958 results match your criteria: "Robertson Centre for Biostatistics[Affiliation]"

Myocardial ischaemia following COVID-19: a cardiovascular magnetic resonance study.

Int J Cardiovasc Imaging

December 2024

Institute of Cardiovascular and Metabolic Medicine, University of Leeds, and Leeds Teaching Hospitals NHS Trust, Leeds, UK.

The pathophysiology of myocardial injury following COVID-19 remains uncertain. COVID-HEART was a prospective, multicentre study utilising cardiovascular magnetic resonance (CMR) to characterise COVID-related myocardial injury. In this pre-specified analysis, the objectives were to examine (1) the frequency of myocardial ischaemia following COVID-19, and (2) the association between ischaemia and myocardial injury.

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Operator Characteristics and Reintervention Following Pacemaker Implant - Insights From A National Database.

Heart Rhythm

December 2024

Department of Cardiology, King's College Hospital NHS Foundation Trust, London, UK; King's British Heart Foundation Centre of Research Excellence, School of Cardiovascular and Metabolic Medicine & Sciences, King's College London, London, UK; National Institute for Cardiovascular Outcomes Research (NICOR), NHS Arden & GEM Commissioning Support Unit, Leicester, UK.

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Aims: Iron deficiency (ID) is highly prevalent in patients with heart failure (HF) and associated with morbidity and poor prognosis, but pathophysiological mechanisms are unknown. We aimed to identify novel biological pathways affected by ID.

Methods And Results: We studied 881 patients with HF from the BIOSTAT-CHF cohort.

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Effect of IV Thrombolysis With Alteplase in Patients With Vessel Occlusion in the WAKE-UP Trial.

Neurology

January 2025

From the Center for Stroke Research Berlin (I.G., J.B.F.), Charité-Universitätsmedizin Berlin, Germany; Service de Biostatistique (F.B., P.R.), Hospices Civils de Lyon, France; Department of Neurology (B.C., C.G., G.T.), University Medical Center Hamburg-Eppendorf, France; Department of Stroke Medicine (T.-H.C.), Université Claude Bernard Lyon 1, Hospices Civils de Lyon, France; Neurologie der Rehaklinik Medical Park Humboldtmühle (M. Ebinger), Berlin; Klinik und Hochschulambulanz für Neurologie (M. Endres), Charité-Universitätsmedizin Berlin; Center for Stroke Research Berlin (M. Endres); German Center for Neurodegenerative Diseases (DZNE), partner site Berlin (M. Endres); German Centre for Cardiovascular Research (DZHK), partner site Berlin (M. Endres); German Center for Mental Health (DZPG), partner site Berlin (M. Endres), Germany; Department of Neurology (C.E.), Medical University of Graz, Austria; Department of Diagnostic and Interventional Neuroradiology (J.F.), Universitätsklinikum Hamburg-Eppendorf, Germany; Robertson Centre for Biostatistics (I.F.), University of Glasgow, Scotland; mediri GmbH (J.G.); Fraunhofer Institute for Digital Medicine MEVIS (M.G.), Bremen, Germany; Department of Neurosciences (R.L., A.W.), Experimental Neurology, KU Leuven-University of Leuven, Belgium; School of Psychology & Neuroscience (K.W.M.), University of Glasgow, Scotland; Department of Stroke Medicine (N.N.), Université Claude Bernard Lyon 1, and Hospices Civils de Lyon, France; Department of Neurology (C.Z.S.), Aarhus University Hospital, Denmark; Florey Institute of Neuroscience and Mental Health (V.N.T.), Heidelberg, Australia; and Institut d'Investigació Biomèdica de Girona (S.P.), Hospital Universitari Doctor Josep Trueta, Girona, Spain.

Background And Objectives: Data from randomized trials on the treatment effect of pure thrombolysis in patients with vessel occlusion are lacking. We examined data from a corresponding subsample of patients from the multicenter, randomized, placebo-controlled WAKE-UP trial to determine whether MRI-guided IV thrombolysis with alteplase in unknown-onset ischemic stroke benefits patients presenting with vessel occlusion.

Methods: Patients with an acute ischemic lesion visible on MRI diffusion-weighted imaging but no marked parenchymal hyperintensity on fluid-attenuated inversion recovery images were randomized to treatment with IV alteplase or placebo.

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While digital cardiac rehabilitation (CR) is an effective alternative to center-based CR, its components and mechanisms of change remain poorly understood. The Multiphase Optimization Strategy (MOST) provides a framework that allows the effects of individual components of complex interventions to be studied. There is limited guidance within MOST on how to develop a conceptual model.

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Aims: Patients with a reduced left ventricular ejection fraction (LVEF) following an acute myocardial infarction (MI) are considered to be at risk of progressive adverse cardiac remodelling which can lead to the development of heart failure and death. The early addition of a sodium-glucose cotransporter 2 (SGLT2) inhibitor to standard treatment may delay or prevent progressive adverse remodelling in these patients.

Methods And Results: We performed a randomized, double-blind, placebo-controlled, multicentre trial using cardiovascular magnetic resonance imaging (MRI), in patients with left ventricular systolic dysfunction following MI.

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Article Synopsis
  • The study aims to use machine learning clustering to categorize distinct patient types among those with ischaemic heart failure and reduced ejection fraction (HFrEF) to improve personalized treatment approaches.
  • Analysis of 8,591 HFrEF patients revealed five unique clusters based on clinical and biological traits, with varying risks for hospitalization and death, highlighting the need for tailored management strategies.
  • The findings indicate that specific clusters correlate with different outcomes, suggesting that treatments like mineralocorticoid receptor antagonists may be more beneficial for certain patient groups, ultimately enhancing patient care in the future.
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Natriuresis-Guided Diuresis in Patients Admitted to Hospital With Heart Failure: Barking up the Wrong Tree?

J Card Fail

December 2024

Department of Cardiology, Hull University Teaching Hospitals NHS Trust, Castle Hill Hospital, Cottingham, Kingston-Upon-Hull, East Riding of Yorkshire, HU16 5JQ, UK.

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Background: The Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement has improved the quality of reporting of randomised trial protocols. Extensions to the SPIRIT statement are needed to address specific issues of trial protocol reporting, including those relevant to particular types of interventions. Methodological and reporting deficiencies in protocols of clinical trials of implantable neurostimulation devices are common.

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Reporting guidelines for randomised controlled trial reports of implantable neurostimulation devices: the CONSORT-iNeurostim extension.

EClinicalMedicine

December 2024

MRC/CSO Social and Public Health Sciences Unit & Robertson Centre for Biostatistics, Institute of Health and Well Being, University of Glasgow, Glasgow, UK.

Background: The Consolidated Standards of Reporting Trials (CONSORT) statement has improved the quality of reporting of randomised trials. Extensions to the CONSORT statement are often needed to address specific issues of trial reporting, including those relevant to particular types of interventions. Methodological and reporting deficiencies in clinical trials of implantable neurostimulation devices are common.

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Article Synopsis
  • The study investigates the link between atherosclerosis (plaque buildup in arteries) and types of myocardial ischemia (insufficient blood flow to the heart) in patients without significant coronary artery blockage (INOCA).
  • It employs advanced invasive tests to assess coronary microvascular function and quantifies plaque burden using the Gensini score, which takes into account the severity of artery blockage.
  • Findings reveal that higher Gensini scores correlate with poorer microvascular function, and different INOCA endotypes (like microvascular angina and vasospastic angina) show variations in plaque scores, indicating the complexity of heart conditions in patients without obvious artery blockage.
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Background: Physical rehabilitation may improve health and wellbeing outcomes for some adults living with long COVID. However, individuals living with pre-existing multiple long-term conditions (MLTCs) and long COVID may have additional rehabilitation challenges. This scoping review aims to identify the available evidence describing physical rehabilitation interventions for adults living with long COVID, to systematically map the reporting of pre-existing MLTCs, and to describe the characteristics of physical rehabilitation interventions used in adults with both pre-existing long-term conditions (LTCs) and long COVID.

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Background: Frailty is of increasing interest in trials, either as a target of intervention, as an outcome or as a potential treatment modifier. However, frailty measurement is often highly variable. This scoping review assessed how frailty is quantified in randomised controlled trials (RCTs), in what context and for what purposes.

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Aims: Concerns exist that intravenous (IV) iron might increase the risk of infections. The IRONMAN trial provided an opportunity to investigate whether giving IV ferric derisomaltose (FDI) to patients with heart failure and iron deficiency alters the rate of hospitalization or death due to infections.

Methods And Results: IRONMAN was a randomized trial of IV FDI versus usual care in patients with symptomatic heart failure, left ventricular ejection fraction (LVEF) ≤45%, and transferrin saturation (TSAT) <20% or ferritin <100 μg/L.

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Adjudication of Hospitalizations and Deaths in the IRONMAN Trial of Intravenous Iron for Heart Failure.

J Am Coll Cardiol

October 2024

Department of Cardiology, Portsmouth Hospitals University NHS Trust, Portsmouth, United Kingdom; Faculty of Science and Health, University of Portsmouth, Portsmouth, United Kingdom; College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, United Kingdom.

Background: Patients with heart failure and iron deficiency have diverse causes for hospitalization and death that might be affected by iron repletion.

Objectives: The purpose of this study was to explore causes of hospitalizations and deaths in a randomized trial (IRONMAN) of heart failure comparing intravenous ferric derisomaltose (FDI) (n = 568) and usual care (n = 569).

Methods: Patients with heart failure, left ventricular ejection fraction ≤45%, and either transferrin saturation <20% or serum ferritin <100 μg/L were enrolled.

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Article Synopsis
  • - The ATTEST-2 trial evaluated if tenecteplase, a newer thrombolytic agent, is at least as effective as the standard alteplase within 4.5 hours of an acute ischaemic stroke by comparing outcomes like the modified Rankin Scale (mRS) at 90 days post-treatment.
  • - Conducted across 39 UK stroke centers, the study randomly assigned 1,777 eligible stroke patients to receive either tenecteplase or alteplase, focusing on their recovery outcomes and safety, including complications such as bleeding.
  • - Results showed that tenecteplase was non-inferior to alteplase regarding the distribution of mRS scores, but it did not
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Introduction: Chronic pain is a personal experience influenced by multiple biopsychosocial factors. Using a pain intensity measure alone to assess the effectiveness of a chronic pain intervention fails to fully evaluate its impact on the multifaceted chronic pain experience. The holistic minimal clinically important difference (MCID) is a composite outcome developed to provide a comprehensive assessment of chronic pain in response to intervention, across 5 outcome domains: pain intensity, health-related quality of life, sleep quality, physical, and emotional function.

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Article Synopsis
  • The SENZA-PDN study looked at a special treatment called 10-kHz spinal cord stimulation (SCS) to help people with painful diabetic neuropathy (PDN).
  • After 24 months, those who received this treatment felt a lot less pain and improved their quality of life.
  • Most participants were really happy with the treatment, making it clear that 10-kHz SCS is a helpful option for managing PDN.
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Article Synopsis
  • Randomized trials show intraosseous basivertebral nerve ablation (BVNA) is more effective than sham and standard care for improving pain and quality of life in chronic low back pain patients.
  • * The study aims to evaluate the cost-effectiveness of BVNA compared to standard treatment for vertebrogenic chronic low back pain.
  • * Results indicate that BVNA is cost-effective, with an incremental cost-effectiveness ratio (ICER) of US$11,376 per quality-adjusted life year (QALY) over five years, suggesting over 99% probability of being cost-effective at a $100,000 willingness-to-pay threshold.
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Introduction: Diagnosing and treating lung cancer in early stages is essential for survival outcomes. The chest X-ray (CXR) remains the primary screening tool to identify lung cancers in the UK; however, there is a shortfall of radiologists, while demand continues to increase. Image analysis by machine-learning software has the potential to support radiology workflows with a focus on immediate triage of suspicious X-rays.

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Article Synopsis
  • Atrial fibrillation (AF) is a common heart condition causing irregular heartbeats, which increases risks for strokes and heart failure, and can negatively affect quality of life.
  • The study aims to evaluate the benefits and potential drawbacks of exercise-based cardiac rehabilitation (ExCR) compared to non-exercise methods for individuals with AF or those who have received treatment for it.
  • Researchers conducted a thorough search for randomized clinical trials assessing ExCR interventions, ensuring include participants over 18 with any subtype of AF, and analyzed data to determine the effectiveness and reliability of the evidence gathered.
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A service evaluation of weight management for glycaemic control and remission of type 2 diabetes using traditional food in Nepal (Ho-DIRECT NEPAL): a single-arm trial.

Lancet Reg Health Southeast Asia

October 2024

Department of Human Nutrition, School of Medicine, Dentistry and Nursing, College of Medical, Veterinary and Life Sciences, University of Glasgow, UK.

Background: Remission of early type 2 diabetes (T2D) is possible; however, diet programmes proven effective are unaffordable in many southeast Asian populations where T2D is more frequent and more aggressive at lower body weight and younger age. We evaluate an entirely food-based service.

Methods: This study employed a single-arm intervention and follow-up design for intervention evaluation in existing hospital people with T2D of under 5 years known duration.

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Article Synopsis
  • The study investigated the effects of spironolactone on blood pressure (BP) during exercise in heart failure (HF) patients, finding that it significantly reduced both pre- and post-exercise BP levels over 9 months.
  • While spironolactone showed a small improvement in the number of completed shuttles during exercise tests, there was no significant difference in overall exercise capacity or quality of life (QoL) between the spironolactone group and the control group.
  • The results suggest that while spironolactone can lower BP in patients at increased risk of HF, it does not enhance their ability to exercise or improve their overall well-being.
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Background: We aimed to characterise the variation in access to and outcomes of cardiac surgery for people in England.

Methods: We included people >18 years of age with hospital admission for ischaemic heart disease (IHD) and heart valve disease (HVD) between 2010 and 2019. Within these populations, we identified people who had coronary artery bypass graft (CABG) and/or valve surgery, respectively.

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