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Ayer — Junio 14th 2026Tus fuentes RSS

Continuation of first-line therapy with radiotherapy for oligoprogression versus early switch to second-line therapy in oligoprogressive hepatocellular carcinoma (CROSS): study protocol of a multicentre, randomised, controlled, open-label, phase III trial

Por: Wang · H. · Shi · F. · Zhang · X. · Zhu · K. · Jiang · S. · Feng · R. · Dou · X. · Xu · L. · Yue · J.
Introduction

Treatment options remain limited for patients with advanced hepatocellular carcinoma (HCC) who experience oligoprogression during first-line systemic therapy (FLST), especially given the modest efficacy and restricted availability of second-line systemic therapy (SLST). This trial aims to evaluate whether continuing FLST combined with radiotherapy (RT) to oligoprogressive lesions can improve progression-free survival (PFS) compared with an early switch to SLST in patients with oligoprogressive HCC while maintaining an acceptable safety profile.

Methods and analysis

The continuation of first-line therapy with radiotherapy for oligoprogression versus early switch to second-line therapy in oligoprogressive hepatocellular carcinoma trial is a prospective, multicentre, randomised phase III study that will enrol 132 patients with advanced HCC who experience their first oligoprogression during FLST. Oligoprogression is defined as one to five progressive lesions involving no more than one to three organs. Participants will be randomised (1:1) to either continuation of FLST combined with RT to all oligoprogressive lesions or discontinuation of FLST followed by initiation of SLST. RT will be delivered with a biologically effective dose (linear–quadratic model, α/β=10) of at least 60 Gy whenever feasible. The primary endpoint is PFS. Secondary endpoints include overall survival, objective response rate, disease control rate, duration of response and quality of life. Predefined exploratory analyses include circulating tumour DNA profiling, optional paired tumour biopsies, functional imaging with fibroblast activation protein inhibitor positron emission tomography-CT and longitudinal immune profiling.

Ethics and dissemination

This study has been approved by the Ethics Committee of the Affiliated Cancer Hospital of Shandong First Medical University (number: SDZLEC2025-025-02) and has been registered in ClinicalTrials. gov (NCT06841172). Final study results will be disseminated through peer-reviewed journals.

Trial registration number

NCT06841172.

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Evaluating the VOCORDER device for early disease detection through breath analysis: study protocol for a two-phase clinical study

Por: Kontopidou · F. · Swift · S. J. · Kokkotis · C. · Moustakidis · S. · Kavouras · I. · Vidaki · A. N. · Brebou · S. · Zavvos · V. · Panagiotou · A. · Iatrou · C. · Grosomanidis · D. · Zacharouli · Z. · Giannoukos · S.
Introduction

The survival rate of patients with life-threatening diseases primarily depends on the speed of diagnosis. Too often, diseases are detected only after symptoms appear, which usually occurs at later stages of a disease when available treatments may be less effective. Current detection techniques primarily depend on identifying metabolites in biofluids such as blood and urine. The analysis of these fluids is typically performed in laboratories, resulting in lengthy waiting times for patients to receive their results. In severe cases, invasive biopsies and radiative methods are used to diagnose conditions such as cancer. These biopsies can cause distress for patients who are already experiencing significant emotional or physical stress, while imaging techniques involving ionising radiation may pose additional health risks. Additionally, these methods can be costly. In recent years, exhaled breath has become a biofluid matrix of interest for disease detection, allowing for the identification of volatile organic compounds (VOCs) or VOC profiles associated with specific conditions. To improve early disease detection through breath analysis, the VOCORDER project aims to develop a device that provides a fast, simple, user-friendly and cost-effective method for continuous health monitoring to identify diseases in their early stages before symptoms appear.

Methods and analyses

A literature review was initially conducted to identify five reference diseases of interest (lung cancer, stomach/colon cancer, breast cancer and kidney insufficiency) and previously reported VOC profiles associated with these diseases. In this trial, the project team from the MITERA Hospital will select patients, and the hospital staff will conduct personal interviews with these subjects. Each participant will also complete a questionnaire for the acquisition of demographic and medical history data, after being informed in detail about the purposes of the questionnaire and signing a consent form. The study protocol consists of two phases. Phase 1 is a baseline study designed to detect and identify breath biomarkers for the early diagnosis of the diseases mentioned above using gas chromatography-mass spectrometry (GC-MS) and secondary electrospray ionisation high-resolution mass spectrometry (SESI-HR-MS). Prescreening will select 120 healthy controls and 175 patients for the baseline phase of the clinical trial, for which breath samples will be collected in 1 L Supel-Inert Multi-Layer Foil gas sampling bags. New biomarkers and VOC profiles will be extracted from these data, and further statistical analysis will allow for artificial intelligence (AI) models to be produced and tested. For phase 2 (validation phase), 120 healthy controls and 100 patients will be selected. Breath samples will again be collected in 1 L gas sampling bags for analyses with GC-MS and SESI-HR-MS. The VOCORDER device will also be used, and its functioning with the newly developed AI models will be evaluated.

Ethics and dissemination

This clinical study has been approved by the scientific council at the MITERA hospital in Athens, Greece (#513/2024). The outcomes will be disseminated through peer-reviewed journal publications and presentations at scientific conferences.

Trial registration number

NCT06711939.

Association between difficulties navigating the French healthcare system and healthcare utilisation: results from the National Health Literacy Survey (HLS19)

Por: Touzani · R. · Rouquette · A. · Allaire · C. · Hardouin · J.-B. · Mancini · J.
Objectives

To examine the association between navigational health literacy (HL), defined as the skills required to effectively navigate healthcare systems, access services and make informed decisions and healthcare utilisation among French adults with and without chronic health conditions.

Design

Cross-sectional online survey.

Setting

National survey conducted in metropolitan France as part of the Health Literacy Survey (HLS19) in 2020 and 2021.

Participants

A total of 2 003 individuals were included: 1103 without chronic condition and 900 with at least one chronic condition.

Outcomes measures

Number of general practitioner (GP) and specialist visits in the previous 12 months

Results

The chronic condition group reported more frequent GP (4.3 vs 2.1/year) and specialist (2.8 vs 1.1/year) visits than the no chronic condition group. A high navigational HL was significantly associated with fewer GP (p=0.016) and specialist visits (p

Conclusions

High navigational HL was associated with less healthcare utilisation in individuals with no chronic condition. Among the chronic condition group, this aspect seemed less influential, likely due to greater healthcare system familiarity and structured care. Our findings highlight the importance of strengthening HL navigation skills early to improve healthcare use.

Capturing heat illness in vulnerable populations through the lens of older adults: a scoping review protocol of health administrative data

Por: St-Arnaud · J.-G. · Raymond · C. · Boukari Abdou · S. · Roussafi · F. · Dufour · I. · Castonguay · F. M.
Introduction

Heatwaves are among the fastest-growing climate-related threats to human health, increasing in frequency, intensity and duration with climate change. Older adults are disproportionately affected, reflecting intersecting physiological, social and economic vulnerabilities. Beyond mortality, heatwaves drive substantial but often under-recognised morbidity, including emergency visits and hospitalisations for cardiovascular, respiratory, renal and metabolic conditions. Health administrative data provide valuable opportunities to improve understanding of these phenomena and for the quantification of their impacts. However, comparability is limited by heterogeneity in case definitions, that is, the criteria used to determine which health events are counted as cases: some studies only clinically diagnosed heat illness, while others also capture outcomes plausibly triggered or exacerbated by heat. It is further constrained by differences in International Classification of Diseases (ICD) versions, national adaptations, coding practices and adoption timelines across countries. No synthesis has yet mapped these heterogeneous approaches for older adults, despite their over-representation among those most affected by heat-health risks. This heterogeneity limits the ability to capture the true burden of disease and to inform adaptation planning.

Methods and analysis

We will conduct a scoping review to map how heat-related diagnoses among older adults are identified and measured in health administrative data. The review will follow the initial methodological framework of Arksey and O’Malley refined by Levac et al and adhere to the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines. The search strategy will be developed with a public health librarian and applied to MEDLINE (Ovid), Embase and Web of Science. We will include peer-reviewed and grey literature published in English or French from 2010 onward. Two reviewers will independently screen titles, abstracts and full texts in Covidence, with disagreements resolved by consensus or a third reviewer. Data will be extracted using a standardised form to capture study characteristics, ICD codes, definitions of heat exposure and approaches to measurement. A descriptive and thematic analysis will be conducted, and findings will be presented narratively and in tables.

Ethics and dissemination

Ethical approval is not required for this review as it involves secondary analysis of published and publicly available data; for more information, contact University of Montreal’s Research Integrity department at plaintes-crr@umontreal.ca. Results will be published through a peer-reviewed publication, conference presentations and knowledge transfer activities with public health stakeholders in Québec. This review contributes to the MEDICCS (Modélisation économique des impacts des changements climatiques sur la santé) project and will support recommendations for improving the capture of heat-related morbidity in health administrative data.

Protocol for a phase I single-centre dose escalation trial of autologous thymus derived regulatory T cells in paediatric heart transplant recipients to prevent cardiac allograft vasculopathy (ATT-Heart)

Por: Aiyengar · A. · Fanelli · G. · Romano · M. · Patel · P. · Issa · F. · Panesar · D. · Muthialu · N. · Douiri · A. · Lombardi · G. · Burch · M.
Introduction

Cardiac allograft vasculopathy (CAV) is a critical predictor of the long-term success of heart transplantation and once it is established, progression to graft dysfunction and loss is inevitable, despite adherence to immunosuppression and medications that ameliorate cardiac risk factors. Regulatory T cells (Tregs) are key for maintaining immune balance in the periphery. Studies investigating adoptive transfer of ex vivo expanded Tregs isolated from blood have been shown to be feasible and safe with good evidence for Tregs reducing CAV lesions in animal models of transplantation. Here, we describe the protocol for the ATT-Heart Study which is a phase I clinical trial investigating autologous thymus-derived Treg cell therapy in nine paediatric heart transplant recipients.

Methods and analysis

Patients will be recruited from the heart transplant waiting list at Great Ormond Street Hospital. Individualised autologous thymus-derived and expanded Tregs (TR006) will be injected into patients 3–6 months after transplant and follow-up will be conducted as per the post-transplant standard of care protocol with no wean of standard of care immunosuppression. Primary endpoint includes occurrence of Dose-limiting Toxicities in patients receiving TR006. Further data from blood tests, endomyocardial biopsy tissue, coronary imaging and clinical follow-up will be collected.

Ethics and dissemination

This article is based on the ATT-Heart study Protocol (V.1.1; dated 19 December 2024). The ATT-Heart trial has received a favourable ethical opinion from the Health Research Authority and South-Central Oxford A Research Ethics Committee (IRAS Number: 1008875/REC reference: 24/SC/0333). Clinical trials authorisation approval from UK Medicines and Healthcare products Regulatory Agency has also been received. The clinical trial will be conducted in accordance with the principles of Good Clinical Practice and following the guidelines set as part of the Research Governance Framework for Health and Social Care and all applicable necessary local policies. It is intended that the findings of the clinical trial will be presented at national/international conferences and using social media and through patient groups for dissemination among their members. The results will also be published in international peer-reviewed journals.

Trial registration number

ISRCTN15374803.

In their own words: experiences surrounding masculinising chest surgery among transgender and gender-diverse adolescents - a secondary analysis of GENDER-Q data

Por: Armstrong · K. · Quan · I. · Kennedy · S. L. · Kaur · M. N. · Cornacchi · S. D. · Rae · C. · Johnson · N. · Khatchadourian · K. · Marinkovic · M. · Sequeira · G. M. · Bradley · B. · Cheung · K. · Morrison · S. D. · Klassen · A. F.
Objective

Masculinising chest surgery, also known as top surgery, is the most requested gender-affirming procedure among transgender and gender-diverse (TGD) adolescents, yet research on patient experiences remains limited. This study explored the experiences of TGD adolescents who were seeking or had undergone masculinising chest surgery.

Design

Qualitative secondary analysis using existing themes framework and data from the GENDER-Q (GQ) and GENDER-Q Youth (GQY) research programmes, which aim to develop comprehensive patient-reported outcome measures for gender-affirming care.

Setting

Participants were sampled from five high-volume gender-affirming care clinics, three in Canada and two in the United States. Interviews were conducted online.

Participants

35 GQ and GQY participants aged 13–18 years who were assigned female at birth, identified as trans men or non-binary, and were pursuing (n=19) or had undergone (n=16) masculinising chest surgery.

Results

Three major themes emerged: chest appearance, health-related quality of life (HRQL) and gender practices. Most participants expected a flatter chest that aesthetically aligned with their gender identity. Presurgery participants anticipated that surgery would allow them to engage in previously avoided physical activities and would enhance their relationships. Postoperative participants reported increased physical activity, mental resilience, bodily connection and social comfort. Most reported binder use and related reliance or discomfort as motivators for pursuing surgery.

Conclusions

This study highlights the multidimensional experiences surrounding masculinising chest surgery on TGD adolescents with impacts on chest appearance, HRQL and gender practices. Centering adolescents’ perspectives, these findings underscore the importance of accessible, affirming surgical care and provide valuable insights for clinicians, policymakers and future research.

Comparison of iloprost therapy versus non-iloprost therapy for severe frostbite: a retrospective cohort study of two Canadian cities

Por: ODochartaigh · D. · Douma · M. J. · Picard · C. · Violato · E. · Poole · A. · Gauthier · J. · Armour · A. · Tiwana · D. · Harrigan · T. · Gabriel · V. · Brown · J. · Ghosh · S. M. · MacNairn · I. · Khangura · J. · Boucher · H. · Robinson · L. · Watt · L. · Van Nest · J. · Bown · J. l. · Mage
Objectives

Frostbite is a common reason for emergency department (ED) presentations in Canada. Iloprost, a prostacyclin analogue, has been investigated to reduce the risk of amputation with its use expanding. Two Canadian cities implemented iloprost over different times leading to a practice variation that allowed for treatment comparison. Our objective is to evaluate the effectiveness of iloprost compared with non-iloprost treatment. Secondary objectives include assessing the impact of iloprost dosage and homelessness.

Methods

A retrospective cohort study was conducted on adult severe frostbite cases presenting to EDs in Calgary and Edmonton between November 2021 and April 2024. Data were abstracted from clinical databases and analysed for demographic and injury characteristics, treatment and amputation outcomes.

Results

Of 1812 total ED encounters for frostbite, 257 patients with grades 2–4 extremity frostbite were included for analysis. Logistic regression found that overall patients receiving iloprost were associated with reduced likelihood of any amputation (OR=0.49, 95% CI 0.25 to 0.96) and fewer digit amputations (p

Conclusions

Iloprost infusion was associated with a reduction in amputation rates in grade 3 and 4 frostbite with the greatest association seen in grade 3 cases. Greater iloprost dosage was associated with improved digit salvage. Homelessness was associated with delayed ED presentation.

Developing a job retention vocational rehabilitation intervention for people with long covid: a person-based approach

Por: Boutry · C. · Phillips · J. · Knight · C. · Holmes · J. · Patel · P. · Morriss · R. · das Nair · R. · Douglas · E. · Bolton · C. E. · Guo · B. · Radford · K.
Background

Long covid affects a significant proportion of people following SARS-CoV-2 infection and is associated with persistent symptoms such as fatigue, cognitive dysfunction and breathlessness which can negatively impact a person’s ability to return to and remain in work. Although tiered vocational rehabilitation (VR) models have been proposed, these are often generic, lack empirical validation and may not address the complex, fluctuating needs of this population.

Objectives

To co-design a VR intervention (the COVID-19-VR intervention) to support return to work (RTW) for people with long covid (pwLC).

Setting

Primary and secondary care.

Design

Mixed-methods target population-centred, person-based approach in three stages: Stage 1: interviews (n=21) with pwLC to identify issues and challenges faced in working with long covid. Stage 2: three co-design workshops with pwLC and service providers to (a) generate guiding principles, (b) identify key intervention features to address work needs, (c) create a logic model to illustrate how the intervention could work and (d) develop a treatment plan and resources. Stage 3: feasibility and acceptability testing in six cases (three critical care admissions, three primary care referrals).

Results

PwLC described work-related problems relating to: fluctuating symptoms (cognition, fatigue and breathlessness), employer, coworker and family’s understanding of long covid and workplace adjustments. We developed a 6-session, 12-week individually tailored, remotely delivered intervention that included vocational goal setting, RTW planning, fatigue/symptom management, financial advice, and where permitted, education for family/employers, employer engagement and negotiation of a phased RTW. Following feasibility testing, changes included accommodating the long-term nature of long covid, addressing unmet psychological needs, and adding content on adjustment, processing traumatic experience and performance/symptom anxiety, with extended delivery including monitoring, review and case coordination.

Conclusions

PwLC may need specialist help to RTW. Our COVID-19-VR appears feasible and acceptable and warrants further evaluation using a staged approach, prior to any definitive effectiveness trial.

Risk factors and population attributable fraction for large-for-gestational-age and macrosomic births in low- and middle-income countries between 2000 and 2025: a protocol for systematic review and meta-analysis

Por: Kirakoya-Samadoulougou · F. · Blencowe · H. · Ilboudo · D. · Ukwishaka · J. · Suarez Idueta · L. · Hazel · E. A. · Ohuma · E. · Erchick · D. J. · Katz · J. · Lee · A. C. · Black · R. E.
Introduction

Large-for-gestational-age (LGA) and macrosomic births pose significant maternal and neonatal health risks, particularly in low- and middle-income countries (LMICs), where access to care are often limited. Despite well-established associations between LGA, macrosomia, and various risk factors, the relative contributions of these factors remain underexplored in LMICs. This study aims to identify risks factors for LGA and macrosomia in LMICs, with an emphasis on modifiable ones, and quantify their population attributable fractions (PAFs).

Methods and analysis

A systematic review will be conducted across the following databases: MEDLINE, Scopus and ProQuest Central and regional databases (Africa Index Medicus, Index Medicus for South Asia and Latin America and Caribbean literature of health sciences). Eligible studies will include observational studies, reviews and interventional research conducted between 2000 and 2025 that report on prevalence or association of risk factors for large-for-gestational-age (LGA) and/or macrosomia births in low- and middle-income countries (LMICs). Data extraction will encompass study characteristics, prevalence/incidence estimates, risk factor distributions and measures of association. Quality assessment will be performed by two independent reviewers using the Newcastle-Ottawa Scale for observational cohort, case–control and cross-sectional studies. While Cochrane Risk of Bias Tool will be used for randomised controlled trials and a Measurement Tool to Assess Quality of Systematic Reviews 2 (AMSTAR-2) for systematic reviews and meta-analyses. Meta-analyses using a random-effects model, which accounts for population heterogeneity, will synthesise risk estimates for factors examined in three or more studies from LMICs, up-to-date meta-analysis including all relevant studies identified through our search. Population attributable fractions for individual and combined risk factors will be calculated.

Ethics and dissemination

This systematic review will use only previously published information. Ethical approval is therefore not required. The results will be submitted for publication in a peer-reviewed journal and the findings will be presented at international conferences to engage relevant stakeholders including policymakers and public health organisations in LMICs with the aim of informing the development of targeted interventions to reduce the burden of LGA and macrosomia births in the region.

Dose dE-eScalaTion IN prostATe radIOtherapy usiNg an MR-Linac in 2 Fractions (DESTINATION 2): protocol for a randomised, phase II/R-IDEAL2b trial

Por: Cooper · S. · Alexander · S. · Breitkreutz · D. · Casey · F. · Christodouleas · J. · Dassen · M. G. · Dellacqua · V. · Dunlop · A. · Herbert · T. · Kolias · P. · Mitchell · A. · Pos · F. J. · Westley · R. · Tree · A. C. · Van Der Heide · U. A. · Vesprini · D.
Introduction

Stereotactic body radiotherapy (SBRT) delivered on an MRI-guided linear accelerator (MR-linac) enables highly conformal prostate cancer irradiation. The DESTINATION 2 trial is a federated, randomised phase II/R-IDEAL 2b study evaluating whether de-escalating the dose to prostate tissue, while maintaining a high dose to MRI-visible tumour(s) in two fractions, reduces genitourinary (GU) treatment-related adverse events (AE) without compromising disease control in men with localised prostate cancer.

Methods

200 men worldwide with localised, MRI-visible prostate cancer will be randomised 1:1 to receive either (1) prescribed uniform dose MR-linac SBRT (27 Gy in two fractions to the whole prostate and seminal vesicles with 0 mm CTV-PTV margin) or (2) de-escalated SBRT (20 Gy in two fractions to whole prostate with 0 mm CTV-PTV margin and 27 Gy in two fractions to MRI-visible tumour(s) with a 4 mm intraprostatic margin applied to the GTV. All treatments are delivered using MRI-guided adaptive Radiotherapy (MRIgRT). The primary endpoint is the absolute and relative risk reduction in acute grade 2+GU AE (CTCAE v5) within 12 weeks of completing radiotherapy. Secondary endpoints include late GU AE, acute and late gastrointestinal (GI) AE, sexual AE, patient-reported outcomes, dosimetry, technical feasibility and 2-year biochemical relapse-free survival.

Ethics and dissemination

This is a federated trial design in which each centre operates independently with its own sponsor, ethics committee approval and regulatory oversight. Each centre is responsible for obtaining and maintaining local ethics approval in accordance with their national and institutional requirements. The UK centre (The Royal Marsden NHS Foundation Trust) has received ethical approval from the East of England–Cambridge South Research Ethics Committee (REC reference: 24/EE/0163; IRAS: 338368). Results will be disseminated via peer-reviewed publications and conference presentations.

Trial registration number

NCT06638541.

Impact of the POPulation Medicine Multimorbidity Intervention in Xishui County (POPMIX) on people at high risk for COPD who smoke: protocol for the POPMIX-Smoking cluster randomised controlled trial

Por: Chen · S. · Huang · K. · Zheng · Z. · Liu · Y. · Zhang · S. · Chen · W. · Tang · X. · Cao · Z. · Tang · L. · Tong · X. · Zhao · J. · He · L. · Jiao · L. · Wang · Y. · Zhao · T. · Luo · Y. · Lai · Q. · Lyu · X. · Dou · R. · Chen · Q. · Bunker · A. · Vollmer · S. · Geldsetzer · P. · Jamison · D. · Bär
Introduction

Tobacco use is a major contributor to the burden of chronic obstructive pulmonary disease (COPD) and other non-communicable diseases in China. People at high risk for COPD who smoke, particularly those with pre-existing chronic conditions, often remain underserved by conventional smoking cessation programmes. Population medicine offers a promising framework for proactively identifying high-burden diseases, managing multimorbidity and prioritising interventions for vulnerable populations.

Methods and analysis

This protocol describes a stratified, two-arm cluster randomised controlled trial (Population Medicine Multimorbidity Intervention in Xishui County-Smoking) being conducted in Xishui County, a rural area of Guizhou Province, China. A total of 26 townships were stratified by population size and randomly assigned in a 1:1 ratio to receive either a multicomponent intervention or usual care. Eligible participants were individuals aged 35 years or older who smoked and were at high risk for COPD as identified by the COPD Screening Questionnaire. The intervention package integrates multiple components, including a digital smoking cessation programme, digital mental health support, community-based spirometry, tailored chronic disease management, health education and a performance-linked ‘pay-for-population’ scheme that aligns healthcare worker reimbursement with population health outcomes. Primary outcomes are smoking amount and nicotine dependence and secondary outcomes include COPD-related health outcomes, hypertension, diabetes, health risk behaviours, quality of life, healthcare utilisation and productivity loss. Follow-up occurs at 3, 6 and 12 months.

Ethics and dissemination

Ethical approval has been granted by the Peking Union Medical College Ethics Committee (CAMS&PUMC-IEC-2024-042). Informed consent was obtained from all participants prior to enrolment. Results will be shared through peer-reviewed publication and (inter)national conference presentations.

Trial registration number

NCT06458205.

Translation and psychometric evaluation of the Chinese version of the Kings Stool Chart in patients receiving enteral nutrition

Por: Wang · G. · Dou · H. · Wang · H. · Hu · J. · Wang · L. · Li · W. · Wang · X. · Zhang · H.
Objectives

This study aims to translate, culturally adapt, and validate the Chinese version of the King’s Stool Chart among patients receiving enteral nutrition for use in nursing practice.

Design

This is a descriptive, cross-sectional study.

Setting

This study was conducted in the intensive care unit (ICU) of a tertiary hospital in Henan Province, China.

Participants

A total of 144 patients receiving enteral nutrition were included.

Methods

This study was conducted in two phases. Phase I involved the translation and cultural adaptation of the King’s Stool Chart using established methodologies, including forward translation, synthesis, back-translation and expert review. Phase II comprised psychometric evaluation with 144 patients receiving enteral nutrition. The Chinese version of the King’s Stool Chart was used to assess stool frequency, consistency, weight and the daily total score. Validity was tested through content, construct and concurrent validity, while inter-rater reliability was assessed using the kappa coefficient.

Results

The Chinese version of the King’s Stool Chart demonstrated excellent content validity, with item-level indices ranging from 0.95 to 1.00. Construct validity was supported by the ability of the Chinese version of the King’s Stool Chart to differentiate between clinical subgroups with varying stool characteristics. Sensitivity rates for stool weight categorisation were above 89%, and substantial inter-rater reliability (kappa=0.735) was observed. The daily total score was effective in identifying patients at risk for diarrhoea, with significant differences observed among clinical subgroups. Diarrhoea classification, using a threshold of ≥15 points, showed strong construct validity.

Conclusions

Within the scope of this single-centre sample, the Chinese version of the King’s Stool Chart demonstrates acceptable validity and substantial to excellent inter-rater reliability for assessing stool frequency, consistency, weight and diarrhoea classification in enterally fed ICU patients in China. These psychometric properties provide preliminary support for its use in routine nursing practice for gastrointestinal function monitoring in ICU settings. Further multicentre and large-sample studies are required to verify its external validity and generalisability to broader Chinese-speaking populations and non-ICU clinical settings.

Facilitators and barriers to the practice of intermittent auscultation fetal monitoring in UK maternity services: a qualitative study using the Consolidated Framework for Implementation Research (CFIR)

Por: MacLellan · J. · Ade · M. · Douthwaite · M. · Fitzsimons · B. · Joash · K. · Mulla · S. · Sanders · J. · Kenyon · S. · Pope · C. J. · Rowe · R.
Objectives

To explore barriers and facilitators to midwifery practice of intermittent auscultation according to national guidance in the UK.

Design

Multisite ethnographic study using observations of practice, semistructured interviews and informal conversations. Framework analysis using the Consolidated Framework for Implementation Research (CFIR).

Setting

11 maternity units across seven NHS maternity services in England and Wales in 2024.

Participants

Midwives and other maternity care professionals involved in fetal monitoring during labour.

Intervention

‘Intermittent auscultation’ (IA), or listening to the fetal heart rate at regular intervals, to monitor fetal well-being during active labour.

Outcome measures

Not applicable.

Results

IA monitoring was frequently observed to be marginalised due to national and local pressures. IA is a complex skill that requires expertise and practice to develop and maintain. However, lack of a robust evidence base for IA methods is a further barrier to implementation. The study uncovered examples of facilitators that include: leadership engagement, access to knowledge and information supported in mentorship programmes and peer support models. These features created micro-environments where IA was valued, supported and integrated into care.

Conclusions

Our study highlights the significant impact of multilevel factors on the implementation of IA within UK maternity care. However, when organisational readiness, strong leadership engagement and supportive conditions are present, IA can be delivered in accordance with guidance. These findings underscore the need to align policy, infrastructure and organisational culture to sustain evidence-based, woman-centred practices such as IA.

Study protocol for testing pharmacological conditioning as a drug dose reduction strategy in patients with psoriasis in a randomised controlled trial

Por: Savvidou · P. · Hölsken · S. · Krefting · F. · Benson · S. · Sondermann · W.
Introduction

Psoriasis is a chronic inflammatory skin disease that significantly impacts patients’ quality of life. Although biological therapies are effective, they are associated with high costs and potential side effects, necessitating strategies for dose reduction. Pharmacological conditioning, using placebo mechanisms through associative learning, presents a promising approach to maintain therapeutic efficacy with lower doses of medication.

Methods and analysis

The single-centre, randomised controlled trial aims to investigate pharmacological conditioning with secukinumab in patients with moderate-to-severe psoriasis (N=168). Participants will be randomly allocated to a treatment-as-usual group or one of two experimental groups receiving partial or continuous reinforcement schedules with reduced secukinumab doses combined with a distinctive gustatory stimulus. Primary outcomes include changes in itch intensity, skin-related quality of life and objective disease severity. Secondary outcomes encompass psychological variables, side effects and biological markers. Results may contribute to optimised long-term psoriasis management, reducing medication burden while maintaining treatment efficacy.

Ethics and dissemination

The study protocol was approved by the ethics committee of the University Hospital Essen (19–8636 BO) on 20 November 2023. Written informed consent will be obtained from all participants. Participant confidentiality will be ensured through pseudonymised data handling and secure storage. The results will be disseminated through peer-reviewed publications.

Trial registration number

DRKS00034977.

Isolated and Combined Effects of Sedentary Behaviour and Physical Activity on Muscle Strength in Older Adults: A Prospective Cohort Study

ABSTRACT

Aim

We aim the isolated and combined effects of sedentary behaviour exposure time and physical activity levels on muscle strength in older adults.

Design

This prospective observational cohort study, analytical in nature, using exploratory survey methods and physical performance testing. With 5-year longitudinal follow-up (2015–2020).

Methods

A total of 459 older adults participated in the baseline, with a total of 224 being included/located again in the follow-up. We evaluate muscle strength using handgrip tests and sit-to-stand tests. The international physical activity questionnaire was used to measure physical activity and sedentary behaviour. Generalised Estimation Equations tested both independent and combined effects, reporting results as β coefficients and confidence intervals.

Results

Older adults exhibiting low sedentary behaviour displayed enhanced handgrip strength compared to those with high sedentary behaviour. Notably, older adults who were sufficiently active with low sedentary behaviour, sufficiently active with high sedentary behaviour, and insufficiently active with low sedentary behaviour showed increased handgrip strength compared to their counterparts who were insufficiently active with high sedentary behaviour. This trend was consistent for lower limb strength.

Conclusion

Interventions that encourage a reduction in sedentary behaviour and an increase in physical activity are essential to maintain muscle strength among older adults.

Implications for Practice

The findings of this study underscore the importance of addressing both sedentary behaviour and physical activity levels in clinical interventions aimed at preserving muscle strength in older adults. Routine assessments of physical activity and sedentary behaviour could help tailor personalised exercise programs, potentially enhancing functional independence and reducing the risk of frailty and disability in older patients.

Patient or Public Contribution

Patients were involved in the sample of the study.

Reporting Method

This study was conducted in accordance with the Strengthening Research in Observational Studies in Epidemiology (STROBE) guidelines.

Perceptions and Experiences of Animal‐Assisted Interventions for People Living With Dementia: A Qualitative Evidence Synthesis

ABSTRACT

Aim

To synthesise stakeholders' experiences and perceptions of animal-assisted intervention (AAI) for people with dementia in community care settings.

Design

Qualitative evidence synthesis.

Methods

We systematically searched Medline, CINAHL, Embase, Scopus, Web of Science, PsycINFO and AgeLine for potentially eligible studies. Thematic synthesis was used to analyse the data from included studies. We assessed the methodological limitations of included studies using an adaptation of the Critical Appraisal Skills Programme checklist and used Confidence in the Evidence from Reviews of Qualitative Research (GRADE-CERQual) tool to assess confidence in review findings. This review is reported using the ENTREQ checklist.

Results

We included 14 reports from 11 studies and developed three analytical themes incorporating a gardening analogy: planting–connecting with animals, growing–engaging in AAI and nurturing–making AAI work; and six subthemes: willingness to connect, building relationships, a rich experience, the benefits of AAI, individualised and holistic approach and training and support, with 15 key findings.

Conclusion

This review describes people's experiences and perceptions of AAI for people with dementia, and provides recommendations on the development and implementation of AAI, with moderate to high confidence. Nurses need to consider the factors that influence the implementation of AAI identified in this review, to facilitate engagement and long-term impacts while adopting AAI in community care settings.

Implications for the Profession and Patient Care

This review may enhance healthcare professionals' understanding of AAI for people with dementia in community care settings. AAI is a complex intervention that can be delivered in varied manner. A multicomponent, flexible and individualised AAI is important. Additional training and education for staff are needed.

Patient or Public Contribution

A man with dementia and his wife who share a love of dogs, advised at each step of the review, providing insights and perspectives and contributing as co-authors.

[89Zr]bevacizumab PET/CT imaging of vestibular schwannomas for the prediction of bevacizumab treatment effect in patients with symptomatic NF2-related schwannomatosis: a study protocol for a phase II single centre, prospective, feasibility trial

Por: Douwes · J. P. J. · Tops · A. L. · Dibbets-Schneider · P. · Verbist · B. M. · Fuentealba Bassaletti · C. A. · Jansen · J. C. · Koetsier · K. S. · van Dam · V. S. · Koot · R. W. · van Velden · F. H. P. · Pool · M. · Vugts · D. · Schopman · J. E. · Goeman · J. J. · De Geus-Oei · L.-F.
Introduction

Treatment with bevacizumab achieves both tumour stabilisation or regression and preservation or improvement of hearing. However, the efficacy of bevacizumab varies between patients and within patients. Side effects due to bevacizumab treatment are also common. It would be of value to predict therapeutic response prior to initiating therapy to prevent unnecessary exposure in patients unlikely to benefit.

Methods and analysis

We aim to recruit 25 patients with NF2-related schwannomatosis (NF2) with bilateral vestibular schwannomas. Patients will receive an intravenous injection of 37 MBq [89Zr]bevacizumab followed by positron emission tomography (PET)/CT imaging 4 days later. After clinical evaluation at baseline, patients undergo bevacizumab treatment and are followed up at 3 and 6 months. The primary objective is to examine associations between pretreatment [89Zr]bevacizumab uptake on PET/CT and changes in multiple hearing outcomes and radiological characteristics of the target tumour following treatment. Secondary outcome measures include vestibular functioning, patient reported outcome measures, cranial nerve functionality, peripheral neurology, non-target schwannoma response and renal function. Given the explorative nature of the study, associations between PET-derived metrics and clinical and radiological outcomes will be examined without formal hypothesis testing, using generalised estimating equations to account for within-patient correlation. Pairwise associations will be summarised in an association matrix with multiplicity addressed using an all-resolutions inference approach, and findings will be considered hypothesis generating.

Ethics and dissemination

This study was submitted via the Clinical Trials Information System reviewed and approved by the Medical Research Ethics Committee Leiden–The Hague–Delft Delft. The study findings will be disseminated through publication in peer-reviewed scientific journals and by presentation at national and international conferences.

Trial registration number

The trial is registered at ClinicalTrials.gov Protocol Registration and Results System under the registration ID: NCT05685836.

Factors That Influence the Implementation of Animal‐Assisted Intervention for People With Dementia in Community Care Settings: A Qualitative Study

ABSTRACT

Aim

To explore the factors that influence the implementation of animal-assisted intervention (AAI) for people with dementia in community care settings in Ireland.

Design

Descriptive qualitative study.

Methods

Semi-structured interviews were carried out with 13 people with dementia, 11 care partners and 18 health and social care practitioners from November 2024 to June 2025. Interviewees were recruited from 10 community care settings and local dementia networks across 11 counties in Ireland. A photo elicitation approach was applied. Framework method was used for data analysis, integrating the Consolidated Framework for Implementation Research (CFIR).

Results

A variety of AAI types were used across community care settings. The complexity and variation in AAI delivery and factors that influence its implementation were described. We developed four themes and 11 subthemes to illustrate the inter-relationship among factors combining five domains of CFIR: attitudes toward AAI; available and accessible resources; design and development of AAI; and scaffolding to facilitate AAI implementation.

Conclusions

AAI has promising benefits for people with dementia. Our findings provide rich insights into the multi-level factors that influence AAI practice. Future research should focus on developing and enhancing implementation strategies, applying user-centred design, to address barriers, leverage facilitators and tailor to local context, ultimately increasing the adoption and impact of AAI.

Impact

The findings contribute to the evidence base for best practices of AAI, inform the development of strategies, guidelines and policies of dementia care, and foster the creation of a dementia-friendly community.

Patient and Public Involvement

Two patients and members of the public (both co-authors) and four advisory group members who share a love of animals were involved in this study, contributing to the research design, recruitment, data analysis and final paper.

Impaired dynein function preserves spinal interneuron survival and positioning in an ALS-like mouse model

by Eleni Christoforidou, Jordan S. Rowe, Fabio A. Simoes, Raphaelle Cassel, Luc Dupuis, Peter Nigel Leigh, Majid Hafezparast

Impaired cytoplasmic dynein function has been implicated in amyotrophic lateral sclerosis (ALS) pathogenesis, yet the contributions of spinal interneurons to disease phenotypes remain unclear. We tested the hypothesis that hypomorphic dynein function in cholinergic neurons disrupts the development, survival, or positioning of inhibitory interneuron populations in the lumbar spinal cord. Using ChAT-Cre recombination, we generated four mouse genotypes with graded reductions in dynein activity in ChAT+ cells: Dync1h1+/+ (wildtype), Dync1h1−/+ (hemizygous wildtype), Dync1h1+/Loa (heterozygous Loa mutation), and Dync1h1−/Loa (hemizygous Loa). At 52 weeks of age, lumbar spinal cords (L3–L6) were harvested, cryosectioned, and immunostained for ChAT, GAD-67, Parvalbumin, and Calbindin. Cell counts were performed on confocal images from eight sections per mouse (N = 3 male mice/genotype), and radial distances from the central canal were normalised to gray matter width. Angular distributions were analysed via circular statistics. There were no significant genotype-dependent differences in the numbers of ChAT+, GAD-67+, Parvalbumin+, or Calbindin+ cells, nor in ChAT+ subpopulations (motor neurons versus interneurons) or double‐positive interneuron subsets (e.g., ChAT+–GAD-67+, Parvalbumin+–GAD-67+, Parvalbumin+–Calbindin+). Radial positioning relative to the central canal was similarly preserved across all markers and genotypes. Circular‐median tests revealed statistically significant shifts in mean angle for ChAT+, GAD-67+, and certain double‐positive cells, but these amounted to only 5–10° displacements, translating to lateral shifts of ~10–20 µm, well within single laminar bands, and are unlikely to impact circuit connectivity. Despite substantial motor deficits and hallmark TDP-43 pathology previously seen in these models, impaired dynein function does not precipitate interneuron loss or gross migratory defects in the lumbar spinal cord. Instead, our findings suggest that the primary contributions of dynein to ALS-like phenotypes likely arise from functional disruptions in axonal transport, synaptic maintenance, and neuronal physiology rather than from structural alterations or loss of interneuron populations.

Global maternal and infant health monitoring systems: a scoping review protocol

Por: Al-Habbal · K. · Hassan · Z. · Kaddoura · R. · Yousef · S. · Fetty · J.
Introduction

Enhancing maternal and infant health is a cornerstone of global health advancement. This can be achieved by building sustainable health monitoring systems that can accurately and reliably generate high-quality data and produce evidence-based recommendations for policymakers. By identifying gaps and strengths in current systems, this review aims to highlight current practices in monitoring maternal and infant health outcomes, including low birth weight.

Methods and analysis

The review will adopt the Arksey and O’Malley framework and the Joanna Briggs Institute’s Scoping Review Methods Manual. Three databases, including PubMed, Embase and CINAHL (Cumulative Index to Nursing and Allied Health Literature), as well as relevant grey literature sources, will be searched for articles describing active global population-based maternal and infant health monitoring systems published in English from the year of database inception till 30 September 2025. Two reviewers will independently screen titles and abstracts, followed by independent full-text screenings against predefined eligibility criteria, with data extracted using a data extraction form. After data extraction, a narrative synthesis will be performed. The findings will adhere to Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews guidelines.

Ethics and dissemination

This review is based on publicly available data; no ethical approval is required. The findings of this scoping review will be published in journals and presented at relevant conferences.

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