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Hoy — Diciembre 16th 2025Tus fuentes RSS

<i>Mycobacterium tuberculosis</i> complex lineages and drug resistance patterns among tuberculosis patients with or without diabetes mellitus in southern Ghana

by Emelia Konadu Danso, Prince Asare, Amanda Yaa Tetteh, Phillip Tetteh, Augustine Asare Boadu, Ivy Naa Koshie Lamptey, Augustina Angelina Sylverken, Kwasi Obiri-Danso, Jane Sandra Afriyie-Mensah, Abraham Adjei, Dorothy Yeboah-Manu

Drug-resistant (DR) tuberculosis (TB) and diabetes mellitus (DM) are intersecting epidemics that complicate management of both diseases and worsen patient outcomes. We conducted a prospective cohort study of 758 GeneXpert-confirmed pulmonary TB patients, of whom 75 had DM. Demographic, clinical, radiographic, and anthropometric data were collected at baseline. Sputum samples were cultured for mycobacterial isolation, and the obtained isolates were characterized for Mycobacterium tuberculosis complex (MTBC) lineage and drug-susceptibility testing using spoligotyping and microplate alamar blue assay. The TB-diabetes (TB-DM) comorbid cohort was older [TB-DM: 53/75 (70.7%) vs. 241/683 (35.3%) aged 41–60 years) (p 

Cyclodextrin reduces cholesterol crystal uptake by circulating monocytes in patients undergoing coronary angiography

by Nikola Lübbering, Alexander Krogmann, Felix Jansen, Eicke Latz, Georg Nickenig, Sebastian Zimmer

Background

Atherosclerosis is a chronic inflammatory disease driven by endothelial dysfunction, cholesterol accumulation, and immune activation leading to thrombosis and vascular stenosis. While LDL-lowering therapies are firmly established, targeting the underlying inflammation is still an emerging strategy. Cholesterol crystals (CC) contribute to inflammation by activating the NLRP3 inflammasome in monocytes and promoting disease progression. Cyclodextrin (CD), an FDA-approved drug carrier, has shown atheroprotective effects by enhancing cholesterol metabolism and reducing inflammation in preclinical models. This study investigated whether CC-uptake in human monocytes, a prerequisite for inflammasome activation, is also influenced by CD pretreatment.

Methods

Human peripheral mononuclear cells were isolated from whole blood samples provided by 76 patients undergoing coronary angiography at the University Hospital Bonn between November 2017 and February 2018. After separation, peripheral mononuclear cells were stimulated with 2-Hydroxypropyl-γ-Cyclodextrin and CC. CC-uptake by monocytes was analyzed using flow cytometry.

Results

CC-uptake by monocytes varied greatly between patients (8–37%), with lower uptake observed in patients with elevated leukocytes (p = 0.0058) and diabetes mellitus (p = 0.0448). CD-pretreatment significantly reduced CC-uptake (20.1% ± 0.8% vs. 15.0% ± 0.6%, p p = 0.0316), requirement for percutaneous coronary intervention (PCI) (p = 0.0030), and elevated leucocyte levels (p = 0.0135) had lower CCΔCD, suggesting a link between systemic inflammation and attenuated CD efficacy.

Conclusion

We demonstrated that CD significantly reduced CC-uptake in patients undergoing coronary angiography, which supports its role in inhibiting CC-phagocytosis and promoting cholesterol efflux. Interestingly, patient response to CD varied, with those exhibiting greater systemic inflammation or CAD showing a less pronounced reduction in CC-uptake. Our findings provide insight into the atheroprotective mechanisms of CD and suggest its potential utility in evaluating individual cardiovascular risk and monitoring CD-based therapeutic interventions in humans.

Optimizing vitamin A supplementation: A comparative cost-effectiveness analysis of routine distribution strategies in northern Côte d’Ivoire

by Melissa M. Baker, Lyonel Nerolin Doffou Assalé, David Doledec, Romance Dissieka, Ahmenan Claude Liliane Konan, Agnes Helen Epse Assagou Mobio, Koffi Landry Kouadio, Oka René Kouamé, Ama Emilienne Yao, Hubert Zirimwabagabo

Background

While recent data on vitamin A deficiency (VAD) prevalence is lacking, the 2004 Côte d’Ivoire Nutrition and Mortality Survey reported that 26.7% of children aged 6–59 months were affected by VAD, and approximately 60% were at risk. Since 2016, the government has transitioned from mass campaigns to routine vitamin A supplementation (VAS) delivery integrated into health services. However, evidence on the cost-effectiveness of the routine distribution approaches is limited. This study evaluated the cost, coverage, and cost-effectiveness of three routine VAS delivery strategies across two health districts in northern Côte d’Ivoire.

Methods

A mixed-methods study evaluated three routine VAS delivery strategies – routine-fixed, advanced community-based, and catch-up – across two health districts, Ferkessédougou and Niakaramadougou, in northern Côte d’Ivoire. The quantitative cost data were collected via a structured tool covering six cost categories: planning, procurement, training, social mobilization, distribution, and supervision. VAS coverage was assessed through a post-event coverage survey (PECS) via a two-stage cluster sampling methodology. A cost-effectiveness analysis determined the cost per child supplemented, the cost per DALY averted, and a sensitivity analysis tested the robustness of the findings under different cost scenarios.

Results

The total program cost for July-December 2023 was 25.5 million FCFA, with personnel costs comprising over 70% of expenditures. In Ferkessédougou, the routine advanced community-based strategy was the most cost-effective, at 458 FCFA per child in rural areas (versus 596 FCFA for the routine-fixed facility-based approach in the same area). In Niakaramadougou, the December catch-up was more cost-effective in rural areas (606 FCFA per child) than the routine-fixed approach (714 FCFA). Across both districts combined, the routine-fixed strategy averaged roughly 651 FCFA per child supplemented, and the cost per DALY averted ranged from 30,093 FCFA (advanced strategy in Ferkessédougou) to 89,550 FCFA (catch-up Jul 2023 in Niakaramadougou) – all below Côte d’Ivoire’s cost-effectiveness threshold (0.5 x GDP per capita; approximately USD 1,265).

Conclusion

All three strategies were cost-effective, though the advanced community-based strategy achieved the best balance of reach and efficiency. Scaling advanced strategies within health system constraints may enhance sustainability and coverage in low-resource settings.

Is price associated with the quality of medicines? Evidence from active pharmaceutical ingredient testing in Nigeria

by Marie Chantel Montás, Chimezie Anyakora, Elisa Maria Maffioli

Determining the quality of medicines remains a challenge, particularly in low- and middle-income countries, where regulatory oversight and enforcement vary, and resources and infrastructure for quality testing are often constrained. In these settings, price is often used as a proxy for higher-quality medicines, yet empirical evidence supporting this assumption remains scarce. We conducted a mystery shopper survey in over 1,200 retail pharmacies across urban and rural areas in the six geopolitical zones of Nigeria, purchasing one drug sample from a list of twenty branded medicines, including analgesics, antimalarials, antibiotics, antihypertensives, and multivitamins. A sub-sample of the purchased medicines (N = 246) was tested for quality, defined as passing a laboratory test using High-Performance Liquid Chromatography (HPLC) to measure the Active Pharmaceutical Ingredient (API) content of each medicine. Using probit regressions, we examined the extent to which price is associated with quality, controlling for observable pharmacy and drug sample characteristics. A 1% increase in price is associated with a 16.7 percentage point increase in the probability of passing the laboratory test, conditional on other factors. Receiver Operating Characteristic (ROC) analysis shows strong out-of-sample classification performance, with an Area Under the Curve (AUC) of 0.82 for the price-only model, indicating that price alone explains much of the variation in quality. Other results show that medicines organized by brand and displaying visible expiration dates may signal higher quality, while the presence of other observable characteristics (e.g., packaging, storage, display) shows more counterintuitive associations with drug quality in this context. Stratified analyses show that the association between price and quality is particularly strong for analgesics and antibiotics. These findings suggest that price appears to be a reliable signal of medicine quality, whereas other characteristics of pharmacies and drug samples provide weaker and less consistent indicators. This underscores the need for stronger regulatory oversight, greater market transparency, and targeted consumer education to promote safer access to quality medicines.

Optimising time-limited trials in acute respiratory failure: a multicentre focused ethnography protocol

Por: Kruser · J. M. · Wiegmann · D. A. · Nadig · N. R. · Secunda · K. E. · Hanlon · B. M. · Moy · J. X. · Ahmad · A. · Campbell · E. G. · Donnelly · H. K. · Martinez · F. J. · Polley · M. · Orhan · C. · Korth · E. · Stalter · L. N. · Rowe · T. J. · Wu · A. L. · Viglianti · E. M. · Eisinger · E
Introduction

The ‘time-limited trial’ for patients with critical illness is a collaborative plan made by clinicians, patients and families to use life-sustaining therapies for a defined duration. After this period, the patient’s response to therapy informs decisions about continuing recovery-focused care or transitioning to comfort-focused care. The promise of time-limited trials to help navigate the uncertain limits and benefits of life-sustaining therapies has been extensively discussed in the palliative and critical care literature, leading to their dissemination into clinical practice. However, we have little evidence to guide clinicians in how to conduct time-limited trials, leading to substantial variation in how and why they are currently used. The overall purpose of this study is to characterise the features of an optimal time-limited trial through a rich understanding of how they are currently shaping critical care delivery.

Methods and analysis

We are conducting an observational, multicentre, focused ethnography of time-limited trials in patients with acute respiratory failure receiving invasive mechanical ventilation in six intensive care units (ICUs) within five hospitals across the US. Study participants include patients, their surrogate decision makers and ICU clinicians. We are pursuing two complementary analyses of this rich data set using the open-ended, inductive approach of constructivist grounded theory and, in parallel, the structured, deductive methods of systems engineering. This cross-disciplinary, tailored approach intentionally preserves the tension between time-limited trials’ conceptual formulation and their heterogeneous, real-world use.

Ethics and dissemination

This study has been reviewed and approved by the University of Wisconsin Institutional Review Board (IRB) as the single IRB (ID: 2022-1681; initial approval date 23 January 2023). Our findings will be disseminated through peer-reviewed publication, conference presentations, and summaries for the public.

Trial registration number

NCT06042621.

Development and validation of a case identification algorithm for hand trauma patients using health administrative data and the epidemiology of hand trauma in a universal healthcare system

Por: Wong · C. R. · Tu · K. · Hernandez · A. · Urbach · D. R. · Witiw · C. · Hansen · B. · Ko · A. · Tsai · P. · Baltzer · H.
Objectives

Our primary objectives were (1) to develop and validate an administrative data algorithm for the identification of hand trauma cases using clinical diagnoses documented in medical records as the reference standard and (2) to estimate the incidence of hand trauma in a universal public healthcare system from 1993 to 2023 using a population-based research cohort constructed using a validated case identification algorithm.

Design

A population-based retrospective validation study.

Setting

Ontario, Canada, from 2022 to 2023 (validation) and from 1993 to 2023 (estimation).

Participants

Our reference standard was the known hand trauma status of 301 patients (N=147 with hand trauma) who presented to an urban tertiary-care hand trauma centre in Toronto, Ontario.

Primary and secondary outcome measures

(1) The sensitivity, specificity, positive and negative predictive values of the optimal algorithm to identify hand trauma using provincial health administrative data and (2) age-standardised and sex-standardised incidence rates of hand trauma among men and women, by age, and by area of patient residence.

Results

The optimal algorithm had a sensitivity of 73.8% (95% CI 66.6% to 81.0%), specificity of 80.1% (95% CI 73.8% to 86.5%), positive predictive value of 78.1% (95% CI 71.2% to 85.0%) and negative predictive value of 76.1% (95% CI 69.5% to 82.7%). Over the study period, the age-standardised and sex-standardised incidence of hand trauma increased from 384 to 530 per 100 000. The greatest increase was observed in males and individuals aged 0–19 and 80+, with higher incidence rates in Southern compared with Northern Ontario.

Conclusions

Our algorithm enabled identification of hand trauma cases using health administrative data suitable for population-level surveillance and health services research, revealing a rising burden of hand trauma from 1993 to 2023. These findings can support improved surveillance, resource allocation and care delivery for this public health problem.

Caught in the undertow: a qualitative study exploring the relationship between the sustainable employability of healthcare workers and quality of care

Por: van de Voort · I. · Leistikow · I. · Bal · R. · Weenink · J.-W.
Objectives

The sustainable employability of healthcare workers is associated with quality of care and vice versa, but how both interact remains largely unknown. This study aims to better understand the underlying mechanisms that explain the interconnectedness between healthcare workers’ sustainable employability and quality of care by examining organisational practices in two hospital teams that work on improving specific clinical processes.

Design

A qualitative study was conducted, where team leaders, department managers and healthcare teams were observed and interviewed about their experiences with, and perspectives on, the (organisation of the) respective clinical process and daily (quality improvement) work. Transcripts and field notes were analysed in accordance with reflexive thematic analysis.

Setting

The emergency room and operating room of a recently merged Dutch hospital.

Participants

A total of 49 hours of observations and 10 interviews were conducted with team leaders, department managers, (scrub) nurses, physicians and other allied health professionals. Interviewees were purposively recruited when they were involved in, or considered knowledgeable about, the clinical processes.

Analysis

This study identified three mechanisms as a result of different organisational practices that affected healthcare workers’ sustainable employability and quality of care separately and set in motion their interconnectedness: routinely overburdened staff, prolonged perceived distance between staff and regular disregard of raised concerns by staff. Over time, as these mechanisms remained unaddressed, undertows of slumbering sentiments—discontent, distrust and inertia—emerged. These sentiments proved hard to bring to the surface and to resolve and, in turn, may further compromise sustainable employability of healthcare workers and quality of care.

Conclusions

In this study, we show how the relationship between the sustainable employability of healthcare workers and quality of care is set in motion by seemingly unrelated organisational practices. To benefit both healthcare workers and patients, leadership and healthcare teams are urged to prevent (undertows of) slumbering sentiments by recognising sentiments as important signals of dysfunctional circumstances and by effectively organising participatory practices that enable healthcare workers’ voice and input.

Organising maternal and newborn care in high-income countries: a scoping review of organisational elements and their association with outcomes

Por: Liebregts · J. · Goodarzi · B. · Valentijn · P. · Downe · S. · Erwich · J. J. · Burchell · G. · Batenburg · R. · de Jonge · A. · Verhoeven · C. J. M. · VOICE Study Group · Burzynska · de Graaf · van Heemstra · Rippen · Koster · van der Voort · Kaiser · Fransen · Berks · Haga · Vermo
Introduction

Countries face challenges in maternal and newborn care (MNC) regarding costs, workforce and sustainability. Organising integrated care is increasingly seen as a way to address these challenges. The evidence on the optimal organisation of integrated MNC in order to improve outcomes is limited.

Objectives

(1) To study associations between organisational elements of integrated care and maternal and neonatal health outcomes, experiences of women and professionals, healthcare costs and care processes and (2) to examine how the different dimensions of integrated care, as defined by the Rainbow Model of Integrated Care, are reflected in the literature addressing these organisational elements.

Results

We included 288 papers and identified 23 organisational elements, grouped into 6 categories: personal continuity of care; interventions to improve interdisciplinary collaboration and coordination; care by a midwife; alternative payment models (non-fee-for-service); place of birth outside the obstetric unit and woman-centred care. Personal continuity, care by a midwife and births outside obstetric units were most consistently associated with improved maternal and newborn outcomes, positive experiences for women and professionals and potential cost savings, particularly where well-coordinated multidisciplinary care was established. Positive professional experiences of collaboration depended on clear roles, mutual trust and respectful interdisciplinary behaviour. Evidence on collaboration interventions and alternative payment models was inconclusive. Most studies emphasised clinical and professional aspects rather than organisational integration, with implementation barriers linked to prevailing biomedical system orientations.

Conclusions

Although the literature provides substantial evidence of organisational elements that contribute to improved outcomes, a significant gap remains in understanding how to overcome the barriers in sustainable implementation of these elements within healthcare systems. Interpreted through a systems and transition science lens, these findings suggest that strengthening integrated maternity care requires system-level changes aligning with WHO policy directions towards midwifery models of person-centred care.

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Triple-drug therapy with Goreisan, tranexamic acid and carbazochrome sodium sulfonate hydrate to prevent recurrence after chronic subdural haematoma surgery: a multicentre, randomised, controlled trial protocol

Por: Negishi · H. · Hirata · K. · Aiyama · H. · Fujita · K. · Komatsu · Y. · Kato · N. · Shibata · Y. · Tsuda · K. · Yamazaki · T. · Sato · M. · Watanabe · S. · Sugii · N. · Konishi · T. · Mathis · B. J. · Ohigashi · T. · Endo · M. · Ishikawa · E. · Matsumaru · Y. · The Triple Study Investigato
Introduction

Chronic subdural haematoma (CSDH) is a common neurosurgical condition in older adults, with a recurrence rate of approximately 7.1–13% after burr-hole drainage. Although surgical adjuncts such as subdural drains and middle meningeal artery embolisation may reduce recurrence, these are not suitable for all patients. Pharmacological strategies, including tranexamic acid, Goreisan and carbazochrome sodium sulfonate hydrate, have shown potential, but high-level evidence remains lacking. A prior retrospective study suggested that a triple oral regimen combining these agents may reduce recurrence. This randomised controlled trial aims to evaluate its efficacy and safety.

Methods and analysis

This is a prospective, multicentre, open-label, randomised controlled trial conducted across six hospitals in Ibaraki, Japan. A total of 180 patients undergoing first-time burr-hole surgery for CSDH will be randomised 1:1 to receive either triple therapy (Goreisan 7.5 g/day, carbazochrome sodium sulfonate hydrate 90 mg/day and tranexamic acid 750 mg/day for up to 90 days) or standard postoperative care. The primary outcome is recurrence requiring reoperation within 90 days. Secondary outcomes include time to recurrence and haematoma volume reduction on serial CT imaging. All analyses will follow the intention-to-treat principle, using logistic regression, Cox proportional hazards models and mixed-effects models.

Ethics and dissemination

Written, informed consent will be obtained from all participants at each participating hospital by trained staff from that hospital. The trial protocol has been approved by the ethics committee of the University of Tsukuba Hospital (approval no. TCRB23-025) and the Institutional Review Boards of all participating centres. Study findings will be disseminated through presentations at scientific conferences and publications in peer-reviewed journals. A summary of the results will also be provided to participating institutions and made publicly available in accordance with the BMJ Open data sharing policy.

Trial registration number

jRCTs031240007.

Improving collaborative care networks for functional disorders and persistent somatic symptoms: a participatory action research study in the Netherlands

Por: Mamo · N. · Hanssen · D. J. C. · Korten · S. · Olde Hartman · T. C. · Rosmalen · J. G. · Tak · L.
Background

Persistent somatic symptoms and functional disorders are conditions requiring a biopsychosocial approach to care, often from multiple professionals. The fragmentation of care common in most health systems results in unsatisfactory and challenging care experiences. Collaborative care networks form an important route towards improving outcomes and the overall experience of care for patients and professionals. While we have a good idea of what such collaborative care networks can look like, we lack knowledge on the practicalities of implementing change in such networks.

Objectives

The core objective of this study is to implement change in a collaborative care network for persistent somatic symptoms and functional disorders care. Our questions were twofold: first, what are examples of realistic action processes to improve such collaborative care networks? Second, what are, in our experience, conditions for an effective change process in such a collaborative care network?

Design

Participatory action research approach embedded within an active regional network between May 2023 and May 2024. The process was led by an action group who selected objectives and related actions with the aim of improving the network, leading to better care for people with persistent somatic symptoms and functional disorders as well as improving satisfaction among professionals.

Setting

ALK Netwerk Salland, a regional network of professionals and experts-by-experience, focused on care of persistent somatic symptoms. This network is based in the Salland region in the east of the Netherlands, centred around the city of Deventer.

Participants

The action group was made up of local stakeholders including experts-by-experience and health and social care professionals, facilitated by a researcher-in-residence. Other participants included members of the regional network who provided input towards the different objectives.

Results

Over the course of a year, three objectives were selected and enacted, including assessing the resources of the network, improving knowledge of treatment options and improving the shared vision of care. The process faced some challenges, such as changes in action group members and a lack of resources and time to enact changes. However, by having a trusted and engaged team, working with an active network, we were able to enact significant changes to the network, which may be sustained and built on through the ongoing action group.

Conclusions

Future participatory action research studies would benefit from a trusted and embedded researcher-in-residence, meaningful involvement early in the process of experts-by-experience, and serious consideration of realistic outcome measures to monitor for evaluation of changes made.

Preclinical safety and burn wound healing activity of “Novostron”, a novel topical iodine-based therapeutic

by Nailya Ibragimova, Arailym Aitynova, Seitzhan Turganbay, Marina Lyu, Alexandr Ilin, Tamari Gapurkhaeva, Galina Ponomareva, Karina Vassilyeva, Diana Issayeva, Amirkan Azembayev, Serzhan Mombekov, Aralbek Rsaliyev, Nurgul Sikhayeva, Yergali Abduraimov, Saki Raheem

Iodine-based antiseptics are essential in wound care but are often limited by cytotoxicity, instability, and rapid iodine release. Novostron is a novel polymer–iodine complex incorporating dextrin, polyvinyl alcohol, and metal ions, designed to enable controlled iodine release. Structural integrity and composition were confirmed by ¹H and 13C NMR spectroscopy and physicochemical analysis, indicating a molecular weight of ~9500 g/mol, a pH of 4.23, and an iodine content of 8.13%. Pharmacokinetic analysis in rabbits demonstrated that following a single dermal application, systemic iodine absorption was minimal, with peak blood iodine concentrations remaining within physiological limits and rapid elimination within 24 hours. Evaluation of thyroid function revealed no significant changes in serum T₃, T₄, or TSH levels compared with those of the controls, confirming that topical application of Novostron does not disrupt thyroid homeostasis. In compliance with OECD guidelines in rabbits, guinea pigs, and rats, Novostron showed no signs of dermal irritation, skin sensitization, or systemic toxicity (LD₅₀ > 2000 mg/kg). In a rat cotton pellet granuloma model, Novostron significantly reduced the inflammatory mass (23.65% inhibition), supporting its anti-inflammatory potential. In a murine burn model, Novostron accelerated wound contraction (25.95% at day 10), increased epidermal thickness, and enhanced collagen deposition (~44%), outperforming controls and matching or exceeding betadine. These findings suggest that Novostron promotes tissue repair by modulating inflammation. Overall, Novostron demonstrated a favourable preclinical safety and efficacy profile, and its polymer–iodine composition, which enables controlled release and localized activity highlights its potential as a promising topical therapeutic. However, the study was limited to animal models and short-term observation; further long-term and clinical investigations are needed to confirm its translational potential in human wound healing.

Palliative Care Interventions for Caregivers of People With Advanced Dementia: A Meta‐Analysis

ABSTRACT

Background

Palliative care reduces caregiver burden, alleviates patient symptoms, and supports treatment decision-making. However, despite these benefits, there is limited evidence on the effectiveness of palliative care interventions for caregivers of individuals with advanced dementia.

Aims

To integrate and analyze data on the effectiveness of palliative care interventions in improving caregiver outcomes in order to ensure that both patients and caregivers receive the support necessary for optimal care experiences, quality of life management, and advanced care planning.

Methods

A systematic search was conducted of six databases to identify relevant studies published from database inception to 12 December 2024. Randomized controlled trials (RCTs) investigating palliative care interventions for caregivers of people with advanced dementia were included. Version 2 of the Cochrane Risk of Bias tool was used to assess the risk of bias in the methodology of each study. Standardized mean differences (SMDs) between each intervention and control group were calculated. A random-effects DerSimonian and Laird model was applied to generate pooled SMD estimates for each outcome and assess its heterogeneity. A leave-one-out sensitivity analysis was performed to ensure the stability of the pooled effect sizes.

Findings

Eight RCTs were included in the final analysis. Palliative care interventions appeared to reduce conflict in decision-making among caregivers of people with advanced dementia.

Conclusion

Palliative care interventions were successful in reducing conflict in decision-making of caregivers of people with advanced dementia. However, the modality's effects on caregiver satisfaction and caregiver distress need further investigation.

Linking Evidence to Action

Future palliative care interventions for caregivers of advanced dementia patients should focus on developing the contents of palliative care materials based on evidence-based evaluations and explore strategies to improve engagement between patients, caregivers, and healthcare professionals.

Clinical Nurses' Attitudes and Self‐Reported Practices of Family Nursing in Japan Following COVID‐19 Visitation Restrictions: A Cross‐Sectional Study

ABSTRACT

Aim

To examine clinical nurses' attitudes towards and self-reported experiences of family nursing in Japan following the relaxation of COVID-19 visitation restrictions. Particular attention is paid to early career nurses whose formative training occurred during visitation bans. The study focused on nurses' negative perceptions and emotional burdens associated with family involvement.

Design

A quantitative-dominant mixed-methods cross-sectional study reported in accordance with the STROBE guideline.

Methods

Using a convenience sampling approach, a self-administered, paper-based questionnaire was distributed to clinical nurses in four general hospitals in Japan between January and May 2024. The questionnaire consisted of four parts: demographic and professional background, learning methods related to family nursing, 17 items including negatively valenced statements adapted from the Families' Importance in Nursing Care–Nurses' Attitudes (FINC-NA) scale, and one open-ended question. Quantitative data were analysed using descriptive statistics and t-tests, and qualitative responses were thematically analysed.

Results

Of 1921 nurses invited, 957 responded (response rate: 49.8%), and data from 892 valid responses were analysed. Overall, the nurses demonstrated positive recognition of family nursing as a professional value but also reported lingering emotional burdens and practical challenges when interacting with families. Early-career nurses who began practice during the pandemic showed greater uncertainty and lower affective engagement. Thematic analysis revealed five key themes: relational disruption, emotional stress, moral conflict, reappraisal of family engagement and ongoing barriers.

Conclusion

The findings underscore the need to structurally and educationally reintegrate families into nursing care. Simulation-based training, clear institutional policies and hybrid communication models are essential to rebuild relational continuity and support nurses' emotional and ethical capacity for family nursing.

Implications for the Profession and/or Patient Care

The findings highlight the need to structurally and educationally reintegrate families into clinical care to address the emotional burden and ambivalence reported by nurses. Organisational support—such as clear visitation policies, simulation-based education and reflective opportunities—can help rebuild nurses' relational competence and confidence in engaging with families. Creating supportive learning environments, including on-the-job mentoring and team-based reflection, may further facilitate the restoration of family nursing.

Impact

This study addressed how prolonged COVID-19 visitation restrictions disrupted family nursing practice in Japan, created generational differences in nurses' competencies, and shaped nurses' perceptions of family involvement. Nurses reported emotional strain, feelings of being monitored and lack of time when families were present. Early career nurses showed lower relational engagement, while experienced nurses expressed moral distress. ‘Latent indifference’ was also noted. The findings provide valuable insights for healthcare organisations, nurse educators and policymakers by informing strategies to reintegrate families into patient care, improve discharge planning and strengthen training models.

Reporting Method

The STROBE checklist.

Patient or Public Contribution

No patient or public contribution.

Relationship Between Empowering Leadership, Resilience and Organisational Learning from Incidents: A Cross‐Sectional Study

ABSTRACT

Aim

To examine the relationship between nurse managers' empowering leadership, nurses' resilience and organisational learning from incidents.

Design

Cross-sectional observational study.

Methods

Secondary data from a study conducted in June–July 2022 was used. The sample included 1049 nurses working in three special-functioning hospitals. The self-administered questionnaires assessed nurse managers' empowering behaviours, nurses' resilience and attitudes and behaviours fostering organisational learning from incidents. The analysis employed multilevel analysis with hierarchical linear modelling.

Results

Nurse managers' empowering behaviours and nurses' resilience were significantly positively associated with attitudes and behaviours fostering organisational learning from the following incident subscales: make efforts to identify the problem, discuss safety in the workplace, identify and give feedback to address the at-risk behaviour. The interaction of empowering behaviours and resilience was not significant.

Conclusion

Nurse managers' empowering behaviours and nurses' resilience can contribute to attitudes and behaviours that foster organisational learning, even when nurses face stressful incidents.

Implications for the Profession and/or Patient Care

Fostering empowering leadership in nurse managers and resilience in nurses enhances organisational learning and improves safety and care quality.

Reporting Method

The reporting is based on the STROBE guidelines.

Patient or Public Contribution

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

Mental health in patients with rheumatoid arthritis and axial spondyloarthritis: a cross-sectional, case-control tertiary centre study from Czechia

Por: Husakova · M. · Balajkova · V. · Pavelka · K. · Senolt · L. · Kucharikova · K. · Mohr · P. · Kotrs · J. · Olejarova · M.
Objectives

To evaluate the mental health burden in rheumatoid arthritis (RA) and axial spondyloarthritis (axSpA) using diagnostic and self-reported tools and to examine its associations with current disease activity, patient-reported outcomes and barriers to appropriate care.

Design

Single-centre, cross-sectional, case–control study.

Setting

Rheumatology centre of a tertiary care hospital, serving as a referral clinic with outpatient and inpatient care in Czech Republic.

Participants

233 patients with rheumatic diseases (113 RA, 120 axSpA) and 170 healthy controls (HC).

Outcome measures

Mental disorders (MD) were assessed through a structured psychiatric interview using the International Neuropsychiatric Interview (Mini International Neuropsychiatric Interview) administered by a trained professional and by self-reported questionnaires including the Beck Depression Inventory-II (BDI-II) and Beck Anxiety Inventory (BAI). Disease activity was evaluated with the Disease Activity Score-28 with C-reactive protein (DAS28-CRP) for RA and the Ankylosing Spondylitis Disease Activity Score with CRP (ASDAS-CRP) for axSpA, alongside patient-reported outcomes (PROs).

Results

At least one MD was present in 24.8% of RA, 31.7% of axSpA and 7.0% of HC (p

Conclusions

Mental disorders in RA and axSpA are closely associated with higher disease activity and unfavourable PROs, while access to and acceptance of psychiatric care remain markedly insufficient. Systematic integration of mental health assessment and management into rheumatology practice is strongly warranted.

Impact assessment of neonatal care interventions on regional neonatal care capacity: a simulation study based on clinical data in the Netherlands

Por: Wagenaar · J. H. L. · Dietz · A. · Huang · Y. · Reiss · I. K. M. · Been · J. V. · Spaan · J. · Kornelisse · R. F. · Taal · H. R. · Hinrichs-Krapels · S.
Objective

To analyse the impact of selected neonatal care interventions on regional care capacity.

Design

Discrete event simulation modelling based on clinical data.

Setting

Neonatal care in the southwest of the Netherlands, consisting of one tertiary-level neonatal intensive care unit (NICU), four hospitals with high-care neonatal (HCN) wards and six with medium-care neonatal (MCN) wards.

Participants

44 461 neonates admitted to at least one hospital within the specified region or admitted outside of the region but with a residential address inside the region between 2016 and 2021.

Interventions

The impact of three interventions was simulated: (1) home-based phototherapy for hyperbilirubinaemia, (2) oral antibiotic switch for culture-negative early onset infection and (3) changing tertiary-level NICU admission guidelines.

Main outcome measure

Regional neonatal capacity defined as: (1) occupancy per ward level, (2) required operational beds per ward level to provide care to all inside region patients at maximum 85% occupancy, (3) proportion rejected, defined as outside region transfers due to no capacity to provide local care and (4) the weekly rejections in relation to occupancy to provide a combined analysis.

Results

In the current situation, with many operational beds closed due to nurse shortages, occupancy was extremely high at the NICU and HCNs (respectively 91.7% (95% CI 91.4 to 92.0) and 98.1% (95% CI 98.0 to 98.2)). The number of required beds exceeded available beds, resulting in >20% rejections for both NICU and HCN patients. Although the three interventions individually demonstrated effect on capacity, clinical impact was marginal. In combination, NICU occupancy was reduced below the 85% government recommendation at the cost of an increased burden for HCNs, highlighting the need for redistribution to MCNs.

Conclusion

Our model confirmed the severity of current neonatal capacity strain and demonstrated the potential impact of three interventions on regional capacity. The model showed to be a low-cost and easy-to-use method for regional capacity impact assessment and could provide the basis for making informed decisions for other interventions and future scenarios, supporting data-driven neonatal capacity planning and policy development.

Comparison of Vyntus CPX and Vmax Encore 29N for indirect calorimetry: a randomised crossover study in participants of the German Diabetes Study with type 2 diabetes

Por: Trinks · N. · Pützer · J. · Sutkowski · A. · Burkart · V. · Roden · M. · Kuss · O.
Objectives

This study compared the reliability of two metabolic cart systems, Vyntus CPX and Vmax Encore 29N, to measure whole-body energy metabolism by indirect calorimetry (IC) in individuals with type 2 diabetes (T2D).

Design

Randomised, prospective, crossover study.

Setting

Single-centre study conducted in the clinical research centre of the German Diabetes Study (GDS).

Participants

Five participants (3 men, 2 women, mean age 49±6 years, body mass index (BMI) 32.62±4.2 kg/m²) with T2D completed the study protocol. Eligibility requires existing participation in GDS and availability for four consecutive study days.

Interventions

Participants underwent four IC measurements per day on four consecutive days, totalling 16 measurements per device. On each study day, two measurements with both devices, Vyntus CPX and Vmax Encore 29N, were performed in randomised order. Postcalorimetric gas calibration with normalisation was applied after each measurement.

Primary outcome measures

Reliability of respiratory quotient (RQ) and resting energy expenditure (REE), as assessed from the coefficient of variation (CV) and 95% CIs.

Results

Device comparison showed minor differences in CV (95% CI) for carbon dioxide production (VCO2) (3.5% vs 5.3%; 95% CI –8.2% to 8.0%), oxygen consumption (VO2) (3.4% vs 5.7%; 95% CI –9.3% to 8.2%), RQ (3.6% vs 2.3%; 95% CI –3.5% to 3.7%) and REE (3.1% vs 5.6%; 95% CI –8.4% to 7.8%). Postcalorimetric calibration did not consistently affect RQ or REE. 

Conclusions

Vyntus CPX provides reliable IC measurements comparable to Vmax Encore 29N and may serve as a suitable replacement in clinical settings.

Trial registration number

ClinicalTrials.gov identifier: NCT01055093.

Protocol for a prospective observational study linking research domain criteria-based phenotypes with clinical and care-related outcomes in psychiatric patients and healthy controls: the VeRDoC study

Por: Koller-Schlaud · K. · Meixner · J. · Jost · K. · Waghals · F. · Rentzsch · J. · Förstner · B. R. · Heinze · M. · Behr · J. · Rapp · M. · Tschorn · M.
Introduction

The Research Domain Criteria (RDoC) approach initiated by the National Institute of Mental Health provides a comprehensive framework for guiding research on mental illness and health. Since retrospective studies have indicated associations between RDoC characteristics and clinically relevant as well as care-relevant outcomes, there is a need for prospective, theory-driven investigations that systematically link a priori defined assessments of RDoC constructs to clinically and care-relevant outcomes in a transdiagnostic psychiatric sample.

Methods and analysis

This prospective observational study assesses six domains—Positive Valence Systems, Negative Valence Systems, Cognitive Systems, Social Processes, Arousal and Regulatory Systems and Sensorimotor Systems—employing a comprehensive set of self-report and additional paradigms to assess cognitive functioning developed a priori in alignment with the RDoC framework while also assessing clinically and care-relevant variables (eg, length of hospital stay). A total of 300 adult participants will be recruited among in- and outpatients of two psychiatric hospitals in Germany (patient group) as well as from the general population (healthy control group). Including healthy individuals will allow for the investigation of continuous variations in psychological functioning rather than categorical distinctions between health and disease. Data collection includes self-reports, clinician ratings, file review and behavioural assessments. Electroencephalography is recorded in a subgroup of participants. A confirmatory factor analysis will be conducted to reproduce the factor structure and regression models will be used to investigate associations between RDoC domains and clinically relevant as well as care-related variables.

Ethics and dissemination

Ethics approval was obtained from the local ethics committee of the Brandenburg Medical School—Theodor Fontane (E-01-20220822). Results will be disseminated through peer-reviewed journals and academic conferences.

Effects of glucagon-like peptide-1 analogues on hard binary outcomes for patients at increased risk of cardiovascular events: a protocol for a systematic review with network meta-analysis and Trial Sequential Analysis

Por: Sillassen · C. D. B. · Faltermeier · P. · Petersen · J. J. · Kamp · C. B. · Grand · J. · Dominguez · H. · Frolich · A. · Gaede · P. H. · Gluud · C. · Mathiesen · O. · Jakobsen · J. C.
Background

Cardiovascular diseases, overweight, type 2 diabetes and chronic kidney disease increase the risk of cardiovascular events.

Glucagon-like peptide-1 analogues are recommended by the European Society of Cardiology and the American College of Cardiology to lower the risk of death and progression of cardiovascular disease in patients with cardiovascular disease and type 2 diabetes. Semaglutide, tirzepatide and liraglutide are approved by the US Food and Drug Administration and the European Medicines Agency for the treatment of type 2 diabetes mellitus and overweight. CagriSema is currently not approved, but several phase III trials are ongoing.

No previous systematic review has investigated the effects of semaglutide, tirzepatide, CagriSema and liraglutide, which may not be disease-specific, on hard binary outcomes for all trial populations at increased risk of cardiovascular events.

Methods and analyses

We will conduct a systematic review and search major medical databases (Cochrane Central Register of Controlled Trials, Medical Literature Analysis and Retrieval System Online, Excerpta Medica database, Latin American and Caribbean Health Sciences Literature, Science Citation Index Expanded, Conference Proceedings Citation Index—Science) and clinical trial registries from their inception and onwards to identify relevant randomised trials. We expect to perform the literature search in December 2025. Two review authors will independently extract data and assess the risk of bias. We will include randomised trials assessing the effects of semaglutide, tirzepatide, CagriSema and/or liraglutide in participants with an increased risk of cardiovascular events. The primary outcome will be all-cause mortality. Secondary outcomes will be myocardial infarction, stroke and all-cause hospitalisation. Data will be synthesised by aggregate data meta-analyses, Trial Sequential Analyses and network meta-analysis, risk of bias will be assessed with Cochrane Risk of Bias tool V. 2, and the certainty of the evidence will be assessed by Grading of Recommendations, Assessment, Development and Evaluations and the Confidence in Network Meta-Analysis approach.

Ethics and dissemination

This protocol does not present any results. Findings of this systematic review will be published in international peer-reviewed scientific journals.

PROSPERO registration number

CRD42024623312.

Surgical and oncological outcomes of right hemicolectomy with complete mesocolic excision in the treatment of right colon cancer: study protocol for a single-centre retrospective cohort study

Por: Nava · C. M. · Najberg · H. · Adamina · M. · Litchinko · A.
Introduction

Complete mesocolic excision (CME) with central vascular ligation (CVL) has been proposed as an oncologically superior surgical technique for right-sided colon cancer, mirroring the impact of total mesorectal excision (TME) in rectal cancer. While promising results have been reported, evidence from routine clinical practice, particularly within Swiss healthcare settings, remains limited. This study aims to evaluate the surgical and oncological outcomes of CME compared with standard right hemicolectomy (non-CME) over a 10-year period.

Methods and analysis

This is a retrospective cohort study of adult patients who underwent right hemicolectomy, either CME or non-CME, for histologically confirmed adenocarcinoma of the right colon or right third of the transverse colon at a tertiary centre, between 2010 and 2020. Patients with concomitant malignancies or distant metastases will be excluded. The primary outcome is 3-year and 5-year disease-free survival. Secondary outcomes include number of harvested lymph nodes, 3-year and 5-year overall survival, and 30-day morbidity.

Ethics and dissemination

This study was approved by the relevant Ethics Committee (CER-VD 2025-00503). All patients provided general consent for secondary use of anonymised data. Results will be submitted to a peer-reviewed journal and presented at national and international conferences.

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