External validation of Villalta score in high-middle income country patients with deep vein thrombosis.

ABSTRACT: Post-thrombotic syndrome (PTS) is a late complication that does not have a cure yet, with a prevalence estimated between 20 to 75%, associated with previous deep vein thrombosis event. Although the Villalta score (VS) is the gold-standard clinical tool for diagnostic and prognostic evaluation of PTS, there are currently no VS intra-rater agreement established and no validation studies for VS' application into Brazilian Portuguese. We sought to translate and validate VS reliability systematically; and, secondarily, to compare the ultrasound findings with the severity of PTS.We systematically translated the original VS into Brazilian Portuguese (BP). Fifty participants who underwent two outpatient visits were evaluated using the translated VS. We assessed its intra-rater and inter-rater agreement and compared BP VS versus CEAP clinical component (CEAP C), and the clinical PTS severity versus the duplex ultrasound (DUS) findings. The study and its report followed the Guidelines for Reporting Reliability and Agreement Studies.The intra-rater evaluation of VS grades had a simple Kappa coefficient of 0.73, and the simple Kappa coefficient inter-rater for VS grades was 0.67. When VS was compared to CEAP C, it established a remarkably high correlation over 0.9. There was difference among VS values compared to DUS initial deep vein thrombosis territory, with femoropopliteal showing higher values than distal veins. Higher VS values were correlated to DUS venous recanalization and reflux.There was a substantial inter-rater and intra-rater agreement when the BP VS was applied; and when compared to CEAP C, VS showed a high correlation. When VS grading was compared to DUS characteristics, there were significant statistical and clinical correlation, with presence of reflux and recanalization showing higher VS values. This external VS validation also changes the clinical practice allowing the VS use in a different population and establishes the VS intra-rater agreement.

Peripherally inserted central catheter versus central venous catheter for intravenous access: A protocol for systematic review and meta-analysis.

BACKGROUND: Since the first description of the central venous catheter (CVC) in 1952, it has been used for the rapid administration of drugs, chemotherapy, as a route for nutritional support, blood components, monitoring patients, or combinations of these. When CVC is used in the traditional routes (eg, subclavian, jugular, and femoral veins), the complication rates range up to 15% and are mainly due to mechanical dysfunction, infection, and thrombosis. The peripherally inserted central catheter (PICC) is an alternative option for CVC access. However, the clinical evidence for PICC compared to CVC is still under discussion. In this setting, this systematic review (SR) aims to assess the effects of PICC compared to CVC for intravenous access. METHODS: We will perform a comprehensive search for randomised controlled trials (RCTs), which compare PICC and traditional CVC for intravenous access. The search strategy will consider free text terms and controlled vocabulary (eg, MeSH and Entree) related to "peripherally inserted central venous catheter," "central venous access," "central venous catheter," "catheterisation, peripheral," "vascular access devices," "infusions, intravenous," "administration, intravenous," and "injections, intravenous." Searches will be carried out in these databases: MEDLINE (via PubMed), EMBASE (via Elsevier), Cochrane CENTRAL (via Wiley), IBECS, and LILACS (both via Virtual Health Library). We will consider catheter-related deep venous thrombosis and overall successful insertion rates as primary outcomes and haematoma, venous thromboembolism, reintervention derived from catheter dysfunction, catheter-related infections, and quality of life as secondary outcomes. Where results are not appropriate for a meta-analysis using RevMan 5 software (eg, if the data have considerable heterogeneity and are drawn from different comparisons), a descriptive analysis will be performed. RESULTS: Our SR will be conducted according to the Cochrane Handbook of Systematic Reviews of Interventions and the findings will be reported in compliance with PRISMA. CONCLUSION: Our study will provide evidence for the effects of PICC versus CVC for venous access. ETHICS AND DISSEMINATION: This SR has obtained formal ethical approval and was prospectively registered in Open Science Framework. The findings of this SR will be disseminated through peer-reviewed publications or conference presentations. REGISTRATION:: osf.io/xvhzf. ETHICAL APPROVAL: 69003717.2.0000.5505.

Early mobilization for children in intensive therapy: A protocol for systematic review and meta-analysis.

INTRODUCTION: Intensive care units focus primarily on life support and treatment of critically ill patients, but there are many survivors with complications, such as generalized muscle disorders, functional disability and reduced quality of life after hospital discharge, resulting from prolonged stays in these units. The current evidence suggests that early mobilization-based rehabilitation (exercise initiated immediately after the patient's significant physiological changes have stabilized) in critically ill adults can alleviate these complications from immobility and critical illness. However, there are a lack of practice guidelines, conflicting perceptions about safety, and knowledge gaps about benefits in the critically ill paediatric population. Therefore, we aim to assess the effects of early mobilization for children in intensive therapy. METHODS AND ANALYSIS: Systematic searches will be carried out in Medical Literature Analysis and Retrieval System Online, Excerpta Medica database, Cochrane Central Register of Controlled Trials, Latin American and Caribbean Centre on Health Sciences Information, Cumulative Index to Nursing & Allied Health Literature and physiotherapy evidence database databases at a minimum without date or language restrictions for relevant individual parallel, cross-over and cluster randomized controlled trials. In addition, a search will also be carried out in the World Health Organization International Clinical Trials Registry Platform, and in the clinical trial registries of ClinicalTrials.gov, looking for any on-going randomised controlled trials that compare early mobilization with any other type of intervention. Two review authors will independently perform data extraction and quality assessments of data from included studies, and any disagreements will be resolved by discussion or by arbitration. The primary outcomes will be mortality and adverse events. Secondary outcomes will include duration of critical care (days), duration of mechanical ventilation support, muscle strength, pain and neuropsychomotor development. The Cochrane handbook will be used for guidance. If the results are not appropriate for a meta-analysis in RevMan 5 software (e.g., if the data have considerable heterogeneity and are drawn from different comparisons), a descriptive analysis will be performed. ETHICS AND DISSEMINATION: This protocol was prospectively registered at Open Science Framework and approved by the Ethics and Research Committee of the Federal University of Sao Paulo (8543210519). We intend to update the public registry used in this review, report any important protocol amendments and publish the results in a widely accessible journal. REGISTRATION:: osf.io/ebju9.