FreshRSS

🔒
❌ Acerca de FreshRSS
Hay nuevos artículos disponibles. Pincha para refrescar la página.
Hoy — Abril 21st 2026Tus fuentes RSS

Effects of rehabilitation and behavior change interventions on physical capacity and physical activity behavior following lumbar surgery for degenerative disease: A systematic review and meta-analysis

by José Manuel García-Moreno, Tyler Adams, Amber Beynon, Janine Vlaar Olthuis, Stephan U. Dombrowski, Richelle Witherspoon, Niels Wedderkopp, Jeffrey J. Hébert

Background

Rehabilitation and behavior change interventions are commonly used after lumbar surgery to improve recovery, but their effects on physical capacity and physical activity remain unclear. This study aimed to investigate the effectiveness of rehabilitation and behavior change interventions on physical capacity and physical activity behavior in patients following lumbar surgery for degenerative disease.

Methods

EMBASE, MEDLINE, PsycINFO, and CENTRAL were searched from inception to September 2025 and reference lists were hand-searched. Randomized controlled trials assessing rehabilitation or behavior change interventions on physical capacity or physical activity behavior in adults with lumbar degenerative disc disease who underwent lumbar surgery were included. Review author pairs independently extracted data and assessed included studies. Risk of bias was assessed with the Cochrane tool, and study quality with the Grading of Recommendations Assessment, Development and Evaluation classification. Results were pooled using random-effects models and reported as standardized mean differences (SMD) with 95% confidence intervals (CI).

Results

Exercise was more effective than minimal or usual care in improving trunk extension endurance in the immediate term (SMD, 1.54; 95% CI, 0.93–2.16). Supervised exercise outperformed self-directed exercise in improving trunk extension endurance in the immediate term (SMD, 1.28; 95% CI, 0.75–1.81). Psychologically informed rehabilitation was more effective than minimal or usual care in increasing physical activity levels in the intermediate term (SMD, 0.26; 95% CI, 0.02–0.49), but not in the immediate term (SMD, 0.17; 95% CI, −0.14 to 0.49). Physical activity advice did not increase physical activity levels compared to minimal or usual care in the immediate term (SMD, 0.21; 95% CI, −0.13 to 0.55). Prehabilitation was more effective than minimal or usual care in increasing physical activity levels in the intermediate term (SMD, 0.28; 95% CI, 0.03–0.53). Certainty of evidence ranged from low to moderate.

Conclusions

For adults with lumbar degenerative disease who underwent lumbar surgery, exercise, especially supervised programs, improved trunk extension endurance in the immediate term. Psychologically informed rehabilitation and prehabilitation increased physical activity levels in the intermediate term, while physical activity advice showed no benefit. Findings are limited by low certainty of evidence and high risk of bias.

AnteayerTus fuentes RSS

A Nurse‐Led Educational Intervention for Patients With Type 1 Diabetes Using Continuous Glucose Monitoring

ABSTRACT

Background

The primary barrier to maximizing the benefits of intermittently scanned continuous glucose monitoring (isCGM) is low scan frequency. Higher daily scan frequency correlates with better glycemic control.

Aim

To evaluate the effect of a nurse-led educational intervention on scan frequency and behavioral change in adults with type 1 diabetes (T1D) showing low scanning frequency.

Methods

In this 12-week quasi-experimental study, adults with T1D using isCGM and low scan frequency participated in a single, individualized, direct education session led by a diabetes nurse educator. The intervention focused on increasing daily scan frequency and supporting patient engagement in self-management.

Results

Thirty-four patients using isCGM participated. Mean daily scan frequency increased from 3.1 to 6.1 scans/day following the intervention. This rise was associated with an 8.0% improvement in TIR. A positive correlation was observed between scan frequency and TIR, with each additional daily scan associated with a 0.51% increase in TIR.

Linking Evidence to Action

A single, targeted educational session can significantly improve isCGM adherence and glycemic control in adults with T1D and low adherence, supporting its value as a practical strategy in routine clinical care.

Trial Registration

The protocol was publicly registered at ClinicalTrials.gov (NCT05570162)

Promoting active outdoor play and healthy dietary behaviours through the co-creation of supporting physical and social environments for and with primary school-aged children living in underserved neighbourhoods in Europe: the protocol of the B-Challenged

Por: Altenburg · T. M. · Pawlowski · C. S. · Ahrens · W. · Brand · T. · Buck · C. · Börnhorst · C. · Dzielska · A. · Klaufus · L. · De Miguel-Etayo · P. · Moreno · L. · Okulicz-Kozaryn · K. · Vrijkotte · T. G. M. · Wink · R. · Belmon · L. S. · Chinapaw · M. J. M.
Introduction

An alarmingly low number of children meet public health guidelines for physical activity and dietary behaviours and, therefore, are at increased risk of developing lifestyle-related diseases. This paper describes the protocol of the B-Challenged project, which aims to co-create systemic actions to promote active outdoor play and healthy dietary behaviours before, during or after their outdoor play together with children themselves.

Methods and analysis

In five European countries, child-centred Participatory Action Research (PAR)—combined with systems dynamics methods—was conducted with 15–20 child co-researchers (aged 9–12 years) and 15–20 adult actors (eg, youth workers, local policy makers). In the first phase, the main drivers of children’s active outdoor play and related dietary behaviours were mapped by (1) analysing existing cohort data, and (2) conducting child-centred PAR. In the second phase, systemic actions targeting the local physical and social environments will be co-created and implemented by child co-researchers and adult actors to promote children’s active outdoor play and related healthy dietary behaviours. A mixed-methods design will be used to evaluate (1) if actions positively contributed to systems change and 6- to 12-year-olds’ outdoor play and related dietary behaviours (140 children per country); (2) the process of conducting multi-actor, child-centred PAR and implementing the co-created actions and (3) if the child-centred PAR positively contributed to child co-researchers’ feelings of empowerment.

Ethics and dissemination

Ethics approval for the mapping phase was obtained and approval for implementation and evaluation will be obtained from the five local research institutions. Participating children, one of their parents/caregivers and adult actors had given informed consent before participating in the project. Throughout the project, child-friendly methods, materials and language will be applied, and ethical challenges and potential solutions will be discussed. Project results will be disseminated locally and internationally through various channels and activities among the scientific community, professionals—for example, in health and policy making, children and other citizens.

Trial registration number

NCT07136376.

Experiencias de enfermería en el uso de herramientas informáticas de Planes de Cuidados

Introducción. Los planes de cuidados en enfermería (PCE) son instrumentos para documentar e informar las actividades de enfermería. Actualmente existen varias herramientas digitales totalmente de PCE (softwares y/o aplicaciones móviles).

Objetivo: Comprender los significados de las experiencias vividas por los profesionales de enfermería que laboran en servicios de hospitalización de unidades de segundo y tercer nivel de atención de Sevilla y Alicante (España) con el uso de herramientas informáticas de PCE.

Metodología: Se realizó un estudio fenomenológico en unidades de segundo y tercer nivel de atención en salud de Sevilla y Alicante (España). Mediante muestreo intencional se incluyeron 9 profesionales de enfermería de servicios de hospitalización. Los datos se obtuvieron en septiembre y octubre de 2023 mediante una entrevista semiestructurada y fueron analizados mediante un enfoque fenomenológico interpretativo.

Resultados: Se comprendieron las siguientes categorías descritas por los profesionales de enfermería: experiencias positivas tales como generación de Planes de Cuidados Estandarizados de Enfermería, experiencias negativas como ambigüedad de las herramientas informáticas e inadecuada accesibilidad a las herramientas y la propuesta ideal para desarrollar un software de Planes de Cuidados Individualizado de Enfermería (PCIE).

Conclusiones: Se lograron comprender los significados de las experiencias vividas de los profesionales de enfermería acerca del uso de las herramientas informáticas de PCE, las cuales posteriormente sirvieron para generar un software de PCIE que permita responder a las necesidades actuales en salud de individualizar el cuidado de enfermería.

Grief and Psychopathology in Bereaved Caregivers of Palliative Care Patients: The Mediating and Moderating Roles of Distress, Burden and Social Support

ABSTRACT

Aim(s)

This study examines the mediating roles of distress, burden and social support, as well as the moderating effect of social support, in the relationship between the risk of prolonged grief and psychopathology in bereaved family caregivers of palliative care patients.

Design

A cross-sectional study was conducted with 125 bereaved family caregivers. Validated assessment tools and the PROCESS macro in SPSS were used for mediation and moderation analyses.

Results

Emotional burden mediated the relationship between prolonged grief risk and psychopathology, while distress and physical burden did not. Instrumental social support was a key mediator, highlighting the protective role of practical assistance, whereas emotional social support did not show significant mediation. Both types of social support moderated the relationship, buffering the negative impact on mental health.

Conclusions

Findings underscore the complex interactions between bereavement risk factors and psychopathology. Addressing emotional burden and enhancing social support may help reduce mental health risks in bereaved caregivers.

Implications for the Profession and/or Patient Care

Healthcare professionals in palliative care should implement targeted interventions to reduce burden and strengthen support systems for bereaved caregivers. Nursing-led initiatives focused on emotional burden reduction may mitigate psychopathology risks.

Impact

Findings are relevant for healthcare professionals in palliative care and those designing interventions for bereaved caregivers. Emotional burden mediated the relationship between prolonged grief and psychopathology, while instrumental and emotional social support moderated its effects.

Reporting Method

This study adhered to STROBE guidelines for cross-sectional research.

Patient or Public Contribution

Beyond caregiver participation in data collection, patients and healthcare professionals contributed to study design, protocol development and dissemination.

Individual and Institutional Factors Associated With Urinary Incontinence Among Nursing Home Residents: A Multilevel Analysis

ABSTRACT

Aims

(1) To analyse individual and institutional-level factors associated with urinary incontinence in older adults living in nursing homes; (2) to estimate the prevalence of urinary, faecal and double incontinence in nursing home residents.

Design

Cross-sectional study.

Methods

Residents aged 65+ living in 22 nursing homes in Catalonia (Spain) were included. Descriptive, bivariate, and multilevel analyses were performed.

Results

The final sample comprised 452 residents (75.9% female, mean age of 87.0 years). The prevalence of urinary, faecal and double incontinence was 77.5%, 46.1% and 45.7%, respectively. Urinary incontinence was statistically significantly associated with neurological conditions, moderate cognitive impairment, moderate dementia, severe cognitive impairment, very severe cognitive impairment and age.

Conclusion

Approximately three out of four nursing home residents suffered from urinary incontinence and almost half of the sample from faecal or double incontinence. Individual-level factors (cognition, neurological conditions and age) played a more important role than institutional-level factors for urinary incontinence.

Implications for the Profession and Patient Care

The findings of this study highlight the importance of individual-level interventions to prevent and manage urinary incontinence in nursing homes.

Impact

In Catalonian nursing homes, individual factors such as cognitive impairment and neurological conditions were more strongly associated with urinary incontinence than institutional factors. This has implications for improving care provided to older adults, particularly those with dementia and neurological conditions.

Reporting Method

STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) guidelines.

Patient or Public Contribution

Nursing home residents were not involved in this study.

A Mixed Effects Model Analysis for Inpatient Falls Using Health Record Data From 72 Hospitals

ABSTRACT

Aim/Design

This retrospective cohort study evaluated the relationship between patient falls, Morse Fall Scale (MFS) items, patient demographics, length of stay and hospital site.

Methods

Data were acquired from 72 hospitals in a health system. Logistic regression models were conducted including MFS items, demographics, length of stay, and interaction terms. The final mixed effects logistic regression model included significant patient-level covariates as fixed effects and hospital site as a random effect.

Results

6531 of 978,920 total admissions included a patient fall. Four MFS items (fall history, secondary diagnosis, gait weak/impaired, mental status—overestimates/forgets limitations) and three demographic items (male gender, increased age, longer length of stay) were associated with increased likelihood of falling. Two MFS items (ambulatory aids, intravenous therapy/lock) and Hispanic ethnicity were associated with decreased risk of falling. An interaction effect was present between male gender and mental status. Males who overestimate/forget limitations had 3.16 times higher odds of falling than females oriented to their own ability. The proportion of variance in falls between hospitals was 0.23 and the median odds ratio (MOR) 1.57.

Conclusion

This study uniquely assessed fall risk at the level of the patient and hospital, using data from nearly 1 million admissions at 72 hospitals. Controlling for patient characteristics, results demonstrate variability in fall risk among hospitals. Research informing hospital differences as well as gender and racial/ethnic differences in falls is needed to identify appropriate interventions.

Implications for Patient Care

As hospitals increasingly adopt risk-directed fall prevention, assessment tools should be re-evaluated for clinical utility and corresponding prevention practices. The MFS may be enhanced by removing intravenous lock as a risk and screening for additional risks such as medications and medical equipment. Quality improvement efforts must also consider the hospital's environment and processes that may further contribute to fall risk.

Reporting Method

Authors adhered to STROBE guidelines for reporting.

Patient Contribution

No Patient or Public Contribution.

Influence of Social Determinants of Health on Adherence to Lifestyle Modifications in Individuals With Prediabetes: A Mixed Methods Study

ABSTRACT

Aim

To explore the relationship between social determinants of health and adherence to lifestyle recommendations, and how these determinants can help explain contextual and interpersonal factors contributing to adherence among individuals with prediabetes.

Design

Explanatory sequential mixed methods study integrating a cross-sectional quantitative analysis with an ethnomethodological qualitative approach grounded in critical social paradigm.

Methods

The quantitative phase used data from the intervention arm (n = 86) of the PREDIPHONE trial, a randomised controlled study evaluating the effectiveness of a nurse-led telephone intervention for lifestyle changes in glycaemic control. Adherence was measured using a composite index, analysed as both a continuous and categorical variable. Correlation analysis examined adherence and age. Chi-square and ANOVA tests were used to analyse differences in participant characteristics across adherence quartiles. The qualitative phase included individual semi-structured interviews and a focus group with participants showing high or low adherence. Thematic content and discourse analysis were employed, ensuring validity through triangulation, reflexivity and discourse saturation.

Results

Employment status was identified as a significant factor, with unemployed or retired participants showing better adherence. Although no statistical differences in adherence were found by social class or gender, lower social class participants reported financial barriers to healthy eating and time constraints limiting physical activity (PA). Women reported facing greater challenges due to caregiving responsibilities, whereas men benefited from household support.

Conclusions

Employment status emerged as a determinant of time availability for self-care, alongside social class and gender in adherence to lifestyle modifications. Women, especially those from lower social classes, experienced heightened barriers to adherence, underscoring the need for tailored, gender-sensitive and equity-focused interventions.

Implications

Addressing social determinants is essential for effective lifestyle advice among individuals with prediabetes.

Impact

The study highlights the role of social class and gender in adherence.

Reporting Method

STROBE and COREQ guidelines.

Patient Contribution

Through interviews and focus group.

Barriers and facilitators to performing benign paroxysmal positional vertigo manoeuvres among primary care physicians in Barcelona: a qualitative study

Objective

To explore the barriers and facilitators in adherence to the guidelines in the management of benign paroxysmal positional vertigo from the perspective of primary care physicians.

Design

Qualitative study using focus groups.

Setting

L’Hospitalet del Llobregat (Barcelona), Spain.

Study design

Qualitative study using focus groups. Structured 90 min focus groups were conducted until data saturation was reached. Each session included a moderator and an observer from the research team. Sessions were transcribed and thematically analysed by three independent researchers.

Participants

Purposeful sampling was used to form four groups of 4–10 participants, selected by sex, age, years of experience and primary care team (PCT). Participants were recruited between January and February 2023.

Results

A total of 34 family physicians belonging to four PCTs participated in the study. The main barriers identified were a lack of time, negative initial experiences, a fear of harming patients (especially older adults), difficulty in nystagmus visualisation and challenges in managing patient expectations, as many preferred medication over physical manoeuvres. Facilitators included potential time savings from effective early management, the value of initial practical training with periodic refreshers, access to expert consultants for case discussions and the availability of digital tools, such as tutorials, videos and aids for nystagmus interpretation.

Conclusion

Health systems should invest in protected time for history-taking and physical examination, and in regular, updated training for primary care professionals. This could improve vertigo management and reduce unnecessary investigations and medications, ultimately benefiting both patients and the healthcare system.

Stiefel MD Anderson OroPharynx cancer (MDA-OPC) cohort: a single-institution, prospective longitudinal outcomes study

Por: Moreno · A. · Sahli · A. J. · Johnson · F. · Sun · X. · Barbon · C. · Rinsurongkawong · W. · Song · W. · Luciani · F. M. · Liang · H. · Li · J. · Liu · W. · Lee · J. J. · Frank · S. · Lai · S. · Fuller · C. · Hutcheson · K. · P01 MD Anderson Oropharynx Cancer Program · Hutcheson · Lai · F
Purpose

The MD Anderson Oropharynx Cancer (MDA-OPC) cohort is a unique single-institution, prospective longitudinal cancer cohort. The cohort aims to enhance the therapeutic index of OPC management by supporting data needs for independent investigators to conduct rigorous observational studies examining exposures and factors associated with acute and late toxicities, cancer progression, recurrence, new malignancies and quality of life in OPC survivors.

Participants

A total of 1811 patients with OPC with a minimum follow-up of 6 months have been consented to our prospective registry between 18 March 2015 and 29 December 2023. Clinical and treatment (Tx) data are available on all patients, including previously untreated patients (1443, 80%). Most previously untreated patients (97%) consented to longitudinal patient-reported outcomes and functional assessments for critical time points including pre-Tx, during-Tx and post-Tx at 3–6 months, 12 months, 18–24 months and annually up to 5 years.

Findings to date

The median age for the MDA-OPC cohort is 66 years (range, 25–96) with the majority being male (89%), white (92%) and with human papillomavirus (HPV)/p16-associated OPC (88%) primarily located in the tongue base or tonsil (90%). For previously untreated patients, 79% were diagnosed with stage I/II disease, and nearly half underwent curative intent chemoradiation. Overall survival was significantly higher for HPV/p16-associated OPC at 1 year (98% vs 93%) and 5 years (83% vs 54%; p

Future plans

Future work includes expansion of the MDA-OPC cohort and survivorship surveillance to 10 years under the recently funded OPC-SURVIVOR research programme (P01CA285249), which aims to identify non-invasive, clinic-ready biomarkers and examine novel phenotypes and mechanistically matched mitigation strategies for latent OPC sequelae. Additionally, we aim to expand our advanced data infrastructure by integrating large data streams from parallel clinical trials and imaging registries.

Trial registration numbers

NCT01893307, NCT03145077.

Effect of music therapy on vital signs and heart rate variability of paediatric patients during the extubation process in the paediatric intensive care unit: a multicentre randomised clinical trial protocol

Por: Beltran · Y. M. · Charum · D. P. · Zuluaga · C. A. · Vega · M. A. · Benavides-Cruz · J. · Amarillo · M. · Canon · E. · Alvarez · I. · Ramirez-Moreno · J. · Paez · L. · Garzon · M. C. · Calderon · P. D. · Quintero · T. C. · Moreno · J. · Ettenberger · M.
Introduction

A successful extubation process is critical for the future health outcomes of paediatric patients, as it tests the functioning of the respiratory system without the support of mechanical ventilation. However, extubation can cause stress, pain, anxiety or discomfort in patients, which may sometimes lead to an increased likelihood of reintubation. Music-based interventions and therapies have been shown to be effective in reducing anxiety and stress levels in ventilated patients in the paediatric intensive care unit (PICU), but studies evaluating the effect of music therapy during the extubation process in the PICU are scarce.

Methods and analysis

This is a pragmatic multicentre randomised clinical trial with two parallel arms. The intervention group will receive standard care + music therapy during the extubation process, and the control group will receive standard care alone. The main outcome measure is heart rate, which will be measured every minute for 5 min pre-extubation, during the extubation process and up to 10 min postextubation. Secondary outcome measures are: oxygen saturation, respiratory rate, blood pressure and heart rate variability. A total of 82 patients will be randomised.

Ethics and dissemination

This study was approved by the Research Ethics Committee of the Fundación Universitaria Sanitas (CEIFUS 1356-24, date of approval: 3 May 2024). All parents or legal guardians of patients will sign a written informed consent, and if applicable, assent from participants will be sought. The results will be disseminated through publications in peer-reviewed journals, conferences and presentations at the hospitals’ clinical committees.

Protocol version

Version 1.0, 18 December 2024.

Trial registration number

NCT06591533, trial registration date: 10 September 2024.

Research Capacity and Culture on Nurses' Evidence‐Based Practice Implementation

ABSTRACT

Background

The research-to-practice gap often occurs when evidence-based practice (EBP) is inadequately implemented into clinical practice. Nurses are critical to bridging the gap in EBP implementation (EBPI) and identifying effective strategies to promote its use in practice; however, they need a supportive work environment to develop the necessary research capacity/culture (RCC).

Aims

The purpose of this study was to examine relationships between nurses' perceptions of individual RCC and EBPI, team RCC and EBPI, and health care organization RCC and EBPI, adjusting for educational background, health care organization setting, and health care organization type.

Methods

Survey data were collected from 175 nurses across the United States using a prospective cross-sectional study design. The Research Capacity in Context (RCC) tool and EBPI scale were used to measure nurses' perception of RCC and nurses' EBPI, respectively. Simple linear regression was used to assess the relationship between organizational, team, and individual RCC and EBPI. Multiple linear regression was used to adjust for pertinent participant demographics.

Results

The results of this study indicated that organization (R 2 = 0.033, p = 0.016), team (R 2 = 0.064, p < 0.001), and individual (R 2 = 0.155, p < 0.001) RCC were significantly associated with nurse EBPI. Moreover, findings remained significant after adjusting for educational background, health care organization setting, and type. The regression model suggested that education significantly predicted EBPI (R 2 = 0.142, p < 0.001).

Linking Evidence to Action

These results emphasize the importance of building RCC in health care organizations, as it can be an effective strategy to increase nurses' EBPI, which has been shown to impact patient outcomes directly. Future research should identify strategies to assist organizations and leadership in building RCC among nurses.

Global prevalence of violence against women with disabilities: protocol for a systematic review and meta-analysis

Por: Campo-Tena · L. · Sardinha · L. · Meyer · S. R. · Garcia-Moreno · C.
Introduction

Violence against women (VAW) is a public health, gender equality and human rights issue, with women with disabilities facing heightened risks due to intersecting discrimination. However, research on violence against people with disabilities often lacks sex-disaggregated data and primarily focuses on intimate partner violence, neglecting other perpetrators like family members or caregivers and leading to potential underestimation of its prevalence.

Methods and analysis

This protocol outlines the methods for a systematic review and meta-analysis to estimate the global prevalence of VAW with disabilities, focusing on intimate partner violence by intimate partners, domestic violence and sexual violence by any perpetrator. The review will adhere to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and will include population-based quantitative studies focusing on women with disabilities aged 15 and older. 12 databases will be searched, and records will be screened by two independent reviewers. The risk of bias will be assessed. The global prevalence and pooled ORs comparing women with and without disabilities will be calculated.

Findings will contribute to global efforts in addressing VAW with disabilities, informing the development of targeted, evidence-based policies and programmes and ensuring that interventions are responsive to their specific needs and circumstances.

Ethics and dissemination

Ethics approval is not required, as this review analyses previously published data. Findings will inform ongoing World Health Organization (WHO)/Human Reproductive Programme (HRP) work on strengthening the measurement of VAW with disabilities and will be disseminated through a peer-reviewed publication, conference presentations and sharing with relevant organisations.

PROSPERO registration number

CRD42023427512.

Understanding and reframing clinical errors through just culture: protocol for the DECIDE mixed-methods study in Spanish healthcare and community contexts

Por: Mira · J. J. · Lorenzo · S. · Aranaz-Andres · J. M. · Macias-Maroto · M. · Cobos-Vargas · A. · Moreno Campoy · E. E. · Perez-Perez · P. · Trillo-Lopez · P. · Corpas-Nogales · E. · Gea Velazquez de Castro · M. T. · Arencibia-Jimenez · M. · Asencio · A. · Diez Herrero · D. · Molina
Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

ClinicalTrials.gov identifier

NCT06835517.

Authentic Nursing Leadership and Safety Climate Across Hospital Settings During the COVID‐19 Pandemic: A Cross‐Sectional Study

ABSTRACT

Aim

To analyse the relationship between authentic nursing leadership and safety climates across hospital settings during the COVID-19 pandemic.

Background

Authentic nursing leadership shapes the safety climate by fostering positive perceptions of workplace policies, processes, procedures and practices that influence how safety is prioritised and addressed within an organisation.

Design

A cross-sectional study.

Methods

Our study was conducted from December 2021 to December 2022 in six Brazilian hospitals. Participants were nursing staff working in General Medicine Units, Intensive Care Units (ICU) and Emergency Departments (ED) who provided care to patients with COVID-19. The Authentic Leadership Questionnaire and the Safety Attitudes Questionnaire were used to measure nursing staff perceptions of authentic leadership and safety climates. Data were analysed using descriptive and inferential statistics.

Results

391 nursing staff across six hospitals participated. Self-awareness significantly enhanced perceptions of the safety climates. Additionally, being a Registered Nurse and working in the ICU were positively associated with achieving safe climates in the working environment. In contrast, working in EDs was significantly negatively related to safety climates.

Conclusions

The COVID-19 pandemic underscored a lack of authentic nursing leadership and unsafe climates. Therefore, it is critical to implement educational strategies that foster authentic leadership, particularly focusing on self-awareness, to promote more positive safety climates. Ensuring that leadership and safety climates are relationship-focused is critical to enhancing patient outcomes.

Implications for the Profession and/or Patient Care

Nursing staff's perceptions of authentic leadership and safety climates are important in making more informed decisions about patient management.

Impact

Since self-awareness increases positive perceptions of safety climates, nursing staff should exercise it to guide their actions in facing future health crises.

Reporting Method

STROBE guidelines.

Patient or Public Contribution

Higher self-awareness in relationships with others is a predictor of safety climates and can lead to enhanced patient outcomes.

Impact of CMV-specific immune reconstitution at the end of letermovir prophylaxis on the development of late cytomegalovirus infection in haematopoietic stem cell transplant recipients (INMUNOEND): a protocol for a prospective, observational, multicentre

Por: Caston · J. J. · Aparicio · C. · Paez-Vega · A. · Pozo Lopez · L. · Garcia · E. · Martin · C. · Ruiz-Arabi · E. · Cuesta-Casas · M. A. · Bermudez-Rodriguez · M. A. · Cerezo-Martin · J. M. · Gonzalez-Sierra · P. A. · Machuca · I. · Martin Dominguez · F. M. · Saldana-Moreno · R. · He
Introduction

Cytomegalovirus (CMV) infection is a common complication in patients undergoing haematopoietic stem cell transplantation (SCT). Letermovir (LTV) prophylaxis during the first 100 days post-SCT is effective and safe in preventing this infection, although it may be associated with a delay in CMV-specific immune reconstitution. Hence, a study is needed to evaluate whether the absence of CMV-specific immune reconstitution at the end of LTV prophylaxis is associated with the development of late infection. This could facilitate the individualisation of CMV prophylaxis duration in these patients.

Methods and analysis

INMUNOEND is a multicentre, prospective, observational, non-interventional study including CMV seropositive patients undergoing allo-SCT who receive LTV prophylaxis during the first 100 days post SCT. Immunological and virological monitoring will be conducted until day+200 post-SCT. The primary outcome is the percentage of patients who develop clinically significant CMV infection up to day+200 post-SCT after completing LTV prophylaxis. Data collected will include baseline characteristics of the haematological diseases and comorbidities, variables related to SCT (ie, engrafment, graft-versus-host disease, use of LTV and CMV replication) and variables related to CMV-specific immune reconstitution.

Ethics and dissemination

Ethical approval has been obtained from the institutional review board (Comité de Ética de la Investigación de Córdoba; SICEIA-2024–0 01 762). The results of this study will be published in peer-reviewed journals and disseminated at national and international conferences.

Trial registration number

NCT06814301.

Model-based pharmacoeconomic analysis of anti-VEGF strategies for neovascular age-related macular degeneration: a value-based comparison of real-world administration approaches

Objectives

To evaluate the cost-effectiveness of anti-vascular endothelial growth factor (VEGF) treatments for neovascular age-related macular degeneration (nAMD) using a value-based model that considers drug durability, dosing regimens and real-world administration strategies, including safe vial fractionation.

Design and setting

Model-based pharmacoeconomic analysis using data from randomised clinical trials and network meta-analyses. Analysis conducted from the payer perspective using cost data from the Spanish National Health System.

Methods

A model-based analysis compared five anti-VEGF agents—innovator and biosimilar ranibizumab, aflibercept 2 mg, brolucizumab and faricimab—across three dosing regimens: fixed, Pro Re Nata and Treat-and-Extend (TAE). Administration formats included single-use vials, prefilled syringes and vial fractionation (VF), with or without dead-space-free (DSF) syringes to minimise waste. The primary outcome was cost per optimal responder, defined as a patient gaining ≥15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters, with and without adverse events. Cost-effectiveness was evaluated using Number Needed to Treat (NNT), Net Efficacy Adjusted for Risk-NNT (adjusted for safety) and incremental cost-effectiveness ratios. Secondary outcomes included the number of treated patients and optimal responders achievable within a fixed 1 000 000 budget.

Results

The most cost-effective strategy was aflibercept 2 mg under a TAE regimen using DSF VF, with a total cost of 6214 per patient and a cost per optimal responder of 27 155. Under a fixed budget of 1 000 000, this approach allowed treatment of 160 patients, yielding 36 optimal responders. Faricimab with DSF VF ranked second, with a total cost of 5847 and a cost per optimal responder of 28 652, treating 171 patients and achieving 34 responders. In contrast, single-use vials without VF led to substantially higher total costs (eg, 11 305 for aflibercept TAE) and lower treatment capacity (eg, 88 patients treated).

Conclusions

This model demonstrates that combining durable agents, extended dosing intervals and optimised delivery strategies (eg, prefilled syringes and DSF VF) can substantially improve the cost-effectiveness and sustainability of anti-VEGF therapy in public health systems.

Efficacy and safety of dexamethasone compared to placebo in patients with severe influenza infection. (FLUDEX study): a study protocol for a randomised controlled trial in Spain

Por: Ramos-RIncon · J.-M. · Cebollada · J. · Giner · L. · Paz Ventero · M. · Moreno-Perez · O. · Otero-Rodriguez · S. · Sanchez-Paya · J. · Rodriguez · J. C. · Merino · E.
Introduction

The combination with corticosteroids as immunomodulators has been the subject of debate in different infectious syndromes. The main objective of this study is to evaluate the efficacy (the percentage of patients hospitalised with influenza with a status of 3 or higher according to the Hospital Recovery Scale (HRS) on day 7 after the start of treatment) and safety of dexamethasone.

Methods and analysis

Investigator-initiated multicentre, blinded, randomised placebo-controlled trial with two parallel treatment arms. The study population will consist of adult patients (over 18 years of age) hospitalised with severe influenza. One arm will receive one capsule of 6 mg of dexamethasone for 7 days, and the other arm will receive one capsule of placebo for 7 days of antibiotic treatment for 7 days or longer. Both groups will receive oseltamivir (75 mg/12 hours orally) for 5 days, extendable to 10 days depending on the investigator decision. Randomisation will occur in equal proportion (1:1). Patients with bronchial hyper-responsiveness that requires systemic corticosteroids for more than 24 hours, preinclusion treatment with corticosteroids for more than 24 hours at a dose equal to or higher than 1 mg/kg methylprednisolone (0.2 mg/kg dexamethasone or 1.25 mg/kg prednisone), inability to administer oral oseltamivir, patients with severe comorbidity with a life expectancy of

Ethics and dissemination

The study is approved by the Institutional Review Board of Alicante Health Department—Dr. Balmis General University Hospital (LOC-100061146). The results of the main trial and each of the secondary endpoints will be submitted for publication in a peer-reviewed journal

Trial registration number

NCT06528444.

Changes in prescription patterns of antidiabetic medication in patients newly diagnosed with type 2 diabetes in Spain: an observational study

Por: Cea-Soriano · L. · Moreno · A. · Calonge · M. · Rivas · A. · Pulido-Manzanero · J. · Colchero · M. C. · Artola · S. · Serrano · R. · Franch-Nadal · J. · Regidor · E. · the PRECOZIN Study Group · Adan · Almanzar · Alonso · Alonso · Alonso · Alvarez · Alvarez · Amoros · Araujo · Arbide
Objective

To estimate the frequency of antidiabetic prescriptions in type 2 diabetes mellitus (T2DM) in Spain and describe changes in prescription patterns between 2018–2022 and 2023-2024.

Design

Observational study.

Participants

Patients from primary care centres newly diagnosed with T2DM in 2018–2022 and 2023–2024.

Primary and secondary outcomes

In each period, the prescription frequency of an antidiabetic medication at the diagnosis of T2DM was calculated and subsequently subdivided into monotherapy and combination therapy. The prescription frequency of the most common antidiabetic drugs was also calculated. Calculations were made for the entire group of subjects and stratified by sex and age (under 60 years and 60 years or older). Comparison of the frequencies between the two periods was performed using the chi-square test.

Results

In 2018–2022 and 2023–2024, 78.4% and 88.9% of patients, respectively, were prescribed an antidiabetic medication. The prescription frequencies for monotherapy and combination therapy were 66.1% and 33.9% in the first period and 57.4% and 42.6% in the second. The prescription frequencies for metformin as monotherapy and combination therapy were 57.4% and 27.8% in the first period and 46.6% and 39.8% in the second. Prescribing metformin with sodium-glucose cotransporter-2 inhibitors (SGLT2i) and/or glucagon-like peptide receptor 1 agonists (GLP1a) was the most frequent combination therapy: 12.8% in 2018–2022 and 29.5% in 2023–2024. With a few exceptions, the prescribing pattern was similar by sex and age. The difference between the prescribing distributions in the two periods is significant.

Conclusion

Antidiabetic medication prescribing at the diagnosis of T2DM was high. Most prescriptions contained metformin. Monotherapy decreased in 2023–2024 compared with 2018–2022, while combination therapy increased due to increased prescriptions of metformin with SGLT2i and/or GLP1a.

Vivencias del “YO PURO” en mujeres privadas de su libertad con antecedentes de consumo de drogas

Objetivo: describir las vivencias del “YO PURO” en mujeres privadas de libertad con antecedentes de consumo de drogas. Metodología: estudio cualitativo descriptivo de enfoque fenomenológico, utilizando un análisis de contenido temático e inductivo. La selección de participantes se realizó mediante un muestreo no probabilístico e intencional, incluyendo a seis mujeres privadas de su libertad. Para la recolección de datos, se aplicó una entrevista en profundidad basada en una pregunta detonadora. El análisis se llevó a cabo siguiendo los planteamientos propuestos por Edmund Husserl. Resultados: emergieron siete temas con sus unidades de significado. Experiencia en prisión, experiencia vivida del consumo de sustancias, dependencia y necesidad, reflexión y cuestionamiento del “YO PURO”, Sentimientos de culpa y pérdida, resignificación del presente a través de “YO PURO” y Anhelo de reconstrucción familiar. Conclusión: Este estudio exploró las vivencias de mujeres en reclusión, destacando los factores que influyen en su realidad diaria. Desde el enfoque fenomenológico de Edmund Husserl, se evidenció que la prisión no solo implica sufrimiento, sino que también propicia reflexión y transformación personal.

❌