Conectar
Emotional and behavioural problems (EBPs) are receiving increasing attention at the global level, and preschool children are no exception. These issues have a significant impact on future development. Preventive interventions in preschool age are effective in preventing more serious disorders by improving social skills, emotional regulation and resilience in children. Although various preventive interventions have been developed and their effectiveness demonstrated, the evidence remains fragmented. At present, there has been no comprehensive study mapping EBPs prevention interventions at the preschool age level using the Neuman Systems Model approach.
This scoping review will be conducted in accordance with the Joanna Briggs Institute (JBI) methodology for scoping reviews.The completed scoping review will be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Scoping Reviews (PRISMA-ScR). A systematic search will be conducted in four major databases, namely Scopus, PubMed, Web of Science, Cochrane Library, and online searches using Google Scholar, without language and publication year restrictions. Two reviewers will independently screen the literature according to the inclusion criteria and then extract the data. Any differences between the two reviewers will be resolved through discussion with a third reviewer. We will compile, summarise and analyse the extracted data and present the results in figures, tables and descriptive narratives to ensure clarity and facilitate comparison across studies.
Ethical approval is not required, as the review will use only published literature. Findings will be disseminated through publication in a peer-reviewed international journal and may inform policy and practice in early childhood preventive interventions.
Open Science Framework (https://osf.io/zg6ty).
Surgical site infection (SSI) following transmetatarsal amputation (TMA) is common and associated with significant morbidity. However, there is limited evidence to guide perioperative strategies for SSI prevention in this population. A prospective, cross-sectional survey was conducted among vascular specialists. The questionnaire assessed current practice in SSI prevention for TMA, perceptions of evidence gaps, and willingness to participate in future research. Responses were analysed descriptively. Eighty-four valid responses were analysed, with 64.3% from consultant vascular surgeons and 84.5% from UK centres. Most respondents (84.5%) considered SSI after TMA to be a significant issue. The majority preferred primary closure in clean wounds (78.6%) and commonly used short-course antibiotics and interrupted sutures. Over 70% agreed no clear best practice exists, and 65.5% felt high-quality randomised trials are needed. Ninety-three percent expressed willingness to engage in future studies. Equipoise existed regarding interventions including antibiotic duration, wound adjuncts, and closure techniques. Opinion varied regarding whether TMA and major lower limb amputation should be pooled when undertaking research into SSI prevention. Current practice in SSI prevention for TMA is highly variable. This survey demonstrates broad support for rigorous trials to establish effective strategies and highlights the feasibility of future research in this area.
To explore the experiences of nurses transitioning from a clinical ward to a newly established respiratory intermediate care unit (IMCU).
A qualitative descriptive approach was adopted to capture the lived experiences of redeployed nurses. This design was selected to address the research question: What are the initial experiences of nurses transitioning from general ward settings to a newly established IMCU for respiratory patients?
Two focus groups were conducted in June 2024, involving 14 purposefully selected registered nurses. Data were analysed using Braun and Clarke's thematic analysis framework, with the study reported in line with the Standards for Reporting Qualitative Research.
The analysis revealed two interconnected themes reflecting the complexity of the redeployment experience. The first theme, ‘The introspection of waiting amidst change and readiness’, captures the emotional ambivalence nurses felt, characterised by anticipation, uncertainty and a perceived lack of preparedness. This phase was marked by concerns over clinical competence, fear of errors and the weight of new legal and ethical responsibilities. The second theme, ‘The road to organizational change with both driving forces and obstacles’, highlights nurses' concerns about physician readiness, feeling undervalued and limited involvement in planning. At the same time, nurses emphasised the importance of teamwork, structured preparation, experiential training and having the right equipment.
The study underscores the complexity of role transitions for nurses moving into semi-critical care settings like IMCUs. It reveals the need for targeted support strategies to reduce uncertainty and enhance role readiness.
To improve the redeployment experience and patient outcomes, healthcare organisations should prioritise structured training, tailored preceptorship programmes and inclusive decision-making processes. These measures can strengthen nurses' resilience, support workforce sustainability and ensure the delivery of high-quality, patient-centred care in intermediate care environments.
This study highlights the significant impact of inadequate preparation and communication on redeployed nurses' experiences in respiratory IMCUs, emphasising the need for structured training and supportive team dynamics. These findings can guide healthcare leaders, nurse managers and policymakers in developing evidence-based redeployment strategies that reduce anxiety, strengthen team cohesion and ultimately improve nurse adaptation and patient care in semi-critical settings.
We used the SRQR guidelines for reporting qualitative studies.
No patient or public contribution.
To explore the narrated experiences of adult children during the initial phase of their transition process when their elderly parent transfers from home to a nursing home.
The article describes part of a qualitative study with a narrative, longitudinal, prospective design.
Narrative interviews were conducted with a sample comprising eight adult children at three time points between February and July 2022. Narratives from the first interviews obtained during the initial transition phase are presented. This article explores the narratives of one woman and one man. The data were analysed using a thematic narrative approach. A constructed timeline gave a narrative chronology and facilitated the generation of three storylines and a unifying plot.
The narratives provide insight into a complex, emotionally demanding, and morally challenging initial transition phase. This generated the following three storylines: doubting the decisions, a shift in the filial responsibilities and an emotional roller coaster. These storylines were closely intertwined, and they shaped the unifying plot of experiencing persistent ambivalence.
Adult children encounter significant burdens due to shifting roles and experiences of intergenerational ambivalence during the initial transition phase when their elderly parent transfers from home to a nursing home. Informal caregivers are crucial for maintaining and developing a sustainable health-care service, which makes it necessary to allocate resources and provide systematic support to enable adult children to continue their care responsibilities.
Nurses and other health-care personnel need to acknowledge the challenges and heavy burdens experienced by adult children when their elderly parent transfers from home to a nursing home. This should be addressed through systematic follow-up and dialogue with adult children.
This study provides knowledge that will enable health-care personnel to recognise adult children in this situation and support them during this phase.
Reporting was performed in accordance with the consolidated criteria for reporting qualitative research (COREQ). There were no patient or public contributions.
To determine whether a novel urine collection device (the ‘Pee-in-Pot (PiP)’) produces the same rates of reportable urine culture results as standard of care (SOC) urine collection. To determine whether the PiP produces comparable microscopy results to SOC urine collection. To estimate the carbon footprint of the PiP compared to SOC urine collection.
A prospectively designed, single-centre, paired comparison study.
A district general hospital in Southwest England, including antenatal clinical, accident and emergency, medical and surgical ward environments.
Adults aged 18 or over.
Urine passed through the PiP device before being decanted into a 10 mL boric acid tube for microscopy and culture, compared with the same urine contained only in a sterile plastic vessel before being decanted into a boric acid tube for microscopy and culture.
The proportion of positive urine culture results.
The proportion of heavy mixed growth culture results. Comparison of particle counts: all small particles, bacteria, red blood cells and white blood cells.
Microscopy was performed for 1353 paired samples, of which 808 paired samples both underwent culture. Overall, urine cultures were positive in 9.3% (75/808) and 10.0% (81/808) of PiP and control cases, respectively. Overall matching between PiP and control arms for reportable positive culture results was 98.5% (796/808), with a Cohen’s Kappa test coefficient () of 0.9149 (almost perfect agreement). There was no significant difference in the rate of positive urine culture results between testing arms for any organisms (margin of non-inferiority prospectively defined as ±2.5% for Escherichia coli positive cultures). For microscopy, there was agreement in meeting culture thresholds for 1308 of 1353 paired samples with a difference in culturing rates of 0.00517 (95% CI –0.0045 to 0.015, ie, high level of agreement). The estimated base case carbon footprint of PiP testing was 95g CO2e compared to 270g CO2e for SOC testing.
This study found the PiP to be non-inferior for routine urine microscopy and culture testing and to have a lower carbon footprint compared with SOC urine testing.
To investigate what works when using Patient-Reported Outcome Measures (PROMs), for whom, in what contexts, and why in four Value-Based Healthcare (VBHC) programmes.
Realist evaluation.
Evaluation of Heart Failure, Parkinson's Disease, Epilepsy and Cataract surgery programmes using data from a scoping review, documentary analysis, questionnaires, quantitative routinely collected data and semi-structured interviews with staff, patients and carers (July 2022–August 2023). Programme theories and logic models were developed, tested and refined.
We conducted 105 interviews (67 patients, 21 carers and 17 staff) and collected data from 230 patients (66 Epilepsy, 140 Heart Failure and 24 Parkinson's Disease) and 14 staff via questionnaires. Clinicians used PROMs data to regularly monitor patients with Heart Failure and Epilepsy, which resulted in better triage and tailoring treatment, prioritisation of access based on the urgency of need, and facilitation of referral to relevant professionals. In Heart Failure, this further resulted in a more efficient provision of care and better use of resources, care closer to home, improved health outcomes (e.g., better symptom management) and service redesign. The same was not observed in Epilepsy, as patients who required mental health treatment had to be referred, but they were not always able to access specialist services. PROMs were discontinued in Cataract surgery services mainly due to the lack of integrated IT systems, which caused an increased workload and staff resistance. In Parkinson's Disease, patients were asked to complete PROMs even though the information was not consistently being used.
Findings challenge the orthodoxy that implementing PROMs is universally good and brings about real improvements in patient outcomes in a VBHC context. PROMs are generally ill-suited for long-term use with patients in routine care without further adaptation. Greater staff and patient involvement are imperative to enhance the acceptability and relevance of the programmes.
Patient-Reported Outcome Measures can improve care when embedded in well-supported systems. Implementation must be realistic, involve staff and patients, and be underpinned by clear leadership and robust digital infrastructure. Co-designed patient-facing tools can improve accessibility and engagement.
What problem did the study address? There is limited evidence on how Patient-Reported Outcome Measures function across different routine healthcare contexts. What were the main findings? Patient-Reported Outcome Measures improved care in Heart Failure but not in other services, largely due to contextual barriers. Where and on whom will the research have an impact? Findings are relevant for clinicians, service designers, and policymakers seeking to implement meaningful person-centred outcome measurement in long-term conditions.
We adhered to Realist and Meta-narrative Evidence Syntheses: Evolving Standards II guidance and to the Guidance for Reporting Involvement of Patients and the Public.
The study was developed alongside a wide range of patient and public stakeholders involved in the Aneurin Bevan University Health Board Value-Based Healthcare programme, third sector and specific individuals and groups representing the four included services (i.e., St. David's Hospice Care, British Heart Foundation, Digital Communities Wales, Epilepsy Action, Digital Communities Wales, Parkinson's UK Cymru, Race Equality First, Aneurin Bevan Community Health Council, Value- Based Healthcare Patient Reference Group and Wales Council of the Blind). A total of 10 virtual meetings were strategically planned to address gaps, assist in the interpretation of findings, and ensure that outcomes were pertinent and accessible to the specific needs and circumstances of under-represented or vulnerable groups.
The aim of this study was to explore the digital health technology readiness of nurses, nursing students, nurse-academics, and nurses in leadership roles. Workforce digital readiness impacts the adoption of digital health technologies and quality and safety outcomes. This study sought to identify key factors affecting nurses' readiness for specific digital health technologies and provide recommendations to accelerate readiness levels in alignment with rapidly advancing digital health technologies.
Cross-sectional multi-method study.
An online survey was followed by semi-structured interviews. Survey data (N = 160) were analysed using descriptive and inferential statistics, whereas qualitative responses (N = 8 interviews, 43 open-ended responses) were thematically analysed.
Participants were confident regarding openness to innovation, reporting highest confidence Levels around telehealth, wearable devices, and information technology. The lowest confidence scores were seen in health smart homes technology, followed by health applications, social media, patient online resources, and EHRs. Four themes were developed from the qualitative interviews including ‘opportunities for efficient ways of working’, ‘digital technology turning experts into novices’, ‘disillusionment between expectation and reality’ and ‘shared responsibility for development of digital expertise’. Open-ended data was focused on the need for comprehensive education, ongoing support, and infrastructure improvements to prepare healthcare professionals for digital health environments.
Notable findings include age-related differences, the need for shared responsibility in workforce preparation, and a link between problem-solving ability and help-seeking.
Low confidence among nurses around the use of digital health technologies such as electronic health records, in-home monitoring technology, and other wearable technologies could impact adoption readiness. Because patient safety is increasingly and inextricably linked to digital health technologies, nurses must not only be digital health literate but also included in the design and implementation process of these technologies.
This study adhered to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines for the reporting of cross-sectional survey research, and the Consolidated Criteria for Reporting Qualitative (COREQ) research guidelines.
Limited patient and public involvement was incorporated, focusing on feedback from digital health researchers and practitioner-academics during the academic peer review process. Their insights informed the clarity and relevance of the survey design and data interpretation, ensuring alignment with real-world workforce development priorities in nursing.
Negative-pressure wound therapy (NPWT) is widely used in clinical practise to enhance wound healing; however, its biological effects on intact skin remain poorly understood. Given the expanding applications of NPWT, understanding its impact beyond open wounds is increasingly important. This study aimed to evaluate the biological responses of intact skin to negative-pressure, specifically focusing on epithelial-mesenchymal transition (EMT). The effects of negative-pressure loading were assessed using an in vitro model of non-diabetic human keratinocytes and an in vivo model of intact diabetic mouse skin. Human keratinocytes exposed to negative-pressure exhibited increased expression of thrombospondin-1 (THBS1), transforming growth factor-beta 1 (TGF-β1), plasminogen activator inhibitor-1 (PAI-1), and hypoxia-inducible factor 1-alpha (HIF-1α), alongside decreased epithelial markers and increased mesenchymal markers. These EMT-related changes were mitigated by inhibiting the THBS1-TGF-β1 interaction. Similarly, in diabetic mice, intermittent negative-pressure loading applied to intact dorsal skin significantly increased THBS1 and TGF-β1 levels, resulting in epidermal and dermal thickening, and promoted hypoxic, prothrombotic and angiogenic responses, as evidenced by increased HIF-1α, PAI-1, fibrinogen and vascular endothelial growth factor expression. These findings suggest that negative-pressure loading can induce EMT-like responses and tissue remodelling in intact skin primarily via mechanisms involving the THBS1-TGF-β1 signalling axis. This study expands the understanding of the biological influence of NPWT beyond traditional wound treatment applications, potentially informing future therapeutic considerations and safety guidelines.
by Wafa Dhouib, Meriem Kacem, Oumayma belghayeb, Meriem Oumaima Beji, Cyrine Bennasrallah, Ameni Maatouk, Imen Zemni, Hela Abroug, Ines bouanene, Haythem Sriha, Maha Mastouri, Mourad ghali, Asma Sriha Belguith, Manel Ben Fredj
BackgroundUnderstanding post-infection immunity with the first SARS-CoV-2 variant may provide valuable insights into the duration and effectiveness of the humoral immune response. This study aims to characterize the serological profile of naïve individuals infected with the first SARS-CoV-2 variant.
MethodsA prospective study with repeated measures was conducted in Tunisia, from March to October 2020, during the first wave of COVID-19. Adults confirmed with confirmed COVID-19 were monitored during the first wave of the pandemic. ELISA blood tests were conducted at multiple intervals: day 7, day 14, and at 1, 2, 3, 4, and 6 months post-infection.
Results173 serum samples were collected from immunologically naïve individuals infected with the first circulating SARS-CoV-2 variant, ranging from 7 days to 6 months post-RT-PCR confirmation. The study revealed a robust humoral immune response in most participants, with 94.1% testing positive for IgM anti-N, 88.2% for IgM anti-S, 98% for IgG anti-N, and 100% for IgG anti-S antibodies. Anti-N IgM antibodies peaked at days 14 and 30 with high positive values (>0.260), while anti-S IgM antibodies showed elevated levels (>0.990) at days 7 and 14. For IgG, anti-N antibodies reached their highest levels (>0.810) at month 4, while anti-S IgG antibodies maintained high positive values (>0.490) at days 7 and 14, and remained elevated at months 4 and 6. No significant differences in antibody levels were observed based on gender, age, comorbidities, or symptoms presence.
ConclusionA typical adaptive immune response was observed in naïve individuals infected with the initial SARS-CoV-2 variant, showing typical IgM and IgG antibody production from day 7 to month 6. We specifically investigated immunologically naïve individuals infected with the first circulating SARS-CoV-2 variant, from the earliest stage of infection, a context that is no longer reproducible.
Limited data exist on temporal changes in antibiotic use in low and middle-income countries. We evaluated trends in antibiotic use at tertiary hospitals in Uganda.
Retrospective trend analysis of a repeated point prevalence survey (PPS).
This study utilised antibiotic use data from quarterly PPS conducted among inpatients at nine regional referral hospitals in Uganda between October 2020 and December 2023.
We determined the proportions of antibiotic use, prescriptions guided by culture and sensitivity tests (CST), WHO AWaRe (Access, Watch and Reserve) categories, and prescriptions without documented indication. Linear regression was used to derive slope coefficients and 95% confidence interval (CI).
Of 15,154 patients surveyed, 8,892 (58.7%) received systemic antibiotics. The median age was 23 years (IQR: 11–38), 5,338 (60.5%) were female, and 4,583 (51.5%) were on treatment for infectious syndromes, including sepsis (1,400, 15.7%) and pneumonia (867, 9.8%). The drug utilisation index (DU75) consisted of ceftriaxone, metronidazole, gentamicin and ampicillin, which accounted for 76.9% (12,291/15,989) of total antibiotic use. The distribution of prescribed antibiotics was 46.6% Access, 45.5% Watch, 0.1% Reserve and 7.7% unrecommended combinations. Overall, 5,402 (60.8%) prescriptions were aligned with national guidelines, 2,147 (24.1%) prescriptions were issued without an indication, and CST guided 271 (3%) prescriptions. Over time, there was no significant change in antibiotic prescription prevalence (slope=0.09, CI –0.93 to 1.10) and prescriptions without indication (slope=–0.70, CI –1.79 to 3.98). However, adherence to treatment guidelines (slope=2.06, CI 0.14 to 3.98) and prescriptions based on CST results (slope=0.62, CI 0.12 to 1.13) significantly increased, while ‘Watch’ antibiotics prescriptions decreased (slope=–0.40, CI –0.63 to –0.17).
The antibiotic prescription rate remained high, with no significant change over time. Improvements were seen in adherence to treatment guidelines, use of CST and reduced use of ‘Watch’ antibiotics. Strengthening antibiotic stewardship is recommended to further improve practices.
Status epilepticus (SE) in adults is a serious neurological emergency that can lead to high morbidity and mortality rates. Although functional outcomes are often assessed using general scoring systems, limited data on health-related quality of life (HRQoL) in patients admitted to intensive care units (ICUs) are still limited. Furthermore, comprehensive evaluations of patient-reported physical, cognitive, mental health and psychological outcomes are lacking in this population. POSEIDON 2 aims to assess HRQoL and cognitive, physical and psychological impairments at 3 and 12 months after ICU discharge following SE and quantify caregiver burden.
POSEIDON 2 is a prospective, multicentre, longitudinal study conducted in 19 French ICUs. The study combines data from the SE ICTAL Registry with data from patients who survived admission to the ICU for SE, who will be recruited for the study. The study also includes patient-reported outcome (PRO) data collected 3 (M3) and 12 (M12) months after discharge from the ICU using validated instruments. The Zarit scale will be used to measure the burden on caregivers at M3 and M12. The primary endpoint is the prevalence of overall HRQOL impairment at M3 and M12, as defined by dichotomous scores on the physical and mental components of the 36-Item Short Form Health Survey compared with those of the general population. Secondary endpoints include domain-specific impairments, such as cognitive function, dependence, mental health and patient experiences. The sample size has been calculated based on an estimated prevalence of 75% for HRQoL impairment, with a planned sample size of 140 patients.
The POSEIDON 2 study protocol received ethical approval from the ethics committee ‘Comité de Protection des Personnes Ouest VI’ on 5 October 2023 (#2023-A01223-42). The study is conducted in accordance with the Declaration of Helsinki, Good Clinical Practice and the regulatory requirements of France. Written informed consent is obtained from participants, who are able to decline participation or withdraw from the study at any time. Findings will be disseminated through publication in peer-reviewed journals and presentations at scientific conferences.
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
BackgroundParenting 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.
MethodsA 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.
ResultsAlthough 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.
ConclusionPsychiatrists 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.
To examine practice nurse knowledge, attitudes, and practices about medication abortion in Australia.
Cross-sectional survey.
A national online survey was conducted from July to December 2021. Nurses working in general practice were recruited using convenience sampling. Data collected included demographics, knowledge, attitudes, and practices in abortion care. Analyses used included descriptive statistics and Poisson regression.
From 489 responses, knowledge about medication abortion, its provision, and efficacy was low. Although many respondents felt it was acceptable to assist in medication abortion, few indicated involvement. Those with advanced qualifications had greater perceived knowledge of abortion counselling. Respondent involvement in medication abortion was more likely if they had worked in general practice for a long time, their primary place of work was outside of general practice, or had advanced nursing qualifications.
Given their role in the community, there is an opportunity to better utilise practice nurses for abortion care. Incorporation of abortion into the nursing curriculum and routine practice, including supportive funding mechanisms for care, is needed.
Low knowledge and a lack of practice nurses providing abortion services adversely impact patient access.
Practice nurse provision of medication abortion has not yet been optimised. While practice nurses reported acceptability to provide abortion care, this could be enhanced with funding, education, and service normalisation. These results will inform policy makers, educators, patients, general practices, and nurses to support patient access to abortion care. Incorporating abortion care into nursing curriculum and practice will support women's access to these services.
CHERRIES guideline.
Professional groups, family planning organisations, industry, and government grant partners supported the study's recruitment.
ACTRN12622000655741
To elucidate the essential strategies used by home-visit nurses to support the independence of individuals with dementia who live alone.
Qualitative interview study employing the Interpretive Description methodology.
Purposive sampling was conducted across three home-visit nursing offices in Tokyo. Individual semi-structured interviews were conducted with 14 home-visit nurses between June and August 2022. The interviews explored the strategies the participants employed while caring for individuals with dementia living alone. The transcribed data were analysed using reflexive thematic analysis.
Four strategies were identified: Strategy 1. Cultivating a relationship of trust to manage client refusal, Strategy 2. Fostering a balance between client and practical realities, Strategy 3. Optimising limited support resources and Strategy 4. Educating and advocating for a lack of understanding among supporters.
Home-visit nurses incorporate their standard practices into four strategies at both the direct care and support network levels to support independent living of individuals with dementia living alone. These strategies address the challenge of balancing autonomy with safety and health protection, which is a key consideration in supporting this population.
The findings provide guidance for home-visit nursing practice and inform the development of educational programmes to enhance their training.
This study advances understanding of how home-visit nurses navigate the challenges of autonomy, safety and health for people with dementia living alone, offering insights to inform future research and educational initiatives.
This study adhered to the Consolidated Criteria for Reporting Qualitative Research.
This study did not include patient or public involvement in its design, conduct, or reporting.
This study assessed the feasibility of implementing a phase 3 field-based clinical trial protocol to evaluate paediatric praziquantel (PED-PZQ) for the treatment of Schistosoma mansoni infection in children aged 3 months to 6 years in endemic areas of Brazil, focusing on operational aspects such as recruitment logistics, documentation management, investigational product handling and protocol adherence.
Pilot and feasibility study for a phase 3 clinical trial, comprising two components: a randomised, open-label, parallel-group, two-arm trial and a single-arm trial.
Conde, Bahia, Brazil, from December 2024 to January 2025.
Two trials aim to screen 5774 participants from three rural areas in Bahia and three in Sergipe, states in northeastern Brazil, and enrol 403 children eligible for either randomisation or allocation. Trial 1 will randomise (1:1 ratio) 240 children aged 4–6 years into the PED-PZQ treatment arm or the standard praziquantel (PZQ) 1. Trial 2 will enrol 163 children aged 3 months to 3 years, all receiving PED-PZQ. Both trials are open label. Eligible participants shall meet age criteria, test positive for S. mansoni and fulfil other inclusion criteria. In the first recruiting centre, Conde (Bahia), it was estimated that 650 participants would need to be screened for trial 1 and 552 for trial 2, assuming schistosomiasis prevalence of 5% and 4%, respectively. This pilot study reports on the first 60 participants enrolled.
The primary outcome of this pilot study is the feasibility of implementing the research protocol in a real-world field setting, focusing on key aspects such as study documentation challenges, participant safety, investigational medicinal product custody chain and protocol adherence. In addition to providing preliminary data on the parasitological cure rate, secondary outcomes include the prevalence of S. mansoni infection and the reduction in S. mansoni egg count (Kato-Katz method). Furthermore, the occurrence and severity of drug-related adverse events are monitored from drug administration to day 21 post-treatment, alongside changes in renal, hepatic and cardiac functions assessed through biochemical markers.
A total of 60 participants were recruited, and 55 provided stool samples for screening. The pilot phase demonstrated the feasibility of implementing the clinical protocol under field conditions, with successful completion of all planned procedures and minimal protocol deviations. Operational challenges were identified mainly in documentation processes, participant recruitment and investigational product management and were addressed through preventive and corrective quality assurance actions. The experience also highlighted logistical and infrastructural barriers typical of field-based trials in remote endemic areas, which informed adjustments for the subsequent phase 3 study. Preliminary parasitological results indicated an overall S. mansoni prevalence of 9.1% (5/55), with 21% in trial 1 and 2.8% in trial 2. All infected participants met the eligibility criteria, received treatment and completed follow-up. Four achieved a parasitological cure, and one case of treatment failure was observed (trial 1, PZQ group). Two mild adverse events (diarrhoea) were reported, with no serious complications or clinically significant changes in biochemical parameters.
This pilot study demonstrated the feasibility of implementing a field-based phase 3 clinical trial protocol for PED-PZQ in endemic areas of Brazil. The findings confirm that the protocol can be successfully applied in primary care settings, despite operational challenges related to recruitment, logistics and documentation. The study also provided preliminary evidence supporting the safety and effectiveness of the paediatric formulation and highlighted the need to revise prevalence assumptions to improve future screening strategies. Overall, the experience offers valuable insights to guide the large-scale phase 3 trial and supports the incorporation of PED-PZQ into national schistosomiasis control policies.
Brazilian Clinical Trials Registry; RBR-86kcy37.
Functional seizures (FS) are events that resemble epileptic seizures, but are not attributed to brain pathology and are instead thought to be due to psychological factors. A small, multisite, open-label, single-arm, pilot trial of a breathing intervention known as breathing control training (BCT) found it to be safe and effective in reducing seizure frequency in FS. We propose a protocol for a study to confirm these results.
A 24-week, multicentre, individually-randomised, assessor-blinded, two-arm, parallel-group efficacy and acceptability trial of BCT versus control (Befriending) in 220 participants ≥16 years of age with FS. Eligible participants will be randomly allocated to receive two sessions of either BCT or Befriending over a 4-week period. Sessions will be delivered by a respiratory physiotherapist at a clinical care site or via telehealth. They will complete assessments prior to commencing treatment and at 4, 12 and 24 weeks after their initial session of BCT/Befriending. The trial will be conducted alongside treatment as usual. An economic evaluation including cost-utility and cost-effectiveness analyses will be carried out from health sector and societal perspectives.
The study has been approved by The Austin Health Human Research Ethics Committee (HREC/84335/Austin-2022) and the New Zealand Central Health and Disability Ethics Committee (2022 FULL 12324). Findings will be reported to trial participants and consumers; presented at local, national and international conferences; and disseminated by a peer-reviewed scientific journal.
Falls represent the most frequent reason older people are admitted to hospital and significantly increase the likelihood of functional decline, healthcare utilisation and early mortality. The aim of this study is to comprehensively delineate the burden of falls amongst community-dwelling older people in Ireland.
Population-representative analysis of Wave 6 of the Irish Longitudinal Study on Ageing (TILDA) estimating incidence of falls requiring medical attention and emergency department (ED) attendance, fractures and fear of falling over 12 months. Additional data detailing falls-risk increasing drugs (FRIDs) and prior falls were also analysed.
Using Central Statistics Office Census 2022, the population of older people in Ireland was multiplied by the proportion of TILDA participants with each outcome of interest to yield population-level estimates.
Population-representative sample of 2299 (55% female) community-dwelling people in Ireland aged ≥70 years.
Almost 12% (proportion 0.12 (95% CI 0.10 to 0.13)) of participants, corresponding to almost 62 000 older people in Ireland, reported a fall requiring medical attention in 12 months, with 6% (proportion 0.06 (95% CI 0.05 to 0.07)), or over 32 000 people, attending ED due to a fall. Over 3% (proportion 0.03 (95% CI 0.03 to 0.04)) reported sustaining a fracture. Almost half of participants reporting a fall requiring medical attention were prescribed FRIDs, and over half had also reported a fall when assessed at the prior wave of the study (ie, 2 years ago).
The burden of falls amongst community-dwelling older people is considerable; 1 in 8 required medical attention for a fall and 1 in 16 attended the ED with falls over 12 months.
Currently, there is no national falls strategy in Ireland. These findings, alongside our ageing population, underscore the need for strengthened falls-prevention strategies to reduce avoidable morbidity and healthcare utilisation.
by Annyi Tatiana Belalcazar, Valeria Monroy Lasso, José Darío Álvarez Herazo, Ana Clarete, Roger Figueroa-Paz, Duban Maya-Portillo, Julio Diez-Sepúlveda
BackgroundThe Shock Index (SI) is a validated prognostic tool in conditions such as severe trauma and obstetric hemorrhage. During the COVID-19 pandemic, it was used to identify patients at higher risk of clinical deterioration, but results have been inconsistent. This study aimed to evaluate the prognostic value of the SI and its variants in predicting mortality, need for mechanical ventilation, and hospital length of stay in patients with moderate COVID-19.
Methods and findingsThis longitudinal analytical observational study was conducted at a high-complexity hospital in southwestern Colombia and included adults over 18 years of age with moderate COVID-19 treated between 2020 and 2022, using data from the institutional RECOVID registry. A total of 283 patients were analyzed (median age: 61 years; 58.7% male), with cardiovascular and renal comorbidities being predominant. On admission, vital signs were stable (NEWS2: 3.0; shock index: 0.7). ICU admission was required in 29.3% of cases, and overall mortality was 12%. ROC curves and diagnostic accuracy parameters were used to assess the discriminatory ability of the SI and its variants. Most SI variants showed low discriminatory power (AUC Conclusions
Early identification of patients at risk for complications in moderate COVID-19 is essential for optimizing hospital resources. The shock index and its variants showed limited utility as standalone predictors for mortality, ICU admission, and hospital length of stay. Combining SI with other clinical parameters may offer some benefit, but heterogeneity limits generalizability. Future studies should develop and prospectively validate multivariable models integrating clinical, laboratory, and imaging biomarkers.
This article examines the evolution of nursing in 20th-century
Spain, focusing on the processes of professionalization and
the development of secular nursing education. Central
to this transformation was the Valdecilla School and the
work of Dr. Manuel Usandizaga, whose Manual de la
Enfermera became a foundational textbook. The study
employs a historiographical and hermeneutical approach,
grounded in Gadamer’s philosophy, to analyze the historical,
educational, and conceptual significance of Usandizaga’s
contributions. A comparative analysis of the first (1934) and
ninth (1970) editions of the manual reveals how the text
not only aligned with but also advanced official curricula.
Usandizaga emphasized core nursing values, technical
competencies, and the integration of theory and practice,
introducing innovative pedagogical methods that supported
the emergence of a distinct professional identity. The article
further compares Usandizaga’s approach with contemporary
academic nursing curricula, demonstrating the continued
relevance of the foundational principles he promoted.
Influenced by the Nightingale model, his humanistic and
interdisciplinary vision contributed significantly to the shift
from nursing as a vocation to a recognized profession. His
legacy remains evident in current educational frameworks,
reflecting a lasting impact on the philosophy and practice
of nursing in Spain.
To describe practice nurse long-acting reversible contraception (LARC) knowledge and practices.
Cross-sectional survey.
Between July and December 2021, we conducted an online survey using convenience sampling to recruit Australian nurses who work in primary care, known as practice nurses. We collected data about demographics and knowledge and practices relating to LARC. Analysis used descriptive statistics and Poisson regression.
From 489 eligible responses, most respondents were women and the majority worked in metropolitan practices. Most (90.4%) believed that their advice could influence women's contraceptive choices. Few inserted/removed intrauterine devices (IUDs) (11.2%) or implants (15.9%). Of those that did insert LARC, most did so one to five times in the last month (IUDs 72.2%; implants 73.6%). General practice as a primary place of work was negatively associated with implant provision. Respondents with more general practice experience (≥ 15 years) and/or higher qualifications were more likely to respond correctly to knowledge questions and provide IUDs or implants. Most (62.8%) correctly identified IUD suitability for nulliparous women.
Practice nurses have knowledge gaps and limited practice opportunities for LARC provision.
Practice nurses need supportive funding policies and ongoing education and skills development to enhance patient access to LARC and their choice of provider.
CHERRIES guideline.
Partner organisations assisted with the study's recruitment.
ACTRN12622000655741
FreshRSS 