Conectar
by Catharina Bartmann, Vanessa Schmidt, Michael Mörz, Michael Schwab, Monika Rehn, Bettina Blau-Schneider, Achim Wöckel, Ulrike Kämmerer
IntroductionCOVID-19 (Corona Virus Induced Disease-19) caused by the SARS-CoV-2 coronavirus can be a serious in pregnancy. Therefore, vaccination with modRNA vaccines was recommended depending on the immunity status for women of reproductive age and pregnant women since 2022. However, there are only preliminary data on transplacental transmission of the virus and modRNA from genetic vaccines so far.
MethodsThe study population included 106 women who have given birth at the Department of Obstetrics and Gynecology, University Hospital of Würzburg during November 2020 to October 2022. In addition to medical data and vaccination history, immunohistochemical examination of the placenta was performed with antibodies against SARS-CoV-2 spike and nucleocapsid proteins. RNAscope in situ Hybridization was used to show RNA detection in positive placental tissues as a proof of concept.
ResultsAltogether, 87% of participants received at least one vaccine dose against SARS-CoV-2 and 56 women (42 vaccinated, 14 not vaccinated) contracted COVID-19. In total, 31 placentas were found positive for the spike protein. Spike positive cells were predominantly Hofbauer cells and trophoblasts. In three cases of vaccinated and then infected woman, an additional nucleocapsid staining was detected, but there was no significant difference in staining pattern in correlation to the vaccine/COVID-19 status. Interestingly, we did not find viral RNA in the investigated samples, but we could show a positive in situ Hybridization of BNT162b2 and S-encoding mRNA-1273 in two individual samples.
DiscussionThe spike protein of SARS-CoV-2 has been be detected in placental Hofbauer and Trophoblast cells as well as villous endothelia after infection and vaccination indicating a possible transplacental transfer or uptake. These findings may suggest a potential for transplacental transfer or cellular uptake; however, the extent, mechanisms, and clinical significance of this phenomenon remain to be fully understood.Clinical trial registration: DRKS00022506.
by Elham Ahmadi, Sophia Baierl, Stephan Voss, Ida Asenkerschbaumer, Ursula Berndt, Leonie Bernhard, Anita Hennig, Anna-Lena Würfele, Michaela Coenen
Urban soundscapes, particularly those experienced in green spaces, have been increasingly recognized as factors that influence human mental health. This scoping review explores the existing literature on soundscapes within urban green spaces and their associated mental health outcomes. It aims to classify the methodologies used in this domain, identify mental health outcomes related to urban green space soundscapes, and examine specific soundscape elements and their correlations with mental health. A systematic search of peer-reviewed studies was conducted. After screening titles, abstracts, and full texts, 22 studies met the inclusion criteria. Diverse methodological approaches were identified, with an emphasis on quantitative multi-method designs. Commonly studied mental health outcomes include stress reduction, mood enhancement, perceived restorativeness, and cognitive restoration. Standardized psychometric tools, such as the Perceived Stress Scale (PSS-14), Positive and Negative Affect Schedule (PANAS) and Perceived Restorativeness Soundscape Scale (PRSS) are frequently used as outcome measures. Natural soundscape elements such as birdsong, water sounds, and rustling leaves had a positive association with relaxation and perceived mental restoration throughout all studies, while mechanical sounds, such as traffic noise were linked to adverse mental health outcomes. These findings highlight that natural soundscapes in urban green spaces have a potential positive relationship with mental health by reducing stress and enhancing mood. However, the cross-sectional design and methodological heterogeneity of the included studies limit causal interpretation. Future research should explore multi-sensory experiences and examine soundscapes in diverse urban contexts to provide more robust insights into their relationship with mental health. The practical implications suggest that urban planners should prioritize integrating natural sound elements into urban areas to improve mental health. The study protocol of this scoping review had been registered at OSF (osf.io/4r7gd).The debate about whether health visiting, a specialist community public health nursing role, is at the level of advanced practice nurse has gone on for more than a decade. There is little empirical evidence that the role matches the traditional role of an advanced practice nurse, although many of the attributes of advanced practice nursing such as prescribing rights, managing complex cases, caseloads with undifferentiated need and advanced assessment and decision-making are certainly present.
The current study aimed to develop, refine and test the Health Visiting Advanced Practice Scale to assess the scope of advanced practice of UK health visitors.
A cross-sectional and methodological scale validation design, following classical test theory.
The design consisted of three phases; the first involved scale development including item generation, phase two assessed the content validity index, and the third phase involved a cross-sectional survey to establish construct validity, content validity, and internal consistency reliability, and conduct exploratory and confirmatory factor analysis.
The initial 44-item scale underwent iterative exploratory and confirmatory factor analyses, leading to a refined 5-factor structure with 29 items covering domains such as family-centred care, leadership, prescribing, diagnostic reasoning, and professional practice. This final version demonstrated strong reliability and construct validity in the EFA but mixed fit indices in the CFA, supporting both internal consistency and validity of the scale.
The final scale offers a rigorously validated tool for assessing advanced practice among UK health visitors, capturing core domains such as family-centred care, leadership, prescribing, and diagnostic reasoning. By bridging theoretical frameworks with real-world practice, it fills a critical gap in evaluating and supporting the professional scope of this public health nursing specialty.
These findings provide valid and reliable insights for measuring and improving health visitors' advanced practice and developing future professional policies.
No patient or public contribution.
STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) guidelines for cross-sectional studies.
This study investigated the efficacy and safety of a novel thermo-reversible antimicrobial wound gel (TRG, revyve Antimicrobial Wound Gel) designed to combat biofilm-related infections in wounds. The TRG was evaluated for its ability to disrupt biofilms, sustain antimicrobial activity and promote wound healing. The gel exhibited thermo-reversible properties, transitioning from a less viscous liquid ≤ 18°C to a highly viscous solid gel at wound temperature which would facilitate easy application and removal. Antimicrobial testing demonstrated that TRG effectively inactivated a broad range of wound-related pathogens, including Staphylococcus aureus and Pseudomonas aeruginosa, with a 99.99%–99.9999% reduction in bacterial counts within 30 min. The TRG also maintained its antimicrobial efficacy after multiple inoculations with high microbial load (107 CFU/mL) over 7 days. In vitro biofilm assays showed effectiveness against biofilm bacteria with a reduction of ≥ 99.99% bacterial counts with one application over the course of 7 days. Biocompatibility testing confirmed that TRG was safe, with no signs of tissue necrosis or signs of tissue damage and no impact on wound healing in a porcine wound model. TRG's ability to reduce both planktonic and biofilm-based bacteria without compromising wound healing makes it a promising candidate for treating both chronic and acute wounds.
To explore experiences of healthcare providers, stroke survivors and caregivers on stroke transitional care delivery at a tertiary hospital in Tanzania.
A qualitative descriptive design with a phenomenological approach was used. Colaizzi’s thematic analysis was conducted using Dedoose software to identify significant information that describes the transitional care experiences of the study participants.
This study was conducted in the internal medicine and outpatient departments of a tertiary hospital in Tanzania.
15 triads of healthcare providers, stroke survivors and caregivers were purposively recruited to participate in semi-structured in-depth interviews between June and September 2024.
The analysis identified four themes: communication and exchange of information, involvement of patients and caregivers in transitional care, coordination of transitional care and experiences with changing care setting. Effective communication and information exchange among healthcare providers, survivors and caregivers ensured that survivors and their caregivers were well informed about the care process, clinical condition, prognosis and transitional care needs. A collaborative care approach enabled survivors and caregivers to actively participate in care, decision-making and discharge planning during hospital-to-home transition. Coordination of care was equally important during hospital-to-home transition as it provided survivors with home-care instructions and opportunities for follow-up care. However, miscommunication among the healthcare team, insufficient information exchange, inadequate discharge planning, poor social support and lack of care coordination prevented smooth hospital-to-home transition leading to a crisis at home.
The experiences of healthcare providers, patients and caregivers during stroke transitional care in Tanzania highlight achievements and key areas for improvement. Hospital-to-home transition is often characterised by uncertainty and emotional strain, emphasising the need for effective communication, involving patients and caregivers in care, as well as coordinating transitional care to address medical and psychosocial needs of survivors and their caregivers during and after discharge.
by Taylor E. Gin, Charlotte O. Moore, Trey Tomlinson, Grace Wilson, Amiah Gray, Cameron Sutherland, Kamilyah Miller, Krista Li, Michael Canfield, Brian Herrin, Erin Lashnits, Benjamin Callahan
BackgroundCtenocephalides felis is a common ectoparasite of dogs and cats and can transmit a variety of pathogens including Bartonella and Rickettsia species. These bacteria, along with the known endosymbiont Wolbachia, are well-documented members of the C. felis microbiome, but species-level information is limited. Additionally, little is known about the variation in the C. felis microbiome in fleas from different sources and when different sequencing methods are applied to the same samples.
ObjectiveThis study aimed to characterize the flea microbiome using both short-read (V3/V4) and long-read (full-length) 16S rRNA gene sequencing, determine whether long-read sequencing improves species-level identification especially in known pathogenic genera, and evaluate differences in microbial composition between fleas collected from cats, dogs, and environmental traps.
MethodsFleas were collected from cats, dogs, and traps in flea-infested homes in Florida, pooled by source, and sequenced using short- (V3/V4) and long-read (full-length) 16S rRNA gene sequencing. Microbial prevalence and abundance were compared across sequencing approaches. Community composition was evaluated for differences between sources and houses. Candidate members of the flea microbiome were identified based on a combination of prevalence, abundance, and statistical signatures of potential contaminant origin. For Rickettsia and Bartonella, species-level taxonomic assignments were refined using a phylogenetic approach.
ResultsWolbachia, Rickettsia, and Bartonella were the most prevalent and abundant taxa. Spiroplasma was identified as a fourth core member of the flea microbiome. Long-read sequencing enabled better, but not perfect, species-level classification of Bartonella and Rickettsia compared to short-read sequencing. Important relationships between specific ASVs and flea sources were identified, for example fleas from cats harbored higher abundances of B. clarridgeiae and B. henselae than fleas from traps.
by Michael Loizos Mavrovouniotis
Computations of length of stay in animal shelters rely on fixed animal cohorts. This is appropriate for research studies that pre-select cohorts, but it is problematic for operational assessments of animal shelters in fixed calendar periods or for comparisons among periods or shelters. Considering only the length of stay of animals whose stay ended within the study period leads to misinterpretation. The use of the Kaplan-Meier and Cox proportional hazards methods with left-truncation and right-censoring is proposed to correctly account for all animals present in the shelter for any fraction of a study period, including those that were present at the beginning and those that remain in care at the end of the period. Examples of dog length of stay in Orange County Animal Care in California show that this computation method corrects the misleading view of historically used calculations of length of stay. Statistically significant changes in length of stay are observed in 8 out of 23 quarterly periods. In a comparison of length of stay before and after the COVID-19 pandemic, the observed significant change in length of stay cannot be explained by variations in sizes and ages of incoming dogs and may be connected to operational policies that restricted visitor access. The proposed approach enables timely tracking of length of stay, accurate comparisons, and assessment of shelter practices and resource needs.Viral hepatitis B (HBV) and C (HCV) infections remain major public health threats in Ghana, with prevalence rates significantly higher in prison populations than in the general population. Despite this, incarcerated individuals are frequently excluded from national testing and treatment programmes. Overcrowding, poor sanitation and limited access to healthcare create a high transmission risk. There is an urgent need for targeted, evidence-based interventions to address this health inequity and support Ghana’s progress towards viral hepatitis elimination.
This protocol describes a study designed to evaluate the effectiveness of a multicomponent targeted educational intervention in increasing knowledge, intention to test, testing uptake and treatment initiation for HBV and HCV among adult prison inmates in the Greater Accra and Eastern Regions of Ghana.
A cluster randomised controlled trial (RCT) with a 1:1 parallel design will be conducted in eight prisons stratified by gender (six male, two female) with 208 inmates per arm. The intervention group will receive the Prison Education for Prevention of Hepatitis Intervention, comprising an education programme (posters, infographics, film screenings, peer-led discussions and structured health education) alongside HBV and HCV testing, treatment and care linkage. The control group will receive standard health education and basic printed materials. Testing intentions, uptake, prevalence and treatment outcomes will be measured. Cost-effectiveness analysis will inform sustainability and scale-up. The primary endpoint is uptake of hepatitis B and C testing. Secondary outcomes include changes in hepatitis knowledge and testing intentions, prevalence of hepatitis B and C, treatment uptake among diagnosed inmates, linkage to hepatitis care services and cost-effectiveness of the intervention.
Data will be analysed, accounting for prison clustering, using mixed-effects models and regression methods. Outcomes include testing uptake, knowledge, intentions, prevalence, treatment initiation and sustained virologic response, adjusted for key covariates. Baseline characteristics and intervention reach will be summarised descriptively. Analyses will follow intention-to-treat and Consolidated Standards of Reporting Trials guidelines. Cost-effectiveness will estimate Incremental Cost Effectiveness Ratio (ICERs) per inmate tested, infection detected and treatment initiated.
The RCT was approved by the College of Health Sciences ethics and protocol review committee (no. CHS-E/M.1-P 4.7/2025–2026). Results will be presented at relevant national and international meetings and conferences and will be published in international peer-reviewed journals. Furthermore, we plan to communicate the results to relevant stakeholders in the Ghanaian Prisons and Healthcare systems.
PACTR202512558588684.
Nurse practitioner-sensitive outcomes (NPSOs) are critical indicators of the quality and effectiveness of nursing care provided to older adults. These outcomes, which include metrics such as falls, pressure ulcers, infection rates, frailty, delirium, length of stay, hospital readmissions, and quality of life (QoL), are essential for assessing the impact of nurse practitioners (NPs) and enhancing patient safety. Despite their importance, the current literature on NPSOs in services for older adults remains limited. This scoping review aims to address this gap by systematically mapping the existing research, identifying key themes, and uncovering areas needing further exploration. By doing so, the authors seek to provide a comprehensive overview that will inform future research directions and contribute to the enhancement of clinical practice in older person services (OPS). This review is important for healthcare providers, policymakers, and researchers who are committed to improving the quality of nursing care and outcomes for older people.
The aim of this scoping review is to map the existing research on NPSOs in services for older adults. This review seeks to identify key themes and gaps in the current literature to guide future research and enhance clinical practice in this area.
The Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews (PRISMA-ScR) guidelines were utilised to structure this scoping review.
From initial screening of 3593 manuscripts drawn from seven databases, 66 were deemed eligible for full screen. Five studies met the inclusion criteria and were ultimately selected for data extraction and analysis. The most common outcome measures reported were complications and comorbidities, and QoL.
This review highlights that the reporting of NPSOs in older person care is lacking and requires further attention.
To determine the prevalence of burnout and back pain in homecare workers in Switzerland and assess their associations with psychosocial work environment factors.
National multicentre cross-sectional study.
Using paper-pencil questionnaires, data were collected from January 2021 to September 2021 from employees of 88 homecare agencies across Switzerland. Respondents who identified themselves as administrators, apprentices, or trainees, who were in leadership positions, or who were not involved in the provision of care or housekeeping were excluded from this analysis. Burnout was assessed with the Copenhagen Burnout Inventory Scale (possible score range 0–100) and back pain with a single item from the Federal Statistical Office's Swiss Health Survey. Multilevel regression analyses were used to assess burnout and back pain's associations with psychosocial work environment factors.
We included 2514 homecare workers. More than two-thirds (68.6%) reported back pain in the past 4 weeks. The overall mean burnout score was 36.0 (SD 18.3). Poorer work-life balance, higher perceived workload and verbal aggression from clients were positively associated with both outcomes. Better leadership and social support from colleagues were negatively associated with burnout. Higher role conflict levels correlated with higher burnout levels.
Our findings indicate that the psychosocial work environment should be considered when designing interventions to reduce the prevalence of burnout and back pain among homecare workers.
The high reported burnout and back pain prevalences among homecare workers highlight an urgent need to design and implement psychosocial work environment-improving interventions. In addition to contributing to homecare employees' long-term attraction and retention, protecting and promoting their health and well-being will likely not only benefit them, but also contribute to patient safety, quality of care and homecare sustainability.
The study reports the prevalence of burnout and back pain among homecare workers and their associations with psychosocial work environment factors. The results indicate that six psychosocial work environment factors—work-life balance, perceived workload, leadership quality, levels of social support from colleagues, role conflict levels, and verbal aggression from clients—all correlate with burnout and/or back pain in homecare workers. For policy makers, researchers, healthcare managers, and homecare agencies, this study's findings will inform the development of interventions to enhance homecare work environments, leading to improvements both in workers' health and in the quality of their care.
We have adhered to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) reporting checklist for cross-sectional studies.
Our stakeholder group included patient representatives, policy makers, researchers, clinicians and representatives of professional associations. Throughout the study, all provided support and input on topics including questionnaire development, result interpretation and the design of strategies to improve response rates.
by Carmen Villagrasa, Giorgio Baiocco, Zine-El-Abidine Chaoui, Michael Dingfelder, Sébastien Incerti, Pavel Kundrát, Ioanna Kyriakou, Yusuke Matsuya, Takeshi Kai, Alessio Parisi, Yann Perrot, Marcin Pietrzak, Jan Schuemann, Hans Rabus
Biological effects induced by diverse types of ionizing radiation are known to show important variations. Nanodosimetry is suitable for studying the link between these variations and the patterns of radiation interactions within nanometer-scale volumes, using experimental techniques complemented by Monte Carlo track structure (MCTS) simulations. However, predicted nanodosimetric quantities differ among MCTS codes, primarily because each code employs distinct molecular-scale particle interaction models. This multi-code study examines these variations for low-energy electrons (20–10,000 eV), which play a critical role in energy deposition and biological effects by virtually all types of ionizing radiation. Specifically, the hypothesis tested in this work is that inter-code variability in nanodosimetry results is mainly caused by differences in assumptions regarding total interaction cross sections. Ionization cluster size distributions and derived nanodosimetric parameters were simulated with seven MCTS codes (PARTRAC, PHITS-TS, MCwater, PTra, and three Geant4-DNA options) in liquid water as a surrogate for biological tissue. Significant inter-code differences were observed, especially at the lowest energies. They were substantially reduced upon replacing the original cross sections in each code with a common, averaged dataset, created ad-hoc for this study and not based on theoretical assumptions. For example, for 50 eV electrons in 8 nm spheres, the variability in the predicted mean ionization numbers decreased from 23% to 5%, and in the probability of inducing two or more ionizations from 34% to 7% (relative standard deviations). This quantification demonstrates that total interaction cross sections are the primary source of uncertainty at low electron energies. A sensitivity test using DNA damage simulations with the PARTRAC code revealed that cross section variations notably affect biological outcome predictions. Replacing the code’s original cross sections with the averaged ones increased the predicted double-strand break yield by up to 15%. These findings underscore the urgent need for improved characterization of low-energy electron interaction cross sections to reduce uncertainties in MCTS simulations and enhance mechanistic understanding of radiation-induced biological effects.To review how life-course theories, models and frameworks define and classify life stages and transitions; how they characterise trajectories of care needs and care provision; and to consider how these insights might inform future developments of care-focused life-course frameworks.
Narrative review using a theory synthesis approach.
The review synthesised 56 theories, models and frameworks, drawn from 90 articles published up to 2024, using a three-stage process: extraction and summarisation of conceptual content; comparison to identify convergence and divergence; and interpretive synthesis to generate an overarching account of how frameworks conceptualise life-course development, care transitions and care trajectories.
Earlier life-course perspectives emphasise normative, age-graded stages, while more recent approaches highlight transitional junctures, relational contexts and structural influences on care trajectories. Life stages were defined variably, encompassing developmental phases, chronological age bands, major life transitions, historical and cultural perspectives and diverse lived experiences. Trajectories of care needs and provision were shaped by social networks, socioeconomic conditions, timing of transitions, transgenerational relationships and interdependencies, and intersectionality. Findings suggest that care needs and care provision fluctuate across time and are best understood as interrelated, dynamic processes influenced by life-course biographies, as well as broader social, economic and policy environments at individual (micro), relational (meso) and structural (macro) levels.
Life-course frameworks are shifting from age-based models towards personalised, context-sensitive perspectives that better capture the complexity and diversity of care trajectories.
Care planning should incorporate not only developmental stage but also individual, relational and structural factors influencing care needs, care provision and care trajectories over time.
Applying a personalised, multilevel life-course perspective may improve assessment accuracy, coordination of resources and equity in care delivery.
This narrative review did not involve patients or the public.
To adapt an instrument to measure patient safety culture, as rated by home care workers, and examine its psychometric properties.
A multicentre cross-sectional psychometric study.
We adapted the Nursing Home Survey SOPS to measure safety culture in home care. The questionnaire was translated to French following the Translation, Review, Adjudication, Pretest and Documentation (TRAPD) approach. Experts in home care evaluated the content validity of the adapted and translated instrument. To pre-test the questionnaire, we conducted cognitive interviews. We invited home care workers from two home care agencies in the French-speaking region of Switzerland to participate in the cross-sectional study from November to December 2024. We performed confirmatory factor analysis using the R package ‘lavaan’ and assessed convergent, discriminant and known-groups validity.
Eight experts assessed the content validity of the adapted and translated instrument. Responses from 672 home care workers were analysed. Except for compliance with procedures, all dimensions showed acceptable or good internal consistency. Regarding construct validity, first-order and second-order level confirmatory factor analysis showed acceptable model fit. Safety culture correlated with overall patient safety rating and psychosocial safety climate. Regarding known-groups validity, participants who do not work directly with clients most of the time, and those willing to recommend the organisation rated the safety culture higher.
The psychometric evaluation indicated that the adapted instrument can be used as a valid and targeted tool to assess patient safety climate/culture in Swiss French-speaking home care agencies.
The existence of an adapted and validated instrument for use in home care enables managers to monitor safety culture and develop interventions to improve it and consequently ensure patient safety.
To the best of our knowledge, there was no instrument specifically targeting the measurement of patient safety culture in the home care setting. The adapted instrument for home care showed to be a valid tool to provide information about safety culture in this setting. The availability of an instrument to measure safety culture in the home care setting can promote its monitoring, raise awareness of safety culture among staff, help managers prioritise key aspects for culture change, and thus improve patient safety. A wider adoption of the same instrument could also facilitate comparative analyses.
We used the COSMIN guidelines for the psychometric evaluation of the instrument and the STROBE reporting guidelines for the cross-sectional study.
This study did not include patient or public involvement in its design, conduct or reporting.
While paediatric cardiac arrest is a rare event, consequences for the patients are significant with a considerable risk of morbidity, disability and mortality. The risk of cardiac arrest is substantially increased in children with congenital heart disease. Nevertheless, there is a lack of data concerning this population. To close this knowledge gap, this multicentre, prospective, open registry aims to implement a standardised structure for data collection and follow-up of paediatric cardiac arrests associated with heart diseases in Germany.
All paediatric patients who experience a cardiac arrest and receive at least 2 minutes of cardiopulmonary resuscitation are invited to participate in this registry. The dataset comprises demographical, clinical, resuscitation and outcome data, collected in accordance with the Utstein guidelines. Neurological assessments, cognitive and motor tests are conducted at fixed intervals. Additionally, patient-reported outcome measures will be surveyed. Primary outcomes are survival to discharge and neurodevelopmental outcome after discharge and 2 years. The data are pseudonymised prior to submission to an online REDCap database, which is centrally hosted on a server located in Leipzig, Germany.
This study follows the Declaration of Helsinki and received ethical approval from the Ethics Committee in Leipzig. Registry results will allow us to understand the epidemiology, guideline adherence, risk factors and will be presented at conferences and submitted to a peer-reviewed journal for publication.
by Thea Lynne Hedemann, Yun Lu, Sofia Campitelli, Lisa D. Hawke, Nelson Shen, Sarah Saperia, Brett D. M. Jones, Gillian Strudwick, Chelsey R. Wilks, Wei Wang, Marco Solmi, Michael Grossman, Muhammad Ishrat Husain, Nicole Kozloff, George Foussias, Muhammad Omair Husain
BackgroundYouth at clinical high risk (CHR) for psychosis often experience emotional dysregulation, psychiatric symptoms, substance use, suicidality, and functional impairment. Dialectical behaviour therapy (DBT) is an evidence-based intervention that improves emotion regulation, clinical outcomes, and functioning across psychiatric populations. Digital adaptations (d-DBT) may enhance accessibility and engagement for CHR youth, but acceptability and potential benefits in this group are unknown.
ObjectiveTo adapt d-DBT for CHR youth and evaluate the acceptability of delivering it to this population, as well as the feasibility of a larger-scale clinical trial.
MethodsThis mixed-methods clinical trial has two phases. In Phase 1, d-DBT will be adapted for CHR youth in collaboration with a lived-experience youth advisory group. In Phase 2, an assessor-masked randomized controlled trial will compare d-DBT (n = 30) with treatment as usual (n = 30). The intervention consists of eight weekly modules, with primary outcomes assessing acceptability, usability, and trial feasibility. Secondary outcomes include changes in emotional dysregulation, psychiatric symptoms, substance use, suicidality, and functioning.
ConclusionsWe anticipate that d-DBT will be acceptable to CHR youth and that conducting a larger trial will be feasible. Preliminary findings may demonstrate improvements in emotion regulation, psychiatric symptoms, suicidality, and functioning. Results will guide further refinement of the intervention and inform the design of a confirmatory clinical trial.
Trial registrationClinicalTrials.gov #NCT06928935
by Thomas C. Scheier, Richard Whitlock, Mark Loeb, Philip James Devereaux, Andre Lamy, Michael McGillion, MacKenzie Quantz, Ingrid Copland, Shun-Fu Lee, Dominik Mertz
Sternal surgical site infections after cardiac surgery can lead to significant morbidity, mortality, and cost. The effects of negative pressure wound management and adding vancomycin as perioperative antimicrobial prophylaxis are unknown. The PICS-PREVENA pilot/vanguard trial, a 2x2 factorial, open label, cluster-randomized crossover trial with 4 periods, was conducted at two major cardiac surgery hospitals in Ontario, Canada. Sites were randomized to one of eight sequences of the four study arms (Cefazolin or Cefazolin + Vancomycin (not analyzed) and standard wound dressing or a negative pressure 3M Prevena incision management system (Prevena). Only diabetic or obese patients were eligible for the latter comparison. This trial investigated feasability including adherence to protocol of each intervention (goal: > 90% each) and loss to follow-up (goal:by Michael C. Reed, Ayako Suzuki, Allison Cruikshank, Mizuki Suzuki, H. Frederik Nijhout
Homocysteine (Hcy), a sulfur-containing amino acid, is produced in prodigious quantities by the methionine cycle in the liver. Hcy is the major biomarker for cardio-vascular disorders and is associated with many other diseases. In previous work, we have explained why menstruating women have lower serum homocysteine than men due to higher concentrations of estradiol. In this study, we first present epidemiological evidence from NHANES data that synthetic estradiol supplementation lowers serum Hcy in post-menopausal women, but raises Hcy in pre-menopausal women. Secondly, we give an explanation of this puzzling phenomenon using previously developed mathematical models of one-carbon and glutathione metabolism. The simulation analysis demonstrated that the non-monotonic response of glutathione to rising estradiol levels may account for the differing Hcy responses to estradiol supplementation in postmenopausal versus premenopausal women, through activation of cystathionine β-synthase, a key enzyme regulating tissue homocysteine levels. Our findings further highlight the importance of considering menopausal status and synthetic hormone use when evaluating the health effects of homocysteine.Process evaluation provides insight into how interventions are delivered across varying contexts and why interventions work in some contexts and not in others. This manuscript outlines the protocol for a process evaluation embedded in a hybrid type 1 effectiveness-implementation randomised clinical trial of incremental-start haemodialysis (HD) versus conventional HD delivered to patients starting chronic dialysis (the TwoPlus Study). The trial will simultaneously assess the effectiveness of incremental-start HD in real-world settings and the implementation strategies needed to successfully integrate this intervention into routine practice. This manuscript describes the rationale and methods used to capture how incremental-start HD is implemented across settings and the factors influencing its implementation success or failure within this trial.
We will use the Consolidated Framework for Implementation Research (CFIR) and the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) frameworks to inform process evaluation. Mixed methods include surveys conducted with treating providers (physicians) and dialysis personnel (nurses and dialysis administrators); semi-structured interviews with patient participants, caregivers of patient participants, treating providers (physicians and advanced practice practitioners), dialysis personnel (nurses, dieticians and social workers); and focus group meetings with study investigators and stakeholder partners. Data will be collected on the following implementation determinants: (a) organisational readiness to change, intervention acceptability and appropriateness; (b) inner setting characteristics underlying barriers and facilitators to the adoption of HD intervention at the enrollment centres; (c) external factors that mediate implementation; (d) adoption; (e) reach; (f) fidelity, to assess adherence to serial timed urine collection and HD treatment schedule; and (g) sustainability, to assess barriers and facilitators to maintaining intervention. Qualitative and quantitative data will be analysed iteratively and triangulated following a convergent parallel and pragmatic approach. Mixed methods analysis will use qualitative data to lend insight to quantitative findings. Process evaluation is important to understand factors influencing trial outcomes and identify potential contextual barriers and facilitators for the potential implementation of incremental-start HD into usual workflows in varied outpatient dialysis clinics and clinical practices. The process evaluation will help interpret and contextualise the trial clinical outcomes’ findings.
The study protocol was approved by the Wake Forest University School of Medicine Institutional Review Board (IRB). Findings from this study will be disseminated through peer-reviewed journals and scientific conferences.
To assess the early risk of diabetic foot ulcer (DFU) among adult patients with diabetes and to identify clinical and behavioural correlates associated with DFU risk using Inlow’s 60-Second Screening Tool.
A cross-sectional analytical study.
Conducted at a tertiary-level referral hospital in Southwest Ethiopia.
The study included 164 adult patients with diabetes (aged ≥18 years) who attended routine follow-up visits at the diabetic clinic between February and March 2025. Patients who were critically ill, unable to communicate during data collection or pregnant were excluded. The median age of participants was 55 years (IQR 46–60), and 54.9% were male.
The primary outcome was early DFU risk, categorised as ‘at risk’ or ‘not at risk’ using Inlow’s 60-Second Screening Tool. Secondary outcomes included factors associated with DFU risk, such as glycaemic control, lipid profile and foot care practices.
Of the 164 participants, 32.3% (n=53) were found to be at risk for DFU. Participants who performed foot self-checks infrequently had more than threefold higher odds of DFU risk compared with those who practiced daily foot care (adjusted OR (AOR)=3.35; 95% CI 1.48 to 7.58; p=0.004). Poor glycaemic control (AOR=2.39; 95% CI 1.03 to 5.55; p=0.042) and dyslipidaemia (AOR=2.63; 95% CI 1.18 to 5.85; p=0.018) were also significantly associated with increased DFU risk.
Nearly one-third of patients with diabetes in this Ethiopian hospital setting were at early risk for DFU. Factors such as inadequate foot care, poor glycaemic control and dyslipidaemia were associated with increased risk. Incorporating rapid foot screening tools like Inlow’s 60-Second assessment into routine diabetes care, together with strengthened patient education and metabolic management, may help reduce the risk of DFU in resource-limited settings.
FreshRSS 