Search results for "Randomized controlled"
showing 10 items of 2220 documents
Power of the Wilcoxon–Mann–Whitney test for non‐inferiority in the presence of death‐censored observations
2017
In clinical trials with patients in a critical state, death may preclude measurement of a quantitative endpoint of interest, and even early measurements, for example for intention-to-treat analysis, may not be available. For example, a non-negligible proportion of patients with acute pulmonary embolism will die before 30 day measurements on the efficacy of thrombolysis can be obtained. As excluding such patients may introduce bias, alternative analyses, and corresponding means for sample size calculation are needed. We specifically consider power analysis in a randomized clinical trial setting in which the goal is to demonstrate noninferiority of a new treatment as compared to a reference t…
Assessing covariate imbalance in meta-analysis studies.
2010
The main goal of meta-analysis is to combine data across studies or data sets to obtain summary estimates. In this paper, the novelty is to propose a statistical tool to assess a possible covariate imbalance in baseline variables to investigate similarity of trials. We conducted the detection of the covariate imbalance, first, through some graphical comparison of the empirical cumulative distribution functions or ECDFs, which are built by putting together arms or trials according to some risk factor, and second, through some non-parametric tests such as the Kolmogorov–Smirnov and the Anderson–Darling tests. To overcome the huge presence of ties, we conducted the statistical tests on perturbe…
Test and power considerations for multiple endpoint analyses using sequentially rejective graphical procedures
2009
A variety of powerful test procedures are available for the analysis of clinical trials addressing multiple objectives, such as comparing several treatments with a control, assessing the benefit of a new drug for more than one endpoint, etc. However, some of these procedures have reached a level of complexity that makes it difficult to communicate the underlying test strategies to clinical teams. Graphical approaches have been proposed instead that facilitate the derivation and communication of Bonferroni-based closed test procedures. In this paper we give a coherent description of the methodology and illustrate it with a real clinical trial example. We further discuss suitable power measur…
Sample size in cluster-randomized trials with time to event as the primary endpoint
2011
In cluster-randomized trials, groups of individuals (clusters) are randomized to the treatments or interventions to be compared. In many of those trials, the primary objective is to compare the time for an event to occur between randomized groups, and the shared frailty model well fits clustered time-to-event data. Members of the same cluster tend to be more similar than members of different clusters, causing correlations. As correlations affect the power of a trial to detect intervention effects, the clustered design has to be considered in planning the sample size. In this publication, we derive a sample size formula for clustered time-to-event data with constant marginal baseline hazards…
Short implants (8mm) versus longer implants (≥8mm) with lateral sinus floor augmentation in posterior atrophic maxilla: A meta-analysis of RCT`s in h…
2019
Background One of the greatest challenges that dentists face today is to rehabilitate severe atrophied alveolar ridges in partially and completely edentulous patients with implants. Despite the high survival rate of implants placed next to sinus elevation, this technique presents complications that can be avoided by placing short implants, an option that also presents high survival rates. For this reason, the aim of this study is to compare the survival rate, marginal bone loss and complications associated with short implants (<8 mm) versus longer implants (≥8mm) placed with lateral sinus floor elevation in posterior atrophic maxillae. Material and Methods A literature search was conducted …
Stroke subtypes and their possible implication in stroke prevention drug strategies
2014
Thrombotic strokes can affect large or small arteries in the brain. Drugs to prevent atherosclerosis complication such as thrombotic strokes, should be drugs able to prevent the accumulation of intravascular fat, reduce vascular proliferation, decrease blood pressure levels with the resulting shear stress, reduce platelet aggregation, and possibly partially or totally reverse carotid plaques. Any of the commonly used antihypertensive drugs lower the incidence of stroke, with larger reductions in BP resulting in larger reductions in risk. Experimental and clinical data suggest that reducing the activity of the renin-angiotensin aldosterone system (RAAS) may have beneficial effects beyond the…
Everolimus eluting bioresorbable vascular scaffolds in patients with acute coronary syndromes: Two‐year results from the German‐Austrian ABSORB regis…
2021
Abstract Objectives To identify potential differences in 2‐year outcome between patients who underwent coronary revascularization using bioresorbable vascular scafffolds (BVS) in stable coronary artery disease (CAD) and acute coronary syndromes (ACS). Background Data from randomized trials suggest a significantly higher event rate following coronary revascularization using everolimus‐eluting BVS as compared to new generation drug eluting stents. Whether particular patient subgroups are at increased risk for scaffold thrombosis and target lesion failure (TLF) has not clearly been demonstrated. Methods German‐Austrian ABSORB RegIstRy is a prospective all‐comer multi‐center observational study…
Effectiveness of Technology-Based Distance Physical Rehabilitation Interventions for Improving Physical Functioning in Stroke: A Systematic Review an…
2019
OBJECTIVE: To study the effectiveness of technology-based distance physical rehabilitation interventions on physical functioning in stroke. DATA SOURCES: A systematic literature search was conducted in 6 databases from January 2000 to May 2018. STUDY SELECTION: Inclusion criteria applied the patient, intervention, comparison, outcome, study design framework as follows: (P) stroke; (I) technology-based distance physical rehabilitation interventions; (C) any comparison without the use of technology; (O) physical functioning; (S) randomized controlled trials (RCTs). The search identified in total 693 studies, and the screening of 162 full-text studies revealed 13 eligible studies. DATA EXTRACT…
Comparison of GTR, T-PRF and open-flap debridement in the treatment of intrabony defects with endo-perio lesions : a randomized controlled trial
2019
Background Titanium- prepared platelet rich fibrin (T-PRF) is an autologous hemo-component with a high concentration of platelets that also incorporates leukocytes, and growth factors into the dense fibrin matrix and can be used as a healing biomaterial. This study assesses the adjunctive use of T-PRF in intrabony defects (IBDs) with open flap debridement (OFD) in comparison with guided tissue regeneration (GTR) as a gold standard and OFD alone as a control. Material and Methods A total of 45 patients (15 per group) were randomized as either T-PRF (test group), GTR (test group), or OFD alone (control group) sites. Probing depth (PD), clinical attachment level (CAL), and IBD were recorded. T…
Methods for evaluating causality in observational studies.
2019
BACKGROUND: In clinical medical research, causality is demonstrated by randomized controlled trials (RCTs). Often, however, an RCT cannot be conducted for ethical reasons, and sometimes for practical reasons as well. In such cases, knowledge can be derived from an observational study instead. In this article, we present two methods that have not been widely used in medical research to date. METHODS: The methods of assessing causal inferences in observational studies are described on the basis of publications retrieved by a selective literature search. RESULTS: Two relatively new approaches—regression-discontinuity methods and interrupted time series—can be used to demonstrate a causal relat…