Effect of high-flow nasal therapy on patient-centred outcomes in patients at high risk of postoperative pulmonary complications after cardiac surgery: update to the statistical analysis plan for NOTACS, a multicentre adaptive randomised controlled trial.

Background: The NOTACS trial will assess the efficacy, safety and cost-effectiveness of high-flow nasal therapy (HFNT) compared to standard oxygen therapy (SOT) on the outcomes of patients after cardiac surgery.

Methods/design: NOTACS is an adaptive, international, multicentre, parallel group, randomised controlled trial, with a pre-planned interim sample size re-estimation (SSR). A minimum of 850 patients will be randomised 1:1 to receive either HFNT or SOT.

Evaluation of microcirculatory protection in percutaneous revascularisation: A stent implantation technique and device comparison.

Background: Coronary microvascular dysfunction (CMD) after percutaneous coronary intervention (PCI) is prognostically important and may also be a cause of persistent angina. The stent balloon inflation technique or material properties may influence the degree of CMD post-PCI.

Methods: Thirty-six patients with stable angina attending for elective PCI were randomized to either slow drug eluting stent (DES) implantation technique (DES slow group): +2 atm.

Continuous Positive Airway Pressure plus Mandibular Advancement Therapy (PAPMAT): study protocol for an adaptive randomised crossover trial comparing the benefits and costs of combining two established treatments for obstructive sleep apnoea.

Background: Obstructive sleep apnoea (OSA) involves repeated breathing pauses during sleep due to upper airway obstruction. It causes excessive daytime sleepiness and has other health impacts. Continuous positive airway pressure (CPAP) therapy is effective first line treatment for moderate to severe OSA.

Effect of high-flow nasal therapy on patient-centred outcomes in patients at high risk of postoperative pulmonary complications after cardiac surgery: a statistical analysis plan for NOTACS, a multicentre adaptive randomised controlled trial.

Background: The NOTACS trial will assess the efficacy, safety and cost-effectiveness of high-flow nasal therapy (HFNT) compared to standard oxygen therapy (SOT) on the outcomes of patients after cardiac surgery.

Methods/design: NOTACS is an adaptive, international, multicentre, parallel-group, randomised controlled trial, with a pre-planned interim sample size re-estimation (SSR). A minimum of 850 patients will be randomised 1:1 to receive either HFNT or SOT.

Five-year results of Amaze: a randomized controlled trial of adjunct surgery for atrial fibrillation.

Objectives: The Amaze trial showed that adding atrial fibrillation (AF) surgery to cardiac operations increased return to sinus rhythm (SR) without impact on quality of life or survival at 2 years. We report outcomes to 5 years.

Methods: In a multicentre, phase III, pragmatic, double-blind, randomized controlled superiority trial, cardiac surgery patients with >3 months of AF were randomized 1:1 to adjunct AF surgery or control.

Effect of high-flow nasal therapy on patient-centred outcomes in patients at high risk of postoperative pulmonary complications after cardiac surgery: a study protocol for a multicentre adaptive randomised controlled trial.

Background: High-flow nasal therapy is a non-invasive form of respiratory support that delivers low-level, flow dependent positive airway pressure. The device can be better tolerated by patients than alternatives such as continuous positive airway pressure. The primary objective is to determine if prophylactic high-flow nasal therapy after tracheal extubation can result in an increase in the number of days alive and at home within the first 90 days after surgery, when compared with standard oxygen therapy.

Endovascular stent grafting and open surgical replacement for chronic thoracic aortic aneurysms: a systematic review and prospective cohort study.

Background: The management of chronic thoracic aortic aneurysms includes conservative management, watchful waiting, endovascular stent grafting and open surgical replacement. The Effective Treatments for Thoracic Aortic Aneurysms (ETTAA) study investigates timing and intervention choice.

Objective: To describe pre- and post-intervention management of and outcomes for chronic thoracic aortic aneurysms.

Aneurysm growth, survival, and quality of life in untreated thoracic aortic aneurysms: the effective treatments for thoracic aortic aneurysms study.

Aims: To observe, describe, and evaluate management and timing of intervention for patients with untreated thoracic aortic aneurysms.

Methods And Results: Prospective study of UK National Health Service (NHS) patients aged ≥18 years, with new/existing arch or descending thoracic aortic aneurysms of ≥4 cm diameter, followed up until death, intervention, withdrawal, or July 2019. Outcomes were aneurysm growth, survival, quality of life (using the EQ-5D-5L utility index), and hospital admissions.

Rituximab in patients with acute ST-elevation myocardial infarction: an experimental medicine safety study.

Aims: In pre-clinical models of acute myocardial infarction (MI), mature B cells mobilize inflammatory monocytes into the heart, leading to increased infarct size and deterioration of cardiac function, whilst anti-CD20 antibody-mediated depletion of B cells limits myocardial injury and improves cardiac function. Rituximab is a monoclonal anti-CD20 antibody targeted against human B cells. However, its use in cardiovascular disease is untested and is currently contraindicated.

Dynamic individual vital sign trajectory early warning score (DyniEWS) versus snapshot national early warning score (NEWS) for predicting postoperative deterioration.

Aims: International early warning scores (EWS) including the additive National Early Warning Score (NEWS) and logistic EWS currently utilise physiological snapshots to predict clinical deterioration. We hypothesised that a dynamic score including vital sign trajectory would improve discriminatory power.

Methods: Multicentre retrospective analysis of electronic health record data from postoperative patients admitted to cardiac surgical wards in four UK hospitals.

CASPA (CArdiac Sarcoidosis in PApworth) improving the diagnosis of cardiac involvement in patients with pulmonary sarcoidosis: protocol for a prospective observational cohort study.

Introduction: Sarcoidosis is a multisystem disease, predominantly affecting the lungs but can involve the heart, resulting in cardiac sarcoidosis (CS). Patients require MRI/Positron Emission Tomography (PET) scans for diagnosis. Echocardiography, ECG and Holter monitoring may be indicative but not diagnostic alone.

Outcomes of the NHS England National Extracorporeal Membrane Oxygenation Service for adults with respiratory failure: a multicentre observational cohort study.

Background: Extracorporeal membrane oxygenation (ECMO) is increasingly used to support adults with severe respiratory failure refractory to conventional measures. In 2011, NHS England commissioned a national service to provide ECMO to adults with refractory acute respiratory failure. Our aims were to characterise the patients admitted to the service, report their outcomes, and highlight characteristics potentially associated with survival.

A critical review of graphics for subgroup analyses in clinical trials.

Subgroup analyses are a routine part of clinical trials to investigate whether treatment effects are homogeneous across the study population. Graphical approaches play a key role in subgroup analyses to visualise effect sizes of subgroups, to aid the identification of groups that respond differentially, and to communicate the results to a wider audience. Many existing approaches do not capture the core information and are prone to lead to a misinterpretation of the subgroup effects.

Obstructive Sleep Apnea in Patients With Primary-open Angle Glaucoma: No Role for a Screening Program.

Unlabelled: PRéCIS:: In this study, we found a high prevalence of obstructive sleep apnea (OSA) among patients with primary open-angle glaucoma (POAG) but this was not different (nor was OSA more severe) to matched people without glaucoma.

Rationale: It has been proposed that OSA might be a contributing factor in the development of POAG and by extension that there could be a role for screening people with POAG for OSA.

Objectives: To assess whether the prevalence of OSA among patients with POAG is different from that in people without glaucoma and to examine for associations between apnea-hypopnea index (AHI) and markers of functional and structural changes in POAG.

Design and estimation in clinical trials with subpopulation selection.

Population heterogeneity is frequently observed among patients' treatment responses in clinical trials because of various factors such as clinical background, environmental, and genetic factors. Different subpopulations defined by those baseline factors can lead to differences in the benefit or safety profile of a therapeutic intervention. Ignoring heterogeneity between subpopulations can substantially impact on medical practice.