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Personalising anal cancer radiotherapy dose (PLATO): protocol for a multicentre integrated platform trial

Por: Frood · R. · Gilbert · A. · Gilbert · D. · Abbott · N. L. · Richman · S. D. · Goh · V. · Rao · S. · Webster · J. · Smith · A. · Copeland · J. · Ruddock · S. P. · Berkman · L. · Muirhead · R. · Renehan · A. G. · Harrison · M. · Adams · R. · Hawkins · M. · Brown · S. · Sebag-Montefiore · D.
Introduction

The incidence of anal carcinoma is increasing, with the current gold standard treatment being chemoradiotherapy. There is currently a wide range in the radiotherapy dose used internationally which may lead to overtreatment of early-stage disease and potential undertreatment of locally advanced disease.

PLATO is an integrated umbrella trial protocol which consists of three trials focused on assessing risk-adapted use of adjuvant low-dose chemoradiotherapy in anal margin tumours (ACT3), reduced-dose chemoradiotherapy in early anal carcinoma (ACT4) and dose-escalated chemoradiotherapy in locally advanced anal carcinoma (ACT5), given with standard concurrent chemotherapy.

Methods and analysis

The primary endpoints of PLATO are locoregional failure (LRF)-free rate for ACT3 and ACT4 and LRF-free survival for ACT5. Secondary objectives include acute and late toxicities, colostomy-free survival and patient-reported outcome measures. ACT3 will recruit 90 participants: participants with removed anal tumours with margins ≤1 mm will receive lower dose chemoradiotherapy, while participants with anal tumours with margins >1 mm will be observed. ACT4 will recruit 162 participants, randomised on a 1:2 basis to receive either standard-dose intensity modulated radiotherapy (IMRT) in combination with chemotherapy or reduced-dose IMRT in combination with chemotherapy. ACT5 will recruit 459 participants, randomised on a 1:1:1 basis to receive either standard-dose IMRT in combination with chemotherapy, or one of two increased-dose experimental arms of IMRT with synchronous integrated boost in combination with chemotherapy.

Ethics and dissemination

This study has been approved by Yorkshire & The Humber – Bradford Leeds Research Ethics Committee (ref: 16/YH/0157, IRAS: 204585), July 2016. Results will be disseminated via national and international conferences, peer-reviewed journal articles and social media. A plain English report will be shared with the study participants, patients’ organisations and media.

Trial registration number

ISRCTN88455282.

Exploring the evidence for the use of protein biomarkers of muscular damage and disease progression in Duchenne and Becker muscular dystrophy: a systematic review and meta-analysis protocol

Introduction

Duchenne and Becker muscular dystrophies (DMD and BMD) are devastating conditions characterised by progressive muscle degeneration and weakness. Despite advances in understanding their pathogenetic processes, there is a critical need for reliable biomarkers to aid in patient stratification and inform clinical decision-making, predict disease progression and evaluate therapeutic responses. Several promising protein biomarkers have been investigated as potential diagnostic/prognostic tools, but, to date, this evidence has not been systematically synthesised. We aim to comprehensively and critically review and summarise published studies reporting the use of protein signatures of muscular damage in DMD and BMD.

Methods and analysis

We will systematically search Ovid MEDLINE (PubMed), OVID Embase, OVID Evidence-Based Medicine Reviews and Cochrane Library to retrieve all relevant articles. For ongoing trials, we will search WHO International clinical trials registry and ClinicalTrials.gov registry. We will include studies that measure circulating and urine levels of established and/or promising protein biomarkers associated with skeletal muscular damage and disease progression, such as creatine kinase, myoglobin, skeletal troponin I fast-twitch (type II), myostatin, creatine/creatinine ratio, creatinine and titin. We will consider randomised controlled trials, observational studies and longitudinal cohort studies with serial sampling, without restrictions on sample size, geographic location or language, while excluding animal and in vitro studies. Two independent reviewers will screen articles for inclusion using predefined eligibility criteria and extract data of retained articles. A third author will be consulted in case of disagreement. The approach recommended by the Agency for Healthcare Research and Quality’s Methods Guide for Effectiveness and Comparative Effectiveness Reviews will be used. The risk of bias and reporting quality will be assessed with standardised scales. The analysis will involve a structured narrative synthesis and evidentiary tables. If a meta-analysis is possible, biomarker data for each outcome will be pooled using random effects models. Subgroup analyses have been planned as a function of age, genetic mutation, disease severity, imaging and clinical assessment, length of the observation and risk of bias.

Ethics and dissemination

Ethics approval is not required for this study as no original data will be collected. The findings will be shared through peer-reviewed publications and conference presentations. Additionally, this systematic review will guide the recommendations of the Duchenne Regulatory Science Consortium. This work will provide a rigorous, exhaustive and accessible evidence synthesis to identify candidate biomarkers of potential clinical value. Furthermore, it is expected that these results could be used to facilitate the development of future research strategies and guidelines, inform resource allocation decisions and accelerate the route towards clinical implementation of biomarkers for DMD and BMD.

PROSPERO registration number

CRD42024549471. Available from: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42024549471

Comparative effectiveness of opioid versus opioid-free analgesia after outpatient breast surgery: PAIN-Alt trial protocol

Por: Fiore · J. F. · Shirzadi · S. · Roversi · K. · Prakash · I. · Wong · S. · Meterissian · S. · Meguerditchian · A. N. · Desbiens · C. · Rivard · J. · Delisle · M. · Findlay-Shirras · L. · Abou Khalil · J. · Maciver · A. · Quan · M. L. · Verreault · K. · Johnston · S. · Feldman · L. · McDon
Introduction

Excessive opioid prescribing after surgery can lead to adverse events and exacerbate the opioid crisis. Patients undergoing outpatient breast surgery are often prescribed opioids to manage pain at home; however, the value of this approach is uncertain. The Postoperative Analgesia Intervention with Non-opioid Alternatives (PAIN Alt) trial will address the following research question: among patients undergoing outpatient breast surgery, does opioid-free analgesia (OFA) result in non-inferior 7-day pain intensity and pain interference in comparison to opioid analgesia (OA)?

Methods and analysis

This is a parallel, assessor-blind, open-label randomised trial conducted at seven university-affiliated hospitals in Canada. A sample of 540 adult patients (>18 years) undergoing outpatient mastectomy or lumpectomy will be included. Participants are allocated 1:1 to receive OA (around-the-clock non-opioids and opioids for breakthrough pain) or OFA (around-the-clock non-opioids, with adjustment of non-opioid drugs and/or non-pharmacological interventions for breakthrough pain). The co-primary outcomes are 7-day pain intensity and pain interference (measured using the Brief Pain Inventory). Secondary outcomes include adverse drug events, physical and mental health status, satisfaction with pain management, postoperative complications, chronic pain, opioid misuse, persistent opioid use, healthcare utilisation and costs. The primary statistical analyses will follow the intention-to-treat principle and be conducted using mixed-effects modelling.

Ethics and dissemination

This trial is coordinated by the McGill University Health Centre (ethics approval MP-37-2024-102530), with ethics approval being sought at all participating sites. Our results will be published in an open-access, peer-reviewed journal, presented at relevant conferences and disseminated to the public through press releases.

Trial registration number

NCT06507345.

Telenursing practice in the care of patients with surgical cancer: a scoping review

Por: Mozer · C. A. d. N. · Goncalves · J. d. C. · Rozetti · C. M. T. · Carvalho · R. d. · Fiorin · B. H. · Furieri · L. B. · Fioresi · M.
Objectives

Surgical oncology patients often experience doubts and uncertainties in the preoperative and postoperative periods, which can be addressed remotely through telenursing. Expanding telenursing services could contribute to more comprehensive perioperative care. We conducted a scoping review to characterise these telenursing services, identify their outcome indicators and examine the content of the care delivered.

Design

A scoping review was conducted in accordance with the Joanna Briggs Institute (JBI) recommendations.

Data sources

MEDLINE (PubMed), EMBASE, CINAHL, SCOPUS, Web of Science and Virtual Health Library (VHL), with searches performed up to 5 May 2025.

Eligibility criteria for selecting studies

We included studies that implemented telenursing interventions in the preoperative or postoperative period in adult oncology patients.

Data extraction and synthesis

Two independent reviewers used a standardised search to select and extract data from the included studies. Study characteristics were presented descriptively using absolute and relative frequencies, and the content of telenursing interventions was organised into a circular thematic matrix.

Results

A total of 37 studies were included, published between 1996 and 2024, conducted in 12 countries and primarily focused on postoperative telenursing via telephone or video calls. Preoperative care focused on psychosocial support and guidance related to surgical preparation. Postoperative topics included surgical wound care; handling of devices such as drains, ostomy bags and catheters; instructions for returning to work and support groups for financial and social assistance. Outcome indicators were primarily related to care, including levels of anxiety, stress, depression and quality of life.

Conclusions

Oncologic surgical telenursing remains primarily focused on postoperative care and the delivery of personalised support. Reporting on the protocols used, frequency and duration of sessions, nurse training and profiles, integration with in-person care workflows and operational cost data could strengthen the knowledge base for perioperative telenursing in oncology.

Prevalence and Determinants of Workplace Violence Against Nurses in the Italian Home Care Settings: A Cross‐Sectional Multicentre Study

ABSTRACT

Aims

To describe the prevalence and determinants of workplace violence against nurses in the Italian home care setting.

Design

Secondary cross-sectional analysis of data from the multicentre study AIDOMUS-IT.

Methods

Nurses employed in home care services provided by Italian Local Health Authorities were interviewed using a variety of instruments. A multivariable binary logistic regression model was performed to model the risk of workplace violence against nurses in the last 12 months. Variables related to violence were selected among sociodemographic characteristics (such as age and gender), work-related factors (including years of experience, team composition, overtime working, previous experience in mental health care, burnout) and organisational elements (including leadership and support, workload, staffing and resources adequacy, and time to reach the patients' homes). Adjusted odds ratios (aOR) were used to present the results.

Results

A total of 3949 nurses participated in the study and 20.49% of them reported to have experienced an episode of violence in the last 12 months. Determinants of higher risk of violence episodes were younger age (aOR = 1.02, p = 0.002), higher workload (aOR = 1.01, p = 0.002), working in a multiprofessional team (aOR = 1.24, p = 0.018), perception of inadequate managerial leadership and support (aOR = 1.38, p = 0.003), and higher burnout levels (aOR = 1.01, p < 0.001).

Conclusion

The prevalence of workplace violence against Italian home care nurses is high. Several modifiable determinants were found to be associated with a higher risk of violence, which can potentially be mitigated with tailored interventions.

Implications for the Profession and/or Patient Care

Effective preventive strategies must be developed to lessen workplace violence against nurses in the home care setting. These strategies should focus on strengthening nursing managers' leadership and support skills, enhancing team-building strategies, avoiding inadequate workload, monitoring nurses' burnout, estimating optimum staffing levels, and assigning advanced-career nurses to home care services. These measures are imperative to guarantee the quality and safety of home care organisations and to attain favourable outcomes in the provision of care.

Impact

This study aimed to explore the prevalence and determinants of workplace violence against nurses in the Italian home care settings. We found that out of the 3949 nurses surveyed, 20% of the sample reported one episode of violence during the last 12 months. Determinants of this violence included younger age, higher workload and burnout, being in a multiprofessional team, and perception of lack of leadership and support by the nurse manager. The results of this study can be used to tailor interventions aimed at mitigating the risk factors of violence, particularly those that can be modified (e.g., workload, burnout, and leadership).

Reporting Method

The study adhered to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines.

Patient or Public Contribution

No patient or public contribution.

Digital Health Literacy in Patients With Hypertension: A Cross‐Sectional Study

ABSTRACT

Aim

To assess Digital Health Literacy (DHL) levels among hypertensive patients.

Design

Cross-sectional study.

Methods

The study, conducted from March to August 2024 among hypertensive patients using convenience sampling, employed a 35-item questionnaire assessing: (I) sociodemographic; (II) physical activity, dietary habits, antihypertensive pharmacological treatment and medical history; (III) online health-related information knowledge and confidence; (IV) DHL, through the HLS19-DIGI questionnaire with subscales on: (i) dealing with digital health information (HL-DIGI), (ii) interaction with digital resources (HL-DIGI-INT), (iii) frequency of digital device use for health (HL-DIGI-DD).

Results

Among 311 participants (mean age 63.9 years, SD = 14.8), 42.1% completed high school, 25.4% held a bachelor's degree and 22.8% were physically inactive. While 49.8% were aware of online health-related information, 28.9% were uncertain and 47.6% lacked confidence in using it for health decisions. On average, participants showed a problematic level of DHL in HL-DIGI, a sufficient level in HL-DIGI-INT, and used digital health devices just over once a week. Older age emerged as a predictor of higher online health-related knowledge and DHL, while higher education level predicted higher knowledge, confidence and DHL. Physical inactivity was associated with lower online health-related information knowledge and confidence.

Conclusions

These findings point to the need to design proactive strategies and implement targeted training and educational interventions to improve DHL in hypertensive patients.

Implications for the Profession and/or Patient Care

Enhancing DHL levels through targeted interventions in patient care allows patients to effectively benefit from digital healthcare, achieve positive health outcomes and reduce disparities in care pathways.

Reporting Method

This study adhered to the STROBE checklist for reporting.

Patient or Public Contribution

Patients were involved as the study population.

Protocol Registration

Local Ethical Committee of the University Hospital Company of the Marche Region, Italy (protocol: 2023/279, date: 28/09/2023).

Cuidados en el hogar al niño hospitalizado con infecciones respiratorias agudas desde un enfoque cultural

Introducción: Las prácticas culturales que tienen las madres para tratar las infecciones respiratorias en sus niños pueden tener efectos positivos o negativos para su recuperación. Objetivo: Describir los cuidados en el hogar al niño hospitalizado con infecciones respiratorias agudas desde un enfoque cultural. Método: Estudio cualitativo descriptivo. La muestra estuvo representada por 12 madres de niños menores de cinco años con infecciones respiratorias agudas hospitalizados. Los datos se recolectaron a través de la entrevista semiestructurada y fueron procesados mediante análisis de contenido. Resultados: Se establecen tres categorías: a) Uso de la medicina tradicional como práctica ancestral para tratar las infecciones respiratorias agudas, b) Hábitos en la alimentación durante las infecciones respiratorias agudas, c) Costumbres en el abrigo y la higiene frente a las infecciones respiratorias agudas. Conclusiones: Las madres tratan las infecciones respiratorias con plantas medicinales que son oriundas de su comunidad. Existen aspectos positivos que se deben preservar como brindar lactancia materna durante la enfermedad, pero se debe negociar el baño diario, y reestructurar el sobreabrigar al niño. Asimismo, el personal de enfermería debe tener conocimientos sobre la medicina tradicional y sus efectos, con la finalidad de brindar una educación sanitaria intercultural.

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