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Functional seizures (FS) are events that resemble epileptic seizures, but are not attributed to brain pathology and are instead thought to be due to psychological factors. A small, multisite, open-label, single-arm, pilot trial of a breathing intervention known as breathing control training (BCT) found it to be safe and effective in reducing seizure frequency in FS. We propose a protocol for a study to confirm these results.
A 24-week, multicentre, individually-randomised, assessor-blinded, two-arm, parallel-group efficacy and acceptability trial of BCT versus control (Befriending) in 220 participants ≥16 years of age with FS. Eligible participants will be randomly allocated to receive two sessions of either BCT or Befriending over a 4-week period. Sessions will be delivered by a respiratory physiotherapist at a clinical care site or via telehealth. They will complete assessments prior to commencing treatment and at 4, 12 and 24 weeks after their initial session of BCT/Befriending. The trial will be conducted alongside treatment as usual. An economic evaluation including cost-utility and cost-effectiveness analyses will be carried out from health sector and societal perspectives.
The study has been approved by The Austin Health Human Research Ethics Committee (HREC/84335/Austin-2022) and the New Zealand Central Health and Disability Ethics Committee (2022 FULL 12324). Findings will be reported to trial participants and consumers; presented at local, national and international conferences; and disseminated by a peer-reviewed scientific journal.
Cardiogenic shock (CS) is a complex syndrome characterised by primary cardiac dysfunction. Despite advances in therapeutic options such as mechanical cardiac support, it remains associated with high mortality. Although previous registries have described heterogeneous populations and outcomes across different centres, contemporary real-world data on management practices remain limited. This gap is particularly evident in low- and middle-income countries, where there is no robust registry that clearly defines the current state of CS management. Therefore, a multicentre registry is needed to better characterise current practices and outcomes. Our study aims to gain insight into current therapeutic trends in Mexico, a low- to middle-income country with a significant cardiovascular disease burden.
The Mexican Registry of Cardiogenic Shock is a quality initiative that aims to identify therapeutic trends, demographic characteristics and clinical presentations. It also aims to evaluate outcomes, including mortality and cognitive function at in-hospital and 1-year follow-ups, and to identify areas for improvement in the care process across the broad spectrum of CS.
Ethical approval for this multicentre study was obtained from the local research ethics committees of all participating institutions. The study results will be disseminated to all participating institutions in the form of summary reports and presentations on completion of the analysis.
by María-Angélica Calderón-Peláez, Myriam L. Velandia-Romero, Jaime E. Castellanos
Zika virus (ZIKV) poses a significant threat to neural tissue, causing substantial damage to unborn children exposed to the virus in utero, with consequences that can manifest even after birth, despite being born with a normal head circumference. Regardless of the extensive research, the interactions between ZIKV and the nervous system cells remain insufficiently understood, particularly regarding how neuronal responses influence broader inflammatory and viral dynamics especially in postnatal stages of development. This study evaluated the susceptibility to ZIKV infection, viral replication, immune response, and survival of neurons, astrocytes and microglial cells during postnatal developmental stages, using both in vivo and in vitro mice models. In vivo, a non-lethal but extensive infection of neurons and microglia was shown. The infection caused a robust but controlled immune response with elevated levels of MCP-1, TNF-α, and IL-6, that prevented severe neuronal damage. In vitro, neurons exhibited high susceptibility to ZIKV, with elevated levels of pro-inflammatory cytokines and IFN-β, indicating a strong inflammatory response. In contrast, astrocytes and microglia displayed varied responses, contributing to a pro-inflammatory feedback loop. These findings offer critical insights into the cellular dynamics of ZIKV infection, enhancing our understanding of its effects during postnatal nervous system development. By clarifying the interactions between ZIKV and neuronal cell types, this study deepens the comprehension of the virus’s pathophysiology and its broader implications for neurodevelopmental outcomes, extending beyond the well-documented association with microcephaly.About 30% of depressed patients suffer from a protracted course in which the disorder continues to cause significant burden despite treatment efforts. While originally developed for relapse prevention, mindfulness-based cognitive therapy (MBCT) has increasingly been investigated in depressed patients with such ‘difficult-to-treat’ courses. This is a protocol for an individual participant data (IPD) meta-analysis aiming to determine efficacy and potential moderators of MBCT treatment effects in this group based on evidence from randomised controlled trials.
Systematic searches in PubMed, Web of Science, Scopus, PsycINFO, EMBASE and the Cochrane Controlled Trials Register for randomised controlled trials were completed on 17 June 2024. Authors of identified studies have contributed IPD, and data extractions have been completed. An update search will be conducted immediately before the start of data analyses. We will investigate the following outcomes: (a) self-reported and observer-reported severity of depression symptomatology, (b) remission and (c) clinically meaningful improvement and deterioration. One-stage and two-stage IPD-MA will be conducted with one-stage models using the observed IPD from all studies simultaneously as the primary approach. One-stage IPD models will include stratified study intercepts and error terms as well as random effects to capture between-study heterogeneity. Moderator analyses will test treatment-covariate interactions for both individual patient-level and study-level characteristics.
The results will inform understanding of the use of MBCT in patients with current ‘difficult-to-treat’ depression and will contribute to arguments in favour of or against implementing MBCT as a treatment for this group. They will be published in a peer-reviewed journal and made available to stakeholders in accessible formats. No local ethical review was necessary following consultation with the Ethics and Governance Board of the University of Surrey. Guidance on patient data storage and management will be adhered to throughout.
CRD42022332039.
Nurses' burnout, work instability (WI), and job satisfaction (JS) in their practice environment (PE) are well established in the literature. However, perinatal missed care (PMC), a subset of missed nursing care, remains underreported among maternity nurses.
To examine the mediating role of PE and burnout in the associations of WI, JS, and PMC among maternity nurses.
A cross-sectional and correlational study employed consecutive sampling to recruit maternity nurses (n = 312) from five hospitals in Saudi Arabia (three government and two private hospitals in Hail and Makkah regions, respectively). Maternity staff nurses, regardless of their sex, years of professional nursing experience, or nationality, who met inclusion criteria were included in this study. Data was collected from July to September 2024 using four standardized self-report scales. Structural equation modeling was utilized for statistical analyses.
Maternity nurses' WI negatively influenced PE (β = −0.23, p = 0.014), while positively affected PMC (β = 0.15, p = 0.031). The PE positively affected JS (β = 0.24, p = 0.034) but had a negative effect on burnout (β = −0.24, p = 0.007) and PMC (β = −0.21, p = 0.038). Burnout negatively affected JS (β = −0.25, p = 0.028), while positively associated with PMC (β = 0.20, p = 0.022). PE mediated the associations between WI and burnout (β = 0.05, p = 0.019), JS (β = −0.07, p = 0.020), and PMC (β = −0.06, p = 0.008). Meanwhile, burnout mediated between PE and JS (β = 0.05, p = 0.030) and PMC (β = −0.04, p = 0.023).
Understanding the relationships among maternity nurses' burnout, JS, PE, and PMC is key to improving the quality of perinatal care and ensuring the patients' well-being. By focusing on strategies to enhance the PE (e.g., adequate staffing and resources, improved nurse–patient ratio), reduce burnout (e.g., meditation and mindfulness programs, coping intervention programs), and improve JS (e.g., work schedule flexibility, facilitate work-life balance, staff professional development), healthcare organizations can mitigate the occurrence of PMC.
Patient safety culture plays a crucial role in reducing clinical errors. By improving healthcare professionals’ and patients’ understanding of human fallibility and error attribution, patient care can be enhanced, fostering greater engagement from both groups. A Just Culture approach, which balances accountability and learning from errors, is a key factor in fostering this safety culture. The DECIDE Project aims to: (1) examine the conceptualisation of human fallibility within and beyond healthcare, (2) identify barriers and facilitators to Just Culture adoption, (3) assess the impact of psychoeducational interventions on professionals’ and social leaders’ attitudes toward clinical errors and (4) develop a roadmap for Just Culture implementation in healthcare.
A 36-month mixed-methods study including qualitative research, a survey of 1255 healthcare professionals, an experimental study with 180 participants (60 per arm) testing interventions based on cognitive dissonance and reasoned action theories and a consensus conference to develop a Just Culture roadmap. Participants include professionals from hospitals, primary care, long-term care, nursing homes and social leaders in Spain. The qualitative data collected during stages 1 and 4 will be analysed using MAXQDA software. In identifying factors related to the implementation of Just Culture during stage 2, ANOVA, t-tests and multiple linear regression will be conducted. To examine the effects of the interventions in phase 3, a linear mixed-effects model for repeated measures will be employed.
This study has received ethical approval from three institutional review boards. Findings will be disseminated through peer-reviewed publications, conference presentations and policy recommendations aimed at integrating Just Culture into national and international patient safety strategies. By promoting a constructive approach to errors, the project could enhance incident reporting, strengthen professional engagement in safety policies and foster a culture of learning and accountability. Its findings will guide policy recommendations for integrating Just Culture into national and international patient safety strategies, with potential applications beyond Spain.
The standard treatment of oral cavity cancers (OCC) relies on surgery and postoperative radiotherapy (poRT) for advanced stages or poor factors. In more than 75% of cases, reconstructive surgery with a flap aims to restore the function lost with tumour resection. Current poRT planning and delineation guidelines omit the presence of a flap. It may be assumed that poRT with flap sparing may allow for reducing radio-induced toxicities and improving functional outcomes, without impairing local primary control. The OPTIFLAP trial assesses non-inferior locoregional control using flap sparing compared with conventional flap-agnostic radiotherapy in patients with OCC, while reducing treatment-related toxicity and improving functional outcomes.
The OPTIFLAP study is a French, multicentre, 1:1 randomised, phase III, controlled trial. It will recruit 348 patients with OCC with a flap. Recruitment is active with the first enrolment on 2 July 2025 and is planned over 48 months. The primary outcome is non-inferior 2-year locoregional control rate using flap sparing compared with flap-agnostic radiotherapy (as per standard routine practice) in completely resected OCCs undergoing poRT. Key secondary outcomes include rates of toxicities, locoregional relapse-free survival, progression-free survival, overall survival, quality of life, functional outcomes (assessed by the Performance Status Scales for Head and Neck Cancer, the MD Anderson Dysphagia Inventory (self-questionnaire) and the Phonation Handicap Index (self-questionnaire)), flap doses and outcomes between arms depending on dosimetric parameters. The trial incorporates translational ancillary studies addressing individual radiosensitivity, salivary microbiome evolution, radiomics and dosiomics of flap changes, as well as medico-economic evaluation.
The study protocol has been approved by the Medical Ethics Committee East III (January 2025; Ref 24.05832.000442) and the French Agency for Medical and Health Products Safety (December 2024; ID-RCB: 2024-A01764-43) and was validated by review boards of all participating centres. Written informed consent will be obtained from all participants. Study results will be published in international peer-reviewed scientific journals and presented at relevant scientific conferences.
En el presente artículo se presenta la ciencia como un producto cultural occidental que ha evolucionado desde la modernidad. Debido a ello se obtuvo su forma actual, la cual logró imponerse, por su efectividad, a nivel global. Se reflexiona también sobre el origen y la evolución de lo que se conoce como “método científico” y se problematiza la naturaleza de la hipótesis y su corroboración empírica. El objetivo de este trabajo es reflexionar epistemológicamente sobre la práctica social de la ciencia, el método y la hipótesis científica. El escrito está estructurado en tres apartados. El primero, presenta la ciencia y el método científico desde sus orígenes hasta la actualidad. El segundo, se centra en los supuestos epistemológicos del método científico, profundizando en el inductivismo y las diversas alternativas que Bunge, Popper y Hempel plantean. Por último, se analiza la hipótesis científica, estudiando su naturaleza y los requisitos obligatorios que esta exige. Concluye sosteniendo que la “ciencia” es un producto occidental con tendencias empiristas y en muchos casos experimentales. Además, se logró determinar los componentes fundamentales del método científico, el cual no es estático, pues varía cada vez que cambia la concepción o la práctica social de la ciencia. Asimismo, se estableció que la contrastación empírica es fundamental para confrontar la hipótesis con la realidad.
Introducción. El incremento de la incidencia de la anorexia nerviosa conduce a unas cifras de prevalencia cada vez mayores, especialmente tras la pandemia COVID-19. El abordaje de esta patología es complejo y requiere de una colaboración y coordinación multidisciplinar, donde la enfermera desempeña un rol esencial, con unas competencias definidas y unas habilidades terapéuticas necesarias. Objetivos. Explorar la vivencia de las enfermeras en la relación terapéutica con personas con anorexia nerviosa y las consecuencias de las mismas. Del mismo modo, relatar las emociones experimentadas por las enfermeras en la atención de este tipo de pacientes, las herramientas percibidas como facilitadoras, las dificultades en la comunicación, así como la percepción en la necesidad del cuidado y el papel que juega la institución. Metodología. Se empleará un diseño cualitativo, concretamente la teoría fundamentada, a través de entrevistas semiestructuradas en profundidad, en el Instituto de Psiquiatría y Salud Mental del Hospital General Universitario Gregorio Marañón. Se procederá a la transcripción, revisión, lectura y relectura de las transcripciones para su posterior codificación. A partir de los códigos y su interpretación, se generarán las grandes áreas temáticas que representarán los fenómenos. Se seguirá un proceso de triangulación de datos por medio de tres investigadores.
ABSTRACT
Introduction. The increasing incidence of anorexia nervosa leads to increasing prevalence figures, especially after the COVID-19 pandemic. The approach to this pathology is complex and requires multidisciplinary collaboration and coordination, where the nurse plays an essential role, with defined competencies and necessary therapeutic skills. Objetives. To explore nurses’ experiences in the therapeutic relationship with people with anorexia nervosa and its consequences. Likewise, report the emotions experienced by nurses in caring this type of patients, the tools perceived as facilitators, difficulties in communication, as well as the perception of the need for caring and the role played by the institution. Methodology. A qualitative design will be used, specifically grounded theory, through in-depth semi-structured interviews, at the Institute of Psychiatry and Mental Health of the Gregorio Marañón University General Hospital. The interviews will be transcribed, reviewed, read and reread for subsequent coding. From the codes and their interpretation, the large thematic areas that will represent the phenomena will be generated. A data triangulation process will be followed by three researchers.
En este relato bibliográfico se abordo la experiencia de un profesional del futbol tras una operación de ligamento cruzado anterior de la rodilla derecha. El objetivo fue conocer la vivencia personal tras sufrir esta intervención y las modificaciones derivadas a nivel profesional, familiar e individual. Se llevó a cabo un abordaje cualitativo basado en una entrevista en profundidad para analizar esta experiencia. El informante aportó una reflexión crítica sobre su vivencia y otros elementos trascendentales como su relación con familiares, compañeros y profesionales sanitarios. Se abordó este episodio desde el desencadenante brusco de la lesión y la recaída hasta la actualidad. Se observó un importante impacto personal con una gran implicación afectiva.
Objetivo: Describir variables clínicas, sociodemográficas, Calidad de Vida Relacionada con la Salud (CVRS) en Hemodiálisis (HD) y Peritoneodiálisis (PD), en Hospital Puerto Montt, Chile. Metodología: cuantitativo descriptivo, transversal. n=75 (47 HD, 28 PD). Aprobado por Comité de Ética, revisión fichas clínicas, cuestionario sociodemográfico y KDQOL-36. Resultados: 51% mujeres, 49% hombres, 56% sector urbano, 20% 51-60 años. HD: 49% casados, 36% tratamiento sobre 84 meses. PD; 43% casados, 25% tratamiento 12-48 meses. KDQOL-36: 43% HD y 54% PD perciben “Buena” su salud. Esfera física; 25%, ambas terapias, refiere limitación en actividades de la vida diaria; 38% de PD refiere dolor “moderado”. Esfera psicológica; HD 28% refiere tranquilidad y sosiego “casi siempre”; PD 35% desánimo y tristeza “algunas veces”. Conclusiones: existe impacto negativo en dimensiones de CVRS; pero, globalmente considerada “Buena”; permitiendo formular mejoras para pacientes.
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