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[18F]AlF-FAPI-74 PET/CT for preoperative assessment of the peritoneal cancer index and comparison with MRI-based, surgical and pathological assessment in colorectal cancer patients eligible for CRS-HIPEC: study protocol for a prospective observational pro

Por: van den Bos · M. · Vogel · W. V. · van Duijvenvoorde · M. · Kok · N. F. M. · Aalbers · A. G. J. · Snaebjornsson · P. · Lacle · M. M. · Willemse · J. R. J. · Kool · W. · Hendrikx · J. J. M. A. · de Hingh · I. H. J. T. · van Grevenstein · W. M. U. · Boerma · D. · Milne · A. N. · van
Introduction

Colorectal cancer patients with peritoneal metastases have a very poor prognosis. A minority of these patients is eligible for curative cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC). The peritoneal cancer index (PCI) is an important criterion to select patients for CRS-HIPEC. Due to challenges in peritoneal metastasis detection by imaging, the PCI is currently routinely assessed by invasive diagnostic laparoscopy in addition to CT and/or MRI. Yet, open-close procedures and early disease recurrence following CRS-HIPEC are common, indicating the need for better patient selection tools. Fibroblast activation protein (FAP)-targeted imaging has recently emerged as a promising strategy for visualising peritoneal disease. The aim of this study is to assess the potential value of FAP inhibitor positron emission tomography/CT (FAPI-PET/CT) as an alternative non-invasive tool for quantitative PCI assessment.

Methods and analysis

TROMPET is a prospective observational proof-of-concept study. A total of 25 colorectal cancer patients with suspected or verified peritoneal metastases who are eligible for CRS-HIPEC based on MRI will be included in this study. Patients younger than 18, pregnant and/or breastfeeding, with any contraindication(s) for MRI, PET, CT and/or CRS-HIPEC, and/or with a known additional malignancy within the past five years are excluded. Participants will receive [18F]AlF-FAPI-74 PET/CT prior to surgery. The primary objective is to determine the correlation between PCI scores determined by FAPI-PET/CT and ‘true’ PCI scores determined by histopathological analysis of all resected lesions. The secondary objectives include the correlations between PCI scores determined by FAPI-PET/CT, by MRI and during surgery, the potential of FAPI-PET/CT to detect extraperitoneal metastases, and molecular and immunohistochemical analysis of resected tissue to provide insight into the nature of FAPI-PET-positive lesions. The primary endpoint is all PCI scores determined by FAPI-PET and histopathology and their correlation on patient level. If this study shows that the PCI score can be accurately determined preoperatively by FAPI-PET/CT, it will form the basis for further developing FAPI-PET/CT as a quantitative, standardised, non-invasive diagnostic tool for selecting patients for CRS-HIPEC. Moreover, the ‘radiology-pathology’ setup of the study will allow us to characterise FAPI-PET-positive and PET-negative lesions in detail, providing further insight into the strengths and potential pitfalls of FAPI-PET/CT in the detection of peritoneal metastases from colorectal cancer.

Ethics and dissemination

This study is approved by the assigned Medical-Research-Ethics-Committee (METC NedMec) on 19-08-2024. All participants will provide written informed consent. Study results will be disseminated through (inter)national meetings and peer-reviewed publications.

Trial registration number

2024-512301-16-01

Evaluating the feasibility and acceptability of an online research capacity-building education programme for the health and care workforce: a mixed-methods pilot study

Por: Lamont · S. · Berzins · K. · Aspinall · G. · Lowther-Payne · H. J. · Boland · P. · Harris · C. · Harrison · J. · Hirst · Y. · Spencer · J. · Weldon · J. C. · Watkins · C. L.
Objectives

To evaluate the feasibility and acceptability of an online research capacity-building (RCB) education programme for the health and care workforce and explore its preliminary outcomes.

Design

Mixed-methods pilot study incorporating quantitative survey data and a qualitative group interview.

Setting

Single Health Innovation organisation in England’s North West region.

Participants

Staff working in research, evaluation and innovation-related roles.

Interventions

16 one-hour online RCB education sessions, informed by the Research Capacity and Culture Tool (individual domain), were delivered weekly via Microsoft Teams between February 2024 and October 2024.

Primary and secondary outcome measures

The primary outcomes were feasibility and acceptability of the programme, assessed through attendance and a participant group interview. The secondary outcome was change in behaviour intention measured pre–post education sessions using the Continuing Professional Development Reaction (CPD-R) questionnaire.

Results

Attendance per RCB education session ranged from 2 to 11 participants. Post-session CPD-R completion was low, limiting matched pre–post analysis, but median scores were generally higher post-session across most constructs. Four themes and eight sub-themes were identified from qualitative data. The four core themes were: establishing a common ground for research capacity building; creating pathways for meaningful involvement; translating knowledge within organisational contexts; and bridging individual development and collective momentum. The online format was received well for its accessibility and convenience, fitting within busy working schedules. Participants also reported increased confidence and perceived skill development.

Conclusions

This pilot study demonstrates initial feasibility and acceptability of an online format for RCB education within the health and care workforce. The format has potential for delivery at scale, where time and service pressures limit access to face-to-face programmes. Session length and content support require refinement in future iterations. Further research should examine implementation across diverse settings with larger samples.

Intraepithelial serous carcinoma of the endometrium: protocol for a prospective multicentre registry in the Netherlands

Por: Slaager · F. C. · Hoogduin · K. J. · Hofhuis · W. · Groenendijk · F. H. · van Beekhuizen · H. J.
Introduction

Serous endometrial intraepithelial carcinoma (SEIC) is a rare, non-invasive lesion of the endometrial epithelium, typically characterised by p53 abnormalities. Although regarded as a precursor lesion, recent classification systems increasingly position SEIC within the broader spectrum of serous carcinomas and current guidelines place non-invasive p53-abnormal serous lesions in an uncertain risk category due to limited outcome data. As a result, SEIC is not consistently addressed as a distinct diagnosis, contributing to variation in clinical management. Complete surgical staging, including pelvic and para-aortic lymph node assessment, is frequently performed, yet supporting evidence remains scarce. This study aims to collect longitudinal data to evaluate surgical management strategies in relation to clinical outcomes, survival and quality of life.

Methods and analysis

This multicentre prospective observational cohort will enrol patients diagnosed with SEIC or equivalent non-invasive serous lesions who provide informed consent. Data will be collected using electronic case report forms (Castor Electronic Data Capture). Baseline clinical, pathological, molecular and treatment data will be collected, including imaging, histopathology, immunohistochemistry and molecular classification when available. Patient-reported outcomes will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Endometrial Cancer Module (EORTC QLQ-EN24) and EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) questionnaires at baseline, 6 months, 2 years and 5 years after diagnosis. The primary outcome is progression-free survival, secondary outcomes include overall survival, health-related quality of life and adverse events. Analyses will be primarily descriptive. Survival outcomes will be estimated using Kaplan-Meier methods, with Cox proportional hazards modelling used to explore predictors of outcome where feasible.

Ethics and dissemination

The study will be conducted in accordance with the Declaration of Helsinki and applicable regulations. Ethical approval was obtained at the Erasmus MC (MEC-2025-0368). Results will be disseminated through peer-reviewed publications and scientific meetings.

Trial registration number

NCT06677242.

Comparative performance of 24G and 26G short peripheral catheters in neonates: a single-centre retrospective cohort study in a tertiary neonatal intensive care unit

Por: van Rens · M. F. P. T. · Piersigilli · F. · Elmalik · E. E. · Francia · A. L. V. · van Loon · F. H. J. · Bayoumi · M. A. A.
Background

Short peripheral catheters (SPCs) are the most frequently used vascular access devices in neonates but are associated with complications and limited dwell times. International guidelines recommend using the smallest appropriate catheter gauge, yet 24G SPCs remain the default choice in many neonatal intensive care units (NICUs) while 26G SPCs are less often used because of concerns about flow adequacy particularly during blood transfusions. Evidence directly comparing these gauges in neonates is limited.

Methods

We conducted a retrospective cohort study in a tertiary NICU and national referral centre for high-risk neonatal care in Doha, Qatar. Data were collected between 1 August 2018 and 31 December 2023. Eligible participants were neonates (0–28 days) who received at least one SPC insertion. Data extracted included demographics, catheter characteristics, dwell time, complications and reasons for removal. Analyses were performed at the catheter episode level. Dwell times were analysed using Kaplan–Meier survival curves with log-rank testing, and group comparisons were performed with parametric or non-parametric tests as appropriate.

Results

A total of 45 753 SPC episodes were analysed: 10 531 (23.0%) 24G and 35 222 (77.0%) 26G. Baseline characteristics were comparable between the groups. The mean dwell time was slightly longer for 26G than for 24G (35.1 vs 32.6 hours, pp

Conclusion

In this large neonatal cohort, 26G SPCs were associated with a statistically longer dwell time than 24G SPCs, although the absolute difference was small. Therapy completion and complication rates were comparable between the groups, whereas first-attempt insertion success rates were higher with 26G SPCs.

Fluorescence imaging using indocyanine green to identify sentinel lymph nodes during surgery for breast cancer (INFINITE): protocol for a hybrid effectiveness-implementation trial using a stepped-wedge cluster design

Por: Henskens · I. J. · Dinger · T. L. · Stekelenburg · I. · Dijksman · L. M. · Verkooijen · H. M. · Postma · E. L. · Doeksen · A. · Schuijt · H. J. · INFINITE Study Group · Doeksen · Postma · Henskens · Dijksman · van Swol · Lavalaye · Schuijt · Verkooijen · Volders · Evers · de Widt-
Introduction

Sentinel lymph node biopsy (SLNB) is the standard procedure for axillary staging in clinically node-negative breast cancer. Traditionally, SLNB is performed using technetium-labelled (99mTc) nanocolloid, with or without blue dye. However, both tracers have important limitations. Blue dye poses safety risks, while 99mTc-nanocolloid introduces additional hospital visits, radiation exposure, logistical complexity and high costs. Indocyanine green (ICG) fluorescence is a non-radioactive alternative, offering real-time visualisation while addressing many limitations of traditional tracers. Yet, adoption of ICG-guided SLNB remains limited. This trial aims to guide the implementation of ICG-guided SLNB via axillary incision, evaluate its real-world effectiveness and inform conditions for nationwide scale-up.

Methods and analysis

The INFINITE trial is a multicentre, hybrid effectiveness-implementation study employing a stepped-wedge cluster design across seven Dutch hospitals. Clusters sequentially transition from SLNB using 99mTc-nanocolloid alone (Phase I) to ICG as the primary tracer and 99mTc-nanocolloid as a within-patient control (Phase II), and finally to ICG alone (Phase III). The hybrid design enables evaluation of implementation outcomes (penetration, adoption, fidelity, appropriateness, feasibility, acceptability), intervention outcomes (effectiveness, safety, costs) and patient-reported experience (patient satisfaction). The primary outcome is penetration, the proportion of Phase III SLNB procedures performed with ICG alone. An integrated implementation approach combines the Grol and Wensing model (process model), the Consolidated Framework for Implementation Research (determinant framework) and Proctor’s outcomes framework (evaluation framework). Outcomes are assessed quantitatively, supplemented by an embedded mixed-methods component to explain variation in implementation across centres.

Ethics and dissemination

Ethical approval was obtained from the Medical Research Ethics Committees United (6 November 2024; NL87551.100.24). Results will be submitted to open-access, peer-reviewed journals and presented at conferences focused on oncological or image-guided surgery. Implementation tools, including a clinical protocol, implementation guide, educational materials and patient information, will be developed to support national adoption.

Trial registration number

NCT07146295.

Association between the use of anti-herpetic drugs and subsequent initiation of Alzheimers disease drug treatment: Dutch population-based inception cohort study

Por: Alghamdi · A. · Balafas · S. · Bos · J. H. J. · van Munster · B. C. · Rafie · K. · Dolga · A. M. · Hak · E.
Objectives

To examine whether exposure to anti-herpetic drugs (AHDs: acyclovir, valacyclovir, famciclovir) is associated with reduced risk of Alzheimer’s disease (AD) treatment initiation.

Design

Population-based retrospective matched cohort study.

Setting

University Groningen community pharmacy database IADB.nl, covering approximately 125 Dutch pharmacies (1994–2024).

Participants

262 757 adults aged 50–80 years without prior dementia or AD treatment. Exposed individuals with antiherpetic prescriptions (n=23 887) were matched 1:10 to unexposed controls (n=238 870) by age, sex and calendar time.

Intervention

AHDs: acyclovir, valacyclovir, famciclovir.

Main outcome measures

Initiation of AD drug treatment, defined as at least two prescriptions for rivastigmine, donepezil, galantamine or memantine within 1 year. Cox proportional hazards models estimated HRs with 95% CIs, adjusted for comorbidities and medications. Analyses were stratified by period (1994–2018 vs 2019–2024) and drug type.

Results

During follow-up, 2495 participants initiated AD treatment. The age of the participants was 65 (SD 9), and 59% were female. Any AHD exposure was associated with 90% reduced hazard of AD treatment (HR 0.09, 95% CI 0.07 to 0.13, p

Conclusions

AHD exposure was consistently associated with markedly lower risk of AD treatment initiation, with similar findings observed in recent years. These findings support the hypothesis that herpesvirus reactivation may contribute to AD pathogenesis and suggest antiviral therapy could have preventive implications. Confirmation through prospective studies and randomised trials is needed.

Effect of yoga on musculoskeletal complaints in women during endocrine treatment for breast cancer: protocol of the randomised controlled COBRA trial

Por: Veenhuizen · S. G. A. · Gal · R. · Cramer · H. · Bijlsma · R. M. · Blickle · P. · van der Palen · J. · Wagenaar · Q. R. C. M. · van Leer · E. · Konings · I. · van den Bongard · D. H. J. G. · May · A. M. · Monninkhof · E. M.
Introduction

Approximately 40% of women stop endocrine therapy for hormone-receptor-positive breast cancer within the first 5 years of prescribed treatment because of side effects. Musculoskeletal complaints are among the most frequently reported side effects. The Cancer Of the BReast Asanas (COBRA) study examines the effect of an 18-week yoga programme on endocrine therapy-associated musculoskeletal complaints in women with breast cancer.

Methods and analysis

In total, 140 women will be randomised in a 1:1 ratio to the intervention or waitlist control group. The intervention programme consists of two times a week 1-hour supervised Hatha or (easy) Vinyasa yoga classes at a yoga or sports centre for 18 weeks and once per week a half-hour at home using videos. The waitlist control group is asked to maintain their habitual lifestyle during the first 18 weeks and will participate in a similar yoga programme to the intervention group for the following 18 weeks. The control group yoga programme is offered live-remote. The primary outcome (musculoskeletal complaints) is assessed with the Brief Pain Inventory questionnaire at baseline and 18 weeks (primary comparison) and additionally at 36 weeks. Secondary outcomes include lower and upper extremity joint complaints, menopausal symptoms, fatigue, sleep, quality of life, anxiety and depression, cognitive complaints and habitual physical activity (all patient-reported), vital signs and anthropometrics, physical fitness, blood biomarkers, medication use, safety data and patient and teacher experiences. At baseline and 18 weeks, cognitive complaints are also assessed with an online neuropsychological test battery.

Ethics and dissemination

The COBRA study was approved by the Medical Ethical Committee of the University Medical Center Utrecht. The study started on 8 October 2024, and 65 participants have been included (20 January 2026). Results will be submitted to an international peer-reviewed journal.

Trial registration number

NCT06480513.

Feasibility of NIV-NAVA as a primary respiratory support and its clinical impacts in a targeted group of preterm infants: protocol for a prospective observational study

Por: Cho · H. · Jung · Y. H. · Park · J. · Yang · H. J. · Kim · M. J. · Lee · J.
Introduction

Non-invasive neurally adjusted ventilatory assist (NIV-NAVA) is a promising respiratory support method for avoiding invasive mechanical ventilation in neonatal intensive care units (NICUs). However, its effectiveness and safety have not been widely established through clinical evidence. In this study, we aim to evaluate the feasibility of NIV-NAVA as a primary respiratory support method after birth and its effects on short-term clinical outcomes and long-term neurodevelopment in preterm infants.

Methods and analysis

In this prospective multicentre observational study, 230 preterm infants will be recruited after birth. This study will include preterm infants born between 27+0 and 31+6 weeks of gestation who require respiratory support within the first 48 hours after birth. NIV-NAVA will be initiated as primary respiratory support either immediately after birth or during the early NICU stay, with settings adjusted according to each infant’s clinical condition. Discontinuation of NIV-NAVA or transition to continuous positive airway pressure or high-flow nasal cannula will be performed based on clinical stability. A less invasive surfactant administration method will be used for infants with respiratory distress syndrome to avoid intubation whenever possible. Infants intubated at birth will be extubated to NIV-NAVA as early as is clinically feasible. Invasive ventilation may be applied if clinical deterioration occurs. The rate of NIV-NAVA failure, duration of non-invasive and invasive ventilation, rate of bronchopulmonary dysplasia and clinical outcomes, such as air leak, patent ductus arteriosus, intraventricular haemorrhage and retinopathy of prematurity, will be measured. The neurodevelopmental outcomes of infants will be assessed for up to 3 years.

Ethics and dissemination

The Institutional Review Board (IRB) of Korea University Anam Hospital (2024AN0554) and Seoul National University Bundang Hospital (IRB No. B-2507-984-304) approved this study. The results will be disseminated through scientific conferences and publications.

Trial registration number

NCT06786039 registered on 14 January 2025.

ODIN Biobank: a Danish cohort for dementia research- cohort profile

Por: Laugesen · K. · Skjaerbaek · C. · Okkels · N. · Moller · H. J. · Borghammer · P. · Gottrup · H. · Parkner · T.
Purpose

Biomarkers related to the diagnosis, prognosis and treatment of dementia will play a key role in future clinical practice. The overarching aim of the ODIN (blood and cerebrospinal fluid) Biobank is to study biomarkers for dementia and contribute to the transition from cerebrospinal fluid to blood-based biomarkers.

Participants

ODIN recruited 451 patients (median age 74 years, 53% females) referred to the Department of Neurology at Aarhus University Hospital, Denmark, for diagnostic assessment of dementia. Enrolment started in March 2020 and ended in July 2025. Patients referred for a lumbar puncture were eligible for inclusion. Cerebrospinal fluid and blood samples (plasma, serum and buffy coat) were stored at –80°C. Information about sociodemographic, educational level, dementia subtype, cognitive test scores, neuroimaging results, hypertension, diabetes, height, weight, alcohol consumption and smoking was collected.

Findings to date

The most frequent diagnoses were Alzheimer’s disease (n=268, 59%), frontotemporal dementia (n=26, 5.8%) and mixed Alzheimer’s and vascular disease (n=23, 5.1%). N=82 (18%) were cognitively unimpaired or had mild cognitive impairment but not dementia. The median Mini–Mental State Examination score was 23 (IQR: 20–26) and the median Addenbrooke’s Cognitive Examination score was 68 (IQR: 58–77).

Future plans

ODIN will contribute to the development, validation and implementation of new biomarkers related to diagnosis, prognosis and treatment of dementia. Furthermore, the cohort will assist the transition from cerebrospinal fluid to blood-based biomarkers.

Exploring the impact of Namaste Care for individuals with advanced dementia: a systematic review of costs, effects and benefits

Por: Parks · T. · Soukopova · J. · Tothova · D. · Smaling · H. J. A. · Murphy · A. · Vidovicova · L. · Hlavka · J.
Objectives

Namaste Care, a non-pharmaceutical daily multicomponent palliative care intervention, offers care for people with dementia, aiming to improve quality of life of those living with dementia as well as their family and caregivers. This systematic review explores the Namaste Care intervention and its clinical and economic effects in multiple care settings. The aim of this review is to consolidate existing evidence on Namaste Care’s clinical and economic outcomes and examine the tools used for data collection.

Design

A systematic literature search was conducted (PubMed, Scopus and Web of Science) to identify peer-reviewed studies on Namaste Care’s impact on quality of life, costs, health, economic outcomes and benefits up to 22 February 2026. Methodological quality was assessed using the Mixed Methods Appraisal Tool, while the completeness of reporting of economic evaluation studies was evaluated according to the Consolidated Health Economic Evaluation Reporting Standards 2022 (CHEERS).

Results

31 studies reported the clinical and/or economic outcomes of Namaste Care. The results for quality of life and quality of dying were mixed, while 5 of 11 studies evaluating quality of life reported significant improvements. The various quality-of-life instruments used include the Quality of Life in Late-Stage Dementia (QUALID), EQ-5D-3L and EQ-5D-5L instruments, ICEpop CAPability Measure for Older People (ICECAP-O), ICECAP Supportive Care Measure (ICECAP-SCM), Quality of Life for People with Dementia (QUALIDEM) and Carers-DEMentia Quality of Life (C-DEMQOL). The clinical outcomes considered included pain, behavioural symptoms and quality of end-of-life care. The Medication Quantification Scale and Minimum Data Set indicated reductions in antidepressant and antianxiety medication use. Seven studies reported significant improvements in well-being, and two studies reported reduced stress among family members following Namaste Care sessions. A subset of five studies reported a range of economic outcomes.

Conclusion

The findings suggest that Namaste Care improves well-being, reduces caregiver stress and lowers the use of antidepressant and antianxiety medications at a moderate cost. The current literature is characterised by small, non-random, heterogeneous studies. Randomised controlled trials, which include economic evaluations, help to improve evidence-based research to support funding and implementation decisions on Namaste Care.

PROSPERO registration number

CRD42024560056.

The Associations Between Nurses' Perceived Adequacy of Staffing and Quality of Nursing Care and Job Enjoyment: A Multilevel Modelling Approach

ABSTRACT

Aim

To explore the associations of (1) shift-to-shift Nurse Perceived Adequacy of Staffing Scale (NPASS) scores and (2) the relative contribution of individual NPASS items to nurse-perceived quality of care (NPQoC) and job enjoyment.

Design

Multihospital prospective observational study.

Methods

The study was conducted across 15 medical, surgical or acute admission hospital wards in three teaching hospitals in the Netherlands. Vocationally and bachelor-trained nurses conducted 1550 measurements of perceived adequacy of staffing using the NPASS, NPQoC and job enjoyment in 797 shifts. Multilevel models were used to assess associations between NPASS scores and NPASS items and the outcome variables.

Results

Higher NPASS scores were significantly associated with improved NPQoC and job enjoyment. An increase in 1.0 point NPASS score leads to an increase of 0.97 points in NPQoC and 1.04 points in job enjoyment. Of the NPASS items, energy level, adherence to protocols and the opportunity for adequate breaks had the most positive effect on both outcomes.

Conclusion

Perceived adequacy of staffing as measured by the NPASS is highly relevant for improvements in both NPQoC and job enjoyment.

Implications for the Profession and/or Patient Care

Decision-makers on nurse staffing should incorporate the NPASS in staffing methods to ensure adequate staffing and the associated benefits. Policies that ensure adequate breaks, adherence to protocols and maintenance of nurses' energy levels during the shift should be implemented with special attention.

Impact

This study provides supportive evidence for incorporating nurses' perceived adequacy of staffing, as measured by the NPASS, to ensure adequate staffing. This is crucial for nurse retention, and therefore vital to maintaining accessible healthcare given the global nursing shortages.

Reporting Method

The STROBE checklist was used to conduct and describe the study.

Patient or Public Contribution

This study did not include patient or public involvement in its design, conduct or reporting.

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