visits and hospitalizations for hypoglycemia, but no significant change in emergency department visits or hospitalizations for hyperglycemia or for any reason. Because of the observational study design, findings may have been susceptible to selection bias.


Assuntos
Técnicas Biossensoriais/métodos , Automonitorização da Glicemia/métodos , Diabetes Mellitus Tipo 1/sangue , Diabetes Mellitus Tipo 2/sangue , Adulto , Técnicas Biossensoriais/instrumentação , Automonitorização da Glicemia/estatística & dados numéricos , Intervalos de Confiança , Diabetes Mellitus Tipo 1/tratamento farmacológico , Diabetes Mellitus Tipo 2/tratamento farmacológico , Feminino , Hemoglobina A Glicada/análise , Necessidades e Demandas de Serviços de Saúde/estatística & dados numéricos , Hospitalização/estatística & dados numéricos , Humanos , Hiperglicemia/sangue , Hiperglicemia/diagnóstico , Hiperglicemia/epidemiologia , Hipoglicemia/sangue , Hipoglicemia/diagnóstico , Hipoglicemia/epidemiologia , Hipoglicemiantes/uso terapêutico , Insulina/uso terapêutico , Masculino , Pessoa de Meia-Idade , Números Necessários para Tratar , Pontuação de Propensão , Estudos Retrospectivos , Viés de Seleção , Fatores de Tempo , Resultado do Tratamento
9.
JAMA ; 325(22): 2285-2293, 2021 06 08.
Artigo em Inglês | MEDLINE | ID: mdl-34100870

RESUMO

Importance: Seasonal influenza vaccination in pregnancy can reduce influenza illness among pregnant women and newborns. Evidence is limited on whether seasonal influenza vaccination in pregnancy is associated with adverse childhood health outcomes. Objective: To assess the association between maternal influenza vaccination during pregnancy and early childhood health outcomes. Design, Setting, and Participants: Retrospective cohort study, using a birth registry linked with health administrative data. All live births in Nova Scotia, Canada, between October 1, 2010, and March 31, 2014, were included, with follow-up until March 31, 2016. Adjusted hazard ratios (HRs) and incidence rate ratios (IRRs) with 95% confidence intervals were estimated while controlling for maternal medical history and other potential confounders using inverse probability of treatment weighting. Exposures: Seasonal influenza vaccination during pregnancy. Main Outcomes and Measures: Childhood outcomes studied were immune-related (eg, asthma, infections), non-immune-related (eg, neoplasms, sensory impairment), and nonspecific (eg, urgent or inpatient health care utilization), measured from emergency department and hospitalization databases. Results: Among 28 255 children (49% female, 92% born at ≥37 weeks' gestation), 10 227 (36.2%) were born to women who received seasonal influenza vaccination during pregnancy. During a mean follow-up of 3.6 years, there was no significant association between maternal influenza vaccination and childhood asthma (incidence rate, 3.0 vs 2.5 per 1000 person-years; difference, 0.53 per 1000 person-years [95% CI, -0.15 to 1.21]; adjusted HR, 1.22 [95% CI, 0.94 to 1.59]), neoplasms (0.32 vs 0.26 per 1000 person-years; difference, 0.06 per 1000 person-years [95% CI, -0.16 to 0.28]; adjusted HR, 1.26 [95% CI, 0.57 to 2.78]), or sensory impairment (0.80 vs 0.97 per 1000 person-years; difference, -0.17 per 1000 person-years [95% CI, -0.54 to 0.21]; adjusted HR, 0.82 [95% CI, 0.49 to 1.37]). Maternal influenza vaccination in pregnancy was not significantly associated with infections in early childhood (incidence rate, 184.6 vs 179.1 per 1000 person-years; difference, 5.44 per 1000 person-years [95% CI, 0.01 to 10.9]; adjusted IRR, 1.07 [95% CI, 0.99 to 1.15]) or with urgent and inpatient health services utilization (511.7 vs 477.8 per 1000 person-years; difference, 33.9 per 1000 person-years [95% CI, 24.9 to 42.9]; adjusted IRR, 1.05 [95% CI, 0.99 to 1.16]). Conclusions and Relevance: In this population-based cohort study with mean follow-up duration of 3.6 years, maternal influenza vaccination during pregnancy was not significantly associated with an increased risk of adverse early childhood health outcomes.


Assuntos
Vacinas contra Influenza/efeitos adversos , Influenza Humana/prevenção & controle , Complicações Infecciosas na Gravidez/prevenção & controle , Vacinação/efeitos adversos , Adulto , Asma/epidemiologia , Pré-Escolar , Intervalos de Confiança , Feminino , Seguimentos , Necessidades e Demandas de Serviços de Saúde/estatística & dados numéricos , Humanos , Incidência , Lactente , Recém-Nascido , Infecções/epidemiologia , Vacinas contra Influenza/administração & dosagem , Nascido Vivo/epidemiologia , Masculino , Idade Materna , Neoplasias/epidemiologia , Nova Escócia/epidemiologia , Avaliação de Resultados em Cuidados de Saúde , Gravidez , Modelos de Riscos Proporcionais , Estudos Retrospectivos , Estações do Ano , Transtornos das Sensações/epidemiologia , Vacinação/estatística & dados numéricos , Adulto Jovem
10.
J Int Soc Sports Nutr ; 18(1): 51, 2021 Jun 28.
Artigo em Inglês | MEDLINE | ID: mdl-34183020

RESUMO

BACKGROUND: Dietary supplement use among recreational athletes is common, with the intention of reducing inflammation and improving recovery. We aimed to describe the relationship between omega-3 fatty acid supplement use and inflammation induced by strenuous exercise. METHODS: C-reactive protein (CRP) concentrations were measured in 1002 healthy recreational athletes before and 24 h after a 91-km bicycle race. The use of omega-3 fatty acid supplements was reported in 856 out of 1002 recreational athletes, and the association between supplement use and the exercise-induced CRP response was assessed. RESULTS: Two hundred seventy-four subjects reported regular use of omega-3 fatty acid supplements. One hundred seventy-three of these used cod liver oil (CLO). Regular users of omega-3 fatty acid supplements had significantly lower basal and exercise-induced CRP levels as compared to non-users (n = 348, p < 0.001). Compared to non-users, regular users had a 27% (95% confidence interval (CI): 14-40) reduction in Ln CRP response (unadjusted model, p < 0.001) and 16% (95% CI: 5-28, p = 0.006) reduction after adjusting for age, sex, race duration, body mass index, delta creatine kinase, MET hours per week, resting heart rate and higher education. CLO was the primary driver of this response with a 34% (95% CI: 19-49) reduction (unadjusted model, p < 0.001) compared to non-users. Corresponding numbers in the adjusted model were 24% (95% CI: 11-38, p < 0.001). CONCLUSION: Basal CRP levels were reduced, and the exercise-induced CRP response was attenuated in healthy recreational cyclists who used omega-3 fatty acid supplements regularly. This effect was only present in regular users of CLO. TRIAL REGISTRATION: NCT02166216 , registered June 18, 2014 - Retrospectively registered.


Assuntos
Proteína C-Reativa/análise , Óleo de Fígado de Bacalhau/administração & dosagem , Exercício Físico/fisiologia , Vitaminas/administração & dosagem , Adulto , Ciclismo/fisiologia , Intervalos de Confiança , Creatina Quinase/sangue , Ácidos Graxos Ômega-3/administração & dosagem , Feminino , Frequência Cardíaca/fisiologia , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos
11.
Stat Med ; 40(14): 3227-3250, 2021 06 30.
Artigo em Inglês | MEDLINE | ID: mdl-33942338

RESUMO

A cluster randomization trial is one in which clusters of individuals are randomly allocated to different intervention arms. This design has become the standard for the evaluation of health care and educational strategies. To assess treatment effect, many cluster randomization trials involve outcomes that are lack meaningful units, making interpretation difficult. This difficulty may be dealt with by estimating the Mann-Whitney probability, which quantifies the probability that a typical response from one treatment arm is larger (or smaller) than a typical response from the other arm. In this work, we propose procedures for estimating this probability in cluster randomization trials. Primary emphasis is given to confidence interval estimation in trials with a small number of large clusters. The essence of the procedures is to obtain placement values based on overall ranks and arm-specific ranks prior to application of the ratio estimator, cluster-size-weighted means and mixed models for adjusting clustering effects. Nine confidence intervals were developed by applying three interval methods each based on the three variance estimators. The proposed methods can be applied to studies with binary, ordinal or continuous outcomes without making parametric assumptions. Simulation results demonstrated that the three variance estimators performed equally well, with the confidence interval procedures based on logit and inverse hyperbolic sine transformations performing better in terms of coverage and average interval width, even when the numbers of clusters are as small as 3 to 5 clusters per arm. The methods are illustrated using data from three published cluster randomization trials with SAS code provided.


Assuntos
Intervalos de Confiança , Análise por Conglomerados , Simulação por Computador , Humanos , Distribuição Aleatória
14.
N Engl J Med ; 384(18): 1705-1718, 2021 05 06.
Artigo em Inglês | MEDLINE | ID: mdl-33951360

RESUMO

BACKGROUND: Rifapentine-based regimens have potent antimycobacterial activity that may allow for a shorter course in patients with drug-susceptible pulmonary tuberculosis. METHODS: In an open-label, phase 3, randomized, controlled trial involving persons with newly diagnosed pulmonary tuberculosis from 13 countries, we compared two 4-month rifapentine-based regimens with a standard 6-month regimen consisting of rifampin, isoniazid, pyrazinamide, and ethambutol (control) using a noninferiority margin of 6.6 percentage points. In one 4-month regimen, rifampin was replaced with rifapentine; in the other, rifampin was replaced with rifapentine and ethambutol with moxifloxacin. The primary efficacy outcome was survival free of tuberculosis at 12 months. RESULTS: Among 2516 participants who had undergone randomization, 2343 had a culture positive for Mycobacterium tuberculosis that was not resistant to isoniazid, rifampin, or fluoroquinolones (microbiologically eligible population; 768 in the control group, 791 in the rifapentine-moxifloxacin group, and 784 in the rifapentine group), of whom 194 were coinfected with human immunodeficiency virus and 1703 had cavitation on chest radiography. A total of 2234 participants could be assessed for the primary outcome (assessable population; 726 in the control group, 756 in the rifapentine-moxifloxacin group, and 752 in the rifapentine group). Rifapentine with moxifloxacin was noninferior to the control in the microbiologically eligible population (15.5% vs. 14.6% had an unfavorable outcome; difference, 1.0 percentage point; 95% confidence interval [CI], -2.6 to 4.5) and in the assessable population (11.6% vs. 9.6%; difference, 2.0 percentage points; 95% CI, -1.1 to 5.1). Noninferiority was shown in the secondary and sensitivity analyses. Rifapentine without moxifloxacin was not shown to be noninferior to the control in either population (17.7% vs. 14.6% with an unfavorable outcome in the microbiologically eligible population; difference, 3.0 percentage points [95% CI, -0.6 to 6.6]; and 14.2% vs. 9.6% in the assessable population; difference, 4.4 percentage points [95% CI, 1.2 to 7.7]). Adverse events of grade 3 or higher occurred during the on-treatment period in 19.3% of participants in the control group, 18.8% in the rifapentine-moxifloxacin group, and 14.3% in the rifapentine group. CONCLUSIONS: The efficacy of a 4-month rifapentine-based regimen containing moxifloxacin was noninferior to the standard 6-month regimen in the treatment of tuberculosis. (Funded by the Centers for Disease Control and Prevention and others; Study 31/A5349 ClinicalTrials.gov number, NCT02410772.).


Assuntos
Antibióticos Antituberculose/administração & dosagem , Antituberculosos/uso terapêutico , Moxifloxacina/administração & dosagem , Mycobacterium tuberculosis/isolamento & purificação , Rifampina/administração & dosagem , Tuberculose Pulmonar/tratamento farmacológico , Adolescente , Adulto , Antibióticos Antituberculose/efeitos adversos , Antituberculosos/efeitos adversos , Criança , Intervalos de Confiança , Esquema de Medicação , Quimioterapia Combinada , Feminino , Humanos , Masculino , Moxifloxacina/efeitos adversos , Rifampina/efeitos adversos , Adulto Jovem
15.
N Engl J Med ; 384(20): 1910-1920, 2021 05 20.
Artigo em Inglês | MEDLINE | ID: mdl-34010530

RESUMO

BACKGROUND: The effectiveness of endovascular therapy in patients with stroke caused by basilar-artery occlusion has not been well studied. METHODS: We randomly assigned patients within 6 hours after the estimated time of onset of a stroke due to basilar-artery occlusion, in a 1:1 ratio, to receive endovascular therapy or standard medical care. The primary outcome was a favorable functional outcome, defined as a score of 0 to 3 on the modified Rankin scale (range, 0 to 6, with 0 indicating no disability, 3 indicating moderate disability, and 6 indicating death) at 90 days. The primary safety outcomes were symptomatic intracranial hemorrhage within 3 days after the initiation of treatment and mortality at 90 days. RESULTS: A total of 300 patients were enrolled (154 in the endovascular therapy group and 146 in the medical care group). Intravenous thrombolysis was used in 78.6% of the patients in the endovascular group and in 79.5% of those in the medical group. Endovascular treatment was initiated at a median of 4.4 hours after stroke onset. A favorable functional outcome occurred in 68 of 154 patients (44.2%) in the endovascular group and 55 of 146 patients (37.7%) in the medical care group (risk ratio, 1.18; 95% confidence interval [CI], 0.92 to 1.50). Symptomatic intracranial hemorrhage occurred in 4.5% of the patients after endovascular therapy and in 0.7% of those after medical therapy (risk ratio, 6.9; 95% CI, 0.9 to 53.0); mortality at 90 days was 38.3% and 43.2%, respectively (risk ratio, 0.87; 95% CI, 0.68 to 1.12). CONCLUSIONS: Among patients with stroke from basilar-artery occlusion, endovascular therapy and medical therapy did not differ significantly with respect to a favorable functional outcome, but, as reflected by the wide confidence interval for the primary outcome, the results of this trial may not exclude a substantial benefit of endovascular therapy. Larger trials are needed to determine the efficacy and safety of endovascular therapy for basilar-artery occlusion. (Funded by the Dutch Heart Foundation and others; BASICS ClinicalTrials.gov number, NCT01717755; Netherlands Trial Register number, NL2500.).


Assuntos
Procedimentos Endovasculares , Fibrinolíticos/uso terapêutico , Acidente Vascular Cerebral/cirurgia , Trombectomia/métodos , Insuficiência Vertebrobasilar/complicações , Idoso , Arteriopatias Oclusivas/complicações , Artéria Basilar/diagnóstico por imagem , Intervalos de Confiança , Feminino , Humanos , Análise de Intenção de Tratamento , Masculino , Pessoa de Meia-Idade , Índice de Gravidade de Doença , Método Simples-Cego , Acidente Vascular Cerebral/tratamento farmacológico , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/mortalidade , Terapia Trombolítica , Tempo para o Tratamento , Resultado do Tratamento
17.
Stat Med ; 40(16): 3695-3723, 2021 07 20.
Artigo em Inglês | MEDLINE | ID: mdl-33906262

RESUMO

This article considers a setting in diagnostic studies (or biomarker study) which involves a healthy class and a diseased class and the latter consists of several subclasses. The problem of interest is to evaluate the accuracy of a biomarker (or a diagnostic test) measured on a continuous scale correctly identifying healthy subjects from diseased subjects without requiring specification of an ordering in terms of marker values for subclasses relative to each other within the diseased class. Such setting is quite common in practice and it falls in the framework of tree ordering or umbrella ordering. This article explores several parametric and nonparametric approaches for estimating confidence intervals of sensitivity of single biomarker and difference between sensitivities of two correlated biomarkers under tree ordering at a given specificity. The performances of all the methods are evaluated and compared by a comprehensive simulation study. A published microarray data set is analyzed using the proposed methods.


Assuntos
Testes Diagnósticos de Rotina , Árvores , Simulação por Computador , Intervalos de Confiança , Humanos , Curva ROC , Sensibilidade e Especificidade
18.
Cancer Med ; 10(9): 2956-2966, 2021 05.
Artigo em Inglês | MEDLINE | ID: mdl-33835722

RESUMO

BACKGROUND: There is a paucity of studies describing the incidence and risk factors for late-occurring (≥1 year) infectious complications in contemporary survivors of hematopoietic cell transplantation (HCT). METHODS: This was a retrospective cohort study of 641 1-year survivors of HCT, transplanted between 2010 and 2013 as adults, and in remission from their primary disease. Standardized definitions were used to characterize viral, fungal, and bacterial infections. Cumulative incidence of infections was calculated, with relapse/progression considered as a competing risk event. Fine-Gray subdistribution hazard ratio estimates and 95% confidence intervals (CI) were obtained, adjusted for relevant covariates. RESULTS: Median age at HCT was 55.2 years (range 18.1-78.1 years); 54.0% were survivors of allogeneic HCT. The 5-year cumulative incidence of a late-occurring infection for the entire cohort was 31.6%; the incidence of polymicrobial (≥2) infections was 10.1%. In survivors who developed at least one infection, the 5-year incidence of a subsequent infection was 45.3%. Among allogeneic HCT survivors, patients with acute lymphoblastic (HR = 1.82 95% CI [1.12-2.96]) or myeloid (HR = 1.50 95% CI [1.02-2.20]) leukemia, and those with an elevated HCT-Comorbidity index score (HR = 1.09 95% CI [1.01-1.17]) were more likely to develop late-occurring infections; there was an incremental risk associated with severity of graft versus host disease (GVHD) at 1-year post-HCT (mild: HR = 2.17, 95% CI [1.09-4.33]; moderate/severe: HR = 3.78, 95% CI [1.90-7.53]; reference: no GVHD). CONCLUSIONS: The burden of late-occurring infections in HCT survivors is substantial, and there are important patient- and HCT-related modifiers of risk over time. These findings may help guide personalized screening and prevention strategies to improve outcomes after HCT.


Assuntos
Infecções Bacterianas/epidemiologia , Transplante de Células-Tronco Hematopoéticas/efeitos adversos , Micoses/epidemiologia , Viroses/epidemiologia , Adulto , Idoso , Aloenxertos , Autoenxertos , Infecções Bacterianas/microbiologia , Intervalos de Confiança , Progressão da Doença , Feminino , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Micoses/microbiologia , Recidiva , Estudos Retrospectivos , Sobreviventes , Viroses/virologia , Adulto Jovem
19.
J Parasitol ; 107(2): 358-363, 2021 03 01.
Artigo em Inglês | MEDLINE | ID: mdl-33906232

RESUMO

The life cycle of Dioctophyma renale involves an intermediate host (oligochaete), a paratenic hosts (fish and frogs), and a definitive host (mustelids and canids). Dogs are at risk of infection with D. renale when they consume paratenic hosts infected with the larval form of D. renale. Water containing the oligochaete intermediate host cannot be disregarded as another source of infection. Infections occur mainly in the right kidney, but worms have also been found in the abdominal cavity as well as other organs. Most dogs appear asymptomatic and infections are usually noted as incidental findings on necropsy. Recently, the Ontario Society for the Prevention of Cruelty to Animals (SPCA) and Humane Society conducted transports of dogs located in northern remote communities. In 2016, some female dogs were found to be infected with D. renale upon ovariohysterectomy. In response to this discovery, we developed a screening protocol to screen for D. renale infections. In 2018, a total of 130 intact dogs were transferred from 2 northern communities in the provinces of Ontario and Manitoba. A prevalence of 7.94% (95% confidence interval 3.87-14.11%) was found from dogs from the northern communities. The screening protocol we developed provides a method of screening for dogs that are transported from communities that could be at risk of infection with D. renale.


Assuntos
Dioctophymatoidea/fisiologia , Doenças do Cão/parasitologia , Infecções por Enoplida/veterinária , Animais , Intervalos de Confiança , Dioctophymatoidea/isolamento & purificação , Doenças do Cão/diagnóstico , Doenças do Cão/epidemiologia , Doenças do Cão/terapia , Cães , Infecções por Enoplida/diagnóstico , Infecções por Enoplida/epidemiologia , Infecções por Enoplida/terapia , Feminino , Rim/parasitologia , Rim/fisiologia , Testes de Função Renal/veterinária , Masculino , Manitoba/epidemiologia , Programas de Rastreamento/veterinária , Ontário/epidemiologia , Prevalência , Urina/parasitologia
20.
Arthroscopy ; 37(4): 1057-1063, 2021 04.
Artigo em Inglês | MEDLINE | ID: mdl-33812509

RESUMO

Despite great advances in our understanding of statistics, a focus on statistical significance and P values, or lack of significance and power, persists. Unfortunately, this dichotomizes research findings comparing differences between groups or treatments as either significant or not significant. This creates a false and incorrect sense of certainty. Statistics provide us a measure of the degree of uncertainty or random error in our data. To improve the way in which we communicate and understand our results, we must include in reporting a probability, or estimate, of our degree of certainty (or uncertainty). This will allow us to better determine the risks and benefits of a treatment or intervention. Approaches that allow us to estimate, account for, and report our degree of uncertainty include use of confidence intervals, P-value functions, and Bayesian inference (which incorporates prior knowledge in our analysis of new research data). Surprise values (S values, which convert P values to the number of successive identical results of flips of a fair coin) express outcomes in an intuitive manner less susceptible to dichotomizing results as significant or not significant. In the future, researchers may report P values (if they wish) but could go further and provide a confidence interval, draw a P-value function graph, or run a Bayesian analysis. Authors could calculate and report an S value. It is insufficient to mindlessly report results as significant versus not significant without providing a quantitative estimate of the uncertainty of the data.


Assuntos
Modelos Estatísticos , Incerteza , Teorema de Bayes , Intervalos de Confiança , Humanos , Probabilidade , Manguito Rotador/patologia
SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA
...