Your browser doesn't support javascript.
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 137
Filtrar
Filtros adicionais











País/Região como assunto
Intervalo de ano
1.
BMC Cardiovasc Disord ; 19(1): 207, 2019 Sep 02.
Artigo em Inglês | MEDLINE | ID: mdl-31477020

RESUMO

BACKGROUND: Colchicine has been used as anti-inflammatory agent in pericardial effusion (PE). We sought to perform a meta-analysis of randomized trials assessing the efficacy and safety of colchicine in patients with pericarditis or postpericardiotomy syndrome (PPS). METHODS: In the systematic literature search following the PRISMA statement, 10 prospective randomized controlled studies with 1981 patients with an average follow-up duration of 13.6 months were identified. RESULTS: Colchicine reduced the recurrence rate of pericarditis in patients with acute and recurrent pericarditis and reduced the incidence of PPS (RR: 0.57, 95% CI: 0.44-0.74). Additionally, the rate of rehospitalizations as well as the symptom duration after 72 h was significantly decreased in pericarditis (RR 0.33; 95% CI 0.18-0.60; and RR 0.43; 95% CI 0.34-0.54; respectively), but not in PPS. Treatment with colchicine was associated with significantly higher adverse event (AE) rates (RR 1.42; 95% CI 1.05-1.92), with gastrointestinal intolerance being the leading AE. The reported number needed to treat (NNT) for the prevention of recurrent pericarditis ranged between 3 and 5. The reported NNT for PPS prevention was 10, and the number needed to harm (NNH) was 12, respectively. Late colchicine administration > 7 days after heart surgery did not reduce postoperative PE. CONCLUSIONS: Our meta-analysis confirms that colchicine is efficacious and safe for prevention of recurrent pericarditis and PPS, while it reduces rehospitalizations and symptom duration in pericarditis. The clinical use of colchicine for the setting of PPS and postoperative PE after heart surgery should be investigated in further multicenter RCT.

2.
Heart Fail Rev ; 2019 Aug 08.
Artigo em Inglês | MEDLINE | ID: mdl-31396762

RESUMO

Meta-analysis on immunohistological (IHC) concepts for the detection of inflammatory cardiomyopathy (InfCM) in endomyocardial biopsies (EMB). We included 61 publications, with 10,491 patients (mean age 47.1 years; men 66%) who underwent EMB and IHC evaluation. The 460 control patients were devoid of IHC proof of InfCM. The mean IHC detection rate of InfCM was 50.8% (95% CI 47.7-53.8%; range 18.4-91.7%). A publication bias was excluded (Funnel Plot p = 0.4264). This IHC detection rate was significantly (p < 0.0001) higher compared to the histological detection of myocarditis according to the Dallas criteria (mean 8.04%; 95% CI 5.08-12.5%; subset of 3274 patients in 30 publications). However, 13 different diagnostic IHC criteria were described in the publications, with various thresholds of diverse phenotypes of quantified infiltrates, and endothelial expression of diverse cell adhesion molecules (CAM), quantified either visually or by digital image analysis (DIA). The comparison of IHC with cardiac magnetic resonance (CMR) data available in a subset of 13 publications with 1185 patients revealed a sensitivity for CMR of 69% (95% CI 58-79%), a specificity of 73% (95% CI 59-84%), and a ROC-AUC of 0.77 (95% CI 0.73-0.81). This meta-analysis encompassing 10,491 patients confirms a mean detection rate of InfCM in 50.8% of EMB, being significantly more sensitive compared to the histological Dallas criteria. IHC cannot be fully substituted by CMR. However, standardization of the diverse IHC markers and protocols seems pertinent, especially considering the published adverse prognostic impact of IHC-confirmed InfCM and its published suitability for the selection of candidates responding favorably to immunosuppression.

3.
Trials ; 20(1): 330, 2019 Jun 06.
Artigo em Inglês | MEDLINE | ID: mdl-31171029

RESUMO

BACKGROUND: Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection with a hospital mortality in excess of 40%. Along with insufficient and delayed empirical antimicrobial therapy, inappropriate antimicrobial exposure has been identified to negatively affect patient outcomes. Receipt of prolonged infusion (i.e. extended or continuous infusion) of piperacillin/tazobactam (TZP) improves antimicrobial exposure and is associated with reduced mortality in patients with sepsis. Using therapeutic drug monitoring (TDM) with dosing tailored to the altered pharmacokinetics of the individual patient to avoid under- and overdosing may be a further strategy to improve patient outcomes. This current trial will address the question whether a TDM-guided therapy with TZP administered by continuous infusion will result in a greater resolution of organ dysfunction and hence better clinical outcome compared to continuous infusion of the total daily dose of TZP without TDM. METHODS: The study is an investigator-initiated, multi-centre, parallel-group, single-blinded, randomised controlled trial. The trial will be conducted in several centres across Germany. Adult patients (aged ≥ 18 years) with severe sepsis or septic shock will be eligible for study participation. Participants will be randomly assigned to receive either TZP by continuous infusion guided by daily TDM of piperacillin (experimental group) or by continuous infusion without TDM guidance (total daily dose in normal renal function 13.5 g TZP) (control group). The pharmacokinetic (PK)/pharmacodynamic (PD) target will be 100% f T>4MIC (percentage of time during a dosing interval that the free [f] drug concentration exceeds 4 times the minimum inhibitory concentration). The primary efficacy endpoint is the change in mean total Sequential Organ Failure Assessment score from day 1 after randomisation until day 10 or discharge from the intensive care unit or death, whichever comes first. Secondary outcomes include mortality, clinical cure, microbiological cure, overall antibiotic use, individual components of the primary outcome, adverse events and analysis of PK and (PD) indices. DISCUSSION: This trial will assess for the first time whether continuous infusion of TZP guided by daily TDM in patients with sepsis will result in a greater resolution of organ dysfunction and hence better clinical outcome compared to continuous infusion without TDM. TRIAL REGISTRATION: German Clinical Trials Register (GermanCTR), DRKS00011159 . Registered on 10 October 2016.

4.
BMJ ; 365: l1945, 2019 06 12.
Artigo em Inglês | MEDLINE | ID: mdl-31189617

RESUMO

OBJECTIVE: To determine whether coronary computed tomography angiography (CTA) should be performed in patients with any clinical probability of coronary artery disease (CAD), and whether the diagnostic performance differs between subgroups of patients. DESIGN: Prospectively designed meta-analysis of individual patient data from prospective diagnostic accuracy studies. DATA SOURCES: Medline, Embase, and Web of Science for published studies. Unpublished studies were identified via direct contact with participating investigators. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Prospective diagnostic accuracy studies that compared coronary CTA with coronary angiography as the reference standard, using at least a 50% diameter reduction as a cutoff value for obstructive CAD. All patients needed to have a clinical indication for coronary angiography due to suspected CAD, and both tests had to be performed in all patients. Results had to be provided using 2×2 or 3×2 cross tabulations for the comparison of CTA with coronary angiography. Primary outcomes were the positive and negative predictive values of CTA as a function of clinical pretest probability of obstructive CAD, analysed by a generalised linear mixed model; calculations were performed including and excluding non-diagnostic CTA results. The no-treat/treat threshold model was used to determine the range of appropriate pretest probabilities for CTA. The threshold model was based on obtained post-test probabilities of less than 15% in case of negative CTA and above 50% in case of positive CTA. Sex, angina pectoris type, age, and number of computed tomography detector rows were used as clinical variables to analyse the diagnostic performance in relevant subgroups. RESULTS: Individual patient data from 5332 patients from 65 prospective diagnostic accuracy studies were retrieved. For a pretest probability range of 7-67%, the treat threshold of more than 50% and the no-treat threshold of less than 15% post-test probability were obtained using CTA. At a pretest probability of 7%, the positive predictive value of CTA was 50.9% (95% confidence interval 43.3% to 57.7%) and the negative predictive value of CTA was 97.8% (96.4% to 98.7%); corresponding values at a pretest probability of 67% were 82.7% (78.3% to 86.2%) and 85.0% (80.2% to 88.9%), respectively. The overall sensitivity of CTA was 95.2% (92.6% to 96.9%) and the specificity was 79.2% (74.9% to 82.9%). CTA using more than 64 detector rows was associated with a higher empirical sensitivity than CTA using up to 64 rows (93.4% v 86.5%, P=0.002) and specificity (84.4% v 72.6%, P<0.001). The area under the receiver-operating-characteristic curve for CTA was 0.897 (0.889 to 0.906), and the diagnostic performance of CTA was slightly lower in women than in with men (area under the curve 0.874 (0.858 to 0.890) v 0.907 (0.897 to 0.916), P<0.001). The diagnostic performance of CTA was slightly lower in patients older than 75 (0.864 (0.834 to 0.894), P=0.018 v all other age groups) and was not significantly influenced by angina pectoris type (typical angina 0.895 (0.873 to 0.917), atypical angina 0.898 (0.884 to 0.913), non-anginal chest pain 0.884 (0.870 to 0.899), other chest discomfort 0.915 (0.897 to 0.934)). CONCLUSIONS: In a no-treat/treat threshold model, the diagnosis of obstructive CAD using coronary CTA in patients with stable chest pain was most accurate when the clinical pretest probability was between 7% and 67%. Performance of CTA was not influenced by the angina pectoris type and was slightly higher in men and lower in older patients. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42012002780.


Assuntos
Angina Pectoris/diagnóstico por imagem , Angiografia por Tomografia Computadorizada/métodos , Doença da Artéria Coronariana/diagnóstico por imagem , Vasos Coronários/diagnóstico por imagem , Angina Pectoris/etiologia , Doença da Artéria Coronariana/complicações , Estudos de Viabilidade , Humanos , Valor Preditivo dos Testes , Probabilidade
5.
Dtsch Arztebl Int ; 116(14): 237-244, 2019 Apr 05.
Artigo em Inglês | MEDLINE | ID: mdl-31092311

RESUMO

BACKGROUND: There have been many individual studies on the question whether air- craft noise is a risk factor for stroke, but until now there has not been any summary of the current state of the evidence of adequately high methodological quality. METHODS: In a systematic review and meta-analysis (PROSPERO registry number CRD42013006004), we evaluated the relation between address-based aircraft noise exposure and the incidence of stroke. A systematic literature search was performed in the MEDLINE, EMBASE, and BIOSIS databases including publications up to August 2017. Two of the authors, working independently of each other, screened the titles, abstracts, and full texts for eligible articles and evaluated the quality of the included studies on a three-level scale. The change of risk per 10 dB increase in the weighted mean aircraft noise level (LDEN) was calculated. LDEN is a noise level indicator with additional weighting of evening and nighttime noise. RESULTS: Of the nine studies that met the inclusion criteria, seven were suitable for inclusion in the meta-analysis. The result of the meta-analysis indicated a relative stroke risk of 1.013 (95% confidence interval, [0.998; 1.028]) per 10 dB increase in LDEN, corresponding with an estimated 1.3% increase in the risk of stroke for each additional 10 dB of aircraft noise. The underlying studies were of poor to medium quality. The analyses of the studies included adjustments for various combinations of confounders, including age, sex, ethnicity, and socioeconomic status. CONCLUSION: The present meta-analysis indicates that aircraft noise increases the risk of stroke, even if the overall finding just fails to reach statistical significance. The differing measures of exposure in the included studies, the lack of differentiation be- tween ischemic and hemorrhagic stroke, and the lack of consideration of maximum noise levels are all factors that may have led to a marked underestimation of the risk of stroke.

6.
Artigo em Alemão | MEDLINE | ID: mdl-31065736

RESUMO

Research in humans is associated with risks. These risks are only justifiable if an independent institutional review board (IRB) has evaluated the planned research in terms of scientific integrity. Only scientifically sound research can be considered ethical. A biostatistician should be a member of the IRB to assure adequate evaluation of fundamental topics like design, sample size estimation, and statistical analysis of the study.This paper presents core biostatistical concepts following the current guidelines of the International Council of Harmonization (ICH E6 and ICH E9). We discuss important pitfalls based on examples from published clinical trials. Furthermore, we discuss new concepts like estimands and their relevance for biostatisticians working in IRBs. Finally, we discuss the role of biostatisticians in IRBs and present thoughts on the way they should be trained.

7.
J Affect Disord ; 251: 136-140, 2019 05 15.
Artigo em Inglês | MEDLINE | ID: mdl-30921597

RESUMO

BACKGROUND: Lithium augmentation (LA) of antidepressants is an effective strategy for treatment-resistant depression (TRD). Nevertheless, it is rarely used in geriatric patients. The purpose of this study was to investigate treatment response of LA in geriatric compared to non-geriatric patients. METHOD: In a prospective multicenter cohort study, severity of depression was measured weekly in 167 patients with unipolar depression (nage≥65years = 22; nage<65years = 145) at baseline and over at least four weeks of LA. RESULTS: Geriatric patients showed a significantly better response to LA compared to non-geriatric patients (Hazard Ratio = 1.91; p = 0.04). LIMITATIONS: An important limitation of our study is the lack of a control group of LA and the missing evaluation of side effects in both groups. CONCLUSIONS: This is the first study investigating the efficacy of LA for TRD in geriatric compared to non-geriatric patients. Our data suggest that LA is an effective treatment option in geriatric patients that clinicians might consider more frequently and earlier on in the course of treatment.


Assuntos
Antidepressivos/uso terapêutico , Transtorno Depressivo Resistente a Tratamento/tratamento farmacológico , Carbonato de Lítio/uso terapêutico , Idoso , Idoso de 80 Anos ou mais , Estudos de Coortes , Depressão , Transtorno Depressivo Maior/tratamento farmacológico , Quimioterapia Combinada , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Resultado do Tratamento
8.
Eur Neuropsychopharmacol ; 29(2): 211-221, 2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-30554862

RESUMO

Weight gain is a common adverse effect of lithium augmentation. Previous studies indicate an impact of genetic variants at the leptin gene on weight gain as a consequence of psychopharmacological treatment. The primary aim of our study was to identify variants at the leptin locus that might predict lithium-induced weight gain. The secondary aim was to investigate if these variants modulate leptin levels. In 180 patients with acute major depressive disorder, body mass index was measured before and after 4 weeks of lithium augmentation, in a subsample also after 4 and/or 7 months. In a subsample of 89 patients, leptin serum concentrations were measured before and during lithium augmentation. We used linear mixed model analyzes to investigate the effects of 2 polymorphisms at the leptin locus (rs4731426 and rs7799039, employing the respective proxy SNPs rs2278815 and rs10487506) on changes in body mass index and leptin levels. For both polymorphisms, which are in high linkage disequilibrium, body mass index was significantly lower in homozygous A-allele carriers than in carriers of other genotypes at baseline. Over the follow-up period, body mass index increased less in homozygous A-allele carriers of rs4731426 than in carriers of other genotypes. This was not the case for rs7799039. Neither polymorphism modulated leptin protein expression. Our study strongly supports the hypothesis that genetic variability at the leptin locus is involved in lithium augmentation-associated weight gain in major depressive disorder. Furthermore, Genotype-Tissue Expression data provide strong evidence that rs4731426 influences the expression of leptin messenger ribonucleic acid in fibroblasts.


Assuntos
Transtorno Depressivo Maior/tratamento farmacológico , Transtorno Depressivo Maior/genética , Leptina/genética , Lítio/efeitos adversos , Polimorfismo de Nucleotídeo Único/genética , Ganho de Peso/efeitos dos fármacos , Ganho de Peso/genética , Adulto , Transtorno Depressivo Maior/sangue , Feminino , Genótipo , Humanos , Peso Corporal Ideal , Leptina/sangue , Masculino , Pessoa de Meia-Idade , Escalas de Graduação Psiquiátrica , Estudos Retrospectivos
9.
Laryngorhinootologie ; 2018 Dec 05.
Artigo em Alemão | MEDLINE | ID: mdl-30517967

RESUMO

BACKGROUND: In Germany, about 15 million people are suffering from hearing loss (HL), whereas only 16 % are using hearing aids. Untreated hearing loss may lead to severe complications (e. g. social isolation, depression, progress of dementia). An early and widespread screening, beginning at the age of 50, is meant to improve this shortage in medical care. By this study, the Mini-Audio-Test (MAT), a six-question and three-step answers containing questionnaire on subjective HL, should be verified on a normal collective of subjects (sensitivity (Se), specificity (Sp), positive predictive value (Ppv)). METHODS: 943 subjects (older 50 years) without any history of ear disease answered the MAT and received pure-tone audiometry. The Se, Sp, and Pv to detect a relevant HL with the MAT for the age-group < 60 years (AG1) and ≥ 60 years (AG2) were determined. RESULTS: The Se for AG1 was 0.66, the Sp 0.61, the Ppv 0.60, for AG2 the Se was 0.47, the Sp 0.80, the Ppv 0,89. CONCLUSION: Following our results, the MAT is recommended as a general screening-tool for HL in patients over 50 years of age for general practitioners. Hereby, severe secondary diseases (loss of cognitive power, risk of fall, depression, dementia) could be influenced positively.

10.
BMJ Open ; 8(12): e022952, 2018 12 14.
Artigo em Inglês | MEDLINE | ID: mdl-30552261

RESUMO

INTRODUCTION: Selective (incomplete/partial) carious tissue removal is suitable for treating deep carious lesions in teeth with vital, asymptomatic pulps. In the periphery of a cavity, removal to hard dentin is performed, while in pulpo-proximal areas, leathery or soft dentin is left to avoid pulp exposure. As the decision of what contains 'soft' or 'leathery' dentin is subjective, using self-limiting burs which help to standardise the hardness of the remaining dentin, has been suggested to increase the reliability of carious tissue removal. The trial compares subjectively measured selective carious tissue removal in deep lesions in primary teeth with objectively measured selective removal with a self-limiting bur (Polybur, Komet). METHODS AND ANALYSIS: A community-based single-blind clustered randomised controlled superiority trial nested into a larger evaluation is performed. Recruitment for this trial has been concluded. We have recruited 115 children aged 6-8 years with ≥1 vital primary molar with a deep dentin lesion. The unit of randomisation was the child, with all eligible molars per child treated identically. Treatment was performed in a mobile dental unit. Subjective and objective carious tissue removal was performed at random. Teeth were restored using glass ionomer cement (Equia Forte, GC). Our primary outcome will be the time until complications occur, evaluated via multilevel survival analysis. Secondary outcomes will be the time until extraction is needed, subjective satisfaction of the child with the treatment (measured using a Likert scale) and cost-effectiveness. Re-examination will be performed after 12, 24 and 36 months (the final examination is expected in 2020). ETHICS AND DISSEMINATION: This trial has been approved by the Ethics Committee of the Health Sciences of the University of Brasília (CAAE 51310415.0.0000.0030). Trial results will be published in peer-reviewed journals and presented on conferences. TRIAL REGISTRATION NUMBER: NCT02754466.

11.
J Nephrol ; 2018 Nov 15.
Artigo em Inglês | MEDLINE | ID: mdl-30443763

RESUMO

OBJECTIVE: Attempts to discontinue calcineurin inhibitors (CNIs) early after renal transplantation without conversion to an alternative immunosuppressive have failed due to high rates of acute rejection. Data on "late" CNI withdrawal are lacking so far. DESIGN AND METHOD: We carried out a matched case-control study on the effects of CNI withdrawal on graft loss and mortality in 90 patients (1500 screened) with advanced graft dysfunction (serum creatinine > 3.5 mg/dl) and a cyclosporine-based triple immunosuppressive regimen at the Charité University Hospital, Berlin. RESULTS: Cyclosporine was withdrawn at a mean of 54.0 ± 32.8 months post-transplant in 45 subjects. Whereas estimated glomerular filtration rate (eGFR) did not significantly differ between the groups at this time (12.4 ± 2.7 vs. 14.7 ± 8.9 in the control group, p = 0.08), it was significantly higher in subjects undergoing withdrawal after 120 months (Δ 4.1 ml/min; p < 0.001). In a Cox regression analysis adjusted for age, gender and eGFR, patients with CNI withdrawal showed better survival rates for the combined endpoint death/graft loss (hazard ratio, HR [95% confidence interval]: 0.19 [0.12-0.33], p = 0.001) compared to matched controls. The survival benefit was significant for the endpoints death (p = 0.01) and graft loss (p = 0.001). CONCLUSIONS: CNI withdrawal was associated with improved survival rates in patients with advanced graft dysfunction in this retrospective analysis.

12.
Neuroepidemiology ; 51(3-4): 207-215, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-30205396

RESUMO

BACKGROUND: To evaluate if weather or changes in weather are risk factors for Bell's palsy (BP) as exposure to draught of cold air has been popularly associated with the occurrence of BP. METHODS: Using a multicenter hospital-based case-crossover study, we analyzed the association between ambient temperature, atmospheric pressure, relative air humidity or their 24 h changes and the risk for BP in 825 patients or subgroups. RESULTS: One day following a 24 h increase in atmospheric pressure of more than 6 hPa, the risk for BP increased by 35% (OR 1.35; 95% CI 1.03-1.78) in the overall population. The risk for BP more than doubled in patients with diabetes mellitus after rapid variations in ambient temperature, independent of the direction (temperature decrease > 2.25°C; OR 2.15; 95% CI 1.08-4.25; temperature increase between 0.75 and 2.25°C; OR 2.88; 95% CI 1.63-5.10). CONCLUSIONS: Our findings support the hypothesis of an association between certain weather conditions and the risk for BP with acute changes in atmospheric pressure and ambient temperature as the main risk factors. Additionally, contrasting results for risk of BP after temperature changes in the diabetic and non-diabetic subgroups support the paradigm of a diabetic facial palsy as a distinct disease entity.

13.
Trials ; 19(1): 472, 2018 Sep 04.
Artigo em Inglês | MEDLINE | ID: mdl-30180873

RESUMO

BACKGROUND: The time to diagnosis of invasive Candida infection (ICI) is often too long to initiate timely antifungal therapy in patients with sepsis. Elevated serum (1,3)-ß-D-glucan (BDG) concentrations have a high diagnostic sensitivity for detecting ICI. However, the clinical significance of elevated BDG concentrations is unclear in critically ill patients. The goal of this study is to investigate whether measurement of BDG in patients with sepsis and a high risk for ICI can be used to decrease the time to empiric antifungal therapy and thus, increase survival. METHODS/DESIGN: This prospective multicenter open randomized controlled trial is being conducted in 19 German intensive care units. All adult patients with severe sepsis or septic shock and an increased risk for ICI are eligible for enrolment. Risk factors are total parenteral nutrition, previous abdominal surgery, previous antimicrobial therapy, and renal replacement therapy. Patients with proven ICI or those already treated with systemic antifungal substances are excluded. Patients are allocated to a BDG or standard care group. The standard care group receives targeted antifungal therapy as necessary. In the BDG group, BDG serum samples are taken after randomization and 24 h later. Antifungal therapy is initiated if BDG is ≥80 pg/ml in at least one sample. We plan to enroll 312 patients. The primary outcome is 28-day mortality. Other outcomes include antifungal-free survival within 28 days after enrolment, time to antifungal therapy, and the diagnostic performance of BDG compared to other laboratory tests for early ICI diagnosis. The statistical analysis will be performed according to the intent-to-treat principle. DISCUSSION: Because of the high risk of death, American guidelines recommend empiric antifungal therapy in sepsis patients with a high risk of ICI despite the limited evidence for such a recommendation. In contrast, empiric antifungal therapy is not recommended by European guidelines. BDG may offer a way out of this dilemma since BDG potentially identifies patients in need of early antifungals. However, the evidence for such an approach is inconclusive. This clinical study will generate solid evidence for health-care providers and authors of guidelines for the use of BDG in critically ill patients. TRIAL REGISTRATION: Clinicaltrials.gov, NCT02734550 . Registered 12 April 2016.

16.
PLoS One ; 13(7): e0200799, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-30016343

RESUMO

BACKGROUND: Fetal heart rate variability (fHRV) of normal-to-normal (NN) beat intervals provides high-temporal resolution access to assess the functioning of the autonomic nervous system (ANS). AIM: To determine critical periods of fetal autonomic maturation. The developmental pace is hypothesized to change with gestational age (GA). STUDY DESIGN: Prospective longitudinal observational study. SUBJECTS: 60 healthy singleton fetuses were followed up by fetal magnetocardiographic heart rate monitoring 4-11 times (median 6) during the second half of gestation. OUTCOME MEASURE: FHRV parameters, accounting for differential aspects of the ANS, were studied applying linear mixed models over four predefined pregnancy segments of interest (SoI: <27; 27+0-31+0; 31+1-35+0; >35+1 weeks GA). Periods of fetal active sleep and quiescence were accounted for separately. RESULTS: Skewness of the NN interval distribution VLF/LF band power ratio and complexity describe a saturation function throughout the period of interest. A decreasing LF/HF ratio and an increase in pNN5 indicate a concurrent shift in sympathovagal balance. Fluctuation amplitude and parameters of short-term variability (RMSSD, HF band) mark a second acceleration towards term. In contrast, fetal quiescence is characterized by sequential, but low-margin transformations; ascending overall variability followed by an increase of complexity and superseded by fluctuation amplitude. CONCLUSIONS: An increase in sympathetic activation, connected with by a higher ability of parasympathetic modulation and baseline stabilization, is reached during the transition from the late 2nd into the early 3rd trimester. Pattern characteristics indicating fetal well-being saturate at 35 weeks GA. Pronounced fetal breathing efforts near-term mirror in fHRV as respiratory sinus arrhythmia.

17.
Methods Inf Med ; 57(3): 111-119, 2018 05.
Artigo em Inglês | MEDLINE | ID: mdl-29719917

RESUMO

BACKGROUND: Meta-analyses require a thoroughly planned procedure to obtain unbiased overall estimates. From a statistical point of view not only model selection but also model implementation in the software affects the results. OBJECTIVES: The present simulation study investigates the accuracy of different implementations of general and generalized bivariate mixed models in SAS (using proc mixed, proc glimmix and proc nlmixed), Stata (using gllamm, xtmelogit and midas) and R (using reitsma from package mada and glmer from package lme4). Both models incorporate the relationship between sensitivity and specificity - the two outcomes of interest in meta-analyses of diagnostic accuracy studies - utilizing random effects. METHODS: Model performance is compared in nine meta-analytic scenarios reflecting the combination of three sizes for meta-analyses (89, 30 and 10 studies) with three pairs of sensitivity/specificity values (97%/87%; 85%/75%; 90%/93%). RESULTS: The evaluation of accuracy in terms of bias, standard error and mean squared error reveals that all implementations of the generalized bivariate model calculate sensitivity and specificity estimates with deviations less than two percentage points. proc mixed which together with reitsma implements the general bivariate mixed model proposed by Reitsma rather shows convergence problems. The random effect parameters are in general underestimated. CONCLUSIONS: This study shows that flexibility and simplicity of model specification together with convergence robustness should influence implementation recommendations, as the accuracy in terms of bias was acceptable in all implementations using the generalized approach.


Assuntos
Testes Diagnósticos de Rotina , Metanálise como Assunto , Modelos Estatísticos , Software , Humanos , Sensibilidade e Especificidade
18.
Thorac Cardiovasc Surg ; 66(7): 564-571, 2018 10.
Artigo em Inglês | MEDLINE | ID: mdl-29672815

RESUMO

BACKGROUND: Isolated tricuspid valve (TV) surgery is considered a high risk-procedure. The optimal surgical approach is controversial. We analyzed our experience with isolated TV redo surgery performed either minimally invasively (redo-MITS) or through sternotomy. METHODS: We retrospectively analyzed all patients with previous cardiac surgery who underwent redo-MITS (n = 26) and compared them to redo-Sternotomy (n = 17). A group of primary-MITS (n = 61) served as control. RESULTS: The redo-MITS approach consisted of a right anterolateral mini-thoracotomy, transpericardial right atrial access, and beating heart TV surgery without caval occlusion. Redo-MITS patients were oldest and had the most comorbidities (EuroScore II: 9.83 ± 6.05% versus redo-Sternotomy: 8.42 ± 7.33% versus primary-MITS: 4.15 ± 4.84%). There were no intraoperative complications or conversions to sternotomy in both MITS groups. Redo-Sternotomy had the highest 30-day mortality (24%), the poorest long-term survival, and the highest perioperative complication rate. Redo-MITS did not differ in perioperative outcome from primary-MITS. Multivariable logistic regression analysis identified redo-Sternotomy (odds ratio [OR] = 9.76; 95% confidence interval [CI] 1.88-63.26), liver cirrhosis (OR = 9.88; 95% CI 2.20-54.20), and body mass index (BMI) (OR = 1.16; 95% CI 1.02-1.35) as independent predictors of 30-day mortality. The Cox model revealed redo-Sternotomy (hazard ratio [HR] = 2.67; 95% CI 1.18-6.03), liver cirrhosis (HR = 3.31; 95% CI 1.45-7.58), and pulmonary hypertension (HR = 2.26; 95% CI 1.04-4.92) as risk factors for poor long-term survival. TV surgery significantly reduces NYHA class. CONCLUSION: Minimally invasive, isolated TV surgery as reoperation without caval occlusion and on the beating heart can be safe and may improve clinical outcome.

19.
Res Synth Methods ; 9(3): 382-392, 2018 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-29504289

RESUMO

In systematic reviews, meta-analyses are routinely applied to summarize the results of the relevant studies for a specific research question. If one can assume that in all studies the same true effect is estimated, the application of a meta-analysis with common effect (commonly referred to as fixed-effect meta-analysis) is adequate. If between-study heterogeneity is expected to be present, the method of choice is a meta-analysis with random effects. The widely used DerSimonian and Laird method for meta-analyses with random effects has been criticized due to its unfavorable statistical properties, especially in the case of very few studies. A working group of the Cochrane Collaboration recommended the use of the Knapp-Hartung method for meta-analyses with random effects. However, as heterogeneity cannot be reliably estimated if only very few studies are available, the Knapp-Hartung method, while correctly accounting for the corresponding uncertainty, has very low power. Our aim is to summarize possible methods to perform meaningful evidence syntheses in the situation with only very few (ie, 2-4) studies. Some general recommendations are provided on which method should be used when. Our recommendations are based on the existing literature on methods for meta-analysis with very few studies and consensus of the authors. The recommendations are illustrated by 2 examples coming from dossier assessments of the Institute for Quality and Efficiency in Health Care.

20.
Lancet Respir Med ; 6(3): 223-230, 2018 03.
Artigo em Inglês | MEDLINE | ID: mdl-29508706

RESUMO

The incidence of sepsis is highest in neonates and children, yet the global burden of sepsis in these age groups has not been assessed. We reviewed available evidence from observational epidemiological studies to estimate the global burden and mortality of sepsis in neonates and children. We did a systematic review and meta-analysis of studies reporting population-based sepsis incidence in neonates and children, published between 1979 and 2016. Our search yielded 1270 studies, 23 of which met the inclusion criteria; 16 were from high-income countries and seven from middle-income countries. 15 studies from 12 countries reported complete data and were included in the meta-analysis. We found an aggregate estimate of 48 (95% CI 27-86) sepsis cases and 22 (14-33) severe sepsis cases in children per 100 000 person-years. Mortality ranged from 1% to 5% for sepsis and 9% to 20% for severe sepsis. The population-level estimate for neonatal sepsis was 2202 (95% CI 1099-4360) per 100 000 livebirths, with mortality between 11% and 19%. Extrapolating these figures on a global scale, we estimate an incidence of 3·0 million cases of sepsis in neonates and 1·2 million cases in children. Although these results confirm that sepsis is a common and frequently fatal condition affecting neonates and children globally, few population-based data are available from low-income settings and the lack of standardisation of diagnostic criteria and definition of sepsis in the reviewed studies are obstacles to the accurate estimation of global burden. Robust epidemiological monitoring to define global sepsis incidence and mortality in children is urgently needed.


Assuntos
Efeitos Psicossociais da Doença , Saúde Global/estatística & dados numéricos , Sepse Neonatal/mortalidade , Sepse/mortalidade , Criança , Pré-Escolar , Feminino , Humanos , Incidência , Lactente , Recém-Nascido , Masculino
SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA