Search results for "randomized controlled trials"

Statin therapy in patients with aortic stenosis after the ASTRONOMER trial: is there still any space?

2011

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…

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…

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…

Early Response to treatment in Eating Disorders: A Systematic Review and a Diagnostic Test Accuracy Meta-Analysis

2016

Objective: Early response to eating disorders treatment is thought to predict a later favourable outcome. A systematic review of the literature and meta-analyses examined the robustness of this concept. Method: The criteria used across studies to define early response were summarised following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Diagnostic Test Accuracy methodology was used to estimate the size of the effect. Results: Findings from 24 studies were synthesized and data from 14 studies were included in the meta-analysis. In Anorexia Nervosa, the odds ratio of early response predicting remission was 4.85(95%CI: 2.94–8.01) and the summary Area Unde…

[Choosing a quality-of-life questionnaire].

2006

International audience; Define the objective of the questionnaire: Discrimination: do you want a questionnaire to enable you to describe the quality of life of patients or to compare the quality of life between groups of patients, for example, to determine who has improved and who has gotten worse? Assessment: do you want a questionnaire to help you measure changes over time (improvement or aggravation) in your patients? Determine the properties of instruments necessary for this objective: If the objective is discrimination, analyze: construct validity, reliability. If the objective is assessment, analyze construct validity, sensitivity to changes. Choose the general category of questionnai…

The Artificial Kidney Initiation in Kidney Injury 2 (AKIKI2): study protocol for a randomized controlled trial

2019

Abstract Background The Artificial Kidney Initiation in Kidney Injury (AKIKI) trial showed that a delayed renal replacement therapy (RRT) strategy for severe acute kidney injury (AKI) in critically ill patients was safe and associated with major reduction in RRT initiation compared with an early strategy. The five criteria which mandated RRT initiation in the delayed arm were: severe hyperkalemia, severe acidosis, acute pulmonary edema due to fluid overload resulting in severe hypoxemia, serum urea concentration > 40 mmol/l and oliguria/anuria > 72 h. However, duration of anuria/oliguria and level of blood urea are still criteria open to debate. The objective of the study is to compar…

A central nervous system-focused treatment approach for people with frozen shoulder: protocol for a randomized clinical trial

2019

Background: Frozen shoulder (FS) is a musculoskeletal condition of poorly understood etiology that results in shoulder pain and large mobility deficits. Despite some physical therapy interventions, such as joint mobilization and exercise, having shown therapeutic benefit, a definitive treatment does not currently exist. The aim of this study will be to compare the effectiveness of a central nervous system (CNS)-directed treatment program versus a standard medical and physical therapy care program on outcomes in participants with FS. Methods/design: The study is a two-group, randomized clinical trial with blinding of participants and assessors. Participants will be recruited via referrals fr…