Search results for "Randomized Controlled Trial"

2013

Background: Nonpharmacological secondary prevention of coronary heart disease is considered a safe and effective measure to substantially reduce mortality. Despite the effectiveness of lifestyle changes, the compliance rate of patients is very low mainly due to psychosocial barriers. Psychotherapeutic approaches that address how persons think about themselves and their behaviors appear to have a significant potential for improving health behavior. Methods/design: Against this background, our study aims to examine the feasibility and effects of a Psychodynamic Motivation and Training program (PMT) as compared to one session of advice in exercise training (EX) and treatment as usual (TAU). Fo…

The Effects of Using High-Fidelity Simulation in Undergraduate Nursing Education: A Multicenter Randomized Controlled Trial with a Process Evaluation

2021

Abstract The overall aim of this study was to examine the effects of a high-fidelity simulation on the knowledge and self-confidence of a total of 177 undergraduate nursing students in recognizing and responding to hypovolemia. A randomized experimental pre- and post-test research design with a process evaluation was employed. A significantly larger proportion of students in the intervention group than in the control group increased the number of correct responses in their knowledge and levels of self-confidence postintervention. As enablers for the successful implementation of the intervention, a need for a safe environment, fidelity, and learning in different roles were identified.

SEQUENTIALLY ADJUSTED RANDOMIZATION TO FORCE BALANCE IN CONTROLLED TRIALS WITH UNKNOWN PREVALENCE OF COVARIATES: APPLICATION TO ALCOHOLISM RESEARCH

2005

In treatment outcome studies with small to medium sample sizes (n200), the balance of groups with regard to important factors, which sometimes occur at low prevalence, is indispensable for adequate interpretation. This study tested a method for use in clinical alcoholism research, an uncomplicated procedure for satisfactory randomization of patients to different treatments, taking into account relevant background variables.An easily applicable modification of Efron's biased coin method for the randomization of treatments within strata of unknown but low prevalence was compared with the original approach and alternative methods by computer simulation (10,000 runs). An application example for…

Covariate-constrained Randomization Routine for Achieving Baseline Balance in Cluster-randomized Trials

2017

In cluster-randomized trials, groups or clusters of individuals, rather than individuals themselves, are randomly allocated to intervention or control. In this article, we describe a new command, ccrand, that implements a covariate-constrained randomization procedure for cluster-randomized trials. It can ensure balance of one or more baseline covariates between trial arms by restriction to allocations that meet specified balance criteria. We provide a brief overview of the theoretical background, describe ccrand and its options, and illustrate it using an example.

Exercise training improves peak oxygen consumption and hemodynamics in patients with pulmonary hypertension – A prospective, randomized, controlled t…

2016

Aims: This prospective randomized controlled study investigates the effects of exercise training on peak VO 2 /kg, hemodynamics and further clinically relevant parameters in pulmonary hypertension (PH) patients. Methods: Eighty-seven patients with pulmonary arterial hypertension and inoperable chronic thromboembolic PH (54% female, 56±15years, 84% WHO functional class III/IV, 53% combination therapy) on stable disease-targeted medication were randomly assigned to a control and training group. Medication remained unchanged during the study period. Non-invasive assessments and right heart catheterization at rest and during exercise were performed at baseline and after 15 weeks. Primary endpoi…

Liver failure after partial hepatic resection: definition, pathophysiology, risk factors and treatment

2008

Liver failure is a dreaded and often fatal complication that sometimes follows a partial hepatic resection. This article reviews the definition, incidence, pathogenesis, risk factors, risk assessment, prevention, clinical features and treatment of post-resectional liver failure (PLF). A systematic, computerized search was performed using key words related to 'partial hepatic resection' and 'liver failure' to review most relevant literature about PLF published in the last 20 years. The reported incidence of PLF ranges between 0.7 and 9.1%. An inadequate quantity or quality of residual liver mass are key events in its pathogenesis. Major risk factors are the presence of comorbid conditions, p…

The impact of deep vein thrombosis in critically ill patients: a meta-analysis of major clinical outcomes

2015

Background. Critically ill patients appear to be at high risk of developing deep vein thrombosis (DVT) and pulmonary embolism during their stay in the intensive care unit (ICU). However, little is known about the clinical course of venous thromboembolism in the ICU setting. We therefore evaluated, through a systematic review of the literature, the available data on the impact of a diagnosis of DVT on hospital and ICU stay, duration of mechanical ventilation and mortality in critically ill patients. We also tried to determine whether currently adopted prophylactic measures need to be revised and improved in the ICU setting. Materials and methods. MEDLINE and EMBASE databases were searched up…

Is routine second-look endoscopy effective after endoscopic hemostasis in acute peptic ulcer bleeding? A meta-analysis

2012

Background Routine second-look endoscopy in modern-era peptic ulcer bleeding (PUB) remains controversial. Objective To assess the effectiveness of routine second-look endoscopy in patients with PUB exhibiting high-risk stigmata after standard medical care and endoscopic therapy. Design Comprehensive literature searches (1990-2011) were performed, seeking randomized trials comparing a routine with an as-needed second endoscopy. Main Outcome Measurements The main outcome was rebleeding. Secondary outcomes were surgery and mortality. Subanalyses assessed the influence of study quality, rebleeding definitions, endoscopic hemostasis modality, and proton pump inhibitor (PPI) therapies. Analyses w…

Rivaroxaban in Peripheral Artery Disease after Revascularization

2020

Abstract Background Patients with peripheral artery disease who have undergone lower-extremity revascularization are at high risk for major adverse limb and cardiovascular events. The efficacy and ...

Small-diameter titanium Grade IV and titanium-zirconium implants in edentulous mandibles: three-year results from a double-blind, randomized controll…

2015

OBJECTIVE: The aim of this study was to compare crestal bone-level changes, soft tissue parameters and implant success and survival between small-diameter implants made of titanium/zirconium (TiZr) alloy or of Grade IV titanium (Ti) in edentulous mandibles restored with removable overdentures. MATERIALS AND METHODS: This was a randomized, controlled, double-blind, split-mouth multicenter clinical trial. Patients with edentulous mandibles received two Straumann bone-level implants (diameter 3.3 mm), one of Ti Grade IV (control) and one of TiZr (test), in the interforaminal region. Implants were loaded after 6-8 weeks and removable Locator-retained overdentures were placed within 2 weeks of l…