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Ayer — Octubre 2nd 2025Tus fuentes RSS

FAST MRI: DYAMOND trial protocol (can an abbreviated MRI scan detect breast cancers missed by mammography for screening clients with average mammographic density attending their first screening mammogram?)--a diagnostic yield study within the NHS populati

Por: Jones · L. I. · Geach · R. · Loose · A. · McKeown-Keegan · S. · Marshall · A. · Halling-Brown · M. · Curtis · S. · Harding · S. · Rose · J. · Matthews · H. · Vinnicombe · S. · Shaaban · A. M. · Taylor-Phillips · S. · Dunn · J. · On behalf of The FAST MRI Study Group
Introduction

First post-contrAst SubtracTed (FAST) MRI, an abbreviated breast MRI scan, has high sensitivity for sub-centimetre aggressive breast cancer and short acquisition and interpretation times. These attributes promise effective supplemental screening. Until now, FAST MRI research has focused on women above population-risk of breast cancer (high mammographic density or personal history). DYAMOND aims to define the population within the population-risk NHS Breast Screening Programme (NHSBSP) likely to benefit from FAST MRI. The study population is the 40% of screening clients aged 50–52 who have average mammographic density (BI-RADS (Breast Imaging Reporting and Data System) B) on their first screening mammogram. DYAMOND will answer whether sufficient numbers of breast cancers, missed by mammography, can be detected by FAST MRI to justify the inclusion of this group in a future randomised controlled trial.

Methods and analysis

Prospective, multicentre, diagnostic yield, single-arm study with an embedded qualitative sub-study: all recruited participants undergo a FAST MRI. An internal pilot will assess the willingness of sites and screening clients to participate in the study. Screening clients aged 50–52, with a clear first NHSBSP mammogram and BI-RADS B mammographic density (by automated measurement) will be invited to participate (recruitment target: 1000). The primary outcome is the number of additional cancers detected by FAST MRI (missed by screening mammography). A Fleming’s two-stage design will be used as this allows for early stopping after stage 1, to save participants, funding costs and time continuing to the end of the study if the question can be answered earlier.

Ethics and dissemination

The NHSBSP Research and Innovation Development Advisory Committee and the Yorkshire and Humber–Sheffield Research Ethics Committee (23/YH/0268, study ID (IRAS): 330059) approved this research protocol. Participation involves a two-stage informed consent process, enabling screening for eligibility through automated mammographic density measurement. Patients with breast cancer helped shape the study design and co-produced participant-facing documents. They will disseminate the results to the public in a clear and meaningful way. Results will be published with open access in international peer-reviewed scientific journals.

Trial registration number

ISRCTN74193022

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Changes in prescription patterns of antidiabetic medication in patients newly diagnosed with type 2 diabetes in Spain: an observational study

Por: Cea-Soriano · L. · Moreno · A. · Calonge · M. · Rivas · A. · Pulido-Manzanero · J. · Colchero · M. C. · Artola · S. · Serrano · R. · Franch-Nadal · J. · Regidor · E. · the PRECOZIN Study Group · Adan · Almanzar · Alonso · Alonso · Alonso · Alvarez · Alvarez · Amoros · Araujo · Arbide
Objective

To estimate the frequency of antidiabetic prescriptions in type 2 diabetes mellitus (T2DM) in Spain and describe changes in prescription patterns between 2018–2022 and 2023-2024.

Design

Observational study.

Participants

Patients from primary care centres newly diagnosed with T2DM in 2018–2022 and 2023–2024.

Primary and secondary outcomes

In each period, the prescription frequency of an antidiabetic medication at the diagnosis of T2DM was calculated and subsequently subdivided into monotherapy and combination therapy. The prescription frequency of the most common antidiabetic drugs was also calculated. Calculations were made for the entire group of subjects and stratified by sex and age (under 60 years and 60 years or older). Comparison of the frequencies between the two periods was performed using the chi-square test.

Results

In 2018–2022 and 2023–2024, 78.4% and 88.9% of patients, respectively, were prescribed an antidiabetic medication. The prescription frequencies for monotherapy and combination therapy were 66.1% and 33.9% in the first period and 57.4% and 42.6% in the second. The prescription frequencies for metformin as monotherapy and combination therapy were 57.4% and 27.8% in the first period and 46.6% and 39.8% in the second. Prescribing metformin with sodium-glucose cotransporter-2 inhibitors (SGLT2i) and/or glucagon-like peptide receptor 1 agonists (GLP1a) was the most frequent combination therapy: 12.8% in 2018–2022 and 29.5% in 2023–2024. With a few exceptions, the prescribing pattern was similar by sex and age. The difference between the prescribing distributions in the two periods is significant.

Conclusion

Antidiabetic medication prescribing at the diagnosis of T2DM was high. Most prescriptions contained metformin. Monotherapy decreased in 2023–2024 compared with 2018–2022, while combination therapy increased due to increased prescriptions of metformin with SGLT2i and/or GLP1a.

Health economic impact of early versus delayed treatment of herpes simplex virus encephalitis in the UK

Por: Defres · S. · Navvuga · P. · Moore · S. · Hardwick · H. · Easton · A. · Michael · B. D. · Kneen · R. · Griffiths · M. · ENCEPHUK Study Group · Medina-Lara · A. · Solomon · T. · Barlow · Beeching · Blanchard · Body · Boyd · Cebria-Prejan · Chadwick · Cooke · Crawford · Davies · Davies
Objective

Thanks to the introduction of recent national guidelines for treating herpes simplex virus (HSV) encephalitis, health outcomes have improved. This paper evaluates the health system costs and the health-related quality of life implications of these guidelines.

Design and setting

A sub-analysis of data from a prospective, multi-centre, observational cohort ENCEPH-UK study conducted across 29 hospitals in the UK from 2012 to 2015.

Study participants

Data for patients aged ≥16 years with a confirmed HSV encephalitis diagnosis admitted for treatment with aciclovir were collected at discharge, 3 and 12 months.

Primary and secondary outcome measures

Patient health outcomes were measured by the Glasgow outcome score (GOS), modified ranking score (mRS) and the EuroQoL; healthcare costs were estimated per patient at discharge from hospital and at 12 months follow-up. In addition, Quality Adjusted Life Years (QALYs) were calculated from the EQ-5D utility scores. Cost–utility analysis was performed using the NHS and Social Care perspective.

Results

A total of 49 patients were included; 35 were treated within 48 hours, ‘early’ (median (IQR) 8.25 [3.7–20.5]) and 14 were treated after 48 hours ‘delayed’ (median (IQR) 93.9 [66.7–100.1]). At discharge, 30 (86%) in the early treatment group had a good mRS outcome score (0–3) compared with 4 (29%) in the delayed group. According to GOS, 10 (29%) had a good recovery in the early treatment group, but only 1 (7%) in the delayed group. EQ-5D-3L utility value at discharge was significantly higher for early treatment (0.609 vs 0.221, p

Conclusions

This study suggests that early treatment may be associated with better health outcomes and reduced patient healthcare costs, with a potential for savings to the NHS with faster treatment.

Design of aSpiration based thrombectomy in acUte large vessel oCclusive sTroke with dIfferent etiOlogies: a real-world multiceNtre (SUCTION) study

Por: Yan · P. · Li · M. · Yang · L. · Song · C. · Liu · S. · Chen · X. · Chen · S. · Yuan · H. · Li · K. · Guo · Q. · Liu · H. · Lu · Y. · Wang · F. · Mu · L. · Li · Z. · Han · J. · Sun · Y. · Qin · H. · Jiao · L. · Sun · Q. · SUCTION study Investigators
Introduction

Intracranial atherosclerosis is the main cause of stroke globally, with acute large vessel occlusive (LVO) stroke being a predominant contributor to stroke-related mortality. In recent years, aspiration thrombectomy (AT) has emerged as a novel therapeutic method for treating acute LVO stroke. The purpose of this study aims to investigate the safety and efficacy of AT alone or combined with stent retriever thrombectomy (SRT) in the treatment of acute LVO stroke

Methods and analysis

This is a multicentre and observational real-world study involving patients diagnosed with acute LVO stroke. Participants will be treated with AT alone or combined with SRT. According to the actual annual number of embolectomy in the sub-centre and the research years, the sample size of this study is estimated to be 400 patients, of which 300 patients of anterior circulation lesions and 100 patients of posterior circulation lesions are planned to be recruited, being considered that the incidence of posterior circulation is about 20–25%. Clinical data, including baseline characteristics, intraoperative details, postoperative outcomes and follow-up results, will be systematically collected using an Electronic Data Capture system over a follow-up period of 3 months. The primary efficacy endpoint is the rate of excellent functional outcome (modified Rankin Scale score range 0–3) after 90 days, and the successful recanalisation confirmed by digital subtraction angiography. The primary safety outcome is symptomatic intracranial haemorrhage within 48 hours (National Institutes of Health Stroke Scale score increase ≥4). This study will provide us with powerful guidance for the treatment of acute LVO stroke with different aetiologies.

Ethics and dissemination

This study protocol was approved by the Ethics Committee on Human Experimentation at Shandong Provincial Hospital Affiliated to Shandong First Medical University (approval number: SWYX:2022–1025). All the participating sites have received the ethics approval. The outcomes will be disseminated through national and international presentations and peer-reviewed publications.

Trial registration number

ChiCTR2200065172.

Propofol-based versus sevoflurane-based anaesthesia for deceased donor kidney transplantation: the VAPOR-2 study protocol for an international multicentre randomised controlled trial

Por: Huisman · G. J. J. · Berger · S. P. · Thyrrestrup · P. S. · Hausken · J. · Veelo · D. P. · Guirado · L. · Pol · R. · Jensen · L. L. · Tonnessen · T. I. · Bemelman · F. J. · Facundo · C. · THE VAPOR-2 STUDY GROUP · Tamasi · K. · Lunter · G. · Jespersen · B. · Leuvenink · H. G. D. · Str
Introduction

Ischaemia reperfusion injury (IRI) is inevitable in kidney transplantation and negatively affects patient and graft outcomes. Anaesthetic conditioning (AC) refers to the use of anaesthetic agents to mitigate IRI. AC is particularly associated with volatile anaesthetic (VA) agents and to a lesser extent to intravenous agents like propofol. VA like sevoflurane interferes with many of the processes underlying IRI and exerts renal protective properties in various models of injury and inflammation. We hypothesise that a sevoflurane-based anaesthesia is able to induce AC and thereby reduce post-transplant renal injury, reflected in improved graft and patient outcome, compared with a propofol-based anaesthesia in transplant recipients of a deceased donor kidney.

Methods and analysis

Investigator-initiated, multicentre, randomised, controlled and prospective clinical trial with two parallel groups. The study will include 488 kidney transplant recipients from donation after brain death (DBD) or donation after circulatory death (DCD) donors. Participants are randomised in a 1:1 design to a sevoflurane (intervention) or propofol (control) group. The primary endpoint is the incidence of delayed graft function in recipients of DCD and DBD donor kidneys and/or 1-year biopsy-proven and treated acute rejection. Secondary endpoints include functional delayed graft function defined as failure of serum creatinine levels to decrease by at least 10% per day for three consecutive days; primary non-function is defined as a permanent lack of function of the allograft; length of hospital stay and postoperative complications of all kinds, estimated glomerular filtration rate at 1 week and 3 and 12 months calculated with the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula; readmissions at 3 and 12 months, graft survival and all-cause mortality at 12 months.

Ethics and dissemination

The study is approved by the local ethical committees and national data security agencies. Results are expected to be published in 2025.

Trial registration number

NCT02727296.

Multiparametric MRI for local staging in patients with suspected muscle-invasive bladder cancer: study protocol for a multicentre, non-inferiority randomised controlled trial (the BladParadigm study)

Introduction

Muscle-invasive bladder cancer (MIBC) is an aggressive type of cancer. About 50% of patients will die from the disease within 5 years despite radical treatment. This implies that in many patients, the disease has already spread at the time of radical treatment, even though imaging shows no signs of metastasis. We hypothesise that the standard local staging method, transurethral resection of the bladder tumour (TURBT), is partly responsible for tumour cell spread. Furthermore, TURBT (and re-TURBT in many patients) contributes to a significant delay to definitive therapy. The aim of this randomised study is to determine whether multiparametric MRI (mpMRI) of the bladder, in combination with a single outpatient bladder tumour biopsy for histological confirmation, is a safer, faster, less costly and, therefore, more cost-effective diagnostic pathway than TURBT to detect or rule out MIBC.

Methods and analysis

BladParadigm is a two-arm multicentre randomised controlled trial (RCT) conducted in the Netherlands. Over a 3-year period, patients with clinically suspected MIBC without evidence of metastases will be recruited and randomised 1:1 to either TURBT or 3-Tesla mpMRI with same-day outpatient bladder biopsy. The Vesical Imaging Reporting and Data System (VI-RADS) will be used to standardise mpMRI reporting. Patients will undergo definitive treatment based on the results of the TURBT or mpMRI. The study is powered to demonstrate that the mpMRI-based strategy is at least non-inferior to standard TURBT in patients treated with radical cystectomy alone, assuming a relative hazard of 0.55. The required sample size is 360 patients (180 TURBT, 180 mpMRI). The primary outcome is 2-year progression-free survival. Progression will be assessed by imaging, according to the current standard of care. Secondary outcome measures are time to definitive treatment, quality of life (EuroQol 5D-5L), healthcare costs and cost-effectiveness.

Ethics and dissemination

This study has received ethical approval from the Medical Ethical Committee Oost-Nederland (NL83685.091.23). All participants will provide written informed consent prior to inclusion. Findings of this study will be disseminated through peer-reviewed, open-access publications, presentations at scientific conferences and stakeholder briefings.

Trial registration number

NCT05779631.

The INfectious DIsease REgistry BIObank (INDI-REBIO): protocol for the design and implementation of a single-centre, prospective registry and biobank in a tertiary care centre in Italy for advancing infectious disease research

Por: Ripa · M. · Galli · L. · Cinque · P. · Nozza · S. · Spagnuolo · V. · Tassan Din · C. · Guffanti · M. · Lolatto · R. · Piromalli · G. · Carletti · S. · Locatelli · M. · Sanvito · F. · Ponzoni · M. · Cantarelli · E. · Tresoldi · C. · Castagna · A. · on behalf of the INDI-REBIO Study Grou
Introduction

Infectious diseases are a major global health concern, responsible for significant morbidity and mortality. To advance the understanding and treatment of these diseases, biobanks and biorepositories play a crucial role in guaranteeing sample traceability through their entire life cycle (collection, acquisition and registration, processing, storage, distribution) and future analysis of clinical and biological data.

Methods and analysis

The INfectious DIsease REgistry BIObank (INDI-REBIO) is an observational, prospective, monocentric, open-ended registry with ad hoc procedures and a systematic collection of uniform clinical, laboratory, imaging and therapeutic data of patients with suspected or microbiologically documented bacterial, viral, fungal and parasitic infectious diseases from the IRCCS San Raffaele Hospital (Milan, Italy). The study aims to collect both uniform data and biological samples such as blood and other relevant specimens. The registry aims to include significant patient numbers across various conditions (among others: bloodstream infections, endovascular infections as infective endocarditis, central nervous system infections, bone and joint infections, multidrug-resistant organisms (MDROs) colonisation, sexually transmitted infections, HIV infection, emerging and re-emerging infectious diseases), enabling comprehensive research on disease evolution, treatment outcomes and the identification of biomarkers.

Ethics and dissemination

The study adheres to ethical principles outlined by the Helsinki Declaration and Good Clinical Practice guidelines. It has received ethical approval (Comitato Etico CET Lombardia 1, CET 138–2023) and is registered on clinicaltrials.gov (NCT06418048). Participants will provide informed consent and can withdraw at any time. The study results will be disseminated through major international conferences and submitted to peer-reviewed research journals.

Trial registration number

ClinicalTrials.gov, NCT06418048.

Core outcome set and measures of chest health in children and young people with cerebral palsy in the community setting: the CHESTI study protocol

Por: Knight Lozano · R. · Morris · C. · Shannon · H. · Bell · K. · Malyon · H. · Melluish · J. · Latour · J. · CHESTI-study steering group · Andrews · Crombie · Gibson · Grace · Goddard · Kolawole · Lowndes · McNamara · Pilbury · Rapson · Scivier · Sellers · Weighton · Winston
Introduction

Poor chest health is the leading cause of early mortality in children with cerebral palsy (CP). It is also the most common reason to seek healthcare, accruing significant costs and reducing quality-of-life for children and families. Clinical trials examining chest health interventions in CP are characterised by inconsistent outcome measures, limiting the capacity for evidence synthesis to inform clinical application. The study aims to develop a core outcome set (COS) and related measurement instruments to assess, monitor and evaluate chest health in children with CP, both in research and routine clinical practice. The COS will reflect the views of children, young people, parent/carers, clinicians and researchers, emphasising under-represented groups in research and those at risk of poorer chest health.

Methods and analysis

A 3-phase methodology will be conducted in line with the Core Outcome Measures in Effectiveness Trials (COMET) Initiative. (1) Candidate outcomes will be identified through a qualitative evidence synthesis and interviews with key stakeholders. Findings will be mapped to COMET-taxonomy, generating a list of candidate outcomes. (2) An international e-Delphi survey will invite stakeholders to rate the importance of each outcome, followed by a consensus meeting to ratify the COS. (3) A structured review, guided by health measurement taxonomy, will evaluate relevant instruments, with a final meeting to agree on recommended measures for each COS domain.

Ethics and dissemination

Ethical approval was provided by the University of Plymouth Research Ethics Committee for the qualitative interview study (ID5116), e-Delphi study and consensus meeting (ID5636). Study findings will be published open access in a peer-reviewed journal and presented at relevant national and international conferences.

Study registration

COMET registration: 2590 (https://www.comet-initiative.org/Studies/Details/2590)

PROSPERO registration number

CRD42024562735.

Surgical versus non-surgical management of orbital fractures: study protocol for evidence generation of a prospective multicentre observational cohort registry

Introduction

There remains little consensus or guidelines for the clinical management of traumatic orbital fractures (OFx). The OFx Registry aims to increase real-world clinical evidence for the treatment of OFx via prospective, multicentre, international data collection. The primary objectives of this observational cohort study are (1) to document current treatment practices for and (2) to assess the outcomes of surgical and non-surgical treatment of orbital floor and/or medial wall fractures.

Methods and analysis

Approximately 300 adult patients presenting with a displaced OFx in the orbital floor and/or medial wall will be enrolled prospectively over a recruitment period of ~36 months. All eligible patients treated either surgically or non-surgically as per routine standard of care will have follow-up assessments at 6 weeks, 3 months and 6 months post-treatment. Demographic data, injury details, treatment details and outcome measures will be documented in a cloud-based database. Outcome measures include clinical outcomes (eg, diplopia, extraocular motility, and condition of the eyelid, globe and soft tissues), radiological outcomes from collected images, patient-reported outcomes (eg, Diplopia Questionnaire and the newly developed AO Craniomaxillofacial (CMF) Injury Symptom Battery) and complications. A statistical analysis plan will be prepared before final analysis summarising the descriptive statistics to be used for data assessment. Appropriate research questions and statistical tests may be applied additionally, depending on the availability and quality of data collected.

Ethics and dissemination

Ethics approval was obtained before patients were enrolled at each participating site. Patient enrolment followed an informed consent process approved by the responsible ethics committee. Peer-reviewed publications are planned to disseminate the study results.

Trial registration number

NCT03887988.

Deconstructing resuscitation training for healthcare providers: a protocol for a component network meta-analysis

Introduction

The necessity of enhancing resuscitation training has been encouraged by The International Liaison Committee on Resuscitation and the American Heart Association to reduce mortality, disability and healthcare costs. Resuscitation training is a complicated approach that encompasses various components and their mixture. It is essential to identify the most effective of these components and their combinations, to measure the corresponding effect size and to understand which participant groups may enjoy the greatest advantage.

Methods and analysis

We will systematically search 12 databases and two clinical trial registries for randomised controlled trials (RCTs) that examine different resuscitation training methods from inception to April 2025. The analysis will be carried out using the standard network meta-analysis and component network meta-analysis models. Resuscitation skills of staff will be the primary outcome of this analysis. Paired reviewers will independently screen and extract data. A consensus will be sought with the principal investigators to resolve any disagreements that cannot be achieved through regular meetings. Each intervention in each RCT will be decomposed according to its constituent components, such as delivery method, interactivity, teamwork, digitalisation and type of simulator. The analysis will be conducted using the frequentist and bayesian approach in the R environment. RoB V.2.0 and Confidence in Network Meta-Analysis will, respectively, be used to assess the risk of bias and the certainty of the evidence.

Ethics and dissemination

As we will use only aggregated secondary data without individual identities, ethical approval is not required. Results of this review will be shared through a peer-reviewed publication and presentation of papers at any relevant conferences.

PROSPERO registration number

CRD42024532878

A Model of the Determinants of Maternal Mortality for Indigenous Women

ABSTRACT

Aims

To present a model of the determinants of maternal mortality for Indigenous women—social, structural, political and biological.

Design

Non-Indigenous academicians and an Indigenous tribal citizen and scholar partnered to amplify Indigenous women's voices.

Method

With epistemic decolonisation and Indigenist feminism as our theoretical basis, we used theory derivation to create a model of the determinants of Indigenous maternal mortality.

Results

Risk factors include biological warfare and ongoing cultural genocide. We also identified protective factors like resilience and cultural connectedness. Finally, we illustrate complex and multifaceted relationships among and between these concepts in a model of the determinants of Indigenous maternal mortality.

Conclusion

Solutions that address determinants of Indigenous maternal mortality are critical for Indigenous families to flourish. Academic researchers and tribal communities must continue to partner to support the safety and vitality of Indigenous women.

Implications for the Profession

Our model can inform nursing and other research, including interdisciplinary research, policy development and trauma-informed, culturally relevant clinical practice to address disparities in maternal mortality that Indigenous women experience.

Impact

Despite increasing attention to the United States' maternal health crisis, stark disparities persist between groups of women. At its peak in December 2021, Indigenous maternal mortality was 118.7 deaths per 100,000 live births—the highest of all groups, and almost 5 times higher than that of their White counterparts (26.6).

Reporting Method

Not applicable.

Patient or Public Contribution

Three members of the public who identify as Indigenous agreed to review and comment on the model specifically from their Indigenous lens.

Australasian Resuscitation In Sepsis Evaluation: FLUid or vasopressors In emergency Department Sepsis (ARISE FLUIDS) trial: study protocol

Por: Howe · B. D. · Macdonald · S. P. J. · Arendts · G. · Bellomo · R. · Burcham · J. · Delaney · A. · Egerton-Warburton · D. · Fatovich · D. · Fraser · J. F. · Higgins · A. · Jones · P. · Keijzers · G. · Milford · E. · Udy · A. A. · Williams · P. · Young · P. · Peake · S. L.
Introduction

International consensus guidelines support the initial administration of 30 mL/kg of intravenous fluids for haemodynamic resuscitation of newly diagnosed septic shock. Practice variation exists between the volume of fluids administered and timing of vasopressor commencement. The optimal approach in patients with septic shock is uncertain.

Methods and analysis

Australasian Resuscitation In Sepsis Evaluation: FLUid or vasopressors In emergency Department Sepsis is a 1000-participant multicentre, randomised, open-label, parallel group clinical trial conducted in patients with septic shock presenting to the emergency department in participating sites in Australia, New Zealand and Ireland. Participants are randomised (1:1) to either restricted fluids and early vasopressors or a larger initial intravenous fluid volume and later vasopressors. The primary outcome is days alive and out of hospital at day 90 postrandomisation. Secondary outcomes are all-cause mortality at day 90, time from randomisation until death (to day 90), days alive and at home at day 90 and ventilator-free, vasopressor-free and renal replacement-free days to day 28 postrandomisation and death or disability at 6-month and 12-month postrandomisation. Health-related quality of life will be assessed at day 180 and 12 months following randomisation.

Ethics and dissemination

The study was approved by Northern Sydney Local Health District Human Research Ethics Committee (HREC2020/ETH02874) on 21 January 2021. Patients will be enrolled under a waiver of prior consent. The patient or next-of-kin (or equivalent according to local jurisdiction) is approached at the first available opportunity and given a trial information sheet. According to local approvals, the patient or next-of-kin chooses to either continue in the trial or opt-out/decline continued participation. Results will be disseminated in peer-reviewed journals and presented at academic conferences.

Trial registration number

NCT04569942

Surgery or radiotherapy for early-stage cancer study (SORT) target trial protocol: stereotactic ablative radiotherapy (SABR) with curative intent versus surgical resection for early-stage non-small cell lung cancer (NSCLC)

Por: Kagenaar · E. · Lugo-Palacios · D. G. · Hutchings · A. · Aggarwal · A. · ONeill · S. · Rachet · B. · Edwards · J. · Faivre-Finn · C. · Grieve · R. · Surgery or Radiotherapy Study (SORT) group · Choudhury · Vohra · Cresswell · Charlton · Chuter · Nolte · Gravenhorst · Alencar · Mon
Introduction

Randomised controlled trials have aimed to assess the effectiveness of stereotactic ablative radiotherapy (SABR) with curative intent versus surgical resection for individuals diagnosed with early-stage non-small cell lung cancer (NSCLC) but have failed to recruit sufficient numbers of patients. Non-randomised studies for early-stage NSCLC have reported mixed outcomes following curative SABR versus surgical resection, but did not fully address confounding by indication. The Surgery Or RadioTherapy for early-stage cancer study (SORT) will assess the comparative effectiveness of SABR with curative intent versus surgical resection for NSCLC with a target trial emulation approach, as this can reduce biases in observational studies that aim to estimate the causal effect of interventions.

Methods and analysis

The SORT study will use the National Cancer Registry for individuals diagnosed with early-stage NSCLC in England during 2015–2020 (inclusive) who received SABR with curative intent or surgical resection. These data will be linked to Hospital Episode Statistics, National Radiotherapy Data Set and the Systemic Anti-Cancer Therapy dataset to obtain information on clinical and sociodemographic characteristics and the treatment received. This target trial emulation will define study population eligibility criteria and regimens for SABR with curative intent and surgical resection. We will reduce the risk of residual confounding with instrumental variable analyses that will exploit geographical variation across the National Health Service in England in the use of SABR with curative intent versus surgical resection for early-stage NSCLC. The primary outcome will be 3-year all-cause mortality after treatment initiation. Secondary outcomes will include 3-month, 6-month, 12-month and 24-month all-cause and lung-cancer mortality, time to death, numbers of hospitalisations, incremental costs and incremental cost-effectiveness.

Ethics and dissemination

Ethical approval was obtained from the London School of Hygiene and Tropical Medicine Research Ethics Committee (reference number 29 717–1). Results will be disseminated to clinicians, patients, policy-makers and researchers.

Longitudinal study of infants born preterm (<33 weeks) or with a very low birth weight in the Ile de France region of France (SEV-IDF programme): cohort profile

Por: Anzelin · L. · Thiebaut · A. C. M. · Leloup · L. · Lapillonne · A. · Pierrat · V. · Tubert-Bitter · P. · Escolano · S. · Desplanques · L. · Granier · M. · Hanf · M. · study group · S.-I. · SEV-IDF study group · Desplanques · Granier · Leloup · Zupan-Simunek · Lebeaux · Mathieu · Bri
Purpose

The SEV-IDF programme aims to track infants born before 33 weeks of gestation, with very low birth weight (VLBW), neonatal encephalopathy or severe birth anomalies and perinatal disease. It employs an open, prospective, multicentric, population-based cohort approach. This report aims to describe the methodology employed to establish and manage the programme, details regarding follow-up procedures, baseline characteristics of the included infants, and highlights new research opportunities emerging from the "Suivi des Enfants Vulnérables d'Ile-de-France" (SEV-IDF) programme.

Participants

The programme aims to (1) detect developmental anomalies early, (2) improve prevention using standardised data, (3) optimise follow-up care and (4) support multidisciplinary research.

Eligible participants are infants alive at discharge from the 59 maternities with a neonatal unit of the Île-de-France (IDF) region (France). A network of 567 trained physicians monitors the children’s development at 4 months, 1 and 2 years of corrected age, and 3, 4, 5, 6 and 7 years of age. Collected data include sociodemographic, pregnancy and neonatal characteristics, and standardised child development scores.

Findings to date

The programme enrolled 21 175 participants between 2016 and 2023, with 16 461 (77.7%) having a gestational age less than 33 weeks, 1916 (9.0%) others having VLBW, 1525 (7.2%) having encephalopathy and 1273 (6.0%) having another severe birth anomaly.

Future plans

The collected data will enable the SEV-IDF scientific committee to describe high-risk infants in the IDF region, design evidence-based campaigns to improve the quality and effectiveness of the follow-up as well as conduct research on developmental anomalies in these high-risk infants. Ongoing research currently focuses on anticipating loss to follow-up and early detection of developmental anomalies.

Realist evaluation of Belgian pilot projects for paediatric transmural care: protocol for a mixed methods study

Introduction

The Belgian healthcare system is to a large extent hospital-centred, prompting government initiatives to shift care towards patient’s homes and reduce hospital stays. To avoid unnecessary hospital stays and offer alternative and innovative forms of care, the Belgian federal health authorities selected five pilot projects for transmural care for chronically ill children. Guided by the Medical Research Council framework, this study aims to evaluate the paediatric transmural care projects to inform new models for paediatric care.

Methods and analysis

Using a mixed-methods realist evaluation, the study comprises three phases: (1) initial programme theory development, (2) initial programme theory testing and (3) programme theory refinement. In a first phase, the initial programme theory rooted in the normalisation process theory will be refined from insights retrieved from document review and focus group interviews with healthcare professionals. In the second phase, the initial programme theory will be tested using empirical data. Routine data and questionnaires will examine whether characteristics of participants and outcomes are in line with the quintuple aim framework. Focus groups with children, parents and stakeholders, and document analysis will be used to evaluate the structure of the intervention, examine the process and context, and understand more in-depth the outcomes. A budget impact analysis will be used to assess whether the pilot project is affordable. In a third phase, qualitative and quantitative data will be analysed using a convergent mixed-methods model, involving continuous triangulation of multiple data sets to facilitate greater understanding of the context and refinement of the programme theory.

Ethics and dissemination

The study protocol was reviewed and approved by the Ethics Committee of the Ghent University Hospital (Belgian Registration Number B6702024000193) after consultation with all Ethics Committees of the participating hospitals. Written informed consent will be obtained from participants or their legal representatives prior to data collection. Participant confidentiality will be maintained throughout the study. Study results will be published in international peer-reviewed journals and will be presented at national and international conferences. The general population will be informed of the aggregated results.

Trial registration number

ClinicalTrials.gov, NCT06679595.

Enhancing early detection and treatment of psychosis in Germany: a protocol for the health economic evaluation of an artificial intelligence-guided complex intervention

Introduction

Psychosis, characterised by chronic symptoms often emerging in youth, imposes a substantial burden on individuals and healthcare systems. While early detection and intervention can mitigate this burden, there is limited evidence on the cost-effectiveness of such approaches. To address this lack of evidence, this study protocol outlines the health economic implications of an artificial intelligence (AI)-based intervention, the Computer-Assisted Risk-Evaluation (CARE), designed to prevent psychosis. The intervention uses AI technologies to enhance the diagnosis and treatment quality for individuals at high risk of psychosis.

Methods and analysis

The health economic evaluation has been designed alongside a 12-month multicentre randomised controlled trial comparing CARE with treatment as usual from both payer and societal perspectives. An implementation cost analysis will complement the evaluation, and long-term consequences beyond the trial will be explored descriptively. Based on a literature review, an initial economic logic model will guide subsequent analyses by depicting CARE’s programme theory.

The cost-effectiveness assessment will include averted cases of manifest psychosis and quality-adjusted life-years using the EuroQol 5-Dimensions 3-Level instrument. Other effectiveness outcomes will also be incorporated into a cost–consequence analysis. Cost-effectiveness acceptability curves reflecting statistical uncertainty will be constructed, incorporating various payer and societal willingness-to-pay values. The implementation cost analysis will follow a mixed-methods approach to capture facility-specific costs.

A dark logic model, emphasising negative outcomes, will be developed to investigate long-term consequences. Further, the initial economic logic model will be refined using trial data and expert interviews. This comprehensive approach aims to provide decision-makers not only with evidence on the cost-effectiveness of CARE, but also with a broader understanding of the implications of the intervention.

Ethics and dissemination

The study has received ethical approval and plans to disseminate its findings through publication in a peer-reviewed journal and conference presentations.

Trial registration number

NCT05813080.

Abatacept versus tocilizumab for the treatment of rheumatoid arthritis in TNF inhibitor inadequate responders: study protocol of the SUNSTAR randomised controlled open-label superiority trial

Por: Pascart · T. · Fautrel · B. · Gottenberg · J.-E. · Ducoulombier · V. · Richez · C. · Truchetet · M.-E. · Avouac · J. · Morel · J. · Basch · A. · Cormier · G. · The SUNSTAR Study Group · The CRI-IMIDIATE Network · Houvenagel · E. · Mariette · X. · Norberciak · L. · Pascart · Ducoulom
Introduction

Biological disease modifying antirheumatic drugs (bDMARDs) have a central role in the treatment of rheumatoid arthritis (RA). Tumour necrosis factor inhibitors (TNFis) are commonly used as first-line agents, while non-TNFis (tocilizumab, abatacept and rituximab) have shown to be non-inferior to TNFis in head-to-head trials. In case of TNFi inadequate response, using other mechanisms of action provides a better response than using an alternate TNFi. Which non-TNFi bDMARD administered subcutaneously to allow for ambulatory management to choose in case of first line TNFi inadequate response has not been tested in a randomised clinical trial, while observational data support a potential superiority of tocilizumab over abatacept.

Methods and analysis

The SUNSTAR (SUbcutaNeouS Tocilizumab vs Abatacept in TNF Alpha inadequate responders for the treatment of Rheumatoid arthritis) study is a 52-week prospective, randomised, multicentre, open-label, superiority phase IV trial comparing subcutaneous tocilizumab with abatacept in a 1:1 ratio. Patients with active RA (Disease Activity Score-erythrocyte sedimentation rate >3.2 and Clinical Disease Activity Index (CDAI) >10) and with inadequate 3-month response to a first or second TNFi are included in 25 centres in France. The primary outcome is the CDAI improvement at week 24. Intention-to-treat analysis will be applied primarily. The secondary outcome is a composite outcome of the percentage of responders defined as a CDAI

Ethics and dissemination

Ethics approval was obtained from the committee for the protection of persons (Comité de protection des personnes Sud Méditerranée I 17.00608.001744). The findings from this study, whether positive or negative, will be published in peer-reviewed journals and will be presented at national and international conferences. The results will inform future recommendations on the management of RA.

Trial registration number

NCT03227419 and EudraCT2017-000947-41.

Low-dose versus high-dose intravenous nitroglycerin in the treatment of sympathetic crashing acute pulmonary oedema: a systematic review and meta-analysis focusing on efficacy, safety and outcomes

Por: Pramudyo · M. · Kamarullah · W. · Pranata · R. · Prameswari · H. S. · Iqbal · M. · Dewi · T. I. · Hidayat · S. · Akbar · M. R.
Objectives

Sympathetic crashing acute pulmonary oedema (SCAPE) is a menacing medical emergency and a severe form of acute heart failure that requires urgent intervention. Nitroglycerin (NTG) is commonly used in SCAPE management, but the optimal dosing remains uncertain. This meta-analysis compared the efficacy and safety of high-dose vs low-dose NTG in SCAPE patients, assessing mechanical ventilation need, symptom resolution, hospital stay and major adverse cardiovascular events (MACE).

Design

Systematic review and meta-analysis conducted per Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines, registered in Prospective Register of Systematic Reviews (CRD42024527486).

Data sources

A comprehensive search in PubMed, Europe PMC and ScienceDirect up to November 2024. Reference lists of included studies were also reviewed.

Eligibility criteria

Randomised controlled trials (RCTs) and observational studies comparing high-dose NTG (≥100 mcg/min) with low-dose NTG (

Data extraction and synthesis

Two authors independently screened the titles and abstracts of identified studies for eligibility. Full texts of potentially relevant articles were then reviewed. Any discordance or disagreements were resolved through discussion, with final decisions made by consensus. Risk of bias was assessed using the Newcastle–Ottawa Scale. Meta-analysis was performed using STATA 17.0 and Review Manager 5.4. The Mantel–Haenszel method was applied for dichotomous outcomes, and the inverse variance approach for continuous outcomes. Heterogeneity was assessed via I-squared (I)2, with a random-effects model applied when needed.

Results

Four studies (one RCT, three observational) with 185 SCAPE patients met inclusion criteria. High-dose NTG reduced mechanical ventilation need (RR=0.31, 95% CI: 0.10 to 0.96; p=0.04, I2=0%, high certainty) and increased symptom resolution within 6 hours (RR=3.88, 95% CI: 1.95 to 7.71; p2=27%, moderate certainty). Hospital stay was shorter (MD=–47.49 hours, 95% CI: –93.76 to –1.21; p=0.04, I2=78%, low certainty). No significant difference was found in MACE risk (RR=0.41, 95% CI: 0.06 to 2.68; p=0.35, I2=72%, very low certainty). Hypotension incidence was 0% in both groups.

Conclusions

High-dose NTG improved clinical outcomes in SCAPE, reducing mechanical ventilation need, symptom duration and hospital stay without increased adverse events. These findings suggest high-dose NTG as a promising treatment strategy. Further large-scale studies are needed to optimise dosing protocols.

Secondary prevention by striking the balance in 24-hour movement behaviour by empowering people at risk with a stroke: rationale and design of the RISE intervention randomised controlled trial

Por: Biemans · C. F. M. · Hartman · Y. A. W. · Broers · S. · Pagen · S. · Hendrickx · W. · RISE Study Group · van Dongen · J. M. · Verschuren · O. W. · English · C. · Veenhof · C. · Visser-Meily · J. M. A. · Pisters · M. F.
Introduction

Striking the balance in 24-hour movement behaviour (sedentary behaviour, physical activity and sleep) is expected to reduce the risk of a new major cardiovascular event or death (MACE). We aim to determine the effectiveness and cost-effectiveness of the RISE (Reduce and Interrupt sedentary behaviour using a blended behavioural intervention to Empower people at risk towards sustainable 24-hour movement behaviour change) intervention by improving 24-hour movement behaviour for prevention of MACE and gaining quality-adjusted life years (QALYs) in community-dwelling people at risk with a first-ever stroke.

Methods and analysis

This assessor-blinded multicentre randomised controlled trial includes about 1000 participants with a first-ever stroke, of which 752 participants require secondary prevention based on their 24-hour movement behaviour. Participants will be randomly assigned to the experimental group (RISE intervention + usual care) or control (usual care) group. RISE is a 15-week blended care intervention: primary care physiotherapists coach people in their home setting using behaviour change techniques and the RISE eCoaching system. This system consists of: (1) an activity monitor, (2) a smartphone application that provides real-time feedback and contains e-learning modules and (3) a monitoring dashboard for the physiotherapist. A close relative of the participant is involved during the intervention to provide social support. The primary outcome is the effectiveness of the RISE intervention regarding the prevention of MACE measured at one year post randomisation using survival analysis comparing the experimental and control groups. Secondary outcomes include cost-effectiveness for MACE prevention and QALYs and changes in 24-hour movement behaviour over time using compositional data analysis.

Ethics and dissemination

Ethical approval is obtained from Medical Ethics Review Committee Utrecht, NedMec NL83940.000.23. Findings will be disseminated through international peer-reviewed journals and conferences. A sustainable 24-hour movement behaviour change is needed to gain long-term benefits of lowering MACE in patients with stroke. The RISE intervention offers this foundation by integrating behaviour change techniques, the RISE eCoaching system, involvement of participatory support and extensively trained RISE physiotherapists. Consequently, the RISE intervention is expected to be (cost-)effective compared with usual care, and hence, this study will offer a foundation for implementing the RISE intervention in standard poststroke care.

Trial registration number

NCT06124248.

Burnout, Mental Health, and Workplace Characteristics: Contributors and Protective Factors Associated With Suicidal Ideation in High‐Risk Nurses

ABSTRACT

Background

A call for action has been issued nationwide to prevent suicide among nurses. An increased understanding of contributing and protective factors associated with suicidal ideation in nurses is needed to implement preventive measures. Factors needing exploration include nurses' burnout, mental well-being, physical health, and workplace characteristics.

Aims

This study aimed to determine factors associated with suicidal ideation in 501 moderate-to-high-risk nurses, including their mental health, level of burnout, health-related personal beliefs, healthy lifestyle behaviors, and workplace characteristics.

Methods

A descriptive, cross-sectional correlational study was conducted on baseline survey data that was completed before the nurses were randomized to one of two interventions as part of their participation in a randomized controlled trial investigating the efficacy of a combined mental health screening program and cognitive-behavioral skills building intervention versus a screening program alone. Nurses were recruited from across the United States via email. Only nurses identified with moderate-to-high-risk adverse mental health outcomes, including suicidal ideation, were included. The survey used valid and reliable measures to assess burnout, anxiety, depression, suicidal ideation, post-traumatic stress, healthy lifestyle behaviors, health-related personal beliefs, resilience, job satisfaction, self-perceived mattering to the workplace, and intent to leave. Bivariate tests were performed.

Results

Burnout, anxiety, depression, and post-traumatic stress were individually correlated with increased odds of suicidal ideation, as were nurses working 12-h shifts and those who reported an intent to leave their jobs. Protective factors against suicidal ideation included resilience, positive health-related personal beliefs, healthy lifestyle behaviors, job satisfaction, and workplace mattering.

Linking Action to Evidence

There is an urgent need for policies and implementation of evidence-based interventions to address mental health issues in nurses to ultimately prevent suicide. Burnout should be considered as a possible precursor to serious adverse mental health problems and not just an operational retention issue. Leaders need to invest in resources to enhance nurses' mental health, fix system problems that are at the root cause of burnout, routinely recognize employees for their excellent work, and communicate that they matter. Leaders should listen carefully to their nurses, prioritize their ideas for impactful change, and appreciate those who contribute to improving culture and caring practices.

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