The NEON (Nerve rEpair Or Not) trial: a randomized controlled trial of microsurgical repair versus nerve alignment for digital nerve injury.

Background: Digital nerves provide sensibility to the fingers. They are commonly injured through accidental sharp laceration. The aim of the NEON (Nerve rEpair Or Not) study was to investigate whether microsurgical suture repair of lacerated digital nerves is superior to nerve alignment alone without suture repair.

A systematic review of outcomes reported in randomized controlled trials involving people with patellar dislocations.

Aims: The primary aims were to determine what outcome domains, outcome measurement instruments, and outcome measurement timepoints are reported in randomized controlled trials (RCTs) involving people with patellar dislocations. The secondary aims were to determine what primary outcomes were used and how a recurrent patellar dislocation was defined when this was used as an outcome.

Methods: We searched MEDLINE, Embase, CINAHL, the Cochrane Database of Controlled Trials, and trial registries (last search: January 2024) for RCTs evaluating treatments for people with a patellar dislocation irrespective of age or sex.

Risk factors associated with the development of complications after a hip fracture.

Aims: Mortality after a hip fracture has declined in recent years, but the risk of complications remains high. The aim of this study was to identify non-modifiable and, specifically, modifiable factors associated with the development of complications after hip fracture.

Methods: This was a multicentre, prospective cohort study of adults aged ≥ 60 years with a hip fracture who were treated in 77 hospitals in England, Wales, and Northern Ireland between July 2014 and November 2021.

The clinical effectiveness of clarithromycin versus endoscopic sinus surgery for adults with chronic rhinosinusitis with and without nasal polyps (MACRO): a pragmatic, multicentre, three-arm, randomised, placebo-controlled phase 4 trial.

Background: A paucity of evidence regarding use of endoscopic sinus surgery and antibiotics in managing chronic rhinosinusitis has contributed to a five-times variation in endoscopic sinus surgery rates, as well as variation in the use of antibiotics. The main aim of the present trial was to compare the clinical effectiveness of endoscopic sinus surgery or 3 months of clarithromycin treatment alongside intranasal medication in adults with chronic rhinosinusitis with or without nasal polyps.

Methods: In this pragmatic, three-arm, randomised, placebo-controlled phase 4 trial, participants were recruited from 20 secondary and tertiary care sites in the UK.

Ipilimumab with temozolomide vs. temozolomide alone after surgery and chemoradiotherapy in recently diagnosed glioblastoma: a randomized phase II clinical trial.

Background: Glioblastoma confers a bleak prognosis, with median survival of less than a year. This trial evaluated whether addition of the CTLA-4 immune checkpoint inhibitor ipilimumab to standard therapy improves survival in patients with recently diagnosed glioblastoma.

Methods: Ipi-Glio was a stratified randomized, open-label, multicenter, academic phase II study.

Fomites Could Determine Severity of SARS-CoV-2 Outbreaks in Low-Density White-Tailed Deer () Populations.

The establishment of a reservoir species for zoonotic diseases is concerning for both animal and human health. Severe acute respiratory syndrome coronavirus (SARS-CoV)-2, the coronavirus responsible for the COVID-19 pandemic, has been detected in white-tailed deer () in the United States. Since its initial detection, various studies have documented circulation and evolution of SARS-CoV-2 in deer, with human cases suspected of spill-back from infectious deer.

A review of the statistical analysis of randomised controlled trials conducted within OCTRU.

Introduction: Despite a proliferation of statistical methodologies and developments within randomised controlled trials (RCTs) in recent decades, it is unclear which approaches are being implemented in practice. Oxford Clinical Trials Research Unit (OCTRU) is a UK Clinical Research Collaboration (UKCRC) registered Clinical Trials Unit (CTU) that has been operational since 2013 based in the Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences at the University of Oxford. We performed a review of all published RCTs conducted within OCTRU, with particular emphasis on trial methodology, statistical study design and statistical analysis.

The burden of hand trauma surgery on primary care in the United Kingdom: a nation-wide analysis of antibiotic and opioid prescriptions.

Although surgical site infection (SSI) risk after hand trauma surgery is around 5%, the severity of these infections is not known. The risk of superficial SSI in a cohort study was evaluated using NHS UK-wide primary care records ( = 641,223), using the Clinical Practice Research Datalink GOLD database. Within this cohort, a subcohort of those who had undergone a hand surgery operation for trauma were identified ( = 3,088).

Development of the rehabilitation interventions for people with an acute patellar dislocation in the Physiotherapy Rehabilitation Post Patellar Dislocation (PRePPeD) pilot randomized controlled trial.

Aims: To develop the rehabilitation interventions for people with an acute patellar dislocation in the Physiotherapy Rehabilitation Post Patellar Dislocation (PRePPeD) pilot randomized controlled trial (RCT), and to describe how these interventions are delivered.

Methods: We developed the interventions drawing on a range of established intervention development approaches and frameworks. We selected intervention components after reviewing the existing evidence, clinical guidelines, UK NHS practice, and relevant scientific theory.

A 3-week pause versus continued Bruton tyrosine kinase inhibitor use during COVID-19 vaccination in individuals with chronic lymphocytic leukaemia (IMPROVE trial): a randomised, open-label, superiority trial.

Background: Chronic lymphocytic leukaemia is the commonest leukaemia and is associated with profound immunosuppression. Bruton tyrosine kinase inhibitors (BTKi) have revolutionised chronic lymphocytic leukaemia management; however, therapy impairs vaccine-induced immunity. We evaluated whether a 3-week pause of BTKi treatment improved spike protein receptor binding domain (RBD) immunity to SARS-CoV-2 booster vaccination while maintaining disease control.

The World Hip Trauma Evaluation (WHiTE) platform trial: a framework for randomized comparisons of interventions for fragility hip fracture.

Aims: Hip fracture is one of the biggest challenges facing patients and healthcare systems. Worldwide, there are currently 1.3 million hip fractures per year, projected to rise to more than six million by 2050.

The risk of complications after hip fracture.

Aims: The risk of mortality after a hip fracture has been extensively investigated, but there is little high-quality information available dealing with the overall risk of complications. The aim of this study was to report the risk of complications in the first 120 days after a hip fracture.

Methods: This was a multicentre, prospective cohort study of patients aged > 60 years with a hip fracture, involving 77 hospitals in England, Wales, and Northern Ireland, between January 2015 and 2022.

Prevalence of complications in older adults after hip fracture surgery : a systematic review and meta-analysis.

Aims: Older adults with hip fractures are at high risk of experiencing complications after surgery, but estimates of the rate of specific complications vary by study design and follow-up period. The aim of this systematic review was to determine the prevalence of complications in older adults after hip fracture surgery.

Methods: MEDLINE, Embase, CINAHL, and CENTRAL databases were searched from inception until 30 June 2023.

Describing the landscape of nutrition- and diet-related randomized controlled trials: metaresearch study of protocols published between 2012 and 2022.

Background: Publishing protocols promotes transparency and reproducibility. The scope and methods of protocols for nutrition- and diet-related randomized controlled trials (RCTs) have not been investigated yet.

Objectives: This study aims to map the landscape of nutrition- and diet-related interventions research.

A simulation study showed that linear regression and Mann-Whitney test can be used to analyze the Days Alive and at Home by Day 30 outcome in a randomized controlled trial.

Background And Objectives: The aims of the work were to consider the properties of the Days Alive and at Home by Day 30 (DAH30) from a statistical perspective, and to conduct a simulation study exploring the use of simple (unadjusted) linear regression and Mann-Whitney test as the method of analysis reflect realized analysis options.

Study Design And Setting: The Days Alive and at Home by Day 30 (DAH30) has been proposed a patient-centric outcome, and clinically relevant outcome suitable for clinical trials. It has unusual statistical properties, and suitability of standard statistical analysis methods is unclear.

Investigating the presence of surgical learning in the Timing of Primary Surgery for cleft palate randomised trial.

Background/aimsWhen conducting a randomised controlled trial in surgery, it is important to consider surgical learning, where surgeons' familiarity with one, or both, of the interventions increases during the trial. If present, learning may compromise trial validity. We demonstrate a statistical investigation into surgical learning within a trial of cleft palate repair.

Epidemiological modeling of SARS-CoV-2 in white-tailed deer (Odocoileus virginianus) reveals conditions for introduction and widespread transmission.

Emerging infectious diseases with zoonotic potential often have complex socioecological dynamics and limited ecological data, requiring integration of epidemiological modeling with surveillance. Although our understanding of SARS-CoV-2 has advanced considerably since its detection in late 2019, the factors influencing its introduction and transmission in wildlife hosts, particularly white-tailed deer (Odocoileus virginianus), remain poorly understood. We use a Susceptible-Infected-Recovered-Susceptible epidemiological model to investigate the spillover risk and transmission dynamics of SARS-CoV-2 in wild and captive white-tailed deer populations across various simulated scenarios.

Granulocyte-macrophage colony-stimulating factor neutralisation in patients with axial spondyloarthritis in the UK (NAMASTE): a randomised, double-blind, placebo-controlled, phase 2 trial.

Background: Granulocyte-macrophage colony-stimulating factor (GM-CSF) is a proinflammatory cytokine overproduced in several inflammatory and autoimmune diseases, including axial spondyloarthritis. Namilumab is a human IgG1 monoclonal anti-GM-CSF antibody that potently neutralises human GM-CSF. We aimed to assess the efficacy of namilumab in participants with moderate-to-severe active axial spondyloarthritis.

Do video or telephone consultations impact attendance rates in an addiction medicine specialist outpatient clinic?

Background: Effective alcohol and other drugs (AODs) treatment has been proven to increase productivity and reduce costs to the community. Telehealth has previously been proven effective at delivering AOD treatment in the right settings. Yet, Australia's current Medicare funding restricts telephone consultations.