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AnteayerBMJ Open

Imaging analysis using Artificial Intelligence to predict outcomes after endovascular aortic aneurysm repair: protocol for a retrospective cohort study

Por: Lareyre · F. · Raffort · J. · Kakkos · S. K. · DOria · M. · Nasr · B. · Saratzis · A. · Antoniou · G. A. · Hinchliffe · R. J. · on behalf of the European Research Hub Working Group · Venermo · Boyle · Pherwani · Trenner
Introduction

Endovascular aortic aneurysm repair (EVAR) requires long-term surveillance to detect and treat postoperative complications. However, prediction models to optimise follow-up strategies are still lacking. The primary objective of this study is to develop predictive models of post-operative outcomes following elective EVAR using Artificial Intelligence (AI)-driven analysis. The secondary objective is to investigate morphological aortic changes following EVAR.

Methods and analysis

This international, multicentre, observational study will retrospectively include 500 patients who underwent elective EVAR. Primary outcomes are EVAR postoperative complications including deaths, re-interventions, endoleaks, limb occlusion and stent-graft migration occurring within 1 year and at mid-term follow-up (1 to 3 years). Secondary outcomes are aortic anatomical changes. Morphological changes following EVAR will be analysed and compared based on preoperative and postoperative CT angiography (CTA) images (within 1 to 12 months, and at the last follow-up) using the AI-based software PRAEVAorta 2 (Nurea). Deep learning algorithms will be applied to stratify the risk of postoperative outcomes into low or high-risk categories. The training and testing dataset will be respectively composed of 70% and 30% of the cohort.

Ethics and dissemination

The study protocol is designed to ensure that the sponsor and the investigators comply with the principles of the Declaration of Helsinki and the ICH E6 good clinical practice guideline. The study has been approved by the ethics committee of the University Hospital of Patras (Patras, Greece) under the number 492/05.12.2024. The results of the study will be presented at relevant national and international conferences and submitted for publication to peer-review journals.

Skills for adolescent WELLbeing (SWELL): protocol for a preventive effectiveness randomised controlled trial for young people at high-familial risk of depression with treatment optimisation for parents with depression at study entry comparing online group

Por: Rice · F. · Powell · V. · Eyre · O. · Bevan Jones · R. · Michelson · D. · Airdrie · J. · Collishaw · S. · Thapar · A. · Grozeva · D. · Munnery · K. · Randell · E. · Brookes-Howell · L. · Garber · J. · Thapar · A. · Moore · G. · Harrison · N. A. · Playle · R. · Bisson · J. · McNamara · R.
Introduction

Young people (YP) whose parents have depression are at elevated risk for developing depression themselves and could benefit from preventive interventions. However, when parents are in a depressive episode, this reduces the effects of psychological interventions for depression in YP. Moreover, parental depression is often managed suboptimally in usual care. There is, therefore, a case for identifying and optimising parental depression treatment to enhance the effectiveness of psychological preventive interventions for depression in YP.

Methods and analysis

This is a randomised controlled trial (Skills for adolescent WELLbeing) to determine the effectiveness of a cognitive behavioural therapy (CBT) intervention compared with usual care in increasing the time to a major depressive episode in YP by 9-month follow-up (primary outcome). The intervention offers a 12-week treatment-optimisation phase for parents depressed at study entry, followed by randomisation of the young person to a small group manualised online CBT programme facilitated by a therapist. YP allocated to the intervention will receive eight weekly sessions plus three monthly continuation sessions. Secondary outcomes include the number of depression-free weeks, mental health symptoms and functioning. Mechanisms of intervention action will be assessed with mediation analysis of quantitative data and thematic analysis of qualitative interviews. Participants (parents/carers with depression and their children aged 13–19 years) will be identified through existing cohorts of adults with depression, from primary care through health boards in Wales and England, UK, schools and advertising including via social media.

Ethics and dissemination

The trial has received ethical approval from Wales NHS Research Ethics Committee (REC) 5, the Health Research Authority and Health and Care Research Wales (IRAS 305331; REC 22/WA/0254). This manuscript is based on V.5.7 of the protocol (17 January 2025). Findings will be disseminated in peer-reviewed journals and conferences. Reports and social media messages will be used to disseminate findings to the wider public.

Trial registration number

ISRCTN13924193 (date registered: 15 March 2023).

Epidemiology and excess mortality of antimicrobial resistance in bacteraemias among cancer patients: a cohort study using routinely collected health data from regional hospital trusts in Oxford and Oslo, 2008-2018

Por: Danielsen · A. S. · Lim · C. · Yoon · C. H. · Gran · J. M. · Kacelnik · O. · Eyre · D. W. · Bjornholt · J. V.
Objectives

We investigated the epidemiology and impact on mortality of antimicrobial resistance (AMR) in cancer patients with bacteraemia at Oxford University Hospitals (OxUH), UK, and Oslo University Hospital (OsUH), Norway, during 2008–2018.

Design

Historical cohort study.

Setting

Regional hospital trusts with multiple sites in OxUH and OsUH.

Methods

Patients with cancer and blood cultures positive for one of six pathogen groups during a hospital stay within 3 years following their first cancer diagnosis were followed for 30 days after their first bacteraemia episode. We determined the number of cases and the proportion of infections with an AMR phenotype. Excess mortality and the population-attributable fraction (PAF) due to AMR were estimated by contrasting observed mortality at the end of follow-up with an estimated counterfactual scenario where AMR was absent from all bacteraemias, using inverse probability weighting.

Main outcome measure

30-day all-cause mortality following the first bacteraemia episode.

Main exposure measure

A resistant phenotype of the causative pathogen.

Results

The study included 1929 patients at OxUH and 1640 patients at OsUH. The highest resistance proportions were found for vancomycin resistance in enterococci (85/314, 27.1%) and carbapenem-resistance in Pseudomonas aeruginosa (63/260, 24.2%) at OxUH, and third-generation cephalosporin resistance in Escherichia coli (62/743, 8.3%) and Klebsiella pneumoniae (14/223, 6.3%) at OsUH. Observed mortality for all infections was 26.4% at OxUH, with an estimated counterfactual mortality without AMR of 24.7%, yielding an excess mortality of 1.7% (95% CI: 0.8 to 2.5%). The PAF was 6.3% (95% CI: 2.9 to 9.6%), meaning an estimated 32 of 509 deaths could be attributed to AMR. Limited events at OsUH precluded a similar estimate.

Conclusions

Despite estimating modest excess mortality, the mortality attributable to resistance in these two high-income, low-prevalence settings highlights the potential for escalation if global resistance trends continue to worsen.

Artificial intelligence-based personalised rituximab treatment protocol in membranous nephropathy (iRITUX): protocol for a multicentre randomised control trial

Por: Teisseyre · M. · Destere · A. · Cremoni · M. · Zorzi · K. · Brglez · V. · Benito · S. · Bailly · L. · Fernandez · C. · Seitz-Polski · B.
Introduction

Membranous nephropathy is an autoimmune kidney disease and the most common cause of nephrotic syndrome in non-diabetic Caucasian adults. Rituximab is now recommended as first-line therapy for membranous nephropathy. However, Kidney Disease Improving Global Outcomes guidelines do not recommend any specific protocol. Rituximab bioavailability is reduced in patients with membranous nephropathy due to urinary drug loss. Underdosing of rituximab is associated with treatment failure. We have previously developed a machine learning algorithm to predict the risk of underdosing. We have retrospectively shown that patients with a high risk of underdosing required higher doses of rituximab to achieve remission. The aim of this prospective study is to evaluate the efficacy of algorithm-driven rituximab treatment in patients with membranous nephropathy compared to standard treatment.

Methods

A multicentre, randomised, controlled, open-label, prospective superiority clinical trial will be conducted in 13 French hospitals. 130 consecutive patients with primary membranous nephropathy and active nephrotic syndrome will be randomised to either the standard protocol control group (two 1 g rituximab infusions on days 0 and 15) or the algorithm-driven rituximab treatment group. In the latter, the rituximab dose will depend on the algorithm-estimated risk of underdosing. Patients with an algorithm-estimated risk of underdosing ≤50% will receive 1 g of rituximab on days 0 and 15. Patients with an algorithm-estimated risk of underdosing between 51% and 75% will receive 1 g of rituximab on days 0, 15 and 30. Finally, patients with an estimated risk of underdosing >75% will receive 1 g of rituximab on days 0, 15, 30 and 45. The primary study outcome is the rate of clinical remission (complete or partial) at month 6 after treatment initiation. The secondary outcomes include clinical remission at month 12, immunological remission, proteinuria, albuminuria, serum creatinine, estimated glomerular filtration rate, phospholipase A2 receptor type 1 antibody titre, anti-rituximab antibody occurrence, lymphocyte count, serum rituximab level and related adverse events.

Ethics and dissemination

The trial received ethics approval from the local ethics boards. The results of this study will confirm whether algorithm-driven rituximab treatment is more effective in inducing remission than the standard regimen and thus may contribute to improving management of patients with membranous nephropathy. The results of our study will be submitted to a peer-review journal.

Trial registration number

NCT06341205 trial number. Registered on 2 April 2024.

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