RESUMO
PURPOSE: To explore the clinical evidence available on mindful organizing (MO) that will improve teamwork for positioning and managing central venous catheters in patients admitted to neonatal intensive care and other pediatric intensive care units to decrease central-line-associated and catheter-related bloodstream infections (CLABSI and CRBSI). METHODS: We searched several databases (PubMed, Embase, CINAHL, CENTRAL, SCOPUS, and Web of Science) up to June 2018. We included studies investigating the effectiveness of MO teamwork in reducing CLABSI and CRBSI. The systematic review followed the PRISMA guidelines. We used validated appraisal checklists to assess quality. RESULTS: Seven studies were included: only one was a non-randomized case-controlled trial (CCT). All the others had a pre-post intervention design, one a time-series design and one an interrupted time-series design. The methodological heterogeneity precluded a meta-analysis. Despite the low certainty of evidence with the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system, three studies including thousands of participants provided numerical data for calculating risk ratios (RR) and 95% confidence intervals (CI) comparing MO with no intervention for decreasing the CLABSI rate in neonatal and pediatric ICUs. The one CCT disclosed no significant difference in the CLABSI rate decrease between groups (RR = 0.96; 95%CI 0.47-1.97). Nor did the pre- and post-intervention interrupted time-series design disclose a significant decrease (RR = 0.80; 95%CI 0.36 1.77). In the study using a before-after study design, the GRADE system found that the CLABSI rate decrease differed significantly in favor of post-intervention (RR = 0.13; 95%CI 0.03 0.57; p = 0.007). CONCLUSIONS: Despite the decreased CLABSI rate, the available evidence is low in quality. To reduce the unduly high CLABSI rates in neonatal and pediatric intensive care settings, custom-designed clinical trials should further define the clinical efficacy of MO to include it in care bundles as a new international standard.
Assuntos
Infecções Relacionadas a Cateter , Cateterismo Venoso Central , Cateteres Venosos Centrais , Infecções Relacionadas a Cateter/diagnóstico , Infecções Relacionadas a Cateter/prevenção & controle , Cateterismo Venoso Central/efeitos adversos , Cateteres Venosos Centrais/efeitos adversos , Criança , Atenção à Saúde , Humanos , Recém-Nascido , Unidades de Terapia Intensiva , Unidades de Terapia Intensiva Neonatal , Unidades de Terapia Intensiva Pediátrica , Terapia Intensiva NeonatalRESUMO
BACKGROUND: medical cannabis refers to the use of cannabis or cannabinoids as medical therapy to treat disease or alleviate symptoms. In the United States, 23 states and Washington DC (May 2015) have introduced laws to permit the medical use of cannabis. Within the European Union, medicinal cannabis laws and praxis vary wildly between Countries. OBJECTIVES: to provide evidence for benefits and harms of cannabis (including extracts and tinctures) treatment for adults in the following indications: control of spasticity and pain in patients with multiple sclerosis; control of pain in patients with chronic neuropathic pain; control of nausea and vomiting in adults with cancer receiving chemotherapy. METHODS: we searched the Cochrane Central Register of Controlled Trials, PubMed, and EMBASE from inception to September 2016. We also searched for on-going studies via ClinicalTrials.gov and the World Health Organization and International Clinical Trials Registry Platform (ICTRP) search portal. All searches included also non-English language literature. All relevant randomized controlled trials (RCTs) evaluating the safety and efficacy of cannabis (including extracts and tinctures) compared with placebo or other pharmacological agents were included. Three authors independently evaluated the titles and abstracts of studies identified in the literature searches for their eligibility. For studies considered eligible, we retrieved full texts. Three investigators independently extracted data. For the assessment of the quality of evidence, we used the standard methodological procedures recommended by Cochrane and GRADE working Group. RESULTS: 41 trials (4,550 participants) were included; 15 studies considered efficacy and safety of cannabis for patients with multiple sclerosis, 12 for patients with chronic pain, and 14 for patients with cancer receiving chemotherapy. The included studies were published between 1975 and 2015, and the majority of them were conducted in Europe. We judged almost 50% of these studies to be at low risk of bias. The large majority (80%) of the comparisons were with placebo; only 8 studies included patients with cancer receiving chemotherapy comparing cannabis with other antiemetic drugs. Concerning the efficacy of cannabis (compared with placebo) in patients with multiple sclerosis, confidence in the estimate was high in favour of cannabis for spasticity (numerical rating scale and visual analogue scale, but not the Ashworth scale) and pain. For chronic and neuropathic pain (compared with placebo), there was evidence of a small effect; however, confidence in the estimate is low and these results could not be considered conclusive. There is uncertainty whether cannabis, including extracts and tinctures, compared with placebo or other antiemetic drugs reduces nausea and vomiting in patients with cancer requiring chemotherapy, although the confidence in the estimate of the effect was low or very low. In the included studies, many adverse events were reported and none of the studies assessed the development of abuse or dependence. CONCLUSIONS: there is incomplete evidence of the efficacy and safety of medical use of cannabis in the clinical contexts considered in this review. Furthermore, for many of the outcomes considered, the confidence in the estimate of the effect was again low or very low. To give conclusive answers to the efficacy and safety of cannabis used for medical purposes in the clinical contexts considered, further studies are needed, with higher quality, larger sample sizes, and possibly using the same diagnostic tools for evaluating outcomes of interest.
Assuntos
Analgésicos/uso terapêutico , Antieméticos/uso terapêutico , Maconha Medicinal/uso terapêutico , Esclerose Múltipla/tratamento farmacológico , Neuralgia/tratamento farmacológico , Parassimpatolíticos/uso terapêutico , Fitoterapia , Adulto , Analgésicos/efeitos adversos , Antieméticos/efeitos adversos , Antineoplásicos/efeitos adversos , Canabinoides/efeitos adversos , Canabinoides/uso terapêutico , Ensaios Clínicos como Assunto , Estudos Cross-Over , Medicina Baseada em Evidências , Humanos , Hipnóticos e Sedativos/efeitos adversos , Hipnóticos e Sedativos/uso terapêutico , Itália , Maconha Medicinal/efeitos adversos , Esclerose Múltipla/complicações , Espasticidade Muscular/tratamento farmacológico , Espasticidade Muscular/etiologia , Náusea/induzido quimicamente , Náusea/tratamento farmacológico , Neoplasias/complicações , Neoplasias/tratamento farmacológico , Parassimpatolíticos/efeitos adversos , Fitoterapia/efeitos adversos , Extratos Vegetais/uso terapêutico , Distúrbios do Início e da Manutenção do Sono/tratamento farmacológico , Distúrbios do Início e da Manutenção do Sono/etiologia , Resultado do Tratamento , Vômito/induzido quimicamente , Vômito/tratamento farmacológicoRESUMO
BACKGROUND: Non-alcoholic fatty liver disease (NAFLD) is the most common hepatic disorder worldwide, reaching prevalence up to 90 % in obese patients with type 2 diabetes (T2D), and representing an independent risk factor for cardiovascular mortality. Furthermore, the coexistence of T2D and NAFLD leads to higher incidence of diabetes' complications and additive detrimental liver outcomes. The existence of a close association between NAFLD and hypovitaminosis D, along with the anti-inflammatory and insulin-sensitizing properties of vitamin D, have been largely described, but vitamin D effects on hepatic fat content have never been tested in a randomized controlled trial. We assessed the efficacy and safety of 24-week oral high-dose vitamin D supplementation in T2D patients with NAFLD. METHODS: This randomized, double-blind, placebo-controlled trial was carried out at the Diabetes Centre of Sapienza University, Rome, Italy, to assess oral treatment with cholecalciferol (2000 IU/day) or placebo in T2D patients with NAFLD. The primary endpoint was reduction of hepatic fat fraction (HFF) measured by magnetic resonance; as hepatic outcomes, we also investigated changes in serum transaminases, CK18-M30, N-terminal Procollagen III Propeptide (P3NP) levels, and Fatty Liver Index (FLI). Secondary endpoints were improvement in metabolic (fasting glycaemia, HbA1c, lipids, HOMA-IR, HOMA-ß, ADIPO-IR, body fat distribution) and cardiovascular (ankle-brachial index, intima-media thickness, flow-mediated dilatation) parameters from baseline to end of treatment. RESULTS: Sixty-five patients were randomized, 26 (cholecalciferol) and 29 (placebo) subjects completed the study. 25(OH) vitamin D significantly increased in the active treated group (48.15 ± 23.7 to 89.80 ± 23.6 nmol/L, P < 0.001); however, no group differences were found in HFF, transaminases, CK18-M30, P3NP levels or FLI after 24 weeks. Vitamin D neither changed the metabolic profile nor the cardiovascular parameters. CONCLUSIONS: Oral high-dose vitamin D supplementation over 24 weeks did not improve hepatic steatosis or metabolic/cardiovascular parameters in T2D patients with NAFLD. Studies with a longer intervention period are warranted for exploring the effect of long time exposure to vitamin D. TRIAL REGISTRATION: This trial was approved on July 2011 by the Ethics Committee of Policlinico Umberto I, Sapienza University of Rome, Italy, and registered at www.clinicaltrialsregister.eu number 2011-003010-17.
Assuntos
Colecalciferol/administração & dosagem , Diabetes Mellitus Tipo 2/complicações , Suplementos Nutricionais , Hepatopatia Gordurosa não Alcoólica/complicações , Administração Oral , Método Duplo-Cego , Feminino , Humanos , Itália , Masculino , Pessoa de Meia-Idade , Fatores de RiscoRESUMO
INTRODUCTION: Cardiovascular diseases (CVD) remain the biggest cause of disability and premature death throughout the world. AIM: The aim of this study was to describe and determine the prevalence of major cardiovascular risk factors emerged at the first medical examination carried out by a group of an oil and gas contractor company workers in the observation period 2000-2010. METHODS: An observational cross-sectional study was conducted on 1073 workers (mean age 41 years, SD = 9.5) presenting overweight BMI (body mass index) values, hypertension and cholesterol problems. RESULTS: In particular, we found that workers > 45 years had significant higher risk to have obesity (OR = 3.8, CI 95% = 2.5-5.7), hypertension (OR = 2.7, CI 95% = 2.1-3.6), high blood fasting glucose (OR = 2.6, CI 95% = 1.2-5.5), high cholesterol (OR = 2.7, CI 95% = 2.0-3.6), high triglycerides (OR = 1.8, CI 95% = 1.4-2.4) compared to younger (< 45 years).