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Infections are a leading cause of non-relapse mortality following chimeric antigen receptor T-cell therapy (CAR-T) and bispecific antibody (BsAb) therapies. However, infection data from clinical trials are often incomplete, lack pathogen-level detail and rarely capture late infectious complications. This CAR-T treatment in Lymphoma: Analysis of Risk of Infection following Therapy (CLARITY) study aims to generate real-world, longitudinal infection data with extended follow-up to characterise infection timing, including late events and inform risk prediction in patients with lymphoma and myeloma receiving novel immunotherapies.
CLARITY is a multicentre observational cohort study across six Australian centres enrolling adults treated with CAR-T or BsAb therapies. A co-designed REDCap (Research Electronic Data Capture) instrument captures infections classified as microbiologically defined, clinically defined or fever of unknown origin, using internationally standardised definitions. Patients were enrolled between 2019 and 2023, with at least 2 years follow-up per patient, allowing time-updated data on immunosuppressive exposures, haematological recovery and prophylaxis. Multivariable regression and landmark analyses will estimate infection incidence and identify dynamic risk factors over time. Incidence rate ratios will assess prophylaxis effectiveness. Data integrity is supported by central adjudication and site-level audits.
The study has received a waiver of consent (HREC/PMCC/89002) and was co-designed by haematology and infectious diseases investigators. Findings will be disseminated through peer-reviewed publications, scientific meetings and national guideline committees to inform infection prevention and late effects surveillance in immunotherapy-treated populations.
To explore hospital staff experiences and perceptions of patient-perpetrated violence.
Descriptive qualitative study.
Twelve semi-structured interviews (June–August 2022) were held with a diverse sample of hospital nurses, doctors, allied health professionals, security and a non-clinical manager. The framework approach was used to organise and analyse data, using Attribution Theory as a theoretical lens.
Three themes were identified: violence as (un)predictable, violence as (un)preventable and the cumulative toll of violence. In making sense of why patients become violent, participants described different ‘types’ of aggressive patients and variably attributed behaviours to situation, disposition or a combination of both. Regardless of perceived causal factors, staff overwhelmingly appeared to view violence as predictable. Participants also reflected on the wider structural problems underpinning violence, frequently alluding to their sense of relative powerlessness to initiate change. The cumulative toll of violence was a common thread, with staff describing their acquisition of ‘resilience’ and reflecting on its role in their responses to escalating situations.
Many hospital staff are resigned to the inevitability of violence. The concept of staff ‘resilience’ following violence is not unproblematic, having the potential to serve as a guise for acceptance and as an additional variable for which staff are held accountable. When designing strategies, organisations should ensure that accountability for violence reduction is distributed across multiple levels. This study makes a novel contribution by exploring the perspectives of multiple staff groups working across diverse hospital settings, and adds to a sparse literature on this subject in the UK.
Efforts to address violence against healthcare staff need to be power-conscious, ensuring that accountability is distributed across multiple levels.
This study is reported in line with the Consolidated Criteria for Reporting Qualitative Studies (COREQ).
No patient or public contribution.
Alcohol use disorder and treatment-resistant depression (TRD) often co-occur, presenting a major clinical challenge with limited effective treatments. However, ketamine produces rapid antidepressant effects and has shown promise in reducing alcohol use, and acceptance and commitment therapy (ACT) can be effective for both substance use and mood disorders. This study explores the feasibility and acceptability of combining ACT with ketamine within the framework of the Montreal Model—a structured, integrative psychedelic ketamine therapy developed for severe TRD.
This study is a single-group, open-label feasibility trial at the Centre hospitalier de l'Université de Montréal (CHUM) Neuromodulation Ketamine Clinic in Montreal, Canada. 30 participants diagnosed with both alcohol use disorder and treatment-resistant depression will receive eight weekly in-person or virtual ACT sessions in addition to six intravenous ketamine infusions. The primary outcome is feasibility, assessed through study completion and protocol adherence. Secondary outcomes include recruitment rate, tolerability, safety, data completeness and healthcare resource use. Exploratory measures will examine changes in depressive symptoms, alcohol use and quality of life using validated tools. A subset of participants will participate in semistructured qualitative interviews to explore their experiences.
This study was approved by the ethics committee of the CHUM on 14 May 2025. The results of the trial, including primary and secondary outcomes, will be published in peer-reviewed scientific journals.
Necrotising fasciitis (NF) is a rapidly progressing, life-threatening infection with mortality rates that are exceedingly high. Despite the notably high risks of developing NF in patients with diabetes mellitus (DM), factors associated with mortality in this population are poorly understood. Therefore, to determine at-risk patients and to improve overall clinical outcomes via hastening management, the objective of this systematic review is to determine what factors are associated with mortality for diabetic patients with NF. This systematic review followed the PRISMA guidelines. Patient data pertaining to outcomes and surgical management were extracted, and mortality rates were evaluated. Studies were assessed for quality using the Alberta Heritage Foundation for Medical Research (AHFMR) and Risk of Bias tool. A total of 25 studies were reviewed, covering 7879 patients with NF and DM with a 23.5% mortality rate. The most prevalent comorbidities among those who died included chronic kidney disease (15.95%), hypertension (9.42%) and obesity (9.02%). While limbs were the most common location for the disease, NF in the trunk and groin regions showed the highest mortality rates at 62.07%. Among those who died, common complications were acute renal failure (13.41%), pulmonary issues (20.41%) and septicaemia (12.80%). Mortality rates by surgical management were fasciotomy (42.9%), surgical debridement (40.68%) and amputation (9.09%). Mortality was comparable between patients with NF and DM (23.54%) and those with NF alone (23.61%). Although DM may not independently increase mortality, it can worsen outcomes when combined with other comorbidities, indicating a need for clearer clinical guidance.
Transvaginal and transabdominal cerclage procedures have become established interventions to prevent mid-trimester pregnancy loss and preterm birth. Transabdominal cerclage seems to be superior to transvaginal cerclage in women with a history of a failed transvaginal cerclage. However, with the availability of a less invasive laparoscopic procedure, there is limited evidence concerning which type of cerclage to recommend to many other risk groups. The objective of this trial is to compare laparoscopic abdominal cerclage and transvaginal cerclage in women at moderate to high risk of spontaneous preterm birth.
The trial is an open, multicentre, superiority, parallel arm randomised controlled investigator-initiated trial with an embedded internal pilot. Women in whom the clinician has clinical equipoise between laparoscopic and transvaginal cerclage are randomised to either laparoscopic abdominal or transvaginal cerclage in a ratio of 1:1. The trial extends from sites in Denmark, Finland and Norway. The primary outcome is birth
The Central Denmark Region Committee on Biomedical Research Ethics, Denmark, Helsinki University Hospital Ethics committee, Finland and the Regional Committees for Medical and Health Research Ethics, Norway approved the trial. This protocol is published prior to complete data collection and analysis. Important protocol changes will be made publicly available on ClinicalTrials.org, on the trial website and distributed electronically to all active sites. Positive, inconclusive as well as negative results from the trial will be published in peer-reviewed international scientific journals.
FreshRSS 