Blood pressure variability and outcome after acute intracerebral haemorrhage: a post-hoc analysis of INTERACT2, a randomised controlled trial

The Lancet Neurology, Early Online Publication, 13 February 2014 Background High blood pressure is a prognostic factor for acute stroke, but blood pressure variability might also independently predict outcome. We assessed the prognostic value of blood pressure variability in participants of INTERACT2, an open-label randomised controlled trial (ClinicalTrials.gov number NCT00716079). Methods INTERACT2 enrolled 2839 adults with spontaneous […]

Analysis of early phase and subsequent phase III stroke studies of neuroprotectants: outcomes and predictors for success

Experimental & Translational Stroke Medicine: February 7, 2014 Background Efficacy of neuroprotective treatments for ischemic stroke was not convincingly demonstrated in clinical phase III trials so far, whereas some preceding early phase studies found neuroprotection to be beneficial. We aimed to determine the frequency with which phase III studies are preceded by positive early phase studies, […]

Effect of a Novel Video Game on Stroke Knowledge of 9- to 10-Year-Old, Low-Income Children

STROKEAHA: January 30, 2014 Background and Purpose—Improving actionable stroke knowledge of a witness or bystander, which in some cases are children, may improve response to an acute stroke event. Methods—We used a quasiexperimental pre-test post-test design to evaluate actionable stroke knowledge of 210 children aged 9 to 10 years in response to a single, 15-minute exposure […]

Hemicraniectomy and Durotomy Upon Deterioration From Infarction-Related Swelling Trial

STROKEAHA: January 14, 2014 Background and Purpose—Hemicraniectomy and Durotomy Upon Deterioration From Infarction-Related Swelling Trial (HeADDFIRST) was a randomized pilot study to obtain information necessary to design a Phase III trial to evaluate the benefit of surgical decompression for brain swelling from large supratentorial cerebral hemispheric infarction. Methods—All patients with stroke were screened for eligibility (age […]

Polypills: Essential Medicines for Cardiovascular Disease Secondary Prevention?

JACC: February 2014 In 1977, the World Health Organization (WHO) developed its first Model List of Essential Medicines to guide countries in the creation of national formularies and policies for access, quality, and use of essential medicines as part of achieving the right to health. In 2012, the WHO announced its goal of reducing the number […]

Radiofrequency Ablation vs Antiarrhythmic Drugs as First-Line Treatment of Paroxysmal Atrial Fibrillation (RAAFT-2) A Randomized Trial

JAMA: 2/19/14 Importance  Atrial fibrillation (AF) is the most common rhythm disorder seen in clinical practice. Antiarrhythmic drugs are effective for reduction of recurrence in patients with symptomatic paroxysmal AF. Radiofrequency ablation is an accepted therapy in patients for whom antiarrhythmic drugs have failed; however, its role as a first-line therapy needs further investigation. Objective  To compare […]

Simulating sequential multiple assignment randomized trials to generate optimal personalized warfarin dosing strategies

Clin Trials: January 24, 2014 Background Due to the cost and complexity of conducting a sequential multiple assignment randomized trial (SMART), it is desirable to pre-define a small number of personalized regimes to study. Purpose We proposed a simulation-based approach to studying personalized dosing strategies in contexts for which a therapeutic agent’s pharmacokinetic and pharmacodynamics properties are well […]

Target Indices for Clinical Ablation in Atrial Fibrillation Insights From Contact Force, Electrogram, and Biophysical Parameter Analysis

CIRCEP: January 18, 2014 Background—In animal studies of radiofrequency ablation, lesion sizes plateau as the maximum lesion size is reached for an ablation. Lesion parameters are not available in clinical ablations, but preclinical work suggests that these correlate with impedance drop and electrogram attenuation. Characterization of the relationships between catheter contact force, ablation duration, and these […]

Using Internally Developed Risk Models to Assess Heterogeneity in Treatment Effects in Clinical Trials

CIRCOUTCOMES: January 14, 2014 Background—Recent proposals suggest that risk-stratified analyses of clinical trials be routinely performed to better enable tailoring of treatment decisions to individuals. Trial data can be stratified using externally developed risk models (eg, Framingham risk score), but such models are not always available. We sought to determine whether internally developed risk models, developed […]

Primer on Statistical Interpretation or Methods Informed Choice of Composite End Points in Cardiovascular Trials

CIRCOUTCOMES: January 14, 2014 A composite end point is often used as the primary end point to assess the efficacy of a new treatment in randomized clinical trials. In cardiovascular trials, the often rare event of the relevant primary end point (individual or composite), such as cardiovascular death, myocardial infarction, or both, is combined with a […]

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