Virtual Wards (VWs) facilitate hospital-level monitoring, diagnostics and treatment within patients’ homes, while the hospital team retains responsibility for care. International research indicates that VWs decrease hospital length of stay without increasing readmissions; however, the feasibility and key operational determinants within Dutch care remain uncertain. This protocol outlines the VW for Early Discharge in Patients Receiving Inpatient Care (VIP Care) study.
The VIP Care study is a single-centre prospective feasibility cohort study conducted at Erasmus University Medical Center (Erasmus MC), Rotterdam, the Netherlands. The study encompasses seven predefined subcohorts with n=51 eligible patients per subcohort: (1) bacterial, fungal or parasitic infections; (2) viral respiratory infections; (3) dehydration; (4) decompensated heart failure; (5) high-dose corticosteroid treatment; (6) post-transsphenoidal pituitary surgery follow-up and (7) severe inflammatory skin disease with or without bacterial or viral superinfection. Adults who require hospital-level monitoring and/or therapy may qualify for early discharge to the VW.
The VW integrates scheduled, patient-performed measurements using (European Conformity) CE-marked devices with structured symptom assessment submitted via a patient application, and data review in an electronic health record-integrated clinician cockpit. Submissions are evaluated by VW tele-nurses using prespecified Early Warning Score based thresholds and an escalation protocol. Patients receive a daily physician telephone review. Diagnostics and treatments are administered at home to hospital standards through established home-care services.
The primary outcome (feasibility) is adherence to transfer, defined as the proportion of eligible inpatients who provide written informed consent and are subsequently successfully transferred to the VW. The prespecified feasibility threshold is 30%. Secondary outcomes include reach (eligibility, invitation and consent rates among admitted patients), operational performance during the VW episode (alert frequency and handling, contact volumes and actions), length of stay on the ward and in the VW, emergency department reassessments and 30-day readmissions. Qualitative interviews will be conducted to identify implementation determinants.
The study received approval from the Erasmus MC Medical Ethics Committee (MEC-2024–0060; amendment MEC-2024–0060 A0001). Incremental risk is considered minimal. Written informed consent is obtained. Findings will be disseminated through peer-reviewed publications, conference presentations and an accessible lay summary.
ClinicalTrials.gov NCT06936891; CCMO NL85516.078.24. Recruitment began in May 2025 and is ongoing.
Accurate estimates of the burden of vaccine-preventable community-acquired pneumonia (CAP) hospitalisations both overall and due to the most frequent and vaccine-preventable pathogens are needed to inform the use of respiratory vaccines in adults.
This was a prospective, population-based CAP surveillance study at three hospitals in Germany. All patients admitted with clinically suspected CAP were tested for Streptococcus pneumoniae using urine antigen tests and for respiratory syncytial virus (RSV), influenza virus and SARS-CoV-2 using multiplex PCR from nasopharyngeal swabs. Incidence rate calculations for all-cause CAP were based on eligible patients, regardless of enrolment status.
Individuals admitted to study hospitals within the surveillance period with suspected or confirmed diagnosis of pneumonia who provided informed consent.
Radiologically confirmed (RAD) CAP.
Active surveillance between 1 January 2021 and 30 June 2023 identified at the three study sites 4319 adults with RAD-CAP that met eligibility criteria, of which 1479 (34.2%) were enrolled and included in the analysis for pathogen distribution. The main reason for non-enrolment was the inability to provide informed consent. Incidence estimates were based on 1254 study-eligible individuals admitted at the largest study site. SARS-CoV-2, S. pneumoniae, RSV or influenza were identified in 36.5%, 9.1%, 3.7% and 1.8% of patients with RAD-CAP, respectively. Serotypes included in the 20-valent pneumococcal conjugate vaccine were detected in 6.9% of RAD-CAP and 76.0% of pneumococcal CAP. The overall adjusted annual incidence of all-cause RAD-CAP over the study period was 490/100 000 (95% CI 461 to 521). The incidence of pneumococcal and RSV-related RAD-CAP increased 8.6-fold and 10.0-fold over the study period, resulting in an incidence of 60/100 000 (95% CI 45 to 75) and 30/100 000 (95% CI 19 to 41) in 2022/2023, respectively, while SARS-CoV-2 related RAD-CAP declined by 70% to 97/100 000 (95% CI 78 to 116).
Active pneumonia surveillance reported a high burden of RAD-CAP hospitalisations in Germany, especially among older adults. The resurgence of CAP due to RSV, S. pneumoniae or influenza, alongside maintained activity of SARS-CoV-2, was associated with an overall increase of RAD-CAP among adults.
Fibrosing interstitial lung disease (F-ILD) are a heterogeneous group of diseases with multiple subtypes. Both idiopathic pulmonary fibrosis and other ILDs associated with a risk of developing progressive pulmonary fibrosis (PPF) are subtypes of this category. A multidisciplinary team discussion, including a chest high-resolution CT (HRCT), is usually considered the gold standard for diagnosis of F-ILD. Repeated HRCT is one of several established methods to assess progression and thus development of PPF, but it is associated with substantial costs and radiation exposure. Thoracic ultrasound (TUS) and other ultrasound (US) methods have emerged as radiation-free methods for both diagnosing and monitoring disease severity in F-ILD. Yet, consistent knowledge on the use of different TUS- and US methods in patients with F-ILD is limited.
The LORD study is a prospective cohort study conducted in participants with F-ILD at a tertiary ILD centre in Denmark. Physiological testing and patient-related outcome measures, together with TUS- and US examinations, will be performed at inclusion, after 6 and 12 months. The correlations between these assessments will be evaluated. HRCT will be conducted between 3 months prior to and 1 month after baseline, and after 1 year. At least 34 participants will be included.
The protocol was approved by the Danish Data Protection Agency (journal number: 22/45135) and the Science Ethics Committee for the Region of Southern Denmark (journal number: S-20220036). Results will be published in peer-reviewed international journals and will be presented at an international congress.
Administering supplemental oxygen to prevent hypoxaemia is a fundamental treatment for patients hospitalised with acute injury or illness. However, the amount of oxygen administered frequently exceeds that needed to maintain normoxaemia, causing patients to experience hyperoxaemia and wasting supplemental oxygen. Closed-loop, autonomous oxygen titration systems are designed to optimise oxygen delivery by administering the lowest possible oxygen flow that maintains peripheral oxygen saturation (SpO2) within a predefined range. For adults hospitalised with an acute injury or illness, it remains uncertain whether the use of a closed-loop, autonomous oxygen titration system safely increases the proportion of time spent in normoxaemia (SpO2 90%–96%) compared with usual care.
The Strategy to Avoid Excessive Oxygen using Autonomous Oxygen Titration Intervention trial is a multicentre, unblinded, parallel-group, randomised trial being conducted at four level 1 trauma centres in the USA. The trial compares an autonomous oxygen titration system versus usual care among 300 adults hospitalised for major trauma, burn, acute care surgery or acute respiratory illness. The primary outcome is the proportion of patient-time spent within the targeted normoxaemia range (SpO2 90%–96%) as measured by continuous non-invasive pulse oximetry, during the first 72 hours after randomisation. Secondary outcomes include the amount of supplemental oxygen administered and the proportion of time spent in hypoxaemia (SpO22 >96%). Specifying the protocol and statistical analysis plan before the conclusion of enrolment increases the rigour, reproducibility and interpretability of the trial. Enrolment began on 6 May 2024.
The trial protocol was approved by the single institutional review board at the University of Colorado School of Medicine and the Office of Human Research Oversight at the Department of Defense. We will present the results at scientific conferences and submit them for publication in a peer-reviewed journal.
Long-term brain health profiles following exposure to repetitive head impacts and/or concussions in contact sports are a public health focus and the subject of a national debate. The true prevalence rates of mild cognitive impairment (MCI) or neurobehavioural dysregulation are unknown in the nearly 20 000 current/living former professional football players. Here, we describe the procedures and methodology of the prevalence study of cognitive function in former professional football players from the Brain Health Initiative at the University of Pittsburgh. The objective is to define the prevalence of normal cognitive function versus neurodegeneration in former professional football players through clinical, neuroimaging and biomarker assessments.
Participants include former professional football players aged 29–59 years at study onset who played a minimum of three professional football games in three professional seasons and non-exposed controls. Participants are recruited by two mechanisms, a random and non-random sample. The full study protocol includes a 3–4-day, multidomain assessment (eg, neurological, neurocognitive, psychiatric, sleep, vestibular, orthopaedic and cardiovascular) for neurodegenerative disease and overall health and function, including MRI, positron emission tomography scans, analysis of blood plasma and cerebrospinal fluid, neurocognitive assessments, applanation tonometry, overnight sleep study and informant interview. A multidisciplinary clinical panel conducts a blinded diagnostic consensus conference to adjudicate the presence of MCI and/or traumatic encephalopathy syndrome, which serve as the study’s primary and secondary outcomes, respectively. Point prevalence of these for both the exposed and unexposed cohorts will be calculated as the primary statistical analysis.
The University of Pittsburgh Institutional Review Board approved the study prior to recruiting human subjects (protocol numbers STUDY19010008: sIRB - Brain Health Initiative (Part 1) and STUDY19030211: sIRB - Brain Health Initiative (Part 2)). The results will be disseminated in peer-reviewed journals and as presentations at national and international scientific conferences.
Saskatchewan is facing a public health crisis driven by high rates of HIV, syphilis and hepatitis C virus (HCV) infections, particularly among people who use drugs. Injection drug use is a major contributor to these syndemic infections, exacerbated by structural barriers such as stigma, poverty and limited culturally safe healthcare. Innovative, community-informed approaches are urgently needed to improve prevention, testing and linkage to care.
This study will implement a rapid assessment and response system in Regina, Saskatchewan, Canada, integrating geospatial mapping of community needle prevalence with pop-up interventions. Needle hotspot maps will be used to guide the deployment of community-based pop-up events offering point-of-care testing for HIV, syphilis and HCV, alongside education on pre-exposure prophylaxis (PrEP) and postexposure prophylaxis (PEP). A convergent participatory mixed-methods design will be used to evaluate feasibility, acceptability and effectiveness, guided by the Reach, Effectiveness, Adoption, Implementation and Maintenance framework. Quantitative data will assess changes in knowledge of PrEP and PEP, satisfaction with the intervention and report new diagnoses and participant demographics descriptively. A qualitative substudy will include 30 participants and will explore experiences with the intervention, barriers to care and perceptions of service delivery.
Ethical approval has been obtained from the research ethics board of the Saskatchewan Health Authority (#24–91). Findings will be disseminated through peer-reviewed publications, conference presentations and community reporting. This study may provide a model of community-based geospatial testing and education that could be scaled up and adapted elsewhere.
Open Science Framework https://doi.org/10.17605/OSF.IO/HVK3B
Nurses are expected to effectively manage and educate the growing number of patients with diabetes in sub-Saharan Africa. This review aimed to map and describe literature relating to the nurses’ diabetes knowledge and the factors promoting and hindering the acquisition of their knowledge.
Sub-Saharan Africa.
Scoping review.
A systematic literature search was conducted in electronic databases, such as CINAHL, PubMed, Scopus, African Journals Online and Web of Science and grey literature. Authors and experts in diabetes care and scoping reviews were also contacted. Included studies were assessed using the inclusion criteria developed in advance. Searches were conducted between March and June 2020 and updated in November 2024. Results were presented descriptively.
A total of 2974 records were retrieved through systematic database and hand searches, resulting in 1900 records when duplicates were removed. Of these, 250 potentially relevant studies were identified for thorough assessment for eligibility. The process yielded 20 studies that focused on diabetes knowledge among nurses in sub-Saharan Africa. Most studies reported gaps in diabetes knowledge among nurses including pathology, laboratory investigations, insulin therapy, type two diabetes treatment, exercise, diet and complications. Barriers to diabetes knowledge acquisition included lack of hospital guidelines, staff, training and inadequate salary. Facilitators included experience in managing or counselling patients with diabetes and refresher nutrition courses.
Nurses in sub-Saharan Africa have gaps in diabetes knowledge. Further research is required on tailor-made strategies for enhancing the nurses’ diabetes knowledge and implementation of the same to prepare nurses and other clinical team members to effectively care for, support and teach patients with diabetes.
The glucose-lowering drug metformin has shown promise in non-diabetic conditions for improving endothelial dysfunction, but the literature of metformin’s effect on endothelial dysfunction and the biomarkers used to measure endothelial dysfunction have not yet been synthesised.
We aimed to map the extent and nature of the existing research related to metformin for endothelial dysfunction in non-diabetic non-communicable diseases (NCDs). This scoping review was conducted following the methodological framework by Arksey and O’Malley and the recommendations from the Joanna Briggs Institute, and was reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews.
We considered any peer-reviewed studies in adult humans on the use of metformin for endothelial dysfunction in non-diabetic NCDs. Narrative reviews, expert opinion, preclinical studies and qualitative studies were excluded.
An unrestricted search was conducted on four electronic databases and three registries from inception to October 2024.
Data charting was performed using predetermined data extraction headings. We used a systematic charting method and narrative synthesis to organise, synthesise and report the data.
We identified 56 studies comprising 4620 participants (71.7% female). Polycystic ovarian syndrome was the most investigated NCD (57.1% of studies). 19 distinct biomarkers of endothelial dysfunction were identified, with flow-mediated dilation being the most frequently assessed (18 studies, 745 participants). Metformin showed a trend towards improvement for 7/19 (36.8%) biomarkers. Male participants were underrepresented in the literature and only five studies (9%) were conducted in the global south, potentially limiting the generalisability of repurposed metformin in diverse populations or settings. Studies with an active comparator reported a significant difference between the metformin and comparator groups in 20% (4/20), in contrast to studies without an active comparator (placebo or pre–post studies) reporting significant results favouring metformin in 83.3% (30/36). A knowledge gap also exists for metformin use in people with HIV, given that they are known to develop cardiovascular NCDs at a twofold higher rate than their HIV-negative counterparts.
While there is a growing evidence base supporting metformin as treatment for endothelial dysfunction in non-diabetic NCDs, our scoping review highlighted knowledge gaps in optimal biomarker selection and dosing strategies, and applications in a broader range of NCDs, including in people with HIV. More primary and secondary research using robust methodologies and study designs is needed to determine the quantitative effect of metformin on endothelial dysfunction.
Families offer promising targets for mental health interventions. Existing evidence investigates parent-child dyads or partners; we use an innovative approach to look at triads of parents and their children. This gives us more detail on mental health dimensions and individuals central to mental health transmission in families.
Both cross-sectional and longitudinal network models
We identified triads of children (under age 16), mothers and fathers from the UK Household Longitudinal Study, between 2009 and 2022.
Cross-sectional networks captured independent associations between family members’ mental health (n=8795 families). Longitudinal networks examined directional temporal associations among family members’ emotional symptoms (n=3757 families).
Children’s and parents’ mental health dimensions were assessed using the Strengths and Difficulties Questionnaire and the General Health Questionnaire, respectively.
Mothers’ mental health, particularly emotional symptoms, was linked to children’s mental health, while fathers’ symptoms showed no independent association. In the longitudinal network, maternal feelings of being overwhelmed were associated with children’s future worry, affecting symptoms of nervousness and unhappiness, which then fed back into worsening maternal emotional symptoms.
Investigating family mental health using network models highlights mothers’ central role. The longitudinal relationship between maternal feelings of being overwhelmed and children’s anxiety, and the subsequent feedback into maternal anxiety, indicates a promising target for intervention.
Nipah virus (NiV) is a bat-transmitted paramyxovirus causing recurrent, high-mortality outbreaks in South and South-East Asia. As a WHO priority pathogen, efforts are underway to develop therapies like monoclonal antibodies and small-molecule antivirals, which require evaluation in clinical trials. However, trial design is challenging due to limited understanding of NiV’s clinical characteristics. Given the rarity of NiV infections, strategies targeting improved outcomes for the broader acute encephalitis syndrome (AES) patient population, including those with NiV, are essential for advancing therapeutic research. To address these gaps, we designed the Bangladesh AES cohort study to characterise the patient population, clinical features, treatment practices, common aetiologies and outcomes in patients presenting with AES, including NiV infection, as a clinical characterisation study to inform the design of clinical trials for NiV and AES more broadly.
This prospective cohort study will be conducted in Bangladesh, a NiV endemic country with annual outbreaks. In collaboration with the ongoing NiV surveillance programme in Bangladesh, we aim to enrol up to 2000 patients of all ages presenting with AES at three tertiary care hospitals within the Nipah belt. Patients who provide informed consent to participate will be monitored throughout their hospital stay until 90 days post enrolment. Data will be systematically collected through interviews and medical record reviews at several time points: on the day of enrolment, day 3, day 7, the day of critical care admission (if applicable), discharge day and 90 days post enrollment. Additionally, a portion of the cerebrospinal fluid collected under the concurrent NiV surveillance protocol will be tested for an array of viral and bacterial pathogens responsible for encephalitis at the International Centre for Diarrhoeal Disease Research Bangladesh (icddr,b) laboratory.
The study received ethical approval from the Oxford Tropical Research Ethics Committee, University of Oxford, UK (OxTREC Ref: 576–23) and the institutional review board of icddr,b, Bangladesh (icddr,b protocol number: 24016). By characterising the AES patient population, this study will generate essential evidence on key clinical parameters, which will be pivotal in optimising the design of clinical trials for potential interventions aimed at improving outcomes in patients with AES, including those with NiV disease. Findings will be shared with participating hospitals, patients and relevant government stakeholders. Results will also be disseminated through conference presentations and peer-reviewed publications.
Not applicable (this is an observational study).
Despite an increasing use of screens among preschool children and evidence suggesting potential adverse effects, there is a paucity of longitudinal research that aims to disentangle the multifaceted components of screen use and their unique associations with development. We present a protocol for a large-scale national longitudinal study with repeated measurements in Danish preschool children, with the aim of investigating the cross-sectional and cross-lagged longitudinal associations between screen use and psychological outcomes.
The Digital Child Study is a national prospective observational cohort of Danish preschool children. Baseline parent-report data collection commenced in 2024 via online questionnaires, and in total will include three time points over 1 year: baseline (age 4 years), and follow-ups at 6 and 12 months (ages 4.5 and 5 years). Participants were divided into two waves based on birth dates, starting in March and September 2024. Recruitment targeted parents and primary caregivers of all Danish children born between specific dates in 2020. Of 30 235 children whose parents were sent invitations, baseline questionnaire data were available for 11 690 (39%).
Children’s screen use was measured by detailed information of amount, content and timing of children’s screen use, and the broader context, incorporating parental mediation strategies, attitudes, motivations and practices. Cognitive and socioemotional developmental outcomes were measured using validated tools such as the Strengths and Difficulties Questionnaire, the Nordic Five-to-Fifteen parent questionnaire and the Behaviour Rating Inventory of Executive Function—Preschool Version. Questionnaire data will be linked to national social and health registries to enable long-term follow-up. Statistical analyses will include longitudinal modelling to explore associations between screen use and developmental outcomes, with sensitivity analyses for robustness. The study’s large sample size provides high statistical power to detect meaningful effects.
The study adheres to ethical research guidelines, ensuring voluntary participation, confidentiality and compliance with data protection laws, with approvals from relevant authorities. Findings will be disseminated through peer-reviewed publications, conferences and plain-language summaries to engage stakeholders and the broader community.
Cohort studies of ageing and cognitive decline typically do not begin fielding comprehensive cognitive assessments until older adulthood. However, for identifying preventable dementia risk factors, there is strong value in beginning at earlier ages. The case is especially compelling in sub-Saharan Africa, where the number of older individuals is expected to triple in the next three decades, and where risk factors may operate more intensively at earlier ages. This study reports on the adaptation and validity of the Harmonised Cognitive Assessment Protocol (HCAP) approach in the Kenya Life Panel Survey (KLPS), collected among middle-aged respondents.
To evaluate the validity of the HCAP approach in Kenya, this study assesses model fit statistics from confirmatory factor analyses (CFA) and tests measurement invariance by respondent characteristics.
Both rural and urban areas in Kenya.
A sample of n=5878 individuals from the KLPS, who have been surveyed regularly since they were schoolchildren in the 1990s. The HCAP assessment was administered in 2023 at an average age of 37 years (10–90 range 34 to 41).
For each individual, the CFA generates a general cognitive performance score, and cognitive performance scores for five distinct domains, including memory, executive functioning, language, orientation to time and place, and visuospatial functioning.
Fit of the models to the data was adequate for general cognitive performance (root mean squared error of approximation (RMSEA)=0.03; comparative fit index (CFI)=0.94; standardised root mean residual (SRMR)=0.05), language (RMSEA=0.02; CFI=0.95; SRMR=0.05) and good for memory (RMSEA=0.05; CFI=0.99; SRMR=0.02) and executive functioning (RMSEA=0.03; CFI=0.98; SRMR=0.03). The CFA indicate that the factor structure is consistent with findings from other countries and that reliability for the general cognitive performance score was high. Statistical models also suggest invariance at the scalar level for leading demographic (gender, age) and socioeconomic (education, occupational complexity) characteristics.
This study demonstrates that the cognitive functioning of mid-age Kenyans appears to be well captured by the adapted protocol. While there is a moderate decline in cognitive performance among older individuals, this relationship appears to be mediated by education, indicating that this KLPS HCAP provides a valuable baseline for studying future cognitive decline.
To assess predictors of timely transition to adult diabetes care among individuals diagnosed with type 1 diabetes during childhood and adolescence. We hypothesised that older age at the last paediatric visit and urban residency would be predictors of timely transition.
Retrospective cohort study using healthcare administrative data in a jurisdiction with a universal healthcare system.
2045 adolescents and young adults diagnosed with type 1 diabetes between the ages of 0.5 and 18 years.
We ascertained age at the last paediatric diabetes visit (LPDV), age at the first adult diabetes visit (FADV) and transition duration, defined as the time between LPDV and FADV. Timely transition was defined as a transition duration of
Only 31.3% of individuals saw an adult provider within 1 year of their LPDV. Each 1-year increase in the age at LPDV was associated with increased odds of timely transition (adjusted OR 1.82, 95% CI 1.71 to 1.93, p0.05).
Older age at the LPDV and urban residency are associated with increased odds of timely transition. Interventions should be developed to help keep adolescents engaged in paediatric care until an older age before referring them to adult diabetes care. Limitations of this study include unmeasured confounding and limited generalisability to non-universal healthcare systems.
Guidelines for symptomatic knee osteoarthritis (OA) dictate the initiation of conservative treatment (physical therapy, analgesics and intra-articular injections with corticosteroids) as a first line defence. When conservative treatment fails, the golden standard is invasive joint replacement surgery, but for a substantial group of patients who do not respond to the current conservative treatment, this is not (yet) indicated. The RADIOPHENOL study investigates if denervation of knee sensory (genicular) nerves can serve the gap between conservative and invasive treatment for younger patients and for patients who cannot undergo joint replacement surgery due to comorbid health conditions.
The RADIOPHENOL study is a multicentre unblinded randomised controlled trial with three parallel arms (1:1:1). In total, 192 patients with knee OA Kellgren-Lawrence grades 2–4 but not eligible for joint replacement according to the orthopaedic surgeon due to young age, old age and/or comorbidity or technical reasons are eligible and will be randomised to three groups of 64 patients. Group A: traditional radiofrequency ablation, group B: chemical neurolysis with phenol, group C: conservative medical management. Primary outcome is the Oxford Knee Score at 6 months. Secondary outcomes include Western Ontario and McMaster Universities Osteoarthritis Index, knee pain by numeric rating scale, physical functionality, health-related quality of life, mental health, change in medication use, predictive value of a diagnostic block, procedure time, patient discomfort score during the intervention and adverse events.
The protocol (V.2.0, 15 May 2023), was approved by the Ethics Committee of Amsterdam UMC (NL83410.018.22 – METC2022.0890) on 31 July 2023. We aim to publish our results in international peer-reviewed journals.
ClinicalTrials.gov NCT06094660, including the WHO Trial Registration data set items. Registered on 20 October 2023, first patient enrolled on 27 November 2023.