Large, randomised trials are the bedrock of evidence-based medicine, but the resources required to complete such trials greatly limit the number of important clinical questions that can be addressed within a reasonable period of time. Adaptive platform trials can identify effective, ineffective, or harmful treatments faster. These trials have been shown to deliver rapid evidence through the COVID-19 pandemic and are now being adopted across surgery and anaesthesia, with many opportunities for surgeons, anaesthetists, and other perioperative physicians to conduct and collaborate in platform trials.
View Article and Find Full Text PDFBackground: Chronic post-surgical pain (CPSP) is recognised as one of the most common and debilitating complications of major surgery. Progression from acute to chronic pain after surgery involves sensitisation of central nervous system pathways with the N-methyl-D-aspartate (NMDA) receptor having a central role. Ketamine is a potent, non-selective NMDA antagonist commonly used for management of acute postoperative pain.
View Article and Find Full Text PDFWithout careful dissection of the ways in which biases can be encoded into artificial intelligence (AI) health technologies, there is a risk of perpetuating existing health inequalities at scale. One major source of bias is the data that underpins such technologies. The STANDING Together recommendations aim to encourage transparency regarding limitations of health datasets and proactive evaluation of their effect across population groups.
View Article and Find Full Text PDFLarge, randomized trials are the bedrock of evidence-based medicine, but the resources required to complete such trials greatly limit the number of important clinical questions that can be addressed within a reasonable period of time. Adaptive platform trials can identify effective, ineffective, or harmful treatments faster. These trials have been shown to deliver rapid evidence through the COVID-19 pandemic and are now being adopted across surgery and anaesthesia, with many opportunities for surgeons, anaesthetists, and other perioperative physicians to conduct and collaborate in platform trials.
View Article and Find Full Text PDFDecentralized clinical trials involving the use of digital tools to facilitate remote research are gaining momentum. Rapid advancements in digital technologies have supported the adoption of these trials. These innovations facilitate virtual interactions between clinical trial teams and participants by making it easier to collect, transfer and store electronic data.
View Article and Find Full Text PDFObjectives: Evaluate the utility of a joint model when analysing a patient-reported endpoint as part of a randomized controlled trial (RCT) in which censoring occurs when patients die during follow-up.
Study Design And Setting: The present study comprises two parts as follows: first we reanalyzed data from a previously published RCT comparing two fluid regimens in the first 24 hours of major abdomino-pelvic surgery ('Restrictive versus Liberal Fluid Therapy for Major Abdominal Surgery [RELIEF]' trial). In this trial, patient-reported disability was measured at multiple timepoints before and after surgery.
Background: Critical care beds are a limited resource, yet research indicates that recommendations for postoperative critical care admission based on patient-level risk stratification are not followed. It is unclear how prioritisation decisions are made in real-world settings and the effect of this prioritisation on outcomes.
Methods: This was a prespecified analysis of an observational cohort study of adult patients undergoing inpatient surgery, conducted in 274 hospitals across the UK and Australasia during 2017.
Coronavirus disease 2019 (COVID-19) has affected not only individual lives but also the world and global systems, both natural and human-made. Besides millions of deaths and environmental challenges, the rapid spread of the infection and its very high socioeconomic impact have affected healthcare, economic status and wealth, and mental health across the globe. To better appreciate the pandemic's influence, multidisciplinary and interdisciplinary approaches are needed.
View Article and Find Full Text PDFObjectives: About 60% of antibiotic prescribing in primary care is for respiratory tract infections (RTIs), some of which is likely unnecessary. There is limited evidence on the association between reduced antibiotic prescribing and adverse events. We aimed to identify associations between practice-level prescribing rates for RTIs in general practice, and patient-level adverse outcomes.
View Article and Find Full Text PDFBackground: High-dose corticosteroids have been used to attenuate the inflammatory response to cardiac surgery and cardiopulmonary bypass, but patient outcome benefits remain unclear. The primary aim was to determine whether using dexamethasone was superior to not using dexamethasone to increase the number of home days in the first 30 days after cardiac surgery. The secondary aim was to evaluate efficiency, value, and impact of the novel trial design.
View Article and Find Full Text PDFThe prevention of thromboembolism in atrial fibrillation (AF) is typically restricted to patients with specific risk factors and ignores outcomes such as vascular dementia. This population-based cohort study used electronic healthcare records from 5,199,994 primary care patients (UK; 2005-2020). A total of 290,525 (5.
View Article and Find Full Text PDFBackground: Aortic valve replacement in asymptomatic severe aortic stenosis is controversial. The Early valve replacement in severe ASYmptomatic Aortic Stenosis (EASY-AS) trial aims to determine whether early aortic valve replacement improves clinical outcomes, quality of life and cost-effectiveness compared to a guideline recommended strategy of 'watchful waiting'.
Methods: In a pragmatic international, open parallel group randomized controlled trial (NCT04204915), 2844 patients with severe aortic stenosis will be randomized 1:1 to either a strategy of early (surgical or transcatheter) aortic valve replacement or aortic valve replacement only if symptoms or impaired left ventricular function develop, or other cardiac surgery becomes nessessary.
Background: Acute kidney injury (AKI) is common after major abdominal surgery. Selection of candidate kidney protective strategies for testing in large trials should be based on robust preliminary evidence.
Methods: A secondary analysis of the Restrictive versus Liberal Fluid Therapy in Major Abdominal Surgery (RELIEF) trial was conducted in adult patients undergoing major abdominal surgery and randomly assigned to a restrictive or liberal perioperative fluid regimen.
Background: There is limited knowledge about the effect of liberal intraoperative oxygen on non-infectious complications and overall recovery from surgery.
Methods: In this retrospective cohort study, we investigated associations between mean intraoperative fraction of inspired oxygen (FiO), and outcome in adults undergoing elective surgery lasting more than 2 h at a large metropolitan New Zealand hospital from 2012 to 2020. Patients were divided into low, medium, and high oxygen groups (FiO ≤ 0.
Advanced synthetic data generators can simulate data samples that closely resemble sensitive personal datasets while significantly reducing the risk of individual identification. The use of these advanced generators holds enormous potential in the medical field, as it allows for the simulation and sharing of sensitive patient data. This enables the development and rigorous validation of novel AI technologies for accurate diagnosis and efficient disease management.
View Article and Find Full Text PDFBackground: Dexamethasone has been shown to reduce acute pain after surgery, but there is uncertainty as to its effects on chronic postsurgical pain (CPSP). We hypothesised that in patients undergoing major noncardiac surgery, a single intraoperative dose of dexamethasone increases the incidence of CPSP.
Methods: We devised a propensity score-matched analysis of the ENIGMA-II trial CPSP dataset, aiming to compare the incidence of CPSP in patients who had received dexamethasone or not 12 months after major noncardiac surgery.
Objective: We hypothesized that days at home alive up to 30 days after surgery (DAH30), a novel patient-centered outcome metric, as well as long-term mortality, would be impaired in patients with type 1 or 2 diabetes mellitus (DM) undergoing major surgery.
Methods: This cohort study investigated patients > 18 years with and without DM presenting for major non-cardiovascular, non-ambulatory surgical procedures at 23 hospitals in Sweden between 2007 and 2014. We identified 290,306 patients.
Background: Guidelines for the evaluation and grading of diastolic dysfunction are available for transthoracic echocardiography (TTE). Transesophageal echocardiography (TEE) is used for this purpose intraoperatively but the level of agreement between these 2 imaging modalities for grading diastolic dysfunction is unknown. We assessed agreement between awake preoperative TTE and intraoperative TEE for grading diastolic dysfunction.
View Article and Find Full Text PDFObjective: To ascertain and develop recommendations for analgesic management, discharge planning and further healthcare utilisation of adults presenting to an Australian tertiary ED with radicular or low back pain (LBP).
Methods: This prospective cohort study included adults presenting with non-specific LBP or radicular pain to an Australian tertiary ED. Participants with trauma/cancer-related pain, and those requiring hospital admission or surgical interventions were excluded.
The 12-item World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) provides a standardised method for measuring health and disability.
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