271 research outputs found
Recruitment to publicly funded trials - are surgical trials really different?
Good recruitment is integral to the conduct of a high-quality randomised controlled trial. It has been suggested that recruitment is particularly difficult for evaluations of surgical interventions, a field in which there is a dearth of evidence from randomised comparisons. While there is anecdotal speculation to support the inference that recruitment to surgical trials is more challenging than for medical trials we are unaware of any formal assessment of this. In this paper, we compare recruitment to surgical and medical trials using a cohort of publicly funded trials. Data: Overall recruitment to trials was assessed using of a cohort of publicly funded trials (n = 114). Comparisons were made by using the Recruitment Index, a simple measure of recruitment activity for multicentre randomised controlled trials. Recruitment at the centre level was also investigated through three example surgical trials. Results: The Recruitment Index was found to be higher, though not statistically significantly, in the surgical group (n = 18, median = 38.0 IQR (10.7, 77.4)) versus (n = 81, median = 34.8 IQR (11.7, 98.0)) days per recruit for the medical group (median difference 1.7 (− 19.2, 25.1); p = 0.828). For the trials where the comparison was between a surgical and a medical intervention, the Recruitment Index was substantially higher (n = 6, 68.3 (23.5, 294.8)) versus (n = 93, 34.6 (11.7, 90.0); median difference 25.9 (− 35.5, 221.8); p = 0.291) for the other trials. Conclusions: There was no clear evidence that surgical trials differ from medical trials in terms of recruitment activity. There was, however, support for the inference that medical versus surgical trials are more difficult to recruit to. Formal exploration of the recruitment data through a modelling approach may go some way to tease out where important differences exist.The first author was supported by a Medical Research Council UK Fellowship.Peer reviewedAuthor versio
Influence of anterior mitral valve length and septal wall thickness on the prevalence of left ventricular outflow tract obstruction in hypertrophic cardiomyopathy
The relationship between the Dark Triad and attitudes towards feminism
The Dark Triad traits are considered a male-centric framework of personality with women generally scoring lower on narcissism, Machiavellianism, and psychopathy. Research has examined the drivers behind this relationship attributing effects mostly to biological or evolutionary reasons with less work understanding environmental factors. To date, no research has examined the relationship between the Dark Triad and attitudes towards feminism. Three hundred and forty-three participants completed self-report measures of the Dark Triad and feminist attitudes. Results reported no differences between men and women on feminist attitudes, but men scored higher on the Dark Triad. Multiple linear regression indicated a negative association between the Dark Triad and feminist attitudes with all three traits significantly negatively contributing to the model. In all cases, this effect was stronger in men. These findings suggest that whilst men and women hold similar feminist attitudes, Dark Triad traits may facilitate a disregard for feminism
Intra-thoracic fat volume is associated with myocardial infarction in patients with metabolic syndrome
Background: Visceral adiposity is increased in those with Metabolic Syndrome (MetS) and atherosclerotic disease burden. In this study we evaluate for associations between intra-thoracic fat volume (ITFV) and myocardial infarction (MI) in patients with MetS. Methods. Ninety-four patients with MetS, MI or both were identified from a cardiovascular CMR clinical registry. MetS was defined in accordance to published guidelines; where-as MI was defined as the presence of subendocardial-based injury on late gadolinium enhancement imaging in a coronary vascular distribution. A healthy control group was also obtained from the same registry. Patients were selected into the following groups: MetS+/MI- (N = 32), MetS-/MI + (N = 30), MetS+/MI + (N = 32), MetS-/MI- (N = 16). ITFV quantification was performed using signal threshold analysis of sequential sagittal CMR datasets (HASTE) and indexed to body mass index. Results: The mean age of the population was 59.8 ± 12.5 years. MetS+ patients (N=64) demonstrated a significantly higher indexed ITFV compared to MetS- patients (p = 0.05). Patients in respective MetS-/MI-, MetS+/MI-, MetS-/MI+, and MetS+/MI + study groups demonstrated a progressive elevation in the indexed ITFV (22.3 ± 10.6, 28.6 ± 12.6, 30.6 ± 12.3, and 35.2 ± 11.4 ml/kg/m2, (p = 0.002)). Among MetS+ patients those with MI showed a significantly higher indexed ITFV compared to those without MI (p = 0.02). Conclusions: ITFV is elevated in patients with MetS and incrementally elevated among those with evidence of prior ischemic myocardial injury. Accordingly, the quantification of ITFV may be a valuable marker of myocardial infarction risk among patients with MetS and warrants further investigation. © 2013 Jolly et al.; licensee BioMed Central Ltd
Clinical feasibility of targeted cardiac resynchronization lead delivery using a 3D MRI cardiac model
Delayed enhancement cardiac magnetic resonance imaging predicts future arrhythmic events in primary prevention ICD candidates irrespective of ischemic or non-ischemic etiology
The challenges faced in the design, conduct and analysis of surgical randomised controlled trials
Randomised evaluations of surgical interventions are rare; some interventions have been widely
adopted without rigorous evaluation. Unlike other medical areas, the randomised controlled trial
(RCT) design has not become the default study design for the evaluation of surgical interventions.
Surgical trials are difficult to successfully undertake and pose particular practical and methodological challenges. However, RCTs have played a role in the assessment of surgical innovations and there is scope and need for greater use. This article will consider the design, conduct and analysis of an RCT of a surgical intervention. The issues will be reviewed under three
headings: the timing of the evaluation, defining the research question and trial design issues.
Recommendations on the conduct of future surgical RCTs are made. Collaboration between
research and surgical communities is needed to address the distinct issues raised by the assessmentof surgical interventions and enable the conduct of appropriate and well-designed trials.The Health Services Research Unit is funded by the Scottish Government Health DirectoratesPeer reviewedPublisher PD
Paced segment characteristics predict clinical response to cardiac resynchronization therapy: results from the multimodality imaging assessment of pacing intervention in heart failure (MAPIT-HF) study
Conformation and dynamics of human urotensin II and urotensin related peptide in aqueous solution
Conformation
and dynamics of the vasoconstrictive peptides human
urotensin II (UII) and urotensin related peptide (URP) have been investigated
by both unrestrained and enhanced-sampling molecular-dynamics (MD)
simulations and NMR spectroscopy. These peptides are natural ligands
of the G-protein coupled urotensin II receptor (UTR) and have been
linked to mammalian pathophysiology. UII and URP cannot be characterized
by a single structure but exist as an equilibrium of two main classes
of ring conformations, <i>open</i> and <i>folded</i>, with rapidly interchanging subtypes. The <i>open</i> states
are characterized by turns of various types centered at K<sup>8</sup>Y<sup>9</sup> or F<sup>6</sup>W<sup>7</sup> predominantly with no
or only sparsely populated transannular hydrogen bonds. The <i>folded</i> conformations show multiple turns stabilized by highly
populated transannular hydrogen bonds comprising centers F<sup>6</sup>W<sup>7</sup>K<sup>8</sup> or W<sup>7</sup>K<sup>8</sup>Y<sup>9</sup>. Some of these conformations have not been characterized previously.
The equilibrium populations that are experimentally difficult to access
were estimated by replica-exchange MD simulations and validated by
comparison of experimental NMR data with chemical shifts calculated
with density-functional theory. UII exhibits approximately 72% <i>open</i>:28% <i>folded</i> conformations in aqueous
solution. URP shows very similar ring conformations as UII but differs
in an <i>open:folded</i> equilibrium shifted further toward <i>open</i> conformations (86:14) possibly arising from the absence
of folded N-terminal tail-ring interaction. The results suggest that
the different biological effects of UII and URP are not caused by
differences in ring conformations but rather by different interactions
with UTR
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