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The clinical practicum is a critical component of nursing education. In Spain, it is currently facing systemic challenges that compromise its quality and sustainability. A persistent nursing shortage, combined with increasing pressure on healthcare systems and a growing number of students intended to address this gap, is adding strain to clinical learning environments, which may compromise the capacity of nurses to provide adequate supervision and meaningful learning experiences for nursing students. This not only diminishes the quality of the training experiences, but also negatively affects the well-being of both students and nurses, further worsening the situation. This protocol outlines a study aimed at conducting an in-depth analysis of the current challenges affecting the clinical practicum and proposing a new model that effectively addresses them, with significant potential for adaptation and implementation across different health education fields and geographical locations.
The study will employ a sequential mixed-methods design comprising two integrated phases. In phase I, quantitative, qualitative and scoping review methodologies will be combined to identify current challenges and opportunities. Quantitative data will be obtained by administering questionnaires to nursing students and clinical mentors (CMs) tutoring them in Catalonia, examining potential barriers and facilitators to their mentoring role. Data will be analysed through descriptive and inferential statistics. Qualitative data will emerge from semistructured interviews with CMs and nurse coordinators, as well as from a visual elicitation technique, the ‘Emojional’ Calendar, conducted with students to understand their clinical practicum experiences. These will be analysed through an inductive thematic analysis approach. The scoping review, following the Arksey and O’Malley framework, will identify best practices in clinical practicums in nursing and other health studies globally. Phase II will involve a three-round qualitative Delphi study in which all preceding results will be presented to stakeholders and decision makers in order to redesign the clinical practicum model.
Ethical approval for this study was obtained from Hospital del Mar Clinical Research Ethics Committee (Ref #2023/11123). Results will be disseminated through peer-reviewed journals and conference presentations, as well as via strategic actions (forums and meetings with healthcare managers, deans and policymakers) and general outreach (talks, social media and websites) targeted at professionals, students and the public.
To compare attitudes and perceptions towards opioid use disorder among people with opioid use disorder and emergency providers, describe interactions between the two groups, and identify barriers to providing and receiving care.
Mixed methods observational study.
Participants were recruited from an academic, tertiary care hospital and a community-based harm reduction agency in New England. Emergency healthcare providers (nurses, physicians, and paramedics) and adult people with opioid use disorder were enrolled. Electronic surveys were administered to providers, and semi-structured interviews were conducted with people with opioid use disorder and a subset of providers. Descriptive statistics were calculated for surveys, and directed content analysis was used to analyse semi-structured interviews.
Sixty-eight providers completed the survey, 11 of whom also completed a semi-structured interview. Twenty-two people with opioid use disorder completed the semi-structured interview. Both providers and people with opioid use disorder agreed that addiction is a disease; however, opinions differed on the extent to which personal choice played a role in the onset of opioid use disorder. Participants described how factors such as experiencing homelessness, alongside other personal or familial challenges, contributed to ongoing substance use and presented barriers to accessing healthcare. There was discordance in priorities between providers and people with opioid use disorder, which often drove conflict and perceived stigma. Both groups described physical and emotional trauma from prior interactions, which shaped expectations of future interactions and biases towards each other.
Educational initiatives should arm providers not only with clinical knowledge about opioid use disorder but with skills to recognize implicit biases, navigate unique barriers related to social determinants of health, and effectively deploy shared decision-making techniques. Healthcare organizations should provide support for trauma that emergency care providers are exposed to in caring for people with opioid use disorder.
Consolidated criteria for reporting qualitative studies (COREQ)–32 item checklist.
This study did not include patient or public involvement in its design, conduct, or reporting.
This study aimed to explore informal caregivers' (family members of patients) perspectives on their involvement in ongoing multidisciplinary treatment of diabetes-related foot ulcers in a highly specialised outpatient service with a multidisciplinary team structure that was still evolving. Using focus group interviews and template analysis, we identified patterns in caregivers' experiences, needs, and preferences. The findings suggest considerable potential to improve patient care through earlier caregiver involvement. While some caregivers reported positive experiences, many rarely or never attended consultations and struggled to define involvement in practical terms. However, caregivers consistently expressed a strong wish for earlier involvement—ideally at the time of diabetes diagnosis—to acquire the knowledge and skills needed to support patients between clinical visits. Caregivers play an important role in foot ulcer management, as complex regimens such as wound care, offloading, and lifestyle adjustments require ongoing support outside clinical settings. However, involvement may also create strain. Participants described emotional and practical burden, feelings of guilt, and uncertainty about their roles. The study highlights the need for structured caregiver education, clear communication, and systemic support to balance the benefits of caregiver involvement with the risk of caregiver burden.
This study aimed to understand hospital doctors’ priorities (target use cases and aetiologies) for the development of a new rapid diagnostic test for patients with fever.
A cross-sectional online survey.
Europe-wide.
Secondary and tertiary care doctors involved in patient assessment and diagnosis across Europe.
Online survey from April to September 2024.
Importance of developing a new test on a scale of 1–10 for up to 19 ‘use cases’ (types of febrile presentations in specific demographic groups): use case scores and ranks and differences across subgroups of respondents, with free text to capture additional suggestions; respondents’ preferences (multiple choice) regarding which aetiologies should be included in a new test.
265 respondents from 30 European countries (out of 270 starting the survey) were included in the analysis. Top priorities included febrile immunocompromised patients and fever without a focus for both paediatric and adult use cases, and 1–3 months old febrile infants. Rankings were similar across clinician subgroups despite some differences in average scores. 92% (243/263), 95% CI 89% to 95%, of respondents would find a ‘generic’ test for bacterial aetiology useful, even if it does not differentiate between Gram-positive and Gram-negative aetiologies. 54% (63/116), 95% CI 45% to 63%, of respondents would find a ‘generic’ test for inflammatory aetiology useful when seeking to diagnose children for whom Kawasaki’s disease (KD) is on the differential, even in the absence of any KD-specific test, 83% (96/116), 95% CI 75% to 89%, would find such a ‘generic’ test useful if they could use it alongside a KD test when desired.
Clinicians prioritise the most vulnerable patients (because of age or comorbidities) and unclear presentations (fever without a focus) for the development of a new fever diagnostic test. Even relatively simple (eg, bacterial, inflammatory) tests could provide added value to most clinicians.
Infections are a major cause of morbidity and mortality among individuals with haematological cancers, but the duration of elevated risk in long-term survivors remains uncertain. Although previous attempts to summarise the existing literature on this topic would have been hampered by the sheer volume of studies on cancer and all-cause infections, emerging artificial intelligence tools now offer the ability to streamline the screening process, allowing for broader and more comprehensive reviews.
This protocol follows the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols guidelines. Eligible studies will include original observational data reporting long-term (≥1 year follow-up from diagnosis) infection-related outcomes in haematological cancer survivors compared with a general or cancer-free population. Screening will be supported by ASReview, an artificial intelligence-based tool for abstract prioritisation. An internal validation step will be conducted by comparing artificial intelligence-assisted screening results with manual review performed by two independent researchers on a subset of abstracts. The primary outcomes of infection incidence and infection mortality will be summarised by type of infection, type of haematological cancer and time since cancer diagnosis. Information on anti-cancer treatments received will also be described. Data synthesis will be mostly narrative due to the broad scope of the review, though meta-analyses will be performed in cases where studies are sufficiently homogenous. Risk of bias will be assessed using the Newcastle-Ottawa Scale.
Ethical approval is not applicable to this study. The results of the review will be disseminated to clinical audiences and submitted to a peer-reviewed journal.
CRD420251047091.
To assess the potential for microbial contamination of open-but-unused portions of wound dressings stored under real-life conditions in healthcare facilities, to inform safer and evidence-based wound care practices. Observational, descriptive, longitudinal, prospective study. Eleven types of non-adhesive wound dressings were sampled after opening and storage under usual clinical conditions in a hospital inpatient unit and a primary care centre in Andalusia, Spain. Samples were collected on six predefined sampling days (Days 0, 2, 3, 4, 5 and 6 after opening), cultured under standardised laboratory conditions and microorganisms were identified using mass spectrometry. Differences in contamination were examined by dressing type, healthcare setting, storage time and handling conditions. Microbial growth was frequently detected in open-but-unused dressings from the first day after opening, particularly after enrichment culture and increased with handling and time. The most frequent microorganisms were coagulase-negative staphylococci and Staphylococcus aureus. Contamination patterns were similar across settings, although microbial diversity was higher in the hospital. Silver-containing dressings showed slightly lower contamination, but not enough to indicate protection. Scissors used for cutting dressings had high microbial loads, suggesting a potential source of cross-contamination. Open-but-unused dressings may become contaminated shortly after opening under routine clinical practice conditions, across different healthcare settings and dressing types.
Despite anatomical correction, people born with oesophageal atresia±tracheoesophageal fistula (OA-TOF) experience lifelong morbidity. Core outcome sets (COSs) are recognised as a means of improving research quality and, as a consequence, improving patient outcomes; one was not available for this population.
The scope of the study was to develop a COS for people born with OA-TOF that would be applicable regardless of age or geographic location.
Patient input was paramount to this study. For long-list generation, in addition to the systematic review (SR), patients and representatives were invited to participate in focus groups, interviews or complete activity packs to ascertain outcomes that matter most to them. International consensus was then sought using a two-step Delphi survey followed by an online consensus meeting.
Eight outcomes were identified through patient events that had not been picked up from SR. 175 people completed the Delphi survey from 26 countries and health care professionals from 13 different disciplines. 24 outcomes met predefined criteria for inclusion and following discussion and voting in the consensus meeting, and 14/24 outcomes were agreed for inclusion in the COS.
14 outcomes have been agreed on to form the COS. 12 of these outcomes are relevant to people of all ages, 1 to paediatric population and 1 to adult cohorts. The COS is, therefore, truly applicable lifelong, which was the scope of the project. This COS will help reduce research heterogeneity, enabling better quality research outcomes and more comparable data.
To explore the impact of multiple long-term conditions (MTLCs) and a comorbid mental health condition on decision-making processes, attendance and engagement in NHS community-based therapy groups.
Qualitative in-depth interviews analysed using reflexive codebook analysis as part of a study within a trial.
Secondary community mental health teams from two UK sites.
Purposive sample of 20 participants recruited to a randomised controlled trial of group therapies (arts therapies and counselling) holding a mental health diagnosis and self-reported as having at least one additional physical health condition.
Six themes were constructed: (1) MLTCs influenced arts modality choices and goals; (2) importance of planning ahead to be organised; (3) the journey loomed over participants; (4) the impact of MLTCs on group attendance and participation; (5) the group was valued and important; (6) determination and fighting to get what I need.
Decisions about arts modalities and group attendance were based on a self-perceived level of felt capability. It was important for participants to plan in advance and feel informed ahead of making commitments, enabling them to prepare and manage symptoms. Travelling to the groups was dreaded, and many participants required support with travel in order to attend. Managing symptoms during the journey and groups was challenging; however, participants had a strong determination to uphold the commitment to attend despite their difficulties, as the group was highly valued.
MLTCs have a large impact on people’s capacity to engage in community groups, requiring additional planning and effort. The scale of this impact is often not recognised. Despite this, the benefits of groups for people with MLTCs are especially important, including motivation to leave the house, opportunities for socialisation and a means of reaching one’s own goals. Clinicians are recommended to accommodate the needs of MLTCs when designing community group interventions and consider multiple attendees with MLTCs in the group composition to improve attendance and group engagement.
Status epilepticus (SE) in adults is a serious neurological emergency that can lead to high morbidity and mortality rates. Although functional outcomes are often assessed using general scoring systems, limited data on health-related quality of life (HRQoL) in patients admitted to intensive care units (ICUs) are still limited. Furthermore, comprehensive evaluations of patient-reported physical, cognitive, mental health and psychological outcomes are lacking in this population. POSEIDON 2 aims to assess HRQoL and cognitive, physical and psychological impairments at 3 and 12 months after ICU discharge following SE and quantify caregiver burden.
POSEIDON 2 is a prospective, multicentre, longitudinal study conducted in 19 French ICUs. The study combines data from the SE ICTAL Registry with data from patients who survived admission to the ICU for SE, who will be recruited for the study. The study also includes patient-reported outcome (PRO) data collected 3 (M3) and 12 (M12) months after discharge from the ICU using validated instruments. The Zarit scale will be used to measure the burden on caregivers at M3 and M12. The primary endpoint is the prevalence of overall HRQOL impairment at M3 and M12, as defined by dichotomous scores on the physical and mental components of the 36-Item Short Form Health Survey compared with those of the general population. Secondary endpoints include domain-specific impairments, such as cognitive function, dependence, mental health and patient experiences. The sample size has been calculated based on an estimated prevalence of 75% for HRQoL impairment, with a planned sample size of 140 patients.
The POSEIDON 2 study protocol received ethical approval from the ethics committee ‘Comité de Protection des Personnes Ouest VI’ on 5 October 2023 (#2023-A01223-42). The study is conducted in accordance with the Declaration of Helsinki, Good Clinical Practice and the regulatory requirements of France. Written informed consent is obtained from participants, who are able to decline participation or withdraw from the study at any time. Findings will be disseminated through publication in peer-reviewed journals and presentations at scientific conferences.
To translate, culturally adapt and validate the first Spanish version of the Person-centred Practice Inventory-Care (PCPI-C) instrument.
Cross-cultural adaptation and psychometric validation.
Two-phase research design: (1) the PCPI-C's translation and cultural adaptation from English to Spanish following the ‘Translation and Cultural Adaptation of Patient-Reported Outcomes Measures-Principles Guide of Good Practice’ tool; and (2) a cross-sectional quantitative survey to assess the Spanish version's psychometric properties.
A sample of 200 patients participated to obtain the PCPI-C's Spanish version. No significant issues arose during the translation process or the consulting sessions. No item exhibited an inadequate value following adjustment via the weighted kappa index (−scale-level content validity average of 0.95 for clarity and 0.97 for relevance). Psychometric evaluation revealed acceptable internal consistency (Cronbach's alpha from 0.67 to 0.84) and strong construct validity. Exploratory and confirmatory factor analyses supported a five-dimensional structure consistent with the domain Person-Centred Processes. Fit indices improved after model refinements, achieving CFI = 0.92, SRMR = 0.05 and RMSEA = 0.07. This study's observed psychometric properties confirm that the PCPI-C's Spanish version retains the original instrument's theoretical integrity, while showing strong reliability and validity in the new context.
The PCPI-C's Spanish translation was psychometrically valid when tested with Spanish patients, thus providing a culturally appropriate, psychometrically sound tool to evaluate Spanish-speaking patients' perception of person-centred care.
This study provides a validated instrument that allows for the assessment of person-centred practice in Spanish-speaking clinical environments. It enables healthcare professionals to measure patients' perceptions, track the implementation of person-centred principles and supports international comparative studies, contributing to the development of more ethical and responsive models of care.
Patients participated in cognitive consultations and completed the survey for psychometric testing, ensuring that the translated items were understandable, culturally appropriate and reflective of their experiences of person-centred care.
To explore the views of community registered general nurses and directors of public health nursing on the current and future role of the community registered general nurse in the Republic of Ireland.
Anonymous cross-sectional descriptive survey.
Two questionnaires were developed; one targeted at community registered general nurses and one targeted at assistant directors of public health nursing or directors of public health nursing who were working with community registered general nurses. Social media was used to recruit participants. Descriptive statistics were used while data from open-ended questions were analysed using NVivo software.
A total of 97 community registered general nurses and 28 assistant directors of public health nursing or directors of public health nursing completed the surveys in 2023. There was consensus that community registered general nurses provide holistic care, including case management of adults with complex health needs living in the community. However, lack of promotional opportunities coupled with poor remuneration has resulted in job dissatisfaction. Respondents felt that community registered general nurses should focus on older adults, whereas public health nurses should focus on child health.
The role of the community registered general nurse needs to be clarified, and a promotional pathway developed to attract new graduates to this post.
This paper outlined the current role and vision for the future role of community registered general nurses.
CROSS guidelines.
No patient or public contribution.
This paper contributes to the challenges community nurses face regarding increased demand for community nursing, lack of career structure for some community nurses, and difficulties with staff retention within the community.
Surgical site infections (SSI) in vascular surgery have a huge impact on patients’ morbidity and mortality and healthcare systems worldwide. Dialkylcarbamoylchoride (DACC) is a synthetically produced material that can irreversibly bind and inactivate bacteria that exhibit cell-surface hydrophobicity (CSH). The DACC in the Reduction of Surgical Site Infection (DRESSINg) trial is a multicentre randomised controlled trial which aims to assess the effectiveness of DACC-coated post-operative dressings in the prevention of SSI in vascular surgery. Seven hundred and eighteen participants undergoing clean or clean-contaminated lower limb vascular surgery will be randomised in a 1:1 ratio to either DACC-coated dressings or standard dressings for their postoperative wounds. The primary outcome is the incidence of SSI defined by the Centers for Disease Control and Prevention (CDC) criteria or total ASEPSIS score of 21 or more within 30 days of surgery. The secondary outcomes include satisfactory wound healing with a total ASEPSIS score of 10 or less, quality of life pre and post surgery, Bluebelle wound healing scores, resource use and financial (£), and environmental (KgCO2e) cost analyses. This multicentre randomised controlled trial will provide level 1 evidence on the effectiveness of preventing SSI in lower limb vascular surgery.
Within the UK there are 33 deaths every day from prostate cancer, second only to lung cancer as the most common cause of cancer death in males in the UK. Of the 55 000 new cases each year, up to 50% of these patients will receive radiotherapy either alone or after prostatectomy. Although there have been significant improvements in the accuracy of radiotherapy delivery leading to better tumour targeting and a reduction in dose to normal tissues, significant permanent genito-urinary or gastrointestinal-related side effects are all too common. With nearly 80% of patients with prostate cancer surviving for 10 years or more, minimising life-limiting radiation damage to normal tissues is vitally important. However, at present, it is not possible to identify which patients will suffer a poorer outcome after radiotherapy. The aim of this study, improving radiotherapy in PROState cancer using EleCtronic population-based healthCAre data (PROSECCA), is to do this by using the existing information in a patient’s digital healthcare record. By linking primary, secondary and tertiary clinical data, including digital image information, with radiotherapy treatment plans and outcome data, the PROSECCA study will identify de novo predictive biomarkers of radiation response and provide clinicians with a tool to individualise a radiotherapy dose and plan to maximise cure and minimise toxicity.
The PROSECCA study is a large multidisciplinary project, the purpose of which is to analyse healthcare records from up to 15 000 patients with prostate cancer who underwent radiotherapy in the treatment of their cancer in Scotland between 2010 and 2022. Through the linkage of data obtained specifically for radiotherapy and data held within each patient’s unique electronic health record (EHR), the factors that indicate why some patients have a poor response to treatment, or an increased risk of side effects from radiation, will be identified. This will be made possible by the use of artificial intelligence and machine learning (AL/ML), which will help to identify at-risk patients earlier and allow adaptation of their treatment accordingly.
The study is being conducted in accordance with the ethical principles set out in the Declaration of Helsinki and Good Clinical Practice that respects and protects the rights, and maintains confidentiality, of all trial participants. The study protocol (V.1.0) was reviewed by the South Central Oxford A Research Ethics Committee (REC) on 13 December 2021 and received a favourable opinion subject to each National Health Service (NHS) organisation confirming permission for patients treated within their area. Approval for the use of unconsented healthcare record data for patients included in the study and treated at one of the five Scottish Cancer Centres required an application to the NHS Scotland Public Benefit and Privacy Panel for Health and Social Care (HSC-PBPP). Full approval from the HSC-PBPP panel was received on 1 July 2024, which covered the use of pseudoanonymised EHR data for all patients participating in the study. The study is publicly listed on the NHS Health Research Authority site, with IRAS ID 306245 and REC reference 21/SC/0402. Dissemination of the study findings will take place through field-leading cancer, radiation oncology and medical physics journals. All manuscripts will be approved by the main study team and authorship determined by mutual agreement.
This study aims to evaluate a structured nurse-led follow-up programme coordinated by an advanced practice nurse (APN) as an alternative to conventional postdischarge care for patients with heart failure (HF). The main objective is to assess the clinical effectiveness and economic efficiency of the programme using quality-adjusted life years and healthcare costs related to resource use as outcome measures.
A quasiexperimental multicentre study will be conducted including an intervention group and a comparison group of patients discharged with HF from three public hospitals in the province of Málaga, Spain. The intervention group will be followed by an APN using a structured follow-up model, while the comparison group will receive standard care. Sociodemographic, clinical, quality of life, self-care, therapeutic adherence and healthcare resource utilisation data will be collected. The economic evaluation will be conducted from the perspective of the public healthcare system through a cost-utility analysis.
The study protocol has been approved by the corresponding Research Ethics Committee. All participants will provide written informed consent prior to inclusion. The results will be disseminated through peer-reviewed publications and presentations at national and international scientific conferences.
RESUMEN
Se pretende describir la Enfermería del Hospital de San Hermenegildo (1455-1837), aplicar una visión enfermera actual, a la obra iconográfica de El Tránsito de San Hermenegildo y relacionar Enfermería, iconografía y musicoterapia atendiendo a la obra pictórica del extinguido Hospital de San Hermenegildo. Para realizar este trabajo se ha utilizado el método histórico descriptivo, la recogida de información se ha realizado a través de fuentes primarias y secundarias. Como resultados, resaltar la Enfermería en el Hospital de San Hermenegildo, pieza clave en la atención sanitaria, indicando sus funciones e intervenciones, así como la descripción del cuadro de “El Tránsito de San Hermenegildo”, situado en el extinguido Hospital de San Hermenegildo de Sevilla, así como aplicar una Mirada Enfermera a esta obra pictórica, resumiendo un Plan de Cuidados utilizando la nomenclatura NANDA-NIC-NOC. relacionando dicha iconografía con la Terapia Musical.
La Fundación del Hospital de San Hermenegildo en 1455, conocido popularmente como hospital del Cardenal, supuso un cambio, un avance en la Medicina, en la Enfermería, en los Cuidados, en las formas de curar, siguiendo una metodología diferente e innovadora.
Dar a conocer el extinguido hospital de San Hermenegildo, describir la Enfermería del Hospital de San Hermenegildo (1455-1837), aplicar una visión enfermera actual, a la obra iconográfica de El Tránsito de San Hermenegildo, así como relacionar Enfermería, iconografía y musicoterapia/terapia musical atendiendo a la obra pictórica del extinguido Hospital de San Hermenegildo de Sevilla.
Palabras clave: Enfermería; hospital de San Hermenegildo; Sevilla; iconografía; plan de cuidados de enfermería; musicoterapia; terapia musical; historia de la enfermería.
Gestational weight gain (GWG) is an important indicator of maternal nutrition to be monitored during pregnancy. However, there is no evidence-based tool that can be used to monitor it across all geographic locations and pre-pregnancy body mass index (BMI) categories. The WHO is undertaking a project to develop GWG charts by pre-pregnancy BMI category, and to identify GWG ranges associated with the lowest risks of adverse maternal and infant outcomes. This protocol describes all the steps that will be used to accomplish the development of these GWG charts.
This project will involve the analysis of individual participant data (researcher-collected or administrative). To identify eligible datasets with GWG data, a literature review will be conducted and a global call for data will be launched by the WHO. Eligible individual datasets obtained from multiple sources will be harmonised into a pooled database. The database will undergo steps of cleaning, data quality assessment and application of individual-level inclusion criteria. Heterogeneity of maternal weight and GWG will be assessed to verify the possibility of combining datasets from multiple sources and regions into a single database. Generalized Additive Models for Location, Scale and Shape will be applied for the construction of the centile curves. Diagnostic measures, internal and external validation procedures will also be performed.
This project will include an analysis of existing study de-identified data. To be included in the pooled database, each included study should have received ethics approvals from relevant committees. Manuscripts will be submitted to open-access journals and a WHO document will be published, including the GWG charts and cut-offs for application in antenatal care.
Crohn’s disease (CD) is a chronic inflammatory disorder of the gastrointestinal tract distinguished by progressive bowel damage with a risk of structuring and penetrating complications. It is characterised by focal or segmental transmural inflammation that disrupts intestinal mucosal integrity and favours the development of abscesses and fistulas. Perianal fistula develops in 13%–39% of patients with CD. Their care is difficult but improves with medical and surgical treatment to preserve anal continence and avoid a maximum proctectomy. Combined treatment with seton placement and concomitant anti-TNF (infliximab, adalimumab) allows wound healing in 40%–70% of cases. The currently available treatments are not curative and fail to provide a long-term resolution. The injection of adipose stromal cells is currently being evaluated in clinical studies for repair-damaged tissues in various diseases (limb ischaemia, osteoarthritis, systemic sclerosis, etc). Immunoregulatory and anti-inflammatory properties of AdMSC (adipose-derived stroma/stem cells) are responsible for accelerating healing and represent an innovative approach for treating perianal fistulas associated with CD.
This phase I/IIa study is designed to assess the treatment of complex perianal fistulas linked with CD after failure of conventional treatment by injection of AdMSC (CellReady) into the fistula. Two doses of associated AdMSC will be tested for a dose escalation (5x107 and 10x107 cells) and injected into the wall of the fistula. Those eligible for inclusion include patients with controlled luminal CD characterised by a Harvey-Bradshaw score below or equal to eight and diagnosed on clinical, endoscopic, histological and/or radiological criteria, a colonoscopy dating back less than 1 year without ulcer in the rectum and presence of complex chronic perianal fistula with a maximum of two internal ports and three external ports. All patients must have social security insurance or equivalent social protection. The aim of this study is to determine the optimal dose corresponding to maximum efficacy 6 months after injection of cells with a treatment-related adverse event rate of 20%.
The EU CT number 2024-511821-75-00 was approved by the following Ethics Committee: CPP (committee for the protection of persons in French: comité de protection des personnes) Ouest 1 – Tours #2024UEMED-18 and ANSM (French Agency for the Safety of Health and Medicinal Products in French : Agence nationale de sécurité du médicament et des produits de santé) #2024-511821-75-00 (Sponsor number RC31/13/7030, protocol V2.1). The results will be disseminated through conventional scientific channels.
The results will be disseminated through conventional scientific channels.
To explore nurse managers' perceptions at first-line, middle and executive levels regarding their transition to first-line management in two divisions of a highly specialised university hospital in Spain.
A qualitative descriptive study.
A purposive sampling technique was employed to conduct four focus groups and two semi-structured interviews with 31 nurse managers across three hierarchical levels in two divisions of a highly specialised university hospital in Spain. Participants included two Chief Nursing Officers, four Nursing Directors and 25 first-line nurse managers. Data were analysed thematically.
Three themes emerged: ‘Bridging the Readiness Gap: Training, Role Clarity, and Institutional Alignment’, revealing the lack of structured transition plans, role ambiguity and gaps in managerial skills, such as human resources, financial management and leadership; ‘Fighting Loneliness: A Common Challenge in Care Management’, highlighting the isolation of first-line nurse managers due to the absence of structured mentorship and peer support; ‘Clinical Expertise as a Cornerstone: The Role of Prior Experience in Nurse Management’, examining how clinical expertise facilitates leadership transitions but also presents challenges, particularly for managers promoted within their teams, where authority negotiation and role redefinition become critical.
Findings underscore the need for structured training and mentorship to address role ambiguity, enhance managerial competencies and support nurse managers' transitions through targeted education.
Structured transition programmes focusing on role clarity, training and institutional alignment can ease transitions, boost leadership confidence and enhance peer collaboration. Providing mentoring and training tailored to first-line nurse managers can improve team dynamics, support professional integration and strengthen organisational cohesion.
Tailored educational interventions are essential in supporting nurse managers' transitions. Structured mentorship and targeted training enhance leadership readiness, adaptability and institutional alignment, strengthening healthcare leadership, efficiency and patient care quality.
No patient or public contribution.
Nasogastric tubes (NGTs) are standard practice in the management of adhesive small bowel obstruction (ASBO). Their insertion can be associated with significant patient discomfort and complications. Current research suggests that patients with ASBO managed with NGTs may experience poorer outcomes and higher rates of operative intervention compared with those managed without. However, to date, there are no prospective clinical trials evaluating this.
This study will be designed as a single centre, prospective, non-inferiority randomised controlled trial to determine if the avoidance of an NGT is non-inferior to its use in ASBO. Patients meeting inclusion criteria will be randomised to either receive an NGT or no NGT for ASBO management. The primary outcome will be the rate of operative intervention as determined by review of medical records at day 30 post discharge. Secondary outcomes will include rate of bowel resection or bowel ischaemia, length of hospital and intensive care unit (ICU) stay, time to operative intervention, rate of ICU admission, incidence of postoperative complications (Clavien-Dindo classification), quality of life scores (European Quality of Life 5 Dimension 5 Level: EQ-5D-5L) at admission, day 30 and day 90, 90-day mortality, incidence of pulmonary complications (Melbourne Group Scale), rate of NGT specific complications and rate of Gastrografin use. The study will be powered at 80% to detect a clinically relevant difference of 10% between groups receiving an NGT compared with no NGT, requiring a total of 490 study participants. Statistical analysis will follow intention to treat principles. Differences between treatment arms will be summarised using mean differences, 95% CIs and p values.
This study has been approved by the Hunter New England Human Research Ethics Committee (2023/ETH00296). Results will be disseminated through peer-reviewed publication and conference presentations.
This study has been registered prospectively in the Australia and New Zealand Clinical Trials Registry (ACTRN12623000341628).
To develop prediction models for short-term outcomes following a first acute myocardial infarction (AMI) event (index) or for past AMI events (prevalent) in a national primary care cohort.
Retrospective cohort study using logistic regression models to estimate 1-year and 5-year risks of all-cause mortality and composite cardiovascular outcomes.
Primary care practices in England contributing data to the Clinical Practice Research Datalink (CPRD) Aurum and CPRD GOLD databases between 2006 and 2019.
Patients with an incident (index) or prevalent AMI event. Models were trained on a random 80% sample of CPRD Aurum (n=1018 practices), internally validated on the remaining 20% (n=255) and externally validated using CPRD GOLD (n=248).
Discrimination assessed using sensitivity, specificity and area under the receiver operating characteristic curve (AUC). Calibration assessed using calibration plots.
In the index (prevalent) cohorts, 94 241 (64 789) patients were included in the training and internal validation sets, and 16 832 (7479) in the external validation set. For the index cohort, AUCs for 1-year [5-year] all-cause mortality were 0.802 (95% CI 0.793 to 0.812) [0.847 (0.841 to 0.853)] internally and 0.800 (0.790 to 0.810) [0.841 (0.835 to 0.847)] externally. For the primary composite outcome (stroke, heart failure and all-cause death), AUCs were 0.763 (0.756 to 0.771) [0.824 (0.818 to 0.830)] internally and 0.748 (0.739 to 0.756) [0.808 (0.801 to 0.815)] externally. Discrimination was higher in the prevalent cohort, particularly for 1-year mortality (AUC: 0.896, 95% CI 0.887 to 0.904). Models excluding treatment variables showed slightly lower but comparable performance. Calibration was acceptable across models.
These models can support clinicians in identifying patients at increased risk of short-term adverse outcomes following AMI, whether newly diagnosed or with a prior history. This can inform monitoring strategies and secondary prevention and guide patient counselling on modifiable risk factors.
FreshRSS 