Randomised, double-blind clinical trial protocol to evaluate whether early and perioperative tranexamic acid administration reduces transfusion rates and blood loss of patients undergoing hip fracture surgery in Spain

Introduction

In patients with a hip fracture, anaemia has been associated with increased transfusion requirements, poor functional outcomes, prolonged hospital stays and increased mortality. While anaemia in elderly patients with hip fractures has traditionally been attributed to bleeding during or after surgery, many of these patients are anaemic on hospital admission. Thus, detecting and managing anaemia in the perioperative, postoperative and, most significantly, the preoperative period is important to avoid the need for blood transfusions and to improve patient outcomes. The protocol for this clinical trial is designed to evaluate the efficacy and safety of both combined intravenous and topical tranexamic acid (TXA) therapy, or topical administration alone, assessing its effect on blood loss and the need for blood transfusions in elderly patients undergoing hip fracture surgery.

Methods and analysis

This is a multicentre, double-blinded, randomised, placebo-controlled trial with a 1:1 allocation ratio. Patients of both sexes, aged ≥65 years, who are admitted to the emergency department and will undergo hip fracture surgery are eligible for enrolment. Eligible patients who provide their consent will be stratified according to the type of fracture (intracapsular and extracapsular) and whether or not they are suitable for intravenous TXA therapy, and they will then be randomly allocated to receive either TXA or a placebo. The primary outcome is the blood transfusion rate from patient admission to the emergency department until discharge, while the secondary outcomes include: the preoperative, perioperative and postoperative haemoglobin and haematocrit levels; the preoperative and postoperative occult and total blood loss; the mean length of hospital stay; and any adverse events assessed for up to 1 year after patient discharge.

Ethics and dissemination

The study was approved by the Basque Country Ethics Committee (Ref.: 2021012) and the Spanish Agency for Medicines and Healthcare Products (Agencia Española de Medicamentos y Productos Sanitarios). All participants will provide their written informed consent prior to study inclusion. The trial’s results, regardless of its outcomes, will be disseminated through presentations at scientific conferences and publication in peer-reviewed journals, and they will be made publicly available through the European Union Clinical Trials Register after the end of the clinical trial.

Trial registration numbers

EudraCT Number 2020-002144-23; EUCT Number 2024-519349-31-00.

Use of ultrasound for early detection of ICU patients at risk of acquiring swallowing disorders: EIDAR, a prospective diagnostic study protocol

Introduction

Postextubation swallowing disorders (SD) are common in the intensive care unit (ICU) and are associated with severe complications, including aspiration pneumonia, a three-fold increase in reintubation risk and higher mortality. While fibreoptic endoscopic evaluation of swallowing (FEES) and videofluoroscopy are gold standards for diagnosis, they are often impractical or impossible to perform on intubated patients. The use of ultrasound offers a non-invasive, bedside alternative to evaluate the musculoskeletal structures involved in swallowing. The Echographie Identifier les troubles de Déglutition Acquis en Réanimation (EIDAR) study aims to evaluate the diagnostic performance of pre-extubation ultrasound in identifying patients at risk of SD following mechanical ventilation.

Methods and analysis

This prospective, monocentric diagnostic study conducted at the Dijon University Hospital ICU will include 100 adult patients ventilated for ≥48 hours. The primary outcome is the presence of SD, defined as a Penetration-Aspiration Scale score >2 during a FEES procedure performed 3 to 24 hours postextubation and independently assessed by an otolaryngologist blinded to index test results. Pre-extubation cervical ultrasound (Index Test) will be performed within 3 hours prior to extubation and measure hyoid bone ascension (primary variable of interest), geniohyoid muscle surface area and digastric muscle cross-sectional area. The diagnostic performance of cervical ultrasonographic parameters will be assessed using their discriminative capacity via a receiver operating characteristic curve. The feasibility of the ultrasound procedure in a critical care setting will also be assessed.

Ethics and dissemination

The study received a favourable opinion from the independent ethics committee CPP Ouest III and is registered with the French health authority ANSM (national agency on safety in medicine and health products). It is conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. Participants or their proxies provide free and informed oral consent. Results will be submitted for publication in peer-reviewed medical journals and presented at international conferences.

Trial registration numbers

RCB 2023-A00461-44 and NCT05922085

The LIFE study: a cross-sectional study protocol for LIfestyle risk Factors for chronic disease across the stagEs of reproductive ageing

Introduction

The dynamic physiological and hormonal changes through the menopause transition predispose women to an increased risk of chronic diseases including cardiovascular disease, metabolic disease, depression and dementia. The underlying mechanisms remain unclear, yet it is thought that chronic systemic inflammation and changes to lifestyle behaviours play important roles. The LIfestyle risk Factors for chronic disease across the stagEs of reproductive ageing (LIFE study) is a cross-sectional study aimed to characterise how hormonal and lifestyle (physical activity, diet and sleep) differences across pre, peri and postmenopause influence chronic systemic inflammation, visceral adiposity, cognitive function and sleep health.

Methods and analysis

Women aged between 40 and 65 years were recruited and classified into pre, peri or postmenopausal groups. Body composition measures and blood samples were collected. Sleep and physical activity were objectively measured using activPAL4 and ActiGraph GT9X link accelerometer over 7 days. Participants were also provided with a sleep diary. Physical function was assessed using the Short Physical Performance Battery. Cognitive function was evaluated using Addenbrooke’s Cognitive Examination-III and Cambridge Neuropsychological Test Automated Battery. Participants completed a series of questionnaires: Depression, Anxiety and Stress Scale-21, RuSATED, Berlin Questionnaire, Insomnia Severity Index, Activities-specific Balance Confidence Scale and the Australian Eating Survey.

Ethics and dissemination

Ethical approval was received from the relevant University Human Research Ethics Committee (ethics approval number #S221718) prior to the commencement of the research project. Data collection is ongoing and expected to be completed by April 2026. Results are expected to be available from July 2026. Findings will be disseminated in national and international conferences and in peer-reviewed journals and expected to inform how differences in lifestyle behaviours across menopause influence chronic systemic inflammation, visceral adiposity and cognitive function. Understanding and characterising the links between lifestyle behaviours and menopausal symptoms will inform targeted strategies to improve long-term well-being, heart, brain and metabolic health.

Medical adhesive-related skin injury (MARSI) in intensive care: prevalence and associated factors

Journal of Wound Care, Volume 35, Issue 6, Page 480-493, June 2026.

Validation of the Spanish Version of the Wound‐QoL‐14 Wound‐Specific Health‐Related Quality of Life Questionnaire

ABSTRACT

The aim was to validate the Spanish/Spain version of the Wound-QoL-14. Clinical data were prospectively collected from participants who completed the questionnaire at baseline and at a follow-up visit. COSMIN guidelines were followed to evaluate feasibility, reliability, construct validity and responsiveness. Overall, 323 participants (71.1 ± 14.6 years; 52% males) were included. Feasibility was excellent (missing items: 0.95%). Reliability was good (very good internal consistency [McDonald's omega: 0.934] and test–retest reliability [concordance correlation coefficient: 0.915; 95% CI: 0.837–0.956. Standard error of measurement: 0.141]). Regarding construct validity, the survey showed good structural validity since the three factors extracted after the exploratory factor analysis were confirmed (Comparative fit index: 0.942. Tucker–Lewis index: 0.927. Standardized root mean square residual: 0.042. Root mean square error of approximation: 0.089; 90% CI: 0.077–0.102) and good known-groups and convergent validities (4/4 and 7/9 predefined hypotheses supported, respectively). Criterium validity was excellent (Spearman's rho with Wound-QoL-17 global score: 0.934). Finally, the instrument was suitable to detect improvement (Floor effect: 0.3%. Ceiling effect: 1.5%. Area under the receiving operator characteristic curve: 0.795; 95% CI: 0.732–0.858; p < 0.001. Standardized effect size: 0.928. Standardized response mean: 0.852). The Spanish/Spain version of the Wound-QoL-14 is a reliable and valid instrument to assess the health-related quality of life in Spanish patients with chronic wounds.

Unveiling the burden of long covid in hospital and community settings: findings from the Post-Acute Sequelae of SARS-CoV-2 Network (PASCNET) cohort study in Italys pandemic epicentre

Objectives

Post-COVID-19 condition (PCC) has emerged as a major public health concern. We aimed to estimate the 1-year incidence of PCC in adults with confirmed SARS-CoV-2 infection in Lombardy, Italy, comparing community-managed and hospitalised patients and to assess the prognostic value of the National Institutes of Health (NIH) Researching COVID to Enhance Recovery (RECOVER) score to support estimation of long-term PCC prevalence.

Design

Retrospective-prospective observational cohort study enrolling patients infected between 1 March 2020 and 31 December 2022. The study visit was conducted between 16 January and 23 December 2024.

Setting

Multicentre study involving seven public hospitals and general practitioners across Lombardy.

Participants

Randomly sampled adults aged 18–70 years with confirmed SARS-CoV-2 infection. Hospitalised patients (HP) were admitted for COVID-19; general practitioner patients (GPP) were managed in the community. The total sample comprised: 1162 (546 HP, 616 GPP).

Intervention

This is an observational study with no active intervention.

Primary and secondary outcome measures

Primary outcome: 1-year incidence of PCC retrospectively assessed at the study visit.

Secondary outcomes: symptom profiles, long-term PCC prevalence at the study visit and predictive value of the NIH RECOVER score.

Results

Median age was 57.1 years in HP and 42.9 years in GPP; 66.1% of HP and 47.7% of GPP were male. PCC developed in 280 patients (223 HP, 57 GPP). The 1-year cumulative incidence was 39.9% in HP (95% CI 35.9% to 44.1%) and 9.1% in GPP (95% CI 7.1% to 11.7%). The NIH RECOVER score was associated with PCC at 1 year (OR 1.18, 95% CI 1.14 to 1.21). Model-based long-term PCC prevalence was 31.8% in HP and 6.3% in GPP.

Conclusions

PCC remained frequent and heterogeneous, particularly among previously HP. In this cohort, the NIH RECOVER score showed prognostic value for estimating longer-term PCC burden. These findings underscore the need for structured long-term follow-up across both hospital and primary care settings.

Designing interventions guided by digital phenotype and pharmacogenetics in Spain for suicidal behaviour based on retrospective data: the multicentre SMARTomicS study protocol

Introduction

Each year, suicide claims approximately 700 000 lives worldwide and generates a significant financial burden. Integrating genomic data, exposomic factors and digital phenotypes can enhance the development of short-term predictive models. Current knowledge and available tools provide the basis for designing personalised treatment strategies that incorporate real-time interventions to prevent suicide attempt recurrence cost-effectively. This study aims to develop a predictive algorithm for suicidal behaviour integrating psychiatric assessments, genetic risk markers, digital phenotypes and exposomic data.

Methods and analysis

This protocol describes a retrospective multicentre study that will recruit participants with a clinical history of suicide across 25 hospitals across Spain with a catchment area of 8.6 million people (17.8% of Spain’s population). Our sample target is over 5000 participants, aged over 12 years old, ensuring 93.5% statistical power for genetic analysis. Eligible participants must be over 12 years old. Data collection will include psychiatric assessments, biospecimen collections (DNA, RNA, plasma and serum), Google Takeout data for digital phenotyping, and a standardised set of administrative and clinical data registered for each patient. Genotyping will be performed with the Axiom Spanish array (>750 000 markers), and genome-wide association studies (GWAS) will be performed after genetic imputation in a whole sample of >10 000 individuals (5000 suicide attempters; 5000 controls). Prescription and clinical history will also be retrospectively integrated, and codified data statistics forms will periodically be sent to the Government. Statistical analyses will combine traditional regression models and AI-based algorithms to identify predictive behavioural, genomic profiles, and digital markers of suicidal behaviour. Cost-effectiveness analyses of pharmacogenomic markers for antidepressant response will also be conducted.

By successfully implementing this project, we aim to help reduce suicide reattempts and lessen the emotional and economic burden on families and the healthcare system.

Ethics and dissemination

This study has been approved by the Ethics Committee of the Fundación Jiménez Díaz (PIC301-24_FJD) and complies with the Declaration of Helsinki. It adheres to the GDPR (EU Regulation 2016/679), Spain’s Organic Law 3/2018 on Personal Data Protection and Digital Rights, and Law 41/2002 on patient autonomy. All required data protection measures will be implemented, including those under Real Decreto 1718/2010 on prescriptions and treatment adherence. Underaged participants will require parental consent for participation. The results will be disseminated through publication in peer-reviewed scientific journals and presentations at psychiatric conferences.

Trial registration number

NCT07422090.

Blended adapted sailing therapy with telerehabilitation for rare skeletal disorders: protocol for a pilot randomised controlled feasibility trial in Italy (PaS2-EXTEND)

Introduction

Rare skeletal disorders (RSDs) cause lifelong functional impairment, chronic pain and reduced quality of life. Evidence-based rehabilitation strategies remain underdeveloped, particularly for adolescents and young adults. We previously demonstrated preliminary feasibility of a 5-day adapted sailing intervention but observed benefit attenuation at 3-month follow-up. This pilot trial evaluates feasibility, acceptability and safety of intensive adapted sailing therapy followed by home-based telerehabilitation maintenance versus telerehabilitation alone.

Methods and analysis

This is a prospective, randomised, assessor-blinded, parallel two-arm pilot feasibility trial. 24 participants aged 12–30 years with confirmed RSDs will randomise with a 1:1 allocation ratio to: (1) 5-day adapted sailing therapy followed by 3-month telerehabilitation (n=12) or (2) 3-month telerehabilitation alone (n=12). Primary outcomes assess feasibility through recruitment efficiency (≥80% eligible patients enrolled), intervention adherence (≥75% sessions completed), participant retention (≥80% at 6-month follow-up), and safety (zero serious adverse events attributable to interventions). Secondary outcomes include sensor-based motor function (balance, gait, upper extremity mobility via inertial measurement units) and patient-reported outcomes (health-related quality of life, functional capacity, kinesiophobia, pain), measured at baseline, 3-month and 6-month follow-up. Exploratory analyses will estimate preliminary between-group effect sizes. Statistical analysis uses intention-to-treat principles with linear mixed-effects models.

Ethics and dissemination

The study received approval from the Area Vasta Emilia Centro Ethics Committee (363/2025/Sper/IOR) on 7 July 2025. The study is ongoing, and data collection is expected to be completed by March 2026. Results will be disseminated through peer-reviewed open-access publications, conference presentations, patient organisation partnerships and plain-language summaries.

Trial registration number

NCT07102875.

Use of implementation science models, theories, and frameworks in pediatric rehabilitation: Protocol for a scoping review

by Bayley Levy, Dorothy Luong, Shauna Kingsnorth, Iveta Lewis, Gillian King, Evdokia Anagnostou, Nadia Lise Tanel, Brayden Levillard, Gillian Molzon, Himanshi Elugoti, Mariam Jawad, Sarah Munce

Introduction

Implementation science frameworks – including process models, determinant frameworks, classic theories, implementation theories, and evaluation frameworks – are increasingly used to guide the translation of evidence-based interventions into practice. In paediatric rehabilitation, where interventions are complex and often require multidisciplinary collaboration, these frameworks can support systematic and context-sensitive implementation. However, the extent to which these frameworks have been used has not been comprehensively reviewed.

Objective

Determine the extent, nature, and specific contexts of the existing literature on the use of implementation science models, theories, and/or frameworks (MTFs) in paediatric rehabilitation.

Methods

This scoping review will follow the Joanna Briggs Institute (JBI) methodological guidance for scoping reviews. A comprehensive search strategy will be developed with a health sciences librarian and applied across multiple electronic databases: MEDLINE (Ovid), Embase, CINAHL, PsycINFO, ACM Digital Library, Web of Science, the Cochrane Central Register of Controlled Trials, PEDro, and RehabData. We will search English language articles published since 2006. Studies will be included if they report on the application of implementation science MTFs in the context of paediatric rehabilitation. Screening of titles and abstracts and full texts will be performed independently and in duplicate using Covidence. Discrepancies will be resolved through discussion or a third reviewer. Data will be extracted using a standardized form. Quantitative data will be summarized using numerical counts. Qualitative data will be analyzed using content analyses.

Results

This review will report on the use of implementation science MTFs in paediatric rehabilitation, identifying trends on the specific types applied, highlight gaps and/or underutilization across domains or developmental stages, and potentially uncover emerging frameworks. Finally, the results may inform the development of future implementation strategies and capacity-building initiatives within the field.

Maternal Zika virus exposure and neurodevelopmental outcomes: A longitudinal study of preschool children in the ZIKAlliance Colombian Cohort

by Víctor Herrera, María Consuelo Miranda, Anyela Lozano-Parra, Diana Niño, Luis Ángel Villar, Rosa Margarita Gélvez Ramírez, Thomas Jaenisch, Laura Pezzi, Claudia Acevedo, Jürg Niederbacher

Background

Zika virus (ZIKV) infection has been inconsistently associated with neurodevelopmental delay (ND). We aimed to compare the incidence of ND between ZIKV-exposed and ZIKV-unexposed children within the ZIKAlliance (ZA) cohort, in Colombia, assessed 2 years after birth (2018–2021).

Methods

We performed a neurodevelopmental evaluation on normocephalic children (aged 40–72 months) from the ZIKAlliance cohort. Children were classified as ZIKV-exposed (maternal positive RT-qPCR or virus neutralization test – VNT) or unexposed (maternal negative IgG ELISA or VNT in paired antenatal samples). A trained psychologist, blinded to exposure status, administered the Denver Developmental Screening Test II (DDST-II). Children were considered at ND risk if they presented ≥1 delay or ≥2 cautions in one or more areas, within their age range in the DDST-II scale. Inconclusive initial tests were re-evaluated. Adjusted odds ratios were estimated using logistic regression.

Results

We analyzed conclusive DDST-II results from 153 children (mean age: 4.7 years; 53.8% male). Overall, 57.2% (n = 83) were classified as cases of ND. Children with ND were more likely to be male (61.4% versus 43.5%) and less likely to attend daycare or school (42.2% versus 11.3%) than children with normal development. After adjusting for child age, sex, household size, and education, the association between in utero ZIKV exposure and ND was not statistically significant (OR = 0.71; 95% CI: 0.32–1.59, p = 0.320). However, children attending daycare or school had a significantly lower risk of ND compared to those who stayed at home.

Conclusions

Prenatal ZIKV exposure was not associated with ND in this cohort of normocephalic preschool children. Instead, attending a community daycare or school emerged as a significant protective factor against developmental delays.

Integrating natural gradients and controlled assays to reveal bacterial responses to cadmium in <i>Theobroma cacao</i> L., soils

by Claudia Jaramillo-Mazo, Daniel Bravo, Diego Fernando Villanueva-Mejía, Javier Correa-Alvarez

Cadmium (Cd), a toxic heavy metal found in agricultural landscapes worldwide, has been pointed out in cropped soils with Theobroma cacao L., as one of the main contaminants that translocate into plant tissues. Among the factors linked to cadmium translocation into plants, the role of soil bacterial communities in chemical transformation in soils has been poorly investigated. Overall, soil bacterial communities are shaped by diverse environmental and anthropogenic factors that influence crop yield and health. Cadmium alters soil microbial communities and increases the risk to human health through plant uptake. Although the impacts of cadmium on soil bacteria have been studied in other crops, there is limited information on cacao. Thus, this study aimed to assess the responses of soil bacterial communities in cacao farms to cadmium exposure, both natural and spiked. A total of 225 rhizosphere soil samples were collected from 16 plots across five cacao farms in two Colombian departments. The complementary approaches used were: (i) 16S rDNA amplicon sequencing to assess the composition of the bacterial community in soils with natural Cd concentrations, and (ii) isothermal microcalorimetry (IMC) to measure the temporal metabolic responses of bacteria to Cd in closed systems for 80 hours at 25 °C. The findings suggest that nearly 28% of the bacterial community responds to high cadmium concentrations in soils, both in natural and experimental conditions. Field-based observations revealed that Cd-responsive taxa detected under natural soil conditions included several unculturable bacterial groups, whereas laboratory experiments with Cd spiking predominantly selected for previously characterized cadmium-tolerant bacteria (CdtB). Significant variation in natural Cd-bacterial community composition and Cd-related metabolic activity was observed across the farms. Moreover, Cd-responsive bacterial taxa exhibited increased abundance during Cd spikes. As expected, contrasting patterns were revealed by the activity-response measured by IMC and taxonomic analyses of 16S rRNA gene sequences.

Hospital‐Acquired Pressure Injuries: Application of Preventive and Reactive Measures in Real Practice

ABSTRACT

Aims

To determine the application rate of the preventive measures, alternate air anti-decubitus mattress and postural changes in patients who develop hospital-acquired pressure injury (HAPI) on the basis of their preventive or reactive temporality.

Design

This is an ambispective observational study that included adult patients without pressure injuries admitted to Mancha Centro Hospital (Spain) who developed at least one HAPI during hospitalisation (August 2022 to March 2023).

Method

The main variables were the implementation of preventive measures and the time of their application. Other variables were comorbidities, sociodemographic and clinical variables, Braden and Barthel scale, variables related to the application of preventive measures and information to characterise HAPI.

Results

180 patients who developed 276 HAPI during their admission were included; 73.9% of the patients received a risk assessment upon admission, and 53.9% were re-evaluated. At some point during admission, an anti-decubitus mattress was placed in 73.3% of the patients, and 76.1% received postural changes.

Among the patients at risk at the time of HAPI onset, 49.4% had received anti-decubitus mattress preventively, 23.9% had received it reactively, and 26.7% did not receive it. Among the patients without contraindication for postural changes, 51.4% received them before the lesions appeared, 33.6% received them after the lesions appeared, and 13.6% did not receive them.

We detected a significant association between the preventive application of anti-decubitus mattress and postural changes with the Braden reassessment; admission to the intensive care unit; mechanical ventilation, vasopressors, nasogastric tube; mental state confused; hospital isolation; low Barthel and Braden scores; impaired mobility; inability to perform postural changes; diaper; urinary/faecal incontinence; and sedatives.

Conclusions

Only approximately half of the patients received preventive measures. Although patients with a more unfavourable clinical profile were more likely to receive these measures, increased awareness and training among healthcare professionals are necessary to ensure broader and more consistent implementation of preventive strategies.

Implications for the Profession and/or Patient Care

This study explores the real-world use of preventive measures in hospitalized patients who develop HAPI. In half of the patients, these measures were applied reactively, highlighting the need to introduce strategies that facilitate the implementation of evidence-based practices.

Reporting Method

This study was reported following the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) checklist for cross-sectional studies.

No Patient or Public Contribution

In the present study, data from patients have been obtained, but the patients or caregivers have not contributed to the development of the manuscript.

Particulate Evacuation Under NPWT: Bench Evaluation of a Multilayer Foam Prototype Versus Commercial Dressings in a Simulated Exudate Model

ABSTRACT

Negative pressure wound therapy (NPWT) is widely used to facilitate healing by improving local perfusion, reducing edema and controlling exudate. The porous foam dressing is central to NPWT effectiveness, however, its performance in viscous, particle-rich exudates remains challenging. Standard industry tests often rely on protein-free aqueous solutions, which overlook the complex rheology and particulate load of real wounds. This study reports a bench evaluation of a multilayer foam prototype compared with three commercial dressings under NPWT, using a simulated viscous exudate with suspended particles. We recorded 60-min drainage curves and quantified effluent turbidity as a simple, interpretable proxy for particulate transport, summarised as percentage of input turbidity recovered. The mass-based endpoint (percent solid matter recovered) showed the same ranking as turbidity. At −75 mmHg, the prototype recovered 31.6% of input turbidity, exceeding commercial foams (≤ 9.7%). At −125 mmHg, particulate recovery decreased across all dressings (≤ 9.1%). A matrix-only control indicated that commercial effluents, particularly at −75 mmHg, clustered near background level, whereas the prototype evacuated substantially more particulate while maintaining robust fluid drainage. These findings suggest that moderate negative pressure and multilayer architecture can help preserve channel patency and reduce clogging in complex exudates. We highlight the need for test methodologies that incorporate viscosity and particulate content, and for practical guidance that links dressing architecture and pressure settings to exudate characteristics. Prospective validation, including larger-sample confirmation, particle-size distributions and ultimately clinical endpoints, is warranted.

Unequal Leadership: Gender Disparities in Nursing and Healthcare Leadership in a Public Health System

ABSTRACT

Introduction

Women constitute the majority of the global healthcare workforce—especially in nursing—yet remain under-represented in formal leadership roles. Understanding how gender disparities intersect with profession, age, and governance models is critical to advancing equity and strengthening nursing leadership within health systems.

Design

Cross-sectional ecological study across publicly funded healthcare entities in Catalonia, Spain.

Methods

Data from 124 entities were collected as of 31 December 2023 and analyzed by gender, profession (physician, nurse, or other), age group (≤ 55, > 55), and governance model (direct vs. indirect management) across five hierarchical leadership levels. Descriptive and inferential analyses were conducted to examine gender disparities in leadership distribution.

Results

A total of 8015 leadership positions were identified, of which 62.2% were held by women, despite women representing 75% of the workforce. A clear gender gradient emerged across leadership levels, with women's representation decreasing systematically at each step upward in the hierarchy. Women's representation declined significantly with increasing seniority, whereas men's representation increased at higher organizational levels. Among professions, male physicians were markedly represented at senior levels, while nurses—both women and men—were concentrated in lower and mid-level positions. Gender disparities were also shaped by age and governance model: younger women were clustered in frontline roles, and female leaders in indirectly managed entities were more evenly distributed across leadership levels than those in directly managed organizations.

Conclusion

Persistent gender disparities—particularly affecting nurses and younger professionals—highlight the need for inclusive leadership development, transparent promotion pathways, and robust gender-disaggregated data for workforce planning. Strengthening nursing leadership is not only a matter of equity but a strategic priority for building inclusive and responsive health systems.

Evaluation of usability and acceptability of a Peruvian telemental health service for early assessment among vulnerable occupational workers: Mixed-method study with a user-centered design approach

by Jimmy Andreyvan Cainamarks-Alejandro, Liliana Cruz-Ausejo, Miguel Angel Burgos-Flores, Jaime Rosales-Rimache, Jonh Astete-Cornejo, David Villarreal-Zegarra

Background

The COVID-19 pandemic marked an increase in depressive, anxiety, and post-traumatic stress disorder symptoms, more specifically among healthcare workers, teachers, and police officers. These workers face external and occupational factors which had a significant impact on mental health, significant increase in workload and direct exposure to the virus, shortage of personnel protective equipment, and instances of abuse, including discrimination. Mental health care in primary care requires a process of early identification and timely referral of complex cases. Telehealth emerges as an effective alternative for addressing challenges in mental health care, although its implementation encounters obstacles.

Objective

To design a telehealth service that facilitates screening, initial management, and timely referral for mental health diagnoses in workers with prior SARS-CoV-2 infection, and to evaluate usability, acceptability, and user satisfaction.

Methods

Mixed-method study with a user-centered design approach involving key external and internal service users in three sequential stages (pre-design, co-design, and post-design). The study phases lasted 6 months, involving a total of 23 participants in the pre-design phase (contextual inquiry and preparation and training), 12 participants in the co-design phase (framing the issue, generative design, and sharing design), and in the post-design phase, 4 participants were involved in service implementation, and 81 participants—drawn from the subgroup of 134 users who received psychoeducation—were included in the efficacy assessment.

Results

The proposal included the development and evaluation of a service model guide and a telehealth software platform. First, the participants took part in a series of workshops (Pre-design, Co-design) where they provided ideas for meeting the product requirements, based on the Design Thinking methodology framework. The telehealth service model was named TelePsico CENSOPAS. It comprised four processes: a) Service promotion; b) User pre-identification; c) Appointment management; d) Psychoeducation counseling and referral. The Telehealth platform was designed through three cycles of an iterative process and integrated a proprietary development platform with third-party service technologies for communication support and information exchange. During post-design, the pilot test involved 698 screened patients; 193 were identified with mental health risks, and 134 of them received psychoeducation sessions. In addition to user acceptance, the usability score of the platform was 86.1 ± 16.9 SD, satisfaction dimensions of the service was 45.1 ± 7.2 SD for satisfaction with care processes, and 36.7 ± 5.2 SD satisfaction with psychological care.

Conclusion

The proposal for mental health telehealth services and its supporting platform was successfully developed and accepted by both internal and external users, particularly within well-structured occupational health services in workplaces serving vulnerable occupational groups. In addition, it achieved higher satisfaction and usability scores than Peru’s outpatient care services. These findings support the replicability of user-centered design frameworks—such as design thinking—within the occupational health sphere.

Epidemiological investigation of perinatal depression among pregnant and postpartum women: findings from a cross-sectional survey in the Philippines

Objective

This study investigated perinatal depressive symptoms among pregnant and postpartum Filipino women.

Design

Cross-sectional survey.

Setting

The Philippines.

Participants

Participants were recruited online and face-to-face from maternal care facilities.

Primary outcome measure

Perinatal depressive symptoms were assessed using the Edinburgh Postnatal Depression Scale (EPDS) score, with prevalence calculated based on ≥13 cut-off, indicating clinically significant symptoms of depression. Patterns of depressive symptoms were examined by demographics, perinatal time period and other obstetric information using adjusted regression coefficients (ab) and risk ratios (aRR).

Results

A total of 856 women participated in the study, comprising 356 pregnant and 500 postpartum women. EPDS scores were, on average, similar between pregnant (14.4) and postpartum women (14.1). Using the locally validated cut-off of ≥13 revealed that 69.1% of pregnant and 62.0% of postpartum women reported clinically significant depressive symptoms. Consistent EPDS scores and prevalence were observed across pregnancy trimesters and within 12 months postpartum and beyond. Women who received adequate prenatal care were less likely to experience antenatal (ab=–1.59, 95% CI –3.13 to –0.05) and postpartum (ab=–1.30, 95% CI –2.48 to –0.12) depressive symptoms. Postpartum EPDS scores and depressive symptom prevalence (EPDS score ≥13) were higher among 18–24-year olds (ab=1.96, 95% CI 0.30 to 3.61; aRR=1.23, 95% CI 1.03 to 1.47) and single mothers (ab=3.46, 95% CI 0.22 to 6.71; aRR=1.42, 95% CI 1.07 to 1.90), compared with older and married mothers, respectively.

Conclusions

At least 60% Filipino mothers experienced clinically significant perinatal depressive symptoms, which exceeds the established global average of 25%. Younger and single postpartum women were at greater risk, while pregnant and postpartum women who attended adequate prenatal visits were less likely to report depressive symptoms. Our study underscores the need for further research to uncover the true burden of poor perinatal mental health and calls for targeted early interventions and integrative public health strategies to support at-risk mothers, particularly those from socially disadvantaged backgrounds.

Exploring psychiatrists’ perspectives on supporting parents with mental health Challenges: A mixed-methods study

by Mireille Jasmin, Geneviève Piché, Aude Villatte, Andrea Reupert, Marie-Ève Clément, Anne Dorothee Müller, Marianne Fournier-Marceau, Darryl Maybery, Marie-Hélène Morin, Stéphane Richard-Devantoy

Background

Parenting responsibilities can be particularly challenging for patients receiving mental health services, often resulting in a range of negative impacts on children. Incorporating a family-focused approach into the usual care of parents with mental illness has been recommended to promote patient recovery while supporting the well-being of children and the entire family unit. This study aimed to document the family-focused practices undertaken by psychiatrists working with parents who have a mental illness and to explore potential facilitators and barriers to these practices.

Methods

A sequential explanatory mixed-method design was used, combining an online survey and individual interviews. Family-focused practices were reported by 27 psychiatrists through the French version of the Family-Focused Mental Health Practice Questionnaire. Follow-up qualitative individual interviews were conducted with 5 psychiatrists. Item-by-item analysis of the quantitative data was performed, followed by a thematic analysis of the qualitative data, integrating findings from both sources.

Results

Although psychiatrists acknowledge their patients’ parenting role, most are reluctant to provide further support. Key barriers to family-focused practice include the predominantly individual-focused nature of psychiatric care, stigma, consent issues, and limited collaboration between adult and child services. Facilitators include psychiatrists’ professional autonomy, personal experience, and confidence in conducting family meetings.

Conclusion

Psychiatrists can play a pivotal role in identifying, acknowledging, and providing appropriate support to parents with mental illness and their families, including children. Developing comprehensive guidelines and targeted training is essential to equip psychiatrists with effective strategies for addressing parenting challenges in patients with complex mental health issues. Additionally, psychoeducational resources for children should be incorporated. Implementing these initiatives may lead to more compassionate, targeted care and improved outcomes for parents and their families.

Let's Talk About the Elephant in the Room: A Psychological Safety Climate Intervention Among Nursing Teams—A Qualitative Evaluation

ABSTRACT

Aim

To explore how a staff and managers experienced a multi-component and multi-level intervention to influence the psychological safety climate within nursing teams.

Design

Qualitative, to explore the experiences of registered nurses, licensed practical nurses, and managers in a Swedish hospital.

Methods

Four focus group discussions were conducted in March 2023 with staff and managers (n = 20). A deductive thematic analysis was conducted, guided by a theoretical model of psychological safety, to examine work climate perceptions and antecedent conditions. An inductive approach was used to explore how participants experienced the intervention.

Results

Participants experienced a shift from a blame-oriented to a more psychologically safe work climate. These developments were enabled by enhanced self-awareness, more supportive interpersonal dynamics, and leaders adopting a more accessible and vulnerable role. The intervention created a safe space to reflect on team dynamics.

Conclusion

Sustained efforts that integrate self-awareness, interpersonal dynamics, and managerial support are important to intentionally develop psychological safety. The creation of safe spaces can serve as a first step to confront unaddressed group beliefs.

Implications for the Profession and/or Patient Care

Interventions aimed at improving psychology safety can have positive effects if they focus on developing individual trust and vulnerability, targeting group dynamics, and including leaders.

Impact

Problem addressed: Inadequate psychological safety among nursing teams, hindering effective collaboration. Main findings: By changing work conditions, the intervention led to improved perceived psychological safety. Research impact: Creating conditions for psychological safety can improve how teams function.

Reporting Method

COREQ-checklist.

Patient or Public Contribution

No PPI patient or public contribution.

Stress and Health‐Related Quality of Life in Adults With Type 1 Diabetes: The Mediating Role of Perceived Support and Treatment Adherence

ABSTRACT

Aims

To examine the associations among diabetes-related stress, treatment adherence, perceived social support, and health-related quality of life (HRQoL) in adults with type 1 diabetes mellitus (DM1), and to explore the mediating roles of support and adherence in this relationship.

Design

A cross-sectional observational study using self-report standardised measures and mediation analysis.

Methods

A total of 772 Spanish adults with DM1 completed validated instruments measuring diabetes-related distress, perceived social support, treatment adherence, and HRQoL. Hierarchical multiple regression and serial mediation analysis (PROCESS Model 6, 10,000 bootstraps) were conducted, controlling for age, sex, and time since diagnosis.

Data Sources

Not applicable (primary data collection, not a review).

Results

Diabetes-related stress was the strongest predictor of lower HRQoL. Perceived social support and treatment adherence also contributed significantly. Mediation analyses indicated that the impact of stress on HRQoL was partially mediated by perceived social support and, in sequence, by treatment adherence. The indirect path through social support alone and the sequential path involving both mediators were significant.

Conclusion

Stress and social support are critical in understanding and improving HRQoL in adults with DM1. Treatment adherence appears to be influenced by perceived support, highlighting an indirect mechanism linking stress to quality of life.

Implications for the Profession and/or Patient Care

Healthcare professionals should integrate psychosocial assessments and interventions into routine diabetes care. Targeting stress reduction and enhancing social support may improve adherence and overall well-being in adults with DM1.

Impact

What problem did the study address? The study addressed the need to understand how psychosocial factors—specifically stress, perceived social support, and treatment adherence—contribute to HRQoL in adults with DM1. While prior research often focused on paediatric or clinical populations and rarely explored mediation models, this study sought to fill those gaps with data from a large community sample of adults.

What were the main findings? The main findings indicate that diabetes-related stress is the most significant predictor of reduced HRQoL. This relationship is partially mediated by perceived social support and, sequentially, by treatment adherence. While stress directly affects HRQoL, its negative impact is also channelled through diminished social support and decreased adherence. The indirect effect through treatment adherence alone was not significant.

Where and on whom will the research have an impact? The research has implications for adults living with DM1, particularly those in community settings outside of clinical supervision. It informs healthcare providers, diabetes educators, and policymakers on the importance of addressing emotional distress and strengthening support networks to improve both treatment adherence and overall quality of life.

Reporting Method

This study adhered to the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) guidelines for cross-sectional studies. All methods and results are reported in alignment with EQUATOR Network recommendations for transparent and rigorous research reporting.

Patient or Public Contribution

The study was conducted in collaboration with the Spanish Diabetes Federation (FEDE), which supported participant recruitment and dissemination through its affiliated associations. Patient input was incorporated throughout the study. A person with lived experience of type 1 diabetes contributed to the conceptual development of the research questions and the interpretation of findings. Their perspective helped ensure that the study design, choice of measures, and implications were relevant and meaningful to people living with the condition. This involvement supported a patient-centred approach to both the research and the manuscript preparation. Patients' participation as voluntary contributors was essential to the data collection process.

Voices beyond the margins: a protocol for a qualitative systematic review and meta-synthesis of Indigenous patients experiences accessing mainstream healthcare services in Canada

Introduction

First Nations, Inuit and Métis Peoples in Canada continue to face significant disparities in healthcare access compared with non-Indigenous populations. Understanding their experiences in accessing healthcare is essential for addressing systemic barriers and promoting equitable, patient-centred care. Although existing studies have identified various barriers and facilitators to accessing healthcare, a lack of synthesised qualitative evidence delves into the intricacies of patients’ experiences. This systematic review aims to investigate Indigenous patients’ experiences with mainstream Canadian healthcare services and their recommendations for service improvement through a meta-synthesis of qualitative literature.

Methods and analysis

Meta-aggregation will be used to conduct a systematic review of qualitative studies and qualitative components of mixed-methods studies exploring experiences of Indigenous patients accessing mainstream healthcare services in Canada. Papers published in English will be searched using electronic databases, including MEDLINE, APA PsycINFO, CINAHL, Global Health, the Bibliography of Indigenous Peoples in North America and Web of Science. A comprehensive list of non-indexed and grey literature will also be searched to ensure the inclusion of community-based and non-peer-reviewed evidence. Studies meeting the inclusion criteria will be assessed for methodological quality using the Joanna Briggs Institute (JBI) Critical Appraisal Checklist for Qualitative Research and the Aboriginal and Torres Strait Islander Quality Appraisal Tool. The review will involve the extraction of findings, categorisation into themes and synthesis into broader insights guided by the JBI meta-aggregation approach. An Indigenous advisory committee will guide the process, including interpretation of findings and ensuring alignment with Indigenous health research principles.

Ethics and dissemination

Ethics approval is not required for this study as it is based on a secondary analysis of publicly available primary studies. The completed review will be published in a peer-reviewed manuscript. Findings will also be shared with relevant Indigenous organisations and community partners through plain-language summaries and community-engaged knowledge-sharing activities.

PROSPERO registration number

CRD420250656486.