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Measuring Advanced Practice in Health Visiting: Development and Psychometric Testing of the Health Visiting Advanced Practice Scale in Public Health Nursing

ABSTRACT

Background

The debate about whether health visiting, a specialist community public health nursing role, is at the level of advanced practice nurse has gone on for more than a decade. There is little empirical evidence that the role matches the traditional role of an advanced practice nurse, although many of the attributes of advanced practice nursing such as prescribing rights, managing complex cases, caseloads with undifferentiated need and advanced assessment and decision-making are certainly present.

Aim

The current study aimed to develop, refine and test the Health Visiting Advanced Practice Scale to assess the scope of advanced practice of UK health visitors.

Design

A cross-sectional and methodological scale validation design, following classical test theory.

Methods

The design consisted of three phases; the first involved scale development including item generation, phase two assessed the content validity index, and the third phase involved a cross-sectional survey to establish construct validity, content validity, and internal consistency reliability, and conduct exploratory and confirmatory factor analysis.

Results

The initial 44-item scale underwent iterative exploratory and confirmatory factor analyses, leading to a refined 5-factor structure with 29 items covering domains such as family-centred care, leadership, prescribing, diagnostic reasoning, and professional practice. This final version demonstrated strong reliability and construct validity in the EFA but mixed fit indices in the CFA, supporting both internal consistency and validity of the scale.

Conclusion

The final scale offers a rigorously validated tool for assessing advanced practice among UK health visitors, capturing core domains such as family-centred care, leadership, prescribing, and diagnostic reasoning. By bridging theoretical frameworks with real-world practice, it fills a critical gap in evaluating and supporting the professional scope of this public health nursing specialty.

Impact

These findings provide valid and reliable insights for measuring and improving health visitors' advanced practice and developing future professional policies.

Patient or Public Contribution

No patient or public contribution.

Reporting Method

STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) guidelines for cross-sectional studies.

Contribution of contrast-enhanced ultrasound for diagnosis of adnexal torsion (COVARIAN): protocol for a randomised controlled trial

Por: Fijean · A.-L. · Manhertz · D. · Massicot · L. · Lecointre · L. · Mottet · N. · Raimond · E. · Simon · E. · Gabriele · V. · Morel · O. · Beaumont · M. · Hossu · G. · Bertholdt · C.
Introduction

Adnexal torsion is a gynaecological emergency in which prompt diagnosis and management are critical to preserving ovarian function. However, the clinical presentation is often non-specific, and diagnosis primarily relies on pelvic ultrasound, a modality with limited sensitivity that can lead to misdiagnosis and unnecessary surgery. Contrast-enhanced ultrasound (CEUS) has emerged as a promising imaging technique that may enhance diagnostic accuracy by better characterising adnexal vascularisation.

The aim of this study is to assess whether the addition of CEUS to standard diagnostic procedures can reduce the rate of unnecessary emergency surgeries. Specifically, we compare two diagnostic strategies in cases of high clinical suspicion of adnexal torsion: the current standard approach versus an experimental strategy incorporating CEUS. The primary outcome is the rate of inappropriate surgical interventions, defined as emergency surgery performed within 6 hours without intraoperative confirmation of torsion.

Methods and analysis

This is a prospective, open-label, multicentre, randomised (1:1), controlled, superiority trial. A total of 256 women presenting with a high clinical suspicion of adnexal torsion will be enrolled over a period of 36 months. Participants will be randomly assigned to either the standard diagnostic strategy or an experimental strategy that includes CEUS. The primary endpoint is the proportion of emergency surgical procedures (performed within 6 hours of hospital admission) in which adnexal torsion is not confirmed.

Ethics and dissemination

The study was approved by the French Ethics Committee, the CPP (Comité de Protection des Personnes) on 28 October 2024. The results of this study will be published in peer-reviewed journals and presented at relevant national and international conferences. The ethical approval number from the CPP is 6115.

Registration number

NCT06677554; 2024-511720-13-00.

Mechanisms of SGLT inhibitor action and physiological mediators: systematic review and protocol for the MOSAIC collaborative meta-analysis

Por: Kugathasan · L. · Nardone · M. · Muskiet · M. · Diaz Martinez · J. P. · Lovblom · L. E. · Orchanian-Cheff · A. · Nielsen · S. · Rotbain · V. · Kazup · A. · Cersosimo · E. · Gullaksen · S. · Vernstrom · L. · van Baar · M. J. B. · van Bommel · E. · Kannenkeril · D. · Scholtes · R. · Hesp
Introduction

Sodium-glucose cotransporter (SGLT) inhibitors have shown substantial benefit in reducing cardiovascular and kidney events across diverse clinical populations, but the underlying physiological mechanisms remain unclear. However, existing mechanistic studies on renal and cardiovascular haemodynamics show variability in design, have limited statistical power and yield inconsistent outcomes, thus limiting the ability to draw generalisable conclusions. To address this gap, we conducted a systematic review and proposed the first meta-analysis to aggregate individual participant-level data from mechanistic studies to identify consistent physiological patterns and enhance understanding of the therapeutic effects of SGLT inhibition.

Methods and analysis

Gold-standard measured glomerular filtration rate (mGFR) was selected as the primary outcome for this systematic review, which aimed to identify all completed mechanistic studies investigating the effects of SGLT inhibition. Electronic databases including Ovid MEDLINE; Ovid Embase; Cochrane Database of Systematic Reviews; and Cochrane Central Register of Controlled Trials were searched using a detailed search strategy. In total, 24 studies (n=1296) were identified. This systematic review was reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Key variables including demographics, medical history, concomitant medications, vital signs, mGFR, renal haemodynamics, urine and plasma biochemistry, tubular sodium handling, echocardiography, cardiac output monitoring, arterial stiffness and fluid volume will be extracted. A one-stage individual participant data meta-analysis under a Bayesian framework will be conducted, using hierarchical models to simultaneously analyse data from all eligible studies. The risk of bias due to missing results will be assessed. Sensitivity analyses and subgroup evaluations will be incorporated to explore sources of heterogeneity and assess robustness of findings.

Ethics and dissemination

Ethics approval was obtained from University Health Network, Toronto, Canada. Findings from the Mechanisms of SGLT Inhibitor Action and Physiological Mediators (MOSAIC) meta-analysis will be published in peer-reviewed journals and results will be disseminated at scientific conferences.

PROSPERO registration number

CRD420251001413.

Building the Ship While Sailing: A Qualitative Evidence Synthesis of the Implementation of Nursing Care Delivery Models in a Hospital Setting

ABSTRACT

Aim

To explore factors influencing the implementation of a nursing care delivery model in a hospital setting.

Design

A qualitative evidence synthesis with a thematic synthesis was conducted.

Methods

The search string consisted of four ‘cluster topics’: (1) nursing, (2) care delivery models, (3) hospital setting, (4) qualitative and mixed methods designs. Four electronic databases were searched from January 2000 until July 2024: MEDLINE (PubMed interface), Embase (embase.com interface), CINAHL (EBSCOhost interface) and Web of Science. A thematic synthesis was conducted consisting of the following steps; the ‘line-by-line’ coding of the text, the development and allocation of ‘descriptive themes’ and the generation of ‘analytical themes’.

Results

In total, 3976 references were screened, of which 25 were included in the qualitative evidence synthesis. Eight analytical themes were generated that influence the implementation of a nursing care delivery model in a hospital setting: shared understanding of the care delivery model, ownership of the change, scope of practice and role clarity, collaboration, communication, responsibility, a double-loop process and aggregated recommendations. The themes were categorised on four different levels: vision, process, interactional factors and contextual factors.

Conclusion

The eight themes identified in this qualitative evidence synthesis showed that during the implementation of a nursing care delivery model, a clear implementation strategy is often missing. It is advised that future implementation processes have a clear guide and goal.

Impact

The analytical themes can guide the future implementation of a new nursing care delivery model in a hospital setting. This review can support nurses, researchers, hospital management and policymakers when implementing organisational alternatives to reorganise nursing care in a hospital setting.

Reporting Method

The qualitative evidence synthesis was reported according to the enhancing transparency in reporting the synthesis of qualitative research (ENTREQ) statement.

Patient or Public Contribution

No patient or public contribution.

Intergenerational Influence on Hypertension Prevention and Management: A Discursive Paper

ABSTRACT

Background

Hypertension remains a critical health disparity among Black older adults, driven by factors such as socioeconomic inequities, chronic stress and barriers to healthcare access. Within this population, family relationships, particularly intergenerational interactions, significantly influence health behaviours and the management of hypertension remain understudied.

Aim

To explore intergenerational factors influencing hypertension prevention and management among Black older adults, focusing on how family relationships impact health behaviours, knowledge transfer and treatment adherence.

Methods

A discursive paper applying the Transtheoretical Model of Change and Self-Determination Theory as guiding frameworks to examine the role of family dynamics in hypertension management. PubMed, Scopus and Google Scholar were searched for peer-reviewed papers published from 2015 to 2025.

Discussion

The role of family in health behaviours is examined, including the transmission of health knowledge, caregiving dynamics and emotional support. Both barriers and facilitators to effective hypertension management are identified, including cultural beliefs, community resources and the impact of intergenerational role modelling.

Implications for Practice

The discussion underscores the need for nurses to adopt family-centred approaches in hypertension management, considering the intergenerational influences on health outcomes. Recommendations for integrating these insights into clinical practice and nursing education are provided.

Conclusion

Understanding the intergenerational context of hypertension management can enhance patient care by improving adherence and prevention strategies. Future research should further explore the role of family in managing hypertension among Black older adults.

Mutuality and Self‐Care in the Patient–Caregiver Dyads in the Context of Coronary Heart Disease: An Exploration of the Mediating Role of Self‐Efficacy

ABSTRACT

Aims

To evaluate the effect of mutuality on self-care in people with CHD and the contribution of their caregivers, and whether such relationships can be mediated by self-efficacy.

Design

Secondary analysis of baseline data from a multi-centre longitudinal study.

Methods

Patients at the onset of coronary artery disease who underwent angioplasty, along with their caregivers, were included in the sample. Data from 136 patients and 136 caregivers were used for the analysis. Mutuality between patients and caregivers was measured using the Mutuality Scale. Self-care was measured using the Self-Care of Coronary Heart Disease Index and the Caregiver Contribution to Self-Care of Coronary Heart Disease Index. The actor–partner interdependence mediation models were used to assess the mediating role of self-efficacy for self-care between perceived mutuality and self-care behaviours.

Results

An actor indirect effect was found between patient mutuality and their self-care maintenance, self-care monitoring, and self-care management, through the mediation of their self-efficacy. Caregiver mutuality had a positive indirect effect on their contribution to self-care maintenance, self-care monitoring, and self-care management, through the mediation of their self-efficacy. Caregiver mutuality had a positive indirect effect on patient self-care maintenance and on patient self-care monitoring, through the mediation of patient self-efficacy. All models demonstrated satisfactory fit to the data.

Conclusions

Mutuality between patients and caregivers enhances self-care behaviours in patients with coronary heart disease, and self-efficacy is a crucial mediator in this relationship. Interventions targeting both mutuality and self-efficacy within patient–caregiver dyads may improve self-care outcomes.

Reporting Method

We adhered to STROBE guidelines.

Patient or Public Contribution

Patients and members of the public were not involved in the design, conduct, reporting, or dissemination plans of this research.

Italian EBP Implementation Scales: A Psychometric Validation Study

ABSTRACT

Background

Evidence-based practice (EBP) is widely endorsed as a cornerstone for high-quality, patient-centered care. However, its integration into daily clinical routines remains inconsistent, particularly in settings where cultural, educational, and organizational challenges persist. Reliable, contextually adapted tools are essential to measure EBP implementation and guide improvement efforts.

Aims

This study aimed to validate the Italian versions of the EBP Implementation Scale and its short-form (3-item) version.

Methods

A cross-sectional survey design was adopted. Both versions of the EBP Implementation Scale were translated and culturally adapted in accordance with internationally recognized guidelines. Data were gathered from a national sample of 405 nurses through a combination of convenience and snowball sampling. Psychometric assessment encompassed confirmatory and Bayesian factor analyses, evaluation of internal consistency and test–retest reliability, and measurement invariance testing. All analyses were performed in R Studio.

Results

Confirmatory factor analyses confirmed that both versions (long and short) of the scale measure a single underlying construct. The instruments demonstrated high reliability (ω = 0.96 and 0.87 respectively). Measurement invariance across educational groups was partially established, as the partial scalar invariance model demonstrated acceptable fit (CFI = 0.991, RMSEA = 0.045), suggesting consistent interpretation of the scale across different levels of EBP training. Latent profile analysis revealed distinct subgroups of EBP implementers, with notable differences in latent means (p < 0.001) associated with previous education in evidence-based practice.

Discussion

The Italian EBP Implementation Scales are valid and reliable tools for assessing EBP implementation behaviors. They can support education planning, monitor practice changes over time, and inform interventions aimed at enhancing evidence-based care.

Mitigating chronic respiratory disease through the lens of multimorbidity: the MARES mixed-methods study protocol

Por: Mendes · R. G. · Leonardi · N. T. · Castello-Simoes · V. · Kawakami · D. M. d. O. · Souza · J. V. R. · Schafauser-Segundo · N. S. · Simoes · R. P. · Pinto · F. G. · Araujo · G. H. G. · da Silva · M. M. C. · Moriguchi · C. S. · Franco · F. J. B. Z. · Pires Di Lorenzo · V. A. · Jor
Introduction

Chronic respiratory diseases (CRDs), such as asthma and chronic obstructive pulmonary disease (COPD), are among the leading non-communicable diseases (NCDs) worldwide. However, diagnosing CRDs in low-income and middle-income countries (LMICs) remains challenging due to limited access to spirometry and trained professionals. Aggravating the burden, CRDs often coexist with other NCDs, increasing healthcare costs, reducing quality of life and elevating mortality. These challenges highlight the need for simple case-finding approaches for CRDs, such as the COPD in Low-Income and Middle-Income Countries Assessment (COLA-6) questionnaire, to support prompt identification and appropriate care within NCD services in LMICs.

Objective

To evaluate the discriminative accuracy, feasibility and implementation of the COLA-6 questionnaire in identifying and managing CRDs in Brazilian Primary Healthcare (PHC) services for NCDs.

Methods and analysis

The Multimorbidity Approach for REspiratory Solutions (MARES) study consists of three work packages to be conducted in PHC services in São Carlos/SP and São Paulo/SP, Brazil.

MARES-1: A cross-sectional observational study enrolling 859 individuals with at least one NCD receiving care in PHC. The COLA-6 questionnaire will be administered by the research team and compared with quality-assured spirometry. The Chronic Airways Assessment Test (CAAT), Asthma Control Questionnaire (ACQ-7) and fractional exhaled nitric oxide (FeNO) will also be assessed. The diagnostic performance of COLA-6 for identifying CRDs—including COPD, asthma, preserved ratio impaired spirometry, restriction and overlaps—will be assessed using area under receiver operating characteristic curves and 95% CIs.

MARES-2: A cross-sectional observational study enrolling 20 healthcare professionals (physicians, physiotherapists, community health agents and nurses) from five PHC services. These professionals will apply the COLA-6 during routine NCD care to a total sample of 1000 patients. Qualitative interviews will be conducted to explore barriers and facilitators to the implementation of COLA-6, using deductive thematic analysis.

MARES-3: A longitudinal, prospective observational study in which patients from MARES-1 and MARES-2 will be reassessed at 6-month follow-up. A total sample of 473 participants with abnormal spirometry, a diagnosis of CRD or high risk for CRDs is expected. Participants will undergo spirometry, and a subset will be interviewed to explore their healthcare experiences through qualitative thematic analysis. Access to diagnostic and treatment services in Brazil will be assessed. Changes in spirometry values, FeNO, CAAT and ACQ-7 scores from baseline to 6 months in patients from MARES-1 will be analysed.

Ethics and dissemination

This study has been approved by the Ethics Committees of Federal University of São Carlos and University of Santo Amaro (UNISA). Ethical approval was also granted by the University College London. Results will be disseminated through peer-reviewed medical journals and presentations at international conferences. Results will improve identification of CRDs, addressing a significant gap in current PHC settings.

Trial registration number

NCT07050823/NCT07093021/NCT07134855.

Burnout and Back Pain and Their Associations With Homecare Workers' Psychosocial Work Environment—A National Multicenter Cross‐Sectional Study

ABSTRACT

Aims

To determine the prevalence of burnout and back pain in homecare workers in Switzerland and assess their associations with psychosocial work environment factors.

Design

National multicentre cross-sectional study.

Methods

Using paper-pencil questionnaires, data were collected from January 2021 to September 2021 from employees of 88 homecare agencies across Switzerland. Respondents who identified themselves as administrators, apprentices, or trainees, who were in leadership positions, or who were not involved in the provision of care or housekeeping were excluded from this analysis. Burnout was assessed with the Copenhagen Burnout Inventory Scale (possible score range 0–100) and back pain with a single item from the Federal Statistical Office's Swiss Health Survey. Multilevel regression analyses were used to assess burnout and back pain's associations with psychosocial work environment factors.

Results

We included 2514 homecare workers. More than two-thirds (68.6%) reported back pain in the past 4 weeks. The overall mean burnout score was 36.0 (SD 18.3). Poorer work-life balance, higher perceived workload and verbal aggression from clients were positively associated with both outcomes. Better leadership and social support from colleagues were negatively associated with burnout. Higher role conflict levels correlated with higher burnout levels.

Conclusion

Our findings indicate that the psychosocial work environment should be considered when designing interventions to reduce the prevalence of burnout and back pain among homecare workers.

Implications for the Profession and Patient Care

The high reported burnout and back pain prevalences among homecare workers highlight an urgent need to design and implement psychosocial work environment-improving interventions. In addition to contributing to homecare employees' long-term attraction and retention, protecting and promoting their health and well-being will likely not only benefit them, but also contribute to patient safety, quality of care and homecare sustainability.

Impact

The study reports the prevalence of burnout and back pain among homecare workers and their associations with psychosocial work environment factors. The results indicate that six psychosocial work environment factors—work-life balance, perceived workload, leadership quality, levels of social support from colleagues, role conflict levels, and verbal aggression from clients—all correlate with burnout and/or back pain in homecare workers. For policy makers, researchers, healthcare managers, and homecare agencies, this study's findings will inform the development of interventions to enhance homecare work environments, leading to improvements both in workers' health and in the quality of their care.

Reporting Method

We have adhered to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) reporting checklist for cross-sectional studies.

Patient or Public Contribution

Our stakeholder group included patient representatives, policy makers, researchers, clinicians and representatives of professional associations. Throughout the study, all provided support and input on topics including questionnaire development, result interpretation and the design of strategies to improve response rates.

‘We've Taken on a More Advanced Clinical Role’: A Multimethod Study of Community Nurses' Extended Roles in Palliative Care

ABSTRACT

Aim

To explore community nurses' experiences of changes to their roles in palliative and end-of-life care.

Design

An e-survey was followed by focus groups.

Methods

Fifty-one community nurses with recent experience of delivering end-of-life care in the United Kingdom completed a survey about changes to their roles. A purposive sample of 35 respondents participated in focus groups exploring these changes in more depth; thematic analysis was used with constant comparison.

Results

As well as two new roles—prescribing and verifying death—many participants talked about a broader expansion of their role, increasing their leadership in making complex end-of-life care decisions with patients and families. Most nurses expressed pride in their new knowledge and skills, and satisfaction with the care they were providing. Yet many also expressed distress that heavy workloads impaired their capacity both to provide good clinical care and to train junior colleagues. The importance of General Practitioner support with complex cases was often highlighted, but accessing such support was sometimes difficult.

Conclusion

While welcoming the opportunity to extend their palliative care roles, many participants indicated experiencing moral distress.

Implications for the Profession and/or Patient Care

Excessive workloads and patchy medical support threaten the retention of the experienced nurses upon whom community palliative care depends.

Impact

Our findings suggest that new and extended palliative care roles are viewed positively by nurses. To be sustainable, these changes require better workload management and consistent medical back-up.

Reporting

We adhered to relevant EQUATOR guidelines, using the SRQR checklist.

Patient or Public Contribution

Our Public and Clinician Advisory Group helped shape questions and commented on findings.

Monitoring the health of wolves (<i>Canis lupus</i>): Integrating conservation and public health

by Elisabetta Ferraro, Graziana Da Rold, Roberto Celva, Elisa Dalla Libera, Stefania Leopardi, Giulia Simonato, Paola De Benedictis, Nadia Cappai, Arianna Dissegna, Carlo Vittorio Citterio, Rudi Cassini, Federica Obber

The grey wolf (Canis lupus) population is expanding in parts of Europe due to legal protection and favorable ecological conditions. As wolves increasingly move into urban and suburban areas, interactions with domestic dogs become more frequent, raising the risk of pathogen transmission and posing potential threats to both wolf conservation and public health. This study investigated the health status of wolves in the Foreste Casentinesi National Park (Italy) using non-invasive fecal sampling conducted between May 2019 and March 2020. Samples were genetically analyzed to identify individuals and then screened for viral pathogens, Canine Coronavirus and Parvovirus, using PCR, Sanger sequencing, and phylogenetic analysis. Parasitological examinations were performed using flotation techniques on whole samples, and real-time PCR targeting Echinococcus granulosus and E. multilocularis was conducted on selected samples. Of the 260 samples collected, genetic analysis identified 80 individual wolves belonging to 8 packs. Only one sample tested positive for Coronavirus (1.2%), and none for Parvovirus. The detected sequence clustered with strains previously reported in wolves and foxes in Italy. Copromicroscopy revealed a high prevalence of veterinary-relevant endoparasites, including Eucoleus spp. (90.0%), Sarcocystis spp. (42.5%), Taeniids (28.7%), and Ancylostomatids (26.2%). Trichuris vulpis, Toxocara canis, and coccidia showed prevalence rates below 2%. All 104 samples tested for E. granulosus or E. multilocularis were negative. These findings suggest that while wolves in the FCNP commonly harbor several canine parasites, their role in the transmission of zoonotic pathogens appears limited. Although phylogenetic data suggest that coronavirus strains tend to cluster within wildlife species, molecular data on domestic dogs remain scarce. Nonetheless, the high prevalence of shared parasites highlights the need for ongoing surveillance in both wild canids and domestic carnivores. As wolves increasingly inhabit human-dominated landscapes, understanding disease dynamics at the wildlife–domestic interface is essential for effective conservation and public health strategies.

Adaptation and Psychometric Evaluation of a Patient Safety Culture Instrument for Home Care—A Multicentre Cross‐Sectional Study

ABSTRACT

Aims

To adapt an instrument to measure patient safety culture, as rated by home care workers, and examine its psychometric properties.

Design

A multicentre cross-sectional psychometric study.

Methods

We adapted the Nursing Home Survey SOPS to measure safety culture in home care. The questionnaire was translated to French following the Translation, Review, Adjudication, Pretest and Documentation (TRAPD) approach. Experts in home care evaluated the content validity of the adapted and translated instrument. To pre-test the questionnaire, we conducted cognitive interviews. We invited home care workers from two home care agencies in the French-speaking region of Switzerland to participate in the cross-sectional study from November to December 2024. We performed confirmatory factor analysis using the R package ‘lavaan’ and assessed convergent, discriminant and known-groups validity.

Results

Eight experts assessed the content validity of the adapted and translated instrument. Responses from 672 home care workers were analysed. Except for compliance with procedures, all dimensions showed acceptable or good internal consistency. Regarding construct validity, first-order and second-order level confirmatory factor analysis showed acceptable model fit. Safety culture correlated with overall patient safety rating and psychosocial safety climate. Regarding known-groups validity, participants who do not work directly with clients most of the time, and those willing to recommend the organisation rated the safety culture higher.

Conclusion

The psychometric evaluation indicated that the adapted instrument can be used as a valid and targeted tool to assess patient safety climate/culture in Swiss French-speaking home care agencies.

Implications for the Profession and/or Patient Care

The existence of an adapted and validated instrument for use in home care enables managers to monitor safety culture and develop interventions to improve it and consequently ensure patient safety.

Impact

To the best of our knowledge, there was no instrument specifically targeting the measurement of patient safety culture in the home care setting. The adapted instrument for home care showed to be a valid tool to provide information about safety culture in this setting. The availability of an instrument to measure safety culture in the home care setting can promote its monitoring, raise awareness of safety culture among staff, help managers prioritise key aspects for culture change, and thus improve patient safety. A wider adoption of the same instrument could also facilitate comparative analyses.

Reporting Method

We used the COSMIN guidelines for the psychometric evaluation of the instrument and the STROBE reporting guidelines for the cross-sectional study.

Patient or Public Contribution

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

Obinutuzumab versus Rituximab to maintain remission in children with steroid-dependent and frequently relapsing nephrotic syndrome: the OBIRINS study protocol, a double-blind randomised controlled trial

Por: Dossier · C. · Sellier-Leclerc · A.-L. · Simon · T. · Parmentier · C. · Boyer · O. · Samaille · C. · Fila · M. · Roussey-Kesler · G. · Magnavacca · M. · Chartier · Y. · Louillet · F. · Zaloszyc · A. · Vrillon · I. · Elaribi · D. · Bouatia · S. · Kaguelidou · F. · Guilmin-Crepon · S. · Ho
Introduction

There is an unmet clinical need for the development of novel treatment strategies to improve the outcome of children with frequent relapsing or steroid-dependent nephrotic syndrome. Obinutuzumab (OBI) is a second-generation anti-CD20 monoclonal antibody that has demonstrated its superiority to rituximab (RTX) in vitro and in vivo. Our assumption is that a single infusion of low-dose OBI will induce longer B-cell depletion, longer sustained remission and reduce the frequency of relapses and the use of oral immunosuppressors compared with a single infusion of RTX.

Methods and analysis

We conduct a double-blind, multicentre, randomised, parallel group in a 1:1 ratio controlled trial. In the experimental group, patients receive 1 infusion of OBI (300 mg/1.73 m2) and in the control group, the patients receive 1 infusion of RTX (375 mg/m2). The primary outcome of the study is the occurrence of the first relapse within 12 months following the initiation of treatment and secondary outcomes include the time to first relapse, the total number of relapses during the 24-month follow-up period, and any adverse events such as infusion-related complications, infectious complications, hypogammaglobulinaemia and neutropenia.

Ethics and dissemination

The study has been approved by the ethics committee (Comité de Protection des Personnes) of Sud Méditerrannée 2 and authorised by the French drug regulatory agency (Agence Nationale de Sécurité du Médicament et des Produits de Santé). Results of the primary study and the secondary aims will be disseminated through peer-reviewed publications.

Trial registration number

NCT05786768.

Eudract N°

2022-003336-59.

Does a history of sickle cell disease affect the prescription of morphine? An international, randomised study based on clinical vignettes conducted among emergency physicians

Por: Coisy · F. · Simon · A. · Occelli · C. · Dupriez · F. · Ageron · F.-X. · NDiaye · L. · Feral-Pierssens · A.-L. · Yates · G. · Bobbia · X.
Objectives

To assess whether emergency physicians prescribe morphine differently for patients with or without sickle cell disease (SCD). Given the difficulty of comparing strictly homogeneous patients in real clinical settings, we used a standardised clinical vignette to ensure that all clinical information was identical except for SCD status and sex.

Design

International, randomised controlled, vignette-based study conducted online. The four vignette versions differed only in patient sex and SCD status, with all other clinical information fully standardised. Vignettes were validated by an expert panel and randomly allocated using a computer-generated sequence.

Setting

Emergency physicians practising in France, the UK, Belgium and Switzerland were invited to complete an online survey between 17 February and 17 March 2025.

Participants

A total of 1060 physicians responded, of whom 953 (90%) met eligibility criteria and were included in the analysis. Respondents were practising emergency department (ED) physicians without exclusion based on seniority or training level.

Primary and secondary outcome measures

The primary outcome was the proportion of simulated patients for whom morphine was prescribed. Secondary outcomes included the number and type of analgesics prescribed and the proportion of cases meeting predefined criteria for maximal level of care (urgent triage category, lactate sampling, CT imaging and morphine administration).

Results

Morphine was prescribed in 444 of 492 (90%) SCD vignettes and 389 of 461 (84%) non-SCD vignettes (absolute difference: 6% (95% CI 1% to 10%)). Morphine monotherapy was used in 41% of SCD cases and combined analgesia in 50%. No significant differences were observed according to patient sex or physician characteristics. Maximal level of care was recommended in 22% of SCD cases.

Conclusion

In this randomised vignette study, emergency physicians prescribed morphine more frequently for simulated patients with SCD than for those without SCD, despite identical clinical presentations. These findings contrast with real-world reports of inadequate analgesia in SCD and suggest that the absence of perceptual cues—such as skin colour or names—may reduce implicit bias in opioid prescribing.

Trial registration number

NCT06835335. IRB CHU Nîmes No 25.02.01.

Persistent Changes of Nurses' Practices and Working Conditions in High Acuity Settings in the Post‐Pandemic Era: A Qualitative Meta‐Aggregation

ABSTRACT

Aims

To explore the persistent changes in working conditions and nursing practices in high acuity settings in the post COVID-19 pandemic era.

Design

A qualitative systematic review using the meta-aggregation design of the Joanna Briggs Institute.

Methods

After screening by two authors based on the inclusion and exclusion criteria, 36 studies were included. Quality was appraised using the Joanna Briggs Institute Critical Appraisal Checklist for Qualitative Research. Data were then extracted and synthesised. Confidence of findings was assessed using the ConQual approach.

Data Sources

The electronic databases: MEDLINE, CINAHL, Embase, and Scopus were searched in November 2023. Additional searches were conducted using the preprint servers: medRxiv, Open Science Foundation, Social Science Research Network, and Journal of Medical Internet Research.

Results

Synthesised findings of ‘unfavourable working conditions and changed nursing practices’ and ‘health concerns caused by the nursing practices’ with eight categories were identified. Significant findings included increased workloads; overwhelming use and insufficient supply of personal protective equipment; decreased communication between nurses and patients, families, and other healthcare workers; lack of knowledge of the disease; and adequate support from coworkers, but inadequate support from nurse managers and physicians.

Conclusion

This study synthesised existing knowledge and offered insight into the nursing practices and working conditions of high acuity nurses during the COVID-19 pandemic. Clinical nurses and managers need to actively take action on those modifiable aspects of their practices in a future similar crisis. This review did not identify any studies focusing on high acuity nurses' working conditions and practices in the post-pandemic era. This kind of research is urgently needed.

Impact

Nurse managers and policy makers can use the findings of this review to help construct better working conditions for their high-acuity nursing staff in a future similar crisis. Frontline high-acuity clinical staff may use the findings of this review to help better guide their nursing practices and mitigate negative effects of a future similar crisis on their practice and health.

Reporting Method

The study was reported according to the Enhancing Transparency in Reporting the Synthesis of Qualitative Research statement.

Patient or Public Contribution

No patient or public contribution.

Trial Registration

International Prospective Register of Systematic Reviews: CRD42023473414

A mixed-methods study to explore the modifiable aspects of treatment burden in Parkinson’s disease and develop recommendations for improvement

by Qian Yue Tan, Kinda Ibrahim, Helen C. Roberts, Khaled Amar, Simon D.S. Fraser

Background

People with Parkinson’s (PwP) and their caregivers have to manage multiple daily healthcare tasks (treatment burden). This can be challenging and may lead to poor health outcomes.

Objective

To assess the extent of treatment burden in Parkinson’s disease(PD), identify key modifiable factors, and develop recommendations to improve treatment burden.

Methods

A mixed-methods study was conducted consisting of: 1) a UK-wide cross-sectional survey for PwP and caregivers using the Multimorbidity Treatment Burden Questionnaire (MTBQ) to measure treatment burden levels and associated factors and 2) focus groups with key stakeholders to discuss survey findings and develop recommendations.

Results

160 PwP (mean age = 68 years) and 30 caregivers (mean age = 69 years) completed the surveys. High treatment burden was reported by 21% (N = 34) of PwP and 50% (N = 15) of caregivers using the MTBQ. Amongst PwP, higher treatment burden was significantly associated with advancing PD severity, frailty, a higher number of non-motor symptoms, and more frequent medication timings (>3 times/day). Caregivers reporting higher treatment burden were more likely to care for someone with memory issues, had lower mental well-being scores and higher caregiver burden. Three online focus groups involved 11 participants (3 PwP, 1 caregiver and 7 healthcare professionals) recruited from the South of England. Recommendations to reduce treatment burden that were discussed in the focus groups include improving communication. clear expectation setting, and better signposting from healthcare professionals, increasing education and awareness of PD complexity, flexibility of appointment structures, increasing access to healthcare professionals, and embracing the supportive role of technology.

Conclusions

Treatment burden is common amongst PwP and caregivers and could be identified in clinical practice using the MTBQ. There is a need for change at individual provider and system levels to recognise and minimise treatment burden to improve health outcomes in PD.

Development of a competition assay to assess the <i>in vitro</i> fitness of dengue virus serotypes using an optimized serotype-specific qRT-PCR

by Anne-Fleur Griffon, Loeïza Rault, Clément Tanvet, Etienne Simon-Lorière, Myrielle Dupont-Rouzeyrol, Catherine Inizan

Background

Comparing the in vitro fitness of dengue virus (DENV) isolates is a pivotal approach to assess the contribution of DENV strains’ replicative fitness to epidemiological contexts, including serotype replacements. Competition assays are the gold standard to compare the in vitro replicative fitness of viral strains. Implementing competition assays between DENV serotypes requires an experimental setup and an appropriate read-out to quantify the viral progeny of strains belonging to different serotypes.

Methods

In the current study, we optimized an existing serotyping qRT-PCR by adapting primer/probe design and multiplexing the serotype-specific qRT-PCR reactions, allowing to accurately detect and quantify all four DENV serotypes. We next developed an in vitro competition assay to compare the replicative fitness of two DENV serotypes in the human hepatic cell line HuH7.

Findings

The qRT-PCR was specific, and had a limit of detection below 7.52, 1.19, 3.48 and 1.36 genome copies/µL, an efficiency of 1.993, 1.975, 1.902, 1.898 and a linearity (R²) of 0.99975, 0.99975, 0.99850, 0.99965 for DENV-1, −2, −3 and −4, respectively. Challenge of this multiplex serotype-specific qRT-PCR on mixes of viral supernatants containing known concentrations of strains from two serotypes evidenced an accurate quantification of the amount of genome copies of each serotype. Quantification of the viral progeny of each serotype in the inoculum and the supernatant of competition assays using the serotype-specific multiplex qRT-PCR unveiled an enrichment of the supernatant in DENV-1 genome copies, uncovering the enhanced replicative fitness of this DENV-1 isolate.

Conclusions

This optimized qRT-PCR combined with a relevant cellular model allowed to accurately quantify the viral progeny of two DENV strains belonging to two different serotypes in a competition assay, allowing to determine which strain had a replicative advantage. This reliable experimental setup is adaptable to the comparative study of the replicative fitness of any DENV serotypes.

Do professional experience and qualification influence knowledge about law concerning informed consent and end-of-life decisions? A quantitative online survey among German intensive care physicians

Por: Schumann · C. · Wachter · M. · Eslauer · E. · Angeli · R. · Girrbach · F. · Weiss · M. · Friedrich · S. · Simon · P. · Heller · A. R.
Background

Recently, legal questions have increasingly arisen in intensive care medicine (ICM), especially when it comes to end-of-life decisions. Still, for Europe, there is not much evidence about doctors’ situational legal knowledge and legal education during medical studies and further qualification. The present study was initiated to analyse these hitherto unexplored aspects in Germany.

Design

A quantitative online survey has been performed among German intensive care physicians. The voluntary participants of the anonymous online survey were asked to answer legal questions related to end-of-life policies, informed consent, surrogate decision making or advance directives. We tested pure factual knowledge in five questions. The other five questions tested situational knowledge using case vignettes. Every question could be answered with ‘yes’, ‘no’ or ‘do not know’. Furthermore, the participants were asked to assess their subjective certainty on a Likert scale and to provide information about their professional experience (PE) and qualification.

Setting

All members of the two German professional societies for anaesthesiology who work in ICM were asked to take part in the survey.

Participants

952 completed questionnaires were analysed. 86% of the participants were specialists, and 56% held the additional qualification in ICM. 78% had more than 10 years of general clinical experience, and 62% had more than 5 years of experience in ICM.

Results

On average, the participants answered the five facts–questions in 90.8% correctly. However, only 73.6% of the five case vignettes were answered correctly. Specialists, physicians with a lot of PE or physicians holding the additional qualification in ICM did not perform better than assistants or physicians with little PE.

Conclusion

German intensive care physicians have relevant gaps regarding situational legal knowledge, which are independent of their PE or qualification and persist. This may be due to difficulties in interpretation and implementation of law. Since these knowledge gaps can lead to liability and criminal prosecution, these gaps should be closed through awareness-raising and continuous education.

Profiling Healthcare Professionals' Digital Health Competence and Associated Factors: A Cross‐Sectional Study

ABSTRACT

Aim

To assess healthcare professionals' digital health competence and its associated factors.

Design

Cross-sectional study.

Methods

The study was conducted from October 2023 to April 2024 among healthcare professionals in Italy, using convenience and snowball sampling. The questionnaire included four sections assessing: (i) socio-demographic and work-related characteristics; (ii) use of digital solutions as part of work and in free time, and communication channels to counsel clients in work; and DigiHealthCom and DigiComInf instruments including measurements of (iii) digital health competence and (iv) managerial, organisational and collegiality factors. K-means cluster analysis was employed to identify clusters of digital health competence; descriptive statistics to summarise characteristics and ANOVA and Chi-square tests to assess cluster differences.

Results

Among 301 healthcare professionals, the majority were nurses (n = 287, 95.3%). Three clusters were identified: cluster 1 showing the lowest, cluster 2 moderate and cluster 3 the highest digital health competence. Most participants (n = 193, 64.1%) belonged to cluster 3. Despite their proficiency, clusters 2 and 3 scored significantly lower on ethical competence. Least digitally competent professionals had significantly higher work experience, while the most competent reported stronger support from management, organisation, and colleagues. Communication channels for counselling clients and digital device use, both at work and during free time, were predominantly traditional technologies.

Conclusion

Educational programmes and organisational policies prioritising digital health competence development are needed to advance digital transition and equity in the healthcare workforce.

Implications for the Profession

Greater emphasis should be placed on the ethical aspects, with interventions tailored to healthcare professionals' digital health competence. Training and policies involving managers and colleagues, such as mentoring and distributed leadership, could help bridge the digital divide. Alongside traditional devices, the adoption of advanced technologies should be promoted.

Reporting Method

This study adheres to the STROBE checklist.

Patient or Public Contribution

None.

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