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☐ ☆ ✇ BMJ Open

Rationale and protocol of the CREFEL trial: a single-centre, single-arm pilot trial of cardiac radiotherapy for heart failure with reduced left ventricular ejection fraction

Por: Goethals · E. · Berkovic · P. · Voros · G. · De Roover · R. · Poels · K. · Depuydt · T. · Ector · J. · Vandenberk · B. — Octubre 30th 2025 at 04:18
Introduction

Heart failure with reduced ejection fraction (HFrEF) remains a significant cause of morbidity and mortality worldwide, particularly in patients who remain symptomatic despite guideline-directed medical therapy (GDMT). Preliminary data suggest that a single fraction low-dose whole-heart external beam radiotherapy (EBRT) may improve cardiac function by modulating inflammatory and fibrotic processes. This trial aims to evaluate the preliminary efficacy of a single fraction 5 Gy whole-heart EBRT to improve left ventricular ejection fraction (LVEF) in patients with HFrEF on GDMT. Secondary objectives will assess safety, cardiac biomarkers and patient-reported outcomes.

Methods and analysis

Single-centre, single-arm, prospective interventional trial aiming to enrol 40 patients with HFrEF (LVEF≤35%) on maximal GDMT, New York Heart Association (NYHA) classes II–IV, and stable for ≥6 months prior to enrolment, without recent heart failure admissions or GDMT changes. All participants are required to have cardiac implantable electronic devices. Recruitment will be balanced with 20 patients with ischaemic and 20 with non-ischaemic aetiology. Eligible patients will receive a single fraction of 5 Gy whole-heart EBRT guided by a non-contrast enhanced primary planning CT. Follow-up assessments will be conducted at baseline, 6 weeks, 12 weeks and 6 months. The primary outcome is an improvement in LVEF of ≥5% at 6 months, assessed by transthoracic echocardiography. This is an open-label trial with blinded ascertainment of the primary outcome. Secondary outcomes include acute and late toxicity, overall survival, hospital admission for heart failure, patient-reported quality of life, cardiac biomarkers and device-reported arrhythmia burden.

Ethics and dissemination

The trial has been approved by the Ethics Committee Research UZ/KU Leuven, Belgium (S69569). The study results will be shared through peer-reviewed journals and presentations at academic conferences.

Trial registration number

NCT06661876.

☐ ☆ ✇ Journal of Nursing Scholarship

Quality and Bias in Randomized Controlled Trials Published in Latin American Nursing Journals: A Meta‐Epidemiological Study

ABSTRACT

Introduction

Randomized controlled trials (RCTs) are essential for evidence-based nursing care. However, the quality of reporting and adherence to methodological standards in Latin American nursing journals remains unclear. This study evaluates the characteristics, reporting quality, and potential risk of bias of RCTs published in Latin American nursing journals.

Objective

To assess the reporting compliance and risk of bias of RCTs published in Latin American nursing journals.

Design

Meta-research study.

Methods

A comprehensive handsearch of 29 Latin American nursing journals was performed covering publications from 2000 to 2024. Identified RCTs were assessed for adherence to CONSORT reporting guidelines and evaluated for risk of bias. Outcomes were classified using the COMET taxonomy. A descriptive analysis was performed.

Results

A total of 6377 references were screened, identifying 34 eligible RCTs, most published after 2018. The median CONSORT compliance was 19 reported items (IQR 16–22). High compliance (> 90%) was observed in abstract reporting items, study objectives, and participant selection criteria. However, critical methodological features such as randomization procedures, blinding, and protocol registration showed low adherence (< 40%). Risk of bias was mostly rated as having “some concerns”, largely due to insufficient reporting. According to the COMET taxonomy, the most frequently reported outcome domains were “Delivery of care” and “Physical functioning”.

Conclusions

Reporting compliance and risk of bias of RCTs published in Latin American nursing journals presents significant gaps, particularly in key methodological domains. These shortcomings hinder transparency, reproducibility, and integration into evidence synthesis. Strengthening editorial policies and enforcing reporting standards could enhance the quality and reliability of published research in Latin American nursing journals.

☐ ☆ ✇ Journal of Advanced Nursing

Understaffing as a Two‐Dimensional Phenomenon: A Cross‐Sectional Study of Hospital Nurses' Manpower and Expertise Understaffing

Por: Shani Pindek · Melisa R. Hayman · David J. Howard · Maryana L. Arvan · Paul E. Spector — Septiembre 25th 2025 at 07:02

ABSTRACT

Aim(s)

To examine whether manpower and expertise understaffing are distinct, and whether they relate similarly to nursing stressors, burnout, job satisfaction and intentions to turnover.

Design

A cross-sectional survey of hospital nurses nested within units was used.

Methods

The sample included 402 nurses. Nurses provided ratings of the study's variables using validated self-report measures. The data were analysed both as multilevel and single-level data.

Results

Manpower and expertise understaffing contributed unique explained variance to all of the examined outcomes. Nurses within the same units experience different understaffing levels. Expertise understaffing emerged as a significantly stronger predictor than manpower understaffing for three of the six of the outcome variables (illegitimate tasks, job satisfaction and turnover intentions).

Conclusion

Manpower and expertise understaffing are distinct, and both are associated with nurse outcomes.

Reporting Method

We have adhered to the STROBE guideline for cross-sectional studies.

Implications for the Profession and/or Patient Care

Considering both manpower and expertise understaffing to maintain proper staffing levels in nursing units is crucial.

Patient or Public Contribution

A Director of Patient Care Services from the hospital where the study was conducted is a member of the research team. This member contributed to designing and conducting the study as well as interpreting the results.

☐ ☆ ✇ Index de Enfermería

Riesgo de ex-posición a la Covid-19 en auxiliares de enfermería, enfermeras y médicos de un hospital universitario ante la pandemia

Objetivo principal: Los profesionales sanitarios fueron los trabajadores más afectados por Covid-19, especialmente durante las primeras oleadas. El objetivo del estudio es evaluar la percepción del riesgo de exposición al Covid-19, información recibida y participación laboral entre enfermeros, médicos y auxiliares de enfermería. Metodología: Se realizó un estudio transversal mediante una encuesta epidemiológica entre enfermeras, médicos y auxiliares de enfermería de un hospital universitario. Se realizó una validación de aspecto y contenido, un pretest cognitivo y un pilotaje de la encuesta epidemiológica con treinta sujetos. Se realizó un análisis descriptivo utilizando media y desviación estándar (DE) para las variables cuantitativas y las frecuencias absolutas (n) y relativas (%) para variables cualitativas. Se aplicó el test chi-cuadrado y el test ANOVA para evaluar la asociación de las respuestas con las variables: sexo, tipo de trabajador, área de trabajo y actividad en Unidades Covid-19. Resultados principales: Las enfermeras, médicos y auxiliares de enfermería trabajaban principalmente en áreas asistenciales y en unidades de alto riesgo de exposición. Los auxiliares de enfermería y las enfermeras tenían una mayor percepción de riesgo. Las enfermeras estaban menos implicadas en la organización, pero se sentían más apoyadas por sus compañeros. Los médicos se sentían más apoyados por sus superiores y mejor atendidos cuando tenían problemas de salud. Conclusión principal: Las enfermeras y auxiliares de enfermería presentaron mayor percepción de riesgo, las enfermeras se implicaron menos en la organización de la atención sanitaria, mientras que los médicos se sintieron más apoyados por sus superiores.

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